On May 12, 2014 The Centers for Medicare and Medicaid Services (CMS) published the “Final Rule – Promoting Program Efficiency, Transparency, and Burden Reduction; Part II”.  This implements reforms that CMS identified as unnecessary, obsolete, or excessively burdensome on health care providers and beneficiaries, as well as certain regulations under the Clinical Laboratory Improvement Amendments of 1988 (CLIA).

This rule includes adjustments to regulations governing actions taken when the most serious violation of proficiency testing requirements is discovered: that of referring a PT sample to another laboratory.  Under recent regulations, any laboratory that intentionally referred a PT sample to another laboratory for analysis automatically lost its CLIA certificate for at least one year.  CMS has always interpreted the term “intentional” very broadly to mean an intention to act and thus has not considered the circumstances surrounding the referral of a PT sample when imposing revocation.

This regulation from CMS does a better job of explaining exactly what labs can and cannot do with PT samples.  This reflects the inclusion of the recently enacted Taking Essential Steps for Testing Act of 2012 (TEST Act), which gives CMS the express authority to impose alternative sanctions in the event of a PT referral.  Specifically, the word “will” would be replaced with “may” in the regulation that currently requires revocation of a laboratory’s CLIA certificate if it refers a PT sample to another laboratory.

The regulation defines a three-tiered system of penalties for those that break the rules—all the way from mandated education and fines, to shutting down labs.

Three Levels of Penalties

The first category of offense encompasses cases of repeat PT referral or cases in which a laboratory intentionally reports another laboratory’s test results as its own—deliberate cheating.

In these instances, CMS has the authority to revoke the lab’s CLIA certificate for at least 1 year, ban the owner and operator from owning or operating a CLIA-certified laboratory for at least 1 year, and potentially impose a civil monetary penalty.

CMS allows itself a certain amount of discretion when the owner of the lab is a large health system that operates several laboratories. In such a case, a full owner ban could shut down a large number of laboratories in one community, threatening patient care.  In the new regulation, CMS added a provision to limit the reach of the owner ban for laboratories under the same ownership as the revoked laboratory, but only if there is no evidence that the other labs participated or were complicit in the PT referral.

The second category of sanctions apply when a lab refers PT samples to another lab—defined as a lab that operates under a different CLIA number—before the PT event close date, but still reports its own results to the PT program.

In this case, CMS could suspend or limit the CLIA certificate for less than 1 year rather than revoke the CLIA certificate, and include other alternative sanctions, such as training for the lab’s staff.

For the third, least serious category, CMS has the option to use only alternative sanctions, including a civil monetary penalty and CMS-directed staff training.

This category covers a variety of cases in which a lab may unintentionally refer a PT sample to another lab, but catches the error, reports its own results, and importantly, never receives any results back from the second lab. CMS notes this can happen if a reference lab courier mistakenly picks up PT samples along with patient samples.

In the final rule CMS clarified that a referral would not be considered “intentional” if a CMS investigation revealed that PT samples were sent to another laboratory for reflex, distributive, or confirmatory testing; the referral was not a repeat offense; and the referral “occurred while acting in full conformance with the laboratory’s written, legally accurate, and adequate standard operating procedure.”  In effect, this rule clarifies that the laboratory should treat the PT sample like a patient sample up until the point it would refer the patient sample to a second laboratory for further testing; that referral is not acceptable, even if that is the protocol for patient specimens.

An Ounce of Prevention…

Probably the easiest way to avoid accidentally referring a PT sample to another lab involves creating special mock patients in the laboratory information system (LIS).  The lab can flag the mock patient records, noting they should never be sent out. This enables the PT sample to make its way through the lab just like an ordinary patient specimen—one of the cornerstones of PT—but not end up leaving the lab, explained Gary Horowitz, MD, the director of clinical chemistry at Beth Israel Deaconess Medical Center in Boston and associate professor of Pathology at Harvard Medical School.

“We put them in as patients because that ensures they’re handled like patients, but you have to have the flag that says ‘don’t refer’,” Horowitz said. “This system works very well for us. It’s very clean and simple. And to the bench technologist, it’s just another patient.”  Having such a system in place is especially important with reflex testing rules, which are becoming more common as a quality assurance strategy, Horowitz said.

CMS: Survey and Certification Letter  14-33:  May 20,, 2014- Final Rule – Promoting Program Efficiency, Transparency, and Burden Reduction; Part II – Informational Only
J Lapus and K Levitch. CMS Publishes Proposed Changes to CLIA’s Proficiency Testing Regulations.  Mintz Levin- Health Law and Policy matters. Feb 5, 2013.  https://www.healthlawpolicymatters.com/2013/02/05/cms-publishes-proposed-changes-to-clias-proficiency-testing-regulations/
B. Malone.  New Rules For Proficiency Testing Referral. AACC Clinical Laboratory News. August 2014.  https://www.aacc.org/publications/cln/articles/2014/august/new-rules-for-proficiency-testing-referral/
B. Malone.  New Rules For Proficiency Testing Referral. AACC Clinical Laboratory News. August 2014.  https://www.aacc.org/publications/cln/articles/2014/august/new-rules-for-proficiency-testing-referral