A framework to support risk assessment in hospitals.

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.

Evaluating inputs of failure modes and effects analysis in identifying patient safety risks.

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.

Evaluation of system mapping approaches in identifying patient safety risks.

OBJECTIVE: While many system mapping approaches (SMAs) have been broadly used in safety-critical 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.

Design for patient safety: a systems-based risk identification framework.

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.

A participatory systems approach to design for safer integrated medicine management.

It is recognised that whole systems approaches are required in the design and development of complex health care services. Application of a systems approach benefits from the involvement of key stakeholders. However, participation in the context of community based health care is particularly challenging due to busy and geographically distributed stakeholders. This study used action research to investigate what processes and methods were needed to successfully employ a participatory systems approach. Three participatory workshops planned and facilitated by method experts were held with 30 representative stakeholders. Various methods were used with them and evaluated through an audit of workshop outputs and a qualitative questionnaire. Findings on the method application and participation are presented and methodological challenges are discussed with reference to further research. Practitioner Summary: This study provides practical insights on how to apply a participatory systems approach to complex health care service design. Various template-based methods for systems thinking and risk-based thinking were efficiently and effectively applied with stakeholders.

Trust-level risk evaluation and risk control guidance in the NHS East of England.

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.

Performing Qualitative Mask Fit Testing Without a Commercial Kit: Fit Testing Which Can Be Performed at Home and at Work.

OBJECTIVE: Qualitative fit testing is a popular method of ensuring the fit of sealing face masks such as N95 and FFP3 masks. Increased demand due to the coronavirus disease 2019 (COVID-19) pandemic has led to shortages in testing equipment and has forced many institutions to abandon fit testing. Three key materials are required for qualitative fit testing: the test solution, nebulizer, and testing hood. Accessible alternatives to the testing solution have been studied. This exploratory qualitative study evaluates alternatives to the nebulizer and hoods for performing qualitative fit testing. METHODS: Four devices were trialed to replace the test kit nebulizer. Two enclosures were tested for their ability to replace the test hood. Three researchers evaluated promising replacements under multiple mask fit conditions to assess functionality and accuracy. RESULTS: The aroma diffuser and smaller enclosures allowed participants to perform qualitative fit tests quickly and with high accuracy. CONCLUSIONS: Aroma diffusers show significant promise in their ability to allow individuals to quickly, easily, and inexpensively perform qualitative fit testing. Our findings indicate that aroma diffusers and homemade testing hoods may allow for qualitative fit testing when conventional apparatus is unavailable. Additional research is needed to evaluate the safety and reliability of these devices.

Pulmonary rehabilitation referral and uptake from primary care for people living with COPD: a mixed-methods study.

Healthcare service and patient barriers contribute to low referral to and uptake of pulmonary rehabilitation (PR). Solutions should support skilled clinician-patient conversations and span primary care-PR boundaries to prevent disjointed working. http://bit.ly/2PVKHZf.

Rebalancing risk management--Part 2: The Active Risk Control (ARC) Toolkit.

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.

Trust-level risk identification guidance in the NHS East of England.

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.

An analysis of medical device-related errors: prevalence and possible solutions.

The UK and USA are currently undergoing a period of considerable change in their attitude towards medical error and their understanding of its causes and magnitude. In both countries, with increasing rapidity, a disturbing situation is being revealed. This paper presents the results of an investigation into medical errors in the UK and the USA, and focuses in particular on the magnitude and causes of errors when using medical devices. Contrary to the traditional approach of blaming users, it is suggested here that many such errors are caused partly by poor device design, which fails to account adequately for the needs of users. In response, this paper also discusses the basics of a Human Factors Engineering (HFE) approach as a step towards overcoming this problem and offers a challenge to device users and design companies (manufacturers) to follow HFE principles in order to improve the efficiency of operation and reduce errors during device use.

Generating Options for Active Risk Control (GO-ARC): introducing a novel technique.

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.

Rebalancing risk management--part 1: The Process for Active Risk Control (PARC).

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.

Use of the Generating Options for Active Risk Control (GO-ARC) Technique can lead to more robust risk control options.

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. 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.

Getting to zero: evidence-based healthcare risk management is key.

In this article we call for a new approach to patient safety improvement, one based on the emerging field of evidence-based healthcare risk management (EBHRM). We explore EBHRM in the broader context of the evidence-based healthcare movement, assess the benefits and challenges that might arise in adopting an evidence-based approach, and make recommendations for meeting those challenges and realizing the benefits of a more scientific approach.

Beyond FMEA: the structured what-if technique (SWIFT).

Although it is probably the best-known prospective hazard analysis (PHA) tool, failure mode and effects analysis (FMEA) is far from the only option available. This article introduces one of the alternatives: The structured what-if technique (SWIFT). SWIFT is a flexible, high-level risk identification technique that can be used on a stand-alone basis, or as part of a staged approach to make more efficient use of bottom-up methods like FMEA. In this article we describe the method, assess the evidence related to its use in healthcare with the use of a systematic literature review, and suggest ways in which it could be better adapted for use in the healthcare industry. Based on the limited evidence available, it appears that healthcare workers find it easy to learn, easy to use, and credible. Especially when used as part of a staged approach, SWIFT appears capable of playing a useful role as component of the PHA armamentarium.