Ohio State settles medical lab sanctions case

ANDREW WELSH-HUGGINS AP Legal Affairs Writer Published:

COLUMBUS, Ohio (AP) -- Ohio State University will pay $268,000 and replace its medical lab director as part of a settlement with federal health authorities over the mishandling of test samples at the university's medical center clinical lab, the university announced Wednesday

The university will also conduct additional training for lab personnel as part of the settlement, which allows the university to continue to own, operate and manage its laboratories without interruption and keep its federal certification. As a result, the university can continue to receive Medicare payments for services.

At issue were quality control samples the government says were improperly sent from the university's clinical lab to other hospital laboratories, including the Mayo Clinic in Minnesota, in violation of university and federal policies that prohibit samples from being analyzed elsewhere.

The tracking involved dummy samples and no patients were affected, the university said. Ohio State, which reported the mistake to the government, said the mishandling was an accident and won't happen again.

The Centers for Medicare and Medicaid Services said for months that it was proceeding with sanctions that would have included loss of the lab's certification and a ban on receiving Medicare payments. The government reiterated its position in a Dec. 11 administrative court filing calling for sanctions against the university.

The university told the government in June that such sanctions would have dire consequences for patients and doctors throughout central Ohio.

Dr. Daniel Sedmak, a professor of pathology and long-time Ohio State doctor, was named the lab's new medical director. He replaces former director Dr. Amy Gewirtz, who will continue her work at the medical center.

The settlement allows the hospital lab's work to continue, said Larry Anstine, CEO of the Ohio State University Hospital.

"Last year the labs performed more than nine million tests and many of those tests are unique and not widely available at other testing facilities," Anstine said in a statement Wednesday. "We are grateful to CMS for its willingness to work toward a resolution that best meets the needs of our patients and the community."

The Centers for Medicare and Medicaid Services declined to comment.

___

Andrew Welsh-Huggins can be reached on Twitter at https://twitter.com/awhcolumbus.

Want to leave your comments?

Sign in or Register to comment.