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Disclosing Medical Errors

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	Michael Sweeney Total Posts: 4 Moderator	Disclosing Medical Errors 4/9/2008 9:20:08 AM Sent: Monday, April 7, 2008 11:19 AM It is unfortunate that patients and families would be left out of the conversation but can absolutely understand how this happens. Given an opportunity to share some insight on alternative dispute resolution and medical injury disclosure I can tell you that as long as medical professionals (including administration) and lawyers, continue to discuss alternatives to litigation behind closed doors, which includes leaving out every person who uses healthcare, the public will continue to see litigation as the only option following an unplanned outcome. This audience needs to include every participating group that works in healthcare. Example: a dear friend and colleague is the president of a large local breast cancer coalition. She regularly hears about misdiagnosis, surgical problems and medication mix-ups. She also regularly, along with many others who associate with these groups, suggests the patient or family get legal council. There is nothing else (at least in New York) to offer them. When we start developing programs (and I don't mean take away anyone's rights) that can address what a patient or family can do if they receive - or perceive a medical error, all groups that address healthcare must be on board. When I suggest perceive, it is often because the patient may seek legal attention (I have received numerous calls like this) before even informing the doctor or hospital that something may be wrong closing doors to any further discussion. We are actually moving in a position to 1) help stop medical errors from happening before the patient is actually injured and 2) help guide patients and the families back to the healthcare facility to receive an apology or disclosure or even a conversation (I still don't care what its called) or more important, additional medical attention, but we have not implemented anything reasonable to offer. So, we (you) in healthcare can continue this conversation but if we don't get the word out to the public that movement is happening - nothing changes. ilene Ilene Corina, President PULSE of NY www.pulseofny.org phone (516)579-4711 cell (516)650-2421 fax (516)520-8105 From: Marty Hatlie [mailto:mhatlie@p4ps.org] Sent: Friday, April 04, 2008 3:28 PM Dale, just wanted to say that I really appreciated your comments. I’m working on a patient safety curriculum with people at Northwestern and as we were preparing it, we had to decide where to stick disclosure. In the communication module? The medico-legal module? There were several places it could work. In the end we put it at the beginning of the patient engagement piece, on the premise that it is foundational to trust and working relationships between physicians and patients. As you observe, a good place to start. I’m also glad that it has stayed central to our discussion on patient safety. One could imagine it being sidelined to the realm of ethics, as it is arguably removed from systems reliability and prevention of harm – except when you think about its role in earning and maintaining trust and functional relationships. So, thank you Dale and all. MJH From: Hetzler, Dale [mailto:Dale.Hetzler@choa.org] Sent: Friday, April 04, 2008 12:54 PM Sitting here in Seattle, a long way from home, preparing for a talk this afternoon at the ABA Dispute Resolution Section annual conference – subject of our talk = Apology in healthcare, and I for one can’t get enough of this discussion. From the view of someone who represents a hospital that uses an interest based approach to both disclose and apologize for outcomes that are not what anyone had hoped for, these discussion points are the very ones that confound the best intended providers in trying to move to adopting any form of enlightened approach to resolving questions about the unintended outcomes of care. For years we have felt that healthcare was the perfect venue for a thriving and vigorous dispute resolution practice, but have seen relatively few providers truly cross into the open and honest disclosure and apology realm. There are some noted institutions doing so, but they are a small percentage of the industry. I believe you all are artfully dissecting the core reasons we have seen much potential but slow, hesitant adoption. Disclosure is one very important link in the chain of things that must be done in a more thoughtful manner in order to transform the relationship with patients and families. Informed risk/consent processes, disclosure, apology, and adoption of system-wide conflict/communication protocols would go a long way to allowing all opportunities for improvement of patient care to be recognized. Disclosure is a tremendous starting point. As several of you have opined, disclosure does not prevent liability, and apology does not prevent liability, but it is the appropriate path to continuing to serve that patient and family. It may indeed help in reaching resolution of