Unofficial translation
Footnote. The title is in the wording of the joint order of the Minister of Healthcare of the Republic of Kazakhstan dated April 29, 2019 No. KR HCM-56 and the Minister of National Economy of the Republic of Kazakhstan dated April 30, 2019 No. 33 (shall be enforced upon expiry of ten calendar days after its first official publication).
In accordance with paragraphs 2 and 3 of Article 141, paragraph 1 of Article 143 of the Entrepreneurial Code of the Republic of Kazakhstan dated October 29, 2015, WE HEREBY ORDER :
Footnote. The preamble is in the wording of the joint order of the Minister of Healthcare of the Republic of Kazakhstan dated 06.01.2021 No. KR HCM-3 and the Minister of National Economy of the Republic of Kazakhstan dated 06.01.2021 No. 5 (shall be enforced upon expiry of ten calendar days after its first official publication).
1. To approve:
1) the criteria for assessing the degree of risk in the sphere of medical services quality in accordance with Appendix 1 to this joint order;
2) a checklist in the sphere of state control of medical services quality in respect of subjects (objects), rendering inpatient, hospital-replacing assistance in accordance with Appendix 2 to this joint order;
3) a checklist in the sphere of state control of medical services quality in respect of subjects (objects) rendering outpatient-polyclinic assistance (primary health care and consultative-diagnostic assistance) in accordance with Appendix 3 to this joint order;
4) a checklist in the sphere of state control of medical services quality in respect of subjects (objects) of obstetric assistance in accordance with Appendix 4 to this joint order;
5) a checklist in the sphere of state control of medical services quality in respect of subjects (objects) rendering cardiological, cardiac surgery assistance in accordance with Appendix 5 to this joint order;
6) a checklist in the sphere of state control of medical services quality in respect of subjects (objects) rendering hemodialysis assistance in accordance with Appendix 6 to this joint order;
7) a checklist in the sphere of state control of medical services quality in respect of subjects (objects) rendering dental assistance in accordance with Appendix 7 to this joint order;
8) a checklist in the sphere of state control of medical services quality in respect of subjects (objects) rendering phthisiological assistance in accordance with Appendix 8 to this joint order; 9) a checklist in the sphere of state control of medical services quality in respect of subjects (objects) rendering oncological assistance in accordance with Appendix 9 to this joint order;
10) a checklist in the sphere of state control of medical services quality in respect of subjects (objects) rendering narcological assistance in accordance with Appendix 10 to this joint order;
11) is excluded by the joint order of the Minister of Healthcare of the Republic of Kazakhstan dated 06.01.2021 No. KR HCM-3 and the Minister of National Economy of the Republic of Kazakhstan dated 06.01.2021 No. 5 (shall be enforced upon expiry of ten calendar days after its first official publication).
12) a checklist in the sphere of state control of medical services quality in respect of subjects (objects) providing laboratory services in accordance with Appendix 12 to this joint order;
13) a checklist in the sphere of state control of medical services quality in respect of subjects (objects) rendering emergency medical assistance, medical assistance in the form of air ambulance in accordance with Appendix 13 to this joint order;
14) a checklist in the sphere of state control of medical services quality in respect of subjects (objects) rendering assistance to HIV-infected people and taking measures to prevent HIV infection in accordance with Appendix 14 to this joint order;
15) a checklist in the sphere of state control of medical services quality in respect of subjects (objects) carrying out activity in the sphere of blood service in accordance with Appendix 15 to this joint order;
16) criteria for assessing the degree of risk in the sphere of circulation of medicines, medical products and medical equipment in accordance with Appendix 16 to this joint order;
17) a checklist in the sphere of circulation of medicines, medical products and medical equipment in respect of all subjects (objects) of pharmaceutical activity in accordance with Appendix 17 to this joint order;
18) a checklist in the sphere of circulation of medicines, medical products and medical equipment in respect of medical organizations on drug provision issues in accordance with Appendix 18 to this joint order;
19) a checklist in the sphere of circulation of medicines, medical products and medical equipment in respect of subjects (objects) of pharmaceutical activity carrying out production of medicines, medical products and medical equipment in accordance with Appendix 19 to this joint order;
20) a checklist in the sphere of circulation of medicines, medical products and medical equipment in respect of subjects (objects) of pharmaceutical activity carrying out the manufacture of medicines and medical products in accordance with Appendix 20 to this joint order;
21) a checklist in the sphere of circulation of medicines, medical products and medical equipment in respect of subjects (objects) of pharmaceutical activity carrying out wholesale sale of medicines, medical products and medical equipment in accordance with Appendix 21 to this joint order;
22) a checklist in the sphere of circulation of medicines, medical products and medical equipment in respect of subjects (objects) of pharmaceutical activity carrying out the retail sale of medicines, medical products and medical equipment in accordance with Appendix 22 to this joint order.
Footnote. Paragraph 1 as amended by the joint order of the Minister of Healthcare of the Republic of Kazakhstan dated 06.01.2021 No. KR HCM-3 and the Minister of National Economy of the Republic of Kazakhstan dated 06.01.2021 No. 5 (shall be enforced upon expiry of ten calendar days after its first official publication).
2. To recognize invalid the joint order of the Minister of Healthcare and Social Development of the Republic of Kazakhstan dated December 29, 2015 No. 1064 and the Minister of National Economy of the Republic of Kazakhstan dated December 29, 2015 No. 831 "On approval of risk assessment criteria and checklists in the sphere of medical services quality, circulation of medicines, medical products and medical equipment "(registered in the Register of state registration of regulatory legal acts for the number 12763, published March 25, 2016 in the information and the legal system "Adіlet").
3. The committee of public health protection of the Ministry of Healthcare of the Republic of Kazakhstan shall ensure:
1) state registration of this joint order at the Ministry of Justice of the Republic of Kazakhstan;
2) within ten calendar days from the date of state registration of this joint order sending its copy in the Kazakh and Russian languages to the Republican state enterprise on the right of economic management "Republican Center for Legal Information" for official publication and inclusion into the Standard control bank of regulatory legal acts of the Republic of Kazakhstan ;
3) placement of this joint order on the official Internet resources of the Ministry of Healthcare of the Republic of Kazakhstan and the Ministry of National Economy of the Republic of Kazakhstan after its official publication;
4) within ten working days after the state registration of this joint order in the Ministry of Justice of the Republic of Kazakhstan, submission of information on implementation of measures provided for in subparagraphs 1), 2) and 3) of this paragraph to the Legal department of the Ministry of Healthcare of the Republic of Kazakhstan.
4. Control over implementation of this joint order shall be entrusted on the Vice-Minister of Healthcare of the Republic of Kazakhstan.
5. This joint order shall be enforced upon expiry of ten calendar days after its first official publication.
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Minister of Healthcare
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of the Republic of Kazakhstan
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E. Birtanov
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Minister of National Economy
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of the Republic of Kazakhstan
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T. Suleymenov
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"AGREED"
Committee on legal statistics
and special accounts
of General Prosecutor's office
of the Republic of Kazakhstan
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Appendix 1
to the joint order of the
Minister of Healthcare of the
Republic of Kazakhstan
dated November 15, 2018
No. KR HCM-32 and the Minister of
National Economy of the
Republic of Kazakhstan
dated November 15, 2018 No. 70 |
Criteria for assessing the degree of risk in the sphere of medical services (assistance) quality
Footnote. Appendix 1 is in the wording of the joint order of the Minister of Healthcare of the Republic of Kazakhstan dated 06.01.2021 No. KR HCM-3 and the Minister of National Economy of the Republic of Kazakhstan dated 06.01.2021 No. 5 (shall be enforced upon expiry of ten calendar days after its first official publication).
Chapter 1. General provisions
1. These Criteria for assessing the degree of risks in the sphere of medical services (assistance) quality (hereinafter- the Criteria) are developed in accordance with Article 30 of the Code of the Republic of Kazakhstan dated July 7, 2020 "On Public Health and Healthcare System", Article 141 of the Entrepreneurial Code of the Republic of Kazakhstan dated October 29, 2015 and the Rules for the formation of a risk assessment system by state bodies, approved by the order of acting Minister of National Economy of the Republic of Kazakhstan dated July 31, 2018 No. 3 (registered in the Register of state registration of regulatory legal acts under No. 17371).
2. The following concepts are used in these Criteria:
1) an assessment period - a specific time period for which risks assessment is carried out according to the objective and subjective criteria based on reporting data, the results of monitoring of automated information systems, the results of previous inspections and other sources of information. For the subjects of control, the assessment period used in the Criteria is once every six months;
2) significant violations - violations, including non-compliance with the requirements of legislation in the sphere of healthcare, not related to gross and minor violations;
3) minor violations - violations of the requirements of the legislation of the Republic of Kazakhstan in the sphere of healthcare, non-compliance with which has entailed and (or) may entail formally committed, but not causing any appreciable harm to the population;
4) risk in the sphere of rendering medical services - probability of causing harm to human life or health, legitimate interests of individuals and legal entities, the state as a result of carrying out medical activity of the subject of control;
5) gross violations - deliberate or careless obvious and significant violation of the legislation of the Republic of Kazakhstan in the sphere of healthcare, non-compliance with which has entailed and (or) may entail serious consequences for the health of the population;
6) objective criteria for assessing the degree of risk (hereinafter – the objective criteria) - the criteria used to select subjects (objects) of control depending on the degree of risk in the sphere of rendering medical services when carrying out activities and not directly dependent on the individual subject (object) of control;
7) subjective criteria for assessing the degree of risk (hereinafter – the subjective criteria) – the criteria for assessing the degree of risk used to select subjects (objects) of control for conducting preventive control, depending on the results of activity of a particular subject (object) of control.
3. The criteria for assessing the degree of risk for a special procedure for conducting inspections and for preventive control and supervision with a visit to the subject (object) of control and supervision shall be formed by means of objective and subjective criteria.
Chapter 2.
The criteria for assessing the degree of risk used for a special procedure for conducting
inspections in relation to the subjects (objects) of healthcare rendering obstetric aid services
Paragraph 1. The objective criteria for assessing the degree of risk
4. The objective criteria shall be formed through the following stages:
1) definition of risk;
2) distribution of subjects (objects) of control by degrees of risk (high and not classified as high).
5. Objects of obstetrics and inpatient organizations, which include departments of newborns pathology, belong to a high degree of risk.
In relation to the subjects (objects) of a high degree of risk, inspections shall be conducted in a special procedure with a frequency of 1 time per year.
6. If an object of high importance is put into operation after the approval of a six-month schedule of inspections, then it is included in the schedule of inspections for the next six months with a frequency of inspections once a year.
Paragraph 2. The subjective criteria for assessing the degree of risk
7. To determine the subjective criteria for assessing the degree of risks, the following sources of information are used:
1) the results of previous inspections and a special procedure for conducting inspections (in this case, the severity of violations shall be established in case of non-compliance with the requirements established in the checklists);
2) the results of monitoring information received from automated information systems;
3) the presence and number of confirmed complaints, appeals from individuals and legal entities over the past year.
8. The subjective criteria are developed in order to implement the principle of encouraging bona fide inspected subjects (objects) in the form of exempting them from conducting inspections in a special procedure.
If the subject (object) has conducted an external comprehensive assessment (accreditation) for compliance with the accreditation standards and provided a certificate of accreditation for the audited period, then the subject (object) is exempt from inspections for the next calendar year.
9. Determination of the risk group of objects of high significance, related to one subject (legal entity) shall be carried out for each object separately.
10. Formation of the inspections schedule of subjects (objects) of control shall be drawn up on the basis of the principles of minimum necessity and sufficiency, encouragement of bona fide inspected subjects, concentration of control on violators.
11. The subjective criteria for assessing the degree of risk in relation to inspections in a special procedure with distribution according to the degree of significance of violations and sources of information shall be determined in accordance with Appendix 1 to these Criteria.
If one gross violation is identified, the subject (object) being checked shall be equated with a risk degree of 100 and a special procedure inspection shall be carried out in relation to it.
If no gross violations have been identified, then for determination the risk degree indicator, an overall indicator for violations of significant and minor degree shall be calculated.
When determining the indicator of significant violations, a coefficient of 0.7 shall be applied and this indicator shall be calculated using the following formula:
SРs = (SР2 х 100/SР1) х 0,7
where: SРs – an indicator of significant violations;
SР1- the total number of required significant violations;
SР2 - the number of identified significant violations.
When determining the indicator of minor violations, a coefficient of 0.3 shall be applied and this indicator shall be calculated using the following formula:
SРm = (SР2 х 100/SР1) х 0,3
where: SРm – an indicator of minor violations;
SР1 - the total number of required minor violations;
SР2 - the number of identified minor violations.
The overall indicator of the risk degree (SР) shall be calculated on a scale from 0 to 100 and shall be determined by summing the indicators of significant and minor violations using the following formula:
SР = SРs + SРm
where: SР - general indicator of the risk degree;
SРs – an indicator of significant violations;
SРm – an indicator of minor violations.
12. According to indicators, the inspected subject (object) shall:
1) be exempted from a special procedure for conducting inspections on the basis of semi-annual schedules for the next six months, established in the criteria for assessing the degree of risk of the regulatory state body - with a degree of risk from 0 to 60;
2) not be exempted from a special procedure for conducting inspections on the basis of semi-annual schedules - with a risk index from 61 to 100 inclusive.
Chapter 3.
The criteria for assessing the degree of risk used for preventive control with visits
to the subjects (objects) in the sphere of rendering medical services (assistance)
Paragraph 1. Objective criteria
13. The objective criteria shall be formed through the following stages:
1) risk determination;
2) distribution of subjects (objects) of control by degrees of risk (high and not classified as high).
14. Assignment of subjects of control to the degree of risk shall be carried out taking into account the following objective criteria:
1) the level of danger (complexity) of the subject (object), depending on the activity being performed;
2) the scale of severity of possible negative consequences of harm in the process of carrying out medical activities;
3) the possibility of adverse effects on human health, the legitimate interests of individuals and legal entities, the state.
15. After determining the risk, the subjects (objects) of control shall be distributed according to two degrees of risk (high and not classified as high).
In relation to the subjects (objects) of control, classified according to objective criteria to a high degree of risk, the subjective criteria shall be applied in order to conduct preventive control with a visit to the subject (object) of control.
16. High degree of risk includes the subjects (objects) of control, rendering outpatient and polyclinic care, inpatient, ambulance and medical aviation, laboratory services, carrying out activities in the sphere of pathological diagnostics and HIV prevention, blood services.
17. Not classified as high degree of risk - subjects (objects) of control carrying out restorative treatment and medical rehabilitation, providing first aid, palliative care and nursing care, as well as organizations carrying out activities in the sphere of promoting a healthy lifestyle.
Paragraph 2. Subjective criteria
18. To determine the subjective criteria for assessing the degree of risk, the following sources of information shall be used:
1) the results of previous inspections and preventive control with a visit to the subjects (objects) of control (in this case, the severity of violations is established in case of non-compliance with the requirements established in the checklists);
2) the results of monitoring information received from automated information systems;
3) the results of monitoring the reporting data provided by the subject of control;
4) the results of analysis of information received from authorized bodies and organizations;
5) the presence and number of confirmed complaints, appeals from individuals and legal entities over the past year.
19. The data from electronic information resources of the authorized body in the field of healthcare and medical information systems shall be used to assess the subjects of control according to subjective criteria,.
20. Subjective criteria in the sphere of the quality of medical services shall be divided into three degrees of violations: gross, significant, and minor.
Subjective criteria for conducting preventive control with a visit to the subject of control with distribution according to the degree of violations significance and sources of information shall be given in Appendix 2 to these Criteria. Non-compliance of criteria determines the appropriate degree of violations.
21. To classify the subject to the degree of risk, the following procedure for calculating the indicator of the risk degree shall be applied.
If one gross violation is identified, the risk index of 100 shall be equated to the subject of control and preventive control shall be carried out in relation to it with a visit to the subject (object) of control.
If no gross violations have been identified, then for determination the risk degree indicator, an overall indicator for violations of significant and minor degree shall be calculated.
When determining the indicator of significant violations, a coefficient of 0.7 shall be applied and this indicator shall be calculated using the following formula:
SRs = (SR2 х 100/SR1) х 0,7
where: SRs – an indicator of significant violations;
SR1 - the required number of significant violations;
SR2 - the number of identified significant violations.
When determining the indicator of minor violations, a coefficient of 0.3 shall be applied and this indicator shall be calculated using the following formula:
SRm = (SR2 х 100/SR1) х 0,3
where: SRm – an indicator of minor violations;
SR1 - the required number of minor violations;
SR2 - the number of identified minor violations.
The overall indicator of the risk degree (SP) shall be calculated on a scale from 0 to 100 and shall be determined by summing the indicators of significant and minor violations using the following formula:
SR = SRs + SRm
where: SR – an overall indicator of the risk degree;
SRs – an indicator of significant violations;
SRm – an indicator of minor violations.
22. According to the overall indicator of the risk degree, the subject (object) of control relates to:
1) a high degree of risk - with a degree of risk from 61 to 100 inclusive and in relation to it, preventive control shall be carried out with a visit to the subject (object) of control;
2) not classified to a high degree of risk - with an indicator of the risk degree from 0 to 60 inclusive and in relation to it, preventive control shall not be carried out with a visit to the subject (object) of control.
23. The frequency of preventive control with a visit to the subject (object) of control shall be determined by the results of conducted analysis and assessment of the information received according to the subjective criteria and no more than once a year.
24. Preventive control with a visit to the subject (object) of control shall be carried out on the basis of semi-annual lists of preventive control with a visit to the subject (object) of control, formed in accordance with paragraph 3 of Article 141 of the Entrepreneurial Code of the Republic of Kazakhstan.
25. The basis for assignment of preventive control with a visit to the subject (object) of control is a semi-annual list of conducting preventive control with a visit to the subject (object) of control, approved by the first head of the regulatory state body.
26. Semi-annual lists of preventive control with a visit to the subject (object) of control shall be formed in relation to the subjects of control with obligatory indication of the objects in respect of which preventive control is assigned with a visit to the subject (object) of control.
27. The lists of preventive control with a visit to the subject (object) of control shall be drawn up taking into account the priority of the subject of control with the highest degree of risk according to the subjective criteria.
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Annex 1
to the Criteria for assessing
the degree of risk in the sphere of
medical services (assistance) quality |
Subjective criteria for assessing the degree of risk in relation to inspections in a special procedure
with distribution according to the degree of significance of violations and sources of information
№
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Name of criteria
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Degree of violations
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1. Criteria for the source of information "The results of previous inspections and special procedure for conducting inspections (the degree of severity shall be established if the following requirements are not met)
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Criterion for obstetric care facilities and (or) inpatient organizations, having maternity wards and neonatal pathology departments
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1.
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Availability of a license and annexes to it for the activities carried out
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Gross
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2.
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Availability of a specialist certificate in the relevant clinical specialty
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Gross
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3.
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Availability of a conclusion on compliance of a healthcare subject with the provision of high-tech medical services
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Gross
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4.
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Availability of a written voluntary consent of the patient or his/her legal representative for invasive interventions and for conducting medical and diagnostic measures
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Significant
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5.
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The time spent by the emergency medical team or the emergency department in the organization of primary health care in the hospital reception department does not exceed 10 minutes (the time for transferring the patient to the emergency department doctor) from the moment of its arrival at the hospital, except in cases of the need to provide emergency medical care in emergency situations.
After the transfer by the ambulance teams or the emergency department, when organizing the primary health care of the patient to the hospital reception department, the nurse conducts the distribution of incoming patients (medical sorting according to the triage-system) into groups, based on the priority of emergency medical care.
Medical sorting according to the triage -system shall be conducted continuously and successively. Upon completion of the assessment, the patients shall be marked with the color of one of the sorting categories, in the form of a special colored tag or colored tape.
According to medical sorting, there are 3 groups of patients:
the first group (red zone) - patients whose condition poses an immediate threat to life or who have a high risk of deterioration and require emergency medical care;
the second group (yellow zone) - patients whose condition poses a potential threat to health or may progress with the development of a situation requiring emergency medical care;
the third group (green zone) - patients whose condition does not pose an immediate threat to life and health and does not require hospitalization
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gross
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6.
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In the absence of indications for hospitalization in a healthcare organization, the doctor of the reception department shall issue a medical conclusion to the patient with a written justification for the refusal.
The nurse of the reception department sends the asset to the PHC organization at the place of attachment of the patient
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Significant
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7.
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Indications for hospitalization:
the need to provide pre-medical, qualified, specialized medical care, including the use of high-tech medical services, with round-the-clock medical supervision of patients:
1) in a planned manner - on the referral of PHC specialists or other healthcare organization:
2) for emergency indications (including weekends and holidays) - regardless of the availability of a referral
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significant
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8.
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Examination of the patient by the head of the department of severe patients on the day of hospitalization, thereafter - daily. Patients in a moderate condition shall be examined at least once a week. The results of examination of the patient shall be recorded in the medical record, indicating the recommendations for further tactics of managing the patient with obligatory identification of the medical worker making the entries
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significant
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9.
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Daily examination of patients in the hospital by the attending physician, except for weekends and holidays. When examining and appointing additional diagnostic and therapeutic manipulations by the doctor on duty, appropriate entries shall be made in the medical record
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significant
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10.
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Additional and repeated conduct of studies, conducted before hospitalization in a primary health care organization or other health care organization, according to medical indications, with justification in the medical record for a dynamic assessment of the patient's condition, in accordance with clinical protocols for diagnosis and treatment.
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significant
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11.
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Compliance with the following requirements when issuing a sheet and certificate of temporary disability due to pregnancy and childbirth:
- a sheet or certificate of temporary disability due to pregnancy and childbirth shall be issued by a medical worker (obstetrician-gynecologist), and in his/her absence - by a doctor, together with the head of the department after the conclusion of the MAC from thirty weeks of pregnancy for a period of one hundred and twenty-six calendar days (seventy calendar days before delivery and fifty-six calendar days after delivery) in normal childbirth.
A sheet or a certificate of temporary disability due to pregnancy and childbirth shall be issued for the women living on the territories, affected by nuclear tests from twenty-seven weeks with a duration of one hundred seventy calendar days (ninety-one calendar days before delivery and seventy-nine calendar days after delivery) in normal childbirth;
2) a sheet or certificate of temporary disability due to pregnancy and childbirth shall be issued (extended) at the medical organization where the act of delivery took place or in the antenatal clinic (office) at the place of observation according to the extract (prenatal record) of an obstetric organization for the women who temporarily left their permanent place of residence within the Republic of Kazakhstan;
3) in case of complicated childbirth, the birth of two or more children, a sheet or certificate of temporary disability shall be extended for an additional fourteen calendar days by a medical worker (obstetrician-gynecologist), and in his/her absence - by a doctor, together with the head of the department after the conclusion of the MAC at the place of observation according to the extract of the obstetric health care organization. In these cases, the total duration of prenatal and postnatal leave is one hundred and forty calendar days (seventy calendar days before delivery and seventy calendar days after delivery).
A sheet or certificate of temporary disability shall be extended by an additional fourteen calendar days, the total duration of prenatal and postnatal leave is one hundred and eighty-four days (ninety-one calendar day before delivery and ninety-three calendar days after delivery) for the women living on the territories affected by nuclear tests, in case of complicated childbirth, the birth of two or more children;
4) in the case of childbirth at a period of twenty-two to twenty-nine weeks of pregnancy and the birth of a child weighing five hundred grams or more, who has lived for more than seven days, a sheet or a certificate of temporary disability for work on the fact of childbirth shall be issued to a woman for seventy calendar days after delivery.
In the case of childbirth with a period of twenty-two to twenty-nine weeks of pregnancy and the birth of a still fetus or a child weighing five hundred grams or more, who died before seven days of life, a sheet or certificate of temporary disability for work on the fact of childbirth shall be issued to a woman for fifty-six calendar days after delivery;
5) a sheet or a certificate of temporary disability shall be issued for ninety- three calendar days after childbirth to the women, living on the territories affected by nuclear tests, in case of childbirth at a period of twenty-two to twenty-nine weeks of pregnancy and the birth of a child weighing five hundred grams or more, who has lived for more than seven days.
A sheet or a certificate of temporary disability shall be issued for seventy-nine calendar days after childbirth to the women living on the territories affected by nuclear tests, in the case of childbirth at a period of twenty-two to twenty-nine weeks of pregnancy and the birth of a still fetus or a child weighing five hundred grams or more, who died before seven days of life;
6) when a woman applies for a sheet of temporary disability for work during pregnancy, maternity leave shall be calculated in total and be provided completely regardless of the number of days actually used by her before childbirth.
When a woman applies in the period after childbirth for a sheet of temporary disability, only a leave after childbirth shall be granted for the duration provided for in this paragraph;
7) upon the onset of pregnancy during the period when a woman is on paid annual labor leave or unpaid leave to care for a child until he/she reaches three years of age, a certificate of temporary disability shall be issued for all days of maternity leave, with the exception of cases provided for in part two of subparagraph 6) of this paragraph;
8) in the event of death of the mother during childbirth or in the postpartum period, a sheet or a certificate of temporary disability for work shall be issued to the person caring for the newborn;
9) in the case of an operation for the artificial termination of pregnancy, a sheet or a certificate of temporary disability shall be issued by a doctor together with the head of the department for the duration of stay in the hospital and outpatient clinic where the operation was performed, and in case of complication - for the entire period of temporary disability.
In case of spontaneous abortion (misbirth), a sheet or certificate of temporary disability shall be issued for the entire period of temporary disability;
10) when carrying out an embryo transfer operation, a sheet or a certificate of temporary disability shall be issued by the medical organization that performed the operation, from the day of embryo transfer until pregnancy is established.
Persons who have adopted (adopted) a newborn child (children), as well as a biological mother with surrogacy directly from the maternity hospital, a sheet or a certificate of temporary disability shall be issued from the date of adoption (adoption) and until the expiration of fifty-six calendar days from the date of birth of the child
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significant
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12.
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Availability of a clinical audit by the patient support Service and internal expertise and its assessment according to the following criteria:
1) quality of anamnesis collection, which is assessed according to the following criteria:
lack of anamnesis collection;
completeness of anamnesis collection;
availability of data on past, chronic and hereditary diseases, blood transfusions, drug tolerance, allergic status; the development of complications as a result of tactical mistakes made during treatment and diagnostic measures due to poor-quality collection of anamnesis;
2) completeness and validity of diagnostic studies, which are assessed according to the following criteria:
lack of diagnostic measures;
an incorrect conclusion or lack of a conclusion on the results of diagnostic tests carried out, which led to an incorrect diagnosis and mistakes in treatment tactics;
conducting diagnostic studies provided for by clinical protocols;
conducting diagnostic studies with a high, unjustified risk to the patient's health, the validity of conducting diagnostic studies that are not included in the clinical protocols;
conducting diagnostic studies that are not informative for the correct diagnosis and led to an unreasonable increase in the duration of treatment and an increase in the cost of treatment;
3) correctness, timeliness and validity of the clinical diagnosis, taking into account the results of conducted studies (with planned hospitalization, studies conducted at the pre-hospital stage shall be taken into account ), which are assessed according to the following criteria:
the diagnosis is missing, incomplete or incorrect, does not correspond to the international classification of diseases;
the leading pathological syndrome, determining the severity of the disease course has not been identified, concomitant diseases and complications have not been recognized;
the diagnosis is correct, but incomplete, the leading pathological syndrome has not been identified with the identified complications, concomitant diseases that affect the outcome have not been recognized;
the diagnosis of the underlying disease is correct, but concomitant diseases affecting the result of treatment have not been diagnosed.
Objective reasons for incorrect and (or) untimely diagnosis (atypical course of the underlying disease, asymptomatic course of concomitant disease, rare complications and concomitant diseases) are reflected in the results of the expertise. An assessment of impact of incorrect and (or) untimely diagnosis on the subsequent stages of medical services (assistance) provision shall be made;
4) timeliness and quality of consultations from specialized specialists, which are assessed according to the following criteria:
lack of consultation, which led to an erroneous interpretation of symptoms and syndromes that adversely affected the outcome of the disease;
the consultation is timely, the failure to take into account the opinion of the consultant when making the diagnosis partially influenced the outcome of the disease;
the consultation is timely, the opinion of the consultant was taken into account when making the diagnosis, failure to comply with the consultant's recommendation for treatment partially influenced the outcome of the disease;
the consultant's opinion is erroneous and influenced the outcome of the disease.
In cases of delayed consultations, an assessment of objectivity of the reasons for the untimely consultation and the impact of the untimely diagnosis on the subsequent stages of medical services (assistance) provision shall be made;
5) the volume, quality and validity of the treatment measures, which are assessed according to the following criteria:
lack of treatment if indicated;
prescribing treatment in the absence of indications;
appointment of ineffective therapeutic measures without taking into account the characteristics of the disease course, concomitant diseases and complications;
implementation of therapeutic measures not in full, without taking into account the functional state of organs and systems, prescribing drugs without proven clinical efficacy;
non-compliance with the requirements of the Standards, unjustified deviation from the requirements of clinical protocols, the presence of polypragmasia, which led to the development of a new pathological syndrome and deterioration of the patient's condition;
6) absence or development of complications after medical interventions, all complications that have occurred shall be assessed, including those caused by surgical interventions (delayed surgical intervention, inadequate volume and method, technical defects) and diagnostic procedures;
7) the achieved result, which is assessed according to the following criteria:
achieving the expected clinical effect in compliance with the technology of providing medical services (assistance);
lack of clinical effect of therapeutic and preventive measures due to poor-quality collection of anamnesis and diagnostic studies;
lack of the expected clinical effect due to ineffective therapeutic, preventive measures without taking into account the peculiarities of the disease course, concomitant diseases, complications, prescribing drugs without proven clinical efficacy;
the presence of polypragmasia, which caused the development of undesirable consequences;
8) the quality of maintaining medical documentation, which is assessed by availability, completeness and quality of records in primary medical documentation intended for recording data on the health status of patients, reflecting the nature, volume and quality of medical care provided in accordance with the forms of reporting and accounting documentation in the field of healthcare according to subparagraph 31) of Article 7 of the Code
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significant
|
13.
|
Availability of informed voluntary consent (refusal) for transfusion of blood components in the form of accounting and reporting documentation in the field of healthcare
|
significant
|
14.
|
Compliance with the following actions when conducting a pathoanatomical autopsy:
1) carrying out a pathoanatomical autopsy of corpses after the doctors have stated biological death, after providing the medical record of an inpatient patient or the medical record of an outpatient patient with a written order of the chief physician or his/her deputy for the medical (treatment) part of the healthcare organization to send for a pathoanatomical autopsy;
2) registration of the results of the pathoanatomical autopsy in the form of a pathoanatomical diagnosis (the pathoanatomical diagnosis includes: underlying disease, complication of underlying disease, concomitant disease, combined underlying disease);
3) transfer of a medical record of an inpatient patient or a medical record of an outpatient patient with the pathoanatomical diagnosis entered into it to the medical archive of the healthcare organization no later than ten working days after the pathological autopsy;
4) conducting clinical and pathoanatomical analysis in cases of death of patients in healthcare organizations;
5) pathoanatomical autopsy in case of suspected acute infectious, oncological diseases, pathology of childhood, fatal outcome due to medical manipulations in order to establish the cause of death and clarify the diagnosis of disease with a fatal outcome;
6) organization of autopsy materials in cases of suspected infectious diseases by the chief physician and head of the pathoanatomical department of virological (immunofluorescent) and bacteriological examination;
7) transfer to the pathoanatomical bureau, the centralized pathoanatomical bureau and the pathoanatomical department of the medical records of inpatients for all deaths for the previous day no later than 10 am of the day following the establishment of the fact of death;
8) registration of:
- a medical certificate of death (preliminary, final) by a doctor in the specialty "pathological anatomy (adult, pediatric)" on the day of the pathoanatomical autopsy;
- a medical certificate of perinatal death (preliminary, final) by a doctor in the specialty "pathological anatomy (adult, pediatric)" on the day of the pathoanatomical autopsy;
9) registration of the results of the autopsy in the form of a protocol of pathoanatomical examination;
10) the presence of a written notification to the forensic authorities to resolve the issue of transferring the corpse for forensic medical examination upon detection of signs of violent death and termination of the pathoanatomical examination of the corpse;
11) the presence of a written notification from a doctor in the specialty "pathological anatomy (adult, pediatric)" in case of initial detection during the autopsy of signs of an acute infectious disease, food or industrial poisoning, an unusual reaction to vaccination, as well as an emergency notification to the bodies of the state sanitary and epidemiological service immediately after their identification;
12) conducting a pathoanatomical examination of the placenta:
in the case of stillbirth;
for all diseases of newborns identified at the time of birth;
in cases suspected of hemolytic disease of newborns;
in case of early discharge of water and in case of dirty waters;
in case of diseases of the mother, occurring with a high temperature in the last trimester of pregnancy;
with an obvious abnormality of development or attachment of the placenta;
13) mandatory registration of a fetus weighing less than 500 grams with anthropometric data (weight, height, head circumference, chest circumference);
14) establishment of a pathoanatomical autopsy, depending on the complexity, into the following categories:
first category;
second category;
third category;
fourth category;
15) establishment by the doctor in the specialty "pathological anatomy (adult, pediatric)" of the category of pathoanatomical autopsy and the reasons for discrepancy in diagnoses when the final clinical and pathoanatomical diagnoses differ
16) availability of a detailed analysis with the definition of the profile and categories of iatrogeny in all cases of iatrogenic pathology identified as a result of a pathoanatomical autopsy
|
gross
|
15.
|
Compliance with the following requirements when organizing obstetric and gynecological care at the outpatient level:
1) dispensary observation of pregnant women in order to prevent and early detection of complications of pregnancy, childbirth and the postpartum period with the allocation of women "by risk factors";
2) conducting prenatal screening - a comprehensive examination of pregnant women in order to identify the risk group for chromosomal pathology and congenital malformations of the intrauterine fetus;
3) identification of pregnant women in need of timely hospitalization in day hospitals, departments of pregnancy pathology at inpatient-level medical organizations providing obstetric and gynecological care, specialized medical organizations with extragenital pathology, in compliance with the principles of regionalization of perinatal care;
4) referral of pregnant women, women in labor and parturient women to receive specialized care with medical supervision, including the use of high-tech medical services to medical organizations of the republican level;
5) conducting prenatal training for pregnant women in preparation for childbirth, including partner childbirth, informing pregnant women about warning signs, effective perinatal technologies, the principles of safe motherhood, breastfeeding and perinatal care;
6) conducting patronage of pregnant women and women in childbirth according to indications;
7) counseling and provision of services on the issues of family planning and reproductive health protection;
8) prevention and identification of sexually transmitted infections for referral to specialized specialists;
9) examination of women of fertile age with appointment, if necessary, in-depth examination using additional methods and involvement of specialized specialists for the timely detection of extragenital, gynecological pathology and their registration;
10) organization and conduct of preventive examinations of the female population with the aim of early detection of extragenital diseases;
11) examination and treatment of gynecological patients using modern medical technologies;
12) clinical examination of gynecological patients, including rehabilitation and sanatorium-resort treatment;
13) performance of small gynecological operations using modern medical technologies;
14) conducting an expertise of temporary disability due to pregnancy, childbirth and gynecological diseases, determining the need and timing of temporary or permanent transfer of an employee for health reasons to another job, referring, in accordance with the established procedure, to a medical and social examination of women with signs of persistent disability;
15) double examination during pregnancy for HIV infection with registration of the patient's informed consent with the recording of data
|
gross
|
16.
|
Provision of first aid to women during and outside pregnancy by medical workers (midwives, paramedics, nurses/male nurses), including:
1) self-admission and medical examination in order to determine the patient's health status, identify diseases and complications of pregnancy
2) entering data into the subsystem "Register of pregnant women and women of fertile age" of the electronic portal "Register of attached population" for the purpose of automated management of groups of pregnant women and women of fertile age (hereinafter-WFA) and monitoring of indicators of the health status of pregnant women and WFA;
3) provision of emergency and emergency pre-medical care to pregnant women, postpartum women and women of fertile age in conditions that threaten the life and health of a woman, in accordance with clinical protocols for diagnosis and treatment;
4) dynamic monitoring of pregnant women with chronic diseases together with local doctors and specialized specialists;
5) fulfillment of the prescriptions of an obstetrician-gynecologist in accordance with functional duties;
6) management of physiological pregnancy and patronage of pregnant women and parturient women with the timely provision of directions and recommendations in accordance with the clinical protocol for diagnosis and treatment;
7) medical care at home for pregnant women, postpartum women, gynecological patients and the social risk group of WFA;
8) conducting a preventive medical examination of women with the aim of early identification of precancerous and cancerous diseases of the female genital organs and other localizations (skin, mammary glands);
9) conducting a nursing examination of women of all age groups who have applied for medical help;
10) participation in screening and preventive examinations to detect diseases
|
gross
|
17.
|
Compliance with the following requirements when organizing the provision of obstetric and gynecological care at the inpatient level:
1) provision of inpatient consultative and diagnostic, therapeutic-preventive and rehabilitation assistance to pregnant women, women in labor, postpartum women and newborns;
2) conducting a joint examination of the attending doctor with the head of the department upon admission of pregnant women up to 36 weeks of pregnancy suffering from chronic diseases who need treatment in specialized departments of multidisciplinary hospitals to assess the severity of the disease course, the course of pregnancy and treatment tactics.
3) drawing up a plan for the management of pregnancy, childbirth and the postpartum period, taking into account an individual approach;
4) management of pregnancy, childbirth and the postpartum period in accordance with clinical protocols for diagnosis and treatment, as well as with a management plan;
5) consulting pregnant women, women in labor and parturient women, carrying out control on compliance with the level of medical care;
6) conducting rehabilitation measures for mothers and newborns, including caring for premature newborns;
7) consultations on the provision of medical care to pregnant women, women in labor, parturient women and newborns using telecommunication systems;
8) carrying out an expertise of temporary disability, issuance of a sheet and a certificate of temporary disability for pregnancy and childbirth, gynecological patients;
9) provision of resuscitation and intensive care to mothers and newborns, including those with low and extremely low body weight;
10) availability of a minimum list of equipment for the intensive care unit (ICU):
a functional bed (according to the number of beds);
anti-decubitus mattress (1 for 3 beds);
a bedside cardiac monitor (by the number of beds);
a portable electrocardiograph (1 for 6 beds);
an electrocardiostimulator (1 for 6 beds);
a portable apparatus for ultrasound examination of the heart and blood vessels (1 for 9 beds);
an apparatus for auxiliary blood circulation (intra-aortic balloon counterpulsation ) (1 for 9 beds);
a centralized oxygen supply system to each bed (according to the number of beds);
a surgical electric suction device with a bacterial filter (1 for 3 beds);
a defibrillator biphasic with synchronization function (1 for 3 beds);
an apparatus for artificial ventilation of the lungs (1 for 6 beds);
a portable breathing apparatus for transportation (1 per ICU);
a set for tracheal intubation (2 per ICU);
a set for catheterization of great vessels (100 sets);
an automatic syringe dispenser of medicinal substances (2 per 1 bed);
an infusion pump (1 for 1 bed);
a bedside tonometer for measuring blood pressure (by the number of beds);
a mobile (portable) kit for resuscitation in other departments (1 on ICU);
a mobile X-ray machine (1 on ICU);
a glucometer (1 per ICU);
a set of instruments and devices for minor surgical interventions (1 per ICU)
a block of electrical outlets (at least 8 sockets) with grounding at each bed, including for power supply of energy-intensive devices (X-ray machines) (by the number of beds).
11) carrying out medical and psychological assistance to women;
12) notifying medical organizations of a higher level of regionalization of perinatal care and local public health authorities when a critical condition is detected during admission or being in a hospital for a pregnant woman, a woman in labor, a postpartum woman;
13) compliance with the notification scheme in the event of a critical situation in women;
14) transportation of pregnant women, parturient women, women in critical condition to the third level of perinatal care, to regional and republican healthcare organizations shall be carried out by the decision of a council of doctors with participation of the medical team specialists of medical aviation after restoration of hemodynamics and stabilization of vital functions with notification of the receiving medical organization;
15) calling qualified specialists "on oneself", providing a complex of primary resuscitation care in the event of emergency conditions, diagnosing threatening conditions in the mother and the fetus, resolving the issue of delivery, conducting intensive and supportive therapy before transferring to higher level in case of a non-transportable state of pregnant women, women in labor, parturient women.
|
gross
|
Rendering medical care to newborns
|
18.
|
Compliance with the following requirements when organizing the provision of medical care to newborns at the inpatient level:
1) provision of medical care to newborns according to the levels of regionalization of perinatal care, depending on the indications;
2) the structure of the organizations of hospitals of the first level of regionalization of perinatal care: individual maternity wards, a department for joint stay of mother and child, a vaccination office, intensive care wards for newborns, as well as the rate of a doctor in the specialty "Pediatrics (neonatology)" provided by the staffing table and a round-the-clock post of a neonatal nurse;
3) in second-level hospitals, the organization of resuscitation and intensive care wards for newborns with a full set for resuscitation, mechanical ventilation devices with various ventilation modes (constant positive airway pressure), incubators, a clinical diagnostic laboratory, as well as a round-the-clock post provided for by the staff schedule (neonatologist and pediatric nurse);
4) in hospitals of the third level of regionalization of perinatal care:
there is a round-the-clock neonatal post, clinical, biochemical and bacteriological laboratories, an intensive care unit for women and newborns, as well as departments for pathology of newborns and nursing premature babies together with their mother.
intensive care units for newborns, departments for pathology of newborns and nursing of premature babies shall be organized, equipped with modern medical and diagnostic equipment, medicines, a round-the-clock post (medical and nursing), and an express laboratory.
in hospitals of the first level, the following measures shall be carried out for a sick newborn:
primary resuscitation care;
intensive and supportive therapy;
oxygen therapy;
invasive or non-invasive respiratory therapy;
phototherapy;
therapeutic hypothermia;
infusion therapy and/or parenteral nutrition;
treatment according to approved clinical protocols for diagnosis and treatment.
5) In hospitals of the second level, the following measures shall be carried out for a sick newborn:
primary resuscitation care for a newborn and stabilization of the condition, nursing premature babies with a gestational age of more than 34 weeks;
catheterization of the central veins and peripheral vessels;
identification and treatment of congenital malformations, intrauterine growth retardation, hypoglycemia of newborns, hyperbilirubinemia, neonatal sepsis, lesions of the central nervous system, respiratory distress syndrome, pneumothorax, necrotizing enterocolitis and other pathological conditions of the neonatal period;
conducting of intensive care, including correction of vital functions (respiratory, cardiovascular, metabolic disorders), invasive and non-invasive respiratory therapy, infusion therapy and parenteral nutrition;
if it is necessary to provide highly specialized care, the degree of readiness for transportation with the mother to a third-level obstetric aid organization or an institution of republican significance shall be determined
|
gross
|
19.
|
Rendering medical care to newborns in third-level medical organizations includes:
1) primary neonatal resuscitation and newborn care;
2) conducting intensive and supportive therapy: respiratory therapy, catheterization of the central veins and peripheral vessels, therapeutic hypothermia, parenteral nutrition, nursing premature infants;
3) diagnosis and treatment of congenital malformations, intrauterine growth retardation (low weight by gestational age ), neonatal hypoglycemia, neonatal sepsis, respiratory distress syndrome, hyperbilirubinemia, necrotizing enterocolitis, pneumothorax, bronchopulmonary dysplasia, persistent neonatal pulmonary hypertension, systems and other pathological conditions of the neonatal period;
4) conducting intensive and supportive therapy, therapeutic hypothermia, parenteral nutrition;
5) conducting invasive and non-invasive respiratory therapy;
6) nursing premature babies;
7) provision of round-the-clock advisory and medical-diagnostic assistance to specialists of the first and second levels of regionalization, provision of emergency and urgent medical care with a visit to a medical organization
|
gross
|
20.
|
Providing a healthy newborn with basic care, including prevention of hypothermia in accordance with the "thermal chain", skin contact with the mother or skin-to-skin contact, early breastfeeding within the first hour (if the baby is ready), prevention of nosocomial infections
|
gross
|
21.
|
Anthropometry of a healthy newborn, its full examination and other activities 2 hours after delivery
|
significant
|
22.
|
Provision of emergency medical care in case of identification of violations of the newborn condition, according to indications, transfer to the intensive care unit or neonatal intensive care unit
|
gross
|
23.
|
Observation of a mother and a healthy newborn by the obstetrician in the delivery room for two hours after birth:
1) measures the body temperature of a newborn 15 minutes after birth, then every 30 minutes;
2) monitors the heart rate and respiration, the nature of respiration (identification of an expiratory groan, assessment of the degree of retraction of the lower chest), the color of the skin, the activity of the sucking reflex, if necessary, determines the saturation with a pulse oximeter
|
significant
|
24.
|
Transfer of a healthy newborn with the mother to the unit of joint stay of the mother and the child 2 hours after the birth
|
significant
|
25.
|
In the postnatal department in the wards of joint stay of the mother and the child, round-the-clock supervision of medical personnel and constant participation of the mother in carrying out the child's care shall be ensured, except for cases of moderate and severe conditions of a mother
|
significant
|
26.
|
Dynamic observation of the newborn with timely detection of violations of the newborn condition, necessary examination, examination of the head of the department, organization of a council to clarify the tactics of management. According to the indications, emergency medical care shall be provided, transfer to the intensive care unit or the neonatal intensive care unit shall be carried out
|
gross
|
27.
|
In the wards of joint stay of a mother and a child, the medical workers shall:
1) consult on the benefits of breastfeeding, on the technique and frequency of manual expression of breast milk, carry out a visual assessment of breastfeeding to provide practical assistance in the correct positioning and attachment of the baby to the mother's breast in order to avoid conditions such as cracked nipples or lactostasis;
2) if there are contraindications to breastfeeding, teach the mother (parent or legal representative) alternative methods of feeding children; advise mothers on how to maintain lactation in cases of separate stay of newborns
|
significant
|
28.
|
Daily examination of newborns by a neonatologist, consultation of mothers on care, prevention of hypothermia and vaccination
|
significant
|
29.
|
In the presence of three or more microanomalies of development or identification of congenital pathology of newborns, the organization of consultation with specialized specialists, with the conduct of medical-diagnostic measures and providing the mother with recommendations for examination, treatment and rehabilitation
|
gross
|
30.
|
In case of emergence of emergency conditions in a newborn (asphyxia, respiratory distress syndrome and others), stabilization of its condition and determination of the degree of readiness for transportation with the mother to the organization of obstetrics of the second or third level
|
gross
|
31.
|
Vaccination of newborns shall be carried out on the basis of voluntary informed consent of parents (mother, father or legal representatives) to carry out preventive vaccinations in accordance with the terms of preventive vaccinations in the Republic of Kazakhstan.
|
gross
|
32.
|
Pre-discharge neonatal screening for phenylketonuria, congenital hypothyroidism and audiological screening for all newborns
|
gross
|
33.
|
In case of emergency conditions in a newborn, the neonatologist assesses the severity of the condition, stabilizes it, assesses the degree of readiness for transportation, and organizes its transfer with the mother (in agreement with the obstetrician-gynecologist) to a second-or third-level medical organization
|
gross
|
34.
|
In case of suspicion and (or) identification of acute surgical pathology in a newborn, an urgent consultation shall be carried out with a doctor specializing in “Pediatric Surgery (Neonatal Surgery)”. After the indicators of vital functions have stabilized, the newborn shall be transferred to the surgical department of another medical organization (children's or multidisciplinary hospital) or to the neonatal (or children's) surgical department, if available in the structure of the obstetric medical organization to provide it with the appropriate specialized medical care
|
gross
|
35.
|
Full-term newborns after reaching the age of 28 days or premature newborns, after reaching the post - conceptual age of 42 weeks, needing further round-the-clock medical supervision shall be transferred to a pediatric hospital
|
gross
|
36.
|
Availability of medical devices and medical products for the provision of medical care to newborns in accordance with the standard of organization of pediatric care depending on the level of regionalization of perinatal care
|
gross
|
37.
|
Availability of medical devicesand medical products for equipping the resuscitation team vehicle for transporting newborns:
1. equipment:
1) a couveuse (portable or transportable);
2) a "stove" for heating the car interior;
3) thermal insulating film for a child;
4) underwear for the baby (blanket, diapers, clothes);
5) a ECG and blood pressure monitor with a set of cuffs and sensors,
6) a pulse oximeter with disposable cuffs;
7) a watch with a second hand;
8) an electronic thermometer;
8) a phonendoscope.
2.Respiratory support equipment:
1) an oxygen cylinder;
2) an air compressor for artificial ventilation of the lungs and the use of vacuum means;
3) an oxygen dosimeter for cylinders;
4) a portable artificial lung ventilation apparatus with a system of humidification and heating of the respiratory mixture;
5) an oxygen mixer;
6) Ambu bag, volume not exceeding 700 cubic centimeters;
7) a set of masks of different sizes for artificial lung ventilation;
8) oral airways;
9) respiratory support system N CPAP.
3. Equipment and medical devices for tracheal intubation and airway sanitation:
1) a laryngoscope with straight blades No. 0 and No. 1;
2) intubation tubes (D-diameter 2.5; 3.0; 3.5; 4.0);
3) an electric or vacuum suction, disposable bulb and a set of catheters for aspiration (No. 5, 6, 8, 10, 12, 14);
4) a nasogastric tube - diameter 6 mm.
4. Equipment and medical devices for the administration of drugs:
1) infusomat, syringe pump (2-3 pieces on batteries);
2) kits for peripheral vein catheterization;
3) systems for infusion;
4) syringes of various sizes;
5) tees;
6) butterfly needles;
7) surgical tweezers, scalpel, scissors;
8) sterile gloves
|
gross
|
38.
|
Availability of a mandatory pathoanatomical examination of the fetus and placenta during termination of pregnancy for medical reasons in case of suspicion of congenital malformations in the fetus
|
gross
|
39.
|
Availability of clinical and pathoanatomical analysis of all cases of maternal and infant death after the completion of the entire complex of pathoanatomical studies
|
gross
|
2. Criteria for the source of information "Results of monitoring information received from automated information systems"
|
1
|
Presence of maternal mortality
|
gross
|
2
|
Increase in infant mortality compared with the previous assessment period by 5% or more
|
gross
|
3
|
Presence of cases of postoperative complications
|
significant
|
4
|
Presence of cases of an increase in the rate of birth injuries of newborns compared to the previous assessment period
|
significant
|
3. Criteria for the source of information "The number of confirmed complaints and appeals"
|
1
|
Availability of one or more confirmed complaints and appeals in the subjects (objects) of healthcare providing obstetric services
|
gross
|
| |
Annex 2 to the Criteria
for assessing the degree of risk
in the sphere of
medical services (assistance) quality |
Subjective criteria for conducting preventive control with a visit to the subject of control
with distribution according to the degree of violations significance and sources of information
№ п\п
|
Name of criteria
|
Degree of violations
|
1. Criteria for the source of information "The results of previous inspections and preventive control with visits to the subjects (objects) of control" (the degree of severity is established if the following requirements are not met)
|
Criteria for the subjects (objects) rendering inpatient, inpatient replacing care*
|
1.
|
Availability of a license and annexes to it for the activities carried out
|
gross
|
2.
|
Availability of a specialist certificate in the relevant clinical specialty
|
gross
|
3.
|
Availability of a conclusion on compliance of a healthcare subject with the provision of high-tech medical services
|
gross
|
4.
|
Availability of a written voluntary consent of the patient or his/her legal representative for invasive interventions and for conducting medical and diagnostic measures
|
significant
|
5.
|
The time spent by the emergency medical team or the emergency department in the organization of primary health care in the hospital reception department does not exceed 10 minutes (the time for transferring the patient to the emergency department doctor) from the moment of its arrival at the hospital, except in cases of the need to provide emergency medical care in emergency situations.
After the transfer by the ambulance teams or the emergency department, when organizing the primary health care of the patient to the hospital reception department, the nurse conducts the distribution of incoming patients (medical sorting according to the triage-system) into groups, based on the priority of emergency medical care.
Medical sorting according to the triage -system shall be conducted continuously and successively. Upon completion of the assessment, the patients shall be marked with the color of one of the sorting categories, in the form of a special colored tag or colored tape.
According to medical sorting, there are 3 groups of patients:
the first group (red zone) - patients whose condition poses an immediate threat to life or who have a high risk of deterioration and require emergency medical care;
the second group (yellow zone) - patients whose condition poses a potential threat to health or may progress with the development of a situation requiring emergency medical care;
the third group (green zone) - patients whose condition does not pose an immediate threat to life and health and does not require hospitalization
|
gross
|
6.
|
Hospitalization of a serious patient who needs constant monitoring of vital functions for medical reasons, by the decision of the council and notification of the heads of healthcare organizations after stabilization of the condition shall be transferred to another medical organization according to the disease profile for further examination and treatment
|
significant
|
7.
|
In the absence of indications for hospitalization in a healthcare organization, the doctor of the reception department shall issue a medical conclusion to the patient with a written justification for the refusal.
