Performing HCV RNA, HBV DNA and HIV RNA for 38,000 blood donations by molecular biology (NAT) for the Regional Blood Donation and Blood Treatment Center dr Konrad Vieth in Radom, ul. Limanowskiego 42. Molecular biology testing for three virological markers should be performed in a single donation or in pools of no more than 6 samples. The expected number of tests commissioned to the Contractor for implementation over a 12-month period will be 27,000 (minimum amount - 24,000).
Performing HCV RNA, HBV DNA and HIV RNA for 38,000 blood donations by molecular biology (NAT) for the Regional Blood Donation and Blood Treatment Center dr Konrad Vieth in Radom, ul. Limanowskiego 42. Molecular biology testing for three virological markers should be performed in a single donation or in pools of no more than 6 samples. The expected number of tests commissioned to the Contractor for implementation over a 12-month period will be 27,000 (minimum amount - 24,000).
Secured and described blood samples will be sent to the Contractor's premises:
- by rail / bus transport from Radom to ........, by own transport or express courier, at times agreed by both parties,
- the collection of samples from the train / bus station in ..... from the transporter will be made by the Contractor at his own expense and risk,
- maximum allowable distance between the Contractor's laboratory and the RCKiK headquarters in Radom - 120 km,
- transport time of blood samples to the Contractor max 2 hours.
Requirements:
1. Tests should be performed by TMA or PCR.
2. Successful implementation of 27,000 blood donations from the date of signing the contract until the number of tests is exhausted. The Employer provides
based on the previous 12 months that he will submit samples for testing each business day from Monday to Friday. The average number of samples per day is 100, however it can happen that it will be between 100 and 250 samples. The Purchaser also reserves that the number of donation samples intended for testing may be less than 100.
3. The results of the tests in the form of an electronic file shall be immediately sent by the Contractor to the e-mail address provided. The Awarding Entity expects to receive the test results no later than the day after sending the samples by 7:30 am.
4. Printouts of test results, confirmed by the date, signature and seal of the Laboratory Manager and a qualified person will be collected directly by the Employer at least once a month.
5. The Ordering Party shall attach a thermometer with a transport protocol to the package with tubes. It is the Contractor's responsibility to check the temperature and enter it in the abovementioned the protocol together with the date, stamp and signature of the person collecting the package. Required transport temperature in accordance with the test tube and test manufacturers' recommendations.
6. The Employer will collect copies of transport protocols in person at least once a month.
7. Samples will be delivered in EDTA / separating gel tubes for NAT.
8. Tests will be performed by the Contractor immediately after delivery of the samples.
9. Samples after the tests will be disposed of by the Contractor.
10. For each donation tested for HCV / HIV RNA and HBV DNA, two automated archiving samples should be made so that the final volume is a minimum of 1,000 μl (2 x 500 microliters) so that they can be fully identification and quick search
If necessary. After completion, archiving samples should be frozen and stored at ≤ -25
11. Testing and archiving samples should be carried out in accordance with applicable requirements - GMP, GLP and the current announcement of the Minister of Health on the requirements of good practice for blood and blood components collection, testing, preparation, storage, issuing and transport for public organizational units blood service.
12. In order to ensure the required quality of tests, the Contractor is obliged to maintain the quality assurance system in accordance with the requirements in force in the public blood service and GMP.
13. The contractor must have:
a) current certificate of the Institute of Hematology and Transfusion Medicine regarding the admission of analyzers used in the Contractor's laboratory for routine work;
b) current authorization for the production of medicinal products, which includes biological products, issued by the Main Pharmaceutical Inspector;
c) current Good Manufacturing Practice Certificate (GMP) issued by the Main Pharmaceutical Inspector.
14. The Contractor shall ensure the automatic transmission of the Blood Bank system test results. The cost of installing and running the program for the transmission of results, as well as the cost of necessary modifications should be included in the calculation of the price for one test.
15. The Awarding Entity reserves the right to carry out an audit in terms of proper implementation of the contract conditions.