Proposed Enhancing CLIA Act Seeks to Reshape Lab Test Oversight

The bill seeks to formalize the Clinical Laboratory Improvement Amendments as the central regulatory authority for these tests. For laboratories like ARUP, the proposal represents a shift toward transparency without the burden of device-level regulation. Jonathan Genzen, ARUP’s chief medical officer, noted that the legislation provides a constructive framework for ongoing industry discussions regarding test quality and patient safety.

The act includes provisions requiring the Centers for Medicare and Medicaid Services to maintain a public database of test performance specifications. It also mandates that laboratories report test errors resulting in serious harm and introduces a voluntary pathway for third-party validation of clinical and analytical validity. If passed, the legislation would provide a two-year implementation delay, allowing the sector time to adapt to the new reporting requirements while preserving existing device clearances.