Yet Again – A Patient Harmed as Hospital Lab Mixes Up Specimens

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Freeport woman sues hospital after biopsy mix-up

This is really discouraging to see yet another serious specimen labeling mishap in a pathology department that's led to the good news / bad news situation that we've read about before:

  • Good News: You don't have cancer after all
  • Bad News: We performed an unnecessary surgery because we made a procedural error

From the recent news, in Long Island, as we've seen before:

A biopsy at Winthrop-University Hospital in Mineola had confirmed the diagnosis, and so in June, the anguished Freeport woman had surgery to remove a lump and lymph nodes – only to find out days later that she hadn't had cancer at all.

The biopsy results, she learned, had been mixed up. A label with her name had been put on the tissue samples of a different patient.

I've written about this issue previously:

Being Careful Isn't Enough, Particularly in Pathology

There, I told the story of a hospital lab I visited where the Director basically relied on her “careful” people to avoid making a similar mistake. The technologists, in the case I saw, were clearly “batching” their work – a misguided attempt at very minimal productivity improvement that puts patients in jeopardy. Good, safe practice is to have only one patient specimen active in the workspace at a given time.

With batching, they were labeling multiple sets of slides at once, leaving three different patient sets in the field of work, creating the opportunity for error if the technologist grabbed the wrong slide to place a specimen on. This saves the technologist the minor effort of setting the pen down and picking it up (if they're labeling manually, as often happens).

I asked a former colleague who has done more work in Anatomic Pathology and he confirmed that the time saved from batching is extremely minimal. I'd say it's basically a misguided bad habit, this batching. Laboratory managers need to be aware of the risk of batching and they need to oversee the process and the people to make sure batching doesn't take place — ever.

This Will Happen Again, Unless…
A sad case from 2007 where a woman, Darrie Eason, had an unnecessary mastectomy and “batching” was blamed — an individual was fired… does that really fix the process? As McDreamy asked recently on Grey's Anatomy, who is responsible for the system? Leadership.

Another Pathology Mishap
As I predicted, here was another Long Island mixup, from 2008. So what the heck is wrong with Long Island that they are having so many errors of this kind??

Pathology Mistakes (Again) on Oprah and in the News
Earlier this year, Oprah had a woman on her show who was harmed by a similar situation.

So back to the most recent case, it sounds very familiar:

Winthrop spokesman John Broder said the hospital has not been officially served with the lawsuit but acknowledges the mix-up.

“After a thorough investigation, this was determined to be as a result of human error and procedural issues,” Broder said. “All procedures for the handling and labeling of tissue samples were immediately revised.”

Broder did not provide any information about personnel involved in the mix-up or specifics about changes in procedure.

So it sounds like the hospital acknowledges, viz a vis the change in the process, that the old process was bad. I'm guessing, but it wouldn't be unreasonable to assume that batching was involved.

We can't just shrug our shoulders and say “oh well, human error.” That runs the risk of being an excuse. We have to design systems and processes that make it harder for errors to be created.

I partially agree with this expert statement:

Arthur Levin, director of the nonprofit Center for Medical Consumers in Manhattan, said that tissue-sample mistakes point to a system breakdown.

“These kinds of mistakes are human errors that can only be prevented by having systems in place to prevent them,” Levin said. “You have to develop a tried-and-true system that has double checks.”

I agree with Levin that this is a systemic problem. I'd rather focus on prevention and error proofing (through good processes, including NOT batching) than relying on extra inspections or double checks.

So what do we do as patients?

I normally try to not be an alarmist, but it appears that the Anatomic Pathology profession is demonstrating an ability to fix their processes and learn from the mistakes of others. Until proven otherwise, my policy would be the following if it was myself or a loved one who was given a positive cancer diagnosis:

  • I'd insist on a second opinion and second confirming lab test (ugh, this might require a second biopsy or out of pocket costs???)
  • Or I'd demand to go to the lab where my testing was done to investigate the process myself. A manufacturer can go inspect a supplier's process, why can't a patient do the same as a customer???

