Many clinical laboratory directors are unaware that CLIA officials have proposed heavy sanctions against the medical laboratory of the Ohio State University Wexner Medical Center, located in Columbus, Ohio. The enforcement actions include possible revocation of the lab’s CLIA license because of the inadvertent referral of proficiency testing specimens by the OSUWMC lab.
This is a significant event for the clinical laboratory profession. It will certainly catch the attention of those pathologists who serve as laboratory directors in labs holding Clinical Laboratory Improvement Amendments (CLIA) certification. It is extremely rare for any first-rank medical laboratory organization to face the possibility of having its CLIA license revoked by CLIA officials.
Clinical Laboratory Case Was Subject of News Stories in Columbus
This case was made public on July 15, 2012. That is when NBC4i television news of Columbus, Ohio, broadcast a story reporting that officials from the Centers for Medicare & Medicaid Services (CMS) had sent a letter to the OSUWMC laboratory director stating that it had found the clinical laboratory to be non-compliant with CLIA requirements during a survey of the lab conducted on March 28, 2012.
On the subject of proficiency testing (PT), it is the language of the CLIA (Clinical Laboratory Improvement Amendments) that creates a Catch 22 for medical laboratories. Labs are required to handle PT specimens like they handle patient specimens. CLIA also directs laboratories not to refer PT specimens to outside laboratories. Yet, inadvertent referrals of PT specimens do occur, generally as a result of human error. In these cases, CMS officials interpret the language of CLIA to require severe sanctions when such deficiencies occur.
Based on a list of deficiencies presented in the CMS letter, which was dated June 11, 2012, CMS proposed to revoke the lab’s CLIA certificate, effective on August 10, 2012. OSUWMC has appealed this action.
At the heart of this matter is the inadvertent referral of proficiency test specimens to an outside laboratory. OSUWMC’s laboratory director responded to the notice of deficiencies from CMS with a letter dated June 25, 2012. In this letter, it was disclosed that a total of six PT samples had been inadvertently referred to outside laboratories between 2009 and the present. It was also noted that the laboratory had self-reported these inadvertent PT specimen referrals to CMS and had taken immediate corrective actions.
More Cases of Medical Laboratories Facing Sanctions for PT Violations
Lab industry insiders tell our sister publication, The Dark Report, that the case of the clinical laboratory at Ohio State University is not unique. Over the past 24 months, an unknown number of high-profile clinical laboratory organizations have found themselves ensnared in CLIA enforcement efforts resulting from the discovery that PT specimens were inadvertently referred to an outside laboratory.
During these past two years, two things seem to be different in how CMS officials enforce instances of inadvertent proficiency test referrals that come to their attention. First, there may be a larger number of hospital and health system laboratories—including some highly-respected and prominent institutions—found to have been in violation of this aspect of CLIA regulations, compared to earlier years.
Second, administrators of some of those clinical laboratories that were the subject of CMS enforcement actions for the inadvertent referral of PT specimens indicate that the severest of sanctions are being imposed by CMS. This can include revocation of the lab’s CLIA certificate. In such situations, the sanctioned organization is banned from owning a laboratory for two years and the laboratory director is banned from directing a CLIA-licensed laboratory for two years.
Evidence the CLIA officials have increased their enforcement of inadvertent proficiency test specimen referrals is not yet visible in the CLIA Laboratory Registry. This is the public record maintained by CMS on its website. Due to internal processes, CMS does not post each year’s report of laboratory sanctions and enforcement actions until almost a full year later. Thus, only actions taken through the end of 2010 are posted on the CLIA laboratory registry at this time. The activity that occurred during 2011 will not be posted until later this year and the activity of 2012 will not be posted until the end of 2013.
Inadvertent PT Specimen Referrals Are a Catch 22 for Nation’s Labs
It is extremely rare for a clinical laboratory with the reputation and credibility of Ohio State University Wexner Medical Center to face CLIA sanctions that include possible revocation of its laboratory’s CLIA certificate. Yet, this has apparently happened with some frequency in recent years, but the laboratory organizations subject to these actions have kept their cases out of the public eye.
