The Milwaukee Journal Sentinel, as part of its ongoing look at laboratory safety and inspection processes, is reporting the Cleveland Clinic hospital lab that was shut down in March 2015 because it placed patients in “immediate jeopardy” had passed a College of American Pathologists (CAP) inspection just three months earlier.
I drew attention to the closure of the Marymount Hospital lab in one of my News Roundups back in September, but not too many details about what the lab did (or did not do, as it were) to necessitate its closure were available at that time. Fortunately, the Milwaukee Journal Sentinel article fills in a few gaps:
Government regulators found dozens of violations in Marymount Hospital’s lab, including six serious enough to be considered an “immediate jeopardy” to patients, which means the problems are likely to cause serious injury or death.
[Lab workers] used expired chemicals to run tests, failed to calibrate machines, didn’t run quality control checks and had poor procedures in one of the most critical departments of a lab — the blood bank.
Technicians weren’t tracking the temperature of blood being returned to the lab from operating rooms…
The lab wasn’t quickly investigating transfusion reactions, couldn’t find records for patients who had received transfusions, and was using expired products to screen blood for compatibility with patients.
[E]mployees had not been properly trained and weren’t following well-known rules for proficiency testing…
Some employees had not been evaluated on their ability to perform specific tests, and the lab couldn’t provide documentation that they met the educational requirements for their jobs.
Some might be wondering how these deficiencies were discovered if the CAP’s inspection, which the CAP says uses “the most scientifically rigorous customized checklist requirements”, missed them. The answer is: Potentially just dumb luck.
Every year, the Centers for Medicare and Medicaid Services (CMS) randomly inspects up to 2% of labs that had recently been inspected by its deemed accreditation agencies to see how well those agencies are doing their jobs. In other words, the inspectors get inspected. And CMS just happened to choose Marymount this year.