New CLIA Proficiency Testing Regulations Coming January 1 – Are You Ready?

Written by Chris Cotreau | December 18, 2024 at 6:52 PM

Testing technology has undoubtedly advanced since 1992, when the Clinical Laboratory Improvement Amendments of 1988 (CLIA ‘88) was introduced. Some of today’s routine tests were not even required then. These factors led the Centers for Medicare & Medicaid Services (CMS) and the Centers for Disease Control and Prevention (CDC) to undertake an extensive review process that resulted in amended CLIA proficiency testing (PT) regulations for the first time in 32 years.

The final rule, announced in 2022, became effective earlier this year. Its implementation date for newly-regulated analytes and updated PT acceptance limits (ALs) is January 1, 2025. CMS and the CDC delayed implementation of these parts of the regulation to align with the calendar year enrollment requirements for laboratories and the annual approval process for PT providers.

What's changed?

Non-microbiology specialties and subspecialties:

29 analytes were added, and five were removed
Acceptable performance criteria, including target values and acceptance limits (ALs), were updated. Analytes have percentage-based ALs with or without additional fixed ALs.

Microbiology:

The wording of the regulations now includes broad testing categories to reflect current practices better and offer flexibility for new technologies.
The regulations now include tests such as bacterial toxins and fungal antigens and require two challenges per test event for antimicrobial susceptibility testing.

For a complete list, see Clinical Laboratory Improvement Amendments of 1988 (CLIA) Proficiency Testing Regulations Related to Analytes and Acceptable Performance.

What does this mean for my lab?

A robust quality control program will quickly adapt to the new requirements, but the scope may cause some concerns, even in the best-performing labs. For example, the updated PT rules mean that specific analytes may need new CalVer TEa’s to prepare for a PT event and be confident the assay is working as expected under CLIA 2024.

Labs can take steps to ensure they’re ready for 2025:

Examine your current CV% and determine if they’re less than half (or ideally less than one-third) of the new percentage limits.
Review past PT evaluation results to determine whether they are close to the new limits and where to focus efforts to improve precision.
Compare the 29 new analytes with your test menu to ensure 2025 PT enrollment where it has not been required in the past.
Review your accuracy and reliability strategy for tests such as bacterial toxins, fungal antigens, and molecular ID to determine whether you now need regulated PT for these tests.

Why is CLIA important?

CLIA was created to ensure the accuracy and reliability of testing in all laboratories, including, but not limited to, those that participate in Medicare and Medicaid, that test human specimens for the purpose of providing information for the diagnosis, prevention, or treatment of any disease or impairment, or the assessment of health, of human beings.

PT helps maintain laboratory testing performance by independently verifying the accuracy and reliability of laboratory testing and personnel competency by testing unknown samples as test patient samples.

Which labs are affected?

Laboratories performing testing for analytes or microbiology subspecialties listed in CLIA regulations (subpart I) must follow the new requirements. The 2022 final rule also clarified that laboratories participating in PT for waived tests are required to treat that PT the same as PT for regulated analytes.

Where can I get answers to my questions?

Consider contacting your PT provider, regulatory agency, or technical consultant for support specific to your lab. For more information, download our white paper, CLIA Proficiency Testing Rule: A Guide to Major Update.

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