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Behind Closed Doors
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.
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.
The Challenges Ahead
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."
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