Unofficial translation
Footnote. The title is in the wording of the joint order of the Minister of Healthcare of the Republic of Kazakhstan dated 29.04.2019 № ҚР ДСМ-56 and the Minister of National Economy of the Republic of Kazakhstan dated 30.04.2019 № 33 (shall be enforced upon expiry of ten calendar days after its first official publication).In accordance with paragraphs 5 and 6 of Article 141, paragraph 1 of Article 143 of the Entrepreneurial Code of the Republic of Kazakhstan 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 30.11.2022 № ҚР ДСМ-147 and the Minister of National Economy of the Republic of Kazakhstan dated 01.12.2022 № 115 (shall be enforced from 01.01.2023).1. To approve:
1) risk assessment criteria in the sphere of medical services (aid) according to Annex 1 to this joint order;
2) checklist in the sphere of state control of medical services quality with regard to subjects (objects) providing inpatient and hospital replacing care according to Annex 2 to this joint order;
3) checklist in the sphere of state control of medical services quality with regard to subjects (objects) providing outpatient and polyclinic care (primary medical and sanitary care and consultative and diagnostic care) according to Annex 3 to this joint order;
4) checklist in the sphere of state control of medical services quality with regard to obstetric subjects (objects) and (or) inpatient organizations with maternity wards and neonatal pathoanatomical departments according to Annex 4 to this joint order;
5) checklist in the sphere of state control of medical services quality with regard to subjects (objects) providing cardiologic, cardiac surgical care according to Annex 5 to this joint order;
6) checklist in the sphere of state control of medical services quality with regard to subjects (objects) providing hemodialysis care according to Annex 6 to this joint order;
7) checklist in the sphere of state control of medical services quality with regard to subjects (objects), providing dental care according to Annex 7 to this joint order;
8) checklist in the sphere of state control of medical services quality with regard to subjects (objects), providing phthisiatric care according to Annex 8 to this joint order;
9) checklist in the sphere of state control of medical services quality with regard to subjects (objects), providing oncology care according to Annex 9 to this joint order;
10) checklist in the sphere of state control of medical services quality with regard to subjects (objects), providing medical and social assistance in the field of mental health care according to Annex 10 to this joint order;
11) checklist in the sphere of state control of medical services quality with regard to subjects (objects), providing laboratory services according to Annex 11 to this joint order;
12) checklist in the sphere of state control of medical services quality with regard to subjects (objects), providing emergency medical assistance, medical assistance in the form of medical aviation according to Annex 12 to this joint order;
13) checklist in the sphere of state control of medical services quality with regard to subjects (objects), carrying out the activities in the field of HIV prevention according to Annex 13 to this joint order;
14) checklist in the sphere of state control of medical services quality with regard to subjects (objects), carrying out activities in the field of blood service according to Annex 14 to this joint order;
15) risk assessment criteria in the sphere of circulation of medicines, medical devices and medical equipment according to Annex 15 to this joint order;
16) checklist in the sphere of circulation of medicines and medical devices for compliance with qualification requirements with regard to subjects (objects) of control according to Annex 16 to this joint order;
17) checklist in the sphere of circulation of medicines, medical devices and medical equipment with regard to medical organizations on drug provision issues according to Annex 17 to this joint order;
18) checklist in the sphere of circulation of medicines, medical devices and medical equipment with regard to subjects (objects) of pharmaceutical activities engaged in the production of medicines, medical devices and medical equipment according to Annex 18 to this joint order;
19) checklist in the sphere of circulation of medicines, medical devices and medical equipment with regard to subjects (objects) of pharmaceutical activities, manufacturing pharmaceuticals and medical devices according to Annex 19 to this joint order;
20) checklist in the sphere of circulation of medicines, medical devices and medical equipment with regard to subjects (objects) of pharmaceutical activities, engaged in the wholesale sale of medicines, medical devices and medical equipment according to Annex 20 to this joint order;
21) checklist in the sphere of circulation of medicines, medical devices and medical equipment with regard to subjects (objects) of pharmaceutical activities, engaged in retail sales of medicines, medical devices and medical equipment according to Annex 21 to this joint order;
22) checklist in the sphere of state control of medical services quality with regard to subjects (objects), providing pathoanatomical diagnostics according to Annex 22 to this joint order;
23) checklist in the sphere of state control of medical services quality with regard to subjects (objects), regardless the activity according to Annex 23 to this joint order;
24) checklist in the sphere of state control of medical services quality with regard to subjects (objects), providing care in the field of nuclear medicine according to Annex 24 to this joint order;
25) checklist in the sphere of circulation of medicines and medical devices in with regard to the state expert organization in the sphere of circulation of medicines and medical devices according to Annex 25 to this joint order.
Footnote. Paragraph 1 – as amended by the joint order of the Acting Minister of Healthcare of the Republic of Kazakhstan dated 30.11.2022 № ҚР ДСМ-147 and the Minister of National Economy of the Republic of Kazakhstan dated 01.12.2022 № 115 (shall be enforced from 01.01.2023); with amendments made by the joint orders of the Acting Minister of Healthcare of the Republic of Kazakhstan dated 24.05.2023 № 87 and the Minister of National Economy of the Republic of Kazakhstan dated 24.05.2023 № 77 (shall be enforced upon expiry of ten calendar days after its first official publication); Minister of Healthcare of the Republic of Kazakhstan dated 29.05.2023 № 90 and the Minister of National Economy of the Republic of Kazakhstan dated 29.05.2023 № 91 (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 № 1064 and the Minister of National Economy of the Republic of Kazakhstan dated December 29, 2015 № 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.
| Minister of Healthcare | |
| of the Republic of Kazakhstan | E. Birtanov |
| Minister of National Economy | |
| of the Republic of Kazakhstan | T. Suleymenov |
"AGREED"
Committee on legal statistics
and special accounts
of General Prosecutor's office
of the Republic of Kazakhstan
| Appendix 1 to the joint order of the Minister of Healthcare of the Republic of Kazakhstan dated November 15, 2018 № KR HCM-32 and the Minister of National Economy of the Republic of Kazakhstan dated November 15, 2018 № 70 |
Risk assessment criteria in the sphere of provision of medical services (assistance)
Footnote. Annex 1 – as amended by the joint order of the Minister of Healthcare РК от 29.05.2023 № 90 and the Minister of National Economy РК от 29.05.2023 № 91 (shall be enforced upon expiry of ten calendar days after its first official publication).
Chapter 1. General provisions
1. These Risk assessment criteria in the sphere of provision of medical services (assistance) (hereinafter referred to as the Criteria) have been developed in accordance with paragraphs 5 and 6 of Article 141 and paragraph 1 of Article 143 of the Entrepreneur Code of the Republic of Kazakhstan, the order of the Acting Minister of National Economy of the Republic of Kazakhstan dated June 22, 2022 № 48 "On approval of the Rules of formation by the regulating state bodies of the risk assessment and management system and on amendments to the order of the Acting Minister of National Economy of the Republic of Kazakhstan dated July 31, 2018 № 3 "On approval of the Rules for the formation of a risk assessment system by state bodies and the form of checklists"" (registered in the Register of State Registration of Regulatory Legal Acts under № 28577) and the order of the Acting Minister of National Economy of the Republic of Kazakhstan dated July 31, 2018 № 3 "On approval of the form of a checklist " (registered in the Register of State Registration of Regulatory Legal Acts under № 17371).
2. The following concepts are used in these Criteria:
1) score – quantitative measure of risk assessment;
2) minor violations – violations of the requirements of the legislation of the Republic of Kazakhstan non-compliance with which has entailed and (or) may entail formally committed, but not causing any appreciable harm to the population;
3) significant violations – violations, including non-compliance with the requirements of legislation in the sphere of healthcare, not related to gross and minor violations;
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) risk assessment and management system - a process of making managerial decisions aimed at reducing the probability of occurrence of unfavorable factors by categorizing subjects (objects) of control into risk levels for subsequent preventive control with visits to the subject (object) of control and (or) inspection for the compliance with qualification requirements (hereinafter referred to as the inspection for compliance with requirements) in order to minimize the possible degree of restriction of the freedom of entrepreneurship to the minimum extent possible, while ensuring an acceptable level of risk, as well as those aimed at changing the level of risk for a particular subject (object) of control and (or) exempting such subject (object) of control from preventive control with visits to the subject (object) of control and (or) inspection for compliance with requirements;
7) 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;
8) 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. Risk assessment criteria for conducting an inspection for compliance with requirements or authorization requirements for issued permits, requirements for notifications sent in accordance with the Law of the Republic of Kazakhstan "On Permissions and Notifications" and preventive control with a visit to the subject (object) of control are formed by determining objective and subjective criteria.
Chapter 2. Objective criteria for assessing the degree of risk for compliance inspections and preventive control of subjects (objects) of control
4. Determination of objective criteria shall be carried out by determining the risk of state control, which shall be carried out taking into account one of the following criteria:
1) the level of danger (complexity) of the subject (object) depending on the activity performed;
2) the scale of severity of possible negative consequences of harm in the process of medical activity;
3) the possibility of adverse effects on human health, legitimate interests of individuals, legal entities and the state.
5. Based on the analysis of all possible risks, control subjects (objects) shall be categorized into three degrees of risk (high, medium and low).
The subjects (objects) of high risk control include organizations providing inpatient care (district hospital, number district hospital, multidisciplinary interdistrict hospital, city hospital, multidisciplinary city hospital, multidisciplinary city children's hospital, multidisciplinary regional hospital, multidisciplinary regional children's hospital), subjects (objects) of obstetrics, organizations of emergency medical care and medical aviation, organizations carrying out activities in the field of blood service, dental polyclinic (center, office), phthisiopulmonological organizations, oncological center or dispensary, nuclear medicine centers, disaster medicine organizations, health care organizations carrying out activities in the field of HIV prevention.
Subjects (objects) of control of medium risk degree include subjects (objects) providing primary medical and sanitary care (medical station, paramedical and midwifery station, doctor's outpatient clinic, primary medical and sanitary care center, number district polyclinic, district polyclinic, city polyclinic), subjects (objects) providing specialized medical care in outpatient conditions, healthcare organizations performing pathological and anatomical diagnostics, health care organizations performing laboratory diagnostics, inpatient organizations providing medical assistance in the field of mental health, traditional medicine facilities.
The subjects (objects) of control of low-risk degree include subjects (objects) of control providing restorative treatment and medical rehabilitation and subjects (objects) of control providing palliative care and nursing care.
6. With regard to subjects (objects) of control classified as high and medium risk, compliance inspections, preventive control with a visit to the subject (object) of control, preventive control without a visit to the subject (object) of control and unscheduled inspections shall be carried out.
7. With regard to subjects (objects) of control classified as low risk, compliance checks, preventive control without a visit to the subject (object) of control and unscheduled inspections shall be carried out.
Chapter 3.
Subjective criteria for assessing the degree of risk for compliance inspections
and preventive control of the subjects (objects) of control
8. Determination of subjective criteria shall be carried out using the following steps:
1) formation of a database and collection of information;
2) analyzing information and risk assessment.
9. Formation of the database and collection of information are necessary to identify subjects (objects) of control violating the legislation of the Republic of Kazakhstan.
The processes of collection and processing of information are fully automated and allow for the possibility of checking the correctness of the data obtained.
10. The following sources of information shall be used to determine subjective criteria for assessing the degree of risks for preventive control with a visit to the subject (object) of control:
1) results of previous inspections and preventive control with visits to control subjects (objects) (the severity of violations shall be established in case of non-compliance with the requirements set forth in the checklists);
2) results of monitoring of reports and information provided by the subject of control;
3) availability and number of confirmed complaints, appeals from individuals and legal entities for the period under evaluation;
4) results of analysis of information provided by state bodies and organizations;
5) the results of preventive control without visiting the subject (object) of control (final documents issued following the results of preventive control without visiting the subject (object) of control).
11. The following sources of information shall be used to determine the subjective criteria for assessing the degree of risk for conducting an inspection for compliance with the qualification requirements:
1) availability and number of confirmed complaints and appeals against subjects (objects) of control received from individuals or legal entities, state bodies;
2) results of previous inspections with regard to subjects (objects) of control;
3) results of certification, advanced training of employees of subjects of control for the last 5 years;
4) results of accreditation of subjects of control in case of urgency of issued authorizations.
12. Based on the available sources of information, the regulatory state bodies shall form subjective criteria to be evaluated.
The analysis and assessment of subjective criteria enable concentrating the compliance inspection and preventive control of the control subject (object) in respect of the control subject (object) with the highest potential risk.
At the same time, data of subjective criteria, previously recorded and used in relation to a particular subject (object) of control or data for which the statute of limitation period has expired are not used in the analysis and evaluation process in accordance with the Civil Code of the Republic of Kazakhstan.
With regard to the subjects of control who have eliminated in full the violations issued on the basis of the results of the previous preventive control with visits and (or) compliance inspection, it shall not be allowed to include them in the formation of schedules and lists for the next period of state control.
Priority of applied information sources and significance of indicators of subjective criteria shall be established in the criteria for risk assessment according to the list of subjective criteria for determining the degree of risk according to subjective criteria in the form according to Annexes 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16 and 17 to these Criteria.
Indicators of subjective criteria shall be determined for each homogeneous group of the subjects (objects) of control. Specific weight by importance of indicators of subjective criteria shall be determined depending on the importance of the indicator in risk assessment for each homogeneous group of subjects (objects) of control. Permissible values of indicators of subjective criteria are regulated by normative legal acts of the Republic of Kazakhstan.
13. Degrees of violations of requirements in the sphere of provision of medical services (assistance) are subdivided into gross, significant and minor ones.
The requirements for compliance inspections and preventive control of the subjects (objects) of control with a visit to the subject of control categorized by the degree of significance of violations and sources of information are given in Annexes 1 and 2 to these Criteria. on-compliance with the requirement determines the corresponding degree of violations.
14. The subjects (objects) of control shall be exempt from compliance inspections and preventive control of the subjects (objects) of control for the next calendar year, if the subject (object) of control has undergone an external comprehensive assessment (accreditation) for compliance of its activities with accreditation standards and has been provided with a certificate of accreditation for the inspected period.
15. Compliance inspection and preventive control with a visit to the subject (object) shall be carried out depending on the purpose and types of activities of the objects, in accordance with checklists in the sphere of provision of medical services to population according to Annexes 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 22, 23 and 24 to this joint order.
16. The basis for assigning a compliance review is a schedule approved by the regulatory state agency.
17. The basis for assigning preventive control with a visit to the subject (object) of control shall be a semi-annual list of subjects (objects) of control, approved by the first head of the regulating state body.
18. The subjects (objects) of control are transferred with the application of the information system from high risk to medium risk or from medium risk to low risk in the relevant areas of activities of the subjects of control in cases:
1) if the laws of the Republic of Kazakhstan and the criteria for assessing the degree of risk of the regulatory state bodies define cases of exemption from preventive control with a visit to the subject (object) of control or conducting inspections.
19. When the control body draws up a schedule of compliance inspections and semi-annual lists of preventive control with a visit to the subject (object) of control in respect of the same subjects (objects) of control, uniform terms of the period of their conduct shall be established.
20. For the subjects (objects) of control classified as high risk, the frequency of compliance checks shall be determined by the criteria for assessing the degree of risk, but not more often than once a year.
For control subjects (objects) classified as medium risk, the frequency of compliance audits shall be determined by the risk assessment criteria, but not more often than once every two years.
For control subjects (objects) classified as low risk, the frequency of compliance audits shall be determined by the risk assessment criteria, but not more often than once every three years.
Chapter 4. Procedure for calculating the degree of risk according to subjective criteria
21. The following procedure for calculation the indicator of risk degree shall apply to classify the subject of control to the risk degree in accordance with paragraph 3 of these Criteria.
22. Calculation of the risk level indicator by subjective criteria (R) shall be carried out in an automated mode by summing up the risk level indicator of violations based on the results of previous inspections and preventive control with visits to the subjects (objects) of control (SP) and the risk level indicator by subjective criteria, with subsequent normalization of data values into a range from 0 to 100 points.
Rinterim= SP + SC, where
Rinterim– an intermediate indicator of the degree of risk according to subjective criteria,
SР – indicator of the degree of risk according to violations,
SC – indicator of the degree of risk according to subjective criteria.
The calculation shall be made for each subject (object) of control of a homogeneous group of subjects (objects) of control of each sphere of state control. In this case, the list of assessed subjects (objects) of control attributable to a homogeneous group of subjects (objects) of control of one sphere of state control forms a selective population (sample) for the subsequent normalization of data.
23. Based on the data obtained from the results of previous inspections and preventive control with visits to the subjects (objects) of control, an indicator of the risk level of violations shall be formed, assessed in points from 0 to 100.
If one gross violation is detected according to any of the sources of information specified in paragraphs 10 and 11 of these Criteria, the subject of control shall be assigned a risk level indicator of 100 points and shall be subject to a compliance check and (or) preventive control with a visit to the subject (object) of control.
If no gross violations are detected, the risk level indicator for violations shall be calculated by summing up the indicator for significant and minor violations.
When determining the indicator of significant violations, a coefficient of 0.7 shall be applied.
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 required number of significant violations;
SР2 – the number of identified significant violations;
When determining the indicator of minor violations, a coefficient of 0.3 shall be applied.
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 required number of minor violations;
SР2 – the number of identified minor violations;
The violation risk score (SR) shall be calculated on a scale from 0 to 100 points and shall be determined by summing up the indicators of significant and minor violations according to the following formula:
SР = SРs + SРm, where:
SР – indicator of risk degree by violations;
SРs – an indicator of significant violations;
SРm – an indicator of minor violations.
The resulting value of the indicator of risk degree by violations is included in the calculation of the indicator of risk degree by subjective criteria.
24. Calculation of the risk level indicator by subjective criteria shall be calculated on a scale from 0 to 100 points and shall be carried out according to the following formula:
xi – an indicator of subjective criterion,
wi – specific weight of the indicator of subjective criterion xi,
n – number of indicators.
The resulting value of the risk level indicator by subjective criteria is included in the calculation of the risk level indicator by subjective criteria.
25. The values calculated by subjects (objects) for indicator R shall be normalized into the range from 0 to 100 points. Data normalization shall be carried out for each sampling population (sample) using the following formula:
R – indicator of risk degree (final) according to subjective criteria of an individual subject (object) of control.
Rmax – maximum possible value on the scale of risk degree by subjective criteria for subjects (objects) included in one sampling population (sample) (upper limit of the scale)),
Rmin – the minimum possible value on the scale of risk degree by subjective criteria for subjects (objects) included in one sampling population (sample) (the lower limit of the scale),
Rinterim – an intermediate indicator of risk degree by subjective criteria, calculated in accordance with paragraph 22 of these Criteria.
| Annex 1 to the Risk assessment criteria in the sphere of provision of medical service (assistance) |
Degrees of violations of the requirements for compliance inspection of the subjects (objects) of control
Item № | Name of requirements | Degree of violations |
1 | Availability of a specialist certificate for admission to clinical practice | gross |
2 | Availability of a license and (or) an annex to the license | gross |
3 | Compliance of the premises or building on the right of ownership or lease agreement, or contract of gratuitous use of immovable property (loan), or trust management of property, or public-private partnership agreement with the standards of organization of medical care of specialized services for the provided subspecialties of medical activity, as well as the corresponding sanitary rules establishing sanitary and epidemiological requirements for the objects of health cate | gross |
4 | Availability of functioning medical and (or) special equipment, apparatus and instruments, devices, furniture, inventory, transport and other means (if necessary), approved in the standards of organization of medical care of profile services for the provided subspecialties of medical activity and minimum standards of equipment of health care organizations with medical products | gross |
5 | Availability of specialists for the provided types of activities | gross |
6 | Availability of specialization or improvement and other types of advanced training for the last 5 (five) years on the provided subtypes of medical activity (except for the graduates of internship, residency, secondary educational institution who have completed their training not later than 5 (five) years at the time of inspection). | gross |
| Annex 2 to the Risk assessment criteria in the sphere of provision of medical service (assistance) |
Degrees of violations of requirements for preventive control of the subjects (objects) of control
Item № | Name of requirements | Degree of violations |
For obstetric facilities and (or) inpatient organizations with maternity wards and neonatal pathoanatomical departments | ||
1 | Availability of an opinion on the compliance of the subject of health care to the provision of high-tech medical care when the organization provides high-tech services, including in vitro fertilization | gross |
2 | Availability of supporting documentation on the provision of medical care included in the guaranteed volume of free medical care and (or) the system of compulsory social health insurance on a free basis | gross |
3 | Availability of a written voluntary consent of the patient or his/her legal representative for invasive interventions and therapeutic and diagnostic measures | significant |
4 |
Availability of supporting documentation (emergency medical team call card form № 085/y, register of admissions and refusals to hospitalization, medical card of an inpatient form № 001/y), that the stay of an ambulance or emergency medical services team in the emergency room of a hospital does not exceed 10 minutes (time for transferring the patient to the doctor of the emergency room) from the moment of its arrival at the hospital, except when emergency medical care is needed in emergency situations. | gross |
5 |
Presence of a medical report issued by the doctor of the emergency room with a written justification of refusal in the absence of indications for hospitalization in a health care organization. | significant |
6 |
Availability of supporting records in medical documentation on indications for hospitalization: | significant |
7 | Availability of records in the medical documentation on the examination of severe patients by the head of the department on the day of hospitalization, and daily thereafter. Patients in a moderately severe condition are examined at least once a week. Availability of the results of the patient's examination recorded in the medical card with recommendations on further tactics of patient management with mandatory identification of the medical worker making the records | significant |
8 | Availability of records in medical documentation confirming daily examination of inpatients by the attending physician, except for weekends and holidays. Availability of appropriate records in the medical card in case of examination and prescription of additional diagnostic and treatment manipulations by the doctor on duty | significant |
9 | Availability of justification in the medical card for dynamic assessment of the patient's condition according to clinical protocols of diagnosis and treatment in case of identification of the fact of additional and repeated tests conducted before hospitalization in primary health care organizations or other health care organizations, for medical reasons | significant |
10 |
Availability of supporting documentation that the following requirements have been met when issuing a maternity leave and certificate of temporary incapacity for pregnancy and childbirth: | significant |
11 |
Availability of medical documentation on compliance with the following requirements for the examination of temporary incapacity for work, issuance of certificates and certificates of temporary incapacity for work (Form № 001/y "Medical card of an inpatient", form 052/y "Medical card of an outpatient", stubs of certificates of temporary incapacity for work of patients, form № 025/y "Register for Recording Conclusions of Medical Consultative Board", form № 029/y "Book of registration of certificates of temporary incapacity for work", form № 037/y "Certificate №__________ on temporary incapacity of a student, college student, vocational school, illness, quarantine and other reasons for the absence of a child attending school, pre-school organization (underline)", form № 038/y "Certificate №______ on temporary incapacity" etc.): | significant |
12 | Availability of informed written consent of the patient for transfusion of blood components | significant |
13 |
Availability of records in medical documentation on compliance with the requirements for transfusion of blood components. | Gross |
14 |
Availability of documentation on compliance with the following when performing post-mortem examination: | gross |
15 |
Availability of supporting documentation on compliance with the following requirements in the organization of obstetric and gynecological care at the outpatient and polyclinic level: | gross |
16 | The use of germ cells, tissues of reproductive organs by a recipient who is (are) married (matrimonial) shall be carried out with the written consent of both spouses. | minor |
17 | Availability of supporting documentation of the birth of ten (10) children from a single donor 6 which is the basis for discontinuing the use of that donor for recipients. | significant |
18 |
Availability of supporting documentation on donation of germ cells, tissues of reproductive organs from the donor under the following conditions: | significant |
19 | Oocyte donation shall be carried out in the presence of a written informed consent of the donor for superovulation induction or in a natural cycle in compliance with the requirements for donors of germ cells, tissues of reproductive organs and donors of oocytes undergo medical and genetic examinations | significant |
20 |
Availability of supporting documentation for in vitro fertilization (hereinafter referred to as the IVF) with the use of donor oocytes is carried out according to the indications: | gross |
21 | Availability of supporting documentation on work with donors by an obstetrician-gynecologist (reproductologist), medical examination of the donor before each procedure of donor material collection, controls the timeliness and results of laboratory tests in accordance with the calendar plan of examination. | significant |
22 |
Availability of supporting documentation on oocyte donation according to the following algorithm: | significant |
23 |
Availability of supporting documentation on compliance with the requirements for denial of IVF using donor oocytes for the following contraindications: | gross |
24 |
Availability of supporting documentation on the use of donor sperm in assisted reproductive methods and technologies (hereinafter referred to as ARMT)). Sexual abstinence for 3-5 days is required before semen donation. Semen is obtained by masturbation. The ejaculate is collected in a special sterile, pre-labeled container. This procedure is carried out in a special room with a separate entrance, appropriate interior, sanitary unit with a washbasin. In the absence of donor sperm in the medical organization, or at the patient's request, donor sperm from other organizations that have a donor sperm bank is used. | significant |
25 |
IVF with the use of donor sperm is performed in the following indications | gross |
26 | The individual donor card is filled out and coded by a doctor. The coding scheme is free. The donor's application and his/her individual card shall be kept in a safe as documents for official use. | significant |
27 |
Availability of supporting documentation of work with donors by a doctor-uroandrologist and a doctor-embryologist. The doctor organizes medical examinations of the donor, controls the timeliness and results of laboratory tests in accordance with the calendar plan of examination. | significant |
28 |
Availability of supporting documentation of compliance, that the embryo donors are IVF patients who have unused cryopreserved embryos left in the bank. By free decision and written informed consent of the patients, these embryos are disposed of or donated to a medical organization. Embryos transferred to the medical organization are used for donation free of charge to infertile married couple, women (recipients) who are not married (matrimonial). | gross |
29 | Availability of supporting documentation on compliance with assisted reproductive techniques and technologies | gross |
30 |
Availability of supporting documentation of the following functions in the provision of pre-hospital care to women during and outside pregnancy by paramedics (obstetricians, paramedics, nurses/nurses): | gross |
31 |
Availability of supporting documentation on compliance with the following requirements when organizing obstetric and gynecological care at the inpatient level: | gross |
Providing medical care to newborns | ||
32 |
Availability of supporting documentation on compliance with the following requirements when organizing medical care for newborns at the inpatient level: | gross |
33 |
Availability of supporting documentation on compliance with the requirements for the provision of medical care to newborns in third-level medical organizations: | gross |
34 | Availability of supporting documentation on compliance with requirements to provide a healthy newborn with basic care that includes prevention of hypothermia with "heat chain" compliance, skin-to-skin or skin-to-skin contact with the mother, early initiation of breastfeeding within the first hour (if the infant shows signs of readiness), and prevention of hospital-acquired infections | significant |
35 | Availability of supporting documentation on compliance with requirements to perform healthy newborn anthropometry, full examination and other measures 2 hours after delivery | significant |
36 | Availability of supporting documentation on compliance with the requirements of emergency medical care in case of detection of disorders of the newborn's condition, transfer to the intensive care ward or neonatal intensive care unit, if indicated | gross |
37 |
Availability of supporting documentation on compliance with requirements for observation of the mother and healthy newborn in the delivery room by an obstetrician within two hours of birth: | significant |
38 | Availability of supporting documentation on compliance with transfer 2 hours after birth of a healthy newborn with the mother to a mother-and-child care unit | significant |
39 | Availability of supporting documentation on round-the-clock observation by medical staff and continuous involvement of the mother in the care of the child, except in cases of moderate and severe maternal conditions in the postpartum ward in the mother-and-child wards | significant |
40 | Availability of supporting documentation on compliance with the requirements for dynamic monitoring of the newborn with timely detection of violations of the newborn's condition, conducting the necessary examination, examination by the head of the department, organization of a concilium to clarify the tactics of management. Provision of emergency medical care when indicated, timely transfer to the intensive care ward or neonatal intensive care unit | gross |
41 |
Compliance with the requirements for medical workers in the wards of joint stay of mother and child: | significant |
42 | Availability of records in medical documentation on daily examination of newborns by a neonatologist, consultations with mothers on care, prevention of hypothermia and vaccinations | significant |
43 | Availability of supporting documentation on compliance with the requirements for the organization of consultations by specialized professionals, with treatment and diagnostic measures and recommendations to the mother on examination, treatment and rehabilitation in the presence of three or more micro anomalies of development or detection of congenital pathology of newborns | gross |
44 | Availability of supporting documentation on compliance with the requirements of medical care in case of emergency conditions in the newborn (asphyxia, respiratory distress syndrome etc.) stabilization of its condition and determination of the degree of readiness for transportation with the mother to the second or third level obstetrics organization | gross |
45 | Availability of supporting documentation on vaccination of newborns on the basis of voluntary informed consent of parents (mother, father or legal representatives) for prophylactic vaccinations within the timeframe of prophylactic vaccinations in the Republic of Kazakhstan. | gross |
46 | Availability of supporting documentation on compliance with requirements for all newborns to undergo neonatal screening for phenylketonuria, congenital hypothyroidism and audiologic screening prior to discharge | gross |
47 | Availability of supporting documentation on compliance with the requirements for neonatologist's assessment of the severity of the condition, stabilization of the condition, assessment of the degree of readiness for transportation in case of emergencies in the newborn, and organization of its transfer with the mother (in coordination with the obstetrician-gynecologist) to the second or third level medical organization | gross |
48 | Availability of supporting documentation on compliance with the requirements in case of suspicion and (or) detection of acute surgical pathology in a newborn baby, in case of emergency consultation of a doctor specializing in “Pediatric surgery (neonatal surgery)”. After stabilization of vital signs, the newborn shall be transferred to a surgical department of another medical organization (children's or multidisciplinary hospital) or to a neonatal (or children's) surgical department, if there shall be one in the structure of the obstetric medical organization, to provide him/her with appropriate specialized medical care | gross |
49 | Availability of supporting documentation on compliance with the requirements for transfer to a pediatric inpatient facility for premature newborns after 28 days of age or premature newborns after post-conceptional age of 42 weeks who require further 24-hour medical care | significant |
50 | Availability of mandatory post-mortem examination of the fetus and placenta in cases of medically indicated termination of pregnancy for suspected congenital anomalies in the fetus | gross |
51 | Availability of documentation on clinical and pathoanatomical review of all maternal and infant deaths after completion of all pathological investigations | gross |
52 | Availability of an agreement for provision of paid medical services in health care organizations. Availability of documents establishing the fact of co-payment | gross |
53 | Availability of medical documentation on consultation with a pediatric cardiologist (cardiac surgeon) when a congenital malformation of the cardiovascular system is detected in obstetrics organizations, and if medically indicated, transfer of the newborn to a specialized hospital | gross |
54 | Availability of medical documentation on the use of opportunities for consultation with specialized national organizations, through telemedicine network in case of difficulty in verifying the diagnosis of the child, determining the tactics of management. If it is necessary to transfer the child to specialized republican organizations. | significant |
55 |
Availability of documentation (internal orders, regulations, protocols, questionnaires, analytical briefs) of the clinical audit by Patient Support Services and internal expertise and its evaluation according to the following criteria: | significant |
Requirements for subjects (objects) providing inpatient, inpatient substitution care | ||
56 | Availability of supporting documentation on the provision of medical care included in the guaranteed volume of free medical care and (or) the system of compulsory social health insurance on a free basis | gross |
57 | Availability of an opinion on the compliance of the healthcare entity to provide high-tech medical care | gross |
58 | Availability of a written voluntary consent of the patient or his/her legal representative for invasive interventions and therapeutic and diagnostic measures | significant |
59 |
Availability of supporting documentation (form № 085/y “emergency medical team call card”, register of admissions and refusals to hospitalization, form № 001/y “medical card of an inpatient”), that the stay of the EMS team or EMS department when organizing primary health care in the emergency room of the hospital does not exceed 10 minutes (time for transferring the patient to the doctor of the emergency room) from the moment of its arrival in the hospital, except for the need for emergency medical care in emergency situations. | gross |
60 | Availability of supporting medical documentation (form №001/y “Medical Card of Inpatient”) on hospitalization of a severe patient who needs constant monitoring of vital functions for medical reasons, by decision of the concilium and notification of the heads of health care organizations with subsequent transfer to another medical organization on the profile of the disease for further examination and treatment after stabilization of the condition | significant |
61 |
Availability of supporting documentation on the medical opinion of the emergency room doctor with a written justification of the refusal in the absence of indications for hospitalization in a health care organization (Journal of admissions and refusals of hospitalization from medical information systems, certificate in form №027/y (refusals of hospitalization)). | significant |
62 |
Availability of records in medical documentation (Register of patient admission and refusals of hospitalization from the MIS, scheduled hospitalization coupons, “Medical card of an inpatient” (form №001/y) on indications for hospitalization: | significant |
63 | Availability of supporting medical documentation (Form № 001/y “Medical Card of Inpatient”) on the examination of heavy patients by the head of the department on the day of hospitalization, and daily thereafter. Patients in a moderately severe condition are examined at least once a week. The results of the examination of the patient are recorded in the medical card with recommendations on further tactics of patient management with the obligatory identification of the medical worker making the entries | significant |
64 | Availability of the established clinical diagnosis in conjunction with the head of the department no later than three calendar days from the day of hospitalization of the patient in the health care organization in the form № 001/y “Medical Card of Inpatient”. | significant |
