Unofficial translation
Pursuant to paragraph 5 of Article 35 of the Code of the Republic of Kazakhstan “On Public Health and Healthcare system” I hereby ORDER:
Footnote. Preamble – as amended by the order of the Minister of Health of the Republic of Kazakhstan dated 29.04.2022 № ҚР ДСМ-39 (effective from 01.07.2022).1. That the attached rules for the organisation and conduct of internal and external quality reviews of health services (care) shall be approved.
2. That certain orders in the field of healthcare shall be deemed to have lost force pursuant to the Annex hereto.
3. That, in the order established by the legislation of the Republic of Kazakhstan, the Committee for Medical and Pharmaceutical Control of the Ministry of Healthcare of the Republic of Kazakhstan shall ensure:
1) state registration hereof with the Ministry of Justice of the Republic of Kazakhstan;
2) posting hereof on the website of the Ministry of Healthcare of the Republic of Kazakhstan after its official publication;
3) within ten working days after the state registration hereof, submission to the Legal Department of the Ministry of Healthcare of the Republic of Kazakhstan of information on the implementation of the measures stipulated in sub-paragraphs 1) and 2) of this paragraph.
4. That the supervising Vice-Minister of Healthcare of the Republic of Kazakhstan shall be charged with control over this order.
5. That this order shall be enforced ten calendar days after the date of its first official publication.
|
Minister of Healthcare of the Republic of Kazakhstan |
A. Tsoy |
| Approved by order of the Minister of Healthcare of the Republic of Kazakhstan № KR DSM-230/2020 dated December 3, 2020 |
Rules for organizing and conducting internal and external examinations of the quality of medical services (care)
Footnote. Rules - as amended by the order of the Minister of Health of the Republic of Kazakhstan dated 06.06.2023 № 104 (effective ten calendar days after the date of its first official publication).
Chapter 1. General provisions
1. These rules for organizing and conducting internal and external examinations of the quality of medical services (care) (hereinafter referred to as the Rules) were developed pursuant to paragraph 5 of Article 35 of the Code of the Republic of Kazakhstan “On Public Health and Healthcare system” (hereinafter referred to as the Code) and establish the procedure for organizing and conducting internal and external examinations of the quality of medical services (care) provided by healthcare entities, regardless of the form of ownership and departmental affiliation.
2. The following terms shall be used in these Rules:
1) in-hospital commissions - commissions established in health care organizations providing medical care (infection control commissions, commissions for the study of lethal outcomes, ethics commission, formulary commission);
2) social health insurance fund (hereinafter referred to as the Fund) - a non-profit organization that accumulates deductions and contributions, and also procures and pays for the services of health care entities that provide medical care in the amounts and on the terms and conditions stipulated by the contract for the procurement of medical services, and other functions defined by the laws of the Republic of Kazakhstan;
3) profile specialist - a medical professional with higher medical education who holds a certificate in health care;
4) standard in the field of health care (hereinafter - the Standard) - a regulatory legal act that establishes rules, general principles and characteristics to ensure standardization in healthcare in the field of medical, pharmaceutical activities, educational and scientific activities in health care, digital healthcare;
5) authorized health care body (hereinafter - authorized body) - a central executive body exercising management and cross-sectoral coordination in the health protection of citizens of the Republic of Kazakhstan, medical and pharmaceutical science, medical and pharmaceutical education, sanitary-epidemiological welfare of the population, circulation of medicines and medical devices, quality of medical services (assistance);
6) treated case - a set of medical services rendered to a patient in inpatient and (or) hospital substitution conditions from the moment of admission to discharge;
7) clinical audit - a detailed retrospective and (or) current analysis of conducted treatment and diagnostic activities for their compliance with health care standards;
8) clinical protocol – scientifically proven recommendations for prevention, diagnosis, treatment, medical rehabilitation and palliative care for a specific disease or condition of the patient;
9) medical services - actions of healthcare entities that have a preventive, diagnostic, therapeutic, rehabilitation and palliative orientation in relation to a specific person;
10) examination of the quality of medical services (care) - a set of organizational, analytical and practical activities carried out to make a conclusion on the quality of medical services provided by individuals and legal entities, using external and internal indicators reflecting the indicator of efficiency, completeness and compliance of medical services with the Standards;
11) medical care - a set of medical services aimed at preserving and restoring the health of the population, including drug provision;
12) quality of medical care - the level of compliance of the provided medical care with the standards of medical care;
13) independent examination of the quality of medical services (care) is a procedure carried out by independent experts within the framework of internal and external examination in order to make a conclusion on the quality of medical services (care) provided by healthcare entities, using indicators reflecting the effectiveness, completeness and compliance of the provided medical services (care) to Standards;
14) state body in the provision of medical services (care) (hereinafter - state body) - a state body exercising leadership in the provision of medical services (care), control over the quality of medical services (care);
15) defect in the provision of medical services (hereinafter - defect) - violation of the procedure for the provision of medical services (care), consisting in non-compliance with the Standards and unjustified deviation from clinical protocols, which affected the outcome of treatment and in the event that this caused adverse consequences for the patient's health, as well as the fact of an unconfirmed case of provision of medical services and (or) care;
16) retrospective analysis - analysis based on the study of medical records of patients who received medical care at the time of the expert review;
17) external indicators - indicators used in external examination that characterize efficiency, completeness and compliance of medical activity of a healthcare entity with healthcare standards in order to analyze and assess the quality of medical activity;
18) independent expert - an individual who meets the requirements established by the authorized body and is on the register of independent experts;
19) internal indicators - indicators used in internal examination for the purposes of analysis and evaluation of the quality of medical activity, which characterize the efficiency, completeness of medical activity of each structural unit of the health care organization.
3. The stages of internal and external examination of the quality of medical services (care) are:
analyzing accounting and reporting documentation;
clinical audit;
generalization of the results of expert examination of the quality of medical services (care).
4. During the expert examination, the activities of the medical organization and the quality of medical care provided by it shall be assessed for compliance with the standards of organization of medical care provision by profile, for detection of unjustified deviations from clinical protocols of diagnosis and treatment using the results of monitoring of internal and external indicators, including the analysis of the dynamics of changes in indicators for the analyzed periods.
