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Poka Yoke – Wrong Side Operations

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  • #24892

    Kerri Simon
    Participant

    Hi everyone,This week’s article on Poka Yoke (click here for the full article) discusses how ‘mistake proofing’ (the meaning of poka yoke) can help businesses waste less energy, time and resources doing things wrong…preventing mistakes from occuring in the first place.Since wrong-side surgery tops a list of 27 serious, preventable events in the United States, I thought a great real-world poka yoke challenge would be to help prevent wrong side operations (see the article for an excerpt and link to a recent newspaper article). Let’s use our collective iSixSigma brain power and help the medical industry with ideas to poka yoke wrong side operations! I’ve presented the first idea below…what new ideas, modifications, and suggestions do you have?- Kerri

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    #59764

    Kerri Simon
    Participant

    Problem: The X-ray film was accidentally reversed when viewed by the doctors, leading the doctors to operate on the wrong side.
    Poka Yoke Solution: My solution is to create a situation where the doctor cannot reverse the film when viewing. I’m not in the medical industry, but I’m going to make some assumptions about how things work in my solution.
    Since the film must load into the X-ray camera in only one manner (assumption…you can’t load it upside down or backwards, etc.), require the film manufacturers to print “CAN YOU READ THIS?” (or something similar) in big letters on a majority of the film. This will serve as a visual confirmation to the doctor to prevent the film from being reversed. Otherwise they would see the inverse of “CAN YOU READ THIS?” and, being the brilliant minds that they are, would reverse the film for reading.
    Is this fool-proof enough? Maybe not…what are your ideas?
    – Kerri

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    #59765

    Kumaresan
    Participant

    Why to print “CAN YOU READ THIS”? That may lead to some other possible mistake. The name of the patient should be printed on the front side of the film so that it will be not be viewed the reverse side, by mistake. Is that not possible?

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    #59770

    Lance Moon
    Participant

    To be viewed correctly the X-ray must be placed onto a viewing screen. If the X-ray film is produced with a small `cut-out` in one corner this could then locate around a location peg on the same corner of the viewing screen.
    It would not then be possible to locate the X-ray correctly onto the viewing screen. ( square peg into a round hole does not go ! )

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    #59767

    Tim Chambers
    Member

    Here we talk a lot about the two different styles of poke yoke – I don’t know whether there are official terms for them, the indicators – colour coding, shadow boards, tick boxes, and the physically preventative – jigs, pins, barriers etc. Obviously the ‘harder’ solution being physically preventative.
    With this X ray idea, surely we should/could generate a physical barrier ? I’m not fully aware of the scenario – but what about some type of cut-out in the film and key for this to fit into on the light board ? Or – if the film is always held in a gripper – having left/right hand teeth so the film will not be held the wrong way round.

    What about going a little further and having the film polarised ? – polarise it diagonally, and have all the light boards similarly polarised – then with the film the wrong way round it will appear totally black – thus ‘automatically’ preventing the film from being read. Wether this can be done with the film I’m not sure (any takers ?) – creating poke yokes for the generation of the film would also be required of course. (I wonder if this idea had been patented ?)

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    #59768

    Hogg
    Participant

    It is standard practice to mark patients with plastic tags containing metal for x-ray photography, and to fully describe patient orientation when using computer driven scanners.
     
    Whether or not film is ‘handed’ in any way is irrelevant, since a chest x-ray for example may be taken from the front or the back, and the doctor/surgeon may wish to view the picture from the back or front depending on which way they intend to operate (if that is indeed the outcome).
     
    Fool proofing this process requires that the patient (not film) orientation at x-ray is indicated in a way that can be correctly deduced and reproduced at viewing. As in many transactional processes this comes down to convention and human error, which is why radiographers are specialists, and only trained personnel are allowed to stage x-ray photographs on light boxes in operating theatres.
     
