So next we'll be talking about quality indicators for EGD, ERCP, and EUS. Okay, so we're going to switch subjects now to advanced endoscopy. First, we're going to start with background information. And as we've all been talking about this morning, are these defining quality indicator papers that I refer everyone to that was from 2015 that was from our task force. Initially, they were all started in 2006. And I also want to mention that our ASGE quality committee is currently working on a number of documents that augment these papers. So keep an eye on these new documents that will focus on interventions to improve the quality of each of these procedures, and will be again excellent resources for providers and units who are not meeting quality. So background. All patients should have access to high quality endoscopic procedures, of which we've been talking about this morning. Most of it centers on key factors including indication, which is correct and relevant diagnoses that are recognized and to be excluded, therapy provided that is appropriate, and all steps taken to minimize risk. And the quality of care that we provide can be evaluated by comparing the performance of an individual group or group with a benchmark, which is a quality indicator. In order to identify poor performers and retrain and educate them in order to meet performance targets. So we're not going to go too much into this. But there are pre-procedure, intra-procedure, and post-procedure indicators that we should be looking at. And the grades of recommendations and the targets that we should be looking at. So we all heard this morning and are very familiar with the grade of recommendations and the level of evidence. 1A, 1B are randomized controls, strong recommendations, 1C are over observational data, so on and so forth. So understanding quality indicators. What is important to know is that when you look at the performance target, when it says more than 90% of the time, this is something that we should be doing at all times. And based on clinical relevance and importance, these are items that everyone should be focusing. That's the priority indicators. So let's move on to ERCP. ERCP is unique in that it's one of the most technically demanding and high-risk procedures that we perform as endoscopists. It requires significant focus training and experience to maximize success and to minimize poor outcomes. So what is high-quality ERCP? There's got to be a benefit. We have to show that it's going to improve health. Risk we have to address is to minimize adverse events, which can happen. And there has to be shown a reduced cost and patient satisfaction that we are addressing comfort, compassion, and or palliation. So quality assurance. How do we as a community assure high-quality ERCP? How do I, as an endoscopist, perform high-quality ERCP? So first question for our audience today, what are quality indicators for ERCP? A, ERCP is performed for the indication of biliary structure that's confirmed on MRCP in a jaundiced patient. B, your successful cannulation rate is 50-50. C, antibiotics are administered after successful stone extraction and complete bile duct clearance. D, you are the fastest ERCPist in your unit. Great. So like any other endoscopic procedure, everything is about the right indication. Biliary structure confirmed on MRCP. So there's documents and lists of appropriate indications that you can refer to, but this is a priority indicator. The indication should be documented in more than 90% of the time. This is just a quick list of these indications. So this is really important for particular ERCP compared to other endoscopic procedures. And the reason why is that unlike general procedures where the performance target is about 80%, in ERCP it's 90% given that we know the higher risks that are involved. And so we have to make sure that the indications are pretty solid. We have to make sure that there isn't another test that may be diagnostic, not less invasive, such as an MRCP or EUS, which can help guide management without having to do an invasive procedure. So ERCP really shouldn't be done for diagnostic purposes at this point. The ERCP quality indicator is informed consent, which is not any different from endoscopy procedures. But particularly looking at ERCP, we want to look and focus on six possible adverse outcomes. The most feared is post-ERCP pancreatitis, which in general can be up to 5% to 8%, but as high as 25% to 30% in patients with SOD that are requiring ampulectomies. The second complication is bleeding, which is less than 2%, and generally related to sphincterotomy. Three is infection, typically cholangitis, particularly if you're not adequately draining or completely draining the duct. Four, cardiopulmonary events. Most of our patients require, they may get away with MAC, but sometimes may need general anesthesia, intubation, and so there's separate cardiopulmonary events that you may have to think of. Five, allergic reactions to contrast dye that you might want to document and mitigate, and six, perforations, which can happen for a couple of reasons. One is guidewire-induced, two is sphincterotomy-induced, or three, endoscope-induced. And the overall perforation rate is low, thank goodness, but these things should be discussed and documented well with the patients. And another thing is also to discuss the possibility of failed or multiple procedures. And so, as all of us who do ERCP, we know that every patient and every anatomy is not a guarantee, and so that's a discussion that also has to be had with the patient. Informed consent, very important. Features of a good informed consent, that it's a process, it's not just a document. Also, to be open-minded to potentially safer alternatives, so talking about potentially percutaneous alternatives if someone is leery of going through an invasive procedure. And also, stratify risk based on patient-specific, procedure-specific risk factors. So essentially, do not undersell