CLIA Proficiency Testing Final Rule

The Proficiency Testing Final Rule was published on July 11, 2022.

The final rule has been issued for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Proficiency Testing (PT) regulations related to analytes and acceptable performance. This final rule implements revised regulations that the Centers for Medicare & Medicaid Services (CMS) and the Centers for Disease Control and Prevention (CDC) proposed in 2019 to update CLIA PT regulations. The final rule includes:

• The addition and deletion of analytes and microbiology tests that require PT, as well as updates to the criteria for acceptable performance and administrative processes for CLIA PT programs.
• An update to align the CLIA regulations with the statute (42 U.S.C. 263a (i)(4)), which does not exclude waived tests from the ban on improper PT referral.

This final rule will affect laboratories that perform testing for any of the analytes or microbiology subspecialties listed in the CLIA regulations under subpart I. It will also affect any laboratory that participates in PT referral involving waived testing.

The revisions to PT requirements related to addition and deletion of analytes or microbiology tests and updates to the criteria for acceptable performance and administrative processes for PT programs (§§ 493.2 and 493.801 through 493.959) are effective on July 11, 2024, two years after the publication date of the final rule in the Federal Register .

• The delayed effective date reflects the timeframe that CMS and CDC believe PT programs will need to produce the PT samples to meet the revised regulations and incorporate any updates to PT reporting requirements. The delayed effective date also gives laboratories time to subscribe to PT for the new analytes or microbiology tests.

The regulations related to laboratories performing tests of moderate and high complexity testing that also perform waived testing and voluntarily enroll in PT for the waived tests (§§ 493.20 and 493.25) are effective on August 10, 2022, 30 days after the publication date of the final rule in the Federal Register .

Read the CLIA PT final rule in the Federal Register .

Download a CMS fact sheet about the final rule.