Regulators warn Missouri hospital that lab's ‘deficient practices' could put patients at risk

Yahoo

31-01-2025

St. Mary's Medical Center officials said they are correcting problems called out by regulators (Suzanne King/The Beacon).
Regulators recently warned officials at St. Mary's Medical Center in Blue Springs that 'deficient practices' at its laboratory, including lax testing procedures and insufficient training, could endanger patients.
The Missouri Department of Health and Senior Services informed hospital officials that they had found the lab to be in 'immediate jeopardy,' the most severe level of noncompliance in health regulation.
The state's Dec. 20 letter said the finding was based on a 'complaint survey' completed on Dec. 17. This survey, or inspection, included an onsite visit Dec. 10-11, a phone interview Dec. 16-17 and additional documentation, the state's report said.
Citing federal regulations, the letter said a finding of immediate jeopardy was made because the lab's noncompliance 'has already caused, is causing, or is likely to cause, at any time, serious injury or harm, or death, to individuals served by the laboratory or to the health and safety of the general public.'
In a written statement, the hospital acknowledged the finding and said it had submitted a corrective action plan to the state.
'We take survey findings very seriously and have taken proactive steps to implement changes addressing issues identified by the Missouri Department of Health and Senior Services,' the hospital said.
The hospital's statement said the hospital is fully operational with 'comprehensive laboratory services.'
'No St. Mary's patients were ever identified as being harmed throughout the survey process,' the statement said.
The Missouri Department of Health and Senior Services (DHSS) conducts surveys of health care facilities in the state on behalf of the U.S. Centers for Medicare and Medicaid Services (CMS).
In this case, said Sami Jo Freeman, a DHSS spokeswoman, CMS identified concerns and directed the state agency to perform a complaint investigation into the laboratory, which led to the immediate jeopardy findings.
Freeman confirmed that St. Mary's officials had responded to the state report in writing.
'Their response has been forwarded to, and is currently under review by, CMS, who will decide if the response is adequate and decide the next steps,' Freeman said in an email.
St. Mary's, an 80-bed hospital owned by the for-profit chain Prime Healthcare, said the immediate jeopardy finding was related to blood bank processes and based on inspections conducted in October 2023, a month before the hospital shifted blood bank services to St. Joseph Medical Center, another Kansas City-area hospital owned by Prime.
St. Mary's statement said blood bank services 'will continue to be provided to St. Mary's patients uninterrupted through this partnership.'
A hospital spokeswoman did not explain why the blood bank process had been shifted to St. Joseph Medical Center in 2023.
She also didn't answer questions about more recent issues raised in the state's December report. The report said the laboratory 'failed to provide blood bank procedures for all blood bank processes that started October 2023.'
The hospital spokeswoman also declined to respond to questions about concerns raised in the report that did not involve blood bank services.
A finding of immediate jeopardy could result in fines, onsite monitoring and the loss of Medicare accreditation. Such a finding is relatively uncommon. One study from 2021 found that less than 3% of hospital citations reached that most serious level.
In 2022, St. Mary's Hospital faced another immediate jeopardy finding, according to a database of inspection reports. That time regulators raised concerns about physical force used against patients in the hospital's emergency department. The immediate jeopardy finding was removed after the hospital implemented an action plan, which included the dismissal of an employee directly involved, executives spending more time in the department and staff education.
The state's December report cited a range of problems with St. Mary's laboratory, many of them relating to testing procedures, documentation, quality control and training.
Overall, the report said, the lab's director 'failed to provide overall management and direction of the laboratory.'
This included failure to 'ensure overall operation' of the lab's blood bank; failure to properly train staff before they performed patient testing; a lack of remedial actions when 'significant deviations' were identified; and quality control lapses, such as a failure to ensure that follow-up crossmatch testing was performed.
The lapses, regulators said, could lead to inaccurate patient test results, which could cause issues or delays of patient diagnosis and treatment. The failures, the report said, 'have a significant potential to cause patient harm.'
The position of lab director is currently posted as an open job on the hospital's website. It isn't clear who was director during the period of time covered by the inspection.
The state also called out the lab's failure to maintain analytic systems, including a lack of laboratory procedures and a failure to perform and document quality control measures.
For example, the report found that the lab didn't document the inspection of whole blood before issuing it. In one case in November, the report said, blood was given to a patient 'without units being labeled and proper procedure was not followed.'
The report said the lab also did not perform alarm inspections on a blood bank refrigerator, and lacked or failed to document certain test control procedures.
The state called out problems with the lab's procedures for urinalysis, saying the machine used in tests, a urinalysis centrifuge, was operating at the incorrect speed. In another instance involving a test for vitamin B12 levels, a test control was not within acceptable limits for several hours, the state said.
This article first appeared on Beacon: Kansas City and is republished here under a Creative Commons license.