Unofficial translation
In obedience to paragraph 5 of Article 35 of the Code of the Republic of Kazakhstan of 7 July 2020 “On Public Health and the Healthcare System”, I HEREBY ORDER:
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.
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Minister of Healthcare of the Republic of Kazakhstan |
A. Tsoy |
| Approved by order of the Minister of Healthcare of the Republic of Kazakhstan No. KR DSM-230/2020 dated December 3, 2020 |
Rules for the organisation and conduct of internal and external quality reviews of health services (care)
Chapter 1. General provisions
1. The rules for organization and and conduct of internal and external quality reviews of health services (care) (hereinafter referred to as Rules) have been developed pursuant to paragraph 5 of article 35 of Code of the Republic of Kazakhstan of July 7, 2020 “On Public Health and Healthcare System” (hereinafter referred to as Code) and determine the order of organization and carrying out of internal and external expertise of quality of healthcare services (care), rendered by healthcare entities regardless of ownership form and departmental affiliation.
2. The following basic concepts shall be used in these Rules:
1) intrahospital commissions - commissions created in healthcare organizations (commissions for infection control, commissions for the study of lethal outcomes);
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 healthcare entities that provide medical care in the volume and on the terms stipulated in the contract for procurement of medical services, and other functions defined by the laws of the Republic of Kazakhstan;
3) a specialized expert - a health professional with a higher medical education who holds a certificate in healthcare;
4) standard in the field of healthcare (hereinafter referred to as the Standard) - a regulatory legal act that establishes rules, general principles and characteristics for ensuring standardization in healthcare in the field of medical, pharmaceutical activities, educational and scientific activities in healthcare, digital healthcare;
5) the authorized healthcare body (hereinafter referred to as the authorized body) - the central executive body that exercises management and cross-sectoral coordination in the health protection of citizens of the Republic of Kazakhstan, in medical and pharmaceutical science, medical and pharmaceutical education, sanitary- epidemiological welfare of the population, circulation of medicines and medical devices, the quality of medical services (assistance);
6) treated case - a set of medical services provided to a patient in inpatient and (or) hospital-replacing conditions from the moment of admission to discharge;
7) clinical audit - a detailed retrospective and / or current analysis of the performed medical and diagnostic measures for their compliance with healthcare standards;
8) clinical protocol - scientifically proven recommendations for prevention, diagnosis, treatment, medical rehabilitation and palliative care for a specific disease or condition of a patient;
9) independent examination of the quality of medical services (assistance) - a procedure carried out by independent experts within the internal and external examination to make a conclusion on the quality of medical services (assistance) provided by healthcare entities, using indicators reflecting the indicator of efficiency, completeness and compliance of rendered medical services (assistance) with the Standards;
10) medical services - actions of healthcare entities that have a preventive, diagnostic, therapeutic, rehabilitative and palliative orientation to a particular person;
11) medical care - a set of medical services aimed to protect and restore the population’s health, including drug provision;
12) examination of medical services (assistance) quality - a set of organizational, analytical and practical measures carried out to draw an opinion on the quality of medical services provided by individuals and legal entities, using external and internal indicators that reflect the indicator of efficiency, completeness and compliance of medical services with the Standards ;
13) state body in the field of rendering medical services (assistance) (hereinafter referred to as the state body) - a state body that manages the provision of medical services (assistance), controls the medical services (assistance) quality;
14) defect in medical services (hereinafter - the defect) - violation of the procedure of medical services (assistance), consisting in non-compliance with the Standards and non-justified deviation from clinical protocols, as well as the fact of an unconfirmed case of the provision of medical services and (or) assistance;
15) polypharmacy - unreasonable, excessive prescription of medicines;
16) retrospective analysis - analysis based on the study of medical records of patients who received medical care at the time of the examination;
17) external indicators - indicators used in external examination that characterize the efficacy, completeness and compliance of the medical activity of a healthcare entity with healthcare standards for the purpose of analyzing and assessing the medical activity quality;
18) an independent expert - an individual who meets the requirements determined by the authorized body and is included in the register of independent experts);
19) internal indicators - indicators applied during internal examination with the purpose of analyzing and assessing the medical care quality, which characterize the efficacy, completeness of medical activity of each structural unit of the healthcare organization.
Footnote. Paragraph 2 - as amended by Order No. ҚР ДСМ-115 of the Minister of Healthcare of the Republic of Kazakhstan dated 16.11.2021 (effective ten calendar days after the date of its first official publication).3. The stages of internal and external quality reviews of healthcare services (care) shall be:
analysis of accounting and reporting documentation;
clinical audit;
generalization of the results of the quality reviews of healthcare services (care).
4. During analysis of accounting and reporting documentation the organization's activity indicators for a certain period of work shall be compared with the indicators of the previous similar period, as well as with national and regional indicators of public health.
