ORDER OF THE MINISTER OF HEALTH OF THE REPUBLIC OF KAZAKHSTAN

of April 15, 2019 No. KR DSM-34

About approval of Requirements to medical examination of donors, to safety and quality in case of production of products of blood for medical application

According to Item 1 article 164 of the Code of the Republic of Kazakhstan of September 18, 2009 "About health of the people and health care system" PRIKAZYVAYU:

1. Approve Requirements to medical examination of donors, safety and quality in case of production of products of blood for medical application according to appendix 1 to this order.

2. Recognize invalid some orders of the Ministry of Health of the Republic of Kazakhstan according to appendix 2 to this order.

3. To provide to department of the organization of medical care of the Ministry of Health of the Republic of Kazakhstan in the procedure established by the legislation 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 from the date of state registration of this order in the Ministry of Justice of the Republic of Kazakhstan the direction it the copy in paper and electronic type in the Kazakh and Russian languages in the company Republican state 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 order on Internet resource of the Ministry of Health of the Republic of Kazakhstan;

4) within ten calendar 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 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 order on the vice-Minister of Health of the Republic of Kazakhstan Aktayeva L. M.

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

Appendix 1

to the Order of the Minister of Health of the Republic of Kazakhstan of April 15, 2019 No. KR DSM-34

Requirements to medical examination of blood donors and its components and safety and to quality in case of production of products of blood for medical application

Chapter 1. General provisions

1. These Requirements to medical examination of blood donors and its components and safety and quality in case of production of products of blood (further - Requirements) are developed for medical application according to Item 1 of article 164 of 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 requirements to medical examination of blood donors and its components and safety and quality in case of production of products of blood for medical application.

Chapter 2. Requirements to medical examination of blood donors and its components

2. Branch or the admission to donation of the potential donor, determination of type and amount of donation is performed by the doctor of the organization of service of blood (further - the doctor).

The conclusion is taken out based on assessment of results:

1) confidential conversation regarding detection of risk factors taking into account information from the questionnaire added, if necessary, with oral answers of the donor;

2) preliminary (for all categories of donors) and (in the presence) additional laboratory inspection (for regular donors) according to the requirements established by the order of the deputy. The Minister of Health of the Republic of Kazakhstan of November 10, 2009 No. 680 "About approval of Rules of physical examination of the donor before donation of blood and its components" (it is registered in the Register of state registration of regulatory legal acts for No. 5934);

3) general condition at the moment with use of methods of fizikalny inspection (measurement of temperature, growth and body weight, arterial pressure, rhythm and pulse rate).

3. In case of suspicion or establishment of factors of risk behavior of the potential donor which can cause risk of transfer of haemo inoculable disease and also in the presence of signs of other diseases, the amount of physical examination extends: inspection of integuments and visible mucous is performed, the auskultation, percussion, palpation, and also are appointed additional laboratory researches or consultations of specialists.

4. In case of assessment of results of laboratory researches are guided by regulations of indicators of laboratory researches for blood donors and its components according to appendix 1 to these Requirements and criteria of permanent and temporary branch from donorship of blood and its components according to appendices 2 and 3 to these Requirements.

5. In the presence of aberrations of indicators of laboratory researches the donor is discharged of donation according to criteria of temporary discharge from donorship of blood and its components according to appendix 3 to these Requirements.

6. In the presence of contraindications the donor is notified on the branch reason from donation, if necessary passing of additional inspection across the place of attachment in the organization of primary medico-sanitary help is recommended.

7. The reason of branch is registered in electronic databases about the donors and persons who are not subject to blood donorship and in the donor card.

8. In the absence of contraindications to donorship the type and amount of donation of blood and (or) its components is determined, at the same time are guided by the following criteria:

1) availability of requests from the medical organizations for blood components;

2) the voluntary informed consent of the donor on donation of blood and its components;

3) the minimum intervals between the different types of donations of blood and its components determined according to appendix 4 to these Requirements;

4) in the most admissible amounts of donation of blood and (or) its components which make:

for donors of whole blood:

weighing more than 50 kilograms (further - the kg) and height more than 150 centimeters (further - cm) makes withdrawal of whole blood in volume of 450 milliliters (further - ml) ± 10%, and also with additional withdrawal of 30-35 ml of blood for laboratory researches and for storage as an example of blood of the donor after donation;

weighing less than 50 kg and height less than 150 cm withdrawal of smaller amount of blood, in calculation of 4-6 ml on kilogram of body weight, but no more than 13% of total amount of the circulating blood (further - OTsK) is possible which normal constitutes body weight % 6,5-7; and also with additional withdrawal of 30-35 ml of blood for laboratory researches;

for donors of plasma:

weighing more than 50 kg and height more than 150 cm withdrawal of plasma of 600-800 ml, but no more than 16% of OTsK, and also with additional withdrawal of 30-35 ml of blood is made for laboratory researches and for storage as an example of blood of the donor after donation;

weighing less than 50 kg and height less than 150 cm to donation of plasma are not performed.

