(Official Gazette of the Republika Srpska, No. 64/10)
Pursuant to Article 24, paragraph 2 of the Law on Transplantation of Human Organs (Official Gazette of the Republika Srpska, no
14/10) and Article 82, paragraph 2 of the Law on Republic Administration (“Official Gazette of Republika Srpska”,
no. 118/08 and 11/09), the Minister of Health and Social Welfare adopts
RULE BOOK
ON THE CRITERIA FOR THE TESTING OF HUMAN BODIES ASSOCIATED WITH REGARD TO THE DISEASES THAT CAN BE TRANSLATED
Article 1.
This ordinance lays down criteria for testing human organ donors for diseases that may be present
transplanted (hereinafter: criteria).
Article 2
The criteria are based on an analysis of the risks identified on the basis of personal, family and
socio-epidemiological history, medical history, clinical examination, bioassay and autopsy.
Article 3
The criteria referred to in Article 2 of this Rulebook may be general and specific: a) general criteria:
1) unknown cause of death,
2) medical history of unknown etiology,
3) the existence of a malignant disease in the donor's personal history, with the exception of primary basal skin cancer, initial
cervical cancer and histologically proven non-metastatic primary tumors of the central nervous system,
4) the existence of diseases caused by prions, including Kreuzfeld-Jakob disease, rapid-onset dementia
or degenerative neurological disease, for recipients of pituitary hormone recipients, recipients of corneal graft,
juvenile and durable cerebellum, as well as persons undergoing neurosurgical surgery with use
hard cerebral during surgery,
5) systemic bacterial, viral, fungal or parasitic infection not under control at the time of administration
(e.g., septicemia, syphilis, active tuberculosis, malaria, chronic toxoplasmosis, Chagas disease, leishmaniasis,
babesiosis, chronic Q-fever and other diseases),
6) history, clinical evidence or positive laboratory tests for HIV infection, type B infectious jaundice (except
in people with proven immunity), infectious jaundice type C, HTLV I / II infection, and the existence of a risk factor in history
diseases,
7) the existence of a chronic, systemic autoimmune disease in the donor's personal history (eg systemic erythematosus
lupus, rheumatoid arthritis, chronic eczema, sarcoidosis, systemic lupus and other diseases),
8) ingestion or exposure to a toxic substance that can be transmitted to the recipient at a dose that would endanger his health,
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9) recent vaccination with live attenuated virus if there is a risk of transmission,
10) transplantation with xenotransplants; b) specific criteria:
1) pregnancy, 2) breastfeeding and
3) children under 18 months born of mothers with HIV infection, infectious jaundice type B, infectious jaundice type
C or HTLV infections, or are at risk of these infections and have been breastfed in the last 12
months.
Article 4
Biological tests based on human organ donor testing may be mandatory and additional:
a) mandatory bioassays:
1) AntiHIVI / II,
2) HbsAG,
3) Anti HBc, 4) Anti HCVAb,
5) syphilis test;
b) additional bioassays:
1) Ag p24,
2) Anti HTLV I,
3) Anti CMV and 4) Anti EBV.
Article 5
This Rulebook shall enter into force on the eighth day after its publication in the Official Gazette of the Republika Srpska.
No: 11 / 04-020-22 / 10
June 17, 2010Minister, Banja LukaDr Ranko Škrbić, sr
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