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

Phillip Benton pgbentonmd at AOL.COM
Thu Jun 29 17:28:04 UTC 2017


Helene,
Great point and great summary. 
I would extend your 'wrong emphasis on fixing the problem(s)' analysis to the Task Force's advice to discontinue prostate PSA testing because the surgery is sometimes more morbid than the disease. Why not concentrate instead on improving the surgery for better outcomes than just giving in to the disease? Surely surgical techniques can be analyzed and improved to make them safer.
 
Phillip Benton
pgbentonmd at aol.com


 
 
-----Original Message-----
From: Vic Nicholls <nichollsvi2 at GMAIL.COM>
To: IMPROVEDX <IMPROVEDX at LIST.IMPROVEDIAGNOSIS.ORG>
Sent: Thu, Jun 29, 2017 12:51 pm
Subject: Re: [IMPROVEDX] The Lab Says It’s Cancer. But Sometimes the Lab Is Wrong. - The New York Times


    
Now that there is this bill:        http://www.medscape.com/viewarticle/882263, based on no evidence        (rather than profits)        http://www.miamiherald.com/news/state/article1961331.html, and        I'm looking for the reference about not wanting the JCAHO        results released publically so people can make their own        judgements, 
      
    
I'd have to say there is basically no incentive to fix the        below. Plus: 
      
    
    
    
http://www.fiercehealthcare.com/finance/texas-hospitals-fear-losing-6-2b-medicaid-deal,          
          
    
Hospitals are counting on the          cash          to absorb the costs of uncompensated care, which they say has          escalated even as the state’s uninsured                rate fell from 20% in          2013 to 16% in          2015, according to the Kaiser Family Foundation’s          estimates. (Kaiser Health News is an editorially independent          program of the foundation.) Without the money,        programs and        services to the poor will have to be cut, including many new        health        clinics opened to expand access, hospitals say.
    

      
    
I'm missing why we need more        than 5 admin per doctor at the salaries they are making. Seems        to me we cut all the admin and pay for doctors and mid levels,        and copy what other countries do for undocumented people, we        could have that money. 
      
    
Vic
    

    
    
    
On 6/28/2017 9:46 PM, HM Epstein wrote:
    
    
      
        
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 GRADY                                    March                    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, 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 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, challenge                  the common belief that a biopsy is the gold                  standard and will resolve any questions that might                  arise from an unclear mammogram or ultrasound.
                
In the United States, about                  1.6 million women a year have breast biopsies; about                  20 percent of the tests find cancer. 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 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. is cancer.
                
“It is often thought that                  getting the biopsy will give                  definitive answers, but our study says maybe it                  won’t,” said Dr. Joann G. 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 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, 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.”
              
            
          
          

            
            
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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®ion=top-stories-below&WT.nav=top-stories-below
                      
                    
                    
                      
                        
The                          Lab Says It’s Cancer. But Sometimes the Lab Is                          Wrong.
                        
                          By                              GINA                                  KOLATAJUNE                              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                              of his prostate was positive for cancer.
                            
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 — 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 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.                              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                              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,                              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. 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                              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.    
                            
                          
                        
                      
                    
                  
                
              
            
            
            
            
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