Medical review officer.

CFR · 2024-01-01 · US · Title 10

(a) (b) (1) The laboratory employs an MRO who reviews test results produced by the laboratory; (2) The laboratory has a contract or retainer with the MRO for the review of test results produced by the laboratory; (3) The laboratory designates which MRO the licensee or other entity is to use, gives the licensee or other entity a slate of MROs from which to choose, or recommends certain MROs; (4) The laboratory gives the licensee or other entity a discount or other incentive to use a particular MRO; (5) The laboratory has its place of business co-located with that of an MRO or MRO staff who review test results produced by the laboratory; or (6) The laboratory permits an MRO, or an MRO's organization, to have a financial interest in the laboratory. (c) (1) In carrying out these responsibilities, the MRO shall examine alternate medical explanations for any positive, adulterated, substituted, invalid, or dilute test result. This action may include, but is not limited to, conducting a medical interview with the donor, reviewing the donor's medical history, or reviewing any other relevant biomedical factors. The MRO shall review all medical records that the donor may make available when a positive, adulterated, substituted, invalid, or dilute test result could have resulted from responsible use of legally prescribed medication, a documented condition or disease state, or the demonstrated physiology of the donor. (2) The MRO may only consider the results of tests of specimens that ar

official document · source cfr-2024 · id 10:§ 26.183