Laboratory Question for the Week of March 11, 2019

Laboratory Compliance Question of the Week


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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