The list of some orders of the Minister of Heath Care of the Republic of Kazakhstan, wherein changes and amendments are introduced

Appendix to the order

of the Minister of Health Care and

Social Development

of the Republic of Kazakhstan

dated «___»____________2015

No.______

The list of some orders of the Minister of Heath Care of the Republic of Kazakhstan, wherein changes and amendments are introduced

1. In the order of the acting Minister of Health Care of the Republic of Kazakhstan dated November 6, 2009 No. 666 “On approval of the Nomenclature, Regulations on banking, processing, storing, and selling of blood and its components, as well as Regulations on storage and transfusion of blood, its components and products” (entered into the Register of state registration of laws and regulations No. 5925, published in the Collection of acts of central executive and other central government bodies of the Republic of Kazakhstan No.4, 2010):

The nomenclature of blood, its components and blood-derived products, approved by the said order, shall be amended in accordance with Appendix 1 to this List;

The Regulations on banking, processing, storing, and selling of blood and its components, approved by the said order, shall be amended in accordance with Appendix 2 to this List;

The Regulations on storing, transfusion of blood, its components and products approved by the said order, shall be amended in accordance with Appendix 3 to this List.

2. In the order of the acting Minister of Health Care of the Republic of Kazakhstan dated November 10, 2009 No. 680 “On approval of the Regulations on medical examination of a donor prior to giving (donation) of blood and its components” (entered into the Register of state registration of laws and regulations No. 5934, published in the “Yuridicheskaya gazeta” newspaper dated April 21, 2010, No. 56 (1852)):

the headline shall be amended as follows:

“On approval of the Regulations on medical examination of a donor prior to donation of blood and its components”

paragraph 1 shall be amended as follows:

“1. To approve the attached Regulations on medical examination of a donor prior to donation of blood and its components.”;

The Regulations on medical examination of a donor prior to donation of blood and its components, approved by the said order, shall be amended in accordance with Appendix 4 to this List.

3. In the order of the acting Minister of Health Care of the Republic of Kazakhstan dated November 10, 2009 No. 684 “On approval of the Regulations on control of quality and safety of donated blood and its products” (entered into the Register of state registration of laws and regulations No. 5930, published in the Collection of acts of central executive and other central government bodies of the Republic of Kazakhstan No.5, 2010):

in the Regulations on control of quality and safety of donated blood and its products, approved by the said order:

Appendices 1, 3 shall be amended in accordance with Appendices 5, 6 to this list;

in Appendix 2:

paragraph 81 shall be amended as follows:

«81. If during the laboratory study of the selected blood product sample, one or several indicators of quality requirements, such as hemoglobin, hematocrit, hematocrit with additive solution, residual white blood cells, factor VIII, pH, are deviated by more than 5% from the standard requirements, or if deviations evidencing hazard changes for the recipient, such as bacterial contamination, high rates of hematolysis and (or) residual protein and osmotic concentration, the study shall be conducted again.

If the obtained result is confirmed, 2-3 blood product samples, prepared at this day, shall be selected and additionally studied at the re-examination.

If the indicators of quality requirements constantly deviate from the standard requirements, the implementation of the process regulation for blood components shall be checked, and adjusted, if necessary.

If the presence of deviation evidencing hazard changes for the recipient, also in the samples selected for re-inspection, all analogous blood products of this series or prepared in one day, shall be discontinued.

subparagraph 3) paragraph 89 shall be amended as follows:

“3) during the research of hemoglobin in supernatant of unfrozen restored red blood cells and washed red blood cells, the samples shall be taken in the final portion of the weighting solution in the blood bag of the blood component;”;

paragraph 94 shall be amended as follows:

“94. The samples of cryoprecipitate are taken after fractionation of plasma into cryoprecipitate and cryosupernatant plasma.

The whole share of cryoprecipitate is submitted for the laboratory study.