    It is almost impossible to fool proof a convention. It is a convention that we drive on one side of the road, or run trains down one track, or wire electricity up one way, or write and read in one direction. Dealing with many ‘handed’ situations often requires a physical key that simple cannot be reversed – often impossible in convention. Here we need a context indicator that enables 100% correct interpretation of the convention under all situations and by all people, which is a tall order.
    Where packing boxes are to be stored in one direction only internationally recognized symbols are used to indicate ‘up’ (‘up’ being a handed direction commonly taken to be the opposite to ‘down’). Such symbols are often umbrellas, which in certain African tribes resemble ceremonial objects which must always be the other way up. Which explains why packing boxes often now have three different symbols for ‘up’ in the hope that at least two mean something!
     
    And if “can you read this” was in ‘Chinese’ then, of course, it would read “siht daer uoy nac” (vertically).

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    #59755

    Allard Munters
    Participant

    How about this idea:
    In my view the flow is often as follows:
    Scanning device => computer (image manipulation) => filming device => film => viewer box
    In each of these steps there is a risk of misorientation. For a good Poka Yoke solution we have to go back to the source: the scanning device (Xray machine, CT scanner).
    The scanning device should always create a black square located at the left top corner of each image. This is the ‘raw’ image, that will usually be further processed on the computer before it is printed on film.
    If the computer operator by accident rotates/mirrors/flips the image, then the black square will appear in another corner.
    If the film in incorrectly loaded in the filming device, then the square will also appear in another corner.
    And also when the film is placed incorrectly on the viewer box.
    The viewer box should be equipped with a light sensor that senses the black square on the film. If the black square is not in the correct corner, then the lights in the viewer box should simply switch off.

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    #59756

    lin
    Participant

    A word such as FRONT AND OR BACK on Xray.

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    #59757

    John Holding
    Participant

    Thinking about this problem from a six sigma view point, it became obvious that xrays are not the only likely contributor to wrong side operations.  Any facet of the pre surgery process may lead to the surgeon making a mistake and many may not be their fault.  Before embarking on potentially difficult methods of trying to prevent wrong sided operations a complete understanding of the defects, and their causes, arising from the process is needed.  Only after understanding the root causes and what are the principle contributors can any attempt be made to mistake proof a human activity. 

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    #59771

    Connie Kash
    Participant

    The surgeon and the patient must speak shortly before the operation where they discuss the specifics of the surgery. At that time, they can:

    also mark the patient’s body with a symbol before the operating room doors open, and
    sign a drawing of the body and an “x” on the spot.
    The x-ray would become a check for accuracy.

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    #59772

    Darren Occleston
    Participant

    Finally the voice of customer.  Thanks Connie !!
    This is an amusing excercise, but let us not forget that the data must drive the solution. 
     

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    #59773

    George Dorsett
    Participant

    Put an enable notch in one corner like on a floppy disc drive and each peace of equipment used to process the film have enable switches including the viewer.

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    #59776

    ConnieKash
    Participant

    If data drives the decision, we must then know  how often the error occurs, and any particular circumstances (particular operations, hospitals, doctors, time of day or night) to create a baseline so our improvement can be documented, and our theories substantiated.

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    #59777

    J Silver
    Participant

    CT Films are marked R and L. Mark the patients head at the time of pre-surg. testing, or at time when consenting the pt. A better nights sleep perhaps………

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    #59758

    Juan Correa
    Participant

    There is a very simple way of solving that problem…Just have the printer system watermark the X-Rays with the word “FRONT”.  If you can read it the patient is safe.If, on the other hand, you need to use a mirror in order to see the word face the right war, well, self explanatory…. isn’t it? 

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    #59778

    Steve Hart
    Member

    There is alot of discussion about the x-ray orientation. I see the problem as caused by the surgeon picking up the scalpel and cutting on the healthy side of their patient.
    If you mark the x-ray properly it still allows for the surgeon to perform the correct-sided operation on the wrong patient, or the incorrect procedure on the correct patient.
    It appears to me that a more durable poka-yoke solution is to train surgeons on examples on the history of wrong sided operations, the impact on affected patients, and the impact on the offending surgeon’s personal lives.
    Back this education up with a termination-assured policy on wrong-sided procedures.