The nurse of the reception department sends the asset to the PHC organization at the place of attachment of the patient
|
significant
|
8.
|
Indications for hospitalization:
the need to provide pre-medical, qualified, specialized medical care, including the use of high-tech medical services, with round-the-clock medical supervision of patients:
1) in a planned manner - on the referral of PHC specialists or other healthcare organization:
2) for emergency indications (including weekends and holidays) - regardless of the availability of a referral
|
significant
|
9.
|
Examination of the patient by the head of the department of severe patients on the day of hospitalization, thereafter - daily. Patients in a moderate condition shall be examined at least once a week. The results of examination of the patient shall be recorded in the medical record, indicating the recommendations for further tactics of managing the patient with obligatory identification of the medical worker making the entries
|
significant
|
10.
|
Clinical diagnosis shall be established together with the head of the department no later than three calendar days from the date of hospitalization of the patient to the healthcare organization
|
significant
|
11.
|
Daily examination of patients in the hospital by the attending physician, except for weekends and holidays. When examining and appointing additional diagnostic and therapeutic manipulations by the doctor on duty, appropriate entries shall be made in the medical record
|
significant
|
12.
|
Compliance with the requirements for planned hospitalization:
1) availability of a referral for hospitalization to the hospital and a card for planned hospitalization; 2) hospitalization of the patient in accordance with the established date of planned hospitalization in the referral;
3) availability of clinical and diagnostic (laboratory, instrumental and functional) studies and consultations of specialized specialists according to the diagnosis
|
significant
|
13.
|
Availability of consultations or councils in case of difficulty in identifying the diagnosis, ineffectiveness of conducted treatment, as well as for other indications
|
gross
|
14.
|
Compliance with discharge criteria, in particular:
1) generally accepted treatment outcomes (recovery, improvement, no change, death, transferred to another medical organization);
2) a written statement of the patient or his/her legal representative in the absence of an immediate danger to the patient's life or to others;
3) cases of violation of the internal regulations established by the healthcare organization, as well as the creation of obstacles for the treatment and diagnostic process, infringement of the rights of other patients to receive adequate medical care (in the absence of an immediate threat to his/her life), which is recorded in the medical record.
|
significant
|
15.
|
Availability of the issuance of a discharge summary to the patient at the time of discharge with an indication of full clinical diagnosis, the volume of diagnostic studies, therapeutic measures and recommendations for further observation and treatment. Discharge data shall be entered into information systems on a day-to-day basis, indicating the actual time of discharge.
|
minor
|
16.
|
Compliance with the requirements for transfusion of blood components and in the event of complications:
Before the transfusion of blood components, the recipient shall be examined for markers of blood- borne infections HIV, hepatitis B and C, and after the end of treatment, the discharge summary indicates the need for re-examination for HIV and hepatitis B and C at the place of residence.
Examination of recipients for the presence of HIV infection within the guaranteed volume of free medical care shall be carried out in state healthcare organizations, carrying out activities in the sphere of HIV prevention
Before the start of transfusion therapy information regarding the transfusion and obstetric history shall be entered into the patient's medical record:
presence of previous transfusions, when and in connection with what;
whether there were post-transfusion complications, pregnancies that ended in the birth of children with hemolytic disease of the newborn.
In the event of complications during a biological test, during or after a transfusion, a detailed record (records) with a description of the recipient's condition, monitoring data of vital functions, treatment methods and their effectiveness shall be made.
Immediate laboratory monitoring of the recipient's blood and urine shall be performed.
|
gross
|
17.
|
Compliance with indications for hospitalization in a day hospital at outpatient healthcare organizations and in a hospital at home shall be:
1) exacerbation of chronic diseases that do not require round-the-clock medical supervision;
2) active planned rehabilitation of a group of patients with chronic diseases subject to dynamic observation;
3) follow-up treatment of the patient the next day after a course of inpatient treatment for medical reasons;
4) conducting courses of medical rehabilitation of the second and third stages;
5) palliative care;
6) orphan diseases in children associated with a high risk of infectious complications and requiring isolation during the period of seasonal viral diseases in order to receive regular enzyme replacement and antibacterial therapy.
The requirements for a day hospitalization to a 24-hour hospital shall be:
1) performing operations and interventions with special preoperative preparation and resuscitation support;
2) conducting complex diagnostic studies requiring special preliminary training, and also not available in outpatient healthcare organizations;
3) observation of patients whose treatment is associated with transfusion of blood products, intravenous injections of blood-substituting fluids, specific hyposensitizing therapy, injections of potent drugs, intra-articular injections of drugs;
4) follow-up treatment the next day after inpatient treatment if there are indications for early discharge after surgical treatment;
5) palliative care;
6) chemotherapy, radiation therapy, correction of pathological conditions that occurred after specialized treatment of cancer patients
|
significant
|
18.
|
Availability of persons examination for clinical indications for HIV infection in identification of the following diseases, syndromes and symptoms: 1) enlargement of two or more lymph nodes lasting more than 1 month, persistent, generalized lymphadenopathy;
2) fever of unknown etiology (persistent or recurrent lasting more than 1 month);
3) unexplained severe cachexia or severe eating disorders that do not respond well to standard treatment (in children), unexplained weight loss of 10% or more;
4) chronic diarrhea for 14 days or more (in children), unexplained chronic diarrhea lasting more than a month;
5) seborrheic dermatitis, itchy papular rash (in children);
6) angular cheilitis;
7) recurrent upper respiratory tract infections (sinusitis, otitis media, pharyngitis, tracheitis, bronchitis);
8) shingles;
9) any disseminated endemic mycosis, deep mycoses (coccidioidosis, extrapulmonary cryptococcosis (cryptococcal meningitis), sporotrichosis, aspergillosis, isosporosis, extrapulmonary histoplasmosis, strongyloidosis, actinomycosis);
10) pulmonary and extrapulmonary tuberculosis, including disseminated infection caused by atypical mycobacteria, except for peripheral lymph node tuberculosis;
11) hairy leukoplakia of the oral cavity, linear erythema of the gums;
12) severe lingering recurrent pneumonia and chronic bronchitis, not amenable to conventional therapy (multiple two or more times during the year), asymptomatic and clinically pronounced lymphoid interstitial pneumonia;
13) sepsis, lingering and recurrent purulent-bacterial diseases of internal organs (pneumonia, pleural empyema, meningitis, meningoencephalitis, infections of bones and joints, purulent myositis, salmonella septicemia (except for Salmonella typhi ), stomatitis, gingivitis, periodontitis);
14) pneumocystis pneumonia;
15) infections caused by the herpes simplex virus, with damage to internal organs and chronic (lasting more than one month from the moment of illness) damage to the skin and mucous membranes, including the eyes;
16) cardiomyopathy;
17) nephropathy;
18) encephalopathy of unknown etiology;
19) progressive multifocal leukoencephalopathy;
20) Kaposi's sarcoma;
21) neoplasms, including lymphoma (of the brain) or B-cell lymphoma;
22) toxoplasmosis of the central nervous system;
23) candidiasis of the esophagus, bronchi, trachea, lungs, mucous membranes of the mouth and nose;
24) disseminated infection caused by atypical mycobacteria;
25) cachexia of unknown etiology;
26) protracted recurrent pyoderma, not amenable to conventional therapy;
27) severe chronic inflammatory diseases of the female genital area of unclear etiology;
28) invasive neoplasms of the female genital organs;
29) mononucleosis after 3 months from the onset of the disease;
30) sexually transmitted infections (syphilis, chlamydia, trichomoniasis, gonorrhea, genital herpes, viral papillomatosis and others) with an established diagnosis;
31) viral hepatitis B and C, upon confirmation of the diagnosis;
32) extensive confluent warts;
33) molluscum contagiosum with extensive eruptions, giant disfiguring molluscum contagiosum;
34) primary dementia in previously healthy individuals;
35) patients with hemophilia and other diseases who systematically receive transfusion of blood and its components;
36) generalized cytomegalovirus infection.
|
gross
|
19.
|
Availability of an agreement for the provision of paid services in healthcare organizations
|
minor
|
20.
|
Compliance with the following requirements when conducting an examination of temporary disability, issuing a sheet and a certificate of temporary disability:
1) availability of a person examination and a record of data about his/her state of health in the medical record of an outpatient (inpatient) patient, justifying the need for temporary release from work;
2) issuance of a sheet and a certificate of temporary disability on the day of discharge of persons with inpatient treatment (including day hospitals, rehabilitation centers) for the entire period of inpatient treatment;
3) closing the sheet and certificate of temporary disability by the date of discharge from the hospital if the working capacity of persons is fully restored;
4) extension of a sheet and a certificate of temporary disability for work to the persons who continue to be temporarily disable for a period, taking into account the time required for his/her appearance to a medical worker of a polyclinic or to call a medical worker at home (but not more than for one calendar day). For persons who received treatment outside the region of residence, the time required to arrive at the place of his/her permanent residence shall be taken into account (but not more than four calendar days);
5) issuance of a certificate of temporary disability for injuries sustained in a state of alcoholic or drug intoxication, as well as for acute alcohol or drug intoxication, for the entire period of temporary disability;
6) issuance of a sheet and certificate of temporary disability to the persons suffering from mental illness, in case of untimely contact to a medical organization over the past days, at the conclusion of a medical advisory commission of a neuropsychiatric dispensary or a medical worker (psychiatrist) together with the head of a medical organization;
7) issuance of a sheet and a certificate of temporary disability to the persons sent by the court decision for a forensic medical or forensic psychiatric examination and recognized as disabled from the date of admission for an examination;
8) issuing both a sheet and a certificate of temporary disability to a person who combines training with work.
|
significant
|
21.
|
Availability of a clinical audit by the patient support Service and internal expertise and its assessment according to the following criteria:
1) the quality of anamnesis collection, which is assessed according to the following criteria:
lack of anamnesis collection;
completeness of anamnesis collection;
availability of data on past, chronic and hereditary diseases, blood transfusions, drug tolerance, allergic status; development of complications as a result of tactical mistakes made during treatment and diagnostic measures due to poor-quality anamnesis;
2) completeness and validity of diagnostic studies, which are assessed according to the following criteria:
lack of diagnostic measures;
an incorrect conclusion or lack of a conclusion on the results of conducted diagnostic studies, which led to an incorrect diagnosis and mistakes in treatment tactics;
conducting diagnostic studies provided for by clinical protocols;
conducting diagnostic studies with a high, unjustified risk to the patient's health, the validity of conducting diagnostic studies that are not included in the clinical protocols;
conducting diagnostic studies that are not informative for the correct diagnosis and led to an unreasonable increase in the duration of treatment and an increase in the cost of treatment;
3) correctness, timeliness and validity of the clinical diagnosis, taking into account the results of the studies conducted (with planned hospitalization, studies conducted at the pre-hospital stage shall be taken into account ), which are assessed according to the following criteria:
the diagnosis is missing, incomplete or incorrect, does not correspond to the international classification of diseases;
the leading pathological syndrome that determines the severity of the disease course has not been identified, concomitant diseases and complications have not been recognized;
diagnosis is correct, but incomplete, the leading pathological syndrome has not been identified with the identified complications, concomitant diseases that affect the outcome have not been recognized;
diagnosis of the underlying disease is correct, but concomitant diseases affecting the result of treatment have not been diagnosed.
Objective reasons for incorrect and (or) untimely diagnosis (atypical course of the underlying disease, asymptomatic course of concomitant disease, rare complications and concomitant diseases) shall be reflected in the results of the examination. An assessment of the impact of incorrect and (or) untimely diagnosis on the subsequent stages of provision of medical services (assistance) shall be made
4) timeliness and quality of consultations from specialized specialists, which are assessed according to the following criteria:
lack of consultation, which led to an erroneous interpretation of symptoms and syndromes that adversely affected the outcome of the disease;
the consultation is timely, failure to take into account the opinion of the consultant when making the diagnosis partially influenced the outcome of the disease;
the consultation is timely, the opinion of the consultant was taken into account when making the diagnosis, failure to comply with the consultant's recommendation for treatment partially influenced the outcome of the disease;
the consultant's opinion is erroneous and influenced the outcome of the disease.
In cases of delayed consultations, an assessment of objectivity of the reasons for untimely consultation and the impact of the untimely diagnosis on the subsequent stages of provision of medical services (assistance) shall be made;
5) volume, quality and validity of conducting treatment measures, which are assessed according to the following criteria:
lack of treatment if indicated;
prescribing treatment in the absence of indications;
prescription of ineffective therapeutic measures without taking into account the characteristics of the disease course, concomitant diseases and complications;
implementation of therapeutic measures not in full, without taking into account the functional state of organs and systems, prescribing drugs without proven clinical efficacy;
non-compliance with the requirements of the Standards, unjustified deviation from the requirements of clinical protocols, presence of polypragmasia, which led to the development of a new pathological syndrome and deterioration of the patient's condition;
6) absence or development of complications after medical interventions, all complications that have arisen are assessed, including those caused by surgical interventions (delayed surgery, inadequate volume and method, technical defects) and diagnostic procedures;
7) the achieved result, which is assessed according to the following criteria:
achievement of the expected clinical effect while adhering to the technology of rendering medical services (assistance);
lack of clinical effect of therapeutic and prophylactic measures due to poor-quality anamnesis and diagnostic studies;
наличие полипрагмазии, обусловившее развитие нежелательных последствий;
absence of the expected clinical effect due to ineffective therapeutic, preventive measures without taking into account the peculiarities of the disease course, concomitant diseases, complications, prescribing drugs without proven clinical efficacy;
presence of polypragmasia, which caused the development of undesirable consequences;
8) the quality of medical documentation, which is assessed by the presence, completeness and quality of records in primary medical documentation intended to record data on the health status of patients, reflecting the nature, volume and quality of medical care provided in accordance with the forms of reporting and accounting documentation
|
significant
|
22.
|
Compliance with the following actions when conducting a pathoanatomical autopsy:
1) carrying out a pathoanatomical autopsy of corpses after the doctors have stated biological death, after providing the medical record of an inpatient patient or the medical record of an outpatient patient with a written order of the chief physician or his/her deputy for the medical (treatment) part of the healthcare organization to send for a pathoanatomical autopsy;
2) registration of the results of the pathoanatomical autopsy in the form of a pathoanatomical diagnosis (the pathoanatomical diagnosis includes: underlying disease, complication of underlying disease, concomitant disease, combined underlying disease);
3) transfer of a medical record of an inpatient patient or a medical record of an outpatient patient with the pathoanatomical diagnosis entered into it to the medical archive of the healthcare organization no later than ten working days after the pathological autopsy;
4) conducting clinical and pathoanatomical analysis in cases of death of patients in healthcare organizations;
5) pathoanatomical autopsy in case of suspected acute infectious, oncological diseases, pathology of childhood, fatal outcome due to medical manipulations in order to establish the cause of death and clarify the diagnosis of disease with a fatal outcome;
6) organization of autopsy materials in cases of suspected infectious diseases by the chief physician and head of the pathoanatomical department of virological (immunofluorescent) and bacteriological examination;
7) transfer to the pathoanatomical bureau, the centralized pathoanatomical bureau and the pathoanatomical department of the medical records of inpatients for all deaths for the previous day no later than 10 am of the day following the establishment of the fact of death;
8) registration of:
- a medical certificate of death (preliminary, final) by a doctor in the specialty "pathological anatomy (adult, pediatric)" on the day of the pathoanatomical autopsy;
- a medical certificate of perinatal death (preliminary, final) by a doctor in the specialty "pathological anatomy (adult, pediatric)" on the day of the pathoanatomical autopsy;
9) registration of the results of the autopsy in the form of a protocol of pathoanatomical examination;
10) the presence of a written notification to the forensic authorities to resolve the issue of transferring the corpse for forensic medical examination upon detection of signs of violent death and termination of the pathoanatomical examination of the corpse;
11) the presence of a written notification from a doctor in the specialty "pathological anatomy (adult, pediatric)" in case of initial detection during the autopsy of signs of an acute infectious disease, food or industrial poisoning, an unusual reaction to vaccination, as well as an emergency notification to the bodies of the state sanitary and epidemiological service immediately after their identification;
12) conducting a pathoanatomical examination of the placenta:
- in the case of stillbirth;
- for all diseases of newborns identified at the time of birth;
- in cases, suspected of hemolytic disease of newborns;
- in case of early discharge of water and in case of dirty waters;
- in case of diseases of the mother, occurring with a high temperature in the last trimester of pregnancy;
- with an obvious abnormality of development or attachment of the placenta;
- in cases of suspect for the presence of congenital malformations of the fetus;
- in cases of preeclampsia, eclampsia
13) mandatory registration of a fetus weighing less than 500 grams with anthropometric data (weight, height, head circumference, chest circumference);
14) establishment of a pathoanatomical autopsy, depending on the complexity, into the following categories:
first category;
second category;
third category;
fourth category;
15) establishment of the category of pathoanatomical autopsy and the reasons for discrepancy in diagnoses when the final clinical and pathoanatomical diagnoses differ by the doctor in the specialty "pathological anatomy (adult, pediatric)"
16) availability of a detailed analysis with the definition of the profile and categories of iatrogeny in all cases of iatrogenic pathology identified as a result of a pathoanatomical autopsy
|
gross
|
23.
|
Availability of a written statement of the spouse, close relatives or legal representatives of the deceased, or a written statement of will given by a person during his/her lifetime for the delivery of a corpse without a post mortem examination, in the absence of suspicion of violent death
|
gross
|
Criteria for the subjects (objects) providing outpatient and polyclinic care (primary health care and consultative-diagnostic assistance)**
|
24.
|
Availability of a license and annexes to it for the activities carried out
|
gross
|
25.
|
Availability of a specialist ceritificate in the relevant clinical specialty
|
gross
|
26.
|
Compliance of the performed medical and diagnostic measures with the recommendations of clinical protocols
|
significant
|
27.
|
Compliance with the following requirements when organizing and conducting a medical advisory commission:
1) availability of an order from the head of a medical organization:
- on creation of a medical advisory commission;
- on the composition, number of members (at least three doctors),
- on the procedure and schedule of work of the medical advisory commission
2) availability of conclusion of the medical advisory commission
|
significant
|
28.
|
Compliance with the general procedure for conducting preventive medical examinations of target population groups by primary health care organizations:
1) availability of lists of target groups of persons subject to screening examinations;
2) ensuring continuity with specialized medical organizations for carrying out these examinations;
3) inform the population about the need to undergo screening studies;
4) entering data on the passage of screening studies in the medical information system;
5) conducting a monthly analysis of the screening studies performed with the provision of information to local government health authorities by the 5th day of the month following the reporting one.
|
significant
|
29.
|
Compliance of the levels of medical rehabilitation provision to patients:
1) primary level – medical organizations of primary healthcare that have an office /department of rehabilitation in their structure, a day hospital and provide medical rehabilitation to patients whose condition is assessed from 1 to 2 points on the Rehabilitation Routing Scale (hereinafter- RRS);
2) secondary level - medical organizations that have specialized departments and (or) centers in their structure, carrying out medical rehabilitation in outpatient, inpatient-replacing and inpatient conditions, providing medical rehabilitation to patients whose condition is assessed from 2 to 4 points according to RRS ;
3) tertiary level - specialized medical organizations that have departments and (or) centers in their structure that provide medical rehabilitation, including with the use of high-tech services, in outpatient, inpatient-replacing and inpatient conditions to the patients whose condition is assessed from 2 to 4 points according to RRS.
|
significant
|
30.
|
Compliance with the provision of anti-tuberculosis care at the outpatient-polyclinic level:
1) conducting information and explanatory work on prevention, early detection of tuberculosis;
2) planning (formation of lists of subject persons, drawing up a schedule), organization and conduct of fluorographic examination with registration of examination results in medical documentation;
3) planning (forming lists of subject persons, drawing up a schedule), organization and conduct of tuberculin diagnostics of children and adolescents with registration of examination results in medical documentation, conducting additional examination of tuberculin -positive children);
4) referral for examination of persons with suspected tuberculosis according to the diagnostic algorithm of the examination
5) referral to a phthisiatrician of persons with positive results of fluorographic examination, children and adolescents with newly diagnosed positive and hyperergic tuberculin test, with an increase in tuberculin sensitivity by 6 mm or more, children with adverse reactions and complications for vaccination against tuberculosis;
6) planning, organizing and conducting vaccination against tuberculosis;
7) controlled treatment of latent tuberculosis infection (hereinafter referred to as LTI) as prescribed by a phthisiatrician, including in a video - monitored mode;
8) examination of contact persons;
9) outpatient direct-controlled or video -monitored treatment of patients with tuberculosis;
10) diagnosis and treatment of adverse reactions to anti-tuberculosis drugs as prescribed by a phthisiatrician;
11) diagnosis and treatment of concomitant diseases;
12) maintaining medical records of tuberculosis patients undergoing outpatient treatment, including multidrug-resistant and extensively drug-resistant tuberculosis;
13) regular entry of data into the National register of tuberculosis patients within the competence
|
gross
|
31.
|
Compliance with the following procedure for the provision of oncological care in the form of outpatient care:
formation of groups of people at risk of developing cancer;
examination by a doctor in order to determine the patient's condition and establish a diagnosis;
laboratory and instrumental examination of the patient for the purpose of making a diagnosis;
dynamic monitoring of cancer patients;
selection and referral to hospitalization of cancer patients to receive specialized medical care, including high-tech medical services;
additional examination of persons with suspected MN in order to verify the diagnosis;
determination of the tactics of management and treatment of the patient;
conducting outpatient anticancer therapy
|
significant
|
32.
|
Availability of mandatory confidential medical examination for the presence of HIV infection of persons for clinical and epidemiological indications, including sexual partners of pregnant women, persons who applied voluntarily and anonymously
|
significant
|
33.
|
At the first visit of a woman about pregnancy and, if she wants to save it, the obstetrician-gynecologist needs to carry out the following measures:
1) collects anamnesis, finds out the presence of diseases in the pregnant woman and relatives (diabetes mellitus, arterial hypertension, tuberculosis, mental disorders, oncological diseases and others), the birth of children with congenital malformations and hereditary diseases;
2) pays attention to the diseases (somatic and gynecological), operations, transfusions of blood and its components suffered in childhood and adulthood;
3) when collecting anamnesis, identifies a "risk" group for congenital and hereditary pathology for referral to a doctor in the specialty "Medical genetics" (without ultrasound screening and analysis of maternal serum markers) for the following indications: the age of a pregnant woman is 37 years and older, presence in the anamnesis of cases of termination of pregnancy for genetic indications and /or the birth of a child with congenital malformations or chromosomal abnormalities, presence in the anamnesis of cases of the birth of a child (or presence of relatives) with a monogenic hereditary disease, presence of family carriage of a chromosomal or gene mutation, a burdened obstetric history (stillbirth, habitual miscarriage and others);
4) directs pregnant women for blood sampling for analysis of maternal serum markers in the first trimester of pregnancy and prescribes ultrasound screening in the first, second and third trimesters of pregnancy;
5) studies the features of reproductive function;
6) clarifies the state of health of the spouse, blood type and rhesus affiliation;
7) studies the nature of the production where the spouses work, bad habits;
8) carries out early registration of pregnant women up to 12 weeks and registration on the day of pregnancy detection for timely examination;
9) finds out the presence of contraindications to pregnancy;
10) uses the opportunity to obtain information from the register of pregnant women and WFA about the course of previous pregnancies and previously identified somatic diseases.
11) draws up a preliminary management plan, taking into account the identified factors
|
significant
|
34.
|
The obstetrician-gynecologist provides and organizes obstetric and gynecological care for women during pregnancy, after childbirth, provides services for family planning and reproductive health, as well as prevention, diagnosis and treatment of gynecological diseases of the reproductive system by:
1) dispensary observation of pregnant women in order to prevent and early detection of complications of pregnancy, childbirth and the postpartum period with allocation of women "by risk factors";
2) conducting prenatal screening - a comprehensive examination of pregnant women in order to identify a risk group for chromosomal pathology and congenital malformations (hereinafter - congenital malformations) of an intrauterine fetus;
3) identifying pregnant women in need of timely hospitalization in day hospitals, departments of pregnancy pathology at inpatient-level medical organizations providing obstetric and gynecological care, specialized medical organizations with extragenital pathology, in compliance with the principles of regionalization of perinatal care;
4) referrals of pregnant women, women in labor and parturient women to receive specialized care with medical supervision, including with the use of high-tech medical services to medical organizations of the republican level;
5) conducting prenatal training for pregnant women in preparation for childbirth, including partner childbirth, informing pregnant women about warning signs, effective perinatal technologies, the principles of safe motherhood, breastfeeding and perinatal care;
6) conducting patronage of pregnant women and women in childbirth according to indications;
7) counseling and provision of services on the issues of family planning and reproductive health protection;
8) prevention and detection of sexually transmitted infections for referral to specialized specialists;
9) examination of women of fertile age with the appointment, if necessary, in-depth examination using additional methods and involvement of specialized specialists for the timely detection of extragenital, gynecological pathology and their registration;
10) according to the results of examination, the woman shall be included in the dynamic observation group of women of fertile age, depending on the state of reproductive and somatic health, for timely preparation for the planned pregnancy in order to improve the outcomes of pregnancy for the mother and child;
11) organizing and conducting preventive examinations of the female population with the aim of early detection of extragenital diseases;
12) examination and treatment of gynecological patients using modern medical technologies;
13) identification and examination of gynecological patients to prepare for hospitalization in specialized medical organizations;
14) clinical examination of gynecological patients, including rehabilitation and sanatorium-resort treatment;
15) performing minor gynecological operations using modern medical technologies;
16) ensuring the continuity of interaction in the examination and treatment of pregnant women, postpartum women and gynecological patients;
17) conducting an examination of temporary disability due to pregnancy, childbirth and gynecological diseases, determining the need and timing of temporary or permanent transfer of an employee to another job for health reasons, referring of women with signs of persistent disability for a medical and social examination in accordance with the established procedure;
|
gross
|
35.
|
Additional data of subsequent examinations and studies shall be recorded in the Individual card of the pregnant and postpartum women and the Prenatal record of the pregnant and postpartum women at each visit of the pregnant obstetrician-gynecologist
|
significant
|
36.
|
Home patronage by a midwife or a patronage nurse for pregnant women who do not show up for an appointment within 3 days after the appointed date
|
significant
|
37.
|
Availability of the conclusion of the medical advisory commission on the possible carrying of pregnancy in women with contraindications to pregnancy due to extragenital pathology
|
significant
|
38.
|
Availability of an agreement for the provision of paid services in healthcare organizations
|
minor
|
39.
|
Compliance by a nurse of a medical center of an educational organization with the following requirements:
1) availability of a single list of students in educational organizations;
2) availability of a list of students (target groups) subject to screening examinations;
3) organization and conduct of immunization followed by post-vaccination supervision of the vaccinated person;
4) monitoring compliance with the deadlines for passing mandatory medical examinations of all school employees and catering workers;
5) maintaining accounting and reporting documentation
|
significant
|
40.
|
Compliance with the following measures when conducting an examination of temporary disability, issuing a sheet and a certificate of temporary disability:
1) presence of an examination of a person and a record of data on his/her state of health in the medical record of an outpatient (inpatient) patient, justifying the need for temporary release from work;
2) compliance with the deadlines for issuing a sheet and a certificate of temporary disability:
- in case of diseases and injuries, individually and at a time for three calendar days and with a total duration of no more than six calendar days;
- in the period of increased incidence of the population with influenza, acute respiratory viral infection on the basis of the order of the head of a medical organization up to six calendar days;
3) joint implementation of extension of a sheet and a certificate of temporary disability for more than six calendar days with the head of the department of a medical organization with a total duration of no more than twenty calendar days;
4) availability of conclusion of the medical advisory commission when extending the sheet on temporary disability for work for more than twenty calendar days;
5) compliance with the deadlines (no more than six calendar days) when issuing a sheet and a certificate of temporary disability by individuals engaged in private medical practice;
6) issuance of a sheet and a certificate of temporary disability on the basis of a certificate confirming an appeal to a trauma center and an ambulance station, taking into account the day of treatment and subsequent days off and holidays;
7) issuance of a sheet and a certificate of temporary disability to nonresident persons at the place of their temporary stay in agreement with the head of the relevant medical organization. In the event of an extension of the specified sheet and a certificate of temporary disability, it is carried out in a medical organization at the place of attachment of the person in the availability of conclusion of a medical advisory commission of medical organization that opened a sheet and a certificate of temporary disability;
8) registration of issued sheets of temporary disability shall be made in the registration book of sheets of temporary disability
|
significant
|
41.
|
Compliance with the following requirements when issuing a sheet and certificate of temporary disability due to pregnancy and childbirth:
- a sheet or certificate of temporary disability due to pregnancy and childbirth shall be issued by a medical worker (obstetrician-gynecologist), and in his/her absence - by a doctor, together with the head of the department after the conclusion of the MAC from thirty weeks of pregnancy for a period of one hundred and twenty-six calendar days (seventy calendar days before delivery and fifty-six calendar days after delivery) in normal childbirth.
A sheet or a certificate of temporary disability due to pregnancy and childbirth shall be issued for the women living on the territories, affected by nuclear tests from twenty-seven weeks with a duration of one hundred seventy calendar days (ninety-one calendar days before delivery and seventy-nine calendar days after delivery) in normal childbirth;
2) a sheet or certificate of temporary disability due to pregnancy and childbirth shall be issued (extended) at the medical organization where the act of delivery took place or in the antenatal clinic (office) at the place of observation according to the extract (prenatal record) of an obstetric organization for the women who temporarily left their permanent place of residence within the Republic of Kazakhstan;
3) in case of complicated childbirth, the birth of two or more children, a sheet or certificate of temporary disability shall be extended for an additional fourteen calendar days by a medical worker (obstetrician-gynecologist), and in his/her absence - by a doctor, together with the head of the department after the conclusion of the MAC at the place of observation according to the extract of the obstetric health care organization. In these cases, the total duration of prenatal and postnatal leave is one hundred and forty calendar days (seventy calendar days before delivery and seventy calendar days after delivery).
A sheet or certificate of temporary disability shall be extended by an additional fourteen calendar days, the total duration of prenatal and postnatal leave is one hundred and eighty-four days (ninety-one calendar day before delivery and ninety-three calendar days after delivery) for the women living on the territories affected by nuclear tests, in case of complicated childbirth, the birth of two or more children;
4) in the case of childbirth at a period of twenty-two to twenty-nine weeks of pregnancy and the birth of a child weighing five hundred grams or more, who has lived for more than seven days, a sheet or a certificate of temporary disability for work on the fact of childbirth shall be issued to a woman for seventy calendar days after delivery.
In the case of childbirth with a period of twenty-two to twenty-nine weeks of pregnancy and the birth of a still fetus or a child weighing five hundred grams or more, who died before seven days of life, a sheet or certificate of temporary disability for work on the fact of childbirth shall be issued to a woman for fifty-six calendar days after delivery;
5) a sheet or a certificate of temporary disability shall be issued for ninety- three calendar days after childbirth to the women, living on the territories affected by nuclear tests, in case of childbirth at a period of twenty-two to twenty-nine weeks of pregnancy and the birth of a child weighing five hundred grams or more, who has lived for more than seven days.
A sheet or a certificate of temporary disability shall be issued for seventy-nine calendar days after childbirth to the women living on the territories affected by nuclear tests, in the case of childbirth at a period of twenty-two to twenty-nine weeks of pregnancy and the birth of a still fetus or a child weighing five hundred grams or more, who died before seven days of life;
6) when a woman applies for a sheet of temporary disability for work during pregnancy, maternity leave shall be calculated in total and be provided completely regardless of the number of days actually used by her before childbirth.
When a woman applies in the period after childbirth for a sheet of temporary disability, only a leave after childbirth shall be granted for the duration provided for in this paragraph;
7) upon the onset of pregnancy during the period when a woman is on paid annual labor leave or unpaid leave to care for a child until he/she reaches three years of age, a certificate of temporary disability shall be issued for all days of maternity leave, with the exception of cases provided for in part two of subparagraph 6) of this paragraph;
8) in the event of death of the mother during childbirth or in the postpartum period, a sheet or a certificate of temporary disability for work shall be issued to the person caring for the newborn;
9) in the case of an operation for the artificial termination of pregnancy, a sheet or a certificate of temporary disability shall be issued by a doctor together with the head of the department for the duration of stay in the hospital and outpatient clinic where the operation was performed, and in case of complication - for the entire period of temporary disability.
In case of spontaneous abortion (misbirth), a sheet or certificate of temporary disability shall be issued for the entire period of temporary disability;
10) when carrying out an embryo transfer operation, a sheet or a certificate of temporary disability shall be issued by the medical organization that performed the operation, from the day of embryo transfer until pregnancy is established.
Persons who have adopted (adopted) a newborn child (children), as well as a biological mother with surrogacy directly from the maternity hospital, a sheet or a certificate of temporary disability shall be issued from the date of adoption (adoption) and until the expiration of fifty-six calendar days from the date of birth of the child
|
significant
|
42.
|
Availability of a clinical audit by the patient support Service and internal expertise and its assessment according to the following criteria:
1) quality of anamnesis collection, which is assessed according to the following criteria:
lack of anamnesis collection;
completeness of anamnesis collection;
availability of data on past, chronic and hereditary diseases, blood transfusions, drug tolerance, allergic status; the development of complications as a result of tactical mistakes made during treatment and diagnostic measures due to poor-quality collection of anamnesis;
2) completeness and validity of diagnostic studies, which are assessed according to the following criteria:
lack of diagnostic measures;
an incorrect conclusion or lack of a conclusion on the results of diagnostic tests carried out, which led to an incorrect diagnosis and mistakes in treatment tactics;
conducting diagnostic studies provided for by clinical protocols;
conducting diagnostic studies with a high, unjustified risk to the patient's health, the validity of conducting diagnostic studies that are not included in the clinical protocols;
conducting diagnostic studies that are not informative for the correct diagnosis and led to an unreasonable increase in the duration of treatment and an increase in the cost of treatment;
3) correctness, timeliness and validity of the clinical diagnosis, taking into account the results of conducted studies (with planned hospitalization, studies conducted at the pre-hospital stage shall be taken into account ), which are assessed according to the following criteria:
the diagnosis is missing, incomplete or incorrect, does not correspond to the international classification of diseases;
the leading pathological syndrome, determining the severity of the disease course has not been identified, concomitant diseases and complications have not been recognized;
the diagnosis is correct, but incomplete, the leading pathological syndrome has not been identified with the identified complications, concomitant diseases that affect the outcome have not been recognized;
the diagnosis of the underlying disease is correct, but concomitant diseases affecting the result of treatment have not been diagnosed.
Objective reasons for incorrect and (or) untimely diagnosis (atypical course of the underlying disease, asymptomatic course of concomitant disease, rare complications and concomitant diseases) are reflected in the results of the expertise. An assessment of impact of incorrect and (or) untimely diagnosis on the subsequent stages of medical services (assistance) provision shall be made;
4) timeliness and quality of consultations from specialized specialists, which are assessed according to the following criteria:
lack of consultation, which led to an erroneous interpretation of symptoms and syndromes that adversely affected the outcome of the disease;
the consultation is timely, the failure to take into account the opinion of the consultant when making the diagnosis partially influenced the outcome of the disease;
the consultation is timely, the opinion of the consultant was taken into account when making the diagnosis, failure to comply with the consultant's recommendation for treatment partially influenced the outcome of the disease;
the consultant's opinion is erroneous and influenced the outcome of the disease.
In cases of delayed consultations, an assessment of objectivity of the reasons for untimely consultation and the impact of untimely diagnosis on the subsequent stages of medical services (assistance) provision shall be made;
5) the volume, quality and validity of the treatment measures, which are assessed according to the following criteria:
lack of treatment if indicated;
prescribing treatment in the absence of indications;
appointment of ineffective therapeutic measures without taking into account the characteristics of the disease course, concomitant diseases and complications;
implementation of therapeutic measures not in full, without taking into account the functional state of organs and systems, prescribing drugs without proven clinical efficacy;
non-compliance with the requirements of the Standards, unjustified deviation from the requirements of clinical protocols, the presence of polypragmasia, which led to the development of a new pathological syndrome and deterioration of the patient's condition;
6) absence or development of complications after medical interventions, all complications that have occurred shall be assessed, including those caused by surgical interventions (delayed surgical intervention, inadequate volume and method, technical defects) and diagnostic procedures;
7) the achieved result, which is assessed according to the following criteria:
achieving the expected clinical effect in compliance with the technology of providing medical services (assistance);
lack of clinical effect of therapeutic and preventive measures due to poor-quality collection of anamnesis and diagnostic studies;
lack of the expected clinical effect due to ineffective therapeutic, preventive measures without taking into account the peculiarities of the disease course, concomitant diseases, complications, prescribing drugs without proven clinical efficacy;
the presence of polypragmasia, which caused the development of undesirable consequences;
8) the quality of maintaining medical documentation, which is assessed by availability, completeness and quality of records in primary medical documentation intended for recording data on the health status of patients, reflecting the nature, volume and quality of medical care provided in accordance with the forms of reporting and accounting documentation in the field of healthcare
|
significant
|
Criteria for the subjects (objects) providing cardiological, cardiac surgical care***
|
43.
|
The presence of determination of the following indicators during the planned hospitalization:
- daily monitoring of the electrocardiogram;
- ergometric research (stress tests, spiroergometry) based on treadmill and /or bicycle ergometer;
- electrophysiological research;
- 24-hour blood pressure monitoring;
- catheterization of cardiac cavities with angiocardiography in an intracardiac research room;
- computer and magnetic resonance imaging
|
significant
|
44.
|
Availability of conducting in an urgent manner (around the clock, including on weekends and holidays) of procedures for, in particular:
- laboratory studies necessary to assess the functional state of organs and systems in the pre- and postoperative period;
- electrocardiogram and its analysis;
- echocardiography;
- gastroduodenoscopy;
- bronchoscopy;
- ultrasound examination of blood vessels;
- catheterization of cardiac cavities with angiocardiography;
- micro-ultrafiltration and dialysis;
- albumin dialysis (using a molecular adsorbent recirculating system);
- extracorporeal membrane oxygenation;
- intra-aortic counterpulsation;
- installation of a pacemaker;
- X - ray endovascular treatment methods.
|
significant
|
45.
|
Availability of a minimum list of equipment for the cardiology department (adult or pediatric), in particular:
- a functional bed (50% of the bed capacity of the department);
- an electrocardiograph (2 sets);
- a defibrillator;
- a portable apparatus for ultrasound examination of the heart and blood vessels;
- a centralized oxygen supply to each bed;
- a system of emergency notification (alarm) from the wards from each bed to the post of a nurse;
- a block of electrical outlets: at least 2 sockets with grounding at each bed and 4 sockets in the ward (1 dispenser for 1 bed);
- an automatic syringe dispenser of medicinal substances;
- an infusion pump (1 device for 1 bed);
- tonometers for measuring blood pressure (3 pieces);
- a glucometer;
- a nebulizer;
- a daily ECG monitor (3 pieces);
- a daily blood pressure monitor (3 pieces);
- a stress system (bicycle ergometer or treadmill);
- medical scales and height gauge;
- a mobile (portable) kit for resuscitation measures
|
significant
|
46.
|
Availability of the minimum list of equipment for the intensive care unit:
- a functional bed (according to the number of beds);
-an anti-decubitus mattress (1 for 3 beds);
- a bedside cardiac monitor (according to the number of beds);
- a portable electrocardiograph (1 for 6 beds);
- a pacemaker (1 for 6 beds);
- a portable apparatus for ultrasound examination of the heart and blood vessels (1 for 9 beds);
- an apparatus for auxiliary blood circulation (intra-aortic balloon counterpulsation ) (1 for 9 beds);
- a centralized oxygen supply system to each bed (according to the number of beds);
- a surgical electric suction device with a bacterial filter (1 for 3 beds);
- a biphasic defibrillator with synchronization function (1 for 3 beds);
- an apparatus for artificial lung ventilation (1 for 6 beds);
- a portable breathing apparatus for transportation (1 per ICU);
- a set for tracheal intubation (2 per ICU);
- a set for catheterization of great vessels (100 sets);
- an automatic syringe dispenser of medicinal substances (2 per 1 bed);
- an infusion pump (1 for 1 bed);
- a bedside tonometer for measuring blood pressure (by the number of beds);
- a mobile (portable) kit for resuscitation measures in other departments (1 on ICU);
- a mobile X-ray machine (1 on ICU);
- a glucometer (1 per ICU);
- a set of instruments and devices for minor surgical interventions (1 on ICU);
- a block of electrical outlets (at least 8 sockets) with grounding at each bed, including for power supply of energy-intensive devices (X-ray machines) (according to the number of beds).
|
significant
|
47.
|
Availability of a minimum list of equipment for the department of interventional cardiology, in particular:
- an angiograph (2 sets);
- an electrophysiological station (hereinafter - EF-station);
- a pacemaker combined with an EF-station;
- a radio frequency destructor combined with an EF station;
- a mapping system for building a pulse propagation map;
- an irrigation pump for cold ablation;
- an electrocoagulator;
- a mobile operating lamp;
- an apparatus for carrying out transesophageal electrocardiostimulation;
- a functional bed (according to the number of beds);
- a bedside cardiac monitor (according to the number of beds);
- an electrocardiograph (2 sets);
- a portable electrocardiograph (1 for 6 beds);
- an equipment for the study of main parameters of hemodynamics (at least 1 set for 6 beds);
- a portable apparatus for ultrasound examination of the heart and blood vessels;
- a pacemaker (at least 1 per 3 beds);
- an apparatus for auxiliary blood circulation (intra-aortic balloon counterpulsation ) (2 sets);
- a centralized oxygen supply system to each bed (according to the number of beds);
- a surgical electric suction device with a bacterial filter (2 pcs.);
- a biphasic defibrillator with synchronization function (3 pcs.);
- an apparatus for artificial lung ventilation (2 sets);
- an apparatus for spontaneous breathing;
- a portable breathing apparatus for transportation;
- a set for tracheal intubation (2 pcs.);
- a set for catheterization of great vessels of single use (100 sets);
- an automatic syringe dispenser of medicinal substances (2 per 1 bed);
- an infusion pump (1 for 1 bed);
- a mobile (portable) kit for resuscitation measures in other departments;
- a mobile X-ray machine;
- a glucometer;
- a set of instruments and devices for minor surgical interventions;
- a block of electrical outlets (at least 8 sockets) with grounding at each bed, including for power supply of energy-intensive devices (X-ray machines) (according to the number of beds);
- communication equipment with ambulance crews
|
significant
|
48.
|
Availability of a minimum list of equipment for the cardiac surgery department (adult, pediatric):
- a functional bed (20 pcs.);
- a heated resuscitation table for newborns (3 pcs.);
- a couveuse for newborns (3 pcs.);
- a lamp for phototherapy of newborns;
- a bed for young children with a protective grill (7 pcs.);
- centralized oxygen supply (according to the number of beds);
- stationary or portable devices for room sterilization (2 sets);
- a tripod ( infusion stand) (20 pcs.);
- a biphasic defibrillator with synchronization function (2 sets);
- 12-channel electrocardiograph (2 pcs.);
- a portable sterilizer of baby food bottles;
- a pacemaker (2 pcs.);
- a stationary or portable device for ultrasound examination of the heart and blood vessels;
- a cardiac monitor with 5-channel electrocardiography (3 sets);
- a portable pulse oximeter (2 pcs.);
- floor scales (adults, children);
- electronic baby scales;
- an ultrasonic inhaler ( nebulizer ) (6 pcs.);
- a perfuser (1 per bed);
- an infusion pump (5 pcs );
- a mobile portable kit for carrying out resuscitation measures in other departments;
- a set of instruments and devices for emergency and minor surgical interventions (1 set);
- a negatoscope for 2 pictures (2 pcs.);
- a set of endotracheal tubes.
for the operating room:
- a functional operating table (2 sets);
- an equipment for creating a laminar air flow in the operating room;
- an air conditioner;
- a working nurse's table on wheels (2 sets);
- an operating lamp (stationary, shadowless) (2 pcs.);
- a set of instruments for cardiovascular surgery (for 2 adjacent operating rooms) (3 sets);
- a set of instruments for coronary surgery (2 sets);
- headlamp (2 pcs.);
- a sternotomy saw (for 2 adjacent operating rooms) (3 pcs.);
- a sternotomic oscillating saw;
- an irradiator - ultraviolet air recirculator;
- a defibrillator monitor;
- an apparatus for echocardiography;
- a transesophageal sensor;
- a transoesophageal sensor for children;
- a transoesophageal neonatal sensor;
- an ice maker;
- a thermostat;
- a surgical electrocoagulator (2 pcs.);
- an analyzer of acid-base balance with determination of electrolytes;
- a surgical aspirator (suction) (4 pcs.);
- an operational monitor (1 + 1);
- anesthesia and respiratory apparatus for patients from 0.5 kg with monitoring;
- an external temporary pacemaker (2 set);
- sensors for operating monitors (12 pcs.);
- baby sensors for operating monitors (12 pcs.);
- a perfuser (syringe dispenser) (6 pcs.);
- a device for injecting solutions under pressure (3 sets);
- an anesthesia table (2 pcs.);
- an apparatus for intraoperative assessment of the blood flow quality in shunts by the method of transient flow time (1 (on demand)).
|
significant
|
49.
|
Availability of a minimum list of equipment for performing artificial blood circulation:
- an artificial blood circulation device;
- a gas mixer;
- a temperature control device with two circulation circuits;
- an apparatus for autohemotransfusion ( hemoseparator);
- a portable apparatus for measuring activated clotting time;
- an apparatus for extracorporeal membrane oxygenation;
- a nurse's table;
- a bronchoscope
|
significant
|
50.
|
Availability of a minimum list of equipment for the organization of healthcare, providing outpatient care to the population, in the structure of which there is a cardiology office, in particular:
- a 12-channel electrocardiograph (3 pcs.);
- a 6-channel electrocardiograph (portable);
- a treadmill system;
- holter- ECG monitor 3-channel, 2-channel 1 installation + 10 recorders;
- a biphasic defibrillator (2 pcs.);
- a 24-hour blood pressure monitor (1 unit + 10 recorders);
- Ultrasound machine with 4V in real time with cardiological, abdominal, vascular sensors;
- Ultrasound machine with 4V in real time with a cardiac sensor, portable (2 pcs.);
- a spirometer (2 pcs.);
- a tonometer;
- a phonendoscope;
- a glucometer (all pre-medical control rooms);
- lipidometer (all pre-medical control rooms);
- koaguchek for determining international normalized relationship (all pre-medical control rooms);
- a centimeter tape for measuring waist
|
significant
|
51.
|
Assessment of the complexity of surgical interventions for congenital heart defects according to the Basic Aristotle scale and the effectiveness of operations in the cardiac surgery department
|
significant
|
52.
|
Availability of a department for restorative treatment and rehabilitation
|
significant
|
53.
|
Availability of a cardiology office in the structure of organizations providing outpatient care to the population (district, city, region, republic) and organizations providing inpatient care
|
significant
|
54.
|
Availability of a referral of the patient for consultation to the clinical diagnostic center to provide CDA with a consilium, if necessary, with involvement of specialized specialists, including consultants from medical organizations of the republican level, if it is impossible to establish a diagnosis of CVD in the PHC organization.
|
significant
|
55.
|
Availability of CDA provision to a patient with CVD by a specialized specialist in the referral of a PHC specialist or another specialized specialist
|
significant
|
56.
|
Availability of a conclusion on preparation of documents for referral to a medical and social examination in the presence of high blood pressure (crisis course), arrhythmias of various origins, an increase in angina attacks and an increase in symptoms of heart failure, issuance and prolongation of a sheet or a certificate of temporary disability, and with persistent loss of disability (condition after myocardial infarction, coronary artery bypass grafting, congestive heart failure)
|
significant
|
57.
|
Availability of a patient’s examination by the doctor in the reception department of the hospital with filling out the inpatient card, with the written consent of the patient or his/her legal representative to provide him/her with medical care
|
significant
|
58.
|
Availability, with hospitalization at the inpatient level of:
1) primary examination of a patient by the doctor in order to determine his/her condition and establish a preliminary diagnosis;
2) conducting therapeutic and diagnostic non-invasive testing methods to reduce the risk of invasive studies;
3) selection and prescription of treatment;
4) conducting, if necessary, consultations of specialists of a different profile
|
significant
|
59.
|
In case of emergency, establishment of the main diagnosis within 24 hours from the moment the patient is admitted to the hospital based on the data of clinical and anamnestic examination, the results of instrumental and laboratory research methods and is entered into the medical record of the inpatient
|
significant
|
60.
|
Availability of issuance of a discharge summary to a patient upon discharge with an indication of the complete clinical diagnosis, conducted volume of diagnostic studies, therapeutic measures and recommendations for further observation and treatment. Discharge data shall be entered into the information systems on a day-to-day basis, indicating the actual time of discharge
|
significant
|
61.
|
Compliance with the provision of medical care to the patients with acute coronary syndrome and (or) acute myocardial infarction shall be carried out according to the levels of regionalization:
1) at the first level, the provision of medical care by ambulance organizations, primary health care, as well as by organizations providing inpatient care without the possibility of percutaneous coronary interventions to the patients with acute coronary syndrome or acute myocardial infarction;
2) at the second level - by organizations providing inpatient care with the possibility of percutaneous coronary interventions without a cardiac surgery department;
3) at the third level - by organizations providing inpatient care and republican medical organizations, with the presence of a cardiac surgery department
|
gross
|
Criteria for the subjects (objects) providing hemodialysis care***
|
62.
|
The patients have a decision of the Commission on the selection of patients for renal replacement therapy on the basis of the conclusion of the polyclinic nephrologist
|
gross
|
63.
|
Compliance by the department (center) of extrarenal blood purification with daily two-shift use of hemodialysis equipment with the throughput of one hemodialysis site at least 624 (2496 hours / year) hemodialysis sessions per year (12 hours per week per a patient) on calendar days
|
gross
|
64.
|
The ability of the department (center) to provide urgent resuscitation measures and laboratory control of the dialysis therapy quality by biochemical studies of water for hemodialysis during dialysis and in the inter - dialysis period
|
gross
|
65.
|
Provision of food for outpatients after a hemodialysis session within the established tariff for a hemodialysis session in the department (center)
|
gross
|
66.
|
Providing transportation of patients for a hemodialysis session within the established tariff for a hemodialysis session
|
significant
|
67.
|
Compliance with the criteria for the selection and initiation of renal replacement therapy, in particular:
1) serum urea over 30 mmol/l and/or a decrease in the glomerular filtration rate (hereinafter - GFR) below 10 ml/min/1.73 m2 (in patients with diabetes mellitus below 20 ml/min/1.73 m2), calculated by the formula MDRD/СKD-EPI;
2) GFR (ml/min/1.73m2) = 186 x (plasma creatinine) -1,154 x (age) - 0.203 x (0.742 - for women);
3) reduction of standard bicarbonate below 20 mmol/l and/or deficiency of buffer bases less - 10 mmol/l;
4) hyperkalemia - over 6.5 mmol/l.
|
gross
|
68.
|
Compliance with indications for emergency extrarenal blood cleansing in patients with acute renal failure:
1) renal acute kidney failure with hypercatabolism (increase in urea per day more than 5 mmol/l, creatinine - more than 88 - 177, potassium - more than 0.5 mmol/l);
2) oliguria (diuresis <0.3 ml / kg/h in 24 hours) or anuria for 12 hours or more and/or an increase in serum creatinine 3 times higher than normal (a decrease in GFR by more than 75% of the initial) and/or an increase in blood urea more than 30 mmol/l);
3) uncontrolled hyperkalemia (more than 6.0 mmol/l), hypernatremia, hyponatremia;
4) pulmonary edema resistant to diuretics;
5) metabolic acidosis with a decrease in arterial blood pH <7.2;
6) uremic pericarditis/uremic encephalopathy.
|
gross
|
69.
|
Compliance with the material and technical equipment of dialysis rooms, in particular:
- availability of apparatus "Artificial kidney";
- tap water purification system;
- availability of a nephrologist and a nurse trained in hemodialysis for one dialysis room
|
gross
|
70.
|
Compliance of the hemodialysis machine with quality standards and certificates, with sufficient resource and performance, provided by the country of origin
|
gross
|
71.
|
Availability of a minimum list of equipment for dialysis rooms, in particular:
- hemodialysis machines - 2 pcs.;
- mobile beds - 2 pcs.;
- a doctor's table - 1 piece;
- a table for a nurse - 1 piece;
- a chair - 2 pcs.;
- a table for medicines - 1 pc.;
- a stand for long-term infusions - 2 pcs.;
- a cabinet for medicines - 1 pc.;
- a medical refrigerator - 1 pc.;
- a first aid kit - 1 pc.;
- a multichannel electrocardiograph - 1 pc.;
- a defibrillator - 1 pc.;
- a set for tracheostomy - 1 pc.;
- a breathing apparatus - 1 pc.;
- a medical thermometer - 1 pc.;
- a phonendoscope - 1 pc.;
- a blood pressure meter - 1 piece;
- an irradiator - ultraviolet air recirculator - 1 pc.;
- medical scales - 1 pc.
|
gross
|
72.
|
Compliance with the algorithm for the hemodialysis procedure:
- preparation of the "artificial kidney" apparatus for operation: testing and inspection of AKA apparatus with control of the ionic composition of the dialysis solution on an ionometer;
- preparation of the nurse’s workplace in the dialysis room: the layout of sterile packing, preparation of fistula needles, dialyzer, solutions for filling lines and dialyzer;
- assembly of the extracorporeal circuit (blood lines, dialyzer) with the installation of an "artificial kidney" apparatus;
- filling and flushing of the extracorporeal circuit with saline solution with anticoagulant;
- patient’s preparation: weighing on electronic scales with registration of the value of interdialysis weight gain in the dialysis card, treatment of the skin surface with disinfectants at the puncture site of the vascular access;
- connecting the patient to the "artificial kidney" apparatus;
- setting the blood flow rate on the "artificial kidney" apparatus;
- control over blood pressure, heart rate and pulse rhythm at least 1 time per hour, with hourly registration of results in the dialysis card;
- control of the correctness of the ultrafiltration volume (at the end of dialysis), with the registration of the results in the dialysis card;
- control of the position of the fistula needles in the arteriovenous fistula (constantly);
- control of readings of sensors of venous and arterial pressure (constantly);
- monitoring of anticoagulation (constantly visually);
- control of the ionic composition of blood during the procedure (according to indications);
- at the end of the procedure: stopping the blood pump, removing the fistular needles from the vascular access, controlling the stop of bleeding from the puncture sites, finally stopping the bleeding, ligating the fistular limb with a sterile dressing material;
- control weighing of the patient on electronic scales with registration of the results in the dialysis card;
- cold washing of the apparatus, hot disinfection;
- transportation of used consumables for disposal
|
gross
|
Criteria for the subjects (objects) providing dental care***
|
73.
|
Compliance with the following requirements when organizing dental care:
1) attracting doctors of related specialties to provide advisory assistance in the presence of concomitant pathology in patients with dental diseases (for medical reasons);
2) availability of referral of patients with dental diseases to the maxillofacial departments of multidisciplinary hospitals in cases requiring the provision of specialized medical care and high-tech medical services with round-the-clock medical supervision;
3) availability of an advisory and diagnostic opinion indicating the results of the examination and treatment, as well as recommendations for further treatment of a patient with dental diseases;
4) provision of dental healthcare to the patient after receiving his/her informed consent according to the approved form of written voluntary consent of the patient during invasive interventions;
5) compliance with indications for emergency hospitalization:
- acute or exacerbation of chronic odontogenic and non- odontogenic inflammatory diseases of the maxillofacial region;
- injuries of the maxillofacial area;
- bleeding of the maxillofacial area;
6) compliance with indications for planned hospitalization of a patient with dental diseases:
- clarification of the diagnosis in unclear and difficult cases for diagnosis and treatment and selection of the necessary treatment regimen;
- treatment of chronic diseases of the oral cavity and maxillofacial area in the acute stage;
- surgical treatment of benign tumors and tumor-like diseases;
- treatment of injuries and pyoinflammatory diseases of the maxillofacial region;
- surgical treatment of defects and deformities of the maxillofacial region;
- surgical treatment of congenital pathology of the maxillofacial region.
|
gross
|
74.
|
Availability of an agreement for the provision of paid services in healthcare organizations
|
minor
|
75.
|
Compliance with clinical and diagnostic studies by levels of dental care
|
significant
|
Criteria for the subjects (objects) providing phthisiological care***
|
Provision of anti-tuberculosis care at the outpatient-polyclinic level
|
76.
|
Implementation of the following activities by PHC specialists:
1) conducting information and explanatory work on prevention, early detection of tuberculosis;
2) planning (formation of lists of subjected persons, drawing up a schedule), organization and conduct of fluorographic examination with registration of examination results in medical documentation;
3) planning (formation of lists of subjected persons, drawing up a schedule), organizing and conducting tuberculin diagnostics of children and adolescents with registration of examination results in medical documentation, conducting additional examination of tuberculin-positive children);
4) referral for examination of persons with suspected tuberculosis according to the diagnostic algorithm of the examination;
5) referral to a phthisiatrician of persons with positive results of fluorographic examination, children and adolescents with newly diagnosed positive and hyperergic tuberculin test, with an increase in tuberculin sensitivity by 6 mm or more, children with adverse reactions and complications for vaccination against tuberculosis;
6) planning, organizing and conducting vaccination against tuberculosis;
7) controlled treatment of latent tuberculosis infection (hereinafter - LTI) as prescribed by a phthisiatrician, including in a video - monitored mode;
8) examination of contact persons;
9) outpatient direct-controlled or video -monitored treatment of patients with tuberculosis;
10) diagnosis and treatment of adverse reactions to anti-tuberculosis drugs as prescribed by a phthisiatrician;
11) diagnosis and treatment of concomitant diseases;
12) maintaining medical records of tuberculosis patients undergoing outpatient treatment, including multidrug-resistant and extensively drug-resistant tuberculosis;
13) regular entry of data into the National register of tuberculosis patients within the competence
|
gross
|
77.
|
Examination of a patient with suspected tuberculosis in organizations providing primary health care, in accordance with the approved scheme
|
gross
|
78.
|
Detection of tuberculosis by fluorography among the target population: with a high risk of the disease and subject to mandatory annual fluorographic examination
|
significant
|
79.
|
Organization of directly controlled treatment rooms in PHC organizations for outpatient treatment.