any potential liability, as we have found, but we are a hospital. When it is an individual provider, a physician, disclosing and apologizing, it is their career, their professional reputation, academic and financial standing that is at risk. Having discussed and debated in private with John Banja the need for so much more attention to be paid to this, I am thrilled to see this level of analysis expressed in a shared venue. Please continue, and I would think that there is no audience too broad for this discussion. -Dale Dale C. Hetzler, MSCM, JD Children’s Healthcare of Atlanta From: Johnson, Connie [mailto:Connie.Johnson@va.gov] Sent: Friday, April 04, 2008 9:49 AM After working with Steve Kraman in Lexington for 15+ years to hone and refine a disclosure process for unexpected events resulting in harm to patients I'd like to contribute the following thought to ponder in this discussion: There are 2 types of disclosure to be done in the adverse event category: clinical and organizational. A clinical disclosure is "just the facts, ma'am". An example: Mr. M., who has many chronic conditions including diabetes, is ordered 10 units of insulin every morning. This morning, he received 100 units. The clinical disclosure would go something like: o "Mr. M., you received 100 units of insulin. Your physician is aware and has ordered finger sticks every 30 minutes for the next few hours. We will be watching closely to see that your blood sugar is ok". o At some later point, but not too far in the future, the physician might say something like "We are watching closely to be sure that your blood sugar levels remain acceptable. We will also be reviewing our processes to see if we can determine how you came to receive 100 units. Someone from the administration will be getting with you about that. Please feel free to ask questions". Please note that in this disclosure there is no mention of inciting terms like error, misadventure, adverse event, etc. Generally, we prefer to keep the clinical side strictly clinical, and determinations of error or system failures can't be made at that time in the process. o The organizational disclosure of process failure would hopefully occur following detailed RCA (or whatever you might call your systems investigation process). The organizational disclosure, ideally, is done by someone at the top of the organization, someone who carries the weight of organizational authority for: an apology, an explanation of the process failure and a preview of changes made in the process to prevent future events. Those 3 things are what patients (and people in general) want when they have been injured. On the flip side, there are events that result from system (or individual performance) errors that cause no harm. When patients inquire, we call our discussions of these things "closure". It gives the patient/ family an opportunity to air their grievance and be aware that the organization looked at the processes in a systematic way that may/ may not result in process change. At least they know we're looking. In Lexington, we have many more of these than disclosures. I will close this communication with our results over the years: patients who are kept in the loop about what we are doing to determine what, where, when and why they had an unexpected event. They sue less often, and our settlements have been extremely low when we 'fess up to errors. From: Marty Hatlie [mailto:mhatlie@p4ps.org] Sent: Tuesday, April 01, 2008 7:33 PM Very interesting. 1. On Al's point, I'm not sure that most people would hear "disclosure" to mean telling something that was hidden, rather I hear it as conveying something to the patient/family that the patient doesn't fully know. But Australians and many Europeans have the same or similar sensitivities, and so modify the term as "open disclosure" or even "open and honest disclosure." 2. It's interesting that the sensitivites about the "error" and "disclosure" terms usually come from those who are trying to get physicians to actually do the process, and I wonder if you're reflecting back the anxiety about doing it disquised as anxiety about the term. Lot's of words have connotative baggage, multiple meanings or are prone to sloppy usage: lady, disabled, fat, negligence, love, liberal, and a million more. We define them as best we can and then work to get our meanings across when others use them differently. I'm with the group who says let's not get waylayed by fine distinctions when we need to get on with the truthiness process of saying what happened. If you are disclosing and you don't feal comfortable with the error word, start with "something went wrong" and see if that works. If the persons you are disclosing to use "error," "mistake" or "accident," respond and continue to move through the process. At the policymaking level, we can continue to shape meaning as if these terms are tightly linked to single concepts, but at the communication delivery end let's accept that words are often imprecisely used. 3. Re shifting the needle -- you do that by modifying the underlying forces that keep the needle pointing where it is. One of