65 |
Availability of supporting documentation (Form № 001/y “Medical Card of Inpatient”) on daily examination of patients in the hospital by the attending physician, except for weekends and holidays. In case of examination and appointment of additional diagnostic and therapeutic manipulations by the doctor on duty, appropriate entries are made in the medical card. If the patient's condition worsens, the doctor on duty shall notify the head of the department and (or) the attending physician, agree on changes in the process of diagnosis and treatment, and make an entry in the medical card (paper and (or) electronic) version. | significant |
66 |
Compliance with requirements for planned hospitalization: | significant |
67 | Availability of medical records of consultations or conciliums in case of difficulty in identifying the diagnosis, ineffectiveness of the current treatment, as well as other indications | gross |
68 |
Availability of medical documentation of compliance with discharge criteria, such as: | significant |
69 | Availability of a discharge epicrisis to the patient upon discharge, indicating the full clinical diagnosis, the scope of diagnostic tests, therapeutic measures and recommendations for further follow-up and treatment. The data on discharge shall be entered into the information systems on a day-to-day basis, indicating the actual time of discharge. | minor |
70 |
Availability of documentation on compliance with the requirements for transfusion of blood components and in case of complications (orders on the establishment of the commission, algorithm of interaction of staff, “Medical card of an inpatient” form № 001/y): | gross |
71 |
Availability of supporting medical documentation on the indications for hospitalization in day hospital at outpatient and polyclinic health care organizations and in hospital at home: | significant |
72 |
Availability of medical documentation on the examination of persons for clinical indications of HIV infection upon detection of the following diseases, syndromes and symptoms: | gross |
73 | Availability of an agreement for provision of paid medical services in health care organizations. Availability of documents establishing the fact of co-payment | gross |
74 |
Availability of medical documentation on compliance with the following requirements for the examination of temporary incapacity for work, issuance of a sheet and certificate of temporary incapacity for work (Form № 001/y “Medical Card of Inpatient”, form 052/y “Medical Card of Outpatient”, stubs of sheets on temporary incapacity of patients, form № 025/y “Register for Recording Conclusions of Medical Consultative Board”, form № 029/y "Book of Registration of certificates of temporary incapacity for work”, form № 037/y “Certificate №__________ on temporary incapacity of a student, college or vocational school pupil, sickness, quarantine and other reasons for absence of a child attending school or pre-school organization (underline as necessary)", form № 038/y "Certificate №______ on temporary incapacity" and other): | significant |
75 |
Availability of documentation (internal orders, regulations, protocols, questionnaires, analytical reports) of the clinical audit conducted by the Patient Support Service and internal expertise and its evaluation according to the following criteria: | significant |
76 |
Availability of documentation on compliance with the following steps for post-mortem examinations: | gross |
77 | Availability of a written application of the spouse, close relatives or legal representatives of the deceased or a written will issued by the person during his/her lifetime to release the corpse without post-mortem examination, if there is no suspicion of death through violence | significant |
78 | Availability of a record by a medical worker in the medical documentation with subsequent collection of biological materials to determine the content of a psychoactive substance and recording the results in the medical card when signs of psychoactive substance use are detected during the application for medical assistance to a health care organization without issuing a medical examination conclusion to establish the fact of psychoactive substance use and state of intoxication. | minor |
79 | Availability of medical documentation on treatment and diagnostic measures, drug provision, organization of therapeutic nutrition and appropriate care of the patient from the moment of admission to the health care organization (Medical card of inpatient” form № 001/y) | significant |
80 | Availability of medical documentation on the use of opportunities for consultation with specialized national organizations, through telemedicine network in case of difficulty in verifying the diagnosis of the child, determining the tactics of management. If necessary, the child shall be transferred to specialized republican organizations. | significant |
81 | Availability of medical documentation on the provision of supportive care (support for adequate feeding, water balance, pain control, fever management, oxygen therapy) | significant |
82 | Availability of medical documentation of the use of less painful alternative treatments, if available, that are as effective, to avoid unnecessary painful procedures | significant |
83 | Availability of medical documentation on daily examination of the child by a doctor, examination by the head of the department (on admission on the first day, repeatedly at least once a week) | significant |
84 |
Availability of medical documentation on compliance with the requirements of anesthesiology and resuscitation care: | significant |
85 | Availability of medical documentation on compliance of treatment and diagnostic measures with the recommendations of clinical protocols | significant |
86 | Availability of medical documentation on provision of the first stage of medical rehabilitation for the main disease (form № 001/y “Medical card of inpatient”, “form № 047/y” rehabilitation card). | significant |
87 | Availability of medical documentation on the examination by the head of the department upon admission of neurosurgical patients and subsequently on the necessity of the disease (Medical card of inpatient form № 001/y) | significant |
Requirements for the subjects (objects) providing outpatient and polyclinic care (primary health care and consultative-diagnostic care) | ||
88 | Availability of supporting documentation on the provision of medical care included in the guaranteed volume of free medical care and (or) the system of compulsory social health insurance on a free basis | Gross |
89 | Presence of written voluntary consent of the patient or his/her legal representative for invasive interventions and therapeutic and diagnostic measures | significant |
90 | Availability of medical records of an outpatient on compliance of treatment and diagnostic measures with recommendations of clinical protocols | significant |
91 |
Availability of documentation on compliance with the following requirements when organizing and conducting a medical consultative board: | significant |
92 |
Availability of documentation on compliance by primary health care organizations in conducting preventive medical examinations of target population groups: | significant |
93 |
Availability of documentation on compliance with the levels of provision of medical rehabilitation to patients: | significant |
94 |
Availability of documentation on compliance of TB care at the outpatient and polyclinic level with the following requirements: | gross |
95 |
Availability of documentation on compliance with the requirements for oncologic care in the form of outpatient care: | significant |
96 7 | Availability of mandatory confidential medical screening for HIV infection of persons on clinical and epidemiological indications, including sexual partners of pregnant women, persons who applied voluntarily and anonymously | significant |
97 |
Availability of documentation on compliance with the requirements of the following activities by an obstetrician-gynecologist when a woman first applies for pregnancy and wishes to keep it: | significant |
98 |
Availability of documentation on compliance with the requirements of an obstetrician-gynecologist for the provision and organization of obstetric and gynecological care to women during pregnancy, after childbirth, provision of family planning and reproductive health services, as well as prevention, diagnosis and treatment of gynecological diseases of the reproductive system | gross |
99 | Availability of results and additional data of follow-up examinations and investigations in the Individual Card of a pregnant and postpartum woman and the Exchange Card of a pregnant and postpartum woman at each visit of a pregnant woman to an obstetrician-gynecologist | significant |
100 | Availability of home care by a midwife or foster nurse for pregnant women, who do not show up for an appointment within 3 days after the scheduled date | significant |
101 | Availability of the conclusion of the medical consultative board on possible pregnancy in women with contraindications to pregnancy due to extragenital pathology | significant |
102 | Availability of an agreement for provision of paid medical services in health care organizations. Availability of documents establishing the fact of co-payment | gross |
103 |
Availability of documentation on compliance by the paramedical staff of the medical unit of the educational organization with the following requirements: | significant |
104 |
Availability of medical documentation on compliance with the following requirements for the examination of temporary incapacity for work, issuance of a sheet and certificate of temporary incapacity for work (Form № 001/y “Medical Card of Inpatient”, form 052/y “Medical Card of Outpatient”, stubs of sheets on temporary incapacity of patients, form № 025/y “Register for Recording Conclusions of Medical Consultative Board”, form № 029/y "Book of Registration of certificates of temporary incapacity for work”, form № 037/y “Certificate №__________ on temporary incapacity of a student, college or vocational school pupil, sickness, quarantine and other reasons for absence of a child attending school or pre-school organization (underline as necessary)", form № 038/y "Certificate №______ on temporary incapacity" and other): | significant |
105 |
Compliance with the following requirements when issuing a sick leave certificate and certificate of temporary incapacity for work for maternity: | significant |
106 |
Availability of documentation (internal orders, regulations, protocols, questionnaires, analytical briefs) of the clinical audit by Patient Support Services and internal expertise and its evaluation according to the following criteria: | significant |
107 | Availability of documentation on compliance with the requirements to provide a guaranteed volume of free medical care | gross |
108 |
Availability of documentation on compliance with the requirements of surgical (abdominal, thoracic, coloproctological) care to patients at the outpatient and polyclinic level | gross |
109 | Availability of documentation on compliance with the requirements of primary health care organizations for dynamic monitoring of persons with chronic diseases, compliance with the frequency and timing of observation, the mandatory minimum and frequency of diagnostic tests | significant |
110 | Documentation of compliance with requirements for active home visits by primary health care staff | significant |
111 |
Availability of documentation on compliance with pediatric care requirements: | significant |
112 |
Availability of documentation on compliance with the requirements for traumatological and orthopedic care at the outpatient and polyclinic level | significant |
113 |
Availability of documentation on compliance with the requirements of neurological care at the outpatient and polyclinic level | significant |
114 |
Availability of documentation of compliance with nephrology care, which includes: | gross |
115 |
Availability of documentation on compliance with the requirements of neurosurgical care in outpatient settings | significant |
116 |
Availability of documentation on compliance with the requirements of neurological care at the outpatient and polyclinic level | significant |
117 | Reasoned registration of the notification on the expert opinion of medical and social assessment, form № 031/y (availability of data for a comprehensive assessment of the state of the organism and the degree of restriction of vital activity) | gross |
Requirements for subjects (objects) providing cardiologic, cardiac surgical care | ||
118 | Availability of supporting documentation on the provision of medical care included in the guaranteed volume of free medical care and (or) the system of compulsory social health insurance on a free basis | Gross |
119 | Availability of medical documentation on compliance of treatment and diagnostic measures with the recommendations of clinical protocols | Significant |
120 | Availability of a written voluntary consent of the patient or his/her legal representative for invasive interventions and therapeutic and diagnostic measures | significant |
121 |
Availability of supporting documentation (emergency medical team call card form № 085/y, register of admissions and refusals of hospitalization, Medical card of inpatient form № 001/y) that the stay of the CEMS or EMS team when organizing primary health care in the emergency room of the hospital does not exceed 10 minutes (time for transferring the patient to the doctor of the emergency room) from the moment of its arrival in the hospital, except for cases of emergency medical care in emergency situations. | Gross |
122 | Availability of documentation on ensuring hospitalization of a severe patient in need of constant monitoring of vital functions for medical reasons, by decision of the concilium and notification of the heads of health care organizations with subsequent transfer to another medical organization according to the profile of the disease for further examination and treatment after stabilization of the condition | significant |
123 |
A medical report with a written justification of refusal in the absence of indications for hospitalization in a health care organization is issued to the patient by the doctor of the reception department. | significant |
124 |
Availability of supporting documentation on indications for hospitalization: | significant |
125 | Availability of examination of severe patients by the head of the department on the day of hospitalization, and daily thereafter. Patients in a moderately severe condition are examined at least once a week. The results of the patient's examination are recorded in the medical card with recommendations on further tactics of patient management with obligatory identification of the medical worker making the entries | significant |
126 | Availability of supporting documentation on the establishment of the main diagnosis in emergency conditions within 24 (twenty-four) hours from the moment of the patient's admission to a 24-hour hospital on the basis of clinical and anamnestic examination data, results of instrumental and laboratory methods of research with entry in the medical card of an inpatient in form № 001/y, in stable patients - availability of the established clinical diagnosis in conjunction with the head of the department no later than three calendar days from the date of hospitalization | significant |
127 |
Availability of supporting documentation of planned hospitalization in the presence of indicators: | significant |
128 |
Availability of documentation on urgent (round-the-clock, including weekends and holidays) procedures, in particular: | significant |
129 | Availability of documentation on hospitalization to the catheterization laboratory, bypassing the admission department, intensive care unit (ward) if the patient is diagnosed with acute coronary syndrome with segment elevation, acute myocardial infarction | significant |
130 |
Availability of documentation on ensuring daily examination by the attending physician of patients in the hospital except for weekends and holidays. When examining and prescribing additional diagnostic and therapeutic manipulations by the doctor on duty, appropriate entries are made in the medical record. In case of deterioration of the patient's condition, the doctor on duty shall notify the head of the department and (or) the attending physician, agree on changes in the process of diagnosis and treatment, and make an entry in the medical card (paper and (or) electronic) option. | significant |
131 | Availability of documentation on the assessment of the complexity of surgical interventions for congenital heart disease using the Aristotle Basic Scale and the effectiveness of operations in the cardiac surgical unit | significant |
132 |
Availability of documentation on compliance of medical care provision to patients with acute coronary syndrome and (or) acute myocardial infarction by levels of regionalization: | significant |
133 |
Availability of supporting documentation of compliance for planned hospitalization: | significant |
134 | Availability of a conclusion of consultations or the concilium in case of difficulty in identifying the diagnosis, ineffectiveness of the current treatment, as well as in other indications | significant |
135 |
Availability of supporting documentation during hospitalization at the inpatient level: | significant |
136 | Ensuring that a discharge summary is issued to the patient upon discharge, indicating the full clinical diagnosis, the scope of diagnostic tests, therapeutic measures and recommendations for further follow-up and treatment. Discharge data shall be entered into the information systems on a day-to-day basis, indicating the actual time of discharge | significant |
137 |
Availability of documentation of adherence to discharge criteria, specifically: | significant |
138 | Availability of an agreement for provision of paid medical services in health care organizations. Availability of documents establishing the fact of co-payment | gross |
139 |
Documentation of compliance with blood component transfusion requirements and in case of complications: | gross |
140 |
Presence of examination of persons on clinical indications for HIV infection upon detection of the following diseases, syndromes and symptoms: | gross |
141 |
Availability of medical documentation on compliance with the following requirements for the examination of temporary incapacity for work, issuance of a sheet and certificate of temporary incapacity for work (form №001/y "Medical card of inpatient", form 052/y "Medical card of outpatient", stubs of patients' certificates of temporary incapacity for work, form № 025/y Register for Recording Conclusions of Medical Consultative Board, form № 029/y "Book of Registration of certificates of temporary incapacity for work”, form № 037/y “Certificate №__________ on temporary incapacity of a student, college or vocational school pupil, sickness, quarantine and other reasons for absence of a child attending school or pre-school organization (underline as necessary)", form № 038/y "Certificate №______ on temporary incapacity" and other): | significant |
142 |
Compliance with the following requirements in the organization and conduct of the medical consultative board: | significant |
143 |
Availability of supporting documentation on the indications for hospitalization in day hospital at outpatient and polyclinic health care organizations and in hospital at home: | significant |
144 | Availability of a recovery and rehabilitation department | significant |
145 | Availability of a cardiology room in the structure of organizations providing outpatient care to the population (district, city, region, republic) and organizations providing in-patient care | significant |
146 | If it is impossible to establish the diagnosis of CDV in a primary health care organization, referral of the patient for consultation in a clinical diagnostic center for the provision of diagnostic assistance, with a consultation, if necessary, with the involvement of specialized professionals, including consultants from medical organizations at the republican level. | significant |
147 | Availability of supporting documentation of consultative diagnostic assistance provided to a patient with CDV by a specialized professional referred by a PHC specialist or another specialized professional | significant |
148 | availability of an opinion on execution of documents for referral for medical and social assessment in the presence of high blood pressure (crisis course), arrhythmia of various genesis, increased frequency of angina attacks and increasing symptoms of heart failure, issuance and prolongation of a sheet or certificate of temporary incapacity for work, and in case of permanent disability (condition after myocardial infarction, aorto-coronary bypass surgery, congestive heart failure) | significant |
149 | Availability of supporting documentation on treatment and diagnostic measures, drug provision, organization of therapeutic nutrition and appropriate care of the patient from the moment of admission to the health care organization. | significant |
150 | Availability of supporting documentation on the use of opportunities for consultation with specialized republican organizations, via telemedicine network in case of difficulty in verifying the diagnosis of the child, determining the tactics of management. If necessary, the child shall be transferred to specialized republican organizations. | significant |
151 | Provision of supportive care (support adequate feeding, maintenance of water balance, pain control, fever management, oxygen therapy) | significant |
152 |
Availability of medical documentation on the provision of the following treatment and diagnostic measures within the framework of primary health care: | significant |
153 | Availability of supporting documentation on the use of less painful, equally effective alternative treatments when available, to avoid unnecessarily painful procedures | significant |
154 |
Availability of documentation on compliance with the requirements of anesthesiology and resuscitation care: | significant |
155 |
Compliance with the following actions when conducting post-mortem examination: | gross |
156 | Availability of a written application of the spouse, close relatives or legal representatives of the deceased or a written will issued by the person during his/her lifetime to release the corpse without post-mortem examination, if there is no suspicion of death through violence | significant |
157 |
Availability of documentation (internal orders, regulations, protocols, questionnaires, analytical briefs) of the clinical audit by Patient Support Services and internal expertise and its evaluation according to the following criteria: | significant |
158 | The patient has been examined by a doctor in the emergency room of an inpatient hospital with the completion of an inpatient card, if the patient or his/her legal representative has given written consent to the provision of medical care to the patient | significant |
159 | Provision by a cardiologist (cardiac surgeon) of a consultative-diagnostic report in the form № 075/y, indicating the results of the conducted examination and treatment, as well as the further treatment of the patient with medical diseases to the primary care physician who referred the patient for consultative services when providing consultative diagnostic assistance | significant |
160 | In the presence of abnormalities in blood pressure (crisis course), arrhythmias of various genesis, increased frequency of angina attacks and increasing symptoms of heart failure, the cardiologist of the Ministry of Health issues and extends a sheet or certificate of temporary disability, and in case of persistent disability (condition after myocardial infarction, aorto-coronary bypass surgery, congestive heart failure) gives an opinion on drawing up documents for referral for medical and social expert assessment (hereinafter referred to as the MSA) | significant |
161 | Availability of documentation on emergency hospitalization of a patient with circulatory diseases to the intensive care unit (ward), bypassing the emergency room in case of life-threatening diseases | significant |
162 | Availability of documentation on hospitalization of a patient diagnosed with acute coronary syndrome (hereinafter - ACS) with segment elevation, acute myocardial infarction (hereinafter - AMI) to the catheterization laboratory, bypassing the admission department, intensive care unit (ward). | significant |
163 |
Availability of documentation on the provision of cardiologic (cardiac surgery) care in inpatient settings, which includes: | significant |
164 | Availability of documentation on the immediate transfer of a patient undergoing treatment in the MO without the possibility of IV therapy when indications for urgent interventional or cardiac surgery are identified, by ambulance, including medical aviation to the MO with the possibility of IV therapy in a 24-hour mode. | significant |
165 |
Availability of supporting documentation on the performance of surgical interventions in cardiac surgery according to the principle of regionalization with regard to the level of complexity: | significant |
Requirements for subjects (objects), providing the hemodialysis care | ||
166 | Availability of written voluntary consent of the patient or his/her legal representative in case of invasive interventions and therapeutic and diagnostic activities | significant |
167 | Availability of a conclusion on the compliance of a healthcare entity to provide high-tech medical services | gross |
168 | Availability of supporting documentation on compliance of treatment and diagnostic measures with the recommendations of clinical protocols | significant |
169 |
Availability of supporting documentation of eligibility for selection and initiation of renal replacement therapy, specifically: | gross |
170 |
Availability of supporting documentation of compliance with the indication for emergency extrarenal blood purification in patients with acute renal failure: | gross |
171 | Availability of supporting documentation that the hemodialysis machine complies with quality certificates, with sufficient life and capacity as stipulated by the country of manufacture | gross |
172 |
Availability of supporting documentation on compliance with the algorithm of hemodialysis procedure: | gross |
173 | Availability of supporting documentation on the provision of drugs and supplies according to the dialysis protocol | significant |
174 | Availability of water treatment system and compliance with requirements for hemodialysis fluid preparation, quality of hemodialysis solutions and blood purification system | significant |
175 | Availability of an agreement for provision of paid medical services in health care organizations. Availability of documents establishing the fact of co-payment | gross |
176 |
Availability of documentation (internal orders, regulations, protocols, questionnaires, analytical briefs) of the clinical audit by Patient Support Services and internal expertise and its evaluation according to the following criteria: | significant |
177 | Availability of supporting documentation on the provision of medical care included in the guaranteed volume of free medical care and (or) the system of compulsory social health insurance on a free basis | Gross |
178 | Availability of supporting documentation on record keeping and accounting records | minor |
Requirements for subjects (objects), providing dental care | ||
179 | Availability of supporting documentation on the provision of medical care included in the guaranteed volume of free medical care and (or) the system of compulsory social health insurance on a free basis | Gross |
180 |
Availability of supporting documentation on compliance with the following requirements in the organization of dental care: | gross |
181 | Availability of a contract for provision of paid services in health care organizations. | gross |
182 | Availability of medical documentation confirming compliance with clinical and diagnostic tests by level of dental care provision | significant |
183 | Availability of form № 058/y “Medical card of a dental patient (including sanitation)” per each patient | minor |
184 | Availability of supporting documentation on compliance of treatment and diagnostic measures with the recommendations of clinical protocols. In the absence of clinical protocols, according to international standards and guidelines based on evidence-based medicine. | significant |
185 | Availability of supporting documentation on record-keeping by specialized professionals working in health care organizations providing dental care | significant |
186 | Availability of completed documentation with information on the provision of dental care (electronic medical records, accompanying materials on the patient's health status and diagnosis), including in the MIS for each tooth in the chart of examination of primary teeth and the chart of examination of permanent teeth | significant |
187 | Availability of documentation on determining the patient's allergy history before dental interventions requiring local (local) anesthesia and, if indicated, referral of the patient to primary health care organizations or medical organizations for laboratory testing to identify drug allergies | gross |
188 |
Availability of supporting documentation on the provision of dental care to children in outpatient settings in the form of consultative and diagnostic assistance by referral and self-referral, includes: | significant |
189 | Availability of an informed consent of parents or representatives in case of dental interventions for children associated with the risk of painful sensations, manipulations are carried out according to the indications with the use of anesthesia (local, sedation, general) | significant |
190 |
Availability of supporting documentation for the provision of dental care to adults in outpatient settings in the form of consultative and diagnostic care by self-referral and referral, which includes: | significant |
191 | Availability of supporting documentation on the provision of dental care in inpatient settings by oral and maxillofacial surgeons and includes prevention, diagnosis, treatment of diseases and conditions requiring the use of special medical methods and technologies, as well as medical rehabilitation | significant |
192 | Availability of supporting documentation on the conduct of a concilium or the use of remote medical services in the differential diagnosis of complex, unclear cases to verify the diagnosis | significant |
193 | Children aged from 0 to 17 years inclusive and pregnant women are subject to dynamic observation and dental examinations | significant |
194 | Availability of supporting documentation on the provision of preventive measures for pregnant women and adults, which include control over the hygienic condition of the oral cavity, instruction on brushing teeth, selection of means and items of oral hygiene, professional oral hygiene, sanitation of the oral cavity (with the use of modern materials and technologies), informational and explanatory work on risk factors for dental diseases, conducted along the route of the primary preventive examination of pregnant women and adults | significant |
195 |
Compliance with the following requirements in the organization and conduct of the medical consultative board: | significant |
196 |
Availability of medical documentation on compliance with the following requirements for the examination of temporary incapacity for work, issuance of a sheet and certificate of temporary incapacity for work (Form № 001/y “Medical Card of Inpatient”, form 052/y “Medical Card of Outpatient”, stubs of sheets on temporary incapacity of patients, form № 025/y “Register for Recording Conclusions of Medical Consultative Board”, form № 029/y "Book of Registration of certificates of temporary incapacity for work”, form № 037/y “Certificate №__________ on temporary incapacity of a student, college or vocational school pupil, sickness, quarantine and other reasons for absence of a child attending school or pre-school organization (underline as necessary)", form № 038/y "Certificate №______ on temporary incapacity" etc.): | significant |
197 | Availability of written voluntary consent of the patient or his/her legal representative in case of invasive interventions and therapeutic and diagnostic activities | significant |
198 |
Availability of supporting documentation on compliance with the requirements of anesthesiology and resuscitation care: | significant |
199 |
Availability of documentation (internal orders, regulations, protocols, questionnaires, analytical briefs) of the clinical audit by Patient Support Services and internal expertise and its evaluation according to the following criteria: | significant |
Requirements for persons/entities (facilities) rendering phthisiatric care | ||
Provision of anti-tuberculosis care at the outpatient and polyclinic level | ||
200 | Presence of supporting documentation on rendering medical care included in the guaranteed volume of free medical care and (or) the system of mandatory social health insurance on a free of charge basis | Gross violation |
201 |
There is supporting documentation that PHC practitioners have undertaken the following activities: | Gross violation |
202 | Existence of supporting documentation on patient screening for suspected tuberculosis in health facilities delivering primary health care under the scheme | Gross violation |
203 | Presence of supporting documentation on the detection of tuberculosis by fluorography among the target population: those at high risk of the disease and subject to mandatory annual fluorography screening | Major violation |
204 | Existence of supporting documentation on the arrangement of directly observed treatment rooms (hereinafter referred to as “DOT”) in primary health care facilities to provide outpatient treatment. The patient shall receive and takes medicine in the DOT room under the supervision of the responsible health care provider. Once every 10 days, patients on directly supervised treatment shall be examined by a primary care physician/phthisiologist of the outpatient clinic, more frequently if specified. Patients residing in rural areas shall be seen by a phthisiatrician once a month | Major violation |
205 |
Evaluation of the clinical condition of a patient receiving anti-tuberculosis treatment for the presence of adverse reactions and events shall be made daily by the attending physician or phthisiatrician, a health care provider of the directly observed treatment room. A health care provider who has revealed adverse reactions and events to a medicinal product shall fill in a report card and make an entry in the patient's medical records. | Gross violation |
206 | Presence of records of anti-tuberculosis medicines movement at the outpatient level in the ATP logbook | Major violation |
207 | Interviewing the patient (parents or guardians of children) prior to treatment about the need for a full course of chemotherapy, followed by signing an informed consent form | Major violation |
208 | Presence of supporting documentation on registration and dispensary monitoring of tuberculosis patients shall be performed in PHC facilities at the place of actual residence, work, study or military service, irrespective of residence registration | Major violation |
209 |
Presence of supporting documentation on compliance with the following requirements in the organisation and conduct of the medical advisory board: | Major violation |
210 |
Existence of supporting documentation on the appropriateness of the levels of medical rehabilitation rendered to patients: | Major violation |
Delivering tuberculosis care at the inpatient level | ||
211 | Existence of supporting documentation on rendering health care included in the guaranteed volume of free medical care and (or) the system of mandatory social health insurance on a free-of-charge basis | Gross violation |
212 |
Assignment of patients to wards based on laboratory data and drug sensitivity at the time of admission and during treatment. | Major violation |
213 |
Presence of daily examination by a physician-phthisiatrician of inpatients. | Major violation |
214 | Presence of supporting documentation on the organisation of a consilium in complex situations to verify the diagnosis and determine treatment tactics with the participation of specialists at regional and national levels in person or remotely through telemedicine | Gross violation |
215 | Availability of records of anti-tuberculosis medicines movement at the inpatient level in the ATM logbook | Major violation |
216 |
Existence of supporting documentation that the criteria for discharging a tuberculosis patient from hospital have been met: | Major violation |
217 | Presence of written voluntary consent of the patient or his/her legal representative in case of invasive interventions and therapeutic and diagnostic measures | Major violation |
218 | Severe patients shall be examined by the head of the ward on the day of admission and daily thereafter. Patients in a moderately severe condition shall be examined at least once a week. The findings of the patient's examination are recorded in the medical record with recommendations on further tactics of patient management with the obligatory identification of the medical worker making the entries | Major violation |
219 | Having an identified clinical diagnosis jointly with the head of department no later than three calendar days from the day of the hospitalisation of the patient by a health care facility | Major violation |
220 | Consultations or consiliums in case of difficulty in identifying the diagnosis, inefficiency of the current treatment, as well as other indications | Gross violation |
221 | A discharge summary is issued to the patient upon discharge, specifying the full clinical diagnosis, the scope of diagnostic tests, therapeutic measures and recommendations for further follow-up and treatment. Discharge data are entered into the information systems on a day-to-day basis, indicating the actual time of discharge. | Minor violation |
222 |
Existence of supporting documentation of compliance with anaesthetic and resuscitation care: | Major violation |
223 |
Evidence of compliance with transfusion requirements for blood components and in case of complications: | Gross violation |
224 |
Examination of persons on clinical indications for HIV infection when the following diseases, syndromes and symptoms are detected: | Gross violation |
225 |
Presence of medical documentation on observance of the following requirements for the examination of temporary incapacity for work, issuance of temporary incapacity for work and certificates of temporary incapacity for work (Form № 001/y “Medical Record of Inpatient Patient”, Form 052/y “Medical Record of Outpatient Patient”, stubs of temporary incapacity for work sheets of patients, form № 025/y “Log for Recording of Reports of Medical Advisory Board”, form № 029/y “Book of Registration of Sheets on Temporary Disability”, form № 037/y “Certificate №__________ on Temporary Disability of a Student, College Student, Vocational School Student, on Illness, Quarantine and Other Reasons for the Absence of a Child Attending School, Pre-School Institution (underline as appropriate)”, form № 038/y “Certificate №______ on Temporary Disability” and others): | Major violation |
226 |
Existence of documentation (internal orders, regulations, protocols, questionnaires, analytical briefs) of the clinical audit by Patient Support Services and internal expertise and its evaluation based on the following criteria: | Major violation |
227 |
Presence of documentation of adherence to the following when performing pathologic autopsies: | Gross violation |
228 | A written application from the spouse, close relatives or lawful guardians of the deceased or a written will given by the person during his or her lifetime to release the corpse without a pathological anatomical autopsy, if there is no suspicion of violent death | Major violation |
229 | Presence of an agreement for rendering paid medical services by health care providers. Availability of documents establishing the fact of co-payment | Gross violation |
230 |
Existence of supporting documentation on conformity of levels of medical rehabilitation delivery to patients: | Major violation |
231 | A medical worker's entry in the medical record with the subsequent collection of biological materials to determine the content of a psychoactive substance and recording the results in the medical record when signs of psychoactive substance use are detected during a request for medical assistance in a health care facility without issuing a medical examination report to establish the fact of psychoactive substance use and state of intoxication. | Minor violation |
232 | Availability of supporting documentation on consistency of treatment and diagnostic measures with the recommendations of clinical protocols. | Major violation |
Requirements for entities (facilities) rendering oncological care | ||
233 | Existence of supporting documentation on the delivery of medical care included in the guaranteed volume of free medical care and (or) the system of compulsory social health insurance on a free-of-charge basis | Gross violation |
234 |
Existence of a multidisciplinary team to ensure an individualised approach to the delivery of medical care to patients with malignant neoplasms. | Gross violation |
235 |
Presence of supporting documentation of review at the MDG sessions: | Gross violation |
236 |
Presence of supporting documentation on the organisation by PHC experts of: | Major violation |
237 |
Existence of supporting documentation on the provision of CDC, which includes: | Major violation |
238 |
There is supporting documentation that the GP has referred the patient to an oncologist or cancer care co-ordinator if a tumour disease is diagnosed or suspected. | Major violation |
239 |
Presence of supporting documentation on observance of requirements when rendering oncological care in the form of outpatient and polyclinic care: | Major violation |
240 |
Presence of supporting documentation on immunohistochemical studies and molecular genetic studies to evaluate molecular and biological features of tumours in order to individualise treatment of patients, as well as to confirm (verify) the diagnosis of MN. IHC studies are performed at the level of pathomorphological laboratories of oncological care providers at the secondary level and reference centres at the tertiary level and are performed following clinical protocols. | Major violation |
241 | Presence of confirming documentation of international teleconsultations of tumour biosamples via the telepathology system to clarify the diagnosis in complex clinical cases. The timeframe for teleconsultations does not exceed thirty working days. | Gross violation |
242 |
There is confirmatory documentation that the entire period of examination of patients with suspected MN in outpatient clinics with cancer precautionary markers within the following examination timeframes is reflected in the MIS: | Gross violation |
243 | Presence of supporting documentation that a patient with MN receives specialised treatment no later than thirty calendar days after the diagnosis is established and the patient is placed under dynamic monitoring. | |
244 |
There are supporting documents on dynamic follow-up of clinical groups of patients with suspected MN and confirmed diagnosis of MN: | Major violation |
245 |
Patients with MN are subject to lifelong follow-up in an institution rendering medical care in outpatient conditions at the place of registration - primary level (III clinical group) and institutions rendering oncological care at the secondary level (II clinical group) at the place of residence and registration. | Major violation |
246 | Upon establishing a diagnosis of MN for the first time, a form № 034/y “Notification” is filled out for each patient, which is sent within three working days to the institution rendering oncological care at the secondary level at the place of the patient's permanent residence for registration in the Electronic Register of Oncological Patients and Registration, specifying the circumstances of the diagnosis (patient's self-referral to a primary health care facility, CDC - primary level, patient's self-referral to an institution offering oncological care at secondary and tertiary levels, diagnosis established during screening examination, diagnosis established during preventive examination) | Major violation |
247 |