The patient receives and takes medications at the DCTR under the supervision of a responsible healthcare professional. Once every 10 days, patients who are on direct controlled treatment shall be examined by a primary healthcare doctor/phthisiatrician of the polyclinic, if indicated - more often.
Patients living in rural areas shall be examined by a phthisiatrician once a month
|
significant
|
80.
|
An assessment of the clinical condition of a patient receiving anti-tuberculosis treatment for the presence of adverse reactions and phenomena shall be carried out daily by the attending physician or phthisiatrician, a medical worker in the directly observed treatment room. A medical worker who has identified adverse reactions and events to a drug fills out a message card and draws up an entry in the patient's medical record.
Primary information on adverse reactions and phenomena shall be provided by the responsible person of the medical organization to the state expert organization in the field of circulation of medicines and medical devices. Control over the registration of card messages shall be assigned to the person in charge of pharmacovigilance.
Each case of adverse reactions and phenomena shall be considered at a meeting of the centralized medical advisory commission to determine the causal relationship with the medications taken.
|
gross
|
81.
|
Tracking the movement of anti-tuberculosis drugs at the outpatient level in the registration log of anti-tuberculosis drugs
|
significant
|
82.
|
Before starting treatment, the patient (parents or guardians of children) shall be interviewed about the need for a full course of chemotherapy, followed by signing an informed consent
|
significant
|
83.
|
Registration and dispensary observation of patients with tuberculosis shall be carried out in organizations providing primary health care, at the place of actual residence, work, study or military service, regardless of registration
|
significant
|
Rendering anti-tuberculosis care at the inpatient level
|
84.
|
Distribution of patients in departments by wards, taking into account laboratory data and drug sensitivity at the time of admission and during treatment.
Keeping patients with bacteriological secretions with unknown drug sensitivity in single wards or boxes until drug sensitivity test results are obtained
|
significant
|
85.
|
Daily examination of patients who are in the hospital by a phthisiatrician.
Keeping a record in the patient's medical record, depending on the severity of his/her condition (at least 3 times a week in case of mild and moderate condition of the patient and daily - in case of serious condition of the patient).
Examination of patients with tuberculosis, multidrug-resistant tuberculosis and extensively drug-resistant tuberculosis by the head of the department at least 1 time per week with an entry in the patient's medical record
|
significant
|
86.
|
Organization of a consilium in difficult situations to verify the diagnosis and determine treatment tactics with participation of specialists at regional and republican levels in full-time or remote form through telemedicine
|
gross
|
87.
|
Tracking the movement of anti-tuberculosis drugs at the inpatient level in the registration log of anti-tuberculosis drugs
|
significant
|
88.
|
Compliance with the criteria for the discharge of a patient with tuberculosis from the hospital:
1) absence of bacterial excretion and the need for round-the-clock medical supervision;
2) obtaining two negative results of microscopy, sequentially taken with an interval of at least 10 calendar days in patients with initial bacterial excretion;
3) generally accepted outcomes of inpatient treatment (recovery, improvement, no change, deterioration, death and transferred to another medical organization);
4) at the written request of the patient (his/her legal representative) before the end of the treatment course in the absence of an immediate danger to the patient's life or to others
|
significant
|
Criteria for the subjects (objects) rendering oncologic assistance***
|
89.
|
Availability of material and technical equipment of the oncologic office:
- a cabinet for medical documentation;
- an ultraviolet bactericidal irradiator;
- a first aid kit
- scales for adults;
- a stadiometer;
- a tonometer;
- a phonendoscope;
- a thermometer;
- spatulas
|
significant
|
90.
|
Availability of material and technical equipment for the mammological office:
- a negatoscope for viewing mammological images;
- a bactericidal lamp;
- a medical couch;
- a screen;
- a first aid kit
|
significant
|
91.
|
Availability of material and technical equipment for the proctology office:
- a sigmoidoscope with a set of tubes (length from 20 cm to 35 cm) - 5 tubes;
- a gynecological chair;
- a set of glasses for biopsy;
- an anoscope;
- rectal mirrors;
- an electrocoagulator;
- a nurse's table;
- a mobile medical table;
- a shadowless lamp;
- a wall lamp for UFO;
- a soft clamp;
- anatomical tweezers;
- surgical tweezers;
- operating scissors;
- working scissors;
- a button probe;
- a grooved probe;
- surgical gloves;
- a first aid kit.
|
significant
|
92.
|
Availability of material and technical equipment for the office of centralized dilution of cytostatic drugs:
- a laminar flow box with a cut-off air flow, an ultraviolet irradiation system for the inner chamber and a protective screen for personnel;
- medical cabinets for storing solutions for the preparation of cytostatics;
- rotary thermosealing machine for hermetic packaging of syringes and vials with ready-made solutions of cytostatics;
- a roll holder;
- polyethylene bags for packaging ready-made diluted solutions in vials and/or syringes, roll 300 mm* 200 m;
- containers for disinfecting solutions (10 liters), for surface treatment;
- a sink and dispensing devices with liquid soap and hand sanitizer;
- a safe for storing cytostatics;
- a wall-mounted bactericidal irradiator;
- containers for transportation of chemotherapy drugs;
- holders for liquid soap and disinfectants;
- disposable containers for the disposal of used chemotherapy drugs. Class A, B;
- closed medical cabinet for storing chemotherapy drugs;
- a pharmaceutical refrigerator;
- a hydrometer;
- a cabinet for storing documentation;
- a wardrobe;
- a computer desk;
- a computer chair;
- a desk;
- a cabinet for storing disposable protective clothing sets;
- a computer;
- a printer/copier;
- an air conditioning;
- a table;
- a container for household waste;
-a telephone
|
significant
|
93.
|
Availability of a multidisciplinary group to provide an individual approach for rendering medical care to the patients with malignant neoplasms, consisting of doctors in the specialties: "Oncology (chemotherapy, mammology) (adult)", "Radiation therapy (radiation oncology)", "General surgery (thoracic surgery, abdominal surgery, transplantology, coloproctology, oncological surgery, ultrasound diagnostics according to the profile of the main specialty, endoscopy according to the profile of the main specialty)","Pathological anatomy (cytopathology) (adult, pediatric)". If necessary, other specialized specialists shall be involved
|
gross
|
94.
|
Availability of decisions of the multidisciplinary group in the journal of meetings of the multidisciplinary group, the minutes of the multidisciplinary group meeting (2 copies), followed by sticking into the medical record of the outpatient patient and the medical record of the inpatient patient
|
significant
|
95.
|
Compliance with the requirements for the provision of oncological care in the form of outpatient care:
formation of groups of people at risk of developing oncology;
examination by a doctor in order to determine the patient's condition and establish a diagnosis;
laboratory and instrumental examination of the patient for the purpose of making a diagnosis;
dynamic monitoring of oncologic patients;
selection and referral to hospitalization of oncologic patients to receive specialized medical care, including high-tech medical services;
additional examination of persons with suspected MN in order to verify the diagnosis;
determination of the tactics of management and treatment of the patient;
conducting outpatient anticancer therapy
|
significant
|
96.
|
Timeliness of additional examination of patients with suspicion or detection of a tumor disease:
- PHC specialists, within 5 working days from the moment of detection, refer the patient to an oncologist, in the absence of an oncologist in the staff, to the coordinator of rendering oncological care (hereinafter-CROC);
- The oncologis/CROC conducts an examination and necessary studies within 7 working days and, based on the results, sends the patient to an independent city/regional oncological center/dispensary or as part of a multidisciplinary hospital (hereinafter-an oncological center) to confirm the diagnosis and determine the subsequent management and treatment tactics;
-Term of immunnogistological studies did not exceed fourteen working days from the receipt of laboratory material
- in-depth examination of patients of the Ia clinical group shall be carried out within 10 working days from the moment of contacting the oncological center/dispensary
|
gross
|
97.
|
Grounds for deregistering a patient with MN:
1) moving to another country with the issuance of a detailed extract from the outpatient card;
2) observation in an organization providing oncological care with a diagnosis of skin basal cell carcinoma for more than five years after recovery, in the absence of relapses;
3) Death based on a final medical death certificate
|
significant
|
98.
|
Justification and control of prescription of narcotic pain medications:
The decision on appointment of narcotic pain medications at the outpatient level shall be made by a commission and shall be drawn up by the appropriate protocol. The conclusion shall be entered into the patient's outpatient card at the place of attachment.
MN patients receiving narcotic drugs shall be examined by a PHC specialist at least once every ten working days. In the case of a patient taking narcotic drugs for more than three months, a commission analysis shall be conducted with participation of PHC and CDA specialists with involvement of specialized specialists with the provision of recommendations for further observation and treatment. Control over the timing of the appointment of narcotic drugs shall be carried out by an oncologist/CROC
|
gross
|
99.
|
Requirements for the provision of oncological care at the inpatient level. Determination of the method and tactics of MDG treatment.
Meetings of the MDG shall be held at the oncologic center every day (excluding weekends and holidays).
Availability of rooms for centralized dilution of cytostatic drugs (hereinafter - RCDC) to ensure the safety of medical personnel from the toxic effects of anticancer drugs and the rational use of drugs. The work in the RCDC for the breeding of anticancer drugs shall be organized in shifts.
Availability and control of applications for the dilution of anticancer drugs for each patient.
Requirements for packaging, labeling, transportation (medicines are packed in disposable sterile containers (vials, syringes), labeled. Transportation of medicines shall be carried out in containers.)
|
gross
|
100.
|
Compliance of the provided medical care with clinical protocols
|
significant
|
Criteria for subjects (objects) rendering medical and social assistance in the field of mental health
|
Criteria for subjects (objects) rendering medical and social assistance in the field of mental health at the outpatient-polyclinic level
|
101.
|
Compliance with the criteria for taking on dynamic observation of persons with MBD:
1 group of dynamic psychiatric observation - persons prone by their mental state to socially dangerous actions, including those who have the risk of committing violent acts of a sexual nature against minors, as well as those who have committed especially dangerous acts in a state of insanity, and for whom the court has determined compulsory measures of medical character in the form of outpatient compulsory treatment;
2 group of dynamic psychiatric observation - Persons with MBD who have mental disabilities, with the exception of MBD indicated in diagnostic headings F8 and F9; a person with a diagnosis of F20 "Schizophrenia" within one year after establishing diagnosis (while in the case of recognition as a disabled person, he/she continues to be observed in the 2nd group of dynamic psychiatric observation);
2A - persons with frequent and severe exacerbations of psychotic symptoms, decompensation, in need of psychopharmacotherapy within the framework of free outpatient treatment, including persons with MBD indicated in diagnostic headings F8 and F9
2B - persons with stabilized conditions, with a moderately progressive course of the process and spontaneous remissions;
group of dynamic narcological observation - Persons prone to socially dangerous actions due to clinical manifestations of MBD,
caused by the abuse of psychoactive substances.
Compliance with the periodicity and frequency of observation of persons with mental, behavioral disorders (diseases):
1 group of dynamic psychiatric observation - at least once a month
2 group of dynamic psychiatric observation:
2A - at least once every three months,
2B - at least once every six months;
group of dynamic narcological observation - at least once a month
|
significant
|
102.
|
Compliance with the requirements for drug provision for the persons with MBD who are under dynamic observation
Drug provision for the persons with MBD, being under dynamic observation shall be carried out within the framework of the current legislation
|
significant
|
103.
|
Compliance with the requirements for deregistration and transfer to another dynamic observation group, termination of dynamic observation of persons with MBD and deregistration
Removal from the register and transfer to another dynamic observation group shal be carried out on the basis of the decision of the MAC on the recommendation of the district psychiatrist. Termination of dynamic observation of persons with MBD and deregistration shall be carried out in the following cases:
1) absence of the criteria, registration for the provision of dynamic observation of persons with MBD for at least 12 months;
2) change of place of residence with departure from the Republic of Kazakhstan (confirmed by a document).
In the event of a change in the patient's permanent place of residence within the Republic of Kazakhstan, the attachment to the corresponding territorial organization providing medical care in the field of mental health shall be carried out with a change of data in the EIS;
3) absence of reliable information about the location within 12 months;
4) death, on the basis of a medical death certificate, and (or) confirmed by data in the register of the attached population;
5) persons diagnosed with F20 "schizophrenia" according to the international classification of diseases of the 10th revision, who are registered in the second group of dynamic psychiatric observation: in case of not establishing a disability group within 12 months from the date of taking for dynamic observation
|
significant
|
104.
|
Presence of dynamic observation of persons who were subjected to compulsory treatment after discharge.
Persons with MBD associated with the use of psychoactive substances, after the end of compulsory treatment and discharge from an organization providing medical care in the field of mental health, except for those discharged by the court order as recovered early shall be observed in the group of dynamic narcological observation in accordance with the rules of dynamic observation, as well as the termination of dynamic observation of persons with MBD, approved by the authorized body
|
significant
|
105.
|
Availability of an individual treatment plan and a rehabilitation program for the persons after discharge from an organization providing medical care in the field of mental health, except for those discharged by the court order as recovered early.
With supportive treatment for the persons with MBD, a psychiatrist (narcologist) shall draw up an individual treatment plan and an individual rehabilitation program.
An individualized treatment plan and an individualized rehabilitation program include:
1) diagnostic metods: analysis of the psychoactive substances content in biological fluids and body tissues, testing for HIV, experimental psychological diagnostics, determining the quality of life and social functioning, clinical and biochemical diagnostics, neurophysiological diagnostics;
2) drug therapy: psychopharmacotherapy, symptomatic therapy, therapy of comorbid pathology, antagonistic therapy using opioid receptor blockers;
3) advisory methods: medical, psychological and social counseling of persons dependent on psychoactive substances and codependent persons;
4) training methods: motivational trainings for the continuation of supportive anti-relapse therapy, for the formation of adaptive skills and stress resistance, for the formation of properties of psychological resistance to re-involvement in dependence on psychoactive substances;
5) psychotherapeutic methods: individual and group psychotherapy of persons dependent on psychoactive substances, individual express psychotherapy of persons dependent on psychoactive substances, who are in a state of breakdown.
|
significant
|
Criteria for subjects (objects) rendering medical and social assistance in the field of mental health in inpatient conditions, providing round-the-clock medical supervision
|
106.
|
Availability of grounds for hospitalization in inpatient clinical departments.
The grounds for hospitalization in inpatient clinical departments shall be:
1) a referral of a psychiatric doctor;
2) the resolution, decision, determination of the judicial and investigative bodies;
3) a referral of the military-medical commission;
4) a written statement of the person himself, if there are indications;
5) a court decision on compulsory treatment of persons with MBD caused by the use of psychoactive substances, which entered into legal force;
6) a court decision on application of compulsory medical measures provided for in Article 93 of the Criminal Code of the Republic of Kazakhstan, which entered into force
|
significant
|
107.
|
The completeness of measures taken for planned hospitalization in inpatient clinical departments of the Republican Scientific and Practical Center for Mental Health (RSPCMH), CMH.
In case of planned hospitalization in inpatient clinical departments of the Republican Scientific and Practical Center for Mental Health, the Centre of Mental Health, the head or psychiatrist (narcologist) of the clinical department, reception and diagnostic department shall carry out the following activities:
1) patient identification;
2) checks the availability of available medical and other documentation, if necessary, directs to undergo regulated and (or) additional examinations;
3) checks the availability of a court decision on hospitalization that has entered into legal force, if any;
4) assesses the mental and somatic state, the results of laboratory-diagnostic tests, determines the need for emergency care at the level of reception and diagnostic department and (or) presence of indications and contraindications for hospitalization;
5) establishes a preliminary diagnosis, determines the scope of differential diagnosis, observation regime, medical nutrition and other therapeutic and diagnostic measures in accordance with the protocols of diagnosis and treatment;
6) fills in primary medical documentation;
7) in case of anonymous treatment of a patient, the name and patronymic (if any), date of birth, address of residence shall be filled in according to the patient's words.
The completeness of measures taken during planned hospitalization in inpatient clinical departments of the Republican Scientific and Practical Center for Mental Health, CMH of persons with MBD, caused by the use of psychoactive substances for treatment in an anonymous manner.
In case of planned hospitalization in inpatient clinical departments of the Republican Scientific and Practical Center for Mental Health, CMH of persons with MBD caused by the use of psychoactive substances for treatment on an anonymous basis, the head or psychiatrist (narcologist) of the clinical department or reception-diagnostic department shall carry out the following measures:
1) assigns a medical registration code to the patient;
2) directs to undergo compulsory and (or) additional examinations;
3) assesses the mental and somatic state, the results of laboratory and diagnostic studies, determines the need for emergency care at the level of reception and diagnostic department and (or) presence of indications and contraindications for hospitalization;
4) establishes a preliminary diagnosis, determines the scope of differential diagnosis, observation regime, therapeutic nutrition and other therapeutic and diagnostic measures in accordance with the protocols of diagnosis and treatment;
5) fills in primary medical documentation
|
significant
|
108.
|
The completeness of measures taken during hospitalization in the inpatient clinical department of the RSPCMH, CMH for emergency indications.
When hospitalized in the inpatient clinical department of the RSPCMH, the CMH, the head or psychiatrist (narcologist) of clinical department or the reception and diagnostic department, or the doctor on duty shall carry out the following activities:
1) patient identification;
2) assesses mental and somatic conditions, the results of laboratory and diagnostic studies and determines the need for emergency care at the level of reception and diagnostic department and (or) presence of indications and contraindications for hospitalization;
3) establishes a preliminary diagnosis, determines the scope of differential diagnostics, observation regime, medical nutrition and other therapeutic and diagnostic measures in accordance with the diagnostic and treatment protocols;
4) fills in primary medical documentation
|
significant
|
109.
|
The completeness of measures taken for planned hospitalization at SPOIS (specialized psychiatric organization with intensive supervision).
With a planned hospitalization at SPOIS, the doctor on duty shall carry out the following activities:
1) checks the availability and compliance of the available documentation:
a court decision that has entered into legal force;
an identity document.
2) conducts identification of the patient;
3) assesses the mental and somatic state, the results of laboratory and diagnostic studies, determines the need for emergency care at the level of reception and diagnostic department and (or) presence of indications and contraindications for hospitalization;
4) determines the department, establishes the observation regime, medical nutrition and other medical and diagnostic measures in accordance with the diagnostic and treatment protocols;
5) fills in primary medical documentation
|
significant
|
110.
|
The completeness of measures taken after the admission of a person with MBD to the inpatient clinical department.
After the admission of a person with MBD to the inpatient clinical department, the following activities shall be carried out:
1) patient identification;
2) checking the availability and compliance of available medical and other documentation;
3) assessment of mental and somatic state, the results of laboratory and diagnostic studies, establishment of a preliminary diagnosis, determination of the scope of differential diagnosis, observation regime, medical nutrition and other therapeutic and diagnostic measures in accordance with the protocols of diagnosis and treatment;
4) filling in primary medical documentation
|
significant
|
111.
|
The completeness of measures taken after the person has entered the inpatient clinical department of SPOIS
After a person enters the inpatient clinical department of SPOIS, the following activities shall be carried out:
1) patient identification;
2) checking the availability and compliance of available medical and other documentation;
3) assessment of mental and somatic state, the results of laboratory and diagnostic studies, establishment of a preliminary diagnosis, determination of the scope of differential diagnosis, observation regime, medical nutrition and other therapeutic and diagnostic measures in accordance with the protocols of diagnosis and treatment;
4) filling in primary medical documentation
|
significant
|
112.
|
Compliance with observation regimes.
In clinical inpatient departments of the RSPCMH, the CMH and multidisciplinary city (regional) hospitals, the following types of observation shall be assumed:
1) a general observation regime - round-the-clock observation without restriction of movement in the department. The general regime for patients shall be established when:
no danger to yourself and others;
the ability to maintain personal hygiene without assistance;
2) a partial hospitalization regime - the possibility of staying in the department during the day or at night, taking into account the need for its adaptation in out-of-hospital conditions, as well as the possibility of carrying out labor activities against the background of treatment and control of MBD symptoms for the purpose of resocialization. The regime of partial hospitalization shall be established by the decision of the medical commission (hereinafter - MC) consisting of two doctors with:
no danger to yourself and others;
the ability to maintain personal hygiene without assistance;
stabilization of the mental state, requiring daily, but not round-the-clock observation and control;
3) the regime of medical vacations - the ability to stay outside the department from several hours to several days in order to gradually adapt to out-of-hospital conditions, solve household and social issues, as well as to assess the achieved therapeutic effect. The regime of medical vacations shall be established by the decision of the MC consisting of two doctors and provided with:
no danger to yourself and others;
the ability to maintain personal hygiene without assistance;
stabilization of the mental state, which does not require daily observation.
4) an enhanced observation regime - round-the-clock observation and restriction of movement outside the department. An enhanced observation observation shall be established for patients with:
acute MBD that do not pose a danger to themselves and others;
the ability to maintain personal hygiene without assistance;
absence of mental and somatic disorder, requiring a different regime of observation and maintenance;
5) a strict observation regime - round-the-clock continuous observation in the observation room, constant accompaniment by medical personnel in the department and outside it. A strict patient regime shall be established for patients with:
immediate danger to yourself and others;
helplessness, that is, the inability to independently satisfy their vital needs, in the absence of proper care;
possible significant harm to health if the person is left without observation.
In clinical inpatient departments of SPOIS, the following types of observation shall be assumed:
1) a general observation regime - round-the-clock observation with movement in the department according to the daily routine, the possibility of participating in occupational therapy outside the department;
2) an enhanced observation regime - round-the-clock observation and restriction of movement within the department;
3) a strict observation regime - round-the-clock continuous observation in the observation ward, constant accompaniment by medical personnel in the department and outside it
|
significant
|
113.
|
Compliance with the conditions of discharge.
Discharge from inpatient clinical departments shall be made upon the patient's recovery or improvement in his/her mental state, when no further inpatient treatment is required, as well as upon completion of the examination, expertise, security measures, compulsory medical measures, which were the grounds for admission to the hospital.
Discharge of a patient who is in inpatient clinical departments voluntarily shall be made at his/her personal application, the application of his/her legal representative or by the decision of his/her attending physician.
Discharge of a patient, to whom compulsory medical measures and security measures have been applied according to the court's decision shall be made only on the basis of a court ruling that has entered into force.
A patient, hospitalized in an inpatient clinical department voluntarily shall be refused discharge if the MAC establishes the grounds for compulsory hospitalization
|
significant
|
Criteria for subjects (objects) rendering medical and social assistance in the field of mental health in hospital-substituting conditions that do not require round-the-clock medical supervision and treatment and provide for medical observation and treatment in the daytime with the provision of a bed
|
114.
|
Availability of indications for treatment in hospital-substituting conditions for persons with MBD
The indications for treatment in hospital-substituting conditions for persons with MBD shall be:
1) the need for active therapy of persons with MBD, including those caused by the use of psychoactive substances, which does not require round-the-clock observation;
2) the need for gradual adaptation to usual life situation, after receiving a course of treatment in a round-the-clock hospital;
3) conducting examinations and expertise that do not require round-the-clock stationary observation
|
significant
|
115.
|
Requirements for the duration of treatment and the time spent in the day hospital.
The duration of treatment in a day hospital is no more than 30 calendar days.
In cases of deterioration of the patient's state, requiring round-the-clock medical observation and treatment, he/she shall be hospitalized in the appropriate inpatient department.
The daily time spent in the day hospital is at least 6 hours. The day hospital provides two meals a day, taking into account the time of taking psychotropic drugs
|
significant
|
116.
|
Compliance with the requirements for discharge from the day hospital.
Discharge shall be made upon the patient's recovery or improvement in his/her mental state, when it is possible to transfer to outpatient treatment, as well as upon completion of examination, expertise, which were the grounds for placement in a day hospital
|
significant
|
Criteria for subjects (objects) rendering medical and social rehabilitation in the field of mental health
|
117.
|
Compliance with the requirements for medical and social rehabilitation in outpatient or hospital-substituting conditions.
When rendering medical and social rehabilitation in an outpatient or inpatient conditions, the daily stay shall be at least 6 (six) hours, excluding weekends and holidays, with two meals a day, taking into account the time of taking psychotropic drugs. In the department of medical and social rehabilitation, the patient shall be provided with the necessary drug therapy and necessary examination.
Medical and social rehabilitation of patients with MBD shall be provided in accordance with the individual rehabilitation program for a patient with MBD
|
significant
|
118.
|
Compliance with the requirements for medical and social rehabilitation in stationary conditions.
When hospitalized for medical and social rehabilitation, the following activities shall be carried out:
1) patient identification;
2) checking the availability and compliance of available medical documentation, referral to undergo regulated and (or) additional examinations;
3) an individual program for the rehabilitation of a patient with MBD is being developed;
4) primary medical documentation is filled in.
General contraindications for hospitalization for medical and social rehabilitation shall be:
1) acute conditions requiring a strict or enhanced observation regime;
2) presence of concomitant diseases requiring treatment in hospitals of a different profile;
3) infectious diseases during the period of epidemiological danger
|
significant
|
119.
|
Presence of a multidisciplinary group.
Medical and social rehabilitation of adults with MBD shall be carried out by a multidisciplinary group:
1) supervisor (physician, health care manager or physician psychiatrist);
2) a psychiatrist;
3) a psychologist;
4) a social worker or social work specialist;
5) a labor instructor or specialist in the field of occupational therapy, sports;
6) a paramedical worker.
The composition of a multidisciplinary group expands with the increase in the list and (or) volume of services
|
gross
|
120.
|
Requirements for the duration of medical and social rehabilitation.
The duration of medical and social rehabilitation of adult patients with MBD shall be no more than 3 (three) months.
The duration of medical and social rehabilitation of children with MBD shall be no more than 3 (three) months.
The duration of medical and social rehabilitation for adults with MBD due to the use of psychoactive substancess shall be no more than 9 (nine) months.
The duration of medical and social rehabilitation of children with MBD, due to the use of psychoactive substances shall be no more than 9 (nine) months.
|
significant
|
Criteria for subjects (objects) rendering medical examination for establishing the fact of the use of a psychoactive substance and the state of intoxication
|
121.
|
Compliance with the requirements for identification of the person sent or came for a medical examination.
Before conducting a medical examination, a medical worker shall carry out an identification of the person who was sent or came for a medical examination, having familiarized with his/her identity documents.
In the absence of documents in the Conclusion of a medical examination for establishing the fact of the use of psychoactive substancess and the state of intoxication, special signs of the person shall be indicated with a mandatory indication of obtaining passport data from the words of the person who delivered or the examined person, photographing of the examined person shall be allowed
|
significant
|
122.
|
Compliance with the requirements for medical examination of persons delivered in a serious unconscious state.
In a specialized healthcare organization, when a person is delivered in a severe, unconscious state to determine the state associated with the use of psychoactive substancess, a double (with an interval of 30-60 minutes) quantitative research shall be carried out for the presence of psychoactive substancess in biological fluids of the body (blood, urine, saliva).
In a specialized healthcare organization, at the time of rendering medical care, a record shall be made in the patient's medical record about the presence (absence) of a person's state of intoxication or the fact of using psychoactive substancess based on the results of a clinical examination and laboratory research of biological samples, while a Conclusion shall not be drawn up
|
significant
|
123.
|
Compliance with the requirements for the conditions of laboratory research or rapid testing of biological media.
Laboratory research or rapid testing of biological media (blood or urine if alcohol intoxication is suspected, urine if drug or toxic intoxication is suspected ) shall be carried out in the following cases:
1) the impossibility of a complete examination due to the severity of state of the person being examined;
2) if a medical worker has doubts about a comprehensive assessment of the state of intoxication (mental, behavioral, autonomic and somatoneurological disorders);
3) disagreement of the examined person with the results of the Conclusion;
4) re-examination;
5) when establishing the fact of the use of psychoactive substancess and absence of signs of a state of intoxication (mental, behavioral, autonomic and somatoneurological disorders);
6) in the event of a road traffic accident or commission of an offense with the presence of injured persons;
7) if more than 3 (three) hours have passed since the moment of the road traffic accident and the offense without the injured persons
|
significant
|
124.
|
Compliance with the requirements for laboratory research or rapid testing of biological media.
The nature and sequence of biological samples shall be determined by the medical worker performing the examination, depending on the characteristics of clinical state of the examined person.
Sealing and labeling of selected biological samples for laboratory research shall be carried out in the presence of the examined person and the person who sent and (or) delivered the examined person.
In cases when the examined person is not able to objectively assess the events taking place, this procedure shall be carried out in the presence of attesting witnesses (disinterested persons)
|
significant
|
125.
|
Compliance with the requirements for a quantitative research of exhaled air for alcohol.
When conducting a medical examination to establish the fact of alcohol consumption and the state of alcoholic intoxication, a quantitative research of exhaled air for alcohol shall be carried out.
The research of exhaled air for the presence of alcohol shall be carried out using technical measuring instruments officially registered in the Republic of Kazakhstan.
If it is not possible to conduct the examination in full due to mental and (or) somatoneurological disorders, or the person's refusal to be examined, the Conclusion shall indicate the reasons for the impossibility of conducting the examination in full.
|
significant
|
126.
|
Compliance with the requirements for registration of refusal from medical examination
In case of refusal of a person from a medical examination, the medical worker shall fill in paragraph 1 of the Conclusion and signatures of the attesting witnesses (disinterested persons) shall be put.
Presence of attesting witnesses (disinterested persons) in the case when the examined person is not able to assess the events taking place or refuses to undergo a medical examination shall be provided by the persons on whose initiative the examination is carried out.
|
significant
|
127.
|
Compliance with the requirements for establishing the state of the examined person.
When drawing up a Conclusion and when conducting a full examination and the consent of a person to conduct an examination, a medical worker shall establish one of the following conditions based on the available clinical and (if necessary) laboratory data or the results of express testing, confirming the type of psychoactive substance that caused intoxication:
1) sober;
2) the fact of using psychoactive substancess, signs of intoxication were not identified;
3) alcohol intoxication (mild, moderate, severe);
4) state of intoxication (narcotic, toxicomaniac) caused by the use of psychoactive substancess (drugs - opioids, cannabinoids, cocaine; sedatives, hypnotics; psychostimulants; hallucinogens; volatile solvents)
|
significant
|
128.
|
Compliance with the requirements for registration of the Conclusion of a medical examination.
The Conclusion shall be drawn up in 3 (three) copies, certified by the signature of a medical worker and the seal of a medical organization in which the examination was carried out. One copy shall be issued to the person who delivered the examined person, or to the person who came for examination on their own, the second copy remains in the medical organization and shall be stored in the archive for 5 (five) years, the third copy shall be issued to the person delivered for medical examination.
In the absence of an accompanying person, a copy of the Conclusion, upon an official written request of the person who directed for a medical examination, shall be sent by mail or to the specified e-mail address.
The results of the examination shall be communicated to the examined person immediately in the presence of the person who sent him/her and (or) delivered. In cases when the Conclusion is issued after receiving the results of laboratory tests, a copy of the Conclusion shall be issued no later than 5 working days from the date of receipt of laboratory test results.
If the examined person, or the official who delivered him/her disagrees with the results of medical examination, a repeated medical examination shall be carried out.
|
significant
|
129.
|
Compliance with the requirements for a repeated medical examination.
A repeated medical examination shall be carried out no later than 2 (two) hours after the initial examination.
|
significant
|
130.
|
Compliance with the requirements for the placement and discharge of patients of the Center for temporary adaptation and detoxification:
- information about the presence of documents, personal belongings (clothes, money and other valuables) of the patient in the register of documents and personal belongings placed before the patient's placement in the Center for temporary adaptation and detoxification;
- availability of a record of the patient who is in the center of temporary adaptation and detoxification;
- availability of a medical examination conclusion after conducting medical examination for each patient delivered to the Center for temporary adaptation and detoxification;
- entering of the doctor's prescription into the record of the patient who is in the Center for temporary adaptation and detoxification;
- registration of the results of dynamic observation of the patient in the patient's record, being in the Center for temporary adaptation and detoxification;
- discharge of the patient from the center for temporary adaptation and detoxification when an improvement is achieved that does not require further observation and treatment in the center.
|
significant
|
Criteria for subjects (objects) providing laboratory services****
|
131.
|
Availability of a license and annexes to it for the activities carried out
|
gross
|
132.
|
Availability of a specialist certificate in the relevant clinical specialty
|
gross
|
133.
|
Availability of a biosafety specialist in the laboratory staff (with a laboratory staff of more than twenty staff units)
|
significant
|
134.
|
Availability of portable test strip analyzers in primary healthcare organizations
|
significant
|
135.
|
Availability at the inpatient level in healthcare organizations as part of the consultative and diagnostic laboratory (hereinafter-the CDL), an additional subdivision or a separate express laboratory shall be created at the intensive care units for performing emergency and urgent laboratory tests in the minimum terms from taking a sample to reporting the result (within 15-60 minutes).
For an urgent assessment of the pathological state of patients, general clinical and biochemical studies, including express tests shall be carried out. Laboratory diagnostics by the express laboratory shall be carried out in various emergency conditions (during surgical interventions, the provision of anesthesia, management of patients in the resuscitation unit and intensive care unit) around the clock. In the absence of an express laboratory in healthcare organizations that provide inpatient care in the evening and at night, as well as on Sundays and holidays, work in the CDL shall be provided by a team on duty, consisting of doctors and laboratory assistants
|
significant
|
136.
|
Implementation of processes for quality management of clinical laboratory researches on the principle of staging, which includes pre-analytical, analytical and post-analytical stages of laboratory research
|
significant
|
137.
|
Use of equipment certified and registered in the Republic of Kazakhstan, diagnostic reagent kits, test systems and component consumables for research purposes
|
significant
|
138.
|
Availability of laboratory information system
|
significant
|
139.
|
Conducting in-laboratory quality control of the research
|
significant
|
140.
|
Availability of a written voluntary consent of the patient for invasive interventions
|
significant
|
141.
|
Transportation of biomaterial, including by road, air and rail shall be carried out in compliance with the rules of triple packaging and temperature conditions
|
significant
|
142.
|
To ensure the availability of laboratory diagnostics in outpatient and inpatient healthcare organizations, points for collection and reception of biomaterials shall be organized. At points for collection and reception of biomaterials, rooms for blood sampling, a room for receiving biological material, a room for sample preparation and temporary storage of biological material shall be provided.
|
significant
|
143.
|
Compliance with the requirements for storage and transportation of samples of biological materials
|
significant
|
144.
|
Compliance with the analytical quality control algorithm in laboratory diagnostics
|
significant
|
Criteria for subjects (objects) rendering emergency medical care and medical assistance in the form of medical aviation
|
General requirements
|
145.
|
Availability of a license and annexes to it for the activities carried out
|
gross
|
146.
|
Compliance with the certificate of a specialist in the relevant clinical specialty
|
gross
|
147.
|
Compliance of the conducted medical and diagnostic measures with the recommendations of clinical protocols
|
significant
|
For emergency medical services
|
148.
|
Equipping ambulance vehicles with radio communication and navigation system
|
gross
|
149.
|
Availability of an automated control system for receiving and processing calls and systems, which allows monitoring medical vehicles through navigation systems, as well as a computer recording system for dialogues with subscribers and an automatic identifier of the telephone number from which a call comes in the ambulance service of regions, cities of republican significance and the capital city. Records of dialogues shall be stored for at least 2 years.
|
gross
|
150.
|
Availability of regional Call-centers ( call-centers) as part of regional ambulance stations and ambulance stations in the cities of republican significance and the capital city
|
gross
|
151.
|
The call processing time from the moment it is received by the dispatcher shall be five minutes, during which the call shall be sorted according to the urgency of the call. The time of arrival of the team to the patient's location from the moment of receiving the call from the dispatcher according to the list of categories of urgency of ambulance calls (from 10 minutes to 60 minutes)
|
Significant
|
152.
|
The correct determination by the ambulance station dispatcher of calls by the category of urgency according to:
1) a call of the 1st (first) category of urgency - a patient's condition that poses an immediate threat to life, requiring the provision of immediate medical care;
2) a call of the 2nd (second) category of urgency - a patient's condition that poses a potential threat to life without medical assistance;
3) a call of the 3rd (third) category of urgency - a patient's condition that poses a potential threat to health without the provision of medical assistance;
4) a call of the 4th (fourth) category of urgency - a patient's condition caused by an acute illness or exacerbation of a chronic disease, without sudden and pronounced disorders of organs and systems, in the absence of an immediate and potential threat to life and health of the patient.
|
significant
|
153.
|
Based on the results of the examination data, instrumental diagnostics, dynamics of the patient's condition against the background or after the treatment measures taken, in accordance with the preliminary diagnosis reflecting the causes of this condition, the paramedic or doctor of the ambulance station team or the emergency department shall make one of the following decisions when organizing PHC:
transportation of a patient to a medical organization providing inpatient care (hereinafter -a hospital);
the patient was left at the place of the call;
the patient was left at home (at the place of residence)
|
gross
|
154.
|
If a patient who does not need hospitalization is left at the place of call or at home, the ambulance station team or the emergency department during the organization of primary care shall provide medical recommendations for further contacting the primary care organization (at the place of residence or attachment)
|
significant
|
155.
|
Availability of a signal sheet for the patient in case of illness of the patient and the need to visit him/her at home by the local doctor
|
significant
|
156.
|
Availability of recording the following data when a call is received to the dispatch service of the ambulance station: 1) surname, name, patronymic (if any), age and gender of the patient;
2) data on the patient's condition and the circumstances of the accident, injury or illness; 3) address and telephone number, as well as approximate information on how to get to the patient's location.
|
significant
|
157.
|
Compliance with the time of arrival of paramedic and specialized (medical) teams to the location of the patient from the moment of receiving a call from the dispatcher of the ambulance station, taking into account the category of urgency:
1) 1 category of urgency - up to ten minutes;
2) 2 category of urgency - up to fifteen minutes;
3) 3 category of urgency - up to thirty minutes;
4) 4 category of urgency - up to sixty minutes
|
significant
|
158.
|
In the event that a decision is made by the ambulance station team or the emergency department when organizing PHC to transport the patient to the hospital, the ambulance station dispatcher shall inform the reception department of the hospital about the patient's delivery.
|
gross
|
For medical assistance in the form of medical aviation
|
159.
|
Availability of a task for a medical flight according to the form No. 090/af
|
significant
|
160.
|
Conducting of assessment of the condition and treatment of a patient (s) on an ongoing basis in accordance with clinical diagnostic and treatment protocols by a mobile team of medical aviation during transportation of a patient (s)
|
|
161.
|
Availability of grounds for the provision of medical care in the form of medical aviation (an extract from the medical record of a patient in need of medical assistance in the form of medical aviation; application of the coordinator doctor of the medical aviation department to the dispatcher of the Coordinating organization; in urgent cases, a verbal instruction from the authorized body with written confirmation; call from the ambulance service and other emergency services)
|
gross
|
162.
|
Availability of approval by the dispatcher of the Coordinating organization of composition of the mobile medical aviation brigade and the involved qualified specialized specialist (s) from the medical organizations of the region with their informed consent
|
significant
|
163.
|
Availability in the Coordinating organization of a schedule of qualified specialists for the provision of medical care in the form of medical aviation, approved by healthcare subjects and medical education organizations
|
gross
|
164.
|
Availability of the informed consent of the patient (s) for the provision of medical assistance in the form of medical aviation during his/her transportation.
In relation to minors and citizens declared legally incompetent by the court, the consent shall be provided by their legal representatives. The provision of medical care to unconscious patients shall be made by the decision of a council or a doctor of a medical organization in the region, or a mobile medical aviation brigade, or a qualified specialist with notification in any form of officials of a medical organization.
|
gross
|
Criteria for subjects (objects) carrying out activities in the sphere of HIV prevention
|
165.
|
Availability of a license and annexes to it for the activities carried out
|
gross
|
166.
|
Compliance with the certificate of a specialist in the relevant clinical specialty
|
gross
|
167.
|
Conducting an examination based on the results of an express test.
In the case of a negative result of the express test, the subject shall be re-examined for HIV infection after 3 (three) months in the presence of risk factors for infection.
In the case of a positive result of the express test, with the informed consent of the person being tested, a test for HIV infection shall be carried out.
|
significant
|
168.
|
Compliance with the deadlines for issuing negative results and availability of post-test consultation.
The test subject receives a negative result at the place of blood sampling upon presentation of an identity document within 3 (three) working days from the moment the blood sample is received for research at the laboratory. Before the issuance of the result, post-test counseling is carried out .
The examined person receives a negative result at the place of blood collection upon presentation of an identity document within 3 (three) working days from the date of receipt of the blood sample for examination in the laboratory. Before issuing the result, a post-test consultation shall be conducted.
|
significant
|
169.
|
Compliance with the deadlines for sending serum samples to the RSHO (republican state healthcare organization that carries out activities in the sphere of HIV prevention). Upon receipt of two positive test results, a serum sample with a volume of at least 1 (one) ml shall be sent to the RSHO laboratory for confirming studies no later than three working days from the moment of the last setting.
|
significant
|
170.
|
Compliance with the terms of repeated examination in case of a doubtful result.
When receiving contradictory research results, the result shall be considered doubtful. After 14 (fourteen) calendar days, a repeated blood sampling and testing for HIV infection shall be carried out, according to the first stage of the procedure for diagnosing HIV infection in adults (RSHO transfers information about a dubious result for HIV infection to the territorial state healthcare organization carrying out activities in the sphere of prevention of HIV infection, for retesting for HIV infection).
When receiving a second doubtful result for HIV infection after 14 (fourteen) calendar days, additional studies shall be conducted using other serological tests. A negative result shall be given for two negative results from three studies conducted. A positive result shall be given for two positive results from three studies conducted. In the case of examination of pregnant women, molecular biological tests are additionally used (quantitative determination of HIV ribonucleic acid with a test sensitivity of no more than 50 copies/ml or determination of HIV proviral deoxyribonucleic acid).
|
significant
|
171.
|
Availability of pre-test and post-test consultation.
Pre-test consultation shall be provided through visual agitation tools that are displayed in waiting areas.
Pre-test consultation includes:
1) information about the benefits of testing for HIV infection, transmission routes and the significance of HIV-positive and HIV-negative test results;
2) an explanation of the services available in the case of an HIV-positive diagnosis, including an explanation of free antiretroviral therapy;
3) a brief description of the methods of prevention and examination of a partner with a positive HIV test result;
4) guarantee of confidentiality of test results.
Availability of post-test consultation of the examined.
Post-test consultation includes:
1) communication of the test result and the value of the result to the patient;
2) informing about the possible stay in the seronegative window (with an undefined or negative result) and the need for re-examination for HIV infection;
3) explaining how to reduce the risk of infection by changing behavior;
4) informing about the possibilities of additional medical care for key groups of population, psycho-social assistance;
5) psychological help and support.
|
significant
|
172.
|
Availability of the informed consent to enter personal data into the information systems of persons with positive results.
If the result of testing for HIV infection is positive, an informed consent to enter personal data into the electronic tracking system shall be signed. In case of refusal to enter personal data, the number and date of the IB result, initials, date of birth, epidemiological history data shall be entered into the electronic tracking system
|
significant
|
173.
|
Monitoring and assessment of coverage of key population groups and people living with HIV shall be carried out by maintaining a database of individual records of clients and corresponding forms of accounting and reporting documentation by the specialists of healthcare organizations, carrying out activities in the sphere of HIV prevention
|
significant
|
174.
|
Carrying out diagnostics and treatment of STI(sexually transmitted infections).
In friendly offices, STI diagnostics and treatment shall be carried out in accordance with clinical protocols for STI diagnosis and treatment
|
significant
|
175.
|
Availability of equipped transport for mobile trust points
|
significant
|
176.
|
Implementation of pre-contact and post-contact prevention among the population and key population groups
|
gross
|
177.
|
Availability of observation of the contact persons in a timely manner.
The contact persons shall be observed in a healthcare organization carrying out activities in the sphere of HIV prevention. The duration of observation of the contact persons shall be established for:
1) the children born from HIV-infected mothers - eighteen months;
2) medical workers in the event of an emergency - three months;
4) recipients of donor biomaterial - three months;
5) sexual partners of HIV-infected and the contact persons for joint drug injection - until 3 months after the end of contact, a negative HIV test result; with continued contact, the contact persons shall be examined for HIV infection 2 times a year;
6) persons from the nosocomial focus - three months after discharge from the medical organization; if more than three months have passed since discharge, the contact persons shall undergo a single examination; if the result is negative, the observation shall be terminated.
|
gross
|
178.
|
Availability of dynamic observation and provision of antiretroviral therapy for HIV-infected individuals.
The results of laboratory examination of contact persons shall be recorded in the outpatient card of an HIV-infected person registered with a dispensary ( discordant couples). An HIV-infected person in dynamics shall submit data on changes in marital status, surname, first name, patronymic (if any), data on new contact persons for examination and observation, which are entered into the electronic tracking database.
