Take action now to prevent medication errors: lessons from a fatal error involving an automated dispensing cabinet.

An error in the administration of an anaesthetic medication related to an automated dispensing cabinet resulted in a patient fatality and a highly publicised criminal prosecution of a healthcare worker, which concluded in 2022. Urgent action is required to re-engineer systems and workflows to prevent such errors. Exhortation, blame, and criminal prosecution are unlikely to advance the cause of patient safety.

A prospective observational study on the effect of emboli exposure on cerebral autoregulation in cardiac surgery requiring cardiopulmonary bypass.

OBJECTIVE: Cerebrovascular autoregulation impairment has been associated with stroke risk in cardiac surgery. We hypothesized that greater arterial emboli exposure in open-chamber surgery might promote dysautoreguation. METHODS: Forty patients underwent closed or open-chamber surgery. Transcranial Doppler detected emboli and measured bilateral middle cerebral artery flow velocities. Cerebral autoregulation was assessed by averaging the mean velocity index ("Mx," a continuous moving correlation between cerebral blood flow velocity and mean arterial pressure) over 30 min before and after aortic cross-clamp removal. RESULTS: Median (interquartile range) emboli counts were 775 (415, 1211) and 2664 (793, 3734) in the closed-chamber and open-chamber groups. Most appeared after the removal of the aortic cross-clamp (open-chamber 1631 (606, 2296)), (closed-chamber 229 (142, 384)), with emphasis on the right hemisphere (open-chamber: 826 (371, 1622)), (closed-chamber 181 (66, 276)). Linear mixed model analyses of mean velocity index change showed no significant overall effect of group (0.08, 95% CI: -0.04, 0.21; p = 0.19) or side (0.01, 95% CI: -0.03, 0.05; p = 0.74). There was an interaction between group and side (p = 0.001), manifesting as a greater increase in mean velocity index in the right hemisphere in the open than the closed group (mean difference: 0.15, 95% CI: 0.02, 0.27; p = 0.03). CONCLUSIONS: Overall, change in mean velocity index before and after cross-clamp removal did not differ between groups. However, most emboli entered the right cerebral hemisphere where this change was significantly greater in the open-chamber group, suggesting a possible association between embolic exposure and dysautoregulation.

A rose by any other name would smell as sweet: defining patient safety-related terminology.

The definitions of terms related to iatrogenic harm and the potential for iatrogenic harm (e.g. error, medication error, near miss) in the anaesthesia literature are imprecise and variable, resulting in wide discrepancy in conclusions about their rates and potential solutions. Clarification of these terms is both critical and difficult: a concerted effort to achieve expert consensus is warranted.

A prospective observational study of emboli exposure in open versus closed chamber cardiac surgery.

OBJECTIVE: Exposure to cerebral emboli is ubiquitous and may be harmful in cardiac surgery utilizing cardiopulmonary bypass. This was a prospective observational study aiming to compare emboli exposure in closed-chamber with open-chamber cardiac surgery, distinguish particulate from gaseous emboli and examine cerebral laterality in distribution. METHODS: Forty patients underwent either closed-chamber procedures (n = 20) or open-chamber procedures (n = 20). Emboli (gaseous and solid) were detected using transcranial Doppler in both middle cerebral arteries in two monitoring phases: 1, initiation of bypass to the removal of the aortic cross-clamp; and 2, removal of aortic cross-clamp to 20 minutes after venous decannulation. RESULTS: Total (median (interquartile range)) emboli counts (both phases) were 898 (499-1366) and 2617 (1007-5847) in closed-chamber and open-chamber surgeries, respectively. The vast majority were gaseous; median 794 (closed-chamber surgery) and 2240 (open-chamber surgery). When normalized for duration, there was no difference between emboli exposures in closed-chamber and open-chamber surgery in phase 1: 6.8 (3.6-15.2) versus 6.4 (2.0-18.1) emboli per minute, respectively. In phase 2, closed-chamber surgery cases were exposed to markedly fewer emboli than open-chamber surgery cases: 9.6 (5.1-14.9) versus 43.3 (19.7-60.3) emboli per minute, respectively. More emboli (total) passed into the right cerebral circulation: 985 (397-2422) right versus 376 (198-769) left. CONCLUSIONS: Patients undergoing open-chamber surgery are exposed to considerably higher numbers of cerebral arterial emboli after removal of the aortic cross-clamp than those undergoing closed-chamber surgery, and more emboli enter the right middle cerebral artery than the left. These results may help inform the evaluation of the pathophysiological impact of emboli exposure.