Each patient with a first-time diagnosis of stage IV MN and visually accessible localisations of stage III disease should have a protocol completed in case a patient is diagnosed with an advanced form of malignant neoplasm (clinical group V). | Gross violation |
248 | Presence of mandatory confidential medical screening for HIV infection of persons based on clinical and epidemiological grounds, including sexual partners of pregnant women, persons who applied voluntarily and anonymously. | Major violation |
249 |
Presence of supporting documentation on observance of indicators for hospitalisation in a day hospital at outpatient and polyclinic health care facilities and inpatient care at home: | Major violation |
250 |
Presence of medical documentation on observance of the following requirements during the examination of temporary incapacity for work, issuance of a sheet and a certificate of temporary incapacity for work (form № 001/y “Medical Records of an Inpatient Patient”, form № 052/y “Medical Records of an Outpatient Patient”, stubs of certificates of temporary incapacity for work of patients, form № 025/y “Log for Recording Opinions of Medical Advisory Board”, form № 029/y “Book of Registration of Certificates of Temporary Incapacity for Work”, form № 037/y “Certificate №__________ on Temporary Disability of a Student, Pupil of a College, Vocational School, Sickness, Quarantine and Other Reasons for Absence of a Child Attending School, Preschool Institution (underline as appropriate)”, form № 038/y “Certificate №______ on Temporary Disability” and others. | Major violation |
251 |
Presence of documentation (internal orders, regulations, protocols, questionnaires, analyses) of the clinical audit by the Patient Support Service and internal expertise and its evaluation against the following criteria: | Major violation |
Delivery of oncological care at the inpatient level | ||
252 | Presence of confirming documentation regarding rendering medical care included in the guaranteed volume of free medical care and (or) the system of mandatory social health insurance on a free-of-charge basis | Gross violation |
253 |
Presence of confirming documentation on dilution of antitumour drugs in the rooms of centralised dilution of cytostatic drugs (hereinafter - RCDC) to ensure safety of medical personnel from toxic effects of antitumour drugs and rational use of drugs. | Major violation |
254 |
Presence of supporting documentation that radiation therapy is performed based on the principle of “single physician - radiation therapist (radiation oncologist)”, providing for clinical management of the patient, pre-radiation preparation and radiation treatment by a single physician - radiation therapist (radiation oncologist). | Major violation |
255 |
Presence of supporting documentation that anti-tumour therapy, radiation and radionuclide therapy, palliative care in cases that do not require constant medical supervision are delivered to patients with MN under inpatient substitution conditions in institutions rendering oncological care at secondary and tertiary levels in chemotherapy, radiation therapy, palliative care, medical rehabilitation wards. | Major violation |
256 | Hospitalisation of a severe patient in need of constant monitoring of vital functions for medical reasons, by decision of a consilium and notification of the heads of health care facilities, followed by transfer to another healthcare facility based on the profile of the disease for further examination and treatment after stabilisation of the condition | Major violation |
257 | Severe patients are examined by the head of the ward on the day of hospitalisation and daily thereafter. Patients in a moderately severe condition are examined at least once a week. The results of the patient's examination are recorded in the medical record with recommendations on further tactics of the patient's management with obligatory identification of the medical worker making the entries | Major violation |
258 | Presence of an established clinical diagnosis jointly with the head of ward no later than three calendar days from the day of the patient's hospitalisation in a health care facility | Major violation |
259 |
Daily examination of patients in the hospital by the attending physician, excluding weekends and public holidays. Upon examination and appointment of additional diagnostic and therapeutic manipulations by the physician on duty, appropriate entries are made in the medical record. If the patient's condition worsens, the physician on duty notifies the head of the ward and (or) the attending physician, agrees to make changes in the process of diagnosis and treatment, and makes an entry in the medical record (paper and (or) electronic) option. | Major violation |
260 | Consultations or consiliums in case of difficulty in identifying the diagnosis, inefficiency of the current treatment, as well as other indications | Gross violation |
261 |
Presence of examination of persons on clinical indications for HIV infection upon detection of the following diseases, syndromes and symptoms: | Gross violation |
262 | Presence of an agreement for rendering paid medical services in health care facilities. Availability of documents establishing the fact of co-payment | Gross violation |
263 |
Presence of confirming documentation that discharge criteria have been met, such as: | Major violation |
264 | Discharge epicrisis is issued to the patient upon discharge, stating the full clinical diagnosis, the scope of diagnostic tests, therapeutic measures and recommendations for further follow-up and treatment. Discharge data are entered into information systems on a day-to-day basis, specifying the actual time of discharge. | Minor violation |
265 |
There is supporting documentation of adherence to the requirements for transfusion of blood components and in case of complications: | Gross violation |
266 |
Presence of supporting documentation on the determination of the method and tactics of treatment by the MDG. | Gross violation |
267 | Presence of confirming documentation on conformity of the provided medical care to clinical protocols | Major violation |
268 |
Presence of medical documentation on observance of the following requirements for the examination of temporary incapacity for work, issuance of certificates of temporary incapacity for work (form № 001/y “Medical Record of Inpatient Patient”, form № 052/y “Medical Record of Outpatient Patient”, stubs of patients' certificates of temporary incapacity for work, form № 025/y “Log for Recording Medical Advisory Board Reports”, form № 029/y “Book of Registration of Certificates of Temporary Incapacity for Work”, Form № 037/y “Certificate №__________ on Temporary Incapacity for Work of a Student, a Student of a College, a Vocational School, on Illness, Quarantine and Other Reasons for the Absence of a Child Attending School, Pre-School Institution (to be underlined)”, Form № 038/y “Certificate №______ on Temporary Incapacity for Work” and others): | Major violation |
269 |
Presence of documentation (internal orders, regulations, protocols, questionnaires, analyses) of the clinical audit by the Patient Support Service and internal expertise and its evaluation against the following criteria: | Major violation |
270 |
Presence of confirming documentation of observance of the following actions when performing pathological autopsies: | Gross violation |
271 | Presence of a written application from the spouse, close relatives or lawful guardians of the deceased or a written will given by the person during his/her lifetime to release the corpse without a pathological anatomical autopsy, in the absence of suspicion of violent death | Major violation |
272 |
Presence of supporting documentation on rendering oncological care at home: | Major violation |
Requirements for persons (facilities) offering medical and social assistance in the field of mental health care | ||
Requirements for actors (facilities) offering medical and social care in the field of mental health at the outpatient and polyclinic level | ||
273 | Presence of supporting documentation on rendering health care included in the guaranteed volume of free medical care and (or) the system of mandatory social health insurance on a free-of-charge basis | Gross violation |
274 |
Presence of confirming documentation on observance of the criteria for dynamic observation of persons with MBD: | Major violation |
275 |
Presence of confirming documentation on observance of the requirement to supply medicines to persons with MBD under dynamic monitoring | Major violation |
276 |
Presence of confirming documentation of adherence to the requirements for deregistration and transfer to another group of dynamic monitoring: | Major violation |
277 |
Presence of confirming documentation on the implementation of the following activities during dynamic monitoring of a person with MBD by a psychiatric doctor: | Major violation |
278 |
Presence of an individual treatment plan and rehabilitation programme for persons after discharge from a facility rendering health care in the field of mental health, excluding those discharged by court order as early recovered. | Major violation |
279 |
Presence of confirming documentation of the implementation of PHC by a physician, upon suspicion or identification of a person with a MBD, excluding MBD requiring emergency and urgent medical and social care: | Major violation |
280 |
Implementation of the following activities by a mental health clinician of a MHU or PMHC when a person with PPR is suspected or identified, excluding MBD requiring emergency and urgent medical and social care: | Major violation |
281 |
There is confirming documentation regarding the implementation of the following activities by the psychiatric physician of the MHU or PMHC when a person who was previously on dynamic follow-up with a MBD applies and is deregistered from the EIS with a reason for deregistration other than “convalescence, persistent improvement”: | Major violation |
282 |
Presence of documentation (internal orders, regulations, protocols, questionnaires, analyses) of the clinical audit by the Patient Support Service and internal expertise and its evaluation against the following criteria: | Major violation |
Requirements for entities (facilities) delivering health and social care in the field of mental health in inpatient settings with 24-hour medical supervision | ||
283 | Presence of confirming documentation on rendering medical care included in the guaranteed volume of free medical care and (or) the system of mandatory social health insurance on a free of charge basis | Gross violation |
284 |
There are grounds for hospitalisation in inpatient clinical units. | Major violation |
285 |
Comprehensiveness of the measures implemented during planned hospitalisation in inpatient clinical wards of RSPCMH, MHC. | Major violation |
286 |
Comprehensiveness of the measures undertaken during hospitalisation in the inpatient clinical ward of RSPCMH, MHC for emergency indications. | Major violation |
287 |
Comprehensiveness of the activities undertaken during routine hospitalisation in PFSIS. | Major violation |
288 |
Comprehensiveness of the activities undertaken after admission of a person with MBD to the inpatient clinical unit. | Major violation |
289 |
Comprehensiveness of interventions following the person's admission to the PFSIS inpatient clinical unit | Major violation |
290 |
Adherence to observation regimes. | Major violation |
291 |
Presence of confirming documentation that the criteria for forced hospitalisation in an inpatient hospital have been met: | Major violation |
292 |
There is confirming documentation that the conditions of discharge have been met. | Major violation |
293 |
Presence of documentation (internal orders, regulations, protocols, questionnaires, analyses) of the clinical audit by the Patient Support Service and internal expertise and its evaluation against the following criteria: | Major violation |
Requirements for entities (facilities) delivering health and social care in the field of mental health in inpatient substitute conditions that do not require 24-hour medical supervision and treatment and include medical supervision and treatment during the day with the provision of a bed place | ||
294 | Presence of confirming documentation on the delivery of medical care included in the guaranteed volume of free medical care and (or) the system of mandatory social health insurance on a free-of-charge basis | Gross violation |
295 |
Indications for inpatient substitution treatment for persons with MBD | Major violation |
296 |
Implementation of the following activities during day hospitalisation: | Major violation |
297 |
Requirements for the duration of treatment and time of stay in the day hospital. | Major violation |
298 |
Observing the requirements for discharge from the day care hospital. | Major violation |
299 |
Presence of documentation (internal orders, regulations, protocols, questionnaires, analyses) of the clinical audit by the Patient Support Service and internal expertise and its evaluation against the following criteria: | Major violation |
Requirements for entities (facilities) delivering health and social care to persons with mental, behavioural disorders (diseases) in the form of emergency health and social care | ||
300 | Emergency specialised psychiatric care is rendered by specialised teams organised as part of the organisation delivering emergency health and social care or MHC. | Major violation |
Requirements for actors(facilities) offering health and social rehabilitation in the field of mental health | ||
301 | Presence of confirming documentation on the delivery of health care included in the guaranteed volume of free medical care and (or) the system of mandatory social health insurance on a free-of-charge basis | Gross violation |
302 |
Presence of confirming documentation on fulfilment of the requirements for health and social rehabilitation in outpatient or inpatient substitute conditions. | Major violation |
303 |
Presence of confirming documentation on adherence to the requirements for medical and social rehabilitation in inpatient settings. | Major violation |
304 |
Presence of proving documentation on the implementation of the activities of the multidisciplinary group. | Gross violation |
305 |
Requirements for the duration of medical and social rehabilitation. | Major violation |
Requirements for entities (facilities) rendering health examinations to establish the fact of psychoactive substance use and intoxication status | ||
306 | Presence of confirming documentation on the delivery of healthcare included in the guaranteed volume of free medical care and (or) the system of mandatory social health insurance on a free-of-charge basis | Gross violation |
307 |
Presence of confirmatory documentation on observance of the requirements for identification of the person referred or coming for health examination. | Major violation |
308 |
Presence of confirming documentation on observance of the requirements for performing the examination of foreign citizens and underage citizens of the Republic of Kazakhstan. Foreign citizens permanently residing and temporarily staying on the territory of the Republic of Kazakhstan, as well as stateless persons who are intoxicated in a public place, at work, or driving a vehicle, should undergo physical examination on general grounds. | Major violation |
309 |
Presence of supporting documentation on observance of the requirements for health examination of persons brought in in a seriously unconscious state. | Major violation |
310 |
Presence of confirming documentation on observance of the requirements to the conditions for laboratory examination or rapid testing of biological media. | Major violation |
311 |
Presence of confirming documentation on observance of the requirements for laboratory examination or rapid testing of biological media. | Major violation |
312 |
Presence of confirming documentation on observance of the requirements for the quantitative breath alcohol test. | Major violation |
313 |
Presence of confirming documentation of fulfilment of the requirements for issuing a refusal of health examination | Major violation |
314 |
Presence of confirmatory documentation on observance of the requirements for establishing the condition of the person being examined. | Major violation |
315 |
Presence of supporting documentation on adherence to the requirements for drawing up the Report of Medical Examination. | Major violation |
316 |
Presence of confirming documentation on observance of the requirements for repeated medical examination. | Major violation |
Requirements for actors (facilities) offering temporary adaptation and detoxification services | ||
317 | Presence of confirming documentation on the delivery of medical care included in the guaranteed volume of free medical care and (or) the system of mandatory social health insurance on a free-of-charge basis | Gross violation |
318 |
There is confirming documentation on observance of the requirements for the operation of the temporary adaptation and detoxification centre: | Major violation |
319 |
Establishing the identity of the delivered person by the internal affairs officers and reporting it to the health care personnel of the TADC. | Major violation |
320 |
Registration of a person delivered with suspected alcohol intoxication in the logbook of admissions and refusals of hospitalisation in the approved form | Major violation |
321 |
The findings of the medical examination are recorded in a report on the medical examination conducted at the TADC (hereinafter - the report) as per the approved form | Major violation |
322 |
Registration of personal belongings, documents, money and other valuables by health care personnel in the patient's document and personal belongings registration log pursuant to the form prior to the patient's admission to the TADC. | Major violation |
323 | Availability of the record of the patient placed in the TADC (hereinafter referred to as the patient's record) If there are medical indications, treatment is prescribed. The doctor's prescriptions are recorded in the patient's card. The frequency of medical examinations depends on the patient's condition. | Major violation |
324 | The patient is discharged by a psychiatrist (narcologist) on a planned basis if the patient's condition has improved and does not require further observation and treatment at the TADC within twenty-four (24) hours of admission. When the patient is discharged, a relevant entry is made in the patient's card and in the log of admissions and refusals to hospitalisation. | Major violation |
325 | Written confirmation from the patient that upon receipt of his/her documents and personal belongings, all documents and personal belongings have been received as recorded in the log book of patients' documents and personal belongings, excluding items that are illegal to keep. | Major violation |
Requirements for actors (facilities) offering medical examinations and sex reassignment for persons with gender identity disorder | ||
326 | Presence of confirming documentation on the delivery of healthcare included in the guaranteed volume of free medical care and (or) the system of mandatory social health insurance on a free-of-charge basis | Gross violation |
327 |
Presence of confirming documentation on observance of the requirement for medical examination of persons with gender identity disorder for sex reassignment: | Major violation |
328 | Referral by a psychiatrist of the person being examined, if there are doubts about his or her mental state, to a healthcare facility for an inpatient examination | Major violation |
329 |
Referral of the person to be examined by a psychiatrist, in the absence of MBD, being contraindications for sex reassignment, to the polyclinic at the place of residence, for medical examination | Major violation |
Requirements for entities (facilities) providing laboratory services | ||
330 | Presence of supporting documentation on the delivery of medical care included in the guaranteed volume of free medical care and (or) the system of mandatory social health insurance on a free-of-charge basis | Gross violation |
331 | Presence of written voluntary consent of the patient or his/her lawful guardian for invasive interventions and therapeutic and diagnostic measures | Major violation |
332 | The presence of a biosafety expert in the laboratory staff (if the laboratory staff is more than twenty full-time units) | Major violation |
333 | Availability of portable test strip analysers in primary health care facilities | Major violation |
334 |
Presence at the inpatient level in health care facilities as part of the consultative and diagnostic laboratory (hereinafter - CDL) of an additional unit or a separate express-laboratory in intensive care units to perform emergency and urgent laboratory tests within a minimum time from sample collection to reporting the result (within 15-60 minutes). | Major violation |
335 | Running quality management processes for clinical laboratory tests based on the principle of staging, which includes the pre-analytical, analytical and post-analytical stages of a laboratory test | Major violation |
336 | Use of equipment, diagnostic reagent kits, test systems and complete consumables certified and registered in the Republic of Kazakhstan to perform tests | Major violation |
337 | Availability of laboratory information system | Major violation |
338 | Conducting intra-laboratory quality control of the tests | Major violation |
339 | Observance of triple packaging and temperature regime when transporting biomaterial, including by road, air and railway transport. | Major violation |
340 | Presence of supporting documentation of observance of the algorithm of analytical quality control in laboratory diagnostics | Major violation |
341 | Presence of an agreement for rendering paid medical services in health care facilities. Presence of documents establishing the fact of co-payment | Gross violation |
342 | Availability of supporting documentation on the competence and quality of laboratory diagnostics | Major violation |
343 | Documenting the performance of laboratory diagnostics | Major violation |
Requirements for entities (facilities) delivering emergency medical aid and medical aid in the form of medical aviation | ||
General requirements | ||
344 | Presence of confirming documentation on the delivery of medical care included in the guaranteed volume of free medical care and (or) the system of mandatory social health insurance on a free-of-charge basis | Gross violation |
345 | Presence of supporting documentation on conformity of treatment and diagnostic measures with the recommendations of clinical protocols | Major violation |
346 |
Presence of documentation (internal orders, regulations, protocols, questionnaires, analytical reports) on clinical audit by the Patient Support Service and internal expertise and its evaluation against the following criteria: | Major violation |
For emergency ambulance service | ||
347 | Equipping sanitation vehicles with radio communication and navigation system | Gross violation |
348 | Availability in the ambulance service of regions, cities of national importance and the capital city of an automated control system for receiving and processing calls and systems enabling monitoring of ambulance vehicles by means of navigation systems, as well as a system of computer recording of dialogues with subscribers and an automatic identifier of the telephone number from which the call is received. Dialogue recordings are stored for at least 2 years. | Gross violation |
349 | Presence of regional call-centres (call-centres) within regional emergency medical aid stations and emergency medical aid stations of cities of national importance and the capital city | Gross violation |
350 | Observance of a five-minute processing time of an ambulance call from the moment it is received by the dispatcher, during which time the call is triaged by urgency category. | Major violation |
351 | Adherence to the time of arrival of the brigade to the patient's location from the moment of receiving the call from the dispatcher as per the list of urgency categories of emergency medical calls (from 10 minutes to 60 minutes) | Major violation |
352 |
The dispatcher of the emergency health care service (EHCS) correctly identifies calls by urgency category as per: | Major violation |
353 |
A paramedic or a physician of an EMS or team makes one of the following decisions when organising primary health care, based on the results of examination data, instrumental diagnostics, patient's condition dynamics against the background of or after treatment measures, in line with the preliminary diagnosis reflecting the causes of the condition: | Gross violation |
354 | Medical recommendations are offered for further referral to a primary health care facility (at the place of residence or registration in case a patient who does not need hospitalisation is left at the place of call or at home, by a team from an EMC or an EHCS unit at a primary health care facility) | Major violation |
355 | Presence of a patient signalling sheet in case a patient is ill and needs a home visit by a precinct physician | Major violation |
356 |
Availability of recording of the following data when a call is received by the dispatch service of the ambulance station: | Major violation |
357 |
Observance of the time of arrival of paramedic and specialised (medical) teams to the patient's location from the moment of receiving a call from the dispatcher of the ambulance station, with due regard to the category of urgency: | Major violation |
358 | The dispatcher of the EHCS is informed of the patient's delivery in case a decision is made by the team of the EMC or the EHCS department to transport the patient to the hospital. | Major violation |
359 | Availability of a minimum list of medical devices for ambulance station transport by classes A, B and C | Major violation |
For medical assistance in the form of medical aviation | ||
360 | Presence of an assignment for sanitary flight as per form № 090/y | Major violation |
361 | Supporting documentation that the mobile medical aviation team, while transporting the patient(s), routinely evaluates and treats the patient(s) following appropriate clinical protocols for diagnosis and treatment. | Major violation |
362 | Presence of grounds for granting medical assistance in the form of medical aviation ( an excerpt from the medical record of a patient in need of medical assistance in the form of medical aviation; a request from the coordinating physician of the medical aviation department to the dispatcher of the Coordinating Entity; in emergency cases, a verbal order from a competent authority with written confirmation; a call from the emergency medical services and other emergency services) | Gross violation |
363 | Dispatcher of the Coordinating Entity has agreed on the membership of the mobile medical aviation brigade and the involved qualified specialist(s) from the regional healthcare facilities with their informed consent. | Major violation |
364 | Presence in the Coordinating Entity of a schedule of qualified specialists for medical assistance in the form of medical aviation approved by health care entities and medical education institutions | Gross violation |
365 |
Presence of informed consent of the patient (s) for medical assistance in the form of medical aviation during his/her transportation. | Gross violation |
Requirements for actors (facilities) engaged in HIV prevention activities | ||
366 | Availability of supporting documentation on the delivery of healthcare included in the guaranteed volume of free medical care and (or) the system of mandatory social health insurance on a free-of-charge basis | Gross violation |
367 |
Examination by express testing method with registration in the register of HIV tests by express testing method. | Major violation |
368 | Availability of written notification by the health care facility, which revealed during medical examination the fact of HIV infection in the examined person of the result obtained, of the necessity to observe precautionary measures aimed at protecting one's own health and the health of others, as well as warning of administrative and criminal liability for evasion from treatment and infection of other persons, with the patient signing a confidential interview sheet with a person infected with HIV as per form № 095/y | Major violation |
369 |
Presence of supporting documentation on adherence to the deadlines for issuing negative results. | Major violation |
370 |
Presence of supporting documentation on adherence to the deadlines for sending serum samples to the RSHF. | Major violation |
371 |
Presence of supporting documentation of fulfilment of re-examination deadlines in case of doubtful results. | Major violation |
372 |
Pre-test and post-test counselling is available. | Major violation |
373 | Health care facility engaged in HIV prevention activities sends an emergency notification in form № 034/y to the territorial public authority in the field of sanitary and epidemiological well-being for each case of HIV infection presumably related to the delivery of medical care (intra-hospital one) | Gross violation |
374 | Presence of the Confidential Interview Sheet with a person infected with HIV, Form № 095/y, that includes: his/her consent to enter personal data into electronic information resources. In case of refusal to enter personal data into the ES system, data is entered, specifying immune blocking number (hereinafter - IB), date of IB, initials, date of birth, data of epidemiological anamnesis | Major violation |
375 | Monitoring and evaluation of the coverage of key populations and people living with HIV infection is performed by maintaining a database of individual client records and relevant forms of accounting and reporting documentation by experts from health care facilities involved in HIV prevention activities | Major violation |
376 | Transfer by the health care workers diagnosed with HIV-infection to another job that does not involve violation of the integrity of skin or mucous membranes. | Gross violation |
377 |
Availability of supporting documentation on the diagnosis and treatment of STIs. | Major violation |
378 | Availability of equipped transport for mobile confidence-building centres | Major violation |
379 | Availability of confirmatory documentation of implementation of pre-exposure and post-exposure prophylaxis in the population and key populations | Major violation |
380 |
Surveillance of contact persons within the established timeframes. | Gross violation |
381 |
Dynamic monitoring and ensuring antiretroviral therapy of HIV-infected persons. | Gross violation |
382 |
Presence of documentation (internal orders, regulations, protocols, questionnaires, analyses) of the clinical audit by the Patient Support Service and internal expertise and its evaluation against the following criteria: | Major violation |
Requirements for actors (facilities) engaged in activities in the field of blood services | ||
383 | Presence of supporting documentation on the delivery of medical care included in the guaranteed volume of free medical care and (or) the system of mandatory social health insurance on a free-of-charge basis | Gross violation |
384 | Evidence of adherence by the blood service institution to the requirements for the stepwise labelling of blood and blood components. Ensuring the traceability of each blood product from the donor to the finished product and its use | Gross violation |
385 | Presence of supporting documentation on meeting the requirements for laboratory testing of recipient blood samples for the presence of markers of haemotransmissible infections before and after transfusion by qualitative immunoserological and molecular-biological methods on automatic closed-type analysers. | Gross violation |
386 | Registration in the electronic information database after donation of blood and its components of all data 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, correspondence of documents on transfer to the primary fractionation unit with the accompanying documentation of the collected blood and its components | Major violation |
387 | Availability of a blood and blood component donor questionnaire and an information sheet given to the donor, which he/she fills in independently or with the participation of a medical registrar | Major violation |
388 | Presence of confirmatory documentation of adherence to the requirements for performing immunohaematology studies for irregular anti-erythrocyte antibodies in liquid-phase systems on plane and in vitro, reading the result of agglutination reaction with obligatory microscopy. | Major violation |
389 |
Presence of confirming documentation of adherence to the requirements for incoming and daily in-laboratory quality control of reagents to confirm their activity and specificity. Input control includes: | Major violation |
390 | Placement of blood collected in travelling conditions in thermocontainers labelled “Untested Haemoproducts, not to be Handed Out” and delivered at 22±2°C for 18-24 hours to the blood service centre. | Major violation |
391 | Use of reagents with monoclonal antibodies and equipment registered by the public authority in the sphere of circulation of medicines and medical devices for immunohaematological studies of blood samples of potential recipients | Major violation |
392 | Presence of supporting documentation on fulfilment of requirements for transfusion of blood, its components | Major violation |
393 | Presence of supporting documentation on observance of the requirements of compulsory medical examination of the donor before donation of blood and its components within the framework of the guaranteed volume of free medical care | Major violation |
394 | Consistency with donor medical clearance, safety and quality requirements in the manufacture of blood products for medical use | Major violation |
395 | Presence of confirming documentation on observing the requirements of external quality evaluation of measurement quality of laboratory tests in reference laboratories | Major violation |
396 | Adherence to incoming and daily in-laboratory quality control of reagents to confirm reagent activity, and specificity. | Major violation |
397 | Presence of a blood and blood components donor questionnaire available to the donor, which he/she fills in on his/her own or with the assistance of a medical registrar. | Major violation |
398 |
The following are subject to input control: | Major violation |
399 | Conformity with donor medical clearance, safety and quality requirements in the manufacture of blood products for medical use | Major violation |
400 |
Presence of documentation (internal orders, regulations, protocols, questionnaires, analyses) of the clinical audit by the Patient Support Service and internal expertise and its evaluation against the following criteria: | Major violation |
Requirements for entities (facilities) performing pathological anatomical diagnostics | ||
401 | Presence of supporting documentation on the delivery of medical care included in the guaranteed volume of free medical care and (or) the system of mandatory social health insurance on a free-of-charge basis | Gross violation |
402 | Observance of the requirement to register the refusal to accept biological material, stapled with a copy of the referral for analysis of biological material in the pathology unit in a separate folder (“Rejected Samples”), as well as in a separate log (“Rejected Samples”). | Major violation |
403 | Adherence by the pathologist to the requirement for participation of the laboratory technician in the work on based on the act of excision, macroscopic examination and macroscopic description of the biological material. The medical specialist who sent the material for examination is involved when additional clinical information is required at the stage of macroscopic examination of the biological material | Major violation |
404 | Observance of the requirement that tissue fragments have a thickness of 5 millimetres (hereinafter - mm) and an average diameter of no more than 24 mm. | Major violation |
405 | Presence of microscopic description in the protocol of pathological and anatomical examination of biopsy (surgical) and autopsy material | Major violation |
406 | Adherence to the requirement to issue the results of pathomorphological examination with entries in the established form logs by the medical registrar or laboratory technician | Major violation |
407 | Presence of supporting documentation on meeting the requirement to store tissue samples in paraffin blocks in a single archive organised by the principle of end-to-end numbering | Major violation |
408 | Presence of supporting documentation on meeting the requirement to store tissue specimens in paraffin blocks in a specially equipped dry and cool room, using specialised archiving systems and adapted containers, as well as storage of microdrugs in specialised archiving systems. | Gross violation |
409 | Adherence to the requirement to place micro specimens in boxes in such a way that slides pertaining to one case are arranged in one indivisible unit | Major violation |
410 | Observance of the requirement for the laboratory technician to sort and prepare biological and medical waste for disposal | Major violation |
411 | Presence of written consent of the spouse or one of the close relatives or lawful guardian in case of pathological and anatomical diagnosis in case of unspecified immediate cause of death | Major violation |
412 | Adherence to the requirement for an independent (independent) expert(s) to perform a pathological anatomical autopsy of the deceased at the request of the spouse, close relatives or legal representative | Major violation |
413 | Adherence to the requirement to issue a medical certificate of death (preliminary, final) on the day of the pathological anatomical autopsy by a physician specialising in pathological anatomy (adult, paediatric) | Major violation |
414 | Adherence to the requirement to document autopsy results in the form of a pathological examination report | Major violation |
415 | Observance of the requirement to stop the autopsy when signs of violent death are detected during the pathological anatomical examination of the corpse, the head of the healthcare facility reports the incident in writing to the forensic and investigative authorities to address the issue of transferring the corpse for forensic medical examination. A physician specialising in pathological anatomy (adult, paediatric) undertakes measures to preserve the body, organs and tissues of the corpse for further forensic medical examination. A protocol is prepared for the performed part of the pathological anatomical examination, at the end of which the reason for further forensic medical examination is indicated. In each case of interrupted pathological autopsy, the pathologist informs in writing the head of the ward, the administration of the health care facility where the death occurred immediately after the interruption of the autopsy | Major violation |
416 | Observance of the requirement to send an emergency notification to the public authority in the sphere of sanitary and epidemiological well-being of the population by a physician specialising in “Pathological Anatomy (for Adults, for Children)” in case of initial detection during autopsy of signs of acute infectious disease, food or industrial poisoning, unusual reaction to vaccination | Major violation |
417 | Observance of the requirement for pathological and anatomical autopsy of all newborn children who died in healthcare facilities, including obstetric facilities (regardless of how long after birth they showed signs of life) and stillborn foetuses with a body weight of 500 grams or more at a gestational age of 22 weeks or more, including after termination of pregnancy (spontaneous, for medical and social reasons) with mandatory histological examination of the placenta and registration of a medical certificate of perinatal care. | Major violation |
418 | Observance of the requirement of the head of the pathological anatomy department to ensure that autopsies are performed on dead newborns and stillborns with mandatory histological examination of tissue and organ fragments and inclusion in the protocol of pathological anatomical examination. | Major violation |
419 | Adherence to the requirement by the heads of health care facilities and heads of pathological anatomical units of the facility for the required virological and bacteriological examination of autopsy materials of deceased newborns, stillborns and placentas, using appropriate laboratories of health care facilities or public authorities and agencies in the field of sanitary and epidemiological well-being of the population. | Major violation |
420 | Adherence to the requirement to issue a medical certificate of perinatal death (preliminary, final, instead of preliminary) by a physician specialising in pathological anatomy (adult, paediatric) on the day of the pathological anatomical autopsy. | Major violation |
421 |
Adherence to the requirement by a physician specialising in “Pathological Anatomy (for Adults, for Children)” when drawing up a pathological anatomical diagnosis based on the results of a pathological anatomical autopsy: | Major violation |
422 | Observance of the requirements for registration and maintenance of primary medical documentation | Major violation |
423 |
Presence of supporting documentation on observance of the requirement for accounting of pathological anatomical examination materials (biopsy, surgical and autopsy material): | Major violation |
424 |
Observance of the requirement not to submit the protocol of pathological anatomical examination to the spouse, close relatives, legal representatives or other persons for familiarisation. | Major violation |
425 | Adherence to the requirement to issue originals or copies of pathological anatomical examination reports at the request of bodies of enquiry and preliminary examination, prosecutor, lawyer and (or) court due to investigation or court proceedings, as well as at the request of public authorities in the field of medical services (aid) | Major violation |
426 |
Observance of requirements for cytological examinations, which include: | Major violation |
427 | Presence of supporting documentation on meeting the requirement for the laboratory technician's acceptance, initial sorting and registration of biological material received in the cytology laboratory, macroscopic examination, description of biological material, processing of biological material (preparation, fixation, staining, conclusion, sorting of cytological microdrugs). | Major violation |
428 | There is documentation of adherence to the requirement to perform microscopic examination in the first step by a laboratory technician, then by a cytologist | Major violation |
429 | Observance of the requirement to involve a physician ( relevant expert) when it is required to obtain additional clinical information at the stage of microscopic examination of biological material, who sent the material for examination. The final microscopic examination of smears and drawing up a protocol of the results of the study is performed by a cytologist | Major violation |
430 | Adherence to the requirement to establish the category of pathological anatomy (adult, paediatric) by a physician specialising in pathological anatomy (adult, paediatric) and the reason for the discrepancy between the final clinical and pathological diagnoses | Gross violation |
Requirements for entities (facilities) assisting in the field of nuclear medicine | ||
431 | Presence of supporting documentation on the delivery of medical care included in the guaranteed volume of free medical care and (or) the system of mandatory social health insurance on a free-of-charge basis | Gross violation |
432 | Presence of supporting documentation on conformity of treatment and diagnostic measures with the recommendations of clinical protocols | Major violation |
433 |
Presence of documentation confirming the status of the Nuclear Medicine Centre (hereinafter referred to as the Centre) as a structural unit of a multidisciplinary hospital or an independent healthcare facility rendering medical care to the population of the Republic of Kazakhstan on RND and (or) RNT. | Major violation |
434 |
Presence of supporting documentation on the main tasks and areas of activity of entities rendering medical care in the field of nuclear medicine and observance of the main objectives: | Major violation |
435 | Presence of supporting documentation on the delivery of medical care using nuclear medicine methods within the guaranteed scope of free medical care, voluntary medical insurance and on a paid basis. | Gross violation |
436 |
