In-Hospital NORA Safety Introduction

By: Gregory Kirby, M.D.; John Bellemente, M.D.; Richard D. Urman, M.D., M.B.A.; Fred E. Shapiro, D.O., FASA

updated May 5, 2020

This project aims to curate recent practice-changing articles regarding patient safety in nonoperative room anesthesia (NORA). The focus of this collection is currently exclusive to in-hospital practice environments. These works were largely published in the past five years and are compiled in an effort to present only the most current data, trends and opinions seen in hospital-based NORA.

For the sake of juxtaposition to current ASA Closed Claims database-derived studies, we included one of the seminal works of NORA-related safety by Julia Metzner, M.D. and colleagues from 2009.

The publications below highlight the growing proportion of NORA cases within the practice of anesthesia. Challenges to the care of patients in nonoperating room (O.R.) settings continue to grow as procedures become more complex—especially with NORA locations seeing a greater proportion of older and sicker patients. Death and respiratory-adverse events continue to represent a greater proportion of claims in NORA versus O.R. cases, with a preponderance of these events occurring in cardiology and radiology locations. It is worth noting that a significant percentage of these events continue to be deemed preventable with better monitoring. We look forward to continued research on this topic asWe look forward to continued research on this topic as NORA continues to mature.

In-Hospital NORA Safety Articles

Metzner J, Posner KL, Domino KB. The risk and safety of anesthesia at remote locations: the US closed claims analysis. Curr Opin Anaesthesiol. 2009;22(4):502–508.

1. Reviewed ASA Closed Claims from 1990-2009. They found that anesthetics in NORA locations involved older and sicker patients, a trend that would be replicated in later studies. The proportion of closed claims cases that resulted in death was significantly higher for NORA locations compared to traditional O.R.s (54% versus 29%). Respiratory events (specifically those involving inadequate ventilation/oxygenation) were significantly more likely in NORA locations (44% versus 20% in O.R.), and the events that occurred were more likely to be judged as having been preventable (32% versus 8% preventable claims in O.R. cases).
2. This study sets an important baseline for the rate of adverse events experienced in NORA—including claims that existed prior to the 2011 ASA requirement for capnography for continuous respiratory monitoring in moderate/deep sedation.

Woodward ZG, Urman RD, Domino KB. Safety of nonoperating room anesthesia: a closed claims update. Anesthesiol Clin. 2017;35(4):569-581.

1. Malpractice claims for non–operating room anesthesia care (NORA) had a higher proportion of claims for death compared with O.R. settings; however malpractice claims for NORA occurred at a lower rate compared to O.R. anesthetics. Despite the lower overall incidence of malpractice claims, there were some notable trends:
2. Aspiration pneumonitis occurred in a higher proportion of NORA malpractice claims, compared with claims in O.R. settings.
3. NORA claims most frequently involved monitored anesthesia care. Inadequate oxygenation/ventilation was responsible for nearly one-third of NORA claims.
4. NORA claims occurred at a higher rate in cardiology and radiology locations compared to other procedural locations, suggesting a higher risk of adverse events in these locations.
5. This paper provides important insight into the acuity of the NORA patient population, the higher percentages of cases involving monitored anesthesia care (MAC) and unsecured airways, and the rate of oxygenation/ventilation claims outpacing those seen in traditional O.R. settings. 
6. Compared to the 2009 study, proportions of adverse respiratory outcomes (53% of NORA claims), death (61% of NORA claims) and claims judged to be preventable by better monitoring (35%) are similar in this update, and significantly outweigh O.R. claims of this nature. Additionally, there is data suggesting that cardiology and radiology NORA settings might now offer the most challenging/claim-prone practice settings. Interestingly, NORA claims now resulted in more payments and higher payment amounts than O.R. claims, which was not the case from 1990-2009.

Nagrebetsky A, Gabriel RA, Dutton RP, Urman RD. Growth of nonoperating room anesthesia care in the United States: a contemporary trends analysis. Anesth Analg. 2017;124(4):1261-1267.

1. NACOR® data (covers ~25% of anesthetics delivered annually) was analyzed from 2010-2014.  This dataset includes an increased NORA proportion from 28.3% to 35.9%, along with an increased proportion of outpatient NORA cases from 69.7% in 2010 to 73.3% in 2014 (P <0.001).  Further, this study found NORA patients were more likely to be ASA III-V compared to their traditional O.R. counterparts. NORA cases were shorter in duration but more likely to be started after “normal working hours.”
2. While this paper was not practice changing, it is important that anesthesia providers are aware of the increasing burden that NORA is likely to play in their practices going forward. The knowledge that these patients are often sicker with more complex medical comorbidities (as seen in the higher percentage of ASA III-V patients in non-O.R. locations) should heighten the awareness of nonoperating room anesthesia providers.

Chang B, Kaye AD, Diaz JH, Westlake B, Dutton RP, Urman RD. Interventional procedures outside of the operating room: results from the National Anesthesia Clinical Outcomes Registry. J Patient Saf. 2018;14(1):9-16.

