Laboratory Testing Services (Blood Donor Screening)

The National Institutes of Health (NIH) Bethesda, Maryland is seeking qualified contractors to submit their capability statements to provide the following service. 1 OVERVIEW The NIH Clinical Center Department of Transfusion Medicine (DTM) operates an FDA-licensed, hospital-based blood bank that collects and processes blood components for transfusion and for laboratory research use. In addition, it collects and processes HCT/P products for cellular therapy and laboratory research use. Laboratory tests required for lot release of these products are performed according to FDA regulations and AABB Accreditation Standards. Products are collected 6 days/week, Monday - Saturday. The DTM collects and tests approximately 12,000 products each year as follows: For Transfusion For Laboratory Research Use Whole blood 6500 350 Platelets, pheresis 2600 Plasma, pheresis 100 10 Granulocytes, pheresis 200 Leukocytes, pheresis 75 1500 PBSC 200 25 Pre-assessment for Research 100 Pre-assessment for Transplant 500 2 REQUIREMENTS 2.1 Supplier qualifications 2.1.1 The Offeror must be registered with the U.S. Food and Drug Agency for laboratory testing of blood donors. 2.1.2 The Offeror must be certified by Centers for Medicaid and Medicare Services for performance of the laboratory tests listed in Section 2.2. 2.1.3 The Offeror must agree to scheduled audits by NIH Clinical Center DTM QA Officers of the testing laboratory's quality management system. 2.1.4 The Offeror must provide assurance that it has alternate testing sites or arrangement in the event that one testing location is not operational (e.g, if a NAT lab is temporarily decommissioned due to contamination issues). 2.1.5 The Offeror must be capable of providing testing services seven days/week except for Federal holidays. 2.1.6 The Offerer must be capable of testing and reporting results for approximately 12,000 specimens per year for the test panels described in section 2.2. 2.2 Test Panels 2.2.1 DTM requires two types of testing panels to be performed on each specimen with supplemental and/or confirmatory testing as needed based on FDA regulations and agreed upon test algorithms. These panels are: Transfusion donors: HBsAg, anti-HBc, anti-HCV, anti-HIV-1/2, anti-HTLV-I/II, HIV NAT, HCV NAT, WNV NAT, Chagas, T pallidum. Research donors: HBsAg, anti-HCV, anti-HIV-1/2, anti-HTLV-I/II 2.3 Test methods and algorithms 2.3.1 Test methods must be FDA approved for use in blood donor screening and meet minimum sensitivity standards as determined by the FDA 2.3.2 Test algorithms must be performed according to current FDA regulation and published guidance, and shall be agreed upon with DTM. 2.3.3 Test methods used for supplemental and confirmatory testing shall be FDA approved when an FDA approved method exists. 2.3.4 Testing procedures must conform with manufacturer's instructions and FDA regulations. 2.3.5 Specific requirements for blood donor screening and supplemental or confirmatory tests include: Screening Test (performed on each donation) Supplemental, confirmatory, or as needed tests (performed on some donations as reflex test or upon request) Hepatitis B Virus HBsAg (Abbott PRISM is preferred method) HBsAg neutralization or acceptable equivalent Anti-HBc HBV DNA (not required if Abbott PRISM is screening method for HBsAg) Hepatitis C Virus Anti-HCV Anti-HCV RIBA HCV NAT (TMA is preferred method, individual testing required for HCT/P donors) Discriminatory NAT HIV-1/2 Anti-HIV-1/2 Anti-HIV-1 Western blot HIV-2 EIA HIV-2 Western blot Anti-HIV-1 Whole Virus Lysate, HIV IFA or acceptable equivalent tests that meet FDA guidelines for donor eligibility for re-entry or reinstatement HIV-1 NAT (TMA is preferred method, individual testing required for HCT/P donors) HTLV-I/II Anti-HTLV-I/II Anti-HTLV Western blot or acceptable equivalent West Nile Virus WNV NAT (TMA is preferred method, individual testing required for HCT/P donors) WNV IgM WNV IgG (not required) Alternate WNV PCR/NAT method Chagas FDA approved methodology FDA approved algorithm Treponema pallidum FDA approved methodology FDA approved algorithm 2.3.6 Immunohematology tests that are optional this procurement: Screening Test (performed on each donation) Supplemental, confirmatory, or as needed tests (performed on some donations as reflex test or upon request) Red cell serology ABO/Rh Antibody screen Antibody identification 2.4 Specimen management 2.4.1 Please describe specimen requirements for the laboratory tests listed in 2.2, including specimen type, anticoagulants, minimum volume, storage and transportation. 2.4.2 The Offeror must be capable of multiple formats for labeling specimens, including industry standard ISBT with ISBT-Code 128 barcode symbology as well as laboratory information system generated alphanumeric identifiers using standard Code 128 barcode symbology. 2.5 Shipping 2.5.1 Please describe packaging and shipping methods proposed for this procurement 2.5.2 The testing laboratory must be able to receive same day or overnight shipments seven days/week. 2.6 Result reporting 2.6.1 The Offeror shall report initial results within 12 hours of receiving shipment. Initial results that are reactive shall be reported immediately. 2.6.2 The Offeror shall report repeat test results within 24 hours of receiving shipment 2.6.3 Observed and numerical results (e.g., OD values and cutoff value or equivalent) shall be reported for all reactive, borderline, or indeterminate specimens. 2.6.4 The Offeror shall provide reports via FAX or via a validated electronic interface. 2.6.5 Follow-up confirmatory and supplemental test results shall be reported within 3 business days after reporting of the repeat reactive screening test.