For which reason would a CLIA-waived laboratory be subject to inspection by CMS?

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A CLIA-waived laboratory can be subject to inspection by the Centers for Medicare & Medicaid Services (CMS) for a variety of reasons, including those listed in the options.

Failure to report test results is a serious issue as it directly impacts patient care and safety, potentially delaying necessary interventions. Incorrect modification of tests can compromise the validity and reliability of the test results, which is crucial in a clinical setting where timely and accurate diagnosis can be life-saving. The reporting of a fatal infection reflects potential lapses in compliance with laboratory requirements, as it raises concerns about the laboratory's practices and the potential risk to public health.

When all these factors are considered, any situation that raises concerns about the quality of laboratory testing or patient safety can trigger an inspection by CMS. Thus, the broad scope of potential violations encompasses failure to report, incorrect test modifications, and serious public health hazards like fatal infections, making the correct answer a comprehensive acknowledgment of all these circumstances.

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