More dubious test results discovered at hospital

Complaint exposes errors at Maryland General's lab

March 26, 2004|By Walter F. Roche Jr. | Walter F. Roche Jr.,SUN STAFF

State inspectors have found evidence of more widespread problems with laboratory work conducted at Maryland General Hospital, including faulty tests for Legionella bacteria done for patients at a Northwest Baltimore nursing home.

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

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 "By the time the medium arrived, the specimens were no longer valid.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

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

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

5 samples mishandled

State officials have determined that five samples were mishandled. Lee Kennedy, a spokesman for the hospital, acknowledged late yesterday that "test results may have been invalid," but said a review has shown that other urine and sputum samples from the nursing home were handled properly.

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

Kennedy said that a comprehensive review of all of the laboratory operations 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 the quality of our testing," he said.

Surprise inspection

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

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

A limited inspection conducted in January found that laboratory technicians edited and erased data indicating that the HIV and hepatitis tests might not be valid. Under laboratory and manufacturer's guidelines, the readings should have triggered an automatic retest.

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

The Legionella tests were conducted about a year ago after a patient at Villa St. Michael Nursing and Convalescent Center was diagnosed with Legionnaires' disease.

`Tip of the iceberg'

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

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

According to a state inspection report, hospital laboratory personnel manipulated and eliminated data showing that recently completed blood tests might be inaccurate. The results were sent to patients despite the guidelines calling for a retest.

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

Congressional hearing

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

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

`Appalling conditions'

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

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