The provision of antiretroviral therapy to reduce the risk of HIV transmission from the moment of diagnosis shall be conducted in accordance with the recommendations of clinical protocols for the diagnosis and treatment of HIV infection in adults and children, with involvement of outreach workers and social workers.
|
gross
|
Criteria for subjects (objects) carrying out activities in the sphere of blood services
|
179.
|
Availability of a license and annexes to it for the activities carried out
|
gross
|
180.
|
Compliance with the certificate of a specialist in the relevant clinical specialty
|
gross
|
181.
|
Compliance in the organization of the blood service with the requirements of stage-by-stage labeling of blood and its components. Providing conditions for the traceability of the movement of each blood product from the donor to the receipt of the finished product and its use
|
gross
|
182.
|
Laboratory examination of the recipient's blood samples for the presence of markers of blood-borne infections before and after transfusions shall be carried out by qualitative immunoserological and molecular biological methods on automatic closed-type analyzers.
|
gross
|
183.
|
After donation of blood and its components, all information on donation of blood and its components, including the type of reaction and the amount of medical care provided, in case of side effects of donation shall be recorded in the electronic information database. Prepared blood and its components shall be transferred to the primary fractionation unit with accompanying documentation
|
significant
|
184.
|
The donor shall be provided with a questionnaire for the donor of blood and its components, which he/she fills in independently or with the participation of a medical registrar, as well as an information sheet
|
significant
|
185.
|
Performing immunohematological studies for the presence of irregular anti-erythrocyte antibodies in liquid-phase systems on a plane and in test tubes, reading the result of the agglutination reaction with mandatory microscopy.
|
significant
|
186.
|
Input and daily intralaboratory quality control of reagents to confirm their activity and specificity. Entrance control shal be subject to:
1) purchased materials (containers for blood collection, reagents, test systems, disinfectants, instruments and other materials), the nomenclature of which is approved by the first head of the blood service organization;
2) units of donor blood and its components (upon acceptance into production)
|
significant
|
187.
|
The blood collected in field conditions shall be placed in thermocontainers marked "Hemoproducts not examined, not subject to delivery" and shall be delivered at a temperature of 22 ± 2 ° C within 18-24 hours to the blood service organization
|
significant
|
188.
|
For immunohematological studies of blood samples from potential recipients, the reagents with monoclonal antibodies and equipment, registered by the state body in the sphere of circulation of medicines and medical devices shall be used.
|
significant
|
2. Criteria for the source of information "Results of monitoring data received from automated information systems"
|
1.
|
Availability of cases of an increase in the number of preventable deaths by 5% compared to the previous period
|
gross
|
2.
|
Availability of cases of exceeding the indicator of unjustified deviation of medical, diagnostic measures from the standards in the field of healthcare (more than 10% of the number of patients treated)
|
significant
|
3.
|
Availability of cases of postoperative complications
|
significant
|
4.
|
Availability of cases of unjustified hospitalization in a hospital
|
significant
|
5.
|
Availability of cases of surgical treatment after 2 days or more with planned hospitalization
|
significant
|
6.
|
Availability of complications after the transplantation
|
gross
|
7.
|
Availability of cases of reperfusion therapy coverage for transmural infarction is less than 75%
|
significant
|
8.
|
Availability of cases of coverage of percutaneous coronary intervention with subendocardial infarction is less than 40%
|
significant
|
9.
|
Availability of cases of deviations in the average population on the site from the standards
|
significant
|
10.
|
Availability of cases of untimely detection of malignant neoplasms of visual localization
|
gross
|
11.
|
Availability of cases of untimely diagnosed pulmonary tuberculosis
|
gross
|
12.
|
Availability of cases of exceeding the rate of hospitalized patients due to complications of diseases of the circulatory system (acute myocardial infarction, acute cerebrovascular accident) out of more than 5% of those registered in the dispensary
|
significant
|
13.
|
Availability of cases of excess of the child mortality rate (from 7 days to 5 years), preventable at the level of the outpatient organization, in comparison with the previous year by 5%
|
gross
|
14.
|
Availability of cases of untimely hospitalization of bacilli-releasing agents
|
gross
|
15.
|
Availability of cases of destructive forms of pulmonary tuberculosis among newly diagnosed children
|
significant
|
16.
|
Availability of cases of tuberculosis among the employees of anti-tuberculosis organizations
|
gross
|
17.
|
Availability of cases of exceeding the mortality rate in the hospital by 5% or more from the previous period
|
significant
|
18.
|
Availability of cases of non-compliance with the terms of start of specialized treatment from the date of establishing the diagnosis of a malignant neoplasm
|
significant
|
19.
|
Availability of cases of an increase in the rate of birth injuries of newborns compared to the previous assessment period
|
significant
|
20.
|
Availability of cases of complications associated with the use of high-tech medical services, unique technologies
|
significant
|
3. Criteria for the source of information "Results of monitoring reporting data provided by the subject of control"
|
1.
|
Availability of cases of non-compliance of the workload per 1 doctor-laboratory assistant to the approved standards
|
significant
|
2.
|
Availability of cases of non-compliance of the indicator of the patients number removed from the drug treatment register with recovery or remission to the approved standards (less than 8%)
|
significant
|
3.
|
Availability of non-compliance in the indicator of the patients number
who are in remission for 1 year or more at the end of the reporting period to the approved standards (less than 18% - alcohol use, less than 22% - drug use)
|
significant
|
4.
|
Availability of cases of non-compliance of the terms of average stay of patients in medical and social rehabilitation programs to the approved standards (less than 30 bed/days)
|
significant
|
5.
|
Availability of cases of non-compliance of the indicator of the specific weight of patients with dependence on psychoactive substances who have undergone inpatient treatment and rehabilitation during the last year to the total number of persons dependent on psychoactive substances who are on the drug treatment register with the approved values (below 10% of the number of those who are registered)
|
significant
|
6.
|
Availability of cases of a decrease in the indicator of the patients number at the end of the reporting period in remission for 1 year or more compared to the indicator of the previous assessment period
|
significant
|
7.
|
Availability of cases of deviations from the time of arrival in the corresponding category (for organizations providing emergency medical care)
|
significant
|
8.
|
Availability of cases of repeated visits for the same case during the day
|
significant
|
9.
|
Availability of cases of a decrease in the proportion of donations examined by the method of two-stage screening for markers of transfusion infections in the total volume of examined donations is less than 100%
|
significant
|
10.
|
Availability of cases of a decrease in the proportion of donor blood samples subjected to immunological testing for the presence of markers for HIV-1,2, viral hepatitis C, viral hepatitis B, syphilis by enzyme immunoassay or immunochemiluminescence analysis, using a closed automated diagnostic system in the total volume of tested donor blood samples is less 100%
|
significant
|
11.
|
Availability of cases of a decrease in the proportion of donor blood samples subjected to molecular biological research - polymerase chain reaction for the presence of ribonucleic acid to HIV-1,2, viral hepatitis C and deoxyribonucleic acid to viral hepatitis B using a closed automated diagnostic system in the total volume of the samples studied donated blood is less than 100%
|
significant
|
12.
|
Availability of cases of a decrease in the share of gratuitous voluntary donations of blood and its components in the total volume of donations for the reporting period below the national average
|
significant
|
13.
|
Availability of cases of a decrease in the share of automation of the plasma procurement process in the total volume of the procurement by the plasmapheresis method for the reporting period is below the national average
|
significant
|
14.
|
Availability of cases of a decrease in the rate of automation of the platelets procurement process in the total volume of procurement by the cytapheresis method for the reporting period is below the national average
|
significant
|
15.
|
Availability of medical devicesused in the production and quality control of blood products that has not undergone regular scheduled maintenance
|
significant
|
16.
|
Availability of cases of exceeding the rate of the treatment regime violation among new cases with bacterial excretion of more than 5%
|
significant
|
17.
|
Availability of cases of a decrease in the indicator of treatment coverage with reserve-line drugs among all patients with multidrug resistance less than 85%
|
significant
|
18.
|
Availability of cases of providing inaccurate reporting information
|
minor
|
4. Criteria for the source of information "Results of the analysis of information received from authorized bodies and organizations"
|
1.
|
Availability of cases of hepatitis, syphilis in laboratory staff
|
significant
|
2.
|
Availability of cases of a decrease in the percentage of people who inject drugs (less than 50%) and sex workers (less than 60%) who have been diagnosed for HIV infection, from among those who applied to prevention programs, except for those with an established HIV infection status
|
significant
|
3.
|
Availability of five or more confirmed complaints, appeals from individuals and legal entities over the past year (for republican, regional and city medical organizations)
|
gross
|
4.
|
Availability of two or more confirmed complaints, appeals from individuals and legal entities over the past year (for regional medical organizations)
|
gross
|
Explanation of abbreviations:
ICU– intensive care unit
HIV– human immunodeficiency virus
GP – general practitioner
MN– malignant neoplasm
STI – sexually transmitted infections
CDA – consultative and diagnostic assistance
MDG – multidisciplinary group
PAS –psychoactive substances
PHC - primary health care
SPOIS – a specialized psychiatric organization with intensive supervision
MBD – mental, behavioral disorders
ATD - anti-tuberculosis drugs
PMHC - primary mental health center
RSHO - a republican state healthcare organization that carries out activities in the sphere of HIV prevention
RSPCMH – republican scientific and practical center for mental health
EMA – emergency medical assistance
EMAS – emergency medical assistance service
CVD – cardiovascular disease
US – ultrasound examination
MHC – mental health center
EIS –electronic information system
ECG –electrocardiography
| |
Annex 2
to the joint order of the
Minister of Healthcare of the
Republic of Kazakhstan
dated November 15, 2018
No. KR HCM-32 and the Minister of
National Economy of the
Republic of Kazakhstan
dated November 15, 2018 No. 70 |
A checklist in the sphere of state quality control of rendering medical services
in relation to the subjects (objects) providing inpatient, inpatient-replacing assistance*
Footnote. Appendix 2 – is in the wording of the joint order of the Minister of Healthcare of the Republic of Kazakhstan dated 06.01.2021 No. KR HCM-3 and the Minister of National Economy of the Republic of Kazakhstan dated 06.01.2021 No. 5 (shall be enforced upon expiry of ten calendar days after its first official publication).
State body that assigned the inspection _____________________________
________________________________________________________________________
Act on assignment of an inspection/preventive control with a visit to the subject (object) of control
____________________________________________________________________
________________________________________________________________________
No., date
Name of the subject (object) of control
____________________________________________________________________________
(Individual identification number), business identification number of the subject (object)
of control ______________________________________________________________________
_________________________________________________________________
Location address _______________________________________________________
_____________________________________________________________________________
№
|
List of requirements
|
Required
|
Not required
|
Meets the requirements
|
Doesn't meet the requirements
|
1.
|
Availability of a license and annexes to it for the activities carried out
|
|
|
|
|
2.
|
Availability of a specialist certificate in the relevant clinical specialty
|
|
|
|
|
3.
|
Availability of a conclusion on compliance of a healthcare subject with the provision of high-tech medical services
|
|
|
|
|
4.
|
Availability of a written voluntary consent of the patient or his/her legal representative for invasive interventions and for conducting medical and diagnostic measures
|
|
|
|
|
5.
|
The time spent by the emergency medical team or the emergency department in the organization of primary health care in the hospital reception department does not exceed 10 minutes (the time for transferring the patient to the emergency department doctor) from the moment of its arrival at the hospital, except in cases of the need to provide emergency medical care in emergency situations.
After the transfer by the ambulance teams or the emergency department, when organizing the primary health care of the patient to the hospital reception department, the nurse conducts the distribution of incoming patients (medical sorting according to the triage-system) into groups, based on the priority of emergency medical care.
Medical sorting according to the triage -system shall be conducted continuously and successively. Upon completion of the assessment, the patients shall be marked with the color of one of the sorting categories, in the form of a special colored tag or colored tape.
According to medical sorting, there are 3 groups of patients:
the first group (red zone) - patients whose condition poses an immediate threat to life or who have a high risk of deterioration and require emergency medical care;
the second group (yellow zone) - patients whose condition poses a potential threat to health or may progress with the development of a situation requiring emergency medical care;
the third group (green zone) - patients whose condition does not pose an immediate threat to life and health and does not require hospitalization
|
|
|
|
|
6.
|
Hospitalization of a serious patient who needs constant monitoring of vital functions for medical reasons, by the decision of the council and notification of the heads of healthcare organizations after stabilization of the condition shall be transferred to another medical organization according to the disease profile for further examination and treatment
|
|
|
|
|
7.
|
In the absence of indications for hospitalization in a healthcare organization, the doctor of the reception department shall issue a medical conclusion to the patient with a written justification for the refusal.
|
|
|
|
|
8.
|
Indications for hospitalization:
the need to provide pre-medical, qualified, specialized medical care, including the use of high-tech medical services, with round-the-clock medical supervision of patients:
1) in a planned manner - on the referral of PHC specialists or other healthcare organization:
2) for emergency indications (including weekends and holidays) - regardless of the availability of a referral
|
|
|
|
|
9.
|
Examination of the patient by the head of the department of severe patients on the day of hospitalization, thereafter - daily. Patients in a moderate condition shall be examined at least once a week. The results of examination of the patient shall be recorded in the medical record, indicating the recommendations for further tactics of managing the patient with obligatory identification of the medical worker making the entries
|
|
|
|
|
10.
|
Clinical diagnosis shall be established together with the head of the department no later than three calendar days from the date of hospitalization of the patient to the healthcare organization
|
|
|
|
|
11.
|
Daily examination of patients in the hospital by the attending physician, except for weekends and holidays. When examining and appointing additional diagnostic and therapeutic manipulations by the doctor on duty, appropriate entries shall be made in the medical record
|
|
|
|
|
12.
|
Compliance with the requirements for planned hospitalization:
1) availability of a referral for hospitalization to the hospital and a card for planned hospitalization; 2) hospitalization of the patient in accordance with the established date of planned hospitalization in the referral;
3) availability of clinical and diagnostic (laboratory, instrumental and functional) studies and consultations of specialized specialists according to the diagnosis
|
|
|
|
|
13.
|
Availability of consultations or councils in case of difficulty in identifying the diagnosis, ineffectiveness of conducted treatment, as well as for other indications
|
|
|
|
|
14.
|
Compliance with discharge criteria, in particular:
1) generally accepted treatment outcomes (recovery, improvement, no change, death, transferred to another medical organization);
2) a written statement of the patient or his/her legal representative in the absence of an immediate danger to the patient's life or to others;
3) cases of violation of the internal regulations established by the healthcare organization, as well as the creation of obstacles for the treatment and diagnostic process, infringement of the rights of other patients to receive adequate medical care (in the absence of an immediate threat to his/her life), which is recorded in the medical record.
|
|
|
|
|
15.
|
Availability of the issuance of a discharge summary to the patient at the time of discharge with an indication of full clinical diagnosis, the volume of diagnostic studies, therapeutic measures and recommendations for further observation and treatment. Discharge data shall be entered into information systems on a day-to-day basis, indicating the actual time of discharge.
|
|
|
|
|
16.
|
Compliance with the requirements for transfusion of blood components and in the event of complications:
Before the transfusion of blood components, the recipient shall be examined for markers of blood- borne infections HIV, hepatitis B and C, and after the end of treatment, the discharge summary indicates the need for re-examination for HIV and hepatitis B and C at the place of residence.
Examination of recipients for the presence of HIV infection within the guaranteed volume of free medical care shall be carried out in state healthcare organizations, carrying out activities in the sphere of HIV prevention
Before the start of transfusion therapy information regarding the transfusion and obstetric history shall be entered into the patient's medical record:
presence of previous transfusions, when and in connection with what;
whether there were post-transfusion complications, pregnancies that ended in the birth of children with hemolytic disease of the newborn.
In the event of complications during a biological test, during or after a transfusion, a detailed record (records) with a description of the recipient's condition, monitoring data of vital functions, treatment methods and their effectiveness shall be made.
Immediate laboratory monitoring of the recipient's blood and urine shall be performed.
|
|
|
|
|
17.
|
Compliance with indications for hospitalization in a day hospital at outpatient healthcare organizations and in a hospital at home shall be:
1) exacerbation of chronic diseases that do not require round-the-clock medical supervision;
2) active planned rehabilitation of a group of patients with chronic diseases subject to dynamic observation;
3) follow-up treatment of the patient the next day after a course of inpatient treatment for medical reasons;
4) conducting courses of medical rehabilitation of the second and third stages;
5) palliative care;
6) orphan diseases in children associated with a high risk of infectious complications and requiring isolation during the period of seasonal viral diseases in order to receive regular enzyme replacement and antibacterial therapy.
The requirements for a day hospitalization to a 24-hour hospital shall be:
1) performing operations and interventions with special preoperative preparation and resuscitation support;
2) conducting complex diagnostic studies requiring special preliminary training, and also not available in outpatient healthcare organizations;
3) observation of patients whose treatment is associated with transfusion of blood products, intravenous injections of blood-substituting fluids, specific hyposensitizing therapy, injections of potent drugs, intra-articular injections of drugs;
4) follow-up treatment the next day after inpatient treatment if there are indications for early discharge after surgical treatment;
5) palliative care;
6) chemotherapy, radiation therapy, correction of pathological conditions that occurred after specialized treatment of cancer patients
|
|
|
|
|
18.
|
Availability of persons examination for clinical indications for HIV infection in identification of the following diseases, syndromes and symptoms: 1) enlargement of two or more lymph nodes lasting more than 1 month, persistent, generalized lymphadenopathy;
2) fever of unknown etiology (persistent or recurrent lasting more than 1 month);
3) unexplained severe cachexia or severe eating disorders that do not respond well to standard treatment (in children), unexplained weight loss of 10% or more;
4) chronic diarrhea for 14 days or more (in children), unexplained chronic diarrhea lasting more than a month;
5) seborrheic dermatitis, itchy papular rash (in children);
6) angular cheilitis;
7) recurrent upper respiratory tract infections (sinusitis, otitis media, pharyngitis, tracheitis, bronchitis);
8) shingles;
9) any disseminated endemic mycosis, deep mycoses (coccidioidosis, extrapulmonary cryptococcosis (cryptococcal meningitis), sporotrichosis, aspergillosis, isosporosis, extrapulmonary histoplasmosis, strongyloidosis, actinomycosis);
10) pulmonary and extrapulmonary tuberculosis, including disseminated infection caused by atypical mycobacteria, except for peripheral lymph node tuberculosis;
11) hairy leukoplakia of the oral cavity, linear erythema of the gums;
12) severe lingering recurrent pneumonia and chronic bronchitis, not amenable to conventional therapy (multiple two or more times during the year), asymptomatic and clinically pronounced lymphoid interstitial pneumonia;
13) sepsis, lingering and recurrent purulent-bacterial diseases of internal organs (pneumonia, pleural empyema, meningitis, meningoencephalitis, infections of bones and joints, purulent myositis, salmonella septicemia (except for Salmonella typhi ), stomatitis, gingivitis, periodontitis);
14) pneumocystis pneumonia;
15) infections caused by the herpes simplex virus, with damage to internal organs and chronic (lasting more than one month from the moment of illness) damage to the skin and mucous membranes, including the eyes;
16) cardiomyopathy;
17) nephropathy;
18) encephalopathy of unknown etiology;
19) progressive multifocal leukoencephalopathy;
20) Kaposi's sarcoma;
21) neoplasms, including lymphoma (of the brain) or B-cell lymphoma;
22) toxoplasmosis of the central nervous system;
23) candidiasis of the esophagus, bronchi, trachea, lungs, mucous membranes of the mouth and nose;
24) disseminated infection caused by atypical mycobacteria;
25) cachexia of unknown etiology;
26) protracted recurrent pyoderma, not amenable to conventional therapy;
27) severe chronic inflammatory diseases of the female genital area of unclear etiology;
28) invasive neoplasms of the female genital organs;
29) mononucleosis after 3 months from the onset of the disease;
30) sexually transmitted infections (syphilis, chlamydia, trichomoniasis, gonorrhea, genital herpes, viral papillomatosis and others) with an established diagnosis;
31) viral hepatitis B and C, upon confirmation of the diagnosis;
32) extensive confluent warts;
33) molluscum contagiosum with extensive eruptions, giant disfiguring molluscum contagiosum;
34) primary dementia in previously healthy individuals;
35) patients with hemophilia and other diseases who systematically receive transfusion of blood and its components;
36) generalized cytomegalovirus infection.
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19.
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Availability of an agreement for the provision of paid services in healthcare organizations
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20.
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Compliance with the following requirements when conducting an examination of temporary disability, issuing a sheet and a certificate of temporary disability:
1) availability of a person examination and a record of data about his/her state of health in the medical record of an outpatient (inpatient) patient, justifying the need for temporary release from work;
2) issuance of a sheet and a certificate of temporary disability on the day of discharge of persons with inpatient treatment (including day hospitals, rehabilitation centers) for the entire period of inpatient treatment;
3) closing the sheet and certificate of temporary disability by the date of discharge from the hospital if the working capacity of persons is fully restored;
4) extension of a sheet and a certificate of temporary disability for work to the persons who continue to be temporarily disable for a period, taking into account the time required for his/her appearance to a medical worker of a polyclinic or to call a medical worker at home (but not more than for one calendar day). For persons who received treatment outside the region of residence, the time required to arrive at the place of his/her permanent residence shall be taken into account (but not more than four calendar days);
5) issuance of a certificate of temporary disability for injuries sustained in a state of alcoholic or drug intoxication, as well as for acute alcohol or drug intoxication, for the entire period of temporary disability;
6) issuance of a sheet and certificate of temporary disability to the persons suffering from mental illness, in case of untimely contact to a medical organization over the past days, at the conclusion of a medical advisory commission of a neuropsychiatric dispensary or a medical worker (psychiatrist) together with the head of a medical organization;
7) issuance of a sheet and a certificate of temporary disability to the persons sent by the court decision for a forensic medical or forensic psychiatric examination and recognized as disabled from the date of admission for an examination;
8) issuing both a sheet and a certificate of temporary disability to a person who combines training with work.
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21.
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Availability of a clinical audit by the patient support Service and internal expertise and its assessment according to the following criteria:
1) the quality of anamnesis collection, which is assessed according to the following criteria:
lack of anamnesis collection;
completeness of anamnesis collection;
availability of data on past, chronic and hereditary diseases, blood transfusions, drug tolerance, allergic status; development of complications as a result of tactical mistakes made during treatment and diagnostic measures due to poor-quality anamnesis;
2) completeness and validity of diagnostic studies, which are assessed according to the following criteria:
lack of diagnostic measures;
an incorrect conclusion or lack of a conclusion on the results of conducted diagnostic studies, which led to an incorrect diagnosis and mistakes in treatment tactics;
conducting diagnostic studies provided for by clinical protocols;
conducting diagnostic studies with a high, unjustified risk to the patient's health, the validity of conducting diagnostic studies that are not included in the clinical protocols;
conducting diagnostic studies that are not informative for the correct diagnosis and led to an unreasonable increase in the duration of treatment and an increase in the cost of treatment;
3) correctness, timeliness and validity of the clinical diagnosis, taking into account the results of the studies conducted (with planned hospitalization, studies conducted at the pre-hospital stage shall be taken into account ), which are assessed according to the following criteria:
the diagnosis is missing, incomplete or incorrect, does not correspond to the international classification of diseases;
the leading pathological syndrome that determines the severity of the disease course has not been identified, concomitant diseases and complications have not been recognized;
diagnosis is correct, but incomplete, the leading pathological syndrome has not been identified with the identified complications, concomitant diseases that affect the outcome have not been recognized;
diagnosis of the underlying disease is correct, but concomitant diseases affecting the result of treatment have not been diagnosed.
Objective reasons for incorrect and (or) untimely diagnosis (atypical course of the underlying disease, asymptomatic course of concomitant disease, rare complications and concomitant diseases) shall be reflected in the results of the examination. An assessment of the impact of incorrect and (or) untimely diagnosis on the subsequent stages of provision of medical services (assistance) shall be made
4) timeliness and quality of consultations from specialized specialists, which are assessed according to the following criteria:
lack of consultation, which led to an erroneous interpretation of symptoms and syndromes that adversely affected the outcome of the disease;
the consultation is timely, failure to take into account the opinion of the consultant when making the diagnosis partially influenced the outcome of the disease;
the consultation is timely, the opinion of the consultant was taken into account when making the diagnosis, failure to comply with the consultant's recommendation for treatment partially influenced the outcome of the disease;
the consultant's opinion is erroneous and influenced the outcome of the disease.
In cases of delayed consultations, an assessment of objectivity of the reasons for untimely consultation and the impact of the untimely diagnosis on the subsequent stages of provision of medical services (assistance) shall be made;
5) volume, quality and validity of conducting treatment measures, which are assessed according to the following criteria:
lack of treatment if indicated;
prescribing treatment in the absence of indications;
prescription of ineffective therapeutic measures without taking into account the characteristics of the disease course, concomitant diseases and complications;
implementation of therapeutic measures not in full, without taking into account the functional state of organs and systems, prescribing drugs without proven clinical efficacy;
non-compliance with the requirements of the Standards, unjustified deviation from the requirements of clinical protocols, presence of polypragmasia, which led to the development of a new pathological syndrome and deterioration of the patient's condition;
6) absence or development of complications after medical interventions, all complications that have arisen are assessed, including those caused by surgical interventions (delayed surgery, inadequate volume and method, technical defects) and diagnostic procedures;
7) the achieved result, which is assessed according to the following criteria:
achievement of the expected clinical effect while adhering to the technology of rendering medical services (assistance);
lack of clinical effect of therapeutic and prophylactic measures due to poor-quality anamnesis and diagnostic studies;
наличие полипрагмазии, обусловившее развитие нежелательных последствий;
absence of the expected clinical effect due to ineffective therapeutic, preventive measures without taking into account the peculiarities of the disease course, concomitant diseases, complications, prescribing drugs without proven clinical efficacy;
presence of polypragmasia, which caused the development of undesirable consequences;
8) the quality of medical documentation, which is assessed by the presence, completeness and quality of records in primary medical documentation intended to record data on the health status of patients, reflecting the nature, volume and quality of medical care provided in accordance with the forms of reporting and accounting documentation
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22.
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Compliance with the following actions when conducting a pathoanatomical autopsy:
1) carrying out a pathoanatomical autopsy of corpses after the doctors have stated biological death, after providing the medical record of an inpatient patient or the medical record of an outpatient patient with a written order of the chief physician or his/her deputy for the medical (treatment) part of the healthcare organization to send for a pathoanatomical autopsy;
2) registration of the results of the pathoanatomical autopsy in the form of a pathoanatomical diagnosis (the pathoanatomical diagnosis includes: underlying disease, complication of underlying disease, concomitant disease, combined underlying disease);
3) transfer of a medical record of an inpatient patient or a medical record of an outpatient patient with the pathoanatomical diagnosis entered into it to the medical archive of the healthcare organization no later than ten working days after the pathological autopsy;
4) conducting clinical and pathoanatomical analysis in cases of death of patients in healthcare organizations;
5) pathoanatomical autopsy in case of suspected acute infectious, oncological diseases, pathology of childhood, fatal outcome due to medical manipulations in order to establish the cause of death and clarify the diagnosis of disease with a fatal outcome;
6) organization of autopsy materials in cases of suspected infectious diseases by the chief physician and head of the pathoanatomical department of virological (immunofluorescent) and bacteriological examination;
7) transfer to the pathoanatomical bureau, the centralized pathoanatomical bureau and the pathoanatomical department of the medical records of inpatients for all deaths for the previous day no later than 10 am of the day following the establishment of the fact of death;
8) registration of:
- a medical certificate of death (preliminary, final) by a doctor in the specialty "pathological anatomy (adult, pediatric)" on the day of the pathoanatomical autopsy;
- a medical certificate of perinatal death (preliminary, final) by a doctor in the specialty "pathological anatomy (adult, pediatric)" on the day of the pathoanatomical autopsy;
9) registration of the results of the autopsy in the form of a protocol of pathoanatomical examination;
10) the presence of a written notification to the forensic authorities to resolve the issue of transferring the corpse for forensic medical examination upon detection of signs of violent death and termination of the pathoanatomical examination of the corpse;
11) the presence of a written notification from a doctor in the specialty "pathological anatomy (adult, pediatric)" in case of initial detection during the autopsy of signs of an acute infectious disease, food or industrial poisoning, an unusual reaction to vaccination, as well as an emergency notification to the bodies of the state sanitary and epidemiological service immediately after their identification;
12) conducting a pathoanatomical examination of the placenta:
- in the case of stillbirth;
- for all diseases of newborns identified at the time of birth;
- in cases, suspected of hemolytic disease of newborns;
- in case of early discharge of water and in case of dirty waters;
- in case of diseases of the mother, occurring with a high temperature in the last trimester of pregnancy;
- with an obvious abnormality of development or attachment of the placenta;
- in cases of suspect for the presence of congenital malformations of the fetus;
- in cases of preeclampsia, eclampsia
13) mandatory registration of a fetus weighing less than 500 grams with anthropometric data (weight, height, head circumference, chest circumference);
14) establishment of a pathoanatomical autopsy, depending on the complexity, into the following categories:
first category;
second category;
third category;
fourth category;
15) establishment of the category of pathoanatomical autopsy and the reasons for discrepancy in diagnoses when the final clinical and pathoanatomical diagnoses differ by the doctor in the specialty "pathological anatomy (adult, pediatric)"
16) availability of a detailed analysis with the definition of the profile and categories of iatrogeny in all cases of iatrogenic pathology identified as a result of a pathoanatomical autopsy
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23.
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Availability of a written statement of the spouse, close relatives or legal representatives of the deceased, or a written statement of will given by a person during his/her lifetime for the delivery of a corpse without a post mortem examination, in the absence of suspicion of violent death
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Official ( s ) _____________________________________________________________
______________________________________________________________________
position signature
_____________________________________________________________________________
surname, name, patronymic (if any)
Head of the subject of control _____________________________________
__________________________________________________________________
position signature
___________________________________________________________________________
surname, name, patronymic (if any)
List of abbreviations:
HIV - Human Immunodeficiency Virus
EMA – emergency medical assistance
Notes:
* - this checklist is used in relation to all subjects (objects) rendering inpatient, inpatient replacing assistance, regardless of the profile of provided medical services
** - this checklist is used in relation to all subjects (objects) rendering outpatient assistance (primary health care and consultative-diagnostic assistance), regardless of the profile of medical services provided in the form of consultative-diagnostic assistance, (including for the subjects (objects) of rendering pre-medical care)
***- this checklist is used in relation to subjects (objects) rendering medical services in the corresponding profile, as an additional checklist to the main checklist used in relations between subjects (objects) providing inpatient, inpatient-replacing and outpatient assistance, depending on the form of rendering medical care in the subject (object) of control
**** - this checklist is used in relation to subjects (objects) carrying out activities in the sphere of laboratory service, also when conducting an inspection of the subject (object) of health care, which includes a laboratory service, this checklist is used as an additional checklist to the main checklist used depending on the form and profile of rendering medical care in the subject (object) of control
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Annex 3
to the joint order of the
Minister of Healthcare of the
Republic of Kazakhstan
dated November 15, 2018
No. KR HCM-32 and the Minister of
National Economy of the
Republic of Kazakhstan
dated November 15, 2018 No. 70 |
A checklist in the sphere of state quality control of rendering medical services in relation to the subjects (objects)
providing outpatient-polyclinic care (primary health care and consultative-diagnostic assistance)**
Footnote. Appendix 3 - is in the wording of the joint order of the Minister of Healthcare of the Republic of Kazakhstan dated 06.01.2021 No. KR HCM-3 and the Minister of National Economy of the Republic of Kazakhstan dated 06.01.2021 No. 5 (shall be enforced upon expiry of ten calendar days after its first official publication).
State body that assigned the inspection _____________________________
________________________________________________________________________
Act on assignment of an inspection/preventive control with a visit to the subject (object)
of control ____________________________________________________________________
________________________________________________________________________
No., date
Name of the subject (object) of control
____________________________________________________________________________
(Individual identification number), business identification number of the subject (object) of control
______________________________________________________________________
_________________________________________________________________
Location address _______________________________________________________
_____________________________________________________________________________
№
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List of requirements
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Required
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Not required
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Meets the requirements
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Doesn't meet the requirements
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1.
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Availability of a license and annexes to it for the activities carried out
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2.
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Availability of a specialist ceritificate in the relevant clinical specialty
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3.
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Compliance of the performed medical and diagnostic measures with the recommendations of clinical protocols
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4.
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Compliance with the following requirements when organizing and conducting a medical advisory commission:
1) availability of an order from the head of a medical organization:
- on creation of a medical advisory commission;
- on the composition, number of members (at least three doctors),
- on the procedure and schedule of work of the medical advisory commission
2) availability of conclusion of the medical advisory commission
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5.
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Compliance with the general procedure for conducting preventive medical examinations of target population groups by primary health care organizations:
1) availability of lists of target groups of persons subject to screening examinations;
2) ensuring continuity with specialized medical organizations for carrying out these examinations;
3) inform the population about the need to undergo screening studies;
4) entering data on the passage of screening studies in the medical information system;
5) conducting a monthly analysis of the screening studies performed with the provision of information to local government health authorities by the 5th day of the month following the reporting one.
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6.
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Compliance of the levels of medical rehabilitation provision to patients:
1) primary level – medical organizations of primary healthcare that have an office /department of rehabilitation in their structure, a day hospital and provide medical rehabilitation to patients whose condition is assessed from 1 to 2 points on the Rehabilitation Routing Scale (hereinafter- RRS);
2) secondary level - medical organizations that have specialized departments and (or) centers in their structure, carrying out medical rehabilitation in outpatient, inpatient-replacing and inpatient conditions, providing medical rehabilitation to patients whose condition is assessed from 2 to 4 points according to RRS ;
3) tertiary level - specialized medical organizations that have departments and (or) centers in their structure that provide medical rehabilitation, including with the use of high-tech services, in outpatient, inpatient-replacing and inpatient conditions to the patients whose condition is assessed from 2 to 4 points according to RRS.
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7.
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Compliance with the provision of anti-tuberculosis care at the outpatient-polyclinic level:
1) conducting information and explanatory work on prevention, early detection of tuberculosis;
2) planning (formation of lists of subject persons, drawing up a schedule), organization and conduct of fluorographic examination with registration of examination results in medical documentation;
3) planning (forming lists of subject persons, drawing up a schedule), organization and conduct of tuberculin diagnostics of children and adolescents with registration of examination results in medical documentation, conducting additional examination of tuberculin -positive children);
4) referral for examination of persons with suspected tuberculosis according to the diagnostic algorithm of the examination
5) referral to a phthisiatrician of persons with positive results of fluorographic examination, children and adolescents with newly diagnosed positive and hyperergic tuberculin test, with an increase in tuberculin sensitivity by 6 mm or more, children with adverse reactions and complications for vaccination against tuberculosis;
6) planning, organizing and conducting vaccination against tuberculosis;
7) controlled treatment of latent tuberculosis infection (hereinafter referred to as LTI) as prescribed by a phthisiatrician, including in a video - monitored mode;
8) examination of contact persons;
9) outpatient direct-controlled or video -monitored treatment of patients with tuberculosis;
10) diagnosis and treatment of adverse reactions to anti-tuberculosis drugs as prescribed by a phthisiatrician;
11) diagnosis and treatment of concomitant diseases;
12) maintaining medical records of tuberculosis patients undergoing outpatient treatment, including multidrug-resistant and extensively drug-resistant tuberculosis;
13) regular entry of data into the National register of tuberculosis patients within the competence
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8.
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Compliance with the following procedure for the provision of oncological care in the form of outpatient care:
formation of groups of people at risk of developing cancer;
examination by a doctor in order to determine the patient's condition and establish a diagnosis;
laboratory and instrumental examination of the patient for the purpose of making a diagnosis;
dynamic monitoring of cancer patients;
selection and referral to hospitalization of cancer patients to receive specialized medical care, including high-tech medical services;
additional examination of persons with suspected MN in order to verify the diagnosis;
determination of the tactics of management and treatment of the patient;
conducting outpatient anticancer therapy
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9.
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Availability of mandatory confidential medical examination for the presence of HIV infection of persons for clinical and epidemiological indications, including sexual partners of pregnant women, persons who applied voluntarily and anonymously
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10.
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At the first visit of a woman about pregnancy and, if she wants to save it, the obstetrician-gynecologist needs to carry out the following measures:
1) collects anamnesis, finds out the presence of diseases in the pregnant woman and relatives (diabetes mellitus, arterial hypertension, tuberculosis, mental disorders, oncological diseases and others), the birth of children with congenital malformations and hereditary diseases;
2) pays attention to the diseases (somatic and gynecological), operations, transfusions of blood and its components suffered in childhood and adulthood;
3) when collecting anamnesis, identifies a "risk" group for congenital and hereditary pathology for referral to a doctor in the specialty "Medical genetics" (without ultrasound screening and analysis of maternal serum markers) for the following indications: the age of a pregnant woman is 37 years and older, presence in the anamnesis of cases of termination of pregnancy for genetic indications and /or the birth of a child with congenital malformations or chromosomal abnormalities, presence in the anamnesis of cases of the birth of a child (or presence of relatives) with a monogenic hereditary disease, presence of family carriage of a chromosomal or gene mutation, a burdened obstetric history (stillbirth, habitual miscarriage and others);
4) directs pregnant women for blood sampling for analysis of maternal serum markers in the first trimester of pregnancy and prescribes ultrasound screening in the first, second and third trimesters of pregnancy;
5) studies the features of reproductive function;
6) clarifies the state of health of the spouse, blood type and rhesus affiliation;
7) studies the nature of the production where the spouses work, bad habits;
8) carries out early registration of pregnant women up to 12 weeks and registration on the day of pregnancy detection for timely examination;
9) finds out the presence of contraindications to pregnancy;
10) uses the opportunity to obtain information from the register of pregnant women and WFA about the course of previous pregnancies and previously identified somatic diseases.
11) draws up a preliminary management plan, taking into account the identified factors
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11.
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The obstetrician-gynecologist provides and organizes obstetric and gynecological care for women during pregnancy, after childbirth, provides services for family planning and reproductive health, as well as prevention, diagnosis and treatment of gynecological diseases of the reproductive system by:
1) dispensary observation of pregnant women in order to prevent and early detection of complications of pregnancy, childbirth and the postpartum period with allocation of women "by risk factors";
2) conducting prenatal screening - a comprehensive examination of pregnant women in order to identify a risk group for chromosomal pathology and congenital malformations (hereinafter - congenital malformations) of an intrauterine fetus;
3) identifying pregnant women in need of timely hospitalization in day hospitals, departments of pregnancy pathology at inpatient-level medical organizations providing obstetric and gynecological care, specialized medical organizations with extragenital pathology, in compliance with the principles of regionalization of perinatal care;
4) referrals of pregnant women, women in labor and parturient women to receive specialized care with medical supervision, including with the use of high-tech medical services to medical organizations of the republican level;
5) conducting prenatal training for pregnant women in preparation for childbirth, including partner childbirth, informing pregnant women about warning signs, effective perinatal technologies, the principles of safe motherhood, breastfeeding and perinatal care;
6) conducting patronage of pregnant women and women in childbirth according to indications;
7) counseling and provision of services on the issues of family planning and reproductive health protection;
8) prevention and detection of sexually transmitted infections for referral to specialized specialists;
9) examination of women of fertile age with the appointment, if necessary, in-depth examination using additional methods and involvement of specialized specialists for the timely detection of extragenital, gynecological pathology and their registration;
10) according to the results of examination, the woman shall be included in the dynamic observation group of women of fertile age, depending on the state of reproductive and somatic health, for timely preparation for the planned pregnancy in order to improve the outcomes of pregnancy for the mother and child;
11) organizing and conducting preventive examinations of the female population with the aim of early detection of extragenital diseases;
12) examination and treatment of gynecological patients using modern medical technologies;
13) identification and examination of gynecological patients to prepare for hospitalization in specialized medical organizations;
14) clinical examination of gynecological patients, including rehabilitation and sanatorium-resort treatment;
15) performing minor gynecological operations using modern medical technologies;
16) ensuring the continuity of interaction in the examination and treatment of pregnant women, postpartum women and gynecological patients;
17) conducting an examination of temporary disability due to pregnancy, childbirth and gynecological diseases, determining the need and timing of temporary or permanent transfer of an employee to another job for health reasons, referring of women with signs of persistent disability for a medical and social examination in accordance with the established procedure;
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12.
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Additional data of subsequent examinations and studies shall be recorded in the Individual card of the pregnant and postpartum women and the Prenatal record of the pregnant and postpartum women at each visit of the pregnant obstetrician-gynecologist
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13.
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Home patronage by a midwife or a patronage nurse for pregnant women who do not show up for an appointment within 3 days after the appointed date
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14.
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Availability of the conclusion of the medical advisory commission on the possible carrying of pregnancy in women with contraindications to pregnancy due to extragenital pathology
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15.
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Availability of an agreement for the provision of paid services in healthcare organizations
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16.
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Compliance by a nurse of a medical center of an educational organization with the following requirements:
1) availability of a single list of students in educational organizations;
2) availability of a list of students (target groups) subject to screening examinations;
3) organization and conduct of immunization followed by post-vaccination supervision of the vaccinated person;
4) monitoring compliance with the deadlines for passing mandatory medical examinations of all school employees and catering workers;
5) maintaining accounting and reporting documentation
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17.
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Compliance with the following measures when conducting an examination of temporary disability, issuing a sheet and a certificate of temporary disability:
1) presence of an examination of a person and a record of data on his/her state of health in the medical record of an outpatient (inpatient) patient, justifying the need for temporary release from work;
2) compliance with the deadlines for issuing a sheet and a certificate of temporary disability:
- in case of diseases and injuries, individually and at a time for three calendar days and with a total duration of no more than six calendar days;
- in the period of increased incidence of the population with influenza, acute respiratory viral infection on the basis of the order of the head of a medical organization up to six calendar days;
3) joint implementation of extension of a sheet and a certificate of temporary disability for more than six calendar days with the head of the department of a medical organization with a total duration of no more than twenty calendar days;
4) availability of conclusion of the medical advisory commission when extending the sheet on temporary disability for work for more than twenty calendar days;
5) compliance with the deadlines (no more than six calendar days) when issuing a sheet and a certificate of temporary disability by individuals engaged in private medical practice;
6) issuance of a sheet and a certificate of temporary disability on the basis of a certificate confirming an appeal to a trauma center and an ambulance station, taking into account the day of treatment and subsequent days off and holidays;
7) issuance of a sheet and a certificate of temporary disability to nonresident persons at the place of their temporary stay in agreement with the head of the relevant medical organization. In the event of an extension of the specified sheet and a certificate of temporary disability, it is carried out in a medical organization at the place of attachment of the person in the availability of conclusion of a medical advisory commission of medical organization that opened a sheet and a certificate of temporary disability;
8) registration of issued sheets of temporary disability shall be made in the registration book of sheets of temporary disability
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18.
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Compliance with the following requirements when issuing a sheet and certificate of temporary disability due to pregnancy and childbirth:
- a sheet or certificate of temporary disability due to pregnancy and childbirth shall be issued by a medical worker (obstetrician-gynecologist), and in his/her absence - by a doctor, together with the head of the department after the conclusion of the MAC from thirty weeks of pregnancy for a period of one hundred and twenty-six calendar days (seventy calendar days before delivery and fifty-six calendar days after delivery) in normal childbirth.
A sheet or a certificate of temporary disability due to pregnancy and childbirth shall be issued for the women living on the territories, affected by nuclear tests from twenty-seven weeks with a duration of one hundred seventy calendar days (ninety-one calendar days before delivery and seventy-nine calendar days after delivery) in normal childbirth;
2) a sheet or certificate of temporary disability due to pregnancy and childbirth shall be issued (extended) at the medical organization where the act of delivery took place or in the antenatal clinic (office) at the place of observation according to the extract (prenatal record) of an obstetric organization for the women who temporarily left their permanent place of residence within the Republic of Kazakhstan;
3) in case of complicated childbirth, the birth of two or more children, a sheet or certificate of temporary disability shall be extended for an additional fourteen calendar days by a medical worker (obstetrician-gynecologist), and in his/her absence - by a doctor, together with the head of the department after the conclusion of the MAC at the place of observation according to the extract of the obstetric health care organization. In these cases, the total duration of prenatal and postnatal leave is one hundred and forty calendar days (seventy calendar days before delivery and seventy calendar days after delivery).
A sheet or certificate of temporary disability shall be extended by an additional fourteen calendar days, the total duration of prenatal and postnatal leave is one hundred and eighty-four days (ninety-one calendar day before delivery and ninety-three calendar days after delivery) for the women living on the territories affected by nuclear tests, in case of complicated childbirth, the birth of two or more children;
4) in the case of childbirth at a period of twenty-two to twenty-nine weeks of pregnancy and the birth of a child weighing five hundred grams or more, who has lived for more than seven days, a sheet or a certificate of temporary disability for work on the fact of childbirth shall be issued to a woman for seventy calendar days after delivery.
In the case of childbirth with a period of twenty-two to twenty-nine weeks of pregnancy and the birth of a still fetus or a child weighing five hundred grams or more, who died before seven days of life, a sheet or certificate of temporary disability for work on the fact of childbirth shall be issued to a woman for fifty-six calendar days after delivery;
5) a sheet or a certificate of temporary disability shall be issued for ninety- three calendar days after childbirth to the women, living on the territories affected by nuclear tests, in case of childbirth at a period of twenty-two to twenty-nine weeks of pregnancy and the birth of a child weighing five hundred grams or more, who has lived for more than seven days.
A sheet or a certificate of temporary disability shall be issued for seventy-nine calendar days after childbirth to the women living on the territories affected by nuclear tests, in the case of childbirth at a period of twenty-two to twenty-nine weeks of pregnancy and the birth of a still fetus or a child weighing five hundred grams or more, who died before seven days of life;
6) when a woman applies for a sheet of temporary disability for work during pregnancy, maternity leave shall be calculated in total and be provided completely regardless of the number of days actually used by her before childbirth.
When a woman applies in the period after childbirth for a sheet of temporary disability, only a leave after childbirth shall be granted for the duration provided for in this paragraph;
7) upon the onset of pregnancy during the period when a woman is on paid annual labor leave or unpaid leave to care for a child until he/she reaches three years of age, a certificate of temporary disability shall be issued for all days of maternity leave, with the exception of cases provided for in part two of subparagraph 6) of this paragraph;
8) in the event of death of the mother during childbirth or in the postpartum period, a sheet or a certificate of temporary disability for work shall be issued to the person caring for the newborn;
9) in the case of an operation for the artificial termination of pregnancy, a sheet or a certificate of temporary disability shall be issued by a doctor together with the head of the department for the duration of stay in the hospital and outpatient clinic where the operation was performed, and in case of complication - for the entire period of temporary disability.
In case of spontaneous abortion (misbirth), a sheet or certificate of temporary disability shall be issued for the entire period of temporary disability;
10) when carrying out an embryo transfer operation, a sheet or a certificate of temporary disability shall be issued by the medical organization that performed the operation, from the day of embryo transfer until pregnancy is established.
Persons who have adopted (adopted) a newborn child (children), as well as a biological mother with surrogacy directly from the maternity hospital, a sheet or a certificate of temporary disability shall be issued from the date of adoption (adoption) and until the expiration of fifty-six calendar days from the date of birth of the child
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19.
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Availability of a clinical audit by the patient support Service and internal expertise and its assessment according to the following criteria:
1) quality of anamnesis collection, which is assessed according to the following criteria:
lack of anamnesis collection;
completeness of anamnesis collection;
availability of data on past, chronic and hereditary diseases, blood transfusions, drug tolerance, allergic status; the development of complications as a result of tactical mistakes made during treatment and diagnostic measures due to poor-quality collection of anamnesis;
2) completeness and validity of diagnostic studies, which are assessed according to the following criteria:
lack of diagnostic measures;
an incorrect conclusion or lack of a conclusion on the results of diagnostic tests carried out, which led to an incorrect diagnosis and mistakes in treatment tactics;
conducting diagnostic studies provided for by clinical protocols;
conducting diagnostic studies with a high, unjustified risk to the patient's health, the validity of conducting diagnostic studies that are not included in the clinical protocols;
conducting diagnostic studies that are not informative for the correct diagnosis and led to an unreasonable increase in the duration of treatment and an increase in the cost of treatment;
3) correctness, timeliness and validity of the clinical diagnosis, taking into account the results of conducted studies (with planned hospitalization, studies conducted at the pre-hospital stage shall be taken into account ), which are assessed according to the following criteria:
the diagnosis is missing, incomplete or incorrect, does not correspond to the international classification of diseases;
the leading pathological syndrome, determining the severity of the disease course has not been identified, concomitant diseases and complications have not been recognized;
the diagnosis is correct, but incomplete, the leading pathological syndrome has not been identified with the identified complications, concomitant diseases that affect the outcome have not been recognized;
the diagnosis of the underlying disease is correct, but concomitant diseases affecting the result of treatment have not been diagnosed.
Objective reasons for incorrect and (or) untimely diagnosis (atypical course of the underlying disease, asymptomatic course of concomitant disease, rare complications and concomitant diseases) are reflected in the results of the expertise. An assessment of impact of incorrect and (or) untimely diagnosis on the subsequent stages of medical services (assistance) provision shall be made;
4) timeliness and quality of consultations from specialized specialists, which are assessed according to the following criteria:
lack of consultation, which led to an erroneous interpretation of symptoms and syndromes that adversely affected the outcome of the disease;
the consultation is timely, the failure to take into account the opinion of the consultant when making the diagnosis partially influenced the outcome of the disease;
the consultation is timely, the opinion of the consultant was taken into account when making the diagnosis, failure to comply with the consultant's recommendation for treatment partially influenced the outcome of the disease;
the consultant's opinion is erroneous and influenced the outcome of the disease.
In cases of delayed consultations, an assessment of objectivity of the reasons for untimely consultation and the impact of untimely diagnosis on the subsequent stages of medical services (assistance) provision shall be made;
5) the volume, quality and validity of the treatment measures, which are assessed according to the following criteria:
lack of treatment if indicated;
prescribing treatment in the absence of indications;
appointment of ineffective therapeutic measures without taking into account the characteristics of the disease course, concomitant diseases and complications;
implementation of therapeutic measures not in full, without taking into account the functional state of organs and systems, prescribing drugs without proven clinical efficacy;
non-compliance with the requirements of the Standards, unjustified deviation from the requirements of clinical protocols, the presence of polypragmasia, which led to the development of a new pathological syndrome and deterioration of the patient's condition;
6) absence or development of complications after medical interventions, all complications that have occurred shall be assessed, including those caused by surgical interventions (delayed surgical intervention, inadequate volume and method, technical defects) and diagnostic procedures;
7) the achieved result, which is assessed according to the following criteria:
achieving the expected clinical effect in compliance with the technology of providing medical services (assistance);
lack of clinical effect of therapeutic and preventive measures due to poor-quality collection of anamnesis and diagnostic studies;
lack of the expected clinical effect due to ineffective therapeutic, preventive measures without taking into account the peculiarities of the disease course, concomitant diseases, complications, prescribing drugs without proven clinical efficacy;
the presence of polypragmasia, which caused the development of undesirable consequences;
8) the quality of maintaining medical documentation, which is assessed by availability, completeness and quality of records in primary medical documentation intended for recording data on the health status of patients, reflecting the nature, volume and quality of medical care provided in accordance with the forms of reporting and accounting documentation in the field of healthcare
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Official ( s ) ________________________________________
_______________________________ ___________
position signature
_____________________________________________________________________________
surname, name, patronymic (if any)
Head of the subject of control _____________________________________
_______________________________ ____________________
position signature
_____________________________________________________________________________
surname, name, patronymic (if any)
* - this checklist is used in relation to all subjects (objects) rendering inpatient, inpatient replacing assistance, regardless of the profile of provided medical services
** - this checklist is used in relation to all subjects (objects) rendering outpatient assistance (primary health care and consultative-diagnostic assistance), regardless of the profile of medical services provided in the form of consultative-diagnostic assistance, (including for the subjects (objects) of rendering pre-medical care)
***- this checklist is used in relation to subjects (objects) rendering medical services in the corresponding profile, as an additional checklist to the main checklist used in relations between subjects (objects) providing inpatient, inpatient-replacing and outpatient assistance, depending on the form of rendering medical care in the subject (object) of control
**** - this checklist is used in relation to subjects (objects) carrying out activities in the sphere of laboratory service, also when conducting an inspection of the subject (object) of health care, which includes a laboratory service, this checklist is used as an additional checklist to the main checklist used depending on the form and profile of rendering medical care in the subject (object) of control
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Annex 4
to the joint order of the
Minister of Healthcare of the
Republic of Kazakhstan
dated November 15, 2018
No. KR HCM-32 and the Minister of
National Economy of the
Republic of Kazakhstan
dated November 15, 2018 No. 70 |
A checklist in the field of state quality control of rendering medical services in relation to the subjects (objects) of obstetric aid
Footnote. Appendix 4 - is in the wording of the joint order of the Minister of Healthcare of the Republic of Kazakhstan dated 06.01.2021 No. KR HCM-3 and the Minister of National Economy of the Republic of Kazakhstan dated 06.01.2021 No. 5 (shall be enforced upon expiry of ten calendar days after its first official publication).
State body that assigned the inspection _____________________________
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Act on assignment of an inspection/special procedure for conducting inspections
____________________________________________________________________
________________________________________________________________________
No., date
Name of the subject (object) of control
____________________________________________________________________________
(Individual identification number), business identification number of the subject (object)
of control ______________________________________________________________________
_________________________________________________________________
Location address _______________________________________________________
_____________________________________________________________________________
№
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List of requirements
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Required
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Not required
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Meets the requirements
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Doesn't meet the requirements
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1.
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Availability of a license and annexes to it for the activities carried out
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2.
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Availability of a specialist certificate in the relevant clinical specialty
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3.
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Availability of a conclusion on compliance of a healthcare subject with the provision of high-tech medical services
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4.
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Availability of a written voluntary consent of the patient or his/her legal representative for invasive interventions and for conducting medical and diagnostic measures
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5.
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The time spent by the emergency medical team or the emergency department in the organization of primary health care in the hospital reception department does not exceed 10 minutes (the time for transferring the patient to the emergency department doctor) from the moment of its arrival at the hospital, except in cases of the need to provide emergency medical care in emergency situations.
After the transfer by the ambulance teams or the emergency department, when organizing the primary health care of the patient to the hospital reception department, the nurse conducts the distribution of incoming patients (medical sorting according to the triage-system) into groups, based on the priority of emergency medical care.
Medical sorting according to the triage -system shall be conducted continuously and successively. Upon completion of the assessment, the patients shall be marked with the color of one of the sorting categories, in the form of a special colored tag or colored tape.
According to medical sorting, there are 3 groups of patients:
the first group (red zone) - patients whose condition poses an immediate threat to life or who have a high risk of deterioration and require emergency medical care;
the second group (yellow zone) - patients whose condition poses a potential threat to health or may progress with the development of a situation requiring emergency medical care;
the third group (green zone) - patients whose condition does not pose an immediate threat to life and health and does not require hospitalization
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6.
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In the absence of indications for hospitalization in a healthcare organization, the doctor of the reception department shall issue a medical conclusion to the patient with a written justification for the refusal.
The nurse of the reception department sends the asset to the PHC organization at the place of attachment of the patient
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7.
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Indications for hospitalization:
the need to provide pre-medical, qualified, specialized medical care, including the use of high-tech medical services, with round-the-clock medical supervision of patients:
1) in a planned manner - on the referral of PHC specialists or other healthcare organization:
2) for emergency indications (including weekends and holidays) - regardless of the availability of a referral
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8.
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Examination of the patient by the head of the department of severe patients on the day of hospitalization, thereafter - daily. Patients in a moderate condition shall be examined at least once a week. The results of examination of the patient shall be recorded in the medical record, indicating the recommendations for further tactics of managing the patient with obligatory identification of the medical worker making the entries
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9.
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Daily examination of patients in the hospital by the attending physician, except for weekends and holidays. When examining and appointing additional diagnostic and therapeutic manipulations by the doctor on duty, appropriate entries shall be made in the medical record
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10.
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Additional and repeated conduct of studies, conducted before hospitalization in a primary health care organization or other health care organization, according to medical indications, with justification in the medical record for a dynamic assessment of the patient's condition, in accordance with clinical protocols for diagnosis and treatment.
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11.
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Compliance with the following requirements when issuing a sheet and certificate of temporary disability due to pregnancy and childbirth:
- a sheet or certificate of temporary disability due to pregnancy and childbirth shall be issued by a medical worker (obstetrician-gynecologist), and in his/her absence - by a doctor, together with the head of the department after the conclusion of the MAC from thirty weeks of pregnancy for a period of one hundred and twenty-six calendar days (seventy calendar days before delivery and fifty-six calendar days after delivery) in normal childbirth.
