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JOINT ORDER OF THE MINISTER OF HEALTH OF THE REPUBLIC OF KAZAKHSTAN AND MINISTER OF NATIONAL ECONOMY OF THE REPUBLIC OF KAZAKHSTAN

of November 15, 2018 No. KR DSM-32, 15 of November, 2018 No. 70

About approval of criteria for evaluation of risk degree and checking sheets in spheres of quality of rendering medical services, drug circulation and medical products

(as amended on 06-01-2021)

According to Items 2 and 3 of Article 141, Item 1 of article 143 of the Entrepreneurial code of the Republic of Kazakhstan of October 29, 2015 PRIKAZYVAYEM:

1. Approve:

1) criteria for evaluation of risk degree in the sphere of quality of rendering medical services according to appendix 1 to this joint order;

2) checking leaf in the sphere of the state quality control of rendering medical services concerning subjects (objects) giving stationary, hospital-replacing help according to appendix 2 to this joint order;

3) checking leaf in the sphere of the state quality control of rendering medical services concerning subjects (objects) giving out-patient and polyclinic help (primary health care and the consulting and diagnostic help) according to appendix 3 to this joint order;

4) checking leaf in the sphere of the state quality control of rendering medical services concerning subjects (objects) of obstetric aid according to appendix 4 to this joint order;

5) checking leaf in the sphere of the state quality control of rendering medical services concerning subjects (objects) giving cardiological, cardiac help according to appendix 5 to this joint order;

6) checking leaf in the sphere of the state quality control of rendering medical services concerning subjects (objects) giving hemodialysis help according to appendix 6 to this joint order;

7) checking leaf in the sphere of the state quality control of rendering medical services concerning subjects (objects) giving dental help according to appendix 7 to this joint order;

8) checking leaf in the sphere of the state quality control of rendering medical services concerning subjects (objects) giving ftiziatrichesky help according to appendix 8 to this joint order;

9) checking leaf in the sphere of the state quality control of rendering medical services concerning subjects (objects) giving oncological help according to appendix 9 to this joint order;

10) checking leaf in the sphere of the state quality control of rendering medical services concerning subjects (objects) giving narcological help according to appendix 10 to this joint order;

11) No. KR DSM-3 is excluded according to Joint the Order of the Minister of Health of the Republic Kazakhstani, the Minister of national economy of the Republic of Kazakhstan of 06.01.2021

12) checking leaf in the sphere of the state quality control of rendering medical services concerning subjects (objects) providing laboratory services according to appendix 12 to this joint order;

13) checking leaf in the sphere of the state quality control of rendering medical services concerning subjects (objects) providing emergency medical service, medical care in the form of sanitary aircraft according to appendix 13 to this joint order;

14) checking leaf in the sphere of the state quality control of rendering medical services concerning the subjects (objects) giving help to HIV-positive people and performing actions for prevention of HIV infection according to appendix 14 to this joint order;

15) checking leaf in the sphere of the state quality control of rendering medical services concerning subjects (objects) performing activities in the sphere of service of blood according to appendix 15 to this joint order;

16) criteria for evaluation of risk degree in the sphere of drug circulation, products of medical appointment and medical equipment according to appendix 16 to this joint order;

17) checking leaf in the sphere of drug circulation, products of medical appointment and medical equipment concerning all subjects (objects) of pharmaceutical activities according to appendix 17 to this joint order;

18) checking leaf in the sphere of drug circulation, products of medical appointment and medical equipment concerning the medical organizations for provision of medicines according to appendix 18 to this joint order;

19) checking leaf in the sphere of drug circulation, products of medical appointment and medical equipment concerning subjects (objects) of pharmaceutical activities performing production of medicines, products of medical appointment and medical equipment according to appendix 19 to this joint order;

20) checking leaf in the sphere of drug circulation, products of medical appointment and medical equipment concerning subjects (objects) of pharmaceutical activities performing production of medicines and products of medical appointment according to appendix 20 to this joint order;

21) checking leaf in the sphere of drug circulation, products of medical appointment and medical equipment concerning subjects (objects) of pharmaceutical activities enabling wholesale of medicines, products of medical appointment and medical equipment according to appendix 21 to this joint order;

22) checking leaf in the sphere of drug circulation, products of medical appointment and medical equipment concerning subjects (objects) of pharmaceutical activities enabling retail sale of medicines, products of medical appointment and medical equipment according to appendix 22 to this joint order.

2. Declare invalid the joint order of the Minister of health and social development of the Republic of Kazakhstan of December 29, 2015 No. 1064 and the Minister of national economy of the Republic of Kazakhstan of December 29, 2015 No. 831 "About approval of criteria for evaluation of risk degree and checking sheets in spheres of quality of rendering medical services, drug circulation, products of medical appointment and medical equipment" (it is registered in the Register of state registration of regulatory legal acts for No. 12763, it is published on March 25, 2016 in information system of law of Ad_let).

3. To provide to committee of protection of public health of the Ministry of Health of the Republic of Kazakhstan:

1) state registration of this joint order in the Ministry of Justice of the Republic of Kazakhstan;

2) within ten calendar days from the date of state registration of this joint order the direction it the copy in the Kazakh and Russian languages in the Republican state company on the right of economic maintaining "The republican center of legal information" for official publication and inclusion in Reference control bank of regulatory legal acts of the Republic of Kazakhstan;

3) placement of this joint order on official Internet resources of the Ministry of Health of the Republic of Kazakhstan and the Ministry of national economy of the Republic of Kazakhstan after its official publication;

4) within ten working days after state registration of this joint order in the Ministry of Justice of the Republic of Kazakhstan submission to Department of legal service of the Ministry of Health of the Republic of Kazakhstan of data on execution of the actions provided by subitems 1), 2) and 3) of this Item.

