More dubious test results discovered at hospital

Sun Staff

State inspectors have found evidence of more widespread problems withlaboratory work conducted at Maryland General Hospital, including faulty testsfor Legionella bacteria done for patients at a Northwest Baltimore nursinghome.

According to a complaint received by the state, 11 sputum specimens frompatients sat in a hospital refrigerator for two to three weeks last year, eventhough the tests were supposed to be initiated within 24 hours.

Hospital lab staff didn't perform the tests promptly because "they didn'thave the medium," said state Health Secretary Nelson J. Sabatini, referring tothe substance used to detect the presence of the virus. "By the time themedium arrived, the specimens were no longer valid. ... We are investigatingit," Sabatini said.

Sabatini said yesterday that the suspect Legionella test results arefurther evidence that "the lab was not very well run. The problems arepervasive in the whole hospital laboratory."

The Legionella problems occurred in the microbiology section of thehospital's laboratory operations. Previously reported problems with HIV andhepatitis tests occurred in the chemistry/immunology section.

State officials have determined that five samples were mishandled. LeeKennedy, a spokesman for the hospital, acknowledged late yesterday that "testresults may have been invalid," but said a review has shown that other urineand sputum samples from the nursing home were handled properly.

"We're very concerned," said Kennedy, adding that the mishandling of thespecimens was "unacceptable" and that free retests would be offered to thenursing home.

Kennedy said that a comprehensive review of all of the laboratoryoperations was under way with the help of a private consulting firm.

"Basically, we are doing a top-to-bottom review on all levels to ensure thequality of our testing," he said.

State and federal inspectors are analyzing the results of an unannouncedsurvey of hospital lab operations done last week. That visit was triggered bythe discovery that hundreds of HIV and hepatitis test results had been issuedby the hospital despite computer readings showing the results might be invalidand should be discarded.

Health Department spokeswoman Karen Black said the results of thatinspection are not expected to be determined for several weeks.

A limited inspection conducted in January found that laboratory techniciansedited and erased data indicating that the HIV and hepatitis tests might notbe valid. Under laboratory and manufacturer's guidelines, the readings shouldhave triggered an automatic retest.

The 245-bed hospital, an affiliate of the University of Maryland HealthSystem, is continuing efforts to bring in the 460 patients who gotquestionable results for a free retest.

The Legionella tests were conducted about a year ago after a patient atVilla St. Michael Nursing and Convalescent Center was diagnosed withLegionnaires' disease.

According to the complaint received by the state, a copy of which wasobtained by The Sun, laboratory workers repeatedly warned supervisors that anytest results would be invalid because the specimens were allowed to sit in therefrigerator for such a long period. The complaint also refers to theLegionella problem as "only the tip of the iceberg."

Alfred DiBartolo, the administrator at the 200-bed nursing home, said hewas not aware that the tests might not be valid. He pointed out that he wasnot the administrator at the time of the testing.

Kennedy later said that the nursing home had been informed.

No further cases of Legionnaires' disease were reported at the home.

Problems with HIV and hepatitis C testing at Maryland General occurred overa 14-month period ending in August last year, about the same time the facilitystopped using testing equipment manufactured by a Pennsylvania firm, AdaltisUSA Inc.

According to a state inspection report, hospital laboratory personnelmanipulated and eliminated data showing that recently completed blood testsmight be inaccurate. The results were sent to patients despite the guidelinescalling for a retest.

In addition, a former laboratory worker has filed suit in Baltimore CircuitCourt against the hospital and Adaltis, contending that she became infectedwith HIV and hepatitis C as a result of working with faulty testing equipment.

A congressional hearing on the testing problems is scheduled to be held onMay 18 in Washington. U.S. Rep. Elijah E. Cummings, a Democrat who representsthe district in which Maryland General is located, requested the hearing.

The complaint that triggered the inquiry into the Legionella testsindicates that problems in the laboratory were longstanding and well known.

"It is unfortunate that the appalling conditions are scrutinized only aftera former employee becomes infected with life threatening illnesses, files alawsuit and wrong test results are sent out," said the complaint letter, whichwas written by a former Maryland General lab worker who has not beenidentified by state officials.

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