Lethal Errors The occasional mistake in a medical laboratory can be devastating

June 13, 1995|By Patricia Meisol | Patricia Meisol,Sun Staff Writer

Charles Campbell felt relieved when a laboratory report showed that a cyst removed from his right shoulder in 1992 was benign. For two years he didn't give it a second thought, until he felt a tingling sensation down his arms and back, and a lump began to grow under the scar.

The lump grew and grew, until a new doctor insisted it had to come out. But first she dredged up the tissue samples from the old lesion and sent them off to experts. When Mr. Campbell saw the doctor again, she had tears in her eyes.

"There's no question about it," Mr. Campbell remembers Dr. Marcia Ormsby telling him. "It's malignant melanoma, and now it's been there so long it is very, very dangerous." If there was anything he really wanted to do, he should do it now, she told him.

Mr. Campbell, a military strategist and former intelligence officer, never thought to question his initial test results. Now as he empties his home in Arnold, saving only a few belongings for the move home to Montana to put his affairs in order, Mr. Campbell finds it difficult to accept the idea that he may die from a laboratory's mistake.

"I believed what the lab told me," he says.

"I am a trained intelligence officer," he continues, his voice rising. "The first thing you do when you get information is to identify the reliability of the source."

Hundreds of millions of laboratory tests are performed every year to pinpoint and treat medical conditions ranging from high blood pressure to cervical cancer. In the United States, these tests are extraordinarily accurate.

But labs are not perfect. Nobody knows how many mistakes they make. But even under ideal conditions, Pap smears to detect cervical cancer miss an estimated 1 in 5 cases of the disease, according to researchers at the National Cancer Institute. Melanoma, a deadly form of skin cancer, can be difficult to detect because the abnormal cells that signal it hide behind thick tissues. Then there are the inevitable mix-ups -- blood samples that occasionally get lost or diluted.

Now, with labs under pressure to cut prices and the $35 billion business consolidating into mostly large companies, some doctors worry that quality will suffer even in well-regulated states such as Maryland.

While problems are rare, a lab's mistakes can be devastating for the people involved:

* Charles B. Delluomo, 78, of Baltimore, is at risk for cancer after receiving 15 unnecessary radiation treatments for what he thought was prostate cancer. Last month he learned that the laboratory had made a mistake -- he didn't have cancer after all.

* Janet Grebow can't have another baby. The Columbia woman contends a laboratory missed her RH negative blood type until she was pregnant with her second child. Then she developed antibodies that would kill a fetus if she became pregnant again.

* Lisa DelFino of Baltimore spent two years trying to get a laboratory to identify the father of her children after its first blood test excluded him. When a DNA and second blood test identified him, the laboratory admitted it mixed up the blood sample with someone else's.

* Francine Joyner of Montgomery County had a radical hysterectomy after three lab tests incorrectly reported her Pap smears normal. She says she complained to her doctor for a year of bleeding -- a classic sign of cervical cancer -- but he did nothing because the Pap smears were normal. She is under a five-year watch for recurrence of cancer.

All four people have sued laboratories in Maryland. Similar suits have been filed across the country.

In Connecticut, 34 women are suing MetPath Inc. for faulty blood tests that showed their fetuses with genetic defects, including Down Syndrome. The company says it was a victim of sabotage by an employee.

In Rhode Island, a hospital laboratory recalled 20,000 Pap smears after a woman was diagnosed with cancer despite four consecutive normal Pap smears. In Milwaukee, the families of two women who died after the Chem-Bio Corp. missed what experts said were obvious signs of cervical cancer on their Pap smears recently won multimillion-dollar settlements.

Outraged by the shoddy performance of some facilities, Congress passed a law in 1988 to impose federal standards on all labs. The Clinical Laboratory Improvement Amendments went into effect in 1992 and have had a marked effect on quality control at labs across the country.

Much testing is now automated -- blood, for instance, is routinely labeled by computer when it arrives at a lab and tested for diseases without being touched by human hands.

But lawsuits against pathologists -- the doctors who inspect cells and tissue for signs of disease -- are on the increase. The largest group of cases involves difficult-to-decipher tests: Pap smears and tissue samples for melanoma and breast cancer. All three are still read by people instead of machines.

Pathologists are the first to say they can make mistakes.

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