4. To impose control of execution of this joint order on the vice-Minister of Health of the Republic of Kazakhstan.

5. This joint order becomes effective after ten calendar days after day of its first official publication.

Minister of Health of the Republic of Kazakhstan

E.Birtanov

 

Appendix 1

to the joint Order of the Minister of Health of the Republic of Kazakhstan and the Minister of national economy of the Republic of Kazakhstan of November 15, 2018 No. KR DSM-32, 15 of November, 2018 No. 70

Criteria for evaluation of risk degree in the sphere of quality of rendering medical services (help)

Chapter 1. General provisions

1. These Criteria for evaluation of degree of risks in the sphere of quality of rendering medical services (help) (further – Criteria) are developed according to article 30 of the Code of the Republic of Kazakhstan of July 7, 2020 "About health of the people and health care system", article 141 of the Entrepreneurial code of the Republic of Kazakhstan of October 29, 2015 and Rules of forming of system of risks assessment by the state bodies approved by the order of the acting minister of national economy of the Republic of Kazakhstan of July 31, 2018 No. 3 (it is registered in the Register of state registration of regulatory legal acts at No. 17371).

2. In these Criteria the following concepts are used:

1) assessment period – certain time period for which the risks assessment by objective and subjective criteria based on reporting yielded is carried out, results of monitoring of the automated information systems, results of the previous checks and other sources of information. For subjects of control assessment period used in Criteria – once a half-year;

2) considerable violations – violations, including the discrepancies to requirements of the legislation in the field of health care which are not relating to gross and insignificant violations;

Insignificant violations – violations of requirements of the legislation of the Republic of Kazakhstan in health sector which non-compliance entailed and (or) can entail 3) formally allowed, but not done any notable harm to the population;

4) risk in the sphere of rendering medical services – probability of damnification of life or to health of the person, legitimate interests of physical persons and legal entities, the states as a result of implementation of medical activities of the subject of control;

5) gross violations – intentional or careless obvious and fundamental breach of the legislation of the Republic of Kazakhstan in health sector which non-compliance entailed and (or) can entail heavy consequences to health of the population;

6) objective criteria for evaluation of risk degree (further – objective criteria) – the criteria used for selection of subjects (objects) of control depending on risk degree in the sphere of rendering medical services when implementing activities and which are not depending directly on separate subject (object) of control;

7) subjective criteria for evaluation of risk degree (further – subjective criteria) – the criteria for evaluation of risk degree used for selection of subjects (objects) of control for carrying out preventive control and special procedure for conducting checks depending on results of activities of specific subject (object) of control.

3. Criteria for evaluation of risk degree for special procedure for conducting checks and for preventive control and supervision with visit of subject (object) of control and supervision are created by means of objective and subjective criteria.

Chapter 2. The criteria for evaluation of risk degree applied to special procedure for conducting checks concerning subjects (objects) of health care rendering services of obstetric aid

Paragraph 1. Objective criteria for evaluation of risk degree

4. Objective criteria are created by means of the following stages:

1) risk identification;

2) distribution of subjects (objects) of control on risk degrees (high and not carried to high).

5. The objects of obstetric aid and the stationary organizations incorporating departments of pathology of newborns belong to high risk.

Concerning subjects (objects) of high risk are performed in special procedure with frequency once a year.

6. In case of acceptance in operation of object of the high importance after approval of the semi-annual schedule of conducting checks, it is brought in the schedule of conducting checks the next half-year with frequency of checks once a year.

Paragraph 2. Subjective criteria for evaluation of risk degree

7. For determination of subjective criteria for evaluation of degree of risks the following sources of information are used:

1) results of the previous checks and special procedure for conducting checks (at the same time severity of violations is established in case of non-compliance with the requirements established in checking sheets);

2) results of monitoring of the data received from the automated information systems;

3) availability and the number of the confirmed claims, addresses from physical persons and legal entities for last year.

8. Subjective criteria are developed for the purpose of realization of the principle of encouragement of the fair checked subjects (objects) in the form of release them from conducting checks on special procedure.

If at subject (object) external complex assessment (accreditation) on activities compliance to accreditation standards is carried out and the certificate on accreditation for the checked period is provided, then the subject (object) is exempted from checks the next calendar year.

9. Determination of risk group of the objects of the high importance relating to one subject (legal entity) is carried out for each object separately.

10. Forming of the schedule of conducting checks, subjects (objects) of control is constituted proceeding from the principles of the minimum need and sufficiency, encouragement of the fair checked subjects, concentration of control on violators.

11. Subjective criteria for evaluation of risk degree concerning checks by special procedure with distribution on degree of the importance of violations and sources of information it is determined according to appendix 1 to these Criteria.

In case of identification of one gross violation, to the checked subject (object) the exponent of risk 100 is equated and concerning it it is performed on special procedure.

If gross violations are not revealed, for measure definition of risk degree the total indicator on violations of considerable and insignificant degree is calculated.

In case of measure definition of considerable violations the coefficient of 0,7 is applied and this indicator is calculated by the following formula:

SRZ = (SP2 x 100/SP1) x 0,7

where:

SRZ – indicator of considerable violations;

SP1 – total quantity of required considerable violations;

SR2-the number of the revealed considerable violations.

In case of measure definition of insignificant violations the coefficient of 0,3 is applied and this indicator is calculated by the following formula:

SRN = (SP2 x 100/SP1) x 0,3

where:

SRN – indicator of insignificant violations;

SP1 – total quantity of required insignificant violations;

SR2-the number of the revealed insignificant violations.

The general exponent of risk (SP) is calculated on scale from 0 to 100 and is determined by summing of indicators of considerable and insignificant violations by the following formula:

SP = SRZ + SRN

where:

SP – general exponent of risk;

SRZ-indicator of considerable violations;

SRN-indicator of insignificant violations.

12. On indicators the checked subject (object):

1) it is exempted from special procedure for conducting checks based on semi-annual schedules the next half-year established in criteria for evaluation of risk degree of regulatory state agency – in case of exponent of risk from 0 to 60;

2) it is not exempted from special procedure for conducting checks based on semi-annual schedules – in case of exponent of risk from 61 to 100 inclusive.

Chapter 3. The criteria for evaluation of risk degree applied to preventive control with visit of subjects (objects) in the sphere of rendering medical services (help)

Paragraph 1. Objective criteria

13. Objective criteria are created by means of the following stages:

1) risk identification;

2) distribution of subjects (objects) of control on risk degrees (high and not carried to high).

14. Reference of subjects of control to risk degree is performed taking into account the following objective criteria:

1) the level of danger (complexity) of subject (object) depending on the performed activities;

2) scales of weight of possible negative consequences of harm in the course of implementation of medical activities;

3) possibilities of adverse effect on health of the person, legitimate interests of physical persons and legal entities, states.

