CMS Accepts State Department of Health Public Health Laboratory Correction Plan | Covid-19
An inspector from the Center for Medicare and Medicaid Services discovered deficiencies at the Oklahoma State Department of Health’s public health laboratory, which moved to Stillwater, during an October 4 investigation.
The issues included the way the specimens were handled and the understaffing once the lab moved to Stillwater.
According to the CMS report, the laboratory did not comply with the 1988 regulations on the improvement of clinical laboratories in a number of areas. CLIA regulations are federal standards that apply to any facility or site in the United States that test human samples for health assessment or to diagnose, prevent, or treat disease, and are administered by the Centers for Disease Control and Prevention.
Problems found in the report included failure to meet CLIA standards in the areas of virology; maintaining patient confidentiality; document investigations of complaints; establish and follow policies for staff skills assessment and monitoring and assessment of pre-analytical system requirements for various samples, including COVID-19 testing.
The issues were with staff, including having sufficient staff for the volume of tests performed, having written responsibilities and duties for test staff, and having documentation of qualifications available in test files. all senior testing staff.
According to the report, the move to Stillwater affected staff – described as the lab manager failing to “employ a sufficient number of lab staff for the volume of tests performed.”
After the move there were two fewer people for testing and the office staff was reduced from four to none. The office work was absorbed by the test staff.
Pre-analytical systems were a particularly problematic area, with failures to ensure that samples – including samples for COVID-19 testing – were transported and stored under proper conditions and received quickly enough to be stable.
Written policies and procedures in place for patient preparation and labeling, storage, processing and orientation of specimens were not followed, the report said.
A review of patient testing documentation from August and September showed the lab received and analyzed four COVID-19 samples after their 96-hour window expired.
The inspector found that 14 samples were taken using supplies that had not been established in the studies. A follow-up interview found that the transport support tubes in question were used to collect samples from around 100 people per day although they were not part of the facility studies for COVID testing methods. -19 from the laboratory.
Samples delivered by courier have not always been processed in a way that ensures they maintain proper refrigeration and other conditions required for testing for COVID-19, chlamydia and newborns.
Some test reagents were found to be stored at room temperature, which was above their required temperature range for storage. Documentation for testing the refrigeration equipment was missing and the thermometers were out of date.
There was also a failure to ensure that the reagent material used in testing was not expired.
The Frontier first reported in early November that the lab was under investigation.
On November 19, OSDH issued a statement saying that it had published the results of this CMS inspection, but that a copy of the report was not included.
“As a regulatory agency, OSDH appreciates the work CMS has done to identify the opportunities for improvement presented in this report,” Acting Health Commissioner Keith Reed said in the statement. “We recognize that reviews like this are crucial to ensuring the best possible quality of service to Oklahomans, and we have worked alongside CMS throughout the process to achieve this goal. Moving a laboratory to a new location offers opportunities to improve quality standards and operational efficiency. The CMS review came at the right time to aid us in this endeavor and we are delighted with the opportunity to position our public health laboratory for long term success.
OSDH said the lab has taken steps to address and resolve all of the report’s findings, including modernizing lab security; review and adjust staff training protocols; improve and verify test procedures; update sample collection processes; ensure proper temperature control, storage and structural transport of samples; resolve reports of COVID-19 sequencing results and transfer the lab’s CLIA number following the completion of the move from Oklahoma City to Stillwater.
OSDH will periodically conduct internal process reviews to identify areas for continuous improvement, the agency said.
“The PHL team responded quickly to the findings of this report and put in place the appropriate systems that will continue to move the lab forward,” Health and Mental Health Secretary Kevin Corbett said in the statement. .
He was confident that the lab has well-trained staff, the right resources and cutting-edge technology.
Corbett called the last few years “difficult” to be in public health and expressed his appreciation for the service of the PHL staff.
The CMS report was released to state media on Tuesday. A request for CNHI public records made by state journalist Janelle Stecklein in November.
On Tuesday evening, OSDH issued a statement indicating that it had received acceptance of its remediation plan by CMS.
On Monday, CMS sent a letter addressed to Jarrad Wagner – whom he identified as the director of the Oklahoma State Department of Health’s public laboratory – saying he accepted the PHL documentation as credible proof of correction.
Before the lab is considered compliant, an unannounced on-site visit will be made to verify that the corrections have been made, the agency wrote.
Corbett said the initial report was not as favorable as OSDH would have liked, but he believes the path to correction is clear and more than attainable.
“We are on the right track to fully implement our plan,” he said. “CMS has confirmed that we have met the compliance requirements. We look forward to their follow-up visit.
In October 2020, Governor Kevin Stitt first announced that he was moving the public health laboratory – which StateImpact had reported was in such a state of disrepair that it was once at risk of losing its accreditation – from Oklahoma City in Stillwater, where it would be hosted by Oklahoma’s new Pandemic Center for Innovation and Excellence as part of an effort to leverage partnerships in agriculture, human and animal sciences.
The announcement surprised lawmakers, who weren’t happy to have been left out of the decision-making process, and the transition was not without problems.
The move from Oklahoma City resulted in staff resigning and causing delays in processing some tests.
Oklahoma Watch reported in February 2021 that the lab was facing a staffing shortage after longtime staff refused to move to Stillwater and the need to move equipment from Oklahoma City to the new location forced the State to subcontract certain tests to private laboratories.
In April, PHL director D. Michael Kayser, who had been appointed to the post in January, resigned.
On July 14, PHL’s scientific director Dr Jared Taylor said most tests were done in Stillwater, including newborn screenings, testing for sexually transmitted infections and COVID-19 tests. Tuberculosis testing was still contracted out and was due to return to the PHL later in the calendar year, while rabies testing was the only test that continued to be performed in Oklahoma City. This test was due to be transferred to the Animal Disease Diagnostic Laboratory at Oklahoma State University in the fall.
Prairie One Solutions, a nonprofit affiliate of the OSU Research Foundation, headed by OSU’s vice president for research, Kenneth Sewell, is responsible for managing the lab.