Unofficial translation

      In accordance with Article 207, paragraph 1, of the Code of the Republic of Kazakhstan dated July 7, 2020 "On public health and healthcare system," I hereby ORDER:

      1. To approve the attached Rules for the donor to donate blood and its components of the mandatory medical examination within the framework of the guaranteed amount of free medical care.

      2. To recognize the order of the Minister of Healthcare of the Republic of Kazakhstan as invalid dated September 10, 2019 No. RK HM-125 "On approval of the Rules for medical examination of a donor before donation of blood and its components" (registered in the Register of State Registration of Regulatory Legal Acts under No. 19366, published on September 16, 2019 in the Reference Control Bank of Regulatory Legal Acts of the Republic of Kazakhstan in electronic form).

      3. The Department of Medical Care Organization of the Ministry of Healthcare of the Republic of Kazakhstan, in accordance with the procedure established by the legislation of the Republic of Kazakhstan, shall:

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

      2) place this order on the Internet resource of the Ministry of Healthcare of the Republic of Kazakhstan;

      3) within ten working days from the date of the state registration of this order, submit to the Legal Department of the Ministry of Healthcare of the Republic of Kazakhstan information on the implementation of measures provided for in subparagraphs 1) and 2) of this paragraph.

      4. Control over the execution of this order shall be entrusted to the Vice-Minister of Healthcare of the Republic of Kazakhstan A. Giniyat.

      5. This order shall enter into force upon expiry of ten calendar days after the date of its first official publication.

The rules for the donor to donate blood and its components of a mandatory medical
examination within the framework of a guaranteed amount of free medical care Chapter 1. General provisions

      1. These Rules for donor to donate blood and its components to compulsory medical examination within the guaranteed amount of free medical care (hereinafter referred to as the Rules) have been developed in accordance with Article 207, paragraph 1 of the Code of the Republic of Kazakhstan dated July 7, 2020 "On public health and healthcare system" (hereinafter referred to as the Code) and shall determine the procedure for donation of blood and its components of a mandatory medical examination within the framework of a guaranteed amount of free medical care (hereinafter – GAFMC).

      2. Blood service organizations shall carry out donations of blood and its components of the following types: whole blood, plasma, blood cells, mixed.

Chapter 2. The procedure for donation of blood and its components of a mandatory medical examination within the framework of the GAFMC

      3. The donor shall undergo a mandatory medical examination within the framework of the GAFMC before donation of blood and its components, which shall include the following stages:

      1) donor admission and registration;

      2) medical examination of the donor.

      4. Reception, registration, medical examination of blood donor and its components in blood service organizations shall be carried out when a person who has reached the age of 18 years and has voluntarily expressed a desire to donate blood and its components for medical purposes, in accordance with Article 206, paragraph 1 of the Code.

      5. According to the frequency and multiplicity of donations of blood and its components, donors shall be divided into the following categories:

      primary - a person performing donation of blood and its components for the first time in life;

      repeated - a person who had previously donated blood and its components;

      regular - a person performing donation of blood and/or its components for the last 12 months with a multiplicity of 3 or more times.

      6. Acceptance of donors is carried out on the basis of identity documents, or an electronic document from the digital document service (for identification) in accordance with the Law of the Republic of Kazakhstan "On identity documents" or military registration documents for army conscripts.

      7. Prior to donation of blood and its components, the registration of persons who shall not be subject to admission to blood donation and its components shall be checked in the electronic database.

      In the absence of contraindications to blood donation and its components, the passport part of the donor's medical record shall be filled. In the medical record of the donor, shall be marked the verification of information.

      8. Electronic database of persons not subject to blood donation and its components shall be formed on the basis of data sent from health organizations working in the field of prevention of human immunodeficiency virus/acquired immune deficiency syndrome (HIV) (hereinafter referred to as HIV Prevention organization), tuberculosis hospitals (dispensaries), drug treatment hospitals (dispensaries, centers for medical and social rehabilitation), skin and venereological hospitals (dispensaries), psychiatric hospitals (dispensaries), as well as according to the results of the examination for transfusion infections of persons who applied for donation of blood and its components to the organization of a blood service.

      Blood service organizations shall be provided with information about HIV-infected persons in the republic with subsequent updating of information about newly identified persons by organizations for the prevention of HIV in regions, cities of national importance and the capital.

      Information about reconvalescent patients, including COVID-19 who shall be potential donors of immune plasma, shall be transmitted by medical organizations at the request of the organization of the blood service in the service region in order to be able to organize the procurement of immune plasma.

      9. Before each donation of blood and its components, a donor questionnaire shall be conducted to identify additional information that shall prevent admission to donation.

      The questionnaire shall be completed by the donor independently or with the participation of a medical registrar in accordance with the form in accordance with the Annex to these Rules.