Early in June, bills were introduced in both houses of Congress that would provide more definitive guidance to CMS in how to interpret CLIA language as it pertains to proficiency testing and inadvertent referrals of PT specimens to outside laboratories. It is believed that most of the Senators and Representatives who are listed as supporting these bills have clinical laboratories in their districts and states that have faced sanctions by CLIA officials for inadvertent referral of PT specimens.
Given that every CLIA-licensed medical laboratory is just one inadvertent proficiency test referral away from facing similar severe sanctions, The Dark Report devoted its latest issue to a full reporting and analysis of CMS interpretation and enforcement CLIA in response to situations where a medical laboratory has inadvertently referred a proficiency test specimen to an outside laboratory.
As a public service, any pathologist currently serving as a laboratory director of a CLIA-licensed laboratory may receive a complimentary copy of this special issue of The Dark Report. The request should be sent to: info@darkreport.com and should include a full mailing address.
OSUWMC’s Public Statement About the CLIA Matter
Finally, the public communications department at Ohio State University Wexner Medical Center did provide a statement to NBC4i about this matter. The statement as published by NBC4i is: “This letter from CMS constitutes only a notification of a potential action against The Ohio State Wexner Medical Center’s laboratory. The Ohio State Wexner Medical Center intends to provide additional information to CMS as part of the process of appealing against the potential action. Once CMS reviews this additional information Ohio State is confident that the government’s concerns will be addressed. The laboratories at Ohio State’s Wexner Medical Center perform approximately 9.6 million patient tests and 9,200 proficiency tests a year and have been fully accredited by the College of American Pathologists since 1969. This is the first self-reporting of this nature that the laboratories at Ohio State’s Wexner Medical Center have had to make.”
Related Information:
THE DARK REPORT charter membership
Report: OSUMC Lab Faces Sanctions
Link to NBC4i.com posting of the CMS letter to OSUWMC
OSU lab in trouble over test samples; no one at risk
OSU is appealing medical-lab sanctions
Ohio State lab at risk of losing Medicare funding for CLIA violations
The Dark Report laboratory intelligence
Living in Utah, I found this page by clicking on a link from Twitter. Happy I did. Great topic. Keep up the Excellent Work.
Response to Mr. Friedman:
Once a test is categorized as waived by the FDA, there’s not much CMS can do about it. A certain percentage of waived labs are surveyed each year to be sure they are following the manufacturers’ directions for waived testing, and if the surveyors find a problem they can address it. But that leaves a lot of waived labs and tests unsurveyed, and personally I’m uncomfortable with some of the more recently approved waived tests, specifically the handheld electrolyte analyzers. Hopefully nothing much can go wrong with those test modules, and hopefully they are difficult for an operator to mess up. I’d hate to think what could happen if an electrolyte imbalance was misdiagnosed due to operator error.
It is interesting that CMS is taking a hard look at personnel requirements, PT issues (as it should) and LDTs (for which some of its actions can be debated) but is not being more aggressive with cracking down on the spread of waived testing modalities and the incipient potential harm associated with the spread of waived testing; which by its very definition is ludicrous “…•Employ methodologies that are so simple and accurate as to render the likelihood of erroneous results negligible; or
•Pose no reasonable risk of harm to the patient if the test is performed incorrectly;
•Are cleared by the Food and Drug Administration for home use.
In these cases, especially with large state-of-the-art labs, ignorance can’t be an excuse. There have been many communications sent to state CLIA surveyors (who presumably transmit them to surveyed labs), proficiency testing providers, and laboratory directors emphasizing the seriousness with which CMS regards proficiency testing. Additionally, most if not all proficiency testing providers include instructions with the test samples to NOT actually send the sample(s) to a reference lab, even if they would normally do so, but only to indicate on the answer form that such a sample would be referred out.
Proficiency testing tests the entire process from sample receipt and handling to final report. Part of that process is being able to read and follow the instructions of the PT provider. If some of the instructions are not being followed, the rest of the testing process may also be called into question.
And what about the training these laboratorians received regarding PT testing? Did someone instruct them in correct handling of the samples?
As a former CLIA surveyor and program manager, I sympathize with the angst these large labs are having. But the law is there for the reading, and if a doctor accepts the role of laboratory director, he must also accept responsibility for knowing the law and adequately training his techs–especially about something that can potentially shut him down for two years.