The Lab Says It=?UTF-8?Q?=E2=80=99s_?=Cancer. But Sometimes the Lab Is Wrong. - The New York Times

HM Epstein hmepstein at GMAIL.COM
Thu Jun 29 01:46:18 UTC 2017


We want to prevent every error we can. This article talks about identity
mix-ups at the labs, not errors in evaluating the biopsy results, although
obviously the lab errors contribute to inaccurate diagnostic communication
and treatment.

I'd like to look at this from a different angle. I recognize we are
comparing apples to oranges, because the type of Dx error is different, but
the attitudes of the legislators burns me up.

Based on the relatively low rate of errors labs have seen with prostate
exams, the article says our Congress has still introduced legislation this
May to include DNA fingerprinting in Medicare coverage *for prostate cancer
only.* But there are 806 thousand prostate biopsies a year. and an overall
error rate of 0.5%. They'll negotiate a rate for the DNA fingerprinting but
at 50% of cost, that's $121 Million per year.

Compare that to the error rate of breast cancer biopsies and look again at
the legislation. In 2015, it was discovered that the error rate for the 1.6
million breast cancer biopsies was 20-25% (depending on the type of breast
cancer tested). It's not an identity issue, although that probably exists
as well; it's a diagnostic error for biopsies that show DCIS or atypical
cells.

That's double the number of biopsies and 50x the error rate but the male
dominant Congress members writing this legislation have decided that having
Medicare cover costs for DNA fingerprinting is necessary for prostate
biopsies but breast cancer is a pre-existing condition that isn't covered.
If a women with breast cancer is initially told she doesn't have it, and
then they discover she does, she won't be covered. On the other hand, if
she is told she does have breast cancer (right or wrong) and endures the
surgery (lumpectomy or mastectomy), radiation or chemotherapy, and
reconstructive surgery, she can't change insurance policies or stop working
because she loses her insurance. Then, her breast cancer (real or mistaken)
is a pre-existing condition. One more indignity. If the patient discovers
she was mistakenly diagnosed with breast cancer and gets breast cancer
later, she will have to go to court to prove the breast cancer is a new Dx.

Sorry to rail. But if we can't improve the error rates for breast cancer
biopsies, if we aren't even researching how to fix this, we are creating a
health care fiscal crisis for over 300 thousand women every year.

Best,
Helene


​​
https://mobile.nytimes.com/2015/03/18/health/breast-biopsies-dcis-atypia-
diagnosis-leave-room-for-doubt.html

Breast Biopsies Leave Room for Doubt, Study Finds
By DENISE GRADYMarch 17, 2015

Abby Howell chose to have a biopsy when a mammogram showed some
calcification two years ago. Instead of being definitive, the biopsy  found
atypia — abnormal duct cells that are not cancerous but which some doctors
recommend having removed.

Kyle Johnson for The New York Times

Breast biopsies are good at telling the difference between healthy tissue
and cancer
<http://health.nytimes.com/health/guides/disease/cancer/overview.html?inline=nyt-classifier>,
but less reliable for identifying more subtle abnormalities, a new study
finds.

Because of the uncertainty, women whose results fall into the gray zone
between normal and malignant — with diagnoses like “atypia” or “ductal
carcinoma
<http://health.nytimes.com/health/guides/disease/breast-cancer/overview.html?inline=nyt-classifier>
in
situ” — should seek second opinions on their biopsies, researchers say.
Misinterpretation can lead women to have surgery and other treatments they
do not need, or to miss out on treatments they do need.

The new findings, reported Tuesday in JAMA,
<http://jama.jamanetwork.com/article.aspx?doi=10.1001/jama.2015.1405> challenge
the common belief that a biopsy
<http://health.nytimes.com/health/guides/test/biopsy/overview.html?inline=nyt-classifier>
is
the gold standard and will resolve any questions that might arise from an
unclear mammogram
<http://health.nytimes.com/health/guides/test/mammography/overview.html?inline=nyt-classifier>
 or ultrasound
<http://health.nytimes.com/health/guides/test/ultrasound/overview.html?inline=nyt-classifier>
.

