Medical Mistakes: I Was in Total Shock

"I Was in Total Shock"

Lenore Janecek was headed toward her Chicago Home on a September afternoon in 2000 when she received a call on her Cell Phone that would change her life forever. It was her doctor. He told her that the test results from her routine colonoscopy two weeks earlier revealed she had intestinal cancer. Stunned, Janecek, 61, pulled over. "There must be a mistake," she insisted. But the doctor, a gastroenterologist, assured her there was no mistaking the diagnosis. Janecek would need immediate surgery.

There are few things more dreaded than a cancer diagnosis. But for Janecek, the news was doubly traumatic: She had been successfully treated for intestinal cancer ten years earlier, so the thought that the disease had come back was terrifying.

On September 26, in a procedure that lasted three hours, the surgeon made an incision running the length of Janecek's abdomen and removed about two feet of her small and large intestines. The surgery was an ordeal, but at least, she thought, the worst was behind her. In the weeks that followed, however, Janecek, a mother of two who ran her own health insurance consulting firm, became concerned that her recovery was not going well. The pain and digestive troubles were worse than she'd expected. She wondered if they'd gotten all the cancer.

Then, at her six-week checkup with the gastroenterologist, Janecek received ominous news: She might have been the victim of an error at the hospital lab. A genetic test later confirmed that the tissue sample her diagnosis was based on had been contaminated with cancerous cells from another patient's specimen. Janecek did not have cancer. Her surgery had been unnecessary. "I was in total shock," she recalls. "First shock, then anger."

It turned out that the gastroenterologist had questioned the initial lab result, but the lab's review of its procedures still failed to uncover the error. Janecek sued the hospital for negligence and won a $3 million award from the jury. But six years after her ordeal, she continues to suffer bouts of severe abdominal pain and other digestive symptoms stemming from the surgery. "It's like someone punched me as hard as they could right in my abdomen, and I didn't see it coming," she says. "And I will have that for the rest of my life."

Behind Closed Doors

When most people think of medical errors, they think of the sensational cases -- the surgeon who removes the wrong organ, or the patient who dies because he was prescribed the wrong drug. In fact, it's been estimated that medical errors may cause up to 100,000 deaths each year in this country. But stories like Janecek's highlight a problem that hasn't gotten as much attention: errors that occur in pathology labs, where tens of millions of blood samples, biopsies and tissue specimens are analyzed every year, and radiology labs, where a mislabeled MRI or a misinterpreted x-ray or CT scan can have dire consequences for a patient.

No one knows for sure how many lab errors happen annually. Most mistakes are reported on a voluntary basis, and many are never reported at all. Experts are quick to emphasize that the vast majority of medical tests are error-free. But errors do add up, given the huge volume of testing nationwide. For example, a typical large medical center does some 5 million clinical pathology tests each year.

It's not just the amount of testing that makes mistakes inevitable. It's also the complexity of the process. Testing starts in the doctor's office or at the lab, where a specimen is drawn and labeled or an image is taken and ID'd. It then is analyzed and interpreted by the experts. Finally, the results are sent back to the doctor to aid diagnosis and treatment. Errors at any step along the way can threaten your health -- or even your life. Paul N. Valenstein, a pathologist at St. Joseph Mercy health System in Ann Arbor, Michigan, knows of a case in which a patient died when a lab did not get his test results to the right doctor in time, even though the results were accurate.

Are Lab Errors Common?

While the accidental contamination of one patient's tissue with another's, as happened to Janecek, is relatively rare, other more common mistakes can be just as serious. Identification errors occur when specimens are mislabeled or incorrect patient data is entered into laboratory computer systems. A new study of 120 clinical pathology labs, where blood, urine and other fluid tests are done, estimates that each year in the United States, more than 2.9 million of these errors occur, and more than 160,000 patients are harmed in some way as a result. The harm ranges from the stress and anxiety caused by an incorrect diagnosis that's later reversed, to far more dangerous, though less common, outcomes, such as delayed treatment, transfusions of the wrong blood type, even unnecessary surgery.

"This is a serious problem," explains Dr. Valenstein, the study author. And "our error projection is undoubtedly an underestimate."