5. During the clinical audit the following shall be assessed:
1) quality of anamnesis collection, which is evaluated according to the following criteria:
absence of anamnesis collection;
the completeness of the anamnesis;
data on past, chronic and hereditary diseases, haemotransfusions, drug tolerance, allergological status;
the development of complications due to tactical errors in therapeutic and diagnostic measures due to poor anamnesis collection;
2) completeness and validity of diagnostic tests, which are evaluated according to the following criteria:
absence of diagnostic measures;
incorrect medical conclusion or lack of conclusion on the results of diagnostic examinations, which led to incorrect diagnosis and errors in treatment tactics;
performance of diagnostic tests in compliance with clinical protocols;
conducting diagnostic investigations with high, unreasonable risk to the patient's health, validity of diagnostic investigations not included in the clinical protocols;
diagnostic tests that are uninformative for a correct diagnosis and result in unreasonable prolongation of the treatment period and higher treatment costs;
3) correctness, timeliness and validity of the clinical diagnosis made, taking into account the results of the studies (for planned hospitalization, studies conducted at the pre-hospital stage are also taken into account), which are evaluated according to the following criteria:
the diagnosis is missing, incomplete or incorrect, does not correspond to the international classification of diseases;
the leading pathological syndrome that determines the severity of the course of the disease has not been identified, concomitant diseases and complications have not been recognized;
the diagnosis is correct, but incomplete, the leading pathological syndrome is not identified with the identified complications, concomitant diseases that affect the outcome are not recognized;
the diagnosis of the underlying disease is correct, but concomitant diseases that affect the treatment result are not diagnosed.
The objective reasons for incorrect and (or) untimely diagnosis (atypical course of the underlying disease, asymptomatic course of concomitant disease, rare complications and concomitant diseases, lack of conditions necessary for diagnosis - equipment and (or) specialists) shall be reflected in the examination results. An assessment shall be made of the impact of incorrect and (or) untimely diagnosis on the subsequent stages of the medical services (assistance);
4) timeliness and quality of consultations of specialized experts, which shall be evaluated according to the following criteria:
absence of consultation, which led to an erroneous interpretation of symptoms and syndromes that negatively affected the disease outcome;
consultation was timely, the opinion of the consulting physician was not taken into account when making a diagnosis that partially affected the disease outcome;
consultation was timely, the consultant's opinion was taken into account when making a diagnosis, non-compliance with the consultant’s recommendations on the treatment partially affected the disease outcome;
the consultant's opinion was erroneous and affected the disease outcome.
In cases of delayed consultations, objectivity shall be assessed of the reasons for the untimely consultation (lack of necessary conditions, specialists), the impact of untimely diagnosis on the subsequent stages of the medical services (assistance) provision;
5) scope, quality and validity of treatment measures, which shall be assessed pursuant to the following criteria:
absence of treatment in the presence of indications;
prescription of treatment in the absence of indications;
prescription of ineffective treatment measures without taking into account the course of the disease, concomitant diseases and complications;
implementation of therapeutic measures not in full, without taking into account the functional state of organs and systems, the prescription of drugs without proven clinical efficacy;
non-compliance with the requirements of the Standards, unreasonable deviation from the requirements of clinical protocols, polypragmasy leading to the development of a new pathological syndrome and deterioration of the patient's condition;
6) absence or development of complications after medical interventions, all complications are assessed, including those caused by surgical interventions (delayed surgical intervention, inadequate scope and method, technical defects) and diagnostic procedures;
7) the result achieved, which is assessed according to the following criteria:
achievement of the expected clinical effect while complying with the technology of health services (care);
absence of clinical effect of treatment and preventive measures due to poor anamnesis and diagnostic tests;
lack of expected clinical effect due to ineffective treatment, preventive measures without taking into account the specifics of the disease, related diseases, complications, prescribing drugs without proven clinical efficacy;
the presence of polypragmasy, which led to the development of undesirable effects;
8) the quality of medical records management, which is assessed by the presence, completeness and quality of records in primary medical records intended to record data on the health condition of patients, reflecting the nature, volume and quality of medical care provided, in accordance with the order of the Minister of Healthcare of the Republic of Kazakhstan dated 10 December 2020 No. ҚР ДСМ-244/2020 “On approval of the rules for maintaining primary medical records and reporting” (registered in the Register of State Registration of Regulatory Legal Acts under No. 21761).
At the outpatient care level, follow-up monitoring, preventive and rehabilitation measures and screening studies shall be additionally evaluated.
Footnote. Paragraph 5 - as amended by Order No. ҚР ДСМ-115 of the Minister of Healthcare of the Republic of Kazakhstan dated 16.11.2021 (effective ten calendar days after the date of its first official publication).6. When summarizing the results of the quality review of healthcare services (care), a decision shall be made on the compliance (non-compliance) of the provided medical care with the requirements of Standards and clinical protocols.
7. Expert evaluation of the quality of healthcare services (care) shall be carried out with the participation of the patient, if necessary.
8. For fatal cases, the comparison of the results of retrospective analysis, autopsy and (or) forensic medical examination shall be considered as a full and complete review.
Medical records and electronic health information resources shall be used as a source of information in the expert evaluation.
Chapter 2. Procedure for organising and conduct of internal quality review of health services (care)
9. In order to organise and conduct internal review, a Patient Support and Internal Expertise Service (hereinafter referred to as the Service) shall be established in the medical organisation.
The structure and composition of the Service shall be approved by the head of the medical organisation with allowances made for the volume of healthcare services, profile, capacity (number of beds) for organisations providing inpatient care, number of attached population for organisations providing outpatient-polyclinic care.
