Episode #117 Crucial Patient Safety Issues in NORA: Highlights from the 2022 APSF Stoelting Conference

Hello and welcome back to the Anesthesia Patient Safety Podcast.  My name is Alli Bechtel and I am your host. Thank you for joining us for another show. We have a special series that we are starting for you today. If you attended the 2022 APSF Stoelting Conference in person or on zoom, then you already had a sneak-peak because this series will cover the 2022 APSF Stoelting conference, “Crucial Patient Safety Issues in Office-Based and Non-Operating Room Anesthesia (NORA).” The conference was directed by Shane Angus, JW Beard, Emily Methangkool, Lynn Reede, Patty Reilly, and Richard Urman. Today, we will be talking about highlights from the first conference panel.

Before we dive into the episode today, we’d like to recognize GE Healthcare, a major corporate supporter of APSF. GE Healthcare has generously provided unrestricted support to further our vision that “no one shall be harmed by anesthesia care”. Thank you, GE Healthcare – we wouldn’t be able to do all that we do without you!.”

The 2022 Stoelting Conference focused on anesthesia patient safety outside of the operating theatre. This is such an important topic since more and more surgical, diagnostic, and therapeutic procedures are performed in non-operating room or NORA locations and there are unique and increased risks associated with providing care in these locations which may include isolated radiology areas within the hospital or ambulatory surgery centers or even accredited and non-accredited offices. The Stoelting conference brought together anesthesia professionals with other healthcare professionals as well as those in industry, regulatory agencies, and healthcare administration to develop multi-disciplinary, consensus-derived recommendations that can be used to advocate for changes leading to improved NORA patient safety going forward. Let’s review the meeting objectives now.

• Understand the issues that may lead to mismatches in patient selection and preparation and the capabilities of NORA locations and their staff
• Review patient selection criteria, appropriate kinds and numbers of staffing, equipment and monitoring availability to deliver anesthesia appropriate to the situation and any other issues associated with potential patient safety problems in isolated procedure rooms, free-standing surgical centers, offices and procedure centers
• Discuss opportunities to promote patient safety using clear outcome measurements and data-driven improvement initiatives in all NORA cases
• Develop specific recommendations that APSF can use to influence changes that improve patient safety in NORA practices

Before we get to the first session, the APSF President, Dan Cole opened the conference by speaking about the purpose of the conference and the expected outcomes. He described the many roles of the APSF in working towards improved patient safety which include research, education, the Newsletter, Collaboration, Communication, and Advocacy. The Stoelting conference is an important part of the education arm of the APSF with the goal this year facilitate knowledge of anesthesia patient safety considerations in NORA locations.

Let’s move out of the operating room and into the courtroom with Brian Thomas speaking about adverse events in NORA locations. Brian Thomas is a member of the APSF Board of Directors and is the Vice President of Risk Management for Preferred Physicians Medical. He contributed audio clips to the podcast for Episode #111Off-Label Drug Use During Anesthesia Care. If you haven’t listened to that one yet, we hope that you will take a listen.  Thomas reveals that looking at closed claims data from his company and for the past 200 cases, 14% took place in NORA locations. If we look closer at this data, all of the NORA cases settled without going to trial, and the NORA settlements were twice the amount for OR procedures and other Non-OR procedures such as OB and ICU airway procedures. In addition, there was an increased number of claims and lawsuits resulting from complications during endoscopic procedures. This is a big threat to patient safety since many of these cases resulted in catastrophic injuries including brain damage and death.

Let’s look at a case. That patient was an ASA 3 with multiple comorbidities presenting for elective colonoscopy. The plan included monitored anesthetic care with sedation with propofol and lidocaine. Oxygen delivery included nasal cannula. During the procedure, the GI physician noticed an irregular heart rhythm and hypotension. The lights in the room were turned back on and that patient was found to be cyanotic. The heart rate progressed from bradycardia to asystole. A code was called, but even though the patient was resuscitated, he never woke up. The cause of death was determined to be hypercarbia, hypoxia, and brain death. There were several big failures in this case that contributed to the mortality including: failure to secure the airway, lack of capnography monitoring, failure to recognize and treat hypoventilation, lack of vigilance. In fact, the GI physician reported that the anesthesiologist in this case was not paying attention to the patient, talking too much, and showing pictures from his phone. This case went on to settlement.

There are several big threats to patient safety in NORA locations. If you are involved in providing anesthesia care at NORA locations, then these are important considerations. Common allegations following adverse events in NORA locations include the following:

• Inappropriate patient selection for planned procedure
• Inadequate preop assessment
• Lack or insufficient equipment/medications/support staff
• Failure to communicate
• Distractions
• Lack of vigilance

Thomas reveals that these cases are challenging to defend in court for the following reasons.

• Substandard care provided including being distracted and inappropriate monitoring
• Metadata evidence including phone records compared to the medical record data
• Lack of expert support
• Finger-pointing by other staff members, especially if the anesthesia professional was distracted or perceived to be distracted
• Potential jury members perception that these cases are supposed to be safe and low-risk, so when a catastrophic events happens, there is the perception that negligence must have occurred.
• Increased risk of significant jury verdicts possibly exceeding available insurance policy limits

Before wrapping up his talk, Thomas reminds us that any use of a personal cell phone during a case can be traced and used in court to demonstrate that the anesthesia professional was on their phone and not paying attention during the case. It is so important to remain vigilant to help keep patients safe.