15. After risk identification, subjects (objects) of control are distributed on two risk degrees (high and not carried to high).

Subjective criteria for the purpose of carrying out preventive control with visit of subject (object) of control are applied to subjects (objects) of control carried by objective criteria to high risk.

16. Subjects (objects) of control giving out-patient and polyclinic help, stationary, emergency medical service and medical aircraft, the laboratory services performing activities in spheres of pathoanatomical diagnostics and prevention of HIV, service of blood belong to high risk.

17. Not carried to high risk - the subjects (objects) of control performing recovery treatment and medical rehabilitation, giving pre-medical help, palliative care and sisterly leaving, and also the organizations performing activities in the sphere of forming of healthy lifestyle.

Paragraph 2. Subjective criteria

18. For determination of subjective criteria for evaluation of degree of risks the following sources of information are used:

1) results of the previous checks and preventive control with visit of subjects (objects) of control (at the same time severity of violations is established in case of non-compliance with the requirements established in checking sheets);

2) results of monitoring of the data received from the automated information systems;

3) results of monitoring of the reporting data represented by the subject of control;

4) analysis results of information, received from authorized bodies and the organizations;

5) availability and the number of the confirmed claims, addresses from physical persons and legal entities for last year.

19. For assessment of subjects of control by subjective criteria data of electronic information resources of authorized body in the field of health care and medical information systems are used.

20. Subjective criteria in the sphere of quality of rendering medical services are subdivided into three extents of violations: rough, considerable, insignificant.

Subjective criteria for carrying out preventive control with visit of the subject of control with distribution on degree of the importance of violations and sources of information are given in appendix 2 to these Criteria. Discrepancy criterion determines the corresponding extent of violations.

21. The following procedure of payments of exponent of risk is applied to reference of the subject to risk degree.

In case of identification of one gross violation, to the subject of control the exponent of risk 100 is equated and concerning it preventive control with visit of subject (object) of control is carried out.

If gross violations are not revealed, for measure definition of risk degree the total indicator on violations of considerable and insignificant degree is calculated.

In case of measure definition of considerable violations the coefficient of 0,7 is applied and this indicator is calculated by the following formula:

SRZ = (SP2 x 100/SP1) x 0,7

where:

SRZ – indicator of considerable violations;

SP1 – the required number of considerable violations;

SP2 - the number of the revealed considerable violations.

In case of measure definition of insignificant violations the coefficient of 0,3 is applied and this indicator is calculated by the following formula:

SRN = (SP2 x 100/SP1) x 0,3

where:

SRN – indicator of insignificant violations;

SP1 – the required number of insignificant violations;

SP2 – the number of the revealed insignificant violations.

The general exponent of risk (SP) is calculated on scale from 0 to 100 and is determined by summing of indicators of considerable and insignificant violations by the following formula:

SP = SRZ + SRN

where:

SP - general exponent of risk;

SRZ - indicator of considerable violations;

SRN - indicator of insignificant violations.

22. On general exponent of risk the subject (object) of control belongs:

1) to high risk – in case of exponent of risk from 61 to 100 inclusive and concerning it preventive control with visit of subject (object) of control is carried out;

2) not carried to high risk – in case of exponent of risk from 0 to 60 inclusive and concerning it preventive control with visit of subject (object) of control is not carried out.

23. Frequency rate of carrying out preventive control with visit of subject (object) of control is determined by results of the carried-out analysis and assessment of the received data on subjective criteria and is not more often than once a year.

24. Preventive control with visit of subject (object) of control are carried out based on the semi-annual lists of preventive control with visit of subject (object) of control created according to Item 3 of article 141 of the Entrepreneurial code of the Republic of Kazakhstan.

25. The basis for purpose of preventive control with visit of subject (object) of control is the semi-annual list of carrying out preventive control with visit of subject (object) of control approved by the first head of regulatory state agency.

26. Semi-annual lists of carrying out preventive control with visit of subject (object) of control are created concerning subjects of control with obligatory specifying of objects concerning which preventive control with visit of subject (object) of control is appointed.

27. Lists of preventive control with visit of subject (object) of control are constituted taking into account priority of the subject of control with the greatest exponent of risk by subjective criteria.

Appendix 1

to Criteria for evaluation of risk degree in the sphere of quality of rendering medical services (help)

Subjective criteria for evaluation of risk degree concerning checks on special procedure with distribution on degree of the importance of violations and sources of information

No. of payment order

Name of criteria

Extent of violations

1. Criteria on information source "Results of the previous checks and special procedure for conducting checks (severity is established in case of non-compliance with following requirements)

Criterion for the objects of obstetric aid and (or) the stationary organizations incorporating delivery rooms and departments of pathology of newborns

1.

Availability of the license and appendices to it on the performed types of activity

rough

2.

Availability of the certificate of the specialist in the corresponding clinical specialty

rough

3.

Availability of the conclusion about compliance of the subject of health care to provision of high-technology medical services

rough

4.

Availability of written voluntary consent of the patient or his legal representative in case of invasive interventions and on holding medical and diagnostic actions

considerable

5.

Time of stay of crew of SSMP or department SMP under the PHC organization in reception of hospital does not exceed 10 minutes (time for transfer of the patient to the doctor of reception) from the moment of its arrival in hospital, except as specified need of rendering emergency medical service for emergency situations.
After transfer by crews of SMP or department SMP under the PHC organization of the patient the nurse carries out distribution of the arriving patients (medical sorting according to triazh-system) to groups to reception of hospital, proceeding from first priority of rendering the emergency medical care.
Medical sorting according to triazh-system is carried out continuously and preemstvenno. On completion of assessment, patients are marked with color of one of categories of sorting, in the form of special color label or color tape.
According to medical sorting, allocate 3 groups of patients:
the first group (red zone) – patients whose condition poses direct threat of life or deteriorations having high risk and requiring the emergency medical care;
the second group (yellow zone) – patients whose condition poses potential hazard for health or can progress with development of the situation, the requiring emergency medical care;
the third group (green zone) – patients whose condition does not pose direct threat for life and health and does not require hospitalization

rough

6.

In the absence of indications for hospitalization in the organization of health care, the doctor of reception issues to the patient the medical certificate with written reasons for refusal.
The nurse of reception the asset goes to the PHC organization for the place of attachment of the patient

considerable

7.