In the United States, about 1.6 million women a year have breast biopsies;
about 20 percent of the tests find cancer
<http://health.nytimes.com/health/guides/disease/cancer/overview.html?inline=nyt-classifier>.
Ten percent identify atypia, a finding that cells inside breast ducts are
abnormal but not cancerous. About 60,000 women each year are found to
have ductal
carcinoma
<http://health.nytimes.com/health/guides/disease/breast-cancer/overview.html?inline=nyt-classifier>
in
situ, or D.C.I.S., which also refers to abnormal cells that are confined
inside the milk ducts and so are not considered invasive; experts disagree
about whether D.C.I.S.
<http://www.cancer.gov/cancertopics/pdq/screening/breast/healthprofessional/page3>is
cancer.

“It is often thought that getting the biopsy
<http://health.nytimes.com/health/guides/test/biopsy/overview.html?inline=nyt-classifier>
will
give definitive answers, but our study says maybe it won’t,” said Dr. Joann
G. Elmore <http://www.uwmedicine.org/bios/joann-elmore>, a professor at the
University of Washington School of Medicine in Seattle and the first author
of the new study on the accuracy of breast biopsies.

Her team asked pathologists to examine biopsy slides, then compared their
diagnoses with those given by a panel of leading experts who had seen the
same slides. There were some important differences, especially in the gray
zone.

An editorial in JAMA
<http://jama.jamanetwork.com/article.aspx?doi=10.1001/jama.2015.1945> called
the findings “disconcerting.” It said the study should be a call to action
for pathologists and breast cancer scientists to improve the accuracy of
biopsy readings, by consulting with one another more often on challenging
cases and by creating clearer definitions for various abnormalities so that
diagnoses will be more consistent and precise. The editorial also
recommended second opinions in ambiguous cases.

A second opinion usually does not require another biopsy; it means asking
one or more additional pathologists to look at the microscope slides made
from the first biopsy. Dr. Elmore said doctors could help patients find a
pathologist for a second opinion.

A surgeon not involved with the study, Dr. Elisa Port, a co-director of the
Dubin Breast Center and the chief of breast surgery at Mount Sinai Hospital
in Manhattan, said the research underlined how important it is that
biopsies be interpreted by highly experienced pathologists who specialize
in breast disease.

“As a surgeon, I only know what to do based on the guidance of my
pathologist,” Dr. Port said. “Those people behind the scenes are actually
the ones who dictate care.”

In Dr. Elmore’s study, the panel of three expert pathologists examined
biopsy slides from 240 women, one slide per case, and came to a consensus
about the diagnosis.

Pathology of Errors

Video As pathologists help doctors diagnose breast cancer at an earlier,
more survivable stage, the potential for mistakes has grown.

“These were very, very experienced breast pathologists who have written
textbooks in the field,” Dr. Elmore said.

Then the slides were divided into four sets, and 60 slides were sent to
each of 115 pathologists in eight states who routinely read breast
biopsies. The doctors interpreted the slides and returned them, and the
same set was sent to the next pathologist. The study took seven years to
complete.

The goal was to find out how the practicing pathologists stacked up against
the experts. The task was tougher than actual practice, because in real
cases pathologists can consult colleagues about ambiguous findings and ask
for additional slides. They could not do so in the study.

There was good news and bad news. When it came to invasive cancer — cancer
that has begun growing beyond the layer of tissue in which it started, into
nearby healthy tissue — the outside pathologists agreed with the experts in
96 percent of the interpretations, which Dr. Elmore called reassuring. They
found the vast majority of the cancers.

For completely benign findings, the outside pathologists matched the
experts in 87 percent of the readings, but misdiagnosed 13 percent of
healthy ones as abnormal.

The next two categories occupied the gray zone. One was D.C.I.S. For this
condition, the pathologists agreed with the experts on 84 percent of the
cases. But they missed 13 percent of cases that the experts had found, and
diagnosed D.C.I.S. in 3 percent of the readings where the experts had ruled
it out.

The finding is of concern, because D.C.I.S. sometimes becomes invasive
cancer, and it is often treated like an early-stage cancer, with surgery
and radiation. Missing the diagnosis can leave a woman at increased risk
for cancer — but calling something D.C.I.S. when it is not can result in
needless tests and treatments.

The second finding in the gray zone was atypia, in which abnormal, but not
cancerous, cells are found in breast ducts. Women with atypia have an
increased risk of breast cancer, and some researchers recommend surgery to
remove the abnormal tissue, as well as intensified screening and drugs to
lower the risk of breast cancer.

