On February 1, 2019, CMS and CDC published proposed rules to update the CLIA Proficiency Testing Regulations. The PT Regulations had not been updated since first enacted in 1992.
There are several areas wherein changes are proposed:
- For non-microbiology specialties and subspecialties, they propose 29 analytes be added to the regulated analyte list. At the same time, they propose removal of five regulated analytes because they no longer are commonly used. The total number of regulated analytes would rise to 105.
In selecting the additional analytes CMS evaluated the availability of proficiency testing materials that would provide the needed analytes. They required that at least three approved PT providers be available to support the program. They also reviewed the volume of patient testing/analyte performed for each analyte nationwide. They included analytes that had testing volumes of at least 500,000 plus an additional ten analytes that while below the 500,000 threshold were determined to be clinically important.
- In addition, the proposal includes revising the scoring methodology for acceptable performance, a recognition of the improved accuracy and precision of testing available today compared with when first enacted in 1992.
- In microbiology the proposal would institute updates to specify broad categories of tests for proficiency testing. The proposal states that this would enable flexibility for new technologies which have been developed since 1992 and also be appropriate for technologies that will be instituted in the future.
- The proposal also addresses waived proficiency testing performed in moderate and high complexity laboratories. The proposed change would enable CMS to apply the same sanctions for PT referral for waived testing as are in place for the moderate and high complexity testing.
These proposed changes are a recognition of the advances in laboratory technology and methodologies and the availability of analytes either not commonly used or in very limited usage when the original regulations were enacted.
CMS acknowledged that there would probably be an increased cost to laboratories to comply with the new regulations; however, in view of the extensive use of these analytes and in the best interest of patient care, they and most in the laboratory community recognized the necessity of these changes. In addition, the changes were not made quickly or in a vacuum. The CDC and CMS working with the Clinical Laboratory Improvement Advisory Committee spent several years in the development of this proposal.
CMS encourages public comments, questions or thoughts on the proposal and comments must be submitted by April 5. The entire document can be viewed here.
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