Improving patient safety governance and systems through learning from successes and failures: qualitative surveys and interviews with international experts.

Patient harm is a leading cause of global disease burden with considerable morbidity, mortality, and economic impacts for individuals, families, and wider society. Large bodies of evidence exist for strategies to improve safety and reduce harm. However, it is not clear which patient safety issues are being addressed globally, and which factors are the most (or least) important contributors to patient safety improvements. We aimed to explore the perspectives of international patient safety experts to identify: (1) the nature and range of patient safety issues being addressed, and (2) aspects of patient safety governance and systems that are perceived to provide value (or not) in improving patient outcomes. English-speaking Fellows and Experts of the International Society for Quality in Healthcare participated in a web-based survey and in-depth semistructured interview, discussing their experience in implementing interventions to improve patient safety. Data collection focused on understanding the elements of patient safety governance that influence outcomes. Demographic survey data were analysed descriptively. Qualitative data were coded, analysed thematically (inductive approach), and mapped deductively to the System-Theoretic Accident Model and Processes framework. Findings are presented as themes and a patient safety governance model. The study was approved by the University of South Australia Human Research Ethics Committee. Twenty-seven experts (59% female) participated. Most hailed from Africa (n = 6, 22%), Australasia, and the Middle East (n = 5, 19% each). The majority were employed in hospital settings (n = 23, 85%), and reported blended experience across healthcare improvement (89%), accreditation (76%), organizational operations (64%), and policy (60%). The number and range of patient safety issues within our sample varied widely with 14 topics being addressed. Thematically, 532 textual segments were grouped into 90 codes (n = 44 barriers, n = 46 facilitators) and used to identify and arrange key patient safety governance actors and factors as a 'system' within the System-Theoretic Accident Model and Processes framework. Four themes for improved patient safety governance were identified: (1) 'safety culture' in healthcare organizations, (2) 'policies and procedures' to investigate, implement, and demonstrate impact from patient safety initiatives, (3) 'supporting staff' to upskill and share learnings, and (4) 'patient engagement, experiences, and expectations'. For sustainable patient safety governance, experts highlighted the importance of safety culture in healthcare organizations, national patient safety policies and regulatory standards, continuing education for staff, and meaningful patient engagement approaches. Our proposed 'patient safety governance model' provides policymakers and researchers with a framework to develop data-driven patient safety policy.

Sleep, Workload, and Stress in Aerial Firefighting Crews.

BACKGROUND:The challenges of climate change and increasing frequency of severe weather conditions has demanded innovative approaches to wildfire suppression. Australia's wildfire management includes an expanding aviation program, providing both fixed and rotary wing aerial platforms for reconnaissance, incident management, and quick response aerial fire suppression. These operations have typically been limited to day visual flight rules operations, but recently trials have been undertaken extending the window of operations into the night, with the assistance of night vision systems. Already a demanding job, night aerial firefighting operations have the potential to place even greater physical and mental demands on crewmembers. This study was designed to investigate sleep, fatigue, and performance outcomes in Australian aerial firefighting crews.METHODS:A total of nine subjects undertook a 21-d protocol, completing a sleep and duty diary including ratings of fatigue and workload. Salivary cortisol was collected daily, with additional samples provided before and after each flight, and heart rate variability was monitored during flight. Actigraphy was also used to objectively measure sleep during the data collection period.RESULTS:Descriptive findings suggest that subjects generally obtained >7 h sleep prior to flights, but cortisol levels and self-reported fatigue increased postflight. Furthermore, the greatest reported workload was associated with the domains of 'performance' and 'mental demand' during flights.DISCUSSION:Future research is necessary to understand the impact of active wildfire response on sleep, stress, and workload on aerial firefighting crews.Sprajcer M, Roberts S, Aisbett B, Ferguson S, Demasi D, Shriane A, Thomas MJW. Sleep, workload, and stress in aerial firefighting crews. Aerosp Med Hum Perform. 2022; 93(10):749-754.

How effective are Fatigue Risk Management Systems (FRMS)? A review.