Chapter 3. Requirements to safety and quality in case of production of products of blood for medical application

Paragraph 1. Requirements to rooms, the equipment and its maintenance, production organization, materials for production, to incoming inspection of materials and the equipment, the manufacturing documentation

9. Sanitary and epidemiologic requirements to designing, construction, water supply and water disposal, lighting, ventilation and conditioning and heat supply, repair and content of premises of the organizations of service of blood are established according to the health regulations approved by the order of the Minister of Health of the Republic of Kazakhstan of May 31, 2017 No. 357 "About approval of Health regulations "Sanitary and epidemiologic requirements to health care facilities" (it is registered in the Register of state registration of regulatory legal acts for No. 15760) (further - Health regulations).

10. Sanitary and epidemiologic requirements to content of objects of service of blood are established in sootvetstsviya with paragraph 4 of Chapter 5 of Health regulations.

11. Production rooms are located in the logical sequence of production cycle.

The rooms which are technologically connected on work types unite in function blocks.

The arrangement and the size of rooms, placement of workplaces and the equipment within function blocks for providing the corresponding direction of movement of donors, personnel and threading of processes is provided.

Rooms to which donors have access separate from other working areas.

For questioning and survey of donors closed areas are provided.

12. The isolated rooms for arrangement of the equipment creating the increased noise are allocated.

13. Rooms for preparation of products of blood and for carrying out laboratory researches are provided with the authorized access.

14. Rooms for preparation of products of blood are subdivided into the following categories according to procedure type:

1) net rooms where procurement and production is performed within functionally closed system;

2) especially net rooms where functionally closed system is broken during process of conversion and providing aseptic conditions is required.

Zones of net and especially net rooms separate from each other.

In net and especially net rooms purity of air according to Item 172 of Health regulations is controlled.

15. In working areas conditions for washing of hands according to Item 89 of Health regulations are provided.

16. Conditions for separate storage of various categories of products of blood according to Item 90 of Health regulations are provided, and also:

1) packaging and consumable materials;

2) technical stock.

17. At all production phases, storages and transportations of products of blood are provided conditions of "holodovy chain" according to Item 91 of Health regulations.

18. Auxiliary zones, are located near production rooms, are equipped with the corresponding equipment, washing and disinfectants, harvest stock:

1) recreation rooms and object of public catering (buffet);

2) rooms for disguise, washing and toilet;

3) certain rooms for performance of works on maintenance of the equipment and for storage of spare parts and tools;

4) certain rooms for storage of the economic and washing materials.

19. Responsible for control of condition, maintenance and repair of the equipment person having vocational professional technical education is designated.

20. The production equipment is considered in the register of the equipment of the organization.

The list of the equipment which failure of work can exert negative impact on quality and safety of products or on the speed of production process is established and provided its regular maintenance.

The amount of maintenance and intervals of its carrying out are installed separately for each type of the equipment.

Plans and schedules of preventive maintenance and metrological control of the equipment and gages affirm the first head of the organization.

21. Monitoring of the following measurements is provided:

1) temperatures (bodies at the donor; storage conditions, transportation and use of blood and its components; incubations and expositions of samples when carrying out laboratory researches);

2) arterial pressure (at the donor);

3) weight (body of the donor; blood or its components; hinge plates of substance or reagents for carrying out researches);

4) amount (products of blood, reagents);

5) time (separation of blood into components, their storages);

6) rotation speeds (centrifuge rotor);

7) rn (products of blood, solutions, reagents, water);

8) optical density (blood samples in case of blood test on availability of markers of haemo transfusion infections.

22. Cases of breakdowns (refusals) of the equipment are registered, the statement (in the terms installed by the producer of each type of the equipment) which goes to the producer, or the organization providing maintenance of the equipment is drawn up. The defective equipment is marked.

23. The personnel study service regulations and care of the equipment with appendix of documentary confirmation.

24. The instructions describing actions of personnel in case of failures and defect in operation of the equipment of each type are developed.

25. Incoming inspection of the materials which were purchased for production and the equipment and verification of the accompanying documentation is carried out.

The list of materials, line items and indicators which are subject to incoming inspection it is established on the basis of requirements of regulating documents of each specific material taking into account influence on quality of ready-made product and affirms the first head of the organization.

26. Before receipt of results of incoming inspection materials are placed separately from the checked products in the zone "quarantine" with observance of the storage conditions established by manufacturing plant.

In the absence of the accompanying documentation products return to the supplier or are placed on the temporary isolated storage before provision of necessary documentation.

