CALL FOR THE TENDER TO AWARD A CONTRACT OF BUYING FRESH FROZEN PLASMA (FFP)
Public Establishment National Blood Center of Lithuania (hereinafter NBC) is announcing a call for the tender to sell fresh frozen plasma (FFP) on the basis of a contract with a fractionator.
1. AMOUNT. The total annual amount of fresh frozen plasma (FFP) which can be sold on the basis of contracts is around 12 000 liters (the exact amount is depending on the needs of the hospitals, as the providing FFP to the hospitals of Lithuania is the priority).
2. AVAILABILITY TIMING. For the needs of the hospitals 6 month quarantined FFP is being prepared. The availability of FFP (whether quarantined or without quarantine) is a matter of the contract.
3. AMOUNT OF SHIPMENTS. The most preferably for the NBC (National Blood Center) are three shipments per year, nevertheless the amount of shipments can be a matter of the contract taking into consideration, that a permission from the Ministry of Health (MoH) is obligatory for every shipment. Permission issuing procedure is stipulated by the MoH and the time limit for authorization is around 1 (one) month after the application to the MoH.
4. QUALITY. FFP fully meets European GMP standards. It should be noted that starting from 1st of May, 2015, the FFP production process is licensed pharmaceutical activity and the licence issued by competent authority of Lithuania, i.e. State medicines Control Agency, is needed. The GMP audit in NBC was carried out by State medicines Control Agency of Lithuania and the licence for NBC was issued.
5. AUDIT. Provision of the right of buyer to carry out an audit or validation of the equipment will be foreseen in the contract.
6. EXPECTED PRICE . The expected price of 1 liter of FFP is not less than 30 Eur.
7. TESTINGS. Plasma is tested NAT and serology in the laboratory of NBC.
Serology tests:
· HBsAg;
· HIV Ag/Ab Combo (detection of HIV p24 antigen and antibodies to HIV type 1 and 2);
· Anti-HCV;
· Anti-TP.
NAT: Multiplex HIV 1/2 RNR, HCV RNR & HBV DNR test. (Plasma samples are pooled to a minipools that consist of up to 24 individual samples).
It is important to note that in 2016 NBC collected 73 652 donations of blood and the amount of non remunerated donors is 85,4 percent. The increment of non-remunerated donors in 2016 is 4,07 percent.