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This commentary reviews the publication by Smaggus et al published in the IJHPM in July 2021 on "Government Actions and Their Relation to Resilience in Healthcare During the COVID-19 Pandemic in New South Wales, Australia and Ontario, Canada" which analysed media releases to identify how governments contributed to resilience in healthcare (RiH). We suggest media releases might not be the best data to capture the mechanisms, activities and interactions through which government actions enhance or hinder RiH. RiH recognizes healthcare as a complex sociotechnical system, so studies into fostering capacity for RiH should be designed for complex sociotechnical systems. This means data should be derived from multiple sources to allow for diverse perspectives, and preferably include direct observations to capture the intricacies of backstage interactions.

Serious incident investigations—often conducted by means of Root Cause Analysis methodologies—are increasingly seen as platforms to learn from multiple perspectives and experiences: professionals, patients and their families alike. Underlying this principle of inclusiveness is the idea that healthcare staff and service users hold unique and valuable knowledge that can inform learning, as well as the notion that learning is a social process that involves people actively reflecting on shared knowledge. Despite initiatives to facilitate inclusiveness, research shows that embracing and learning from diverse perspectives is difficult. Using the concept of ‘epistemic injustice’, pointing at practices of someone’s knowledge being unjustly disqualified or devalued, we analyze the way incident investigations are organized and executed with the aim to understand why it is difficult to embrace and learn from the multiple perspectives voiced in incident investigations. We draw from 73 semi-structured interviews with healthcare leaders, managers, healthcare professionals, incident investigators and inspectors, document analyses and ethnographic observations. Our analysis identified several structures in the incident investigation process, that can promote or hinder an actor’s epistemic contribution in the process of incident investigations. Rather than repeat calls to ‘involve more’ and ‘listen better’, we encourage policy makers to be mindful of and address the structures that can cause epistemic injustice. This can improve the outcome of incident investigations and can help to do justice to the lived experiences of the involved actors in the aftermath of a serious incident.

ObjectivesA just culture is considered a promising way to improve patient safety and working conditions in the healthcare sector, and as such is also of relevance to healthcare regulators who are tasked with monitoring and overseeing quality and safety of care. The objective of the current study is to explore the experiences in healthcare organisations regarding the role of the healthcare inspectorate in enabling a just culture.DesignQualitative study using interviews and focus groups that were transcribed verbatim, and observations of which written reports were made. Transcripts and observation reports were thematically analysed.SettingThree mental healthcare providers, two hospitals and the healthcare inspectorate in the Netherlands.ParticipantsWe conducted 61 interviews and 7 focus groups with healthcare professionals, managers and other staff in healthcare organisations and with inspectors. Additionally, 27 observations were conducted in healthcare organisations.ResultsWe identified three themes in our data. First, professionals and managers in healthcare organisations perceive the inspectorate as a potential catalyst for learning processes, for example, as an instigator of investigating incidents thoroughly, yet also as a potential barrier as its presence and procedures limit how open employees feel they can be. Second, a just culture is considered relational and layered, meaning that relationships between different layers within or outside the organisation might hinder or promote a just culture. Finally, for inspectors to enable a just culture requires finding a balance between allowing organisations the time to take responsibility for quality and safety issues, and timely regulatory intervention when healthcare providers are unwilling or unable to act.ConclusionsIf regulators intend to enable the development of a just culture within healthcare organisations, they must adopt regulatory procedures that support reflection and learning within the organisations they regulate and consider mutual trust as a vital regulatory tool.

