Safety & quality resources: Articles of interest (archive)

Sugammadex has been used for more than ten years in Australia and New Zealand and has been implicated as an effective treatment, and in some cases a potential cause, of a critical incident. We aimed to identify and analyse critical incidents involving sugammadex reported to webAIRS, a de-identified voluntary online critical incident reporting system in Australia and New Zealand. We identified 116 incidents where the reporter implicated sugammadex as either a cause (23 cases) or a treatment (93 cases) during anaesthesia. There were 17 incidents suggestive of sugammadex anaphylaxis, although not all were confirmed by skin testing. There were six incidents when bradycardia was temporally related to sugammadex administration, although it was not possible to exclude other causes or contributory factors. There were nine incidents in which sugammadex was used to reverse aminosteroid-related neuromuscular blockade successfully in a 'can't intubate, can't oxygenate' (CICO) situation, and a further 67 incidents in which sugammadex was used to reverse aminosteroid neuromuscular blockade as part of the management of other critical incidents. While sugammadex was used during the management of 16 cases of anaphylaxis, there was no clear indication that this altered the course of the anaphylaxis in any of the cases. These reports indicate that sugammadex can be a potential trigger for anaphylaxis and that its use may be associated with the development of significant bradycardia. However, it is not possible to estimate or even speculate on the incidence of these sugammadex-related incidents on the basis of voluntary reporting to a database such as webAIRS. The reports also indicate that sugammadex has been used successfully to reverse residual or deep aminosteroid neuromuscular blockade in critical incident situations and to help rescue CICO scenarios. These findings provide further support for ensuring the ready availability of sugammadex wherever aminosteroid muscle relaxants are used.

Purpose: Noise in the operating room (OR) is common and associated with negative effects on anesthesiologists, surgeons, and patient outcomes. Induction of anesthesia is among the loudest perioperative periods. Despite its critical nature, there is little data on noise levels during induction, associated patient and anesthesiologist satisfaction, and the effects of noise reduction strategies.

Methods: We conducted a two-part prospective interventional quality improvement project on the care of adult patients receiving general anesthesia for elective noncardiac surgery. For part A, we measured average and peak noise (dB[A]) levels during anesthesia induction in N = 100 cases and administered a satisfaction questionnaire to anesthesiologists. We then applied a multidisciplinary educational program to OR personnel on active noise reduction strategies and subsequently collected data during N = 109 cases in a post-intervention phase. For part B, we administered satisfaction questionnaires to N = 100 patients pre- vs postintervention, respectively.

Results: Median [interquartile range] noise levels throughout induction were 66.0 [62.5-68.6] dB(A) preintervention vs 63.5 [60.1-65.4] dB[A] post-intervention (Hodges-Lehmann estimator of the difference, - 2.7 dB[A]; 95% confidence interval [CI], - 4.0 to - 1.5; P < 0.001). Peak noise levels during induction were 87.3 [84.0-90.5] dB(A) preintervention and 86.2 [81.8-89.3] dB(A) postintervention (Hodges-Lehmann estimator of the difference, - 1.8 dB[A]; 95% CI, - 3.3 to - 0.3; P = 0.02). Noise-related anesthesiologist satisfaction postintervention was significantly improved in multiple domains, including assessment of noise having distracted anesthesiologists. Patient satisfaction was high pre-intervention and did not significantly improve further.

Conclusion: In this quality improvement project, average noise levels during induction of anesthesia, anesthesiologist satisfaction, and anesthesiologists' perceived ability to perform were improved following a multidisciplinary educational program on noise reduction in the OR.

Study registration: www.ClinicalTrials.gov (NCT04204785); registered 19 December 2019.