those forces might be internalized guilt or shame, and maybe you can accomplish some shift by "It's the right thing to do" role modeling and training. But that's not enough to guarantee to consumers they will get the disclosure they expect and deserve, because there is another powerful driver -- the fear of liability and its sequelae: humiilation, punishment and the "bad doc" brand. This is the clutch fear when an adverse event occurs: Oh my god, I/we hurt the patient and now I'm going to get sued." I think this is why Doug is so successful in selling apology as a way to avoid or at least hedge against liability -- he hits them in the gut fear of lawsuit place. And again, this might accomplish some further shift in the needle, but it's a limiting factor that we cannot guarantee that disclosure prevents liability. So, in my view error = liability exposure, and liability = blame in our justice system. The blame may not be actual punishment -- well not too often -- but its typically brutal nonetheless, feels terrible and it hangs over your head for years. I just don't see how we are going to effectively and sustainably shift the needle without some dramatic decoupling of accountability after harm (disclosure, compensation, correction and disseminsation of lessons learned) and blame/discipline. This seems far off, but increasingly imperative as patients don't get what they want and are entitled to get. I say this not because I want to relieve physicians of personal responsibility. Rather, what motivates me is the belief that consumers can never be confident of getting the disclosure until this happens, much less the compensation they deserve whe they are harmed. Let's start with the Danes as models and adapt from there. 4. As an interim strategy, we should build into our disclosure training and role modeling an emphasis on the importance of inquiring as to the patient's needs -- financial or otherwise -- as the result of the harm. I was very impressed with the When Things Go Wrong white paper put together by RMF, Lucian and others for advancing short and long term compensation offers as a part of the disclosure process. The language is a little careful, but it strikes me as a major step forward for a medmal insurer. You don't see or hear that often in the disclosure discussion. 5. I want to throw one other idea out here for comments as my own impatience for getting this achieved is leading me to this conclusion. Failure to disclose strikes me as an intentional act. If fear of liablity discourages disclosure, another shift the needle strategy is to make the legal exposure for not doing it more than the legal exposure for disclosing. Swift and sure punishment for failing to disclose, why not? Especially as part of a complex of strategies: A. Training and role modeling a la Lucian et al B. Incentivization a la COPIC or Doug C. Compensation for error that's reliable a la Denmark D. Punishment for the intentional harm of not disclosing Thanks, Marty Hatlie From: allanf [mailto:allan.frankel@lotusforum.com] Sent: Tuesday, April 01, 2008 10:45 AM One more aspect to consider in this discussion. I've become increasingly unsettled about the term "disclosure" because one of its main definitions is the revealing or uncovering of information - terms that assume something was hidden or withheld prior to being revealed. Granted there are other definitions of "disclosure" that are more benign - ie the describing of information - but the connotation in "disclosure" is that something hidden is now revealed. Lucian, - perhaps that's why you titled your consensus document "When things go wrong". In terms of the teamwork efforts i'm spending so much of my time on nowadays, why is this important? If stellar teamwork and transparency exist think about what happens when rounding on a patient in a hospital bed. The team - which now includes the competent patient as a team member - stands around the bed and describes the previous days events and determines the plan for the day. In describing the previous day's events, the team talks about all the events - those that went according to plan and those that did not. The team must do this in order to be effective - there is continuous learning going on all the time. The patient hears it all - they hear discussions about good and bad, mistakes, errors, fixes and adjustments to their care, nothing hidden or covered over that would require an act of disclosure to reveal. If we discussed openly with patients the course of events on a regular basis (in a hospital many times daily), then we would describe the many facets of their care to them in each conversation. Care is complex and direction sometimes unclear, so missteps and recalibration are things we deal with constantly and would talk about more comfortably with the patient. This would then make it much easier when a preventable harm, major error or mistake occurs to frankly discuss those too and the process would not be one of "disclosure" it would be one of conversing and updating a very special team member, the patient. The "special" means shaping the accounting of the event and the information