The RADICAL Framework for Implementing and Monitoring Healthcare Risk Management

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The RADICAL framework for implementing and monitoring healthcare risk management Leroy C. Edozien

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Manchester Academic Health Sciences Centre, University of Manchester, Manchester, UK Abstract Purpose – The purpose of this paper is to facilitate an integrative approach to the implementation, monitoring and reporting of risk management in healthcare settings. Design/methodology/approach – A framework, identified by the acronym RADICAL, is presented. The underlying principles and the strengths of the framework are described. Findings – The framework comprises the following domains in an integrated grid: raise awareness, design for safety, involve users, collect and analyse patient safety data, and learn from patient safety incidents. Practical implications – The RADICAL framework provides a simple but comprehensive approach to the implementation, monitoring and reporting of healthcare risk management. It is designed to facilitate learning and accountability at both individual and organisational levels, advocating a balance between “person” and “system”. It covers all domains of patient safety while also being flexible to allow local customisation of the content and metrics for each domain. Originality/value – The RADICAL framework can be used by service providers and commissioners to implement and monitor risk management, and by regulators for monitoring performance. It can also be used in education and training, and to provide information on quality and safety to service users. Keywords Clinical governance, Patient safety, Risk management, Health services Paper type Conceptual paper

Background Safety is a key aspect of healthcare delivery, and hospitals are obliged to have robust systems in place to continually monitor and improve the safety of care. Unfortunately efforts in this direction are often haphazard rather than tailored, reactive rather than proactive, and diffuse rather than integrated. Risk management has consumed an increasing proportion of healthcare resources in the last decade, most of it committed to promotion of incident reporting. It is narrowly and misleadingly perceived by many frontline staff as little more than incident reporting, and clinicians often wonder whether, for all the resources committed to it, incident reporting makes substantial difference to patient care (Kingston et al., 2004). It can be argued that, at national and local levels, incident reporting has been over-emphasised, to the detriment of other domains in risk management. Despite this perception and the huge investment in the National Reporting and Learning System (2011), many patient safety incidents are unreported, and huge resources are expended on low level incidents. Incident reporting is an important component of risk management, but it is not the only means of Competing interests: The author has no financial interest in the framework. It is freely available to all for non-commercial use. Funding: Nil.

Clinical Governance: An International Journal Vol. 18 No. 2, 2013 pp. 165-175 q Emerald Group Publishing Limited 1477-7274 DOI 10.1108/14777271311317945

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identifying risk. The over-emphasis on incident reporting takes attention away from other sources of patient safety data and other means of identifying risk, such as horizon scanning, prospective risk assessment, case reviews and system analysis. It also diverts attention away from other domains such as user involvement and safety science. Another limitation of the prevailing approach to healthcare risk management is that the role of the individual practitioner in protecting patient safety is insufficiently emphasised, and frontline practitioners are inadequately trained to recognise and interrupt error chains. As a result of the need to eradicate the culture of blame, risk managers are moving from a “person” approach to a “system” approach, but we are now at risk of swapping one extreme for another. What is required is a suitable balance between person and system: as well as building resilience into the system, individual practitioners should be equipped with the cognitive and other skills necessary for safe practice. With the financial squeeze, the time has come for hospitals to demonstrate in concrete terms the output of their risk management programmes. Unless the programmes are built on an integrative framework, they are likely to yield sub-optimal outcomes. This need motivated the author to devise the RADICAL framework for healthcare risk management. The framework was first suggested as a tool that could be applied in gynaecology (Edozien, 2009). In this paper the concept is further developed and more fully described. Examples of how the framework may be applied in practice are given, and the strengths of this framework compared to other approaches are discussed. The framework RADICAL is a framework designed to facilitate an integrative approach to the implementation, monitoring and reporting of risk management in healthcare settings. It comprises the following domains in an integrated grid: Raise Awareness, Design for safety, Involve users, Collect and Analyse patient safety data, and Learn from patient safety incidents (see Figure 1). None of these domains is an original idea, so this framework can be seen as an enhancement of what currently exists. On the other hand, the idea of situating these domains in an integrated grid and with an inviting acronym is original. A unique attribute of RADICAL is that the links between domains are as important as the domains themselves. The framework challenges service providers not only to address each domain but also to demonstrate how each domain has informed, and been informed by, other domains. Apart from providing a procedural framework, RADICAL is also a way of conceptualising risk management, expanding the scope of risk management beyond incident reporting and finding a balance between the individual practitioner and the system. Raise awareness and understanding of patient safety Commitment to patient safety begins with awareness of the problem and understanding of the mechanisms underlying patient safety incidents. Awareness of the scale of patient safety has grown in the last decade, but understanding of its epidemiology, psychology and sociology remains less than satisfactory (Armitage, 2009; Weingart et al., 2000). It is important for staff to grasp basic concepts such as latent and active factors in medical accidents, situational awareness, and defences. When we understand how errors happen,