What are your reactions to this, as a patient or as a laboratory?

Hat tip to the “Dead By Mistake” blog for highlighting this case…

 

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Mark Graban
Mark Graban is an internationally-recognized consultant, author, and professional speaker, and podcaster with experience in healthcare, manufacturing, and startups. Mark's new book is The Mistakes That Make Us: Cultivating a Culture of Learning and Innovation. He is also the author of Measures of Success: React Less, Lead Better, Improve More, the Shingo Award-winning books Lean Hospitals and Healthcare Kaizen, and the anthology Practicing Lean. Mark is also a Senior Advisor to the technology company KaiNexus.

11 COMMENTS

  1. My question is what happened to the patient whose name was placed this partient's sample. Did the other patient, who must have cancer, have her name put on a clean sample and is now at risk of her cancer progressing? If the cancer is found later, who would be to blame? Too often this is just accepted as the way of lab tests. It makes you wonder if these kind of procedural issues are the reason that the disclaimer is given that there could be so many false positives or negatives related to a lab test? Maybe the test can be accurate but the procdures for handling the tests are what causes the variance.It is amazing to me that this situation was allowed in the first place. In manufacturing, our customer would never accept the excuse of human error. They expect substantial evidence that there are attempts at mistake proofing the processes that produce their parts. Only if we can prove that the procedures were not followed will they accept human error as the root cause of a problem. It is disturbing that the medical field in dealing with life and death issues does not take error proofing to a much higher level than manufacturing.

  2. I appreciate your thoughts on this important topic, Mark. I think you might find our post about the same case of interest. http://www.knowerror.com/know_error_blog/2009/11/lab-mix-up-results-in-another-unneccessary-surgery.htmlWe have created a specimen security system for biopsies to prevent these switching errors and any eliminate adverse patient outcomes as a result of the errors.Clearly, you are passionate about the problem for which we have created a solution. I welcome your thoughts and comments.

  3. amy input here is: Has ANYONE considered the persoc accwessioning the specimens? It comes in… with 70 others perhaps… They are prepared and moved along then sent back "YOU ARE GIVING ME TOO MUCH WORK" and the tech is stymied by a screaming doc, administrationWHO KNOWS OF THE ISSUE MONTHS AND MONTHS AGO…DID NOTHING. How do we make this better?? Oh. WE SHALL DECREASE THE NUMBER OF TECHS AND REMOVE THE RESIDENTS AND LEWAVE THE ENTIRE JOB ON THE SHOUKDERS/CONSCIENCES OF TWO TECHS TO COMPLETE AND GET SCREAMED AT WHEN IT IS NOT HAPPENING FAST OR SLOW WENOUGH AND JUST "PUT THAT DSOWN AND GET TO IT LATER. I NEED YOU NOW. THEY HAVE NO SUPPORT BUT THEY WILL BE FIRED BECAUSE RATHER THAN TRULY FIX THE PROBLEM, BLAME WILL BE ASSIGNED TO THE LOWLING WITH 20 TO 30 YRS IN THE PLACE. zxdon't offer to train THREATEN and make them sick with fear.And this is a hospital COMPASSIONATE PLACE FOR HEALING??? Maybe thwe dishonest docs nweewdd to be lookeds at. DONT FIRE THEM…. FIX THE GROSS OVERLOAD HRTEN NEGLIGENCE UNINTENDED YET UNAVOIDABLE WILL GO AWAY.HELP THEWM. THEY ARE LOYAL STAFFERS.OR MAKE EM CRY. SHAME ON YOU FOR ASSIGNING BLAME. i HAVE SEEN THE GUIDELINES AND THEY WEREE LAUGHABLE, INCONSISTENT AND CONFUSING.