OBJECTIVE: Fatigue Risk Management Systems (FRMS) are a data-driven set of management practices for identifying and managing fatigue-related safety risks. This approach also considers sleep and work time, and is based on ongoing risk assessment and monitoring. This narrative review addresses the effectiveness of FRMS, as well as barriers and enablers in the implementation of FRMS. Furthermore, this review draws on the literature to provide evidence-based policy guidance regarding FRMS implementation. METHODS: Seven databases were drawn on to identify relevant peer-reviewed literature. Relevant grey literature was also reviewed based on the authors' experience in the area. In total, 2129 records were screened based on the search strategy, with 231 included in the final review. RESULTS: Few studies provide an evidence-base for the effectiveness of FRMS as a whole. However, FRMS components (e.g., bio-mathematical models, self-report measures, performance monitoring) have improved key safety and fatigue metrics. This suggests FRMS as a whole are likely to have positive safety outcomes. Key enablers of successful implementation of FRMS include organisational and worker commitment, workplace culture, and training. CONCLUSIONS: While FRMS are likely to be effective, in organisations where safety cultures are insufficiently mature and resources are less available, these systems may be challenging to implement successfully. We propose regulatory bodies consider a hybrid model of FRMS, where organisations could choose to align with tight hours of work (compliance) controls. Alternatively, where organisational flexibility is desired, a risk-based approach to fatigue management could be implemented.

Sleep disturbances in caregivers of children with medical needs: A systematic review and meta-analysis.

OBJECTIVE: The sleep of individuals who provide unpaid care for children with medical needs is likely to be significantly impacted by this role. Sleep may be affected by the practical tasks undertaken during the night (e.g., administering medication), in addition to the emotional impact (e.g., worry, rumination). The aim of this systematic review was to examine the available literature on the impact of caregiving for children with medical needs on caregivers' sleep. METHOD: Electronic databases, including PubMed, Medline, and Web of Science, were searched using predetermined criteria. Studies were included if they used validated subjective or objective measures of caregiver sleep, in contexts where caregivers were providing care for one or more children with medical needs. Data on study population, research design, and outcome measures were extracted, and study quality was reviewed by two authors. RESULTS: Search criteria produced 2,172 studies for screening. Based on inclusion criteria, 40 studies were included in the final review. Sleep of caregivers of children with medical needs was poorer than that for noncaregivers. Poor sleep included reduced sleep duration, impaired sleep efficiency, increased wake after sleep onset, and perceived poorer sleep quality. CONCLUSIONS: Providing unpaid care for children with medical needs is associated with sleep disturbances, including less total sleep, and poorer sleep quality. (PsycInfo Database Record (c) 2021 APA, all rights reserved).

A qualitative content analysis of retained surgical items: learning from root cause analysis investigations.

OBJECTIVE: To describe incidents of retained surgical items, including their characteristics and the circumstances in which they occur. DESIGN: A qualitative content analysis of root cause analysis investigation reports. SETTING: Public health services in Victoria, Australia, 2010-2015. PARTICIPANTS: Incidents of retained surgical items as described by 31 root cause analysis investigation reports. MAIN OUTCOME MEASURE(S): The type of retained surgical item, the length of time between the item being retained and detected and qualitative descriptors of the contributing factors and the circumstances in which the retained surgical items occurred. RESULTS: Surgical packs, drain tubes and vascular devices comprised 68% (21/31) of the retained surgical items. Nearly one-quarter of the retained surgical items were detected either immediately in the post-operative period or on the day of the procedure (7/31). However, about one-sixth (5/31) were only detected after 6 months, with the longest period being 18 months. Contributing factors included complex or multistage surgery; the use of packs not specific to the purpose of the surgery; and design features of the surgical items. CONCLUSION: Retained drains occurred in the post-operative phase where surgical counts are not applicable and clinician situational awareness may not be as great. Root cause analysis investigation reports can be a valuable means of characterizing infrequently occurring adverse events such as retained surgical items. They may detect incidents that are not detected by other data collections and can inform the design enhancements and development of technologies to reduce the impact of retained surgical items.

More than hours of work: fatigue management during high-intensity maritime operations.

