Inactive

Notice of Intent to Sole Source HT941024N0028 THIS IS A NOTICE OF INTENT TO AWARD A SOLE SOURCE NON-PERSONAL SERVICES CONTRACT AND IS NOT A REQUEST FOR COMPETITIVE QUOTES. The Defense Health Agency Co... Notice of Intent to Sole Source HT941024N0028 THIS IS A NOTICE OF INTENT TO AWARD A SOLE SOURCE NON-PERSONAL SERVICES CONTRACT AND IS NOT A REQUEST FOR COMPETITIVE QUOTES. The Defense Health Agency Contracting Activity (DHACA), Western Markets Contracting Division (WMCD), San Diego, intends to negotiate and award a firm fixed price contract for medical laboratory testing on an as-needed basis (as a back-up/alternate testing Enzyme ImmunoAssays (EIA) laboratory and confirmatory testing laboratory), Outside the Continental of the United States (OCONUS) in support of United States Naval Hospital Okinawa (USNHO), Japan in accordance with Federal Acquisition Regulation FAR 13.106-1(b)(1)(i), only one source being available to meet the Government’s needs, to: BLOODWORKS 921 Terry Ave Seattle, WA 98104-1239 The North American Industry Classification System (NAICS) code for this requirement is 325413 – In-Vitro Diagnostic Substance Manufacturing, the business size standard is 1,250 # of employees. The Product Service Code (PSC) is 6550 – In-Vitro Diagnostic Substances, Reagents, Test Kits and Sets. The objective of this sole source award is to procure supplies for U. S. Pacific Command Armed Services Blood Bank Center (USPACOM ASBBC). USNHO requires back-up and confirmatory testing that will be determined based on the individual needs of 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. The anticipated period of performance is for a base with four (4) option periods. The contractor’s medical laboratory testing facility will be utilized in the event USPACOM ASBBC’s testing equipment becomes inoperable or reagent delays due to overload. 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. 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. 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) Collected donor samples naturally deteriorate over a period of time, as such the contractor testing facility shall be located within a geographical location to allow for maximum 72 hours for transit time. Beyond 72 hours, the collected samples become unreliable for testing. FDA approved facilities in CONUS west coast are most suitable for this requirement. To date no other testing sites are available that are located within the 72-hour time requirement. This notice of intent is not a request for competitive proposals, and no solicitation document exists for this requirement. Sources interested in responding to this notice are required to submit a capability statement that includes management and technical data and cost information, in sufficient detail and with convincing evidence that clearly demonstrates the capability to provide the required services for United States Naval Hospital Okinawa. Capability statements shall not exceed six (8.5 x 11 inch) pages using a font size no smaller than 10-point. All capability statements received by the due date of this notice will be considered by the Government. A request for documentation or additional information or submissions that only ask questions will not be considered as an affirmative response. A determination by the Government not to compete based on responses to this notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement or to proceed with a sole source purchase order. If a vendor challenges the basis of this requirement, please email capability statements as a Microsoft Word or Adobe PDF attachment to Adrian Nerida at adrian.m.nerida.civ@health.mil. The closing date for challenges is no later than 11:00am Pacific Standard Time, 06 February 2024. NO TELEPHONE REQUESTS/OFFERS WILL BE HONORED.