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Public Health Lab had issues with staffing, storing COVID-19 samples, CMS report shows

Daily Oklahoman - 12/7/2021

Dec. 8—A federal investigation into Oklahoma'sPublic Health Lab found that the lab lacked enough staff for the volume of testing it handles after its move to Stillwater, a report detailing the findings shows.

The on-site investigation conducted by the Centers for Medicare and Medicaid Services began on Sept. 21 and also found issues with how COVID-19 samples were stored, documented and processed according to guidelines, according to a report obtained Tuesday by The Oklahoman.

Without releasing the report, the state Health Department acknowledged the investigation in a statement after The Frontier reported Nov. 19 the lab had been the subject of a CMS review. A complaint sparked the investigation, the interim health commissioner said the following week.

The Health Department said it took action to address and resolve all findings in the report, including:

— Modernizing lab security

— Reviewing and adjusting staff training protocols

— Ensuring proper temperature control, storage and transportation of samples

— Resolving reporting on COVID-19 sequencing results

The Health Department said in a news release Tuesday evening that CMS approved of the Public Health Lab's correction plan.

"Although some aspects of the original report were not as favorable as we would have liked, the path of correction is clear and more than attainable," Kevin Corbett, the state's secretary of health and mental health, said in a statement. "We are well on our way to fully implementing our plan. CMS has confirmed we've met the requirements of being in compliance. We are looking forward to their follow-up visit."

Keith Reed, the interim health commissioner, said the CMS review was timely and "provides us the opportunity to ensure the highest quality of services possible to Oklahomans."

"Moving a lab to a new location presents challenges but also brings with it new opportunities to improve quality standards and operational efficiency," Reed said.

The Public Health Lab has been under scrutiny since the lab's controversial move to Stillwater from Oklahoma City, which staff said came as a shock to them. About a third of employees either resigned, retired or took new jobs within the state government after the announcement.

In the report, CMS found that before the move, the lab employed 11 testing personnel and four clerical staff members for newborn screening.

After the move, personnel records showed nine testing personnel and no clerical staff.

The testing staff had an increased workload: An additional testing protocol was added to the screening, and they had to manually enter demographic information into the screening system, which had previously been done by clerical staff at the old lab location. Their testing volume before and after the move stayed the same.

In response to CMS's findings, the Public Health Lab plans to have three additional employees work on data entry for newborn screening, though that could be increased if necessary. One has been hired, and two positions are vacant. A testing personnel position also needs to be filled, the state said in its response to CMS.

Newborn screenings, which are blood tests that look for certain hidden genetic disorders in infants, were outsourced to a lab in Pennsylvania in March, after the lab's director learned Oklahoma wasn't testing for a genetic marker most other states include in newborn screenings.

The screenings resumed in-house at Oklahoma's lab in June.

Among the reports other findings were:

— COVID-19 test samples had been left in an unlocked, unmonitored area, so patient confidentiality wasn't protected.

— In response, the lab now keeps its front door permanently locked and changed the door code. The state said "there is no indication that patient confidentiality was adversely affected."

— There was no system to document complaints or problems that arose in the lab.

— In response, the lab now has such a system.

— The lab lacked documentation that test samples were kept at the proper temperature when they were transported.

— In response, the lab bought thermometers and set up a log for couriers to track samples' temperatures during transportation.

— Some COVID-19 test samples were processed past their 96-hour window of stability.

— In response, operating procedures were updated so that only samples received within their stable window will be tested.

A CMS spokesperson declined to respond to questions about the inquiry, saying it doesn't comment on ongoing investigations.

CMS regulates all laboratory testing in the U.S. through the Clinical Laboratory Improvement Amendments, or CLIA, program. The agency reviews labs across the country for quality and safety.

Reed, the interim health commissioner, said in late November that the Health Department was screening applicants for the next director of the Public Health Lab.

"Hopefully, we'll have a permanent lab director identified very soon," Reed said then.

The previous director, Dr. Michael Kayser, submitted his resignation notice in April, about four months after the department announced he had been hired to lead the lab and the Oklahoma Pandemic Center of Innovation and Excellence.

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