10. The Service shall carry out a review of:
1) in organizations providing inpatient or inpatient-substituting care, not less than 15% of treated cases per month, as well as all cases of:
lethal outcomes;
complications, including post-operative complications;
hospital-acquired infections;
repeated hospital admissions for the same disease within the same month due to poor previous treatment;
prolongation or reduction of the duration of treatment;
diagnosis discrepancies;
unjustified hospitalization;
2) in organizations providing outpatient and polyclinic care:
not less than 10% of reviews per month:
treated cases, outpatient records of persons subject to immunisation against infectious diseases;
as well as any cases:
maternal deaths;
deaths at home of children from 0 to 5 years of age inclusive;
deaths at home of persons of working age due to diseases;
hospital-acquired infections;
late vaccination or lack of vaccination against infectious diseases;
neglected forms of cancer and tuberculosis;
premature disability of persons of working age;
complications of pregnancy managed at the level of primary health-care organizations;
observations of patients after discharge from hospital (children, women in the postpartum period), patients with circulatory system diseases (after strokes and heart attacks);
3) in emergency medical care organizations, the quality of medical services (assistance) of at least 10% of calls handled per quarter shall be examined, including all cases:
visit to the patient after refused hospitalization by a medical organization providing inpatient care;
refusal from medical care, indicating the possible consequences, recorded in medical records, including in electronic form, signed by the patient or his legal representative, as well as by a health worker;
refusal by the patient or his legal representative to sign the refusal from medical care, with a corresponding entry about this in the medical records, including in electronic form, signed by the medical worker;
repeated calls to the same patient for the same disease within a day from the moment of the first call, except for the following cases:
lethality during calls: death before arrival of the ambulance crew, death in the presence of the ambulance crew;
4) in rehabilitation and medical rehabilitation organizations - any cases:
lethal outcomes;
transfer to hospital organizations;
increase or decrease of duration of treatment;
hospital injuries;
hospital-acquired infections;
5) in palliative care and nursing organizations - any cases:
fatalities;
nosocomial infections;
hospital traumatism;
6) blood service organisations shall carry out a quality assessment of at least 20% of donor medical records per quarter, as well as monitoring compliance with the rules of procurement, processing, quality control, storage, sale of blood, its components, and the rules of transfusion of blood, its components according to paragraph 84 of Article 7 of the Code.
Footnote. Paragraph 10 - as amended by Order No. ҚР ДСМ-115 of the Minister of Healthcare of the Republic of Kazakhstan dated 16.11.2021 (effective ten calendar days after the date of its first official publication).11. The Service shall also conduct monthly review of at least 10% of treated cases on the quality of completion of medical records by mid-level medical workers.
12. The Service shall clarify with the medical workers who have committed violations of the procedure of medical care, therapeutic and diagnostic measures, expressed in unjustified deviation from the Standards and clinical protocols (hereinafter - defects), the reasons for their occurrence, explanations of the requirements of the Standards, and joint development of recommendations for the prevention of defects and errors.
Cases of defects requiring management decisions (referral for additional training, refresher courses for medical staff, purchase of medicines, medical devices, medical equipment) shall be submitted to management for consideration.
13. The Service shall evaluate the activity of the structural subdivisions and the medical organization as a whole based on the evaluation of internal indicators in pursuance of Annex 1 to these Rules. Heads of structural subdivisions of the medical organization shall submit to the Service monthly, pursuant to the schedule approved by the head of the medical organization the results of monitoring by the indicators of assessment of the quality of healthcare services (care).
14. The Service shall assess the extent of patient satisfaction with the level and quality of medical services (assistance) and determine the needs of the population and patients by:
1) using the tool of public dialogue of openness for the purpose of a prompt response of medical organizations and state bodies to the needs of the population and patients;
2) resorting to focus group interviewing of the population, patients and experts of healthcare organizations;
3) questioning patients and (or) their relatives, medical and non-medical personnel of the healthcare organization;
4) analysis of justified complaints about the quality of medical services (assistance) provided;
5) analysis of medical incidents in accordance with the order of the Minister of Healthcare of the Republic of Kazakhstan dated October 22, 2020 No. ҚР ДСМ-147/2020 “On approval of the rules for determining cases (events) of a medical incident, their recording and analysis” (registered in the Register of State Registration of Regulatory Legal acts under No. 21511).
Footnote. Paragraph 14 - as amended by Order No. ҚР ДСМ-115 of the Minister of Healthcare of the Republic of Kazakhstan dated 16.11.2021 (effective ten calendar days after the date of its first official publication).14-1. To develop proposals and recommendations on topical issues of health and healthcare services of the attached population, and also to monitor the follow-up of recommendations, a permanent committee of public confidence in healthcare (hereinafter-the PCH committee) shall be formed at the medical organization, engaging 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.
Footnote. The Rules have been supplemented by paragraph 14-1 in accordance with Order No. ҚР ДСМ-115 of the Minister of Healthcare of the Republic of Kazakhstan dated 16.11.2021 (effective ten calendar days after the date of its first official publication).15. The Service shall consider appeals from patients regarding medical care provided, with the establishment of a commission. In this case the appeal shall be considered within a period not exceeding five calendar days.
16. Internal quality review of healthcare services (care) shall also be carried out through self-control at the level of:
each medical worker;
structural subdivision;
head nurse and (or) deputy head of nursing;
deputy head of nursing; deputy head for treatment.
17. The health care worker's self-assessment shall be carried out by the doctor, each nurse on the ward for all cases treated. The result of the self-monitoring shall be the signature of the health care worker in the medical documentation.
18. The review at the level of a structural subdivision shall be carried out by its head for all treated cases.
18-1. By the outcome of its work, the PCH committee shall quarterly direct information to local public health authorities of regions, cities of republican status and the capital.
Footnote. The Rules have been supplemented by paragraph 18-1 in accordance with Order No. ҚР ДСМ-115 of the Minister of Healthcare of the Republic of Kazakhstan dated 16.11.2021 (effective ten calendar days after the date of its first official publication).19. The performance appraisal of nurses at the level of a structural subdivision shall be performed by a head nurse. The quality review of the work of auxiliary medical workers of structural subdivisions shall be determined by completeness and timeliness of filling of medical documentation, as well as by completeness, timeliness and quality of fulfillment of medical prescriptions;
20. The review at the level of the head nurse or deputy head of nursing of a medical organization shall be carried out by examining and analysing at least 10% of cases treated for the quality of completion of medical documentation by nursing staff.
