Thank you so much, Rabia, for that really excellent overview of infection control as it relates to the endoscope and reprocessing of the endoscope, but also the human capital within a unit. A lot of options for what to do, especially around duodenoscope-related infections in particular, and so I think as unit leaders and nurse managers and so forth, we really need to sort of get into the mechanics of how to achieve, or at the very least how to adhere to federal and international guidelines. So with that said, I'm delighted to welcome Jim Collins. Jim is a world expert in this space. He's currently the endoscopy accreditation specialist for the Digestive Disease and Surgical Institute at the Cleveland Clinic. He has served on various ASGE committees and has been active in the national and local scene for SGNA. He's also a co-author on the Multi-Society Guideline on Reprocessing Flexible GI Endoscopes and Accessories, and so I think Jim will be really instrumental in helping us understand what we actually should be doing from a nuts and bolts point of view in our units to make sure that we keep our patients as safe as possible. So thank you for being with us today, Jim. Thank you for such a warm introduction, and thank you for the privilege to participate in this program today. All right, I do have several financial disclosures to make. I do work with Boston Scientific, Olympus America, Steris U.S. Endoscopy in the form of consulting, but there will be no conflict in the presentation that I am giving to you today. All right, so when we look at infection prevention in the endoscopy unit, what do we think of first and what has gained the marquee attention of the community has been endoscope-associated infections, but we do know that endoscope-associated infections are quite low in their frequency. There is a very long lag time between colonization and the infection that presents. We do have inadequate surveillance of our activity, especially on an outpatient basis. The pathogens causing these problems are usually the enteric flora, and we have learned through today's presentations that the risk of some procedures might be lower than others in the patient acquiring an infection. So what's the scope of the problem? When we look at the overview of infection prevention in the GI setting, again, most of the attention has been given to the inappropriate cleaning and disinfection of endoscopes. Also, there has been attention given to our AERs due to the fact that they have either received poor maintenance or they have not functioned accordingly, though we have learned through several events that there are additional factors that play into infection prevention within the endoscopy unit. So we have learned that there often is reusable tubings that are not changed in between patients. We know that disposable tubings themselves may be used beyond the use life. There are malfunctioning or absent check valves on the tubings. Water bottles themselves have not been properly high-level disinfection or sterilized. We have found that there has been inappropriate reprocessing of reusable GI accessories. Contamination via the hands of caregivers to our patients have occurred. We've heard that environmental concerns of the endoscopy unit as well. Cleaning the procedure room between cases, especially those high-touch surfaces such as endoscopy unit controls, controls on IV pumps, as well as our glucometers have led to blood-borne pathogen exposures. And then safe medication practices, the reuse of syringes, needles, and multidose vials have occurred. When we look at the data from the Joint Commission on the top five noncompliant findings for 2021, behavior health concerns of the reducing suicide has been the number one most cited standard. But we see that the other two and three are related to infection control practices. There's the same standard with elements of performance being cited. And what do you know? There's the third one is safely administers medication. And this includes the safe medication practices. Also environment of care where manages risk related to utility systems as well as hazardous chemicals can exist. So if wearing a PPE is not cited as an infection control standard, it may be cited as an environment of care standard to our caregivers. So just to share a little difference between the standard of O2, O2, O1, the element of performance one deals with the organization reducing the risk of infections associated with medical devices. So this is our plan of action. And element of performance two deals with performing intermediate and high-level disinfection and sterilization of our medical goods. So again, surveyors are quite frequently involved in this activity and the deficiency in these standards have led to infections occurring within our patients. And I like this slide to just show to the crowd that infection prevention within the endoscopy unit caught the attention of CMS back in 2009. So over a dozen years or so ago, CMS looked at 68 centers and they found that there was nearly a third of them failed to adhere to recommended practices in infection prevention within their units. And they shared this data with accreditation agencies and we can see that there was a slow and steep rise of citations that addressed infection control practices. Now as we're in 2022, we can see that from a high of 70% in hospitals and ambulatory centers, we begin to see the number drop below 60% and nearing 50% now. So we have gotten much better in our practices of offering a safer environment. This chart just expounds upon the findings that have been recorded thus far. So let's understand the process of infection prevention within our endoscopy unit. First and foremost, we know that endoscope reprocessing is the most heavily weighed activity within infection prevention in our units. We know that there are several steps that are paramount to endoscope reprocessing and each step builds upon itself. From pre-cleaning of the endoscope at the bedside that needs to be done properly through leak testing, manual cleaning, rinsing after cleaning, the inspection of that endoscope as well before we subject the endoscope to high-level disinfection, rinsing, drying, and storage. Along these nine steps, there can be omissions that occur or there may also be activities that aren't according to the MIFU, the manufacturer's instructions for use. What we see is pre-cleaning, not aspirating the correct volume of solution through the endoscope, failure to perform the leak test as well has been noted, reusing the detergent solution, not placing the appropriate amount of detergent in the wash solution, reusing disposable channel clearing brushes, or not properly reprocessing reusable brushes. Again, lack of inspection of the endoscope, not properly rinsing the endoscope. When we look at high-level disinfection, often the monitoring of the strength or the minimal effective concentration of the disinfectant solution was omitted. And also improper storage and drying of the endoscope. But also what these studies have showed that there's other deficiencies that have gone along with the reprocessing of endoscope. And when we look at these, the occupational concerns that were filed by the study, this was Corey Ofsted's study from 2020 that showed the human factors that affect endoscope reprocessing. The majority of the reprocessing personnel felt pressure to work more quickly. And this was three-quarters of them reporting this. And then there's also the other physical complaints that came from frequent reprocessing and repetitive motions that reprocessing holds indigenous to itself. Numbness and tingling of their fingers and also discomfort of wearing PPE. Which led to 30% of