SOURCES SOUGHT
Q -- Laboratory Testing Services (Blood Donor Screening)
- Notice Date
- 1/30/2009
- Notice Type
- Sources Sought
- NAICS
- 423450
— Medical, Dental, and Hospital Equipment and Supplies Merchant Wholesalers
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, Office of Administration, 6100 Executive Blvd, Rm 7A07, Rockville, Maryland, 20892-7510, United States
- ZIP Code
- 20892-7510
- Solicitation Number
- 66--P-151567
- Point of Contact
- Barbara J Taylor,, Phone: 301-594-5915, Andre M Moody,, Phone: 301-402-2677
- E-Mail Address
-
taylorb@mail.nih.gov, moody@od.nih.gov
- Small Business Set-Aside
- Total Small Business
- Description
- The National Institutes of Health (NIH) Bethesda, Maryland is seeking qualified contractors to submit their capability statements to provide the following service. 1OVERVIEW 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 TransfusionFor Laboratory Research Use Whole blood6500350 Platelets, pheresis2600 Plasma, pheresis10010 Granulocytes, pheresis200 Leukocytes, pheresis751500 PBSC 20025 Pre-assessment for Research100 Pre-assessment for Transplant500 2REQUIREMENTS 2.1Supplier qualifications 2.1.1The Offeror must be registered with the U.S. Food and Drug Agency for laboratory testing of blood donors. 2.1.2The Offeror must be certified by Centers for Medicaid and Medicare Services for performance of the laboratory tests listed in Section 2.2. 2.1.3The Offeror must agree to scheduled audits by NIH Clinical Center DTM QA Officers of the testing laboratory’s quality management system. 2.1.4The 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). 2.1.5The Offeror must be capable of providing testing services seven days/week except for Federal holidays. 2.1.6The 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. 2.2Test Panels 2.2.1DTM 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 2.3Test methods and algorithms 2.3.1Test methods must be FDA approved for use in blood donor screening and meet minimum sensitivity standards as determined by the FDA 2.3.2Test algorithms must be performed according to current FDA regulation and published guidance, and shall be agreed upon with DTM. 2.3.3Test methods used for supplemental and confirmatory testing shall be FDA approved when an FDA approved method exists. 2.3.4Testing procedures must conform with manufacturer’s instructions and FDA regulations. 2.3.5Specific 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 VirusHBsAg (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 VirusAnti-HCVAnti-HCV RIBA HCV NAT (TMA is preferred method, individual testing required for HCT/P donors)Discriminatory NAT HIV-1/2Anti-HIV-1/2Anti-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/IIAnti-HTLV-I/IIAnti-HTLV Western blot or acceptable equivalent West Nile VirusWNV NAT (TMA is preferred method, individual testing required for HCT/P donors)WNV IgM WNV IgG (not required) Alternate WNV PCR/NAT method ChagasFDA approved methodologyFDA approved algorithm Treponema pallidumFDA approved methodologyFDA approved algorithm 2.3.6Immunohematology 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 serologyABO/Rh Antibody screenAntibody identification 2.4Specimen management 2.4.1Please describe specimen requirements for the laboratory tests listed in 2.2, including specimen type, anticoagulants, minimum volume, storage and transportation. 2.4.2The 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. 2.5Shipping 2.5.1Please describe packaging and shipping methods proposed for this procurement 2.5.2The testing laboratory must be able to receive same day or overnight shipments seven days/week. 2.6Result reporting 2.6.1The Offeror shall report initial results within 12 hours of receiving shipment. Initial results that are reactive shall be reported immediately. 2.6.2The Offeror shall report repeat test results within 24 hours of receiving shipment 2.6.3Observed and numerical results (e.g., OD values and cutoff value or equivalent) shall be reported for all reactive, borderline, or indeterminate specimens. 2.6.4The Offeror shall provide reports via FAX or via a validated electronic interface. 2.6.5Follow-up confirmatory and supplemental test results shall be reported within 3 business days after reporting of the repeat reactive screening test.
- Web Link
-
FedBizOpps Complete View
(https://www.fbo.gov/?s=opportunity&mode=form&id=6844b8c0fe8cccb0d9867c4eab5b8a13&tab=core&_cview=1)
- Place of Performance
- Address: National Institutes of Health, 9000 Rockville Pike, Building 10/CRC, Bethesda, Maryland 20892, Bethesda, Maryland, 20892, United States
- Zip Code: 20892
- Record
- SN01741697-W 20090201/090130221216-6844b8c0fe8cccb0d9867c4eab5b8a13 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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