THIS TIME, THE PROVERBIAL CAT MAY BE OUT OF THE BAG when it comes to long-standing dissatisfaction with how federal regulators interpret and enforce CLIA (Clinical Laboratory Improvement Amendments) regulations as they relate to inadvertent errors in the referral of proficiency tests (PT).
For many in the clinical laboratory profession, this issue of THE DARK REPORT will be their first news about the situation at the Ohio State University Wexner Medical Center (OSUWMC), where CLIA officials have sent notice that the laboratory’s CLIA license could be revoked, effective August 10, 2012, and subject to appeal. The sanction is the result of the unintended referral of proficiency testing specimens. It was a situation that the OSUWMC lab self-reported to the Centers for Medicare & Medicaid Services (CMS). (See articles here and here.)
Can you remember the last time it was publicly known that a major, respected laboratory organization had its CLIA license revoked? The closest episode to cancellation that I can recall would be on February 23, 2002. That was when CMS officials issued to Specialty Laboratories, Inc., a “cancellation of approval to receive Medicare payment for all laboratory services.” So, even in that dramatic case, Specialty’s CLIA license was not revoked. In fact, Specialty’s CLIA license cancellation only lasted until June 18, 2002—just 116 days!
So now the entire clinical lab profession will watch as the laboratory of a respected academic medical center could be stripped of its CLIA license because of the inadvertent referral of six proficiency testing specimens since 2009. In the event that CMS prevails at appeal, it could leave OSUWMC officials no option but to transfer ownership of the lab to a new entity and find a new lab director.
This process will likely cost millions of dollars for a lab organization the size of OSUWMC. And what will be achieved by this particular CLIA sanction? The same lab facility will operate with the same lab instruments, manned by the same staff following the same protocols—except as modified in the wake of the root cause analysis for the PT specimen referrals. The only difference will be that the lab will have a new owner and a new laboratory director.
This and similar CLIA license revocations are why members of Congress sponsored bills in both houses to address the CLIA statute’s proficiency testing “Catch 22” language that is the cause of this situation. It would be timely for all of us to contact our members of Congress and urge passage of these bills.