Federal inspectors clear Oklahoma’s public health lab of major infractions
Federal lab inspectors have resolved their major concerns with Oklahoma’s relocated public health lab in Stillwater after re-inspecting the facility, although many types of tests remain outsourced more than a year after the new lab opened.
The reinspection came in February after the Centers for Medicare and Medicaid Services issued a harsh report last fall over testing delays, employee training and inadequate storage of samples.
Oklahoma Watch obtained the latest federal inspection report under the Oklahoma Open Records Act. It showed a few minor paperwork infractions, including inadequate temperature logs and missing patient demographic information. A separate complaint regarding newborn screening was found to be unsubstantiated by federal inspectors. Details of that complaint were not available.
“We are pleased that the latest CMS report found the state’s Public Health Lab (PHL) to be back in substantial compliance, with all three condition-level findings removed,” Keith Reed, interim Health Commissioner, said in a statement. “This reflects the hard work and commitment of staff making significant strides in just a few months. This dedication continues as we now address the remaining standard findings. These CMS surveys are part of our continuous improvement process, and the feedback provided is part of the essential framework necessary for exceptional performance.”
The public health lab has 35 employees, a decline from the pre-pandemic staffing level of 50 at the lab in Oklahoma City. The Stillwater lab is doing newborn screening, some sexually transmitted disease testing and COVID-19 testing and genomic sequencing. It continues to outsource testing specimens for microbiology, mycology, rabies and bioterrorism. Testing for HIV and syphilis is also outsourced, although it is expected to return to the lab soon.
“Although there is not a specific timeline for the return of these tests, we anticipate returning all tests over the next few months,” the department said in a statement. “However, we are more focused on ensuring a quality transition back to the lab versus a quick return, understanding it is a delicate process that can’t be rushed.”
Lab officials are working on new processes to make sure any testing that comes back to the lab is done correctly. That includes writing instructions for specimen collection and for couriers transporting specimens to the lab, a process called pre-analytic collections. Part of the delay in returning testing to the lab has been to make sure data can be securely transmitted with new lab equipment.
“I have to challenge the system, send data loggers through, and prove that specimen never leaves that temperature range,” said Jarrad Wagner, lab director. “If I don’t have the right instructions, and they don’t collect the specimens correctly, that’s on me.”
The lab in Stillwater is full of new equipment, although many pieces of equipment were marked “not in use” during a tour in early April. That equipment is expected to be in use as other testing returns to the lab.
The health department spent more than $6.5 million to outfit the new lab using agency funds made available by using federal CARES Act money for payroll and other expenses during the first year of the pandemic.
“At that time, with the ongoing pandemic, we saw that money best fit to immediately update the (public health lab) and outfit it with state-of-the-art equipment,” the agency said in a statement. “Doing so allowed us to quickly serve Oklahomans in a greater capacity, giving us the ability to expand COVID testing and sequencing for COVID variants.”
When the lab started COVID sequencing, technical issues caused discrepancies between the numbers reported nationally as compared to Oklahoma. Other labs in Oklahoma also report sequencing data directly to the Centers for Disease Control and Prevention.
“When other labs sequence for COVID variants, they report their data to the CDC. They do report to OSDH, but sometimes that is after they have reported to the CDC or another database, causing a delay to our reported numbers,” the agency said. “We are working diligently to share all data that we have from the PHL with necessary databases.”
Planning for a biorepository, which will hold human, plant and animal tissue samples, is underway at the lab. It could hold up to a million samples but will need some retrofitting of the lab, including clearing some existing office space, raising the ceiling and building a vault around the equipment.
The lab continues to be managed by Prairie One Solutions Inc., a nonprofit subsidiary of the Oklahoma State University Research Foundation set up weeks after the announcement of the lab’s relocation to Stillwater in October 2020. Prairie One has been paid more than $2 million to manage the public health lab, the health department said.
Senate Bill 1733, which could be heard on the House floor this week, would exempt nonprofits associated with higher education institutions from the Open Records Act. If passed, it could shut off access to records at the public health lab or the entity created by OSU to manage the state’s share of settlement funds from a lawsuit against opioid companies.
The Oklahoma Pandemic Center of Innovation and Excellence remains a work in progress 18 months after it was announced by Gov. Kevin Stitt. The health department said its completion is dependent on the agency’s application under the state’s $1.87 billion share of American Rescue Plan Act funds. The agency also has authorization to issue bonds for improvements to the Public Health Lab.
The pandemic center plan envisions a research campus around the public health lab that would involve human, animal and agricultural disease research and collaboration with the private sector to promote public health. There are 15 acres available around the existing lab to build the campus. The biorepository would be a linchpin between the public health lab and the pandemic center.
“There’s been a lot of confusion about the (Oklahoma Pandemic Center of Innovation and Excellence) and the public health lab being used interchangeably,” Reed said. “It’s going to be a very collaborative type of enterprise. There will be overlap with equipment and the biorepository, but the public health lab is serving public health needs and OSDH. It will keep doing that, but there will be a point where it becomes an interface with (the center).”
Oklahoma Watch requested a copy of the health department’s application for funding for the research campus. The agency denied the request and referred further questions to the Office of Management and Enterprise Services, which has deemed $18 billion in funding requests as “temporarily confidential” while the governor and Legislature review the applications.
State agencies have requested more than $3.7 billion in American Rescue Plan funds across more than 300 projects. Normally, agency requests for infrastructure or other needs would be vetted publicly through the legislative budget process. State officials have said any approved projects for federal funding would be public information.
Oklahoma Watch, at oklahomawatch.org, is a nonprofit, nonpartisan news organization that covers public-policy issues facing the state.