Most waived test systems are simple,rapid tests run at the so-called“point-of-care”(POC), that is with clinicians, laboratory professionals,or lay-users actually running the test and the supervising physician deciding on appropriate use of the test results while the patient is present and sti...
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51、V. DEMONSTRATING INSIGNIFICANT RISK OF ANERRONEOUS RESULT Failure Alerts and Fail-SafeMechanismsGenerally, the risk of an erroneous result should be far less for waived tests than non-waived tests. You should demonstrate in your CLIA waiver application that (1) the test system design is robus...
The fecaloccult bloodtest (FOBT)is one of the most commonly recommended CRC screeningmethods.By: Stephen KincaidEditor: Karen Appold