The prevention of safety incidents (SI) in health and social care settings is an ongoing undertaking. Limited research has been conducted on SIs outside of acute care. Internationally residential care facilities (RCFs) are typically regulated to promote quality and safeguarding. A part of this regulation is the statutory responsibility of RCFs to notify the regulator about SIs. Notifications include details surrounding SIs and are used to inform the regulatory monitoring approach. The recent development of the Database of Statutory Notifications from Social Care in Ireland facilitates in-depth analysis of notifications which can be used to inform the management of SIs and thus, improve quality and safety. The aim of this study was to analyse narratives provided in statutory notifications for older persons and people with disability, in order to identify current management of SIs, system vulnerabilities and reporting practices. A Qualitative Descriptive approach was taken. A random sample of notifications received in 2018 was drawn and stratified by service-type and notification-type. Data extraction was conducted against priori agreed target areas of management, system vulnerabilities and reporting practices. Inductive thematic analysis was used identifying two parent themes: ‘chronology’ and ‘regulatory input’. ‘Chronology’ subthemes included ‘pre-event’, ‘immediate response’ and ‘continued response’. Measures that are resident focused and follow policies and protocols in RCFs to prevent or mitigate the seriousness of SIs were evident in the immediate response and continued response. The actions taken in the immediate and continued response in turn became part of the pre-event of future SIs. Under ‘regulatory input’ subthemes included ‘inaccurate reporting’, ‘lines of inquiry’, ‘requests for further information’, ‘identification of repetitive patterns’ and ‘satisfactory conclusion’. In conclusion, RCFs manage SIs with short and longer term actions focused on resident wellbeing. These actions in turn become part of the pre-event of future SIs. Regulatory input highlighted regulatory burden.

Decision transparency is often proposed as a way to maintain or even increase citizen trust, yet this assumption is still untested in the context of regulatory agencies. We test the effect of transparency of a typical decision tradeoff in regulatory enforcement: granting forbearance or imposing a sanction. We employed a representative survey experiment (n = 1,546) in which we test the effect of transparency in general (providing information about a decision or not) and the effect of specific types of transparency (process or rationale transparency). We do this for agencies supervising financial markets, education, and health care. We find that overall decision transparency significantly increases citizen trust in only two of the three agencies. Rationale transparency has a more pronounced positive effect only for the Education Inspectorate. We conclude that the overall effect of decision transparency is positive but that the nature of the regulatory domain may weaken or strengthen this effect.

Incident reporting systems (IRSs) have been widely adopted in healthcare, calling for the investigation of serious incidents to understand what causes patient harm. In this article, we study how the Dutch IRS contributed to social and participative learning from incidents. We integrate quantitative and qualitative data in a mixed-methods design. Between 1 July 2013 and 31 March 2019, Dutch hospitals reported and investigated 4667 incidents. Healthcare inspectors scored all investigations to assess hospitals' learning process following incidents. We analysed if and on what aspects hospitals improved over time. Additionally, we draw from semi-structured interviews with incident investigators, quality managers, healthcare inspectors and healthcare professionals. Healthcare inspectors score incident investigation reports better over time, suggesting that hospitals conduct better investigations or have become adept at writing reports in line with inspectors' expectations. Our qualitative data suggests the IRS contributed to practices that support social and participative learning-the professionalisation of incident investigation teams, the increased involvement of patients and families in investigations-and practices that do not-not linking learning from the investigation teams to that of professionals, not consistently monitoring the recommendations that investigations identify. The IRS both hits and misses the mark. We learned that IRSs need to be responsive to the (developing) capabilities of healthcare providers to investigate and learn from incidents, if the IRS is to stimulate social and participative learning from incidents.