Clinicians' experiences of inquiries following mental health related homicide: a qualitative study.

OBJECTIVES: This aim of this qualitative study was to explore the experiences of clinicians involved with inquiries into the mental health care of patients who were perpetrators of homicide in New Zealand. METHODS: Our purposive sample comprised ten clinicians working in New Zealand district health board mental health services. These clinicians were individually interviewed. Interviews were audio-recorded, transcribed and thematically analysed. The coding framework was checked and peer reviewed by an independent researcher. RESULTS: Five themes were identified: the inquiry process; emotional burden; impact on team dynamics; changes to individual clinical practice; and perceptions of inquiries being influenced by organisational culture. Clinicians involved with inquiries reported significant anxiety and disrupted multidisciplinary team dynamics. Some participants found inquiries led to changes to their clinical practice and perceived that a punitive organisational culture limited learning. CONCLUSIONS: Clinicians perceived inquiries as threatening, anxiety provoking and primarily concerned with protecting organisational interests. Communication of the inquiry process and ensuring inquiry findings are disseminated may enhance clinicians' experiences of inquiries and facilitate their participation and their reflection on changes to clinical practice that could contribute to improving services. Support for clinicians and multidisciplinary teams should be emphasised by the commissioning agency.

Communication and team function affect patient outcomes in anaesthesia: getting the message across.

A study in this edition of the Journal has added to data showing that failures in communication in the operating room contribute to patient harm. These data support the view that multidisciplinary teamwork and communication training should be part of the continuous professional development of all members of the perioperative team. Achieving change will require efforts to win the hearts and minds of all concerned, but these data also support an expectation that engagement in initiatives and techniques to enhance communication and teamwork should not be optional.

We Asked the Experts: The WHO Surgical Safety Checklist and the COVID-19 Pandemic: Recommendations for Content and Implementation Adaptations.

BACKGROUND: As surgical systems are forced to adapt and respond to new challenges, so should the patient safety tools within those systems. We sought to determine how the WHO SSC might best be adapted during the COVID-19 pandemic. METHODS: 18 Panelists from five continents and multiple clinical specialties participated in a three-round modified Delphi technique to identify potential recommendations, assess agreement with proposed recommendations and address items not meeting consensus. RESULTS: From an initial 29 recommendations identified in the first round, 12 were identified for inclusion in the second round. After discussion of recommendations without consensus for inclusion or exclusion, four additional recommendations were added for an eventual 16 recommendations. Nine of these recommendations were related to checklist content, while seven recommendations were related to implementation. CONCLUSIONS: This multinational panel has identified 16 recommendations for sites looking to use the surgical safety checklist during the COVID-19 pandemic. These recommendations provide an example of how the SSC can adapt to meet urgent and emerging needs of surgical systems by targeting important processes and encouraging critical discussions.

Reporting of Clinical Outcomes After Endovascular Aortic Aneurysm Repair: A Systematic Review.

BACKGROUND: Endovascular aneurysm repair (EVAR) is an established treatment for many patients with infra-renal abdominal aortic aneurysm (AAA). Reporting standards were published in 2002 to ensure consistent measurement and reporting of outcomes following EVAR. We aimed to assess the range of clinical outcomes reported after EVAR and whether recent studies adhere to established reporting standards. METHODS: We searched MEDLINE and Embase from January 2014 until December 2018, using terms for 'EVAR' and 'AAA'. We included prospective studies and randomised controlled trials which reported clinical outcomes of elective infra-renal AAA repair. Data on clinical outcome reporting were extracted and compared with established reporting standards. RESULTS: 84 studies were included. Technical success was reported in 49 (58.3%) studies, but only defined in 40 (47.6%), with 22 distinct definitions. Clinical success was reported and defined in 19 (22.6%) studies. Aneurysm rupture was reported in 27 (32.1%) studies and death from rupture in 11 (13.1%) studies. All-cause and aneurysm-related mortality were reported in 72 (85.7%) and 52 (61.9%) studies, respectively. Endoleak type I (n = 61, 72.6%) and II (n = 52, 61.9%) were more commonly reported than type III (n = 45, 53.6%) or IV (n = 13, 15.5%). Complications and mortality were reported by a mean of 18 (21.4%) and 42 (50%) studies, respectively. CONCLUSIONS: A wide variety of clinical outcomes were reported following EVAR. Few studies adhered to reporting guidelines. We recommend modification of reporting standards to reflect advances in endovascular technology and creation of a core outcome set for EVAR.

