What are the key criteria behind the CMS and CDC CLIA proposed changes to the addition of analytes for non-microbiology specialties?
For non-microbiology specialties and subspecialties, CMS and the CDC propose to add 29 analytes to Subpart I of the CLIA regulations, based upon the following criteria:
- Current availability of proficiency testing (PT) materials
- The number of PT programs that can provide analytes
- Volume of patient testing performed nationwide
- Impact on patient health and/or public health
- Cost and feasibility of implementation.
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