HIV tests spur joint inspection at Md. General

Federal, state agencies, accreditation panel send 9

Suspect results were sent to 400

Hospital cooperating fully with probe, official says

March 17, 2004|By Walter F. Roche Jr. | Walter F. Roche Jr.,SUN STAFF

Responding to reports of suspect HIV laboratory tests affecting more than 400 patients, state and federal inspectors teamed up with hospital accreditation officials yesterday in an on-site survey of Maryland General Hospital.

Lee Kennedy, a hospital spokesman, said nine inspectors from the government agencies and the Joint Commission for the Accreditation of Healthcare showed up at the 245-bed facility.

Although the visit was unscheduled, it was not a surprise. "We expected them to do a survey once we reported the incident," Kennedy said.

Maryland General President Timothy D. Miller said hospital officials were cooperating fully and making sure inspectors "have the information they need."

Kennedy said some of the inspectors were focusing on laboratory operations, but noted that other hospital programs may also be reviewed. He said he did not know how long the inspection would last.

Mark Forstneger, a spokesman for the joint commission, said the agency was making an "unannounced inspection" in response to a complaint and would have a report in about two weeks.

In addition to the joint commission, the inspection team included representatives of the Maryland Office of Health Care Quality and the Centers for Medicare and Medicaid Services, the federal agency that certifies hospitals and other health care facilities.

Kennedy said the joint commission, a private accreditation agency, made a regularly scheduled visit to the hospital in January, but its report on that inspection has not been issued.

Though the accreditation agency can revoke a hospital's certification, that step is extremely rare.

"Most facilities correct the problems and come into compliance," Forstneger said.

The inspection came a week after the disclosure that the hospital's lab sent results of tests for HIV and hepatitis C to more than 400 patients despite indications that they might not be accurate.

State officials uncovered the problem after receiving a complaint from a former worker.

The problems with HIV and hepatitis C testing at Maryland General occurred over a 14-month period ending in August last year, about the same time the facility stopped using testing equipment manufactured by a Pennsylvania firm, Adaltis USA Inc.

During that period, state inspectors found, hospital laboratory personnel manipulated and eliminated data showing that recently completed blood tests might be inaccurate. The suspect results were then sent to patients despite guidelines that called for a retest.

In addition, a former laboratory worker filed a suit last week in Baltimore Circuit Court contending that she became infected with HIV and hepatitis C as a result of working with faulty testing equipment.

That former worker, Kristin S. Turner, also has alleged that Maryland General officials were repeatedly warned that the test results from the machine were unreliable.

The hospital, Adaltis and James Stewart, Turner's boss, were named as defendants in Turner's suit.

The hospital also has initiated a program to locate the 400 patients who received the suspect results and retest them. Kennedy said 36 patients have come in for retests, all with the same negative results as the original test. By the end of this week, he said, the hospital expects to have completed 100 retests.

According to a corrective action plan submitted to the state late last week, the hospital said it would send two letters to each patient and his or her doctor, hire an outreach coordinator and place advertisements in newspapers.

The disclosure about the test results also has prompted U.S. Rep. Elijah E. Cummings, a Baltimore Democrat, to call for a public hearing by a congressional subcommittee to take testimony and gather evidence on the testing problems.

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