Availability of indications for hospitalization:
need of rendering pre-medical, qualified, specialized medical care, including using high-technology medical services, with the round-the-clock medical observation of patients:
1) in planned procedure – in the direction of specialists of PHC or other organization of health care:
2) according to the emergency indications (including days off and holidays) - regardless of direction availability

considerable

8.

Survey of the patient by the manager of department of heavy patients in day of hospitalization, in subsequent – daily. The patients who are in medium-weight condition are inspected at least once a week. Results of survey of the patient are registered in the medical record with indication of recommendations about further tactics of maintaining the patient with obligatory identification of the health worker making records

considerable

9.

Daily survey of the patients who are in hospital, the attending physician except days off and holidays. In case of survey and appointment of additional diagnostic and medical manipulations as the doctor on duty the corresponding entries in the medical record are carried out

considerable

10.

Additional and repeated carrying out the researches conducted before hospitalization in the PHC organization or other organization of health care on medical indications, with reasons in the medical record for dynamic assessment of condition of the patient, according to clinical protocols of diagnostics and treatment.

considerable

11.

Observance of the following requirements in case of issue of leaf and certificate of temporary disability for pregnancy and childbirth:
- the sheet or the certificate of temporary disability on pregnancy and childbirth is issued by the health worker (the doctor the obstetrician-gynecologist), and in case of its absence - the doctor, together with the manager of department after the conclusion of VKK since thirty weeks of pregnancy for the term of lasting hundred twenty six calendar days (seventy calendar days before childbirth and fifty six calendar days after the delivery) in case of normal childbirth.
To the women living in the territories which were affected by nuclear testing, the sheet or the certificate of disability on pregnancy and childbirth is issued since twenty seven weeks lasting hundred seventy calendar days (ninety one calendar days before childbirth and seventy nine calendar days after the delivery) in case of normal childbirth;
2) to the women who temporarily left from the permanent residence within the Republic of Kazakhstan, the sheet or the certificate of temporary disability on pregnancy and childbirth is issued prolonged) in the medical organization where there was childbirth or in antenatal clinic (office) in the place of observation according to the statement (prenatal record) of the obstetrical organization
3) in case of the complicated childbirth, the birth of two and more children, the sheet or the certificate of temporary disability is prolonged in addition for fourteen calendar days by the health worker (the doctor the obstetrician-gynecologist), and in case of its absence - the doctor, together with the manager of department after the conclusion of VKK in the place of observation according to the statement of the obstetrical organization of health care. In these cases the general duration of prenatal and postnatal leaves constitutes hundred forty calendar days (seventy calendar days before childbirth and seventy calendar days after the delivery).
To the women living in the territories which were affected by nuclear testing in case of the complicated childbirth, the birth of two and more children, the sheet or the certificate of temporary disability is prolonged in addition for fourteen calendar days, the general duration of prenatal and postnatal leaves constitutes hundred eighty four days (ninety one calendar days before childbirth and ninety three calendar days after the delivery);
4) in case of childbirth in case of term from twenty two to twenty nine weeks of pregnancy and the child's birth with body weight five hundred grams and more, lived more than seven days, are issued to the woman the sheet or the certificate of disability upon childbirth for seventy calendar days after the delivery.
In case of childbirth in case of term from twenty two to twenty nine weeks of pregnancy and the birth of dead fruit or the child with body weight five hundred grams and more, died up to seven days of life, are issued to the woman the sheet or the certificate of temporary disability upon childbirth for fifty six calendar days after the delivery;
5) to the women living in the territories which were affected by nuclear testing, in case of childbirth in case of term from twenty two to twenty nine weeks of pregnancy and the child's birth with body weight five hundred grams and more, lived more than seven days, the sheet or the certificate of temporary disability is issued for ninety three calendar days after the delivery.
To the women living in the territories which were affected by nuclear testing, in case of childbirth in case of term from twenty two to twenty nine weeks of pregnancy and the birth of dead fruit or the child with body weight five hundred grams and more, died up to seven days of life, the sheet or the certificate of temporary disability is issued for seventy nine calendar days after the delivery;
6) in case of the address of the woman during pregnancy behind leaf of temporary disability the maternity leave is estimated totally and is provided completely irrespective of number of the days which are actually used by it before childbirth.
In case of the address of the woman to the period after the delivery behind leaf of temporary disability only leave after the delivery is granted by duration provided by this Item;
7) in case of approach of pregnancy during finding of the woman in paid annual labor leave or leave non-paid on child care before achievement of three years by it, the leaf about temporary disability is issued on all vacation days on pregnancy and childbirth, except as specified, provided by subitem part two 6) of this Item;
8) in case of the death of mother in case of childbirth or in the postnatal period, the sheet or the certificate of temporary disability is issued to person performing care of the newborn;
9) in case of transaction on abortion, the sheet or the certificate of temporary disability is issued by the doctor together with the manager of department for the period of stay in hospital and out-patient and polyclinic level where transaction was made, and in case of complication - for the entire period of temporary disability.
In case of spontaneous abortion (abortion) the sheet or the certificate of temporary disability for the entire period of temporary disability is issued;
10) when carrying out transaction of change of embryo the sheet or the certificate of temporary disability is issued by the medical organization performing operation from the date of replanting of embryo to the pregnancy establishment fact.
To persons who adopted (adopted) newborn child(children), and also the natural mother in case of surrogacy it is direct from maternity hospital the sheet or the certificate of temporary disability is issued, from the date of adoption (adoption) and before the expiration of fifty six calendar days since the birth of the child

considerable

12.

