ORDER OF THE MINISTER OF HEALTH AND SOCIAL DEVELOPMENT OF THE REPUBLIC OF KAZAKHSTAN

of June 29, 2015 No. 533

About modification of the order of the Minister of health and social development of the Republic of Kazakhstan of March 10, 2015 No. 127 "About approval of Rules of accreditation of health care"

According to the subitem 76) of Item 1 of article 7 of the Code of the Republic of Kazakhstan of September 18, 2009 "About health of the people and health care system", I ORDER:

1. Bring in the order of the Minister of health and social development of the Republic of Kazakhstan of March 10, 2015 No. 127 "About approval of Rules of accreditation of health care" (registered in the Register of state registration of regulatory legal acts for No. 10735, published in information system of law of regulatory legal acts of the Republic of Kazakhstan of Ad_let on April 24, 2015) the following change:

The rules of accreditation of health care approved by the specified order to state in edition according to appendix to this order.

2. To provide to committee of control of medical and pharmaceutical activities of the Ministry of health and social development of the Republic of Kazakhstan:

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

2) within ten calendar days after state registration of this order in the Ministry of Justice of the Republic of Kazakhstan the direction on official publication in periodic printing editions and information system of law of regulatory legal acts of the Republic of Kazakhstan of Ad_let;

3) placement of this order on Internet resource of the Ministry of health and social development of the Republic of Kazakhstan;

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

3. To impose control of this order on the vice-Minister of health and social development of the Republic of Kazakhstan Tsoi A. V.

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

Appendix

to the Order of the Minister of health and social development of the Republic of Kazakhstan of June 29, 2015 No. 533

Approved by the Order of the Minister of health and social development of the Republic of Kazakhstan of March 10, 2015 No. 127

Rules of accreditation of health care

1. General provisions

1. These rules of accreditation in the field of health care (further - Rules) are developed according to the Code of the Republic of Kazakhstan of September 18, 2009 "About health of the people and health care system" (further - the Code) and establish procedure for carrying out accreditation in the field of health care.

2. In these rules the following basic concepts are used:

1) accrediting body - Committee of control of medical and pharmaceutical activities of the Ministry of health and social development of the Republic of Kazakhstan (further - Committee) and its territorial departments (further - Departments) or the organization accredited by the Ministry of health and social development of the Republic of Kazakhstan;

2) accreditation standard rank - standard level depending on the importance of its influence on safety of patients;

3) the certificate on accreditation - the official document confirming accreditation of the applicant in certain area of accreditation;

4) prolongation of effective period of the certificate on accreditation - the official procedure of prolongation of effective period of the certificate on accreditation by accrediting body;

5) the commission on accreditation - the commission created by accrediting body which considers the applicant's materials carries out assessment on compliance of their activities to requirements of these rules and makes decisions of advisory nature;

6) accreditation on the right of carrying out preclinical (not clinical) researches of biologically active agents, products of medical appointment - the procedure of official recognition by accrediting body of competence of the applicant to perform works in the field of carrying out preclinical (not clinical) researches of biologically active agents, products of medical appointment of evaluating test laboratories as way (research laboratory) to compliance of their activities to requirements of these rules;

7) the applicant on accreditation on the right of carrying out preclinical (not clinical) researches of biologically active agents, products of medical appointment - the test laboratory (research laboratory) which is performing preclinical (not clinical) researches and submitted the application for accreditation;

8) subjects of health care - the organization of health care, and also the physical persons practising private medicine and pharmaceutical activities;

9) the organization for assessment of professional readiness and confirmation of conformity of qualification of specialists in the field of health care - the organization of health care the performing activities for assessment of professional readiness and confirmation of conformity of qualification of specialists in the field of health care (further - the organization for assessment);

10) the register of clinical bases - single system of accounting of the medical organizations accredited on performing clinical trials pharmacological and medicines, products of medical appointment and medical equipment is right;

11) clinical base - the medical organization regardless of its form of business, brought in the list of the organizations for performing clinical trials pharmacological and medicines, products of medical appointment and medical equipment;

12) clinical trial - the research with participation of the person as the subject conducted for identification or confirmation of safety and efficiency of means, methods and technologies of prevention, diagnostics and treatment of diseases;

13) the register of preclinical (not clinical) bases - single system of accounting of the test laboratories accredited on the right carrying out preclinical (not clinical) researches of biologically active agents pharmacological, medicines, products of medical appointment and medical equipment;

14) multicenter clinical trial - clinical trial which is performed in several clinical bases (more than one researcher) under the single protocol;

15) repeated accreditation - another procedure of official recognition by accrediting body of competence of the applicant to perform works in certain area of researches;

16) the medical organization - the organization of health care which main activities is delivery of health care;

