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

THE BALTIMORE SUN

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.

"Something that looks like a benign lesion can be a tumor. Unless you examine them carefully, you can make a mistake. It happens to every pathologist in the United States," says William R. Weisburger, a Johns Hopkins-trained doctor at Anne Arundel Hospital who ultimately diagnosed Mr. Campbell.

It took a month for Dr. Weisburger and other pathologists to get a consensus on Mr. Campbell's 1992 tissue slides. They reached their conclusion after treating the tissue with a stain that pinpoints this type of skin cancer. The test was developed more than a decade ago in Australia, where climate and ozone depletion have made melanoma a near epidemic, and is routinely used there. But it is not routinely used in this country unless a pathologist sees something suspicious.

This spring, Mr. Campbell sued for $6 million the laboratory that tested him in 1992. He contends Maryland Medical Laboratories Inc. should have found the enemy cells.

The cancer "was readable. There were red flags in the tissue," says his lawyer, J. Thomas Giunta of Annapolis. The lab should have seen enough to use the stain, he says.

The laboratory won't discuss Mr. Campbell's case or other lawsuits cited here. But Al Reynolds, the chief operating officer and executive vice president of MetPath, which now owns Maryland Medical, says tissue pathology is "subjective by nature" and heavily dependent on training and experience.

The five surgical pathologists at the Maryland Medical lab who analyze tissue have a stellar reputation in the medical community, he says, and each member has an average of 10 years' experience.

"The lab test by its very nature is not 100 percent accurate, and people should know that," he says. At the same time, he says, "we are obsessed with trying to improve it."

Recovery chances drop

Had Mr. Campbell's cyst been correctly diagnosed in 1992, his ** chances of survival might be 80 percent. By the time it was labeled desmoplastic melanoma, the disease had had two years to spread throughout his body, reducing the possibility of recovery to 20 percent.

As an Air Force officer for nearly three decades, Mr. Campbell spent much of his life identifying enemies of a different sort.

In the 1950s, he pored over 9-by-18-inch prints taken by secret U2 reconnaissance planes along the coasts of China and the Soviet Union. His telegrams recommending potential targets landed on the desk of President Dwight D. Eisenhower. In 1962, he put the first nuclear missile on strategic alert during the Cuban missile crisis.

People said it was unusual that he rose through the ranks without earning a degree. He studied at Yale University for two years before the Korean War began, then quit to join the Air Force.

"He is extremely gifted," says Kenneth J. Hagan, a retired Naval Academy professor who dedicated a 1991 history of American naval power to Mr. Campbell. The two worked together on chapters that question the Navy's strategy during the Cold War. The controversial book is a required text at the academy.

Mr. Campbell discovered sailing and Annapolis while working at the Pentagon. After his retirement from the Air Force in 1978 as a lieutenant colonel, he served as fleet captain of the Naval Station's sailboats.

White-haired, bearded, casually dressed in khakis and TopSiders, Mr. Campbell speaks about his life and battle with cancer in a steady, matter-of-fact tone.

"I guess I have been in situations where there was a risk of death," he says. "Most always it was for a legitimate cause. People make mistakes that get you killed [in warfare]."

But cancer is different than warfare, he says. "You don't get any R&R; on this one."

He blames himself for the late diagnosis, although friends who are doctors told him they wouldn't have done anything differently.

He felt the same way when his second wife, alone with her sailboat preparing for a race, accidentally fell and drowned 14 years ago. Their daughter was 7. Round and round his mind went, wondering how he could have prevented it.

Seven years ago, he married again. His wife, Joni Campbell, 51, is a nurse, speech pathologist and artist. They are avid sailors. He raced to Bermuda; she sailed in high winds in islands near Turkey.

In marriage, they seemed like two sails on one ship, ready to navigate uncertain winds together. But nothing prepared them for his illness. In fact, they believed they had taken precautions against it.

With fair skin, moles, a family history of skin cancer and a lot of time in the sun, Mr. Campbell knew he was at risk. "I would make him go for checks and to have moles removed," Mrs. Campbell says.