When it comes to cancer, diagnostic mistakes can be catastrophic. Based on an analysis of reported errors in patients tested for cancer or precancerous lesions at four major hospitals, Stephen Raab, chief of pathology at the University of Pittsburgh Medical Center, and his colleagues estimate that at least 305,000 specimens are wrongly diagnosed each year. And some 40 percent of these errors, or nearly 128,000 cases, result in harm to the patient. In rare instances, mistakes in cancer diagnosis can lead to unnecessary organ removal or even death. More often these errors cause less serious but still troubling harm: the fear and stress of being told you have cancer when you don't, the trauma of having to be retested and, perhaps most significantly, delays in diagnosis and treatment when signs of cancer are missed in an initial test.

Trouble With Images

Like their counterparts in pathology, the radiologists who perform and analyze everything from old-fashioned (but still common) x-rays to high-tech CT scans are largely unseen players in the medical process. But though less visible to you than your family physician, their role in ensuring your health is just as vital -- and their mistakes can be just as costly.

When Elaine Thomas,* a petite 42-year-old social worker, had her annual mammogram at a local hospital in July 2002, she didn't think she had anything to worry about, since neither the radiologist nor her gynecologist contacted her about the results. "No news is good news," she says. "If you don't hear anything, you assume it's okay."

Thomas had to delay her next mammogram. But with no history of Breast Cancer in her family and having just had a physical breast exam, she wasn't concerned. That changed suddenly one morning in May 2004 when she felt a lump under her left breast. Thomas, mother of an eight-year-old son, called a local radiology clinic as soon as it opened, and scheduled a mammogram for later that day. After analyzing the image, the radiologist told her there was a clearly visible concentrated white area -- a dense mass that was cause for concern. "Even I could see it," Thomas says. An ultrasound exam and biopsy confirmed it was cancer.

Thomas, daughter of a plastic surgeon, knew the importance of getting other opinions. After looking at all of her mammograms and the reports, three different surgeons agreed that she would need immediate treatment for Breast Cancer. But there was something else. All three told her that the worrisome mass that appeared in her most recent mammogram was also visible, though in a less developed stage, in the 2002 mammogram. It was something that should have been followed up on right away, they said, with additional mammography or ultrasound. Yet although the radiologist's report from the earlier exam indicated that dense breast tissue had made evaluation difficult, it recommended only routine follow-up. On hearing this, the normally upbeat Thomas recalls, "I was pretty ticked off."

By now, Thomas had invasive Breast Cancer. She underwent surgery, chemotherapy and 35 radiation treatments. She is now cancer-free, but she will never know whether her treatment might have been less traumatic if the radiologist had recommended more urgent action nearly two years before her disease was discovered.

There are three main stages in the imaging process where errors can occur: recognizing an abnormality, accurately diagnosing it, and communicating the result to the physician and patient. Freya Schnabel knows the importance of getting it right the first time. As chief of breast surgery at Columbia University Medical Center, she depends upon mammograms and other imaging tools to help ensure she gives patients the care they need. And she knows that when labs make mistakes, patients pay. Not being informed about abnormal mammograms is "a huge danger," says Dr. Schnabel. "I hear about these cases all the time." In fact, delay in the diagnosis of Breast Cancer is the most common reason for malpractice lawsuits in the United States.

Patients can be harmed by the mishandling of other radiology procedures as well. A recent study by U.S. Pharmacopeia found that 12 percent of radiology-related medication errors, including incorrect dosing of sedatives or contrast agents, resulted in harm to the patient. That's seven times the percentage of all medication errors combined that were harmful. The American college of Radiology challenged these findings, arguing that drug errors occur in only a small fraction of imaging procedures. Still, the findings are "a call to action for hospitals, radiological centers, health care practitioners and patients," says study author John P. Santell.

* Name altered to protect privacy.

Reducing Mistakes

As health care providers struggle to improve patient safety, Dennis O'Leary, MD, president of the Joint Commission on Accreditation of Healthcare Organizations, says they need to change the way they think about errors. "The fact is, people make mistakes," he says. "That includes doctors, nurses and lab technicians. The challenge is designing internal systems that catch human errors before they reach the patient. And most health care organizations are still in their infancy in understanding how to do that."

A key first step would be for diagnostic labs to institute double checks. For example, have multiple pathologists examine slides so cancer cells don't go undetected. And have two radiologists analyze every scan. Another step would be to create ways to ensure a surgeon doing a biopsy sends a properly diagnosable tissue sample to the lab. These and other measures might increase costs, but to Dr. O'Leary, it's a no-brainer: "What's more important, building a new heart catheterization lab or making sure you've got enough personnel to keep errors from reaching patients? There's money in the system. It's just a matter of priorities."