1. These authors performed a registry analysis from 2010-2013.  Consistent with prior studies, they found NORA to have a higher rate of MAC/sedation compared to traditional O.R. anesthetics.  However, contrasting with other studies, NORA was found to have a lower mortality rate compared to O.R. anesthetics (0.02% versus 0.04% respectively). Cardiology and radiology locations both had increased complication rates, and correspondingly an increased mortality rate of 0.05% compared to the aforementioned 0.02% rate for all NORA. As might be expected, rates of monitored anesthesia care (MAC) (20.15% of cases) and sedation (2.05% of cases) were more common in non-O.R. anesthetics compared to O.R. anesthetics. NORA procedures were performed on a higher percentage of patients older than 50 years (61.92% in NORA versus 55.56% in traditional OR, P < 0.0001).
2. This paper builds on prior publications looking at national outcomes/claims data. Again it was demonstrated that there was increased risk of adverse effects, and more concerning, increased mortality rates for NORA in radiology and cardiology locations compared to total NORA. The most common complications in these locations included upgrade of care, hemodynamic instability, respiratory compromise and awareness—research in this field should focus around these issues in order to maximize impact on patient safety.

Goudra B, Alvarez A, Singh PM. Practical considerations in the development of a nonoperating room anesthesia practice. Curr Opin Anaesthesiol. 2016;29(4):526-530.

1. The authors set out to outline the important safety considerations and challenges that go into developing a NORA practice, given the unique site-specific adverse event profiles in various NORA suites.
2. They found 25% of anesthetics to be NORA, and focused on hypoxemic events and cardiac arrest as key adverse events using a data set of 73,029 GI endoscopic procedures.
• Incidence of cardiac arrest and death (all causes, until discharge) of 6.07 and 4.28 per 10000 in patients sedated with propofol, compared with non-propofol-based sedation (where similar incidences were 0.67 and 0.44). 90% of arrests were hypoxemia-related in patients who received propofol.
3. They found key safety considerations to include: the standard ASA monitoring systems, space considerations for anesthesia workstations, more effective communication surrounding safe patient selection for remote procedures, standardization of mobile airway carts to enhance preparedness to treat adverse events and communication protocols to improve response times to remote locations.
4. Consider having a small pool of dedicated anesthesiologists for the NORA suite, as this approach seems to lead to more consistent patient outcomes and improve proceduralists’ satisfaction.
5. This publication predicts continued challenges in NORA as minimally invasive techniques continue to be developed and employed, and suggests systems-based and practice-based guidelines for safe administration of anesthesia in NORA settings.

Karamnov S, Sarkisian N, Grammer R, Gross WL, Urman RD. Analysis of adverse events associated With adult moderate procedural sedation outside the operating room. J Patient Saf. 2017;13(3):111-121.

1. This is an analysis of 143,000 cases at Brigham and Women’s Hospital involving moderate sedation, with 52 adverse events analyzed; most common adverse event and unplanned intervention was oversedation, leading to apnea (57.7% of cases) and the use of reversal agents (55.8%).
• Poor communication and suboptimal team dynamics comprised a surprisingly high percentage of provider-related events. Another relatively common event in this group was administration of sedation by a provider who was not certified to deliver moderate sedation. Key patient characteristics including age, frailty, BMI and a number of comorbidities also suggested higher rates of adverse outcomes.
2. This publication suggests potential practice-changing strategies such as developing checklists tailored to different NORA locations and patient characteristics, closed-loop communication guidelines, and employing institutional policy that outlines provider credentialing and education processes. The study focused on a majority of the 2018 APSF Perioperative Patient Safety Priorities.
3. October 2018 ASA House of Delegates meeting to learn more about distinguishing MAC from Moderate Sedation (PDF).

Saunders R, Erslon M, Vargo J. Modeling the costs and benefits of capnography monitoring during procedural sedation for gastrointestinal endoscopy. Endosc Int Open. 2016;4(3):E340-E351.

1. This study demonstrates that the implementation of capnography in the endoscopic suite in moderate sedation cases is cost-effective or even cost-saving. These savings are derived from improved patient safety and reduction in adverse events.
• Addition of capnography resulted in a 27.2 % and 18.0 % reduction in the proportion of patients experiencing an apneic episode during deep and moderate procedural sedation/analgesia (PSA), respectively. (NNT apnea 14, NNT desaturation 22, NNT any adverse event 7)

Choi JW, Kim DK, Lee SH, Shin HS, Seong BG. Comparison of safety profiles between non-operating room anesthesia and operating room anesthesia: a study of 199,764 cases at a Korean tertiary hospital (PDF). J Korean Med Sci. 2018;33(28):e183.

1. This is an interesting look at a Korean hospital from 2013-2017, where a NORA-dedicated team of anesthesiologists and a well-trained nurse provided care for every NORA case. This study found that the 48-hour mortality of the NORA cases was similar to that of traditional O.R. cases.
2. There are key differences in this hospital’s NORA population: NORA only accounted for 8.2% of cases, most NORA cases were less invasive and shorter procedures done on healthier patients (93% ASA I-II). For example, 46% of patients were age 0-11, and only 18% were > 65.  Additionally, 38% of cases were pediatric CT/MRI, 19% GI endoscopic, 10% neurointerventional, 4% cardiological procedures. 92% were done under MAC. 
3. The low number of NORA cases (at one of the leading Korean hospitals in NORA volume) was attributed to reluctance to perform out of O.R. cases due to manpower shortage, which could be due to low reimbursement (receiving only 85% of the reimbursement that would be earned for GA) for MAC procedures. The low mortality rate (4.9 per 10,000) was attributed to the hospital’s experienced NORA-dedicated anesthesia care team and standardized monitoring guidelines.