the risks. And then with our ERCP quality indicators, we talked about indication, we talked about frequency of discussing the risks, and antibiotics, which is a 2B, but performance target of more than 98%, so should be happening all the time. And finally, sort of what we touched upon, which is incomplete duct clearance, if there's any potential or possibility, and that's in cases such as PSC, hyaluronic obstructions, which are always challenging, PD access with pseudocysts, and in special patient populations or procedures like post-liver transplants or even in cholangioscopy. So that with ERCP should be performed by people who are fully trained and credentialed. And also, we're going to move on to why that's important with volume. This study, which was a meta-analysis that looked at ERCP procedural success and its relationship with adverse events, was published in 2017, and it basically highlighted that high-volume endoscopists and high-volume centers had higher procedure success, as you would expect. And high-volume endoscopists had less adverse events. And in this paper, how they defined low volume was less than 156 ERCPs a year, or in centers that had less than 200 ERCPs per year. So lower volume can lead to higher failure rate, higher adverse events, and again, higher volume is related to improved outcomes and rescue from serious adverse events if they were to occur. So what about the real world? Well, the real world is such the statistics is that 40 to 80% of providers provide low-volume ERCP, less than 50 ERCPs a year, and only 5% of the hospitals perform over 200 ERCPs a year. The median annual hospital ERCP is about 49, and most trainees feel that they are underprepared. So how can we address this and improve our quality in ERCP? Well, if we look at intra-procedure issues, what a priority indicator is, one, that you want to cannulate the duct that you're interested in. So if you're doing an ERCP for the bile duct versus ERCP for the pancreas, you have to document what you're trying to achieve, and also document that you are cannulating the duct of interest more than 90% of the time in native anatomy without surgically altered anatomy. So obviously a little bit more challenging if people have had Whipple's or Bill Roth's, but in people with normal anatomy, you should be getting into the duct of interest more than 90% of the time. The next is coming down to knowing what your limits are, and ERCP is graded between difficulty from 1 to 4, and in general, most endoscopists who perform ERCP should be able to do grade 1 cases 80 to 90% of the time, so that's deep cannulation, as we talked about, and stenting. Whereas tertiary experts should be doing cases that are higher grade, successful more than 96% of the time. It's been suggested that ERCPs with lower levels of expertise should not attempt these grade 3 or 4 without assistance of a more experienced endoscopist, but this approach has not been validated. So it comes down to knowing your limits. Moving on to other indicators. Fluoroscopy is 2C but should be happening more than 98% of the time, and that just quantifies that fluoroscopy radiation exposure is very important, and we should be mindful of it as endoscopists. We should try to use the lowest level to allow the procedure to be completed in a safe and timely manner, accordance with the as low as reasonably achievable. One study demonstrated that experienced endoscopists had significantly shorter fluoroscopy times when compared with those that are less experienced endoscopists. Fluoroscopy time and radiation doses are usually recorded by the fluoroscopy machine, and if you have the capability, you should be able to put it into your document. Another priority indicator is frequency with which you can clear the duct of stones that are less than one centimeter, and again in a normal anatomy, that should be happening more than 90% of the time. And another priority indicator is that frequency with which you place a stent for biliary obstruction, whether that's for malignant causes or benign causes in a patient with normal anatomy, which is below the bifurcation, and it's successful in more than 90% of the time. Moving on to post-procedure quality indicators. The first one that we talked about here is completing the ERCP report and documenting what your goals are and if you had achieved them. And again, you should also document if you have the frequency of unintended cannulations and injections that are unintended, particularly like in the pancreatic duct for instance, those things should be recorded and documented. A priority indicator that we all take particular notice is our rate of post-ERCP pancreatitis. Now there's no more than 90% or 98% time of when this happens, and the reason why is because it's a difficult set of single performance target that you can measure. So we don't know what that denominator is, but as an individual ERCPist, you should be tracking your own post-ERCP pancreatitis rate, and also documenting mitigating of efforts. So we all know about rectal endomethysin for the procedures, when you think that you're going to have post-ERCP pancreatitis, and also refer you to our new 2023 ASGE SOP guideline for post-ERCP pancreatitis prevention strategies that go into more detail. Oh, before we move on to other things, I also wanted to mention that ERCP-related hemorrhage should also be recorded and tracked. It's not a priority indicator, but it's something that you should document that if you had to do endoscopic intervention for, and the reasons why, and also if the patient needed to have transfusions, or if anything that was significant. And again, efforts to contact patients 14 days afterwards for occurrence of any adverse events after ERCP is good practice. So I wanted to mention this recent study, actually, that came out that looked as a review, looking at mortality related to ERCP. And thankfully, mortality is very rare in ERCP, but again, it's a very complex procedure that