Presence of supporting documentation on the delivery of specialised medical care in the field of nuclear medicine in outpatient, inpatient substitution, inpatient conditions in a planned form: | Major violation |
437 | Presence of supporting documentation on referral of patients for PET/CT, PET/MRI, SPECT, SPECT/CT studies to the RND department by relevant experts | Major violation |
438 | Presence of supporting documentation on conducting radioisotope (radionuclide) studies following clinical protocols, documented procedures, the specific diagnostic method used, with mandatory compliance with radiation safety measures for the patient and personnel as indicated | Gross violation |
439 | A signed informed consent of the patient for radioisotope (radionuclide) examination prior to undergoing this examination, indicating the activity of the RPMP used, after which the patient is examined by a physician and a nurse. | Major violation |
440 | Presence of supporting documentation on the nuclear medicine specialist interpreting the results of the examination after completion of the diagnostic procedure. In complicated cases with mandatory “double-read”, double dependent reading (the image is read twice; during the second reading the result of the first reading is available), PET, PET/CT, PET/MRI, SPECT, SPECT/CT studies by nuclear medicine specialists and a final diagnostic report is issued. | Gross violation |
441 |
Presence of supporting documentation on referral of patients to the RNT department after preliminary examination and clinical decision on the need for RNT with the participation of the head of the department or nuclear medicine physician as per the list of diseases for RNT. A referral for inpatient medical care for oncological diseases is issued by a multidisciplinary group established in health care facilities rendering oncological care; | Gross violation |
442 | Presence of supporting documentation of RNT in inpatient settings in ‘active’ wards and/or beds. After receiving RPMP, the patient is a source of beta-gamma radiation, therefore, daily rounds of the doctor are conducted via audio and video communication. The radiation safety engineer (dosimetrist) registers the dose rate from patients daily via an alarm meter and a stationary dose rate measurement system. | Gross violation |
443 |
Presence of supporting documentation on delivery of the cadaver of a patient with administered RPMP of “active” wards to a specially allocated freezing chamber located in the radionuclide support unit of the RNT unit (in the radioactive waste storage facility) in case of lethal outcome. The corpse is held in the freezing chamber until an acceptable level of radioactive decay (at a distance of 1 metre from the body surface - 20 µSv/h), then the corpse is transported. | Gross violation |
444 |
Presence of documentation (internal orders, regulations, protocols, questionnaires, analyses) of the clinical audit by the Patient Support Service and internal expertise and its evaluation against the following criteria: | Major violation |
445 | Availability of supporting documentation of record-keeping and accounting records | Minor violation |
Note:
HIV - human immunodeficiency virus
STI - sexually transmitted infections
CDC - consultative and diagnostic care
MDG - multidisciplinary group
PS psychoactive substances
PHC - primary health care
PFSIS - a psychiatric facility of a specialised type with intensive supervision
MBD - mental, behavioural disorders
ATM - antituberculosis medicines
PMHC - primary mental health centre
RSHF - republican state health care facility engaged in the prevention of HIV infection
RSPCMH - republican scientific and practical centre for mental health
EMC - emergency medical service
EHCS - emergency health care service
CVD - cardiovascular disease
MHC - mental health centre
EIS - electronic information system
RND - radioisotope (radionuclide) diagnostics
RNT - radionuclide therapy
RPMP - radiopharmaceutical medicinal product
PET/CT - positron emission tomography combined with a computed tomography scanner
SPECT - single photon emission computed tomography scanner
| Annex 3 to the Criteria for Evaluating the Level of Risk in the Delivery of Health Services (Care) |
List of subjective criteria for establishing the degree of risk by
subjective criteria in the sphere of health services (care) provision)
___________________________________________________________________
under Article 138
___________________________________________________________________
Entrepreneurial Code of the Republic of Kazakhstan in respect of entities (facilities)
offering outpatient and polyclinic care (primary medical and sanitary care and consultative and diagnostic care)
_____________________________________________________________________
name of a homogeneous group of entities (facilities)
____________________________________________________________ under control
№ s/o | Subjective criterion indicator | Source of information on the subjective criterion indicator |
Specific weight by significance, point (the total should not exceed 100 points), | Conditions /values,, xi | ||
condition 1/value | condition 2/value | condition 3/value | ||||
1 | 2 | 3 | 4 | 5 | ||
For preventive control with visits | ||||||
1 | Failure to execute recommendations issued as a result of preventive control without visiting the entity (facility) under control | findings of preventive control without visiting the entity (facility) under control (final documents issued based on the findings of preventive control without visiting the entity (facility) under control). | 100.0 | no | yes | |
0% | 100% | |||||
2 | Annual pregnancy rate of women of fertile age with extragenital pathology for whom pregnancy is absolutely contraindicated - | results of monitoring of reports and data supplied by the entity under control | 10.0 | 0-1.9% | between 2% and 4.0% of cases | more than 4 per cent of cases |
0% | 50% | 100% | ||||
3 | Number of stroke deaths (ICD-10 code - I63) at home within 1 month after discharge | results of monitoring of reports and data supplied by the entity under control | 25.0 | 0 to 4 cases | Between 5 and 9 cases | more than 10 cases |
0% | 50% | 100% | ||||
4 | Proportion of hospitalisations of patients with complications of cardiovascular diseases (arterial hypertension, myocardial infarction, stroke) | results of monitoring of reports and data supplied by the entity under control | 10.0 | 0-9.9% | 10% -19.9% cases | more than 20 per cent of cases |
0% | 50% | 100% | ||||
5 | Annual indicator of the proportion of patients with acute cerebral circulation disorder registered after discharge from hospital within 3 working days at the place of registration - | results of monitoring of reports and data supplied by the entity under control | 10.0 | 0 % cases | 0-9.9% cases | From 10% of cases |
0% | 50% | 100% | ||||
6 | Proportion of deaths from circulatory system diseases out of total number of deaths, with ICD-10 diagnosis (I00-I99) | results of monitoring of reports and data supplied by the entity under control | 25.0 | 0-10 % | 10.01 –19.9% cases | more than 20 per cent of cases |
0% | 50% | 100% | ||||
7 | Annual rate of first-time detected patients with malignant neoplasms of stage 3-4 - | results of monitoring of reports and data supplied by the entity under control | 10.0 | 0-9.9% | More than 10% | |
0 | 100 % | |||||
8 | Number of child deaths from 0-5 years of age | results of monitoring of reports and data supplied by the entity under control | 100.0 | no | yes | |
0 | 1 and more | |||||
9 | Number of maternal deaths | results of monitoring of reports and data supplied by the entity under control | 100.0 | no | yes | |
0 | 1 and more | |||||
For compliance inspections | ||||||
1 | Certificate of a professional for admission to clinical practice |
results of monitoring of reports and data presented by the entity under control | 50 | There is a certificate | There is no certificate | |
0% | 100% | |||||
2 | The fact of re-registration of the licensee, change of its name or legal address and (or) reorganisation of the legal entity-licensee | results of analysis of data provided by public authorities and entities | 50 | yes | no | |
0% | 100% | |||||
| Annex 4 to the Criteria for Evaluating the Level of Risk in the Delivery of Health Services (Care) |
List of subjective criteria for establishing the degree of risk based on subjective criteria
in the area of quality of health care services (care)
_________________________________________________________________
as per Article 138
_________________________________________________________________
of the Entrepreneurial Code of the Republic of Kazakhstan in respect of
_________________________________________________________________
entities (facilities) offering in-patient, in-patient substitute care
____________________________________________________
name of a homogeneous group of entities (facilities)___________being controlled
№ s/o | Subjective criterion indicator | Source of information on the subjective criterion indicator | Specific weight by significance, point (the total should not exceed 100 points), wi | Conditions /values, xi | ||
condition 1/value | condition 2/value | condition 3/value | ||||
1 | 2 | 3 | 4 | 5 | ||
For preventive control with visits | ||||||
1 | Non-fulfilment of recommendations issued following the findings of preventive control without a visit to the entity (facility) under control | findings of preventive control without visiting the entity (facility) under control (final documents issued based on the findings of preventive control without visiting the entity (facility) under control). | 100.0 | no | yes | |
0% | 100% | |||||
2 | Postoperative mortality rate in cases of planned hospitalisation - | results of monitoring of reports and data supplied by the entity under control | 25.0 | 0-4.9% | 5-10.0% cases | more than 10 per cent of cases |
0% | 50% | 100% | ||||
3 | Annual rate of repeat unplanned hospitalisations (within a month for the same illness) - | results of monitoring of reports and data supplied by the entity under control | 10.0 | 0-5% cases | 5.01-10% cases | more than 10 per cent of cases |
0% | 50% | 100% | ||||
4 | Annual mortality rate for planned hospitalisations | results of monitoring of reports and data supplied by the entity under control | 25.0 | 0 cases | more than 1 case | |
0% | 100% | |||||
5 | Number of child deaths from 0-5 years of age | results of monitoring of reports and data supplied by the entity under control | 100.0 | no | yes | |
0 | 1 and more | |||||
6 | Number of maternal deaths | results of monitoring of reports and data supplied by the entity under control | 100.0 | no | yes | |
0 | 1 and more | |||||
For compliance inspections | ||||||
1 | Certificate of a professional for admission to clinical practice |
results of monitoring of reports and data presented by the entity under control | 50 | There is a certificate | There is no certificate | |
0% | 100% | |||||
2 | The fact of re-registration of the licensee, change of its name or legal address and (or) reorganisation of the legal entity-licensee | results of analysis of data reported by public authorities and entities | 50 | yes | no | |
0% | 100% | |||||
| Annex 5 to the Criteria for Evaluating the Level of Risk in the Delivery of Health Services (Care) |
List of subjective criteria for establishing the degree of risk based on subjective criteria
in the area of quality of health care services (care)
_________________________________________________________________
as per Article 138
_________________________________________________________________
of the Entrepreneurial Code of the Republic of Kazakhstan in respect of
_________________________________________________________________
entities (facilities), obstetric and (or) inpatient facilities with maternity wards
and neonatal pathology wards newborns ________________________________
name of a homogeneous group of entities ( facilities)
_________________________________________________________ being controlled
№ s/o | Subjective criterion indicator | Source of information on the subjective criterion indicator |
Specific weight by significance, point (the total should not exceed 100 points), | Conditions /values,, xi | ||
condition 1/value | condition 2/value | condition 3/value | ||||
1 | 2 | 3 | 4 | 5 | ||
For preventive control with visits | ||||||
1 | Failure to fulfil recommendations issued as a result of preventive control without visiting the entity (facility) under control | findings of preventive control without visiting the entity (facility) under control (final documents issued based on the results of preventive control without visiting the entity (facility) under control). | 100.0 | no | yes | |
0% | 100% | |||||
2 | Number of child deaths from 0-5 years of age | results of monitoring of reports and data supplied by the entity under control | 100.0 | no | yes | |
0 | 1 and more | |||||
3 | Number of maternal deaths | results of monitoring of reports and data supplied by the entity under control | 100.0 | no | yes | |
0 | 1 and more | |||||
4 | Annual mortality rate for planned hospitalisations | results of monitoring of reports and data supplied by the entity under control | 25.0 | 0 cases | more than 1 case | |
0% | 100% | |||||
5 | Ratio of emergency and planned Caesarean sections | results of monitoring of reports and data supplied by the entity under control | 10.0 | 0-10 % cases | 10.1-24.9% cases | more than 25 % of cases |
0% | 50% | 100% | ||||
6 | Proportion of birth injury cases | results of monitoring of reports and data supplied by the entity under control | 10,0 | 0-10 % cases | 10.1-19.9% cases | more than 20 % of cases |
0% | 50% | 100% | ||||
7 | Postoperative mortality rate in cases of planned hospitalisation - | results of monitoring of reports and data supplied by the entity under control | 25.0 | 0-4.9% | 5-9.9% cases | more than 10 % of cases |
0% | 50% | 100% | ||||
8 | Number of cases of intrapartum fetal death in a health care facility in the absence of CHD ( excluding charts with a final major, concomitant, or clarifying diagnosis with ICD-10 code Q00-Q99.9) | results of monitoring of reports and data supplied by the entity under control | 25.0 | 0 | 1 case | |
0% | 100% | |||||
9 | Rate of repeat unplanned admissions (within one month for the same condition) (female pelvic inflammatory disease (N70-N77) | results of monitoring of reports and data supplied by the entity under control | 10.0 | 0-4.99 % cases | 5-9.9 % cases | more than 10 per cent of cases |
0 | 50 % | 100 % | ||||
For compliance inspections | ||||||
1 | Certificate of a specialist for admission to clinical practice | results of monitoring of reports and data supplied by the entity under control (e-license) | 50 | There is a certificate | There is no certificate | |
0% | 100% | |||||
2 | The fact of re-registration of the licensee, change of its name or legal address and (or) reorganisation of the legal entity-licensee | findings of the analysis of data presented by public authorities and entities | 50 | yes | no | |
0% | 100% | |||||
| Annex 6 to the Criteria for Evaluating the Level of Risk in the Delivery of Health Services (Care) |
List of subjective criteria for establishing the degree of risk based on subjective criteria
in the delivery of health care services (care)
___________________________________________________________________
pursuant to Article 138
___________________________________________________________________
of the Entrepreneurial Code of the Republic of Kazakhstan in respect of
___________________________________________________________________
entities (facilities) offering cardiological, cardiosurgical and cardiosurgical care____
___________________________________________________________________
name of a homogeneous group of entities (facilities)
___________________________________________________________ being controlled
№ s/o | Subjective criterion indicator | Source of information on the subjective criterion indicator | Specific weight by significance, point (the total should not exceed 100 points),wi | Conditions /values, xi | ||
condition 1/value | condition 2/value | condition 3/value | ||||
1 | 2 | 3 | 4 | 5 | ||
For preventive control with visits | ||||||
1 | Failure to fulfil recommendations issued as a result of preventive control without visiting the entity (facility) under control | findings of preventive control without visiting the entity (facility) being controlled (final documents issued based on the findings of preventive control without visiting the entity (facility) being controlled). | 100.0 | no | yes | |
0% | 100% | |||||
2 | Number of stroke deaths (ICD-10 code - I63) at home within 1 month after discharge | results of monitoring of reports and information presented by the entity under control | 25.0 | 0 to 4 cases | Between 5 and 9 cases | over 10 cases |
0% | 50% | 100% | ||||
3 | Proportion of hospitalisations of patients with complications of cardiovascular diseases (arterial hypertension, myocardial infarction, stroke) | findings of monitoring of reports and information presented by the entity under control | 10.0 | 0 | 1- 19.9% cases | more than 20 per cent of cases |
0% | 50% | 100% | ||||
4 | Proportion of deaths from circulatory diseases out of total number of deaths, with ICD-10 diagnosis (I00-I99) | results of monitoring of reports and data supplied by the entity under control | 25.0 | 0-10 % | 10.1 – 20% cases | more than 20 per cent of cases |
0% | 50% | 100% | ||||
5 | The rate of postoperative mortality in cases of planned hospitalisation - | findings of monitoring of reports and data supplied by the entity subject to control | 25.0 | 0-4.9% | 5-10% cases | more than 10 per cent of cases |
0% | 50% | 100% | ||||
6 | Annual rate of repeat unplanned hospitalisations (within a month for the same illness) - | findings of monitoring of reports and data supplied by the entity subject to control | 10.0 | 0-5% cases | 5.1-10% cases | more than 10 per cent of cases |
0% | 50% | 100% | ||||
7 | Annual mortality rate for planned hospitalisations | findings of monitoring of reports and data supplied by the entity subject to control | 25.0 | 0 cases | more than 1 case | |
0% | 100% | |||||
8 | Number of child deaths from 0-5 years of age | findings of monitoring of reports and data supplied by the entity subject to control | 100.0 | no | yes | |
0 | 1 or more | |||||
9 | Number of maternal deaths | findings of monitoring of reports and data supplied by the entity subject to control | 100.0 | no | yes | |
0 | 1 or more | |||||
For compliance inspections | ||||||
1 | Specialist certificate for admission to clinical practice | findings of monitoring of reports and data supplied by the entity subject to control | 50 | There is a certificate | There is no certificate | |
0% | 100% | |||||
2 | The fact of re-registration of the licensee, change of its name or legal address and (or) reorganisation of the legal entity-licensee | findings of the analysis of data presented by public authorities and entities | 50 | yes | no | |
0% | 100% | |||||
| Annex 7 to the Criteria for assessing the degree of Risk assessment criteria in the sphere of rendering medical services (assistance) |
List of subjective criteria for determining the degree of risk by subjective criteria
in the sphere of medical services (assistance)
___________________________________________________________________
in accordance with Article 138
___________________________________________________________________
Entrepreneurial Code of the Republic of Kazakhstan in respect of
___________________________________________________________________
entities (facilities) providing haemodialysis care
___________________________________________________________________
name of homogeneous group of entities (facilities)
__________________________________________________________ of control
№ r/n | Indicator of the subjective criterion | Source of information on the subjective criterion indicator |
Weight by importance, point (the total should not exceed 100 points), | Conditions /values, xi | ||
condition 1/values | condition 2/values | condition 3/values | ||||
1 | 2 | 3 | 4 | 5 | ||
For preventive control with a visit | ||||||
1 |
Failure to fulfil recommendations issued as a result of preventive control without visiting the subject (object) of control |
results of preventive control without visiting the subject (object) of control (final documents issued based on the results of preventive control without visiting the entity (facility) of control). | 100,0 | no | yes | |
0% | 100% | |||||
3 | Annual mortality rate during planned hospitalisation | Results of monitoring of reports and information provided by the entity of control | 25,0 | 0 case | More than 1 case | |
0% | 100,0 | |||||
For compliance verifications | ||||||
1 |
Availability of a certificate of a specialist for admission to clinical practice |
results of monitoring of reports and information provided by the entity of control | 50 | With a certificate | Without a certificate | |
0% | 100% | |||||
2 | The fact of re-registration of the licensee, change of its name or legal address and (or) reorganisation of the legal entity-licensee | results of analysis of information provided by state bodies and organisations | 50 | yes | no | |
0% | 100% | |||||
| Annex 8 to the Criteria for assessing the degree of risk in the sphere of rendering medical services (assistance) |
List of subjective criteria for determining the degree of risk by subjective criteria
in the sphere of quality of medical services (care)
___________________________________________________________________
in accordance with Article 138
___________________________________________________________________
Entrepreneurial Code of the Republic of Kazakhstan in respect of
________________________________________________ entities (facilities),
providing dental care
___________________________________________________________________
name of homogeneous group of entities (facilities)
___________________________________________________________ of control
№ r/n | Indicator of the subjective criterion | Source of information on the subjective criterion indicator |
Weight by importance, point (the total should not exceed 100 points), | Conditions /values, xi | ||
condition 1/values | condition 2/values | condition 3/values | ||||
1 | 2 | 3 | 4 | 5 | ||
For preventive control with a visit | ||||||
1 |
Failure to fulfil recommendations issued as a result of preventive control without visiting the entities (facilities) of control |
results of preventive control without visiting the entities (facilities) of control (final documents issued based on the results of preventive control without visiting the entities (facilities) of control). | 100,0 | no | yes | |
0% | 100% | |||||
3 | Number of child deaths from 0-5 years of age | Results of monitoring of reports and information provided by the entity of control | 100,0 | no | yes | |
0 | 1 and more | |||||
For compliance inspections | ||||||
1 |
Availability of a certificate of a specialist for admission to clinical practice |
results of monitoring of reports and information provided by the entity of control | 50 | With a certificate | Without a certificate | |
0% | 100% | |||||
2 | The fact of re-registration of the licensee, change of its name or legal address and (or) reorganization of the legal entity-licensee | results of analysis of information provided by state bodies and organizations | 50 | yes | no | |
0% | 100% | |||||
| Annex 9 to the Criteria for assessing the degree of risk in the sphere of rendering medical services (assistance) |
List of subjective criteria for determining the degree of risk by subjective criteria
in the sphere of medical services (assistance)
___________________________________________________________________
in accordance with Article 138
___________________________________________________________________
Entrepreneurial Code of the Republic of Kazakhstan in respect of
________________________________________________ entities (facilities),
providing phthisiatric care _name of homogeneous group of entities (facilities)
___________________________________________________________ of the control
№ r/n | Subjective criterion indicator | Source of information on the subjective criterion indicator |
Specific weight in terms of significance, point (the total should not exceed 100 points), | Conditions /values, xi | ||
condition 1/values | condition 1/values | condition 1/values | ||||
1 | 2 | 3 | 4 | 5 | ||
For preventive control with a visit | ||||||
1 |
Failure to fulfil recommendations issued as a result of preventive control without visiting the entities (facilities) of control |
results of preventive control without visiting the entities (facilities) of control (final documents issued based on the results of preventive control without visiting the entities (facilities) of control). | 100,0 | no | yes | |
0% | 100% | |||||
3 | Annual mortality rate during planned hospitalisation | Results of monitoring of reports and information provided by the entity of control | 25,0 | 0 cases | More than 1 case | |
0% | 100,0 | |||||
4 | The rate of postoperative mortality in cases of planned hospitalisation - | results of monitoring of information received from automated information systems | 25,0 | 0-4,9% | 5-9,9% of cases | More than 10% of cases |
0% | 50% | 100% | ||||
For compliance verifications | ||||||
1 | Availability of a certificate of a specialist for admission to clinical practice |
results of monitoring of reports and information provided by the entity of control | 50 | With a certificate | Without a certificate | |
0% | 100% | |||||
2 | The fact of re-registration of the licensee, change of its name or legal address and (or) reorganization of the legal entity-licensee | results of analysis of information provided by state bodies and organizations | 50 | yes | no | |
0% | 100% | |||||
| Annex 10 to the Criteria for assessing the degree of risk in the sphere of rendering medical services (assistance) |
List of subjective criteria for determining the degree of risk by subjective criteria
in the sphere of medical services (assistance)
___________________________________________________________________
in accordance with Article 138
___________________________________________________________________
Entrepreneurial Code of the Republic of Kazakhstan in respect of
________________________________________________ entities (facilities),
providing oncological care _name of homogeneous group
entities (facilities)__________________________________________________________ of control
№ r/n | Subjective criterion indicator | Source of information on the subjective criterion indicator |
Specific weight in terms of significance, point (the total should not exceed 100 points), | Conditions /values, xi | ||
condition 1/values | condition 1/values | condition 1/values | ||||
1 | 2 | 3 | 4 | 5 | ||
For preventive control with a visit | ||||||
1 |
Failure to fulfil recommendations issued as a result of preventive control without visiting the entities (facilities) of control |
results of preventive control without visiting the entities (facilities) of control (final documents issued based on the results of preventive control without visiting the entities (facilities) of control). | 100,0 | no | yes | |
0% | 100% | |||||
3 | Annual mortality rate during planned hospitalisation | Results of monitoring of reports and information provided by the entity of control | 25,0 | 0 case | More than 1 case | |
0% | 100,0 | |||||
4 | The rate of postoperative mortality in cases of planned hospitalisation - | results of monitoring of information received from automated information systems | 25,0 | 0-4,9% | 5-9,9% of cases | More than 10% of cases |
0% | 50% | 100% | ||||
5 | Annual rate of repeated unplanned admissions (within a month for the same illness) - | Results of monitoring of reports and information provided by the entity of control | 10,0 | 0-5% of cases | 5,1-10% of cases | More than 10% of cases |
0% | 50% | 100% | ||||
For compliance inspections | ||||||
1 |
Availability of a certificate of a specialist for admission to clinical practice |
results of monitoring of reports and information provided by the subject of control | 50 | With a certificate | Without a certificate | |
0% | 100% | |||||
2 | The fact of re-registration of the licensee, change of its name or legal address and (or) reorganization of the legal entity-licensee | results of analysis of information provided by state bodies and organizations | 50 | yes | no | |
0% | 100% | |||||
| Annex 11 | |
| to the Criteria for assessing the degree of risk in the sphere of rendering |
|
| medical services (assistance) |
List of subjective criteria for determining the degree of risk by subjective criteria
in the sphere of medical services (assistance)
___________________________________________________________________
in accordance with Article 138
___________________________________________________________________
Entrepreneurial Code of the Republic of Kazakhstan in respect of
________________________________________________ entities (facilities),
providing medical and social assistance in the field of mental health
___________________________________________________________________
name of homogeneous group of entities (facilities)
__________________________________________________________ of control
№ r/n | Subjective criterion indicator | Source of information on the subjective criterion indicator |
Specific weight in terms of significance, point (the total should not exceed 100 points), | Conditions /values, xi | ||
condition 1/values | condition 1/values | condition 1/values | ||||
1 | 2 | 3 | 4 | 5 | ||
For preventive control with a visit | ||||||
1 |
Failure to fulfil recommendations issued as a result of preventive control without visiting the entities (facilities) of control |
results of preventive control without visiting the entities (facilities) of control (final documents issued based on the results of preventive control without visiting the entities (facilities) of control). | 100,0 | no | yes | |
0% | 100% | |||||
2 | Annual mortality rate during planned hospitalisation of patients with mental and behavioural disorders, including substance use F00-F99 (Percentage of inpatient deaths out of the total number of patients discharged (discharged patient, died)). | results of monitoring of information received from automated information systems | 25,0 | 0-10 % of cases | 10,1-25% of cases | More than 25% of cases |
0% | 50% | 100% | ||||
3 | Presence of cases of inappropriate length of stay (3 beds/day or less) (The proportion (%) of inpatient discharges with a length of stay of 3 nights/day or less out of the total number of patients (discharged) with mental and behavioural disorders F00-F99, including those due to substance (ПАВ) use). | results of monitoring of information received from automated information systems | 10,0 | 0-10 % of cases | 10,1-20% of cases | More than 20 % of cases |
0% | 50% | 100% | ||||
For compliance inspections | ||||||
1 | Availability of a certificate of a specialist for admission to clinical practice |
results of monitoring of reports and information provided by the subject of control | 50 | With a certificate | Without a certificate | |
0% | 100% | |||||
2 | The fact of re-registration of the licensee, change of its name or legal address and (or) reorganization of the legal entity-licensee | results of analysis of information provided by state bodies and organizations | 50 | yes | no | |
0% | 100% | |||||
| Annex 12 to the Criteria for assessing the degree of risk in the sphere of rendering medical services (assistance) |
List of subjective criteria for determining the degree of risk by subjective criteria
in the sphere of medical services (assistance)
___________________________________________________________________
in accordance with Article 138
___________________________________________________________________
Entrepreneurial Code of the Republic of Kazakhstan in respect of
________________________________________________ entities (facilities),
providing laboratory services
___________________________________________________________________
name of homogeneous group of entities (facilities)
__________________________________________________________ of control
№ r/n | Subjective criterion indicator | Source of information on the subjective criterion indicator |
Specific weight in terms of significance, point (the total should not exceed 100 points), | Conditions /values, xi | ||
condition 1/values | condition 1/values | condition 1/values | ||||
1 | 2 | 3 | 4 | 5 | ||
For preventive control with a visit | ||||||
1 | Failure to fulfil recommendations issued as a result of preventive control without visiting the entities (facilities) of control | results of preventive control without visiting the entities (facilities) of control (final documents issued based on the results of preventive control without visiting the entities (facilities) of control). | 100,0 | no | yes | |
0% | 100% | |||||
For compliance inspections | ||||||
1 | Availability of a certificate of a specialist for admission to clinical practice | results of monitoring of reports and information provided by the facility of control (e-license) | 50 | With a certificate | Without a certificate | |
0% | 100% | |||||
2 | The fact of re-registration of the licensee, change of its name or legal address and (or) reorganization of the legal entity-licensee | results of analysis of information provided by state bodies and organizations | 50 | yes | no | |
0% | 100% | |||||
| Annex 13 to the Criteria for assessing the degree of risk in the sphere of rendering medical services (assistance) |
List of subjective criteria for determining the degree of risk by subjective criteria
in the sphere of medical services (assistance)
___________________________________________________________________
in accordance with Article 138
___________________________________________________________________
Entrepreneurial Code of the Republic of Kazakhstan in respect of
________________________________________________ entities (facilities),
providing ambulance medical aid, medical aid in the form of
air ambulance _________________________________________________
name of homogeneous group of entities (facilities)
__________________________________________________________ of control
№ r/n | Subjective criterion indicator | Source of information on the subjective criterion indicator |
Specific weight in terms of significance, point (the total should not exceed 100 points), | Conditions /values, xi | ||
condition 1/values | condition 1/values | condition 1/values | ||||
1 | 2 | 3 | 4 | 5 | ||
For preventive control with a visit | ||||||
1 | Number of cases of deviations from the time of arrival in the relevant category (for organisations providing emergency medical care) over the past year | results of monitoring of reports and information provided by the entity of control | 50,0 | 0-4 cases | 5-9 cases | More than 10 cases |
0% | 50% | 100% | ||||
2 | Number of repeat visits for the same incident within a 24-hour period in the past year | Results of monitoring of reports and information provided by the entity of control | 50,0 | 0-4 cases | 5-9 cases | More than 10 cases |
0% | 50% | 100% | ||||
3 | Failure to fulfil recommendations issued as a result of preventive control without visiting the entity (facility) of control | results of preventive control without visiting the entity (facility) of control (final documents issued based on the results of preventive control without visiting the entity (facility) of control). | 100,0 | no | yes | |
0% | 100% | |||||
For compliance inspections | ||||||
1 | Availability of a certificate of a specialist for admission to clinical practice |
results of monitoring of reports and information provided by the entity of control | 50 | With a certificate | Without a certificate | |
0% | 100% | |||||
2 | The fact of re-registration of the licensee, change of its name or legal address and (or) reorganization of the legal entity-licensee | results of analysis of information provided by state bodies and organizations | 50 | yes | no | |
0% | 100% | |||||
| Annex 14 to the Criteria for assessing the degree of risk in the sphere of rendering medical services (assistance) |
List of subjective criteria for determining the degree of risk by subjective criteria
in the sphere of medical services (assistance)
___________________________________________________________________
in accordance with Article 138
___________________________________________________________________
Entrepreneurial Code of the Republic of Kazakhstan in respect of
________________________________________________ entities (facilities),
carrying out activities in the area of HIV prevention
__________________________________________________________________
Name of homogeneous group of entities (facilities) of control
№ r/n | Subjective criterion indicator | Source of information on the subjective criterion indicator |
Specific weight in terms of significance, point (the total should not exceed 100 points), | Conditions /values, xi | ||
condition 1/values | condition 1/values | condition 1/values | ||||
1 | 2 | 3 | 4 | 5 | ||
For preventive control with a visit | ||||||
1 |
Failure to fulfil recommendations issued as a result of preventive control without visiting the entities (facilities) of control |
results of preventive control without visiting the entities (facilities) of control (final documents issued based on the results of preventive control without visiting the entities (facilities) of control). | 100,0 | no | yes | |
0% | 100% | |||||
For compliance inspections | ||||||
1 | Availability of a certificate of a specialist for admission to clinical practice |
results of monitoring of reports and information provided by the subject of control | 50 | With a certificate | Without a certificate | |
0% | 100% | |||||
2 | The fact of re-registration of the licensee, change of its name or legal address and (or) reorganization of the legal entity-licensee | results of analysis of information provided by state bodies and organizations | 50 | yes | no | |
0% | 100% | |||||
| Annex 15 to the Criteria for assessing the degree of risk in the sphere of rendering medical services (assistance) |
List of subjective criteria for determining the degree of risk by subjective criteria
in the sphere of medical services (assistance)
___________________________________________________________________
in accordance with Article 138
___________________________________________________________________
Entrepreneurial Code of the Republic of Kazakhstan in respect of
___________________________________________________________________
entities (facilities) carrying out activities in the field of blood service
___________________________________________________________________
name of homogeneous group of entities (facilities)
__________________________________________________________of control
№ r/n | Subjective criterion indicator | Source of information on the subjective criterion indicator |
Specific weight in terms of significance, point (the total should not exceed 100 points), | Conditions /values, xi | ||
condition 1/values | condition 1/values | condition 1/values | ||||
1 | 2 | 3 | 4 | 5 | ||
For preventive control with a visit | ||||||
1 |
Failure to fulfil recommendations issued as a result of preventive control without visiting the entities (facilities) of control |
results of preventive control without visiting the entities (facilities) of control (final documents issued based on the results of preventive control without visiting the entities (facilities) of control). | 100,0 | no | yes | |
0% | 100% | |||||
For compliance verifications | ||||||
1 | Availability of a certificate of a specialist for admission to clinical practice |
results of monitoring of reports and information provided by the entity of control | 50 | With a certificate | Without a certificate | |
0% | 100% | |||||
2 | The fact of re-registration of the licensee, change of its name or legal address and (or) reorganization of the legal entity-licensee | results of analysis of information provided by state bodies and organizations | 50 | yes | no | |
0% | 100% | |||||
| Annex 16 to the Criteria for assessing the degree of risk in the sphere of rendering medical services (assistance) |
List of subjective criteria for determining the degree of risk by subjective criteria
in the sphere of medical services (assistance)
__________________________________________________________________
in accordance with Article 138
__________________________________________________________________
Entrepreneurial Code of the Republic of Kazakhstan in respect of
__________________________________________________________________
entities (facilities) providing pathological anatomical diagnostics
__________________________________________________________________
name of homogeneous group of entities (facilities)
__________________________________________________________ of control
№ r/n | Subjective criterion indicator | Source of information on the subjective criterion indicator |
Specific weight in terms of significance, point (the total should not exceed 100 points), | Conditions /values, xi | ||
condition 1/values | condition 1/values | condition 1/values | ||||
1 | 2 | 3 | 4 | 5 | ||
For preventive control with a visit | ||||||
1 |
Failure to fulfil recommendations issued as a result of preventive control without visiting the entities (facilities) of control |
results of preventive control without visiting the entities (facilities) of control (final documents issued based on the results of preventive control without visiting the entities (facilities) of control). | 100,0 | no | yes | |
0% | 100% | |||||
For compliance verifications | ||||||
1 | Availability of a certificate of a specialist for admission to clinical practice |
results of monitoring of reports and information provided by the subject of control | 50 | With a certificate | Without a certificate | |
0% | 100% | |||||
2 | The fact of re-registration of the licensee, change of its name or legal address and (or) reorganization of the legal entity-licensee | results of analysis of information provided by state bodies and organizations | 50 | yes | no | |
0% | 100% | |||||
| Annex 17 to the Criteria for assessing the degree of risk in the sphere of rendering medical services (assistance) |
List of subjective criteria for determining the degree of risk by subjective criteria
in the sphere of medical services (assistance)
___________________________________________________________________
in accordance with Article 138
___________________________________________________________________
Entrepreneurial Code of the Republic of Kazakhstan in respect of
___________________________________________________________________
entities (facilities) providing assistance in the field of nuclear medicine
___________________________________________________________________
name of homogeneous group of entities (facilities)
___________________________________________________________ of control
№ r/n | Subjective criterion indicator | Source of information on the subjective criterion indicator |
Specific weight in terms of significance, point (the total should not exceed 100 points), | Conditions /values, xi | ||
condition 1/values | condition 1/values | condition 1/values | ||||
1 | 2 | 3 | 4 | 5 | ||
For preventive control with a visit | ||||||
1 |
Failure to fulfil recommendations issued as a result of preventive control without visiting the entities (facilities) of control |
results of preventive control without visiting the entities (facilities) of control (final documents issued based on the results of preventive control without visiting the entities (facilities) of control). | 100,0 | no | yes | |
0% | 100% | |||||
For compliance inspections | ||||||
1 | Availability of a certificate of a specialist for admission to clinical practice |
results of monitoring of reports and information provided by the subject of control | 50 | With a certificate | Without a certificate | |
0% | 100% | |||||
2 | The fact of re-registration of the licensee, change of its name or legal address and (or) reorganization of the legal entity-licensee | results of analysis of information provided by state bodies and organizations | 50 | yes | no | |
0% | 100% | |||||
| Annex 2 to the joint order of the Minister of Healthcare of the Republic of Kazakhstan dated November 15, 2018 № RK MH-32 and the Minister of National Economy of the Republic of Kazakhstan dated November 15, 2018 № 70 |
Checklist
Footnote. Annex 2 – in the wording of the joint order of the Minister of Healthcare of the RK dated 29.05.2023 № 90 and the Minister of National Economy of the RK dated 29.05.2023 № 91 (shall enter into force upon expiry of ten calendar days after the day of its first official publication).