OBJECTIVES: This study examines the impacts of peak summer demand on operator workload and fatigue in a maritime environment. METHODS: Participants (n = 12) were senior shipboard personnel who were working during the summer "double sailing" period for a roll-on roll-off ferry service. Wrist actigraphy was used to determine sleep opportunity and sleep duration, as well as prior sleep, total wake time, performance and alertness at the beginning and end of work periods. RESULTS: Contrary to expectations, sleep was significantly greater, and both subjective estimates of fatigue and objective neurobehavioral performance were not impacted negatively by periods of increased work intensity. CONCLUSIONS: This study highlights a number of features of a fatigue-risk management system that appear to have been instrumental in ensuring adequate sleep and performance was maintained throughout periods of increased operational intensity. As a simple colloquial description of the fatigue-risk management system at play in this operation, it was fine to "work hard" if you were able to "sleep hard" as well.

Determining the likelihood that fatigue was present in a road accident: A theoretical review and suggested accident taxonomy.

Estimates in developed countries of the extent to which fatigue contributes to road accidents range from as low as 5% to as high as 50% of all accidents. Compared with other causes of road accidents (e.g., speeding, drink-driving), the variability in these estimates is exceptionally high and may be indicative of the difficulty in determining the likelihood of fatigue as a cause of road accidents. This review compares differences in the way road accidents are classified as fatigue-related (or not) by expert panels and road safety regulators, highlighting conflicting conceptual approaches, lack of consistency, and the poor psychometric qualities of classification rules used across jurisdictions. In order to facilitate future research, the review then proposes a new theoretical approach and a potentially more logical accident 'taxonomy'. A putative accident 'taxonomy' is proposed using two dimensions: (1) estimating the likelihood that a driver was fatigued at the time of the accident, and (2) estimating the degree to which accident phenomenology is consistent with fatigue-related error. This 'taxonomy' could assist accident investigators and road safety regulators to more reliably quantify the contribution of fatigue to road accidents, and may also assist researchers and regulators in the post-hoc interrogation of existing accident databases to better determine the relative incidence of fatigue-related road accidents.

Are root cause analyses recommendations effective and sustainable? An observational study.

OBJECTIVE: To assess the strength of root cause analysis (RCA) recommendations and their perceived levels of effectiveness and sustainability. DESIGN: All RCAs related to sentinel events (SEs) undertaken between the years 2010 and 2015 in the public health system in Victoria, Australia were analysed. The type and strength of each recommendation in the RCA reports were coded by an expert patient safety classifier using the US Department of Veteran Affairs type and strength criteria. PARTICIPANTS AND SETTING: Thirty-six public health services. MAIN OUTCOME MEASURE(S): The proportion of RCA recommendations which were classified as 'strong' (more likely to be effective and sustainable), 'medium' (possibly effective and sustainable) or 'weak' (less likely to be effective and sustainable). RESULTS: There were 227 RCAs in the period of study. In these RCAs, 1137 recommendations were made. Of these 8% were 'strong', 44% 'medium' and 48% were 'weak'. In 31 RCAs, or nearly 15%, only weak recommendations were made. In 24 (11%) RCAs five or more weak recommendations were made. In 165 (72%) RCAs no strong recommendations were made. The most frequent recommendation types were reviewing or enhancing a policy/guideline/documentation, and training and education. CONCLUSIONS: Only a small proportion of recommendations arising from RCAs in Victoria are 'strong'. This suggests that insights from the majority of RCAs are not likely to inform practice or process improvements. Suggested improvements include more human factors expertise and independence in investigations, more extensive application of existing tools that assist teams to prioritize recommendations that are likely to be effective, and greater use of observational and simulation techniques to understand the underlying systems factors. Time spent in repeatedly investigating similar incidents may be better spent aggregating and thematically analysing existing sources of information about patient safety.

Fatigue proofing: The role of protective behaviours in mediating fatigue-related risk in a defence aviation environment.