21. The review on the level of deputy head for treatment shall be conducted by reviewing and analysing at least 15% of cases treated per month.
22. The Service shall draw up an opinion based on the results of the internal review, which shall include:
1) the total number of identified irregularities, their structure, possible causes and remedies;
2) the number of detected irregularities that caused the deterioration of the health status;
3) the number of detected deviations which resulted in increase of costs for medical care.
23. The results of internal expert review, including their comparison with the results of external examination, shall be brought up and analyzed at meetings of the Service, in-hospital commissions, at medical conferences, followed by organizational decisions, in order to enhance the medical workers’ knowledge level and develop optimal approaches to the diagnostic and treatment process, which shall be documented in the minutes.
The in-hospital commissions shall include heads of structural units (specialized departments), physicians with practical experience of at least 3 years of continuous practice in their specialization field.
By the internal examination outcome, the Service shall bring monthly proposals to the head of the medical organization to eliminate the identified causes and conditions for decline in the quality of medical services (assistance) provided.
Footnote. Paragraph 23 - as amended by Order No. ҚР ДСМ-115 of the Minister of Healthcare of the Republic of Kazakhstan dated 16.11.2021 (effective ten calendar days after the date of its first official publication).Chapter 3. Procedures for organising and conducting external quality review of health services (care)
24. The external review of the quality of health services (care) shall be carried out by:
1) a state body;
2) by a fund;
3) independent health care experts;
4) department of the Office of the President of the Republic of Kazakhstan in relation to subordinated organizations.
25. Based on the results of an external review, an analysis shall be made of:
the result of the internal review for compliance with the principles of review;
compliance and effectiveness of the measures taken by the Service;
compliance with the threshold values in the dynamics of external indicators in pursuance of Annex 2 to these Rules;
quality of health services (care) provided.
26. External examination shall be carried out by the state body, including with independent experts involvement.
The independent experts shall be engaged in accordance with the order of the Minister of Healthcare of the Republic of Kazakhstan dated September 16, 2020 No. ҚР DSM-103/2020 " On approval of the Rules for the involvement of independent experts in the examination of the quality of medical services (assistance)" (registered in the Register of State Registration of Regulatory Legal Acts under No. 21218).
In the absence of conditions for engaging independent experts, existing conflict of interest of an independent expert in healthcare organizations entitled to provide independent experts, as well as in the period of time from the end of civil law (contractual) relations between healthcare organizations entitled to provide independent experts and the state body and until completion of the tendering procedures, in accordance with the nomenclature of specialties and specializations in healthcare, approved by the order of the Minister of Healthcare of the Republic of Kazakhstan dated December 21, 2020 No. ҚР ДСМ-305/2020 “On approval of the nomenclature of specialties and specializations in the field of healthcare, nomenclature and qualification characteristics of positions of healthcare employees” (registered in the Register of State Registration of Regulatory Legal Acts under No. 21856), for the assessment of the medical care quality by the decision of the state body or its territorial subdivisions, specialized healthcare experts shall be engaged.
Based on the results of medical care quality assessment, specialized experts in healthcare shall provide, within their competence, their statements with conclusions on the quality of medical services (assistance) provision with reference to regulatory legal acts for the formation of conclusions to be included in the conclusion of the external examination conducted by the state body.
Footnote. Paragraph 26 - as amended by Order No. ҚР ДСМ-115 of the Minister of Healthcare of the Republic of Kazakhstan dated 16.11.2021 (effective ten calendar days after the date of its first official publication).27. The external review of any cases of maternal mortality (except for accidents) shall be conducted by the state body.
28. In case of detected defects based on the external examination results, no later than 10 calendar days after completion of the consideration of applications from individuals and legal entities, as well as reports on cases of maternal death and other applications, the state body shall direct the information to the Fund, law enforcement bodies and local healthcare government bodies of regions, cities of republican status and the capital for taking response measures according to competence.
Footnote. Paragraph 28 - as amended by Order No. ҚР ДСМ-115 of the Minister of Healthcare of the Republic of Kazakhstan dated 16.11.2021 (effective ten calendar days after the date of its first official publication).29. In case of revealing of defects which resulted in health damage in the form of invalidity, including with loss of working capacity or lethal outcome, the state body shall direct materials of external review to bodies of internal affairs for acceptance of the procedural decision pursuant to article 179 of the Criminal Procedure Code of the Republic of Kazakhstan.
30. Based on the results of the external review of the quality of healthcare services (care) conducted by the state body and the Fund, the state body shall conduct an analysis to develop proposals to improve the provision of healthcare services (care).
31. When carrying out a review of healthcare entities, a specialist of the state body shall provide the expert with the materials that are the scope of the review. If necessary, he/she shall arrange a meeting with the applicant (with the consent of the applicant).
32. At the end of the review the state body shall draw up a conclusion in the form in compliance with Annex 3 to these Rules.
33. The Fund shall conduct external examination within monitoring of the follow-up of contractual obligations on the quality and volume of medical services in accordance with the order of the Acting Minister of Healthcare of the Republic of Kazakhstan dated December 24, 2020 No. ҚР ДСМ-321/2020 “On approval of the Rules for monitoring the follow-up of the contract terms of medical services procurement from healthcare 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 No. 21904).