5. When conducting a clinical audit, the expert shall form a motivated, reasoned opinion based on the standards of organization of medical care, clinical protocols of diagnosis and treatment, instructions, algorithms, standards of medical organizations, scientific and evidence-based international data. Identified defects with violation of the quality of medical care are confirmed by logical conclusions with references to standards of organization of medical care, clinical protocols of diagnosis and treatment, instructions, algorithms, standards of medical organizations, scientific and evidence-based international data, recognized sources of evidence-based medicine.
When conducting a medical record examination, the following categories of medical records shall be evaluated:
Collection of complaints;
Disease history;
Life history;
Objective status;
Clinical diagnosis;
Diagnostic tests;
Therapeutic measures;
Epicrisis;
Pathologic diagnosis.
In evaluating these categories, the following shall be assessed:
Consistency of the description with the clinical data.
Correctness of diagnosis, choice of diagnostic clinical tactics, as well as assessment of the effectiveness of decisions made to clinical protocols of diagnosis and treatment, standards of medical care, evidence-based data of scientific publications.
Timeliness of diagnosis, recognition of concomitant diseases and complications.
Timely and complete consultation, taking into account the opinion of a specialized professional when making a diagnosis and developing tactics for further treatment.
Timeliness of the necessary treatment.
Absence or development of complications after medical interventions, all complications that occurred are assessed, including those caused by surgical interventions (delayed surgical intervention, inadequate volume and technical defects) and diagnostic procedures. Separately, complications are identified that are expected for a given disease or treatment, described in clinical protocols, and not resulting from defects in the provision of medical care.
Lack of expected clinical outcome due to specifics of the course or severity of the disease, due to the severity of the course of the disease, limited current level of scientific knowledge and medical technologies.
When assessing the impact of identified discrepancies on the quality of medical care provided, the expert shall provide logical conclusions with reasoning.
6. When summarizing the results of the examination of the quality of medical services (care), a decision shall be made on compliance (non-compliance) of the provided medical care with the requirements of the Standards and clinical protocols.
7. Expert examination of the quality of medical services (care) shall be carried out with the participation of the patient, if necessary.
8. For fatal cases, a completed and complete examination is considered to be a comparison of the results of a retrospective analysis, pathological autopsy and (or) forensic medical examination.
Medical records and electronic healthcare information resources shall be used as a source of information during the examination.
Chapter 2.
Procedure for organizing and conducting an internal
expert examination of the quality of medical services (care)
9. To manage the quality of medical care provided, organize quality management and standardization in a medical organization, organize and conduct internal expert examination, including clinical audit, a patient support and internal expert examination service (hereinafter referred to as the Service) shall be established in a medical organization.
The structure and composition of the Service shall be approved by the head of the medical organization, with regard to the volume of medical services provided, profile, capacity (number of beds) for organizations providing inpatient medical care, the number of attached population for organizations providing outpatient and polyclinic care.
The service is headed by a director directly subordinate and appointed to the position by the first executive of the medical organization.
The Service provides for full-time expert physicians, health managers, caseworkers and psychologists, if necessary, depending on the standards of the organization of medical care and the tasks of the medical organization. Physicians, physician-epidemiologists, nurses, pharmacists, clinical pharmacologists, economists and medical statisticians shall be engaged for clinical audit both as independent consultants and from among the employees of the medical organization.
Within the framework of the organization of quality management and standardization of medical care, the Service provides methodological guidance to the structural units of the medical organization on implementation and maintenance of international and national accreditation standards, self-assessment for compliance with the requirements of these standards, implements and evaluates the effectiveness of programs for continuous improvement of quality and patient safety.
10. The Service shall conduct an examination of:
1) in organizations providing inpatient or hospital substitute care, at least 15% of treated cases per month, as well as all cases of:
fatal outcomes;
complications, including postoperative ones;
intrahospital;
re-hospitalization for the same disease within one month due to poor quality of previous treatment;
increase or decrease in the duration of treatment;
discrepancies between clinical and pathologic-anatomical diagnoses;
unjustified hospitalization;
20% of cases of hemotransfusions performed.
"2) in organizations providing outpatient care:
at least 10 % of examinations per month:
treated cases, outpatient records of persons to be immunized against infectious diseases;
and also all cases of:
maternal mortality;
deaths at home of children from 0 to 5 years of age inclusive;
deaths at home of persons of working age from diseases;
untimely vaccination or lack of vaccination against infectious diseases;
neglected forms of cancer and tuberculosis;
primary disability of persons of working age;
pregnancy complications managed at the level of organizations providing primary health care;
patient follow-up after discharge from hospital (children, women in the postpartum period), patients with circulatory diseases (after strokes and heart attacks).
3) in ambulance organizations expert examination of the quality of medical services (assistance) of at least 10% of the calls served during the quarter, including all cases of:
visits to the patient after denied admission to hospital by the medical organization providing inpatient care;
refusal from medical care with indication of possible consequences, recorded in medical documentation, including in electronic form, signed by the patient or his/her legal representative, as well as by a medical worker;
refusal of the patient or his/her legal representative to sign a waiver of medical care, with a corresponding record of this in the medical records, including in electronic form, signed by a medical worker;
repeated calls for the same disease within a day from the moment of the first call, except for cases of:
lethality in calls: death before the arrival of the ambulance team, death in the presence of the team;
4) in rehabilitation and medical rehabilitation organizations - all cases:
transfer to hospital organizations;
increase or decrease in the duration of treatment;
hospital traumatism;
hospital-acquired infections.
fatalities;
hospital-acquired infections;
hospital traumatism;
6) in the blood banking organizations, an expert examination shall be carried out of the quality of medical services (assistance) of at least 20% of medical records of donors per quarter, as well as control over compliance with the order of the Minister of Health of the Republic of Kazakhstan dated October 20, 2020 № ҚР ДСМ- 140/2020 “On approval of the nomenclature, rules of procurement, processing, quality control, storage, banking, use of blood, its components, as well as the rules of transfusion of blood, its components” (registered in the Register of State Registration of Regulatory Legal Acts).
