Maryland General lab chief on paid leave, won't return

He supervised facility where HIV, hepatitis test results questioned

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

The top administrator in Maryland General Hospital's troubled laboratory has been placed on paid leave and will not return to his job, according to a hospital spokesman.

James Stewart's supervision of the laboratory has been strongly criticized by state regulators, who have threatened fines of up to $10,000 a day if the 243-bed city facility doesn't take immediate corrective action.

He has been on administrative leave for about two weeks and "is not going to return," spokesman Lee Kennedy disclosed yesterday, adding that he could not provide further details regarding personnel matters.

Stewart was one of two top lab officials pinpointed recently in two critical reports by the state Office of Health Care Quality. Dr. Philip Whelan, the medical director of the laboratory, remains in his post, Kennedy said, although he indicated a review of the laboratory and its personnel was continuing.

A private firm, Park City Services of Utah, has been hired by the hospital to manage day-to-day operation of the laboratory. Stewart could not be reached yesterday for comment.

Kennedy also disclosed that the hospital has presented a formal response and corrective action plan to the Joint Commission on Accreditation of Healthcare Organizations, the national certification agency for hospitals and other health agencies.

The private accrediting agency and the state have criticized Maryland General for issuing HIV and hepatitis test findings to patients even though laboratory instrument readings indicated the results might be inaccurate.

State Health Secretary Nelson J. Sabatini has said he is "very disturbed" by what he sees as "pervasive problems."

Kennedy said the hospital has reached and retested about 60 percent of the original 460 patients identified as having received suspect results during a 14-month period ending in August last year.

The hospital has expanded its free retesting program to about 2,000 other patients whose specimens were tested on the suspect equipment.

So far, Kennedy said, the retests have shown that two of the patients who originally tested negative for hepatitis have now tested positive. He noted that the changed results in those two cases do not necessarily mean the original tests were wrong because the patients could have become infected after the original test.

The accrediting organization, like the state, faulted Maryland General for not acting sooner to inform patients.

"The organization was aware at the end of August 2003 that the instrument used for HIV and hepatitis testing did not perform reliably. But [the hospital] did not perform retrospective analysis so as to identify and inform at risk patients until March 2004," the report states.

The faulty equipment, state investigators previously reported, had been pointed out to Stewart by lab employees, but he failed to investigate or correct the problems.

One of those to complain was Kristin Turner, who has filed suit in Baltimore Circuit Court contending that because of a malfunction of the analyzer she was splattered with infected blood and now has hepatitis and tests positive for HIV. Stewart, the hospital and the equipment manufacturer, Adaltis USA, are defendants in the suit.

Turner was fired from her job late last year. The hospital stopped using the Adaltis equipment, known as a Labotech, late last summer.

While the reviews of Maryland General by the state and the accrediting agency focused on the laboratory, the inspectors found problems in other areas, including a patient with HIV who apparently did not receive adequate care in the hospital's emergency room. The accreditation agency report indicates the patient, despite reporting a high level of pain, was not treated.

In its response, the hospital said it was addressing the problem by reviewing and updating emergency room procedures.

Kennedy said a similar corrective action plan will be submitted to the state in a few days.

"As much as we would have liked to prevent these problems before they occurred, that's impossible," Kennedy said, adding that the hospital administration was committed to "restoring the faith of regulators and patients in our laboratory and hospital."

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