Footnote. Paragraph 33 - as amended by Order No. ҚР ДСМ-115 of the Minister of Healthcare of the Republic of Kazakhstan dated 16.11.2021 (effective ten calendar days after the date of its first official publication).34. The Fund shall provide to the independent expert the materials that are the scope of the review.
35. At the end of the review, the Fund shall draw up an opinion and (or) an act in the form determined in accordance with sub-paragraph 99) of Article 7 of the Code.
36. Independent experts in the field of health care shall carry out external review if they are engaged by natural or legal persons on a contractual basis.
Information on independent experts shall be contained in the Register of Independent Experts formed by the state body in compliance with sub-paragraph 18) of Article 8 of the Code. The Register of Independent Experts shall be placed on the website of the state body.
37. When carrying out an independent examination, individuals or legal entities that engage independent experts on a contractual basis (hereinafter referred to as the Customer) shall provide the independent expert with materials that are the subject of examination.
If the raised issues are beyond the scope of the independent expert's special knowledge, or if the materials presented are not sufficient to give an expert opinion, the independent expert shall withhold the opinion.
An independent expert shall conduct an independent expert assessment of the medical activity quality in accordance with the current legislation in healthcare and ensure the legality, competence and impartiality of independent examination, as well as scientific validity of the means and methods of conducting research for the completeness and objectivity of an independent examination.
An independent expert shall not be re-engaged on an earlier examination, as well as in case of poor-quality provision of an independent examination service, which is documented, and cannot be involved if he is in any relationship (labor, civil law relationship) with two or more accredited healthcare entities that carry out independent examination in the field of healthcare.
During the examination, an independent expert shall observe confidentiality of official information, the principles of professional ethics.
Footnote. Paragraph 37 - as amended by Order No. ҚР ДСМ-115 of the Minister of Healthcare of the Republic of Kazakhstan dated 16.11.2021 (effective ten calendar days after the date of its first official publication).38. Review conducted by independent experts engaged by a public authority shall be divided into the following categories:
1) review of the quality of healthcare services (care) rendered with an adverse outcome:
review of pathological and anatomical examinations;
review of medical records of no more than two health care organisations (according to the patient's itinerary of care);
review of medical records of three or more health care organisations (according to the patient's itinerary of care);
2) examination of the quality of provided medical services (assistance) with a favorable outcome with examination of the patient (if necessary):
study of postmortem studies;
study of medical records of no more than two healthcare organizations (according to the route of providing medical care to the patient);
study of medical records of three or more healthcare organizations (according to the route of providing medical care to the patient).
The rendered medical services (assistance) with an unfavorable outcome shall mean provision of medical services (assistance) without observance of the Standards and Rules for medical care provision, which led to death, a life-threatening condition, a significant lasting loss of general ability to work, a complete loss of professional ability to work.
The rendered medical services (assistance) with a favorable outcome shall include provision of medical services (assistance) without observance of the Standards and Rules for the provision of medical care, which did not cause harm to human life and health.
Footnote. Paragraph 38 - as amended by Order No. ҚР ДСМ-115 of the Minister of Healthcare of the Republic of Kazakhstan dated 16.11.2021 (effective ten calendar days after the date of its first official publication).39. At the end of the review, the independent expert shall submit an expert opinion in the form according to Annex 3 to these Rules.
The expert opinion of the independent expert shall be drawn up in three copies. One copy shall be delivered to the healthcare entity, the second copy shall be delivered to the Customer, the third copy shall be kept by the independent expert.
40. Comments and (or) objections on the results of the external review shall be stated in writing and attached to the conclusion of the external review. Based on the results of the external review of the quality of healthcare services (care) the head of the medical organization shall take management measures, including determining the need and focus of training programs for doctors and nursing staff.
41. A repeated review shall be carried out in cases of disagreement with the conclusions of an external review based on requests from healthcare entities, natural or legal persons.
Experts who have not participated in the initial review shall be involved in a repeated review.
42. Complaint on disagreement with the conclusions of the external review shall be submitted to the superior state body (superior official) or to the court in accordance with the legislation of the Republic of Kazakhstan.
