City hospital's HIV testing manipulated

Evidence of false results ignored by lab workers at Md. General, state says

More than 400 people affected

Hospital president says patients will be notified to return for free re-tests

March 11, 2004|By Walter F. Roche Jr. | Walter F. Roche Jr.,SUN STAFF

Hundreds of patients at Maryland General Hospital might have received incorrect HIV and hepatitis test results during a 14-month period ending in August of last year, and the hospital failed to notify the patients of the problem, state officials say.

"I think this is unconscionable behavior: people not being told about the status of their tests," said Nelson J. Sabatini, secretary of the state Department of Health and Mental Hygiene.

Sabatini said that some patients might have been told they were HIV-negative when, in fact, they were positive. Others might have been told their test was positive when it was actually negative, he said.

A positive HIV test indicates the presence of the virus that causes AIDS. Hepatitis C, for which some patients were tested, can cause a chronic liver infection that could lead to liver failure and cancer.

Acting on a complaint apparently filed by a former hospital employee, state health officials discovered in January that the Baltimore hospital's laboratory personnel overrode controls in the testing equipment that showed the results might be in error, then mailed them to patients anyway.

In an interview yesterday, Maryland General President Timothy D. Miller insisted that executives of the hospital knew nothing about the problem until they were notified by the state in late January.

State health officials, however, said that during their inspection hospital supervisors had admitted to them that the questionable test results should never have been reported to patients.

The testing problem affected about 460 patients, most of whom were tested for HIV, according to Miller. He added that efforts were under way to notify the patients and urge them to return to the hospital for a free re-test.

A special hot line is being set up today for people to call.

"We want to make this right," Miller said, adding that he and other hospital officials were hopeful that in most cases the original test results will turn out to be accurate.

How many patients received incorrect information won't be known until patients are contacted and re-tested. And state and local officials say it might be impossible to reach some because many of the patients are believed to be homeless.

Sabatini said it was too early to determine whether any penalties will be imposed on the hospital. Hospital officials said they planned no punitive action against employees.

59 prove accurate

In what he described as an encouraging sign, Miller said the hospital already had determined that the initial tests for 59 of those patients were accurate. In those cases, hospital records show that the patients had returned for follow-up treatment.

But Miller said one patient who had been told he did not have hepatitis C turned out to have the virus.

"This is the kind of thing that keeps doctors awake at night," said Dr. Jack Manzari, the medical director at the hospital, a 250-bed affiliate of the University of Maryland Medical System. "We are sorry."

Sabatini indicated state officials will accept nothing less than an all-out effort to reach the patients.

"I am adamant that each and every one of the people that could possibly be affected be contacted and urged to come in for a re-test. Just sending a letter is not going to satisfy me," Sabatini said. "They have a right to know and a right to be re-tested."

The testing problem was uncovered by state inspectors who made two visits to Maryland General in January. The inspectors, through interviews with hospital personnel and a review of records, discovered that employees in the hospital's lab deliberately manipulated control test results to eliminate data showing the patients' tests might be inaccurate.

The state inspectors found that over a 14-month period ending in August, 10 percent to 15 percent of the HIV tests performed might have been inaccurate.

Backup test

Miller said the review thus far showed no evidence that patients who were told they were HIV-positive were actually HIV-negative. He said such a result was unlikely because a second test is performed whenever a positive result is reported.

Sabatini and Baltimore Health Commissioner Peter C. Beilenson said in separate interviews that they regard the situation as extremely serious and stressed that they don't yet know the full scope of the problem. Other tests at the facility, Sabatini said, might also be suspect.

The health secretary said that a complete review of the hospital's lab operations will likely be undertaken to determine whether there are additional problems.

"I think we need to go in and do a much more in-depth review of the whole lab operation. How do we know there aren't others?" he asked.

Miller, the hospital executive, said an already completed internal review and the report of an outside consultant showed no other problems. He attributed the problems with the HIV and hepatitis testing to a combination of "human error and equipment problems."

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