Cummings calls for committee hearing on HIV tests at hospital

Maryland General drafts plan to fix lab problems

March 13, 2004|By Walter F. Roche Jr. | Walter F. Roche Jr.,SUN STAFF

A Maryland congressman called yesterday for a public hearing on the release of questionable HIV test results to patients at Maryland General Hospital, terming the matter "shocking to the conscience."

The hospital submitted a detailed plan to the state yesterday to correct the laboratory problems that became public this week.

Rep. Elijah E. Cummings said he was pleased the hospital has taken steps to inform more than 400 patients that they might have received inaccurate HIV and hepatitis test results. But, upset by the problems, he has formally requested that a hearing be held by the Human Rights and Wellness Subcommittee of the House Government Reform Committee.

Cummings, a Democrat who represents the West Baltimore district where the 245-bed community hospital is located, said the hearing would provide a forum to look into the manufacture and use of the testing equipment at Maryland General. "It just made me feel sad. It made me feel angry," Cummings said of the reports of the testing problems.

"It's one thing to not know something. It's another to have knowledge and fail to act," he added, referring to allegations that the hospital was warned that the testing equipment was not functioning properly but failed to address the problems immediately.

Calling HIV tests "a life-and-death issue," Cummings said he was also concerned about the damage the disclosures may have on efforts to get high-risk groups to get HIV tests.

"I have a hard enough time getting people to go to the hospital for tests. This isn't going to help," Cummings said. He pointed out that his district has "one of the worst AIDS problems in the country" and that fighting the disease is "the No. 1 priority" of the Congressional Black Caucus, of which he is chairman.

Cummings said it would be unacceptable "for there to be the slightest doubt" that tests might not be accurate. Citing a 2002 study by the National Institute of Medicine, Cummings said the HIV test disclosures raise new concerns about disparities in the quality of health care provided to minorities.

The congressman made those comments shortly after Maryland General, an affiliate of the University of Maryland Medical System, submitted a formal plan of corrective action to the state Office of Health Care Quality. Agency inspectors concluded that hundreds of HIV and hepatitis C test results sent to patients of the facility over 14 months ending in August should not have been issued.

A nine-page report by the inspectors stated that hospital laboratory personnel manipulated and eliminated data that showed the test results were questionable.

The Sun reported yesterday that a former laboratory worker sent a letter to her ex-boss at Maryland General setting out a long history of safety and accuracy problems with the machine used to conduct the HIV tests. The former worker has filed a multimillion-dollar lawsuit against the hospital and the manufacturer of the test equipment, Adaltis U.S. Inc.

An official of the Pennsylvania-based company declined to comment on the lawsuit yesterday.

In the suit, Kristin S. Turner charges that she became infected with HIV and hepatitis C when the testing equipment malfunctioned and splattered her with infected blood.

A lengthy response submitted by the hospital late yesterday includes new requirements for quality control and periodic retraining of laboratory technicians. It also sets new requirements to ensure that laboratory technicians follow the operating instructions for the testing equipment. Failure to follow those instructions was cited in the state inspection report.

The plan also includes the appointment of an education coordinator to ensure the new training requirements are met.

Maryland General officials also detailed the outreach efforts under way to locate patients who were given the suspect test results. Letters have been sent to the patients and their physicians, the hospital reported, and follow-up telephone calls will be made and a second letter sent to each patient.

The hospital has set up a hot line, and patients can go in to be retested at any time.

The report notes that the hospital will continue to use an outside contractor to conduct the HIV tests. It halted its HIV testing operation in August.

Joan S. Shnipper, a spokeswoman for the University of Maryland Medical System, said yesterday that the hot line set up this week had fielded 54 calls and that eight of those who received the suspect test results have been scheduled for a retest.

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