| Annex 1 to the rules for the organisation and conduct of internal and external quality reviews of health services (care) |
Internal indicators
№ | Name of indicators | Calculation formula/Unit of measure | Frequency of information |
Information source | Threshold value |
1 | 2 | 3 | 4 | 5 | 6 |
Assessment indicators for inpatient care providers | |||||
1 | Mortality rate for planned hospital admissions | Proportion (%) of inpatient deaths (excluding patients receiving oncological and palliative care) out of the total number of patients discharged (discharged, died) in the reporting period | Monthly | Reporting data, IPMR, ERI IS | The indicator value tends towards zero |
2 | Daily inpatient mortality rate | Proportion (%) of inpatients who died within the first 24 hours of admission in the reporting period | Quarterly | IPMR, DISC, ERI IS | Indicator value does not exceed 4% |
3 | Post-surgery mortality rate for planned hospital admissions | Proportion (%) of post-surgery inpatient deaths out of the number of patients who underwent elective surgery in the reporting period | Monthly | Reporting data, IPMR , ERI IS | The indicator value tends towards zero |
4 | Rate of intraoperative complications | Proportion (%) of intraoperative complications to the total number of operations in the reporting period | Quarterly | Reporting data, IPMR, transaction and manipulation form | Indicator value does not exceed 5% |
5 | Rate of post-operative complications | Proportion (%) of post-operative complications to the total number of operations in the reporting period | Quarterly | Reporting data, IPMR, transaction and manipulation form, ERI IS | Indicator value does not exceed 3 % |
6 | Number of maternal deaths, of which: obstetric haemorrhage, gestosis, abortion, extragenital pathology | Absolute number | Daily | Monitoring data on pregnant and postpartum women in the health centre, maternal mortality chart, ERI IS | The indicator value tends towards zero for reasons that are manageable |
7 | Rate of birth trauma among women | Proportion (%) of birth injuries to the total number of births in the reporting period | Quarterly | IPMR, Transaction and manipulation record form, ERI IS | The indicator value tends towards zero |
8 | Rate of emergency caesarean sections | Proportion (%) of emergency caesarean sections out of the total number of caesarean sections | Quarterly | IPMR, Transaction and manipulation record form, ERI IS | Indicator value does not exceed 20% |
9 | Admission rate of pregnant women admitted to hospital within 24 hours of refusal of admission | Proportion (%) of pregnant women admitted to hospital within 24 hours of refusal of admission as a proportion of all pregnant women admitted | Quarterly | IPMR, ERI IS | The indicator value tends towards zero |
10 | Number of infant deaths, of which: respiratory diseases, intestinal infections, congenital malformations, perinatal diseases | Absolute number | Monthly | IPMR, APR IS | Decrease in the value of the indicator for the reporting period compared to the previous period by 5% |
11 | Injury rate for newborns | Proportion (%) of newborn injuries to the total number of newborns in the reporting period | Quarterly | IPMR, ERI IS | The indicator value tends towards zero |
12 | Indicator of intrapartum fetal death | Proportion (%) of intrapartum fetal deaths per 100 live and stillbirths | Quarterly | IPMR, ERI IS | Decrease in the value of the indicator for the reporting period compared to the previous period by 10% |
13 | Early neonatal mortality rate (up to 7 days of life) | Proportion (%) of early neonatal deaths per 1,000 live births | Quarterly | IPMR, APR IS | Decrease in the value of the indicator for the reporting period compared to the previous period by 5% |
14 | Rate of purulent-septic processes after surgical interventions | Proportion (%) of purulent-septic processes after surgical interventions from the total number of operations in the reporting period | Monthly | IPMR, ERI IS | Indicator value not exceeding 1% |
15 | Indicator of purulent-septic processes in newborns | Proportion (%) of cases of neonatal septicaemia as a proportion of live births | Monthly | IPMR, ERI IS | The indicator value tends towards zero |
16 | 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 | OPMR, DISC, ERI IS | The indicator value tends towards zero |
17 | Number of discrepancies between clinical and pathological diagnoses | Absolute number | Monthly | Pathology protocol, ERI IS | The indicator value tends towards zero |
18 | Indicator of justified complaints about the quality of health services | Number of substantiated complaints per 1,000 patients treated | Monthly | Logbook of appeals | The indicator value must not exceed 1.0 |
19 | Indicator of epidemiological investigation of nosocomial infections | Proportion (%) of cases of nosocomial infections with epidemiological investigation from the total number of reported cases | Monthly | Minutes of the meeting of the infection control committee | The indicator value tends to 100% |
20 | Indicator for identifying causes and factors of nosocomial infections and the spread of nosocomial infections | Proportion (%) of cases of nosocomial infections with identified causes and factors of nosocomial infections from the total number of reported cases | Monthly | Minutes of the meeting of the infection control committee | The value of the indicator tends to 80% |
Evaluation indicators for outpatient care providers | |||||
1 | Number of first-time disability cases among people of working age | Absolute number | once a year | Data from the Territorial Department of the Committee for Labour, Social Protection and Migration | Decrease in the value of the indicator for the reporting period compared to the previous period by 1% |
2 | Maternal mortality rate, with deficiencies in the provision of health services at primary care level | Proportion (%) of maternal deaths among attached residents with confirmed defects (experts) at primary health care level, for the reporting period, per number of attached women of childbearing age | Quarterly | Maternal mortality scorecard (results of external evaluation) | The indicator value tends towards zero |
3 | Rate of recovered women with extragenital pathology among women of fertile age | Proportion (%) of healthy women of childbearing age per total number of women of childbearing age in the assigned population | Quarterly | OMR, outpatient statistical card, MIS, DPER IS | Increase of 5% compared to previous period |
4 | Contraceptive coverage rate for women with absolute contraindications to pregnancy | Proportion (%) of contraceptive prevalence among women with absolute contraindications to carry a pregnancy out of the total number of women with absolute contraindications to carry a pregnancy | Quarterly | OMR, RPWWFA IS | Indicator value tends towards 100% |
5 | Abortion rate in relation to childbirth | Proportion (%) of abortions to births | Quarterly | DISC, ERI IS | Decrease in the value of the indicator for the reporting period compared to the previous period by 5% |