comes with a heavy price of adverse events that can lead to mortality. And so this study looked at particularly trying to identify themes related to ERCP mortality. And it was an Australian-New Zealand audit of surgical mortality, and it was a qualitative analysis of all the procedure deaths that occurred in an eight-year period. And what they looked at was, it was independent and externally peer-reviewed, focusing on these potentially avoidable issues that came up. And what they defined was 58 potentially avoidable deaths following ERCP, with 85 clinical incidents. And clinical incidents were described as aspects of management that may have contributed to death separate to the underlying disease process. So separate from the reason why they came in for ERCP. And the highlights here are that we should avoid unnecessary procedure delays. We should continue to improve our ERCP technical skills. We should recognize adverse events when they occur and actively manage them quickly. Ensure that pre- and post-procedure resuscitation occurs. That means antibiotics that we talked about, IV fluids. And most importantly, that it sort of is a hard thing to measure, particularly a hard thing to look at when you're reviewing, but is communication and or failure to communicate. And in this review, they actually discussed that poor clinical communication was related to some of these clinical events. And that most of the time it was multifactorial. And this poor communication significantly impeded the collaborative effort, which is the hallmark of medical care. And so it's really important, one, to jump on these adverse events when they happen, but also team approach and make sure that all loops are closed and everyone in your team, including intra and extra departmental people are involved and are all on the same page. Critically, critically important. So as a review, ERCP priority quality indicators are the following. Frequency, which ERCP has done for an appropriate indication. Cannulation of the duct of interest is accomplished more than 90% of the time. You can remove small stones less than one centimeter in normal biliary anatomy more than 90% of the time. You can stent biliary obstructions more than 90% of the time below the bifurcation and that you track and try to mitigate your rate of post ERCP pancreatitis. So we're going to move on now to quality indicators for EUS. EUS is similar to ERCP and other procedures and that indication is key, obviously. And these are some of the indications for EUS, mostly for staging of tumors, sampling lesions, evaluation from a diagnostic purposes as well, particularly in cases where it's not so obvious with other imaging that's already been done, for instance, MRCPs or CTs. So pre-procedure quality indicators for EUS, again, again, indication that we talked about, but again, consent, consent process and the specific consents that we should be discussing and specific to EUS adverse events includes the same perforation, bleeding, infection, pancreatitis, tumor seeding, which has been a rare, very rare circumstances. But in cases of cholangiocarcinoma, for instance, needle track seeding can result in a patient being ineligible for liver transplant. So EUS guided sampling of suspected cholangio in patients who are potentially transplant candidates should be avoided. And the following three adverse events are specific to celiac plexus neuralysis and celiac plexus block. They carry unique adverse events, including transient hypotension, which can happen less than 1% of the time, diarrhea that can happen 5 to 15% of the time, in addition to the standard risks. And of course, to talk about ineffectiveness, which, you know, we can talk about with CPN, CPV, but we again, refer you to the ASGE SOP documents for further details. Antibiotics in EUS is important because we want to avoid any potential infections. Currently, there has been no change in recommending appropriate antibiotics and setting of FNA of cystic lesions. And I will say that it's particularly important if you're sampling mediastinal cystic lesions, because there have been events noted to infection when antibiotics are not given in this particular instance. And again, it doesn't go without saying that EUS should be performed by people who are trained. So our next question, what are EUS priority quality indicators? A, frequency with which cancers are staged in the TNM staging system more than 98% of the time. Diagnostic rate sensitivity for cancer and pancreatic masses is 70%, 85% respectively. Adverse event rates, which we talked about pancreatitis, perforation, incidental clinical bleeding is documented, or all of the above? Perfect. All of the above. So all of these things that we talked about, and we're going to go into a little bit more detail. So these are the intra procedure quality indicators. And again, it's really about documenting that you're doing your EUS procedure for a particular indication and you're finding that relevant structure and documenting it more than 98% of the time. And for a lot of what we do, which is related to GI oncology, EUS quality indicator priority is at which that you can accurately TNM stage. And so that includes all the details of which, which is how many nodes you may have to document the tumor size, which is relevant to the T stage. When you're talking about subepithelial lesions, you want to make sure that you're describing what the layer of wall origin is, the echogenicity, the size of the lesion more than 98% of the time. So essentially all the times. You also, if you're interested in sampling the lesion, you want to make sure that your diagnostic rate of adequate sampling and solid lesions is more than 90% of the time and 85% of the time in FNA. What's important here is that the diagnostic rates and sensitivities for malignancies, which is sort of a hallmark of what we do for EUS for pancreatic masses, as we talked about in that question, the diagnostic rate should be more than 70% and