11. The Service shall continuously work on the conclusions of external expertise in terms of implementation of recommendations on accessibility and timeliness of medical care, compliance with clinical treatment protocols and standards of medical care.
12. The Service shall continuously monitor the correctness of patient data entry into medical information systems in accordance with classifiers and directories, according to the data sets of primary medical documentation of health care organizations, corresponding to the profile of the medical organization.
13. The Service shall keep records of medical incidents and send a memo (summary information) on each case (event) of medical incident in accordance with the Order of the Minister of Health of the Republic of Kazakhstan dated October 22, 2020 № ҚР ДСМ -147/2020 “On approval of the rules for determining cases (events) of medical incident, their accounting and analysis” (registered in the Register of State Registration of Regulatory Legal Acts under № 21511) (hereinafter - Order № ҚР ДСМ -147/2020).
14. The service shall also conduct monthly examination of at least 10% of treated cases for the quality of filling out medical records by the medical staff.
15. In cases of detected irregularities in medical care, treatment and diagnostic measures, such as unjustified deviation from the Standards (hereinafter - defects), the Service shall identify and analyze the root causes of their occurrence, develop recommendations to prevent defects and errors.
Cases of committed defects, including repeated and (or) recurring violations requiring managerial decisions (referral for additional training, advanced training courses for medical workers, procurement of medicines, medical devices, medical equipment) shall be submitted to the management for consideration.
16. The Service shall study:
1) internal indicators approved in this medical organization in accordance with the medical care standards, including indicators set out in Appendix 1 to these Rules (in accordance with the possibility of application to this particular profile);
2) corrective action plans and their implementation based on the results of the past examinations;
3) conclusions of clinical auditors;
4) results of questionnaires and interviews with patients, results of work on complaints;
5) results of analysis of medical incidents in accordance with Order № KP DSM - 147/2020.
Based on the results of the analysis, the activity of structural units and the medical organization as a whole is evaluated.
17. The Service shall determine the degree of patient satisfaction with the level and quality of medical services (care) and identify the needs of the population and patients by:
1) application of the tool of public dialogue of openness in order to promptly respond to the needs of the population and patients by medical organizations and state bodies, focus group interviewing of the population, patients and specialists of health care organizations and questionnaires of patients and (or) their relatives, medical and non-medical staff of the health care organization;
2) analysis of justified appeals on the quality of rendered medical services (care).
18. To develop proposals and recommendations on topical issues of health and health care services of the attached population, as well as to monitor the follow-up of recommendations, a permanent commission of public trust in health care (hereinafter referred to as the Commission of Public Trust in Health Care) shall be established at the medical organization, with involvement of representatives of the attached population, private business entities and non-governmental organizations, employees of local public health authorities of the region, cities of republican status and the capital.
Basing on the performance results, the commission shall send quarterly information to the local public health authorities of oblasts, cities of republican status and the capital.
19. The Service shall consider applications of patients regarding the provided medical care with the establishment of a commission. In this case, the application is considered within a period not exceeding fifteen working days, the complaint within a period not exceeding twenty working days.
20. Internal examination of the quality of medical services (care) is also carried out by means of self-control at the level of:
every medical worker;
structural unit.
21. Examination at the level of a medical worker shall be carried out by a doctor and each nurse of the department for all cases treated.
22. Examination at the level of a structural unit shall be carried out by its head as part of its current activities.
23. Examination of the work of paramedical workers at the level of a structural unit shall be carried out by a senior nurse. Examination of the quality of work of paramedical workers of structural units shall be determined by the completeness and timeliness of filling out medical documentation, as well as by the completeness, timeliness and quality of fulfillment of medical prescriptions.
24. The Service shall draw up a conclusion based on the results of the internal examination, which shall include:
1) the total number of identified defects, their structure, possible causes and ways of elimination;
2) the number of identified defects that caused deterioration of health condition;
3) the number of identified defects that resulted in increased costs of medical care.
25. The results of internal examination, including their comparison with the results of external examination, shall be presented and discussed at the meetings of the internal examination unit once a month, intra-hospital commissions, at medical conferences with subsequent adoption of organizational decisions, in order to improve proficiency level of medical workers and to develop optimal approaches to the treatment and diagnostic process, which shall be documented in minutes.
Heads of structural subdivisions (specialized departments), physicians with at least 3 years of continuous work experience in their specialization shall be included in the in-hospital commissions.
Upon the internal examination results, the Service shall submit monthly proposals to the head of the medical organization to eliminate the identified causes and conditions of deterioration in the quality of medical services (care).
Chapter 3.
Procedure for organizing and conducting external
examination of the quality of medical services (care)
26. External examination of the quality of medical services (care) shall be carried out by:
1) a state body;
2) local public health authorities of oblasts, cities of republican status and the capital city;
3) Social Health Insurance Fund within the framework of monitoring of fulfillment of contractual obligations on quality and volume of medical services.
4) independent health care experts;
5) by the Department of the Office of the President of the Republic of Kazakhstan in relation to subordinate organizations.
27. Based on the external examination results, the following shall be analyzed:
the result of the internal examination for compliance with the principles of expertise;
compliance and efficacy of measures taken by the Service;
compliance of threshold values in the dynamics of external indicators in accordance with the standards of medical care and indicators set out in Appendix 2 to these Rules (subject to the possibility of their application to this profile);
quality of medical services (care) provided.
28. The state body, local public health authorities of oblasts, cities of republican status and the capital and the Social Health Insurance Fund shall conduct an external expert examination of the quality of medical services (assistance), including with the involvement of independent health care experts.
In the absence of conditions for attracting independent experts, presence of a conflict of interest of an independent expert among healthcare organizations authorized to provide independent experts, also in the period of time from the completion of civil law (contractual) relations between healthcare organizations authorized to provide independent experts and a state body and before completion of competitive procedures, as well as the absence of an independent expert in this profile according to the nomenclature of specialties and specializations in healthcare, approved by order of the Minister of Health of the Republic of Kazakhstan dated December 21, 2020 № ҚР ДСМ -305/2020 “On approval of the nomenclature of specialties and specializations in healthcare, nomenclature and qualification characteristics of positions of healthcare workers” (registered in the Register of State Registration of Regulatory Legal Acts under № 21856), specialized healthcare experts shall be involved to assess the quality of medical care by decision of:
1) a state body;
2) territorial unit of the state body;
3) local state health care administration bodies of oblasts, cities of republican status and the capital;
4) the Social Health Insurance Fund.