17) accreditation of the medical organizations on the right of performing clinical trials pharmacological and medicines, products of medical appointment and medical equipment - the procedure of official recognition by accrediting body of competence of the applicant to perform works in the field of performing clinical trials pharmacological and medicines, products of medical appointment and medical equipment by evaluating the medical organizations on compliance of their activities to requirements of these rules;

18) self-assessment - the assessment procedure of activities of the medical organization on compliance to accreditation standards conducted by the medical organization independently or with involvement of independent experts;

19) expert group - the group of persons attracted to carrying out external complex assessment of the medical organizations on compliance to accreditation standards;

20) the coordinator of quality - the specialist of service of internal audit and support of the patient of the medical organization;

21) external complex assessment - the assessment procedure of activities of the medical organization on compliance to accreditation standards which is carried out by expert group with exit in the medical organization;

22) test laboratory (research laboratory) - the legal entity or structural division of the legal entity is not dependent on organizationally legal form and departmental accessory;

23) area of accreditation of test laboratory - the field of activity of test laboratory determined in case of its accreditation, establishing set of works on testing which the laboratory is competent to carry out;

24) the independent expert - the physical person accredited in accordance with the established procedure for conducting independent examination of activities of subjects of health care;

25) inspection of the medical organization for the location - official check of documentation, the equipment, other materials concerning clinical trial and which are on clinical base in rooms of the sponsor and/or the contractual research organization, and also other organizations concerning clinical trial for the purpose of assessment on compliance of their activities to requirements of these rules;

26) the applicant on accreditation of the medical organizations on the right of performing clinical trials pharmacological and medicines, products of medical appointment and medical equipment - the medical organization which is applying for accreditation on the right of performing clinical trials pharmacological and medicines, products of medical appointment and medical equipment and submitted the application for accreditation to accrediting body;

27) the international multicenter clinical trial - the multicenter clinical trial conducted under the single protocol in two or more countries.

3. Accreditations in the field of health care are subject:

1) the medical organizations for the purpose of recognition of compliance of their activities to the accreditation standards for subjects of health care approved by the order of the Minister of Health of the Republic of Kazakhstan of October 2, 2012 No. 676 (it is registered in the Register of state registration of regulatory legal acts for No. 8064) and to accreditation standards for the organizations of health care performing activities in the field of service of blood, the approved order of the deputy. The Minister of Health of the Republic of Kazakhstan of January 6, 2014 No. 2 (it is registered with the Register of state registration of regulatory legal acts for No. 9148) (further - standards);

2) the medical organizations on the right of performing clinical trials pharmacological and medicines, products of medical appointment and medical equipment;

3) physical persons - for carrying out independent expert evaluation of activities of subjects of health care;

4) the organization performing assessment of professional readiness and confirmation of conformity of qualification of specialists in the field of health care - for evaluating professional readiness and confirmation of conformity of qualification of specialists in the field of health care;

5) test laboratories (research laboratories) for carrying out preclinical (not clinical) researches of biologically active agents, products of medical appointment.

4. Accreditation has voluntary nature and is performed at the expense of means of the accredited subject and other not prohibited means.

5. The body (organization) performing (performing) accreditation in the field of health care creates the commission on accreditation of subjects of health care and the commission on accreditation of physical persons, and also creates databank of accredited subjects of health care and independent experts in the field of health care.

6. The regulations on the commissions affirm according to the requirement of Item 6 of article 14 of the Code.

2. Procedure for carrying out accreditation of the medical organizations for the purpose of recognition of compliance of their activities to accreditation standards

7. To filing of application to accrediting body the medical organization carries out self-assessment on compliance to accreditation standards in the automated "Quality Management System of Medical Services" database (further - SUKMU) independently or with involvement of independent experts.

8. For accreditation passing the medical organizations represent to the relevant Department in the place of the arrangement the statement in form according to appendix 1 to these rules.

9. The department within two working days from the date of receipt of the statement, considers it regarding completeness and reliability of filling. In case of factual determination of incomplete and doubtful filling of the statement in the specified terms the Department gives written motivated refusal in accreditation.

10. External complex assessment on compliance of the medical organizations to accreditation standards (further - Assessment) consists of the following stages:

1) desk research (studying of documents on the basis of results of self-assessment and other submitted documents on the medical organization);

2) expert evaluation of compliance to accreditation standards by filling of estimative sheets on the basis of mark system taking into account accreditation standard rank;

3) entering of results of external complex assessment into the "Quality Management System of Medical Services" database.

11. For evaluating the accrediting body creates expert groups and among experts determines the head of group. Specialists of accrediting body, independent experts in the field of health care and the profile specialists of the organizations of health care who were trained concerning accreditation in the field of health care are part of expert group.

