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

According to Item 1 of part 2 of 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. Recognize to invalid:

the order of the Government of the Russian Federation of January 26, 2010 No. 29 "About approval of the technical regulation about the safety requirements of blood, its products, krovezameshchayushchy solutions and technical means used in transfusion and infusional therapy" (The Russian Federation Code, 2010, No. 5, the Art. 536);

the order of the Government of the Russian Federation of October 12, 2010 No. 808 "About suspension of action of the technical regulation about the safety requirements of blood, its products, krovezameshchayushchy solutions and technical means used in transfusion and infusional therapy" (The Russian Federation Code, 2010, No. 42, the Art. 5380);

the order of the Government of the Russian Federation of December 31, 2010 No. 1230 "About approval of rules and methods of the researches and rules of sampling of donor blood necessary for application and execution of the technical regulation about the safety requirements of blood, its products, krovezameshchayushchy solutions and technical means used in transfusion and infusional therapy" (The Russian Federation Code, 2011, No. 3, the Art. 553);

Item of 113 changes which are made to acts of the Government of the Russian Federation concerning activities of the Ministry of Health of the Russian Federation, approved by the order of the Government of the Russian Federation of September 4, 2012 No. 882 "About introduction of amendments to some acts of the Government of the Russian Federation concerning activities of the Ministry of Health of the Russian Federation" (The Russian Federation Code, 2012, No. 37, the Art. 5002).

Approved by the Order of the Government of the Russian Federation of June 22, 2019 No. 797

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 (further - safety requirements) in case of their procurement, storage, transportation and clinical use.

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

"alloimmune antibodies" - antibodies which are created as a result of incompatible transfusion, transplantation of allogenic marrow and allogenic haematopoietic stem cells, pregnancy or contact with group antigens of erythrocytes;

"autologous 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 discrepancy to their safety requirements;

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

"granulotsitny concentrate" - the leukocytes weighed in plasma, received by method of aferez from one donor, in number of at least 10 x 109 in unit of component of donor blood, subjected to obligatory radiation;

"blood types on the AB0 system" - the antigenic composition of blood determined by availability or lack of A and B antigens 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 components of donor blood received on all processing stages of components of this donation, and also samples of blood of the corresponding donor;

"individual matching of components of donor blood" - set of the researches directed to identification at the recipient of antibodies to antigens 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 transmissible infections;

"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;

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

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

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

"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;

"the irradiated component of donor blood" - the component of donor blood subjected to additional processing by x-ray radiation or gamma irradiation in the dose 25 - 50 Gray directed to inactivation of donor leukocytes for the purpose of prevention of reactions and complications in connection with transfusion;

"sample of blood of the donor" - the blood taken from the donor, intended for research;

"sample of blood of the recipient" - the blood taken from the recipient, intended for research;

"pathogenic biological agents" - the microorganisms capable in case of hit in human body to cause infectious process;

"patogenredutsirovanny component of donor blood" - the component of donor blood subjected to the additional processing directed to the termination of reproduction of pathogenic biological agents;

"donor blood and (or) its components, suitable for use" - the donor blood and (or) its components conforming to safety requirements;

"pulirovaniye" - consolidation of products of individual donations;

"Rhesus factor accessory" - availability or absence on antigen D erythrocytes;

"freshly frozen plasma" - the plasma received by method of aferez, stored before freezing at temperature of +2... +6 degrees Celsius of 6 hours from the moment of procurement, or received from the donor blood stored before centrifuging at temperature not above +10 degrees Celsius no more than 24 watch;

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