The conduct of inquiries: a qualitative study of the perspectives of panel members who investigate mental health related homicide.

BACKGROUND: Inquiries into mental health related homicides may be held to identify failures in care and areas for improvement, accountability and to enhance public confidence. However, inquiries do not always achieve these aims. AIM: The aim of this study was to explore the perspectives of members of inquiry panels who conduct inquiries into mental health related homicides in order to identify elements that would constitute a good inquiry. METHODS: We selected a sample of inquiry panel members comprising 15 senior clinicians, legal experts and consumer advisors. Semi-structured interviews were audio-recorded, transcribed and analysed using thematic analysis. RESULTS: Participants raised concerns related to: (1) orientation of the panel to the inquiry task; (2) clarity of the process; and (3) impact of the inquiry. Most participants recognised that inquiries require a focus on mental health systems and sensitivity to families and clinicians. They reported difficulties in clarifying purposes, attending to cultural aspects of the case, having a clear method tailored to the mental health context, formulating recommendations and disseminating findings. CONCLUSIONS: Our participants perceived a number of weaknesses in the process by which inquiries into mental health related homicides had been conducted, and recommendations formulated and implemented. There is an opportunity to address these and thereby potentially improve the effectiveness and value of inquiries.

Mental Health Inquiries in the Case of Homicide.

We aimed to identify features of New Zealand government-commissioned inquiries into the provision of mental health services after homicides committed by service users. The analysis of five reports from 1992 to 2016 identified similarities across reports, which included documenting a process; responding to a set terms of reference; detailing a case chronology, risk assessment, team and system issues; making recommendations and giving opportunities to clinicians to respond to adverse comments. Differences included selecting key informants and acknowledging limitations of scope. The inquiries did not specify a means to disseminate findings to stakeholders and follow up recommendations. Unrealised opportunities include attention to relationships between stakeholders and ways to support learning from inquiries. There is no standardised approach to conducting statutory inquiries into mental health services following a homicide. This limits the value of such inquiries for learning and service improvement. We recommend a standardised framework be developed to guide inquiries.

Measurement of patient-reported outcomes after laparoscopic cholecystectomy: a systematic review.

BACKGROUND: Patient-reported outcome (PRO) measures (PROMs) are increasingly used as endpoints in surgical trials. PROs need to be consistently measured and reported to accurately evaluate surgical care. Laparoscopic cholecystectomy (LC) is a commonly performed procedure which may be evaluated by PROs. We aimed to evaluate the frequency and consistency of PRO measurement and reporting after LC. METHODS: MEDLINE, EMBASE, and the Cochrane Central Register of Controlled Trials were searched for prospective studies reporting PROs of LC, between 2013 and 2016. Data on the measurement and reporting of PROs were extracted. RESULTS: A total of 281 studies were evaluated. Forty-five unique multi-item questionnaires were identified, most of which were used in single studies (n = 35). One hundred and ten unique rating scales were used to assess 358 PROs. The visual analogue scale was used to assess 24 different PROs, 17 of which were only reported in single studies. Details about the type of rating scale used were not given for 72 scales. Three hundred and twenty-three PROs were reported in 162 studies without details given about the scale or questionnaire used to evaluate them. CONCLUSIONS: Considerable variation was identified in the choice of PROs reported after LC, and in how they were measured. PRO measurement for LC is focused on short-term outcomes, such as post-operative pain, rather than longer-term outcomes. Consideration should be given towards the development of a core outcome set for LC which incorporates PROs.

Improving Anesthesia Safety in Low-Resource Settings.