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Figure 1. The RADICAL framework for healthcare risk management

we can begin to identify error-producing conditions in our pathways of care. Safety science needs to be incorporated in continuing professional development. Unless clinicians and managers understand the underlying mechanisms as well as the consequences for patients, they are unlikely to be motivated enough to make the necessary changes or to go about this in the right way. This domain includes raising awareness about the important role of the individual practitioner as the “sharp-ender”. Individuals should take responsibility for safe clinical practice and be aware of their position as the possible last link in an

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error chain. The “safety wise” individual at the sharp end is in a better position to trap errors and prevent accidents. Training and educational activities aimed at promoting non-technical skills – such as situational awareness, decision making, communication, combating stress and fatigue – are an important part of this domain.

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Design for safety – deliver health care in ways designed to protect patient safety Human error cannot be totally eliminated, but the risk of patent safety incidents can be reduced if, at individual and unit levels, we aim to provide care in a way that reflects safety awareness and a commitment to reducing the likelihood of error. Interventions such as clinical practice guidelines, care bundles, communication tools, handover protocols, promotion of hand hygiene, use of a surgical safety checklist and team training fall under this heading. Involve service users in enhancing the safety of health care As with other aspects of care, risk management calls for partnership with patients – there should be no talk of patient safety without patients (Davis et al., 2007). Patients can be engaged in a variety of ways: keeping them informed of the unit’s policies, initiatives and statistics relating to patient safety; involving them in the design or reconfiguration of services to enhance safety, and in the protection of their own safety (e.g. by avoiding misidentification). Patient information leaflets on various medical conditions and interventions should include succinct information about how the patient can contribute to safety while undergoing treatment. We can also involve patients in safety by sharing with them lessons learned from patient safety incidents. It should be part of the organisation’s corporate responsibility to keep users informed of its efforts to ensure that safe care is provided. Collect and analyse data on safety of care To improve safety in the care we deliver, we must know the current rates of patient safety incidents in our practice, and then we must have structures and procedures for monitoring our progress on the road to safer care. This is not always as easy as it sounds. Patient safety science still a relatively new field in health services so appropriate metrics are often not available, or staff are not familiar with them. Also this is a field where human behaviour is a dominant confounder, and one that is often difficult to predict, assess and control. It is not enough merely to collect incident reports and amass huge data on patient safety incidents. For such data to be useful, they have to be analysed and used constructively to change practice where necessary and demonstrate safer care. The raw data have to be converted to information that is meaningful and of practical benefit to staff and service users. Finally, there is no size or form that fits all and each unit will have to adapt the general principles described here to its own circumstances. Learn from patient safety incidents Learning is an important element in risk management. It is harrowing enough to have patient safety incidents; to fail to learn from them runs counter to professional ethics. Organisational learning, however, is not a passive osmotic process; it has to be actively promoted and a learning environment has to be nurtured. In the context of patient

safety, a learning organisation is one that is able to create new knowledge from patient safety incidents, learn from its experience and that of others, transfer knowledge acquired, and bring about change in its behaviour as a response to the new knowledge. Once collected data has been transmuted to intelligent information, learning points should be underscored. Learning should be shared. Lessons learned should inform the design of services and can be used to raise awareness of the causes, consequences and prevention of patient safety incidents.

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Application of the framework The RADICAL framework can be applied at hospital-wide, departmental and individual practitioner levels. The various applications include implementing, monitoring and reporting risk management at all levels, multi-professional education, service user engagement, and promoting integration of patient safety initiatives (see Table I). Implementing risk management The RADICAL framework is a useful tool for those wishing to implement a risk management programme from scratch, as well as those wishing to re-structure an existing programme. An organisation wishing to adopt the RADICAL framework can, for a start, incorporate the framework in its quality and safety strategy. The strategy will emphasise integration of initiatives, individual accountability and organisational learning. Taking a comprehensive view of risk management, the RADICAL framework covers practically all domains relating to patient safety. All information relating to patient safety can be entered into one or other domain in RADICAL. Each risk management initiative in the hospital or department is categorised into one of the RADICAL domains, and available resources are distributed across all domains. Monitoring risk management It can serve as the basis of a dashboard for monitoring progress in delivery of risk management objectives, and has potential for use in benchmarking the performance of organisations. The RADICAL domains constitute standing headings for the agenda of risk management committee meetings at all levels. Using the grid afforded by RADICAL, the unit or organisation readily recognises domains where progress has been slow. A checklist for baseline assessment of the organisation’s performance in Service Services providers Commissioners Regulators users Engaging service users Individual clinicians’ performance monitoring, appraisal and revalidation Implementing risk management Monitoring risk management Team communications and organisational briefings Reporting quality and safety Education and training

