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Gambling With Your Life
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Millions of medical mistakes happen in the
lab. Here's how to protect yourself.
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By Pamela F. Gallin, MD, and
Joseph K. Vetter
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"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."
Advice From an Insider: Prevent
Medical Mistakes
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7 need-to-know tips.
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| By Pamela F. Gallin, MD |
Trust Your Instincts
I'm a surgeon. So when I needed surgery on my right
hand, the one I operate with, I chose one of the best hand surgeons in the
world. The procedure went well, and I went home with a large cast on my arm
and lots of narcotics. But the pain was excruciating. The next day I called
the surgeon. "You're fine," he assured me. "Return in six
weeks." I thought I was being hysterical. Would my doctor dislike me if I
pushed too hard?
But I knew I wasn't fine. So after three more days of politely calling and
being ignored, I demanded to be seen. By this time, my fingers had swollen up
like sausages. My surgeon wasn't available, so the doctor on call saw me. When
he examined my arm, his face turned red with anger. The cast was much too
tight. He literally ripped it off and discovered that the swelling had forced
the incision to open. It had to be restitched and another cast put in place.
Months later, I needed two plastic surgeries to improve the unsightly scar,
and each time, my arm was in a cast for six weeks. I couldn't operate, my kids
were young, and it was a very difficult time. If my surgeon had seen me on day
1, these complications would have been avoided.
My experience made me wonder: If even I, a surgeon, was too intimidated to
confront my doctor when my gut told me something was wrong, how much more
difficult must it be for the average patient? We all need to take charge of
our own health. That's especially true when it comes to the invisible doctors
responsible for the tests and images that shape our diagnosis and treatment.
My advice:
Trust your instincts. If you have questions about a lab result,
diagnosis or treatment, speak up. And be persistent. After you have a lab test
or diagnostic image, call your doctor to make sure he received the results.
Don't worry about hurting your doctor's feelings. This is about you.
More Tips From Dr. Gallin
Choose wisely. The doctor you pick is only the first member of a team
of specialists involved in your care. She'll likely assemble the rest of the
team, so finding the right doctor is doubly important. So, too, is the
hospital you choose. There are no guarantees, but usually, the better the
hospital, the better the team.
Read the label. Many lab mix-ups start in your doctor's office. When
giving a blood or other specimen, ask the nurse, politely, to show you the
identification sticker to make sure it's accurate.
Do it again. If a lab result is unexpected or alarming, your doctor may
have you retested. If he doesn't, ask him about a do-over.
Carry a medical passport. A summary of your vital health information is
a must. It should list diseases, medications and doses, food and drug
allergies, and phone numbers of your physician and nearest relative. Take it
with you to every doctor you see -- even the radiologist.
Be a pack rat. Keep copies of all lab reports, x-rays, MRIs and CT
scans, plus names and addresses of your MDs.
Get a second opinion. It's crucial to your health. If a diagnosis
requires surgery, chemotherapy or medications with side effects, find another
specialist (call the hospital's referral service for help), and send him all
your pathology and radiology lab work for review, both the images and reports.
When you get the second opinion, make sure you understand it. If not, talk to
the doctor until you do.
Dr. Gallin is director of pediatric ophthalmology
at New York Presbyterian-Columbia Medical Center.