The pool of 6 (six) separate cryoprecipitate samples of different blood groups is formed during the quality control to conduct the study factor VIII content within the first and the last month of storage.”;

in Appendix 4:

paragraphs 47 and 49 shall be amended as follows:

“47. In the premises for production of sterile blood products (boxes), the purity of air shall be controlled daily before and during the work of the box.”;

“49. The seedings shall be incubated at the temperature from +35оС to +37оС within 24 hours, and then left within 24 hours at the temperature +22оС to +25оС. After that, the total amount of grown colonies is calculated on 2 Petri dishes, and recalculation per the quantity of microorganisms in 1 m3 of air is conducted, the arithmetic mean is determined (the sum of the number of bacteria grown on 2 Petri dishes), which is divided by 2, and the obtained figure is multiplied by 80 (at diameter of the Petri dish 9 cm, the surface area of the dish is equal to 80 cm2), at that, the number of colonies in 1 m3 is obtained.

For instance: 7 colonies grew on 2 plates with diameter of 9 cm, first of all, the arithmetic mean of the total amoun of colonies in both plates is calculated by the means of summing of the number of colonies in both plates and dividing the obtained sum by the number of plates (in this example by 2), further on, the obtained value (7) is multiplied by the surface area of the plate (equal to 80 cm2 in this example), as a result, the number of the colony-forming units is determined (in this example this figure is equal to 560 КОЕ/m3). If the plate diameter is 8 cm, the multiplier factor is 100; the presence and the number of mold shall be pointed out separately.”;

the first part of 50 shall be amended as follows:

“50. To determine St/aures, the seeding shall be made on one of the nutritional mediums: egg yolk high salt, lactic high salt, or lactic egg yolk high salt agar, or other nutritional mediums, registered and approved for use on the territory of the Republic of Kazakhstan.”;

paragraphs 52, 55, 56 and 69 shall be amended as follows:

“52. The sterility control of effectiveness of the personnel’s hands scrub-up during the production process of banking and processing blood shall be controlled selectively with several workers, not less than once a week, of the donors’ elbow bend skin – not less than twice a week. Wipe-samples from elbow bends shall be taken in the amount of 3% of donations.”;

“55. The sterility control of the working conditions shall be conducted in the premises, where the studies of researches of blood, its components and preparations are carried out.

56. The following types of researches shall be carried out at intralaboratory sterility control:

1) sterility of every batch of the prepared nutritional medium;

2) microbial contamination of air in the box;

3) cleanness of hands of the employees at work in the box;

4) work of hot-air sterilizers, autoclaves;

5) work of thermostats;

6) temperature regime of refrigerators;

7) check samples with the use of knowingly sterile preparations.”.

“69. Control of every prepared batch of nutritional mediums after autoclaving shall envisage the assessment of their sterility quality by the means of thermostating of check samples (not less than 2% of the batch) within 48 hours.”.

4. In the order of the acting Minister of Health Care of the Republic of Kazakhstan dated September 16, 2013 No. 529 “On approval of the Standard of transfusion aid provision to the population in the Republic of Kazakhstan” (entered into the Register of state registration of laws and regulations No. 8823, published in the “Kazakhstanskaya Pravda” newspaper dated February 5, 2014, No. 24 (27645)):

in the Standard of transfusion aid provision to the population in the Republic of Kazakhstan, approved by the said order:

subparagraphs 6) and 17) of paragraph 5 shall be amended as follows:

“6) a donor is a human being, a human cadaver or an animal, from whom/which donated blood, its components, other donor material (including sperm, ovocytes, tissues of reproductive organs, germ cells, embryos) are collected or tissues (a part of tissue) and (or) organs (a part of organs) are withdrawn to be transplanted to a recipient;”;

“17) a recipient is a patient to whom donated blood, its components, other donor material (including sperm, ovocytes, tissues of reproductive organs, germ cells, embryos) are transfused or tissues (a part of tissue) and (or) organs (a part of organs) are transplanted from a donor;”;

paragraphs 12-1 and 18-1 shall be inserted as follows:

“12-1. Medical organizations providing specialized or highly specialized hospital care shall plan the demand for the donated blood components, taking into account the demand for the donated blood components with additional safety properties for treatment of pediatric, obstetric patients, as well as persons with immune suppression and transfusion dependence.”;

“18-1. Medical organizations conducting laboratory researches in the sphere of transfusiology aid shall participate in the system of external republican control of quality of laboratory researches for the blood service.”;

paragraphs 21, 22, 24, 29, 30, 31, 32, 34, 36, 37, 38, 42, 63 and 65 shall be amended as follows:

“21. A donor is a person, who had attained the age of eighteen, passed an appropriate medical examination and has no contradiction, voluntarily willing to donate blood and its components for medical purposes.