ObjectivesTo explore characteristics of sexual abuse within residential settings for people with an intellectual disability and to map out measures undertaken and improvement plans made by healthcare organisations after sexual abuse.DesignDescriptive analysis of reports about sexual violence against persons with an intellectual disability submitted to the Dutch Health and Youth Care Inspectorate by healthcare organisations.SettingResidential settings for people with an intellectual disability in The Netherlands.Selection186 incident reports submitted to the Inspectorate between January 2017 and December 2019 were included.Results125 incident reports concerned sexual abuse by fellow clients and 61 reports concerned sexual abuse by professionals. Client perpetrators were predominantly male whereas almost 30% of the abusing professionals were female. The majority of the perpetrating professionals were unlicensed professionals. Clients who committed sexual abuse were mostly relocated to another residential setting. Most healthcare organisations invested in education and training for employees instead of improving the sexual education programme for clients after an incident of sexual abuse. If there was a strong suspicion of sexual abuse by a professional, resignation followed in most cases. In just two cases, the perpetrating professional was reported to a warning registry.ConclusionsA small amount of the perpetrating professionals held a licensed profession, which makes it challenging to address this form of sexual abuse through healthcare regulation. It raises the question why warning registries are not engaged more often after alleged sexual abuse. Constantly relocating abusing clients might endanger the (sexual) safety of clients in these new environments. Previous literature suggests that adequate sexual education regarding social skills and sexual behaviour is very effective for the majority of clients who commit sexual abuse. Healthcare organisations could take up a more prominent role in this to ensure safety for their own clients and for clients residing elsewhere.

BackgroundThe recurrence of sentinel events (SEs) is a persistent problem worldwide, despite repeated analyses and recommendations formulated to prevent recurrence. Research suggests this is partly attributable to the quality of the recommendations, and determining if a recommendation will be effective is not yet covered by an adequate guideline. Our objectives were to (1) develop and validate criteria for high-quality recommendations, and (2) evaluate recommendations using the criteria developed.Methods(1) Criteria were developed by experts using the bowtie method. Medical doctors then determined if the recommendations of Dutch in-hospital SE analysis reports met the criteria, after which interobserver variability was tested. (2) Researchers determined which recommendations of Dutch perioperative SE analysis reports produced from 2017 to 2018 met the criteria.ResultsThe criteria were: (1) a recommendation needs to be well defined and clear, (2) it needs to specifically describe the intended changes, and (3) it needs to describe how it will reduce the risk or limit the consequences of a similar SE. Validation of criteria showed substantial interobserver agreement. The SE analysis reports (n=115) contained 442 recommendations, of which 64% failed to meet all criteria, and 28% of reports did not contain a single recommendation that met the criteria.ConclusionWe developed and validated criteria for high-quality recommendations. The majority of recommendations did not meet our criteria. It was disconcerting to find that over a quarter of the investigations did not produce a single recommendation that met the criteria, not even in SEs with a fatal outcome. Healthcare providers have an obligation to prevent SEs, and certainly their recurrence. We anticipate that using these criteria to determine the potential of recommendations will aid in this endeavour.

Objectives To describe the development of an analyzable database of statutory notifications received from long-term care facilities (LTCFs) and to describe trends in receipt of notifications from 2013 to 2019. Design Description of database development with descriptive and trend analyses. Setting and Participants LTCFs for older persons and for people with disability in Ireland. Methods Data on notifications received and on centers were extracted from a system internal to the health and social services regulator and combined into an analyzable database. Variables were screened for personal information, cleaned, transformed, or redacted and combined into a database suitable for open access publication. Descriptive analyses of the volume of notifications, trends over time and breakdown by service type, notification type, and risk-rating were conducted. Results The Database of Statutory Notifications from Social Care in Ireland was developed and an open access version published in February 2021. Protection of personal data was an important consideration in publishing the data publicly. Uses of the database include examination of national trends and identification of determinants of adverse events and areas for quality improvement. The number of notifications received increased over time. Quarterly notifications contributed to the largest proportion of notifications (older persons, 36.7%; disability, 39.1%). This was followed by serious injury notifications in LTCFs for older persons (33.3%) and abuse allegation notifications in LTCFs for people with disability (36.0%). Less than 1% of individual notifications were risk-rated red (highest severity level of impact on resident welfare). The types of notifications that were collectively risk-rated highest were staff misconduct, abuse allegations, and outbreaks of infectious disease. Conclusions and Implications The methodology and findings can inform publications of notifications, planning and resourcing for receipt and submission of notifications, target areas for quality improvement initiatives, mandating of timelines for receipt of notifications, and the mandating of notifications in legislation.

