Hospital was told of faulty HIV tests

Ex-Md. General worker sent letter in December

Former employee files suit

Woman says flawed gear infected her with diseases

March 12, 2004|By Walter F. Roche Jr. | Walter F. Roche Jr.,SUN STAFF

A former laboratory worker at Maryland General Hospital warned her ex-boss last year of serious safety and accuracy problems in equipment used to perform HIV and other tests - problems the hospital had said it didn't learn of until January.

Kristin S. Turner wrote her former boss Dec. 7 reminding him he had known for many months of equipment defects that could cause patients to receive inaccurate test results and that led her to become infected with HIV and hepatitis C.

State officials investigated in January and concluded that hundreds of patients tested for HIV and hepatitis C might have been misinformed about the findings, The Sun disclosed yesterday.

Maryland General President Timothy D. Miller said this week in an interview that the hospital had "absolutely no indication" of problems until the state investigation ended.

Yesterday, however, Maryland General spokeswoman Joan S. Shnipper acknowledged that the hospital had received and looked into the four-page, Dec. 7 letter.

"We did receive a complaint from a former employee," Shnipper said in a statement. "We took the complaint very seriously and began an investigation in anticipation of a lawsuit."

Turner filed a multimillion-dollar lawsuit yesterday in Baltimore Circuit Court against the 245-bed Baltimore hospital, an affiliate of the University of Maryland Medical System, and Adaltis Inc., manufacturer of the test equipment.

Shnipper, citing the suit, said she could not comment further or directly address the conflict between the Turner letter and Miller's statement this week.

Turner's former boss, Dr. James Stewart, laboratory director at Maryland General, did not respond yesterday to a request for comment. He is also named as a defendant in Turner's suit, which seeks $10 million in compensatory damages and $20 million in punitive damages.

Officials from Adaltis, based in Pennsylvania, also could not be reached yesterday.

The Sun reported yesterday that HIV and hepatitis C test results were sent to about 460 Maryland General patients over a 14-month period ending last August, though routine laboratory procedures indicated those results might be inaccurate.

The hospital stopped performing the tests last August. "We were having challenges with the equipment itself," Miller said Wednesday.

Hospital officials have said they believe that most of the test results will prove to have been accurate. They have confirmed that one patient who had been told he did not have hepatitis C turned out to have the virus.

Hepatitis C can cause a chronic liver infection that could lead to liver failure and disease.

Error message

Turner's 26-page lawsuit charges that on March 12 last year, while performing tests, she received an error message indicating that part of the machinery was out of place.

When she attempted to make the indicated adjustment, part of the machine fell on "numerous different samples of contaminated blood," which then splattered on her face, according to the suit.

"Among the samples were the controls that contained known HIV-infected and Hepatitis C infected blood serum," the complaint continues.

"This infectious blood splashed into the plaintiff's eyes, mouth and nose despite the fact that she was wearing protective goggles and a mask as Adaltis' personnel had trained her. As a direct result of this exposure to these infectious disease containing blood products," Turner has contracted both Hepatitis C and HIV, the suit states.

Turner, who now lives out of state, declined through her attorney, Michael A. Pulver, to be interviewed.

It was her letter to Stewart that triggered the state investigation. After writing it, she e-mailed city health officials with her concerns, which were forwarded to state health officials.

Turner, who by the time she sent the letter had first gone on medical leave and then been fired, wrote in the e-mail that she had hoped hospital officials would act on her complaints, "but nothing has been done to date. ... I realize this may seem like a vendetta, but I assure you it is not."

The reason for her termination was not spelled out. In the e-mail, Turner said she was sending the information to public officials because she feared that hospital administrators would attempt to sweep the matter "under the rug."

Harsh words

Her Dec. 7 letter to Stewart was harsh and specific.

"The fact that the Baltimore community received thousands of test results from a machine that was never validated and was proven to be consistently unreliable and inaccurate is frightening," Turner wrote.

Listing the long history of problems with the safety and accuracy of the machinery, Turner wrote, "This is information you knew all along."

"The machine consistently failed self tests, showed alignment errors, cross contaminated samples and failed runs. This automated machine required hands-on intervention at every step and patient specimens were compromised through the actions of the machines every day," Turner's letter states.

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