So our first speaker is Dr. Megan Adams. Dr. Adams is an assistant professor in the Division of Gastroenterology at the University of Michigan. She is an investigator in the VA at Ann Arbor Center for Clinical Management Research. She's a member of the University of Michigan's Institute Healthcare of Policy and Innovation. And Dr. Adams is one of the few individuals who not only is a gastroenterologist, a health service researcher, but is also an attorney. And we're delighted that she's going to speak to us today about minimizing medical legal risk related to endoscopy. Thank you to ASGE and to course directors Dr. Elmanzer and Lennon for the invitation to speak to you this morning. For the next 20 minutes, we will talk about medical legal issues affecting endoscopic practice. And I hope you leave here today with a better understanding of the prevalence of endoscopy-related medical professional liability, as well as some helpful strategies to reduce medical legal risk in the endoscopy unit. I have no conflicts to disclose, and information in this talk is for educational purposes only. I will begin by briefly summarizing what we know regarding endoscopy-related medical professional liability, and then outline several strategies to reduce medical legal risk in the endoscopy unit in the pre-, intra-, and post-procedure periods. One of the challenges in understanding the medical professional liability landscape is finding reliable and generalizable sources of data regarding liability claims. And to date, we have relied on several sources of information to understand the prevalence and characteristics of medical professional liability claims in medicine in general, and GI in particular. The National Practitioner Data Bank is a data repository created by Congress in the 1980s that contains information regarding medical malpractice payments and adverse actions related to healthcare providers, entities, and others. And this information is typically used by organizations to make licensing and credentialing decisions, but aggregate data has also been analyzed for research purposes. Another rich source of data comes from medical professional liability insurer databases. One of these is the NPL, or Medical Professional Liability Association, which is an association of 50 medical liability insurers that collectively insure over 60% of U.S. private practice physicians, hospitals, and others, and report claims into a common database. And the risk management offices of large health systems often are another rich source of data. So just how common are malpractice claims against gastroenterologists? Well, this figure is from a New England Journal of Medicine study examining malpractice risk by physician specialty using data from the National Practitioner Data Bank. On the x-axis is the percentage of physicians with a malpractice claim annually, and on the y-axis is physician specialty. The blue represents any claim, and the orange are paid claims. So you can see that gastroenterology is sixth on the list in terms of total number of claims, and so the bad news is that around 12% of gastroenterologists face a malpractice claim annually, but the good news is that very few of these result in a paid claim. And when we look at the total number of claims against gastroenterologists, roughly 25% of these claims are endoscopy-related. So what are the characteristics of endoscopy-related claims? Well, this is an analysis of closed endoscopy-related claims against providers of all specialties using data from the NPL Association database, and they found around 1,900 total claims over a 20-year period, around 40% of which involved internists, 30% gastroenterologists, and 17% surgeons. And we know that particularly in rural and resource-poor settings, it's not uncommon for non-gastroenterologists to perform routine endoscopy. Most claims involved colonoscopy at 42%, as well as other lower GI procedures, followed by EGD at 23%, ERCP at 11%, and PEG placement at just 2.5%. Half of these claims involved allegations of improper performance of the procedure, and another 27% involved an alleged error in diagnosis. Looking at the outcomes of these claims, around 70% were dropped by the plaintiff or dismissed before trial, and another 5% resulted in a favorable verdict for the defendant or physician. Only 25% of these claims were settled or resulted in a verdict for the plaintiff or patient. However, even though most of these claims did not result in payment, it's important to remember that even claims that are favorably resolved result in a great deal of stress and anxiety on the part of the physician, as well as the patient, and so it's really important not to discount that. And you can see that colonoscopy-related claims accounted for the highest number of paid claims and total claim payments. ERCP had the highest mean claim payments, followed by EGD with PEG placement, and internists performing endoscopy had the highest number of claims, the highest total claim payments, and the highest mean claim payments, followed by gastroenterologists. And a recent follow-up analysis of claims data through 2015 confirmed these general trends and found that the mean claim payment increased by roughly 8% over time across procedures. And older gastroenterologists and those with a prior claims history are more likely to be named in a claim, and this is true of physicians across specialties. Now I'll discuss some helpful strategies to reduce medical legal risk related to GI endoscopy, and we have just a few minutes today to discuss this very large and important topic, but I'll highlight the areas that I believe are the most critical to keep in mind. The first is informed consent, which is a legal and ethical requirement derived from the principle of personal autonomy, under which the physician must disclose information to the patient to allow them to make intelligent choices about their medical care. And there are really two different standards that are applied to judge the adequacy of informed consent, depending on your state. The first is a provider-based standard, under which the physician must disclose information about the procedure that a reasonable physician believes relevant for the patient to know, and would disclose to patients in like circumstances. And because a provider-based standard is now often seen as