CHA News Article

CHA Comments on Proposed Changes to Proficiency Testing Referral Regulations
For Legal Counsel, Laboratory Staff

Today, CHA submitted comments to the Centers for Medicare & Medicaid Services (CMS) on its proposed rule that would update proficiency testing (PT) and referral requirements under the Clinical Laboratory Improvement Amendments.

In the letter, CHA supports the proposal to amend regulations to clarify that moderate- and high-complexity laboratories that also perform waived tests are not required to perform PT for those waived tests.

However, CHA urges CMS not to finalize the proposal that, if these laboratories voluntarily perform PT on waived tests, they would be subject to the full weight of sanctions for PT that is mishandled, as it would unnecessarily increase regulatory burden on laboratories. CHA believes the proposed rule would discourage these laboratories from performing PT on waived tests because the threat of possible PT referral sanctions for such simple tests would outweigh the benefits of the PT process.

Commands