12. By results of consideration of the application the Department notifies the medical organization on date of Assessment.

13. The expert evaluation of compliance of the medical organization to accreditation standards is performed according to the schedule approved by accrediting body.

14. Before expert evaluation the Department issues to members of expert group login and the password for entrance to information system. Information on login and the password for entrance to information system is confidential, is not subject to disclosure and transfer. In case of detection of the facts of transfer of confidential information the expert is immediately discharged of the further procedure of accreditation, and the results entered by it into information system are cancelled.

15. Before departure in the medical organization members of expert group constitute the actions plan on inspection of the medical organization, in form according to appendix 2 to these rules.

The expert group at carrying out expert evaluation of the organization of health care on compliance to accreditation standards fills in estimative sheets for evaluating compliance to accreditation standards separately according to each Section in form according to appendix 3 to these rules.

16. Results of expert evaluation are brought in the automated SUKMU database. Transfer of data on health care organization activity, about the patients and personnel received during external complex assessment (including, transfer of the right of information input according to the Section (block) of standards in the automated SUKMU database) to other person is not allowed.

17. After information input members of expert group transfer to the SUKMU database, the completed estimative sheets on Sections (blocks) of standards to the head of group.

18. Upon termination of the specified procedures the report for work of expert group is transferred by the head of expert group to Department.

19. Questioning of patients and personnel is carried out, in form according to appendix 4 to these rules. Selection of respondents happens by random sampling. The number of respondents from among medical personnel shall be at least 5% of salaried employees of the organization of health care and at least 5% from among the persons which are on hospitalization or who asked for medical care at the time of questioning.

In questionnaires for poll of respondents number of the corresponding criterion of the accreditation standard and date of questioning is specified.

The number of respondents for interviewing in case of assessment of the corresponding criteria of the standard is determined in each case individually, but at least 3 people.

When carrying out interviewing questions proceeding from content of criterion of the standard, stated in form, clear for the respondent, and excluding double interpretation are set.

20. Assessment of conformity to accreditation standards is carried out on the basis of ball system:

5 points - full compliance to requirements of the standard;

3 points - partial compliance to requirements of the standard;

0 points - not compliance to requirements of the standard;

"is not applicable";

21. For desk research to expert group the following documents staticized on current period are submitted:

1) articles of organization (copy);

2) results of self-assessment of the medical organization with appendices;

3) strategic plan (copy);

4) business plan;

5) comprehensive plan of work of the organization;

6) the plan for year and the report on quality excellence for the last 3 years;

7) the report on monitoring of indicators of activities of the medical organization for the last 3 years;

8) plan and report on risk management.

On the basis of studying of the provided documents the expert group determines missing information which needs to be collected in case of bypass of the medical organization for achievement of final assessment.

22. For the organization of health care which is performing the stationary help and having polyclinic department, department of fast/air service in structure, assessment of clinical activities of this structural division is performed according to accreditation standards for the organizations of health care giving stationary help and the polyclinic service according to standards of the out-patient and polyclinic help (blocks D) and according to standards of the organizations of health care providing emergency medical service (Section D, E) is in addition estimated.

23. For the organization of health care which is performing the consulting and diagnostic help and having department of day hospital in structure, assessment of clinical activities of this structural division is performed according to accreditation standards for the organizations of health care giving out-patient and polyclinic help.

24. Assessment of the diagnostic centers is performed according to accreditation standards for the organizations of health care giving out-patient and polyclinic help.

25. Assessment of the structural divisions of the medical organization located at other address is carried out by selection method at least 20%.

26. Upon termination of assessment information is entered into information system separately on each structural division of the organization of health care, including separately by the structural divisions located at other address of the organization, including branches.

27. In case of inapplicability of separate criterion of the standard for assessment of activities of the medical organization owing to its specifics in the corresponding column the mark "the criterion of the standard is not applicable for this organization" is fixed. In case of calculation of average assessment according to the standard this criterion is not considered.

28. Results of estimates on each standard are approved by all members of the group of experts.

29. The actual amount of points by each criterion of the standard is calculated according to the table of ranks of accreditation standards the automated SUKMU system for form, according to appendix 5 to these rules:

The "I" rank" with weight coefficient - "1,0";

The "II" rank with weight coefficient - "0,9";

"III" rank with weight coefficient - "0,8".

30. On completion of expert evaluation the final meeting with participation of personnel of the medical organization on which experts provide the summary information of the main results of expert evaluation on each of Sections (blocks) of standards is held.

31. By results of the carried-out Assessment in the medical organization the actions plan on elimination of discrepancies to requirements of the accreditation standards revealed in case of external complex assessment in form according to appendix 6 to these rules is constituted.

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