The safety of anesthesia characteristic of high-income countries today is not matched in low-resource settings with poor infrastructure, shortages of anesthesia providers, essential drugs, equipment, and supplies. Health care is delivered through complex systems. Achieving sustainable widespread improvement globally will require an understanding of how to influence such systems. Health outcomes depend not only on a country's income, but also on how resources are allocated, and both vary substantially, between and within countries. Safety is particularly important in anesthesia because anesthesia is intrinsically hazardous and not intrinsically therapeutic. Nevertheless, other elements of the quality of health care, notably access, must also be considered. More generally, there are certain prerequisites within society for health, captured in the Jakarta declaration. It is necessary to have adequate infrastructure (notably for transport and primary health care) and hospitals capable of safely carrying out the "Bellwether Procedures" (cesarean delivery, laparotomy, and the treatment of compound fractures). Surgery, supported by safe anesthesia, is critical to the health of populations, but avoidable harm from health care (including very high mortality rates from anesthesia in many parts of the world) is a major global problem. Thus, surgical and anesthesia services must not only be provided, they must be safe. The global anesthesia workforce crisis is a major barrier to achieving this. Many anesthetics today are administered by nonphysicians with limited training and little access to supervision or support, often working in very challenging circumstances. Many organizations, notably the World Health Organization and the World Federation of Societies of Anaesthesiologists, are working to improve access to and safety of anesthesia and surgery around the world. Challenges include collaboration with local stakeholders, coordination of effort between agencies, and the need to influence national health policy makers to achieve sustainable improvement. It is conceivable that safe anesthesia and perioperative care could be provided for essential surgical services today by clinicians with moderate levels of training using relatively simple (but appropriately designed and maintained) equipment and a limited number of inexpensive generic medications. However, there is a minimum standard for these resources, below which reasonable safety cannot be assured. This minimum (at least) should be available to all. Not only more resources, but also more equitable distribution of existing resources is required. Thus, the starting point for global access to safe anesthesia is acceptance that access to health care in general should be a basic human right everywhere.

World Health Organization-World Federation of Societies of Anaesthesiologists (WHO-WFSA) International Standards for a Safe Practice of Anesthesia.

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.

World Health Organization-World Federation of Societies of Anaesthesiologists (WHO-WFSA) International Standards for a Safe Practice of Anesthesia.

The International Standards for a Safe Practice of Anesthesia were developed on behalf of the World Federation of Societies of Anaesthesiologists (WFSA), a non-profit 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.

Is Conventional Bypass for Coronary Artery Bypass Graft Surgery a Misnomer?

Although recent trials comparing on vs. off-pump revascularization techniques describe cardiopulmonary bypass (CPB) as "conventional," inadequate description and evaluation of how CPB is managed often exist in the peer-reviewed literature. We identify and subsequently describe regional and center-level differences in the techniques and equipment used for conducting CPB in the setting of coronary artery bypass grafting (CABG) surgery. We accessed prospectively collected data among isolated CABG procedures submitted to either the Australian and New Zealand Collaborative Perfusion Registry (ANZCPR) or Perfusion Measures and outcomes (PERForm) Registry between January 1, 2014, and December 31, 2015. Variation in equipment and management practices reflecting key areas of CPB is described across 47 centers (ANZCPR: 9; PERForm: 38). We report average usage (categorical data) or median values (continuous data) at the center-level, along with the minimum and maximum across centers. Three thousand five hundred sixty-two patients were identified in the ANZCPR and 8,450 in PERForm. Substantial variation in equipment usage and CPB management practices existed (within and across registries). Open venous reservoirs were commonly used across both registries (nearly 100%), as were "all-but-cannula" biopassive surface coatings (>90%), whereas roller pumps were more commonly used in ANZCPR (ANZCPR: 85% vs. PERForm: 64%). ANZCPR participants had 640 mL absolute higher net prime volumes, attributed in part to higher total prime volume (1,462 mL vs. 1,217 mL) and lower adoption of retrograde autologous priming (20% vs. 81%). ANZCPR participants had higher nadir hematocrit on CPB (27 vs. 25). Minimal absolute differences existed in exposure to high arterial outflow temperatures (36.6°C vs. 37.0°C). We report substantial center and registry differences in both the type of equipment used and CPB management strategies. These findings suggest that the term "conventional bypass" may not adequately reflect real-world experiences. Instead of using this term, authors should provide key details of the CPB practices used in their patients.

Reporting of complications after laparoscopic cholecystectomy: a systematic review.

