- The Washington Times - Friday, March 19, 2004

BALTIMORE — A former Maryland General Hospital laboratory worker who says she was infected with the HIV virus by an error-prone blood analyzer says thousands of people could have received suspect test results from the hospital — not the hundreds that state and federal officials are investigating.

“Every single test that came off that machine should be in question, from its first day in use,” Kristin Turner said yesterday. “It missed samples all the time.”

Miss Turner, who blames the machine for an accident in which she contracted HIV and hepatitis C, estimated the lab conducted an average of 150 tests weekly for HIV and hepatitis C and B over the course of 14 months — about 8,400 tests.

Miss Turner said she first warned hospital officials in October 2002, within a week of being trained on the device, of problems with it. She said she complained repeatedly thereafter to her boss, administrative lab director James Stewart. She said she was ignored.

After the accident in March 2003, Miss Turner said she sent a letter to city officials, which led to a state investigation in January that found 10 percent to 15 percent of the tests performed during a 14-month period might have been inaccurate. Some patients notified of results between June 2002 and August 2003 might have been told they were sick when in fact they were not — and vice versa.

Miss Turner, 32, filed a lawsuit last week against Maryland General and Adaltis U.S. Inc., which made the Labotech blood analyzer, seeking $30 million in damages.

Maryland General has said it gave 460 suspect HIV and hepatitis C test results to patients. The hospital said in a statement released Thursday that its officials would “widen our outreach and retesting efforts.”

Maryland General also plans, according to the statement, to report the analyzer to the Food and Drug Administration.

According to the state inspection report, lab personnel manipulated and eliminated readings showing completed blood tests might be inaccurate. The report said workers at all levels allowed results to be reported even when instrumentation and quality-control materials were used improperly.

But Miss Turner said the machine itself was a problem. Technicians from Adaltis were either contacted or sent to the hospital several times a week because of malfunctions, she said.

The Labotech machine handled the hospital’s HIV and hepatitis C tests, Miss Turner said. Adaltis has installed more than 2,500 of the machines, which can perform up to eight blood tests simultaneously, according to the company’s Web site.

State and federal inspectors, along with officials of a private accreditation agency, continued yesterday a review of the hospital, a state health department spokeswoman said. She declined to comment further.

On the day Miss Turner was infected — March 12, 2003 — she said the analyzer issued one of its frequent error readings. As she was trained to do, Miss Turner opened the machine to investigate. A loose part crashed onto a plate carrying blood samples from about 30 patients, including some with HIV and hepatitis C.

Miss Turner was wearing goggles and a mask that covered her nose and mouth. A large splash of blood hit her face, and blood ran down under the top edge of the goggles into her eyes, she said. It also dripped behind the mask, into her nose and mouth. She said the goggles fit closely against her face and were designed to prevent a direct splash into the eyes, but did not offer as much protection against liquid coming in from the top.

She rushed to the emergency room, where she tested negative for HIV and hepatitis C.

Still, she said, hospital officials didn’t address problems with the machine.

In June, she came down with a fever and tested positive for HIV and hepatitis C. “It floored me,” she said. “I was completely overwhelmed.”

Miss Turner said she was on medical leave when Maryland General fired her after she did not respond to a letter from her boss about her position.

Miss Turner now lives in another state, which she declined to identify. She is on an anti-viral regimen of five drugs, 12 pills a day, and isn’t working while she concentrates on her treatment.

“Every patient that took their test there — their trust was completely betrayed,” Miss Turner said. “People should be able to trust that when they go somewhere, they are going to get the right results.”

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