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    #59774

    Laura Lockhart
    Participant

    Lets forget the X-ray, think out of the box, what about the surgeon marking the patient prior to surgery with a permanent marker.  Agreement between the surgeon and patient is assured (the patient is awake and concious of the marking).  Then if documentation in the operating room is confusing, missing or upside down, the correct information is right where it should be.  With the patient, you know “X” marks the spot.

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    #59779

    Pat Carpenter
    Participant

    Any system must encompass all forms of data information and preferably all cultures i.e a pictogram :-
    Xray
    CT
    MRI
    Paper
    Some are pre-manufactured like xray plates but some are computer generated like MRI. Hence the same system must be used on all media be they plates, print-outs or CRT screens (not forgetting zoom functions in the software which must always show the symbol).
    Don’t rely on the cutter he/she might never have seen the poor victim (i.e straight from A&E department), never talked to them (they were deaf, dumb, blind, not concious, no translator or had facial injuries). Of course it might have been the cutters under-ling who saw them  then scribbled a note for their boss.
    I was always taught never assume, always try to build it in so it happens automatically.
    Pat

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    #59766

    dave knackstedt
    Participant

    It’s not just X-rays being flipped. It’s sex changes on the wrong patient, which have been in print before. It’s the wrong surgery on a patient for mistaken identity.
    Solution: When the patient is initially found to have a problem the location should be immediatly labled with a dye like (methaline blue) on the affected body part. This type of dye is very persistant and will not go away for weeks on end. The medical proffesional doing surgery would abort immediatly if they did not see the dye marking the location for which the anticipated surgery was to be performed. I think it would work in every situation except the emergency room, however, the same doctor is usually going to perform the whole procedure in this kind of setting and won’t get mixed up. If the patient has to be sent to surgery the ER doctor can apply some dye and move the patient along. By the way (Methaline blue) dye dries almost instantly and is non toxic.

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    #59775

    Matt M
    Participant

    This is similar to what the Naval Military Hospitals do, but they go one step further in mistake proving.  Mark the spot, discuss w/ patient and in the case of an arm/leg surgery put the opposite arm/leg in a “stocking” which prevents inadvertant operation and blood clotting.

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    #59759

    Ashish Patel
    Participant

    Hi All,
    Wrong Side surgery is one of the most crucial mistakes as far as the madical world is concerned, basically its a mistake which if went wrong can take lives. What I feel is that, there should be a proper system for all the factors affecting wrong side surgery i.e.for X-Rays there should be some mark or text on it which says or indicates every time when an x-ray is wrongly viewed for ex. this way up or some thing similar which states to the doctor examing the x-ray that he’s looking at the right side or not. This type of signages will really help in correct viewing of the x-ray, and it can be made compulsory fpr each and every x-ray taken in a jurisdiction so as to minimize the wrong side surgery.
    Regards,
    Ashish Patel.

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    #59780

    keyes
    Participant

    How about this: (1)standardize the loading of x-ray films to ‘x-ray machines’ so that, as others have suggested, the film is restricted to only one correct orientation when loaded to the machine; (2)x-ray ‘film reading machines’ should be similarly standardized to the same restrictions imposed on ‘x-ray machines’. This way, when the film is inserted in the reader for viewing, correct positioning of the film would be possible one way only.

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    #59760

    Curtis Crays
    Participant

    For those that are challenged to transfer the displayed image (in this case the correct side of the head) to the patient, possibly applying a device that shows up on the CAT Scan as well on the patient. Possibly a clamping type of device (clothes pin) that could be affixed to the patients neck while being scanned and would remain while undergoing surgery.

