CLIA

After Nearly 3 Decades, CMS Proposes Updates to Proficiency Testing Rules

When the CLIA (the Clinical Laboratory Improvement Amendments of 1988) proficiency testing (PT) regulations were first implemented in 1992, George H.W. Bush was President, gas cost about $1.05 per gallon and the Washington Redskins won the Super Bowl. Lab technology has sure changed a lot since those days. But the PT regulations haven’t been updated to deal with those changes. Until now, that is. On Feb. 4, 2019, CMS and the Centers for Disease Control and Prevention (CDC) finally got around to issuing a new proposed rule to modernize PT requirements.

Background
As of 2017, there were 246,143 CLIA-certified laboratories, 36,777 of which are required to enroll in a CMS-approved PT program and comply with the PT regulations.  There are also currently 81 analytes on the list of regulated analytes requiring proficiency testing. 

Not surprisingly, labs have been calling for PT updates for years, noting that testing has evolved significantly since 1992, current technology is far more precise and tests for analytes that weren’t included in the original CLIA regulations are now in routine clinical use.

CLIAC Recommendations
The Clinical Laboratory Improvement Advisory Committee (CLIAC), the federal advisory committee charged with providing regulatory and lab quality advice to the CLIA program, kicked things off by issuing recommendations for updating PT rules, including: 

  • Updating the list of required PT analytes;
  • Revising scoring criteria for acceptable performance;
  • Updating requirements for microbiology to include broad categories of organisms rather than a list of specific organisms; and,
  • Clarifying requirements for PT referrals. 

In response, CMS published a request for information in December 2017. The new proposed rule responds to the public input from the RFI. 

The 3 Key Proposed Changes 

CMS and CDC are proposing changes in three broad areas:

1 .Addition of 29 Analytes 

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

  • Current availability of 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; and
  • Cost and feasibility of implementation.

2. Updating of PT Categories

For microbiology specialties and subspecialties, the proposed rule would require updates to specify broad categories of tests requiring PT to allow for flexibility of new technologies currently in use and those that may be developed in the future.

3. Revised Referral Rules for Waived Tests 

The proposed rule would amend regulations on how PT referral rules apply to moderate and high complexity labs that also perform waived tests. Specifically, the change is designed to align CLIA regulations with the CLIA statute provisions allowing CMS to apply sanctions on labs performing waived testing found participating in PT referral. 

Deadline to Comment
CMS will be accepting comments on the proposed rule until April 5, 2019.

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