paternalistic, many states have actually moved to a patient-based standard, under which the physician must disclose as much information as a reasonable patient would wish to know to make an informed decision. And this typically involves discussion of material risks. It's important to understand that there is no comprehensive list of items to discuss, but rather guiding principles, and the more serious and or high probability the risk, the more disclosure is warranted. And ideally, high-quality informed consent should involve elements of both standards, such that the physician and patient will engage in shared decision-making. The core elements of informed consent include explaining the nature and character of the procedure, and really doing this in layman's terms so that you enhance the likelihood that the patient is truly understanding and processing what you're saying, rather than simply nodding their head in agreement. Secondly, you want to explain the material risks of the procedure, which include the nature of the risk, its magnitude, the probability that it will occur, as well as the imminence of the risk, meaning the difference between aspiration, which occurs typically during the procedure, versus something like post-polypectomy bleeding, which can happen up to two weeks following the procedure, which seems fairly remote for the patient. It's also vital to explain the likely benefits of the procedure, as well as to outline potential alternatives. This is particularly important when you're talking about elderly patients or those who are at high risk. Ideally, this conversation should really happen in the clinic or prior to the patient arriving in the endoscopy unit, but it's really vital to discuss the alternative of doing nothing based on the patient's goals of care, comorbidities, and balancing of procedural risks and benefits. It's also vital to allow the opportunity for the patient to ask questions, as well as to assess their competence to understand the information that you are providing to them. I've seen all too often that a patient has been, quote, unquote, consented for a procedure, but when you ask them really simple questions to test that understanding and recall, it's very clear that they haven't truly processed the risk information that you've conveyed. And I really love this quote that speaks to the tension that we, as providers, face when conducting informed consent discussions. Providers must walk a fine line between providing pertinent risk information and overwhelming the patient with frightening statistics. Providing too much extraneous information may be as likely to impair informed decision-making as providing too little. And I try to think about this balance when consenting my own patients prior to their procedures, especially higher-risk patients. Each patient, as you know, is different, and tailoring the consent process to the patient and their information needs is really critical. It's important to recognize that informed consent is a process and not just a document. Really, the purpose of documentation of informed consent is to create a record of what was discussed and protect physicians and patients in the event of future litigation. It's really not meant to serve as a substitute for high-quality verbal consent. Recognize your higher-risk patients and procedures and incorporate this into the consent process, both verbal and written. It's important not to use a canned consent for higher-risk patients or procedures. Really take the time to personalize it. I trained at the University of Michigan under Dr. Grace Alta, and she was notorious for taking the time to handwrite a personalized risk assessment on our stock consent form for her higher-risk patients and procedures. For example, patients at higher-than-average risk of post-ERCP pancreatitis. And I think this is just good practice. Counsel your patients on the risk of missed polyps on colonoscopy. There was a 2019 systematic review and meta-analysis of studies of over 15,000 tandem colonoscopies that found missed rates of 26% for adenomas, 9% for advanced adenomas, and 27% for serrated polyps, which is really much higher than previously thought. Therefore, the risk of missed polyps is actually much higher than other risks that are commonly incorporated into the consent process, including the risks of bleeding and sedation-related risks. And there was actually a recent study of malpractice claims relating to colorectal cancer that found that around 20% of these claims alleged failure to detect colorectal cancer on colonoscopy. Remember to explain the increased risk of potential ancillary procedures, such as esophageal dilation and banding, and incorporate this into your consent process, both verbal and written. If you don't consent for these ahead of time, you really cannot perform these interventions as part of the procedure once the patient is sedated, even if the patient needs it. So this is really critical. Finally, as the endoscopist, it's really your legal and ethical responsibility to consent your patient. At many institutions, including my own, the consent process is largely facilitated through our endoscopy nurses in the prep area. But as the endoscopist, it's really your responsibility to ensure high-quality informed consent. So even if you're using a standardized form, the only way you can ensure that the information was properly conveyed is to do it yourself, or at least to take a moment to reiterate the main procedural risks once the patient reaches the endoscopy room. And it's really vital to ensure team professionalism in all areas of the endoscopy unit, including in the endoscopy room with a sedated patient. There has been increased incidence of covert recording by patients of medical encounters and procedures, including one high profile case from Virginia involving a patient sedated for colonoscopy. And in that case, the patient allegedly intended to set his cell phone to record the post procedure instructions, but instead recorded audio of the entire colonoscopy procedure, during which some very disparaging comments were made about the patient. And while the gastroenterologist was ultimately dropped from the case, there was a $500,000 judgment against the anesthesiologist in that case for defamation, malpractice, and punitive damages. And so I highlight this case here because I