On the results of assessing the quality of medical care specialized health care specialists shall provide, within their competence, an opinion with conclusions on the quality of medical services (care) with reference to regulatory legal acts, standards of medical care, clinical protocols of diagnosis and treatment, evidence-based published data for the formation of reasoned conclusions and inclusion in the conclusion of external expertise of the quality of medical services (care) in accordance with the form of Appendix 3 to these Rules..
29. An external examination of all cases of maternal mortality (except for accidents) shall be carried out by a state body.
30. If defects are identified based on the external examination results, no later than 10 calendar days after the full completion of consideration of applications from individuals and legal entities, as well as reports on maternal mortality cases and other applications, the state body shall send to the Fund, law enforcement bodies and local government health authorities of the oblast, cities of republican status and the capital, information for taking response measures within the competence.
31. If defects are identified that lead to harm to health in the form of disability, including loss of ability to work or death, the state body, in accordance with Article 179 of the Criminal Procedure Code of the Republic of Kazakhstan, shall send the external examination materials to the internal affairs bodies for a procedural decision.
32. Based on the results of an external examination of the quality of medical services (care) carried out by a state body, local public health authorities of oblasts, cities of republican status and the capital and the results of monitoring the quality of medical care carried out by the Fund, the state body shall conduct an analysis to develop proposals for improving the provision of medical services (care).
33. When conducting an inspection of health care entities, a specialist of the state body shall provide the expert with the materials that are the subject of the examination. If necessary, he organizes a meeting with the applicant (with the applicant’s consent).
34. Upon completion of the expert examination by the state body a conclusion shall be drawn up in the form of Appendix 4 to these Rules..
35. The Fund shall conduct an external examination as part of monitoring the fulfillment of contractual obligations on the quality and volume of medical services in accordance with the order of the Acting Minister of Health of the Republic of Kazakhstan dated December 24, 2020 № ҚР ДСМ -321/2020 “On approval of the Rules for monitoring the fulfillment of the contractual terms of the procurement of medical services from health care entities within the guaranteed volume of free medical care and (or) in the system of compulsory social health insurance” (registered in the Register of State Registration of Regulatory Legal Acts under № 21904) (hereinafter referred to as Order № ҚР ДСМ -321/2020).
36. Local public health authorities of oblasts, cities of republican status and the capital shall conduct external examination of the quality of medical services (care) and payment for services of healthcare entities as part of monitoring the fulfillment of contractual obligations on the quality and volume of medical services in relation to medical organizations providing medical care to persons held at pre-trial detention facilities and penal (penitentiary) institutions in accordance with these Rules and the order of the Minister of Health of the Republic of Kazakhstan dated May 13, 2022 № ҚР ДСМ -43 “On approval of the rules for monitoring contractual obligations on the quality and volume of medical services of healthcare entities as part of the additional scope of medical care for persons held in pre-trial detention facilities and institutions of the criminal executive (penitentiary) system” (registered in the Register of State Registration of Regulatory Legal Acts under № 28054) (hereinafter referred to as Order № ҚР ДСМ -43).
37. The Fund, local public health authorities of oblasts, cities of republican status and the capital city shall provide the independent expert with the materials that are the subject of expertise.
38. Upon completion of the external expertise, the Fund draws up a conclusion on monitoring the quality and volume of medical services (assistance), as well as on the proper fulfillment of the terms and conditions of the contract for the procurement of services according to Appendix 2 to the order № ҚР ДСМ-321/2020.
39. Upon completion of the external examination of the quality of medical services (care), local public health authorities of oblasts, cities of republican status and the capital city shall draw up a conclusion on monitoring the quality and volume of medical services according to Appendix 2 to the rules for monitoring of contractual obligations on the quality and volume of medical services of health care entities within the framework of additional medical assistance to persons held in pre-trial detention facilities and penal institutions approved by Order № ҚР ДСМ-43.
40. Independent health care experts shall conduct external expert examination when they are engaged by individuals or legal entities on a contractual basis.
Information on independent experts shall be contained in the Register of independent experts formed by the state body in accordance with the order of the Minister of Health of the Republic of Kazakhstan dated October 21, 2020 № ҚР ДСМ-145/2020 “On approval of the rules for maintaining the register of independent experts, as well as the basis for inclusion in the unified register of independent experts and exclusion from it” (registered in the Register of state registration of Regulatory Legal Acts legal Acts under № 21509). The register of independent experts shall be posted on the website of the state body.
41. When performing an independent expert examination, individuals or legal entities engaging independent experts on a contractual basis (hereinafter referred to as the Customer) shall provide the independent expert with materials that are the subject of the expert examination.
If the questions raised are beyond the scope of special knowledge of the independent expert or the materials provided are insufficient to provide an expert opinion, the independent expert shall refuse to provide an expert opinion.
42. Expertise conducted by independent experts hired by a state body shall be divided into the following categories:
1) examination of the quality of medical services (care) with unfavorable outcome:
examination of histologic and, if available, pathologic studies;
study of medical records of not more than two health care organizations (according to the patient's medical care route);
study of medical records of three or more health care organizations (according to the patient's medical care route);
Medical services (care) provided with an unfavorable outcome include the provision of medical services (care) in the event of non-compliance with the Standards and Rules for the provision of medical care, which resulted in death, a life-threatening condition, significant permanent loss of general ability to work, or complete loss of professional ability to work.
Provision of medical services (care) with a favorable outcome includes provision of medical services (care) with non-compliance with the Standards and Rules for the provision of medical care, which did not result in harm to human life and health.
43. Upon completion of the external expert examination of the quality of medical services (care), the independent expert shall submit an expert opinion in the form of Appendix 3 to these Rules.
