SPECIAL NOTICE
65 -- Notice of Intent to Sole Source Blood Donor EIA and Confirmatory Testing
- Notice Date
- 1/12/2022 12:24:25 PM
- Notice Type
- Special Notice
- NAICS
- 325413
— In-Vitro Diagnostic Substance Manufacturing
- Contracting Office
- DEPT OF DEFENSE
- ZIP Code
- 00000
- Solicitation Number
- HT9406SV01122022
- Response Due
- 1/27/2022 12:30:00 PM
- Point of Contact
- Sheri Vendemia
- E-Mail Address
-
cheryl.r.vendemia.civ@mail.mil
(cheryl.r.vendemia.civ@mail.mil)
- Description
- 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 � Available Tests (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 72 hours for transit time from for Okinawa, Japan to the contractor�s facility via air freight. The contractor�s laboratory must 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.� 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 listed below. 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, free of charge. The contractor is responsible for the cost of the boxes, shipping charges for the supply of boxes and for the return of the empty boxes to the USPACOM ASBBC for reuse. Boxes shall not be priced separately. Table 1 � Available Tests 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) ZIKA BY IDT NAT (back-up) JBV/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) 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 Confirmatory (Captia) (confirmatory) Abbott ESA Chagas Confirmatory Blot ++ (confirmatory)
- Web Link
-
SAM.gov Permalink
(https://sam.gov/opp/923835c71c154edaa63a5d309feb767b/view)
- Place of Performance
- Address: USA
- Country: USA
- Country: USA
- Record
- SN06215568-F 20220114/220112230104 (samdaily.us)
- Source
-
SAM.gov Link to This Notice
(may not be valid after Archive Date)
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