ORDER OF THE MINISTER OF HEALTH OF THE REPUBLIC OF KAZAKHSTAN

of November 12, 2009 No. 693

About establishment of Rules of issue of the conclusion on biological safety of the imported (exported) fabrics and (or) bodies (part of bodies), blood and its components

For the purpose of implementation of the Code of the Republic of Kazakhstan of September 18, 2009 "About health of the people and health care system", PRIKAZYVAYU:

1. Approve the enclosed Rules of issue of the conclusion on biological safety of the imported (exported) fabrics and (or) bodies (part of bodies), blood and its components".

2. To committee of the state sanitary and epidemiological surveillance (Ospanov K. S.) provide state registration of this order in the Ministry of Justice of the Republic of Kazakhstan.

3. To department of administrative and legal work (to Bismildin F. B.) after state registration in the Ministry of Justice of the Republic of Kazakhstan to provide official publication of this order in mass media.

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

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

Approved by the order of the Minister of Health of the Republic of Kazakhstan of November 12, 2009 No. 693

Rules of issue of the conclusion on biological safety of the imported (exported) fabrics and (or) bodies (part of bodies), blood and its components

1. General provisions

1. These rules are developed for the purpose of implementation of the Code of the Republic of Kazakhstan "About health of the people and health care system" and establish procedure for issue of the conclusion about biological safety of the imported (exported) fabrics and (or) bodies (part of bodies), blood and its components (further - the Conclusion).

2. Local authorities of public administration by health care create the Commission on questions of issue of the conclusion about biological safety of the imported (exported) fabrics and (or) bodies (part of bodies), blood and its components (further - the Commission).

3. The conclusion of the Commission is issued in form according to appendix to these rules.

4. The Commissions are included: the chief therapist, the chief surgeon, the chief infectiologist, specialists of state bodies of sanitary and epidemiologic service, the centers of blood, the centers for prevention and fight about AIDS, the organizations which are engaged in medical activities for organ and tissue transplantation.

2. Operating procedure of the Commission

5. The commission considers:

1) availability of the license for medical activities for transplantology and medical activities for procurement, conservation, conversion, storage and realization of blood and its components, preservation of donor fabrics, bodies (part of bodies), blood and its components (further - the license for activities);

2) documentation on inspection of the donor on haemo inoculable infections (human immunodeficiency virus, syphilis, hepatitises B and C, according to indications - on cytomegaloviruses), donors of oocytes and sperm in addition on infection sexually transmitted (gonorrhea, clamidiosis, genital herpes, ureaplasmosis, mycoplasmosis) method of polymerase chain reaction and/or the immunofermental analysis;

3) data of researches of donors on all infections based on the state medical organizations;

4) availability of acts, magazines, documents on withdrawal, preservation of donor materials;

5) result of immunological research of the donor;

6) data of the anamnesis of the donor on absence of diseases;

7) availability of the approved algorithm of inspection and participation of the laboratories performing material researches from donors in quality external control system.

6. Specialists of state bodies of sanitary and epidemiological surveillance when exporting fabrics and (or) bodies (part of bodies), blood and its components consider documentation:

1) on compliance of the medical organization to the sanitary and epidemiologic requirements imposed on the organizations of health care performing activities for withdrawal, preservation and storage of donor fabrics, bodies, blood and its components;

2) on serviceability of the equipment for withdrawal, preservation, storage and transportations of the exported fabrics and (or) bodies (part of bodies), blood and its components and to availability of the state checking;

3) on carrying out microbiological control of the equipment, stock, air, temperature condition and humidity in case of procurement, preservation and storages of fabrics and (or) bodies (part of bodies), blood and its components;

4) on carrying out disinfection and sterilization of the equipment;

5) on availability of individual remedies (gloves, dressing gowns and other protective clothes, masks, goggles or screens for person);

6) on availability of medical examination of the specialists participating in withdrawal of donor material, preservation of fabrics and (or) bodies (part of bodies), cages on the following infections: HIV infection, hepatitises B and C, syphilis and vaccination against hepatitis B;

7) on availability of special containers for safe transportation of donor materials with availability of the corresponding marking;

8) under the terms and to storage durations of tinned donor fabrics and (or) bodies (part of bodies), blood and its components;

9) on separateness of storage of transplants, held for use, not surveyed and subject to utilization;

10) on frequency of carrying out microbiological control of solutions for preservation.

7. The commission considers all submitted documentation for issue of the Conclusion only in the original.

8. The positive Conclusion of the Commission is taken out in case of:

1) availability of the license for activities;

2) negative results of inspection of the donor on haemo inoculable infections (human immunodeficiency virus, syphilis, hepatitises B and C, according to indications - on cytomegaloviruses), donors of oocytes and sperm in addition on infection sexually transmitted (gonorrhea, clamidiosis, genital herpes, ureaplasmosis, mycoplasmosis) method of polymerase chain reaction and/or the immunofermental analysis and carrying out the specified inspections based on the state medical organizations;

3) availability of acts, magazines, documents on withdrawal, preservation of donor materials;

4) positive result of immunological research of the donor;

5) absence at the donor in the anamnesis of diseases;

6) availability of the approved algorithm of inspection and participation of the laboratories performing material researches from donors in quality external control system;

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