The expert opinion of the independent expert shall be drawn up in three copies. One copy shall be given to the health care entity, the second copy - to the Customer, the third copy remains with the independent expert.
Upon completion of the external examination of the quality of medical services (care), the Conclusion of the examination of the state body on the quality of medical services (care) provided shall be completed in accordance with Appendix 4 to these Rules. The conclusion of the examination of the state body on the quality of medical services (care) shall be drawn up in three copies, one copy shall be handed over to the health care entity, the second copy shall be sent to the authorized body in legal statistics and special records, the third copy shall be kept by the state body.
44. Comments and (or) objections on the external examination results shall be stated in writing and attached to the external examination conclusion. Based on the results of the external examination of the quality of medical services (care), the head of a medical organization shall take management measures, including determining the need and direction of training programs for doctors and nursing staff.
45. Repeated expert examination shall be conducted in cases of disagreement with the conclusions of external expert examination on the basis of applications of health care entities, individuals or legal entities.
When conducting a re-examination, experts who did not take part in the initial examination are involved.
46. A complaint about disagreement with conclusions of the external expert examination shall be filed to a higher state body (higher official) or to the court as required by the legislation of the Republic of Kazakhstan.
| Appendix 1 to the Rules for organizing and conducting internal and external examination of the quality of medical services (care) |
Internal indicators
№ | Name of indicators | Calculation formula/Unit of measure | Periodicity of information | Information source | Threshold value |
1 | 2 | 3 | 4 | 5 | 6 |
Evaluation indicators for organizations providing inpatient care | |||||
1 | Mortality rate in planned hospitalization | Share (%) of inpatient deaths (excluding patients receiving oncologic, hematologic and palliative care) of the total number of patients that dropped out (were discharged, died) in the reporting period | Monthly | Reporting data, IPMR, ERI IS | The indicator value approaches zero |
2 | Daily inpatient mortality rate | Share (%) of deaths in the first 24 hours of hospital stay from the total number of patients admitted during the reporting period | Quarterly |
IPMR, DISC, ERI IS | The indicator value does not exceed 4% |
3 | Postoperative mortality rate in cases of planned hospitalization | Share (%) of inpatient deaths after surgical interventions out of the number of patients operated on routinely in the reporting period | Monthly | Reported data, IPMR, ERI IS | The indicator value approaches zero |
4 | Rate of intraoperative complications | Share (%) of intraoperative complications from the total number of surgeries in the reporting period | Quarterly | Reported data, IPMR, form of recording the operation and manipulation | The indicator value does not exceed 5 % |
5 | Rate of postoperative complications | Share (%) of postoperative complications from the total number of surgeries in the reporting period | Quarterly | Reported data, IPMR, form of recording the operation and manipulation, ERI IS | The indicator value does not exceed 3 % |
6 | Number of maternal deaths, of which from: obstetric hemorrhage, gestosis, abortion, extragenital pathology | Absolute number | Daily | Monitoring data of pregnant women and postpartum women of the medical organization, maternal mortality record card, ERI IS | The indicator value tends to zero for reasons that are manageable |
7 | Women's birth injury rate | Share (%) of birth traumatism cases out of the total number of births in the reporting period | Quarterly | IPMR, form of recording the operation and manipulation, ERI IS | The indicator value approaches zero |
8 | Rate of emergency cesarean sections | Share (%) of emergency cesarean sections out of the total number of cesarean sections | Quarterly | IPMR, form of recording the operation and manipulation, ERI IS | The indicator value does not exceed 20 % |
9 | Rate of admission of pregnant women to the hospital within 24 hours of denied hospitalization | Share (%) of pregnant women admitted to hospital within 24 hours of denied hospitalization from the total number of hospitalized pregnant women | Quarterly | IPMR, ERI IS | The indicator value approaches zero |
10 | Infant mortality rate, of which from: respiratory diseases, intestinal infections, congenital malformations, diseases of the perinatal period | Absolute number | Monthly | IPMR, APR IS | Decrease in the value of the indicator of the reporting period compared to the previous one by 5% |
11 | Newborn injury rate | Share (%) of newborn injuries out of the total number of newborns in the reporting period | Quarterly | IPMR, ERI IS | The indicator value approaches zero |
12 | Intrapartum fetal death rate | Share (%) of intrapartum fetal deaths per 100 live and still births | Quarterly | IPMR, ERI IS | Decrease in the value of the indicator of the reporting period compared to the previous one by 10 % |
13 | Early neonatal mortality rate (up to 7 days of life) | Share (%) of cases of early neonatal mortality per 1,000 live births | Quarterly | IPMR, APR IS | Decrease in the value of the indicator of the reporting period compared to the previous one by 5 % |
14 | Indicator of purulent-septic processes after surgical interventions | Share (%) of purulent-septic processes after surgical interventions from the total number of operations in the reporting period | Monthly | IPMR, ERI IS | The indicator value does not exceed 1 % |
15 | Rate of purulent-septic processes of newborns | Share (%) of purulent-septic processes of newborns from the number of live births | Monthly | IPMR, ERI IS | The indicator value approaches zero |
16 | Readmission rate within a month for the same disease | Share (%) of readmissions to hospital within a month for the same disease from the number of hospitalized in the reporting period (except for patients with oncologic and hematologic diseases and patients receiving substitution therapy) | Monthly | IPMR, DISC, ERI IS | The indicator value approaches zero |
17 | Number of discrepancies between clinical and pathological diagnoses | Absolute number | Monthly | Protocol of pathological examination, ERI IS | The indicator value approaches zero |
18 | Indicator of justified complaints for quality of medical services | Number of justified complaints per 1000 patients treated | Monthly | Registration log of applications | The indicator must not exceed 1,0 |
19 | Indicator of epidemiological investigation of hospital-acquired infections | Share (%) of cases of hospital-acquired infections with epidemiologic investigation of the total number of registered cases | Monthly | Minutes of case review at the meeting of the Infection Control Commission | The indicator value approaches100% |