A sheet or a certificate of temporary disability due to pregnancy and childbirth shall be issued for the women living on the territories, affected by nuclear tests from twenty-seven weeks with a duration of one hundred seventy calendar days (ninety-one calendar days before delivery and seventy-nine calendar days after delivery) in normal childbirth;
2) a sheet or certificate of temporary disability due to pregnancy and childbirth shall be issued (extended) at the medical organization where the act of delivery took place or in the antenatal clinic (office) at the place of observation according to the extract (prenatal record) of an obstetric organization for the women who temporarily left their permanent place of residence within the Republic of Kazakhstan;
3) in case of complicated childbirth, the birth of two or more children, a sheet or certificate of temporary disability shall be extended for an additional fourteen calendar days by a medical worker (obstetrician-gynecologist), and in his/her absence - by a doctor, together with the head of the department after the conclusion of the MAC at the place of observation according to the extract of the obstetric health care organization. In these cases, the total duration of prenatal and postnatal leave is one hundred and forty calendar days (seventy calendar days before delivery and seventy calendar days after delivery).
A sheet or certificate of temporary disability shall be extended by an additional fourteen calendar days, the total duration of prenatal and postnatal leave is one hundred and eighty-four days (ninety-one calendar day before delivery and ninety-three calendar days after delivery) for the women living on the territories affected by nuclear tests, in case of complicated childbirth, the birth of two or more children;
4) in the case of childbirth at a period of twenty-two to twenty-nine weeks of pregnancy and the birth of a child weighing five hundred grams or more, who has lived for more than seven days, a sheet or a certificate of temporary disability for work on the fact of childbirth shall be issued to a woman for seventy calendar days after delivery.
In the case of childbirth with a period of twenty-two to twenty-nine weeks of pregnancy and the birth of a still fetus or a child weighing five hundred grams or more, who died before seven days of life, a sheet or certificate of temporary disability for work on the fact of childbirth shall be issued to a woman for fifty-six calendar days after delivery;
5) a sheet or a certificate of temporary disability shall be issued for ninety- three calendar days after childbirth to the women, living on the territories affected by nuclear tests, in case of childbirth at a period of twenty-two to twenty-nine weeks of pregnancy and the birth of a child weighing five hundred grams or more, who has lived for more than seven days.
A sheet or a certificate of temporary disability shall be issued for seventy-nine calendar days after childbirth to the women living on the territories affected by nuclear tests, in the case of childbirth at a period of twenty-two to twenty-nine weeks of pregnancy and the birth of a still fetus or a child weighing five hundred grams or more, who died before seven days of life;
6) when a woman applies for a sheet of temporary disability for work during pregnancy, maternity leave shall be calculated in total and be provided completely regardless of the number of days actually used by her before childbirth.
When a woman applies in the period after childbirth for a sheet of temporary disability, only a leave after childbirth shall be granted for the duration provided for in this paragraph;
7) upon the onset of pregnancy during the period when a woman is on paid annual labor leave or unpaid leave to care for a child until he/she reaches three years of age, a certificate of temporary disability shall be issued for all days of maternity leave, with the exception of cases provided for in part two of subparagraph 6) of this paragraph;
8) in the event of death of the mother during childbirth or in the postpartum period, a sheet or a certificate of temporary disability for work shall be issued to the person caring for the newborn;
9) in the case of an operation for the artificial termination of pregnancy, a sheet or a certificate of temporary disability shall be issued by a doctor together with the head of the department for the duration of stay in the hospital and outpatient clinic where the operation was performed, and in case of complication - for the entire period of temporary disability.
In case of spontaneous abortion (misbirth), a sheet or certificate of temporary disability shall be issued for the entire period of temporary disability;
10) when carrying out an embryo transfer operation, a sheet or a certificate of temporary disability shall be issued by the medical organization that performed the operation, from the day of embryo transfer until pregnancy is established.
Persons who have adopted (adopted) a newborn child (children), as well as a biological mother with surrogacy directly from the maternity hospital, a sheet or a certificate of temporary disability shall be issued from the date of adoption (adoption) and until the expiration of fifty-six calendar days from the date of birth of the child
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12.
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Availability of a clinical audit by the patient support Service and internal expertise and its assessment according to the following criteria:
1) quality of anamnesis collection, which is assessed according to the following criteria:
lack of anamnesis collection;
completeness of anamnesis collection;
availability of data on past, chronic and hereditary diseases, blood transfusions, drug tolerance, allergic status; the development of complications as a result of tactical mistakes made during treatment and diagnostic measures due to poor-quality collection of anamnesis;
2) completeness and validity of diagnostic studies, which are assessed according to the following criteria:
lack of diagnostic measures;
an incorrect conclusion or lack of a conclusion on the results of diagnostic tests carried out, which led to an incorrect diagnosis and mistakes in treatment tactics;
conducting diagnostic studies provided for by clinical protocols;
conducting diagnostic studies with a high, unjustified risk to the patient's health, the validity of conducting diagnostic studies that are not included in the clinical protocols;
conducting diagnostic studies that are not informative for the correct diagnosis and led to an unreasonable increase in the duration of treatment and an increase in the cost of treatment;
3) correctness, timeliness and validity of the clinical diagnosis, taking into account the results of conducted studies (with planned hospitalization, studies conducted at the pre-hospital stage shall be taken into account ), which are assessed according to the following criteria:
the diagnosis is missing, incomplete or incorrect, does not correspond to the international classification of diseases;
the leading pathological syndrome, determining the severity of the disease course has not been identified, concomitant diseases and complications have not been recognized;
the diagnosis is correct, but incomplete, the leading pathological syndrome has not been identified with the identified complications, concomitant diseases that affect the outcome have not been recognized;
the diagnosis of the underlying disease is correct, but concomitant diseases affecting the result of treatment have not been diagnosed.
Objective reasons for incorrect and (or) untimely diagnosis (atypical course of the underlying disease, asymptomatic course of concomitant disease, rare complications and concomitant diseases) are reflected in the results of the expertise. An assessment of impact of incorrect and (or) untimely diagnosis on the subsequent stages of medical services (assistance) provision shall be made;
4) timeliness and quality of consultations from specialized specialists, which are assessed according to the following criteria:
lack of consultation, which led to an erroneous interpretation of symptoms and syndromes that adversely affected the outcome of the disease;
the consultation is timely, the failure to take into account the opinion of the consultant when making the diagnosis partially influenced the outcome of the disease;
the consultation is timely, the opinion of the consultant was taken into account when making the diagnosis, failure to comply with the consultant's recommendation for treatment partially influenced the outcome of the disease;
the consultant's opinion is erroneous and influenced the outcome of the disease.
In cases of delayed consultations, an assessment of objectivity of the reasons for the untimely consultation and the impact of the untimely diagnosis on the subsequent stages of medical services (assistance) provision shall be made;
5) the volume, quality and validity of the treatment measures, which are assessed according to the following criteria:
lack of treatment if indicated;
prescribing treatment in the absence of indications;
appointment of ineffective therapeutic measures without taking into account the characteristics of the disease course, concomitant diseases and complications;
implementation of therapeutic measures not in full, without taking into account the functional state of organs and systems, prescribing drugs without proven clinical efficacy;
non-compliance with the requirements of the Standards, unjustified deviation from the requirements of clinical protocols, the presence of polypragmasia, which led to the development of a new pathological syndrome and deterioration of the patient's condition;
6) absence or development of complications after medical interventions, all complications that have occurred shall be assessed, including those caused by surgical interventions (delayed surgical intervention, inadequate volume and method, technical defects) and diagnostic procedures;
7) the achieved result, which is assessed according to the following criteria:
achieving the expected clinical effect in compliance with the technology of providing medical services (assistance);
lack of clinical effect of therapeutic and preventive measures due to poor-quality collection of anamnesis and diagnostic studies;
lack of the expected clinical effect due to ineffective therapeutic, preventive measures without taking into account the peculiarities of the disease course, concomitant diseases, complications, prescribing drugs without proven clinical efficacy;
the presence of polypragmasia, which caused the development of undesirable consequences;
8) the quality of maintaining medical documentation, which is assessed by availability, completeness and quality of records in primary medical documentation intended for recording data on the health status of patients, reflecting the nature, volume and quality of medical care provided in accordance with the forms of reporting and accounting documentation in the field of healthcare according to subparagraph 31) of Article 7 of the Code
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13.
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Availability of informed voluntary consent (refusal) for transfusion of blood components in the form of accounting and reporting documentation in the field of healthcare
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14.
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Compliance with the following actions when conducting a pathoanatomical autopsy:
1) carrying out a pathoanatomical autopsy of corpses after the doctors have stated biological death, after providing the medical record of an inpatient patient or the medical record of an outpatient patient with a written order of the chief physician or his/her deputy for the medical (treatment) part of the healthcare organization to send for a pathoanatomical autopsy;
2) registration of the results of the pathoanatomical autopsy in the form of a pathoanatomical diagnosis (the pathoanatomical diagnosis includes: underlying disease, complication of underlying disease, concomitant disease, combined underlying disease);
3) transfer of a medical record of an inpatient patient or a medical record of an outpatient patient with the pathoanatomical diagnosis entered into it to the medical archive of the healthcare organization no later than ten working days after the pathological autopsy;
4) conducting clinical and pathoanatomical analysis in cases of death of patients in healthcare organizations;
5) pathoanatomical autopsy in case of suspected acute infectious, oncological diseases, pathology of childhood, fatal outcome due to medical manipulations in order to establish the cause of death and clarify the diagnosis of disease with a fatal outcome;
6) organization of autopsy materials in cases of suspected infectious diseases by the chief physician and head of the pathoanatomical department of virological (immunofluorescent) and bacteriological examination;
7) transfer to the pathoanatomical bureau, the centralized pathoanatomical bureau and the pathoanatomical department of the medical records of inpatients for all deaths for the previous day no later than 10 am of the day following the establishment of the fact of death;
8) registration of:
- a medical certificate of death (preliminary, final) by a doctor in the specialty "pathological anatomy (adult, pediatric)" on the day of the pathoanatomical autopsy;
- a medical certificate of perinatal death (preliminary, final) by a doctor in the specialty "pathological anatomy (adult, pediatric)" on the day of the pathoanatomical autopsy;
9) registration of the results of the autopsy in the form of a protocol of pathoanatomical examination;
10) the presence of a written notification to the forensic authorities to resolve the issue of transferring the corpse for forensic medical examination upon detection of signs of violent death and termination of the pathoanatomical examination of the corpse;
11) the presence of a written notification from a doctor in the specialty "pathological anatomy (adult, pediatric)" in case of initial detection during the autopsy of signs of an acute infectious disease, food or industrial poisoning, an unusual reaction to vaccination, as well as an emergency notification to the bodies of the state sanitary and epidemiological service immediately after their identification;
12) conducting a pathoanatomical examination of the placenta:
in the case of stillbirth;
for all diseases of newborns identified at the time of birth;
in cases suspected of hemolytic disease of newborns;
in case of early discharge of water and in case of dirty waters;
in case of diseases of the mother, occurring with a high temperature in the last trimester of pregnancy;
with an obvious abnormality of development or attachment of the placenta;
13) mandatory registration of a fetus weighing less than 500 grams with anthropometric data (weight, height, head circumference, chest circumference);
14) establishment of a pathoanatomical autopsy, depending on the complexity, into the following categories:
first category;
second category;
third category;
fourth category;
15) establishment by the doctor in the specialty "pathological anatomy (adult, pediatric)" of the category of pathoanatomical autopsy and the reasons for discrepancy in diagnoses when the final clinical and pathoanatomical diagnoses differ
16) availability of a detailed analysis with the definition of the profile and categories of iatrogeny in all cases of iatrogenic pathology identified as a result of a pathoanatomical autopsy
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15.
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Compliance with the following requirements when organizing obstetric and gynecological care at the outpatient level:
1) dispensary observation of pregnant women in order to prevent and early detection of complications of pregnancy, childbirth and the postpartum period with the allocation of women "by risk factors";
2) conducting prenatal screening - a comprehensive examination of pregnant women in order to identify the risk group for chromosomal pathology and congenital malformations of the intrauterine fetus;
3) identification of pregnant women in need of timely hospitalization in day hospitals, departments of pregnancy pathology at inpatient-level medical organizations providing obstetric and gynecological care, specialized medical organizations with extragenital pathology, in compliance with the principles of regionalization of perinatal care;
4) referral of pregnant women, women in labor and parturient women to receive specialized care with medical supervision, including the use of high-tech medical services to medical organizations of the republican level;
5) conducting prenatal training for pregnant women in preparation for childbirth, including partner childbirth, informing pregnant women about warning signs, effective perinatal technologies, the principles of safe motherhood, breastfeeding and perinatal care;
6) conducting patronage of pregnant women and women in childbirth according to indications;
7) counseling and provision of services on the issues of family planning and reproductive health protection;
8) prevention and identification of sexually transmitted infections for referral to specialized specialists;
9) examination of women of fertile age with appointment, if necessary, in-depth examination using additional methods and involvement of specialized specialists for the timely detection of extragenital, gynecological pathology and their registration;
10) organization and conduct of preventive examinations of the female population with the aim of early detection of extragenital diseases;
11) examination and treatment of gynecological patients using modern medical technologies;
12) clinical examination of gynecological patients, including rehabilitation and sanatorium-resort treatment;
13) performance of small gynecological operations using modern medical technologies;
14) conducting an expertise of temporary disability due to pregnancy, childbirth and gynecological diseases, determining the need and timing of temporary or permanent transfer of an employee for health reasons to another job, referring, in accordance with the established procedure, to a medical and social examination of women with signs of persistent disability;
15) double examination during pregnancy for HIV infection with registration of the patient's informed consent with the recording of data
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16.
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Provision of first aid to women during and outside pregnancy by medical workers (midwives, paramedics, nurses/brothers), including:
1) self-admission and medical examination in order to determine the patient's health status, identify diseases and complications of pregnancy
2) entering data into the subsystem "Register of pregnant women and women of fertile age" of the electronic portal "Register of attached population" for the purpose of automated management of groups of pregnant women and women of fertile age (hereinafter-WFA) and monitoring of indicators of the health status of pregnant women and WFA;
3) provision of emergency and emergency pre-medical care to pregnant women, postpartum women and women of fertile age in conditions that threaten the life and health of a woman, in accordance with clinical protocols for diagnosis and treatment;
4) dynamic monitoring of pregnant women with chronic diseases together with local doctors and specialized specialists;
5) fulfillment of the prescriptions of an obstetrician-gynecologist in accordance with functional duties;
6) management of physiological pregnancy and patronage of pregnant women and parturient women with the timely provision of directions and recommendations in accordance with the clinical protocol for diagnosis and treatment;
7) medical care at home for pregnant women, postpartum women, gynecological patients and the social risk group of WFA;
8) conducting a preventive medical examination of women with the aim of early identification of precancerous and cancerous diseases of the female genital organs and other localizations (skin, mammary glands);
9) conducting a nursing examination of women of all age groups who have applied for medical help;
10) participation in screening and preventive examinations to detect diseases
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17.
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Compliance with the following requirements when organizing the provision of obstetric and gynecological care at the inpatient level:
1) provision of inpatient consultative and diagnostic, therapeutic-preventive and rehabilitation assistance to pregnant women, women in labor, postpartum women and newborns;
2) conducting a joint examination of the attending doctor with the head of the department upon admission of pregnant women up to 36 weeks of pregnancy suffering from chronic diseases who need treatment in specialized departments of multidisciplinary hospitals to assess the severity of the disease course, the course of pregnancy and treatment tactics.
3) drawing up a plan for the management of pregnancy, childbirth and the postpartum period, taking into account an individual approach;
4) management of pregnancy, childbirth and the postpartum period in accordance with clinical protocols for diagnosis and treatment, as well as with a management plan;
5) consulting pregnant women, women in labor and parturient women, carrying out control on compliance with the level of medical care;
6) conducting rehabilitation measures for mothers and newborns, including caring for premature newborns;
7) consultations on the provision of medical care to pregnant women, women in labor, parturient women and newborns using telecommunication systems;
8) carrying out an expertise of temporary disability, issuance of a sheet and a certificate of temporary disability for pregnancy and childbirth, gynecological patients;
9) provision of resuscitation and intensive care to mothers and newborns, including those with low and extremely low body weight;
10) availability of a minimum list of equipment for the intensive care unit (ICU):
a functional bed (according to the number of beds);
anti-decubitus mattress (1 for 3 beds);
a bedside cardiac monitor (by the number of beds);
a portable electrocardiograph (1 for 6 beds);
an electrocardiostimulator (1 for 6 beds);
a portable apparatus for ultrasound examination of the heart and blood vessels (1 for 9 beds);
an apparatus for auxiliary blood circulation (intra-aortic balloon counterpulsation ) (1 for 9 beds);
a centralized oxygen supply system to each bed (according to the number of beds);
a surgical electric suction device with a bacterial filter (1 for 3 beds);
a defibrillator biphasic with synchronization function (1 for 3 beds);
an apparatus for artificial ventilation of the lungs (1 for 6 beds);
a portable breathing apparatus for transportation (1 per ICU);
a set for tracheal intubation (2 per ICU);
a set for catheterization of great vessels (100 sets);
an automatic syringe dispenser of medicinal substances (2 per 1 bed);
an infusion pump (1 for 1 bed);
a bedside tonometer for measuring blood pressure (by the number of beds);
a mobile (portable) kit for resuscitation in other departments (1 on ICU);
a mobile X-ray machine (1 on ICU);
a glucometer (1 per ICU);
a set of instruments and devices for minor surgical interventions (1 per ICU)
a block of electrical outlets (at least 8 sockets) with grounding at each bed, including for power supply of energy-intensive devices (X-ray machines) (by the number of beds).
11) carrying out medical and psychological assistance to women;
12) notifying medical organizations of a higher level of regionalization of perinatal care and local public health authorities when a critical condition is detected during admission or being in a hospital for a pregnant woman, a woman in labor, a postpartum woman;
13) compliance with the notification scheme in the event of a critical situation in women;
14) transportation of pregnant women, parturient women, women in critical condition to the third level of perinatal care, to regional and republican healthcare organizations shall be carried out by the decision of a council of doctors with participation of the medical team specialists of medical aviation after restoration of hemodynamics and stabilization of vital functions with notification of the receiving medical organization;
15) calling qualified specialists "on oneself", providing a complex of primary resuscitation care in the event of emergency conditions, diagnosing threatening conditions in the mother and the fetus, resolving the issue of delivery, conducting intensive and supportive therapy before transferring to higher level in case of a non-transportable state of pregnant women, women in labor, parturient women.
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Rendering medical care to newborns
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18.
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Compliance with the following requirements when organizing the provision of medical care to newborns at the inpatient level:
1) provision of medical care to newborns according to the levels of regionalization of perinatal care, depending on the indications;
2) the structure of the organizations of hospitals of the first level of regionalization of perinatal care: individual maternity wards, a department for joint stay of mother and child, a vaccination office, intensive care wards for newborns, as well as the rate of a doctor in the specialty "Pediatrics (neonatology)" provided by the staffing table and a round-the-clock post of a neonatal nurse;
3) in second-level hospitals, the organization of resuscitation and intensive care wards for newborns with a full set for resuscitation, mechanical ventilation devices with various ventilation modes (constant positive airway pressure), incubators, a clinical diagnostic laboratory, as well as a round-the-clock post provided for by the staff schedule (neonatologist and pediatric nurse);
4) in hospitals of the third level of regionalization of perinatal care:
there is a round-the-clock neonatal post, clinical, biochemical and bacteriological laboratories, an intensive care unit for women and newborns, as well as departments for pathology of newborns and nursing premature babies together with their mother.
intensive care units for newborns, departments for pathology of newborns and nursing of premature babies shall be organized, equipped with modern medical and diagnostic equipment, medicines, a round-the-clock post (medical and nursing), and an express laboratory.
5) in hospitals of the first level, the following measures shall be carried out for a sick newborn:
primary resuscitation care;
intensive and supportive therapy;
oxygen therapy;
invasive or non-invasive respiratory therapy;
phototherapy;
therapeutic hypothermia;
infusion therapy and/or parenteral nutrition;
treatment according to approved clinical protocols for diagnosis and treatment.
In hospitals of the second level, the following measures shall be carried out for a sick newborn:
primary resuscitation care for a newborn and stabilization of the condition, nursing premature babies with a gestational age of more than 34 weeks;
catheterization of the central veins and peripheral vessels;
identification and treatment of congenital malformations, intrauterine growth retardation, hypoglycemia of newborns, hyperbilirubinemia, neonatal sepsis, lesions of the central nervous system, respiratory distress syndrome, pneumothorax, necrotizing enterocolitis and other pathological conditions of the neonatal period;
conducting of intensive care, including correction of vital functions (respiratory, cardiovascular, metabolic disorders), invasive and non-invasive respiratory therapy, infusion therapy and parenteral nutrition;
if it is necessary to provide highly specialized care, the degree of readiness for transportation with the mother to a third-level obstetric aid organization or an institution of republican significance shall be determined
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19.
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Rendering medical care to newborns in third-level medical organizations includes:
1) primary neonatal resuscitation and newborn care;
2) conducting intensive and supportive therapy: respiratory therapy, catheterization of the central veins and peripheral vessels, therapeutic hypothermia, parenteral nutrition, nursing premature infants;
3) diagnosis and treatment of congenital malformations, intrauterine growth retardation (low weight by gestational age ), neonatal hypoglycemia, neonatal sepsis, respiratory distress syndrome, hyperbilirubinemia, necrotizing enterocolitis, pneumothorax, bronchopulmonary dysplasia, persistent neonatal pulmonary hypertension, systems and other pathological conditions of the neonatal period;
4) conducting intensive and supportive therapy, therapeutic hypothermia, parenteral nutrition;
5) conducting invasive and non-invasive respiratory therapy;
6) nursing premature babies;
7) provision of round-the-clock advisory and medical-diagnostic assistance to specialists of the first and second levels of regionalization, provision of emergency and urgent medical care with a visit to a medical organization
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20.
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Providing a healthy newborn with basic care, including prevention of hypothermia in accordance with the "thermal chain", skin contact with the mother or skin-to-skin contact, early breastfeeding within the first hour (if the baby is ready), prevention of nosocomial infections
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21.
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Anthropometry of a healthy newborn, its full examination and other activities 2 hours after delivery
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22.
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Provision of emergency medical care in case of identification of violations of the newborn condition, according to indications, transfer to the intensive care unit or neonatal intensive care unit
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23.
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Observation of a mother and a healthy newborn by the obstetrician in the delivery room for two hours after birth:
1) measures the body temperature of a newborn 15 minutes after birth, then every 30 minutes;
2) monitors the heart rate and respiration, the nature of respiration (identification of an expiratory groan, assessment of the degree of retraction of the lower chest), the color of the skin, the activity of the sucking reflex, if necessary, determines the saturation with a pulse oximeter
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24.
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Transfer of a healthy newborn with the mother to the unit of joint stay of the mother and the child 2 hours after the birth
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25.
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In the postnatal department in the wards of joint stay of the mother and the child, round-the-clock supervision of medical personnel and constant participation of the mother in carrying out the child's care shall be ensured, except for cases of moderate and severe conditions of a mother
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26.
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Dynamic observation of the newborn with timely detection of violations of the newborn condition, necessary examination, examination of the head of the department, organization of a council to clarify the tactics of management. According to the indications, emergency medical care shall be provided, transfer to the intensive care unit or the neonatal intensive care unit shall be carried out
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27.
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In the wards of joint stay of a mother and a child, the medical workers shall:
1) consult on the benefits of breastfeeding, on the technique and frequency of manual expression of breast milk, carry out a visual assessment of breastfeeding to provide practical assistance in the correct positioning and attachment of the baby to the mother's breast in order to avoid conditions such as cracked nipples or lactostasis;
2) if there are contraindications to breastfeeding, teach the mother (parent or legal representative) alternative methods of feeding children; advise mothers on how to maintain lactation in cases of separate stay of newborns
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28.
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Daily examination of newborns by a neonatologist, consultation of mothers on care, prevention of hypothermia and vaccination
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29.
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In the presence of three or more microanomalies of development or identification of congenital pathology of newborns, the organization of consultation with specialized specialists, with the conduct of medical-diagnostic measures and providing the mother with recommendations for examination, treatment and rehabilitation
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30.
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In case of emergence of emergency conditions in a newborn (asphyxia, respiratory distress syndrome and others), stabilization of its condition and determination of the degree of readiness for transportation with the mother to the organization of obstetrics of the second or third level
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31.
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Vaccination of newborns shall be carried out on the basis of voluntary informed consent of parents (mother, father or legal representatives) to carry out preventive vaccinations in accordance with the terms of preventive vaccinations in the Republic of Kazakhstan.
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32.
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Pre-discharge neonatal screening for phenylketonuria, congenital hypothyroidism and audiological screening for all newborns
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33.
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In case of emergency conditions in a newborn, the neonatologist assesses the severity of the condition, stabilizes it, assesses the degree of readiness for transportation, and organizes its transfer with the mother (in agreement with the obstetrician-gynecologist) to a second-or third-level medical organization
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34.
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In case of suspicion and (or) identification of acute surgical pathology in a newborn, an urgent consultation shall be carried out with a doctor specializing in “Pediatric Surgery (Neonatal Surgery)”. After the indicators of vital functions have stabilized, the newborn shall be transferred to the surgical department of another medical organization (children's or multidisciplinary hospital) or to the neonatal (or children's) surgical department, if available in the structure of the obstetric medical organization to provide it with the appropriate specialized medical care
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35.
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Full-term newborns after reaching the age of 28 days or premature newborns, after reaching the post - conceptual age of 42 weeks, needing further round-the-clock medical supervision shall be transferred to a pediatric hospital
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36.
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Availability of medical devices and medical products for the provision of medical care to newborns in accordance with the standard of organization of pediatric care depending on the level of regionalization of perinatal care
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37.
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Availability of medical devicesand medical products for equipping the resuscitation team vehicle for transporting newborns:
1. equipment:
1) a couveuse (portable or transportable);
2) a "stove" for heating the car interior;
3) thermal insulating film for a child;
4) underwear for the baby (blanket, diapers, clothes);
5) a ECG and blood pressure monitor with a set of cuffs and sensors,
6) a pulse oximeter with disposable cuffs;
7) a watch with a second hand;
8) an electronic thermometer;
8) a phonendoscope.
2.Respiratory support equipment:
1) an oxygen cylinder;
2) an air compressor for artificial ventilation of the lungs and the use of vacuum means;
3) an oxygen dosimeter for cylinders;
4) a portable artificial lung ventilation apparatus with a system of humidification and heating of the respiratory mixture;
5) an oxygen mixer;
6) Ambu bag, volume not exceeding 700 cubic centimeters;
7) a set of masks of different sizes for artificial lung ventilation;
8) oral airways;
9) respiratory support system N CPAP.
3. Equipment and medical devices for tracheal intubation and airway sanitation:
1) a laryngoscope with straight blades No. 0 and No. 1;
2) intubation tubes (D-diameter 2.5; 3.0; 3.5; 4.0);
3) an electric or vacuum suction, disposable bulb and a set of catheters for aspiration (No. 5, 6, 8, 10, 12, 14);
4) a nasogastric tube - diameter 6 mm.
4. Equipment and medical devices for the administration of drugs:
1) infusomat, syringe pump (2-3 pieces on batteries);
2) kits for peripheral vein catheterization;
3) systems for infusion;
4) syringes of various sizes;
5) tees;
6) butterfly needles;
7) surgical tweezers, scalpel, scissors;
8) sterile gloves
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38.
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Availability of a mandatory pathoanatomical examination of the fetus and placenta during termination of pregnancy for medical reasons in case of suspicion of congenital malformations in the fetus
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39.
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Availability of clinical and pathoanatomical analysis of all cases of maternal and infant death after the completion of the entire complex of pathoanatomical studies
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Official ( s ) ________________________________________
_______________________________ ___________
position signature _____________________________________________________________________________
surname, name, patronymic (if any)
Head of the subject of control _____________________________________
_______________________________ ____________________
position signature _____________________________________________________________________________
surname, name, patronymic (if any)
Explanation of abbreviations:
HIV - Human Immunodeficiency Virus
PHC - Primary Health Care
EMA – emergency medical assistance
ICU - intensive care unit
Notes:
* - this checklist is used in relation to all subjects (objects) rendering inpatient, inpatient replacing assistance, regardless of the profile of provided medical services
** - this checklist is used in relation to all subjects (objects) rendering outpatient assistance (primary health care and consultative-diagnostic assistance), regardless of the profile of medical services provided in the form of consultative-diagnostic assistance, (including for the subjects (objects) of rendering pre-medical care)
***- this checklist is used in relation to subjects (objects) rendering medical services in the corresponding profile, as an additional checklist to the main checklist used in relations between subjects (objects) providing inpatient, inpatient-replacing and outpatient assistance, depending on the form of rendering medical care in the subject (object) of control
**** - this checklist is used in relation to subjects (objects) carrying out activities in the sphere of laboratory service, also when conducting an inspection of the subject (object) of health care, which includes a laboratory service, this checklist is used as an additional checklist to the main checklist used depending on the form and profile of rendering medical care in the subject (object) of control
| |
Appendix 5
to the joint order of the
Minister of Healthcare of
the Republic of Kazakhstan
dated November 15, 2018
No. ЌР DSM-32 and the
Minister of National Economy of
the Republic of Kazakhstan
dated November 15, 2018, No. 70 |
Checklist in the sphere of state control of medical services quality
in respect of subjects (objects) rendering cardiological,
cardiac surgery assistance***
State body, assigned the inspection ____________________________________________
_________________________________________________________________________
The act of inspection assignment/preventive control with a visit to the subject (object)
of control
_________________________________________________________________________
_________________________________________________________________________
No, date
Name of the subject (object) of control __________________________________________
__________________________________________________________________________
(individual identification number), business identification number of the subject (object) of control
__________________________________________________________________________
__________________________________________________________________________
Location address
______________________________________________________________
______________________________________________________________
№
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List of requirements
|
Required
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Not required
|
Meets the requirements
|
Does not meet the requirements
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1
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Availability of determination during hospitalization in a planned manner of indicators for:
- daily monitoring of the electrocardiogram;
- ergometric examination (stress tests, spiroergometry) on the basis of treadmill and / or cycle ergometer;
- electrophysiological examination;
- daily monitoring of blood pressure;
- catheterization of heart cavities with angiocardiography in conditions of intracardiac examinations office;
- computer and magnetic resonance imaging
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2
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Availability of conducting in emergency (around the clock, including weekends and holidays) procedure, in particular of:
- laboratory examinations necessary to assess the functional state of organs and systems in pre- and postoperative period;
- electrocardiogram and its analysis;
- echocardiography;
- gastroduodenoscopy;
- bronchoscopy;
- ultrasound examination of blood vessels;
- catheterization of heart cavities with angiocardiography;
- micro-ultrafiltration and dialysis;
- albumin dialysis (using a molecular adsorbing recirculating system);
- extracorporeal membrane oxygenation;
- intra-aortic counterpulsation;
- installation of an electrocardiostimulator;
- X-ray endovascular methods of treatment.
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3
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Availability of a minimum list of equipment for the department of cardiology (adult or child), in particular:
- a functional bed (50% of the department bed capacity);
- an electrocardiograph (2 sets);
- a defibrillator;
-a portable device for ultrasound examination of the heart and blood vessels;
- a centralized oxygen supply to each bed;
- an emergency alert system (alarm) from the wards from each bed to a nurse's post;
- a block of electrical outlets: at least 2 outlets with grounding at each bed and 4 outlets in the ward (1 dispenser per 1 bed);
- an automatic dispenser of medicinal substances syringe;
-an infuzomat (1 device for 1 bed);
- tonometers for measuring blood pressure (3 pcs.);
- a blood glucose meter;
-a nebulizer;
- a daily ECG monitor (3 pcs.);
-a daily blood pressure monitor (3 pcs.);
- a stress system (bicycle ergometer or treadmill);
- medical scales and height meter;
- a mobile (portable) set for resuscitation.
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4
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Availability of a minimum list of equipment for the intensive care unit:
- a functional bed (according to the number of beds);
- anti-decubitus mattress (1 in 3 beds);
- a bedside heart monitor (by the number of beds);
- a portable electrocardiograph (1 for 6 beds);
- an electrocardiostimulator (1 for 6 beds);
- a portable device for ultrasound examination of the heart and blood vessels (1 for 9 beds);
- an apparatus for assisted blood circulation (intra-aortic balloon counterpulsation) (1 with 9 beds);
- centralized oxygen supply system for each bed (by the number of beds);
- a surgical electric scrubber with bacterial filter (1 for 3 beds);
-a biphasic defibrillator with synchronization function (1 for 3 beds);
- an apparatus for artificial ventilation of the lungs (1 to 6 beds);
- a portable breathing apparatus for transportation (1 for the UIT);
- a set for tracheal intubation (2 for the UIT);
- a set for catheterization of main vessels (100 sets);
- an automatic dispenser of drugs syringe (2 for 1 bed);
-an infuzomat (1 per 1 bed);
- a bed tonometer for measuring blood pressure (by the number of beds);
- a mobile (portable) set for resuscitation in other departments (1 for the UIT);
- a mobile X-ray machine (1 for the UIT);
- a blood glucose meter (1 for the UIT);
- a set of tools and devices for minor surgical interventions (1 for the UIT);
- a block of electrical outlets (at least 8 outlets) with grounding at each bed, including for power supply of energy-intensive devices (X-ray machines) (by the number of beds).
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5
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Availability of a minimum list of equipment for the department of interventional cardiology, in particular:
- an angiograph (2 sets);
- an electrophysiological station (hereinafter - ESP-station);
- an electrocardiostimulator, combined with the ESP-station;
- a radio frequency destructor combined with the ESP-station;
- a mapping system for building an impulse propagation map;
- an irrigation pump for cold ablation;
- an electrocoagulator;
- a mobile operating lamp;
- an apparatus for transesophageal electrocardiostimulaton;
- a functional bed (by the number of beds);
- a bedside cardiomonitor (by the number of beds);
- an electrocardiograph (2 sets);
- a portable electrocardiograph (1 for 6 beds);
- an equipment for the study of main indicators of hemodynamics (at least 1 set for 6 beds);
- a portable apparatus for ultrasound examination of the heart and blood vessels;
- an electrocardiostimulator (at least 1 for 3 beds);
- an apparatus for assisted blood circulation (intra-aortic balloon counterpulsation) (2 sets);
- a centralized oxygen supply system for each bed (by the number of beds);
- a surgical electric scrubber with bacterial filter (2 pcs.);
- a biphasic defibrillator with synchronization function (3 pcs.);
- an apparatus for artificial lung ventilation (2 sets);
- an apparatus for carrying out spontaneous breathing;
- a portable breathing apparatus for transportation;
-a set for tracheal intubation (2 pcs.);
- a set for catheterization of main vessels for one-time use (100 sets);
- an automatic dispenser of drugs syringe (2 for 1 bed);
- an infuzomat (1 per 1 bed);
- a mobile (portable) set for resuscitation in other departments;
-a mobile X-ray machine;
- a blood glucose meter;
- a set of tools and devices for minor surgical interventions;
- a block of electrical outlets (at least 8 outlets) with grounding at each bed, including for power supply of energy-intensive devices (X-ray machines) (by the number of beds);
- a communication equipment with ambulance crews
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6
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Availability of a minimum list of equipment for the cardiac surgery department (adult, children's):
- a functional bed (20 pcs.);
- a resuscitation table for newborns with heating (3 pcs.);
- a baby incubator for newborns (3 pcs.);
- a phototherapy lamp for newborns;
- a bed for young children with a protective grille (7 pcs.);
- a centralized oxygen supply (by the number of beds);
- stationary or portable devices for sterilizing the room (2 sets);
- a tripod (infusion stand) (20 pcs.);
- a biphasic defibrillator with synchronization function (2 sets);
- a 12 channel electrocardiograph (2 pcs.);
-a portable baby bottles sterilizer;
- an electrocardiostimulator (2 pcs.);
- a stationary or portable apparatus for ultrasound examination of the heart and blood vessels;
- a cardiac monitor with 5-channel electrocardiography (3 sets);
- a portable pulse oximeter (2 pcs.);
- floor scales (adults, children);
- electronic baby scales;
- ultrasonic inhaler (nebulizer) (6 pcs.);
- a perfuser (1 per bed);
- an infuzomat (5 pieces);
- a mobile portable set for resuscitation in other departments;
- a set of tools and devices for emergency and minor surgical interventions (1 set);
- an X-ray viewing box for 2 pictures (2 pcs.);
- a set of endotracheal tubes for operating room:
- a functional operating table (2 sets);
- an equipment to create a laminar air flow in the operating room;
- an air conditioner;
- a table of the operating sister working on wheels (2 sets);
- an operating lamp (stationary, shadowless) (2 pcs.);
- a set of tools for cardiovascular surgery (for 2 adjacent operating rooms) (3 sets);
- a set of instruments for coronary surgery (2 sets);
- a headlight illuminator (2 pcs.);
- a sternotomic saw (for 2 adjacent operating rooms) (3 pcs.);
- a sternotomic oscillating saw;
- an ultraviolet recirculator-irradiator of air;
- a defibrillator-monitor;
- an apparatus for echocardiography;
- a transesophageal sensor;
- a transesophageal pediatric sensor;
- a transesophageal neonatal sensor;
- an ice machine;
- a thermostat;
- a surgical electrocoagulator (2 pcs.);
- an acid-base balance analyzer with electrolyte determination;
- an aspirator (suction) surgical (4 pcs.);
- an operational monitor (1 + 1);
- an anesthesia and respiratory apparatus for patients from 0.5 kg with monitoring;
- an electrocardiostimulator external temporary (2 sets);
- sensors for operational monitors (12 pcs.);
- children's sensors for operational monitors (12 pcs.);
- a perfuser (syringe dispenser) (6 pcs.);
- a device for injecting solutions under pressure (3 sets);
- an anesthesia table (2 pcs.);
- an apparatus for intraoperative assessment of the quality of blood flow in shunts using the transient flow time (1 (on request)).
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7
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Availability of the minimum list of equipment for carrying out an artificial circulation:
- an apparatus for artificial blood circulation;
- a gas mixer;
- a thermostatic device with two circulation circuits;
- an apparatus for autohemotransfusion (hemoseparator);
- a portable apparatus for measuring activated clotting time;
- an apparatus for carrying out extracorporeal membrane oxygenation;
- a table of the nurse;
- a bronchoscope.
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8
|
Availability of a minimum list of equipment for the organization of health care, rendering outpatient-polyclinic assistance to the population, in the structure of which there is a cardiological office, in particular:
- a 12-channel electrocardiograph (3 pcs.);
- a 6-channel electrocardiograph (portable);
- a treadmill system;
- an ECG holter-monitor 3-channel, 2-channel 1 installation + 10 recorders;
- a biphasic defibrillator (2 pcs.);
- a daily blood pressure monitor (1 installation + 10 recorders);
- Ultrasound machine with 4V in real time with cardiological, abdominal, vascular sensors;
- Ultrasound machine with 4V in real time with a cardiological sensor, portable (2 pcs.);
- a spirometer (2 pcs.);
- a tonometer;
- a phonendoscope;
- a blood glucose meter (all pre-hospital control rooms);
- a lipidometer (all pre-hospital control rooms);
- a coaguchek to determine international normalized attitude (all pre-hospital control rooms);
- a measuring tape for measuring waist
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9
|
Availability of assessment of complexity of surgical interventions for congenital heart defects according to Aristotle Base scale and effectiveness of operations in the cardiac surgery department
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10
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Availability of the department of recovery treatment and rehabilitation
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11
|
Availability of a cardiological office in the structure of organizations rendering outpatient-polyclinic assistance to the population (district, city, region, republic) and organizations rendering inpatient assistance
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12
|
Availability, when it is impossible to establish a diagnosis of CVD in the organization of primary health care, referring a patient for consultation to the clinical-diagnostic center for rendering CDA with consultation, if necessary, with involvement of profiled specialists, including consultants from medical organizations of the republican level.
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13
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Availability of rendering CDA to the patient with CVD by a specialist in the referral of a primary health care specialist or other profiled specialist
|
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14
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Availability of referral for consultation in the form No. 001-4/e, approved by the Order No. 907 (with the results of laboratory and instrumental examinations) when referring to a cardiologist (cardiac surgeon) for rendering CDA a doctor of primary health care
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15
|
Availability of a cardiologist (cardiac surgeon) provision of a conclusion in the form No. 086 /e and recommendations for further treatment of a patient with CVD in the form No. 071/y, approved by the Order No. 907 to the primary care physician who sent the patient for a consultative-diagnostic consultation
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16
|
Availability of a conclusion on paperwork completion for referral to a medical and social examination in the presence of high blood pressure (crisis), arrhythmias of various origins, increased angina attacks and an increase in heart failure symptoms, issuance and prolongation of the sick leave or a certificate of temporary disability, and with permanent loss of disability (condition after myocardial infarction, aorto-coronary shunting, congestive heart failure)
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17
|
Availability of the patient’s examination by the doctor in the reception department of the hospital with filling in the card of the inpatient according to the form 003/y, approved by the Order No. 907, with the written consent of the patient or his/her legal representative to provide him/her with medical assistance
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18
|
Availability, with hospitalization at the stationary level of:
1) a primary examination by a patient's doctor in order to determine his/her state of health and establish a preliminary diagnosis;
2) conducting therapeutic and diagnostic non-invasive testing methods to reduce the risk of invasive tests;
3) selection and prescription of treatment;
4) if necessary, consultations of specialists of another profile
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19
|
In case of emergency conditions, the establishment of the main diagnosis within 24 hours from the moment of admission of the patient to the hospital on the basis of clinical and anamnestic examination, the results of instrumental and laboratory research methods and is entered into the medical card of the inpatient according to the form No. 003/y, approved by the Order No. 907
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20
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Availability, after completion of treatment in inpatient conditions, issuing an extract from the inpatient medical card "Card of the discharged from the hospital" in the form No. 066 /y, approved by the Order No. 907, with the results of examination, treatment and recommendations for further patient treatment tactics
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21
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Compliance of rendering medical assistance to the patients with acute coronary syndrome and (or) acute myocardial infarction is carried out at the levels of regionalization:
1) at the first level, rendering of medical assistance by ambulance organizations, primary health care organizations, as well as organizations, rendering inpatient assistance without the possibility of percutaneous coronary interventions to the patients with acute coronary syndrome or acute myocardial infarction;
2) at the second level – by organizations, rendering inpatient assistance with the possibility of percutaneous coronary interventions without a cardiac surgery department;
3) at the third level – by organizations, rendering inpatient assistance and republican medical organizations, with availability of a cardiac surgery department.
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22
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Compliance of rendering medical assistance to patients with acute coronary syndrome or acute myocardial infarction with clinical protocols
|
|
|
|
|
Official (s) ___________________________________________ _____________________
position signature ___________________________________________________________
surname, name, patronymic (if any)
Head of the control subject _____________________________________ _______________
position signature
__________________________________________________________________________
surname, name, patronymic (if any)
List of abbreviations:
HIV - human immunodeficiency virus
PHC - Primary Health Care
GP - general practitioner
Ultrasound - ultrasound
Surfactants - psychoactive substances
Emergency medical assistance - ambulance
ICU - Intensive Care Unit
ECG - electrocardiography
BP - blood pressure
CDA - consultative and diagnostic assistance
CVD - cardiovascular diseases
EF - electrophysiological station
ATD - anti-TB drugs
Notes:
* - this checklist is used in respect of all subjects (objects) rendering inpatient, hospital-replacing assistance regardless of the profile of medical services rendered
** - this checklist is used in respect of all subjects (objects) rendering outpatient-polyclinic assistance (primary health care and consultative- diagnostic assistance), regardless of the profile of medical services rendered in the form of consultative- diagnostic assistance (including for subjects (objects) of rendering pre-medical assistance)
*** - this checklist is used in respect of subjects (objects) rendering medical services in the relevant profile as an additional checklist to the main checklist used in relations to subjects (objects) rendering inpatient, hospital-replacing and outpatient-polyclinic assistance, depending on the form of medical assistance in the subject (object) of control
**** - this checklist is used in respect of subjects (objects) carrying out activities in the sphere of laboratory services, also during the inspection of the subject (object) of health care which includes a laboratory service, this checklist is used as an additional checklist to the main checklist used depending on the form and profile of rendering medical assistance in the subject (object) of control
| |
Appendix 6
to the joint order of the
Minister of Healthcare of
the Republic of Kazakhstan
dated November 15, 2018
No. ЌР DSM-32 and the
Minister of National Economy of
the Republic of Kazakhstan
dated November 15, 2018, No. 70 |
Checklist in the sphere of state control of medical services quality
in respect of subjects (objects) rendering hemodialysis assistance***
State body, assigned the inspection _____________________________________
_________________________________________________________________________
The act of inspection assignment/preventive control with a visit to the subject (object)
of control
__________________________________________________________________________
__________________________________________________________________________
No, date
Name of the subject (object) of control _________________________________________
_________________________________________________________________________
(individual identification number), business identification number of the subject (object) of control
__________________________________________________________________________
__________________________________________________________________________
Location address __________________________________________________
___________________________________
№
|
List of requirements
|
Required
|
Not required
|
Meets the requirements
|
Does not meet the requirements
|
1
|
Availability at the patients of decision of the Commission on selection of patients for renal replacement therapy based on the conclusion of a polyclinic nephrologist
|
|
|
|
|
2
|
Observation by the department (center) of conducting extrarenal blood purification with daily two-shift use of hemodialysis equipment with a capacity of one hemodialysis site of at least 624 (2496 hours/year) hemodialysis sessions per year (12 hours per week per patient) on calendar days
|
|
|
|
|
3
|
Availability of the possibility of the department (center) to render emergency resuscitation and laboratory quality control of dialysis therapy by biochemical tests of water for hemodialysis during dialysis and in the interdialysis period
|
|
|
|
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4
|
Availability of provision in the department (center) of nutrition to outpatient patients after a hemodialysis session within the established tariff for the hemodialysis session
|
|
|
|
|
5
|
Ensuring patient transportation for a hemodialysis session within the established tariff for a hemodialysis session
|
|
|
|
|
6
|
Compliance with the criteria for selection and initiation of renal replacement therapy, in particular:
- indicators (glomerular filtration rate);
- presence of overhydration, acidosis;
- potassium level;
- assessment of the nutritional status of the patient)
|
|
|
|
|
7
|
Compliance with the indications for emergency extrarenal clearance of blood in patients with acute renal failure:
- lack of urine;
- hyperkalemia;
- overhydration.
|
|
|
|
|
8
|
Compliance with the material equipment of dialysis rooms, in particular:
- availability of: apparatus "Artificial kidney";
- reverse osmosis systems (supply of centralized oxygen or cylinders);
- availability of a nephrologist and a nurse trained in hemodialysis for one dialysis room.
|
|
|
|
|
9
|
Compliance of the hemodialysis apparatus with the standards and quality certificates, with sufficient resource and performance required by the manufacturing country
|
|
|
|
|
10
|
Availability of a minimum list of equipment dialysis rooms, in particular:
- hemodialysis apparatus - 2 pcs.;
- mobile beds - 2 pcs.;
- a table for the doctor - 1 pc.;
- a table for the nurse - 1 pc.;
- a chair - 2 pcs.;
- a table for medicines - 1 pc.;
- a tripod for long-term infusion infusions - 2 pcs.;
- a medicine cabinet - 1 pc.;
- a medical fridge - 1 pc.;
- a first aid kit - 1 pc.;
- a multichannel electrocardiograph - 1 pc.;
- a defibrillator - 1 pc.;
- a set for tracheostomy - 1 p .;
- a breathing apparatus - 1 pc.;
- a medical thermometer - 1 pc.;
- a phonendoscope - 1 pc.;
- a blood pressure meter - 1 pc.;
- ultraviolet irradiator-recirculator of air - 1 pc.;
- medical scales - 1 pc.
|
|
|
|
|
11
|
Compliance with the algorithm of hemodialysis procedure:
- preparation of the “artificial kidney” apparatus for work: testing and check of AAK devices with control of ionic composition of the dialysis fluid on the ion meter;
- preparation of workplace of the nurse of the dialysis hall: layout of sterile styling, preparation of fistula needles, dialyzer, fluids for filling tubing lines and dialyzer;
- assembly of the extracorporeal circuit (blood supply tubing lines, dialyzer) with installation on the apparatus "artificial kidney";
- filling and washing the extracorporeal circuit with a saline fluid with an anticoagulant;
- preparation of a patient: weighing on an electronic scale with registration of the amount of interdialysis weight gain in the dialysis card, treatment of the skin surface with disinfectants at the puncture site of the vascular access;
- connection of the patient to the apparatus "artificial kidney";
- setting the speed of blood flow on the apparatus "artificial kidney";
- control of arterial blood pressure, heart rate and pulse rhythm at least 1 time per hour, with hourly recording of results in the dialysis card;
- control of correctness of the ultrafiltration volume (at the end of dialysis), with registration of results in the dialysis card;
- control of the position of fistula needles in an arteriovenous fistula (permanently);
- control of indications of venous and arterial pressure sensors (constantly);
- control of anticoagulation (constantly visually);
- control of the ionic composition of the blood during the procedure (if indicated);
- at the end of the procedure time: stopping the pump through the blood, removing fistula needles from the vascular access, control the stopping of bleeding from puncture sites, final stopping of bleeding, bandaging the fistula limb with sterile dressing material;
- control weighing of the patient on electronic scales with registration of results in the dialysis card;
- cold washing of the apparatus, hot disinfection;
- transportation of the used consumables for disposal.
|
|
|
|
|
Official (s) ___________________________________________ _____________________
position signature ___________________________________________________________
surname, name, patronymic (if any)
Head of the control subject _____________________________________ ______________
position signature ___________________________________________________________
surname, name, patronymic (if any)
List of abbreviations:
HIV - human immunodeficiency virus
PHC - Primary Health Care
GP - general practitioner
Ultrasound - ultrasound
Surfactants - psychoactive substances
Emergency medical assistance - ambulance
ICU - Intensive Care Unit
ECG - electrocardiography
BP - blood pressure
CDA - consultative and diagnostic assistance
CVD - cardiovascular diseases
EF - electrophysiological station
ATD - anti-TB drugs
Notes:
* - this checklist is used in respect of all subjects (objects) rendering inpatient, hospital-replacing assistance regardless of the profile of medical services rendered
** - this checklist is used in respect of all subjects (objects) rendering outpatient-polyclinic assistance (primary health care and consultative- diagnostic assistance), regardless of the profile of medical services rendered in the form of consultative- diagnostic assistance (including for subjects (objects) of rendering pre-medical assistance)
*** - this checklist is used in respect of subjects (objects) rendering medical services in the relevant profile as an additional checklist to the main checklist used in relations to subjects (objects) rendering inpatient, hospital-replacing and outpatient-polyclinic assistance, depending on the form of medical assistance in the subject (object) of control
**** - this checklist is used in respect of subjects (objects) carrying out activities in the sphere of laboratory services, also during the inspection of the subject (object) of health care which includes a laboratory service, this checklist is used as an additional checklist to the main checklist used depending on the form and profile of rendering medical assistance in the subject (object) of control
| |
Appendix 7
to the joint order of the
Minister of Healthcare of
the Republic of Kazakhstan
dated November 15, 2018
No. ЌР DSM-32 and the
Minister of National Economy of
the Republic of Kazakhstan
dated November 15, 2018, No. 70 |
Checklist in the sphere of state control of medical services quality in respect of subjects
(objects) rendering dental assistance ***
State body, assigned the inspection _____________________________________________
__________________________________________________________________________
The act of inspection assignment/preventive control with a visit to the subject (object)
of control
__________________________________________________________________________
__________________________________________________________________________
No, date
Name of the subject (object) of control __________________________________________
__________________________________________________________________________
(individual identification number), business identification number of the subject (object) of control
__________________________________________________________________________
__________________________________________________________________________
Location address __________________________________________________
______________________________________________________________
______________________________________________________________
№
|
List of requirements
|
Required
|
Not required
|
Meets the requirements
|
Does not meet the requirements
|
1
|
Compliance with the following requirements when organizing dental assistance:
1) involvement of doctors of related specialties to provide consultative assistance in the presence of comorbidities in patients with dental diseases (for medical reasons);
2) referral of patients with dental diseases to maxillofacial departments of multidisciplinary hospitals in cases requiring the provision of specialized medical assistance and high-tech medical services with round-the-clock medical supervision;
3) availability of a consultative and diagnostic conclusion in the form 071/y, approved by the Order No. 907, indicating the results of conducted examination and treatment, as well as recommendations for further treatment of a patient with dental diseases;
4) provision of dental medical assistance to the patient after obtaining his/her informed consent in the approved form of written voluntary consent of the patient with invasive interventions;
5) compliance with indications for emergency hospitalization:
- acute or exacerbation of chronic odontogenic and nonodontogenic inflammatory diseases of the maxillofacial area;
- injuries of the maxillofacial area;
- bleeding of the maxillofacial area;
6) compliance with indications for planned hospitalization of a patient with dental diseases:
- clarifying the diagnosis in cases that are unclear and difficult to diagnose and treat, and selection of necessary treatment regimen;
- treatment of chronic diseases of the oral cavity and maxillofacial area in the acute stage;
- surgical treatment of benign tumors and tumor-like diseases;
- treatment of injuries and purulent-inflammatory diseases of the maxillofacial area;
- surgical treatment of defects and deformities of the maxillofacial area;
- surgical treatment of congenital maxillofacial pathology.
|
|
|
|
|
2
|
Availability of a contract for rendering paid services in health care organizations
|
|
|
|
|
3
|
Compliance with clinical and diagnostic tests on the levels of rendering dental care
|
|
|
|
|
Official (s) ___________________________________________ ____________________
position signature __________________________________________________________
surname, name, patronymic (if any)
Head of the control subject _____________________________________ _____________
position signature
__________________________________________________________________________
surname, name, patronymic (if any)
List of abbreviations:
HIV - human immunodeficiency virus
PHC - Primary Health Care
GP - general practitioner
Ultrasound - ultrasound
Surfactants - psychoactive substances
Emergency medical assistance - ambulance
ICU - Intensive Care Unit
ECG - electrocardiography
BP - blood pressure
CDA - consultative and diagnostic assistance
CVD - cardiovascular diseases
EF - electrophysiological station
ATD - anti-TB drugs
Notes:
* - this checklist is used in respect of all subjects (objects) rendering inpatient, hospital-replacing assistance regardless of the profile of medical services rendered
** - this checklist is used in respect of all subjects (objects) rendering outpatient-polyclinic assistance (primary health care and consultative- diagnostic assistance), regardless of the profile of medical services rendered in the form of consultative- diagnostic assistance (including for subjects (objects) of rendering pre-medical assistance)
*** - this checklist is used in respect of subjects (objects) rendering medical services in the relevant profile as an additional checklist to the main checklist used in relations to subjects (objects) rendering inpatient, hospital-replacing and outpatient-polyclinic assistance, depending on the form of medical assistance in the subject (object) of control
**** - this checklist is used in respect of subjects (objects) carrying out activities in the sphere of laboratory services, also during the inspection of the subject (object) of health care which includes a laboratory service, this checklist is used as an additional checklist to the main checklist used depending on the form and profile of rendering medical assistance in the subject (object) of control
| |
Appendix 8
to the joint order of the
Minister of Healthcare of
the Republic of Kazakhstan
dated November 15, 2018
No. ЌР DSM-32 and the
Minister of National Economy of
the Republic of Kazakhstan
dated November 15, 2018, No. 70 |
A checklist in the sphere of state quality control of rendering medical services in relation to the subjects (objects) providing phthisiatric care***
Footnote. Appendix 8 - is in the wording of the joint order of the Minister of Healthcare of the Republic of Kazakhstan dated 06.01.2021 No. KR HCM-3 and the Minister of National Economy of the Republic of Kazakhstan dated 06.01.2021 No. 5 (shall be enforced upon expiry of ten calendar days after its first official publication).