Abstract
webAIRS is a web-based de-identified anaesthesia incident reporting system, which was introduced in Australia and New Zealand in September 2009. By July 2016, 4,000 incident reports had been received. The incidents covered a wide range of patient age (<28 days to >90 years), American Society of Anesthesiologists physical status, and body mass index (<18.5 to >50 kg/m2). They occurred across a wide range of anaesthesia techniques and grade of anaesthesia provider, and over a wide range of anaesthetising locations and times of day. In a high proportion the outcome was not benign; about 26% of incidents were associated with patient harm and a further 4% with death. Incidents appeared to be an ever-present risk in anaesthetic practice, with extrapolated estimates exceeding 200 per week across Australia and New Zealand. Independent of outcomes, many anaesthesia incidents were associated with increased use of health resources. The four most common main categories of incident were Respiratory/Airway, Medication, Cardiovascular, and Medical Device/Equipment. Over 50% of incidents were considered preventable. The narratives accompanying each incident provide a rich source of information, which will be analysed in subsequent reports on particular incident types. The summary data in this initial overview are a sober reminder of the prevalence and unpredictability of anaesthesia incidents, and their potential morbidity and mortality. The data justify current efforts to better prevent and manage anaesthesia incidents in Australia and New Zealand, and identify areas in which increased resources or additional initiatives may be required.

Abstract
What we already know about this topic: Debriefing after an actual critical event is an established good practice in medicine, but a gap exists between principle and implementation.

What this article tells us that is new: Failure to debrief after critical events is common among anesthesia trainees and likely anesthesia teams. Communication breakdowns are associated with a high rate of the failure to debrief.

Background: Debriefing after an actual critical event is an established good practice in medicine, but a gap exists between principle and implementation. The authors' objective was to understand barriers to debriefing, characterize quantifiable patterns and qualitative themes, and learn potential solutions through a mixed-methods study of actual critical events experienced by anesthesia personnel.

Methods: At a large academic medical center, anesthesiology residents and a small number of attending anesthesiologists were audited and/or interviewed for the occurrence and patterns of debriefing after critical events during their recent shift, including operating room crises and disruptive behavior. Patterns of the events, including event locations and event types, were quantified. A comparison was done of the proportion of cases debriefed based on whether the event contained a critical communication breakdown. Qualitative analysis, using an abductive approach, was performed on the interviews to add insight to quantitative findings.

Results: During a 1-yr period, 89 critical events were identified. The overall debriefing rate was 49% (44 of 89). Nearly half of events occurred outside the operating room. Events included crisis events (e.g., cardiac arrest, difficult airway requiring an urgent surgical airway), disruptive behavior, and critical communication breakdowns. Events containing critical communication breakdowns were strongly associated with not being debriefed (64.4% [29 of 45] not debriefed in events with a communication breakdown vs. 36.4% [16 of 44] not debriefed in cases without a communication breakdown; P = 0.008). Interview responses qualitatively demonstrated that lapses in communication were associated with enduring confusion that could inhibit or shape the content of discussions between involved providers.

Conclusions: Despite the value of proximal debriefing to reducing provider burnout and improving wellness and learning, failure to debrief after critical events can be common among anesthesia trainees and perhaps anesthesia teams. Modifiable interpersonal factors, such as communication breakdowns, were associated with the failure to debrief.

Abstract
Current models of quality improvement and patient safety (QIPS) education are not fully integrated with clinical care delivery, representing a major impediment toward achieving widespread QIPS competency among health professions learners and practitioners. The Royal College of Physicians and Surgeons of Canada organized a 2-day consensus conference in Niagara Falls, Ontario, Canada, called Building the Bridge to Quality, in September 2016. Its goal was to convene an international group of educational and health system leaders, educators, frontline clinicians, learners, and patients to engage in a consensus-building process and generate a list of actionable strategies that individuals and organizations can use to better integrate QIPS education with clinical care.Four strategic directions emerged: prioritize the integration of QIPS education and clinical care, build structures and implement processes to integrate QIPS education and clinical care, build capacity for QIPS education at multiple levels, and align educational and patient outcomes to improve quality and patient safety. Individuals and organizations can refer to the specific tactics associated with the 4 strategic directions to create a road map of targeted actions most relevant to their organizational starting point.To achieve widespread change, collaborative efforts and alignment of intrinsic and extrinsic motivators are needed on an international scale to shift the culture of educational and clinical environments and build bridges that connect training programs and clinical environments, align educational and health system priorities, and improve both learning and care, with the ultimate goal of achieving improved outcomes and experiences for patients, their families, and communities.

