Lab workers and other observers sounded the alarm long before federal regulators found that Oklahoma’s Public Health Lab had mishandled COVID-19 samples and had critical staffing shortages.
The Centers for Medicare and Medicaid Services found that the facility failed to properly store and test COVID-19 samples according to the lab’s own guidelines, and didn’t employ enough staff to handle testing volume, according to a report released Tuesday. The agency began an investigation of the laboratory in September after a complaint.
The Oklahoma State Department of Health said in an email Wednesday that it now has “sufficient, well-trained staff.” The agency has also said that it has worked to remedy all other issues investigators found there in September.
When Gov. Kevin Stitt announced last year that the lab would move to Stillwater, one Public Health Lab employee reached out to a state legislator, predicting there would be problems retaining enough qualified workers and that the state would have to outsource important tests to neighboring states, potentially delaying test results.
“I feel that it is a hurried, thoughtless decision that needs reconsideration and more planning,” the lab employee wrote in a letter obtained by The Frontier. “It is truly in the best interest and health of Oklahomans that this issue be investigated further.”
Sterling Zearley, director of the Oklahoma Public Employees Association, was also apprehensive about staffing shortages after the move.
“That is a hard position to fill for that type of work, so that was our biggest concern,” Zearley said.
Zearley thought “here we go” when the lab began to outsource some tests to neighboring states earlier this year during the move to Stillwater.
The Centers for Medicare and Medicaid Services found in its investigation that staffing levels at the Public Health Lab were too low for the volume of testing the lab performs after the move to Stillwater. In Oklahoma City, there were 11 personnel in charge of newborn screening and four clerical staff, as well as other nurses that would help with paperwork. In Stillwater, there were only nine testing personnel and no clerical staff in September, according to the inspection report.
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.
Rep. Ryan Martinez, R-Edmond, spoke out early on against moving the Public Health Lab and wanted to block the transition during the last legislative session. He’s not surprised there have been problems after the move.
“When there is not a good plan and things happen abruptly, these are the kinds of things that happen,” Martinez said. “I think that we should have had a longer conversation and a more thorough process of planning.”
Problems processing COVID-19 samples
The Centers for Medicare and Medicaid Services found a number of problems with the Public Health Lab’s handling of COVID-19 samples. The lab failed to ensure that all COVID-19 samples were tested during a critical 96-hour window of stability and that the specimens were kept at required temperatures during transportation and storage, according to the report.
Investigators also found that the lab accepted COVID-19 samples that had been transported and stored in unapproved collection devices and later did not note that negative test results could be compromised as required by the lab’s own guidelines.
After the lab moved to Stillwater, leadership there could not prove that they had sent updated instructions to couriers and those that submit samples on how to handle and transport COVID-19 specimens to the new location and for new testing methods, according to the inspection report.
And the lab lacked a system to ensure that complaints or issues reported to the lab were filed and looked into, including complaints about delayed results, canceled deliveries and samples that went to the wrong location.
The inspection report detailed issues with patient confidentiality after testing specimens were kept in an unlocked fridge, and in boxes and bags on a table in the facility’s main entryway. The lab also had 29 boxes of expired reagent materials needed for COVID-19 testing.
Lab personnel, particularly new hires, were not given full competency assessments prior to working with patient samples against the lab’s written policies, the report also found.
“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, Oklahoma’s secretary of health and mental health, said in a statement Tuesday. “We are well on our way to fully implementing our plan.”
The Public Health Lab operates under the Oklahoma State Department of Health but is now 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.
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. In a Dec. 6 letter to Health Department leadership, CMS accepted the lab’s correction plan and will do an unannounced onsite visit before the lab is considered in compliance with federal regulations again.
After The Frontier reported in November that the Public Health Lab was under investigation, Oklahoma State Department of Health officials said they had made improvements at the lab in response to the federal inquiry and resolved all findings from the report.
These improvements included 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.
The Public Health Lab’s relocation to Stillwater 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 said it will periodically conduct internal reviews of its processes moving forward.