ORDER OF THE MINISTER OF HEALTH OF THE REPUBLIC OF KAZAKHSTAN

of November 25, 2009 No. 780

About approval of Rules of research on biological safety, conservations and transportations of fabrics and (or) bodies (part of bodies), blood and its components intended for import and export

According to the Code of the Republic of Kazakhstan "About health of the people and health care system" of September 18, 2009 PRIKAZYVAYU:

1. Approve the enclosed Rules of research on biological safety, conservations and transportations of fabrics and (or) bodies (part of bodies), blood and its components intended for import and export.

2. To department of the organization of medical care of the Ministry of Health of the Republic of Kazakhstan (Aydarkhanov A. T.) provide state registration of this order in the Ministry of Justice of the Republic of Kazakhstan.

3. To department of administrative and legal work of the Ministry of Health of the Republic of Kazakhstan (Bismildin F. B.) provide official publication of this order according to the procedure, established by the legislation after its state registration in the Ministry of Justice of the Republic of Kazakhstan.

4. To impose control of execution of this order on the vice-minister Voshchenkova T. A.

5. This order becomes effective after ten calendar days from the date of its first official publication.

Approved by the Order of the Minister of Health of the Republic of Kazakhstan of November 25, 2009 No. 780

Rules of research on biological safety, conservations and transportations of fabrics and (or) bodies (part of bodies), blood and its components intended for the import and export intended for import and export

1. General provisions

1. Rules of research on biological safety, conservations and transportations of fabrics and (or) bodies (part of bodies), blood and its components intended for import and export (further - Rules) establish procedure for research on biological safety, conservations and transportation of fabrics and bodies (part of bodies), blood and its components intended for import and export.

2. Research on biological safety, conservation and transportation of donor fabrics and (or) bodies (part of bodies), blood and its components intended for import and export are performed according to Rules and other regulatory legal acts of the Republic of Kazakhstan of health care.

3. Action of Rules does not extend to medicines and transfer materials for which preparation fabrics and their components are used.

2. Procedure for research on biological safety of fabrics and (or) bodies (part of bodies), blood and its components intended for import and export

4. The research on biological safety of fabrics and (or) bodies (part of bodies), blood and its components includes obligatory determination in blood of the donor of infections on human immunodeficiency virus (further - HIV), syphilis, viral hepatitis B, viral hepatitis C, according to indications - on other types of infections and is carried out in the organizations of health care performing activities in the sphere of service of blood and performing activities in the sphere of prevention HIV/AIDS (further - the organizations of health care).

5. For determination in blood of the donor HIV, syphilis, viral hepatitis B, viral hepatitis C - infections with research purpose on biological safety of fabrics and (or) bodies (part of bodies) are used:

express diagnostics method using rapid tests;

method of polymerase chain reaction (further - PTsR);

method of the immunofermental analysis (further - IFA).

6. Blood test of the donor on HIV, hepatitises B and C, syphilis infection is carried out with use of rapid tests before withdrawal of fabrics and (or) bodies (part of bodies). In order to avoid false-negative results carrying out transfusions of blood and (or) its components to the donor before implementation of express diagnostics is not allowed.

7. For confirmation of results of express diagnostics in the organizations of health care blood test of the donor by the IFA and (or) PTsR method on HIV, syphilis, hepatitis B, hepatitis C, according to indications - on other types of infections is conducted.

8. The blood of donors used for inspection on HIV, syphilis, viral hepatitis B, viral hepatitis C - infections rapid tests shall be registered in the Republic of Kazakhstan.

9. All samples of blood researched on HIV, syphilis, the viral hepatitises B and C are archived and stored in the laboratories which are carrying out researches in the conditions of deep freezing (at temperature from minus 200C to minus 700C) within 12 months from the date of accomplishment of analyses.

Agglyutinatsionny and pretsipitatsionny rapid tests do not remain, their results are registered in the magazine and are confirmed by the signatures of the doctor and laboratory assistant conducting research. Stripovy rapid tests before test number and specify surname and initials of the donor. After conducting testing strips dry, cover with transparent film and store at temperature of the household refrigerator (from plus 40C to plus 80C) in the medical organization conducting researches within 12 months.

10. About positive results of blood tests of the donor on HIV, the hepatitises B and C, syphilis information is saved in the organizations of health care.

11. Safety of blood and its components is provided by implementation of technology of ensuring virus and immunological safety, and also technology of long-term storage.

3. Procedure for conservation of fabrics and (or) bodies (part of the bodies) intended for import and export

12. Conservation of fabrics and (or) bodies (part of bodies) is performed by the doctors who underwent specialization in profile and made in the state organizations of health care or in the organizations of health care with the state participation.

13. Conservation of fabrics and (or) bodies (part of bodies) is carried out directly after their withdrawal and with observance of all sanitary and epidemiologic requirements.

14. For conservation of fabrics and (or) bodies (part of bodies) the following methods are used:

1) hypothermal method at temperature (plus 4-50C);

2) low-temperature method at temperature (from 0 to minus 1960C);

3) hypothermal method in the damp camera;

4) storage in the special preserving solutions and environments;

5) storage in cultural circles.

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