Objective: The effectiveness of filtering facepiece respirators such as N95 respirators is heavily dependent on the fit. However, there have been limited efforts to discover the size of the gaps in the seal required to compromise filtering facepiece respirator performance, with prior studies estimating this size based on in vitro models. In this study, we measure the size of leak necessary to compromise the fit of N95 respirators. Methods: Two methods were used to create a gap of specific dimensions. A set of 3D-printed resin spacers and hollow steel rods were used to generate gaps in N95 respirators while worn on 2 participants. Occupational Safety and Health Administration (OSHA) quantitative fit testing methods were used to quantify mask performance with gaps between 0.4 and 2.9-mm diameters. Results: Gap size was regressed against fit factor, showing that overall, the minimum gap size to compromise N95 performance was between 1.5 mm2 and 3 mm2. Conclusions: These findings suggest the fit of a N95 respirator is compromised by gaps that may be difficult to visually detect. The study also adds to the body of evidence supporting the routine use of quantitative fit testing to ensure that masks are well-fitting.

Introduction During the course of the COVID-19 pandemic, there have been suggestions that various techniques could be employed to improve the fit and, therefore, the effectiveness of face masks. It is well recognized that improving fit tends to improve mask effectiveness, but whether these fit modifiers are reliable remains unexplored. In this study, we assess a range of common "fit hacks"to determine their ability to improve mask performance. Methods Between July and September 2020, qualitative fit testing was performed in an indoor living space. We used quantitative fit testing to assess the fit of both surgical masks and KN95 masks, with and without 'fit hacks', on four participants. Seven fit hacks were evaluated to assess impact on fit. Additionally, one participant applied each fit hack multiple times to assess how reliable hacks were when reapplied. A convenience of four participants took part in the study, three females and one male with a head circumference range of 54 to 60 centimetres. Results and discussion The use of pantyhose, tape, and rubber bands were effective for most participants. A pantyhose overlayer was observed to be the most effective hack. High degrees of variation were noted between participants. However, little variation was noted within participants, with hacks generally showing similar benefit each time they were applied on a single participant. An inspection of the fit hacks once applied showed that individual facial features may have a significant impact on fit, especially the nose bridge. Conclusions Fit hacks can be used to effectively improve the fit of surgical and KN95 masks, enhancing the protection provided to the wearer. However, many of the most effective hacks are very uncomfortable and unlikely to be tolerated for extended periods of time. The development of effective fit-improvement solutions remains a critical issue in need of further development.

In England, hospitals routinely conduct a formal risk assessment practice to ensure the safety of patients and staff. However, although specific criticisms have been made on the practice, few investigated the formal risk assessment practice in the literature. This study investigates the risk assessment policies and procedures of one hundred hospitals in the English National Health Service (NHS) through content analysis. Findings revealed that hospitals provided varied descriptions of the terms risk and risk assessment. The concept of risk was often defined to be an undesired event, and risk assessment was often explained with the involvement of risk control step. Despite the variety in the descriptions of the risk terms, all hospitals recommended following similar steps to undertake risk assessments. Risk matrices- and therefore risk scoring–are at the heart of the formal practice, which increases the possibility of wrong risk prioritisation. This study provides several recommendations for the improvement of current guidelines by considering both Safety-I and Safety-II approaches.

Quality problem or issue: A number of challenges have been identified with current risk assessment practice in hospitals, including: a lack of consultation with a sufficiently wide group of stakeholders; a lack of consistency and transparency; and insufficient risk assessment guidance. Consequently, risk assessment may not be fully effective as a means to ensure safety. Initial assessment: We used a V system developmental model, in conjunction with mixed methods, including interviews and document analysis to identify user needs and requirements. Choice of solution: One way to address current challenges is through providing good guidance on the fundamental aspects of risk assessment. We designed a risk assessment framework, comprising: a risk assessment model that depicts the main risk assessment steps; risk assessment explanation cards that provide prompts to help apply each step; and a risk assessment form that helps to systematize the risk assessment and document the findings. Implementation: We conducted multiple group discussions to pilot the framework through the use of a representative scenario and used our findings for the user evaluation. Evaluation: User evaluation was conducted with 10 participants through interviews and showed promising results. Lessons learned: While the framework was recommended for use in practice, it was also proposed that it be adopted as a training tool. With its use in risk assessment, we anticipate that risk assessments would lead to more effective decisions being made and more appropriate actions being taken to minimize risks. Consequently, the quality and safety of care delivered could be improved.