so that it is simple and understandable, truthful about what is known and without conjecture, and transmitted with empathy, with apology that this has happened to them, and, in addition,when appropriate, apology that we did this to them - all the things that Lucian, Gallagher, Truog, Leonard etc have described in the literature. I am having difficulty reconciling the participation of patients as team members on a healthcare team and the concept of disclosing a specific event. It's all a bit of a continuum and the one done well renders the other insignificant. Af On Mar 31, 2008, at 6:07 PM, john fasler wrote: Hi to all, I would also like to weigh in on the side of "truthiness" and say that patients and families deserve the full and complete truth about what has happened when an incident occurs, including whether or not it is caused by error. However, the need for full disclosure should not be based solely upon whether "error" has occurred. Patients need (and want) information about both preventable and unpreventable harms in order to make sound healthcare decisions in the future. I did not read Ward's phrase "disclosure of harm" as excluding the fact that error may or may not have occurred or that it be identified as such. I read it as an obligation to inform patients of all harms, including those involving error. The discussion of all harms is particularly important for improving patient safety. Switching an initial inquiry away from a determination of "error" helps shift the focus away from individual fault and allows one to re-focus on the overall picture and what can be done to prevent future occurrences. When the focus remains on individual error, systems failures are rarely identified as problems since an injury can almost always be attached to the last person who touched the patient. That being said, one does not exist without the other and both components need to be addressed in a truthful manner. As Lucian stated, bringing the individual caregiver and the organization together to accept responsibility is crucial for effective change to occur. A parallel program can provide the necessary framework to integrate the practitioner and the organization from initial disclosure through patient-safety improvements and resolution. Karen Fasler From: Sorry Works! Coalition [mailto:doug@sorryworks.net] Sent: Friday, March 28, 2008 1:22 PM Very well put by Dr. Steve Kraman below. Patients and families want the whole truth in plain, simple terms. Level with us and fix our problems. Don't parse words and don't give the slightest hints of secrecy or holding back any information - share everything in an open, honest manner. Candor is golden post adverse event. Sincerely, Doug Wojcieszak, Founder The Sorry Works! Coalition www.sorryworks.net 618-559-8168 From: Kraman, Steve S [mailto:sskram01@email.uky.edu] Sent: Thursday, March 27, 2008 10:34 AM I agree. We should avoid over-intellectualizing this issue and call things what they are. If one person errs, he or she made a mistake. In the swiss-cheese model, there are a series of mistakes made by many people. They are not evil, just made mistakes. If we make a mistake we should say that in clear terms, clean up the damage, make the patient as whole as possible (and reasonable), repair poor systems that made errors more likely and move on. If instead of an error, it is a poor outcome of properly delivered care, we should say that clearly also. Steve Kraman, MD Professor, Division of Pulmonary, Critical Care and Sleep Medicine University of Kentucky 740 South Limestone St. Kentucky Clinic, K528 Lexington, KY 40536-0298 sskram01@uky.edu Tel:859-257-7335 On 3/27/08 9:43 AM, "John Banja" <jbanja@emory.edu> wrote: Dear All: For what it's worth, I very much disagree with Ward. There is a big difference between being harmed from something unpreventable (or being harmed despite the fact that the care provided met the professional standard), and being harmed from an error (which really denotes the failure to provide care according to the professional standard). While it is absolutely true that system failures dispose to errors, it takes a human being to make an error. (Those two look-alike bottles of insulin can be side by side on the pharmacy shelf for years. It isn't until Nurse Betty pulls the wrong one that you have an error.) Patients are always wronged when an error reaches them (whether they're harmed by it or not) because they have a right to receive care according to the professional standard. They are not wronged when they experience harm from an intervention that was nevertheless appropriately delivered. Consequently, the reason why we need to keep the word error in our lexicon is because of its relationship to the standard of care. All patients have the right to health care delivered according to the professional standard (which is what reasonableness and prudence dictates, not perfection). If we dispense with the word "error," we make it easier to gloss over that adherence and, therefore, easier to hold health professionals less accountable. John John Banja, PhD Professor, Dept. of Rehabilitation Medicine