22. According to the frequency and number of blood and its component donations, donors shall be subdivided into the following categories:

1) a primary donor is a person who donates blood and its components for the very first time in the life;

2) a repeated donor is a person who has previously donated blood and its components in this organization of the blood service;

3) a regular donor is a person who regularly donates blood and its components. Regularity shall imply the frequency of blood donation equal to 3 or more times per year, of blood plasma and cells donation – 12 or more times per year. The exception is donation of red blood cells by the means of red blood cells exchange, in this case regular donation shall be understood as donation 2 or more times per year.”;

“24. Donation of blood and its components is subdivided into the following types:

1) according to the type of donation:

donation of blood;

donation of plasma, including immune plasma;

donation of blood cells;

2) according to the motivation of donation:

non-remunerated (voluntary non-remunerated donation, targeted donation and autologous donation);

donation of blood on the payment basis.

Voluntary non-remunerated donation of blood and its components is the donation of allogenic blood and its components, made without receiving monetary remuneration, except for the guarantees provided to the donor in accordance with Article 167 of the Code.

Targeted donation of blood and its components is the donation of allogenic blood and its components, meant for particular patients and made without receiving monetary remuneration, except for the guarantees provided to the donor in accordance with Article 167 of the Code.

Autologous donation of blood and its components is the donation of blood and its components taken from one person and meant for the further autologous transfusion to this person only.”;

“29. Prior to every donation of blood and its components, the donor shall undergo the preliminary immunohematologic examination of blood on А, В, D, Kell antigens, determination of hemoglobin (hematocrit) level, the donor of HSC of peripheral blood shall undergo the preliminary determination of the content of peripheral blood (hemoglobin (hematocrit), red blood cells, white blood cells, platelets).

30. Medical examination of the donor, rejection or permission, and determination of the type of donation of blood and its components shall be conducted by the transfusiologist or therapist of the blood service organization (hereinafter referred to as the physician), and of the donor of HSC of placental blood – by the qualified obstetric-gynecologic personnel of the obstetric organization, where banking of placental blood is carried out.

31. In case of suspected presence or determination of risk factors and as clinically indicated, the medical examination scope may be extended at the discretion of the physician making permission to donate blood and its components.

32. If the laboratory research indicators deviate from the norm, the donor shall be rejected to donate blood and its components within one month.”; 

“34. After the donation of blood and its components, the primary donor of blood and its components shall be given a Donor card according to the form, in compliance with the order No. 680.”; 

“36. The selection of blood samples for testing on blood-induced infections is conducted during the donation of blood and its components.

37. Prior to donation of blood and its components, the transfusiologist, conducting medical examination, shall acquaint the donor with the information provided to the donor, in compliance with the order No. 680.

38. Prior to donation of blood and its components the donor shall receive sweet tea with sugar-containing confectionery products.”;

“42. In accordance with paragraph 1 of Article 167 of the Code, at the days of medical examination and donation of blood and its components, the employee being a donor shall be granter relief of work by the employer, with retaining the average wage. The donor, performing non-remunerated donor functions, shall be provided an additional recreation day with retaining the average wage.

In accordance with paragraph 7 of Article 167 of the Code, in order to replace the volume of blood and metabolic cost after the donation of blood and its components, the donor, performing non-remunerated donor functions, shall receive either free nutrition, or its monetary equivalent in the amount, determined by the Resolution of the Government of the Republic of Kazakhstan dated December 30, 2009, No. 2300 “On approval of the amount and Regulations on payment to the donors for the donation of blood and its components on the payment basis.”;

“63. In order to prevent the immunological response, particular recipients (children, patients of obstetrics institution, persons with immune suppression and transfusion dependence) shall be provided with leukoreduced components of blood with the minimal shelf life.”;

“65. The requirements, provided by the Article 175 of the Code and the Regulations on accreditation in the sphere of health care, approved by the Order of the Minister of Health Care and Social Development of the Republic of Kazakhstan dated March 10, 2015 “On approval of the Regulations on accreditation in the sphere of health care” (entered into the Register of state registration of laws and regulations No. 10735) shall be applied to the level of professional education of the blood service specialists.”.