Purpose: There is a growing awareness on the use of systems approaches to improve patient safety and quality. While earlier studies evaluated the validity of such approaches to identify and mitigate patient safety risks, so far only little attention has been given to their inputs, such as structured brainstorming and use of system mapping approaches (SMAs), to understand their impact in the risk identification process. To address this gap, the purpose of this paper is to evaluate the inputs of a well-known systems approach, failure modes and effects analysis (FMEA), in identifying patient safety risks in a real healthcare setting. Design/methodology/approach: This study was conducted in a newly established adult attention deficit hyperactivity disorder service at Cambridge and Peterborough Foundation Trust in the UK. Three stakeholders of the chosen service together with the facilitators conducted an FMEA exercise along with a particular system diagram that was initially found as the most useful SMA by eight stakeholders of the service. Findings: In this study, it was found that the formal structure of FMEA adds value to the risk identification process through comprehensive system coverage with the help of the system diagram. However, results also indicates that the structured brainstorming refrains FMEA participants from identifying and imagining new risks since they follow the process predefined in the given system diagram. Originality/value: While this study shows the potential contribution of FMEA inputs, it also suggests that healthcare organisations should not depend solely on FMEA results when identifying patient safety risks; and therefore prioritising their safety concerns.

Current risk identification practices applied to patient safety in healthcare are insufficient. The situation can be improved, however, by studying systems approaches broadly and successfully utilised in other safety-critical industries, such as aviation and chemical industries. To illustrate this, this paper first investigates current risk identification practices in the healthcare field, and then examines the potential of systems approaches. A systems-based approach, called the Risk Identification Framework (RID Framework), is then developed to enhance improvement in risk identification. Demonstrating the strengths of using multiple inputs and methods, the RID Framework helps to facilitate the proactive identification of new risks. In this study, the potential value of the RID Framework is discussed by examining its application and evaluation, as conducted in a real-world healthcare setting. Both the application and evaluation of the RID Framework indicate positive results, as well as the need for further research. Practitioner Summary: The findings in this study provide insights into how to make a better amalgamation of risk identification inputs to the safer design and more proactive risk management of healthcare delivery systems, which have been an increasing research interest amongst human factor professionals and ergonomists.

Although relatively rare, surgical instrument retention inside a patient following central venous catheterization still presents a significant risk. The research presented here compared two approaches to help reduce retention risk: Bow-Tie Analysis and Systems-Theoretic Accident Model and Processes. Each method was undertaken separately and then the results of the two approaches were compared and combined. Both approaches produced beneficial results that added to existing domain knowledge, and a combination of the two methods was found to be beneficial. For example, the Bow-Tie Analysis gave an overview of which activities keep controls working and who is responsible for each control, and the Systems-Theoretic Accident Model and Processes revealed the safety constraints that were not enforced by the supervisor of the controlled process. Such two-way feedback between both methods is potentially helpful for improving patient safety. Further methodology ideas to minimize surgical instrument retention risks are also described.

Objective: While many system mapping approaches (SMAs) have been broadly used in safetycritical industries, few have so far been employed in the healthcare field to assist in the identification of patient safety risks. In this study, we evaluated a set of system modelling approaches to assess their potential contribution to the identification of risks affecting patient safety. The aim was to gain a greater understanding of the practical application of system modelling approaches with the help of the risk categorization framework developed in this study. Setting: We conducted this study in a newly established Adult Attention Deficit Hyperactivity Disorder (ADHD) service at Cambridge and Peterborough Foundation Trust. Study participants: Eight key stakeholders of the chosen service, including clinicians, managers and administrative staff, were individually asked to evaluate a set of pre-defined six SMAs according to their usefulness in identifying patient safety risks through interview-based questionnaires. Results: It was found that each SMA could be useful in the chosen healthcare service in different ways. Further, specific types of diagrams were selected by stakeholders as more useful than others in identifying different sources of risks within the given system. Conclusions: The results of the evaluation showed that the system diagram is the most useful SMA in risk identification within the given system, while limited time, resources and experience of stakeholders with SMAs may present possible obstacles for their potential use in the healthcare field in future.

BACKGROUND: In healthcare, a range of methods are used to improve patient safety through risk identification within the scope of risk management. However, there is no evidence determining what trust-level guidance exists to support risk identification in healthcare organisations. This study therefore aimed to determine such methods through the content analysis of trust-level risk management documents. METHOD: Through Freedom of Information Act, risk management documents were requested from each acute, mental health and ambulance trust in the East of England region of NHS for content analysis. Received documents were also compared with guidance from other safety-critical industries to capture differences between the documents from those industries, and learning points to the healthcare field. RESULTS: A total of forty-eight documents were received from twenty-one trusts. Incident reporting was found as the main method for risk identification. The documents provided insufficient support for the use of prospective risk identification methods, such as Prospective Hazard Analysis (PHA) methods, while the guidance from other industries extensively promoted such methods. CONCLUSION: The documents provided significant insight into prescribed risk identification practice in the chosen region. Based on the content analysis and guidance from other safety-critical industries, a number of recommendations were made; such as introducing the use of PHA methods in the creation and revision of risk management documents, and providing individual guidance on risk identification to promote patient safety further.