in the area of quality of health care delivery
_________________________________________________________________
in accordance with Article 138
_________________________________________________________________
Entrepreneurial Code of the Republic of Kazakhstan in respect of
______________________________________________ entities (facilities),
providing in-patient, in-patient substitute care
name of homogeneous group of control entities (facilities)
____________________________________________________________________
State body that appointed the inspection/preventive control
with a visit to the entity (facility) of control
____________________________________________________________________
____________________________________________________________________
Act on the appointment of an inspection/preventive control with a visit to the entities
(facilities) of control (facility) of control
_____________________________________________________________________
______________________________________________________________ №, date
Name of the entities (facilities) of control ________________________________
______________________________________________________________________
(Individual identification number), business identification number
of the entities (facilities) of control _____________________________________________
______________________________________________________________________
Address of residence ________________________________________________
___________________________________________________________
______________________________________________________________________
№ | List of requirements | Complies with the requirements | Does not comply with the requirements |
1 | 2 | 3 | 4 |
1 | Availability of supporting documentation on the provision of medical care included in the guaranteed volume of free medical care and (or) the system of compulsory social health insurance on a free-of-charge basis | ||
2 | Availability of a conclusion on the compliance of the health care entity to provide high-tech medical care | ||
3 | Presence of written voluntary consent of the patient or his/her legal representative in case of invasive interventions and therapeutic and diagnostic measures. | ||
4 |
Availability of supporting documentation (form № 085/y "emergency medical care team EMCT call card", admission and refusal of hospitalisation log, form № 001/y "medical card of an inpatient"), that the stay of the emergency medical care team or EMCT department in the hospital's emergency room shall not exceed 10 minutes (the time for transferring the patient to the emergency room doctor) from the moment of its arrival at the hospital, except in cases of emergency medical care in emergency situations. | ||
5 | Availability of supporting medical documentation (form № 001/y "Inpatient medical card") on hospitalisation of a severe patient in need of continuous monitoring of vital functions for medical reasons, by the decision of a Concilium and notification of the heads of healthcare organisations with subsequent transfer to another medical organisation according to the profile of the disease for further examination and treatment after stabilisation of the condition | ||
6 |
Availability of supporting documentation on the medical opinion of the emergency room doctor with a written justification of the refusal in the absence of indications for hospitalisation in a health care organisation (Journal of admissions and refusals of hospitalisation from medical information systems, certificate in form № 027/y (refusals of hospitalisation)). | ||
7 |
Presence of records in medical documentation (Journal of patient admission and refusals of hospitalisation from the MIS, scheduled hospitalisation coupons, "Medical card of an inpatient" (form № 001/y) on indications for hospitalisation: | ||
8 | Availability of supporting medical documentation (form № 001/y "Medical card of inpatient") on the examination of heavy patients by the head of the department on the day of admission, and daily thereafter. Patients in a moderately severe condition shall be examined at least once a week. The results of the patient's examination shall be recorded in the medical record with recommendations on further tactics of patient management with obligatory identification of the medical worker making the entries | ||
9 | The presence of an established clinical diagnosis in conjunction with the head of department no later than three working days from the day of the patient's admission to the health care organisation in form № 001/y "Medical card of inpatient". | ||
10 |
Availability of supporting documentation (Form № 001/y "Medical card of inpatient") on daily examination of patients in the hospital by the attending a physician, except for weekends and public holidays. In case of examination and appointment of additional diagnostic and therapeutic manipulations by the doctor on duty, appropriate entries shall be made in the medical record. If the patient's condition worsens, the doctor on duty notifies the head of the department and (or) the attending physician, approves changes in the process of diagnosis and treatment, and makes an entry in the medical record (paper and (or) electronic) version. | ||
11 |
Compliance with the requirements for planned hospitalisation: | ||
12 | Availability of medical records of consultations or Concilium in case of difficulty in identifying the diagnosis, ineffectiveness of the current treatment, as well as other indications | ||
13 |
Availability of medical documentation of compliance with discharge criteria, in particular: | ||
14 | A discharge summary shall be issued to the patient upon discharge, indicating the full clinical diagnosis, the scope of diagnostic tests, therapeutic measures and recommendations for further follow-up and treatment. Discharge data shall be entered into the information systems on a day-to-day basis, indicating the actual time of discharge. | ||
15 |
Availability of documentation on compliance with the requirements for transfusion of blood components and in case of complications (orders on establishment of the commission, algorithm of staff interaction, "Medical card of an inpatient" form № 001/y): | ||
16 |
Availability of supporting medical documentation on indications for hospitalisation in day hospital at outpatient and polyclinic health care organisations and in hospital at home: | ||
17 |
Availability of medical documentation on examination of individuals for HIV infection on clinical indications when the following diseases, syndromes and symptoms shall be detected: | ||
18 | Availability of an agreement for provision of paid medical services in healthcare organisations. Availability of documents establishing the fact of co-payment | ||
19 |
Availability of medical documentation on compliance with the following requirements during the examination of temporary incapacity for work, issuance of temporary incapacity for work and certificates of temporary incapacity for work (form № 001/y "Medical card of hospital patient", form № 052/y "Medical card of hospital patient", stubs of sheets of temporary incapacity for work of patients, form № 025/y "Journal for recording conclusions of medical advisory commission", form № 029/y "Book of registration of sheets of temporary incapacity for work", form № 037/y "Certificate of temporary incapacity for work", form № 037/y "Certificate of temporary incapacity for work", form № 037/y "Certificate of temporary incapacity for work", form № 037/y "Certificate of temporary incapacity for work". | ||
20 |
Availability of documentation (internal orders, regulations, protocols, questionnaires, analyses) of the clinical audit conducted by the Patient support service and internal expertise and its evaluation according to the following criteria: | ||
21 |
There is documentation of compliance with the following actions when performing pathological autopsies: | ||
22 | Availability of a written application from the spouse, close relatives or legal representatives of the deceased, or a written will be given by the person during his/her lifetime to release the corpse without a pathological anatomical autopsy, in the absence of suspicion of violent death | ||
23 | Availability of a medical worker's entry in the medical documentation with the subsequent collection of biological materials to determine the content of a psychoactive substance and recording the results in the medical record when signs of psychoactive substance use are detected during the application for medical assistance to a health care organisation without issuing a medical examination conclusion to establish the fact of psychoactive substance use and the state of intoxication. | ||
24 | Availability of medical documentation on treatment and diagnostic measures, medication, therapeutic nutrition and appropriate care of the patient from the moment of admission to the health care organisation (Medical card of an inpatient" form № 001/y) | ||
25 | Availability of medical documentation on the use of opportunities for consultation with relevant national organisations, through the telemedicine network in case of difficulties in verifying the diagnosis of the child and determining the tactics of management. If necessary, the child is transferred to specialised national organisations. | ||
26 | Medical documentation of supportive care (support for adequate feeding, water balance, pain control, fever management, oxygen therapy). | ||
27 | Medical documentation of the use of less painful, equally effective alternative treatments when available, to avoid unnecessary painful procedures | ||
28 | Availability of medical documentation on daily examination of the child by a doctor, examination by the head of the department (on admission on the first day, repeatedly at least once a week) | ||
29 |
Availability of medical documentation on compliance with the requirements of anaesthesia and resuscitation care: | ||
30 | Availability of medical documentation on compliance of treatment and diagnostic measures with the recommendations of clinical protocols | ||
31 | Availability of medical documentation on the provision of the first stage of medical rehabilitation for the main disease (form № 001/y "Medical card of an inpatient", "form № 047/y" rehabilitation card). | ||
32 | Availability of medical documentation on the examination by the head of the department upon admission of neurosurgical patients and subsequently, if necessary, on the disease (Medical card of an inpatient form № 001/y) |
Official(s) ____________________________________ ____________
position signature
________________________________________________________________________
surname, first name, patronymic (if any)
Head of the subject of control _______________________________ ____________
position signature
________________________________________________________________________
surname, first name, patronymic (if any)
Checklist
Footnote. Annex 3 - in the wording of the joint order of the Minister of Healthcare of the RK dated 29.05.2023 № 90 and the Minister of National Economy of the RK dated 29.05.2023 № 91 (shall enter into force upon expiry of ten calendar days after the date of its first official publication).
in the area of quality of health care delivery
___________________________________________________________________
in accordance with Article 138
___________________________________________________________________
Entrepreneurial Code of the Republic of Kazakhstan in respect of
___________________________________________________________________
entities (facilities) providing outpatient and polyclinic care
(primary medical and sanitary care and consultative-diagnostic
assistance)
___________________________________________________________________
name of a homogeneous group of control entities (facilities) ____________________
_____________________________________________________________________
State body that ordered the inspection/preventive control
with a visit to the entities (facilities) of control
___________________________________________________________________
___________________________________________________________________
Act on the appointment of an inspection/preventive control with a visit to the entities
(facilities) of control (facility) of control
____________________________________________________________________
_____________________________________________________________ №, date
Name of the entity (facility) of control _______________________________
_____________________________________________________________________
(Individual identification number), business identification number
of the entity (facility) of control ____________________________________________
_____________________________________________________________________
Address of residence_____________________________________________________
_____________________________________________________________________
№ | List of requirements | Complies with the requirements | Does not comply with the requirements |
1 | 2 | 3 | 4 |
1 | Availability of supporting documentation on the provision of medical care included in the guaranteed scope of free medical care and (or) the system of compulsory social health insurance on a free-of-charge basis | ||
2 | Presence of written voluntary consent of the patient or his/her legal representative for invasive interventions and therapeutic and diagnostic measures | ||
3 | Availability of medical records of an outpatient patient on compliance of treatment and diagnostic measures with the recommendations of clinical protocols | ||
4 |
Availability of documentation on compliance with the following requirements when organising and conducting a medical advisory board: | ||
5 |
Availability of documentation on compliance by primary health care organisations in conducting preventive medical examinations of target population groups: | ||
6 |
Availability of documentation on compliance with the levels of medical rehabilitation provision to patients: | ||
7 |
Availability of documentation on compliance of tuberculosis care at the outpatient and polyclinic level with the following requirements: | ||
8 |
Availability of documentation on compliance with the requirements for oncological care in the form of outpatient care: | ||
9 77 | Availability of mandatory confidential medical screening for HIV infection of individuals on clinical and epidemiological indications, including sexual partners of pregnant women, individuals who applied voluntarily and anonymously | ||
10 |
Documentation of compliance with the following measures by an obstetrician-gynaecologist when a woman applies for pregnancy at the peri-pregnancy stage and wishes to continue the pregnancy: | ||
11 |
Availability of documentation on compliance with the requirements of an obstetrician-gynaecologist for the provision and organisation of obstetric and gynaecological care to women during pregnancy, after childbirth, provision of family planning and reproductive health services, as well as prevention, diagnosis and treatment of gynaecological diseases of the reproductive system | ||
12 | Availability of results and additional data of follow-up examinations and investigations in the Individual card of pregnant and maternity women and the exchange card of pregnant and maternity women at each visit of a pregnant woman to an obstetrician-gynaecologist | ||
13 | Home patronage by a midwife or a patronage nurse for pregnant women who do not attend an appointment within 3 days of the scheduled date. | ||
14 | Availability of a medical advisory commission's opinion on the possibility of carrying a pregnancy in women with contraindications to pregnancy due to extragenital pathology. | ||
15 | Availability of an agreement for provision of paid medical services in healthcare organisations. Availability of documents establishing the fact of co-payment | ||
16 |
Availability of documentation on compliance by the paramedical staff of the medical unit of the educational organisation with the following requirements: | ||
17 |
Availability of medical documentation on compliance with the following requirements during the examination of temporary incapacity for work, issuance of temporary incapacity for work and certificates of temporary incapacity for work (form № 001/y "Medical card of inpatient patient", form № 052/y "Medical card of outpatient patient", stubs of sheets of temporary incapacity for work of patients, form № 025/y "Journal for recording conclusions of medical advisory commission", form № 029/y "Book of registration of sheets of temporary incapacity for work", form № 037/y "Certificate of temporary incapacity for work", form № 037/y "Certificate of temporary incapacity for work", form № 037/y "Certificate of temporary incapacity for work", form № 037/y "Certificate of temporary incapacity for work". | ||
18 |
Compliance with the following requirements when issuing a maternity leave and certificate of temporary incapacity for work: | ||
19 |
Availability of documentation (internal orders, regulations, protocols, questionnaires, analyses) of the clinical audit by the Patient Support Service and internal expertise and its evaluation according to the following criteria: | ||
20 | Availability of documentation on compliance with the requirements for the guaranteed volume of free medical care | ||
21 |
Availability of documentation on compliance with the requirements of surgical (abdominal, thoracic, coloproctological) care to patients at the outpatient and polyclinic level | ||
22 | Availability of documentation on compliance with the requirements of primary health care organisations for dynamic monitoring of individuals with chronic diseases, compliance with the frequency and timing of monitoring, mandatory minimum and frequency of diagnostic tests | ||
23 | Availability of documentation on compliance with the requirements for active home visits by primary health care workers | ||
24 |
Availability of documentation on compliance with the requirements for paediatric care: | ||
25 |
Availability of documentation on compliance with the requirements for traumatological and orthopaedic care at the outpatient and polyclinic level | ||
26 |
Availability of documentation on compliance with the requirements of neurological care at outpatient and polyclinic level | ||
27 |
Availability of documentation of compliance with nephrological care, which includes: | ||
28 |
Availability of documentation on compliance with the requirements of neurosurgical care in outpatient settings | ||
29 |
Availability of documentation on compliance with the requirements of neurological care at outpatient and polyclinic level | ||
30 | Reasoned execution of the notification of the expert conclusion of medical and social expertise, form № 031/e (availability of data for a comprehensive assessment of the state of the organism and the degree of restriction of life activity) |
Official(s) ____________________________________ ____________
position signature
________________________________________________________________________
surname, first name, patronymic (if any)
Head of the entity of control _______________________________ ____________
position signature
_________________________________________________________________________
surname, first name, patronymic (if any)
Checklist
Footnote. Annex 4 - in the wording of the joint order of the Minister of Healthcare of the RK dated 29.05.2023 № 90 and the Minister of National Economy of the RK dated 29.05.2023 № 91 (shall enter into force upon expiry of ten calendar days after the day of its first official publication).
in the area of quality of health care delivery
____________________________________________________________________
in accordance with Article 138
____________________________________________________________________
Entrepreneurial Code of the Republic of Kazakhstan in respect of
____________________________________________________________________
entities (facilities), obstetrical and (or) in-patient organisations,
having maternity wards and departments of pathology of new-borns
name of a homogeneous group of control entities (facilities)
____________________________________________________________________
State body that ordered the inspection/preventive control
with a visit to the entity (facility) of control
____________________________________________________________________
____________________________________________________________________
Act on the appointment of an inspection/preventive control with a visit to the entity (facility) of control
(facility)) of control
____________________________________________________________________
_____________________________________________________________ №, date
Name of the entity (facility) of control ________________________________
______________________________________________________________________
(Individual identification number), business identification number
of the entity (facility) of control _____________________________________________
______________________________________________________________________
Address of residence ________________________________________________
______________________________________________________________________
№ | List of requirements | Complies with the requirements | Does not comply with the requirements |
1 | 2 | 3 | 4 |
1 | Availability of an opinion on the compliance of a healthcare entity to provide high-tech medical care when the organisation provides high-tech services, including in vitro fertilisation | ||
2 | Availability of supporting documentation on the provision of medical care included in the guaranteed volume of free medical care and (or) the system of compulsory social health insurance on a free-of-charge basis | ||
3 | Presence of written voluntary consent of the patient or his/her legal representative for invasive interventions and therapeutic and diagnostic measures | ||
4 |
Availability of supporting documentation (emergency medical team call card form № 085/y, admission and refusal of hospitalisation log, inpatient medical card form № 001/y) that the stay of the emergency medical team or emergency medical care department in the hospital's emergency room shall not exceed 10 minutes (the time for transferring the patient to the emergency room doctor) from the moment of its arrival at the hospital, except in cases of emergency medical care in emergency situations. | ||
5 |
Availability of a medical report issued by the doctor of the emergency room with a written justification of the refusal in the absence of indications for hospitalisation in a health care organisation. | ||
6 |
Availability of supporting records in medical documentation on indications for hospitalisation: | ||
7 | There shall be records in the medical records of the examination of heavy patients by the head of the department on the day of admission, and daily thereafter. Patients in a moderately severe condition shall be examined at least once a week. Presence of the results of the patient's examination recorded in the medical record with recommendations on further tactics of patient management with obligatory identification of the medical worker making the entries | ||
8 | Presence of records in the medical records confirming the daily examination of inpatients by the attending physician, except for weekends and public holidays. Appropriate entries in the medical records for examination and prescription of additional diagnostic and therapeutic manipulations by the doctor on duty | ||
9 | Justification in the medical record for dynamic assessment of the patient's condition according to clinical protocols of diagnosis and treatment when additional and repeated tests performed before hospitalisation in primary health care or other health care organisations shall be identified for medical reasons | ||
10 |
Availability of supporting documentation that the following requirements shall have been met when issuing a maternity leave and certificate of temporary disability: | ||
11 |
Availability of medical documentation on compliance with the following requirements during the examination of temporary incapacity for work, issuance of certificates and certificates of temporary incapacity for work (form № 001/y "Medical card of inpatient patient", form № 052/y "Medical card of outpatient patient", stubs of certificates of temporary incapacity for work of patients, form № 025/y "Journal for recording conclusions of medical advisory commission", form № 029/y "Book of registration of certificates of temporary inability to work", form № 037/y "Certificate №__________ on temporary disability of a student, college student, vocational school, sickness, quarantine and other reasons for absence of a child attending school, pre-school organisation (underline)", form № 038/y "Certificate №______ on temporary disability" and others): | ||
12 | Availability of informed written consent of the patient for transfusion of blood components | ||
13 |
There shall be records in the medical documentation on compliance with the requirements for transfusion of blood components. | ||
14 |
There shall be documentation of compliance with the following actions when performing pathological autopsies: | ||
15 |
Availability of supporting documentation on compliance with the following requirements in the organisation of obstetric and gynaecological care at the outpatient and polyclinic level: | ||
16 | The use of sex cells, tissues of reproductive organs by a recipient who is (are) married (spouse) shall be carried out with the written consent of both spouses. | ||
17 | Availability of supporting documentation on the birth of 10 (ten) children from one donor 6 which is the basis for termination of the use of this donor for recipients. | ||
18 |
Availability of supporting documentation on donation of germ cells, tissues of reproductive organs from the donor under the following conditions: | ||
19 | Oocyte donation shall be carried out with the donor's written informed consent for superovulation induction or in a natural cycle in compliance with the requirements for donors of germ cells, tissues of reproductive organs, and oocyte donors undergo medical and genetic examinations. | ||
20 |
Availability of supporting documentation on in vitro fertilisation (hereinafter referred to as IVF) using donor oocytes shall be carried out according to the indications: | ||
21 | Availability of supporting documentation on work with donors by an obstetrician-gynaecologist (reproductologist), medical examination of the donor before each procedure of donor material collection, controls the timeliness and results of laboratory tests in accordance with the calendar plan of examination. | ||
22 |
Availability of supporting documentation on oocyte donation according to the following algorithm: | ||
23 |
Availability of supporting documentation of compliance with the requirements for refusal of IVF using donor oocytes for the following contraindications: | ||
24 |
Availability of supporting documentation on the use of donor sperm in assisted reproductive methods and technologies (hereinafter referred to as the ART). Sexual abstinence shall be required for 3-5 days before sperm donation. Sperm shall be obtained by masturbation. The ejaculate shall be collected in a special sterile, pre-labelled container. This procedure shall be carried out in a special room with a separate entrance, appropriate interior, sanitary unit with a washbasin. In the absence of donor sperm in the medical organisation, or at the patient's request, donor sperm from other organisations that have a donor sperm bank is used. | ||
25 |
IVF with the use of donor sperm shall be performed when indicated | ||
26 | The individual donor card shall be filled out and coded by a doctor. The coding scheme shall be free. The donor's application and his/her individual card shall be kept in a safe as documents for official use. | ||
27 |
Availability of supporting documentation on work with donors by a doctor-uroandrologist and a doctor-embryologist. The doctor organises medical examinations of the donor, controls the timeliness and results of laboratory tests in accordance with the calendar plan of examination. | ||
28 |
Availability of supporting documentation of compliance, that the embryo donors shall be IVF patients who have unused cryopreserved embryos left in the bank. Upon free decision and written informed consent of the patients, these embryos shall be disposed of or donated to a medical organisation. Embryos transferred to the medical organisation shall be used for donation free of charge to infertile married couples, women (recipients) who shall not be married (matrimonial). | ||
29 | Availability of supporting documentation of compliance with assisted reproductive techniques and technologies | ||
30 |
Availability of supporting documentation of the following functions in the provision of pre-hospital care to women during and outside pregnancy by paramedics (obstetricians, paramedics, nurses/nurses): | ||
31 |
Availability of supporting documentation on compliance with the following requirements when organising obstetric and gynaecological care at the inpatient level: | ||
Provision of medical care to new-borns | |||
32 |
Availability of supporting documentation on compliance with the following requirements when organising medical care for new-borns at the inpatient level: | ||
33 |
Availability of supporting documentation on compliance with the requirements for the provision of medical care to new-borns in third-level medical organisations: | ||
34 | Supporting documentation of compliance with requirements to provide a healthy new-born with basic care, including prevention of hypothermia with "heat chain", skin-to-skin or skin-to-skin contact with the mother, early initiation of breastfeeding within the first hour (if the infant shows signs of readiness), and prevention of hospital-acquired infections. | ||
35 | Availability of supporting documentation of compliance with the requirements of healthy new-born anthropometry, full examination and other measures 2 hours after delivery | ||
36 | Availability of supporting documentation on compliance with the requirements of emergency medical care in case of detection of disorders of the new-born’s condition, transfer to the intensive care ward or neonatal intensive care unit, if indicated. | ||
37 |
Availability of supporting documentation of compliance with requirements for observation of the mother and healthy new-born in the labour ward by an obstetrician within two hours of birth: | ||
38 | Availability of supporting documentation of compliance with the transfer 2 hours after birth of a healthy new-born with the mother to a mother-baby unit | ||
39 | Supporting documentation of round-the-clock observation by medical staff and continuous involvement of the mother in the care of the child, except in cases of moderate and severe maternal conditions in the postnatal ward in the mother-baby wards. | ||
40 | Availability of supporting documentation on compliance with the requirements for dynamic monitoring of the new-born with timely detection of disorders of the new-born’s condition, conducting the necessary examination, examination by the head of the department, organisation of a Concilium to clarify the tactics of management. Provision of emergency medical care when indicated, timely transfer to an intensive care ward or neonatal intensive care unit | ||
41 |
Compliance with the requirements for medical workers in the wards of joint stay of mother and child: | ||
42 | A record in medical records of daily check-ups of new-borns by a neonatologist, consultations with mothers on care, prevention of hypothermia and vaccinations | ||
43 | Availability of supporting documentation on compliance with the requirements to organise consultations by specialised specialists, with therapeutic and diagnostic measures and recommendations to the mother on examination, treatment and rehabilitation in the presence of three or more developmental micro-anomalies or the detection of congenital pathology of new-borns. | ||
44 | Availability of supporting documentation on compliance with the requirements of medical care in case of emergency conditions in the new-born (asphyxia, respiratory distress syndrome, etc.) Stabilisation of its condition and determination of the degree of readiness for transportation with the mother to the second or third level obstetric care organisation. | ||
45 | Availability of supporting documentation on vaccination of new-borns on the basis of voluntary informed consent of parents (mother, father or legal representatives) for prophylactic vaccinations within the terms of prophylactic vaccinations in the Republic of Kazakhstan. | ||
46 | Availability of supporting documentation of compliance with the requirements for all new-borns to undergo neonatal screening for phenylketonuria, congenital hypothyroidism and audiological screening prior to discharge | ||
47 | Availability of supporting documentation on compliance with the requirements for a neonatologist to assess the severity of the condition, stabilise the condition, assess the degree of readiness for transport in the event of emergency conditions in the new-born, and arrange its transfer with the mother (in coordination with the obstetrician-gynaecologist) to a second- or third-level medical organisation. | ||
48 | Availability of supporting documentation on compliance with the requirements in case of suspicion and (or) detection of acute surgical pathology in a new-born, in case of emergency consultation of a doctor in the speciality "Paediatric surgery (neonatal surgery)". After stabilisation of vital signs, the new-born shall be transferred to the surgical department of another medical organisation (children's or multidisciplinary hospital) or to a neonatal (or paediatric) surgical department, if there is one within the structure of the obstetric medical organisation, to provide the appropriate specialised medical care. | ||
49 | Availability of supporting documentation on compliance with the requirements for transfer to a paediatric inpatient facility for premature new-borns after 28 days of age or premature new-borns after post-conceptional age of 42 weeks who require further round-the-clock medical care. | ||
50 | Mandatory pathological and anatomical examination of the foetus and placenta in cases of medical termination of pregnancy for suspected congenital anomalies in the foetus. | ||
51 | Documentation of clinical and pathological review of all maternal and infant deaths after all pathological investigations have been completed | ||
52 | Availability of an agreement for provision of paid medical services in healthcare organisations. Availability of documents establishing the fact of co-payment | ||
53 | Availability of medical documentation on the consultation of a paediatric cardiologist (cardiac surgeon) when a congenital malformation of the cardiovascular system shall be detected in obstetric institutions, and, if medically indicated, transfer of the new born to a specialised hospital. | ||
54 | Availability of medical documentation on the use of opportunities for consultation with relevant national organisations, through telemedicine network in case of difficulty in verifying the diagnosis of the child, determining the tactics of management. If it is necessary to transfer the child to specialised republican organisations. | ||
55 |
Availability of documentation (internal orders, regulations, protocols, questionnaires, analyses) of the clinical audit by the Patient support service and internal expertise and its evaluation according to the following criteria: | ||
Official(s) ____________________________________ ____________
position signature
________________________________________________________________________
surname, first name, patronymic (if any)
Head of the entity of control _______________________________ ____________
position signature
________________________________________________________________________
surname, first name, patronymic (if any)
| Annex 5 to the joint order of the Minister of Healthcare of the Republic of Kazakhstan dated November 15, 2018 № RK MH-32 and the Minister of National Economy of the Republic of Kazakhstan dated November 15, 2018 № 70 |
Checklist
Сноска. Приложение 5 - в редакции cовместного приказа Министра здравоохранения РК от 29.05.2023 № 90 и Министра национальной экономики РК от 29.05.2023 № 91 (вводится в действие по истечении десяти календарных дней после дня его первого официального опубликования).
in the area of quality of health care delivery
__________________________________________________________________
in accordance with Article 138
__________________________________________________________________
Entrepreneurial Code of the Republic of Kazakhstan in respect of
__________________________________________________________________
subjects (objects) providing cardiological, cardiac surgical care
name of homogeneous group of control entities (facilities)
___________________________________________________________________
State body that appointed the inspection/prophylactic control
with a visit to the entity (facility) of control
____________________________________________________________________
____________________________________________________________________
Act on the appointment of an inspection/preventive control with a visit to the entity (facility) of control
(facility) of control
____________________________________________________________________
_____________________________________________________________ №, date
Name of the entity (facility) of control _______________________________
_____________________________________________________________________
(Individual identification number), business identification number
of the entity (facility) of control ____________________________________________
_____________________________________________________________________
Address of residence _______________________________________________
_____________________________________________________________________
№ | List of requirements | Complies with the requirements | Does not comply with the requirements |
1 | 2 | 3 | 4 |
1. | Availability of supporting documentation on the provision of medical care included in the guaranteed volume of free medical care and (or) the system of compulsory social health insurance on a free-of-charge basis | ||
2. | Availability of medical documentation on the compliance of treatment and diagnostic measures with the recommendations of clinical protocols | ||
3. | Presence of written voluntary consent of the patient or his/her legal representative for invasive interventions and therapeutic and diagnostic measures. | ||
4. |
Availability of supporting documentation (emergency medical team call card form № 085/y, admission and refusal of hospitalisation log, medical card of an inpatient form № 001/y) that the stay of the emergency medical team or emergency medical care department in the emergency department of the hospital shall not exceed 10 minutes (the time for transferring the patient to the doctor of the emergency department) from the moment of its arrival at the hospital, except in cases of emergency medical care in emergency situations. | ||
5. | Availability of documentation on ensuring the hospitalisation of a serious patient in need of constant monitoring of vital functions for medical indications, by decision of a Concilium and notification of the heads of health care organisations with subsequent transfer to another medical organisation according to the profile of the disease for further examination and treatment after stabilisation of the condition | ||
6. |
A medical report with a written justification of refusal in the absence of indications for hospitalisation in a health care organisation shall be issued to the patient by the doctor of the reception department. | ||
7. |
Availability of supporting documentation on the indications for hospitalisation: | ||
8. | Severe patients shall be examined by the head of the department on the day of admission and daily thereafter. Patients in a moderately severe condition shall be examined at least once a week. The results of the patient's examination shall be recorded in the medical record with recommendations on further tactics of the patient's management with obligatory identification of the medical worker making the entries | ||
9. | Availability of supporting documentation on the establishment of the main diagnosis in emergency conditions within 24 (twenty-four) hours from the moment of the patient's admission to the 24-hour hospital on the basis of clinical and anamnestic examination data, results of instrumental and laboratory methods of research with recording in the medical record of an inpatient in form № 001/y, in stable patients - availability of the established clinical diagnosis in conjunction with the head of department no later than three calendar days from the date of admission to the hospital. | ||
10. |
Availability of supporting documentation of planned hospitalisation in the presence of indicators: | ||
11. |
Availability of documentation on urgent (round-the-clock, including weekends and public holidays) procedures, in particular: | ||
12. | Availability of documentation on admission to the catheterisation laboratory, bypassing the admission department, intensive care unit (ward) if the patient is diagnosed with acute coronary syndrome with segment elevation, acute myocardial infarction. | ||
13. |
Availability of documentation on ensuring daily examination by the attending physician of patients staying in the hospital except weekends and public holidays. When examining and prescribing additional diagnostic and treatment manipulations by the doctor on duty, appropriate entries are made in the medical record. If the patient's condition worsens, the doctor on duty notifies the head of the department and (or) the attending physician, agrees to make changes in the process of diagnosis and treatment, and makes an entry in the medical record (paper and (or) electronic) version. | ||
14. | Availability of documentation on the assessment of the complexity of surgical interventions for congenital heart disease according to the Aristotle Basic Scale and the effectiveness of operations in the cardiac surgical unit | ||
15. |
Availability of documentation on the compliance of medical care for patients with acute coronary syndrome and (or) acute myocardial infarction by levels of regionalisation: | ||
16. |
Availability of supporting documentation of compliance during planned hospitalisation: | ||
17. | Consultations or consultations in case of difficulty in identifying the diagnosis, ineffectiveness of the current treatment, as well as other indications | ||
18. |
Availability of supporting documentation during hospitalisation at the inpatient level: | ||
19. | Ensuring that a discharge summary shall be issued to the patient upon discharge, indicating the full clinical diagnosis, the scope of diagnostic tests, therapeutic measures and recommendations for further follow-up and treatment. Discharge data shall be entered into the information systems on a day-to-day basis, indicating the actual time of discharge | ||
20. |
Documentation of adherence to discharge criteria, such as: | ||
21. | Availability of an agreement for provision of paid medical services in healthcare organisations. Availability of documents establishing the fact of co-payment | ||
22. |
Documentation of compliance with blood component transfusion requirements and in case of complications: | ||
23. |
Availability of examination of individuals on clinical indications for HIV infection upon detection of the following diseases, syndromes and symptoms: | ||
24. |
Availability of medical documentation on compliance with the following requirements during the examination of temporary incapacity for work, issuance of certificates and certificates of temporary incapacity for work (form № 001/y "Medical Card of Inpatient Patient", form № 052/y "Medical card of outpatient patient", stubs of certificates of temporary incapacity for work of patients, form № 025/y "Journal for recording conclusions of medical advisory commission", form № 029y "Book of registration of certificates of temporary inability to work", form № 037/y "Certificate of temporary inability to work", form № 037y "Certificate of temporary inability to work", form № 037/y "Certificate of temporary inability to work". | ||
25. |
Compliance with the following requirements in the organisation and conduct of the medical advisory board: | ||
26. |
Availability of supporting documentation on indications for hospitalisation in day hospital at outpatient and polyclinic health care organisations and inpatient care at home: | ||
27. | Availability of a recovery and rehabilitation department | ||
28. | Availability of a cardiology room in the structure of organisations providing outpatient and polyclinic care to the population (district, city, region, republic) and organisations providing inpatient care | ||
29. | If it is impossible to establish the diagnosis of cardiovascular diseases in a primary health care organisation, the patient should be referred for consultation to a clinical diagnostic centre for the provision of Consultative and diagnostic polyclinic with a consultative meeting, if necessary, involving specialised specialists, including consultants from medical organisations at the national level. | ||
30. | Availability of supporting documentation of care provided to a patient with Consultative and diagnostic polyclinic by a specialised specialist on the referral of a renal replacement therapy specialist or other specialised specialist | ||
31. | Availability of an opinion on drawing up documents for referral for medical and social expert assessment in the presence of high blood pressure (crisis course), arrhythmia of various genesis, increased frequency of angina attacks and increasing symptoms of heart failure, issuance and extension of a sheet or certificate of temporary loss of working capacity, and in the case of permanent loss of working capacity (condition after myocardial infarction, aorto-coronary bypass, congestive heart failure) | ||
32. | Availability of supporting documentation on treatment and diagnostic measures, drug provision, organisation of therapeutic nutrition and appropriate care of the patient from the moment of admission to the health care organisation. | ||
33. | Availability of supporting documentation on the use of opportunities for consultation with relevant national organisations, via telemedicine network in case of difficulties in verifying the child's diagnosis and determining the tactics of management. If necessary, the child is transferred to specialised national organisations. | ||
34. | Provide supportive care (support adequate feeding, water balance, pain control, fever management, oxygen therapy) | ||
35. |
Availability of medical documentation on the provision of the following treatment and diagnostic measures as part of primary health care: | ||
36. | Availability of supporting documentation on the use of less painful alternative treatments, if available, that shall be equally effective, to avoid unnecessary painful procedures | ||
37. |
Availability of documentation on compliance with the requirements of anaesthesia and resuscitation care: | ||
38. |
Compliance with the following actions when performing pathological anatomical autopsy: | ||
39. | Availability of a written application from the spouse, close relatives or legal representatives of the deceased, or a written will be given by the person during his/her lifetime to release the corpse without a pathological anatomical autopsy, in the absence of suspicion of violent death | ||
40. |
Availability of documentation (internal orders, regulations, protocols, questionnaires, analyses) of the clinical audit by the Patient support service and internal expertise and its evaluation according to the following criteria: | ||
41. | The patient shall be examined by a doctor in the admission department of an inpatient hospital with the completion of an inpatient card, if the patient or his/her legal representative has given written consent to the provision of medical care to the patient | ||
42. | Provision by a cardiologist (cardiac surgeon) of a consultative-diagnostic report in form № 075/y, indicating the results of the conducted examination and treatment, as well as further treatment of the patient with Diseases of the circulatory system to the primary care physician who referred the patient for consultative services in the course of personnel management provision | ||
43. | In the presence of abnormalities in blood pressure (crisis course), arrhythmias of various genesis, increased frequency of angina attacks and increasing symptoms of heart failure, the cardiologist of the medical organisation issues and extends a temporary disability certificate or certificate, and in case of persistent disability (after myocardial infarction, aorto-coronary bypass surgery, congestive heart failure), the cardiologist of the Ministry of Health issues an opinion on drawing up documents for referral for medical and social expert assessment (hereinafter referred to as the MSE) | ||
44. | Availability of documentation on emergency hospitalisation of a patient with Diseases of the circulatory system to the intensive care unit (ward), bypassing the emergency room in life-threatening cases | ||
45. | Availability of documentation on hospitalisation of a patient with an established diagnosis of acute coronary syndrome (hereinafter referred to as the ACS) with segment elevation, acute myocardial infarction (hereinafter referred to as the AMI) to the catheterisation laboratory, bypassing the admission department, intensive care unit (ward). | ||
46. |
Availability of documentation on the provision of cardiological (cardiac surgery) care in inpatient settings, which shall include: | ||
47. | Availability of documentation on the immediate transfer of a patient undergoing treatment in the medical organisation without the possibility of IV in case of identification of indications for urgent interventional or cardiac surgical interventions by ambulance, including medical aviation to the medical organisation with the possibility of IV in 24-hour mode. | ||
48. |
Availability of supporting documentation on the performance of surgical interventions in cardiac surgery according to the principle of regionalisation with regard to the level of complexity: |
Official(s) ____________________________________ ____________
position signature
________________________________________________________________________
surname, first name, patronymic (if any)
Head of the entity of control _______________________________ ____________
position signature
________________________________________________________________________
surname, first name, patronymic (if any)
Checklist
Footnote. Annex 6 - in the wording of the joint order of the Minister of Healthcare of the RK dated 29.05.2023 № 90 and the Minister of National Economy of RK dated 29.05.2023 № 91 (shall enter into force upon expiry of ten calendar days after the day of its first official publication).