BACKGROUND: Consistent measurement and reporting of outcomes, including adequately defined complications, is important for the evaluation of surgical care and the appraisal of new surgical techniques. The range of complications reported after LC has not been evaluated. This study aimed to identify the range of complications currently reported for laparoscopic cholecystectomy (LC), and the adequacy of their definitions. METHODS: MEDLINE, EMBASE, and the Cochrane Central Register of Controlled Trials were searched for prospective studies reporting clinical outcomes of LC, between 2013 and 2016. RESULTS: In total 233 studies were included, reporting 967 complications, of which 204 (21%) were defined. One hundred and twenty-two studies (52%) did not provide definitions for any of the complications reported. Conversion to open cholecystectomy was the most commonly reported complication, reported in 135 (58%) studies, followed by bile leak in 89 (38%) and bile duct injury in 75 (32%). Mortality was reported in 89 studies (38%). CONCLUSION: Considerable variation was identified between studies in the choice of measures used to evaluate the complications of LC, and in their definitions. A standardised set of core outcomes of LC should be developed for use in clinical trials and in evaluating the performance of surgical units.

Retesting the Hypothesis of a Clinical Randomized Controlled Trial in a Simulation Environment to Validate Anesthesia Simulation in Error Research (the VASER Study).

BACKGROUND: Simulation has been used to investigate clinical questions in anesthesia, surgery, and related disciplines, but there are few data demonstrating that results apply to clinical settings. We asked "would results of a simulation-based study justify the same principal conclusions as those of a larger clinical study?" METHODS: We compared results from a randomized controlled trial in a simulated environment involving 80 cases at three centers with those from a randomized controlled trial in a clinical environment involving 1,075 cases. In both studies, we compared conventional methods of anesthetic management with the use of a multimodal system (SAFERsleep; Safer Sleep LLC, Nashville, Tennessee) designed to reduce drug administration errors. Forty anesthesiologists each managed two simulated scenarios randomized to conventional methods or the new system. We compared the rate of error in drug administration or recording for the new system versus conventional methods in this simulated randomized controlled trial with that in the clinical randomized controlled trial (primary endpoint). Six experts were asked to indicate a clinically relevant effect size. RESULTS: In this simulated randomized controlled trial, mean (95% CI) rates of error per 100 administrations for the new system versus conventional groups were 6.0 (3.8 to 8.3) versus 11.6 (9.3 to 13.8; P = 0.001) compared with 9.1 (6.9 to 11.4) versus 11.6 (9.3 to 13.9) in the clinical randomized controlled trial (P = 0.045). A 10 to 30% change was considered clinically relevant. The mean (95% CI) difference in effect size was 27.0% (-7.6 to 61.6%). CONCLUSIONS: The results of our simulated randomized controlled trial justified the same primary conclusion as those of our larger clinical randomized controlled trial, but not a finding of equivalence in effect size.

A framework of comfort for practice: An integrative review identifying the multiple influences on patients' experience of comfort in healthcare settings.

PURPOSE: Comfort is central to patient experience but the concept of comfort is poorly defined. This review aims to develop a framework representing patients' complex perspective of comfort to inform practice and guide initiatives to improve the quality of healthcare. DATA SOURCES: CINAHL, MEDLINE Complete, PsycINFO and Google Scholar (November 2016); reference lists of included publications. STUDY SELECTION: Qualitative and theoretical studies advancing knowledge about the concept of comfort in healthcare settings. Studies rated for methodological quality and relevance to patients' perspectives. DATA EXTRACTION: Data on design, methods, features of the concept of comfort, influences on patients' comfort. Data were systematically coded and categorized using Framework method. RESULTS OF DATA SYNTHESIS: Sixty-two studies (14 theoretical and 48 qualitative) were included. Qualitative studies explored patient and staff perspectives in varying healthcare settings including hospice, emergency departments, paediatric, medical and surgical wards and residential care for the elderly. From patients' perspective, comfort is multidimensional, characterized by relief from physical discomfort and feeling positive and strengthened in one's ability to cope with the challenges of illness, injury and disability. Different factors are important to different individuals. We identified 10 areas of influence within four interrelated levels: patients' use of self-comforting strategies; family presence; staff actions and behaviours; and environmental factors. CONCLUSION: Our data provide new insights into the nature of comfort as a highly personal and contextual experience influenced in different individuals by different factors that we have classified into a framework to guide practice and quality improvement initiatives.