What is a clear consequence of modifying a CLIA-waived test?

Modifying a CLIA-waived test results in the test no longer being classified as waived. CLIA, which stands for the Clinical Laboratory Improvement Amendments, has specific criteria that define what constitutes a waived test. These tests are designed to be simple and have a low risk for erroneous results, allowing them to be performed in a variety of settings, including physicians' offices and pharmacies, without the need for extensive training or laboratory oversight.

When a test is altered, it may introduce new variables or complexities that compromise its fundamental qualities. As a result, it would require re-evaluation under the CLIA standards. If the modifications change the test’s complexity or the possibility of obtaining inaccurate results, it no longer meets the criteria for being classified as a waived test. This shift has significant implications for how the test can be utilized in clinical practice, including where it can be administered and who can perform it.

The other options presented may reflect valid considerations in a testing environment but do not directly address the core consequence of a modification to the waiver status of a test. The process of reclassification ensures that the integrity and reliability of testing remain paramount in patient care.