So, as much fun as it was talking about ERCP, it's not necessarily as much fun talking about this. This is a topic that it's very important, but I think it makes everybody a little bit nervous. The last thing that any of us go into the field of medicine for is to be involved in any type of legal proceeding, but unfortunately, even with following best practices and doing your best work, it is a situation that many of us will find ourselves in. So I'm going to highlight some of the medical legal aspects of endoscopy and try to emphasize how it applies to APPs. So some of the things that we're going to go over, I'm going to start out with just some very basic legal terminology just to set the stage for some of the other discussion. We'll talk a little bit about the basics of tort law. We'll spend time talking about physician liability for non-physician providers, including APPs, and then we'll give some guidelines for how to minimize liability risk within practice, and then I'll end with some specific examples. So again, just some basic legal terminology. So a claim basically is the assertion of wrong that forms the basis for the suit. Deposition is when it's basically questioning under oath of either the plaintiff, the defendant, sometimes witnesses during the discovery phase of the lawsuit. This is really the most important term here, and that's basically the healthcare provider's failure to meet the standard of care. And then the standard of care is the care that a reasonable physician would deliver under similar circumstances, and this is usually established by an expert witness during the legal proceedings. So the basics of tort law, so there are a number of different types of tort, but the one that applies to medicine is negligence, and negligence basically has four different aspects that the plaintiff's attorney has to prove in order to have a successful medical malpractice lawsuit. When I say successful, I mean successful for the plaintiff. The first is that they have to establish that duty of care was established between the physician and the individual. And so basically, was a physician-patient relationship established? Next, it has to be established that that duty was violated by practicing below the accepted standards. It has to be shown that the substandard practice was the proximate cause of some type of an injury. And finally, that there's compensable harm in the form of damages. And so these are the kind of the four keys that the plaintiff's attorney will try to establish within a given claim. As it applies to advanced practice providers, there is physician liability that can be attributed to non-physician providers. So it could be APPs, it could be nurses working under the care of the physician. And there's basically kind of five different areas, and Dr. Call had touched on these during his talk a little bit earlier today. But basically, the first is lack of adequate supervision. So that's when the provider has limited supervision or maybe even hasn't documented that there's adequate supervision of either an APP or a nurse. And this tends to be an issue in larger practice settings where there might not be as much oversight or collaboration between different levels. Untimely referral is when the non-physician provider attempts to treat a complicated condition which may be beyond their own level of skill. Failure to properly diagnose is potentially having the appropriate information at hand but not interpreting it appropriately and not coming to the correct diagnosis. Inadequate examination is not performing the necessary testing or examination to establish a diagnosis. And then the last one is an interesting one. It's called negligent representation. And this is where the APP doesn't make it clear to the patient that they are an APP. And there have been suits where the patient thought they were seeing a physician. The APP never introduced themselves appropriately and people got in trouble for that. So it emphasizes the importance of properly representing who you are and what you're there for. There are three legal theories which can ascribe the liability to the physician for errors that are made by the APP. The first is vicarious liability. And this is basically where the provider, the APP or other non-physician provider is caring for the patient usually under the supervision of a physician. The physician might not be directly involved. The practice might not be directly involved with the care of this patient. But because of the perhaps the employment model, for example, if the APP is employed by a practice and something goes wrong, it could potentially be attributed to the physician or even to the practice. This is done primarily to bring in basically additional money for the plaintiff to go after in the case of a civil suit. The second is negligent supervision, which is exactly what it sounds like. They're not properly overseeing an APP or not documenting that there's appropriate supervision. And then the last one is negligent hiring. And this is where the practice or the physician is unaware or doesn't do enough background research before hiring the APP to determine that they have adequate level of training to perform the specified duties. So there are some general rules that can be used to try to limit liability. And these apply for both