Clinical Laboratory Improvement Amendments of 1988 (CLIA) Proficiency Testing Regulations Related to Analytes and Acceptable Performance

On February 1, 2019, the Centers for Medicare & Medicaid Services (CMS) and the Centers for Disease Control and Prevention (CDC) issued a Notice of Proposed Rulemaking [CMS-3355-P].  This notice of proposed rulemaking includes the addition and deletion of analytes requiring proficiency testing and updates criteria for acceptable performance under the Clinical Laboratory Improvement Amendments of 1988 (CLIA).

This fact sheet discusses the changes that CMS and CDC are proposing to make:

For non-microbiology specialties and subspecialties, we are proposing to add 29 analytes to Subpart I of the CLIA regulations, based upon the following criteria:

1.  Current availability of proficiency testing (PT) materials
2.  The number of proficiency testing programs that can provide analytes
3.  Volume of patient testing performed nationwide
4.  Impact on patient health and/or public health
5.  Cost and feasibility of implementation

For microbiology specialties and subspecialties, the proposed rule requires updates to specify broad categories of tests when proficiency testing is required to allow for flexibility of new technologies currently in use and those that may be developed in the future.

The proposed rule amends regulations to reflect how moderate and high complexity laboratories that are also performing waived tests are subject to compliance with PT referral requirements found at 42 CFR §493.801(b)(1) through (6).  This change is to align the regulations with the CLIA statute (42 U.S.C. 263a (i)(4)), allowing CMS to apply sanctions to those laboratories performing waived testing found participating in PT referral.

 

Source: https://www.cms.gov/newsroom/fact-sheets/medicare-program-clinical-laboratory-improvement-amendments-1988-clia-proficiency-testing