BackgroundThe Dutch healthcare inspectorate publishes its inspection frameworks to inform both the public and healthcare providers about regulatory procedures and in the hope that publication will motivate healthcare providers to improve quality and comply with standards. This study explores the consequences of publishing these frameworks for the regulation of quality and safety in healthcare.MethodsWe selected recently published inspection frameworks used in three healthcare settings: nursing home care, dental care and hospital care. We conducted 37 interviews with 39 respondents (healthcare professionals, managers, quality officers, policy advisers and inspectors) and explored their awareness of and experiences with these frameworks. We held a group interview with three inspectors to reflect on our findings. All data underwent thematic content analysis.ResultsWe found that the institutional infrastructure of a sector plays an important role in how an inspection framework is used after publication; particularly the presence and maturity of quality improvement work in the sector and the inspectorate’s grip on a sector matter. Respondents mentioned differences in framework use in organisational contexts, particularly relating to scale. In some organisations, the framework served as an accountability mechanism to check if quality meets basic standards, while in other organisations professionals adopted it to stimulate discussion and learning across teams.ConclusionPublication of inspection frameworks might result in quality improvement work, and in particular contexts could be used as a regulatory strategy to target quality improvement in a healthcare sector. For this, it is important that regulators consider the capabilities and possibilities for learning and improving within a sector.

Modern healthcare systems are highly data- and evidence-driven. The use of indicators and other performance management devices, introduced by healthcare leaders and regulators to monitor performance and address patient safety matters, are just two examples. Research has shown that the wish to manage and address risks via measuring practices does not always do justice to the complexities of healthcare organization and delivery, for (patient) safety and quality are not only about measurable things. So, while recognized as valuable, there are calls that hard metrics must be supplemented with soft signals – generally known as qualitative or informal data – to gain a better representation of actual performance and tackle safety issues. With the aim to contribute to the theoretical notion that a dialogical approach to knowledge and information-management is a fruitful way to manage and address risks and problems in healthcare, this paper addresses the research question ‘What role do soft signals play in the assessment of patient safety risks and how are these signals employed in everyday regulatory practices?’ We draw from qualitative interviews, observations and document analyses in a multi-year (2015-2019) research project to show that soft signals are vital to everyday regulatory practices, as they provide context to ‘hard’ signals and help to make sense of and weigh risks. Based on these findings we encourage policy makers and regulatory bodies to start an active dialogue on their use of soft signals and develop work models and working routines for discussing them as well as their implications.

Background In the Netherlands, health care is regulated by the Health and Youth Care Inspectorate. Forty-six indicators are used to prioritize supervision of psychiatric hospitals. The objective of this study is to define a smaller set of weighted indicators which reflects a consensus among inspectors about which aspects are most important for risk assessment. Methods The set of 46 indicators, complemented with missing information, was reduced to six indicators by means of interviews, group discussions and ranking among the inspectors. These indicators were used as attributes in a discrete choice experiment (DCE) to define their weights. Results Twenty-six inspectors defined the top four indicators suitable for the risk assessment of psychiatric hospitals. These are: the policy on prevention of compulsory treatment; the policy on dysfunctional professionals; the quality of internal research after a serious incident; and the implementation of multidisciplinary guidelines on suicidal behaviour. These indicators share the same importance with regard to risk assessment. The screening of somatic symptoms and the policy on integrated care are important indicators too, but less relevant. Conclusion Through a DCE, we reduced the amount of information for risk assessment of psychiatric hospitals to six weighted indicators. Inspectors can use these indicators to prioritize their inspections.

