Reference Laboratory Services for Medical Testing
Original Solicitation Links
RFP797FSS040001R3
]rfp-797-fss-04-0001-r3: 621ii medical laboratory testing & analysis services
Description
This solicitation is for reference laboratory services for medical laboratory testing, intended for the diagnosis, prevention, or treatment of diseases or conditions, and to assist in making clinical decisions for patient care. Offerors must comply with all state, federal, and local regulations, licenses, permits, and accreditations necessary to manage and conduct preanalytic specimen testing services, including holding required state Department of Health permits or licenses for clinical testing on specimens originating in states that require out-of-state licenses or permits. Subcontracting to circumvent these requirements is not permitted; the offeror must meet these requirements independently. Offered diagnostic testing services must be categorized under accepted Special Item Numbers (SINs) and classified according to the Clinical Laboratory Improvement Amendments of 1988 (CLIA). Tests must have CPT codes, and home diagnostic tests are excluded. Reagents used in testing must be FDA cleared or identified as a Laboratory Developed Test (LDT). Only new items are to be provided, and all equipment must be covered by the manufacturer's warranty. The Trade Agreements Act is applicable, restricting purchases to U.S.-made or designated country end products.
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Documents
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