      Donors of immune plasma shall be attracted to donation in the presence of specific antibodies against the infectious agent.

      10. Prior to each donation of blood and its components, a preliminary laboratory examination of the blood of a potential donor shall be carried out, comprising:

      definition of hemoglobin (for all donor categories); determination of alanine aminotransferase activity (hereinafter referred to as ALT) (for all donor categories);

      determining quantity in platelet donors; determining the time of blood coagulation before donation of blood components on automatic separators;

      the presence of specific antibodies, including anti- COVID-19 antibodies, in immune plasma donors.

      11. The study of ALT, titer of specific immune antibodies after donation during production control shall be performed in case it is not possible to carry out diagnostics before donation.

      The results of the study shall be taken into account when selecting blood components.

      12. Before donation, group affiliation shall be determined by ABO system, rhesus of affiliation and presence of K antigen of Kell system, if donor blood type is not established and result is not registered in automated information system.

      13. Laboratory research shall be carried out by methods registered on the territory of the Republic of Kazakhstan, including dry chemistry methods, on equipment registered by the state body in the field of circulation of medicines and medical devices in accordance with Article 10, paragraph 7 of the Code.

      14. Regular donors shall be further examined. At least once a year, a study of the composition of peripheral blood (hemoglobin (hematocrit), red blood cells, white blood cells, platelets, red blood cell sedimentation rate, and white blood cell formula) shall be carried out; people over 40 years old shall be assigned an electrocardiographic study.

      15. Before donating blood and its components, the donor shall be briefly informed on the following issues:

      the procedure for donating blood and its components, as well as the need to use blood components for the treatment of patients;

      possible temporary adverse reactions associated with the donation of blood and its components;

      the right to refuse donation before or during the procedure and the absence of negative effects on the donor;

      the need to observe a gentle regime within 24 hours after donation of blood and its components: restriction of physical and psychoemotional loads, abstinence from dangerous activities;

      the guarantee of confidentiality of personal information and the right to receive information on the results of the survey;

      infections transmitted with blood and its components (HIV, viral hepatitis with parenteral transmission mechanism);

      the purpose of the laboratory examination of blood donation, the importance of obtaining reliable history data and the importance of voluntary informed consent to donation of blood and its components;

      measures taken in the event of detection of markers of hemotransmistic infections: removal from donation, disposal of harvested blood and its components, mandatory transfer of this information to the relevant health organizations.

      16. The donor, after performing the donor function, shall be released from work with an average salary in accordance with Article 208, paragraph 1 of the Code.

      17. The donor, on the basis of a written application, shall be issued an archival certificate on the types and scope of donations carried out by him, which shall be drawn up on the blood service organization form signed by the first head.

      18. In blood service organizations, a laboratory examination of a donor without subsequent donation shall be carried out to obtain research results to resolve the possibility of restoring donor rights or indefinitely diverting persons from blood donation and its components who previously had undefined or positive research results on markers of hemotransmissive infections, as well as other laboratory studies provided for blood donors of its components.

      Thank you for desire to help patients in need of donated blood!

      Please respond frankly to these questions (answer the questions, specifying “yes” or “no”).

      Frank answers to these questions shall be necessary to ensure your safety as a donor and the safety of the patient to whom your blood will be transfused.

      Last name, first name, patronymic of the donor (if any) _____________________________

      Have you changed your last name? If yes, please specify the previous one _______________________

      Date of birth_________________________________

      Gender _____________________________________

      e-mail (if you agree to receive information letters for the purpose of invitations for donation) _______________________________________________________________________________

      Home address: actual residence ________________

      Place of residence _________________________________________________________

      Home phone ________________ Mobile phone ______________________

      Work phone _______________________

      Place of work/study _________________

      Position/Course

      _____________

      I hereby confirm that:

      1) donate blood or its components voluntarily, without coercion for use for medical purposes;

      2) fully understood all questions of the questionnaire and answered them truthfully, realizing the significance of this information for me and for the patient's health when using my blood or its components for transfusion;

      3) warned that if false information is provided, it may be held liable in accordance with the legislation of the Republic of Kazakhstan

      4) I hereby agree to enter my personal data into the electronic database of blood donors and its components and to process them through an automated information system.

      5) warned that:

      my blood will be screened for infection markers (HIV, syphilis, hepatitis B and C);

      if positive test results for infection markers are obtained, the information shall be transmitted to the relevant medical organizations for further examination.

      6) I hereby understand that pre-donation questionnaires, as well as laboratory studies of infection markers, shall be carried out solely to ensure the safety of blood transfusions and its components.

      I hereby agree to use a sample of my blood obtained during donation to conduct scientific studies in an impersonal form.

      Donor signature ________________

      Doctor signature ________________

      Date ________________

      I hereby confirm that I agree to receive information letters to invite you to participate in mobile donation and/or e-mail.

      Donor signature _______________