Medical Ethicist, Center for Ethics Director, Section on Ethics in Research Atlanta Clinical Translation Science Institute Emory University 1462 Clifton Road NE Atlanta, GA 30322 jbanja@emory.edu (404) 712-4804 http://ethics.emory.edu From: Ward Flemons [mailto:Ward.Flemons@CalgaryHealthRegion.ca] Sent: Thursday, March 27, 2008 9:19 AM Jim et al. I believe the work done over the last several years on disclosure is excellent and is helping to change patients' and their families' experience when they have been harmed as a result of receiving care. However, I would make a plea for people to quit talking about 'disclosure of medical errors'. To do so perpetuates the myth that patient harm results from the action of a single individual. If you believe in Reason's 'swiss cheese' model of accident causation and taking a systems approach to patient safety rather than a person approach it should be clear that the language around disclosure needs to change. Patients are interested in disclosure of harm - error, adverse event, and harm are not synonymous. Language and definitions are always important but particularly so in the field of patient safety. So 'leading practice' should be disclosure of harm, not disclosure of medical error. I would refer you to an editorial my colleagues and I wrote in CMAJ (Candian Medical Assocition Journal) in response to an article published last summer on Disclousre of Medical Error. http://www.cmaj.ca/cgi/content/full/177/10/1236 Regards Ward Flemons From: James Conway [jconway@IHI.org] Sent: March 20, 2008 2:18 PM Subject: Disclosing Medical Errors: Best Practices from the Leading Edge First, let me apologize if you got multiple copies of this notice. I have used a few different lists to make sure the word gets out. Two years ago for an IHI Forum we interviewed many of you around organizational best practices in the area of disclosure. A seed that was planted at the time, and supported by Rosemary Gibson of RWJF, was that we write up some of the stories of organizations taking courageous journeys. IHI has just posted on its web site a excellent paper by Eve Shapiro profiling the journeys of a number of organizations. We want to alert you to its presence and encourage you to hyperlink to it. As you know, access by hyperlink vs. pdf allows us to track frequency of access. http://www.ihi.org/IHI/Topics/PatientSafety/SafetyGeneral/Literature/Disclos ingMedicalErrorsBestPracticesLeadingEdge.htm Best wishes, thanks again for your contributions and thanks to Rosemary and Eve for all they have given us. ------------------------------------------------------------------ Jim Conway Senior Vice President, Institute for Healthcare Improvement [IHI] Office Phone: 617-301-4882 Office Fax: 781 207 9192 Cell: 617 460 9799 Edit by: Michael Sweeney on 4/9/2008 2:52:21 PM


	Samuel Lehman Total Posts: 1	Re: Disclosing Medical Errors 4/10/2008 11:05:22 AM As a relatively new PSO trying to establish our ‘culture of safety’ I have started to approach development of a medical error disclosure practice. While I do not doubt that disclosure is the right thing to do, I do wonder how much we should ‘actively’ disclose. On the matrix of ERROR and HARM, there are 4 possibilities: 1. HARM that is not the result of an ERROR (patient who has never had penicillin has an allergic reaction the first time they get it) 2. ERROR that results in NO HARM or no obvious harm (patient who has a reported penicillin allergy gets penicillin by accident but has no adverse reaction) 3. ERROR associated with HARM (penicillin allergic patient who gets penicillin by accident and has a reaction) 4. NO ERROR and NO HARM It is easy to convince people (hospital/physicians/lawyer/etc) to disclose #1 because it seems safe. Number 2 is a little trickier, do we disclose all of these errors? When the last dose of penicillin is given 2 hours late do we go and tell the family? There are families that will believe that any harm that happens to the patient thereafter is a result of the mis-dosed penicillin. As a pediatric intensivist, I try to think about what errors would I want to know about and those are the ones that I tell my patients. Disclosing ALL errors, however, seems to be the way to really open up and address the process of making errors and develop a ‘culture of safety.’ I struggle with what level of “error significance” we disclose to our patients families (or to the patients for those that work with adults). I am considering developing a family council to help to define this level of significance for disclosure for our population of patients. For #3, disclosure is of course the right thing to do (convincing them is another matter) and #4… well that is what we want! Samuel Lehman MD Slehman@childrenscentralcal.org


