Laboratories need to have a clear understanding of the latest regulations and activities pertaining to Proficiency Testing (PT) Referral. Many labs have faced penalties, lost their CLIA certification, and even faced closure due to violation of PT referral rules. While the new regulations from the Centers for Medicare and Medicaid Services (CMS) are more explicit about what is allowed and what is not allowed and are easier to follow, laboratories can avoid PT referral issues only by educating staff on these new regulations and having measures in place for compliance.
PT is a tool that allows the laboratory to verify the accuracy and reliability of its testing. It relies on the integrity of the lab to report its own test results without using another laboratory in any way. Routine reviews of PT reports warn staff and management when and testing falls short of standards and even indicates slight changes and trends that can affect the accuracy of their patient results over time. As it involves review of actual test results, PT is an excellent measure of a laboratory’s performance.
However, there have been many instances when lack of knowledge about CMS rules on PT referrals got laboratories penalized for mistakenly sending PT test samples to another facility. In May 2014, CMS brought out a final rule (“Final Rule”) amending the Clinical Laboratory Improvement Amendments of 1988 by fully implementing the Taking Essential Steps for Testing Act of 2012 (TEST Act) and establishing three categories of sanctions for proficiency testing referral (PT referral).
While there is now more flexibility, this final rule makes it more explicit that laboratories should never send out a PT sample to another lab. Labs must be vigilant, as based on the severity of the PT referral, the Final Rule creates three levels of sanctions for situations of intentional PT referral:
- Deliberate cheating as in cases of repeat PT referral or cases in which a laboratory intentionally reports another laboratory’s test results as its own constitute the first category of offense. Sanctions for these cases include revocation of the CLIA certificate for at least one year, a ban on the owner/operator from owning and operating a CLIA-certified laboratory for at least one year and potential imposition of a civil monetary penalty (CMP).
CMS agrees on some flexibility in the case of owners of multiple laboratories if a ban would result in the closure of several labs in a community, creating issues for patients. Under the new rule, the extent of the ban on an owner of multiple labs will be limited to the revoked laboratory provided there is no evidence that the other labs were involved in the PT referral.
- The second category pertains to moderate violations. A laboratory refers a PT specimen to another facility that operates under a different CLIA number before the PT event close data, and while the laboratory reports its own results to the PT program, it receives results from the second laboratory before the event close date. Here, the penalty could be suspension or limiting of the CLIA certificate by CMS for less than one year as well as alternative sanctions such as training for the lab’s staff.
- Least serious violations such as situations when the samples are referred but the laboratory does not receive the results prior to the PT testing event cut-off date face the third level of sanctions. Such digressions would result in payment of a civil monetary penalty and compliance with a directed plan of correction, including staff training
The final rule clarifies that a referral would not be considered ‘intentional’ if
- a CMS investigation showed that PT samples were sent to another lab for reflex, distributive, or confirmatory testing
- the referral was not a repeat offense
- the referral “occurred while acting in full conformance with the laboratory’s written, legally accurate, and adequate standard operating procedure”
One expert advises that the best way to avoid accidental PT referrals it to treat PT samples like patients by creating mock patient records in the laboratory information system (LIS) and flagging them as ‘don’t refer’. This would ensure that they never leave the lab.
Though the Final Rule offers greater flexibility in dealing with PT referral issues, CMS considers PT referral a grave violation for CLIA-certified laboratories. That’s why laboratories need to be vigilant, review their procedures on PT samples, and update staff on CMS rules on PT sample referral prohibition.