The received materials are exposed to laboratory control according to the regulating document. Based on the received results of researches the conclusion about suitability of material is issued.

27. The initial and packaging materials recognized suitable for use are marked by the words "it is allowed to use" with indication of approval date.

In case of detection of discrepancy, the response about quality of material with indication of the discrepancy reason for presentation to the supplier (damage statement) is drawn up.

28. Initial and packaging materials are released from warehouse on the basis of the principles:

1) the first arrived, the first is released;

2) batches do not mix up;

3) waste is removed safely.

29. Quality and safety of products of blood is ensured in case of:

1) survey of donors according to these Requirements;

2) carrying out laboratory researches (biochemical, immunohematologic, testing for infectious markers) samples of donor blood according to these Requirements;

3) to procurement of blood and its components according to the rules determined according to Item 5 of article 162 of the Code;

4) use of modern methods of procurement of donor blood and production of its products of blood registered in the territory of the Republic of Kazakhstan;

5) screening of donor blood on antileykotsitarny (HLA) antibodies in case of individual matching of components on the HLA system;

6) observance of conditions of "holodovy chain" for safety of products of blood at all stages of procurement, conversion, storage and transportation and transportation of cryotinned components separately from cellular components of blood.

30. Traceability of movement of each product of blood from the donor before receipt of ready-made product and its issue is provided by means of paperless document flow and electronic databases.

31. For the products of blood received by methods with piercing of gemakon the maximum storage time is established:

1) for the products of blood which are stored in case of +2+60 C - 24 (twenty four) hours;

2) for the products of blood which are stored at the room temperature - 6 (six) hours;

3) for the products of blood which are stored in the refrigerated condition before freezing no more than 1 (one) hour after piercing, no more than 6 (six) hours after their defrosting.

32. Initial materials, and also intermediate and end products are supplied with the label on which the features concerning their status are noted.

Marking provides bystry visual recognition of the status of product (on quarantine, issued for use or intended for destruction and so on).

33. On the label of ready-made product of blood information is specified:

1) identification number, unique for each unit of product of blood (on which the personality of the donor is identified);

2) name of product of blood;

3) storage conditions;

4) expiry date of the validity;

5) date of blood extraction of which the blood product is made, or date of production if it makes sense;

6) blood type on the AVO system and Rhesus factor accessory (Rh-D) of the donor;

7) name of the producer of product of blood.

34. The additional information for consumers of blood and its components about features of product, is established according to indicators of quality of donor blood and its components (further - quality Indicators) according to appendix 5 to these Requirements, at the same time information which is not specified on the label is provided in the form of the information leaflet.

35. Issue of products of blood for realization is allowed after completion of all procedures of production supervision and quality control, after establishment that their results meet requirements.

The order of the head of the organization of service of blood appoints authorized personnel for authorization of issue of ready-made products of blood for realization.

After issue from the organization of service of blood products of blood do not return for repeated issue.

36. All procedures, rooms and the equipment exerting impact on quality and safety of products of blood are subject to validation before their enforcement.

Validations repeat in case of any changes in production process, including in cases:

if there is partial replacement of auxiliary materials or the equipment;

in case of implementation of new processes, means, systems, the equipment, tests;

after movement, repair, setup of the units of equipment capable to influence potentially operation of the equipment, in case of any doubts in operational functioning of the equipment.

37. The general plan of validation which joins the list, the procedures which are subject to validation, rooms and the equipment, and also the working schedule is created.

The procedure of validation is documented, its plan and the report on results of carrying out are constituted.

In case of each validation check of compliance of end product of blood to quality Indicators is carried out.

38. In the organization of service of blood the manufacturing documentation is kept according to the approved forms of primary medical documentation of service of blood, approved by the order of the acting minister of health care of the Republic of Kazakhstan of November 23, 2010 No. 907 "About approval of forms of primary medical documentation of the organizations of health care" (it is registered in the Register of state registration of regulatory legal acts for No. 56272).

Access to the documents containing confidential information is limited.

39. Work instructions and (or) standard operational procedures (further - SOP) on accomplishment of production procedures during the attracting and selection of donors, procurement of blood and its components of blood in hospital and in exit conditions are developed, and also in case of production, production supervision of the prepared blood and its components.

40. In SOP the sequence of transactions, methods of its accomplishment is described, the used equipment, materials, forms of primary medical documentation for accounting of data V SOP are determined critical control points of procedures. The system of check of critical control points is determined by means of the planned testing and measurements and accomplishment of the subsequent corrective actions if it is determined that the specific critical point is not controlled.

Control parameters of system of check of critical control points are documented. Corrective actions are taken when observations demonstrate that the situation can leave, leaves or already got out of hand.

