Tuesday, May 18, 2004

A lack of communication between laboratory inspection agencies, whistleblowers who were ignored, and equipment problems were to blame for bad HIV and hepatitis test results at Maryland General Hospital, according to testimony in a congressional hearing yesterday.

The session, organized by Rep. Elijah E. Cummings, Maryland Democrat, was intended to probe for systemic problems with laboratory testing protocols and outside inspections that may have been exposed by the nearly 460 questionable results the Maryland General lab sent to patients.

Maryland Health Secretary Nelson Sabatini pointed out there are four different groups responsible for oversight of hospital labs — the state and federal governments, and two independent accrediting groups.

The four rarely share information and have different approaches to inspection and enforcement, Mr. Sabatini said.

In the Maryland General case, all “dropped the ball,” by failing to realize and correct the problem, he said.

“We can assume that Maryland General’s problems are not unique to the industry,” he said.

A subcommittee of the House Government Reform Committee heard testimony that included the maker of the equipment used in the tests, the head of an accrediting agency that gave the lab a top rating, even while the bad tests were being produced, and a former Maryland General employee who alerted the state to the problems.

The consensus, according to Mr. Cummings, is that changes might be needed in how hospital labs are monitored to ensure more information is shared by different agencies. He also said more scrutiny is needed of the testing machines, about 170 of which are currently used in labs nationwide.

“The Maryland General Hospital situation is just the tip of the iceberg that has national implications,” said Mr. Cummings, whose Baltimore district includes the hospital.

Part of the University of Maryland Medical System, Maryland General provides health care to many of the city’s poor residents.

During a 14-month period that ended in August, the lab sent out HIV and hepatitis blood test results to patients despite instrument readings that showed the results might be errors.

That lab later agreed to retest more than 2,000 patients, and 99.6 percent of the HIV tests turned out to be correct, according to Edmond Notebaert, president of the university medical system.

Maryland General’s president and top lab officials were fired. The College of American Pathologists, which had reaccredited the lab in April 2003 without uncovering the testing problems, suspended its accreditation of two lab divisions.

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