CEO SUMMARY: Problems at the laboratory of Maryland General Hospital came under scrutiny at a recent Congressional hearing. There was plenty of criticism and embarrassment for several entities which should have detected the problems and reacted to the situation more effectively. Serious questions were asked about how and why so many safeguards failed to detect and correct this situation.
IT WAS A CONGRESSIONAL HEARING marked by plenty of criticism about failures of various inspection teams to identify major problems in the laboratory at Baltimore’s Maryland General Hospital (MGH) for as long as two years.
On May 18, 2004, the House Criminal Justice, Drug Policy, and Human Resources subcommittee conducted a three-hour session to hear testimony from the Maryland State Secretary of Health, a representative from the College of American Pathology (CAP), Medicare officials, FDA officials, and a whistleblower from the laboratory. Testimony was also given by an executive from Adaltis U.S., manufacturer of the instrument which produced unreliable results for HIV and HCV during the 14 months it was operated by the Maryland General Hospital laboratory.
“It would be a terrible mistake to categorize this as an isolated incident,” declared Nelson J. Sabatini, Maryland State Health Secretary during his testimony. “I believe that the Maryland General experience is merely a symptom of a system failure.”
Sabatini has harshly criticized the laboratory inspection and accreditation process. It is now known that, during the years 2002 and 2003, the MGH laboratory had serious operational problems. Yet, following a CAP inspection of the laboratory in April 2003, CAP give it the highest rating: “accredited with distinction.”
Although Sabatini’s criticism is valid on many points, it does reflect political sensitivities. Separate inspection teams from both the State of Maryland’s Department of Health (DOH) and the College of American Pathology made multiple visits to the MGH laboratory during the years 2001 through 2003. None of these inspections uncovered serious problems.
“I am not proud of what we did,” admitted Sabatini. In fact, it was not until a second whistleblower from the laboratory notified the DOH that its inspectors finally uncovered the widespread and ongoing problems within the MGH laboratory.
“Patient safety is ultimately a government responsibility, but we have sub- contracted it out,” observed Sabatini. He was referring to the arrangement where-by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO), CAP, and similar industry organizations conduct inspections under an agreement with the federal government.
Inspections By Peers
During his testimony before the sub- committee, Ronald B. Lepoff, M.D., representing CAP, admitted that CAP’s two accrediting inspections, during 2001 and 2003, were performed using inspectors from other laboratories around Greater Baltimore. He asserted that CAP’s inspectors, although peers, maintained independence and this had been demonstrated during the decades that the CAP laboratory accreditation process has been in effect.
He also characterized the inspections conducted by JCAHO and CAP as “collegial” and “leisurely” and not likely to uncover serious deficiencies.
Sabatini responded to Lepoff’s comments by noting that self-inspections were one factor in the failure of the system to detect serious failings with the MGH laboratory. He also characterized the inspections conducted by JCAHO and CAP as “collegial” and “leisurely” and not likely to uncover serious deficiencies.
The potential harm to patients caused by the laboratory’s failings was highlighted by another witness, the President of University of Maryland Medical System (UMMS). UMMS owns Maryland General Hospital. Edmond F. Notebaert, UMMS President, revealed the results of retesting to date. MGH offered retests to approximately 2,100 patients whose HIV and HCV tests were performed during the 14-month period that unreliable results were generated. Of those retests done as of the hearing date, two patients originally tested negative for HIV now test positive. Three patients who originally tested negative for HCV now test positive.
The failures within the laboratory at Maryland General Hospital are unprecedented. THE DARK REPORT can find no comparable incident involving a hospital laboratory in the past two decades. This magnitude of failure in a hospital laboratory is a unique event, with significant consequences. This type of lab failure has the same potential to spook the public as the crash of an airliner full of passengers.
Violated Basic Lab Tenets
What is most disturbing is that this is an example of how, for almost two years, the laboratory of a 243-bed urban hospital can operate in violation of almost every established principle of operational integrity and quality control! During this time, laboratory staff and laboratory administration knowingly violated the most basic tenets of their training.
The MGH laboratory debacle is a reminder to every laboratory manager and pathologist of how quickly public trust in a laboratory can evaporate. THE DARK REPORT can speculate that Maryland General Hospital is surviving this crisis because it is a community institution.
But what if these events had unfolded in a commercial lab company? How would the public respond to news that this lab company had failed to report accurate test results? It is highly likely that public response would force government regulators to shut down a for- profit lab company that had failed as spectacularly as the laboratory at Maryland General Hospital.