Inspectors are called too close to hospitals

State health chief tells Congress flaws found at Md. General are systemic

May 19, 2004|By Walter F. Roche Jr. | Walter F. Roche Jr.,SUN STAFF

WASHINGTON - State Health Secretary Nelson J. Sabatini severely criticized the nation's system for regulating hospitals yesterday, warning a congressional subcommittee that patient safety problems as serious as those found at Maryland General Hospital likely are occurring across the country.

"It would be a terrible mistake to categorize this as an isolated incident," Sabatini said. "I believe that the Maryland General experience is merely a symptom of a system failure."

Sabatini and others who testified in the three-hour hearing before the House Criminal Justice, Drug Policy and Human Resources subcommittee acknowledged that inspectors from the public and private sectors repeatedly failed to communicate with each other, failed to follow up on their own inspections and realized the extent of problems only when a second whistleblower came forward.

So it was two years after problems first surfaced that state inspectors began on-site reviews leading to the discovery that a corrective action plan submitted by the Baltimore hospital had never been implemented.

"Patient safety is ultimately a government regulatory responsibility, but we have subcontracted it out," Sabatini said, referring to the system in which private accreditation agencies take the lead in hospital inspections.

Under state and federal law, hospital inspections are routinely performed by the Joint Commission on the Accreditation of Healthcare Organizations. State inspectors, Sabatini said, can only respond to specific complaints.

Sabatini said that Maryland's Department of Health and Mental Hygiene and the federal government share the blame for failing to detect - despite several early warning signs - the severe and widespread laboratory problems uncovered at 243-bed Maryland General.

"I'm not proud of what the state did," Sabatini told the panel, warning that serious problems were likely at other facilities across the country.

Whistleblower Teresa Williams, who worked in the Maryland General laboratory for two years, pleaded with the lawmakers to do something "to prevent this from happening anywhere, ever again."

Her superiors ignored repeated warnings, she said, and lab workers were threatened with the loss of their jobs if they alerted state inspectors.

While some of those who testified said that simply improving communications would prevent future problems, Sabatini said the entire system needs to be overhauled because those performing hospital inspections "have uncomfortably close ties to the industry they survey."

A single agency, he said, needs to be responsible.

"I just want to say this is a mess and, sadly, it is the poor patients who suffer," said U.S. Rep. Elijah E. Cummings, a Democrat who represents the West Baltimore district where the hospital is. "It's a situation where the right hand doesn't know what the left is doing and the head doesn't know either."

He arranged for yesterday's investigative hearing after the disclosure that Maryland General, an affiliate of the University of Maryland Health System (UMMS), issued HIV and hepatitis test results to more than 450 patients even though the readings on laboratory instruments indicated those results might be inaccurate.

Edmond F. Notebaert, UMMS president, said retests have been offered to about 2,100 patients, two patients who originally tested negative for HIV tested positive in the retests and three who had tested negative for hepatitis tested positive.

He said the new results don't necessarily mean the original results were wrong because the status of the patients might have changed. More than 1,000 patients have been retested, hospital officials say.

The hospital issued questionable test results to patients during a 14-month period ending in August 2003 when Maryland General stopped using a blood analyzer called a Labotech.

Notebaert also disclosed yesterday that a Labotech analyzer had been in use at the University of Maryland. But he said it was taken out of service in early March when the Maryland General problems surfaced. No problems have been reported with that machine.

An official of the College of American Pathologists, which examined Maryland General's lab at the behest of JCAHO, acknowledged that the team that conducted two key inspections of the hospital in 2001 and 2003 included inspectors from other health institutions in the Baltimore area.

Dr. Ronald B. Lepoff insisted, however, that experience has shown that the inspection teams retain their independence regardless of their affiliation.

Sabatini countered that such self-inspections were at the root of the problem. Calling the JCAHO-led inspections "collegial," he said the "leisurely" reviews were unlikely to turn up negative results.

Richard Eckloff, an official of Adaltis U.S., which sold the analyzer to Maryland General, blamed the problems on lab personnel and poor procedures, but added that an internal investigation was under way to determine whether there were any problems with the analyzer.

He said that company records showed there were a high number of service calls from Maryland General but that all problems had been resolved.

Dr. Steven Gutman, director of the U.S. Food and Drug Administration division that evaluates testing devices, also testified that he was unaware of any problems with the Labotech. But he said a complaint filed recently by Maryland General was under review. He said that in June or July inspectors will visit the facility in Italy where the machine is manufactured.

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