State body that assigned the inspection _____________________________
________________________________________________________________________
Act on assignment of an inspection/preventive control with a visit to the subject (object)
of control ____________________________________________________________________
________________________________________________________________________
No., date
Name of the subject (object) of control
____________________________________________________________________________
(Individual identification number), business identification number of the subject (object)
of control ______________________________________________________________________
_________________________________________________________________
Location address _______________________________________________________
_____________________________________________________________________________
№
|
List of requirements
|
Required
|
Not required
|
Meets the requirements
|
Doesn't meet the requirements
|
Provision of anti-tuberculosis care at the outpatient-polyclinic level
|
1.
|
Implementation of the following activities by PHC specialists:
1) conducting information and explanatory work on prevention, early detection of tuberculosis;
2) planning (formation of lists of subjected persons, drawing up a schedule), organization and conduct of fluorographic examination with registration of examination results in medical documentation;
3) planning (formation of lists of subjected persons, drawing up a schedule), organizing and conducting tuberculin diagnostics of children and adolescents with registration of examination results in medical documentation, conducting additional examination of tuberculin-positive children);
4) referral for examination of persons with suspected tuberculosis according to the diagnostic algorithm of the examination;
5) referral to a phthisiatrician of persons with positive results of fluorographic examination, children and adolescents with newly diagnosed positive and hyperergic tuberculin test, with an increase in tuberculin sensitivity by 6 mm or more, children with adverse reactions and complications for vaccination against tuberculosis;
6) planning, organizing and conducting vaccination against tuberculosis;
7) controlled treatment of latent tuberculosis infection (hereinafter - LTI) as prescribed by a phthisiatrician, including in a video - monitored mode;
8) examination of contact persons;
9) outpatient direct-controlled or video -monitored treatment of patients with tuberculosis;
10) diagnosis and treatment of adverse reactions to anti-tuberculosis drugs as prescribed by a phthisiatrician;
11) diagnosis and treatment of concomitant diseases;
12) maintaining medical records of tuberculosis patients undergoing outpatient treatment, including multidrug-resistant and extensively drug-resistant tuberculosis;
13) regular entry of data into the National register of tuberculosis patients within the competence
|
|
|
|
|
2.
|
Examination of a patient with suspected tuberculosis in organizations providing primary health care, in accordance with the approved scheme
|
|
|
|
|
3.
|
Detection of tuberculosis by fluorography among the target population: with a high risk of the disease and subject to mandatory annual fluorographic examination
|
|
|
|
|
4.
|
Organization of directly controlled treatment rooms in PHC organizations for outpatient treatment.
The patient receives and takes medications at the DCTR under the supervision of a responsible healthcare professional. Once every 10 days, patients who are on direct controlled treatment shall be examined by a primary healthcare doctor/phthisiatrician of the polyclinic, if indicated - more often.
Patients living in rural areas shall be examined by a phthisiatrician once a month
|
|
|
|
|
5.
|
An assessment of the clinical condition of a patient receiving anti-tuberculosis treatment for the presence of adverse reactions and phenomena shall be carried out daily by the attending physician or phthisiatrician, a medical worker in the directly observed treatment room. A medical worker who has identified adverse reactions and events to a drug fills out a message card and draws up an entry in the patient's medical record.
Primary information on adverse reactions and phenomena shall be provided by the responsible person of the medical organization to the state expert organization in the field of circulation of medicines and medical devices. Control over the registration of card messages shall be assigned to the person in charge of pharmacovigilance.
Each case of adverse reactions and phenomena shall be considered at a meeting of the centralized medical advisory commission to determine the causal relationship with the medications taken.
|
|
|
|
|
6.
|
Tracking the movement of anti-tuberculosis drugs at the outpatient level in the registration log of anti-tuberculosis drugs
|
|
|
|
|
7.
|
Before starting treatment, the patient (parents or guardians of children) shall be interviewed about the need for a full course of chemotherapy, followed by signing an informed consent
|
|
|
|
|
8.
|
Registration and dispensary observation of patients with tuberculosis shall be carried out in organizations providing primary health care, at the place of actual residence, work, study or military service, regardless of registration
|
|
|
|
|
Rendering anti-tuberculosis care at the inpatient level
|
9.
|
Distribution of patients in departments by wards, taking into account laboratory data and drug sensitivity at the time of admission and during treatment.
Keeping patients with bacteriological secretions with unknown drug sensitivity in single wards or boxes until drug sensitivity test results are obtained
|
|
|
|
|
10.
|
Daily examination of patients who are in the hospital by a phthisiatrician.
Keeping a record in the patient's medical record, depending on the severity of his/her condition (at least 3 times a week in case of mild and moderate condition of the patient and daily - in case of serious condition of the patient).
Examination of patients with tuberculosis, multidrug-resistant tuberculosis and extensively drug-resistant tuberculosis by the head of the department at least 1 time per week with an entry in the patient's medical record
|
|
|
|
|
11.
|
Organization of a consilium in difficult situations to verify the diagnosis and determine treatment tactics with participation of specialists at regional and republican levels in full-time or remote form through telemedicine
|
|
|
|
|
12.
|
Tracking the movement of anti-tuberculosis drugs at the inpatient level in the registration log of anti-tuberculosis drugs
|
|
|
|
|
13.
|
Compliance with the criteria for the discharge of a patient with tuberculosis from the hospital:
1) absence of bacterial excretion and the need for round-the-clock medical supervision;
2) obtaining two negative results of microscopy, sequentially taken with an interval of at least 10 calendar days in patients with initial bacterial excretion;
3) generally accepted outcomes of inpatient treatment (recovery, improvement, no change, deterioration, death and transferred to another medical organization);
4) at the written request of the patient (his/her legal representative) before the end of the treatment course in the absence of an immediate danger to the patient's life or to others
|
|
|
|
|
Official ( s ) ________________________________________
_______________________________ ___________
position signature
_____________________________________________________________________________
(surname, name, patronymic (if any)
Head of the subject of control _____________________________________
_______________________________ ____________________
position signature
_____________________________________________________________________________
(surname, name, patronymic (if any)
List of abbreviations:
PHC - primary health care
Anti-TB drugs - anti-tuberculosis drugs
Notes:
* - this checklist is used in relation to all subjects (objects) rendering inpatient, inpatient replacing assistance, regardless of the profile of provided medical services
** - this checklist is used in relation to all subjects (objects) rendering outpatient assistance (primary health care and consultative-diagnostic assistance), regardless of the profile of medical services provided in the form of consultative-diagnostic assistance, (including for the subjects (objects) of rendering pre-medical care)
***- this checklist is used in relation to subjects (objects) rendering medical services in the corresponding profile, as an additional checklist to the main checklist used in relations between subjects (objects) providing inpatient, inpatient-replacing and outpatient assistance, depending on the form of rendering medical care in the subject (object) of control
**** - this checklist is used in relation to subjects (objects) carrying out activities in the sphere of laboratory service, also when conducting an inspection of the subject (object) of health care, which includes a laboratory service, this checklist is used as an additional checklist to the main checklist used depending on the form and profile of rendering medical care in the subject (object) of control
| |
Appendix 9
to the joint order of the
Minister of Healthcare of
the Republic of Kazakhstan
dated November 15, 2018
No. ЌР DSM-32 and the
Minister of National Economy of
the Republic of Kazakhstan
dated November 15, 2018, No. 70 |
Сhecklist in the sphere of state control of medical services quality in respect of subjects
(objects) rendering oncological assistance ***
State body, assigned the inspection _____________________________________________
__________________________________________________________________________
The act of inspection assignment/preventive control with a visit to the subject (object)
of control
__________________________________________________________________________
__________________________________________________________________________
No, date
Name of the subject (object) of control __________________________________________
__________________________________________________________________________
(individual identification number), business identification number of the subject (object) of control
__________________________________________________________________________
__________________________________________________________________________
Location address __________________________________________________
______________________________________________________________
______________________________________________________________
№
|
List of requirements
|
Required
|
Not required
|
Meets the requirements
|
Does not meet the requirements
|
1
|
Availability of material and technical equipment of an oncology room:
- a cabinet for medical documentation;
- a bactericidal ultraviolet irradiator;
- first aid kit
- scales for adults;
- height meter;
- a tonometer;
- a phonendoscope;
- a thermometer;
- a spatulas.
|
|
|
|
|
2
|
Availability of material and technical equipment of breast office:
- a negatoscope for viewing breast images;
- a bactericidal lamp;
- a medical couch;
- a screen;
- first-aid kit for first aid.
|
|
|
|
|
3
|
Availability of material and technical equipment of proctology office:
- sigmoidoscope with a set of tubes (length from 20 cm to 35 cm) - 5 tubes;
- gynecological chair;
- a set of glasses for biopsy;
- an anoscope;
- rectal mirrors;
- an electrocoagulator;
- a table of the nurse;
- a mobile medical table;
- a shadowless lamp;
- a lamp for UFO wall;
- a soft clamp;
- an anatomical tweezers;
- a surgical tweezers;
- operating scissors;
- working scissors;
- a probe bellied;
- a gouge probe;
- surgical gloves;
- first-aid kit for first aid.
|
|
|
|
|
4
|
Availability of material and technical equipment of the centralized cultivation room of cytostatic drugs:
- a laminar box with a shut-off air flow, a system of ultraviolet irradiation of inner chamber and a protective screen for personnel;
- medical cabinets for storage of solutions for preparation cytostatics;
- rotary thermosealing machine for hermetic packaging of syringes and vials with ready cytostatic solutions;
- a holder for rolls;
- plastic bags for packaging ready diluted solutions in vials and / or syringes, a roll of 300 mm * 200 m;
- tanks for disinfecting solutions (10 liter), for surface treatment;
- sink and dispensing devices with liquid soap and antiseptic for hygienic treatment of hands;
- a safe for storage of cytostatics;
- a wall bactericidal irradiator;
- containers for transportation of chemotherapy drugs;
- holders for liquid soap and disinfectants;
- containers for disposing used chemotherapy drugs disposable. Class A, B;
- a medical cabinet for storage of chemotherapy drugs closed;
- a pharmaceutical refrigerator;
- a hydrometer;
- a cabinet for storage of documentation;
- a wardrobe;
- a computer desk;
- a computer chair;
- a desk;
- a cabinet for storage of disposable sets of protective clothing;
- a computer;
- a printer /copier;
- an air conditioning;
- a table;
- a container for household waste;
- a phone.
|
|
|
|
|
5
|
Participation of a multidisciplinary group in the specialized treatment of patients with cancerous neoplasms
|
|
|
|
|
6
|
Availability of decisions of a multidisciplinary group in the multidisciplinary group meeting journal, minutes of a multidisciplinary group meeting (2 copies) followed by sticking to the medical card of an outpatient (form No. 025 /y) and medical card of a hospital patient, approved by the Order No. 907
|
|
|
|
|
7
|
Compliance with the following requirements when organizing oncologic assistance:
1) at the outpatient-polyclinic level:
- examination by a doctor in order to determine the patient's state and establish a diagnosis;
- laboratory and instrumental examination of citizens in order to verify the diagnosis;
- selection and referral for hospitalization to an oncology organization for the provision of specialized and highly specialized medical assistance;
- dynamic monitoring of oncologic patients;
- registration of medical documentation of the established form;
2) at the in-patient hospital level:
- carrying out necessary prescribed treatment;
- daily examination by a doctor (unless another frequency is provided), correction of treatment;
- consultation of specialists, if necessary.
|
|
|
|
|
8
|
Compliance with the following requirements when organizing the work of radiotherapy department:
1) hospitalization of patients in the radiotherapy department after preliminary examination and addressing the need for radiotherapy with participation of the head of radiotherapy department (unit) or a radiotherapy physician of the department;
2) adherence to the principle of "a single doctor - radiation therapist (radiologist)" when serving inpatients with radiation therapy;
3) availability of the following documentation in the radiotherapy department:
-an office passport;
- a sanitary-epidemiological conclusion for the right to work with sources of ionizing radiation;
- a department structure;
- nomenclature of the department affairs;
- rules of internal labor schedule of the department;
- due instructions (head of the department, a radiation therapist, middle and junior medical personnel, medical physicists, machine maintenance engineers, technicians);
- safety instructions for working with radioactive substances;
- emergency instructions at each work site;
- magazine of personnel instructing about safety measures;
- internal rules for patients;
- fire safety rules.
|
|
|
|
|
Official (s) _________________________________________________ _____________
position signature _________________________________________________________
surname, name, patronymic (if any)
Head of the control subject _____________________________________ _____________
position signature __________________________________________________________
surname, name, patronymic (if any)
List of abbreviations:
HIV - human immunodeficiency virus
PHC - Primary Health Care
GP - general practitioner
Ultrasound - ultrasound
Surfactants - psychoactive substances
Emergency medical assistance - ambulance
ICU - Intensive Care Unit
ECG - electrocardiography
BP - blood pressure
CDA - consultative and diagnostic assistance
CVD - cardiovascular diseases
EF - electrophysiological station
ATD - anti-TB drugs
Notes:
* - this checklist is used in respect of all subjects (objects) rendering inpatient, hospital-replacing assistance regardless of the profile of medical services rendered
** - this checklist is used in respect of all subjects (objects) rendering outpatient-polyclinic assistance (primary health care and consultative- diagnostic assistance), regardless of the profile of medical services rendered in the form of consultative- diagnostic assistance (including for subjects (objects) of rendering pre-medical assistance)
*** - this checklist is used in respect of subjects (objects) rendering medical services in the relevant profile as an additional checklist to the main checklist used in relations to subjects (objects) rendering inpatient, hospital-replacing and outpatient-polyclinic assistance, depending on the form of medical assistance in the subject (object) of control
**** - this checklist is used in respect of subjects (objects) carrying out activities in the sphere of laboratory services, also during the inspection of the subject (object) of health care which includes a laboratory service, this checklist is used as an additional checklist to the main checklist used depending on the form and profile of rendering medical assistance in the subject (object) of control
| |
Appendix 10
to the joint order of the
Minister of Healthcare of
the Republic of Kazakhstan
dated November 15, 2018
No. ЌР DSM-32 and the
Minister of National Economy of
the Republic of Kazakhstan
dated November 15, 2018, No. 70 |
A checklist in the sphere of state quality control of rendering medical services
in relation to subjects (objects) providing medical and social assistance in the field of mental health
Footnote. Appendix 10 – is in the wording of the joint order of the Minister of Healthcare of the Republic of Kazakhstan dated 06.01.2021 No. KR HCM-3 and the Minister of National Economy of the Republic of Kazakhstan dated 06.01.2021 No. 5 (shall be enforced upon expiry of ten calendar days after its first official publication).
State body that assigned the inspection _____________________________
________________________________________________________________________
Act on assignment of an inspection/preventive control with a visit to the subject (object)
of control ____________________________________________________________________
________________________________________________________________________
No., date
Name of the subject (object) of control
____________________________________________________________________________
(Individual identification number), business identification number of the subject (object)
of control ______________________________________________________________________
_________________________________________________________________
Location address _______________________________________________________
_____________________________________________________________________________
№
|
List of requirements
|
Required
|
Not required
|
Meets the requirements
|
Doesn't meet the requirements
|
for the subjects (objects) rendering medical and social assistance in the field of mental health at the outpatient-polyclinic level
|
1.
|
Compliance with the criteria for taking on dynamic observation of persons with MBD:
1 group of dynamic psychiatric observation - persons prone by their mental state to socially dangerous actions, including those who have the risk of committing violent acts of a sexual nature against minors, as well as those who have committed especially dangerous acts in a state of insanity, and for whom the court has determined compulsory measures of medical character in the form of outpatient compulsory treatment;
2 group of dynamic psychiatric observation - Persons with MBD who have mental disabilities, with the exception of MBD indicated in diagnostic headings F8 and F9; a person with a diagnosis of F20 "Schizophrenia" within one year after establishing diagnosis (while in the case of recognition as a disabled person, he/she continues to be observed in the 2nd group of dynamic psychiatric observation);
2A - persons with frequent and severe exacerbations of psychotic symptoms, decompensation, in need of psychopharmacotherapy within the framework of free outpatient treatment, including persons with MBD indicated in diagnostic headings F8 and F9
2B - persons with stabilized conditions, with a moderately progressive course of the process and spontaneous remissions;
group of dynamic narcological observation - Persons prone to socially dangerous actions due to clinical manifestations of MBD,
caused by the abuse of psychoactive substances.
Compliance with the periodicity and frequency of observation of persons with mental, behavioral disorders (diseases):
1 group of dynamic psychiatric observation - at least once a month
2 group of dynamic psychiatric observation:
2A - at least once every three months,
2B - at least once every six months;
group of dynamic narcological observation - at least once a month
|
|
|
|
|
2.
|
Compliance with the requirements for drug provision for the persons with MBD who are under dynamic observation
Drug provision for the persons with MBD, being under dynamic observation shall be carried out within the framework of the current legislation
|
|
|
|
|
3.
|
Compliance with the requirements for deregistration and transfer to another dynamic observation group, termination of dynamic observation of persons with MBD and deregistration
Removal from the register and transfer to another dynamic observation group shal be carried out on the basis of the decision of the MAC on the recommendation of the district psychiatrist. Termination of dynamic observation of persons with MBD and deregistration shall be carried out in the following cases:
1) absence of the criteria, registration for the provision of dynamic observation of persons with MBD for at least 12 months;
2) change of place of residence with departure from the Republic of Kazakhstan (confirmed by a document).
In the event of a change in the patient's permanent place of residence within the Republic of Kazakhstan, the attachment to the corresponding territorial organization providing medical care in the field of mental health shall be carried out with a change of data in the EIS;
3) absence of reliable information about the location within 12 months;
4) death, on the basis of a medical death certificate, and (or) confirmed by data in the register of the attached population;
5) persons diagnosed with F20 "schizophrenia" according to the international classification of diseases of the 10th revision, who are registered in the second group of dynamic psychiatric observation: in case of not establishing a disability group within 12 months from the date of taking for dynamic observation
|
|
|
|
|
4.
|
Presence of dynamic observation of persons who were subjected to compulsory treatment after discharge.
Persons with MBD associated with the use of psychoactive substances, after the end of compulsory treatment and discharge from an organization providing medical care in the field of mental health, except for those discharged by the court order as recovered early shall be observed in the group of dynamic narcological observation in accordance with the rules of dynamic observation, as well as the termination of dynamic observation of persons with MBD, approved by the authorized body
|
|
|
|
|
5.
|
Availability of an individual treatment plan and a rehabilitation program for the persons after discharge from an organization providing medical care in the field of mental health, except for those discharged by the court order as recovered early.
With supportive treatment for the persons with MBD, a psychiatrist (narcologist) shall draw up an individual treatment plan and an individual rehabilitation program.
An individualized treatment plan and an individualized rehabilitation program include:
1) diagnostic metods: analysis of the psychoactive substances content in biological fluids and body tissues, testing for HIV, experimental psychological diagnostics, determining the quality of life and social functioning, clinical and biochemical diagnostics, neurophysiological diagnostics;
2) drug therapy: psychopharmacotherapy, symptomatic therapy, therapy of comorbid pathology, antagonistic therapy using opioid receptor blockers;
3) advisory methods: medical, psychological and social counseling of persons dependent on psychoactive substances and codependent persons;
4) training methods: motivational trainings for the continuation of supportive anti-relapse therapy, for the formation of adaptive skills and stress resistance, for the formation of properties of psychological resistance to re-involvement in dependence on psychoactive substances;
5) psychotherapeutic methods: individual and group psychotherapy of persons dependent on psychoactive substances, individual express psychotherapy of persons dependent on psychoactive substances, who are in a state of breakdown.
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for the subjects (objects) rendering medical and social assistance in the field of mental health in inpatient conditions, providing round-the-clock medical supervision
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6.
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Availability of grounds for hospitalization in inpatient clinical departments.
The grounds for hospitalization in inpatient clinical departments shall be:
1) a referral of a psychiatric doctor;
2) the resolution, decision, determination of the judicial and investigative bodies;
3) a referral of the military-medical commission;
4) a written statement of the person himself, if there are indications;
5) a court decision on compulsory treatment of persons with MBD caused by the use of psychoactive substances, which entered into legal force;
6) a court decision on application of compulsory medical measures provided for in Article 93 of the Criminal Code of the Republic of Kazakhstan, which entered into force
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7.
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The completeness of measures taken for planned hospitalization in inpatient clinical departments of the Republican Scientific and Practical Center for Mental Health (RSPCMH), CMH.
In case of planned hospitalization in inpatient clinical departments of the Republican Scientific and Practical Center for Mental Health, the Centre of Mental Health, the head or psychiatrist (narcologist) of the clinical department, reception and diagnostic department shall carry out the following activities:
1) patient identification;
2) checks the availability of available medical and other documentation, if necessary, directs to undergo regulated and (or) additional examinations;
3) checks the availability of a court decision on hospitalization that has entered into legal force, if any;
4) assesses the mental and somatic state, the results of laboratory-diagnostic tests, determines the need for emergency care at the level of reception and diagnostic department and (or) presence of indications and contraindications for hospitalization;
5) establishes a preliminary diagnosis, determines the scope of differential diagnosis, observation regime, medical nutrition and other therapeutic and diagnostic measures in accordance with the protocols of diagnosis and treatment;
6) fills in primary medical documentation;
7) in case of anonymous treatment of a patient, the name and patronymic (if any), date of birth, address of residence shall be filled in according to the patient's words.
The completeness of measures taken during planned hospitalization in inpatient clinical departments of the Republican Scientific and Practical Center for Mental Health, CMH of persons with MBD, caused by the use of psychoactive substances for treatment in an anonymous manner.
In case of planned hospitalization in inpatient clinical departments of the Republican Scientific and Practical Center for Mental Health, CMH of persons with MBD caused by the use of psychoactive substances for treatment on an anonymous basis, the head or psychiatrist (narcologist) of the clinical department or reception-diagnostic department shall carry out the following measures:
1) assigns a medical registration code to the patient;
2) directs to undergo compulsory and (or) additional examinations;
3) assesses the mental and somatic state, the results of laboratory and diagnostic studies, determines the need for emergency care at the level of reception and diagnostic department and (or) presence of indications and contraindications for hospitalization;
4) establishes a preliminary diagnosis, determines the scope of differential diagnosis, observation regime, therapeutic nutrition and other therapeutic and diagnostic measures in accordance with the protocols of diagnosis and treatment;
5) fills in primary medical documentation
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8.
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The completeness of measures taken during hospitalization in the inpatient clinical department of the RSPCMH, CMH for emergency indications.
When hospitalized in the inpatient clinical department of the RSPCMH, the CMH, the head or psychiatrist (narcologist) of clinical department or the reception and diagnostic department, or the doctor on duty shall carry out the following activities:
1) patient identification;
2) assesses mental and somatic conditions, the results of laboratory and diagnostic studies and determines the need for emergency care at the level of reception and diagnostic department and (or) presence of indications and contraindications for hospitalization;
3) establishes a preliminary diagnosis, determines the scope of differential diagnostics, observation regime, medical nutrition and other therapeutic and diagnostic measures in accordance with the diagnostic and treatment protocols;
4) fills in primary medical documentation
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9.
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The completeness of measures taken for planned hospitalization at SPOIS (specialized psychiatric organization with intensive supervision).
With a planned hospitalization at SPOIS, the doctor on duty shall carry out the following activities:
1) checks the availability and compliance of the available documentation:
a court decision that has entered into legal force;
an identity document.
2) conducts identification of the patient;
3) assesses the mental and somatic state, the results of laboratory and diagnostic studies, determines the need for emergency care at the level of reception and diagnostic department and (or) presence of indications and contraindications for hospitalization;
4) determines the department, establishes the observation regime, medical nutrition and other medical and diagnostic measures in accordance with the diagnostic and treatment protocols;
5) fills in primary medical documentation
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10.
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The completeness of measures taken after the admission of a person with MBD to the inpatient clinical department.
After the admission of a person with MBD to the inpatient clinical department, the following activities shall be carried out:
1) patient identification;
2) checking the availability and compliance of available medical and other documentation;
3) assessment of mental and somatic state, the results of laboratory and diagnostic studies, establishment of a preliminary diagnosis, determination of the scope of differential diagnosis, observation regime, medical nutrition and other therapeutic and diagnostic measures in accordance with the protocols of diagnosis and treatment;
4) filling in primary medical documentation
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11.
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The completeness of measures taken after the person has entered the inpatient clinical department of SPOIS
After a person enters the inpatient clinical department of SPOIS, the following activities shall be carried out:
1) patient identification;
2) checking the availability and compliance of available medical and other documentation;
3) assessment of mental and somatic state, the results of laboratory and diagnostic studies, establishment of a preliminary diagnosis, determination of the scope of differential diagnosis, observation regime, medical nutrition and other therapeutic and diagnostic measures in accordance with the protocols of diagnosis and treatment;
4) filling in primary medical documentation
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12.
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Compliance with observation regimes.
In clinical inpatient departments of the RSPCMH, the CMH and multidisciplinary city (regional) hospitals, the following types of observation shall be assumed:
1) a general observation regime - round-the-clock observation without restriction of movement in the department. The general regime for patients shall be established when:
no danger to yourself and others;
the ability to maintain personal hygiene without assistance;
2) a partial hospitalization regime - the possibility of staying in the department during the day or at night, taking into account the need for its adaptation in out-of-hospital conditions, as well as the possibility of carrying out labor activities against the background of treatment and control of MBD symptoms for the purpose of resocialization. The regime of partial hospitalization shall be established by the decision of the medical commission (hereinafter - MC) consisting of two doctors with:
no danger to yourself and others;
the ability to maintain personal hygiene without assistance;
stabilization of the mental state, requiring daily, but not round-the-clock observation and control;
3) the regime of medical vacations - the ability to stay outside the department from several hours to several days in order to gradually adapt to out-of-hospital conditions, solve household and social issues, as well as to assess the achieved therapeutic effect. The regime of medical vacations shall be established by the decision of the MC consisting of two doctors and provided with:
no danger to yourself and others;
the ability to maintain personal hygiene without assistance;
stabilization of the mental state, which does not require daily observation.
4) an enhanced observation regime - round-the-clock observation and restriction of movement outside the department. An enhanced observation observation shall be established for patients with:
acute MBD that do not pose a danger to themselves and others;
the ability to maintain personal hygiene without assistance;
absence of mental and somatic disorder, requiring a different regime of observation and maintenance;
5) a strict observation regime - round-the-clock continuous observation in the observation room, constant accompaniment by medical personnel in the department and outside it. A strict patient regime shall be established for patients with:
immediate danger to yourself and others;
helplessness, that is, the inability to independently satisfy their vital needs, in the absence of proper care;
possible significant harm to health if the person is left without observation.
In clinical inpatient departments of SPOIS, the following types of observation shall be assumed:
1) a general observation regime - round-the-clock observation with movement in the department according to the daily routine, the possibility of participating in occupational therapy outside the department;
2) an enhanced observation regime - round-the-clock observation and restriction of movement within the department;
3) a strict observation regime - round-the-clock continuous observation in the observation ward, constant accompaniment by medical personnel in the department and outside it
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13.
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Compliance with the conditions of discharge.
Discharge from inpatient clinical departments shall be made upon the patient's recovery or improvement in his/her mental state, when no further inpatient treatment is required, as well as upon completion of the examination, expertise, security measures, compulsory medical measures, which were the grounds for admission to the hospital.
Discharge of a patient who is in inpatient clinical departments voluntarily shall be made at his/her personal application, the application of his/her legal representative or by the decision of his/her attending physician.
Discharge of a patient, to whom compulsory medical measures and security measures have been applied according to the court's decision shall be made only on the basis of a court ruling that has entered into force.
A patient, hospitalized in an inpatient clinical department voluntarily shall be refused discharge if the MAC establishes the grounds for compulsory hospitalization
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Criteria for the subjects (objects) rendering medical and social assistance in the field of mental health in hospital-substituting conditions that do not require round-the-clock medical supervision and treatment and provide for medical observation and treatment in the daytime with the provision of a bed
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14.
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Availability of indications for treatment in hospital-substituting conditions for persons with MBD
The indications for treatment in hospital-substituting conditions for persons with MBD shall be:
1) the need for active therapy of persons with MBD, including those caused by the use of psychoactive substances, which does not require round-the-clock observation;
2) the need for gradual adaptation to usual life situation, after receiving a course of treatment in a round-the-clock hospital;
3) conducting examinations and expertise that do not require round-the-clock stationary observation
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15.
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Requirements for the duration of treatment and the time spent in the day hospital.
The duration of treatment in a day hospital is no more than 30 calendar days.
In cases of deterioration of the patient's state, requiring round-the-clock medical observation and treatment, he/she shall be hospitalized in the appropriate inpatient department.
The daily time spent in the day hospital is at least 6 hours. The day hospital provides two meals a day, taking into account the time of taking psychotropic drugs
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16.
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Compliance with the requirements for discharge from the day hospital.
Discharge shall be made upon the patient's recovery or improvement in his/her mental state, when it is possible to transfer to outpatient treatment, as well as upon completion of examination, expertise, which were the grounds for placement in a day hospital
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Criteria for the subjects (objects) rendering medical and social rehabilitation in the field of mental health
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17.
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Compliance with the requirements for medical and social rehabilitation in outpatient or hospital-substituting conditions.
When rendering medical and social rehabilitation in an outpatient or inpatient conditions, the daily stay shall be at least 6 (six) hours, excluding weekends and holidays, with two meals a day, taking into account the time of taking psychotropic drugs. In the department of medical and social rehabilitation, the patient shall be provided with the necessary drug therapy and necessary examination.
Medical and social rehabilitation of patients with MBD shall be provided in accordance with the individual rehabilitation program for a patient with MBD
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18.
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Compliance with the requirements for medical and social rehabilitation in stationary conditions.
When hospitalized for medical and social rehabilitation, the following activities shall be carried out:
1) patient identification;
2) checking the availability and compliance of available medical documentation, referral to undergo regulated and (or) additional examinations;
3) an individual program for the rehabilitation of a patient with MBD is being developed;
4) primary medical documentation is filled in.
General contraindications for hospitalization for medical and social rehabilitation shall be:
1) acute conditions requiring a strict or enhanced observation regime;
2) presence of concomitant diseases requiring treatment in hospitals of a different profile;
3) infectious diseases during the period of epidemiological danger
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19.
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Presence of a multidisciplinary group.
Medical and social rehabilitation of adults with MBD shall be carried out by a multidisciplinary group:
1) supervisor (physician, health care manager or physician psychiatrist);
2) a psychiatrist;
3) a psychologist;
4) a social worker or social work specialist;
5) a labor instructor or specialist in the field of occupational therapy, sports;
6) a paramedical worker.
The composition of a multidisciplinary group expands with the increase in the list and (or) volume of services
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20.
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Requirements for the duration of medical and social rehabilitation.
The duration of medical and social rehabilitation of adult patients with MBD shall be no more than 3 (three) months.
The duration of medical and social rehabilitation of children with MBD shall be no more than 3 (three) months.
The duration of medical and social rehabilitation for adults with MBD due to the use of psychoactive substancess shall be no more than 9 (nine) months.
The duration of medical and social rehabilitation of children with MBD, due to the use of psychoactive substances shall be no more than 9 (nine) months.
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Criteria for the subjects (objects) rendering medical examination for establishing the fact of the use of a psychoactive substance and the state of intoxication
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21.
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Compliance with the requirements for identification of the person sent or came for a medical examination.
Before conducting a medical examination, a medical worker shall carry out an identification of the person who was sent or came for a medical examination, having familiarized with his/her identity documents.
In the absence of documents in the Conclusion of a medical examination for establishing the fact of the use of psychoactive substancess and the state of intoxication, special signs of the person shall be indicated with a mandatory indication of obtaining passport data from the words of the person who delivered or the examined person, photographing of the examined person shall be allowed
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22.
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Compliance with the requirements for medical examination of persons delivered in a serious unconscious state.
In a specialized healthcare organization, when a person is delivered in a severe, unconscious state to determine the state associated with the use of psychoactive substancess, a double (with an interval of 30-60 minutes) quantitative research shall be carried out for the presence of psychoactive substancess in biological fluids of the body (blood, urine, saliva).
In a specialized healthcare organization, at the time of rendering medical care, a record shall be made in the patient's medical record about the presence (absence) of a person's state of intoxication or the fact of using psychoactive substancess based on the results of a clinical examination and laboratory research of biological samples, while a Conclusion shall not be drawn up
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23.
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Compliance with the requirements for the conditions of laboratory research or rapid testing of biological media.
Laboratory research or rapid testing of biological media (blood or urine if alcohol intoxication is suspected, urine if drug or toxic intoxication is suspected ) shall be carried out in the following cases:
1) the impossibility of a complete examination due to the severity of state of the person being examined;
2) if a medical worker has doubts about a comprehensive assessment of the state of intoxication (mental, behavioral, autonomic and somatoneurological disorders);
3) disagreement of the examined person with the results of the Conclusion;
4) re-examination;
5) when establishing the fact of the use of psychoactive substancess and absence of signs of a state of intoxication (mental, behavioral, autonomic and somatoneurological disorders);
6) in the event of a road traffic accident or commission of an offense with the presence of injured persons;
7) if more than 3 (three) hours have passed since the moment of the road traffic accident and the offense without the injured persons
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24.
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Compliance with the requirements for laboratory research or rapid testing of biological media.
The nature and sequence of biological samples shall be determined by the medical worker performing the examination, depending on the characteristics of clinical state of the examined person.
Sealing and labeling of selected biological samples for laboratory research shall be carried out in the presence of the examined person and the person who sent and (or) delivered the examined person.
In cases when the examined person is not able to objectively assess the events taking place, this procedure shall be carried out in the presence of attesting witnesses (disinterested persons)
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25.
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Compliance with the requirements for a quantitative research of exhaled air for alcohol.
When conducting a medical examination to establish the fact of alcohol consumption and the state of alcoholic intoxication, a quantitative research of exhaled air for alcohol shall be carried out.
The research of exhaled air for the presence of alcohol shall be carried out using technical measuring instruments officially registered in the Republic of Kazakhstan.
If it is not possible to conduct the examination in full due to mental and (or) somatoneurological disorders, or the person's refusal to be examined, the Conclusion shall indicate the reasons for the impossibility of conducting the examination in full.
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26.
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Compliance with the requirements for registration of refusal from medical examination
In case of refusal of a person from a medical examination, the medical worker shall fill in paragraph 1 of the Conclusion and signatures of the attesting witnesses (disinterested persons) shall be put.
Presence of attesting witnesses (disinterested persons) in the case when the examined person is not able to assess the events taking place or refuses to undergo a medical examination shall be provided by the persons on whose initiative the examination is carried out.
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27.
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Compliance with the requirements for establishing the state of the examined person.
When drawing up a Conclusion and when conducting a full examination and the consent of a person to conduct an examination, a medical worker shall establish one of the following conditions based on the available clinical and (if necessary) laboratory data or the results of express testing, confirming the type of psychoactive substance that caused intoxication:
1) sober;
2) the fact of using psychoactive substancess, signs of intoxication were not identified;
3) alcohol intoxication (mild, moderate, severe);
4) state of intoxication (narcotic, toxicomaniac) caused by the use of psychoactive substancess (drugs - opioids, cannabinoids, cocaine; sedatives, hypnotics; psychostimulants; hallucinogens; volatile solvents)
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28.
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Compliance with the requirements for registration of the Conclusion of a medical examination.
The Conclusion shall be drawn up in 3 (three) copies, certified by the signature of a medical worker and the seal of a medical organization in which the examination was carried out. One copy shall be issued to the person who delivered the examined person, or to the person who came for examination on their own, the second copy remains in the medical organization and shall be stored in the archive for 5 (five) years, the third copy shall be issued to the person delivered for medical examination.
In the absence of an accompanying person, a copy of the Conclusion, upon an official written request of the person who directed for a medical examination, shall be sent by mail or to the specified e-mail address.
The results of the examination shall be communicated to the examined person immediately in the presence of the person who sent him/her and (or) delivered. In cases when the Conclusion is issued after receiving the results of laboratory tests, a copy of the Conclusion shall be issued no later than 5 working days from the date of receipt of laboratory test results.
If the examined person, or the official who delivered him/her disagrees with the results of medical examination, a repeated medical examination shall be carried out.
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29.
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Compliance with the requirements for a repeated medical examination.
A repeated medical examination shall be carried out no later than 2 (two) hours after the initial examination.
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30.
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Compliance with the requirements for the placement and discharge of patients of the Center for temporary adaptation and detoxification:
- information about the presence of documents, personal belongings (clothes, money and other valuables) of the patient in the register of documents and personal belongings placed before the patient's placement in the Center for temporary adaptation and detoxification;
- availability of a record of the patient who is in the center of temporary adaptation and detoxification;
- availability of a medical examination conclusion after conducting medical examination for each patient delivered to the Center for temporary adaptation and detoxification;
- entering of the doctor's prescription into the record of the patient who is in the Center for temporary adaptation and detoxification;
- registration of the results of dynamic observation of the patient in the patient's record, being in the Center for temporary adaptation and detoxification;
- discharge of the patient from the center for temporary adaptation and detoxification when an improvement is achieved that does not require further observation and treatment in the center.
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Official ( s ) ________________________________________
_______________________________ ___________
position signature
_____________________________________________________________________________
(surname, name, patronymic (if any)
Head of the subject of control _____________________________________
_______________________________ ____________________
position signature
_____________________________________________________________________________
surname, name, patronymic (if any)
List of abbreviations:
CDA - consultative and diagnostic assistance
PAS - psychoactive substances
PHC - primary health care
POSTIS - a psychiatric organization of a specialized type with intensive supervision
MBD - mental, behavioral disorders
PMHC - Primary Mental Health Center
RSPCMH - Republican Scientific and Practical Center for Mental Health
CMH - Mental Health Center
Notes:
* - this checklist is used in relation to all subjects (objects) rendering inpatient, inpatient replacing assistance, regardless of the profile of provided medical services
** - this checklist is used in relation to all subjects (objects) rendering outpatient assistance (primary health care and consultative-diagnostic assistance), regardless of the profile of medical services provided in the form of consultative-diagnostic assistance, (including for the subjects (objects) of rendering pre-medical care)
***- this checklist is used in relation to subjects (objects) rendering medical services in the corresponding profile, as an additional checklist to the main checklist used in relations between subjects (objects) providing inpatient, inpatient-replacing and outpatient assistance, depending on the form of rendering medical care in the subject (object) of control
**** - this checklist is used in relation to subjects (objects) carrying out activities in the sphere of laboratory service, also when conducting an inspection of the subject (object) of health care, which includes a laboratory service, this checklist is used as an additional checklist to the main checklist used depending on the form and profile of rendering medical care in the subject (object) of control
| |
Appendix 11
to the joint order of the
Minister of Healthcare of
the Republic of Kazakhstan
dated November 15, 2018
No. ЌР DSM-32 and the
Minister of National Economy of
the Republic of Kazakhstan
dated November 15, 2018, No. 70 |
A checklist in the sphere of state quality control of rendering medical services in relation to the subjects (objects) providing psychiatric care***
Footnote. Appendix 11 is excluded by the joint order of the Minister of Healthcare of the Republic of Kazakhstan dated 06.01.2021 No. KR HCM-3 and the Minister of National Economy of the Republic of Kazakhstan dated 06.01.2021 No. 5 (shall be enforced upon expiry of ten calendar days after its first official publication).
| |
Appendix 12
to the joint order of the
Minister of Healthcare of
the Republic of Kazakhstan
dated November 15, 2018
No. ЌР DSM-32 and the
Minister of National Economy of
the Republic of Kazakhstan
dated November 15, 2018, No. 70 |
A checklist in the sphere of state quality control of rendering medical services in relation to the subjects (objects) providing laboratory services****
Footnote. Appendix 12 - is in the wording of the joint order of the Minister of Healthcare of the Republic of Kazakhstan dated 06.01.2021 No. KR HCM-3 and the Minister of National Economy of the Republic of Kazakhstan dated 06.01.2021 No. 5 (shall be enforced upon expiry of ten calendar days after its first official publication).
State body that assigned the inspection _____________________________
________________________________________________________________________
Act on assignment of an inspection/preventive control with a visit to the subject (object)
of control ____________________________________________________________________
________________________________________________________________________
No., date
Name of the subject (object) of control
____________________________________________________________________________
(Individual identification number), business identification number of the subject (object) of control
______________________________________________________________________
_________________________________________________________________
Location address _______________________________________________________
_____________________________________________________________________________
№
|
List of requirements
|
Required
|
Not required
|
Meets the requirements
|
Doesn't meet the requirements
|
1.
|
Availability of a license and annexes to it for the activities carried out
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2.
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Availability of a specialist certificate in the relevant clinical specialty
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3.
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Availability of a biosafety specialist in the laboratory staff (with a laboratory staff of more than twenty staff units)
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4.
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Availability of portable test strip analyzers in primary healthcare organizations
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5.
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Availability at the inpatient level in healthcare organizations as part of the consultative and diagnostic laboratory (hereinafter-the CDL), an additional subdivision or a separate express laboratory shall be created at the intensive care units for performing emergency and urgent laboratory tests in the minimum terms from taking a sample to reporting the result (within 15-60 minutes).
For an urgent assessment of the pathological state of patients, general clinical and biochemical studies, including express tests shall be carried out. Laboratory diagnostics by the express laboratory shall be carried out in various emergency conditions (during surgical interventions, the provision of anesthesia, management of patients in the resuscitation unit and intensive care unit) around the clock. In the absence of an express laboratory in healthcare organizations that provide inpatient care in the evening and at night, as well as on Sundays and holidays, work in the CDL shall be provided by a team on duty, consisting of doctors and laboratory assistants
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6.
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Implementation of processes for quality management of clinical laboratory researches on the principle of staging, which includes pre-analytical, analytical and post-analytical stages of laboratory research
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7.
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Use of equipment certified and registered in the Republic of Kazakhstan, diagnostic reagent kits, test systems and component consumables for research purposes
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8.
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Availability of laboratory information system
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9.
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Conducting in-laboratory quality control of the research
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10.
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Availability of a written voluntary consent of the patient for invasive interventions
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11.
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Transportation of biomaterial, including by road, air and rail shall be carried out in compliance with the rules of triple packaging and temperature conditions
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12.
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To ensure the availability of laboratory diagnostics in outpatient and inpatient health care organizations, points for the collection and reception of biomaterials are organized. At points for sampling and receiving biomaterials, rooms for blood sampling, a room for receiving biological material, a room for sample preparation and temporary storage of biological material are provided.
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13.
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Compliance with the requirements for storage and transportation of samples of biological materials
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14.
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Compliance with the analytical quality control algorithm in laboratory diagnostics
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Official ( s ) ________________________________________
_______________________________ ___________
position signature
_____________________________________________________________________________
(surname, name, patronymic (if any)
Head of the subject of control _____________________________________
_______________________________ ____________________
position signature
_____________________________________________________________________________
surname, name, patronymic (if any)
List of abbreviations: MN - malignant neoplasm MDG - multidisciplinary group PHC - primary health care
Notes:
* - this checklist is used in relation to all subjects (objects) rendering inpatient, inpatient replacing assistance, regardless of the profile of provided medical services
** - this checklist is used in relation to all subjects (objects) rendering outpatient assistance (primary health care and consultative-diagnostic assistance), regardless of the profile of medical services provided in the form of consultative-diagnostic assistance, (including for the subjects (objects) of rendering pre-medical care)
***- this checklist is used in relation to subjects (objects) rendering medical services in the corresponding profile, as an additional checklist to the main checklist used in relations between subjects (objects) providing inpatient, inpatient-replacing and outpatient assistance, depending on the form of rendering medical care in the subject (object) of control
**** - this checklist is used in relation to subjects (objects) carrying out activities in the sphere of laboratory service, also when conducting an inspection of the subject (object) of health care, which includes a laboratory service, this checklist is used as an additional checklist to the main checklist used depending on the form and profile of rendering medical care in the subject (object) of control
| |
Appendix 13
to the joint order of the
Minister of Healthcare of
the Republic of Kazakhstan
dated November 15, 2018
No. ЌР DSM-32 and the
Minister of National Economy of
the Republic of Kazakhstan
dated November 15, 2018, No. 70 |
A checklist in the sphere of state quality control of rendering medical services in relation
to the subjects (objects) providing emergency medical care, medical care in the form of medical aviation
Footnote. Appendix 13 - is in the wording of the joint order of the Minister of Healthcare of the Republic of Kazakhstan dated 06.01.2021 No. KR HCM-3 and the Minister of National Economy of the Republic of Kazakhstan dated 06.01.2021 No. 5 (shall be enforced upon expiry of ten calendar days after its first official publication).
State body that assigned the inspection _____________________________
________________________________________________________________________
Act on assignment of an inspection/preventive control with a visit to the subject (object)
of control ____________________________________________________________________
________________________________________________________________________
No., date
Name of the subject (object) of control
____________________________________________________________________________
(Individual identification number), business identification number of the subject (object) of control
______________________________________________________________________
_________________________________________________________________
Location address _______________________________________________________
_____________________________________________________________________________
№
|
List of requirements
|
Required
|
Not required
|
Meets the requirements
|
Doesn't meet the requirements
|
General requirements
|
1.
|
Availability of a license and annexes to it for the activities carried out
|
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|
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2.
|
Compliance with the certificate of a specialist in the relevant clinical specialty
|
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3.
|
Compliance of the conducted medical and diagnostic measures with the recommendations of clinical protocols
|
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For emergency medical assistance
|
4.
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Equipping ambulance vehicles with radio communication and navigation system
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5.
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Availability of an automated control system for receiving and processing calls and systems, which allows monitoring medical vehicles through navigation systems, as well as a computer recording system for dialogues with subscribers and an automatic identifier of the telephone number from which a call comes in the ambulance service of regions, cities of republican significance and the capital city. Records of dialogues shall be stored for at least 2 years.
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6.
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Availability of regional Call-centers ( call-centers) as part of regional ambulance stations and ambulance stations in the cities of republican significance and the capital city
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7.
|
The call processing time from the moment it is received by the dispatcher shall be five minutes, during which the call shall be sorted according to the urgency of the call. The time of arrival of the team to the patient's location from the moment of receiving the call from the dispatcher according to the list of categories of urgency of ambulance calls (from 10 minutes to 60 minutes)
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8.
|
The correct determination by the ambulance station dispatcher of calls by the category of urgency according to:
1) a call of the 1st (first) category of urgency - a patient's condition that poses an immediate threat to life, requiring the provision of immediate medical care;
2) a call of the 2nd (second) category of urgency - a patient's condition that poses a potential threat to life without medical assistance;
3) a call of the 3rd (third) category of urgency - a patient's condition that poses a potential threat to health without the provision of medical assistance;
4) a call of the 4th (fourth) category of urgency - a patient's condition caused by an acute illness or exacerbation of a chronic disease, without sudden and pronounced disorders of organs and systems, in the absence of an immediate and potential threat to life and health of the patient.
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9.
|
Based on the results of the examination data, instrumental diagnostics, dynamics of the patient's condition against the background or after the treatment measures taken, in accordance with the preliminary diagnosis reflecting the causes of this condition, the paramedic or doctor of the ambulance station team or the emergency department shall make one of the following decisions when organizing PHC:
transportation of a patient to a medical organization providing inpatient care (hereinafter -a hospital);
the patient was left at the place of the call;
the patient was left at home (at the place of residence)
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10.
|
If a patient who does not need hospitalization is left at the place of call or at home, the ambulance station team or the emergency department during the organization of primary care shall provide medical recommendations for further contacting the primary care organization (at the place of residence or attachment)
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11.
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Availability of a signal sheet for the patient in case of illness of the patient and the need to visit him/her at home by the local doctor
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12.
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Availability of recording the following data when a call is received to the dispatch service of the ambulance station: 1) surname, name, patronymic (if any), age and gender of the patient;
2) data on the patient's condition and the circumstances of the accident, injury or illness; 3) address and telephone number, as well as approximate information on how to get to the patient's location.
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13.
|
Compliance with the time of arrival of paramedic and specialized (medical) teams to the location of the patient from the moment of receiving a call from the dispatcher of the ambulance station, taking into account the category of urgency:
1) 1 category of urgency - up to ten minutes;
2) 2 category of urgency - up to fifteen minutes;
3) 3 category of urgency - up to thirty minutes;
4) 4 category of urgency - up to sixty minutes
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14.
|
In the event that a decision is made by the ambulance station team or the emergency department when organizing PHC to transport the patient to the hospital, the ambulance station dispatcher shall inform the reception department of the hospital about the patient's delivery.
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For medical assistance in the form of medical aviation
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15.
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Availability of a task for a medical flight according to the form No. 090/af
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16.
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Conducting of assessment of the condition and treatment of a patient (s) on an ongoing basis in accordance with clinical diagnostic and treatment protocols by a mobile team of medical aviation during transportation of a patient (s)
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17.
|
Availability of grounds for the provision of medical care in the form of medical aviation (an extract from the medical record of a patient in need of medical assistance in the form of medical aviation; application of the coordinator doctor of the medical aviation department to the dispatcher of the Coordinating organization; in urgent cases, a verbal instruction from the authorized body with written confirmation; call from the ambulance service and other emergency services)
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18.
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Availability of approval by the dispatcher of the Coordinating organization of composition of the mobile medical aviation brigade and the involved qualified specialized specialist (s) from the medical organizations of the region with their informed consent
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19.
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Availability in the Coordinating organization of a schedule of qualified specialists for the provision of medical care in the form of medical aviation, approved by healthcare subjects and medical education organizations
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20.
|
Availability of the informed consent of the patient (s) for the provision of medical assistance in the form of medical aviation during his/her transportation.
In relation to minors and citizens declared legally incompetent by the court, the consent shall be provided by their legal representatives. The provision of medical care to unconscious patients shall be made by the decision of a council or a doctor of a medical organization in the region, or a mobile medical aviation brigade, or a qualified specialist with notification in any form of officials of a medical organization.