Objective There is growing recognition among health care providers and policy makers that when things go wrong, the patient or their families should be heard and participate in the incident investigation process. This paper explores how Dutch hospitals organize patient or family engagement in incident investigations, maps out incident investigators’ experiences of involving patients or their families in incident investigations and identifies the challenges encountered. Methods Semi-structured interviews were conducted with managers and incident investigators in 13 Dutch hospitals. Study participants (n = 18) were asked about the incident investigation routines and their experiences of involving affected patients or family members. Interview transcripts were coded and analysed using thematic content analysis. Results Our findings reveal that patient or family involvement in incident investigations is typically organized as a one-time interview event. Interviews with patients or their families were considered to be valuable and important in their own right and seen as a way to do justice to the individual needs of the patient or their family. Yet, the usefulness and validity of the patient or family perspective for incident investigations was often seen to be limited, with the professional perspective afforded more weight. This was particularly the case when the patient or their family were unable to provide verifiable details of the incident under investigation. Study participants described challenges when involving patients or family members, including in relation to the available timeframe for incident investigations, legal issues, managing trust and working with intense emotions. Conclusions We propose that by placing patient and family criteria of significance at the centre of incident investigations (i.e. an ‘emic’ research approach), hospitals may be able to expand their learning potential and improve patient-centeredness following an incident.

These authors reflect on how covid-19 has impacted on patient participation in policy and decision making in the Netherlands

Many nations, healthcare organizations and interest groups are addressing the question of how patients can best be involved in designing and executing patient safety policy. Looking back at how patient engagement has developed in healthcare, we can draw lessons on how to engage patients in patient safety.

Diverse scholars have argued that standards and performance measurements are “instruments of control” that have a profound influence on the day-to-day lives of individuals and organizations, causing constitutive effects. Regulatory bodies increasingly use standards to oversee and monitor the regulated. This paper discusses the Dutch Health and Youth Care Inspectorate’s use of both standards and a performance measurement system introduced to monitor how Dutch hospitals investigate and learn from serious adverse events. Rather than focusing on how standards affect regulated practices and organizations, our study examines how the use of these instruments affects the standard maker, that is, the Inspectorate. We explore how the Inspectorate’s work practices, standards, and coupled performance measurement system influence its regulatory pedagogy, reviewing practices, and decisionmaking. We conclude that standards and performance measurement systems are not by definition “instruments of control” as their constitutive effects are (under)determined by the relationships in which they are enacted.

Incident reporting is widely recognised as an important method for improving safety in healthcare, and many countries have established their own incident reporting systems.1 However, the actual value of these systems is increasingly subject to debate.2 Reporting systems, both local and national, are overwhelmed by the volume of reports and fall short in defining recommendations for improving healthcare safety: ‘We collect too much and do too little’.3 The purpose of these systems is also under debate. The UK, for example, struggles to clarify whether incident reports should be used to help healthcare organisations learn, or whether they should help regulators and funders to make judgements.4 As healthcare inspectors tasked with running a national hospital incident reporting system (IL, SM and JV), we recognise the issues described above. In this article, we show how the theories in the evolving scientific literature on incident reporting apply to our situation. Our work since 2012 acts as an empirical example of how reporting systems could have an effect if they focus on the learning process within hospitals instead of on solutions for reported safety issues. As TS Eliot is quoted as saying: “The journey, not the arrival, matters.” ### The conception of ‘incident’ changes over time Vincent and Amalberti argued that safety in healthcare is a moving target, because innovation and improving standards in healthcare alter the conceptions of both harm and preventability.5 This dynamic view of healthcare safety can be illustrated by the 1996 Dutch legal definition for a sentinel event (SE), the most serious class of incidents that healthcare organisations are mandated to report (see box 1). Since rising standards of care influence the way incidents are judged, an incident in 2005 can be judged differently in 2015 using the identical definition.6 Moreover, the standards of the healthcare quality community change faster, because they …

Involving patients and families in mental healthcare is becoming more commonplace, but little is known about how they are involved in the aftermath of serious adverse events related to quality of care (sentinel events, including suicides). This study explores the role patients and families have in formal processes after sentinel events in Dutch mental healthcare. We analyzed the existing policies of 15 healthcare organizations and spoke with 35 stakeholders including patients, families, their counselors, the national regulator, and professionals. Respondents argue that involving patients and families is valuable to help deal with the event emotionally, provide additional information, and prevent escalation. Results indicate that involving patients and families is only described in sentinel event policies to a limited extent. In practice, involvement consists mostly of providing aftercare and sharing information about the event by providers. Complexities such as privacy concerns and involuntary admissions are said to hinder involvement. Respondents also emphasize that involvement should not be obligatory and stress the need for patients and families to be involved throughout the process of treatment. There is no one-size-fits-all strategy for involving patients and families after sentinel events. The first step seems to be early involvement during treatment process itself.

