A03-RFI_Attachment2.pdf

Attachment 2

The requirements listed in the table below shall be accommodated by the responder offering Fresh human A+ RBCs and plasma in CPD. Please indicate Y (Yes) or N (No) if your product 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

VENDOR:

1 Supplier shall provide A+ packed red blood cells collected in CPD preservative, and A+ plasma collected in CPD preservative.

2 All materials shall be collected in Commercial Donor Establishments and processed in facilities licensed by the US Food and Drug Administration.

All facilities shall be located in the United States of America to insure FDA oversight over all collection and processing operations.

3 Collection of blood and processing of blood to make plasma shall be performed using techniques in conformance with all applicable Federal, State and Local regulations. Donor establishments shall be also members of appropriate certifying organizations (such as the American Association of Blood Banks “AABB”) and all source suppliers shall strictly adhere to guidelines for collection published by the certifying agency.

4 All donors of blood products shall be deemed to be normal and healthy. The health status of donors shall be monitored and each donor shall be screened by a verbal questionnaire.

5 Each individual donor unit shall tested and found negative for HBsAG, HIV ½, HCV, HIV-1AG or HIV-1 NAT, ALT and a test for Syphilis by FDA approved test methods.

REQUIREMENTS/ SPECIFICATIONS

MEETS

REQUIREMENT?

(Y/N)

COMMENTS

6 Records shall be maintained tracing each individual donor unit to date and origin of donation.

(End)

UAttachment 2