Systems-Based Risk Identification for Patient Safety

This article addresses the insufficiency of current risk identification practices in patient safety within healthcare. It argues that the situation can be significantly improved by adopting systems approaches that have been broadly and successfully utilized in other safety-critical industries, such as aviation and chemical industries. While there is growing awareness of Human Factors and Ergonomics (HFE) in accelerating patient safety improvement, systems approaches remain underused in healthcare compared to other industries.

The authors highlight that healthcare predominantly relies on reactive approaches for risk identification, such as incident reporting and investigation, which have shown little measurable evidence of improvement and suffer from limitations like hindsight bias and underreporting. In contrast, proactive risk identification via prospective hazard analysis (PHA) methods is largely underused. Although some PHA methods like Failure Mode Effect Analysis (FMEA) have gained acceptance, they often face time and cost constraints, and concerns about their validity and reliability in healthcare applications persist.

To address these critical gaps, the paper first investigates existing risk identification practices in healthcare and then explores the potential of systems approaches. The core contribution is the development of a novel Risk Identification Framework (RID Framework). This framework is designed to enhance risk identification by demonstrating the strengths of using multiple inputs and methods, thereby facilitating the proactive identification of new risks. The RID Framework is underpinned by a proactive systems-based approach and aims to bridge the gap between reactive and proactive inputs in healthcare risk identification. It supports users in understanding the overall system from a socio-technical perspective and is expected to provide fundamental guidance to healthcare users.

The development of the RID Framework involved a thorough understanding of current risk identification practices, achieved through:

  • Content analysis of NHS documents to determine existing support for risk identification.
  • Interview-based questionnaires to capture healthcare professionals’ knowledge and experience.
  • Case studies to understand the practical application of methods.

These research methods revealed a lack of systems approaches and proactive risk identification, with incident investigation and safety walkabouts being the main methods used. They also showed that while risk registers exist, poor amalgamation of risk information from multiple methods hinders the overall process.

The RID Framework is structured into three main stages:

  1. System Familiarisation: This stage focuses on increasing understanding of the system and awareness of potential patient safety risks. Key inputs include:
    • System Description: Using brief textual/graphical descriptions and potentially System Mapping Approaches (SMAs). SMAs, such as system diagrams and flow diagrams, were found useful, particularly in identifying specific risk sources, and their amalgamation can be helpful.
    • Risk Sources: Considering various risk sources within a classification (e.g., patient-sourced, staff-sourced, equipment-related, communication, task-related, organisational, and environmental risks). This classification helps stimulate the imagination of new risks.
    • Nature of Hazards: Distinguishing different types of hazards (obvious, concealed, developing, transient) to further stimulate the imagination of new risks in changeable healthcare systems.
    • Time: Encouraging users to consider past incidents, present risks, and potential future risks due to change. Past incident reports and reactive results from claims and patient complaints can be used proactively.
  2. Identification of Risks: The aim here is to gather multiple risk identification approaches to create an exhaustive list of risks. The framework incorporates:
    • Brainstorming: Identified as the central approach, stimulating the imagination of new risks and considering System Mapping Approaches (SMAs) and risk source classification. It is suggested that criticism and analysis should be forbidden during brainstorming to foster an open atmosphere.
    • Safety Walkabouts: An adjustable approach that can be used with checklists, such as the NPSA contributing factors classification framework, to cover a range of risk sources.
  3. Presentation of Risks: This stage focuses on recording identified risks clearly and consistently using a predefined risk log sheet. Risks are defined with three components: Hazard (what can go wrong?), Potential Cause (why/how could it go wrong?), and Potential Effect (who/what is at risk?). This standardized description is crucial for collaborative use and effective risk assessment.

The potential value of the RID Framework was discussed through its application and evaluation in a real-world healthcare setting at the Gastroenterology Unit of Cambridge University Hospitals Foundation Trust (CUHFT). Seven participants, including consultants, nurses, and managers, evaluated the framework. While System Mapping Approaches and team-based activities were adjusted due to practical constraints in this specific study, individual workshops were conducted.

The evaluation indicated positive results regarding the framework’s usability and usefulness. Participants generally found the framework easy to use, believed they would use it for future risk identification, and agreed that its components (risk sources, nature of hazards, time, system description) were helpful in increasing understanding and stimulating imagination. The study identified 120 risks from the chosen ward setting. Participants reported being more aware of system-wide safety risks and believed they would not have identified the same risks without the RID Framework. They found the classification of risk sources and the concept of different natures of hazards very helpful, along with the use of past incident examples and ward layouts.

Despite positive feedback, the study also highlighted areas for further research and practical considerations. Participants found defining “hazard” and identifying causes and effects challenging initially. Notable omissions suggested by participants included the need for patient input, a team-based approach, and the consideration of financial issues in safety studies.

The authors conclude that the RID Framework successfully integrates reactive and proactive approaches, helping to identify a comprehensive list of patient safety risks and potentially aiding cultural change for safety improvement. However, it is stressed that the framework should not be used as a stand-alone tool. The quality of identified risks, rather than just quantity, remains a question for future research, and a clear strategy is needed to balance effort between identification, assessment, and mitigation to avoid a “risk bureaucracy” rather than a true “risk culture”. Further case studies in different healthcare settings are suggested to strengthen the generalizability of the findings.

Reference: Simsekler, M. C. E., Ward, J. R., & Clarkson, P. J. (2018). Design for patient safety: a systems-based risk identification framework. Ergonomics, 61(8), 1046–1064. https://doi.org/10.1080/00140139.2018.1437224

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