Abstract
The International Standards for a Safe Practice of Anesthesia were developed on behalf of the World Federation of Societies of Anaesthesiologists (WFSA), a nonprofit organization representing anesthesiologists in 150 countries, and the World Health Organization (WHO). The recommendations have been approved by WHO and the membership of WFSA. These Standards are applicable to all anesthesia providers throughout the world. They are intended to provide guidance and assistance to anesthesia providers, their professional organizations, hospital and facility administrators, and governments for maintaining and improving the quality and safety of anesthesia care. The Standards cover professional aspects; facilities and equipment; medications and intravenous fluids; monitoring; and the conduct of anesthesia. HIGHLY RECOMMENDED standards, the functional equivalent of mandatory standards, include (amongst other things): the continuous presence of a trained and vigilant anesthesia provider; continuous monitoring of tissue oxygenation and perfusion by clinical observation and a pulse oximeter; intermittent monitoring of blood pressure; confirmation of correct placement of an endotracheal tube (if used) by auscultation and carbon dioxide detection; the use of the WHO Safe Surgery Checklist; and a system for transfer of care at the end of an anesthetic. The International Standards represent minimum standards and the goal should always be to practice to the highest possible standards, preferably exceeding the standards outlined in this document.

Abstract
Background: Anaphylaxis during anaesthesia is a serious complication for patients and anaesthetists. There is little published information on management and outcomes of perioperative anaphylaxis in the UK.

Methods: The 6th National Audit Project of the Royal College of Anaesthetists (NAP6) collected and reviewed 266 reports of Grade 3-5 anaphylaxis from all UK NHS hospitals over 1 yr. Quality of management was assessed against published guidelines.

Results: Appropriately senior anaesthetists resuscitated all patients. Immediate management was 'good' in 46% and 'poor' in 15%. Recognition and treatment of anaphylaxis were prompt in 97% and 83% of cases, respectively. Epinephrine was administered i.v. in 76%, i.m. in 14%, both in 6%, and not at all in 11% of cases. A catecholamine infusion was administered in half of cases. Cardiac arrests (40 cases; 15%) were promptly treated but cardiac compressions were omitted in half of patients with unrecordable BP. The surgical procedure was abandoned in most cases, including 10% where surgery was urgent. Of 54% admitted to critical care, 70% were level 3, with most requiring catecholamine infusions. Ten (3.8%) patents (mostly elderly with cardiovascular disease) died from anaphylaxis. Corticosteroids and antihistamines were generally administered early. We found no clear evidence of harm or benefit from chlorphenamine. Two patients received vasopressin and one glucagon. Fluid administration was inadequate in 19% of cases. Treatment included sugammadex in 19 cases, including one when rocuronium had not been administered. Adverse sequelae (psychological, cognitive, or physical) were reported in one-third of cases.

Conclusions: Management of perioperative anaphylaxis could be improved, especially with respect to administration of epinephrine, cardiac compressions, and i.v. fluid. Sequelae were common.

Abstract
In the United States, the Accreditation Council for Graduate Medical Education (ACGME) has instituted a new program, the Clinical Learning Environment Review (CLER), that places focus in six important areas of the resident and fellow working and learning environment. Two of these areas are patient safety and quality improvement (QI). In their early CLER reviews of institutions housing ACGME-accredited training programs, ACGME has found that despite significant progress in patient safety and QI to date much work remains, especially when it comes to meaningful engagement of medical trainees in this work. In this article, the authors argue that peripheral involvement of trainees in patient safety and QI work does not allow the experiential learning that is necessary for professional development and the ultimate ability to execute performance that meets the needs of patients in contemporary clinical practice. Rather, as leaders in patient safety and QI have advocated since early in this movement, embedded and immersed experiences are necessary for learning and success.

Abstract
Reporting adverse events (AEs) and serious AEs (SAEs) are practical steps to ensure safety for volunteers and patients in medical research involving medications, treatments and devices. However, the burden and cost of reporting should be proportionate with the public health benefit of this information. Unfortunately, in Australia there is clear evidence of ever-increasing requirements from sponsors and ethics committees to report AEs and SAEs unnecessarily, leading to a decrease in the uptake of research, particularly less well funded investigator-initiated trials. We believe that individual AE reports to ethics committees serve no useful purpose, because in most cases the study group identity (drug exposure) is not known in studies with blinded treatment arms and their value is limited. Pragmatic, investigator-initiated Phase IV clinical trials of post-marketed drugs or devices are needed to understand their role in everyday clinical practice. In this setting, the workload and costs of systematic, complete reporting of all AEs and SAEs (independent of whether these are treatment-related) is wasteful, and mostly unnecessary. A trial data safety and monitoring committee is in the unique position of being able to review safety information according to the blinded treatment arms of the study. This enables safety data to be analysed appropriately and a summary report provided to the trial steering committee, principal investigators and the relevant ethics committees in a meaningful way. Defined trial endpoints do not need to be reported as safety events (because they are being properly monitored and analysed).