Paragraph 2. Requirements to production supervision of the prepared blood and its components

41. Production supervision of components of donor blood consists in carrying out laboratory researches of samples of donor blood (biochemical, immunohematologic, screening of markers of haemo inoculable infections) in specialized laboratory(laboratories) of the organizations of service of blood.

Results of laboratory researches of samples of donor blood are used when carrying out rejection of components of donor blood in case of determination of suitability for medical use.

42. Laboratory researches of samples of donor blood are conducted:

1) biochemical research on alanineaminotransferase content (further - ALT) (if preliminary blood test of the donor just before donation of blood and its components was not conducted); on determination of amount of general protein at donors of plasma;

2) immunohematologic - determination of blood type on the AVO system, Rhesus factor of accessory, phenotype on anti-genes of the Rhesus factor system, anti-gene To system Kel, screening and identification of irregular antieritrotsitarny antibodies;

3) screening of markers of haemo inoculable infections - the type human immunodeficiency virus 1,2 (further - VICh-1,2), viral hepatitis B (further - VGV), viral hepatitis C (further - VGS), syphilis, additional - for donors of haematopoietic stem cells (dalee-GSK) on infectious markers of Cytomegaloviral infection, toxoplasmosis, T-limfotropnogo type virus I, II.

Paragraph 3. Requirements to biochemical research of samples of donor blood

43. The research of activity of ALT in the sample of donor blood taken in time donation is performed by one of the methods allowed for use in the territory of the Republic of Kazakhstan. Results of research are estimated according to the instruction of the producer of reagents.

Increase in ALT is higher than regulation is the basis for recognition of the received blood products absolute scrap and assignment of the donor for 1 month with the subsequent control inspection.

44. Determination of amount of general protein at donors of plasma is carried out in blood samples from each donation by one of the methods allowed for use in the territory of the Republic of Kazakhstan.

Results of research are estimated according to the instruction of the producer of reagents.

In case of variations of biochemical indicators the admission to the subsequent donations is made according to the criteria of temporary branch from donorship of blood and its components established in appendix 3 to these Requirements.

Paragraph 4. Requirements to immunohematologic research of samples of donor blood

45. The immunohematologic research of samples of donor blood is carried out by methods:

columnar agglutination in the automated and (or) semi-automated laboratory diagnostic systems;

in liquid-phase system on the plane and (or) in test tubes with reagents with monoclonal antibodies.

Laboratory researches and interpretation of results of researches are performed according to the instruction of the producer of reagents and the equipment.

46. In the absence of the automated information system immunohematologic research of donor blood are made in two stages:

1) the first - before blood donation when in the presence of the donor the blood type is determined by the AVO system by direct reaction, Rhesus factor accessory, anti-gene availability Kel;

2) the second - after donation when the sample of donor blood from test tube is researched (vacuum), taken in time blood donation.

In the presence of the automated information system the immunohematologic research of the donor before donation in case of the established blood type is not conducted.

47. The blood type of the donor on the AVO system is considered established and is not determined on primary test stage before donation if the 2-fold research was conducted during different donations with use of the automated technologies in the absence of discrepancy in results of research.

The phenotype of the donor on the Rhesus factor system and its Rhesus factor accessory is considered established and is not determined on primary test stage before donation if the 2-fold research was conducted during different donations with use of the automated technologies in the absence of discrepancy in results of research.

Availability or lack of anti-gene Kel at the donor is considered established and is not determined on primary test stage before donation if the 2-fold research was conducted during different donations with use of the automated technologies and using reagents anti-To. In the absence of discrepancy in results of research, in case of the subsequent donations anti-gene research To not obligatory. In case of identification of anti-gene of K, the donor is involved in donations of plasma or cages (except erythrocytes), and Kel - positive erythrocytes are utilized.

48. Selection of sample of donor blood for immunogematologicheslogichesky research is performed donations in disposable vacuum test tube with the filler permitted in the instruction to reagents or in vacuum test tube about ethylene in time - diamine-tetraacetum acid (further - EDTA).

On brand of test tube the following information is specified: surname and initials of the donor, birth date, date of fence of sample of blood, donation barcode (in the presence of the automated information system).

The immunohematologic research of the samples of blood having signs of gemoliz of hilez is not made.

49. Storage of samples of donor blood is performed in case of temperature condition of +2 +8 °C according to the instruction of producers of reagents, test tubes.

After carrying out immunohematologic researches of test tube at least 2 days remain in the conditions stated above.

50. The confirmatory research group, accessory Rhesus factor, is made in blood samples from all donations.

51. In case of confirmatory research of group accessory on the AVO system double (cross) reaction is carried out:

research of availability of group anti-genes on erythrocytes reagents with IgM anti-And, IgM anti-In, IgM anti-AV antibodies;

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