in the area of quality of health care delivery
__________________________________________________________________
in accordance with Article 138
___________________________________________________________________
Entrepreneurial Code of the Republic of Kazakhstan in respect of
___________________________________________________________________
entities (facilities) providing haemodialysis care
___________________________________________________________________
name of a homogeneous group of control entities (facilities)
___________________________________________________________________
State body that ordered the inspection/prophylactic control
with a visit to the entity (facility) of control
_____________________________________________________________________
_____________________________________________________________________
Act on the appointment of an inspection/preventive control with a visit to the entity (facility) of control
(facility) of control
_____________________________________________________________________
______________________________________________________________ №, date
Name of the entity (facility) of control _______________________________
_____________________________________________________________________
(Individual identification number), business identification number
of the entity (facility) of control _____________________________________________
______________________________________________________________________
Address of residence ________________________________________________
______________________________________________________________________
______________________________________________________________________
№ | List of requirements | Complies with the requirements | Does not comply with the requirements |
1 | 2 | 3 | 4 |
1 | Availability of written voluntary consent of the patient or his/her legal representative for invasive interventions and therapeutic and diagnostic measures | ||
2 | Availability of an opinion on the compliance of the health care entity to provide high-tech medical services | ||
3 | Availability of supporting documentation on the compliance of treatment and diagnostic measures with the recommendations of clinical protocols | ||
4 |
Availability of supporting documentation of eligibility for selection and initiation of renal replacement therapy, specifically: | ||
5 |
Availability of supporting documentation of compliance with the indication for emergency extrarenal blood purification in patients with acute renal failure: | ||
6 | Availability of supporting documentation that the haemodialysis machine shall comply with quality certificates, with sufficient life and capacity as stipulated by the country of manufacture | ||
7 |
Availability of supporting documentation on compliance with the algorithm of haemodialysis procedure: | ||
8 | Availability of supporting documentation on the provision of drugs and consumables according to the dialysis protocol | ||
9 | Availability of a water treatment system and compliance with requirements for preparation of haemodialysis fluids, quality of solutions for haemodialysis and blood purification system | ||
10 | Availability of a contract for provision of paid medical services in health care organisations. Availability of documents establishing the fact of co-payment | ||
11 |
Availability of documentation (internal orders, regulations, protocols, questionnaires, analyses) of the clinical audit by the Patient support service and internal expertise and its evaluation according to the following criteria: | ||
12 | Availability of supporting documentation on the provision of medical care included in the guaranteed volume of free medical care and (or) the system of compulsory social health insurance on a free-of-charge basis | ||
13 | Availability of supporting documentation on record keeping and reporting documentation |
Official(s) ____________________________________ ____________
position signature
________________________________________________________________________
surname, first name, patronymic (if any)
Head of the entity of control _______________________________ ____________
position signature
________________________________________________________________________
surname, first name, patronymic (if any)
| Annex 7 to the joint order of the Minister of Healthcare of the Republic of Kazakhstan dated November 15, 2018 № KR DSM-32 and the Minister of National Economy of the Republic of Kazakhstan dated November 15, 2018 № 70 |
Checklist
Footnote. Annex 7 - as amended by the joint order of the Minister of Healthcare of the Republic of Kazakhstan dated 29.05.2003 № 90 and the Minister of National Economy of the Republic of Kazakhstan dated 29.05.2003 № 91 (shall come into effect ten calendar days after the day of its first official publication).
in the field of quality of medical services
___________________________________________________________________
in accordance with Article 138
___________________________________________________________________
of the Entrepreneurial Code of the Republic of Kazakhstan concerning
___________________________________________________________________
subjects (objects) providing dental care
___________________________________________________________________
name of a homogeneous group of subjects (objects) of control
___________________________________________________________________
State body that appointed the inspection/preventive control
with a visit to the subject (object) of control
___________________________________________________________________
___________________________________________________________________
Act on appointment of inspection/preventive control with a visit to the subject
(object) of control
___________________________________________________________________
____________________________________________________________ №, 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 | Meets requirements | Does not meet requirements |
1 | 2 | 3 | 4 |
1 | Availability of supporting documentation on the provision of medical care included in the guaranteed volume of free medical care and (or) the system of compulsory social health insurance on a free basis | ||
2 |
Availability of supporting documentation of compliance with the following requirements when organizing dental care: | ||
3 | Availability of an agreement for the provision of paid services in healthcare organizations. | ||
4 | Availability of medical documentation confirming compliance with clinical diagnostic studies at levels of dental care | ||
5 | Availability of form № 058/у "Medical record of a dental patient (including sanitation)" for each patient | ||
6 | Availability of supporting documentation on the compliance of the therapeutic and diagnostic measures carried out with the recommendations of clinical protocols. In the absence of clinical protocols, according to international standards and guidelines based on evidence-based medicine. | ||
7 | Availability of supporting documentation on the maintenance of accounting and reporting documentation by specialized experts working in healthcare organizations providing dental care | ||
8 | Availability of completed documentation with information about the provision of dental care (electronic medical records, related materials about the patient’s health status and diagnosis), including in the MIS for each tooth in the examination card of primary teeth and the examination card of permanent teeth | ||
9 | Availability of documentation on determining the allergy history of the patient before dental interventions requiring local anaesthesia, and, if indicated, referral of the patient to primary health care organizations or medical organizations for laboratory examination to identify drug allergies | ||
10 |
Availability of supporting documentation on the provision of dental care to children on an outpatient basis in the form of consultative and diagnostic assistance upon referral and self-referral shall include: | ||
11 | Availability of informed consent of parents or representatives when performing dental interventions on children associated with the risk of pain; manipulations shall be carried out according to indications using anaesthesia (local, sedation, general) | ||
12 |
Availability of supporting documentation on the provision of dental care to adults on an outpatient basis in the form of consultative and diagnostic assistance on self-referral and referral, which shall include: | ||
13 | Availability of supporting documentation on the provision of dental care in a hospital setting by oral and maxillofacial surgeons and includes prevention, diagnosis, treatment of diseases and conditions requiring the use of special medical methods and technologies, as well as medical rehabilitation | ||
14 | Availability of supporting documentation of the consultation or the use of remote medical services in the differential diagnosis of complex, unclear cases to verify the diagnosis | ||
15 | Children aged 0 to 17 years inclusive and pregnant women are subject to dynamic observation and dental examinations | ||
16 |
Availability of supporting documentation on the provision of preventive measures for pregnant women and adults, which shall include | ||
17 |
Compliance with the following requirements when organizing and conducting a medical advisory commission: | ||
18 |
Availability of medical documentation on compliance with the following requirements when examining temporary disability, issuing a sheet and certificate of temporary disability (form № 001/у "Medical record of an inpatient", form 052/у "Medical record of an outpatient", stubs of sheets on temporary disability of patients, form № 025/у "Journal for recording the conclusions of the medical consultation commission", form № 029/у "Book of registration of sheets on temporary incapacity for work", form № 037/у "Certificate №__________ on temporary incapacity for work of a student, college student, professional technical school, about illness, quarantine and other reasons for the absence of a child attending school, a preschool organization (underline as necessary)", form № 038/у "Certificate №______ on temporary disability" and others): | ||
19 | Availability of written voluntary consent of the patient or his/her legal representative for invasive interventions and for carrying out therapeutic and diagnostic measures | ||
20 |
Availability of supporting documentation on compliance with the requirements for the provision of anesthesiological and resuscitation care: | ||
21 |
Availability of documentation (internal orders, regulations, protocols, questionnaires, analytical reports) on the conduct of a clinical audit by the Patient Support and Internal Expertise Service and its assessment according to the following criteria: |
Official(s) ____________________________________ ____________
position signature
_________________________________________________________
surname, first name, patronymic (if any)
Head of the subject of control ____________________________ ____
position signature
_________________________________________________________
surname, first name, patronymic (if any)
| Annex 8 to the joint order of the Minister of Healthcare of the Republic of Kazakhstan dated November 15, 2018 № KR DSM-32 and the Minister of National Economy of the Republic of Kazakhstan dated November 15, 2018 № 70 |
Checklist
Footnote. Annex 8 - as amended by the joint order of the Minister of Healthcare of the Republic of Kazakhstan dated 29.05.2003 № 90 and the Minister of National Economy of the Republic of Kazakhstan dated 29.05.2003 № 91 (shall come into effect ten calendar days after the day of its first official publication).
in the field of quality of medical services
___________________________________________________________________
in accordance with Article 138
___________________________________________________________________
of the Entrepreneurial Code of the Republic of Kazakhstan concerning
___________________________________________________________________
subjects (objects) providing phthisiatric care
___________________________________________________________________
name of a homogeneous group of subjects (objects) of control
___________________________________________________________________
State body that appointed the inspection/preventive control
with a visit to the subject (object) of control
___________________________________________________________________
___________________________________________________________________
Act on the appointment of an inspection/preventive control with a visit to the subject
(object) of control
___________________________________________________________________
______________________________________________________________ №, 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 | Meets requirements | Does not meet requirements |
1 | 2 | 3 | 4 |
Providing anti-tuberculosis care at the outpatient clinic level | |||
1 | Availability of supporting documentation on the provision of medical care included in the guaranteed volume of free medical care and (or) the system of compulsory social health insurance on a free basis | ||
2 |
Availability of supporting documentation on the implementation by PHC specialists of the following activities: | ||
3 | Availability of supporting documentation for the examination of a patient for suspected tuberculosis in organizations providing primary health care according to this scheme | ||
4 | Availability of supporting documentation on the detection of tuberculosis using fluorography among the target population group: those at high risk of the disease and subject to mandatory annual fluorographic examination | ||
5 | Availability of supporting documentation on the organization of directly observed treatment rooms (hereinafter referred to as DOT) in primary health care organizations for outpatient treatment. The patient shall receive and take medications in the DOT office under the supervision of a responsible medical professional. Once every 10 days, patients undergoing direct supervised treatment shall be examined by a primary care physician/clinic phthisiatrician, or more often if indicated. Patients living in rural areas shall be examined by a phthisiatrician once a month | ||
6 |
An assessment of the clinical condition of a patient receiving anti-tuberculosis treatment for the presence of adverse reactions and events shall be carried out daily by the attending physician or phthisiatrician, or a medical worker in the directly observed treatment room. A medical professional who has identified adverse reactions and events to a drug shall fill out a report card and make an entry in the patient’s medical records. | ||
7 | Availability of records of the movement of anti-tuberculosis drugs at the outpatient level in the anti-tuberculosis drug registration log | ||
8 | Conducting a conversation with the patient (parents or guardians of children) before the start of treatment about the need for a full course of chemotherapy, followed by signing informed consent | ||
9 | Availability of supporting documentation on registration and dispensary observation of tuberculosis patients shall be carried out in organizations providing primary health care at the place of actual residence, work, study or military service, regardless of registration | ||
10 |
Availability of supporting documentation on compliance with the following requirements when organizing and conducting a medical advisory commission: | ||
11 |
Availability of supporting documentation regarding compliance with the levels of medical rehabilitation provided to patients: | ||
Providing anti-tuberculosis care at the hospital level | |||
12 | Availability of supporting documentation on the provision of medical care included in the guaranteed volume of free medical care and (or) the system of compulsory social health insurance on a free basis | ||
13 |
Distribution of patients in departments across wards, taking into account laboratory test data and drug sensitivity at the time of admission and during treatment. | ||
14 |
Availability of daily examination by a phthisiatrician of patients in the hospital. | ||
15 | Availability of supporting documentation on the organization of consultation in difficult situations to verify the diagnosis and determine treatment tactics with the participation of specialists at the regional and national levels in person or remotely via telemedicine | ||
16 | Availability of records of the movement of anti-tuberculosis drugs at the hospital level in the anti-tuberculosis drug registration log | ||
17 |
Availability of supporting documentation on compliance with the criteria for discharge of a tuberculosis patient from the hospital: | ||
18 | Availability of written voluntary consent of the patient or his/her legal representative for invasive interventions and for carrying out therapeutic and diagnostic measures | ||
19 | Availability of examination of severely ill patients by the head of the department on the day of hospitalization, and subsequently - daily. Patients in moderate condition shall be examined at least once a week. The results of the patient's examination shall be recorded in the medical record, indicating recommendations for further tactics of patient management with mandatory identification of the medical worker making the notes | ||
20 | Having an established clinical diagnosis together with the head of the department no later than three calendar days from the date of hospitalization of the patient in a healthcare organization | ||
21 | Availability of consultations or council in case of difficulty in identifying the diagnosis, ineffectiveness of the treatment, as well as for other indications | ||
22 | Availability of issuing a discharge summary to the patient upon discharge, indicating the full clinical diagnosis, the scope of diagnostic tests performed, treatment measures and recommendations for further observation and treatment. Data on the discharge shall be entered into information systems on the same day, indicating the actual time of discharge. | ||
23 |
Availability of supporting documentation on compliance with the requirements for the provision of anesthesiological and resuscitation care: | ||
24 |
Availability of supporting documentation on compliance with the requirements for transfusion of blood components and in the event of complications: | ||
25 |
Availability of examination of persons for clinical indications for HIV infection when identifying the following diseases, syndromes and symptoms: | ||
26 |
Availability of medical documentation on compliance with the following requirements when examining temporary disability, issuing a sheet and certificate of temporary disability (form № 001/у "Medical record of an inpatient", form 052/у "Medical record of an outpatient", stubs of sheets on temporary disability of patients, form № 025/у "Journal for recording the conclusions of the medical consultation commission", form № 029/у "Book of registration of sheets on temporary incapacity for work", form № 037/у "Certificate №__________ on temporary incapacity for work of a student, college student, professional technical school, about illness, quarantine and other reasons for the absence of a child attending school, a preschool organization (underline as necessary)", form № 038/у "Certificate №______ on temporary disability" and others): | ||
27 |
Availability of documentation (internal orders, regulations, protocols, questionnaires, analytical reports) on the conduct of a clinical audit by the Patient Support and Internal Expertise Service and its assessment according to the following criteria: | ||
28 |
Availability of documentation on compliance with the following actions when conducting a pathological autopsy: | ||
29 | Availability of a written statement from a spouse, close relatives or legal representatives of the deceased, or a written expression of will given by a person during his/her lifetime for the release of a corpse without performing a pathological autopsy, in the absence of suspicion of violent death | ||
30 | Availability of an agreement for the provision of paid medical services in healthcare organizations. Availability of documents establishing the fact of co-payment | ||
31 |
Availability of supporting documentation on the compliance of the levels of medical rehabilitation provided to patients: | ||
32 | Availability of a medical worker’s entry in the medical record with subsequent collection of biological materials to determine the content of a psychoactive substance with the results being entered into the medical record if signs of psychoactive substance use are detected when seeking medical help from a health care organization without issuing a Medical Examination Conclusion to establish the fact of psychoactive substance use and state of intoxication | ||
33 | Availability of supporting documentation on the compliance of the therapeutic and diagnostic measures carried out with the recommendations of clinical protocols. | ||
Official(s)____________________________________ ____________
position signature
_________________________________________________________
surname, first name, patronymic (if any)
Head of the subject of control __________________ ______________
position signature
_________________________________________________________
surname, first name, patronymic (if any)
Checklist
Footnote. Annex 9 - as amended by the joint order of the Minister of Healthcare of the Republic of Kazakhstan dated 29.05.2003 № 90 and the Minister of National Economy of the Republic of Kazakhstan dated 29.05.2003 № 91 (shall come into effect ten calendar days after the day of its first official publication).
in the field of quality of medical services
___________________________________________________________________
in accordance with Article 138
___________________________________________________________________
of the Entrepreneurial Code of the Republic of Kazakhstan concerning
___________________________________________________________________
subjects (objects) providing oncological care
name of a homogeneous group of subjects (objects) of control
___________________________________________________________________
State body that appointed inspection/preventive control
with a visit to the subject (object) of control
___________________________________________________________________
___________________________________________________________________
Act on the appointment of an inspection/preventive control with a visit to the subject
(object) of control
___________________________________________________________________
______________________________________________________________ №, 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 | Meets requirements | Does not meet requirements |
1 | 2 | 3 | 4 |
Providing oncological care at the outpatient clinic level | |||
1 | Availability of supporting documentation on the provision of medical care included in the guaranteed volume of free medical care and (or) the system of compulsory social health insurance on a free basis | ||
2 |
The presence of a multidisciplinary team (MDT) to provide an individual approach to providing medical care to patients with malignant neoplasms. | ||
3 |
Availability of supporting documentation on consideration at meetings of the MDT: | ||
4 |
Availability of supporting documentation about the organization of primary health care specialists: | ||
5 |
Availability of supporting documentation on the provision of consultative and diagnostic assistance, which shall include: | ||
6 |
Availability of supporting documentation on the referral of the patient’s GP to an oncologist or oncology care coordinator if a tumor disease is suspected or detected. | ||
7 |
Availability of supporting documentation of compliance with the requirements for the provision of oncological care in the form of outpatient care: | ||
8 |
Availability of supporting documentation on the conduct of IHC and molecular genetic studies to determine the molecular biological characteristics of tumours to individualize the treatment of patients, as well as to confirm (verify) the diagnosis of cancer. IHC studies shall be carried out at the level of pathological laboratories of organizations providing oncological care, secondary level and tertiary level reference centres and shall be carried out according to clinical protocols. | ||
9 | Availability of supporting documentation on international teleconsultations of tumor biosamples through the telepathology system to clarify the diagnosis in complex clinical cases. The duration of teleconsultations shall not exceed thirty working days | ||
10 |
Availability of supporting documentation about displaying in the MIS the entire period of examination of patients with suspected cancer in an outpatient setting, indicating markers of cancer alertness within the following examination periods: | ||
11 | Availability of supporting documentation that specialized treatment of a patient with MN shall begin no later than thirty calendar days from the date of diagnosis and placement under dynamic observation. | ||
12 |
Availability of supporting documentation on dynamic observation for clinical groups of patients with suspected MN and a confirmed diagnosis of MN: | ||
13 |
Patients with cancer shall be subject to lifelong medical dynamic observation in an organization providing medical care on an outpatient basis at the place of attachment - the primary level (III clinical group) and organizations providing oncological care at a secondary level (II clinical group) at the place of residence and attachment. | ||
14 | When a diagnosis of cancer is established for the first time, form № 034/у "Notification" shall be filled out for each patient, which shall be sent within three working days to the organization providing oncological care at the secondary level at the patient’s place of permanent residence for registration in the Electronic Register of Cancer Patients and registration, indicating the circumstances of the diagnosis (the patient’s self-referral to a medical organization PHC, CDA - primary level, the patient’s self-referral to an organization providing oncological care at the secondary and tertiary levels, the diagnosis was established during a screening examination, the diagnosis was established during a preventive examination). | ||
15 |
For each patient with a diagnosis of stage IV cancer for the first time in his/her life and with visually accessible stage III localizations, a protocol shall be filled out in case an advanced form of MN is detected in the patient (clinical group V). | ||
16 | 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 | ||
17 |
Availability of supporting documentation on compliance with indications for hospitalization in a day hospital at outpatient healthcare organizations and hospitalization at home: | ||
18 |
Availability of medical documentation on compliance with the following requirements when examining temporary disability, issuing a sheet and certificate of temporary disability (form № 001/у "Medical record of an inpatient", form 052/у "Medical record of an outpatient", stubs of sheets on temporary disability of patients, form № 025/у "Journal for recording the conclusions of the medical consultation commission", form № 029/у "Book of registration of sheets on temporary incapacity for work", form № 037/у "Certificate №__________ on temporary incapacity for work of a student, college student, professional technical school, about illness, quarantine and other reasons for the absence of a child attending school, a preschool organization (underline as necessary)", form № 038/у "Certificate №______ on temporary disability" and others): | ||
19 |
Availability of documentation (internal orders, regulations, protocols, questionnaires, analytical reports) on the conduct of a clinical audit by the Patient Support and Internal Expertise Service and its assessment according to the following criteria: | ||
Providing oncological care at the inpatient level | |||
20 | Availability of supporting documentation on the provision of medical care included in the guaranteed volume of free medical care and (or) the system of compulsory social health insurance on a free basis | ||
21 |
Availability of supporting documentation on the dilution of antitumor drugs in the rooms for centralized dilution of cytostatic drugs (hereinafter referred to as the RCDC) to ensure the safety of medical personnel from the toxic effects of anticancer drugs and the rational use of drugs. | ||
22 |
Availability of supporting documentation that radiation therapy shall be carried out according to the principle of "single doctor – radiation therapist (radiation oncologist)", which provides for clinical management of the patient, pre-radiation preparation and radiation treatment by one doctor – radiation therapist (radiation oncologist). | ||
23 |
Availability of supporting documentation that in inpatient conditions, patients with cancer shall be provided with antitumor therapy, radiation and radionuclide therapy, palliative care in cases that do not require constant medical supervision, in organizations providing oncological care at the secondary and tertiary levels in chemotherapy, radiation departments therapy, palliative care, medical rehabilitation. | ||
24 | Availability of hospitalization of a seriously ill patient requiring constant monitoring of vital functions for medical reasons, by decision of the council and notification of the heads of healthcare organizations, with subsequent transfer to another medical organization according to the profile of the disease for further examination and treatment after stabilization of the condition | ||
25 | Availability of examination of severely ill patients by the head of the department on the day of hospitalization, and subsequently - daily. Patients in moderate condition shall be examined at least once a week. The results of the patient's examination shall be recorded in the medical record, indicating recommendations for further tactics of patient management with mandatory identification of the medical worker making the notes | ||
26 | Availability of an established clinical diagnosis together with the head of the department no later than three calendar days from the date of hospitalization of the patient in a healthcare organization | ||
27 |
Availability of daily examination by the attending physician of patients in the hospital except weekends and holidays. When examining and prescribing additional diagnostic and therapeutic procedures by the doctor on duty, appropriate entries shall be made in the medical record. If the patient's condition worsens, the doctor on duty shall notify the head of the department and (or) the attending physician, agree on changes to the diagnostic and treatment process, and make an entry in the medical record (paper and (or) electronic version). | ||
28 | Availability of consultations or council in case of difficulty in identifying the diagnosis, ineffectiveness of the treatment, as well as for other indications | ||
29 |
Availability of examination of persons for clinical indications for HIV infection in identifying the following diseases, syndromes and symptoms: | ||
30 | Availability of an agreement for the provision of paid medical services in healthcare organizations. Availability of documents establishing the fact of co-payment | ||
31 |
Availability of supporting documentation of compliance with discharge criteria, in particular: | ||
32 | Availability of issuing a discharge summary to the patient upon discharge, indicating the full clinical diagnosis, the scope of diagnostic tests performed, treatment measures and recommendations for further observation and treatment. Data on the discharge shall be entered into information systems on the same day, indicating the actual time of discharge. | ||
33 |
Availability of supporting documentation on compliance with the requirements for transfusion of blood components and in case of complications: | ||
34 |
Availability of supporting documentation regarding the determination of the method and tactics of treatment for MDT. | ||
35 | Availability of supporting documentation confirming compliance of the medical care provided with clinical protocols | ||
36 |
Availability of medical documentation on compliance with the following requirements when examining temporary disability, issuing a sheet and certificate of temporary disability (form № 001/у "Medical record of an inpatient", form 052/у "Medical record of an outpatient", stubs of sheets on temporary disability of patients, form № 025/у "Journal for recording the conclusions of the medical consultation commission", form № 029/у "Book of registration of sheets on temporary incapacity for work", form № 037/у "Certificate №__________ on temporary incapacity for work of a student, college student, professional technical school, about illness, quarantine and other reasons for the absence of a child attending school, a preschool organization (underline as necessary)", form № 038/у "Certificate №______ on temporary disability" and others): | ||
37 |
Availability of documentation (internal orders, regulations, protocols, questionnaires, analytical reports) on the conduct of a clinical audit by the Patient Support and Internal Expertise Service and its assessment according to the following criteria: | ||
38 |
Availability of supporting documentation on compliance with the following actions when conducting a pathological autopsy: | ||
39 | Availability of a written statement from a spouse, close relatives or legal representatives of the deceased, or a written expression of will given by a person during his/her lifetime for the release of a corpse without performing a pathological autopsy, in the absence of suspicion of violent death | ||
40 |
Availability of supporting documentation on the provision of oncological care at home: | ||
Official(s)____________________________________ ____________
position signature
_________________________________________________________
surname, first name, patronymic (if any)
Head of the subject of control ____________________ ____________
position signature
_________________________________________________________
surname, first name, patronymic (if any)
Checklist
Footnote. Annex 10 - as amended by the joint order of the Minister of Healthcare of the Republic of Kazakhstan dated 29.05.2003 № 90 and the Minister of National Economy of the Republic of Kazakhstan dated 29.05.2003 № 91 (shall come into effect ten calendar days after the day of its first official publication).
in the field of quality of medical services
___________________________________________________________________
in accordance with Article 138
___________________________________________________________________
of the Entrepreneurial Code of the Republic of Kazakhstan concerning
___________________________________________________________________
subjects (objects) providing medical and social assistance in the field of
mental health
name of a homogeneous group of subjects (objects) of control
___________________________________________________________________
State body that appointed the inspection/preventive control
with a visit to the subject (object) of control
___________________________________________________________________
___________________________________________________________________
Act on the appointment of an inspection/preventive control with a visit to the subject
(object) of control
___________________________________________________________________
____________________________________________________________№, 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 | Meets requirements | Does not meet requirements |
1 | 2 | 3 | 4 |
Requirements for subjects (objects) providing medical and social assistance in the field of mental health at the outpatient clinic level | |||
1 | Availability of supporting documentation on the provision of medical care included in the guaranteed volume of free medical care and (or) the system of compulsory social health insurance on a free basis | ||
2 |
Availability of supporting documentation on compliance with the criteria for taking persons with mental and behavioural disorders (MBD) for dynamic observation: | ||
3 |
Availability of supporting documentation on compliance with the requirements for drug provision for persons with MBD who are under dynamic observation | ||
4 |
Availability of supporting documentation on compliance with the requirements for deregistration and transfer to another dynamic observation group: | ||
5 |
Availability of supporting documentation on the implementation of the following measures during the dynamic observation of a person with MBD by a psychiatric doctor: | ||
6 |
Availability of an individual treatment plan and rehabilitation program for persons after discharge from an organization providing medical assistance in the field of mental health, except for those discharged by court order as having been cured ahead of schedule. | ||
7 |
Availability of supporting documentation about the provision of primary health care by a doctor, if a person with MBD is suspected or identified, except for MBD requiring the provision of emergency and emergency medical and social care: | ||
8 |
Carrying out the following activities by a psychiatric specialist of the MHC or PMHC if a person with mental health problems is suspected or identified, except for mental health problems requiring the provision of emergency and urgent medical and social care: | ||
9 |
Availability of supporting documentation on the implementation of the following measures by a psychiatric doctor of the MHC or PMHC when applying to a person who was previously on dynamic observation with MBD and was deregistered in the EIS, indicating the reason for the removal, except for "recovery, persistent improvement": | ||
10 |
Availability of documentation (internal orders, regulations, protocols, questionnaires, analytical reports) on the conduct of a clinical audit by the Patient Support and Internal Expertise Service and its assessment according to the following criteria: | ||
Requirements for subjects (objects) providing medical and social assistance in the field of mental health in inpatient conditions, providing for round-the-clock medical supervision | |||
11 | Availability of supporting documentation on the provision of medical care included in the guaranteed volume of free medical care and (or) the system of compulsory social health insurance on a free basis | ||
12 |
Availability of grounds for hospitalization in inpatient clinical departments. | ||
13 |
Completeness of measures taken during planned hospitalization in the inpatient clinical departments of the Republican Scientific and Practical Clinical Hospital, Central Clinical Hospital. | ||
14 |
Completeness of measures taken during hospitalization in the inpatient clinical department of the Republican Scientific and Practical Clinical Hospital, Central Clinical Hospital for emergency indications. | ||
15 |
Completeness of measures taken during planned hospitalization in SPOIS (a specialized psychiatric organization with intensive supervision). | ||
16 |
The completeness of the measures taken after the admission of a person with MBD to the inpatient clinical department. | ||
17 |
Completeness of measures taken after a person’s admission to the inpatient clinical department SPOIS | ||
18 |
Compliance with surveillance regimes. | ||
19 |
Availability of supporting documentation of compliance with the criteria for involuntary hospitalization: | ||
20 |
Availability of supporting documentation of compliance with the conditions of discharge. | ||
21 |
Availability of documentation (internal orders, regulations, protocols, questionnaires, analytical reports) on the conduct of a clinical audit by the Patient Support and Internal Expertise Service and its assessment according to the following criteria: | ||
Requirements for subjects (objects) providing medical and social assistance in the field of mental health in inpatient conditions that do not require round-the-clock medical supervision and treatment and provide for medical supervision and treatment during the day with the provision of a bed | |||
22 | Availability of supporting documentation on the provision of medical care included in the guaranteed volume of free medical care and (or) the system of compulsory social health insurance on a free basis | ||
23 |
Availability of indications for treatment in inpatient conditions for persons with MBD | ||
24 |
Carrying out the following activities during hospitalization in a day hospital: | ||
25 |
Requirements for the duration of treatment and time of stay in a day hospital. | ||
26 |
Compliance with requirements for discharge from day hospital. | ||
27 |
Availability of documentation (internal orders, regulations, protocols, questionnaires, analytical reports) on the conduct of a clinical audit by the Patient Support and Internal Expertise Service and its assessment according to the following criteria: | ||
Requirements for entities (objects) providing medical and social assistance to persons with mental and behavioural disorders (diseases) in the form of emergency medical and social assistance | |||
28 | The provision of emergency specialized psychiatric care shall be carried out by specialized teams organized as part of an organization providing emergency medical and social care or EMS. | ||
Requirements for subjects (objects) providing medical and social rehabilitation in the field of mental health | |||
29 | Availability of supporting documentation on the provision of medical care included in the guaranteed volume of free medical care and (or) the system of compulsory social health insurance on a free basis | ||
30 |
Availability of supporting documentation of compliance with the requirements for medical and social rehabilitation in outpatient or inpatient settings. | ||
31 |
Availability of supporting documentation of compliance with the requirements for medical and social rehabilitation in inpatient settings. | ||
32 |
Availability of supporting documentation for the activities of the multidisciplinary group. | ||
33 |
Requirements for the duration of medical and social rehabilitation. | ||
Requirements for subjects (objects) conducting a medical examination to establish the fact of use of a psychoactive substance and state of intoxication | |||
34 | Availability of supporting documentation on the provision of medical care included in the guaranteed volume of free medical care and (or) the system of compulsory social health insurance on a free basis | ||
35 |
Availability of supporting documentation confirming compliance with the requirements for identifying a person sent or coming for a medical examination. | ||
36 |
Availability of supporting documentation on compliance with the requirements for examination of foreign citizens and minor citizens of the Republic of Kazakhstan. Foreign citizens permanently residing and temporarily staying on the territory of the Republic of Kazakhstan, as well as stateless persons who are intoxicated in a public place, at work, or driving a vehicle, are subject to a medical examination on a general basis. | ||
37 |
Availability of supporting documentation of compliance with the requirements for medical examination of persons delivered in a severe unconscious state. | ||
38 |
Availability of supporting documentation on compliance with the requirements for the conditions of laboratory research or rapid testing of biological media. | ||
39 |
Availability of supporting documentation of compliance with the requirements for laboratory research or rapid testing of biological media. | ||
40 |
Availability of supporting documentation of compliance with the requirements for conducting a quantitative test of exhaled air for alcohol. | ||
41 |
Availability of supporting documentation of compliance with the requirements for registration of refusal of medical examination | ||
42 |
Availability of supporting documentation on compliance with the requirements for establishing the condition of the person being examined. | ||
43 |
Availability of supporting documentation of compliance with the requirements for drawing up the Medical Examination Report. | ||
44 |
Availability of supporting documentation of compliance with the requirements for repeated medical examination. | ||
Requirements for subjects (objects) providing temporary adaptation and detoxification | |||
45 | Availability of supporting documentation on the provision of medical care included in the guaranteed volume of free medical care and (or) the system of compulsory social health insurance on a free basis | ||
46 |
Availability of supporting documentation on compliance with the requirements for organizing the activities of the temporary adaptation and detoxification centre: | ||
47 |
Identification by employees of the internal affairs bodies of the person delivered and notification to the medical personnel of the Central Military District. | ||
48 |
Registration of a person admitted with suspicion of alcohol intoxication in the register of admissions and refusals to hospitalization according to the approved form | ||
49 |
The results of the medical examination shall be documented in the conclusion of the medical examination conducted at the Central Medical Examination Centre (hereinafter referred to as the Conclusion) in the approved form | ||
50 |
Registration by medical personnel of personal belongings, documents, money and other valuables in the journal for registering documents and personal belongings of patients according to the form before placing the patient in the TADT. | ||
51 | Availability of a card placed in the TADT, located in the centre of temporary adaptation and detoxification (hereinafter referred to as the Patient’s card). If there are medical indications, treatment shall be prescribed. The doctor's prescriptions shall be entered into the patient's chart. The frequency of medical examinations shall depend on the patient’s condition. | ||
52 | The patient shall be discharged by a psychiatrist (narcologist) as planned when an improvement in condition is achieved that does not require further observation and treatment in a TADT within 24 (twenty-four) hours from the date of admission. Upon discharge, a corresponding entry shall be made in the patient’s chart and the log of admissions and refusals of hospitalization. | ||
53 | Written confirmation from the patient that upon receipt of his/her documents and personal belongings, all documents and personal belongings were received in accordance with the entry in the register of documents and personal belongings of patients, except for things the storage of which is illegal. | ||
Requirements for subjects (objects) providing medical examination and gender reassignment for persons with gender identity disorders | |||
54 | Availability of supporting documentation on the provision of medical care included in the guaranteed volume of free medical care and (or) the system of compulsory social health insurance on a free basis | ||
55 |
Availability of supporting documentation of compliance with the requirement to conduct a medical examination of persons with gender identity disorders for gender reassignment: | ||
56 | Referral by a psychiatrist of the person being examined, if there are doubts about the mental state, for an inpatient examination at a medical organization | ||
57 |
Referral of the person being examined by a psychiatrist, in the absence of MBD, which are contraindications for gender reassignment, to the clinic at the place of residence for a medical examination | ||
Official(s)____________________________________ ____________
position signature
_________________________________________________________
surname, first name, patronymic (if any)
Head of the subject of control ____________________ ____________
position signature
_________________________________________________________
surname, first name, patronymic (if any)
Checklist
Footnote. Annex 11 - as amended by the joint order of the Minister of Healthcare of the Republic of Kazakhstan dated 29.05.2003 № 90 and the Minister of National Economy of the Republic of Kazakhstan dated 29.05.2003 № 91 (shall be enforced upon the expiration of ten calendar days after the day of its first official publication).
