Waived Testing

Extract

The Government Affairs Committee of ASCLS has made it a high priority to understand and attempt to influence the process of test categorization under the Clinical Laboratory Improvement Amendments (CLIA) regulations. The regulations, published in 1992, classify tests as high complexity, moderate complexity, waived, and provider performed microscopic (PPM). The latter two categories of tests are unregulated, in the sense that laboratories that perform them are not inspected and need not perform and report proficiency testing. The Center for Medicare and Medicaid Services (CMS, formerly HCFA) does have the authority to inspect waived and PPM laboratories if it has reason to suspect that they are performing tests beyond the scope of their certificate, or are not following manufacturers' instructions in performing the tests.

Waived testing has been the subject of many newsletter articles and conference presentations recently as concerns about the quality of testing and patient safety have been raised. These concerns have fallen into two areas:

• How are tests classified as waived and do they perform reliably?

• Are the laboratories that do waived tests performing them correctly? There is recent news on both of these fronts.