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    #59761

    B J Hill
    Participant

    So, why not go all the way back to the manufacture of the film…How about an Industry standard…say, a 45 degree notch out of the right upper corner to indicate the “right side for camera load, viewing, etc..” Then everyone who handles the X-ray is reading from the same sheet of music!

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    #59749

    Bruce Swanson
    Participant

    Have a rectangular dark spot on the scan film made with a metal bar located by the patients head built into the fixture that the person’s head rest on.  Build into the viewing glass a sign that said “Film Loaded inproperly.”  When the film is loaded properly the sign would be covered up.  The mark would need to be in a unique location on the film so that it would only cover up the sign in one location. 

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    #59750

    Owen Berkeley Hill
    Participant

    You may wat to take a look at John Grout’s Poka Yoke page: http://www.campbell.berry.edu/faculty/jgrout/pokayoke.shtml
    He lists some every-day examples to drive home the principal that Error Proofing does not require 6 Super Crays, 90 Terrabytes of disc space, and a zillion years of develpment time.  IT industry please take note!
     

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    #59769

    John Grout
    Participant

    I thought Goeff’s note indicating that patients can be x-rayed on their back or front does add some difficulty to any mistake-proofing solution for image orientation. Often errors cannot be totally and completely eliminated in perpetuity. However there are times when clues about how to proceed can make a big difference. So here’s my idea: Take a regular photo of the patient simulataneously with the x-ray. Use Allard Munters’ black square in the upper left corner to show where the photo should be affixed. This technique insures that the orientation of the patients’ body is obvious relative to the x-ray image, and shows which side of the film is the front. It is not a “strong” mistakeproofing device that controls behavior, but it might help make health professionals’ jobs a little easier.

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    #59762

    S J K
    Member

    YOU ONLY LEARN FROM MISTAKES

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    #59763

    Mike Carnell
    Participant

    You must have had one hell of a weekend.By the way – that is BS. If it were true nobody would read text books. They are boring – particularly the stats books. Is every one reading them trying to get stupid.Why don’t you get some sleep and check back around Wednesday.

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    #59751

    mike blodgett
    Participant

    Create films with 2 non sumetrical notches in the top of the film, Place corresponding locators of different sizes in the clamp bar used to hold the films.  If the film is forced up to the grip bar in the wrong location, the locators will not allow the film to slide into the clamp.  Pre- Surgical(Pre-Drugged) patient and doctor to review film and Mark location of surgery with steril Waterproof pen, both must initial. 

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    #59781

    Jack Welch
    Participant

    Why not just go to only a competent surgeon.   Remember in a graduating class of 150 doctors you call to top graduate doctor, and you call the 150th graduate doctor too. 
    “Go Red Sox!”
    Jack W.

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    #59752

    Annonymous
    Participant

    So many of you seem to be concentrating on just the X-ray reversal “root cause” of surgical errors.  There needs to be conventions, procedures, and poka yoke controls built into the entire process. 
    For example, my mother (a surgical scrub nurse by original training) has developed a fairly serious allergy to latex.  When they did her most recent orthopedic surgery, she insisted on meeting the ENTIRE team who would be in the operating room, and briefing them ALL about her allergy.  The reason was that during a prior operation in that hospital, they had used a latex-based adhesive in the drape needed for the surgical field, even though she had informed the doctor, her floor nurse, and the anethesiologist of her allergy and asked to have the information passed on.  They were all somehow “too busy” to tell the OR assistant, who didn’t normally look at patient charts, where the allergy was recorded, to check every single bit of the disposable materials for latex and substitute the hypo-allergenic version.  As a result, my mother spent an extra week and a half in the hospital, because her healing was so impeded by the allergic reaction. During this time she had plenty of chances to examine in detail the process that led to the error, and make suggestions for how to improve it.
    Since this hospital prides itself on it’s quality control and patient service, (and since they otherwise would probably have been sued) they did revise their procedures.  Every patient is asked at every concious interaction if they have any allergies to any medication, material or common substances.  Any patient with any allergy has this noted on the first page of every document/chart and a sign on their door / bed to alert staff when the patient may not be concious or present (like in X ray).  And every patient with any allergy is invited to review (or have a representative review) every department in the hospital for potential impact on the allergy. 
    This paid off when a kid with peanut allergies was admitted recently, and they had to clear out the candy machines and inspect staff pockets to make extra sure that no-one carried any peanut protien into that unit while that patient was in residence.  Big kudos from the parents in the press for the care and consideration showed by this hospital.  Relatively minor disruption to the routine for the staff, but it eliminated life-threatening situations for their patients.
    That same hospital also uses the “indellible ink mark on operation site” technique.  The “patient consent” process now has 2 parts.  One is for the surgeon and the patient to sign the paper.  The other is for surgeon and patient to initial the operation site in indelible ink.   Sometimes, though, the patient has to watch in a mirror while their initials are written for them. There are places on ones’ body that cannot be reached to write on with one’s own hands.

