Citing a delay due to resources and the COVID-19 pandemic, the Centers for Medicare & Medicaid Services (CMS) extended the timeframe for finalizing proposed CLIA regulatory changes regarding integrity and proficiency testing previously announced.

In 2019 the CMS released a proposed regulation “the Clinical Laboratory Improvement Amendments of 1988 (CLIA) Proficiency Testing Regulations Related to Analytes and Acceptable Performance.” This proposal would update PT regulations under CLIA to address current analytes and newer technologies. Also, the proposed regulation offered additional technical changes to PT referral regulations to align with statute. This is the first update to the CLIA PT regulations since its inception.

In 2019, the CAP encouraged the CMS to add additional regulated analytics to the current CLIA program. Moreover, the CAP supported the agency’s effort to modernize the proposed regulations updating the analytics to align with clinical laboratory practices. The CAP encouraged the updated list of regulated analytes, including the addition of the 29 and the deletion of six proposed analytes. The CAP also supported some changes to the PT programs, such as allowing a CMS onsite visit, re-affirming non-profit status for PT providers, and outlining parameters for PT programs to set up peer-groups and PT offerings.

In addition, the CAP urged the CMS to consider adding analytes in the specialty of toxicology. The CAP also asked the CMS to clarify the regulations of the administrative responsibilities required to be non-profit, peer-group requirements. Finally, the CAP urged the CMS to rescind several proposals from the rule because of the potential burden and cost to laboratories. These proposals include laboratories’ declaration of patient reporting practices to PT programs, reporting microbiology organisms to PT programs at the highest level, and the one-time online submission of PT data. The CAP emphasized a key to modernizing PT regulations is to fix the cytology PT program and allow electronic signatures with electronic PT submissions for regulated analytes.