STATEMENT OF REQUIREMENTS (v2).pdf

STATEMENT OF REQUIREMENTS

The contractor shall provide medical laboratory testing on an as-needed basis (as a back-up/alternate testing Enzyme ImmunoAssays (EIA) laboratory and confirmatory testing laboratory) for U. S. Pacific Command Armed Services Blood Bank Center (USPACOM ASBBC), located at Camp Foster Bldg. 968, 111 Futenma Bara, Ginowan City, Okinawa, Japan, 901-2202. The contractor’s medical laboratory testing facility will be utilized in the event that testing cannot be performed by USPACOM ASBBC due to analyzer malfunction.

The need for back-up and confirmatory testing will be determined based on the individual needs of the USPACOM ASBBC and shall consist of one or all of the tests identified in Table 1 (outlined below), as requested by the USPACOM ASBBC. The contractor will invoice on a cost per test basis.

Blood specimens will be labeled with the required test(s), including confirmatory testing, as applicable, and labeled with Donor Identification Numbers and ISBT codes; no personally identifiable information will be provided.

EIA testing is a required methodology for Infections Disease testing of: HIV-1/HIV-2 Ag/Ab Combo, *Hepatitis B surface Ag, *Antibody to Hepatitis B Core, *Antibody to HTLV-1/HTLV-2, *Antibody to Hepatitis C Virus 2.0, *Antibody to T.Cruzi (Chagas); *confirmatory testing, utilizing another methodology other than EIA, is required if one of these EIA tests are positive.

The Food and Drug Administration (FDA) requires performance of specific viral testing on all donor blood samples.

The contractor shall adhere to FDA regulations and requirements. Refer to the Code of Federal Regulations (CFR) Food and Drugs: Title 21 Part 210, 211, 600, 601, 606, 607, 610, 630, 640, 660, Part 820, Part 1270, Part 1271, and Public Health, Title 42 Part 493.

To retain integrity of the blood samples, the contractor’s testing laboratory shall be located within a geographical location to allow for maximum of 72 hours for transit time from Okinawa, Japan to the contractor’s facility via air freight. The contractor’s laboratory shall be Clinical Laboratory Improvement Amendments (CLIA) / Clinical Laboratory Improvement Program (CLIP) certified, College of American Pathologist (CAP) certified, or Association for the Advancement of Blood and Biotherapies (AABB) accredited for report of testing results.

The contractor shall test samples only using instrumentation and assays approved by the FDA for Blood Donations.

The specific test methodologies, and approved manufacturers are listed in the link below, any other instrumentation or methodologies will not work and is a deviation from FDA guidelines. The contractor shall submit their testing methodologies and manufacturer to ensure the correct approved methods established by the FDA are used for this requirement.

The list of approved methods and manufacturers is listed below.

https://www.fda.gov/vaccines-blood-biologics/complete-list-donor-screening-assays-infectious-agents-and-hiv-diagnostic-assays#Anti- T.%20pallidum%20Assays%20(detect%20antibodies%20to%20Treponema%20pallidum)and%20other%20serologi cal%20tests%20for%20Syphilis

Within 24 hours of receipt of the blood samples at the contractor’s facility, laboratory test results shall be sent either via facsimile or via secure Internet to a fax or email address specified by USPACOM ASBBC.

The contractor shall provide all boxes required for shipment of samples from the USPACOM ASBBC to the testing facility. The boxes shall be provided in sufficient numbers to meet the minimum requirements for 5 shipments per week. The contractor shall provide boxes to support and withstand the required sample temperatures either in wet ice or dry ice packaging. The contractor shall return empty shipping boxes to USPACOM ASBBC at the address provided above, the Government will pay shipping charges. In the event the empty boxes are not returned in a timely manner by the contractor, the USPACOM ASBBC may request additional empty boxes as needed at no charge to the Government. Shipping fee shall be covered by USPACOM ASBBC’s Syncada account. Contractor is responsible for supply of boxes (both refrigerated and freeze items) and return of empty boxes for reuse.

Table 1

Available Tests

Estimated Quantity (12-month period)

Abbott Alinity Panel (6 tests) Antibody to HIV-1/HIV-2 Ag/Ab Combo, *Hepatitis B surface Ag, *Antibody to Hepatitis B Core, *Antibody to HTLV-1/HTLV-2, *Antibody to Hepatitis C Virus 2.0, *Antibody to T.Cruzi (Chagas) (*if positive requires confirmatory testing as requested by USPACOM ASBBC)

6,000

HBV/HCV/HIV BY ID NAT (back-up)

WEST NILE VIRUS BY IDT NAT (back-up)

Anti-A/Anti-B Titer Testing (≥1:256 Dilution) (back-up)

1,000

Babesia by IDT NAT (back-up)

HBsAG Neutralization (confirmatory)

Anti-HIV-1/2 Geenius Western Blot + (confirmatory)

Anti-HTLV-I/II Western Blot (confirmatory)

Syphilis Screening (Captia) (back-up)

3,000

Syphilis Confirmatory (PK-TP or RPR if sample is unacceptable for PK-TP) (confirmatory)

Anti-HCV 3.0 ELISA (Alternate, Confirmatory)

Anti-CMV (Capture-CMV)(back-up)

Abbott ESA chagas Confirmatory Blod ++ (confirmatory)

Available tests may be revised, if needed, to meet FDA requirements. Based on the needs of the USPACOM ASBBC, quantities may be increased via a modification issued upon agreement of the contractor and the Government. 24/7/365 testing that meets the 24-hour (upon receipt) laboratory test results turnaround time.

End Statement of Requirements