Abstract
Background: Cesarean delivery (CD) is associated with significantly increased risks of anesthesia-related adverse events (ARAEs) and nonanesthetic perioperative morbidity compared with vaginal delivery. Temporal trends in these adverse outcomes remain unknown despite efforts to improve maternal safety. This study examines temporal trends in ARAEs and nonanesthetic perioperative complications in CDs in New York hospitals.

Methods: Data are from the State Inpatient Database for New York, 2003-2012. ARAEs, including minor and major ARAEs, and nonanesthetic perioperative complications were identified through International Classification of Diseases, Ninth Revision, Clinical Modification codes. Statistical significance in time trends was assessed using the Cochran-Armitage test and multivariable logistic regression.

Results: Of the 785,854 CDs studied, 5,715 (730 per 100,000; 95% CI, 710 to 750) had at least one ARAE and 7,040 had at least one perioperative complication (890 per 100,000; 95% CI, 870 to 920). The overall annual rate of ARAEs decreased from 890 per 100,000 in 2003 to 660 in 2012 (25% decrease; 95% CI, 16 to 34; P < 0.0001). The rate of minor ARAEs decreased 23% (95% CI, 13 to 32) and of major ARAEs decreased 43% (95% CI, 23 to 63). No decrease was observed in the rate of ARAEs for CDs performed under general anesthesia. The rate of nonanesthetic complications increased 47% (95% CI, 31 to 63; P < 0.0001).

Conclusions: Anesthesia-related outcomes in cesarean deliveries appear to have improved significantly across hospitals in New York in the past decade. Perioperative nonanesthetic complications remain a serious healthcare issue.

Abstract
Background: The Evaluation of Nitrous Oxide in the Gas Mixture for Anaesthesia (ENIGMA)-II trial randomly assigned 7,112 noncardiac surgery patients at risk of perioperative cardiovascular events to 70% N2O or 70% N2 groups. The aim of this follow-up study was to determine the effect of nitrous oxide on a composite primary outcome of death and major cardiovascular events at 1 yr after surgery.

Methods: One-year follow-up was conducted via a medical record review and telephone interview. Disability was defined as a Katz index of independence in activities of daily living score less than 8. Adjusted odds ratios and hazard ratios were calculated as appropriate for primary and secondary outcomes.

Results: Among 5,844 patients evaluated at 1 yr, 435 (7.4%) had died, 206 (3.5%) had disability, 514 (8.8%) had a fatal or nonfatal myocardial infarction, and 111 (1.9%) had a fatal or nonfatal stroke during the 1-yr follow-up period. Exposure to nitrous oxide did not increase the risk of the primary outcome (odds ratio, 1.08; 95% CI, 0.94 to 1.25; P = 0.27), disability or death (odds ratio, 1.07; 95% CI, 0.90 to 1.27; P = 0.44), death (hazard ratio, 1.17; 95% CI, 0.97 to 1.43; P = 0.10), myocardial infarction (odds ratio, 0.97; 95% CI, 0.81 to 1.17; P = 0.78), or stroke (odds ratio, 1.08; 95% CI, 0.74 to 1.58; P = 0.70).

Conclusion: These results support the long-term safety of nitrous oxide administration in noncardiac surgical patients with known or suspected cardiovascular disease.

Abstract
Background: The purpose of this study is to assess the rates of perioperative medication errors (MEs) and adverse drug events (ADEs) as percentages of medication administrations, to evaluate their root causes, and to formulate targeted solutions to prevent them.

Methods: In this prospective observational study, anesthesia-trained study staff (anesthesiologists/nurse anesthetists) observed randomly selected operations at a 1,046-bed tertiary care academic medical center to identify MEs and ADEs over 8 months. Retrospective chart abstraction was performed to flag events that were missed by observation. All events subsequently underwent review by two independent reviewers. Primary outcomes were the incidence of MEs and ADEs.