In the military or emergency services, operational requirements and/or community expectations often preclude formal prescriptive working time arrangements as a practical means of reducing fatigue-related risk. In these environments, workers sometimes employ adaptive or protective behaviours informally to reduce the risk (i.e. likelihood or consequence) associated with a fatigue-related error. These informal behaviours enable employees to reduce risk while continuing to work while fatigued. In this study, we documented the use of informal protective behaviours in a group of defence aviation personnel including flight crews. Semi-structured interviews were conducted to determine whether and which protective behaviours were used to mitigate fatigue-related error. The 18 participants were from aviation-specific trades and included aircrew (pilots and air-crewman) and aviation maintenance personnel (aeronautical engineers and maintenance personnel). Participants identified 147 ways in which they and/or others act to reduce the likelihood or consequence of a fatigue-related error. These formed seven categories of fatigue-reduction strategies. The two most novel categories are discussed in this paper: task-related and behaviour-based strategies. Broadly speaking, these results indicate that fatigued military flight and maintenance crews use protective 'fatigue-proofing' behaviours to reduce the likelihood and/or consequence of fatigue-related error and were aware of the potential benefits. It is also important to note that these behaviours are not typically part of the formal safety management system. Rather, they have evolved spontaneously as part of the culture around protecting team performance under adverse operating conditions. When compared with previous similar studies, aviation personnel were more readily able to understand the idea of fatigue proofing than those from a fire-fighting background. These differences were thought to reflect different cultural attitudes toward error and formal training using principles of Crew Resource Management and Threat and Error Management.

Fatigue risk management by volunteer fire-fighters: Use of informal strategies to augment formal policy.

An increasing number and intensity of catastrophic fire events in Australia has led to increasing demands on a mainly volunteer fire-fighting workforce. Despite the increasing likelihood of fatigue in the emergency services environment, there is not yet a systematic, unified approach to fatigue management in fire agencies across Australia. Accordingly, the aim of this study was to identify informal strategies used in volunteer fire-fighting and examine how these strategies are transmitted across the workforce. Thirty experienced Australian volunteer fire-fighters were interviewed in August 2010. The study identified informal fatigue-management behaviours at the individual, team and brigade level that have evolved in fire-fighting environments and are regularly implemented. However, their purpose was not explicitly recognized as such. This apparent paradox - that fatigue proofing behaviours exist but that they are not openly understood as such - may well resolve a potential conflict between a culture of indefatigability in the emergency services sector and the frequent need to operate safely while fatigued. However, formal controls require fire-fighters and their organisations to acknowledge and accept their vulnerability. This suggests two important areas in which to improve formal fatigue risk management in the emergency services sector: (1) identifying and formalising tacit or informal fatigue coping strategies as legitimate elements of the fatigue risk management system; and (2) developing culturally appropriate techniques for systematically communicating fatigue levels to self and others.

Failures in transition: learning from incidents relating to clinical handover in acute care.

The appropriate handover of patients, whereby responsibility and accountability of care is transferred between healthcare providers, is a critical component of quality healthcare delivery. This paper examines data from recent incidents relating to clinical handover in acute care settings, in order to provide a basis for the design and implementation of preventive and corrective strategies. A sample of incidents (n = 459) relating to clinical handover was extracted from an Australian health service's incident reporting system using a manual search function. Incident narratives were subjected to classification according to the system safety and quality concepts of failure type, error type, and failure detection mechanism. The most prevalent failure types associated with clinical handover were those relating to the transfer of patients without adequate handover 28.8% (n = 132), omissions of critical information about the patient's condition 19.2% (n = 88), and omissions of critical information about the patient's care plan during the handover process 14.2% (n = 65). The most prevalent failure detection mechanisms were those of expectation mismatch 35.7% (n = 174), clinical mismatch 26.9% (n = 127), and mismatch with other documentation 24.0% (n = 117). The findings suggest the need for a structured approach to handover with a recording of standardized sets of information to ensure that critical components are not omitted. Limitations of existing reporting processes are also highlighted.

Flight hours and flight crew performance in commercial aviation.

OBJECTIVE: To examine the relationship between a pilot's flight hours and their performance. BACKGROUND: There is current debate in the aviation industry on the minimum hours required for first officers to gain before they can fly for an airline. Despite years of pilot training and licensing, there are very little data available to determine whether or not pilot performance varies as a function of total hours within an airline environment. METHOD: Flight crew performance was measured during 287 sectors of normal operations against a set of technical and nontechnical measurements. Flightcrew were grouped into a categorical variable which defined low and high experience groups according to industry accepted thresholds. RESULTS: There were no statistically significant differences between experience groups for First Officers or Captains against the set of technical measures; however, there were minor differences with regard to nontechnical measures as a function of crew composition. There was also a difference in automation use, with First Officers with less than 1500 h keeping the autopilot engaged until a significantly lower altitude. DISCUSSION: Despite on-going debate that low-hour First Officers are not as capable as their more experienced colleagues, we found no evidence of this in our study.