In healthcare, various methods are available to support risk identification in risk management process. However, there is no clear evidence on their contribution to risk identification. In this study, different methods used to support risk identification were therefore analysed to compare their contribution to overall risk identification. The study was conducted at Cambridge University Hospitals Foundation Trust, UK. Three main methods were selected to compare their support in risk identification: incident reports through their Risk Management Information System, risk registers through their Risk Registers system, and safety walkabouts through their internal patient safety assessment process. Where possible, simple comparison tests were run between the different methods of identifying risks as well as by the type of risks identified. It was found that each method has contributed to the risk identification by adding different sets of risk sources despite some overlaps. However, they produced discrete assessments from different aspects and none of them, on its own, could produce adequate results for effective risk identification. In any healthcare setting, having a system to put all risk information in one picture would help maximise the contribution of each method within the scope risk management process. Future studies may benefit from broader use of multiple and system-based risk identification approaches, and coding methods for more powerful analytical test.

The adoption of systems-focused risk assessment techniques has not led to measurable improvement in the rate of patient harm. Why? In part, because these tools focus solely on understanding problems and provide no direct support for designing and managing solutions (ie, risk control). This second installment of a 2-part series on rebalancing risk management describes a structured approach to bridging this gap: The Active Risk Control (ARC) Toolkit. A pilot study is presented to show how the ARC Toolkit can improve the quality of risk management practice.

Retained surgical instruments (RSI) are preventable “Never Events”, yet our UK Hospital Trust experienced five retentions between 2011 and 2012. To reduce the retention risk and to aid rapid detection, we propose the deployment of additional technology-based controls: Surgical Data Recorders (SDR) and Radio-Frequency Identification (RFID) systems. In our research, the five relevant incident reports were reviewed, and the risk factors and the report recommendations were analysed. Furthermore, a comprehensive literature search on SDR and RFID was conducted. The current strategy for RSI prevention is manual counting of surgical instruments, but breakdowns in the process is a risk factor for RSI. Our work found that the technological systems proposed are a potentially promising means for accident prevention, monitoring, detection and post-incident learning for the five RSI cases. It is recommended that a systems approach, incorporating solutions like SDR and RFID should be adopted to reduce human errors in “Never Events”.

BACKGROUND: After investing significant amounts of time and money in conducting formal risk assessments, such as root cause analysis (RCA) or failure mode and effects analysis (FMEA), healthcare workers are left to their own devices in generating high-quality risk control options. They often experience difficulty in doing so, and tend toward an overreliance on administrative controls (the weakest category in the hierarchy of risk controls). This has important implications for patient safety and the cost effectiveness of risk management operations. This paper describes a before and after pilot study of the Generating Options for Active Risk Control (GO-ARC) technique, a novel tool to improve the quality of the risk control options generation process.OUTCOME MEASURES: The quantity, quality (using the three-tiered hierarchy of risk controls), variety, and novelty of risk controls generated.RESULTS: Use of the GO-ARC technique was associated with improvement on all measures.CONCLUSIONS: While this pilot study has some notable limitations, it appears that the GO-ARC technique improved the risk control options generation process. Further research is needed to confirm this finding. It is also important to note that improved risk control options are a necessary, but not sufficient, step toward the implementation of more robust risk controls.

Risk assessment, by itself, does nothing to reduce risk or improve safety. It can only change outcomes by informing the design and management of effective risk control interventions. But current practice in healthcare risk management suffers from an almost complete lack of support for risk control. This first installment of a 2-part series on rebalancing risk management describes a new framework to guide risk control practice: The Process for Active Risk Control.

In recent years, the healthcare sector has adopted the use of operational risk assessment tools to help understand the systems issues that lead to patient safety incidents. But although these problem-focused tools have improved the ability of healthcare organizations to identify hazards, they have not translated into measurable improvements in patient safety. One possible reason for this is a lack of support for the solution-focused process of risk control. This article describes a content analysis of the risk management strategies, policies, and procedures at all acute (i.e., hospital), mental health, and ambulance trusts (health service organizations) in the East of England area of the British National Health Service. The primary goal was to determine what organizational-level guidance exists to support risk control practice. A secondary goal was to examine the risk evaluation guidance provided by these trusts. With regard to risk control, we found an almost complete lack of useful guidance to promote good practice. With regard to risk evaluation, the trusts relied exclusively on risk matrices. A number of weaknesses were found in the use of this tool, especially related to the guidance for scoring an event's likelihood. We make a number of recommendations to address these concerns. The guidance assessed provides insufficient support for risk control and risk evaluation. This may present a significant barrier to the success of risk management approaches in improving patient safety.