Availability of carrying out clinical audit by Support service of the patient and internal examination and its assessment by the following criteria:
1) quality of collection of the anamnesis which is estimated by the following criteria:
lack of collection of the anamnesis;
completeness of collection of the anamnesis;
availability of data on the postponed, chronic and heritable diseases, the carried-out hemotransfusions, tolerance of medicines, the allergologichesky status;
development of complications owing to the made tactical mistakes when holding medical and diagnostic actions because of low-quality collection of the anamnesis;
2) completeness and justification of conducting diagnostic testings which are estimated by the following criteria:
lack of diagnostic actions;
the wrong conclusion or lack of the conclusion by results of the conducted diagnostic researches which led to the wrong diagnosis and mistakes in treatment tactics;
conducting the diagnostic testings provided by clinical protocols;
conducting diagnostic testings with high, unjustified risk for the state of health of the patient, justification of conducting the diagnostic testings which did not enter in clinical the protocol;
conducting diagnostic testings, not informative for statement of the correct diagnosis and the terms of treatment which led to unreasonable increase and rise in price of cost of treatment;
3) correctness, timeliness and justification of the exposed clinical diagnosis taking into account results of the conducted researches (in case of planned hospitalization the researches conducted and at pre-hospital stage are considered), which are estimated by the following criteria:
the diagnosis is absent, incomplete or wrong, does not correspond to the international classification of diseases;
the leading pathological syndrome determining weight of course of disease is not allocated, associated diseases and complications are not distinguished;
the diagnosis is correct, but incomplete, the leading pathological syndrome in case of the allocated complications is not allocated, the associated diseases influencing outcome are not distinguished;
the diagnosis of the main disease correct, but the associated diseases influencing result of treatment are not diagnosed.
The objective reasons of the wrong and (or) untimely diagnostics (the atypical course of the main disease, the asymptomatic course of associated disease, seldom found complications and associated diseases) are reflected in results of examination. The impact assessment of the wrong and (or) untimely diagnosis on the subsequent stages of rendering medical services (help) is carried out;
4) timeliness and quality of consultations of profile specialists which are estimated by the following criteria:
the lack of consultation which resulted in wrong interpretation of the symptoms and syndromes which negatively affected disease outcome;
consultation is timely, rejection in attention of opinion of the consultant in case of diagnosis partially affected disease outcome;
consultation is timely, the opinion of the consultant is considered in case of diagnosis, failure to carry out of the recommendation of the consultant for treatment partially affected disease outcome;
the opinion of the consultant wrong also affected disease outcome.
In cases of carrying out consultations with delay, assessment of objectivity of the reasons of untimely consultation and influence of untimely diagnosis on the subsequent stages of rendering medical services (help) is carried out;
5) amount, quality and justification of holding medical actions which are estimated by the following criteria:
lack of treatment in the presence of indications;
purpose of treatment in the absence of indications;
purpose of ineffective medical actions without features of course of disease, associated diseases and complications;
accomplishment of medical actions not in full, without functional condition of bodies and systems, prescription of medicines without the proved clinical efficiency;
non-compliance with requirements of Standards, unreasonable variation from requirements of clinical protocols, the polipragmaziya availability which led to development of new pathological syndrome and deterioration in condition of the patient;
6) absence or development of complications after medical interventions, are estimated all arisen complications including caused by surgeries (overdue surgery, inadequate amount and method, technical defects) and diagnostic procedures;
7) the achieved result which is estimated by the following criteria:
achievement of the expected clinical effect in case of respect for technology of rendering medical services (help);
lack of clinical effect of medical and preventive actions owing to low-quality collection of the anamnesis and conducting diagnostic testings;
lack of the expected clinical effect owing to holding ineffective medical, preventive actions without features of course of disease, associated diseases, complications, prescription of medicines without the proved clinical efficiency;
the polipragmaziya availability which caused development of undesirable consequences;
8) quality of maintaining medical documentation which is estimated on availability, completeness and quality of entries in primary medical documentation intended for data recording about the state of health of the patients reflecting nature, amount and quality of the provided medical care according to forms of reporting and accounting documentation in the field of health care according to the subitem 31) of article 7 of the Code

considerable

13.

Availability of the informed voluntary consent (refusal) to transfusion of components of blood in form of accounting and reporting documentation in the field of health care

considerable

14.

Observance of the following actions when carrying out pathoanatomical opening:
1) carrying out pathoanatomical opening of corpses after ascertaining by doctors of biological death, after provision of the medical record of the inpatient or the medical record of the outpatient with the written order of the chief physician or his deputy for medical (medical) part of the organization of health care about the direction on pathoanatomical opening;
2) registration of results of pathoanatomical opening in the form of the pathoanatomical diagnosis (the pathoanatomical diagnosis includes: the main disease, complication of the main disease, associated disease, the combined main disease);
3) transfer of the medical record of the inpatient or the medical record of the outpatient with the pathoanatomical diagnosis introduced in it in medical archive of the organization of health care no later than ten working days after pathoanatomical opening;
4) carrying out kliniko-pathoanatomical analysis in cases of death of patients in the organizations of health care;
5) pathoanatomical opening in case of suspicions of sharp infectious, oncological diseases, pathology of children's age, lethal outcome in connection with medical manipulations for the purpose of establishment of cause of death and refining of the diagnosis of disease from the death;
6) the organization by the chief physician and manager of pathoanatomical department of virologic (immunofluorescent) and bacteriological research of materials of opening of corpses in cases of suspicion of infectious diseases;
7) transfer to pathoanatomical bureau, centralized pathoanatomical bureau and pathoanatomical department of medical records of inpatients on all dead for prior days no later than 10 o'clock in the morning of the day following after factual determination of death;
8) registration:
- the health certificate on death (preliminary, final) the doctor in "pathological anatomy (adult, children's)" in day of carrying out pathoanatomical opening;
- the health certificate on perinatal death (preliminary, final) the doctor in "pathological anatomy (adult, children's)" in day of carrying out pathoanatomical opening;
9) registration of results of opening in the form of the protocol of pathoanatomical research;
10) availability of the written notice in judicial investigating bodies for the solution of question of transfer of corpse on forensic medical examination in case of detection of signs of violent death and the termination of carrying out pathoanatomical research of corpse;
11) availability of the notice in writing of the doctor in "pathological anatomy (adult, children's)" in case of primary detection during opening of signs of acute infectious disease, food or production poisoning, unusual reaction to inoculation, and also the emergency notice in bodies of the public sanitary and epidemiologic service, at once after their identification;
12) carrying out pathoanatomical research of placenta:
in case of still birth;
in case of all diseases of the newborns revealed at the time of the birth;
in cases, suspicious on hemolytic disease of newborns;
in case of early otkhozhdeniye of waters and in case of dirty waters;
in case of the diseases of mother proceeding with high temperature in the last trimester of pregnancy;
in case of obvious anomaly of development or attachment of placenta;
13) obligatory registration of fruit weighing less than 500 grams with anthropometrical data (weight, growth, head circle, thorax circle);
14) establishment of pathoanatomical opening depending on complexity on the following categories:
first category;
second category;
third category;
fourth category;
15) establishment by the doctor in "pathological anatomy (adult, children's)" categories of pathoanatomical opening and the reason of discrepancy of diagnoses in case of discrepancy of final clinical and pathoanatomical diagnoses
16) availability of the detailed analysis with determination of profile and categories of yatrogeniya in all cases of yatrogenny pathology, revealed as a result of pathoanatomical opening

rough

15.