Restricted sleep and negative affective states in commercial pilots during short haul operations.

This study aims to investigate (1) the relationship between restricted sleep and Heightened Emotional Activity (HEA) during normal flight operations, and (2) whether sleep patterns influence the strength of the HEA as a response to threats. Accident investigation reports continue to highlight the relationship between restricted sleep and poor safety outcomes. However, to date we have a limited understanding of how sleep and HEA interact. A total of 302 sectors of normal airline flight operations were observed by trained observers, and instances of heightened emotional activity were recorded. During the cruise phase of each of these sectors, crew members were asked to calculate the amount of sleep they had obtained in previous 24 and 48 h. In the 302 sectors of normal flight operations, 535 instances of HEA were observed. Descriptive analyses of instances of HEA and sleep in the prior 24 and 48 h showed a significant relationship between the occurrence of HEA and recent sleep. The relationship between restricted sleep and HEA suggests that there may well be further implications with respect to operational safety.

Fatigue-proofing: a new approach to reducing fatigue-related risk using the principles of error management.

In this review we introduce the idea of a novel group of strategies for further reducing fatigue-related risk in the workplace. In contrast to the risk-reduction achieved by reducing the likelihood an individual will be working while fatigued (e.g., by restricting hours of work), fatigue-proofing strategies are adaptive and protective risk-reduction behaviours that improve the resilience of a system of work. That is, they increase the likelihood that a fatigue-related error will be detected and not translate into accident or injury, thus reducing vulnerability to fatigue-related error. The first part of the review outlines the theoretical underpinnings of this approach and gives a series of ethnographically derived examples of informal fatigue-proofing strategies used in a variety of industries. A preliminary conceptual and methodological framework for the systematic identification, development and evaluation of fatigue-proofing strategies is then presented for integration into the wider organisational safety system. The review clearly identifies fatigue-proofing as a potentially valuable strategy to significantly lower fatigue-related risk independent of changes to working hours. This is of particular relevance to organisations where fatigue is difficult to manage using reductions in working hours due to operational circumstances, or the paradoxical consequences for overall safety associated with reduced working hours.

Mapping the limits of safety reporting systems in health care--what lessons can we actually learn?

OBJECTIVES: To assess the utility of Australian health care incident reporting systems and determine the depth of information available within a typical system. DESIGN AND SETTING: Incidents relating to patient misidentification occurring between 2004 and 2008 were selected from a sample extracted from a number of Australian health services' incident reporting systems using a manual search function. MAIN OUTCOME MEASURES: Incident type, aetiology (error type) and recovery (error-detection mechanism). Analyses were performed to determine category saturation. RESULTS: All 487 selected incidents could be classified according to incident type. The most prevalent incident type was medication being administered to the wrong patient (25.7%, 125), followed by incidents where a procedure was performed on the wrong patient (15.2%, 74) and incidents where an order for pathology or medical imaging was mislabelled (7.0%, 34). Category saturation was achieved quickly, with about half the total number of incident types identified in the first 13.5% of the incidents. All 43 incident types were classified within 76.2% of the dataset. Fifty-two incident reports (10.7%) included sufficient information to classify specific incident aetiology, and 288 reports (59.1%) had sufficient detailed information to classify a specific incident recovery mechanism. CONCLUSIONS: Incident reporting systems enable the classification of the surface features of an incident and identify common incident types. However, current systems provide little useful information on the underlying aetiology or incident recovery functions. Our study highlights several limitations of incident reporting systems, and provides guidance for improving the use of such systems in quality and safety improvement.

The breakdown of coordinated decision making in distributed systems.