think it illustrates a potential area of medical legal risk relating to endoscopy, as well as broader clinical practice. And there was a survey study performed in the UK recently, that showed that roughly 25% of patients reported either having secretly recorded a clinical encounter themselves, or personally knew someone who had covertly recorded. And furthermore, an additional 35% indicated that they might consider doing this in the future. And when we look at, you know, why patients record, they typically cite a common desire to replay, relisten and or share the recording with family and caregivers. Those that covertly record typically have had prior experiences of poor quality care and this need to gather verifiable evidence of that. Those that overtly record typically do so because they want to preserve the physician patient relationship. So to minimize medical legal risk, consider placing all patient belongings outside the endoscopy room for safekeeping during the procedure rather than on the gurney under the patient. I would also ask the patient if they would like to record post-procedure instructions to improve their recall. You know, recording of medical encounters is not all bad. It can have some great benefits to patients and it can, in some instances actually enhance the patient provider relationship. And post-procedure, how you deal with complications when they do occur can really have critical implications on your likelihood of being named in a medical malpractice claim. And really the approach to complications begins pre-procedure with the high-quality informed consent process that we discussed earlier. And good communication and high-quality documentation, again, are really critical in this process, both pre-procedure and post-procedure in documenting those conversations. There is growing evidence supporting more disclosure and transparency with patients sustaining complications and really focusing on preventing the error from happening again and sort of the patient safety issues that may have led or contributed to the complications. It's important in this process to understand why patients turn to litigation for remedy. Certainly there is a segment of our society that is sort of litigious at baseline. But when they surveyed patients and relatives who had filed medical malpractice claims and asked them to specify their reasons for pursuing litigation, the primary reason was actually a desire to seek answers or an explanation for what happened. And then secondarily to establish more transparency and improve communication and then a need to prevent error from happening again. And when patients were asked to describe what actions after the incident might have prevented them from suing, about 37% of the respondents said that an apology and an explanation would have potentially prevented them from filing a claim in the first place. And I said before that there is growing evidence supporting more disclosure and transparency with patients who have sustained complications. And I'll illustrate a couple of examples of this. First, in 2001, my institution established what is called a Disclosure Apology and Offer Program. And under this policy, if the institution determines that a mistake was made and we did not meet our own standard of care, that determination is proactively disclosed to the patient along with an offer of compensation. At the same time, we launched a robust patient safety reporting program to proactively identify patient safety events. And in this study, we looked at the impact of this policy on GI-related claims and costs and found that the policy actually significantly reduced the rate of claims as well as the claims-related costs by about half. Notably, it also cut the time to claim resolution in half from 1,000 days to 460 days. And the importance of strong communication and other non-technical skills cannot be overstated. This is a study that was recently published in the American Journal of Gastroenterology, and it looked at closed claims related to endoscopic perforations. And among these claims were a group of claims that just alleged deficits in technical skill or improper performance of this procedure, and then a group which involved not only an allegation of poor technical skills, but also poor communication and or poor clinical judgment. And they found in this study that claims alleging poor technical skills alone were associated with favorable legal outcomes for the physician and that the odds of a paid claim were actually threefold higher in claims involving poor communication or poor clinical judgment. And I think, again, this just illustrates the vital importance of good communication with the patient, both pre-procedure and post-procedure, and good follow-up. And finally, it's really critical to emphasize the importance of a team approach to risk management. We as providers really have to foster a culture of transparency and encourage everyone on our endoscopy team to speak up when the potential for patient harm is present. This includes everyone from the scheduler to the clerk checking in the patient for the procedure, to the endoscopy nurse in the room, to the physician. And it's really vital to have strong communication with patients, both pre and post-procedure, and listen to patient concerns and respond appropriately and transparently. And I think in doing so, you do help to secondarily reduce a medical legal risk. So in conclusion, endoscopy related claims account for about a quarter of all claims against gastroenterologists. And while gastroenterologists are likely to face a claim during their career at some point, it's important to understand that the majority of claims are resolved favorably for the physician. I can't emphasize enough the importance of good communication and documentation. And it's also important to recognize the increased prevalence of patient recording of medical encounters and ensure professionalism in all environments. And finally, a team approach to risk management is really crucial to ensuring patient safety and minimizing medical legal risk in the endoscopy unit. Thank you very much for your attention this morning, and please feel free to contact me with any questions that may arise after today's session.

endoscopy

medical legal issues

risk management

informed consent

communication and documentation