Observance of the following requirements under the organization of the obstetric and gynecologic help at the out-patient and polyclinic level:
1) dispensary observation of pregnant women for the purpose of the prevention and early identification of complications of pregnancy, childbirth and the postnatal period with allocation of women "on risk factors";
2) carrying out prenatal screening - comprehensive examination of expectant mothers for the purpose of identification of risk group on chromosomal pathology and congenital malformations of pre-natal fruit;
3) identification of the pregnant women needing timely hospitalization in day hospitals, departments of pathology of pregnancy of the medical organizations of stationary level giving obstetric and gynecologic help, the profile medical organizations with ekstragenitalny pathology with respect for the principles of regionalization of the perinatal help;
4) the direction of pregnant women, women in labor and women in childbirth for receipt of the specialized help with medical observation, including using high-technology medical services in the medical organizations of republican level;
5) carrying out prenatal training of pregnant women in preparation for childbirth, including to partner childbirth, informing pregnant women on disturbing signs, on effective perinatal technologies, the principles of safe motherhood, breastfeeding and perinatal leaving;
6) carrying out patronage of pregnant women and women in childbirth according to indications;
7) consultation and rendering services in questions of planning of family and protection of reproductive health;
8) prevention and detection of infections, sexually transmitted for the direction to profile specialists;
9) inspection of women of fertile age with appointment, in need of profound inspection with use of additional methods and involvement of profile specialists for timely detection of ekstragenitalny, gynecologic pathology and their capture on dispensary accounting;
10) the organization and performing routine inspections of female population for the purpose of early detection of ekstragenitalny diseases;
11) inspection and treatment of gynecologic patients with use of modern medical technologies;
12) medical examinations of gynecologic patients, including rehabilitation and sanatorium treatment;
13) accomplishment of small gynecologic transactions with use of modern medical technologies;
14) conducting examination about temporary disability on pregnancy, childbirth and gynecologic diseases, determination of need and terms of the temporary or permanent transfer of the worker for health reasons for other work, the directions in accordance with the established procedure for medico-social examination of women with signs of permanent disability;
15) twofold inspection during pregnancy on HIV infection with execution of the informed consent of the patient with fixation of data

rough

16.

Rendering by average health workers (obstetricians, paramedics, medical sisters / brothers) of the pre-medical help to women in time and out of pregnancy, including:
1) independent acceptance and medical examination for the purpose of determination of the state of health of the patient, detection of diseases and complications of pregnancy
2) entering of data into subsystem "The register of pregnant women and women of fertile age" of the electronic portal "Registr Prikreplennogo Naseleniya" for the purpose of the automated maintaining groups of pregnant women and women of fertile age (further – ZhFV) and monitoring of indicators of the state of health of pregnant women and ZhFV;
3) rendering emergency and emergency pre-medical medical care to pregnant women, women in childbirth and women of fertile age in case of conditions, life-endangering and to health of the woman, according to clinical protocols of diagnostics and treatment;
4) dynamic observation of pregnant women with chronic diseases together with district doctors and profile specialists;
5) accomplishment of appointments of the doctor the obstetrician-gynecologist according to functional obligations;
6) conducting physiological pregnancy and patronage of pregnant women and women in childbirth with timely provision of the directions and recommendations according to the clinical protocol of diagnostics and treatment;
7) medical attendance at home pregnant women, women in childbirth, gynecologic patients and ZhFV group of social risk;
8) performing routine medical examination of women for the purpose of early detection of pretumoral and cancer diseases of female genitals and other localizations (skin, mammary glands);
9) carrying out medical sisterly examination of women of all age groupes which asked for medical care;
10) participation in performing screening and routine inspections for detection of diseases

rough

17.

Observance of the following requirements under the organization of rendering the obstetric and gynecologic help at the stationary level:
1) rendering the stationary consulting and diagnostic, treatment-and-prophylactic and rehabilitation help to pregnant women, women in labor, women in childbirth and newborns;
2) carrying out joint survey of the attending physician with the manager of department in case of arrival of expectant mothers up to 36 weeks of pregnancy having chronic diseases, needing treatment in specialized departments of multi-profile hospitals for assessment of weight of course of disease, the course of pregnancy and tactics of treatment.
3) scheduling of conducting pregnancy, childbirth and the postnatal period with accounting of individual approach;
4) conducting pregnancy, childbirth and the postnatal period according to clinical protocols of diagnostics and treatment, and also with the plan of maintaining;
5) carrying out consultation of pregnant women, women in labor and women in childbirth, control on observance of level of delivery of health care;
6) holding rehabilitation actions to mothers and newborns, including care of premature newborns;
7) consultations on delivery of health care to pregnant women, women in labor, women in childbirth and newborns with use of telecommunication systems;
8) implementation of examination about temporary disability, issues of leaf and the reference of temporary disability on pregnancy and childbirth, gynecologic patients;
9) rendering the resuscitation help and intensive therapy to mothers and newborns, including with low and extremely low body weight;
10) availability of the minimum list of the equipment for the block of intensive therapy:
bed functional (on number of beds);
mattress antidecubital (1 on 3 beds);
the bedside cardiomonitor (on number of beds);
the electrocardiograph portable (1 on 6 beds);
electropacemaker (1 on 6 beds);
the portable device for ultrasound examination of heart and vessels (1 on 9 beds);
the device for auxiliary blood circulation (intra aortal balloon counterpulsation) (1 on 9 beds);
centralized system of eyeliner of oxygen to each bed (on number of beds);
elektrootsasyvatel surgical with the bacterial filter (1 on 3 beds);
defibrillator bi-phase with synchronization function (1 on 3 beds);
the device for artificial ventilyation of lungs (1 on 6 beds);
the portable respiratory device for transportation (1 on BIT);
set for trachea intubation (2 on BIT);
set for kateterization of the main vessels (100 sets);
the automatic batcher of medicinal substances spray (2 on 1 bed);
infuzomat (1 on 1 bed);
tonometer bedside for measurement of arterial pressure (on number of beds);
mobile (portable) set for holding resuscitation actions in other departments (1 on BIT);
portable X-ray the device (1 on BIT);
the glucose meter (1 on BIT);
tool kit and devices for small surgical interventions (1 on BIT)
the block of electric sockets (at least 8 sockets) with grounding at each bed, including for power supply of power-intensive devices (x-ray devices) (on number of beds).
11) medico-psychological assistance implementation to women;
12) the notification of the medical organizations of higher level of regionalization of the perinatal help and local authorities of public administration by health care in case of identification during receipt or stay in hospital at the pregnant woman, the woman in labor, the woman in childbirth of critical condition;
13) observance of the scheme of the notification in case of critical situations at women;
14) transportation of pregnant women, women in childbirth, women in labor in critical condition on the third level of the perinatal help, in the regional and republican organizations of health care is performed according to the solution of consultation of doctors with participation of specialists of medical crew of medical aircraft after recovery of haemo dynamics and stabilization of the vital functions with the notification of the accepting medical organization;
15) in case of nontransportable condition of pregnant women, women in labor, women in childbirth implementation of challenge of qualified specialists "on", rendering complex of primary resuscitation help in case of medical emergencies, diagnostics of the menacing conditions at mother and fruit, the solution of question of rodorazresheniye, performing the intensive and supporting therapy before transfer to higher level