6 | Hospital admission rate for pregnant women with regionalisation disorder (based on 24-hour inpatient unit) | Proportion (%) of pregnant women hospitalised with regionalisation as a proportion of all hospitalised pregnant women | Quarterly | DISC (International Classification of Diseases diagnosis with indication of delivery), RPWWFA IS | Decrease in the value of the indicator for the reporting period compared to the previous period by 5% |
7 | Infant mortality rate, with deficiencies in the provision of health services at PHC level | Proportion (%) of deaths of children aged 0 to 1 year prevented at PHC level per number of children aged 0 to 1 year in the attached population | Quarterly | Registration chart of live births, stillbirths and deaths of children under the age of 1 year | Decrease in the value of the indicator for the reporting period compared to the previous period by 5% |
8 | Indicator of training of health workers (doctors, nurses) of PHC under the IMCI programme | Proportion (%) of PHC medical staff (doctors, nurses) trained under the IMCI programme out of the total number of PHC medical staff | once a year | Human resources report | Indicator value of at least 70% |
9 | Doctor attendance rate for newborns in the first 3 days after discharge from hospital (patronage) | Proportion (%) of newborns seen by a doctor in the first 3 days after discharge from hospital (patronage) per number of newborns in the reporting period | Quarterly | OMR, MIS | Indicator value tends towards 100% |
10 | Rate of emergency hospital admissions for children under 5 years of age with AEI, ARI | Proportion (%) of hospital admissions of children under 5 with AEI, ARI to total hospital admissions of children under 5 | Quarterly | DPER IS | Decrease in the value of the indicator for the reporting period compared to the previous period by 1% |
11 | Indicator of parental education of children under 5 years of age on the danger signs according to the principles of the IMCI programme | Proportion (%) of parents of children under 5 years of age who have been taught the danger signs according to the principles of the IMCI programme per number of children under 5 years of age | Quarterly | Healthy child's room log | Indicator value tends towards 100% |
12 | Number of congenital malformations in newborns undiagnosed in utero | Absolute number | Quarterly | OMR, individual card for pregnant women, women in labour and childbirth, MIS | The indicator value tends towards zero |
13 | Indicator of obtaining exclusive breastfeeding of children at 6 months of age | Proportion (%) of children aged 6 months who are exclusively breastfed out of all children aged 6 months, excluding abandoned foundlings and children born to HIV-positive mothers, mothers taking cytostatics | Quarterly | OMR, MIS | Indicator value tends towards 100% |
14 | Breastfeeding rate for children under 2 years of age | Proportion (%) of children breastfed up to age 2 out of all children up to age 2, excluding abandoned foundlings and children born to HIV-positive mothers and mothers taking cytostatics | Quarterly | OMR, MIS | Indicator increase of 5 % compared to the previous period |
15 | 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 in the attached population | Quarterly | DPER IS | Decrease in the value of the current period compared to the previous period by 5% |
16 | Fluorography screening coverage rate for populations at high risk of tuberculosis as determined by the responsible authority | Proportion (%) of populations at high risk of tuberculosis covered by fluorography out of the total population at high risk of tuberculosis | once a year | Plan for fluorography examinations, fluorography logbook, MIS reporting forms | Indicator value tends towards 100% |
17 | Mandatory fluorography screening coverage rate | Proportion (%) of compulsory population covered by fluorography examinations of the total compulsory population | once a year | Plan for fluorography examinations, fluorography logbook, MIS reporting forms | Indicator value tends towards 100% |
18 | Tuberculosis case detection rate by fluorography among populations at high risk of tuberculosis as determined by the responsible authority | Proportion (%) of tuberculosis patients detected by fluorography among populations at high risk of tuberculosis per 1,000 population at high risk of tuberculosis | Quarterly | Logbook for fluorography examinations, MIS | The value of the indicator is at least 2 |
19 | Detection rate of patients with suspected tuberculosis among persons examined by microscopy | Proportion (%) of TB cases detected by microscopy out of the total number of patients with suspected TB referred for microscopy | Quarterly | Laboratory logbook for PHC laboratories, referral for laboratory testing services, consultation services, hospital admission, transfer to another hospital, MIS, NRTP IS | The indicator value is 5-10% |
20 | Number of tuberculosis patients who interrupted therapy at primary care level | Absolute number | Quarterly | OMR, MIS | The indicator value tends towards zero |
21 | Rate of patients with first-time malignant neoplasms 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 | once a year | ERCP IS | Decrease of 5% compared to previous period |
22 | Rate of patients with first-time malignant neoplasms of stage 1-2 | Proportion (%) of first-time malignant tumour patients at stages 1 and 2 of the total number of malignant tumour patients detected in the reporting period | once a year | ERCP IS | Increase of 1% compared to previous period |
23 | 5-year survival rate of patients with malignant neoplasms | Proportion (%) of 5-year survival rate of patients with malignant neoplasms per total number of patients with malignant neoplasms | once a year | ERCP IS | Indicator value is at least 50% |
24 | Indicator of justified complaints about the quality of health services | Number of substantiated complaints per 1,000 outpatient cases | Monthly | Logbook for enquiries | The indicator value must not exceed 3.0 |
25 | Hospitalisation rate for patients with complications of cardiovascular diseases (arterial hypertension, myocardial infarction, stroke) | Proportion (%) of inpatients treated for complications of cardiovascular diseases (arterial hypertension, myocardial infarction, stroke) per population | Quarterly | DISC, ERCP IS | Decrease in the value of the indicator for the reporting period compared to the previous period by 10% |
26 | Indicator of epidemiological investigation of nosocomial infections | Proportion (%) of cases of nosocomial infections with epidemiological investigation out of the total number of reported nosocomial infections | Monthly | Minutes of the meeting of the infection control committee | Indicator value tends towards 100% |
27 | Indicator for identifying causes and factors of nosocomial infections and the spread of nosocomial infections | Proportion (%) of cases of nosocomial infections with identified causes and factors of nosocomial infections from the total number of reported cases of nosocomial infections | Monthly | Minutes of the meeting of the infection control committee | Indicator value tends towards 80% |
28 | Immunization coverage rate for children under 5 years of age against targeted infections | Proportion (%) of immunised children in the target group | Monthly on an incremental basis | Reporting Form No. 4, approved by Order No. 415 of the Minister of National Economy of 30 May 2015, Preventive Immunisation Logbook, MIS | Indicator value aims at 95% for the year (at least 7.9% each month) |