‘Je draagt het als een man’ heb ik altijd een vreemde uitdrukking gevonden als het om pijn gaat. Mannen kunnen juist zo dramatisch doen. Maar toch maakte ik me zorgen toen ik maandagavond thuiskwam en Martijn zo aantrof.

Soms zit het mee. Omdat mijn man naar Engeland was voor een vergadering, moest ik de kinderen naar de creche brengen en was ik daardoor met de auto naar het werk gegaan. Het was vanochtend prachtig weer, dus anders was ik zeker met de fiets gegaan. En dan had ik nu door de regen naar de andere locatie kunnen fietsen. Ik was aan het einde van mijn vierde jaar van de opleiding tot chirurg.

Ik werkte al vijftien jaar als oogarts, waarvan bijna 13 in dit ziekenhuis, toen ik bij deze casus betrokken raakte. Een vreselijke complicatie waar ik geen rekening mee had gehouden. Laat ik bij het begin beginnen.

Zaterdag 6 november 2012 is de slechtste dag uit mijn hele leven geweest. Ik schrijf alles nu achteraf op. De meeste gebeurtenissen van die rampdag zullen tot mijn oude dag nooit meer uit mijn geheugen verdwijnen. Details van de momenten dat ik even te ver weg was om iets op te merken heb ik van mijn man, die een fotografisch geheugen heeft.

Eigenlijk kent deze geschiedenis alleen maar verliezers. Ik kraak mijn hersenen om te bedenken hoe we het anders hadden kunnen doen, of het anders had gekund. Hadden we eerder moeten ingrijpen, doortastender moeten zijn? Of hadden we Freek juist meer ruimte moeten geven, een extra kans?

Ik zeg: het was eigenlijk een casus ‘volgens het boekje’. Vernauwing in een kransslagader. Toegegeven, tot 30 jaar geleden kon je gemakkelijke aan deze aandoening overlijden. Maar nu, 33 jaar nadat in het St. Antonius Ziekenhuis in Nieuwegein voor het eerst succesvol werd gewerkt met de combinatie van een katheter, een ballonnetje en een mooie stent, is er sprake van een standaard-ingreep, waarvan alleen al in Nederland meer dan 100.000 patienten per jaar profiteren.

Tijdens een concours in de zomer van 2011 is onze dochter Nikky van haar paard gevallen en heeft zij haar rug gebroken. Als ik mijn ogen sluit, zie ik nog in slow-motion hoe zij valt. Ik kan veel vertellen over de periode daarna maar het be-langrijkste is dat Nikky wonderwel vrijwel volledig is hersteld.

Het was al donker en guur buiten. Ik trok mijn muts over mijn oren en stapte op mijn fiets. Het was mijn derde nacht. ‘Na vannacht nog maar eentje en dan zit deze nachtdienst er weer op’ dacht ik. Terwijl ik door de gesloten stad fietste flitste de afgelopen jaren aan mij voorbij.

Mijn zoon Jos had mij geholpen om een geschikt verpleeghuis uit te zoeken. De schat had vrijgenomen van zijn werk om alle locaties in de buurt van mijn woonplaats te beoordelen. Uiteindelijk stelde hij mij voor om verpleeghuis D’n Klaverheide te kiezen voor de revalidatie na mijn heupoperatie.

It’s now more than a decade since the US Institute of Medicine’s landmark 1999 report To Err Is Human put patient safety prominently on the international agenda. Despite countless initiatives, publications, and conferences on the topic, improvement has been disappointingly slow. Ian Leistikow and colleagues define the four challenges that make patient safety such a tough nut to crack, and propose a way out of the impasse