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    #59753

    RR Kunes
    Member

    I do not know how you can propose such a general project… If you begin to analyze the data you may find specialties, areas of surgery, types of locatons and hospitsals which are responsible for these attrocities.
    The six sigma way is “In God we trust… All else bring data.”

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    #59754

    lin
    Participant

    Don’t know if anyone has suggested this but…Why not try taking a corner off the X-Ray film and reshape the reading screen so that the X-Ray will only fit on it one way?  Possibly, even a switch could be installed in the eared corner that would light the screen only when the film is placed on the screen correctly?Would be cheap and relatively easy.  It would mean that interested businesses would have to buy teh new reading screens but the cost would pay off in lower malpractice costs.Just an idea, anyway!  Cheers!

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    #59782

    melvin
    Participant

    What about the poor girl who received a heart transplant with the wrong blood match? How can a surgery like that happen without double, triple checks?

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    #59786

    jl
    Participant

    Why not go filmless & read images at a computer workstation. Flashing stop sign (warning) appears if image orientation has been changed from correct.

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    #59847

    Fontanilla
    Participant

    I’m pretty new to the whole six sigma concept, and I do think there is a lot to be gained and learned here. However, I can’t get past thinking that a problem such as this merely takes some creativity and common sense to solve. At what point does this become a six-sigma problem? Do you really need black belts, green belts, champions, process owners, etc. to come up with basically a simple solution? I don’t mean to sound like I’m knocking six sigma, just suggesting that a lot of it boils down to common sense. Appreciate any comments, criticism, etc.

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    #59849

    Mike Case
    Participant

    Dan, you ask a good question regarding when does a problem become a six sigma problem. “Do you really need black belts…etc to come up with basically a simple solution?” The short answer is NO. Any good Six Sigma Belt (Master, Black, whatever) would not waste time following the entire DMAIC methodology to come up with a Quality solution to a simple problem. I am a Master Black Belt with GE Medical Systems’ Performance Solutions business, and we guide our health care customers toward a process called Work-OutTM to approach problems that can be solved by getting the right people into a room that can be led to arrive at a quality solution in a relatively short period of time (anywhere from a couple of hours to several meetings over a period of weeks). As well, it can be pointed out that the Six Sigma DMAIC process is a methodology comprised of a set of tools, steps, and statistical tests. Once the methodology is learned, a belt can pull out any singular tool, test, step, or approach to tackle a variety of issues/problems that can be solved without going through the full methodology. I think that was the intent of the original question that began this discussion thread. Poka Yoke is just one way of attempting to put a process into control and is taught as an approach in the Improve and/or the Control phase. Poka Yoki’ing a process can be done anytime, anyplace it is appropriate without going through the entire Six Sigma methodology to attack the process problem. If Poka Yoke is used as a singular approach to attacking a process problem, that does not infer that the process problem has been attacked using “Six Sigma”.
    Mike

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