Inactive

The contractor shall provide back-up testing 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... The contractor shall provide back-up testing 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, in the event that USPACOM ASBBC analyzers experience a malfunction and testing cannot be performed by USPACOM ASBBC. Back-up 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, as requested by the USPACOM ASBBC. On 26 August 2016 FDA issued Guidance for industry requiring Zika Virus testing on all blood donors performed in accordance with an Investigational New Drug (IND) protocol which has now transitioned into In-Vitro Diagnostic (IVD) test after the IND was approved by the FDA. The contractor shall also provide confirmatory testing on an as-needed basis. 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, as requested by the USPACOM ASBBC. The contractor will be utilized as the Enzyme ImmunoAssy (EIA) testing laboratory and confirmatory testing as the current EIA platform will no longer be supported past 30 Sep 2021. The Food and Drug Administration requires we perform specific viral testing on all donor blood samples. The contractor will be utilized to adhere to the Food and Drug Administration regulations and requirements The contractor testing facility shall be located within a geographical location to allow for maximum 72 hours for transit time for shipments of samples. 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 requirements for 5 shipments per week. Testing shall be conducted at the contractor’s facility. Empty boxes after samples sent shall be returned to USPACOM ASBBC by the contractor to the address listed below. Contractor pays shipping charges. Ship to: U. S. PACOM ASBBC Camp Foster, Bldg. 968 111 Futenma Bara, Ginowan City, Okinawa, Japan 901-2202 Test results for the requested tests shall be sent, via facsimile, to 011-81-98-971-9939 or via secure internet to an email address specified by U.S. Pacific Command Armed Services Blood Bank Center (USPACOM ASBBC). Test results must be provided to USPACOM ASBBC within 24 hours of receipt of the blood samples at the contractor’s testing facility.