the practice physician as well as the APP. So the first is to make sure that you have the adequate educational requirements for the physician. So make sure that the person has adequate training to be involved with the type of patient care that they're doing. There's a lot of state to state variation on how APPs can practice. So it's important that both the APP and the physician become knowledgeable and make sure that they're practicing within their state's rules and regulations. It's appropriate, you want to obtain the appropriate level of training that may be prior to starting at a place of employment, but much of that actually occurs afterwards during an appropriate onboarding process, such as what Sarah talked about earlier. There needs to be appropriate supervision, and that needs to be ongoing between the physician and the APP. And regularly review performance. So go over cases, go over performance benchmarks to make sure that everybody's meeting expected benchmarks. As I mentioned earlier, you want to introduce with an appropriate title, make sure it's clear who you are and what you're there for, and then set high standards for performance. And this is something that we always try to do early on in the course of an employment process. So if we look more generally about gastroenterology and why claims are made, the most common reason, and this is based on a big study from about 2008, the most common reason that they identified were errors in diagnosis. The next most common was improper performance of a procedure. And you can see some of the other causes, failure to communicate appropriately, performing a procedure when not indicated, or even not performing a procedure when it was indicated. So in law, they can come after you for what you do, they can come after you for what you don't do. So both errors of omission and commission. If we look at procedural malpractice claims, by far the most common reason are diagnostic procedures of the large intestine, and we're primarily talking about colonoscopy here. And that's just strictly because of the number of procedures that are performed. Diagnostic procedures of the gallbladder and biliary tract, again, we're primarily talking about ERCP was the next most common. So but colonoscopy still remains the most common reason for a procedural malpractice claim. If you look at the total number of claims by specialty, and you kind of work your way down where gastroenterology is, you see that compared to other specialties, the number of claims is actually on the lower end. We're higher than dermatology, but we're much lower than OBGYN or general surgery. Again, this is total number of claims. But even when you break down by number of physicians, and this is shown in this slide here, the claim rate is really much lower compared to other specialties like CT surgery, general surgery, and OBGYN. So that's not to say that we don't need to worry in GI, but there's a common, I think a common misconception that because we're a procedural specialty that we're going to be at a significantly higher risk for claims, but the data doesn't bear that out. So what are some specific practices as they apply to GI, and these are very useful things for you to know as you go about your daily business. Cross-practice evidence-based medicine, that's good advice for any specialty. One area that you have to be a little bit careful about is open access endoscopy. These are patients who are typically not seen by a provider until the day of the procedure, and so there isn't necessarily a strong provider-patient relationship that's been established. So it's very important to do a good vetting process when you're bringing those patients in for open access endoscopy. Obviously, managing procedural complications appropriately, early identification, appropriate management is key. Be very careful with email communications. Emails are discoverable in a court of law, and they will try to find any type of communication. So if it's something that you wouldn't want people to see, don't put it in an email. You should consider anesthesia support for frail or elderly patients, and informed consent is probably the most important. You need to carefully document informed consent for procedures. You should also probably be performing them for high-risk medications as well, and that's not something that we always think about. So the last thing I want to do is I want to end with some case studies, and these are not real cases. These are cases that I've made up, but I think that they emphasize some of the pitfalls that we can encounter. So the first case is a 25-year-old female who presents for evaluation of right upper quadrant pain for two years. She's had a cholecystectomy for biliary dyskinesia one year ago and did not have any improvement, so basically she did not have gallstones. She had normal liver chemistry. She had normal pancreatic enzymes. An abdominal ultrasound revealed a normal common bile duct. An abdominal CT only revealed cholecystectomy clips. So she was referred to the local gastroenterologist for possible sphincter voti dysfunction. The gastroenterologist suggested that the patient start treatment with a low-dose tricyclic antidepressant for possible functional abdominal pain. However, the patient was very insistent that an ERCP be formed because