these individuals not performing their job accordingly, the missing of work, and also the interference of activities outside the workplace. So significant occupational concerns and those human factors that are attributed to endoscope reprocessing as well. We heard about personal protective equipment. Wearing is essential to be done. Often it has been omitted that has led to exposures to our staff. In the reprocessing room, we have those splashes to the eyes, to the mucous membranes, to the nose, to the mouth that have occurred. But also we've had these occur now within the procedure room as well. And COVID has brought a higher sense of the need to wear PPE during procedures. Also note a frequent omission of reprocessing staff has been the omission of wearing hair protection as well as beard covers as well. So these are two aspects of care that are often omitted. We know about hand hygiene being very critical to providing a safe environment for our patients as well as to our caregivers. And we need to ensure that we monitor our hand washing compliance. We've learned back in 1865 in Vienna the importance of hand hygiene and its reduction of disease transmission. So record and monitor all the caregivers within your facility, be it your attending physicians, your trainees, your anesthesia personnel, all bedside caregivers should be reviewed on a monthly basis. Personal hygiene is also paramount to be performed. We must provide a clean and safe sanitary environment for our patient and for our caregivers again. Before mentioned, the in between procedure cleaning of the procedure room, all those high touch surfaces need to be given the attention they deserve. Here are clean monitor leads that are on the floor. So we have to ensure that even though we do clean the equipment accordingly, that we stow it accordingly after it has been disinfected and cleaned. Also if we do have that case of a C. diff that occurs, that we use the appropriate disinfectant to adequately clean that room with and ensure that the staff has instituted contact precautions and have used soap and water to facilitate their hand washing. Medication practices, the safe medication practices are imperative. What we have found is not cleaning the stoppers of vials, not cleaning the stoppers of the IV access ports to patients, and unfortunately the reuse of needles and syringes does still occur within our practice settings. So creating a culture of safety to reduce likelihood of events occurring and to promote a safe patient environment, the creation of infection prevention plan that is kept up to date, that we have our MIFUs, manufacturers instruction for use readily accessible for our staff as well as safety data sheets for the chemicals and chemistries that we keep within the unit as well. Also we want to ensure that our staff, our caregivers are given the opportunity to have the appropriate immunizations given to them to help reduce the potential of infections from occurring. Personal protective equipment readily available, readily in sight for them to utilize. And safe injection practices being utilized. Meticulous reprocessing of endoscopes with education and competency verification, competency verification of all staff that are going to reprocess an endoscope. And believe it or not, that we have to ensure that our in room staff have the ability to properly pre-clean the endoscope, provide that point of use treatment, ensure that there's appropriate space and equipment is dedicated for the endoscope reprocessing area, that this processing area is large enough to prevent splash and other potential contamination from occurring either by distance or by barrier. Also that this area promotes good traffic flow from dirty to clean. We must ensure that we schedule appropriate staff and the time to complete the entire reprocessing procedure. Make sure that it is performed immediately post-procedure when possible so we do not run into that potential delay of reprocessing that may occur due to the MIFU of the manufacturer. So who is responsible for the infection control plan, infection prevention within the endoscopy unit? When it comes down to it, accreditation agencies look at the governing body. The governing body is responsible for the safety and quality of care, the treatment and services that are offered within that facility. So building a large, a strong, a good quality infection prevention program in your endoscopy unit is built upon the input of several disciplines working together to create that safe environment for the patient and the caregiver. We have infection prevention that stays on tune with the recent developments of qualities and of guidelines and standards to infection prevention. Our clinical engineering to ensure that our equipment is checked and provides preventative maintenance. Our facility leadership to overlook the process together. Our supply chain management and vendor team working together to ensure that equipment is available. Our vendors may provide education and training to promote the safe use of their products as well as to promote infection prevention techniques to help minimize our risk. And again, accreditation and risk management working together to provide a quality program. And those facilities that have an instrument reprocessing department can also share their expertise on instrument reprocessing. We may also look at ASGE and SG&A who have published very excellent recommendation and practices related to infection prevention within the endoscopy unit. So these are great resources for you to review, construct a strong infection prevention program or to review and to validate the practice that you have in your facility already. So quality issues within the infection prevention component of your facility is you want to ensure that your reprocessing plans, your policies, and your procedures are kept up to date, that they're written, that we don't have protocols based upon, well, this is how Emsi's done things and Emsi's been here for 20 years so he must know what we're doing. So we need strong evidence-based reprocessing protocols with regular education and competency verification of our staff. Usually this is performed annually. We want to have readily traceable identifiers so endoscopes may be traced from patient to the AER and through storage without any difficulty that this may be done seamlessly. And lastly, routine maintenance of all our equipment within the unit from IV pumps to our AERs to our electrosurgery units. We want to ensure that routine maintenance is done and our equipment is performing as expected. We also need to have a plan to place into action if there is an infection that is suspected. And ASGE has a nice plan written for reprocessing failure that deals with recommendations of reporting, notification of the patient as well as the local health authorities, testing protocols that should be initiated, also how the patient can contact the facility if there are questions, and also is it available for one-to-one counseling if needed. In closing up for you this afternoon, endoscopy is a life-saving technology. There's over 60 million endoscopies performed annually. Infections are quite rare. Our practices of infection prevention readily eradicates the viral diseases that are in our society, from HIV to the hepatitises, as well as many bacterias are again easily eradicated and adherence to established meticulous cleaning standards are crucial in all phases of our practice. And I want to thank you for your attention, and I look forward to the remaining presentations of the day. Thank you.

endoscopy accreditation specialist

infection prevention

endoscopy unit

cleaning and disinfection

endoscope reprocessing

patient safety