sensitivity more than 85%. When we're talking about EUS and adverse events, as we mentioned, we want to make sure that we talk about the relevance. So if you're biopsying the pancreas, theoretically the risk of pancreatitis, same thing for perforation. And that can just be, again, from the scope passage, from the needle, clinically significant bleeding, which is very rare, but can happen. I've actually had a recent bout of it at our institution, which is why we're sort of looking at our practices and reviewing these quality indications. And again, FNA of pancreatic mass and liver sampling, if it's relevant to the case at hand. So we're going to move on to our last quality indicator, which is for upper GI bleeding. And we come to our last question. What are quality indicators for upper GI bleeding? A, epinephrine, sclerosis for the primary indication of treating bleeding varices. B, documentation of ulcer bleeding using the forest class classification. C, penicillin allergy in your cirrhotic patient who's presented with melana, therefore you've decided not to give antibiotics. D, second look endoscopy for re-bleeding. And E, B and D. Okay, great. So yes, documentation of ulcer bleeding forest class, second look endoscopy, obviously you need to give antibiotics even if they're panallergic, find something else. And we know that sclerotherapy is not the first line of treatment for bleeding varices. So quality indicators pre-procedure. One of the important priority indicators is the antibiotics, which we discussed. The other priority indicator for upper GI bleed is the documentation of using PPI for suspected peptic ulcer bleed. We all know that that should be happening more than 90% of the time. Another important point that is not a priority indicator, but is still clinically important, is giving vasoactive drugs when it's indicated. And we know that giving octreotide or even troleprosin is related to a lower risk of seven-day mortality in cirrhosis patients. And so these are the things that you must document more than 98% of the time. Moving on to intra-procedure. Intra-procedure quality indicators really is more about documenting what you found, what you did, if it was relevant and necessary using what we talked about is the forest classification, because that dictates the management strategies, including the level of care and the need for endoscopic therapy. But what's also important is what I highlighted there, which is the type of bleeding and the location should be documented more than 80% of the time. And even though it's a level grade three, I would say that clinically, this is something that's very important because if there is a high-risk stigmata lesion, and the patient is at risk for re-bleed, you really want to be able to document the location of the bleeding and the need for endoscopic therapy. If the patient is at risk for re-bleed, you really want to document exactly the details so that maybe the next day when you're going in for that second look endoscopy, it's not going to be you, it's going to be your colleague who's on call, and they're going to really need to go back to your report to know exactly where the lesion is, because sometimes it may not be obvious, or there may be multiple sites. So it has to be very clear for that second endoscopist to be able to read your report and go back and make the appropriate management treatments. And same thing we talked about, treating ulcers that needed to be treated, active bleeding, non-bleeding visible vessels that are pigmented protuberance, adherent clots if you can wash it off and find the underlying lesion. We talked about ulcer bleedings and how to treat it, that's the priority that we talked about, should be happening more than 98% of the time. Also documenting that what you did to achieve hemostasis was or was not achieved, and then a 1A more than 98% is just talking about how epinephrine should not be used as a single agent alone. Moving on to variceal ligation, we know that banding is the first modality of treatment. Post-procedure, what we should be looking at is a couple of things. So PPI, lots of people are on PPI, maybe not for the right reasons or not for the right duration of time, but for sure when you have a solid indication, you find PUD, you have to document that you instructed patients to take the PPI for whatever the time period may be. Also what is important is H. pylori. So if you have PUD, you have to document what your plan is to test it and that you will treat if it's found, that's very important, and I think probably don't do more of this as we should in real world. And then again, frequency with which patients with evidence of re-bleeding should go under repeat endoscopy, so we know that second look endoscopy is important and effective. So to wrap up, upper GI bleeding and EGD priority indicators, frequency with which endoscopic treatment is performed for ulcers with active bleeding or with non-bleeding visible vessels more than 90% of the time, frequency with which plans to test for H. pylori infection are documented for patients diagnosed with gastric or duodenal ulcers more than 90% of the time, frequency with which appropriate prophylactic antibiotics are given in patients with cirrhosis and upper GI bleeding who are undergoing EGD, and which frequency with which PPI is used for suspected peptic ulcer bleeding before you scope the patient. So in summary, maintaining the highest level of quality is essential. Empower yourself by reviewing these quality documents and also the relevant documents that go along with those papers that the ASGD provides. Focus on meeting targets on priority indicators, and if you are not meeting these targets, these may be the focus of quality improvement initiatives in your endo unit. Also, refer to recently released ASGD documents with these interventions to improve quality indicators. Thank you so much.

quality indicators

endoscopic procedures

EGD

ERCP

EUS

performance evaluation