OBJECTIVE: This article aims to explore the nature and resolution of breakdowns in coordinated decision making in distributed safety-critical systems. BACKGROUND: In safety-critical domains, people with different roles and responsibilities often must work together to make coordinated decisions while geographically distributed. Although there is likely to be a large degree of overlap in the shared mental models of these people on the basis of procedures and experience, subtle differences may exist. METHOD: Study 1 involves using Aviation Safety Reporting System reports to explore the ways in which coordinated decision making breaks down between pilots and air traffic controllers and the way in which the breakdowns are resolved. Study 2 replicates and extends those findings with the use of transcripts from the Apollo 13 National Aeronautics and Space Administration space mission. RESULTS: Across both studies, breakdowns were caused in part by different types of lower-level breakdowns (or disconnects), which are labeled as operational, informational, or evaluative. Evaluative disconnects were found to be significantly harder to resolve than other types of disconnects. CONCLUSION: Considering breakdowns according to the type of disconnect involved appears to capture useful information that should assist accident and incident investigators. The current trend in aviation of shifting responsibilities and providing increasingly more information to pilots may have a hidden cost of increasing evaluative disconnects. APPLICATION: The proposed taxonomy facilitates the investigation of breakdowns in coordinated decision making and draws attention to the importance of considering subtle differences between participants' mental models when considering complex distributed systems.

Prior sleep, prior wake, and crew performance during normal flight operations.

INTRODUCTION: Industries that operate outside daytime hours are known to carry higher safety risks related to fatigue. While we are beginning to understand better the role of fatigue in increasing the risk of accidents in the workplace, relatively little is known about the manifestation of fatigue in the multicrew environment, where operational safety involves interaction between two or more crewmembers and a complex operating environment. METHOD: Data were collected by trained expert observers during 302 normal flight operations of a commercial airline flying short-haul jet operations. Crewmembers were asked to provide an estimate of their total sleep in the prior 24 h, total sleep in the prior 48 h, and total wake time since their last sleep period at the commencement of cruise. Observers used the Threat and Error Management Model, developed as a standardized and highly structured method to collect operational performance data. RESULTS: Restricted sleep in both the 24-h and 48-h period prior to each sector were found to be associated with changes in crews' threat and error management performance. However, prior wake was not associated with any significant changes in crew performance. Restriction to less than 6 h sleep in the prior 24 h was associated with degraded operational performance and increased error rates. DISCUSSION: The findings of this study provide support to the notion that prior sleep is a critical fatigue-related variable. Moreover, the use of individual subjective assessment of prior sleep as a component of an overall fatigue risk management system is reinforced.

Work hours and sleep/wake behavior of Australian hospital doctors.

The objective of the study was to describe the work and sleep patterns of doctors working in Australian hospitals. Specifically, the aim was to examine the influence of work-related factors, such as hospital type, seniority, and specialty on work hours and their impact on sleep. A total of 635 work periods from 78 doctors were analyzed together with associated sleep history. Work and sleep diary information was validated against an objective measure of sleep/wake activity to provide the first comprehensive database linking work and sleep for individual hospital doctors in Australia. Doctors in large and small facilities had fewer days without work than those doctors working in medium-sized facilities. There were no significant differences in the total hours worked across these three categories of seniority; however, mid-career and senior doctors worked more overnight and weekend on-call periods than junior doctors. With respect to sleep, although higher work hours were related to less sleep, short sleeps (< 5 h in the 24 h prior to starting work) were observed at all levels of prior work history (including no work). In this population of Australian hospital doctors, total hours worked do impact sleep, but the pattern of work, together with other nonwork factors are also important mediators.

Crew familiarity: operational experience, non-technical performance, and error management.

INTRODUCTION: Crew familiarity, in terms of having recent operational experience together as a crew, is seen as an important safety-related variable. However, little evidence exists to unpack the underlying processes with respect to familiarity. This study investigated the relationships between crew familiarity, non-technical performance, and error management. METHOD: Data were collected during normal line operations at a commercial airline by observers using a methodology based on the Line Operations Safety Audit (LOSA). A total of 154 flights were analyzed, 31% of which were operated by an unfamiliar crew, with 69% operated by a familiar crew. RESULTS: The rate of error occurrence was found to be higher for unfamiliar crews, and these crews were found to make different types of errors when compared with familiar crews. However, with respect to the management of error events, no significant difference was found between unfamiliar and familiar crews. No significant effect of crew familiarity was found with respect to crews' non-technical performance. However, strong correlations were found between crews' non-technical performance and the management of errors. DISCUSSION: The findings indicate that crew familiarity, in terms of whether a crew has flown together recently or not, has little operational significance with respect to the management of error events during normal line operations. Accordingly, the suggestion that unfamiliar crews operate at a higher level of safety-related risk was not supported. Non-technical performance appears to be a stronger driver of effective error management than crew familiarity, and is highlighted as a focus for further investigation and intervention.