	Jim Conway Total Posts: 14	Re: Disclosing Medical Errors 4/11/2008 5:02:36 PM Greetings all and welcome to this discussion group. A little history on this discussion will be helpful. In late March 2008 IHI posted on www.ihi.org an excellent paper by Eve Shapiro on Disclosing Medical Errors. A copy was forwarded via email distribution list to many organizational experts on disclosure. This triggered a lively email discussion among those on the list. Many others heard about this and wanted "in" to the discussion. Others wanted the discussion in a more public area so to faciliate broadbased engagement. Attached is the compilation of the historical emails among the group. A summary of this input will be prepared. We look forward to your thoughts on this topic: a topic we at IHI believe is most comprehensively cast as communications, disclosure, support, resolution, and learning. Thanks, Jim Conway, SVP IHI


	Jim Conway Total Posts: 14	Re: Disclosing Medical Errors 4/11/2008 5:08:33 PM Samuel, thanks for the fist post in this forum. Your note is very thoughtful. As I read it I thought about thinking by Frank Federico and many others--we need to first move this conversation from one of disclosue to one around communications. It seems that if the patient was harmed, be it by preventable error or a complicaiton, we would want to communicate with the patient/family about what happened, why it happened, and what if anything can be done to prevent it from happening again. We would provide support, move to resolution, and consider any learning. In those cases where it is preventable, we would also apologize. In this model, error types 1, 2, adn 3 would be communicated. Thoughts.... and thanks, Jim Edit by: James Conway on 4/11/2008 5:08:46 PM


	Karen Fasler Total Posts: 2	Re: Disclosing Medical Errors 4/14/2008 12:08:14 PM I agree that Samuel’s note is very thoughtful and clearly highlights the difficulty in trying to address what to say to patients and when. One of the concerns I have with using an error/harm matrix is the continued focus on determining error first and foremost before deciding to communicate/disclose/tell the patient. Looking for error first keeps the focus on individual fault. Another possible format for a disclosure policy is the following: The need for disclosure should be based upon whether the patient has suffered harm or has any chance of suffering future harm or whether there has been an unanticipated outcome during treatment. The decision to disclose will not be based solely upon whether or not the standard of care has been violated. Switching the initial inquiry from whether or not error exists to whether or not disclosure is required moves the focus away from one of individual fault or wrongdoing on the part of the caregiver toward a focus on the needs of the patient and whether or not the patient has been provided with all the information necessary to make sound healthcare decisions now and in the future. This disclosure protocol will provide information to the patient as follows: 1. HARM OR FUTURE HARM: This category would cover cases such as: - - the patient who has never had penicillin has an allergic reaction the first time they get it * in this scenario the patient would be told because there has been harm and also because there is a chance of future harm (the potential to have future reactions). - - the patient who has a reported penicillin allergy gets penicillin by accident but has no adverse reaction * in this scenario the patient would be told because there is a chance of future harm in having the error occur again (communication to the patient should include how the patient might also help prevent future problems by questioning the medication they are receiving before they take it). *Also, the organization clearly needs to address how and why this error occurred to prevent future occurrences to this and other patients – if only actual harms are addressed, patient safety issues would not be investigated in this scenario. - - the patient who has a penicillin allergy and gets penicillin by accident and has a reactionin this scenario the patient would be told because harm has occurred. 2. UNANTICIPATED OUTCOMES: This category would cover cases such as: - general types of complications associated with treatment (whether or not error is attached) - examples of this would include the patient who has more extensive cancer than originally thought, or the patient who bleeds more than expected during surgery 3. CONTRAST - PROBABLY NO DISCLOSURE REQUIRED WHERE THERE IS NO HARM AND NO CHANCE OF FUTURE HARM This category would include cases such as: - the patient who receives a vitamin pill one hour late (considered a medication error but no harm and no chance of future harm)*However, the organization clearly needs to address this category to see why the error occurred and to prevent future errors. This type of disclosure policy probably better meets the needs of patients (by giving them the information they need to make current and future healthcare decisions); of organizations (by giving them information they need for making patient safety improvements); of physicians (by not having a focus solely on individual error). Any thoughts? Karen Edit by: Karen Fasler on 4/14/2008 12:28:45 PM*


