Under the CLIA, laboratories conducting moderate or high-complexity testing must enroll in an HHS-approved proficiency testing program to ensure accuracy and reliability. Any lab that intentionally refers its proficiency testing samples to another lab for testing may have its certification revoked for at least one year, in which case the owner or operator could be prohibited from owning or operating another lab for two years.
The final rule from CMS fully implements the TEST Act by giving CMS more discretion in applying sanctions in cases of intentional proficiency testing referrals. “In this rule, we are finalizing three tiered categories of sanctions for a PT referral (including revocation of the CLIA Certificate and/or alternative sanctions) to be applied under certain specified conditions, based on the severity and extent of the violation,” CMS states in a factsheet on the rule. “These categories reserve revocations and the most serious sanctions for the most egregious violations while assigning lesser sanctions and civil monetary penalties to cases involving less serious violations.”
More Articles on CMS Regulations:
CMS’ 2015 IPPS Proposed Rule: 10 Points to Know
CMS Finalizes Payment System for Federally Qualified Health Centers
AHA Asks CMS to Delay Deadline for Low-Volume Payment Adjustment
