Croatia – Blood analysis services

Service for testing donors of tissues and cells for blood-borne diseases The selected bidder is obliged to comply with the following conditions when performing the service: - The laboratory for testing donors for blood-borne diseases must have the ability to perform all serological and NAT tests of donors of tissues and cells and conduct confirmatory testing to resolve discrepancies in serological and NAT testing results - The laboratory must perform testing for blood-borne infectious diseases and issue results according to the current revision of the Council of Europe Guide for the Quality and Safety of Tissues and Cells - Testing must be performed from individual donor samples - The laboratory must use tests with the "CE" mark - The tests must be approved or validated for the purpose for which they are used - It is necessary to perform at least 100,000 tests per year for testing blood-borne infectious diseases in donors of blood, tissues and cells and organs - The laboratory must have an organized 24/7/365 service - The laboratory must be accredited according to the current revision of the ISO 15189 standard for the quality system in medical laboratories - The laboratory must have the approval of the Minister for testing tissue and cell donors according to the Ordinance on the conditions regarding premises, professional workers, medical-technical equipment and quality systems for carrying out the activities of collection, removal, testing, processing, preservation, storage and distribution of human tissues and cells (Official Gazette 80/2013)