RFI Attachment 2 MECs Blood.doc

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Human Blood and Serum
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W81XWH-20-Q-0102
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B08-RFI Attachment1.doc DOC document

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Attachment 2 The requirements listed in the table below shall be accommodated by the responder offering Blood and Serum. Please indicate Y (Yes) or N (No) if your system meets each requirement in the requirements list below, and use the comments column to further justify how your product meets the requirement.

REQUIREMENTS/ SPECIFICATIONS

Meets Requirement?

(Y/N) Comments

MAIN SYSTEM

1
All blood products shall be collected in the United States of America from human donors in FDA registered and/or licensed centers and tested at an FDA certified, registered, and/or licensed lab using screening tests that FDA has licensed, approved, and/or cleared for such use, in accordance with the manufacturer’s instructions
2
All blood products shall be tested in accordance with 21 CFR part 610.40 General Biological Products Standards Testing Requirements for Relevant Transfusion-Transmitted Infections and yield non-reactive/negative results for each test performed on each unit.
3
All blood products shall be accompanied by a Certificate of Analysis (COA) certifying the results of all required tests as negative or non-reactive for each unit received.
4
The minimum required tests shall include:

· HIV (Human immunodeficiency virus, type 1, 2)

· HBV (Hepatitis B virus)

· HCV (Hepatitis C virus)

· HTLV (Human T-lymphotropic virus, type I,2)

· Syphilis (T. pallidum)

· Chagas (T. cruzi)

· West Nile virus

· Zika virus

Donors shall be screened or questioned for history of CJD and vCJD (Creutzfeldt-Jakob disease) and malaria. The COA will note that the risk factor or response is acceptable.

5
The collection date and expiration date for each unit (identified by ID or lot number) shall be included on the COA. If the dates are compiled on a packing list or invoice instead of on individual unit COAs, the units and dates shall be clearly linked to the relevant COA.
6
All blood products shall be packaged on wet ice (not frozen) in a manner to maintain a temperature in transit of 1-10oC. Red blood cells will be shipped no later than 5 days after donation. Serum shall be shipped no later than 16 days after donation (serum as liquid, never frozen).
7
The blood products shall arrive via Priority Overnight or Next-Day Delivery, for delivery in the morning.
8
Donors shall not have taken antimalarial drugs in the 4 months prior to donation, nor aspirin within the previous 4 days prior to donation.
9
Blood shall be collected with CPDA-1 anticoagulant. Serum will be collected off-the-clot.

(End)

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