The Centers for Medicare and Medicaid Services (CMS) has published a proposed rule in the September 23 Federal Register (FR pages 58386-58414) that outlines a new enforcement model for sanctioning clinical labs that send their proficiency testing (PT) samples to another laboratory for testing, according to the American Association for Clinical Chemistry (AACC), Washington, DC.

AACCThe current regulations offer little flexibility, requiring CMS to revoke a lab’s certificate and ban the owner and lab director from owning or directing a facility for 2 years.

AACC endorsed the “Taking Essential Steps for Testing Act (TEST)” passed by Congress in 2012, to give the agency greater flexibility in penalizing labs, depending on the severity of the infraction.

The proposed rule would create three categories of sanctions for PT referral:

  • Repeat referral cases: the lab license is revoked for 1 year and the lab owner and director are barred for 1 year. There could also be a civil monetary penalty (CMP).
  • Single infraction: the lab license is suspended or limited in conjunction with other sanctions, including required staff training, a CMP, and a directed plan of action. Further, if the lab license is suspended, state on-site monitoring would be mandated.
  • Lab reports error prior to reporting results: lab would pay a CMP and comply with a directed plan of correction, which would include staff training.

CMS is accepting comments on the proposed rule through November 18.

[Source: AACC]