20 | Indicator for identifying causes and factors of the occurrence and spread of hospital-acquired infections | Share (%) of hospital-acquired infections with established causes and factors of the occurrence and spread of hospital-acquired infections from the total number of registered cases | Monthly | Minutes of case analysis at the meeting of the Infection Control Commission | The indicator value approaches 80% |
Evaluation indicators for organizations providing outpatient care | |||||
1 | Number of working-age persons’ primary disability | Absolute number | 1 time a year | Data of the territorial Department of the Committee of Labor, Social Protection and Migration | Decrease in the value of the reporting period indicator compared to the previous one by1 % |
2 | Maternal mortality rate, with defects in the provision of medical services at the level of PHC organizations | Share (%) of maternal deaths among attached residents with confirmed defects (experts) at the PHC organization level, during the reporting period per number of attached women of fertile age | Quarterly | Maternal mortality record card (results of external examination) | The indicator value approaches zero |
3 | Indicator of women with extragenital pathology who improved health among women of fertile age | Share (%) of health-improved women of fertile age in the total number of women of fertile age in the attached population | Quarterly | OMR, outpatient statistical chart, MIS, DPER IS | Increase of the indicator by 5% compared to the previous period |
4 | Abortion rate relative to births | Share (%) of abortions to the number of births | Quarterly | DISC, ERI IS | Decrease in the value of the reporting period indicator compared to the previous one by 5 % |
5 | Indicator of hospitalization of pregnant women, in violation of the principle of regionalization (based on 24-hour hospital data) | Share (%) of pregnant women, hospitalized in violation of the principle of regionalization from the total number of hospitalized pregnant women | Quarterly | DISC (diagnosis according to the international classification of diseases with indication of delivery), RPWWFA IS | Decrease in the value of the reporting period indicator compared to the previous one by 5 % |
6 | Infant mortality rate, with defects in the provision of medical services at PHC level | Share (%) of deaths of children aged 0 to 1 year prevented at the PHC level per number of children aged 0 to 1 year among the attached population | Quarterly | Registration chart for live born, stillborn and deceased child under 1 year of age | Decrease in the value of the reporting period indicator compared to the previous one by 5 % |
7 | Rate of doctor attendance of newborns in the first 3 days after discharge from maternity hospital (patronage) | Share (%) of newborns visited by a doctor in the first 3 days after discharge from the maternity hospital (patronage) per number of newborns during the reporting period | Quarterly | OMR, MIS | The indicator value approaches 100 % |
8 | Indicator of emergency hospitalization of children under 5 with AEI, ARI | Share (%) of hospitalization of children under 5 years of age with AEI, ARI in the total number of hospitalizations of children under 5 | Quarterly | ERI IS | Decrease in the value of the reporting period indicator compared to the previous one by 1 % |
9 | Number of congenital malformations in newborns undiagnosed in utero | Absolute number | Quarterly | OMR, medical history of a pregnant woman, woman in labor, postpartum woman, MIS | The indicator value approaches zero |
10 | Rate of exclusive breastfeeding for 6 months-old children | Share (%) of children aged 6 months receiving exclusive breastfeeding from the total number of children aged 6 months, with the exception of abandoned foundlings and children born to HIV-infected mothers, mothers taking cytostatics | Quarterly | OMR, MIS | The indicator value approaches 100 % |
11 | Breastfeeding rate for children under 2 years of age | Share (%) of children breastfed up to 2 years of age out of the total number of children up to 2 years of age, excluding abandoned foundlings and children born to HIV-infected mothers, mothers taking cytostatics | Quarterly | OMR, MIS | Increase of the indicator by 5 % compared to the previous period |
12 | Rate of neglected cases among newly diagnosed patients with pulmonary tuberculosis | Proportion (%) of neglected cases in first-time detected pulmonary tuberculosis among the attached population per number of first-time detected pulmonary tuberculosis cases among the attached population | Quarterly | DPER IS | Decrease in the value of the reporting period indicator compared to the previous one by 5 % |
13 | Coverage rate of fluorographic examination of population groups at high risk of tuberculosis determined by the authorized body | Share (%) of population groups at high risk of tuberculosis covered by fluorographic examination out of the total population at high risk of tuberculosis | once a year | Plan of fluorographic examinations, registration log of fluorographic examinations, MIS reporting forms | The indicator value approaches 100 % |
14 | Indicator of coverage of the mandatory contingent with fluorographic examination | Share (%) of the mandatory contingent covered by fluorographic examination from the total number of the mandatory contingent | once a year | Plan of fluorographic examinations, registration log of fluorographic examinations, MIS reporting forms | The indicator value approaches 100 % |
15 | Detection rate of tuberculosis patients by fluorography among population groups at high risk of tuberculosis as determined by the authorized body | Share (%) of tuberculosis patients detected by fluorography among population groups at high risk of tuberculosis per 1000 surveys of population at high risk of tuberculosis disease | Quarterly | Registration log of fluorographic examinations, MIS | The indicator value is not less than 2 |
16 | Detection rate of patients with suspected tuberculosis among persons examined by microscopy | Proportion (%) of cases of tuberculosis detection by microscopy out of the total number of patients with suspected tuberculosis referred for microscopy examination | Quarterly | Laboratory logbook for PHC laboratories, referral for laboratory testing, consultation, hospitalization, transfer to another hospital, MIS, NRTP IS | The indicator value is 5-10% |
17 | Number of TB patients who interrupted therapy at PHC level | Absolute number | Quarterly | OMR, MIS | The indicator value approaches zero |
18 | Rate of first-time detected patients with stage 3-4 malignant neoplasms | Share (%) of patients with malignant neoplasms of 3-4 stages detected for the first time from the total number of patients with malignant neoplasms detected for the first time in the reporting period | once a year | ERCP IS | Decrease in the indicator by 5 % compared to the previous period |
19 | Rate of first-time detected patients with stage 1-2 malignant neoplasms | Share (%) of patients with malignant neoplasms of 1-2 stages detected for the first time from the total number of patients with malignant neoplasms detected for the first time in the reporting period | once a year | ERCP IS | Increase of the indicator by 1 % compared to the previous period |
