Failures that can affect a laboratory performing only waived testing:
(1) performing tests of moderate or high complexity
(2) failing to follow the manufacturer's instructions (see below)
(3) failing to renew the certificate of waiver
(4) testing performed by people who have not be trained or who cannot perform the test properly
(5) lack of management responsibility
(6) failing to permit an on-site inspection by a CMS representative
Deviations from manufacturer's instructions may include:
(1) running a specimen not approved for the method
(2) modifying the method
(3) modifying the test components
(4) using the test in a situation for which the test is not waived
(5) using expired reagents