Inclusive design has unique challenges because it aims to improve usability for a wide range of users. This typically includes people with lower levels of ability, as well as mainstream users. This paper examines the effectiveness of two methods that are used in inclusive design: user trials and exclusion calculations (an inclusive design inspection method). A study examined three autoinjectors using both methods (n= 30 for the user trials). The usability issues identified by each method are compared and the effectiveness of the methods is discussed. The study found that each method identified different kinds of issues, all of which are important for inclusive design. We therefore conclude that a combination of methods should be used in inclusive design rather than relying on a single method. Recommendations are also given for how the individual methods can be used more effectively in this context.

BACKGROUND: Risk assessment is widely used to improve patient safety, but healthcare workers are not trained to design robust solutions to the risks they uncover. This leads to an overreliance on the weakest category of risk control recommendations: administrative controls. Increasing the proportion of non-Administrative risk control options (NARCOs) generated would enable (though not ensure) the adoption of more robust solutions. OBJECTIVES: Experimentally assess a method for generating stronger risk controls: The Generating Options for Active Risk Control (GO-ARC) Technique. METHODS: Participants generated risk control options in response to two patient safety scenarios. Scenario 1 (baseline): All participants used current practice (unstructured brainstorming). Scenario 2: Control group used current practice; intervention group used the GO-ARC Technique. To control for individual differences between participants, analysis focused on the change in the proportion of NARCOs for each group. RESULTS: Control group: Proportion of NARCOs decreased from 0.18 at baseline to 0.12. Intervention group: Proportion increased from 0.10 at baseline to 0.29 using the GO-ARC Technique. Results were statistically significant. There was no decrease in the number of administrative controls generated by the intervention group. CONCLUSION: The Generating Options for Active Risk Control (GO-ARC) Technique appears to lead to more robust risk control options.

BACKGROUND: Central Venous Catheterisation (CVC) has occasionally been associated with cases of retained guidewires in patients after surgery. In theory, this is a completely avoidable complication; however, as with any human procedure, operator error leading to guidewires being occasionally retained cannot be fully eliminated. OBJECTIVE: The work described here investigated the issue in an attempt to better understand it both from an operator and a systems perspective, and to ultimately recommend appropriate safe design solutions that reduce guidewire retention errors. METHODS: Nine distinct methods were used: observations of the procedure, a literature review, interviewing CVC end-users, task analysis construction, CVC procedural audits, two human reliability assessments, usability heuristics and a comprehensive solution survey with CVC end-users. RESULTS: The three solutions that operators rated most highly, in terms of both practicality and effectiveness, were: making trainees better aware of the potential guidewire complications and strongly emphasising guidewire removal in CVC training, actively checking that the guidewire is present in the waste tray for disposal, and standardising purchase of central line sets so that differences that may affect chances of guidewire loss is minimised. CONCLUSIONS: Further work to eliminate/engineer out the possibility of guidewires being retained is proposed.

Complete intravascular loss of guidewires in patients is an on-going medical concern. This research investigates the guidewire insertion and removal procedure by using a common omission error model by James Reason to identify procedural disposition to omission errors. The research builds on a previous Hierarchical Task Analysis for central venous catheterisation and identifies two crucial points that need further examination with regard to guidewire loss. Suggestions for improved equipment, procedural and system design at these two task steps are given.

Background: Central Venous Catheterisation (CVC) is a medical procedure that has been linked with cases of retained guidewires in a patient after surgery. Whilst this is theoretically a completely avoidable complication, a guidewire of up to 60cm being retained in a patient's vascular system poses a major risk. In recently reported cases, guidewires retained inside patients have not been detected for several years. Aims: The ultimate aim was to develop appropriate, operator-centred safe design solutions that reduce guidewire retention errors. Method: This paper focuses specifically on the application of Nielsen's ten usability heuristics 1 to the issue of retained guidewires. Following the development of a task analysis of the procedure, three researchers (from medical, safety and human factors backgrounds) independently applied the usability heuristics, then met to analyse the findings. Results: A range of usability problems were identified in the Central Venous Catheterisation procedure, and solutions to the identified issues were then proposed: These focused on the design of equipment, or the wider guidewire insertion procedure. The paper details the identified usability problems and possible redesign solutions from the 10 usability heuristics. Conclusion: Overall, the application of the usability heuristics was found to be a useful method both to explore medical device interface problems and to generate possible countermeasures. Further work to eliminate/engineer out the possibility of guidewires being retained is briefly reported.