20 | 5-year survival rate of patients with malignant neoplasms | Share (%) of 5-year survival of patients with malignant neoplasms in the total number of patients with malignant neoplasms | once a year | ERCP IS | The indicator value is at least 50% |
21 | Indicator of justified complaints about medical service quality | Number of justified complaints per 1000 cases of patient outpatient applications | Monthly | Registration log of applications | The indicator must not exceed 3,0 |
22 |
Hospitalization rate of persons with cardiovascular complications (arterial hypertension, |
Share (%) of treated inpatients with cardiovascular complications (arterial hypertension, | Quarterly | DISC, ERI IS | Decrease in the indicator of the reporting period compared to the previous one by 10 % |
23 | Indicator of epidemiological investigation of nosocomial infections | Share (%) of cases of nosocomial infections with epidemiological investigations out of the total number of registered nosocomial infections | Quarterly | Minutes of case analysis at a meeting of the infection control commission | The indicator value approaches 100 % |
24 | Indicator for identifying causes and factors of occurrence and spread of hospital-acquired infections | Share (%) of cases of nosocomial infections with identified causes and factors of occurrence and spread of nosocomial infections from the total number of registered cases of nosocomial infections | Monthly | Minutes of case analysis at a meeting of the infection control commission | The indicator value approaches 80 % |
25 | Immunization coverage rate of children under 5 years of age against targeted infections | Proportion (%) of children in the target group covered by immunization | Monthly on an incremental basis | Reporting Form № 4 approved by Order № 415 of the Minister of National Economy of the Republic of Kazakhstan dated May 30, 2015, registration log of preventive vaccination, MIS | The indicator value approaches 95 % in a year (monthly no less than 7,9 %) |
26 | Coverage rate for stage 3 medical rehabilitation | Proportion (%) of patients, covered by 3 medical rehabilitation to the total number of patients subject to medical rehabilitation | Monthly on an incremental basis | OMR, MIS | The indicator value approaches 85 % in a year |
Note:
1. IPMR – In-Patient Medical Record
2. ERI IS -Electronic Register of Inpatients Information System
3. DISC - Discharged Inpatients Statistical Chart
4. APR IS – Attached Patient Register Information System
5. PHC - Primary Health Care
6. OMR - Outpatient Medical Record
7. MIS - Medical Information Systems
8. DPER IS - Dispensary Patients Electronic Register Information System
9. ИС RPWWFA IS - Register of Pregnant Women and Women of Fertile Age Information System
10. IMCI programme - Integrated Management of Childhood Illnesses Programme
11. AEI - Acute Enteric Infection
12. ARI - Acute Respiratory Infection
13. NRTP IS – National Registry of Tuberculosis Patients Information System
14. ERCP IS - Electronic Registry of Cancer Patients Information System
| Appendix 2 to the Rules for organizing and conducting internal and external examination of the quality of medical services (care) |
External indicators
№ | Name of indicators | Measurement unit | Periodicity of information | Source of information | Threshold value |
1 | 2 | 3 | 4 | 5 | 6 |
Assessment indicators for inpatient care providers | |||||
1 | Mortality rate of planned hospital admissions | Proportion (%) of inpatient deaths (excluding patients receiving oncological and palliative care) out of the total number of patients who dropped out ( were discharged, died) in the reporting period | Monthly | Reporting data, IPMR | The indicator value tends towards zero |
2 | Post-operative mortality rate in planned hospital admissions | Proportion (%) of post-operative inpatient deaths out of the number of patients who underwent elective surgery in the reporting period | Monthly | Reporting data, IPMR | The indicator value tends towards zero |
3 | Number of maternal deaths, of which from: obstetric haemorrhage, gestosis, abortion, extragenital pathology | Absolute number | Monthly | Monitoring data of pregnant and postpartum women, maternal mortality record card, ERI IS | The value of the indicator tends towards zero for reasons that that are manageable |
4 | Number of infant deaths, of which from: respiratory diseases, intestinal infections, congenital malformations, perinatal diseases | Absolute number | Monthly | Registration card of live births, stillbirths and deaths of children under 5 years of age, Attached Patient Register information system | Decrease in the value of the indicator for the reporting period compared to the previous period by 5% |
5 | Re-admission rate within a month for the same condition | Proportion (%) of hospital admissions for the same disease within a month of the number of admissions in the reporting period (excluding patients with cancer, haematological diseases and patients receiving substitution therapy) | Monthly | Reporting data, IPMR, DISC | The indicator value tends towards zero |
6 | Number of discrepancies between clinical and pathological diagnoses | Absolute number | Monthly | Postmortem examination protocol | The indicator value tends towards zero |
7 | Indicator of justified complaints about the quality of health services | Number of substantiated complaints per 1,000 patients treated | Monthly | Registration log of applications | The indicator value must not exceed 1.0 |
8 | Indicator of determining causes and factors of the occurrence and spread of nosocomial infections | Proportion (%) of cases of nosocomial infections with established causes and factors of the occurrence and spread of nosocomial infections from the total number of registered cases | Monthly | Minutes of case analysis at a meeting of the infection control committee | Indicator value tends towards 80 % |
Evaluation indicators for outpatient care providers | |||||
1 | Maternal mortality rate, with deficiencies in the delivery of health services at PHC level | Proportion (%) of maternal deaths among attached residents with confirmed defects (by experts) at PHC level, for the reporting period, per number of attached women of childbearing age | Quarterly | Maternal mortality record card (results of external examination) | The indicator value tends towards zero |
2 | Infant mortality rate, with deficiencies in the delivery of health services at PHC level | Proportion (%) of deaths of children aged 0 to 1 year preventable at PHC level per number of children aged 0 to 1 year among the attached population | Quarterly | Registration card of live births, stillbirths and deaths of children under 1 year of age | Decrease in the indicator for the reporting period compared to the previous period by 5% |
3 | The rate of neglected cases among newly diagnosed patients with pulmonary tuberculosis | Proportion (%) of first-time pulmonary tuberculosis cases detected in the attached population per first-time pulmonary tuberculosis cases detected among the attached population | Quarterly | National Registry of Tuberculosis Patients Information System | Decrease in the value of the indicator for the reporting period compared to the previous period by 5% |