in the field of quality of medical services
_______________________________________________________________
in accordance with Article 138
_______________________________________________________________
of the Entrepreneurial Code of the Republic of Kazakhstan concerning
_______________________________________________________________
subjects (objects) providing laboratory services
name of a homogeneous group of subjects (objects) of control
_______________________________________________________________
State body that appointed inspection/preventive control
with a visit to the subject (object) of control
_______________________________________________________________
_______________________________________________________________
Act on the appointment of an inspection/preventive control with a visit to the subject
(object) of control
_______________________________________________________________
_______________________________________________________________ №, 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 | Meets requirements | Does not meet requirements |
1 | 2 | 3 | 4 |
1 | Availability of supporting documentation on the provision of medical care included in the guaranteed volume of free medical care and (or) the system of compulsory social health insurance on a free basis | ||
2 | Availability of written voluntary consent of the patient or his/her legal representative for invasive interventions and for carrying out therapeutic and diagnostic measures | ||
3 | The presence of a biosafety specialist among the personnel of the laboratory (if the laboratory personnel has more than twenty full-time positions) | ||
4 | Availability of portable test strip analyzers in primary health care organizations | ||
5 |
The presence at the hospital level in healthcare organizations as part of a consultative and diagnostic laboratory (hereinafter referred to as the CDL) of an additional unit created or a separate express laboratory at intensive care units to perform emergency and emergency laboratory tests in the shortest possible time from taking a sample to reporting the result (within 15- 60 minutes). | ||
6 | Implementation of processes for managing the quality of clinical laboratory research according to the principle of stages, which shall include pre-analytical, analytical and post-analytical stages of laboratory research | ||
7 | Use of certified and registered in the Republic of Kazakhstan equipment, diagnostic reagent kits, test systems and consumables to perform research | ||
8 | Availability of a laboratory information system | ||
9 | Conducting internal laboratory quality control of research | ||
10 | Compliance with triple packaging and temperature conditions when transporting biomaterial, including by road, air and rail | ||
11 | Availability of supporting documentation on compliance with the algorithm for analytical quality control in laboratory diagnostics | ||
12 | Availability of an agreement for the provision of paid medical services in healthcare organizations. Availability of documents establishing the fact of co-payment | ||
13 | Availability of supporting documentation on the competence and quality of laboratory diagnostics | ||
14 | Documentation of laboratory diagnostics |
Official(s)____________________________________ ____________
position signature
_________________________________________________________
surname, first name, patronymic (if any)
Head of the subject of control ______________________ __________
position signature
_________________________________________________________
surname, first name, patronymic (if any)
| Annex 12 to the joint order of the Minister of Healthcare of the Republic of Kazakhstan dated November 15, 2018 № KR DSM-32 and the Minister of National Economy of the Republic of Kazakhstan dated November 15, 2018 № 70 |
Checklist
Footnote. Annex 12 - as amended by the joint order of the Minister of Healthcare of the Republic of Kazakhstan dated 29.05.2003 № 90 and the Minister of National Economy of the Republic of Kazakhstan dated 29.05.2003 № 91 (shall come into effect ten calendar days after the day of its first official publication).
in the field of quality of medical services
__________________________________________________________________
in accordance with Article 138
__________________________________________________________________
of the Entrepreneurial Code of the Republic of Kazakhstan concerning
__________________________________________________________________
subjects (objects) providing emergency medical care and medical
care in the form of medical aviation name of a homogeneous group of subjects
(objects) of control
__________________________________________________________________
State body that appointed the inspection/preventive control
with a visit to the subject (object) of control
__________________________________________________________________
__________________________________________________________________
Act on the appointment of an inspection/preventive control with a visit to the subject
(object) of control
__________________________________________________________________
____________________________________________________________ №, 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 | Meets requirements | Does not meet requirements |
1 | 2 | 3 | 4 |
General requirements | |||
1 | Availability of supporting documentation on the provision of medical care included in the guaranteed volume of free medical care and (or) the system of compulsory social health insurance on a free basis | ||
2 | Availability of supporting documentation on the compliance of the treatment and diagnostic measures carried out with the recommendations of clinical protocols | ||
3 |
Availability of documentation (internal orders, regulations, protocols, questionnaires, analytical reports) on the conduct of a clinical audit by the Patient Support and Internal Expertise Service and its assessment according to the following criteria: | ||
For emergency medical services | |||
4 | Equipping ambulance vehicles with radio communications and navigation systems | ||
5 | The presence in the emergency medical service of regions, cities of republican significance and the capital of an automated control system for receiving and processing calls and systems that allow monitoring of ambulance vehicles through navigation systems, as well as a system for computer recording of dialogues with subscribers and an automatic identification of the telephone number from which a call comes in. Dialogue recordings shall be stored for at least 2 years. | ||
6 | Availability of regional Call centres (call centres) as part of regional emergency medical care stations and emergency medical care stations in cities of republican significance and the capital | ||
7 | Compliance with a five-minute processing time for an emergency medical call from the moment it is received by the dispatcher, during which sorting shall be carried out according to the category of urgency of the call. | ||
8 | Compliance with the time of arrival of the emergency team to the patient’s location from the moment of receiving a call from the dispatcher according to the list of categories of urgency of emergency medical calls (from 10 minutes to 60 minutes) | ||
9 |
Correct determination by the emergency medical service dispatcher of calls by urgency category according to: | ||
10 |
The paramedic or doctor of the emergency medical service team or emergency medical service department when organizing primary health care shall make one of the following decisions based on the results of examination, instrumental diagnostics, the 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: | ||
11 | Availability of medical recommendations for further contact with the primary health care organization (at the place of residence or attachment in the case of leaving a patient who does not need hospitalization at the place of call or home, the emergency medical service team or the emergency medical service department at the primary health care organization shall be provided | ||
12 | Availability of a signal sheet for the patient in case the patient becomes ill and needs to be visited at home by a local doctor | ||
13 |
Availability of recording the following data when a call is received by the dispatch service of the emergency medical service station: | ||
14 |
Compliance with the time of arrival of paramedics and specialized (medical) teams to the patient’s location from the moment of receiving a call from the emergency medical station dispatcher, taking into account the category of urgency: | ||
15 | Availability of informing the emergency medical service dispatcher of the hospital admission department about the delivery of the patient in the event of a decision by the emergency medical service team or the emergency medical service department when organizing primary health care to transport the patient to the hospital | ||
16 | Availability of a minimum list of medical devices for ambulance transport of an ambulance station in classes A, B and C | ||
For medical assistance in the form of air ambulance | |||
17 | Availability of an assignment for a medical flight in form № 090/у | ||
18 | Availability of supporting documentation about the mobile medical aviation team conducting an ongoing assessment of the condition and treatment of the patient(s) when transporting the patient (s) according to the relevant clinical protocols for diagnosis and treatment | ||
19 | Availability of grounds for the provision of medical care in the form of medical aviation (extract from the medical record of a patient in need of medical care in the form of medical aviation; application from the coordinating doctor of the medical aviation department to the dispatcher of the Coordinating organization; in emergency cases, an oral order from the authorized body, with written confirmation; call from the ambulance service and other emergency services) | ||
20 | Availability of approval by the dispatcher of the Coordinating organization of the composition of the mobile medical aviation team and the involved qualified specialized expert(s) from medical organizations in the region with obtaining their informed consent | ||
21 | Availability of a schedule of qualified specialists in the provision of medical care in the form of medical aviation approved by healthcare entities and medical education organizations in the Coordinating Organization | ||
22 |
Availability of informed consent of the patient(s) for the provision of medical care in the form of medical aviation during its transportation. | ||
Official(s)____________________________________ ____________
position signature
_________________________________________________________
surname, first name, patronymic (if any)
Head of the subject of control ____________________ ____________
position signature
_________________________________________________________
surname, first name, patronymic (if any)
Checklist
Footnote. Annex 13 - as amended by the joint order of the Minister of Healthcare of the Republic of Kazakhstan dated 29.05.2003 № 90 and the Minister of National Economy of the Republic of Kazakhstan dated 29.05.2003 № 91 (shall come into effect ten calendar days after the day of its first official publication).
in the field of quality of medical services
____________________________________________________________________
in accordance with Article 138
____________________________________________________________________
of the Entrepreneurial Code of the Republic of Kazakhstan concerning
____________________________________________________________________
subjects (objects) carrying out activities in the field of
HIV prevention name of a homogeneous group of subjects (objects) of control
____________________________________________________________________
State body that appointed the inspection/preventive control
with a visit to the subject (object) of control
____________________________________________________________________
Act on the appointment of an inspection/preventive control with a visit to the subject
(object) of control
____________________________________________________________________
______________________________________________________________№, 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 | Meets requirements | Does not meet requirements |
1 | 2 | 3 | 4 |
1 | Availability of supporting documentation on the provision of medical care included in the guaranteed volume of free medical care and (or) the system of compulsory social health insurance on a free basis | ||
2 |
Conducting an examination using the rapid testing method with registration in the HIV research journal using the express testing method. | ||
3 | Availability of a written notification from a health care organization that, during a medical examination, revealed the fact of HIV infection in the subject about the result obtained, about the need to take precautions aimed at protecting one’s health and the health of others, as well as a warning about administrative and criminal liability for evading treatment and infecting others persons with the patient signing a confidential interview sheet with a person infected with HIV in accordance with form № 095/у | ||
4 |
Availability of supporting documentation on compliance with the deadlines for issuing negative results. | ||
5 |
Availability of supporting documentation on compliance with the deadlines for sending serum samples to the republican state health care organization. | ||
6 |
Availability of supporting documentation on compliance with the deadlines for re-examination in case of doubtful results. | ||
7 |
Availability of pre-test and post-test counselling. | ||
8 | Sending by a health care organization operating in the field of HIV prevention to the territorial state body in the field of sanitary and epidemiological welfare an emergency notification in form № 034/у for each case of HIV infection allegedly associated with the provision of medical care (in-hospital) | ||
9 |
Availability of a Sheet for a confidential interview with a person infected with HIV, Form № 095/у, which shall include: consent to enter personal data into electronic | ||
10 | Monitoring and assessment of the coverage of key population groups and people living with HIV infection shall be carried out by maintaining a database of individual records of clients and appropriate forms of accounting and reporting documentation by specialists of health care organizations carrying out activities in the field of HIV prevention | ||
11 | Transfer by the employer of medical workers with an established diagnosis of HIV infection to another job that does not involve violating the integrity of the skin or mucous membranes | ||
12 |
Availability of supporting documentation on the diagnosis and treatment of STIs. | ||
13 | Availability of equipped transport for mobile trust points | ||
14 | Availability of supporting documentation on the implementation of pre-exposure and post-exposure prophylaxis among the population and key populations | ||
15 |
Availability of monitoring contacts on time. | ||
16 |
Availability of dynamic monitoring and provision of antiretroviral therapy for HIV-infected persons. | ||
17 |
Availability of documentation (internal orders, regulations, protocols, questionnaires, analytical reports) on the conduct of a clinical audit by the Patient Support and Internal Expertise Service and its assessment according to the following criteria: |
Official(s)____________________________________ ____________
position signature
_________________________________________________________
surname, first name, patronymic (if any)
Head of the subject of control ____________________ ____________
position signature
_________________________________________________________
surname, first name, patronymic (if any)
Checklist
Footnote. Appendix 14 - as amended by the joint order of the Minister of Healthcare of the Republic of Kazakhstan dated 29/05/2023 № 90 and the Minister of National Economy of the Republic of Kazakhstan dated 05/29/2023 № 91 (shall come into effect upon the expiration of ten calendar days after the day of its first official publication).
in the field of quality of medical services
___________________________________________________________________
in accordance with Article 138
___________________________________________________________________
of the Entrepreneurial Code of the Republic of Kazakhstan concerning
___________________________________________________________________
subjects (objects) operating in the field of blood service
name of a homogeneous group of subjects (objects) of control
___________________________________________________________________
State body that appointed the inspection/preventive control
with a visit subject (object) of control
___________________________________________________________________
___________________________________________________________________
Act on the appointment of an inspection/preventive control with a visit to the subject
(object) of control
_____________________________________________________________________
____________________________________________________________ №, 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 | Meets requirements | Does not meet requirements |
1 | 2 | 3 | 4 |
1 | Availability of supporting documentation on the provision of medical care included in the guaranteed volume of free medical care and (or) the system of compulsory social health insurance on a free basis | ||
2 | Availability of supporting documentation on compliance in the organization of the blood service with the requirements for step-by-step labelling of blood and its components. Providing conditions for traceability of the movement of each blood product from the donor to the receipt of the finished product and its use | ||
3 | Availability of supporting documentation confirming compliance with the requirements for laboratory testing of the recipient's blood samples for the availability of markers of blood-borne infections before and after transfusions carried out using high-quality immunoserological and molecular biological methods on closed-type automatic analyzers. | ||
4 | Availability of registration in the electronic information database after the donation of blood and its components of all information about the donation of blood and its components, including the type of reaction and volume of medical care provided, in case of side effects of donation, compliance of documents for transfer to the primary fractionation unit with accompanying documentation collected blood and its components | ||
5 | Availability of blood and its components donor questionnaire provided to the donor, which he/she fills out independently or with the participation of a medical registrar, as well as an information sheet | ||
6 | Availability of supporting documentation on compliance with the requirements for performing immunohematological studies for the availability of irregular anti-erythrocyte antibodies in liquid-phase systems on a plane and in test tubes, reading the result of an agglutination reaction with mandatory microscopy. | ||
7 |
Availability of supporting documentation on compliance with the requirements for incoming and daily in-laboratory quality control of reagents to confirm their activity and specificity. The following shall be subject to incoming control: | ||
8 | Placement of blood collected on-site in thermal containers marked "Unexamined blood products, not subject to issue" and at a temperature of 22±2°C shall be delivered within 18-24 hours to the blood service organization | ||
9 | Use of reagents with monoclonal antibodies and equipment registered by the state body in the field of circulation of medicines and medical devices for immunohematological studies of blood samples of potential recipients | ||
10 | Availability of supporting documentation on compliance with the requirements of blood transfusion and its components | ||
11 | Availability of supporting documentation on compliance with the requirements for the donor to undergo a mandatory medical examination before donating blood and its components within the framework of the guaranteed volume of free medical care | ||
12 | Compliance with requirements for medical examination of donors, safety and quality in the production of blood products for medical use | ||
13 | Availability of supporting documentation on compliance with the requirements of external assessment of the quality of laboratory research measurements in reference laboratories | ||
14 | Compliance with the requirements for incoming and daily in-laboratory quality control of reagents to confirm their activity and specificity. | ||
15 | Availability of a blood donor and its components questionnaire provided to the donor, which he/she fills out independently or with the participation of a medical registrar. | ||
16 |
The following shall be subject to incoming control: | ||
17 | Compliance with requirements for medical examination of donors, safety and quality in the production of blood products for medical use | ||
18 |
Availability of documentation (internal orders, regulations, protocols, questionnaires, analytical reports) on the conduct of a clinical audit by the Patient Support and Internal Expertise Service and its assessment according to the following criteria: |
Official(s)____________________________________ ____________
position signature
_________________________________________________________
surname, first name, patronymic (if any)
Head of the subject of control ____________________ ____________
position signature
_________________________________________________________
surname, first name, patronymic (if any)
| Appendix 15 to the joint order of the Minister of Healthcare of the Republic of Kazakhstan dated November 15, 2018 № KR HCM-32 and the Minister of National Economy of the Republic of Kazakhstan dated November 15, 2018 № 70 |
Criteria for assessing the degree of risk in the sphere of circulation of medicines and medical devices Chapter 1. General provisions
1. These Criteria for assessing the degree of risks in the sphere of circulation of medicines and medical devices (hereinafter - the Criteria) have been developed in accordance with subparagraph 16) of Article 10 of the Code of the Republic of Kazakhstan “On Public Health and Healthcare System”, paragraphs 5 and 6 of Article 141 and paragraph 1 Article 143 of the Entrepreneurial Code of the Republic of Kazakhstan, the Rules for the formation of risks assessment and management system by regulatory state bodies, approved by order of the acting Minister of National Economy of the Republic of Kazakhstan dated June 22, 2022 № 48 (registered in the Register of state registration of regulatory legal acts under № 28577) and by order of the acting Minister of National Economy of the Republic of Kazakhstan dated July 31, 2018 № 3 “On approval of the checklist’s form” (registered in the Register of state registration of regulatory legal acts under № 17371).
2. The following concepts are used in these Criteria:
1) a point – a quantitative measure of risk calculation;
2) data normalization – a statistical procedure that involves bringing values measured on various scales to a conventionally common scale;
3) risk - the probability of causing harm as a result of the activities of the subject of control of human life or health, the environment, the legitimate interests of individuals and legal entities, the property interests of the state, taking into account the severity of its consequences;
4) risks assessment and management system - the process of making management decisions aimed at reducing the probability of adverse factors occurring by distributing subjects (objects) of control according to risk levels for subsequent implementation of preventive control with a visit to the subject (object) of control and (or) inspections conducted for compliance with qualification or permitting requirements for issued permits, requirements for sent notifications in accordance with the Law of the Republic of Kazakhstan “On Permits and Notifications” (hereinafter - verification of compliance with the requirements) in order to limit the freedom of entrepreneurship to the minimum possible extent, while ensuring an acceptable level of risk in the relevant areas of activity, as well as those aimed at changing the level of risk for a specific subject (object) of control and (or) exemption of such subject (object) of control from preventive control with a visit to the subject (object) of control and (or) inspections for compliance with requirements;
5) objective criteria for assessing the degree of risk (hereinafter - objective criteria) - criteria for assessing the degree of risk used to select subjects (objects) of control depending on the degree of risk in a certain field of activity and not directly dependent on the individual subject (object) of control;
6) criteria for assessing the degree of risk - a set of quantitative and qualitative indicators related to the direct activities of the subject of control, features of industry development and factors influencing this development, allowing the subjects (objects) of control to be assigned to various degrees of risk;
7) subjective criteria for assessing the degree of risk (hereinafter - subjective criteria) - criteria for assessing the degree of risk used for selecting subjects (objects) of control and depending on the results of the activities of a particular subject (object) of control;
8) a checklist - a list of requirements for the activities of subjects (objects) of control, non-compliance with which entails a threat to human life and health, the environment, the legitimate interests of individuals and legal entities, the state;
9) sample set (sample) – a list of assessed subjects (objects) classified as a homogeneous group of subjects (objects) of control in a specific area of state control, in accordance with paragraph 2 of Article 143 of the Entrepreneurial Code of the Republic of Kazakhstan.
Chapter 2.
The procedure for forming risks assessment and management system
when conducting preventive control of subjects (objects) of control
3. Risks management when carrying out preventive control with a visit to the subject (object) of control shall be formed by determining objective and subjective criteria, which are carried out in stages (multi-criteria analysis of decisions).
At the first stage, according to objective criteria, subjects (objects) of control are distributed to one of the following degrees of risk:
1) high risk;
2) medium risk;
3) low risk.
According to the indicators of the degree of risk according to subjective criteria, the subject (object) of control refers:
1) to a high degree of risk - with a risk degree indicator from 71 to 100 inclusive;
2) to an average degree of risk - with a risk degree indicator from 31 to 70 inclusive;
3) to a low degree of risk - with a risk degree indicator from 0 to 30 inclusive.
4. Criteria for assessing the degree of risk for conducting preventive control of subjects (objects) of control shall be formed by defining objective and subjective criteria.
Paragraph 1. Objective criteria
5. Determination of risk according to objective criteria shall be carried out depending on the specifics of the area in which state control is carried out, taking into account one of the following criteria:
1) level of danger (complexity) of the object;
2) the scale of severity of possible negative consequences, harm to the regulated area (region);
3) the possibility of an unfavorable incident for human life or health, the legitimate interests of individuals and legal entities, and the state.
6. After analyzing possible risks, subjects (objects) of control shall be distributed into three degrees of risk according to objective criteria (high, medium and low).
7. A high degree of risk includes subjects (objects) of control carrying out activities related to:
1) production of medicines;
2) manufacturing of medicines;
3) wholesale sales of medicines;
4) production of medical devices;
5) manufacturing of medical devices;
8. A medium degree of risk includes subjects (objects) of control:
1) subjects in the field of circulation of medicines and medical devices that carry out retail sales of medicines;
2) healthcare organizations providing outpatient care;
3) healthcare organizations providing inpatient care and (or) inpatient replacing care;
4) healthcare organizations providing emergency medical care and (or) air ambulance services;
5) healthcare organizations engaged in the procurement, preservation, processing, storage, and sale of blood and its components.
9. A low degree of risk includes subjects (objects) of control:
1) subjects in the field of circulation of medicines and medical devices carrying out retail sales of medicines and having a certificate of good pharmacy practice (GPP);
2) subjects (objects) of control carrying out pharmaceutical activities related to the wholesale and retail sale of medical devices.
10. For subjects (objects) of control classified as high and medium degree of risk according to objective criteria, an inspection for compliance with requirements, preventive control with a visit to the subject (object) of control, preventive control without a visit to the subject (object) of control and an unscheduled inspection shall be conducted.
11. For areas of activity of subjects (objects) of control classified as low degree of risk according to objective criteria, an inspection for compliance with the requirements of preventive control without a visit to the subject (object) of control and an unscheduled inspection shall be conducted.
Paragraph 2. Subjective criteria
12. The determination of subjective criteria in the field 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.
13. Formation of a database and collection of information are necessary to identify subjects (objects) of control.
The following sources of information shall be used to assess the degree of risk:
1) the results of previous inspections and preventive control with visits to subjects (objects) of control;
2) Note of the ILLI!Subparagraph 2) shall be enforced from 01.12.2024 by joint order of the acting Minister of Healthcare of the Republic of Kazakhstan dated 24.05.2023 № 87 and Minister of National Economy of the Republic of Kazakhstan dated 24.05.2023 № 77.
3) Note the ILLI!
Subparagraph 3) shall be enforced from 01.12.2024 by joint order of the acting Minister of Healthcare of the Republic of Kazakhstan dated 24.05.2023 № 87 and Minister of National Economy of the Republic of Kazakhstan dated 24.05.2023 № 77.
4) Note of the ILLI!
Subparagraph 4) shall be enforced from 01.12.2024 by joint order of the acting Minister of Healthcare of the Republic of Kazakhstan dated 24.05.2023 № 87 and Minister of National Economy of the Republic of Kazakhstan dated 24.05.2023 № 77.
5) Note of the ILLI!
Subparagraph 5) shall be enforced from 01.12.2024 by joint order of the acting Minister of Healthcare of the Republic of Kazakhstan dated 24.05.2023 № 87 and Minister of National Economy of the Republic of Kazakhstan dated 24.05.2023 № 77.
The following sources of information shall be used to assess the degree of risk when creating a schedule for requirements compliance:
1) the results of previous inspections and preventive control with visits to subjects (objects) of control;
2) the presence of adverse incidents that arose through the fault of the subject of control;
3) the presence and number of confirmed complaints and appeals;
4) results of preventive control without a visit to the subject (object) of control (final documents issued based on the results of preventive control without a visit to the subject (object) of control);
14. Based on available sources of information, data according to subjective criteria, subject to analysis and assessment shall be formed.
Analysis and assessment of subjective criteria allow us to concentrate the conduct of inspection for compliance with requirements and preventive control of the subject (object) of control in relation to the subject (object) of control with the greatest potential risk.
At the same time, the data of subjective criteria previously taken into account and used in relation to a specific subject (object) of control or data for which the statute of limitations has expired in accordance with the legislation of the Republic of Kazakhstan shall not be used in the analysis and assessment.
In relation to subjects of control who have fully eliminated the violations issued based on the results of the previous preventive control with a visit and (or) inspection for compliance with the requirements, their inclusion in the formation of schedules and lists for the next period of state control shall not be allowed.
15. The degree of violations of requirements for subjects (objects) of control in the field of circulation of medicines and medical devices for compliance with qualification requirements shall be determined in accordance with Appendix 1 to these Criteria and the Degree of violation of requirements for subjects (objects) of control in the field of circulation of medicines and medical devices for conducting preventive control of subjects (objects) of control by information sources shall be determined in accordance with Appendix 2 to these Criteria.
16. Based on the priority of the sources of information used and the significance of indicators of the subjective criteria, in accordance with the procedure for calculating the risk degree indicator according to subjective criteria determined in the List of subjective criteria for determining the degree of risk according to subjective criteria in the field of circulation of medicines and medical devices in accordance with Article 138 of the Entrepreneurial Code of the Republic of Kazakhstan in relation to all subjects (objects) in accordance with Appendix 3 to these Criteria, the risk degree indicator shall be calculated according to subjective criteria.
17. Inspection for compliance with requirements and preventive control with a visit to the subject (object) shall be carried out depending on the purpose and types of activity of the objects, in accordance with checklists in the field of circulation of medicines and medical devices according to Appendices 16, 17, 18, 19, 20, 21 and 25 to this joint order.
18. For areas of activity of subjects (objects) of control classified as high-risk, inspections for compliance with requirements shall be determined by criteria, but shall be carried out no more than once a year.
For areas of activity of subjects (objects) of control classified as medium risk, inspections for compliance with requirements shall be determined by criteria, but shall be carried out no more than once every two years.
For areas of activity of subjects (objects) of control classified as low risk, the frequency of inspections for compliance with requirements shall be determined by criteria for assessing the degree of risk, but not more than once every three years.
Chapter 3. The procedure for calculating the degree of risk according to subjective criteria
19. The calculation of the risk degree indicator according to subjective criteria (R) shall be carried out in an automated mode by summing up the risk degree indicator for violations based on the results of previous inspections and preventive control with visits to subjects (objects) of control (SP) and the risk degree indicator according to subjective criteria determined in accordance with paragraph 13 of these Criteria (SC), with subsequent normalization of the values given in the range from 0 to 100 points.
Rinterm = SP + SC, where
Rinterm - an intermediate indicator of the degree of risk according to subjective criteria,
SP – an indicator of the degree of risk for violations,
SC - an indicator of the degree of risk according to subjective criteria determined in accordance with paragraph 13 of these Criteria.
The calculation shall be made for each subject (object) of control of a homogeneous group of subjects (objects) of control of each sphere of state control. In this case, the list of assessed subjects (objects) of control, classified as a homogeneous group of subjects (objects) of control of one sphere of state control shall form a sample set (sample) for subsequent normalization of data.
20. Based on the data obtained from the results of previous inspections and preventive control with visits to subjects (objects) of control, an indicator of the degree of risk for violations shall be formed, assessed in points from 0 to 100.
If one gross violation is detected from any of the sources of information specified in paragraph 16 of these Criteria, the subject of control shall be assigned a risk indicator of 100 points and shall be subject to inspection for requirements compliance or preventive control with a visit to the subject (object) of control.
SРн – показатель незначительных нарушений;
If gross violations are not detected, the risk level indicator for violations shall be calculated by the total indicator for violations of a significant and minor degree.
When determining the indicator of significant violations, a coefficient of 0.7 shall be applied.
This indicator shall be calculated using the following formula:
SРs = (SР2 х 100/SР1) х 0,7, where:
SPs – an indicator of significant violations;
SР1 – required number of significant violations;
SР2 – number of significant violations identified;
When determining the indicator of minor violations, a coefficient of 0.3 shall be applied.
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 – required number of minor violations;
SР2 – number of minor violations identified;
The violation risk indicator (SP) shall be calculated on a scale from 0 to 100 points and shall be determined by summing the indicators of significant and minor violations according to the following formula:
SР = SРs + SРm, where:
SP – an indicator of the risk degree for violations;
SPs – an indicator of significant violations;
SРm - an indicator of minor violations.
The resulting value of the risk degree indicator for violations shall be included in the calculation of the risk degree indicator based on subjective criteria.
21. The calculation of the risk degree indicator according to subjective criteria determined in accordance with paragraph 16 of these Criteria shall be made on a scale from 0 to 100 points and shall be carried out using the following formula:
xi – an indicator of subjective criterion,
wi – specific weight of the subjective criterion indicator xi,
n – number of indicators.
The resulting value of the risk degree indicator according to subjective criteria, determined in accordance with paragraph 13 of these Criteria, shall be included in the calculation of the risk degree indicator according to subjective criteria.
22. The R indicator values calculated for subjects (objects) shall be normalized to a range from 0 to 100 points. Data normalization shall be carried out for each sample set (sample) using the following formula:
R – risk degree indicator (final) according to the subjective criteria of an individual subject (object) of control,
Rmax – the maximum possible value on the risk degree scale according to subjective criteria for subjects (objects) included in one sample set (sample) (upper limit of the scale),
Rmin – the minimum possible value on the risk degree scale according to subjective criteria for subjects (objects) included in one sample set (sample) (lower limit of the scale),
Rinterm - an intermediate indicator of the degree of risk according to subjective criteria, calculated in accordance with paragraph 16 of these Criteria.
| Appendix 1 to the criteria for assessing the degree of risk in the area of circulation of medicines and medical devices |
The degree of violation of requirements for subjects (objects) of control in the sphere
of circulation of medicines and medical devices for compliance with qualification requirements
| Appendix 2 to the criteria for assessing the degree of risk in the area of circulation of medicines and medical devices |
The degree
of violation of requirements for subjects (objects) of control in the sphere of circulation
of medicines and medical devices for conducting preventive control of subjects (objects)
of control by information sources
| Appendix 3 to the criteria for assessment the degree of risk in the area of circulation medicines and medical devices |
List of subjective criteria for determining the degree of risk according to subjective criteria in the field
of circulation of medicines and medical devices in accordance with Article 138 of the Entrepreneurial
Code of the Republic of Kazakhstan in relation to all subjects (objects)
Checklist in the field of circulation of medicines and medical devices for
compliance with qualification requirements for subjects (objects) of control
Footnote. Appendix 16 is in the wording of the joint order of the acting Minister of Healthcare of the Republic of Kazakhstan dated 24.05.2023 № 87 and the Minister of National Economy of the Republic of Kazakhstan dated 24.05.2023 № 77 (shall be enforced upon expiry of ten calendar days after the day of its first official publication).
The state body that appointed an inspection/preventive control with a visit
to the subject (object) of control _______________________________________________________
________________________________________________________________________________
An act on the appointment of an inspection/preventive control with a visit to the subject (object)
of control _______________________________________________________________________
________________________________________________________________________________
№, date
Name of the subject (object) of control
________________________________________________________________________________
(Individual identification number), the business identification number of the subject (object) of control
______________________________________________________________
Location address
________________________________________________________________________________
Official(s)
_______________________________________________________________________________
position signature
_______________________________________________________________________________
surname, name, patronymic (if any)
Head of the subject of control
_______________________________________________________________________________
position signature
_______________________________________________________________________________
surname, name, patronymic (if any)
Checklist in the field of circulation of medicines and medical devices in relation to medical organizations on drug supply issues
Footnote. Appendix 17 – as amended by the joint order of the Acting Minister of Healthcare of the Republic of Kazakhstan dated 24.05.2023 №87 and the Minister of National Economy of the Republic of Kazakhstan dated 24.05.2023 № 77 (effective ten calendar days after the date of its first official publication).
State body that appointed inspection/preventive control with a visit to the
control subject (object) _______________________________________________________
________________________________________________________________________________
Act on appointing inspection / preventive control with a visit to the
control subject (object) _____________________________________________________________
________________________________________________________________________________
№, date
Name of the control subject (object)
________________________________________________________________________________
(Individual Identification Number), Business Identification Number of the
control subject (object) _______________________________________________________________
Location address
Designated person (s)
________________________________________________________________________________
position, signature
________________________________________________________________________________
surname, name, patronymic (if any)
The head of the control subject
________________________________________________________________________________
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 № ҚР ДСМ-32 and the Minister of National Economy of the Republic of Kazakhstan dated November 15, 2018 №70 |
Checklist in the field of circulation of medicines and medical devices regarding subjects (objects)
of pharmaceutical activities engaged in the production of medicines and medical devices
Footnote. Appendix 18 – as amended by the joint order of the Acting Minister of Healthcare of the Republic of Kazakhstan dated 24.05.2023 №87 and the Minister of National Economy of the Republic of Kazakhstan dated 24.05.2023 № 77 (effective ten calendar days after the date of its first official publication).