  4. To Anonymous: you're right, the failure mode could have been in accessioning, not the embedding station.Either way, it sounds like you are in an awful work environment… I'm sorry to hear that.

  5. Mark,The problem you describe can be equally applied to any office worker who's trying to multitask her way through a phone call, four emails, a spreadsheet, and some administrative work. Rather than one-piece flow, they're trying to do multiple things at once, with predictably bad results.

  6. I agree with Dan M above that the situation can be distributed across many lines of work where multi tasking comes into play and mistakes are made and not necessarily caught all of the time.My point, as I have intimate knowledge of this kind of situation, is that the more work that is heaped on two full-time staffers and the now, perhaps, written P&P does not fix the problem.There MUST BE training, re-training, liability ON ALL LEVELS vs the tech's are threatened and when they are most vulnerable, made to sign a docment they cannot even read due to being so upset while the PA's or whomever are 'advised' to change their habits yet not counselled and/or reprimanded. THAT IS FACTUAL.The chain of service must be looked at. Where are the tech's seated? Is there a sec'y or desk person taking and routing calls, etc. Do the tech's have to stop and take calls? VERY DANGEROUS.What are the checks and balances? If ther is an error, WHY DID IT HAPPEN? What was the call volume that day?What was the staffing that day? How many personnel were accessioning? How long is that process? If there is a question on the req slip with the specimen such as spelling error or location discrepancy, WHO IS RESPONSIBLE TO HUNT THAT PERSON DOWN AND GET IT CORRECTED?Do we know how often the tech's are told…'do me a favor… just fix it?'Unfortunately, the lowest on the totem pole is still the strongest support and they have to balance all of the pieces above. What an insurmountablt task.Look deep into this before you terminate the loyal staffers who do not rotate out annually rather they stay and work hard and long.As there are so few errors surfacing in the past two to ten years, WHAT IS DIFFERENT NOW THAT MAKES THIS HAPPEN?EVERYONE NEEDS TO SIGN FOR THEIR OWN STUFF AND BE A TEAM. NOT A COVER UP GROUP… A TEAMI really hope that the eyes are cast all around on each level and blame assignment 101, 102 and 103 cease and decist.Yes, there are common threads to any office worker. BUT, IN THESE CASES, PEOPLES LIVEs ARE HELD IN THE BALANCE. SCARES ME.And these folks who made the error(s) don't sleep, are sick to the stomach, are humiliated because it's all the buzz and in the paper. Another error is in the offing if real, human tactics vs. reprimand and instilling fear of termination before some training and LISTENING TO THE PERSONNEL WHO NEED THE HELP. THEY ARE EXCELLENT EMPLOYEES.I wish them well.Those who should not call them need to leave them alone to complete their job well and safely.I wish I coud be their "teacher". I have a real good handle on this kind of issue and not much; if anything, gets past me.

  7. How Specimen Labeling is Putting Patients and Hospitals in Danger:

    There is nothing more important for getting patients treated properly than timely and accurate diagnoses. One of the major problems is that while the hospital staff is generally able to do this accurately, the correct results are not being relayed to the rest of the staff properly. The results of hospital staff acting on incorrect information can be catastrophic. One person can receive an operation or medicine that they do not need while another patient may not receive a treatment that is needed. The results can be irreversible and in some cases fatal. This is one of the biggest reasons for medical malpractice claims.

    Only 7% to 18% of lab errors occur in the lab, during analysis. Some 11% to 47% occur after the test is completed, and 45% to 71% of lab errors occur before the test is even performed. A good majority of these issues can be fixed with correct labeling. This simple fix can help keep hospital patients healthy as well as save the hospital a great deal of money in malpractice cases.

    Brady Corporation has a wide variety of labeling products that can be used in many different applications. One of the areas of focus for Brady is proper laboratory labeling. bisco industries is an authorized distributor for Brady. You can see their complete Brady line at https://www.biscoind.com/Brady-WH.

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