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Kimberly Maaser was 27 years old, engaged to be married and the holder of a master’s degree in business administration when she visited her doctor for a routine Pap smear examination two years ago. The test, which detects cervical cancer, came back negative. The future looked bright. Seven months later, Maaser — now married to a captain of a luxury yacht — was diagnosed with cervical cancer. Odds are Maaser won’t live to celebrate many wedding anniversaries. “It’s my understanding she has a 5 percent chance of surviving beyond five years,” says her attorney, Joseph Johnson, a partner in Babbitt Johnson Osborne & Le Clainche in West Palm Beach, Fla. Maaser, of Jupiter, Fla., blames the lab that allegedly misread her Pap smear. Last week, she and her husband, Glenn Maaser, sued one of the world’s largest clinical laboratories, Laboratory Corporation of America — better known as LabCorp — in Palm Beach Circuit Court. LabCorp was negligent because it failed to identify and report the presence of abnormal cells in Maaser’s specimen, failed to recommend a repeat Pap smear and cervical biopsy and failed to have a physician review her slide, her complaint alleges. Lawsuits such as Maaser’s have been filed across the nation. “It’s the minefield of pathology,” says Richard Lozano, a cytopathologist in Birmingham, Ala. “I think we’re on the minds more of lawyers and patients than ever before.” An estimated 20 percent, or 12 million, of the 60 million Pap smears done in the United States annually produce false negatives. Most aren’t indicative of cancer, but as Maaser learned, the consequences can be terrible when that is the diagnosis. She has undergone a radical hysterectomy and is receiving chemotherapy. “What’s going on here is a fraud upon consumers going in for these examinations,” Johnson says. “It’s dispensing medicine in a Wal-Mart-type environment.” Johnson takes issue with the fact that Maaser’s Pap smear was analyzed by a technician rather than a doctor, a practice aimed at maximizing profits, he says. “When you look at what hangs in the balance, I think most women would be willing to pay more out of their own pocket” if they knew a doctor was reviewing their test, Johnson says. The fact is, lab technicians everywhere routinely examine Pap smear slides and only consult a pathologist if they find abnormalities in some cells. “I don’t think a [technician] has the same qualifications and ability to identify abnormalities as a medical doctor under the same circumstances,” Johnson says. In the conventional test, a small sample of cells is collected from the cervix. The cells are then smeared onto a glass slide, which is sent to a medical laboratory to be analyzed under a microscope by a technician looking for abnormal cells. These technicians — called cytotechnologists — are permitted by law to analyze Pap smears and are the equivalent of a physician’s assistant, Lozano says. A cytotechnologist specializes in the study of cells, has a bachelor’s degree and usually attends a 12-month training program. In a Pap smear lawsuit that went to Florida’s 5th District Court of Appeal in Daytona Beach in 1999, Judge Charles M. Harris wrote that it’s unrealistic to expect doctors to review all Pap smear slides. “If all slides had to be personally reviewed by a pathologist, as opposed to a trained technician under the direction of a pathologist, then the cost of the procedure might increase so significantly and the time for processing might increase so dramatically that the entire screening process could be rendered unworkable,” Harris wrote. “It is difficult to contend that the use of a technician to read the biopsy slide is itself negligent,” Harris continued. “Of course, it remains possible to show negligence in the selection of the technician or the technician’s active negligence. Just as would be the case if the pathologist himself had incorrectly read the biopsy slide.” Maaser’s complaint alleges that the technician was negligent and Johnson is seeking information about him such as his workload — by law they may review no more than 100 slides a day — and income. But the technician is not a named defendant. Maaser’s 1999 Pap smear was sent to a LabCorp facility in Naples, Fla. Johnson says. The Burlington, N.C.-based company, with $1.9 billion in revenues last year, has 24 labs and 900 patient service centers in the United States. LabCorp spokeswoman Pam Sherry declined to comment on Maaser’s complaint or on the company’s operations in general. But doctors and lab technicians say it’s inevitable and unavoidable that there will be some false negatives with Pap smears. Only 20 percent or less of the cell sample is placed on the slide, Lozano says, and blood and mucous can obscure what cells there are. Three-fourths of women who develop cervical cancer have no abnormalities show up on their Pap smear because of the size of the sample, Lozano says. Delays in preparing the slide can also distort findings. And cytotechnologists point out that a slide containing 500,000 to 3 million cells may have but a few that are abnormal. Combine that with the fact that — by one estimate — these lab techs spend about eight minutes studying each slide, and some suspicious cells may be missed. That’s one reason many doctors recommend women be tested annually — a false negative one year may be caught the next year, and cervical cancer is treatable when detected early. “Almost every case I hear about of a woman with cervical cancer, the woman has had infrequent Pap smears,” Lozano says. Facilities such as LabCorp should at a minimum routinely have a second technician read each Pap smear slide, same as is done with mammograms, Johnson says. If the physician identifies a patient who has had a Pap smear as high risk for cervical cancer, a lab will screen her slide twice, Lozano says. And federal law requires labs to do a second screening of high-risk and randomly selected patients on at least 10 percent of Pap smears it reviews, he adds. “The standard of care is not perfection,” Lozano says. “Nobody is perfect. No test is perfect.” Tests are improving, however. There have been advances in recent years that use computers to help analyze slides and improve methods of collecting and preserving specimens. These methods are more expensive, however, and may not be covered by a patient’s insurer. About half of the Pap smears analyzed by LabCorp utilize these new and improved techniques, Sherry says. “It’s a doctor decision,” she says. “The labs are not really in a position to tell docs what test to use,” Lozano says. “In our lab, we very forcefully educate the docs.” Especially effective is a Pap smear test approved in 1996 by the Food and Drug Administration called ThinPrep, Lozano says. “There has just been a mountain of data in the [medical] literature that supports use of ThinPrep.” Slightly more than half of all labs screening Pap smears use ThinPrep, Lozano says. Instead of being smeared on a slide, the collection device is rinsed vigorously into a vial containing a preservative solution. The vial is then sent to a lab, where a slide is prepared using an automated processor. Maaser’s Pap smear was by the conventional method, Johnson says. Today, he says, his client tries to help her husband a bit at his job on a yacht, but it’s hard. “She’s fatigued on a regular basis,” Johnson says. “Kim is a remarkable young lady who is justifiably unsure what the future holds for her. She and her husband remain very close and are trying to remain optimistic.”

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