But in the study, the outside pathologists and the experts agreed on atypia
in only 48 percent of the interpretations. The outside pathologists
diagnosed atypia in 17 percent of the readings where the experts had not,
and missed it in 35 percent where the experts saw it.

“Women with atypia and D.C.I.S. need to stop and realize it’s not the same
thing as invasive cancer, and they have time to stop and reflect and think
about it, and ask for a second opinion,” Dr. Elmore said.

Abby Howell, 57, who lives in Seattle, two years ago had some
calcifications show up on a mammogram
<http://health.nytimes.com/health/guides/test/mammography/overview.html?inline=nyt-classifier>,
which are sometimes a sign of cancer. She was given the option of just
mammograms every six months or having a biopsy. She chose the biopsy,
thinking it would be definitive. But instead, it showed atypia.

Ms. Howell, who has a master’s degree in public health, looked up the
condition and realized it was unclear whether those odd-looking cells would
ever lead to cancer. Surgery was recommended, but she decided to watch and
wait instead. So far, her mammograms have been normal, but the experience
has shaken her peace of mind.

“If I had to do it all over again, I wouldn’t have jumped for the biopsy,”
Ms. Howell said. “I really regret it. In a way it’s made more anxiety in my
life.”


Sent from my iPhone

Helene's Website <http://hmepstein.com/>
Helene's Twitter Account <https://twitter.com/hmepstein>
Diagnostic Error's Twitter Account <https://twitter.com/DxErrors>
Diagnostic Errors on Facebook <https://www.facebook.com/DiagnosticErrors/>
​
Helene on LinkedIn <https://www.linkedin.com/in/helenekepstein/>
​

On Tue, Jun 27, 2017 at 9:59 PM, David Meyers <dm0015 at icloud.com> wrote:

>
>
> https://www.nytimes.com/2017/06/26/health/the-lab-says-its-
> cancer-but-sometimes-the-lab-is-wrong.html?hp&action=click&
> pgtype=Homepage&clickSource=story-heading&module=mini-
> moth&region=top-stories-below&WT.nav=top-stories-below
>
> The Lab Says It’s Cancer. But Sometimes the Lab Is Wrong.
> By GINA KOLATA <https://www.nytimes.com/by/gina-kolata>JUNE 26, 2017
>
> Timothy Karman discovered he had prostate cancer a few days after being
> told he was cancer-free as a result of a lab error. Logan R. Cyrus for
> The New York Times
>
> It was the sort of bad news every patient fears. Merlin Erickson, a
> 69-year-old retired engineer in Abingdon, Md., was told last year that a
> biopsy
> <http://health.nytimes.com/health/guides/test/biopsy/overview.html?inline=nyt-classifier>
> of his prostate was positive for cancer
> <http://health.nytimes.com/health/guides/disease/cancer/overview.html?inline=nyt-classifier>
> .
>
> Mr. Erickson, worried, began investigating the options: whether to have
> his prostate removed, or perhaps to have radiation treatment. But a few
> days later, the doctor called again.
>
> As it turned out, Mr. Erickson did not have cancer. The lab had mixed up
> his biopsy with someone else’s.
>
> “Obviously, I felt great for me but sad for that other gentleman,” Mr.
> Erickson said.
>
> The other gentleman was Timothy Karman, 65, a retired teacher in Grandy,
> N.C. At first, of course, he had been told he was cancer-free. The phone
> rang again a few days later with news of the mix-up and a diagnosis of
> cancer.
>
> Ultimately he had his prostate removed. “I said, ‘Mistakes happen,’” Mr.
> Karman said.
>
> They may be happening more often than doctors realize. There is no
> comprehensive data on how often pathology labs mix up cancer biopsy
> samples, but a few preliminary studies suggest that it may happen to
> thousands of patients each year.
>
> Fortunately, there is now a high-tech solution: a way to fingerprint and
> track each sample with the donor’s own DNA.
>
> But it costs the patient about $300 per sample, and labs have been slow to
> adopt it, saying that the errors are rare and the test too expensive, and
> that they have plenty of checks in place already to avoid mix-ups.
>
> Dr. John Pfeifer, vice chairman for clinical affairs in the pathology and
> immunology department at Washington University School of Medicine in St.
> Louis, who has studied the problem, is not quite so sanguine.
>
> “All the process improvement in the world does not get rid of human
> errors,” he said. “Millions get biopsies every year. Is society going to
> say, ‘Yeah, mistakes happen but we’re not going to look for them?’”
>
> The fingerprinting method, offered by Strand Diagnostics, is simple: A
> doctor gets a DNA sample by swabbing inside a patient’s mouth. It is sent
> directly to Strand with a bar code identifying the patient.
>
> That bar code is also used to label the patient’s biopsy. If it shows
> cancer, the pathologist sends the biopsy cells to Strand. The lab matches
> the DNA from the swab to that of the biopsy cells.
>
> If these DNA fingerprints did not match, that signaled a lab mix-up. That
> was how pathologists discovered that samples from Mr. Erickson and Mr.
> Karman had been switched.
>
> Despite the best efforts of pathologists to avoid these mix-ups, hints of
> trouble have been turning up for years.
>
> In 2011, researchers conducting a large clinical trial reported that two
> men who were found to have prostate cancer
> <http://health.nytimes.com/health/guides/disease/prostate-cancer/overview.html?inline=nyt-classifier>
> — and who had their prostates removed — did not have the disease at all.
>
> Instead, their biopsy samples had been mishandled. (A third mix-up was
> caught before any action was taken.)
>
> The researchers then performed a rigorous DNA analysis
> <https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3107764/> of more than
> 10,000 biopsies taken during the period. Twenty-seven were mislabeled.
> Among 6,733 blood samples, 31, or 0.5 percent, had been switched.
>
> The percentage of errors may not be high. But each one may lead a patient
> down a life-altering path, to a grueling treatment that was unnecessary, or
> to the neglect of a cancer that may or may not prove deadly.
>
> Pathologists see lab mix-ups routinely, but often the mistake is obvious —
> a sample supposed to be from a brain actually is from a lung, for example.
>
> “You say, ‘O.K., yeah, there’s been a mistake,’” Dr. Pfeifer said. “I
> don’t know many pathologists who haven’t had that occur.”
>
> But what about mix-ups that are not so obvious — two lung tissue samples
> that are switched, or two breast samples? Dr. Pfeifer turned to DNA
> fingerprinting to determine how often such samples are mixed up at
> Washington University.
>
> Merlin Erickson was told he had cancer after a pathology lab mixed up his
> biopsy with another patient’s. Nate Pesce for The New York Times
>
> He found a few errors
> <https://academic.oup.com/ajcp/article-lookup/doi/10.1309/AJCPLNO4PFVZVA4P>.
> One man’s lung tissue was cancerous, but DNA analysis showed the lung cells
> were not his.
>
> Another patient had a liver biopsy that showed cancer, but the cells were
> from somebody else. Still another man was mistakenly thought to have
> advanced aggressive prostate cancer; again, DNA showed the tissue was
> somebody else’s.
>
> To really get an idea of the frequency of these mix-ups nationwide,
