The Ministry Of Health Changes The Rules For Monitoring The Safety Of Donor Blood And Its Components

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The Ministry Of Health Changes The Rules For Monitoring The Safety Of Donor Blood And Its Components
The Ministry Of Health Changes The Rules For Monitoring The Safety Of Donor Blood And Its Components

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The Ministry of Health changes the rules for monitoring the safety of donor blood and its components

The draft Regulation on State Control distributes specialized medical institutions by risk categories, the degree of which will determine the frequency of scheduled inspections. It is about monitoring compliance with the rules for the procurement, storage, transportation and clinical use of donated blood and its components. FMBA is responsible for inspecting hospitals and blood transfusion stations.

The Ministry of Health changes the rules for monitoring the safety of donor blood and its components
The Ministry of Health changes the rules for monitoring the safety of donor blood and its components

Photo: Wikimedia Commons /

The draft Regulation on State Control distributes specialized medical institutions by risk categories, the degree of which will determine the frequency of scheduled inspections. The responsibility of inspecting hospitals and blood transfusion stations remains with the Federal Biomedical Agency.

It is about monitoring compliance with the rules for the procurement, storage, transportation and clinical use of donated blood and its components. Blood transfusion stations, blood centers, medical organizations with blood transfusion departments or transfusion rooms are engaged in this.

The main complications of blood transfusion occur when the blood donor and the recipient are incompatible with the ABO system, the Rh factor, or a violation of the blood transfusion technique. There are fewer cases of poor quality transfused blood, but the mortality rate is very high. Such violations include bacteriological contamination, hemolysis, protein denaturation due to long-term storage, violation of the temperature regime during storage.

Five categories

To date, the regulations adopted in 2011 are in force, according to which scheduled inspections are carried out after three years from the date of state registration or the previous scheduled inspection. According to the new rules, specialized medical facilities are divided by risk categories, taking into account the severity of the potential negative consequences of non-compliance with the requirements imposed on them.

The category of significant risk includes medical organizations that procure, store, transport donated blood and its components and their clinical use. They will be audited every three years.

The category of medium risk includes medical organizations that procure, store, and transport donor blood and its components (without a license for transfusiology). They will be checked no more often than every four years.

The category of moderate risk includes medical organizations that carry out the clinical use and transportation of donated blood and its components, which carry out 5 or more transfusions per year. For them, the frequency of inspections is once every five years.

The low-risk category includes medical organizations that carry out less than 5 transfusions per year. Scheduled checks are not provided for them.

In the high risk category, medical organizations are allocated, which are associated with the facts of harm to health, suspension of activities due to any violations or work without a license for the procurement of donor blood or transfusiology. Such organizations will be audited every two years.

In addition, the document assumes the ability to change the risk category of a medical organization if it allows violations.

Risk degree

As previously reported to MedNovosti, Deputy General Director of the Hematological Research Center for Transfusiology, Head of the Department of Blood Cell Processing and Cryopreservation, Ph.D. Tatyana Gaponova, if the patient even once faced a blood transfusion, then, most likely, he will receive complications from this. If many transfusions are required, then the risks that donated blood carries are multiplied.

A significant role in improving safety was played by the law "On the donation of blood and its components" passed six years ago, which prohibited paid donation (today donors receive only standard compensation for food and two days of rest to replenish their strength). After the material benefit disappeared, a decrease in the marriage of blood began due to the infections detected in it, Gaponova noted. And now the percentage of rejected blood for infectious markers among repeat donors is less than 1%. Among the primary - 2-2.5%. If we take into account antibodies to the short antigen, which is an additional marker, then this is 5%.

But all the same, one cannot talk about absolute safety, because there are always risks that the blood can carry infectious agents in such a small amount that it is impossible to fix it by laboratory methods. The law regulates the plan for screening donors, and there are a number of objective and clearly defined requirements for their health. Although in world practice there is a presumption of guilt of the donor, and the doctor may refuse on the basis of his subjective assessment. There is no such rule in our legislation.

The latest high-profile case involving HIV infected during a blood transfusion occurred several years ago in St. Petersburg. According to the rules, today all blood donated by donors goes to "quarantine", where it is stored until the second check of the donor for HIV after several months. But sometimes, in that order, something "doesn't work."

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