rough

Delivery of health care by the newborn

18.

Observance of the following requirements under the organization of delivery of health care by the newborn at the stationary level:
1) delivery of health care by the newborn on levels of regionalization of the perinatal help depending on indications;
2) structure of the organizations of hospitals of the first level of regionalization of the perinatal help: individual maternity chambers, department for joint stay of mother and the child, inoculative office, chambers of intensive therapy for newborns and also provided by the staff list rate of the doctor in "Pediatrics (neonatology)" and the round-the-clock post of the neonatal nurse;
3) in hospitals of the second level the organization of chambers of resuscitation and intensive therapy of newborns with full range for resuscitation, medical ventilators with various modes of ventilation (permanent positive pressure in airways), couveuses, kliniko-diagnostic laboratory, and also provided by the staff list the round-the-clock post (the doctor neonatolog and the children's nurse);
4) in hospitals of the third level of regionalization of the perinatal help:
have the round-the-clock neonatal post, clinical, biochemical and bacteriological laboratories, intensive care unit and intensive therapy for women and newborns, and also department of pathology of newborns and nursing premature joint stay with mother.
intensive care units of newborns, departments of pathology of newborns and nursing premature, equipped with the modern medical and diagnostic equipment, medicines, the round-the-clock post (medical and sisterly), express laboratory will be organized.
5) in hospitals of the first level to the sick newborn the following events are performed:
primary resuscitation help;
the intensive and supporting therapy;
oxygenotherapy;
invasive or noninvasive respiratory therapy;
phototherapy;
medical hypothermia;
infusional therapy and/or parenteral food;
treatment, according to the approved clinical protocols of diagnostics and treatment.
In hospitals of the second level to the sick newborn the following events are performed:
primary resuscitation help of the newborn and stabilization of condition, nursing of premature children with gestation term more than 34 weeks;
kateterization of the central veins and peripheral vessels;
identification and treatment of congenital defects, delays of pre-natal development, hypoglycemia of newborns, giperbilirubinemiya, neonatal sepsis, damage of the central nervous system, respiratory distress syndrome, pheumothorax, necrotic enterokolit and other pathological conditions of the neonatal period;
performing intensive therapy, the including correction of the vital functions (respiratory, cardiovascular, metabolic violations), invasive and noninvasive respiratory therapy, infusional therapy and parenteral food;
in need of rendering the highly specialized help degree of readiness for transportation with mother in the organization of obstetric aid of the third level or organization of republican value is determined

rough

19.

Delivery of health care by the newborn in the medical organizations of the third level includes:
1) primary resuscitation of newborns and care of newborns;
2) performing the intensive and supporting therapy: respiratory therapy, kateterization of the central veins and peripheral vessels, therapeutic hypothermia, parenteral food, nursing of premature children;
3) diagnostics and treatment of congenital defects, delays of pre-natal development of fruit (small weight to gestation term), hypoglycemia of newborns, neonatal sepsis, respiratory distress syndrome, giperbilirubinemiya, necrotic enterokolit, pheumothorax, bronchopulmonary dysplasia, persistiruyushchy pulmonary hypertensia of newborn, perinatal damages of the central nervous system and other pathological conditions of the neonatal period;
4) performing the intensive and supporting therapy, therapeutic hypothermia, parenteral food;
5) performing invasive and not invasive respiratory therapy;
6) nursing of premature children;
7) rendering the round-the-clock advisory and medical and diagnostic help to specialists of the first and second level of regionalization, rendering emergency and emergency medical service with departure in the medical organization

rough

20.

Providing to the healthy newborn of basic care, including prevention of hypothermia with observance of "thermal chain", skin contact with mother or contact "skin - to - skin", early start of breastfeeding within the first hour (in the presence of signs of readiness of the baby), prevention of intrahospital infections

rough

21.

Anthropometry of the healthy newborn, its complete survey and other actions in 2 hours after the delivery

considerable

22.

Rendering emergency medical service in case of identification of violations of condition of the newborn, according to indications transfer to chamber of intensive therapy or intensive care unit of newborns

rough

23.

In maternity chamber observation of mother and the healthy newborn obstetrician within two hours after the birth:
1) takes body temperature at the newborn in 15 minutes after the birth, then – each 30 minutes;
Watches 2) the frequency of heartbeat and breath, nature of breath (identification of expiratory groan, assessment of extent of retraction of the lower departments of thorax), coloring of integuments, activity of sosatelny reflex, if necessary determines saturation pulsoksimetry

considerable

24.

The translation in 2 hours after the birth of the healthy newborn with mother in department of joint stay of mother and child

considerable

25.

In postnatal department in chambers of joint stay of mother and child the round-the-clock observation of medical personnel and permanent participation of mother in implementation of child care, except as specified conditions of mother of average and heavy severity is provided

considerable

26.

