Question:

What are the key criteria behind the CMS and CDC CLIA proposed changes to the addition of analytes for non-microbiology specialties?

Answer:

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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