Results: A total of 277 operations were observed with 3,671 medication administrations of which 193 (5.3%; 95% CI, 4.5 to 6.0) involved a ME and/or ADE. Of these, 153 (79.3%) were preventable and 40 (20.7%) were nonpreventable. The events included 153 (79.3%) errors and 91 (47.2%) ADEs. Although 32 (20.9%) of the errors had little potential for harm, 51 (33.3%) led to an observed ADE and an additional 70 (45.8%) had the potential for patient harm. Of the 153 errors, 99 (64.7%) were serious, 51 (33.3%) were significant, and 3 (2.0%) were life-threatening.

Conclusions: One in 20 perioperative medication administrations included an ME and/or ADE. More than one third of the MEs led to observed ADEs, and the remaining two thirds had the potential for harm. These rates are markedly higher than those reported by retrospective surveys. Specific solutions exist that have the potential to decrease the incidence of perioperative MEs.

Abstract
Background: Drug administration errors in obstetric neuraxial anesthesia can have devastating consequences. Although fully recognizing that they represent "only the tip of the iceberg," published case reports/series of these errors were reviewed in detail with the aim of estimating the frequency and the nature of these errors.

Methods: We identified case reports and case series from MEDLINE and performed a quantitative analysis of the involved drugs, error setting, source of error, the observed complications, and any therapeutic interventions. We subsequently performed a qualitative analysis of the human factors involved and proposed modifications to practice.

Results: Twenty-nine cases were identified. Various drugs were given in error, but no direct effects on the course of labor, mode of delivery, or neonatal outcome were reported. Four maternal deaths from the accidental intrathecal administration of tranexamic acid were reported, all occurring after delivery of the fetus. A range of hemodynamic and neurologic signs and symptoms were noted, but the most commonly reported complication was the failure of the intended neuraxial anesthetic technique. Several human factors were present; most common factors were drug storage issues and similar drug appearance. Four practice recommendations were identified as being likely to have prevented the errors.

Conclusions: The reported errors exposed latent conditions within health care systems. We suggest that the implementation of the following processes may decrease the risk of these types of drug errors: (1) Careful reading of the label on any drug ampule or syringe before the drug is drawn up or injected; (2) labeling all syringes; (3) checking labels with a second person or a device (such as a barcode reader linked to a computer) before the drug is drawn up or administered; and (4) use of non-Luer lock connectors on all epidural/spinal/combined spinal-epidural devices. Further study is required to determine whether routine use of these processes will reduce drug error.

Abstract
Background: An anesthesia preinduction checklist (APIC) to be performed before anesthesia induction was introduced and evaluated with respect to 5 team-level outcomes, each being a surrogate end point for patient safety: information exchange (the percentage of checklist items exchanged by a team, out of 12 total items); knowledge of critical information (the percentage of critical information items out of 5 total items such as allergies, reported as known by the members of a team); team members' perceptions of safety (the median scores given by the members of a team on a continuous rating scale); their perception of teamwork (the median scores given by the members of a team on a continuous rating scale); and clinical performance (the percentage of completed items out of 14 required tasks, e.g., suction device checked).

Methods: A prospective interventional study comparing anesthesia teams using the APIC with a control group not using the APIC was performed using a multimethod design. Trained observers rated information exchange and clinical performance during on-site observations of anesthesia inductions. After the observations, each team member indicated the critical information items they knew and their perceptions of safety and teamwork.

Results: One hundred five teams using the APIC were compared with 100 teams not doing so. The medians of the team-level outcome scores in the APIC group versus the control group were as follows: information exchange: 100% vs 33% (P < 0.001), knowledge of critical information: 100% vs 90% (P < 0.001), perception of safety: 91% vs 84% (P < 0.001), perception of teamwork: 90% vs 86% (P = 0.028), and clinical performance: 93% vs 93% (P = 0.60).

Conclusions: This study provides empirical evidence that the use of a preinduction checklist significantly improves information exchange, knowledge of critical information, and perception of safety in anesthesia teams-all parameters contributing to patient safety. There was a trend indicating improved perception of teamwork.