29 | Medical rehabilitation coverage rate - 3 stages | Proportion (%) of patients covered by medical rehabilitation to the total number of patients eligible for medical rehabilitation | Monthly on an incremental basis | OMR, MIS | Indicator value tends towards 85% for the year |
Explanation of abbreviations and acronyms:
1. IPMR – In-Door 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. 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
| Annex 2 to the rules for the organisation and conduct of internal and external quality reviews of health services (care) |
External indicators
№ | Name of indicators | Measurement unit | Frequency of information | Source of information | Threshold value |
1 | 2 | 3 | 4 | 5 | 6 |
Assessment indicators for inpatient care providers | |||||
1 | Mortality rate for planned hospital admissions | Proportion (%) of inpatient deaths (excluding patients receiving oncological and palliative care) out of the total number of patients discharged (discharged, died) in the reporting period | Monthly | Reporting data, IPMR | The indicator value tends towards zero |
2 | Post-operative mortality rate for 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: 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 can be managed |
4 | Number of infant deaths, of which: 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 | Logbook for enquiries | The indicator value must not exceed 1.0 |
8 | Indicator of epidemiological investigation of nosocomial infections | Proportion (%) of cases of nosocomial infections with epidemiological investigation from the total number of reported cases | Monthly | Minutes of the meeting of the infection control committee | Indicator value tends towards 100% |
9 | Indicator for identifying causes and factors of nosocomial infections and the spread of nosocomial infections | Proportion (%) of cases of nosocomial infections with identified causes and factors of nosocomial infections from the total number of reported cases | Monthly | Minutes of the 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 primary care level | Proportion (%) of maternal deaths among attached residents with confirmed defects (experts) at PHC level, for the reporting period, per number of attached women of childbearing age | Quarterly | Maternal mortality scorecard (results of external evaluation) | The indicator value tends towards zero |
2 | Infant mortality rate, with deficiencies in the provision of health services at PHC level | Proportion (%) of deaths of children aged 0 to 1 year prevented at PHC level per number of children aged 0 to 1 year in the eligible population | Quarterly | Registration card of live births, stillbirths and deaths of children under 1 year of age | Decrease in the value of the indicator for the reporting period compared to the previous period by 5% |
3 | Pregnancy rate of WFW with extragenital abnormalities who are absolutely contraindicated in pregnancy | Proportion (%) of antenatal pregnancies of WFW with extragenital pathology who are absolutely contraindicated among attached residents per total number of WFW among attached residents | Quarterly |
DISC, Register of Pregnant Women and Women of Fertile Age Information System | The indicator value tends towards zero |
4 | 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 in the attached population | Quarterly | NRTP IS – 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% |
5 | Rate of patients with first-time malignant neoplasms 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 | ERCP IS - 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% |
6 | Indicator of justified complaints about the quality of health services | Number of substantiated complaints per 1,000 outpatient cases | Monthly | Logbook for enquiries | The indicator value must not exceed 3.0 |
7 | Hospitalisation rate for complications of cardiovascular diseases (arterial hypertension, myocardial infarction, stroke) | Proportion (%) of inpatients treated for complications of cardiovascular diseases (arterial hypertension, myocardial infarction, stroke) per population | Quarterly | DISC, ERCP IS | Decrease in the value of the indicator for the reporting period compared to the previous period by 5% |
8 | Indicator of epidemiological investigation of nosocomial infections | Proportion (%) of cases of nosocomial infections with epidemiological investigation from the total number of reported cases | Monthly | Minutes of the meeting of the infection control committee | The indicator value must not exceed 3.0 |
9 | Indicator for identifying causes and factors of nosocomial infections and the spread of nosocomial infections | Proportion (%) of cases of nosocomial infections with identified causes and factors of nosocomial infections from the total number of reported cases | Monthly | Minutes of the meeting of the infection control committee | The value of the indicator tends to 80% |
10 | Immunization coverage rate for children under 5 years of age against targeted infections | Proportion (%) of children in the target group who were immunised | Monthly on an incremental basis | Reporting form No. 4, approved by Order No. 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%) |
Explanation of abbreviations and acronyms :
1. IPMR – In-Door Patient Medical Record
2. ERI IS -Electronic Register of Inpatients Information System
3. DISC - Discharged Inpatients Statistical Chart
4. PHC - Primary Health Care
5. WFW - Women of Fertile Age
| Annex 3 to the rules for the organisation and conduct of internal and external quality reviews of health services (care) |
Expert judgement
1. Surname, first name, patronymic (if any) of the person who carried out the review, indicating specialisation, position, academic degree.
2. Name of health care entity (facility) where the review has been conducted
3) Basis for the review, or information on the customer
4. Timeframe of expert evaluation
5. Period of the review
6. Scope of the review
7. Information on the results of the review, including the detected violations and their nature
8. Conclusions.
9. Recommendations
_________________________________________________ ________________________
Surname, first name, patronymic (if any), signature of the person who carried out the review
Date "____" ___________ 20 ___
| Annex to order of the Minister of Healthcare of the Republic of Kazakhstan No. 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 No. 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 No. 10880, published on 1 October 2015 in the newspaper "Kazakhstanskaya Pravda" No. 187);
2) Order No. 568 of the Minister of Healthcare and Social Development of the Republic of Kazakhstan of 28 June 2016 "On Amendments to Order No. 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 No. 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 No. 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 No. 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 No. 18300, published in the Control Reference Bank of Regulatory Legal Acts of the Republic of Kazakhstan in electronic form on 15 February 2019).