State body that appointed inspection/preventive control with a visit to the
control subject (object) _______________________________________________________
________________________________________________________________________________
Act on appointing inspection / preventive control with a visit to
control subject (object) _____________________________________________________________
________________________________________________________________________________
№, date
Name of the control subject (object)
________________________________________________________________________________
(Individual Identification Number), Business Identification Number of the
control subject (object) _______________________________________________________________
Location address
№ | List of requirements | Compliance with requirements | Non-compliance with requirements |
1. | Compliance with all production processes of medicines and medical devices (GMP) | ||
2. | Availability of state registration in the Republic of Kazakhstan of medicinal substances used in production, with the exception of those produced under Good Manufacturing Practice conditions | ||
3. | Availability of forwarding documents for medicines and medical productsв | ||
4. | Carrying out activities for the production of medicines or wholesale distribution of medicines by suppliers of substances or intermediate products | ||
5. | Compliance of substances, excipients, consumables and packaging materials with the registration dossier | ||
6. | Incoming control of raw materials (substances, auxiliary materials), materials, semi-finished products, components; intermediate control during the production process, control of finished pharmaceutical products | ||
7. | Availability of a quality assurance system, documentation and control of its efficacy in production | ||
8. | Ensuring registration of all technological and auxiliary operations during the production of a separate series of medicines and medical devices | ||
9. | Compliance with the requirements for maintaining documentation of all production processes and materials used in production, its storage order | ||
10. | Compliance with stability testing, shelf-life establishment, and revalidation of medications. | ||
11. | Ensuring that the number of samples is sufficient for testing when necessary (arbitration tests) | ||
12. | Availability of markings indicating the status of manufactured products, initial products, packaging materials | ||
13. | Quality control of materials, intermediate products, finished products. | ||
14. | Maintaining of database of side effects of medicines and medical devices | ||
15. | Availability of a health specialist certificate for each pharmacy worker | ||
16. | Availability of a state license for pharmaceutical activities and of attachments for subtypes of activity or notification of the commencement of activity. Compliance with the types and subtypes of activities declared upon receipt of the state license and attachment to it | ||
17. | Ensuring storage and transportation in accordance with the conditions established by the manufacturer in the regulatory and technical document on monitoring the quality and safety of medicines, in the instructions for medical use for medicines and medical devices, operational documents (for the medical device), indicated in the labeling of their packages | ||
18. | Ensuring safety, storage conditions and handling of various groups of medicines and medical devices by complying with the requirements for design, arrangement, composition, size of the areas, equipment of premises (areas) for storage of medicines and medical devices and their operation, ensuring the safety | ||
19. | Observance of storing medicines and medical devices separate from other products to avoid any impact on them, protection from negative impact of light, temperature, moisture and other external factors | ||
20. | Keeping records of the expiry dates of medicines and medical devices on paper or electronic media | ||
21. | Storage of medicines and medical devices in designated and clearly marked storage areas | ||
22. | Provision of storage premises, including a refrigerating room (chamber) with appropriate equipment for control of temperature, air humidity (thermometers, hygrometers, other types of devices) and their location on the internal walls of the premises away from heating devices based on the results of testing of temperature fluctuation zones for cold and warm seasons | ||
23. | Observance of separation during storage of all medicines and medical devices depending on the pharmacological group, administration method, aggregate state, physicochemical properties, exposure to various environmental factors | ||
24. | Availability of isolated storage space for pending, expired, returned, withdrawn, presumably counterfeit, recalled and rejected medicinal products | ||
25. | Provision of weather protection in the receiving and discharge areas. Availability of equipment in receiving and discharge areas (ventilation/air conditioning system, hygrometer, thermometer), container cleaning equipment. Availability of an equipped area for inspection of received products | ||
26. | Separation of acceptance, quarantine, defective, discharge and storage areas. Availability of a room in which medicines are stored in quarantine, clearly marked and with limited access | ||
27. | Availability of common non-combustible buildings with insulation by non-combustible walls from neighboring premises that meet fire safety requirements in the absence of separate storage facilities for flammable substances, provision of premises with supply and exhaust ventilation | ||
28. | 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 1.2 meters high | ||
29. | Storage of flammable liquids isolated in separate rooms in glass or metal containers from other groups | ||
30. |
Compliance with the storage of flammable and combustible liquid medicines that should not be stored: | ||
31. | Compliance with isolated storage of calcium hypochloride, taking into account its properties | ||
32. | Compliance with the storage of flammable liquids with constant monitoring of the condition of containers, their tightness and serviceability | ||
33. | Implementation of measures in the storage of explosive medicines against their contamination by dust | ||
34. | Compliance with separate storage of explosive and flammable medicines containing acids and alkalis | ||
35. | Ensuring protection of cylinders with oxygen and flammable gases from heat sources, contact with oil and other greasy substances, and their storage in isolated rooms or under sheds | ||
36. | Observance of conditions of storing dressings in a dry ventilated area in cabinets, drawers, on racks, pallets, trays, in conditions ensuring cleanliness | ||
37. | Compliance with the conditions of storing medical instruments, devices, appliances, equipment in dry heated rooms at room temperature, with relative humidity not exceeding 65 percent | ||
38. | Compliance with the requirements for interior finishing of premises (areas) for storing medicines and ensuring cleanliness of storage premises and equipment | ||
39. | Providing protection against the entry of insects, rodents or other animals, and presence of preventive pest control program | ||
40. |
Separation of rest rooms, dressing rooms, showers and toilets for employees from storage rooms (areas). Food, beverages, tobacco products, as well as medicines for personal use shall not be stored in storage rooms (areas). | ||
41. |
Provision of the necessary equipment and inventory in drug storage areas: | ||
42. | Availability of a document on calibration (verification) of equipment used for control and monitoring of storage conditions | ||
43. | Availability of a developed and approved emergency plan in case of malfunction of the refrigeration room (chamber), refrigeration equipment or power outage, emergency situations | ||
44. | Availability of developed and approved instructions for cleaning and disinfection of equipment. The used equipment shall be in good condition and kept in proper cleanliness | ||
45. | Availability of a person responsible for ensuring the safety of the quality of medicines and medical devices at the facilities storing medicines and medical devices. | ||
46. | Availability of a commission for the destruction of medicines and medical devices unsuitable for sale and medical use. | ||
47. | Availability of acts on the destruction of medicines and medical devices unsuitable for sale and medical use. | ||
48. |
Availability of secondary package labeling including the following information: | ||
49. |
Availability of primary packaging labeling indicating the following information: | ||
50. | Organization of work to monitor adverse reactions and (or) lack of efficacy of medicines and medical devices, appointment of responsible persons for monitoring side effects of medicines and medical devices | ||
51. | Provision by the responsible person to the authorized organization of information about side effects and (or) lack of efficacy of medicines and medical devices. Transmission of message cards through the portal of an authorized organization online containing a mandatory minimum amount of information | ||
52. | Compliance with the deadlines for submitting a completed report card about adverse reactions (actions) and (or) efficacy to the authorized organization in cases of detection | ||
53. | Absence of facts of procurement, production, storage, advertising, use, provision and sale of medicines and medical devices that have not passed state registration in the Republic of Kazakhstan | ||
54. | Absence of facts of production, importation, storage, use and sale of counterfeit medicines and medical devices | ||
55. | Absence of facts of sale of medicines and medical devices, the quality of which is not confirmed by the conclusion on safety and quality | ||
56. | Absence of facts of storage, use and sale of expired medicines and medical devices | ||
57. | Compliance of the medicinal product with the requirements of the regulatory document on quality and safety control of the medicinal product and medical device (based on the results of safety and quality assessment of samples withdrawn as doubtful) | ||
58. |
Compliance with the requirements for storage, accounting, destruction of medicines containing narcotic drugs, psychotropic substances and precursors (including substances): | ||
59. | Availability of a list of persons who have conclusions from psychiatrists and narcologists about the absence of drug addiction, substance abuse, chronic alcoholism, as well as about suitability for carrying out activities related to narcotic drugs, psychotropic substances and their precursors and the conclusion of the internal affairs bodies on conducting the relevant check | ||
60. | Storage rooms, safes and cabinets shall be kept closed. After the end of the working day they shall be sealed and (or) stamped. Keys, seal and (or) sealer shall be kept with the responsible person | ||
61. | Availability of a first aid kit | ||
62. | Availability of a signboard indicating the name of the pharmaceutical activity subject, its organizational and legal form and operation mode in the state and Russian languages | ||
63. | Availability of information on telephone numbers and addresses of territorial subdivisions of the state body in the sphere of circulation of medicines and medical devices in a place convenient for the population’s viewing | ||
64. | Ensuring traceability of medicinal products labeled with identification means by providing by participants of circulation of medicinal products and entities in the sphere of circulation of medicinal products and medical devices of information on launch into circulation, on sale and (or) transfer, as well as on withdrawal of labeled medicinal products from circulation on the territory of the Republic of Kazakhstan | ||
65. |
Compliance with the rules of advertising medicinal products and medical devices: | ||
66. |
Non-admission of advertising of medicines and medical devices: | ||
67. | Compliance with manufacturer's price limits | ||
68. | Availability of a certificate of compliance with the requirements of the Good Manufacturing Practice (GMP) Standard |
Designated person (s)
________________________________________________________________________________
position, signature
________________________________________________________________________________
surname, name, patronymic (if any)
The head of the control subject
________________________________________________________________________________
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 № ҚР ДСМ-32 and the Minister of National Economy of the Republic of Kazakhstan dated November 15, 2018 №70 |
Checklist in the field of circulation of medicines and medical devices regarding subjects (objects)
of pharmaceutical activity, engaged in manufacturing of medicines and medical devices
Footnote. Appendix 19 as amended by the joint order of the Acting Minister of Healthcare of the Republic of Kazakhstan dated 24.05.2023 №87 and the Minister of National Economy of the Republic of Kazakhstan dated 24.05.2023 № 77 (effective ten calendar days after the date of its first official publication).
State body that appointed inspection/preventive control with a visit to the
control subject (object) _______________________________________________________
________________________________________________________________________________
Act on appointing inspection / preventive control with a visit to
control subject (object) _______________________________________________________________________
________________________________________________________________________________
№, date
Name of the control subject (object)
________________________________________________________________________________
(Individual Identification Number), Business Identification Number of the
control subject (object) _______________________________________________________________
Location address
Designated person (s)
________________________________________________________________________________
position, signature
________________________________________________________________________________
surname, name, patronymic (if any)
The head of the control subject
________________________________________________________________________________
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 № ҚР ДСМ-32 and the Minister of National Economy of the Republic of Kazakhstan dated November 15, 2018 №70 |
Checklist in the field of circulation of medicines and medical devices regarding subjects (objects)
of pharmaceutical activity, engaged in wholesale sale of medicines and medical devices
Footnote. Appendix 20 – as amended by the joint order of the Acting Minister of Healthcare of the Republic of Kazakhstan dated 24.05.2023 №87 and the Minister of National Economy of the Republic of Kazakhstan dated 24.05.2023 № 77 (effective ten calendar days after the date of its first official publication).
State body that appointed inspection/preventive control with a visit to the
control subject (object) _______________________________________________________
________________________________________________________________________________
Act on appointing inspection / preventive control with a visit to the
control subject (object) ______________________________________________________________
________________________________________________________________________________
№, date
Name of the control subject (object)
________________________________________________________________________________
(Individual Identification Number), Business Identification Number of the
control subject (object) _______________________________________________________________
Location address
Designated person (s)
________________________________________________________________________________
position, signature
________________________________________________________________________________
surname, name, patronymic (if any)
The head of the control subject
________________________________________________________________________________
position, signature
_______________________________________________________________________________
surname, name, patronymic (if any).
Checklist in the field of circulation of medicines and medical devices regarding subjects (objects)
of pharmaceutical activity, engaged in retail sale of medicines and medical devices
Footnote. Appendix 21 – as amended by the joint order of the Acting Minister of Healthcare of the Republic of Kazakhstan dated 24.05.2023 №87 and the Minister of National Economy of the Republic of Kazakhstan dated 24.05.2023 № 77 (effective ten calendar days after the date of its first official publication).
State body that appointed inspection/preventive control with a visit to the
control subject (object) _______________________________________________________
________________________________________________________________________________
Act on appointing inspection / preventive control with a visit to
control subject (object) _______________________________________________________________________
________________________________________________________________________________
№, date
Name of the control subject (object)
________________________________________________________________________________
(Individual Identification Number), Business Identification Number of the
control subject (object) _______________________________________________________________
Location address
№ | List of requirements | Compliance with requirements | Non-compliance with requirements |
1. | Ensuring the sale of medical products related to measuring instruments, in the presence of a certificate of approval of the type of measuring instruments or a certificate of metrological certification of medical measuring equipment | ||
2. | Ensuring the sale of prescription drugs on a doctor’s prescription | ||
3. | Ensuring that medicines sold without a doctor's prescription are placed on display cases | ||
4. | Registration of invalid prescriptions in the Register of invalid prescriptions with the stamp “Prescription invalid”. | ||
5. |
Compliance with the validity term of recipes: | ||
6. | Ensuring provision of reliable information regarding: 1) correct and rational application or use; 2) possible side effects and contraindications; 3) interaction with other medicinal products, precautions in their application or use; 4) expiration dates and rules of storage at home; 5) rules of operation, completeness of medical products | ||
7. | Availability of a document on calibration and (or) verification of a medical device that is a measuring instrument | ||
8. | Making sure that the used medical equipment, at the time of acceptance was new, unused, newest or serial model, free of defects. | ||
9. | Availability of a log of the technical condition of medical equipment subject to service | ||
10. | Availability of documents confirming current and major repairs | ||
11. | Availability of documents confirming warranty service (not less than thirty-seven months from the date of commissioning and periodicity recommended by the manufacturer) consisting of periodic inspection of the technical condition of medical equipment (at least once a year). | ||
12. |
Availability in operated medical equipment: | ||
13. | Presence or absence of facts of operation of medical equipment not provided with service maintenance, removed from service maintenance, or operation of medical equipment by personnel without special training, not trained in the use of the medical equipment. | ||
14. | Presence or absence of facts of unjustified idling of medical equipment (absence of measures for restoration of serviceable condition) | ||
15. | Ensuring implementation of preventive measures: 1) quality control during acceptance and sales; 2) compliance with the rules and shelf life of medicines, keeping records of medicines with a limited shelf life; 3) serviceability and accuracy of weighing instruments; 4) checking the correctness of the prescription, its validity period, compliance of the prescribed doses with the patient’s age, compatibility of ingredients, and the norms for one-time dispensing; 5) keeping records of the validity periods of safety and quality assessment conclusions | ||
16. | Ensuring acceptance of medicines and medical devices with verification of: 1) compliance of quantity, completeness, integrity of containers, compliance of packaging, labeling with regulatory documents, availability of instructions for medical use of medicines and medical devices in the state and Russian languages; availability of an operational document for a medical device; 2) compliance with the name, dosage, packaging, quantity, batch (series) of products specified in the accompanying documents; 3) presence in the accompanying documents of a certificate of conformity or a reference to it in the invoice for the release of goods | ||
17. | Availability in a place convenient for viewing of information on the list of medicines and specialized medicinal products for free provision of certain categories of citizens with certain diseases at the outpatient level | ||
18. | Availability of lists and specimen 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 government healthcare authorities | ||
19. |
Ensuring the placement in a place convenient for familiarization of: | ||
20. |
Ensuring that information of the following nature is placed in a place visible to visitors: "Medicines may not be returned and exchanged"; | ||
21. | Compliance with the maximum price for the trade name of a medicinal product in retail sales | ||
22. | Holding by each pharmacy worker of a health specialist certificate | ||
23. | Availability of a state license for pharmaceutical activities and of attachments for subtypes of activity or notification of the commencement of activity. Compliance with the types and subtypes of activities declared upon receipt of the state license and attachment to it | ||
24. | Ensuring storage and transportation in accordance with the conditions established by the manufacturer in the regulatory and technical document on monitoring the quality and safety of medicines, in the instructions for medical use for medicines and medical devices, operational documents (for the medical device), indicated in the labeling of their packages | ||
25. | Ensuring safety, storage conditions and handling of various groups of medicines and medical devices by complying with the requirements for design, arrangement, composition, size of areas, equipment of premises (areas) for storage of medicines and medical devices and their operation, ensuring the safety | ||
26. | Maintaining separate storage of medicines and medical devices from other products to avoid any impact on them, protection from negative impact of light, temperature, moisture and other external factors | ||
27. | Keeping records of the expiry dates of medicines and medical devices on paper or electronic media | ||
28. | Storage of medicines and medical devices in designated and clearly marked storage areas | ||
29. | Provision of storage premises, including a refrigerating room (chamber) with appropriate equipment for control of temperature, air humidity (thermometers, hygrometers, other types of devices) and their location on the internal walls of the premises away from heating devices based on the results of testing of temperature fluctuation zones for cold and warm seasons | ||
30. | Observance of separation during storage of all medicines and medical devices depending on the pharmacological group, method of administration, aggregate state, physicochemical properties, exposure to various environmental factors | ||
31. | Availability of isolated storage space for pending, expired, returned, withdrawn, presumably counterfeit, recalled and rejected medicinal products | ||
32. | Provision of weather protection in the receiving and discharge areas. Availability of equipment in receiving and shipping areas (ventilation/air conditioning system, hygrometer, thermometer), container cleaning equipment. Availability of an equipped area for inspection of received products | ||
33. | Separation of receiving, quarantine, defective, discharge and storage areas. Availability of a clearly labeled and restricted access quarantine room where medicines are stored. | ||
34. | Availability of common non-combustible buildings with insulation by non-combustible walls from neighboring premises that meet fire safety requirements in the absence of separate storage facilities for flammable substances, provision of premises with supply and exhaust ventilation | ||
35. | 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 1.2 meters high | ||
36. | Storage of flammable liquids isolated in separate rooms in glass or metal containers from other groups | ||
37. |
Compliance with the storage of flammable and combustible liquid medicines that should not be stored: | ||
38. | Compliance with isolated storage of calcium hypochloride, taking into account its properties | ||
39. | Compliance with the storage of flammable liquids with constant monitoring of the condition of containers, their tightness and serviceability | ||
40. | Implementation of measures in the storage of explosive medicines against their contamination by dust | ||
41. | Compliance with separate storage of explosive and flammable medicines containing acids and alkalis | ||
42. | Ensuring protection of cylinders with oxygen and flammable gases from heat sources, contact with oil and other greasy substances, and their storage in isolated rooms or under sheds | ||
43. | Observance of conditions of storing dressings in a dry ventilated area in cabinets, drawers, on racks, pallets, trays, in conditions ensuring cleanliness | ||
44. | Compliance with the conditions of storing medical instruments, devices, appliances, equipment in dry heated rooms at room temperature, with relative humidity not exceeding 65 percent | ||
45. | Compliance with the requirements for interior finishing of premises (areas) for storing medicines and ensuring cleanliness of storage premises and equipment | ||
46. | Providing protection against the entry of insects, rodents or other animals, and presence of preventive pest control program | ||
47. |
Separation of rest rooms, dressing rooms, showers and toilets for employees from storage rooms (areas). Food, beverages, tobacco products, as well as medicines for personal use shall not be stored in storage rooms (areas). | ||
48. |
Provision of the necessary equipment and inventory in drug storage areas: | ||
49. | Availability of a document on calibration (verification) of equipment used for control and monitoring of storage conditions | ||
50. | Availability of a developed and approved emergency plan in case of malfunction of the refrigeration room (chamber), refrigeration equipment or power outage, emergency situations | ||
51. | Availability of developed and approved instructions for cleaning and disinfection of equipment. The equipment used shall be in good condition and kept in proper cleanliness | ||
52. | Availability of a person responsible for ensuring the safety of the quality of medicines and medical devices at facilities storing medicines and medical devices | ||
53. | Availability of a commission for the destruction of medicines and medical devices unsuitable for sale and medical use | ||
54. | Availability of acts on the destruction of medicines and medical devices unsuitable for sale and medical use | ||
55. |
Availability of secondary package labeling including the following information: | ||
56. |
Availability of primary packaging labeling indicating the following information: | ||
57. | Organization of work to monitor adverse reactions and (or) lack of effectiveness of medicines and medical devices, appointment of responsible persons for monitoring side effects of medicines and medical devices | ||
58. | Provision by the responsible person to the authorized organization of information about side effects and (or) lack of effectiveness of medicines and medical devices. Transmission of message cards through the portal of an authorized organization online containing a mandatory minimum amount of information | ||
59. | Compliance with the deadlines for submitting a completed report card about adverse reactions (actions) and (or) effectiveness to the authorized organization in cases of detection | ||
60. | Absence of facts of procurement, production, storage, advertising, use, provision and sale of medicines and medical devices that have not passed state registration in the Republic of Kazakhstan | ||
61. | Absence of facts of production, importation, storage, use and sale of counterfeit medicines and medical devices | ||
62. | Absence of facts of sale of medicines and medical devices, the quality of which is not confirmed by the conclusion on safety and quality | ||
63. | Absence of facts of storage, use and sale of expired medicines and medical devices | ||
64. | Compliance of the medicinal product with the requirements of the regulatory document on quality and safety control of the medicinal product and medical device (based on the results of safety and quality assessment of samples withdrawn as doubtful) | ||
65. |
Compliance with the requirements for storage, accounting, destruction of medicines containing narcotic drugs, psychotropic substances and precursors (including substances): | ||
66. | Availability of the list of persons who have conclusions from psychiatrists and narcologists about the absence of drug addiction, substance abuse, chronic alcoholism, as well as about suitability for carrying out activities related to narcotic drugs, psychotropic substances and their precursors and the conclusion of the internal affairs bodies on conducting the relevant check | ||
67. | Storage rooms, safes and cabinets shall be kept closed. After the end of the working day they shall be sealed and (or) stamped. Keys, seal and (or) sealer shall be kept with the responsible person | ||
68. | Availability of a first aid kit | ||
69. | Availability of a signboard indicating the name of the pharmaceutical activity subject, its organizational and legal form and operation mode in the state and Russian languages | ||
70. | Availability of information on telephone numbers and addresses of territorial subdivisions of the state body in the sphere of circulation of medicines and medical devices in a place convenient for the population’s viewing | ||
71. | Ensuring traceability of medicinal products labeled with identification means by providing by participants of circulation of medicinal products and entities in the sphere of circulation of medicinal products and medical devices of information on launch into circulation, on sale and (or) transfer, as well as on withdrawal of labeled medicinal products from circulation on the territory of the Republic of Kazakhstan | ||
72. |
Compliance with the rules of advertising of medicinal products and medical devices: | ||
73. |
Non-admission of advertising of medicines and medical devices: |
Designated person (s)
________________________________________________________________________________
position, signature
________________________________________________________________________________
surname, name, patronymic (if any)
The head of the control subject
________________________________________________________________________________
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 № ҚР ДСМ-32 and the Minister of National Economy of the Republic of Kazakhstan dated November 15, 2018 №70 |
Checklist
Footnote. Appendix 22 as amended by the joint order of the Minister of Healthcare of the Republic of Kazakhstan dated 29.05.2023 № 90 and the Minister of National Economy of the Republic of Kazakhstan dated 29.05.2023 № 91(effective ten calendar days after the date of its first official publication).
In the field of medical services quality
__________________________________________________________________
pursuant to Article 138
___________________________________________________________________
of Entrepreneur Code of the Republic of Kazakhstan regarding
___________________________________________________________________
subjects (objects), providing pathoanatomical diagnostics
name of homogeneous group of control subjects (objects)
___________________________________________________________________
State body that appointed inspection/preventive control
with a visit to the control subject (object)
___________________________________________________________________
___________________________________________________________________
Act on appointing inspection/ preventive control with a visit to
control subject (object) _________________________________________________
_____________________________________________________________ №, date
Name of control subject (object) ______________________________
____________________________________________________________________
(Individual Identification Number ), Business Identification Number
of control subject (object) ___________________________________________
____________________________________________________________________
Location address ______________________________________________
____________________________________________________________________
№ | List of requirements | Compliance with requirements | Non-compliance with requirements |
1 | 2 | 3 | 4 |
1 | Availability of supporting documentation on the provision of medical care included in the guaranteed volume of free medical care and (or) the system of compulsory social health insurance on a free basis | ||
2 | Compliance with the requirement to register a refusal to accept biological material, attached to a copy of the referral for examination of biological material in the pathology department in a separate folder (“Rejected samples”), as well as in a separate journal (“Rejected samples”) | ||
3 | Compliance of the pathologist with the requirement for participation of the laboratory technician in the work based on the act of excision, macroscopic examination and macroscopic description of biological material. If it is necessary to obtain additional clinical information at the stage of macroscopic examination of biological material, the specialist physician who sent the material for examination is involved | ||
4 | Compliance with the requirement that the thickness of tissue fragments is 5 millimeters (hereinafter - mm), average diameter - no more than 24 mm | ||
5 | Presence of microscopic description in the protocol of pathological examination of biopsy (surgical) and autopsy material | ||
6 | Compliance with the requirement to issue the pathological examination results with entries in the logs of established form by a medical registrar or laboratory technician | ||
7 | Availability of supporting documentation on compliance with the requirement for storing tissue samples in paraffin blocks in a single archive organized according to end-to-end numbering principle | ||
8 | Availability of supporting documentation on compliance with the requirement for storing tissue specimens in paraffin blocks in a specially equipped dry and cool room, using specialized archival systems and adapted containers, as well as storage of micro-slides in specialized archival systems. | ||
9 | Compliance with the requirement to place micro specimens in boxes in such a way that the slides related to one case are arranged in one indivisible block | ||
10 | Compliance with the requirement for a laboratory technician to sort and prepare biological and medical waste for disposal | ||
11 | Presence of written consent of the spouse or one of the close relatives, or legal representative in pathological diagnostics if the immediate cause of death is unknown | ||
12 | Compliance with the requirement for an independent expert (s) to perform a pathological autopsy of a deceased person at the request of a spouse, close relatives or legal representative | ||
13 | Compliance with the requirement to issue a medical certificate of death (preliminary, final) by a doctor with specialization in “pathological anatomy (adult, pediatric)” on the day of the pathological autopsy. | ||
14 | Compliance with the requirement to document the autopsy results in the form of autopsy report | ||
15 | Compliance with the requirement to stop the autopsy if signs of violent death are detected during a pathological examination of the corpse, the head of the medical organization shall report the incident in writing to the judicial investigative authorities to address the issue of transferring the corpse for a forensic medical examination. A doctor specializing in pathological anatomy (adult, pediatric) shall take measures to preserve the body, organs and tissues of the corpse for further forensic medical examination. A report is drawn up for the completed part of the pathological examination, at the end of which the ground for further forensic medical examination is indicated. The pathologist shall notify in writing the head of the department, the administration of the health care organization where the death occurred, immediately after the interruption of the autopsy, about each case of an interrupted pathological autopsy. | ||
16 | Compliance with the requirement to send an emergency notification to the state body in the field of sanitary and epidemiological well-being of the population by a doctor specializing in “pathological anatomy (adult, pediatric)” in case of initial detection during autopsy of signs of acute infectious disease, food or industrial poisoning, unusual reaction to vaccination | ||
17 | Compliance with the requirement for pathological autopsy of all newborn children who died in medical organizations, including obstetric organizations (regardless of how long after birth they showed signs of life) and stillborn fetuses weighing 500 grams or more at a gestational age of 22 weeks or more, including after termination of pregnancy (spontaneous, for medical and social reasons) with mandatory histological examination of the placenta and issuance of a medical certificate of perinatal death | ||
18 | Compliance with the requirement of the head of the pathology department to ensure that autopsies are performed on dead newborns and stillborns with mandatory histological examination of tissue and organ fragments and their inclusion in the pathological examination report. | ||
19 | Compliance with the requirement of the heads of health care organizations and heads of the pathology department of the organization for the necessary virological and bacteriological examination of autopsy materials of deceased newborns, stillborns and placentas, using for this purpose the appropriate laboratories of health care organizations or state bodies and organizations in the field of sanitary and epidemiological welfare of the population | ||
20 | Compliance with the requirement for a doctor specializing in “pathological anatomy (adult, pediatric)” to issue a medical certificate of perinatal death on the day of the pathological autopsy (preliminary, final, instead of preliminary) | ||
21 |
Compliance with the requirement by a doctor specializing in “pathological anatomy (adult, pediatric)” when drawing up a pathological diagnosis based on the pathological autopsy results to indicate: | ||
22 | Compliance with the requirements for registration and maintenance of primary medical documentation | ||
23 |
Availability of supporting documentation on compliance with the requirements for recording pathological examination materials (biopsy, surgical and autopsy material): | ||
24 |
Compliance with the requirement not to issue the pathological examination report to the spouse, close relatives, legal representatives or other persons for familiarization. | ||
25 | Compliance with the requirement to issue originals or copies of pathological examination reports at the request of inquiry and preliminary investigation bodies , prosecutor, lawyer and (or) court in connection with the investigation or trial, as well as at the request of state bodies in the field of medical services (assistance) | ||
26 |
Compliance with the requirements for cytological examinations, including: | ||
27 | Availability of supporting documentation on compliance with the requirement for the laboratory technician of accepting, initially sorting and registration of the biological material received in the cytology laboratory, macroscopic examination, description of biological material, processing of biological material (preparation, fixation, staining, conclusion, sorting of cytological microslides). | ||
28 | Availability of documentation on compliance with the requirement for a microscopic examination at the first stage by a laboratory technician, then by a cytologist | ||
29 | Compliance with the requirement to involve a physician (specialized expert) when it is necessary to obtain additional clinical information at the stage of microscopic examination of biological material, who sent the material for examination. The final microscopic examination of smears and drawing up a protocol of the results of the study shall be performed by a cytologist | ||
30 | Compliance with the requirement for a doctor specializing in “pathological anatomy (adult, pediatric)” to establish the category and reasons for the discrepancy between the final clinical and pathological diagnoses |
Designated person (s) ____________________________________ ____________
position, signature
________________________________________________________________________
surname, name, patronymic (if any)
The head of the control subject _______________________________ ____________
position, signature
________________________________________________________________________
surname, name, patronymic (if any)
Checklist
Footnote. Appendix 23 – as amended by the joint order of the Minister of Healthcare of the Republic of Kazakhstan dated 29.05.2023 № 90 and the Minister of National Economy of the Republic of Kazakhstan dated 29.05.2023 № 91(effective ten calendar days after the date of its first official publication).
In the field of medical services quality
__________________________________________________________________
pursuant to Article 138
___________________________________________________________________
of Entrepreneur Code of the Republic of Kazakhstan regarding
___________________________________________________________________
subjects (objects), irrespective of activity
_________________________________________________________________
name of homogeneous group of control subjects (objects)
___________________________________________________________________
State body that appointed inspection/preventive control
with a visit to the control subject (object)
___________________________________________________________________
___________________________________________________________________
Act on appointing inspection/ preventive control with a visit to
control subject (object) __________________________________________________
_____________________________________________________________ №, date
Name of control subject (object) ______________________________
____________________________________________________________________
(Individual Identification Number ), Business Identification Number
of control subject (object) ___________________________________________
____________________________________________________________________
Location address ______________________________________________
__________________________________________________________________
№ | List of requirements | Compliance with requirements | Non-compliance with requirements |
1 | 2 | 3 | 4 |
1 | Availability of a specialist certificate for admission to clinical practice | ||
2 | Availability of a license and (or) attachment to the license | ||
3 | Compliance of the premises or building on the right of ownership or lease agreement, or contract of gratuitous use of real estate (loan), or trust management of property, or public-private partnership agreement with the standards for organizing medical care of specialized services on the subtypes of medical activity provided, as well as compliance with the corresponding sanitary rules establishing sanitary and epidemiological requirements for health care facilities | ||
4 | Availability of functioning medical and (or) special equipment, apparatus and instruments, devices, furniture, inventory, vehicles and other means (if necessary), approved in the standards of organizing medical care of profile services on the subtypes of medical activities provided and minimum standards of equipping health care organizations with medical products | ||
5 | Availability of specialists for the activities provided | ||
6 | Availability of specialization or upgrades and other types of advanced training over the last 5 (five) years on the provided subtypes of medical activity (except for the graduates of internship, residency, secondary educational institution who have completed their training no later than 5 (five) years at the time of inspection). |
Designated person (s) ____________________________________ ____________
position, signature
________________________________________________________________________
surname, name, patronymic (if any)
The head of the control subject _______________________________ ____________
position, signature
________________________________________________________________________
surname, name, patronymic (if any)
Checklist
Footnote. The joint order as supplemented by Appendix 24 pursuant to the joint order of the Minister of Healthcare of the Republic of Kazakhstan dated 29.05.2023 № 90 and the Minister of National Economy of the Republic of Kazakhstan dated 29.05.2023 № 91(effective ten calendar days after the date of its first official publication).
In the field of medical services quality
_________________________________________________________________
pursuant to Article 138
__________________________________________________________________
of Entrepreneur Code of the Republic of Kazakhstan regarding
__________________________________________________________________
subjects (objects), providing assistance in nuclear medicine
name of homogeneous group of control subjects (objects)
___________________________________________________________________
State body that appointed inspection/preventive control
with a visit to the control subject (object)
___________________________________________________________________
___________________________________________________________________
Act on appointing inspection/ preventive control with a visit to
control subject (object) ____________________________________________________
_____________________________________________________________ №, date
Name of control subject (object) ______________________________
____________________________________________________________________
(Individual Identification Number ), Business Identification Number
of control subject (object) ___________________________________________
____________________________________________________________________
Location address ______________________________________________
_____________________________________________________________________
№ | List of requirements | Compliance with requirements | Non-compliance with requirements |
1 | 2 | 3 | 4 |
1 | Availability of supporting documentation on the provision of medical care included in the guaranteed volume of free medical care and (or) the system of compulsory social health insurance on a free basis | ||
2 | Availability of supporting documentation on compliance of treatment and diagnostic measures with the recommendations of clinical protocols | ||
3 |
Availability of documentation confirming the status of the Nuclear Medicine Center (hereinafter -the Center) as a structural unit of a multidisciplinary hospital or an independent medical organization providing medical care to the population of the Republic of Kazakhstan according to RND and (or) RNT. | ||
4 |
Availability of supporting documentation on the main tasks and activities of organizations providing medical care in nuclear medicine and compliance with the main tasks: | ||
5 | Availability of supporting documentation on the provision of medical care using nuclear medicine methods within the guaranteed scope of free medical care, voluntary medical insurance and on a paid basis. | ||
6 |
Availability of supporting documentation on the provision of specialized medical care in nuclear medicine in outpatient, hospital replacing, inpatient conditions in a planned form: | ||
7 | Availability of supporting documentation on the referral of patients for PET/CT, PET/MRI, SPECT, SPECT/CT examinations to the RND department by profile specialists | ||
8 | Availability of supporting documentation on the conduct of radioisotope (radionuclide) studies according to clinical protocols, documented procedures, the applied specific diagnostic method, with mandatory compliance with radiation safety measures for the patient and personnel as indicated | ||
9 | Presence of a signed informed consent of the patient for radioisotope (radionuclide) examination before undergoing this examination, indicating the activity of the RFMP used, after which the patient is examined by a doctor and a nurse. | ||
10 | Availability of supporting documentation on interpretation of the results of the study by a nuclear medicine physician after completion of the diagnostic procedure. In complicated cases, with the mandatory "double–read ", double dependent reading (the picture is read twice; on the second reading, the result of the first reading is available), PET, PET/CT, PET/MRI, SPECT, SPECT/CT scans are performed by specialists in the field of nuclear medicine and a final diagnostic conclusion is drawn up. | ||
11 | Availability of supporting documentation on the referral of patients to the RNT department after preliminary examination and resolution of the issue on the basis of clinical data on the need for RNT with the participation of the head of the department or a nuclear medicine physician in accordance with the list of diseases for RNT. For inpatient medical care for oncology diseases, a referral is issued by a multidisciplinary group established in health care organizations providing oncology care; in the case of non-oncology diseases, a whole-body scintigraphy with the diagnostic activity of the radiopharmaceutical drug “Sodium iodide I-131” 185 MBq is prescribed according to clinical indications by the medical consultative board of the medical organization. | ||
12 | Availability of supporting documentation of RNT in inpatient settings in “active” wards and/or beds. After receiving RFMP, the patient is a source of beta-gamma radiation, and therefore, daily rounds of the doctor shall be made by means of audio and video communication. The radiation safety engineer (dosimetrist) records the dose rate from patients daily through a dose rate monitor and stationary dose rate measurement system. | ||
13 |
Availability of supporting documentation on delivery of the cadaver of a patient with administered RFLP of “active” wards to a specially allocated freezing chamber located in the radionuclide support unit of the RNT unit (in the radioactive waste storage facility) in case of lethal outcome. The corpse is kept in the freezer until an acceptable level of radioactive decay (at a distance of 1 meter from the body surface - 20 mcSv/h) and then the corpse is transported. | ||
14 |
Availability of documentation (internal orders, regulations, protocols, questionnaires, analytical briefs) of the clinical audit by Patient Support Services and internal expertise and its evaluation according to the following criteria: | ||
15 | Availability of supporting documentation of record-keeping and accounting records |
Designated person (s) ____________________________________ ____________
position, signature
________________________________________________________________________
surname, name, patronymic (if any)
The head of the control subject _______________________________ ____________
position, signature
________________________________________________________________________
surname, name, patronymic (if any)
Checklist in the field of circulation of medicines and medical devices regarding the state
expert organization in the sphere of circulation of medicines and medical devices
Footnote. The joint order as supplemented by Appendix 25 pursuant to the joint order of the acting Minister of Healthcare of the Republic of Kazakhstan dated 24.05.2023 № 87 and the Minister of National Economy of the Republic of Kazakhstan dated 24.05.2023 № 77(effective ten calendar days after the date of its first official publication).
State body that appointed inspection/preventive control with a visit to
to control subject (object) _______________________________________________________
________________________________________________________________________________
Act on appointing inspection/ preventive control with a visit to control subject (object)
_______________________________________________________________________
________________________________________________________________________________
№, date
Name of control subject (object)
________________________________________________________________________________
(Individual Identification Number), Business Identification Number of the control
subject (object) _______________________________________________________________
Location address
________________________________________________________________________________
№ | List of requirements | Compliance with requirements | Non-compliance with requirements |
1. | Violation of the rules of state registration, re-registration of a medicinal product or medical device, introduction of amendments to the registration dossier of a medicinal product or medical device by the State Expert Organization in the field of circulation of medicinal products and medical devices | ||
2. | Violation of the procedure for expert examination of medicines conducted by a state expert organization in the sphere of circulation of medicines and medical devices when conducting an expert examination of the quality and safety of vaccines |
Designated person (s) ____________________________________ ____________
position, signature
________________________________________________________________________
surname, name, patronymic (if any)
The head of the control subject _______________________________ ____________
position, signature
________________________________________________________________________
surname, name, patronymic (if any)