When the lab said the cyst was benign, Mr. Campbell's dermatologist didn't question the test. And it never occurred to Mr. Campbell to get a second opinion.

When the lump began to grow again, he went to several doctors: "Everybody said it was nothing, but I began to worry about it."

Finally, a chiropractor treating Mr. Campbell for unrelated problems urged him to visit Marcia Ormsby, a plastic surgeon and cancer specialist in Annapolis.

When she saw the new lump, "I said, 'It's not normal, it has to come out.' " First she wanted to know what it was, so she researched slides from the former incision. She sent them to a pathologist she knew at Anne Arundel Hospital with instructions about how to stain them.

"It was a very difficult diagnosis to make," Dr. Ormsby says, "because any given cancer has sneaky cells. It required a lot of expertise."

The original diagnosis was dermato-fibroma, or a mass of non-malignant fibrous tissues. A pathologist at Sinai Medical Center in New York who later examined the sample found abnormal cells that should have been a tip-off to do more research, Mr. Campbell's lawyer says.

Melanoma often hides in tissue, but it can be identified with a special stain that costs about $50. Had he known that such a test existed, Mr. Campbell says, he might have asked for one. At least, he says, he should have been given the option.

Dr. Ormsby performed an extensive resection of Mr. Campbell's right shoulder, cutting 2 inches deep and wide around the tumor and through layers of muscle.

The Campbells believe her thoroughness is why he is alive today. It has been more than a year since the tumor was removed.

"So far, so good," Mr. Campbell says. "But the cancer will come back and that's what I am going to die of. It is almost certainly going to show up, and when it does, that's a whole new ballgame."

Labs and managed care

Mr. Campbell's diagnosis took time, money and detective work. Dr. Ormsby's patients are willing to pay (or in Mr. Campbell's case, Medicare) for the pathologists she prefers, she says, and they in turn will go to any expense to get a consensus.

But that is not the norm. More and more, managed care plans are contracting with specific laboratories, making it difficult for doctors to hunt for diseases in concert with pathologists they know and trust.

That relationship between pathologist and doctor is being damaged by managed care, especially by HMOs that go after the lowest bid, Dr. Weisburger of Anne Arundel Hospital believes.

Some big labs do much of their work at central labs in other states, so instead of walking over to the lab to see a slide, he says, a doctor who is suspicious of findings now may find herself calling an (800) number. Ultimately, he says, "You get what you pay for."

In some parts of the country, the bidding to win customers and corner the market means that labs are charging HMOs as little as $1 a Pap smear, or well below cost. In Maryland, lab prices for complete blood counts can be as low as $2 or $3 for an HMO, compared with $8 to $15 charged by a hospital laboratory.

Less than 20 years ago, hospitals had a virtual monopoly on lab tests. They still do a lot of them -- 48 percent compared with 35 percent at independent labs -- but as the medical laboratory industry consolidates, hospitals are beginning to send work out to independent labs.

Dennis G. O'Neill, chair of pathology at Manchester (Conn.) Memorial Hospital, and a member of the College of American Pathologists' accrediting team, predicts that managed care will have "a significant impact on laboratory quality."

Under pressure to keep prices low, labs may hire cheaper, less qualified technicians to read tests and could scrimp on quality control, he says. Of every 100 tests, 30 are performed just to be sure machines are working according to manufacturers' instructions.

Executives of large firms that serve many managed-care companies say size allows efficiencies of scale that enable them to lower prices without compromising quality care. Moreover, the industry is now highly regulated.

"A small lab, a medium lab and large -- we all have to comply," says Bill Bucher, vice president at LabCorp in Burlington, N.C., the largest independent lab in the country.

To compete, labs have to cut costs; none can afford to apply routinely the stain used in Mr. Campbell's case to root out a relatively small number of cancer diagnoses. But without taking the extra steps, they may miss early signs of cancer.

