ORDER OF THE GOVERNMENT OF THE RUSSIAN FEDERATION

of May 14, 2025 No. 641

About approval of Rules of procurement, storage, transportation and clinical use of donor blood and its components

According to article 8 of the Federal law "About Donorship of Blood and Its Components" Government of the Russian Federation decides:

1. Approve the enclosed Rules of procurement, storage, transportation and clinical use of donor blood and its components.

2. Determine that the donor blood and its components prepared till September 1, 2025 according to the procedure, the established Rules of procurement, storage, transportation and clinical use of donor blood and its components approved by the order of the Government of the Russian Federation of June 22, 2019 No. 797 "About approval of Rules of procurement, storage, transportation and clinical use of donor blood and its components and about recognition voided some acts of the Government of the Russian Federation", are used before the expiration of their validity according to the Rules approved by this resolution.

3. The Ministry of Health of the Russian Federation has the right to approve methodical recommendations about questions of clinical use of donor blood and its components.

4. Declare invalid the order of the Government of the Russian Federation of June 22, 2019 No. 797 "About approval of Rules of procurement, storage, transportation and clinical use of donor blood and its components and about recognition voided some acts of the Government of the Russian Federation" (The Russian Federation Code, 2019, No. 27, the Art. 3574).

5. This resolution becomes effective since September 1, 2025.

Item 1 of this resolution is effective till September 1, 2031.

Approved by the Order of the Government of the Russian Federation of May 14, 2025 No. 641

Rules of procurement, storage, transportation and clinical use of donor blood and its components

I. General provisions

1. These rules establish mandatory requirements to procurement, storage, transportation and clinical use of donor blood and its components, including mandatory requirements of safety of donor blood and its components in case of their procurement, storage, transportation and clinical use (further - safety requirements).

2. The concepts used in these rules mean the following:

"alloimmunny antibodies" - antibodies which are created as a result of incompatible transfusion, transplantation of allogenny marrow and allogenny haematopoietic stem cells, pregnancy or contact with group anti-genes of erythrocytes;

"autoimmune antibodies" - the antibodies directed against one or several own anti-genes of blood cells (erythrocytes, platelets, leukocytes);

"autologichny transfusion" - the procedure of blood transfusion and (or) its components, in case of which the donor and the recipient the same person;

"bacterial contamination" - hit in container with donor blood and (or) its components of bacteria potentially hazardous to health of the recipient which can become the reason of reaction or complication in connection with transfusion;

"biological test" - provisional estimate of condition of the recipient in case of intravenous administration of donor blood and (or) its components;

"rejection" - change of the status of donor blood and (or) its components, consumable materials and reagents in case of detection of their discrepancy to safety requirements;

"alternative anti-genes" - anti-genes in the presence of which weak agglutination with standard reagents to anti-genes of blood types is determined;

"haemo inoculable infections" - the infections which are transmitted including through donor blood and its components;

"blood types on the AB0 system" - the anti-gene composition of blood determined by availability or lack of anti-genes of A and B on erythrocytes and antibodies of anti-A and anti-B in serum of blood of the person;

"unit of donor blood" - the donor blood containing in one container;

"unit of component of donor blood" - the component of donor blood containing in one container;

"identification number of the donor" - number assigned to the donor by the subject of the address of donor blood and (or) its components performing their procurement, storage, transportation in case of the first admission of the donor to donation which remains throughout all history of donations;

"identification number of donation" - number assigned to donation by the subject of the address of donor blood and (or) its components performing their procurement, storage, transportation for marking by this number of all units of donor blood and (or) its components received on all processing stages of components of this donation, and also samples of blood of the corresponding donor;

"immunospecific plasma" - the plasma containing specific antibodies and prepared for the purpose of production of the specific immunoglobulins intended for creation of immunity to infectious diseases, treatments of infectious diseases, prevention of alloimmunization Rhesus factor - positive erythrocytes;

"individual matching of components of donor blood" - set of the researches directed to identification at the recipient of antibodies to anti-genes of components of donor blood for the purpose of determination of compatibility of the donor and the recipient;

"plasma karantinization" - storage of plasma with prohibition of its use prior to repeated research of sample of blood of the donor on haemo inoculable infections;

"the concentrate of granulocytes" - the leukocytes weighed in plasma, received in quantity is at least 0, 3 x 109 on 1 kilogram of body weight of the recipient, subjected to obligatory radiation;

"concentrate of platelets" - the component of donor blood containing platelets in plasma or in plasma with additional solution, received by method of aferez or from blood tinned;

"kriopretsipitat" - the component of donor blood containing krioglobulinovy fraction of plasma, received by means of plasma conversion;

"leykotrombotsitny layer" - the part of unit of donor blood containing concentrate of leukocytes and platelets, received by centrifugation method;

"leykoredutsirovanny component of donor blood" - the component of donor blood subjected to additional processing for the purpose of decrease in residual quantity of leukocytes less than 1 x 106 in unit of component of donor blood;

"plasma liofilization" - method of processing of plasma by means of its drying from the refrigerated condition;

"massive transfusion" - the transfusions of 5 and more units of eritrotsitsoderzhashchy components of donor blood applied to correction of massive blood loss;

"method of aferez" - procurement of components of donor blood with target release of plasma or cages from donor blood and return to the donor of residual components of donor blood;

"multiple transfusions" - 5 and more transfusions of donor blood and (or) its components to the recipient in case of one hospitalization;

Disclaimer! This text was translated by AI translator and is not a valid juridical document. No warranty. No claim. More info