So, what can professional liability insurance companies do to help? First up, the use of underwriting criteria to look at the anesthesia professionals and their practice areas to make sure that the setting has the appropriate equipment, medications, staffing, and resources. In addition, identify loss trends and sharing this data with the ASA and AQI to help guide risk management and prevent these losses in the future.  Other strategies include working with anesthesia professionals and facilities to develop and implement appropriate policies and protocols, advocating for best policies and protocols to help avoid problems, and creating focused risk management resources and strategies which may include supporting the APSF.

It’s the time you have been waiting for now. The first session of the 2022 Stoelting Conference, moderated by Emily Methangkool. This session is called, “Is All NORA Created Equal? Requirements for a Safe and Effective Anesthetic Regardless of Location.”

The first speaker is Basem Abdelmalak with his talk, “Defining NORA: Introducing Safety Concerns.”

With all this talk about Non-Operating Room Anesthesia or NORA, it is important that we define NORA. Abdelmalak tells us that NORA is any anesthesia service provided in a location outside the main OR. NORA is not procedural sedation, moderate or conscious sedation performed by a proceduralist with a sedation nurse. Old terms included remote anesthesia or out of operating room anesthesia. Locations may include GI endoscopy suite, Interventional radiology, bronchoscopy suite, cardiac Cath lab and more. There has been significant growth of nonoperating room anesthesia care in the US recently with increased complexity of procedures and patients.

There are important considerations related to providing safe patient care in NORA locations including the following:

• Space
• Equipment and Monitoring
• Staff
• Patients
• Procedures

Keep in mind that every NORA location and procedure may have unique considerations and challenges to keeping patients safe. Abdelmalak uses the example of several challenges in the GI suite which may include monitoring ventilation, determining the airway status, determining NPO status, and the effects of bowel insufflation, prone positioning for certain procedures. Providing safe care becomes even more challenging when you bring a patient with an LVAD to the GI Suite. Is this part of your anesthesia practice? What about patients who may be hypovolemic or have electrolyte abnormalities following the bowel prep before coming to the GI suite. These are important considerations that anesthesia professionals who practice in this space must be prepared for.

Keeping patients safe in NORA locations requires special considerations since patients are older, often done with monitored anesthesia care, greater mortality in cardiology and radiology areas, and higher risk for wrong site/wrong side procedures. Remember, this is something that we have worked to prevent in the OR with checklists and improved communication. There is a call to action for anesthesia professionals to bring our expertise from the OR and apply similar principles to NORA locations which may include the use of checklists and improved communication. Many of these complications are preventable with better monitoring and vigilance. Plus, we need to learn from past events as long as events are reported and evaluated with quality improvement and M&M conferences leading to education with the goal of prevention of future harm.

Before wrapping up, Abdelmalak describes his experience with the bronchoscopy suite at his institution to make this NORA location safe for patients and practicing anesthesia professionals. It started by evaluating the blueprints with attention to the location of the patient and supplies within the room as well as the appropriate monitoring, resources, and ability to call for help. It is vital that anesthesia professionals have the resources available to provide safe care in NORA locations including becoming familiar with new procedures and working together in the multidisciplinary team. On-site simulation may be used whenever there are new locations or new procedures so that the team can learn to work together including anticipating emergencies, assigning roles, and safe execution before the patient enters the room for the first time.

Another opportunity for anesthesia professionals is to contribute to appropriate patient selection for procedural sedation or NORA by evaluating risk factors. Patients at risk for respiratory compromise include long term opioid use, substance use, age greater that 65 years old, sleep apnea. Cases that proceed and have respiratory compromise may have higher admission rates, need for invasive ventilation, and higher ICU cost, longer overall and ICU LOS, and more death before discharge. Anesthesia professionals can have a big impact on patient safety in this area. Abdelmalak is an expert in NORA patient safety and he mentions two of his recent publications which are both blueprints for success. I will include the citations in the show notes as well and we hope that you will check them out for more information about anesthesiology oversight for procedural sedation and a multidisciplinary approach to clinical operations in a NORA location.

We are off to a great start with our coverage of the 2022 APSF Stoelting Conference. We will be back next week to continue our discussion right where we left off in the first panel. Let us know if NORA is part of your anesthesia practice by tagging us on twitter using the hashtag #APSFpodcast.

If you have any questions or comments from today’s show, please email us at [email protected]. Please keep in mind that the information in this show is provided for informational purposes only and does not constitute medical or legal advice. We hope that you will visit APSF.org for detailed information and check out the show notes for links to all the topics we discussed today.

Ellison C Pierce Jr, the founding president of the APSF said, “Patient safety is not a fad…it is not an objective that has been filled. It is an ongoing necessity. It must be sustained by research, training, and daily application in the workplace.”

Until next time, stay vigilant so that no one shall be harmed by anesthesia care.

© 2022, The Anesthesia Patient Safety Foundation