THERE’S A REGULATORY TRAP awaiting the unwary laboratory organization. It involves language in CLIA rules for proficiency testing (PT). All medical directors and lab administrators will want to fully understand the implications of what appears to be an emerging trend in CLIA laboratory enforcement.
In recent years, an ever-greater number of labs have unwittingly found themselves in a classic Catch-22 situation. In simplest terms, CLIA regulations call for a proficiency test specimen to be handled according to the lab’s “normal/standard” procedures. That often means that a positive result may be sent to another laboratory for confirmation. yet CLIA rules also state that PT specimens are not to be sent to another lab.
Therein lies the Catch-22. If the med tech handling the PT specimen follows the lab’s protocols and sends it out for confirmation, CLIA regulators are deeming that to be a violation which puts the laboratory’s CLIA license at risk of suspension or revocation. But, if the med tech did not follow the lab’s procedures by sending out the PT specimen in the same manner that a patient specimen would be handled, that can also be a violation.
This is a high stakes situation. Medical directors can face a two-year ban from being medical director of any CLIA-licensed laboratory. As you will read on pages 6-8, a New Hampshire hospital laboratory has a one-year CLIA license suspension due to this situation and a major laboratory organization has been forced to change its ownership for two years.
We asked attorney Jane Pine Wood to provide an overview of this Catch-22 situation in this issue of THE DARK REPORT. She has represented multiple laboratories that found themselves enmeshed in this exact situation.
Until now, almost nothing has been written about this growing problem. One reason for this is the fact that most laboratory organizations caught in this situation try to keep that news out of the public eye. That is understandable. Having a CLIA license suspended or revoked is certainly not something any lab wants made public. On the other hand, this Catch-22 cannot be fixed or resolved unless labs that find themselves victims to this contradiction in CLIA rules speak out about the injustice of the situation.
It is important to remember that sunshine is the disinfectant to regulatory problems. That is why I encourage any of you experiencing this Catch-22 to contact us here at THE DARK REPORT and allow us to tell your lab’s story.