CEO SUMMARY: “Like peeling back layers of rotten fruit, the deeper state and federal inspectors looked into the management of the hospital’s lab, the more problems they found.”–Editorial, Baltimore Sun, April 7, 2004. Public response to the inspection report of the Maryland General Hospital laboratory has triggered criticism of how providers and accrediting agencies like JCAHO and CAP inter-relate.
AS THIS SCANDAL UNFOLDS, there is growing criticism of those responsible for failures in HIV and HCV testing at Maryland General Hospital’s (MGH) laboratory. Inspections by healthcare accrediting agencies are also now coming under public scrutiny.
“Hospital lab had received highest rating” was the headline in the Baltimore Sun on April 10, 2004. Reporter Walter F. Roche, Jr. wrote “The nation’s primary laboratory accreditation agency gave its highest rating to Maryland General Hospital’s lab in July , failing to detect serious, long-term problems that went unaddressed until a whistleblower’s complaint brought in state inspectors this year.”
“Accredited With Distinction”
The Baltimore Sun then quoted one accrediting agency’s evaluation of the MGH laboratory: “‘Accredited with Distinction,’ the College of American Pathologists [CAP] reported July 16, based on a review conducted in April last year.”
Criticism of the laboratory and healthcare accrediting process is one of the more interesting consequences of the problems recently uncovered in the laboratory at MGH. As disclosed earlier by THE DARK REPORT, for a 14-month period, the laboratory had reported questionable results on HIV and HCV tests to several thousand patients. (See TDR, April 5, 2004.)
The situation was not discovered until Kristin Turner, a former medical technologist at the laboratory, turned whistleblower. In December 2003, after getting no response from hospital administration to letters she sent pointing out problems in the laboratory, Turner then notified state health officials of her concerns.
Turner is the med tech who now tests positive for both HIV and HCV. She claims a malfunctioning lab instrument and management failures were responsible for the lab accident which exposed her to both viruses. She filed a $30 million lawsuit against the laboratory director, the hospital, and Adaltis, manufacturer of the instrument at issue.
Alerted by Turner’s letter, state health officials inspected the laboratory in January. That led to another inspection of the laboratory on March 16, 2004 by officials from the Centers for Medicare and Medicaid Services (CMS), the Maryland Department of Health (DOH), and the Joint Commission on the Accreditation of Healthcare Organizations (JCAHO).
Public Reaction To Results
Earlier this month, the results of these inspections were made public. Negative reaction was strong. State Health Secretary Nelson J. Sabatini declared that the Maryland General case “shows the inadequacy of the whole process” by which accreditation of healthcare providers is done by private organizations closely involved with the healthcare providers they inspect. “We have a totally ineffective process to make sure problems are corrected or people are put out of business,” he noted.
…critics were quick to ask questions about the inspection and healthcare accrediting process. Both JCAHO and CAP were publicly identified and castigated.
At this point, all inspecting agencies are sensitive to these types of criticism. State inspectors had been in the MGH laboratory in November 2003 and did not identify problems during that visit.
Yet, the inspection report made public by the Maryland Department of Health on April 2 contains 60 pages of both serious failures and minor operational deficiencies in the operation of the MGH laboratory. The state has ordered the hospital to take immediate corrective actions or face civil penalties of $10,000 per instance or per day.
On March 19, 2004, Maryland General Hospital retained consulting firm Park City Solutions to become interim manager of the laboratory and implement corrective actions. In early April, Laboratory Director James Stewart was put on a two-week administrative leave and then resigned, according to a hospital spokesperson.
Philip Whalen, M.D. has also resigned as the Medical Director of the MGH laboratory. In the state inspection report, it was noted that “based on a review of records, review of procedures and interview, the laboratory director did not provide overall management of the laboratory.” Whalen will be replaced by pathologist John Braun, M.D.
Less Public Tolerance
This hospital laboratory’s problems trigger three important observations. First, public tolerance for errors and system failures which put patients at risk is disappearing. The level of public debate and comment about the administrative failings within Maryland General Hospital over this matter is substantial—and unusual.
Second, critics were quick to ask questions about the inspection and healthcare accrediting process. Both JCAHO and CAP were publicly identified and castigated by both the local press and state health officials. That is also unusual. It may be a sign of changing public expectations about healthcare quality.
Third, problems within the laboratory itself are a major concern. These circumstances are extraordinary within the laboratory profession. Yet it is important for a detailed evaluation to be done about this situation. Understanding how this lab failed may provide priceless information that other laboratories can use to improve their quality and reliability.