	Mary Ellen Mannix Total Posts: 2	Re: Disclosing Medical Errors 4/15/2008 1:07:27 AM Thank you Jim for opening the discussion. Thank you Karen and Samuel for your shared insights. In Karen's division of error types and their accompanying degrees of disclosure - the overacrching problem in preventable medical errors is perpetuated: the lack of open communication between provider and patient. Using Karen's #3 as the point of arguement: if a patient cannot expect open communication with a simple, harmless error as vitamin dispensed an hour late - how can a patient feel confident when there is an error of type 1 or 2 the disclosure will be full and transparent? To take it a step further - without the ability to disclose simple no harm errors, how will a provider successfully learn/understand how to communicate preventable errors of a harmful, traumatic and even devastating nature? I have one other inquiry that may have been previously addressed, my apologies if I missed it - has there been any discussion as to how cooperative the institutions highlighted in Ms Shapiro's piece were? Were there parameters and restrictions placed on her research into the facilities' disclosure policies and porcedures? Or was she granted full open access? Thank you for your continued dedication to safe healthcare delivery. Mary Ellen Mary Ellen Mannix PULSE of PA www.pulseofpa.org in memory of James 10/2/01-10/13/01


	Linda Dignem Total Posts: 1	Re: Disclosing Medical Errors 4/15/2008 10:18:17 AM As a previous writer stated, involving the patient in ALL healthcare discussions is of paramount importance. Then the admission of harm or error is just another fact of their care, instead of the first time that the health care team really sits down and talks to the patient. Providers think that this takes too much time, but effort in this regard at the beginning of the patient-provider relationship can save a great deal of time (and resources) in the long run. The provider offering a newly ordered medication to the patient should be explaining what the drug is and what it is for, thus negating the possibility of giving a drug to which the patient is allergic. Of course, in our busy health care systems, this doesn't always happen, which is why we advise patients to "Be Involved". This is the slogan for a Patient Safety campaign in Ontario, with brochures and posters to educate patients about their role. In our hospital each unit has a Patient Safety Board with this information on it. This is reinforced by information in a booklet provided on admission. Patients and providers need to work together to prevent errors while organizations repair flawed systems that enable mistakes. Patient safety is everyone's responsibility, as is disclosure. In the event of less harmful incidents like receiving a medication late, the provider needs only say "I'm sorry this is late, (state reason for delay). We'll be monitoring your (BP, sugars, whatever) to make sure you'll be OK. Please let us know if you feel (dizzy, faint, whatever). To make sure this doesn't happen again, we're going to (whatever), and you could help us by (remembering what time this is due, whatever). The simpler, the better is my motto. Linda


	Eve Shapiro Total Posts: 1	Re: Disclosing Medical Errors 4/15/2008 8:53:02 PM Mary Ellen, Thank you for your question about the organizations I highlighted in my white paper. All were generous with their time and thoughtful in their answers to the questions I asked in our hour-long interviews. No restrictions were placed on my research of which I was aware. At least two things became clear to me during my interviews: One is that the organzations featured in my paper differ in the length of time they have been disclosing (or communicating) medical errors to patients and families. Those that have been doing it the longest seem to have the most comprehensive, formal policies and procedures in place for doing so and had the greatest number of experiences and insights to share. The second was that each of these organizations' policies and procedures were (and probably still are) continually evolving. This state of flux seemed to be the result of their earnestly seeking to answer the question, "how can we do this better?" I hope this helps. Warm regards, Eve Shapiro Medical Writer eveshapiro@aol.com Edit by: Eve Shapiro on 4/15/2008 8:54:26 PM


	Karen Fasler Total Posts: 2	Re: Disclosing Medical Errors 4/16/2008 7:58:52 AM I would like to clarify the “harm / chance of future harm / unanticipated outcome” disclosure format that I wrote about earlier because the intent is to expand the “disclosure pool” rather than to restrict it. Currently, physicians disclose as few as 30% of harmful errors to patients and near-miss episodes are often not communicated at all. My intent is to discuss a disclosure format that expands the number of communications and makes it easier (not harder) to disclose and apologize. Therefore, I need to further clarify the types of scenarios that I had envisioned in my prior submission. A recent article defines adverse events as harms that result from unexpected and unintentional occurrences in healthcare delivery. It goes on to divide adverse events into those that are preventable (called errors) - and those that are not preventable (non-errors). The article estimates that approximately 37% of