she looked on the internet and she found that her symptoms were very consistent with sphincter voti dysfunction. An ERCP with a biliary sphincterotomy was performed, and the patient developed severe post-ERCP pancreatitis and was hospitalized for two months, eventually developing a large pseudocyst that required drainage. The physician was sued. In the deposition, the physician reported doing 75 ERCPs during training and only about 20 ERCPs per year in practice. The lawsuit didn't make it to court. It was settled in favor of the plaintiff. So hopefully as you were listening to that case, you identified some of the red flags on what could have been done differently to avoid this. Probably the most important one in this case is to avoid risky procedures when the indications are weak or absent. So in this case, this patient did not meet criteria for going to ERCP, and Dr. Call had talked about this episode study that came out several years ago that has basically eliminated type 3 sphincter voti dysfunction as a real diagnosis, and it showed that you're much more likely to harm patients by doing this procedure than you are to help them. And basically, that's what this physician did, did a procedure that ended up causing harm without any good indications. The other mistake that you probably identified is that this physician probably did not have adequate training or expertise for the level of practice. Those numbers are on the low side, and low volume ERCP is an area that physicians practicing with only that number of ERCPs really shouldn't be doing it. They should be sending it to centers with more expertise. One other case I think illustrates a couple other potential pitfalls in the malpractice world. So this is a 56-year-old male who presents with epigastric pain and weight loss for two months. The patient was evaluated by a nurse practitioner who arranged an upper endoscopy but took two months after the initial consult to perform the EGD because of scheduling issues. The EGD was normal. The patient was given a once-daily proton pump inhibitor. He came back two months later with abdominal pain and a new onset of jaundice. An abdominal CT performed a pancreatic head mass with dilated bile ducts and multiple liver masses. The supervising physician then saw the patient for the first time when he performed an ERCP with palliative biliary stenting. Patient died three months later. The family sued the physician in practice for delay in diagnosis and inadequate supervision of the nurse practitioner. During the discovery phase, emails were identified which showed that the nurse practitioner had requested that the supervisory MD give an opinion, but the physician had not responded to the email. This lawsuit was again settled outside of court in favor of the plaintiff. So again, hopefully identified some problems here. First off was there was not adequate supervision of this nurse practitioner. There was a delay in performance of tests. And this is actually a big concern nowadays because of how busy many GI practices are. It's not unusual for, you know, a couple of months to see the physician and then a couple of months more to actually perform the diagnostic procedure. And this clearly opens up a window when we can run into problems. And as this case demonstrated, email communications are discoverable and can easily land, you know, end up in a court of law. So it's just some things to conclude here. Practice pearls. Physicians can be held liable for actions of non-physician providers, including APPs. Practicing evidence-based medicine within the scope of practice is really the key to limiting liability for APPs. Informed consent and appropriate management of complications limit liability. As this case demonstrated, you really should be limiting communications by email as these are discoverable in a malpractice case. So I'm just going to wrap up with a couple of polling questions here. First polling question, which of the following can help limit APPs liability? Practicing beyond the scope of training, obtaining and documenting informed consent for procedures in high-risk medications, communicating privileged conversations, or avoiding direct contact with the patient after procedural complication? Which can help avoid liability? Very good. So obviously, the informed consent process is key and it's something that you will all play in a very important role in. All right. Second polling question. What is the most common reason for a claim in gastroenterology? Procedural complication, failure delay in diagnosis, failure to supervise or monitor a non-physician provider, or errors in diagnosis. So these are all reasons for a claim, but if you remember that slide that I showed you, it's actually errors in diagnosis which form the most common reason for a claim in gastroenterology. So the last choice. And finally, the last polling question, what is the most common procedure which generates a claim in gastroenterology, colonoscopy, EGD, liver biopsy, or ERCP? Okay, so while ERCP is kind of the most feared procedure in terms of causing complications, it's actually colonoscopy which generates the most claims. So with that, I will wrap it up and I will pass the floor back to Dr. Vicari.

endoscopy

medical-legal aspects

advanced practice providers

tort law

physician liability