Ohio State University Medical Center
Ohio State University (OSU) recently agreed to pay the federal government $268,000 and replace its clinical laboratory director to settle problems regarding federal proficiency testing. The settlement will allow the laboratory to stay open and continue to be run by OSU.
It was announced in June 2012 that the OSU lab ran afoul of the Centers for Medicare and Medicaid Services (CMS) after it self-reported it had violated the rules governing proficiency testing. Apparently six proficiency testing samples sent to OSU were forwarded to the Mayo Clinic and other labs within the OSU system, which is prohibited by federal law. The tests reportedly included Lyme Disease testing and blood cultures. The problems with proficiency testing in this lab date back to November 2009.
CMS said OSU intentionally defied the proficiency testing guidelines, but OSU says it was unintentional.
In addition to the monetary fine, the clinical laboratory directorship has changed hands. Dr. Daniel Sedmak has taken over the directorship from Dr. Amy Gewirtz. Dr. Sedmak is also the chairman of the pathology department.
Commentary
This is the second time (that I know of) a lab has gotten in trouble with proficiency testing within the last year. Readers will recall Wentworth-Douglass Hospital in New Hampshire voluntarily surrendered its CLIA certificate for one year and agreed to pay approximately $190,000 in fines, fees and expenses after it was discovered it was “…reporting proficiency testing results obtained from another laboratory.”
This settlement is actually relatively good news for OSU. As recently as December 2012, CMS asked an administrative judge to simply close the lab down without so much of a hearing.
OSU has a very strong pathology department and I have a hard time believing this was intentional.
It is far more likely a tech simply forwarded (without thinking) the tests in question to the reference labs as they would any other time those specific tests came through the door. Or possibly one tech didn’t tell another tech the Lyme test they were just handed was a proficiency test sample, etc.
But of course I wasn’t there and don’t know for sure. I just don’t think this was some kind of massive conspiracy to conceal bad laboratory medicine at OSU. After all, it was OSU that reported the violations to CMS. People with something to hide don’t generally turn themselves in.
Source: OSU agrees to settlement to keep clinical lab open | The Columbus Dispatch
Ohio State University’s Wexner Medical Center will pay the federal government $268,000 and has appointed a new clinical laboratory director, part of a settlement reached late Tuesday that lets the lab stay open and under OSU control.
The Centers for Medicare and Medicaid Services levied sanctions this past summer after the lab sent six proficiency-test samples — meant for quality control, not patient diagnosis — to the Mayo Clinic and to another OSU lab for testing. Federal law prohibits a lab from sending such samples to another lab, even within the same hospital system.
The sanctions could have cost OSU millions of dollars in Medicare and Medicaid reimbursement.
The penalties had been on hold during the university’s appeal of the sanctions.
A university spokeswoman couldn’t say yesterday whether the $268,000 payment represents the university’s total costs related to the case.
Dr. Daniel Sedmak, a professor of pathology, has been named the lab’s new medical director. He will replace Dr. Amy Gewirtz, who will remain an OSU employee.
Included in the settlement, the lab’s staff will undergo additional training.
“We are grateful to (the Centers for Medicare and Medicaid Services) for its willingness to work toward a resolution that best meets the needs of our patients and the community,” Larry Anstine, CEO of Ohio State University Hospital, said in a statement.
Officials at the Centers for Medicare and Medicaid Services declined to comment yesterday.
In 2011, Ohio State’s medical laboratory network performed 9.1 million patient tests, 7.24 million of which were performed at the lab in question. It is central Ohio’s only fully automated hospital lab.
The important thing is that nobody’s feelings were hurt and that everybody is a team player. The reputation of the pathology department is not as important.
As a CAP inspector who has seen a near miss over such referrals, I advise labs I inspect to set up rigorous firewalls to ensure that referral of PT material cannot occur. I supervise two labs with separate CLIA/ CAP numbers, owned by our hospital and have made it a policy signed annually by each tech at the satellite that they will not refer such materials to the main lab.
Just one of the many ways being a CAP inspector can help you run your own labs.
Hopefully your thorough policies will prevent something like this from happening to you.
Thank you very much for the comment.