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Official ( s ) ________________________________________
_______________________________ ___________
position signature
_____________________________________________________________________________
(surname, name, patronymic (if any)
Head of the subject of control _____________________________________
_______________________________ ____________________
position signature
_____________________________________________________________________________
surname, name, patronymic (if any)
List of abbreviations: PHC - primary health care EMA - emergency medical assistance SEMC – service of emergency medical assistance
Notes:
* - this checklist is used in relation to all subjects (objects) rendering inpatient, inpatient replacing assistance, regardless of the profile of provided medical services
** - this checklist is used in relation to all subjects (objects) rendering outpatient assistance (primary health care and consultative-diagnostic assistance), regardless of the profile of medical services provided in the form of consultative-diagnostic assistance, (including for the subjects (objects) of rendering pre-medical care)
***- this checklist is used in relation to subjects (objects) rendering medical services in the corresponding profile, as an additional checklist to the main checklist used in relations between subjects (objects) providing inpatient, inpatient-replacing and outpatient assistance, depending on the form of rendering medical care in the subject (object) of control
**** - this checklist is used in relation to subjects (objects) carrying out activities in the sphere of laboratory service, also when conducting an inspection of the subject (object) of health care, which includes a laboratory service, this checklist is used as an additional checklist to the main checklist used depending on the form and profile of rendering medical care in the subject (object) of control
| |
Appendix 14
to the joint order of the
Minister of Healthcare of
the Republic of Kazakhstan
dated November 15, 2018
No. ЌР DSM-32 and the
Minister of National Economy of
the Republic of Kazakhstan
dated November 15, 2018, No. 70 |
A checklist in the sphere of state quality control of rendering medical services in relation to the subjects (objects) carrying out activities in the field of HIV prevention
Footnote. Appendix 14 - is in the wording of the joint order of the Minister of Healthcare of the Republic of Kazakhstan dated 06.01.2021 No. KR HCM-3 and the Minister of National Economy of the Republic of Kazakhstan dated 06.01.2021 No. 5 (shall be enforced upon expiry of ten calendar days after its first official publication).
State body that assigned the inspection _____________________________
________________________________________________________________________
Act on assignment of an inspection/preventive control with a visit to the subject (object)
of control ____________________________________________________________________
________________________________________________________________________
No., date
Name of the subject (object) of control
____________________________________________________________________________
(Individual identification number), business identification number of the subject (object) of control
______________________________________________________________________
_________________________________________________________________
Location address _______________________________________________________
_____________________________________________________________________________
№
|
List of requirements
|
Required
|
Not required
|
Meets the requirements
|
Doesn't meet the requirements
|
1.
|
Availability of a license and annexes to it for the activities carried out
|
|
|
|
|
2.
|
Compliance with the certificate of a specialist in the relevant clinical specialty
|
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3.
|
Conducting an examination based on the results of an express test.
In the case of a negative result of the express test, the subject shall be re-examined for HIV infection after 3 (three) months in the presence of risk factors for infection.
In the case of a positive result of the express test, with the informed consent of the person being tested, a test for HIV infection shall be carried out.
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4.
|
Compliance with the deadlines for issuing negative results and availability of post-test consultation.
The test subject receives a negative result at the place of blood sampling upon presentation of an identity document within 3 (three) working days from the moment the blood sample is received for research at the laboratory. Before the issuance of the result, post-test counseling is carried out .
The examined person receives a negative result at the place of blood collection upon presentation of an identity document within 3 (three) working days from the date of receipt of the blood sample for examination in the laboratory. Before issuing the result, a post-test consultation shall be conducted.
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5.
|
Compliance with the deadlines for sending serum samples to the RSHO (republican state healthcare organization that carries out activities in the sphere of HIV prevention). Upon receipt of two positive test results, a serum sample with a volume of at least 1 (one) ml shall be sent to the RSHO laboratory for confirming studies no later than three working days from the moment of the last setting.
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6.
|
Compliance with the terms of repeated examination in case of a doubtful result.
When receiving contradictory research results, the result shall be considered doubtful. After 14 (fourteen) calendar days, a repeated blood sampling and testing for HIV infection shall be carried out, according to the first stage of the procedure for diagnosing HIV infection in adults (RSHO transfers information about a dubious result for HIV infection to the territorial state healthcare organization carrying out activities in the sphere of prevention of HIV infection, for retesting for HIV infection).
When receiving a second doubtful result for HIV infection after 14 (fourteen) calendar days, additional studies shall be conducted using other serological tests. A negative result shall be given for two negative results from three studies conducted. A positive result shall be given for two positive results from three studies conducted. In the case of examination of pregnant women, molecular biological tests are additionally used (quantitative determination of HIV ribonucleic acid with a test sensitivity of no more than 50 copies/ml or determination of HIV proviral deoxyribonucleic acid).
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7.
|
Availability of pre-test and post-test consultation.
Pre-test consultation shall be provided through visual agitation tools that are displayed in waiting areas.
Pre-test consultation includes:
1) information about the benefits of testing for HIV infection, transmission routes and the significance of HIV-positive and HIV-negative test results;
2) an explanation of the services available in the case of an HIV-positive diagnosis, including an explanation of free antiretroviral therapy;
3) a brief description of the methods of prevention and examination of a partner with a positive HIV test result;
4) guarantee of confidentiality of test results.
Availability of post-test consultation of the examined.
Post-test consultation includes:
1) communication of the test result and the value of the result to the patient;
2) informing about the possible stay in the seronegative window (with an undefined or negative result) and the need for re-examination for HIV infection;
3) explaining how to reduce the risk of infection by changing behavior;
4) informing about the possibilities of additional medical care for key groups of population, psycho-social assistance;
5) psychological help and support.
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8.
|
Availability of the informed consent to enter personal data into the information systems of persons with positive results.
If the result of testing for HIV infection is positive, an informed consent to enter personal data into the electronic tracking system shall be signed. In case of refusal to enter personal data, the number and date of the IB result, initials, date of birth, epidemiological history data shall be entered into the electronic tracking system
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|
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9.
|
Monitoring and assessment of coverage of key population groups and people living with HIV shall be carried out by maintaining a database of individual records of clients and corresponding forms of accounting and reporting documentation by the specialists of healthcare organizations, carrying out activities in the sphere of HIV prevention
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|
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10.
|
Carrying out diagnostics and treatment of STI(sexually transmitted infections).
In friendly offices, STI diagnostics and treatment shall be carried out in accordance with clinical protocols for STI diagnosis and treatment
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11.
|
Availability of equipped transport for mobile trust points
|
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12.
|
Implementation of pre-contact and post-contact prevention among the population and key population groups
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13.
|
Availability of observation of the contact persons in a timely manner.
The contact persons shall be observed in a healthcare organization carrying out activities in the sphere of HIV prevention. The duration of observation of the contact persons shall be established for:
1) the children born from HIV-infected mothers - eighteen months;
2) medical workers in the event of an emergency - three months;
4) recipients of donor biomaterial - three months;
5) sexual partners of HIV-infected and the contact persons for joint drug injection - until 3 months after the end of contact, a negative HIV test result; with continued contact, the contact persons shall be examined for HIV infection 2 times a year;
6) persons from the nosocomial focus - three months after discharge from the medical organization; if more than three months have passed since discharge, the contact persons shall undergo a single examination; if the result is negative, the observation shall be terminated.
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14.
|
Availability of dynamic observation and provision of antiretroviral therapy for HIV-infected individuals.
The results of laboratory examination of contact persons shall be recorded in the outpatient card of an HIV-infected person registered with a dispensary ( discordant couples). An HIV-infected person in dynamics shall submit data on changes in marital status, surname, first name, patronymic (if any), data on new contact persons for examination and observation, which are entered into the electronic tracking database.
The provision of antiretroviral therapy to reduce the risk of HIV transmission from the moment of diagnosis shall be conducted in accordance with the recommendations of clinical protocols for the diagnosis and treatment of HIV infection in adults and children, with involvement of outreach workers and social workers.
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Official ( s ) ________________________________________
_______________________________ ___________
position signature
_____________________________________________________________________________
(surname, name, patronymic (if any)
Head of the subject of control _____________________________________
_______________________________ ____________________
position signature
_____________________________________________________________________________
surname, name, patronymic (if any)
List of abbreviations: HIV - Human Immunodeficiency Virus STI - Sexually Transmitted Infections
RSHO - a republican state healthcare organization, carrying out activities in the field of HIV prevention
Notes:
* - this checklist is used in relation to all subjects (objects) rendering inpatient, inpatient replacing assistance, regardless of the profile of provided medical services
** - this checklist is used in relation to all subjects (objects) rendering outpatient assistance (primary health care and consultative-diagnostic assistance), regardless of the profile of medical services provided in the form of consultative-diagnostic assistance, (including for the subjects (objects) of rendering pre-medical care)
***- this checklist is used in relation to subjects (objects) rendering medical services in the corresponding profile, as an additional checklist to the main checklist used in relations between subjects (objects) providing inpatient, inpatient-replacing and outpatient assistance, depending on the form of rendering medical care in the subject (object) of control
**** - this checklist is used in relation to subjects (objects) carrying out activities in the sphere of laboratory service, also when conducting an inspection of the subject (object) of health care, which includes a laboratory service, this checklist is used as an additional checklist to the main checklist used depending on the form and profile of rendering medical care in the subject (object) of control
| |
Appendix 15
to the joint order of the
Minister of Healthcare of
the Republic of Kazakhstan
dated November 15, 2018
No. ЌР DSM-32 and the
Minister of National Economy of
the Republic of Kazakhstan
dated November 15, 2018, No. 70 |
Criteria for the subjects (objects) carrying out activities in the sphere of blood services
Footnote. Appendix 15 - is in the wording of the joint order of the Minister of Healthcare of the Republic of Kazakhstan dated 06.01.2021 No. KR HCM-3 and the Minister of National Economy of the Republic of Kazakhstan dated 06.01.2021 No. 5 (shall be enforced upon expiry of ten calendar days after its first official publication).
State body that assigned the inspection _____________________________
________________________________________________________________________
Act on assignment of an inspection/preventive control with a visit to the subject (object)
of control ____________________________________________________________________
________________________________________________________________________
No., date
Name of the subject (object) of control
____________________________________________________________________________
(Individual identification number), business identification number of the subject (object) of control
______________________________________________________________________
_________________________________________________________________
Location address _______________________________________________________
_____________________________________________________________________________
№
|
List of requirements
|
Required
|
Not required
|
Meets the requirements
|
Doesn't meet the requirements
|
1.
|
Availability of a license and annexes to it for the activities carried out
|
|
|
|
|
2.
|
Compliance with the certificate of a specialist in the relevant clinical specialty
|
|
|
|
|
3.
|
Compliance in the organization of the blood service with the requirements of stage-by-stage labeling of blood and its components. Providing conditions for the traceability of the movement of each blood product from the donor to the receipt of the finished product and its use
|
|
|
|
|
4.
|
Laboratory examination of the recipient's blood samples for the presence of markers of blood-borne infections before and after transfusions shall be carried out by qualitative immunoserological and molecular biological methods on automatic closed-type analyzers.
|
|
|
|
|
5.
|
After donation of blood and its components, all information on donation of blood and its components, including the type of reaction and the amount of medical care provided, in case of side effects of donation shall be recorded in the electronic information database. Prepared blood and its components shall be transferred to the primary fractionation unit with accompanying documentation
|
|
|
|
|
6.
|
The donor shall be provided with a questionnaire for the donor of blood and its components, which he/she fills in independently or with the participation of a medical registrar, as well as an information sheet
|
|
|
|
|
7.
|
Performing immunohematological studies for the presence of irregular anti-erythrocyte antibodies in liquid-phase systems on a plane and in test tubes, reading the result of the agglutination reaction with mandatory microscopy.
|
|
|
|
|
8.
|
Input and daily intralaboratory quality control of reagents to confirm their activity and specificity. Entrance control shal be subject to:
1) purchased materials (containers for blood collection, reagents, test systems, disinfectants, instruments and other materials), the nomenclature of which is approved by the first head of the blood service organization;
2) units of donor blood and its components (upon acceptance into production)
|
|
|
|
|
9.
|
The blood collected in field conditions shall be placed in thermocontainers marked "Hemoproducts not examined, not subject to delivery" and shall be delivered at a temperature of 22 ± 2 ° C within 18-24 hours to the blood service organization
|
|
|
|
|
10.
|
For immunohematological studies of blood samples from potential recipients, the reagents with monoclonal antibodies and equipment, registered by the state body in the sphere of circulation of medicines and medical devices shall be used.
|
|
|
|
|
Official ( s ) ________________________________________
_______________________________ ___________
position signature
_____________________________________________________________________________
(surname, name, patronymic (if any)
Head of the subject of control _____________________________________
_______________________________ ____________________
position signature
_____________________________________________________________________________
surname, name, patronymic (if any)
List of abbreviations:
Notes:
* - this checklist is used in relation to all subjects (objects) rendering inpatient, inpatient replacing assistance, regardless of the profile of provided medical services
** - this checklist is used in relation to all subjects (objects) rendering outpatient assistance (primary health care and consultative-diagnostic assistance), regardless of the profile of medical services provided in the form of consultative-diagnostic assistance, (including for the subjects (objects) of rendering pre-medical care)
***- this checklist is used in relation to subjects (objects) rendering medical services in the corresponding profile, as an additional checklist to the main checklist used in relations between subjects (objects) providing inpatient, inpatient-replacing and outpatient assistance, depending on the form of rendering medical care in the subject (object) of control
**** - this checklist is used in relation to subjects (objects) carrying out activities in the sphere of laboratory service, also when conducting an inspection of the subject (object) of health care, which includes a laboratory service, this checklist is used as an additional checklist to the main checklist used depending on the form and profile of rendering medical care in the subject (object) of control
| |
Appendix 16
to the joint order of the
Minister of Healthcare of
the Republic of Kazakhstan
dated November 15, 2018
No. ЌР DSM-32 and the
Minister of National Economy of
the Republic of Kazakhstan
dated November 15, 2018, No. 70 |
Criteria for assessing the degree of risk in the sphere of circulation of medicines and medical devices
Footnote. The Criteria are in the wording of the joint order of the Minister of Healthcare of the Republic of Kazakhstan dated April 29, 2019 No. KR HCM-56 and the Minister of National Economy of the Republic of Kazakhstan No. 33 dated April 30, 2019 (shall be enforced upon expiry of ten calendar days after its first official publication).
Chapter 1. General provisions
1. These Criteria for assessing the degree of risk in the sphere of circulation of medicines and medical devices (hereinafter - the Criteria) are developed in accordance with the Code of the Republic of Kazakhstan dated September 18, 2009 "On Public Health and Healthcare System", the Entrepreneurial Code of the Republic of Kazakhstan dated October 29, 2015 and the Rules for formation of a risk assessment system and the form of checklists by state bodies approved by order of the Acting Minister of National Economy of the Republic of Kazakhstan No. 3 on July 31, 2018 (registered in the Register of state registration of regulatory legal acts of the Republic of Kazakhstan No. 17371).
2. The following concepts are used in these Criteria:
1) assessment period - a specific time period for which risks assessment is carried out according to objective and subjective criteria based on the results of previous inspections/ preventive control, the results of data analysis and other sources of information. For organizations, carrying ot activities in the sphere of circulation of medicines and medical devices, the assessment period used in the Criteria shall be 3 years previous to the reporting period;
2) minor violations - violations that are not related to gross and significant violations;
3) risk in the sphere of circulation of medicines and medical devices – the probability of causing harm to human life or health as a result of production, manufacture, import, export, transportation, storage, wholesale and retail sale, application (use) of medicines and medical devices that do not meet the requirements of the legislation of the Republic of Kazakhstan, taking into account the severity of its consequences;
4) subjects (objects) of control in the sphere of circulation of medicines and medical devices - healthcare organizations, as well as individuals and legal entities engaged in pharmaceutical and medical activities (hereinafter - subjects (objects) of control;
5) significant violations - violations, including non-compliance with the requirements of legislation in the field of healthcare, causing or leading to a risk of changes in the quality of a medicine and medical device in the process of its circulation, insufficient implementation of measures (procedures) confirming the quality and safety of medicines and medical devices, as well as non-compliance with the requirements related to determination of the need and rational use of medicines and medical devices within the guaranteed volume of free medical care; presence of negative reviews on the quality of rendering pharmaceutical services;
6) gross violations - violations, including non-compliance with the requirements of legislation in the field of healthcare, causing or leading to a significant change in the quality of a medicine and a medical device in the process of its circulation, dangerous to human health and life, to pollution, confusion and cross-contamination; inconsistency associated with the circulation of narcotic drugs, psychotropic substances and precursors; non-compliance with the requirements for confirming the quality and safety of medicines and medical devices; availability of confirmed complaints and appeals, the facts of bringing to administrative and criminal liability; non-observance of the maximum price for the trade name of a medicine during wholesale and retail sales;
7) subjective criteria for assessing the degree of risk (hereinafter- the subjective criteria) - criteria for assessing the degree of risk used for the selection of subjects (objects) of control in the sphere of circulation of medicines and medical devices, depending on the results of activities of a particular subject (object) of control;
8) objective criteria for assessing the degree of risk (hereinafter – the objective criteria) - criteria for assessing the degree of risk used for the selection of subjects (objects) of control in the sphere of circulation of medicines and medical devices, depending on the degree of risk and not directly dependent on a separate subject (object) of control.
3. The Criteria for assessing the degree of risk for preventive control with a visit to the subject (object) shall be formed by means of objective and subjective criteria.
Chapter 2. Objective criteria
4. The objective criteria shall be formed through the following stages:
1) determination of risk;
2) distribution of subjects (objects) of control by degrees of risk (high and not classified as high).
5. Risk determination shall be carried out taking into account the following objective criteria:
1) the possibility of adverse effects on human life and health, the legitimate interests of individuals and legal entities, the state;
2) the scale of the severity of possible negative consequences of harm in the process of carrying out pharmaceutical activities.
6. After determining the risk, the subjects (objects) of control shall be distributed according to two degrees of risk (high and not classified as high).
In relation to the subjects (objects) of control, classified according to objective criteria to a high degree of risk, the subjective criteria shall be applied in order to conduct preventive control with a visit to the subject (object) of control.
7. A high degree of risk includes subjects (objects) of control carrying out activities:
1) related to the production of medicines and medical devices;
2) related to the manufacture of medicines and medical devices;
3) related to the wholesale of medicines;
4) related to the retail sale of medicines;
5) related to the production, wholesale and retail sale of medicines containing narcotic drugs, psychotropic substances and precursors;
6) medical organizations, carrying out the purchase, storage, distribution, use (application) of medicines and medical devices.
8. The group of subjects (objects) of control that are not related to a high degree of risk includes subjects (objects) having the certificates of good manufacturing practice (GMP), good distribution practice (GDP), good pharmacy practice (GPP); legal entities and individuals engaged in pharmaceutical activities related to the wholesale and retail sale of medical devices.
Chapter 3. Subjective criteria
9. Determination of subjective criteria in the sphere of circulation of medicines and medical devices shall be carried out using the following stages:
1) formation of a database and collection of information;
2) analysis of information and risks assessment.
10. For assessment the degree of risk, the following sources of information shall be used:
1) the results of previous inspections/preventive control with a visit to the subject (object) of control;
2) availability and number of confirmed complaints and appeals;
3) analysis of official Internet resources of state bodies, including of the authorized bodies in the field of healthcare of the countries of the Commonwealth of Independent States (CIS), mass media;
4) a list of violations identified based on the results of laboratory tests conducted by a state expert organization in the sphere of circulation of medicines and medical devices and its branches;
5) the results of information analysis provided by the authorized bodies (prosecutors, law enforcement agencies), state organizations;
6) availability of unfavorable incidents caused by the fault of the subject of control. Adverse incidents include the probability of causing harm to health, a threat to human life or health, as a result of production, manufacture, import, storage, sale, application (use) of medicines and medical devices, including those that do not meet the requirements of the legislation of the Republic of Kazakhstan in the field of healthcare;
7) information from international regulatory bodies in the field of quality and safety of medicines and medical devices, state bodies of countries, including the Eurasian Economic Union;
11. Based on the available sources of information, their analysis, the singularity or systematic nature of the violation, analysis of the decisions made, the subjective criteria for assessing the degree of risk in the sphere of circulation of medicines and medical devices shall be divided into three degrees of violation: gross, significant, minor violations. The subjective criteria for assessing the degree of risk in the sphere of circulation of medicines and medical devices are given in the Appendix to these Criteria.
12. To refer the subject of control to the degree of risk, the following procedure for calculating the indicator of the risk degree shall be applied.
If one gross violation is identified, the subject of control shall be equated with a risk degree of 100 and preventive control shall be carried out in relation to it with a visit to the subject (object).
If no gross violations have been identified, then to determine the indicator of the risk degree, an overall indicator for violations of a significant and insignificant degree shall be calculated.
When determining the indicator of significant violations, a coefficient of 0.7 shall be applied and this indicator shall be calculated using the following formula:
Rs = (SR2 х 100/ SR1) х 0,7
where:
SRs – an indicator of significant violations;
SR1 – the required number of significant violations;
SR2 - the number of significant violations identified;
When determining the indicator of minor violations, a coefficient of 0.3 shall be applied and this indicator shall be calculated using the following formula:
SRm = (SR2 х 100/SR1) х 0,3
where:
SRm – an indicator of minor violations;
SR1 – the required number of minor violations;
SR2 - the number of minor violations identified;
The overall risk degree (SР) shall be calculated on a scale from 0 to 100 and shall be determined by summing the indicators of significant and minor violations using the following formula:
SR = SRs + SRm
where:
SR – an overall indicator of the risk degree;
SRs – an indicator of significant violations;
SRn - an indicator of minor violations.
13. According to the indicators of the risk degree, the subject (object) of control relates:
1) to a high degree of risk - with a risk degree from 61 to 100 inclusive and in relation to it preventive control shall be carried out with a visit to the subject (object) of control;
2) to not classified as a high degree of risk - with an indicator of the risk degree from 0 to 60 inclusive and in relation to it, preventive control with a visit to the subject (object) of control shall not be carried out.
14. The frequency of preventive control with a visit to the subject (object) of control shall be determined by the results of annual analysis and assessment of the received information according to subjective criteria and cannot be more often than once a year.
15. Preventive control with a visit to the subject (object) of control shall be carried out on the basis of semi-annual lists of preventive control with a visit to the subject (object) of control, formed in accordance with paragraph 3 of Article 141 of the Entrepreneurial Code.
16. The basis for the assignment of preventive control with a visit to the subject (object) of control shall be a six-month list of preventive control with a visit to the subject (object) of control, approved by the first head of the regulatory state body.
17. Semi-annual lists of preventive control with a visit to the subject (object) of control shall be formed in relation to the subjects of control with obligatory indication of the objects in respect of which preventive control is assigned with a visit to the subject (object) of control.
18. Lists of preventive control with a visit to the subject (object) shall be compiled taking into account the priority of the subjects (objects) of control with the highest indicator of the risk degree according to subjective criteria.
| |
Annex
to the criteria for assessing the degree of
risk in the sphere of circulation of medicines and
medical devices |
Subjective criteria for assessing the degree of risk in the sphere of circulation of medicines and medical devices
№
|
Name of criteria
|
Degree of violation
|
1. Criteria for the source of information "Results of previous inspections/preventive control"
(the severity is established if the following requirements are not met)
|
1.1. Criteria in the sphere of circulation of medicines and medical devices in relation to all subjects (objects) of pharmaceutical activity
|
1.
|
Availability of a state license for pharmaceutical activities and annexes to subtypes of activities or notification on the beginning of activities.
Compliance of the types and subtypes of activities with the declared ones when obtaining a state license and annex to it.
|
gross
|
2.
|
Availability of certificates confirming the passage of specialization or improvement courses, other types of advanced training over the past 5 years from responsible specialists in the sphere of circulation of medicines.
|
gross
|
3.
|
Compliance of the premises, area and equipment with sanitary rules, standard regulations and qualification requirements for licensing pharmaceutical activities and activities in the sphere of trafficking in narcotic drugs, psychotropic substances and precursors.
|
gross
|
4.
|
Ensuring storage and transportation in accordance with the conditions established by the manufacturer in the regulatory and technical document for the control over quality and safety of medicines, in the instructions of medical use for medicines and medical devices, operational documents (for a medical device) specified in the labeling of their packages.
|
gross
|
5.
|
Ensuring the safety, storage conditions of various groups of medicines and medical devices and their handling by complying with the requirements for the design, arrangement, composition, size of areas, equipment of premises (zones) for storing medicines and medical devices and their operation, ensuring safety.
|
gross
|
6.
|
Compliance with separate storage of medicines and medical devices from other products in order to avoid any impact on them, protection from negative effects of light, temperature, moisture and other external factors.
|
gross
|
7.
|
Keeping records of the expiration dates of medicines and medical devices on paper or electronic media.
|
minor
|
8.
|
Carrying out the storage of medicines and medical devices in allotted and clearly marked storage areas.
|
significant
|
9.
|
Provision of a storage room, including a refrigerating room (chamber) with appropriate equipment for monitoring temperature, humidity (thermometers, hygrometers, other types of devices) and their location on the inner walls of premises away from heating devices based on the results of testing zones of temperature fluctuations for cold and warm season.
|
gross
|
10.
|
Compliance with the separation during storage of all medicines and medical devices, depending on the pharmacological group, method of application, state of aggregation, physical and chemical properties, impact of various environmental factors on them.
|
gross
|
11.
|
Availability of an isolated place for storing medicines, the decision on circulation of which has not yet been made, with an expired shelf life, returned, withdrawn from the category suitable for delivery, in respect of which there are suspicions of falsification, withdrawn and rejected.
|
gross
|
12.
|
Providing protection from the effects of weather conditions in the areas of acceptance and shipment. Availability of equipment in the areas of acceptance and shipment (ventilation/air conditioning system, hygrometer, thermometer), equipment for cleaning containers. Availability of an equipped control zone for the received products.
|
gross
|
13.
|
Separation of acceptance, quarantine, rejection, shipment and storage areas.
Availability of a room in which medicines are stored in quarantine, with a clear designation and limited access.
|
gross
|
14.
|
Availability of common fireproof buildings with fireproof walls insulation from neighboring rooms that meet the requirements of fire safety in the absence of separate storage facilities for flammable substances, providing the room with supply and exhaust ventilation.
|
gross
|
15.
|
Storage of flammable medicines separately from other medicines: provision of fireproof and stable racks and pallets, storage of flammable and combustible liquids in built-in fireproof cabinets with doors at least 0.7 meters wide and at least 1.2 meters high.
|
gross
|
16.
|
Storage of flammable liquids isolated in separate rooms in glass or metal containers from other groups.
|
gross
|
17.
|
Compliance with the storage of flammable and flammable liquid medicines that should not be stored:
1) in a fully filled container, the degree of filling is not more than 90 percent of the volume. Alcohol in large quantities shall be stored in metal containers that are filled no more than 95 percent of the volume;
2) with mineral acids (sulfuric, nitric and other acids), compressed and liquefied gases, flammable substances, as well as with inorganic salts that give explosive mixtures with organic substances (potassium chlorate, potassium permanganate).
|
gross
|
18.
|
Compliance with isolated storage of calcium hypochlorite, taking into account its properties.
|
gross
|
19.
|
Compliance with the storage of flammable liquids with constant monitoring of the containers condition, their tightness and serviceability.
|
gross
|
20.
|
Implementation of measures during the storage of explosive drugs against their contamination with dust.
|
gross
|
21.
|
Compliance with the separate storage of explosive and flammable medicines with acids and alkalis.
|
gross
|
22.
|
Ensuring the protection of cylinders with oxygen and combustible gases from heat sources, the ingress of oil and other fatty substances on them, and their storage in isolated rooms or under sheds.
|
gross
|
23.
|
Compliance with the conditions for storing dressings in a dry ventilated room in cabinets, boxes, on racks, pallets, trays, in conditions that ensure cleanliness.
|
gross
|
24.
|
Compliance with the storage conditions for medical instruments, devices, appliances, equipment in dry heated rooms at room temperature, with a relative humidity not exceeding 65 percent.
|
gross
|
25.
|
Compliance with the requirements for finishing the premises (zones) for storing medicines and ensuring the cleanliness of premises and storage equipment.
|
significant
|
26.
|
Providing protection from the entry of insects, rodents or other animals, availability of a preventive pest control program.
|
minor
|
27.
|
Separation of rest rooms, dressing rooms, showers and toilets for the employees from storage rooms (zones). Food, drinks, tobacco products, as well as medicines for personal use shall not be stored in the storage rooms (zones).
Employees, working in the storage area must have protective clothing or uniform appropriate for the work to be performed and personal protective equipment, if necessary. The personnel working with hazardous drugs shall undergo special training.
|
significant
|
28.
|
Provision with the necessary equipment and inventory in the premises for storing medicines:
- racks, pallets, dunnage racks, cabinets for storing medicines and medical devices;
- technological equipment for creating a temperature regime;
- devices for recording temperature and humidity;
- means of mechanization for loading and unloading operations;
- disinfectants and cleaning equipment to ensure a sanitary regime;
- other equipment and tools, ensuring sanitary and hygienic regime, labor protection, safety, fire safety, environmental protection and safety of medicines.
|
gross
|
29.
|
Availability of a document on the calibration (verification) of equipment used to control and monitor storage conditions.
|
gross
|
30.
|
Availability of a developed and approved plan of emergency measures in case of malfunction of the refrigerating room (chamber), refrigeration equipment or power outages, emergencies.
|
significant
|
31.
|
Availability of developed and approved instructions for cleaning and disinfecting equipment. The equipment is used in good condition and kept in proper cleanliness.
|
significant
|
32.
|
Presence of a person responsible for ensuring the safety of quality of medicines and medical devices at facilities, carrying out storage of medicines and medical devices.
|
significant
|
33.
|
Presence of a commission for the destruction of medicines and medical devices unsuitable for sale and medical use.
|
significant
|
34.
|
Availability of acts on the destruction of medicines and medical devices unsuitable for sale and medical use.
|
significant
|
35.
|
Availability of secondary packaging marking, including the following information:
1) trade name of a medicine;
2) an international non-proprietary name (if any) in the state, Russian and English languages;
3) name of the manufacturer of a medicine, address, trademark. Name of the manufacturing organization and its address may be indicated in full or abbreviated (city, country);
4) name of the owner of a registration certificate, his/her address (city, country);
5) dosage form indicating the mass, volume or number of doses in the package, dosage;
6) active substances and their quantitative composition per dose unit or, depending on the dosage form, per unit of mass or volume;
7) the mass of medicinal plant raw materials is indicated at a certain moisture content in percent;
8) for medicines, containing narcotic drugs, psychotropic substances and precursors, the names of these substances and their content in units of weight or percentage shall be indicated. In one-component medicines, subject to the authenticity of the name of a medicine and active substance and indicating its dosage, concentration, activity - the composition of active substances shall not be indicated;
9) a list of excipients:
- for parenteral, ophthalmic drugs and drugs for external use, a list of all excipients shall be indicated;
- for infusion solutions, the qualitative and quantitative composition of all excipients shall be indicated;
- for other dosage forms, a list of antimicrobial preservatives, dyes, as well as sugars and ethanol shall be indicated;
- a list of excipients indicated when labeling medicinal products for oral administration;
10) for infusion solutions containing more than one active ingredient, the value of osmolarity/osmolality value shall be indicated;
11) the method of administration and, depending on the dosage form, the route of administration (the method of administration is not indicated for tablets and capsules intended for oral administration);
12) precautions;
13) warning notices;
14) storage conditions, storage features;
15) sale conditions (with or without a prescription);
16) a batch number;
17) production date (if not entered in the batch number);
18) expiration date: "good before (day, month, year)" or "(day, month, year)";
The expiration date is indicated as "good before (month, year)" or "(month, year)", while the expiration date is determined up to the last day of the specified month, inclusive.
19) registration number of a medicine in the form of the designation "RK-MP-";
20) a barcode (if any).
|
gross
|
36.
|
Availability of labeling of primary packaging with the following information:
1) trade name of a medicine, indicating the dosage, activity or concentration;
2) international non-proprietary name (if any) in the state, Russian and English languages;
3) name of the manufacturer of a medicine and (or) its trademark;
4) mass or volume;
5) a batch number;
6) expiration date "month, year" or "day, month, year".
|
gross
|
37.
|
Organization of work on monitoring adverse reactions and (or) lack of effectiveness of medicines and medical devices, appointment of persons responsible for monitoring side effects of medicines and medical devices.
|
significant
|
38.
|
Submission of information by the responsible person to the authorized organization on side effects and (or) on lack of effectiveness of medicines and medical devices. Online transmission of card messages through the portal of an authorized organization with the content of a mandatory minimum amount of information.
|
significant
|
39.
|
Compliance with the deadlines for submitting the completed report card on adverse reactions (effects) and (or) effectiveness to the authorized organization in cases of detection.
|
significant
|
40.
|
Absence of facts of purchase, production, storage, advertising, use, provision and sale of medicines and medical devices that have not passed state registration in the Republic of Kazakhstan.
|
gross
|
41.
|
Absence of facts of production, import, storage, use and sale of counterfeit medicines and medical devices.
|
gross
|
42.
|
Absence of facts of sale of medicines and medical devices, the quality of which is not confirmed by the conclusion on safety and quality.
|
gross
|
43.
|
Absence of facts of storage, use and sale of expired medicines and medical devices.
|
gross
|
44.
|
Compliance of a medicine with the requirements of a regulatory document for control over the quality and safety of a medicine and a medical device (based on the results of assessing the safety and quality of samples withdrawn as a doubt).
|
gross
|
45.
|
Compliance with the rules and procedure for storage, accounting, destruction of medicines containing narcotic drugs, psychotropic substances and precursors (including substances).
|
gross
|
46.
|
Availability of a list of persons who have the conclusions of psychiatrist and narcologist doctors on the absence of drug addiction, substance abuse, chronic alcoholism, as well as on the suitability to perform activities related to narcotic drugs, psychotropic substances and their precursors, and the conclusion of internal affairs bodies on the conduct of an appropriate check.
|
gross
|
47.
|
Storage rooms, safes and wardrobes shall be in a closed condition. After the end of a working day, they shall be sealed and (or) stamped. Keys, seal and (or) stamp shall be kept by a responsible person.
|
gross
|
48.
|
Availability of a first aid kit for first medical aid.
|
minor
|
49.
|
Availability of a sign indicating the name of the subject of pharmaceutical activity, its organizational and legal form and working regime in the state and Russian languages.
|
minor
|
50.
|
Availability of information on the phones and addresses of territorial divisions of the state body in the sphere of circulation of medicines and medical devices in a convenient place for the population familiarization.
|
minor
|
1.2. Criteria in the sphere of circulation of medicines and medical devices in relation to medical organizations on the issues of drug supply
|
51.
|
Availability of higher pharmaceutical education or secondary pharmaceutical education (work experience in the specialty for at least three years) for the head of the pharmacy or its departments;
- higher or secondary pharmaceutical education for the specialists, carrying out sale of medicines and medical devices at a pharmacy in healthcare organizations that provide primary health care, consultative and diagnostic assistance;
- higher pharmaceutical education or secondary pharmaceutical education (work experience in the specialty for at least three years) for the head of the pharmacy, as well as employees, carrying out sale of medicines and medical devices.
|
gross
|
52.
|
Compliance with the calculation of the need for medicines containing narcotic drugs in accordance with the estimated standards of need per 1000 population per year (in grams).
|
significant
|
53.
|
Compliance with the prescription of drugs containing narcotic drugs, psychotropic substances and their precursors during outpatient and inpatient treatment in healthcare organizations by a healthcare organization doctor who has access to work with narcotic drugs and their precursors.
|
significant
|
54.
|
Compliance with the recording in the patient's medical documents of prescription of medicines containing narcotic drugs, psychotropic substances and precursors of Tables II, III, IV of the List of narcotic drugs, psychotropic substances and precursors subject to control in the Republic of Kazakhstan (hereinafter - the List), indicating a single dose, method and frequency of administration (injection), duration of the treatment course, as well as justification for the prescription of medicines.
|
significant
|
55.
|
Ensuring the use (administration) of medicines containing narcotic drugs, psychotropic substances of Tables II, III List strictly under the supervision of medical personnel at the time of their issuance - oral administration, application of transdermal therapeutic systems (patch, film) - in the presence of a nurse, injection - in the presence of a doctor.
|
significant
|
56.
|
Compliance with the rules and procedure for writing prescriptions for medicines containing narcotic drugs, psychotropic substances and precursors.
|
significant
|
57.
|
Presence of a person responsible for the storage and issuance of special prescription forms.
|
significant
|
58.
|
Providing subject-quantitative accounting of special prescription forms.
|
gross
|
59.
|
Availability of a safe or a metal cabinet for storing special prescription forms. At the end of the work, the room shall be sealed and (or) stamped. The keys to the room, the seal and (or) the stamp shall be are kept by an responsible person.
|
gross
|
60.
|
Ensuring the storage and destruction of unused special prescriptions handed in by relatives of deceased patients. Destruction of prescriptions shall be carried out as the prescriptions are accumulated, but at least once a month, by burning in the presence of a permanent commission, which includes a representative of the internal affairs body. The fact of destruction of unused special prescriptions shall be drawn up by the corresponding act.
|
significant
|
61.
|
Availability of a list of medicines containing narcotic drugs, psychotropic substances of Table II of the List, determined by the order of the head of a healthcare organization, not exceeding a five-day supply, which is used with the permission of a responsible doctor on duty for rendering emergency medical care in a healthcare organization providing inpatient care in the evening and at night.
|
gross
|
62.
|
Ensuring the collection and disposal of empty ampoules from medicines containing narcotic drugs, psychotropic substances of Table II of the List, the contents of which have not been used or partially used, as well as tablets and plasters ( transdermal therapeutic systems).
|
gross
|
63.
|
Availability of an order for a medical worker responsible for registration of a temporary death certificate, ensuring that the relatives of a deceased cancer patient are notified about the delivery of unused special prescription forms and medicines containing narcotic and psychotropic substances of Table II of the List, as well as the reception of special prescription forms and unused medicines, containing narcotic and psychotropic substances of Table II of the List after patients who died at home. Availability of acceptance and transfer acts of medicines containing narcotic drugs, psychotropic substances and their precursors, remaining after the death of the patient.
|
gross
|
64.
|
Availability of a permanent commission, which includes representatives of internal affairs bodies and territorial subdivision of the state body in the sphere of sanitary and epidemiological welfare of the population for destruction of medicines containing narcotic drugs, psychotropic substances of Table II of the List with an expired shelf life, handed over by the relatives of deceased patients, and also scraps, defects, empty ampoules, tablets and patches (transdermal therapeutic systems), as well as ampoules, tablets and patches ( transdermal therapeutic systems), the contents of which have been partially used.
|
significant
|
65.
|
Availability of destruction acts of medicines containing narcotic drugs, psychotropic substances and their precursors of Tables II, III, IV of the List.
|
significant
|
66.
|
Compliance with the rules and procedure for registration and storage of medical documentation, requirements for medicines containing narcotic drugs, psychotropic substances and precursors of Tables II, III, IV of the List.
|
significant
|
67.
|
Compliance with the rules for writing prescriptions.
|
significant
|
68.
|
Ensuring accounting and monitoring of prescriptions for free or preferential receipt of medicines.
|
significant
|
69.
|
Ensuring that samples of signatures of the authorized persons, having the right to sign prescriptions are sent to the facilities of a pharmaceutical organization.
|
minor
|
70.
|
Reflection of the content and number of prescriptions for free or preferential receipt of medicines in the patient's outpatient record.
|
significant
|
71.
|
Ensuring the calculation of the need for medicines:
- in accordance with the medicinal form of the medical organization;
- on the basis of data on dynamics of morbidity and the epidemiological situation in the region, as well as statistical data on the forecasted number of patients;
- taking into account the registers of treated patients;
- taking into account the actual consumption of medicines for the previous year and the forecasted balance as of January 1 of the next financial year.
|
significant
|
72.
|
Compliance with the conditions for the purchase of medicines and pharmaceutical services within the guaranteed volume of free medical assistance (hereinafter- GVFMA) and medical care in the system of compulsory social health insurance.
|
significant
|
73.
|
Ensuring the distribution of medicines, depending on the forecasted number of patients and certain categories of citizens living on the territory of settlements, by types of diseases.
|
significant
|
74.
|
Ensuring the redistribution of medicines purchased at the expense of local and republican budgets, within the framework of relevant programs between medical organizations.
|
significant
|
75.
|
Availability in medical organizations rendering outpatient-polyclinic assistance, on the objects in the sphere of circulation of medicines, carrying out pharmaceutical services within the GVFMA, as well as in periodicals distributed on the territory of the corresponding administrative-territorial unit of the following information placed for patients:
- a list and addresses of objects in the sphere of circulation of medicines, carrying out pharmaceutical services within the framework of GVFMA;
- addresses of organizations, rendering outpatient-polyclinic assistance through which outpatient medicines provision is carried out;
- address and telephone number of the customer for rendering pharmaceutical services.
|
minor
|
76.
|
Compliance with the rational use (prescription) of medicines and formation of a medicinal formulary based on proven clinical efficacy and safety of medicines.
|
significant
|
77.
|
Presence of a permanent commission, which at least once a quarter shall analyze medical prescriptions at the inpatient, inpatient-replacing and outpatient levels.
|
minor
|
78.
|
Ensuring the registration of medicines within the guaranteed volume of free medical assistance in rendering inpatient, inpatient- replacing and outpatient care within the guaranteed volume of free medical assistance in total and quantitative terms in medical documentation or automated programs for accounting, use of medicines.
|
gross
|
79.
|
Reflection of the used medicines in the medical record of the inpatient, in the list of medical prescriptions.
|
significant
|
80.
|
Ensuring the marking of medicines received for rendering emergency, inpatient and inpatient-replacing care within the GVFMA, with a stamp of the medical organization indicating the name of the medical organization, its address and the mark “Free”.
|
minor
|
81.
|
Ensuring separate storage and accounting of medicines purchased for rendering medical care within the GVFMA and paid services.
|
gross
|
82.
|
Entering information about side effects, serious side effects and lack of effectiveness in the medical record of an inpatient and (or) outpatient patient, including maintaining statistics on identified cases of side effects in a medical organization.
|
significant
|
1.3. Criteria in the sphere of circulation of medicines and medical devices in relation to subjects (objects) of pharmaceutical activities carrying out the production of medicines and medical devices
|
83.
|
Availability of:
- higher pharmaceutical or chemical-technological, chemical education and work experience in the specialty for at least three years for the heads of departments directly involved in the production of medicines and medical devices, or technical for the heads of departments directly involved in the production of medical devices;
- higher pharmaceutical or chemical, biological education for the employees, carrying out control of the quality of medicines and medical devices, or technical for the employees, carrying out control of the quality of medical devices;
- technical education for a specialist in the maintenance of equipment used in the technological process of manufacturing medicines and medical devices.
|
gross
|
84.
|
Compliance with all processes for the production of medicines and medical devices.
|
gross
|
85.
|
Availability of state registration in the Republic of Kazakhstan of medicines used in production, with the exception of those produced under the conditions of Good Manufacturing Practice.
|
gross
|
86.
|
Availability of shipping documents for medicines and medical devices.
|
gross
|
87.
|
Implementation of activity for the production of medicines or the wholesale sale of medicines by the suppliers of substances or intermediates.
|
gross
|
88.
|
Compliance of substances, excipients, consumables and packaging materials with the registration dossier
|
gross
|
89.
|
Implementation of incoming control of raw materials (substances, auxiliary material), materials, semi-finished products, components; intermediate control in the production process, control of finished pharmaceutical products.
|
gross
|
90.
|
Availability of a quality assurance system, documentation and control of its effectiveness in production.
|
gross
|
91.
|
Ensuring registration of all technological and auxiliary operations in the production process of a separate series of medicines and medical devices.
|
gross
|
92.
|
Compliance with the requirements for maintaining documentation of all production processes and materials used in production, the procedure for its storage.
|
gross
|
93.
|
Compliance with stability tests, establishment of shelf life and re-control of medicines.
|
gross
|
94.
|
Ensuring the number of samples sufficient for testing in cases of need (arbitration tests).
|
gross
|
95.
|
Availability of markings indicating the status of manufactured products, original products, packaging materials.
|
gross
|
96.
|
Carrying out quality control of materials, intermediate products, finished products.
|
gross
|
97.
|
Maintaining a database on side effects of medicines and medical devices.
|
significant
|
1.4. Criteria in the sphere of circulation of medicines and medical devices in relation to subjects (objects) of pharmaceutical activities, carrying out the manufacture of medicines and medical devices
|
98.
|
-Availability of:
- higher pharmaceutical education and work experience of at least three years in the specialty for the head of a pharmacy, carrying out the manufacture of medicines and its production departments, as well as employees, carrying out control of the quality of medicines and medical devices;
- higher or secondary pharmaceutical education for the employees directly carrying out the manufacture of medicines and delivery of manufactured medices;
- secondary pharmaceutical education and work experience of at least three years for the head of the pharmacy and its production departments in the absence of specialists with higher pharmaceutical education in the regional center and rural areas.
|
gross
|
99.
|
Availability of a pharmacist-analyst's workplace equipped with a standard set of measuring instruments, test equipment, laboratory glassware, and auxiliary materials.
|
gross
|
100.
|
Implementation of preventive (warning) measures, acceptance control of raw materials (drug substance, excipient), written, organoleptic, selective survey control, selective physical and chemical control, control during the delivery of manufactured medicines.
|
gross
|
101.
|
Availability and maintenance of checklists during the manufacture of medicines according to prescriptions and requirements of medical organizations.
|
significant
|
102.
|
Availability and maintenance of a registration journal of the results of organoleptic, physical and chemical control numbered, laced, sealed and signed by the head of the pharmacy.
|
significant
|
103.
|
Availability of state registration in the Republic of Kazakhstan for medicinal substances used in the manufacture, with the exception of those produced under the conditions of Good Manufacturing Practice.
|
gross
|
104.
|
Carrying out activities for the production of medicines or for the wholesale sale of medicines by the suppliers of substances.
|
gross
|
105.
|
Keeping and monitoring the records of expiration dates of medicines, medical devices.
|
significant
|
106.
|
Ensuring of manufacturing technology for a medicinal product, in accordance with the requirements of general articles of the State Pharmacopoeia of the Republic of Kazakhstan.
|
gross
|
107.
|
Implementation of preventive (warning) measures:
1) compliance with the conditions for aseptic preparation of medicinal products;
2) ensuring the serviceability and accuracy of weighing and measuring instruments, conducting their annual verification;
3) ensuring proper conditions for the receipt, collection, storage of purified water, water for injection, the correct labeling of the container in the form of an indication on the tag of the receipt date, analysis number and signature of the person who performed the analysis;
4) compliance with the terms, storage conditions of reagents, standard and titrated solutions and their correct design (on the labels, in addition to the name, the concentration, molarity, date of receipt, expiration date, storage conditions, who manufactured it are indicated);
5) determination of deviations in the tested medicinal products using measuring instruments of the same type (with the same metrological characteristics) as in their manufacture in pharmacies;
6) proper treatment, filling, design of burette installation and shtanglasses.
|
gross
|
108.
|
The design of shtanglasses (pharmaceutical packaging) as follows:
1) name, country and manufacturing plant, serial number of the manufacturing plant, number and validity period of the conclusion on safety and product quality, expiration date of the medicinal substance, the date of filling, signature of the persons filled shtanglas and checking the authenticity of the medicinal substance are indicated on the shtanglasses in storage facilities;
2) date of filling of shtanglas, signatures of the persons filled shtanglas and checking the authenticity of medicinal substance and auxiliary substances are indicated on the shtanglas with medicinal substances and excipients, which are contained in the assistant room;
3) on shtanglas with narcotic drugs, psychotropic substances, precursors, toxic substances additionally the highest single and daily doses are indicated;
4) on shtanglasses with medicinal substances containing cardiac glycosides, the number of units of action in one gram of medicinal plant raw materials or in one milliliter of solution is indicated;
5) on shtanglasses with medicinal substances intended for the manufacture of medicines, requiring aseptic manufacturing conditions, the inscription: "For sterile medicines" is indicated;
6) on shtanglasses with medicinal substances containing moisture, the percentage of moisture on the cylinders with liquids (hydrogen peroxide solution, ammonia solution, formaldehyde) the actual content of the active substance is indicated;
7) shtanglasses with solutions, tinctures and liquid semi-finished products are provided with droplets or pipettes, indicating the number of drops, determined by weighing in a certain volume.
|
gross
|
109.
|
Availability and maintenance of the Journal for registration of the results of control of medicinal substances for authenticity.
|
significant
|
110.
|
Implementation of control over compliance with the manufacturing technology of medicinal products by the pharmacist-technologist.
|
gross
|
111.
|
Carrying out acceptance control of raw materials (medicinal substance, excipient) used for the manufacture of medicinal products (consignment note, quality certificate of the manufacturing plant), compliance of series on the samples of medicinal substances and excipients with the series, specified in the accompanying documentation, compliance with storage conditions, transportation, as well as identification of medicinal substances and auxiliary materials according to the indicators "Packaging", "Marking" and "Description".
|
significant
|
112.
|
Conducting written control of medicinal products manufactured in a pharmacy by filling out a control sheet immediately after the manufacture of a medicinal product.
The checklist indicates:
1) date of manufacture;
2) number of the prescription or requirement of the medical organization indicating the name of the department;
3) names of the medicinal substances taken, their quantity, total volume or weight, number of doses;
4) signatures of the manufacturer, who packaged and checked the medicinal product.
In the checklist, names of narcotic drugs, poisonous, psychotropic substances, precursors shall be underlined with a red pencil, the letter "D" is put on medicines for children.
The checklist is filled out in Latin in accordance with the sequence of manufacturing technology.
All calculations shall be recorded on the back of the checklist.
|
gross
|
113.
|
Conductingod of a selective survey control of medicines manufactured in a pharmacy.
|
gross
|
114.
|
Conductinf of organoleptic control in terms of appearance, color, odor, uniformity, absence of visible mechanical impurities in solutions.
|
significant
|
115.
|
Conducting random physical control by checking the total weight or volume of a medicine, number and weight of individual doses included in this medicine (but not less than three doses), and the quality of the closure.
The following ones are subjected to selective physical control:
1) each series of packaging of industrial products and intra-pharmacy blanks in the amount of three to five packages, including packaging of homeopathic medicinal products for compliance with the deviation rate permissible in the manufacture of medicinal products (including homeopathic ones) in the pharmacy and the deviation rate permissible for packaging industrial products;
2) at least three percent of medicinal products manufactured according to prescriptions (requirements) in one working day;
3) number of homeopathic granules in a certain sample weight;
4) each series of medicinal products requiring sterilization, after filling before sterilization, in an amount of at least five vials (bottles) for mechanical inclusions (mobile insoluble substances, except for gas bubbles, accidentally present in solutions).
|
gross
|
116.
|
Conducting primary and secondary control for mechanical inclusions in the process of making solutions.
|
gross
|
117.
|
Conducting chemical control by indicators:
1) authenticity, purity tests and impurity limits (qualitative analysis);
2) quantitative determination (quantitative analysis) of medicinal substances included in its composition.
|
gross
|
118.
|
Providing a complete chemical analysis of purified water.
|
gross
|
119.
|
Carrying out control during delivery by checking all manufactured medicinal products, including homeopathic ones, for compliance:
1) of packaging of medicinal products with the physical and chemical properties of medicinal substances included in them;
2) of doses indicated in the prescription, including the highest single doses, the highest daily doses of medicines with the age of the patient;
3) the number on the prescription with the number on the label;
4) the patient's surname on the receipt with the surname on the label and on the prescription;
5) registration of medicinal products.
|
gross
|
120.
|
Ensuring the registration of results of control of individual stages for the manufacture of solutions for injections and infusions in the registration journal of results of control of individual stages for the manufacture of solutions for injections and infusions.
|
gross
|
121.
|
Availability of a nomenclature of concentrates, semi-finished products and intra-pharmacy preparation of medicines, manufactured in a pharmacy, annually approved by an accredited testing laboratory, with which an agreement on control and analytical services has been concluded.
|
gross
|
1.5. Criteria in the sphere of circulation of medicines and medical devices in relation to subjects (objects) of pharmaceutical activities, carrying out the wholesale of medicines and medical devices
|
122.
|
Availability of:
- higher pharmaceutical education and work experience of at least three years for the head of a pharmacy warehouse and an employee carrying out sale of medicines and medical devices;
- higher or secondary pharmaceutical education for the heads of departments of the pharmacy warehouse and employees who receive, store and distribute medicines and medical devices.
|
gross
|
123.
|
Availability and functioning of a documentation system for tracking the receipt and shipment of medicines and medical devices.
|
gross
|
124.
|
Ensuring the provision of a copy of conclusion on the safety and quality of products at the request of the subject.
