Editor’s note: This developing story was updated with additional information at 6:45 p.m. CST Nov. 19, 2021.
The Oklahoma State Department of Health said Friday that it had released the results of a federal investigation into its Public Health Lab, but didn’t share a copy of the report with the public.
The agency initially told The Frontier it would have to file an open records request to obtain the document. The Health Department later clarified that it must get final clearance from the Centers for Medicare and Medicaid Services before releasing the report.
The Frontier filed an open records request Friday for the inspection report. The Health Department has been slow to respond to open records requests over the past year, and The Frontier has waited nearly a year to receive some Health Department documents.
Oklahoma State Department of Health officials have declined to answer The Frontier’s questions related to the lab investigation for the past two weeks.
The agency said Friday it has made improvements at the Public Health Lab in response to a federal inquiry. The Health Department made the announcement after The Frontier reported Friday morning that the laboratory was under investigation by the Centers for Medicare and Medicaid Services following months of turmoil after the lab was relocated from Oklahoma City to Stillwater throughout the past year.
The Health Department said it has taken several actions to address issues CMS found at the lab, including modernizing lab security; adjusting staff training protocols; resolving reporting on COVID-19 sequencing results; updating processes for sample collection, and ensuring “proper temperature control, storage and structured transportation of samples.”
CMS, which regulates most laboratory testing for humans, told The Frontier on Nov. 2 that it conducted an on-site investigation of the Public Health Lab from Sept. 21 to Sept. 24 and was still collecting and reviewing information. CMS said additional details wouldn’t be available until it received a response from the lab and the investigative report was released. The agency didn’t respond to follow-up questions.
“We recognize that reviews such as this are crucial to ensuring the highest quality of services possible to Oklahomans, and we have worked alongside CMS throughout the process to achieve that goal,” said interim Commissioner of Health Keith Reed in the press release. “Moving a lab to a new location presents opportunities to improve quality standards and operational efficiency. The CMS review was timely to help us with this endeavor, and we are excited for the opportunity to position our Public Health Lab for long-term success.”
Kenneth Sewell, president of the lab’s nonprofit management group Prairie One Solutions as well as the Oklahoma State University Research Foundation, said Friday he could not provide details of the CMS on-site investigation but that “we are cooperating fully with CMS and committed to maintaining full compliance with all applicable regulatory entities.”
The lab operates under the Oklahoma State Department of Health but is managed by Prairie One Solutions, a recently formed subsidiary of the Oklahoma State University Research Foundation. The facility provides coronavirus testing, disease screenings for newborns, and training for private labs.
Late last year, Gov. Kevin Stitt announced the lab would relocate to Stillwater. Lawmakers, medical groups and lab employees criticized the decision to move the lab away from Oklahoma City’s biomedical hub amid the pandemic and without legislative oversight. The Stitt administration says the move will bolster the state’s rural medical capabilities and bring new investment to the area.
The relocation has been funded by $58 million in bonds previously authorized by the Legislature to replace the state’s old lab as well as federal COVID-19 relief dollars.
At different points throughout the transition, the lab has outsourced screenings for newborns and other tests, including tuberculosis, meningitis, and salmonella, because of equipment relocation and staffing shortages after many employees chose not to relocate to Stillwater, according to Oklahoma Watch and The Oklahoman.
By April, the lab’s new director had resigned after less than four months on the job.
The lab is currently accredited by the College of American Pathologists, though the date of the last on-site inspection was in January of 2019, according to a CAP spokeswoman.
The Health Department will be periodically conducting “internal reviews of our processes” moving forward, according to the department’s statement.