4 | Rate of patients with first-time malignant neoplasms of stage 3-4 | Proportion (%) of first-time detected patients with malignant neoplasms of stage 3-4 from the total number of first-time detected malignant neoplasms in the reporting period | Quarterly | Electronic Registry of Cancer Patients Information System | Decrease in the value of the indicator for the reporting period compared to the previous period by 5% |
5 | Indicator of justified complaints about the health services quality |
Number of substantiated complaints per 1,000 outpatient cases | Monthly | Registration log of applications | The indicator value must not exceed 3.0 |
6 | Hospitalisation rate for cardiovascular complications (arterial hypertension, myocardial infarction, stroke) | Proportion (%) of inpatients treated for complications of cardiovascular diseases (arterial hypertension, myocardial infarction, stroke) per attached population | Quarterly | DISC, ERI IS | Decrease in the value of the indicator for the reporting period compared to the previous period by 5% |
7 | Immunization coverage rate for children under 5 years of age against targeted infections | Proportion (%) of children in the target group covered by immunization | Monthly on an incremental basis | Reporting form № 4, approved by Order № 415 of the Minister of National Economy of 30 May 2015, logbook of preventive vaccinations | Indicator value tends towards 95% for the year (monthly at least 7.9%) |
8 | 5-year survival rate of patients with malignant neoplasms | Proportion (%) of 5-year survival of patients with malignant neoplasms in the total number of patients with malignant neoplasms | Once a year |
ИС ЭРОБ | The indicator value is at least 50% |
Note:
1. IPMR – In-Patient Medical Record
2. ERI IS – Electronic Register of In-Patients Information System
3. DISC – Discharged Inpatients Statistical Chart
4. PHC - Primary Health Care
| Appendix 3 to the Rules for organizing and conducting internal and external examination of the quality of medical services (care) |
Expert evaluation and (or) conclusion
1. Surname, first name, patronymic (if any) of the person who conducted the examination, indicating specialization, position, academic degree
2. Name of the health care entity (facility) where the examination was conducted
3. Ground for the examination, or information on the customer
4. Timing of the examination
6. Subject matter of the examination
7. Information on the results of the expert examination, including identified violations and their nature
8. Conclusions.
9. Recommendations
________________________________________________ ________________________
Surname, first name, patronymic (if any) of the person who conducted the examination
Date “____” ___________ 20 ___
| Appendix 4 to the Rules for organizing and conducting internal and external examination of the quality of medical services (care) |
Conclusion of the examination of the state body on the quality of medical services (care) provided
1. Report on the inspection results №_____;
2. Date, time and place where the report was drawn;
3. Name of the control and supervision body;
4. Date and number of the act on appointment of the inspection, upon which the inspection was conducted;
5. Surname, first name, patronymic (if it is indicated in the identity document) and position of the person (persons) who conducted the inspection;
6. Information about specialists, consultants and experts involved for inspection;
7. Name or surname, first name, patronymic (if it is indicated in the identity document) of the subject of control and supervision, position of the representative of the individual or legal entity who was present during the inspection; Name of the inspected object/ location address of the inspected object, individual identification number/business identification number, area of the territory;
8. Subject of the assigned inspection
9. Period of inspection from “___”____20____ to “___”_____20____
10. Legal grounds for conducting an inspection, including regulatory legal acts, mandatory requirements that are subject to inspection
11. The period under examination from “___”_______20____ to “___”_______20____
12. Items of requirements under examination (checklist in the state control over the medical services quality in relation to subjects (objects);
13. List of materials, medical documentation that is the subject of the examination;
14. Information about the inspection results, including the violations identified and their nature;
15. Conclusions with reference to regulatory legal acts
16. Recommendations
17. Name of the checklist and items of the requirements on which violations were identified;
№ | List of identified violations | Items of requirements and name of the checklist on which violations were identified | Recommendations and instructions for elimination of identified violations, deadlines for their elimination |
1. | |||
2. |
18. The act on the inspection results was sent to the state bodies for taking response measures within the competence;
19. Signature of the official (persons) who conducted the inspection;
20. Information about familiarization or refusal to familiarize with the report on the inspection results of representatives of the subject of control and supervision, the position of the representative of an individual or legal entity, name or surname, first name, patronymic (if it is indicated in the identity document), as well as persons who were present during the inspection, their signatures or refusal to sign;
21. Comments and (or) objections on the inspection results
22. Date of familiarization “____” ___________20__
| Annex to order of the Minister of Healthcare of the Republic of Kazakhstan № KR DSM-230/2020 dated December 3, 2020 |
List of certain repealed orders in the field of healthcare
1) Order of the Minister of Healthcare and Social Development of the Republic of Kazakhstan № 173 of 27 March 2015 "On Approval of the Rules for Organising and Conducting Internal and External Quality Assurance Reviews of Healthcare services" (registered with the Register of State Registration of Regulatory Legal Acts under № 10880, published on 1 October 2015 in the newspaper "Kazakhstanskaya Pravda" № 187);
2) Order № 568 of the Minister of Healthcare and Social Development of the Republic of Kazakhstan of 28 June 2016 "On Amendments to Order № 173 of the Minister of Healthcare and Social Development of the Republic of Kazakhstan of 27 March 2015 "On Approval of the Rules for Organising and Conducting Internal and External Quality Assurance Reviews of Healthcare services" (registered with the Register of State Registration of Regulatory Legal Acts under № 14026, published in the Control Reference Bank of Regulatory Legal Acts of the Republic of Kazakhstan on 15 September 2016 in electronic form);
3) Order of the Minister of Healthcare of the Republic of Kazakhstan № KR DSM-3 of 11 February 2019 “On Amendments and Additions to Order of the Minister of Healthcare and Social Development of the Republic of Kazakhstan № 173 of 27 March 2015 “On Approval of the Rules for the Organisation and Conduct of Internal and External Quality Reviews of Healthcare Services” (registered with the Register o of State Registration of Regulatory Legal Acts under № 18300, published in the Control Reference Bank of Regulatory Legal Acts of the Republic of Kazakhstan in electronic form on 15 February 2019).