"Pathologists are between a rock and a hard place -- the more tests you do, the more stains you do, the more costly it is," says Susan Haynes, spokeswoman for The Doctors Company, a medical malpractice insurer based in Napa, Calif.

Too late for chemotherapy

For Mr. Campbell, it was too late for chemotherapy. He and his wife explored alternative treatments at length, but decided against them in favor of a macrobiotic diet, exercise and laughter -- said to be good for the immune system.

They gave up sailing, sold their house outside Annapolis and plan to spend this summer in Montana, Mr. Campbell's home state. Each is hoping for some solace there. She has been accepted as a resident of an internationally known ceramic institute and his project is to put the family holdings and history in order.

He considers the possibility of his death with the same even keel he relied on to run nuclear weapons systems. "When I am gone, I am gone," he says. But he admits that he has remained calm partly because his wife has been so upset.

When her husband was operated on, Mrs. Campbell quit her job as a speech therapist for high school teen-agers to care for him. She was five years from retirement.

"The part that really got to me was the mistake," she says. "I am a nurse, I have been taking care of people my whole life. . . . I should have known."

She was devastated by the cancer, she says, and sought help when she began feeling suicidal.

"I was very depressed. I feel like it shouldn't have happened," she says. "I feel somehow I should have done the test again or, as we found out later, there is a more specific test you can do . . ."

They spend as much time together as possible. "Everything he does, I do," she says.

Almost ready for the move to Montana, Mr. Campbell stands on the deck of their old home on the Dividing Creek and polishes a Japanese sword from his collection, a gift from a man he calls the "[George] Smiley of Asia," referring to the fictional spy of John le Carre novels.

It is hard to leave. The house is large, built by a sculptor to overlook trees and water. But it has become a burden.

The house is nearly empty now. Some books, a sofa, a Japanese print were moved to Mrs. Campbell's ceramic studio, a free-standing haven set apart from a second, smaller house they built on the property for their retirement. Right now, they expect to come back to the smaller house in September.

It doesn't really matter where they live. "The only thing now that matters is taking care of Charles' immune system," Mrs. Campbell says.

Mr. Campbell views his lawsuit as a bid to improve labs for every patient -- and to make people aware that labs can make mistakes.

"It sounds like a cliche, but if one person makes a better decision than I did, it is worth it," he says.

"If you get a telephone call that 'the lab says everything is OK,' don't quit. Ask more questions. I wish I had," he says, pausing. "I wish I had."

Checking up on the labs

What consumers can do to make sure their lab tests are accurate:

* Ask your doctor whether the lab he or she uses is licensed and accredited and whether the doctor has the opportunity to discuss a case freely with the lab.

* If tests are done in the doctor's office, ask to see the latest state inspection.

* Ask about additional tests if you have a history of disease in your family or are at risk for a particular disease. Be prepared to pay extra because not all insurance plans cover them.

* Question a health maintenance organization or other managed-care company before you sign up about how they choose subcontractors such as labs. Can you obtain a second opinion elsewhere if you or your doctor is not satisfied?

* If you switch doctors, keep your new doctor informed of previous lab tests and reports. Ask your doctor to obtain past slides and records for you, or submit your request in writing to the lab.

* Report concerns about a lab's procedure or errors in writing to state regulators. Write the Office of Laboratory Licensing and Certification, Department of Health and Mental Hygiene, 201 West Preston St., Baltimore, Md. 21201 (764-4694 or 4695).

* If you are willing to pay, you can ask for a second opinion by having your doctor send your specimens to a second lab.

* Report all symptoms, unusual signs and risk factors to your doctor. These help the physician order the right lab tests to make the best diagnosis.

Coming next week: Labs and pap smears

Each year, millions of American women go to their doctors' office to get a Pap smear, the test used to detect cervical cancer. Sun staff writer Patricia Meisol examines how labs handle Pap smears and why as many as one in five cases of cervical cancer are missed.

Copyright © 2019, The Baltimore Sun, a Baltimore Sun Media Group publication | Place an Ad
27°