Conclusions on the safety and quality of medicines and medical devices shall be stored for the period of validity plus one year and shall be available to the consumers and (or) state regulatory authorities.
|
significant
|
125.
|
Carrying out the procurement of medicines and medical devices from entities, having a license for pharmaceutical activities and an annex to a license for subspecies of activities: production of medicines, wholesale of medicines, or having notified about the start of activities for the wholesale of medical products.
|
gross
|
126.
|
Carrying out the sale of medicines and medical devices to the entities, having a license for pharmaceutical or medical activities or having notified about the start of activities for the sale of medical devices.
|
gross
|
127.
|
The sale of medicinal substances shall be carried out to pharmacies licensed for pharmaceutical activities with the right to manufacture, as well as to organizations for the production of medicinal products, which have a license for pharmaceutical activities with the right to manufacture medicinal products.
|
gross
|
128.
|
Carrying out the wholesale of medical devices related to measuring instruments, if there is a certificate of type approval of measuring instruments, or a certificate of metrological certification of medical measuring equipment.
|
gross
|
129.
|
Provision with vehicles and equipment used for transportation and compliance with their purposes of use to protect products from unwanted effects that lead to loss of quality or damage the integrity of the package, and to ensure that:
1) the possibility of their identification and safety assessment has not been lost;
2) were not contaminated with other medicines (dosages), substances and did not contaminate themselves;
3) were protected and not exposed to environmental factors.
The vehicle and its equipment shall be kept clean and treated with detergents and disinfectants as needed.
|
significant
|
130.
|
Compliance with storage conditions during transportation necessary to ensure the quality, safety and efficacy of medicines, as well as to prevent the risk of counterfeit medicines entering the supply chain.
|
gross
|
131.
|
Availability of temperature control devices in vehicles in the event of supply of medicines requiring special transportation conditions. Instrument readings shall be recorded throughout the entire transportation and documented.
|
gross
|
132.
|
Ensuring the protection of medicines and medical devices from environmental factors (precipitation, dust, sunlight, mechanical damage). Medicines and medical devices prepared for transportation shall be packed in group containers (cardboard boxes or stacks) with subsequent packing in transport packaging (containers, boxes, wrapping paper) that meet the requirements of the regulatory document.
|
gross
|
133.
|
Ensuring registration of shipping documents containing the following information for each name, batch (series) of products:
- name;
- dosage (for the medicine);
- packing;
- quantity, unit price;
- amount;
- series;
- expiration date;
- number and validity period of the conclusion on safety and quality (for a medicine or a medical device).
Corrections, additions, blots in shipping documents shall not be allowed.
|
gross
|
133-1.
|
Compliance with the maximum price for the trade name of a medicine during wholesale.
|
gross
|
1.6. Criteria in the sphere of circulation of medicines and medical devices in relation to subjects (objects) of pharmaceutical activities, carrying out retail sale of medicines and medical devices
|
134.
|
Availability of:
- higher pharmaceutical education or secondary pharmaceutical education (work experience in the specialty for at least three years) for the head of a pharmacy or its departments;
- higher or secondary pharmaceutical education for the specialists who sell medicines and medical devices;
- higher pharmaceutical education or secondary pharmaceutical education (work experience in the specialty for at least three years) for the head of a pharmacy in healthcare organizations, rendering primary health care, consultative and diagnostic assistance, as well as workers, carrying out sale of medicines and medical devices.
|
gross
|
135.
|
Ensuring the sale of medical devices related to measuring instruments, if there is a certificate of approval of the type of measuring instruments or a certificate of metrological certification of medical measuring equipment.
|
gross
|
136.
|
Ensuring the sale of prescribed medicines drugs by a doctor’s prescription.
|
gross
|
137.
|
Ensuring the placement of medicines sold without a doctor's prescription on display cases.
|
significant
|
138.
|
Registration of invalid prescriptions in the Register of incorrectly written out prescriptions for their redemption with the stamp "Prescription is invalid".
|
minor
|
139.
|
Ensuring the storage of prescriptions:
- for free medicines - 3 years;
- for medicines containing:
- derivatives of 8-hydroxyquinoline, hormonal steroids, anabolic steroids - 3 months;
- poisonous substances, clonidine, codeine, tropicamide, tramadol, cyclopentolate, pregabalin, zopiclone, diphenhydramine, promethazine - 3 years.
|
significant
|
140.
|
Ensuring the submission of accurate information regarding:
- correct and rational administration or use;
- possible side effects and contraindications;
- interactions with other medicines, precautions for their administration or use;
- shelf life and storage rules at home;
- operating rules, completeness of medical devices.
|
significant
|
141.
|
Ensuring the conduct of preventive measures:
1) quality control during acceptance and sale;
2) compliance with the rules and terms of storage of medicines, keeping records of medicines with a limited shelf life;
3) serviceability and accuracy of weighing instruments;
4) checking the correctness of the prescribed prescription, its validity period, the compliance of the prescribed doses with the patient's age, the compatibility of ingredients, the norms of one-time delivery;
5) keeping records of the validity periods of conclusions on the safety and quality assessment.
|
gross
|
142.
|
Ensuring the acceptance of medicines and medical devices with verification of:
1) compliance of the quantity, completeness, integrity of the container, compliance of the packaging, labeling with regulatory documents, the availability of instructions for the medical use of a medicine and a medical device in the state and Russian languages; availability of an operational document for a medical device;
2) compliance with the name, dosage, packing, quantity, batch (series) of products specified in the accompanying documents;
3) availability of a conclusion on safety and quality in the accompanying documents or a reference to it in the consignment note for the release of goods.
|
gross
|
143.
|
Availability of information about the list of medicines and specialized medical products for free provision of certain categories of citizens with certain diseases at the outpatient level in an easy-to-read place.
|
minor
|
144.
|
Availability of lists and samples of signatures of persons entitled to sign prescriptions for free receipt of medicines, approved by the head of the relevant healthcare organization, in retail sales facilities that have relevant agreements with local state healthcare authorities.
|
minor
|
145.
|
Providing placement in a place convenient for familiarization of:
- copies of a license for pharmaceutical activities and annexes to it or a document (including a printed copy of an electronic document) informing about the beginning or termination of activities or certain actions;
- books of reviews and proposals;
- information on the telephone numbers of the pharmaceutical inquiry service.
|
minor
|
146.
|
Ensuring placement in a visible place for visitors of the following information:
- "Medicines are not subjects to return and exchange";
- "Medicines are not delivered to children";
- "Over-the-counter sale of medicines intended for delivery by the doctor’s prescription shall be prohibited";
- "Shelf life of medicinal products manufactured in a pharmacy."
|
minor
|
146-1.
|
Compliance with the maximum price for the trade name of a medicinal product during retail sales.
|
gross
|
2. Criteria for the sources of information provided for in subparagraphs 2) -7) of paragraph 10 of the Criteria
|
Criteria for the source of information "The number of confirmed complaints and appeals"
|
1.
|
Availability of one or more confirmed complaints and appeals
|
gross
|
Criteria for the source of information "Analysis of official Internet resources of state bodies, including authorized bodies in the field of healthcare of the countries of the Commonwealth of Independent States (CIS), mass media"
|
2.
|
Availability of facts of non-compliance of medicines and medical devices with the requirements of the legislation of the Republic of Kazakhstan on safety, efficacy and quality of medicines and medical devices, revealed by the results of analysis of the official mass media, information by telephone of trust, "hot lines", information provided by state bodies, organizations, including international, as well as sites of authorized bodies in the field of healthcare of the countries of the Commonwealth of Independent States (CIS).
|
gross
|
Criteria for the source of information "The list of violations identified based on the results of laboratory tests conducted by the state expert organization in the sphere of circulation of medicines and medical devices
|
3.
|
Availability of test results submitted by a state expert organization in the field of circulation of medicines and medical devices, confirming the inconsistency of safety, efficacy and quality of medicines and medical devices.
|
gross
|
Criteria for the source of information "Results of the information analysis provided by authorized bodies (prosecutors, law enforcement agencies), state organizations"
|
4.
|
Availability of facts of bringing to administrative and (or) criminal liability.
|
gross
|
Criteria for the source of information “Availability of adverse incidents caused by the fault of the subject of control. Adverse incidents include the probability of causing harm to health, a threat to life or human health, as a result of the production, manufacture, import, storage, sale, administration (use) of medicines and medical devices, including those that do not meet the requirements of the legislation of the Republic of Kazakhstan in the field of healthcare"
|
5.
|
Availability of adverse incidents that endangered human life or health, arising from the fault of the subject of pharmaceutical activities.
|
gross
|
Criteria for the source of information "Information from international regulatory bodies in the field of quality and safety of medicines and medical devices, state bodies of countries, including the Eurasian Economic Union"
|
6.
|
Information from international bodies, state bodies of countries, including the Eurasian Economic Union, on the facts of non-compliance of medicines and medical devices with the requirements of legislation on safety, efficiency and quality.
|
gross
|
| |
Appendix 17
to the joint order of the
Minister of Healthcare of
the Republic of Kazakhstan
dated November 15, 2018
No. ЌР DSM-32 and the
Minister of National Economy of
the Republic of Kazakhstan
dated November 15, 2018, No. 70 |
A checklist in the sphere of circulation of medicines and medical devices in relation to all subjects (objects) of pharmaceutical activity
Footnote. Appendix 17 is in the wording of the joint order of the Minister of Healthcare of the Republic of Kazakhstan dated April 29, 2019 No. KR HCM-56 and the Minister of National Economy of the Republic of Kazakhstan dated April 30, 2019 No. 33 (shall be enforced upon expiry of ten calendar days after its first official publication).
State body that assigned the inspection _____________________________
________________________________________________________________________
Act on assignment of an inspection/preventive control with a visit to the subject (object)
of control ____________________________________________________________________
________________________________________________________________________
No., date
Name of the subject (object) of control
____________________________________________________________________________
(Individual identification number), business identification number of the subject (object)
of control ______________________________________________________________________
_________________________________________________________________
Location address _______________________________________________________
_____________________________________________________________________________
№
|
List of requirements
|
Required
|
Not required
|
Meets the requirements
|
Doesn't meet the requirements
|
1.
|
Availability of a state license for pharmaceutical activities and annexes to subtypes of activities or notification on the beginning of activities.
Compliance of the types and subtypes of activities with the declared ones when obtaining a state license and annex to it.
|
|
|
|
|
2.
|
Availability of certificates confirming the passage of specialization or improvement courses, other types of advanced training over the past 5 years for responsible specialists in the sphere of circulation of medicines.
|
|
|
|
|
3.
|
Compliance of the premises, area and equipment with sanitary rules, standard regulations and qualification requirements for licensing pharmaceutical activities and activities in the sphere of trafficking in narcotic drugs, psychotropic substances and precursors.
|
|
|
|
|
4.
|
Ensuring storage and transportation in accordance with the conditions established by the manufacturer in the regulatory and technical document for the control over quality and safety of medicines, in the instructions of medical use for medicines and medical devices, operational documents (for a medical device) specified in the labeling of their packages.
|
|
|
|
|
5.
|
Ensuring the safety, storage conditions of various groups of medicines and medical devices and their handling by complying with the requirements for the design, arrangement, composition, size of areas, equipment of premises (zones) for storing medicines and medical devices and their operation, ensuring safety.
|
|
|
|
|
6.
|
Compliance with separate storage of medicines and medical devices from other products in order to avoid any impact on them, protection from negative effects of light, temperature, moisture and other external factors.
|
|
|
|
|
7.
|
Keeping records of the expiration dates of medicines and medical devices on paper or electronic media.
|
|
|
|
|
8.
|
Carrying out the storage of medicines and medical devices in allotted and clearly marked storage areas.
|
|
|
|
|
9.
|
Provision of a storage room, including a refrigerating room (chamber) with appropriate equipment for monitoring temperature, humidity (thermometers, hygrometers, other types of devices) and their location on the inner walls of premises away from heating devices based on the results of testing zones of temperature fluctuations for cold and warm season.
|
|
|
|
|
10.
|
Compliance with the separation during storage of all medicines and medical devices, depending on the pharmacological group, method of application, state of aggregation, physical and chemical properties, impact of various environmental factors on them.
|
|
|
|
|
11.
|
Availability of an isolated place for storing medicines, the decision on circulation of which has not yet been made, with an expired shelf life, returned, withdrawn from the category suitable for delivery, in respect of which there are suspicions of falsification, withdrawn and rejected.
|
|
|
|
|
12.
|
Providing protection from the effects of weather conditions in the areas of acceptance and shipment. Availability of equipment in the areas of acceptance and shipment (ventilation/air conditioning system, hygrometer, thermometer), equipment for cleaning containers. Availability of an equipped control zone for the received products.
|
|
|
|
|
13.
|
Separation of acceptance, quarantine, rejection, shipment and storage areas.
Availability of a room in which medicines are stored in quarantine, with a clear designation and limited access.
|
|
|
|
|
14.
|
Availability of common fireproof buildings with fireproof walls insulation from neighboring rooms that meet the requirements of fire safety in the absence of separate storage facilities for flammable substances, providing the room with supply and exhaust ventilation.
|
|
|
|
|
15.
|
Storage of flammable medicines separately from other medicines: provision of fireproof and stable racks and pallets, storage of flammable and combustible liquids in built-in fireproof cabinets with doors at least 0.7 meters wide and at least 1.2 meters high.
|
|
|
|
|
16.
|
Storage of flammable liquids isolated in separate rooms in glass or metal containers from other groups.
|
|
|
|
|
17.
|
Compliance with the storage of flammable and flammable liquid medicines that should not be stored:
1) in a fully filled container, the degree of filling is not more than 90 percent of the volume. Alcohol in large quantities shall be stored in metal containers that are filled no more than 95 percent of the volume;
2) with mineral acids (sulfuric, nitric and other acids), compressed and liquefied gases, flammable substances, as well as with inorganic salts that give explosive mixtures with organic substances (potassium chlorate, potassium permanganate).
|
|
|
|
|
18.
|
Compliance with isolated storage of calcium hypochlorite, taking into account its properties.
|
|
|
|
|
19.
|
Compliance with the storage of flammable liquids with constant monitoring of the containers condition, their tightness and serviceability.
|
|
|
|
|
20.
|
Implementation of measures during the storage of explosive drugs against their contamination with dust.
|
|
|
|
|
21.
|
Compliance with the separate storage of explosive and flammable medicines with acids and alkalis.
|
|
|
|
|
22.
|
Ensuring the protection of cylinders with oxygen and combustible gases from heat sources, the ingress of oil and other fatty substances on them, and their storage in isolated rooms or under sheds.
|
|
|
|
|
23.
|
Compliance with the conditions for storing dressings in a dry ventilated room in cabinets, boxes, on racks, pallets, trays, in conditions that ensure cleanliness.
|
|
|
|
|
24.
|
Compliance with the storage conditions for medical instruments, devices, appliances, equipment in dry heated rooms at room temperature, with a relative humidity not exceeding 65 percent.
|
|
|
|
|
25.
|
Compliance with the requirements for finishing the premises (zones) for storing medicines and ensuring the cleanliness of premises and storage equipment.
|
|
|
|
|
26.
|
Providing protection from the entry of insects, rodents or other animals, availability of a preventive pest control program.
|
|
|
|
|
27.
|
Separation of rest rooms, dressing rooms, showers and toilets for the employees from storage rooms (zones). Food, drinks, tobacco products, as well as medicines for personal use shall not be stored in the storage rooms (zones).
Employees, working in the storage area must have protective clothing or uniform appropriate for the work to be performed and personal protective equipment, if necessary. The personnel working with hazardous drugs shall undergo special training.
|
|
|
|
|
28.
|
Provision with the necessary equipment and inventory in the premises for storing medicines:
- racks, pallets, dunnage racks, cabinets for storing medicines and medical devices;
- technological equipment for creating a temperature regime;
- devices for recording temperature and humidity;
- means of mechanization for loading and unloading operations;
- disinfectants and cleaning equipment to ensure a sanitary regime;
- other equipment and tools, ensuring sanitary and hygienic regime, labor protection, safety, fire safety, environmental protection and safety of medicines.
|
|
|
|
|
29.
|
Availability of a document on the calibration (verification) of equipment used to control and monitor storage conditions.
|
|
|
|
|
30.
|
Availability of a developed and approved plan of emergency measures in case of malfunction of the refrigerating room (chamber), refrigeration equipment or power outages, emergencies.
|
|
|
|
|
31.
|
Availability of developed and approved instructions for cleaning and disinfecting equipment. The equipment is used in good condition and kept in proper cleanliness.
|
|
|
|
|
32.
|
Presence of a person responsible for ensuring the safety of quality of medicines and medical devices at facilities, carrying out storage of medicines and medical devices.
|
|
|
|
|
33.
|
Presence of a commission for the destruction of medicines and medical devices unsuitable for sale and medical use.
|
|
|
|
|
34.
|
Availability of acts on the destruction of medicines and medical devices unsuitable for sale and medical use.
|
|
|
|
|
35.
|
Availability of secondary packaging marking, including the following information:
1) trade name of a medicine;
2) an international non-proprietary name (if any) in the state, Russian and English languages;
3) name of the manufacturer of a medicine, address, trademark. Name of the manufacturing organization and its address may be indicated in full or abbreviated (city, country);
4) name of the owner of a registration certificate, his/her address (city, country);
5) dosage form indicating the mass, volume or number of doses in the package, dosage;
6) active substances and their quantitative composition per dose unit or, depending on the dosage form, per unit of mass or volume;
7) the mass of medicinal plant raw materials is indicated at a certain moisture content in percent;
8) for medicines, containing narcotic drugs, psychotropic substances and precursors, the names of these substances and their content in units of weight or percentage shall be indicated. In one-component medicines, subject to the authenticity of the name of a medicine and active substance and indicating its dosage, concentration, activity - the composition of active substances shall not be indicated;
9) a list of excipients:
- for parenteral, ophthalmic drugs and drugs for external use, a list of all excipients shall be indicated;
- for infusion solutions, the qualitative and quantitative composition of all excipients shall be indicated;
- for other dosage forms, a list of antimicrobial preservatives, dyes, as well as sugars and ethanol shall be indicated;
- a list of excipients indicated when labeling medicinal products for oral administration;
10) for infusion solutions containing more than one active ingredient, the value of osmolarity/osmolality value shall be indicated;
11) the method of administration and, depending on the dosage form, the route of administration (the method of administration is not indicated for tablets and capsules intended for oral administration);
12) precautions;
13) warning notices;
14) storage conditions, storage features;
15) sale conditions (with or without a prescription);
16) a batch number;
17) production date (if not entered in the batch number);
18) expiration date: "good before (day, month, year)" or "(day, month, year)";
The expiration date is indicated as "good before (month, year)" or "(month, year)", while the expiration date is determined up to the last day of the specified month, inclusive.
19) registration number of a medicine in the form of the designation "RK-MP-";
20) a barcode (if any).
|
|
|
|
|
36.
|
Availability of labeling of primary packaging with the following information:
1) trade name of a medicine, indicating the dosage, activity or concentration;
2) international non-proprietary name (if any) in the state, Russian and English languages;
3) name of the manufacturer of a medicine and (or) its trademark;
4) mass or volume;
5) a batch number;
6) expiration date "month, year" or "day, month, year".
|
|
|
|
|
37.
|
Organization of work on monitoring adverse reactions and (or) lack of effectiveness of medicines and medical devices, appointment of persons responsible for monitoring side effects of medicines and medical devices.
|
|
|
|
|
38.
|
Submission of information by the responsible person to the authorized organization on side effects and (or) on lack of effectiveness of medicines and medical devices. Online transmission of card messages through the portal of an authorized organization with the content of a mandatory minimum amount of information.
|
|
|
|
|
39.
|
Compliance with the deadlines for submitting the completed report card on adverse reactions (effects) and (or) effectiveness to the authorized organization in cases of detection.
|
|
|
|
|
40.
|
Absence of facts of purchase, production, storage, advertising, use, provision and sale of medicines and medical devices that have not passed state registration in the Republic of Kazakhstan.
|
|
|
|
|
41.
|
Absence of facts of production, import, storage, use and sale of counterfeit medicines and medical devices.
|
|
|
|
|
42.
|
Absence of facts of sale of medicines and medical devices, the quality of which is not confirmed by the conclusion on safety and quality.
|
|
|
|
|
43.
|
Absence of facts of storage, use and sale of expired medicines and medical devices.
|
|
|
|
|
44.
|
Compliance of a medicine with the requirements of a regulatory document for control over the quality and safety of a medicine and a medical device (based on the results of assessing the safety and quality of samples withdrawn as a doubt).
|
|
|
|
|
45.
|
Compliance with the rules and procedure for storage, accounting, destruction of medicines containing narcotic drugs, psychotropic substances and precursors (including substances).
|
|
|
|
|
46.
|
Availability of a list of persons who have the conclusions of psychiatrist and narcologist doctors on the absence of drug addiction, substance abuse, chronic alcoholism, as well as on the suitability to perform activities related to narcotic drugs, psychotropic substances and their precursors, and the conclusion of internal affairs bodies on the conduct of an appropriate check.
|
|
|
|
|
47.
|
Storage rooms, safes and wardrobes shall be in a closed condition. After the end of a working day, they shall be sealed and (or) stamped. Keys, seal and (or) stamp shall be kept by a responsible person.
|
|
|
|
|
48.
|
Availability of a first aid kit for first medical aid.
|
|
|
|
|
49.
|
Availability of a sign indicating the name of the subject of pharmaceutical activity, its organizational and legal form and working regime in the state and Russian languages.
|
|
|
|
|
50.
|
Availability of information on the phones and addresses of territorial divisions of the state body in the sphere of circulation of medicines and medical devices in a convenient place for the population familiarization.
|
|
|
|
|
Official ( s ) ________________________________________
_______________________________ ___________
position signature
_____________________________________________________________________________
(surname, name, patronymic (if any)
Head of the subject of control _____________________________________
_______________________________ ____________________
position signature
________________________________________________________________________
surname, name, patronymic (if any)
| |
Appendix 18
to the joint order of the
Minister of Healthcare of
the Republic of Kazakhstan
dated November 15, 2018
No. ЌР DSM-32 and the
Minister of National Economy of
the Republic of Kazakhstan
dated November 15, 2018, No. 70 |
Checklist in the sphere of circulation of medicines and medical devices in relation to medical organizations on the issues of medicines supply
Footnote. Appendix 18 is in the wording of the joint order of the Minister of Healthcare of the Republic of Kazakhstan dated April 29, 2019 No. KR HCM-56 and the Minister of National Economy of the Republic of Kazakhstan dated April 30, 2019 No. 33 (shall be enforced upon expiry of ten calendar days after its first official publication).
State body that assigned the inspection _____________________________
________________________________________________________________________
Act on assignment of an inspection/preventive control with a visit to the subject (object)
of control ____________________________________________________________________
________________________________________________________________________
No., date
Name of the subject (object) of control
____________________________________________________________________________
(Individual identification number), business identification number of the subject (object) of control
______________________________________________________________________
_________________________________________________________________
Location address _______________________________________________________
_____________________________________________________________________________
№
|
List of requirements
|
Required
|
Not required
|
Meets the requirements
|
Doesn't meet the requirements
|
1.
|
Availability of higher pharmaceutical education or secondary pharmaceutical education (work experience in the specialty for at least three years) for the head of the pharmacy or its departments;
- higher or secondary pharmaceutical education for the specialists, carrying out sale of medicines and medical devices at a pharmacy in healthcare organizations that provide primary health care, consultative and diagnostic assistance;
- higher pharmaceutical education or secondary pharmaceutical education (work experience in the specialty for at least three years) for the head of the pharmacy, as well as employees, carrying out sale of medicines and medical devices.
|
|
|
|
|
2.
|
Compliance with the calculation of the need for medicines containing narcotic drugs in accordance with the estimated standards of need per 1000 population per year (in grams).
|
|
|
|
|
3.
|
Compliance with the prescription of drugs containing narcotic drugs, psychotropic substances and their precursors during outpatient and inpatient treatment in healthcare organizations by a healthcare organization doctor who has access to work with narcotic drugs and their precursors.
|
|
|
|
|
4.
|
Compliance with the recording in the patient's medical documents of prescription of medicines containing narcotic drugs, psychotropic substances and precursors of Tables II, III, IV of the List of narcotic drugs, psychotropic substances and precursors subject to control in the Republic of Kazakhstan (hereinafter - the List), indicating a single dose, method and frequency of administration (injection), duration of the treatment course, as well as justification for the prescription of medicines.
|
|
|
|
|
5.
|
Ensuring the use (administration) of medicines containing narcotic drugs, psychotropic substances of Tables II, III List strictly under the supervision of medical personnel at the time of their issuance - oral administration, application of transdermal therapeutic systems (patch, film) - in the presence of a nurse, injection - in the presence of a doctor.
|
|
|
|
|
6.
|
Compliance with the rules and procedure for writing prescriptions for medicines containing narcotic drugs, psychotropic substances and precursors.
|
|
|
|
|
7.
|
Presence of a person responsible for the storage and issuance of special prescription forms.
|
|
|
|
|
8.
|
Providing subject-quantitative accounting of special prescription forms.
|
|
|
|
|
9.
|
Availability of a safe or a metal cabinet for storing special prescription forms. At the end of the work, the room shall be sealed and (or) stamped. The keys to the room, the seal and (or) the stamp shall be are kept by an responsible person.
|
|
|
|
|
10.
|
Ensuring the storage and destruction of unused special prescriptions handed in by relatives of deceased patients. Destruction of prescriptions shall be carried out as the prescriptions are accumulated, but at least once a month, by burning in the presence of a permanent commission, which includes a representative of the internal affairs body. The fact of destruction of unused special prescriptions shall be drawn up by the corresponding act.
|
|
|
|
|
11.
|
Availability of a list of medicines containing narcotic drugs, psychotropic substances of Table II of the List, determined by the order of the head of a healthcare organization, not exceeding a five-day supply, which is used with the permission of a responsible doctor on duty for rendering emergency medical care in a healthcare organization providing inpatient care in the evening and at night.
|
|
|
|
|
12.
|
Ensuring the collection and disposal of empty ampoules from medicines containing narcotic drugs, psychotropic substances of Table II of the List, the contents of which have not been used or partially used, as well as tablets and plasters ( transdermal therapeutic systems).
|
|
|
|
|
13.
|
Availability of an order for a medical worker responsible for registration of a temporary death certificate, ensuring that the relatives of a deceased cancer patient are notified about the delivery of unused special prescription forms and medicines containing narcotic and psychotropic substances of Table II of the List, as well as the reception of special prescription forms and unused medicines, containing narcotic and psychotropic substances of Table II of the List after patients who died at home. Availability of acceptance and transfer acts of medicines containing narcotic drugs, psychotropic substances and their precursors, remaining after the death of the patient.
|
|
|
|
|
14.
|
Availability of a permanent commission, which includes representatives of internal affairs bodies and territorial subdivision of the state body in the sphere of sanitary and epidemiological welfare of the population for destruction of medicines containing narcotic drugs, psychotropic substances of Table II of the List with an expired shelf life, handed over by the relatives of deceased patients, and also scraps, defects, empty ampoules, tablets and patches (transdermal therapeutic systems), as well as ampoules, tablets and patches ( transdermal therapeutic systems), the contents of which have been partially used.
|
|
|
|
|
15.
|
Availability of destruction acts of medicines containing narcotic drugs, psychotropic substances and their precursors of Tables II, III, IV of the List.
|
|
|
|
|
16.
|
Compliance with the rules and procedure for registration and storage of medical documentation, requirements for medicines containing narcotic drugs, psychotropic substances and precursors of Tables II, III, IV of the List.
|
|
|
|
|
17.
|
Compliance with the rules for writing prescriptions.
|
|
|
|
|
18.
|
Ensuring accounting and monitoring of prescriptions for free or preferential receipt of medicines.
|
|
|
|
|
19.
|
Ensuring that samples of signatures of the authorized persons, having the right to sign prescriptions are sent to the facilities of a pharmaceutical organization.
|
|
|
|
|
20.
|
Reflection of the content and number of prescriptions for free or preferential receipt of medicines in the patient's outpatient record.
|
|
|
|
|
21.
|
Ensuring the calculation of the need for medicines:
- in accordance with the medicinal form of the medical organization;
- on the basis of data on dynamics of morbidity and the epidemiological situation in the region, as well as statistical data on the forecasted number of patients;
- taking into account the registers of treated patients;
- taking into account the actual consumption of medicines for the previous year and the forecasted balance as of January 1 of the next financial year.
|
|
|
|
|
22.
|
Compliance with the conditions for the purchase of medicines and pharmaceutical services within the guaranteed volume of free medical assistance (hereinafter- GVFMA) and medical care in the system of compulsory social health insurance.
|
|
|
|
|
23.
|
Ensuring the distribution of medicines, depending on the forecasted number of patients and certain categories of citizens living on the territory of settlements, by types of diseases.
|
|
|
|
|
24.
|
Ensuring the redistribution of medicines purchased at the expense of local and republican budgets, within the framework of relevant programs between medical organizations.
|
|
|
|
|
25.
|
Availability in medical organizations rendering outpatient-polyclinic assistance, on the objects in the sphere of circulation of medicines, carrying out pharmaceutical services within the GVFMA, as well as in periodicals distributed on the territory of the corresponding administrative-territorial unit of the following information placed for patients:
- a list and addresses of objects in the sphere of circulation of medicines, carrying out pharmaceutical services within the framework of GVFMA;
- addresses of organizations, rendering outpatient-polyclinic assistance through which outpatient medicines provision is carried out;
- address and telephone number of the customer for rendering pharmaceutical services.
|
|
|
|
|
26.
|
Compliance with the rational use (prescription) of medicines and formation of a medicinal formulary based on proven clinical efficacy and safety of medicines.
|
|
|
|
|
27.
|
Presence of a permanent commission, which at least once a quarter shall analyze medical prescriptions at the inpatient, inpatient-replacing and outpatient levels.
|
|
|
|
|
28.
|
Ensuring the registration of medicines within the guaranteed volume of free medical assistance in rendering inpatient, inpatient- replacing and outpatient care within the guaranteed volume of free medical assistance in total and quantitative terms in medical documentation or automated programs for accounting, use of medicines.
|
|
|
|
|
29.
|
Reflection of the used medicines in the medical record of the inpatient, in the list of medical prescriptions.
|
|
|
|
|
30.
|
Ensuring the marking of medicines received for rendering emergency, inpatient and inpatient-replacing care within the GVFMA, with a stamp of the medical organization indicating the name of the medical organization, its address and the mark “Free”.
|
|
|
|
|
31.
|
Ensuring separate storage and accounting of medicines purchased for rendering medical care within the GVFMA and paid services.
|
|
|
|
|
32.
|
Entering information about side effects, serious side effects and lack of effectiveness in the medical record of an inpatient and (or) outpatient patient, including maintaining statistics on identified cases of side effects in a medical organization.
|
|
|
|
|
Official ( s ) ________________________________________
_______________________________ ___________
position signature
__________________________________________________________________________
(surname, name, patronymic (if any)
Head of the subject of control _____________________________________
_______________________________ ____________________
position signature
_____________________________________________________________________________
surname, name, patronymic (if any)
| |
Appendix 19
to the joint order of the
Minister of Healthcare of
the Republic of Kazakhstan
dated November 15, 2018
No. ЌР DSM-32 and the
Minister of National Economy of
the Republic of Kazakhstan
dated November 15, 2018, No. 70 |
A checklist in the sphere of circulation of medicines and medical devices in relation to the subjects (objects)
of pharmaceutical activities carrying out production of medicines and medical devices
Footnote. Appendix 19 is in the wording of the joint order of the Minister of Healthcare of the Republic of Kazakhstan dated April 29, 2019 No. KR HCM-56 and the Minister of National Economy of the Republic of Kazakhstan dated April 30, 2019 No. 33 (shall be enforced upon expiry of ten calendar days after its first official publication).
State body that assigned the inspection _____________________________
________________________________________________________________________
Act on assignment of an inspection/preventive control with a visit to the subject (object)
of control ____________________________________________________________________
________________________________________________________________________
No., date
Name of the subject (object) of control
____________________________________________________________________________
(Individual identification number), business identification number of the subject (object) of control
______________________________________________________________________
_________________________________________________________________
Location address _______________________________________________________
_____________________________________________________________________________
№
|
List of requirements
|
Required
|
Not required
|
Meets the requirements
|
Doesn't meet the requirements
|
1.
|
Availability of:
- higher pharmaceutical or chemical-technological, chemical education and work experience in the specialty for at least three years for the heads of departments directly involved in the production of medicines and medical devices, or technical for the heads of departments directly involved in the production of medical devices;
- higher pharmaceutical or chemical, biological education for the employees, carrying out control of the quality of medicines and medical devices, or technical for the employees, carrying out control of the quality of medical devices;
- technical education for a specialist in the maintenance of equipment used in the technological process of manufacturing medicines and medical devices.
|
|
|
|
|
2.
|
Compliance with all processes for the production of medicines and medical devices.
|
|
|
|
|
3.
|
Availability of state registration in the Republic of Kazakhstan of medicines used in production, with the exception of those produced under the conditions of Good Manufacturing Practice.
|
|
|
|
|
4.
|
Availability of shipping documents for medicines and medical devices.
|
|
|
|
|
5.
|
Implementation of activity for the production of medicines or the wholesale sale of medicines by the suppliers of substances or intermediates.
|
|
|
|
|
6.
|
Compliance of substances, excipients, consumables and packaging materials with the registration dossier
|
|
|
|
|
7.
|
Implementation of incoming control of raw materials (substances, auxiliary material), materials, semi-finished products, components; intermediate control in the production process, control of finished pharmaceutical products.
|
|
|
|
|
8.
|
Availability of a quality assurance system, documentation and control of its effectiveness in production.
|
|
|
|
|
9.
|
Ensuring registration of all technological and auxiliary operations in the production process of a separate series of medicines and medical devices.
|
|
|
|
|
10.
|
Compliance with the requirements for maintaining documentation of all production processes and materials used in production, the procedure for its storage.
|
|
|
|
|
11.
|
Compliance with stability tests, establishment of shelf life and re-control of medicines.
|
|
|
|
|
12.
|
Ensuring the number of samples sufficient for testing in cases of need (arbitration tests).
|
|
|
|
|
13.
|
Availability of markings indicating the status of manufactured products, original products, packaging materials.
|
|
|
|
|
14.
|
Carrying out quality control of materials, intermediate products, finished products.
|
|
|
|
|
15.
|
Maintaining a database on side effects of medicines and medical devices.
|
|
|
|
|
Official ( s ) ________________________________________
_______________________________ ___________
position signature
___________________________________________________________________________
(surname, name, patronymic (if any)
Head of the subject of control _____________________________________
_______________________________ ____________________
position signature
_____________________________________________________________________
surname, name, patronymic (if any)
| |
Appendix 20
to the joint order of the
Minister of Healthcare of
the Republic of Kazakhstan
dated November 15, 2018
No. ЌР DSM-32 and the
Minister of National Economy of
the Republic of Kazakhstan
dated November 15, 2018, No. 70 |
A checklist
in the sphere of circulation of medicines and medical devices in relation to the subjects (objects)
of pharmaceutical activities carrying out the manufacture of medicines and medical devices
Footnote. Appendix 20 is in the wording of the joint order of the Minister of Healthcare of the Republic of Kazakhstan dated April 29, 2019 No. KR HCM-56 and the Minister of National Economy of the Republic of Kazakhstan dated April 30, 2019 No. 33 (shall be enforced upon expiry of ten calendar days after its first official publication).
State body that assigned the inspection _____________________________
________________________________________________________________________
Act on assignment of an inspection/preventive control with a visit to the subject (object)
of control ____________________________________________________________________
________________________________________________________________________
No., date
Name of the subject (object) of control
____________________________________________________________________________
(Individual identification number), business identification number of the subject (object) of control
______________________________________________________________________
_________________________________________________________________
Location address _______________________________________________________
_____________________________________________________________________________
№
|
List of requirements
|
Required
|
Not required
|
Meets the requirements
|
Doesn't meet the requirements
|
1.
|
Availability of:
- higher pharmaceutical education and work experience of at least three years in the specialty for the head of a pharmacy, carrying out the manufacture of medicines and its production departments, as well as employees, carrying out control of the quality of medicines and medical devices;
- higher or secondary pharmaceutical education for the employees directly carrying out the manufacture of medicines and delivery of manufactured medices;
- secondary pharmaceutical education and work experience of at least three years for the head of the pharmacy and its production departments in the absence of specialists with higher pharmaceutical education in the regional center and rural areas.
|
|
|
|
|
2.
|
Availability of a pharmacist-analyst's workplace equipped with a standard set of measuring instruments, test equipment, laboratory glassware, and auxiliary materials.
|
|
|
|
|
3.
|
Implementation of preventive (warning) measures, acceptance control of raw materials (drug substance, excipient), written, organoleptic, selective survey control, selective physical and chemical control, control during the delivery of manufactured medicines.
|
|
|
|
|
4.
|
Availability and maintenance of checklists during the manufacture of medicines according to prescriptions and requirements of medical organizations.
|
|
|
|
|
5.
|
Availability and maintenance of a registration journal of the results of organoleptic, physical and chemical control numbered, laced, sealed and signed by the head of the pharmacy.
|
|
|
|
|
6.
|
Availability of state registration in the Republic of Kazakhstan for medicinal substances used in the manufacture, with the exception of those produced under the conditions of Good Manufacturing Practice.
|
|
|
|
|
7.
|
Carrying out activities for the production of medicines or for the wholesale sale of medicines by the suppliers of substances.
|
|
|
|
|
8.
|
Keeping and monitoring the records of expiration dates of medicines, medical devices.
|
|
|
|
|
9.
|
Ensuring of manufacturing technology for a medicinal product, in accordance with the requirements of general articles of the State Pharmacopoeia of the Republic of Kazakhstan.
|
|
|
|
|
10.
|
Implementation of preventive (warning) measures:
1) compliance with the conditions for aseptic preparation of medicinal products;
2) ensuring the serviceability and accuracy of weighing and measuring instruments, conducting their annual verification;
3) ensuring proper conditions for the receipt, collection, storage of purified water, water for injection, the correct labeling of the container in the form of an indication on the tag of the receipt date, analysis number and signature of the person who performed the analysis;
4) compliance with the terms, storage conditions of reagents, standard and titrated solutions and their correct design (on the labels, in addition to the name, the concentration, molarity, date of receipt, expiration date, storage conditions, who manufactured it are indicated);
5) determination of deviations in the tested medicinal products using measuring instruments of the same type (with the same metrological characteristics) as in their manufacture in pharmacies;
6) proper treatment, filling, design of burette installation and shtanglasses.
|
|
|
|
|
11.
|
The design of shtanglasses (pharmaceutical packaging) as follows:
1) name, country and manufacturing plant, serial number of the manufacturing plant, number and validity period of the conclusion on safety and product quality, expiration date of the medicinal substance, the date of filling, signature of the persons filled shtanglas and checking the authenticity of the medicinal substance are indicated on the shtanglasses in storage facilities;
2) date of filling of shtanglas, signatures of the persons filled shtanglas and checking the authenticity of medicinal substance and auxiliary substances are indicated on the shtanglas with medicinal substances and excipients, which are contained in the assistant room;
3) on shtanglas with narcotic drugs, psychotropic substances, precursors, toxic substances additionally the highest single and daily doses are indicated;
4) on shtanglasses with medicinal substances containing cardiac glycosides, the number of units of action in one gram of medicinal plant raw materials or in one milliliter of solution is indicated;
5) on shtanglasses with medicinal substances intended for the manufacture of medicines, requiring aseptic manufacturing conditions, the inscription: "For sterile medicines" is indicated;
6) on shtanglasses with medicinal substances containing moisture, the percentage of moisture on the cylinders with liquids (hydrogen peroxide solution, ammonia solution, formaldehyde) the actual content of the active substance is indicated;
7) shtanglasses with solutions, tinctures and liquid semi-finished products are provided with droplets or pipettes, indicating the number of drops, determined by weighing in a certain volume.
|
|
|
|
|
12.
|
Availability and maintenance of the Journal for registration of the results of control of medicinal substances for authenticity.
|
|
|
|
|
13.
|
Implementation of control over compliance with the manufacturing technology of medicinal products by the pharmacist-technologist.
|
|
|
|
|
14.
|
Carrying out acceptance control of raw materials (medicinal substance, excipient) used for the manufacture of medicinal products (consignment note, quality certificate of the manufacturing plant), compliance of series on the samples of medicinal substances and excipients with the series, specified in the accompanying documentation, compliance with storage conditions, transportation, as well as identification of medicinal substances and auxiliary materials according to the indicators "Packaging", "Marking" and "Description".
|
|
|
|
|
15.
|
Conducting written control of medicinal products manufactured in a pharmacy by filling out a control sheet immediately after the manufacture of a medicinal product.
The checklist indicates:
1) date of manufacture;
2) number of the prescription or requirement of the medical organization indicating the name of the department;
3) names of the medicinal substances taken, their quantity, total volume or weight, number of doses;
4) signatures of the manufacturer, who packaged and checked the medicinal product.
In the checklist, names of narcotic drugs, poisonous, psychotropic substances, precursors shall be underlined with a red pencil, the letter "D" is put on medicines for children.
The checklist is filled out in Latin in accordance with the sequence of manufacturing technology.
All calculations shall be recorded on the back of the checklist.
|
|
|
|
|
16.
|
Conducting of a selective survey control of medicines manufactured in a pharmacy.
|
|
|
|
|
17.
|
Conducting of organoleptic control in terms of appearance, color, odor, uniformity, absence of visible mechanical impurities in solutions.
|
|
|
|
|
18.
|
Conducting random physical control by checking the total weight or volume of a medicine, number and weight of individual doses included in this medicine (but not less than three doses), and the quality of the closure.
The following ones are subjected to selective physical control:
1) each series of packaging of industrial products and intra-pharmacy blanks in the amount of three to five packages, including packaging of homeopathic medicinal products for compliance with the deviation rate permissible in the manufacture of medicinal products (including homeopathic ones) in the pharmacy and the deviation rate permissible for packaging industrial products;
2) at least three percent of medicinal products manufactured according to prescriptions (requirements) in one working day;
3) number of homeopathic granules in a certain sample weight;
4) each series of medicinal products requiring sterilization, after filling before sterilization, in an amount of at least five vials (bottles) for mechanical inclusions (mobile insoluble substances, except for gas bubbles, accidentally present in solutions).
|
|
|
|
|
19.
|
Conducting primary and secondary control for mechanical inclusions in the process of making solutions.
|
|
|
|
|
20.
|
Conducting chemical control by indicators:
1) authenticity, purity tests and impurity limits (qualitative analysis);
2) quantitative determination (quantitative analysis) of medicinal substances included in its composition.
|
|
|
|
|
21.
|
Providing a complete chemical analysis of purified water.
|
|
|
|
|
22.
|
Carrying out control during delivery by checking all manufactured medicinal products, including homeopathic ones, for compliance:
1) of packaging of medicinal products with the physical and chemical properties of medicinal substances included in them;
2) of doses indicated in the prescription, including the highest single doses, the highest daily doses of medicines with the age of the patient;
3) the number on the prescription with the number on the label;
4) the patient's surname on the receipt with the surname on the label and on the prescription;
5) registration of medicinal products.
|
|
|
|
|
23.
|
Ensuring the registration of results of control of individual stages for the manufacture of solutions for injections and infusions in the registration journal of results of control of individual stages for the manufacture of solutions for injections and infusions.
|
|
|
|
|
24.
|
Availability of a nomenclature of concentrates, semi-finished products and intra-pharmacy preparation of medicines, manufactured in a pharmacy, annually approved by an accredited testing laboratory, with which an agreement on control and analytical services has been concluded.
|
|
|
|
|
Official ( s ) ________________________________________
_______________________________ ___________
position signature
_____________________________________________________________________________
(surname, name, patronymic (if any)
Head of the subject of control _____________________________________
_______________________________ ____________________
position signature
_____________________________________________________________________________
surname, name, patronymic (if any)
| |
Appendix 21
to the joint order of the
Minister of Healthcare of
the Republic of Kazakhstan
dated November 15, 2018
No. ЌР DSM-32 and the
Minister of National Economy of
the Republic of Kazakhstan
dated November 15, 2018, No. 70 |
A checklist in the sphere of circulation of medicines and medical devices in relation to the subjects (objects)
of pharmaceutical activities carrying out the wholesale of medicines and medical devices
Footnote. Appendix 21 is in the wording of the joint order of the Minister of Healthcare of the Republic of Kazakhstan dated April 29, 2019 No. KR HCM-56 and the Minister of National Economy of the Republic of Kazakhstan dated April 30, 2019 No. 33 (shall be enforced upon expiry of ten calendar days after its first official publication).
State body that assigned the inspection _____________________________
________________________________________________________________________
Act on assignment of an inspection/preventive control with a visit to the subject (object)
of control ____________________________________________________________________
________________________________________________________________________
No., date
Name of the subject (object) of control
____________________________________________________________________________
(Individual identification number), business identification number of the subject (object) of control
______________________________________________________________________
_________________________________________________________________
Location address _______________________________________________________
_____________________________________________________________________________
№
|
List of requirements
|
Required
|
Not required
|
Meets the requirements
|
Doesn't meet the requirements
|
1.
|
Availability of:
- higher pharmaceutical education and work experience of at least three years for the head of a pharmacy warehouse and an employee carrying out sale of medicines and medical devices;
- higher or secondary pharmaceutical education for the heads of departments of the pharmacy warehouse and employees who receive, store and distribute medicines and medical devices.
|
|
|
|
|
2.
|
Availability and functioning of a documentation system for tracking the receipt and shipment of medicines and medical devices.
|
|
|
|
|
3.
|
Ensuring the provision of a copy of conclusion on the safety and quality of products at the request of the subject.
Conclusions on the safety and quality of medicines and medical devices shall be stored for the period of validity plus one year and shall be available to the consumers and (or) state regulatory authorities.
|
|
|
|
|
4.
|
Carrying out the procurement of medicines and medical devices from entities, having a license for pharmaceutical activities and an annex to a license for subspecies of activities: production of medicines, wholesale of medicines, or having notified about the start of activities for the wholesale of medical products.
|
|
|
|
|
5.
|
Carrying out the sale of medicines and medical devices to the entities, having a license for pharmaceutical or medical activities or having notified about the start of activities for the sale of medical devices.
|
|
|
|
|
6.
|
The sale of medicinal substances shall be carried out to pharmacies licensed for pharmaceutical activities with the right to manufacture, as well as to organizations for the production of medicinal products, which have a license for pharmaceutical activities with the right to manufacture medicinal products.
|
|
|
|
|
7.
|
Carrying out the wholesale of medical devices related to measuring instruments, if there is a certificate of type approval of measuring instruments, or a certificate of metrological certification of medical measuring equipment.
|
|
|
|
|
8.
|
Provision with vehicles and equipment used for transportation and compliance with their purposes of use to protect products from unwanted effects that lead to loss of quality or damage the integrity of the package, and to ensure that:
1) the possibility of their identification and safety assessment has not been lost;
2) were not contaminated with other medicines (dosages), substances and did not contaminate themselves;
3) were protected and not exposed to environmental factors.
The vehicle and its equipment shall be kept clean and treated with detergents and disinfectants as needed.
|
|
|
|
|
9.
|
Compliance with storage conditions during transportation necessary to ensure the quality, safety and efficacy of medicines, as well as to prevent the risk of counterfeit medicines entering the supply chain.
|
|
|
|
|
10.
|
Availability of temperature control devices in vehicles in the event of supply of medicines requiring special transportation conditions. Instrument readings shall be recorded throughout the entire transportation and documented.
|
|
|
|
|
11.
|
Ensuring the protection of medicines and medical devices from environmental factors (precipitation, dust, sunlight, mechanical damage). Medicines and medical devices prepared for transportation shall be packed in group containers (cardboard boxes or stacks) with subsequent packing in transport packaging (containers, boxes, wrapping paper) that meet the requirements of the regulatory document.
|
|
|
|
|
12.
|
Ensuring registration of shipping documents containing the following information for each name, batch (series) of products:
- name;
- dosage (for the medicine);
- packing;
- quantity, unit price;
- amount;
- series;
- expiration date;
- number and validity period of the conclusion on safety and quality (for a medicine or a medical device).
Corrections, additions, blots in shipping documents shall not be allowed.
|
|
|
|
|
13.
|
Compliance with the maximum price for the trade name of a medicine during wholesale.
|
|
|
|
|
Official ( s ) ________________________________________
_______________________________ ___________
position signature
_________________________________________________________________
(surname, name, patronymic (if any)
Head of the subject of control _____________________________________
_______________________________ ____________________
position signature
__________________________________________________________________
(surname, name, patronymic (if any)
| |
Appendix 22
to the joint order of the
Minister of Healthcare of
the Republic of Kazakhstan
dated November 15, 2018
No. ЌР DSM-32 and the
Minister of National Economy of
the Republic of Kazakhstan
dated November 15, 2018, No. 70 |
A checklist in the sphere of circulation of medicines and medical devices in relation to the subjects (objects)
of pharmaceutical activities carrying out the retail sale of medicines and medical devices
Footnote. Appendix 22 is in the wording of the joint order of the Minister of Healthcare of the Republic of Kazakhstan dated April 29, 2019 No. KR HCM-56 and the Minister of National Economy of the Republic of Kazakhstan dated April 30, 2019 No. 33 (shall be enforced upon expiry of ten calendar days after its first official publication).
State body that assigned the inspection _____________________________
________________________________________________________________________
Act on assignment of an inspection/preventive control with a visit to the subject (object) of control
____________________________________________________________________
________________________________________________________________________
No., date
Name of the subject (object) of control
____________________________________________________________________________
(Individual identification number), business identification number of the subject (object) of control
______________________________________________________________________
_________________________________________________________________
Location address _______________________________________________________
_____________________________________________________________________________
№
|
List of requirements
|
Required
|
Not required
|
Meets the requirements
|
Doesn't meet the requirements
|
1.
|
Availability of:
- higher pharmaceutical education or secondary pharmaceutical education (work experience in the specialty for at least three years) for the head of a pharmacy or its departments;
- higher or secondary pharmaceutical education for the specialists who sell medicines and medical devices;
- higher pharmaceutical education or secondary pharmaceutical education (work experience in the specialty for at least three years) for the head of a pharmacy in healthcare organizations, rendering primary health care, consultative and diagnostic assistance, as well as workers, carrying out sale of medicines and medical devices.
|
|
|
|
|
2.
|
Ensuring the sale of medical devices related to measuring instruments, if there is a certificate of approval of the type of measuring instruments or a certificate of metrological certification of medical measuring equipment.
|
|
|
|
|
3.
|
Ensuring the sale of prescribed medicines drugs by a doctor’s prescription.
|
|
|
|
|
4.
|
Ensuring the placement of medicines sold without a doctor's prescription on display cases.
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5.
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Registration of invalid prescriptions in the Register of incorrectly written out prescriptions for their redemption with the stamp "Prescription is invalid".
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6.
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Ensuring the storage of prescriptions:
- for free medicines - 3 years;
- for medicines containing:
- derivatives of 8-hydroxyquinoline, hormonal steroids, anabolic steroids - 3 months;
- poisonous substances, clonidine, codeine, tropicamide, tramadol, cyclopentolate, pregabalin, zopiclone, diphenhydramine, promethazine - 3 years.
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7.
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Ensuring the submission of accurate information regarding:
- correct and rational administration or use;
- possible side effects and contraindications;
- interactions with other medicines, precautions for their administration or use;
- shelf life and storage rules at home;
- operating rules, completeness of medical devices.
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8.
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Ensuring the conduct of preventive measures:
1) quality control during acceptance and sale;
2) compliance with the rules and terms of storage of medicines, keeping records of medicines with a limited shelf life;
3) serviceability and accuracy of weighing instruments;
4) checking the correctness of the prescribed prescription, its validity period, the compliance of the prescribed doses with the patient's age, the compatibility of ingredients, the norms of one-time delivery;
5) keeping records of the validity periods of conclusions on the safety and quality assessment.
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9.
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Ensuring the acceptance of medicines and medical devices with verification of:
1) compliance of the quantity, completeness, integrity of the container, compliance of the packaging, labeling with regulatory documents, the availability of instructions for the medical use of a medicine and a medical device in the state and Russian languages; availability of an operational document for a medical device;
2) compliance with the name, dosage, packing, quantity, batch (series) of products specified in the accompanying documents;
3) availability of a conclusion on safety and quality in the accompanying documents or a reference to it in the consignment note for the release of goods.
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10.
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Availability of information about the list of medicines and specialized medical products for free provision of certain categories of citizens with certain diseases at the outpatient level in an easy-to-read place.
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11.
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Availability of lists and samples of signatures of persons entitled to sign prescriptions for free receipt of medicines, approved by the head of the relevant healthcare organization, in retail sales facilities that have relevant agreements with local state healthcare authorities.
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12.
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Providing placement in a place convenient for familiarization of:
- a copy for a license for pharmaceutical activities and annex to it or a document (including a printed copy of an electronic document) informing about the beginning or termination of activities or certain actions;
- books of reviews and proposals;
- information on the telephone numbers of the pharmaceutical inquiry service.
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13.
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Ensuring placement in a visible place for visitors of the following information:
- "Medicines are not subjects to return and exchange";
- "Medicines are not delivered to children";
- "Over-the-counter sale of medicines intended for delivery by the doctor’s prescription shall be prohibited";
- "Shelf life of medicinal products manufactured in a pharmacy."
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14.
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Compliance with the maximum price for the trade name of a medicinal product during retail sales.
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Official ( s ) ________________________________________
_______________________________ ___________
position signature
_____________________________________________________________________________
(surname, name, patronymic (if any)
Head of the subject of control _____________________________________
_______________________________ ____________________
position signature
_____________________________________________________________________________
surname, name, patronymic (if any)
