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ORDER OF THE GOVERNMENT OF THE RUSSIAN FEDERATION

of August 5, 2013 No. 667

About maintaining the single database on implementation of the actions connected with safety of donor blood and its components, development, the organization and promotion of donorship of blood and its components

According to part 2 of article 21 of the Federal law "About Donorship of Blood and Its Components" Government of the Russian Federation decides:

1. Approve the enclosed Rules of maintaining the single database on implementation of the actions connected with safety of donor blood and its components, development, the organization and promotion of donorship of blood and its components.

2. Determine that:

the single database on implementation of the actions connected with safety of donor blood and its components, development the organization and promotion of donorship of blood and its components is the state information system of service of blood;

The Ministry of Health of the Russian Federation performs general coordination of maintaining the specified single database, and Federal Medical Biological Agency - its maintaining and development;

executive bodies of subjects of the Russian Federation in the sphere of health protection provide coordination of activities of the relevant state organizations of subjects of the Russian Federation and the municipal organizations connected with their participation in maintaining the specified single database.

3. Realization of the powers following from this resolution is performed by the corresponding federal executive bodies in the limits set by the Government of the limiting Russian Federation of number of employees of their central offices and budgetary appropriations provided in the federal budget on management and management in the sphere of the established functions.

Russian Prime Minister

D. Medvedev

 

Approved by the order of the Government of the Russian Federation of August 5, 2013 No. 667

Rules of maintaining the single database on implementation of the actions connected with safety of donor blood and its components, development, the organization and promotion of donorship of blood and its components

1. These rules establish procedure for maintaining the single database on implementation of the actions connected with safety of donor blood and its components, development, the organization and promotion of donorship of blood and its components (further - the database of donorship of blood and its components), including maintaining the federal register of donors (further - the register), terms and data representation form for placement in the database of donorship of the blood and its components, and also procedure for information access containing in the database of donor blood and its components and its use.

2. Maintaining and ensuring functioning of the database of donorship of blood and its components is performed by Federal Medical Biological Agency (further - the operator).

3. Placement in the database of donorship of blood and its components of information, its processing, storage, use, and also access to such information and its protection are performed by the operator and the organizations performing activities in the sphere of the address of donor blood and (or) its components with observance of requirements of the legislation of the Russian Federation on information, information technologies and about information security and legislations of the Russian Federation in the field of personal data.

4. Maintaining the database of donorship of blood and its components is performed using infrastructure of the automated information system of the transfusiology allowing including to perform information processing on the basis of use of single formats.

5. In the database of donorship of blood and its components daily information collection is in real time provided:

a) about amount of the prepared donor blood and its components;

b) about inventory of donor blood and its components with indication of blood type, Rhesus factor accessory and phenotype;

c) about post-transfusion reactions and about complications at recipients (since January 1, 2016);

d) about the address of donor blood and (or) its components;

e) about activities of subjects of the address of donor blood and (or) its components (since January 1, 2016);

e) about quantity of cases donated in the organizations which are outside the territory of the Russian Federation, donor blood and (or) its components and their amount;

g) about persons (personal data) at whom medical contraindications (temporary or permanent) for blood donation and (or) its components are revealed.

6. The database of donorship of blood and its components contains the register in which the following information on each donor after accomplishment of donor function by it is daily entered:

a) surname, name and middle name, in case of their change - others surname, name and middle name;

b) birth date;

c) floor;

d) information on registration on the residence or stay;

e) details of the passport or other identity document;

e) date of inclusion in the register;

g) blood type, Rhesus factor accessory, information on the researched anti-genes and about availability of immune antibodies;

h) information on the previous donations;

i) information on the postponed infectious diseases, stay in contact with infectious patients, stay in the territories in which there is threat of origin and (or) spread of mass infectious diseases or epidemics, about the use of drugs, psychotropic substances, about work with harmful and (or) dangerous working conditions, and also about the vaccination and surgical interventions executed within one year about day of blood donation and (or) its components;

j) information on rewarding with breastplates "The honourable donor of the USSR" and "The honourable donor of Russia".

7. In the database of donorship of blood and its components takes place:

a) information specified in subitems "an" - "e" Item 5 and subitems "a" - "z" Item 6 of these rules, - the organizations performing activities in the sphere of the address of donor blood and (or) its components;

b) information specified in the subitem "k" of Item 6 of these rules - the operator.

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