Poland - Services provided by medical laboratories

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Details

Provided by Open Opps
Opportunity closing date
10 April 2020
Opportunity publication date
04 March 2020
Category
85145000: Services provided by medical laboratories
Value of contract
to be confirmed
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Description

Performing RNA HCV, DNA HBV and RNA HIV tests for 38,000 blood donations by molecular biology (NAT) for the Konrad Vieth Regional Centre for Blood Donation and Treatment in Radom, 42 Limanowskiego Street. Molecular biology testing for three virological markers should be performed in a single donation or in pools consisting of no more than 6 samples. The maximum permitted distance between the Contractor's laboratory and the headquarters of the RCKiK in Radom - 120 km, - time of transport of blood samples to the Contractor max 2 hours. Requirements:1. Tests should be performed using TMA or PCR.2. The contracting authority expects, on the basis of the previous 12 months, to submit samples for testing every working day from Monday to Friday. The average number of samples per day is 100, but it may be between 100 and 250 samples. The Ordering Party also stipulates that the number of donation samples to be tested may be less than 100.3. The results of the tests in the form of an electronic file shall be sent by the Contractor immediately by e-mail to the indicated e-mail address. The Orderer expects to receive the test results no later than on the day following the dispatch of samples by 7:30.4. Printouts of test results, certified by the date, signature and stamp of the Laboratory Manager and qualified person will be collected directly by the Orderer at least once a month.5. The Orderer will attach a thermometer with a transport protocol to the tube package. It is the Contractor's duty to check the temperature and enter it in the above-mentioned protocol together with the date, stamp and signature of the person collecting the parcel. The required transport temperature is in accordance with the recommendations of tube and test manufacturers.6 Copies of transport protocols shall be collected by the Purchaser in person at least once a month.7 Samples shall be delivered in tubes for EDTA/separation gel to be tested with NAT methods.8 Tests shall be performed by the Contractor immediately after delivery of samples.9For each donation tested for RNA HCV/HIV and HBV DNA, two archive samples shall be made in an automated system so that the final volume is at least 1,000 μl (2 x 500 microlitres) so that they can be fully identified and quickly retrieved. After the archive samples are made, they should be frozen and stored at a temperature ≤ -25o C until they are received by RCKiK Radom. The platelets with archive samples should be provided with appropriate documentation concerning the donation numbers in particular platelets together with the platelet numbers and the amount of material used to make these samples.11 The performance of tests and archive samples should be carried out in accordance with the applicable requirements - GMP, GLP and the current announcement of the Minister of Health of the day on the requirements of good practice for collection of blood and its components, testing, preparation, storage, distribution and transport for organizational units of public blood service.12In order to ensure the required quality of tests, the Contractor is obliged to maintain a quality assurance system compliant with the requirements applicable in the public blood service and GMP.13The Contractor must hold:a) a current certificate of the Institute of Hematology and Transfusionology in the scope of approval of analyzers used in the Contractor's laboratory for routine work; b) a current permit for manufacturing medicinal products, which include biological products, issued by the Main Pharmaceutical Inspector; c) a current certificate of good manufacturing practice (GMP) issued by the Main Pharmaceutical Inspector.14. The Contractor will ensure automatic transmission of research results of the Blood Bank system. The cost of installing and running the program to transmit the results, as well as the cost of necessary modifications should be included in the calculation of the price of performing one test.15. The Ordering Party reserves the right to conduct an audit for the proper implementation of the terms of the contract.

Opportunity closing date
10 April 2020
Value of contract
to be confirmed

About the buyer

Address
Regionalne Centrum Krwiodawstwa i Krwiolecznictwa im. dr. Konrada Vietha w Radomiu ul. Limanowskiego 42 Radom 26-600 Poland
Contact
przetargi@rckik.radom.pl

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