Dynamic observation of the newborn with timely identification of violations of condition of the newborn, necessary inspection, survey of the manager of department, the organization of consultation for refining of tactics of maintaining. According to indications emergency medical service is provided, transfer in chamber of intensive therapy or intensive care unit of newborns is made

rough

27.

In chambers of joint stay of mother and child health workers:
1) are advised about breastfeeding benefits, about the equipment and frequency rate of decantation of breast milk by manual method, carry out visual assessment of breastfeeding for provision of the practical help in the correct arrangement and applying of the child to mother's breast in order to avoid such conditions as cracks of nipples or laktostaz;
2) in the presence of contraindications to breastfeeding train mother (the parent or the legal representative) in alternative methods of feeding of children; advise women in childbirth how to support lactation in cases of separate stay of newborns

considerable

28.

Daily survey of newborns by the doctor-neonatologom, consultation of mothers concerning leaving, prevention of hypothermia and vaccination

considerable

29.

With three and more microanomalies of development or detection of congenital pathology of newborns the organization of consultation by profile specialists, with holding medical and diagnostic actions and provision of mother of recommendations about inspection, treatment and rehabilitation

rough

30.

In case of medical emergencies at the newborn (asphyxia, respiratory distress syndrome and others) stabilization of its condition and determination of degree of readiness for transportation with mother in the organization of obstetric aid of the second or third levels

rough

31.

Vaccination of newborns is performed based on the voluntary informed consent of parents (mother, the father or legal representatives) on carrying out preventive inoculations according to terms of carrying out preventive inoculations in the Republic of Kazakhstan.

rough

32.

Carrying out by all newborn before the statement of neonatal screening for the purpose of identification of fenilketonuriya, congenital hypothyroidism and audiological screening

rough

33.

In case of medical emergencies at the newborn the doctor neonatolog carries out assessment of weight of condition, stabilization, estimates degree of readiness for transportation, and will organize its translation with mother (in coordination with the obstetrician-gynecologist) in the medical organization of the second or third level

rough

34.

In case of suspicion and (or) identification at the newborn of sharp surgical pathology, in the emergency procedure consultation of the doctor in "Children's surgery (neonatal surgery)" is held. After stabilization of indicators of vital functions the newborn is transferred to surgical department of other medical organization (children's or multi-profile hospital) or in neonatal (or children's) surgical department in case of its availability in structure of the medical organization of obstetric aid for rendering the appropriate specialized medical care to it

rough

35.

The full-term newborns after achievement of age of 28 days or premature newborns, after achievement of post-conceptual age 42 weeks needing further round-the-clock medical observation are transferred to hospital of pediatric profile

rough

36.

Availability of the medical equipment and products of medical appointment for delivery of health care by the newborn according to the standard of the organization of the pediatric help depending on the level of regionalization of the perinatal help

rough

37.

Availability of the medical equipment and products of medical appointment for equipment of the car of resuscitation crew for transportation of newborns:
1. equipment:
1) couveuse (figurative or transportable);
2) "oven" for heating of interior of the car;
3) the thermoisolating film for the child;
4) linen for the child (blanket, diapers, clothes);
5) the ECG monitor and arterial pressure with set of cuffs and sensors,
6) pulsoksimetr with disposable cuffs;
7) hours with second hand;
8) thermometer electronic;
8) phonendoscope.
2. Equipment for respiratory support:
1) oxygen cylinder;
2) the air compressor for carrying out artificial ventilation of lungs and use of vacuum means;
3) the dosimeter oxygen for cylinders;
4) the medical ventilator portable with system of moistening and heating of respiratory mix;
5) oxygen mixer;
6) Ambu's sack, amount no more than 700 cubic centimeters;
7) set of masks of the different sizes for artificial ventilation of lungs;
8) oral air ducts;
9) system of respiratory support N CPAP.
3. The equipment and products of medical appointment for intubation of trachea and sanitation of airways:
1) the laryngoscope with direct blades No. 0 and No. 1;
2) intubatsionny tubes (D-diameter of 2,5; 3,0; 3,5; 4,0);
3) electric or vacuum suction, pear disposable and set of catheters for aspiration (No. 5, 6, 8, 10, 12, 14);
4) the nazogastralny probe – diameter the 6th millimeter.
4. The equipment and products of medical appointment for introduction of medicines:
1) infuzomat, the shpritsevy pump (2-3 pieces on accumulators);
2) sets for kateterization of peripheral veins;
3) systems for performing infusion;
4) syringes of various amounts;
5) tees;
6) needles butterflies;
7) surgical tweezers, scalpel, scissors;
8) sterile gloves

rough

38.

Availability of obligatory pathoanatomical research of fruit and placenta in case of termination of pregnancy on medical indications in case of suspicion on availability of congenital anomalies of development in fruit

rough

39.

Availability of kliniko-pathoanatomical analysis of all cases of maternal and infantile death after completion of all complex of pathoanatomical researches

rough

2. Criteria on information source "Results of monitoring of the data received from the automated information systems"

1

Availability of maternal death rate

rough

2

Growth of infantile death rate in comparison with previous period of assessment for 5% and more

rough

3

Availability of cases of postoperative complications

considerable

4

Availability of cases of growth of indicator of patrimonial injuries of newborns in comparison with previous period of assessment

considerable

3. Criteria on information source "The number of the confirmed claims and addresses"

1

Availability of one and more confirmed claims and addresses in subjects (objects) of health care rendering services of obstetric aid

rough

 

Appendix 2

to Criteria for evaluation of risk degree in the sphere of quality of rendering medical services (help)

Subjective criteria for carrying out preventive control with visit of the subject of control with distribution on degree of the importance of violations and sources of information

No. p\p

Name of criteria

Extent of violations

1. Criteria on information source "Results of the previous checks and preventive control with visit of subjects (objects) of control" (severity is established in case of non-compliance with following requirements)

Criteria for subjects (objects) giving stationary, hospital-replacing help *

1.

Availability of the license and appendices to it on the performed types of activity

rough

2.

Availability of the certificate of the specialist in the corresponding clinical specialty

rough

3.

Availability of the conclusion about compliance of the subject of health care to provision of high-technology medical services

rough

4.

Availability of written voluntary consent of the patient or his legal representative in case of invasive interventions and on holding medical and diagnostic actions

considerable

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