adverse events are preventable (ie: errors). It then sub-divides the errors into those that cause harm, and those that do not cause harm (which are called near-misses – they do no harm due to chance or correction). Disclosure of harmful errors was recommended by these authors who further note that there is no consensus regarding disclosure of near-misses. Using these definitions, if one were to make the decision to disclosure based on error alone, one would limit disclosure to less than 40% of adverse events. If one were to disclose only the harmful errors, then the disclosure pool would be diminished even further. Any suggestion to change the initial focus from “error” to “harms / potential future harms / unanticipated outcomes” is not meant in any way to diminish responsibility for errors, but rather to expand the way it is viewed so that disclosure actually occurs more frequently. If there is a bright-line disclosure rule - that a patient will be informed of all harms / potential future harms / unanticipated outcomes - then disclosure would be expanded greatly to include both errors that caused harm and also those that caused no harm (near-misses with the potential to cause future harm if repeated). Additionally, under this sample plan, disclosure is expanded even further to include some non-errors (unanticipated outcomes - such as complications). Disclosure of Near-Misses is addressed as follows: - In the case where Penicillin is given to a patient with an allergy to Penicillin but no reaction happens (near-miss avoided due to chance) – this event would now be disclosed because there is clearly a chance for harm if the error is repeated. - In the case where an overdose is given that is reversed before harm results (near-miss avoided due to correction) this event would also be disclosed because there is clearly a chance for harm if the error is repeated). All scenarios could then be investigated by a patient-safety team for possible improvements. This is where the organization must work with the individual caregiver to address both harmful and potentially harmful events to make safety improvements. This plan gives patients the information they need to make current and future healthcare decisions. Additionally, it helps develop an organizational culture that re-focuses the need for disclosure from the viewpoint of ‘what a patient needs to make healthcare decisions’ rather than trying to mandate disclosure in an atmosphere of fear by keeping the primary focus on individual error. Providers can be taught communication techniques. The vitamin pill example given earlier was meant to try to distinguish an event where no harm occurred and where there was no potential for future harm. The example cited by Linda is not what I envisioned because if there is the potential for dizziness then it would NOT be considered a harmless event – and such an event would absolutely require disclosure. Disclosure of errors remains a huge obstacle for a number of reasons, including fears of litigation, fears of damage to reputation, lack of training in disclosure techniques, etc. It is hoped that disclosure based on harms / potential future harms / unanticipated outcomes could help eliminate some of these concerns. Edit by: Karen Fasler on 4/16/2008 8:51:35 AM


	Dale Ann Micalizzi Total Posts: 3	Re: Disclosing Medical Errors 4/18/2008 6:28:01 AM I've devoted most of the past seven years, following Justin's death, to this topic of complete, honest disclosure following an adverse medical event. I've participated on task forces, written papers, presented with physician ethicists, learned the stats on who, what, when and where is the appropriate setting or wording of how to reveal to a family what happened to their loved one in another's care. Being the right thing to do just doesn't cut it sometimes and we need the long drawn out discussion which often happens with culture change. After listening to my frustration of why this humane action was moving at a snail's pace, a physician recently wrote to me, "The medical profession is still very fearful of sharing all details of medical errors with family and the public. This is certainly a hold over from centuries of the profession regarding itself as self regulated and responsible only to itself. However, since about 60% of all medical costs are borne by taxpayer dollars that argument is hollow. A better structure of error reporting and analysis is certainly needed for everyone's benefit." Over the past few months, I have seen progress and I am hopeful for rapid change. Bringing the families of harm into the discussion has been the most productive resource. Saving thousands of lives from this needless harm is totally preventable and the most blatant "medical error" that I've seen. Perhaps, the absence or lack of disclosure following any adverse medical event should be the next "never event." Any thoughts? Dale Ann Micalizzi Justin's HOPE at the Task Force For Child Survival and Development http://www.taskforce.org/justinhope.asp Edit by: Dale Ann Micalizzi on 4/18/2008 8:31:05 AM

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