> however, Dr. Pfeifer needed a large database.
>
> Ted Schenberg, the chief executive at Strand, offered to supply the data:
> more than 13,000 biopsy results from men evaluated for prostate cancer at a
> number of laboratories.
>
> Dr. Pfeifer agreed to review data, although he knew the company had a
> significant financial interest in the outcome. To minimize conflicts of
> interest, Mr. Schenberg would not pay him to do the work and would not be
> involved in the analysis.
>
> Dr. Pfeifer documented
> <https://academic.oup.com/ajcp/article/139/1/93/1766518/Rate-of-Occult-Specimen-Provenance-Complications>
> two types of errors in this large sample: an “absolute switch,” in which
> one patient’s tissue was mixed up with another’s. And a “partial switch” in
> which some of one patient’s cells ended up mixed in with cells from someone
> else.
>
> “Every lab had both of these errors,” Dr. Pfeifer said. In general, the
> rates were low — .26 percent of samples were absolute switches, and 0.67
> percent were partial switches.
>
> But the rates were slightly higher among independent labs, including large
> commercial companies that handle huge numbers of specimens: 0.37 percent
> were absolute switches, and 3.14 percent were contaminated.
>
> Remedying these infrequent errors is a costly endeavor. Most private
> insurers are willing to cover the testing; it’s far less expensive than
> paying for unnecessary treatment, or treatment late in the course of a
> disease that should have been identified sooner.
>
> Medicare
> <http://topics.nytimes.com/top/news/health/diseasesconditionsandhealthtopics/medicare/index.html?inline=nyt-classifier>,
> on the other hand, does not cover DNA fingerprinting of biopsies, and many
> of patients receiving cancer biopsies are older. (Legislation introduced in
> Congress in May would require the program to cover the service, but only
> for prostate biopsies.)
>
> Consumers may request DNA fingerprinting themselves, but there is no
> guarantee that the pathology lab to which their biopsies are sent will
> offer the service.
>
> Recently, a group of researchers led by Dr. Kirk Wojno, a pathologist at
> the Comprehensive Urology and Comprehensive Medical Center in Royal Oak,
> Mich., decided to address the financial obstacles to widespread DNA testing
> of biopsies, in this case specifically for prostate cancer.
>
> Unnecessary treatments and lawsuits come with a high price tag, the
> researchers concluded.
>
> There are about 806,000 prostate biopsies a year in the United States. Lab
> mix-ups of these biopsies alone cost the nation about $879.9 million per
> year <https://www.ncbi.nlm.nih.gov/pubmed/25463992>. That figure includes
> cost of lawsuits that result from mix-ups.
>
> The cost of doing DNA fingerprinting, Dr. Pfeifer argues, “is well within
> the range of costs we see with other clinical testing.”
>
> ”You can make an argument that for prostate cancer you should probably do
> this for every patient at the time of initial diagnosis,” he added. “By
> extension, you probably have the same situation for other diseases.”
>
> But other experts are not convinced the test is worth the cost.
>
> While mix-ups do happen, pathologists have put a series of steps
> <http://www.cap.org/web/home/resources/cap-guidelines/current-cap-guidelines/uniform-labeling-surgical-pathology?_afrLoop=303951474392889#!%40%40%3F_afrLoop%3D303951474392889%26_adf.ctrl-state%3D1br6msxspm_4>
> in place to try to avoid them, including 26 requirements for labeling
> containers and identifying patients, and ordering tests, said Dr. Raouf
> Nakhleh, vice chair of the College of American Pathologists’ Council on
> Scientific Affairs and a professor of pathology at the Mayo Clinic in
> Jacksonville, Fla.
>
> “We get paid $125 to process a specimen and produce a diagnosis,” he said.
> He turns to DNA fingerprinting only when he suspects a mix-up — for
> example, a clinical exam is at odds with a pathology report.
>
> Dr. Jennifer Hunt, who chairs the Department of Pathology at the
> University of Arkansas for Medical Sciences, also objects to the cost.
> “It’s related to finances,” she said. “And the risk of error is
> extraordinarily low.”
>
> Dr. Sanford Siegel of Chesapeake Urology used to feel the same way. But in
> 2015, a new patient had a blood test that indicated he might have prostate
> cancer. He had a biopsy, which confirmed it.
>
> The man had his prostate removed — only to learn he had been the victim of
> a lab mix-up. His reaction, as Dr. Siegel recalled? “I am calling a lawyer.”
>
> After that, Chesapeake Urology made the DNA test mandatory.
>
> * Correction: June 27, 2017 *
> An earlier version of this article misstated the percentage of blood
> samples, out of 6,733, that were switched in a clinical trial in 2011. It
> was 0.5 percent, not 0.05 percent.
>
>
> ------------------------------
>
>
> To unsubscribe from IMPROVEDX: click the following link:
> http://list.improvediagnosis.org/scripts/wa-IMPDIAG.exe?
> SUBED1=IMPROVEDX&A=1 or send email to: IMPROVEDX-SIGNOFF-REQUEST@
> LIST.IMPROVEDIAGNOSIS.ORG
>
> Moderator:David Meyers, Board Member, Society for Improving Diagnosis in
> Medicine
>
> To learn more about SIDM visit:
> http://www.improvediagnosis.org/






Moderator: David Meyers, Board Member, Society to Improve Diagnosis in Medicine


HTML Version:
URL: <../attachments/20170628/4f4b3c6a/attachment.html>


More information about the Test mailing list