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Table I. Potential applications of the RADICAL framework for various stakeholders

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Figure 2. Checklist for implementation of the RADICAL framework

each domain is provided in Figure 2. Target goals for each domain can be set locally, for clinical units and for the organisation as a whole. Reporting quality and safety. Promoting integration RADICAL provides the headings for periodic reports on safety and quality of care in the department or organisation. These include quarterly or annual departmental reports, internal reports tabled before the organisation’s Board, and external reports to commissioners, regulators and other stakeholders. For risk management to yield optimal results, efforts should be made not only to enhance all domains but also to integrate them. Internal and external reports should, therefore, not treat the domains as silos but demonstrate how each domain has linked with and impacted on other domains. Progress in each domain becomes not an end in itself but a route to achieving strategic objectives. Take infection control as an example. The mandatory annual corporate training of Central Manchester University Hospitals NHS Foundation Trust includes a graphic demonstration of the dramatic fall in bacteraemia rates after institution of hand hygiene in the Trust. Reporting this in the RADICAL format will bring into sharp relief the following pathways (with the RADICAL domain in parentheses): . Data on morbidity and mortality from bacteraemia highlight a patient safety concern (Collect and Analyse data). . A Trust-wide hand hygiene campaign is undertaken, during which individual accountability is stressed (Raise Awareness).

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The Aseptic Non-Touch Technique (ANTT) for venepuncture and wound dressing is introduced. Training in ANTT is mandatory for medical and nursing staff, and is monitored as part of staff annual appraisal (Design for safety). Patients and relatives are engaged in the campaign through posters, information leaflets and one-to-one communication (Involve users). Bacteraemia rates are monitored continually (Collect and Analyse data) and individual clinicians, ward managers and clinical leads are held accountable for their bacteraemia rates (Raise Awareness). Graphical time series representation of bacteraemia rates shows impressive drop following the interventions (Hand hygiene campaign and ANTT), strongly suggesting a causal relationship (but not necessarily proving it, since the interventions were not introduced in the context of a robust experimental or research programme). The downward trend in bacteraemia rates is cascaded to all staff through newsletters and mandatory training, to reinforce learning and sustain good practice (Learn from patient safety incidents). The results are also shared with patients, relatives and other stakeholders (Involve service users).

Multi-professional education and training The framework can be applied in devising educational curricula at undergraduate and postgraduate levels, conference programmes, and handbooks for local corporate and clinical mandatory training. The RADICAL domains can be used as section headings in textbooks or in designing online or computer-based training packages. It has for example, been used to devise the programme for the annual conference on Risk management in Women’s Healthcare organised jointly by the Royal College of Obstetricians and Gynaecologists and the Endowment for Training and Education in Reproduction (see the following). Programme for the RCOG/ENTER annual conference on Risk Management in Women’s Health, May 2011, based on the RADICAL framework (1) Raising Awareness. . Involuntary automaticity. . Situational awareness. (2) Design for safety. . Effective conduct of clinical handover. . Risk management in laparoscopic surgery. (3) Involve users. . A patient’s perspective of patient safety in maternity care. (4) Collect and Analyse safety data. . UK Obstetric Surveillance System (UKOSS). . The Clinical Negligence Scheme for Trusts (CNST). (5) Learning from patient safety incidents. . Lessons from the King’s Fund Safer Births Programme. . Lessons from the confidential enquiry into maternal deaths.

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Promoting individual accountability for quality and safety Clinician engagement in risk management has been patchy and, overall, suboptimal (Davies et al., 2007). One reason for this is that risk management is often perceived by clinicians as an administrative affair, with little bearing on clinical practice and clinical outcomes. This perception needs to be changed. Another reason is that individual practitioners are not always formally held accountable for risk managing their practice. Incorporating RADICAL in mandatory corporate and clinical training programmes in the organisation could give clinicians a more meaningful perspective of risk management, provide staff with a vivid picture of how the patient safety domains relate to each other, and challenge staff to demonstrate how they have integrated these domains in their own practice. Individual practitioners could use the RADICAL domains to categorise and document their continuing professional development (CPD) activities, and these domains could constitute headings for discussion at annual appraisal meetings (see the following). Through these means, RADICAL has the potential to generate more active interest in the management of risk and to enhance professional development of staff. RADICAL framework applied hypothetically to an individual physician’s continuing professional development and appraisal meeting (1) Raise Awareness . Attended “Human Factors” course. Wrote a reflective diary on how this applies to patient safety in renal medicine. Lectured specialist registrars on “Good Medical Practice for Physicians”. (2) Design for safety . Member of guideline development group for multidisciplinary management of dialysis and transplantation (3) Involve users . Gave a talk at the last meeting of the dialysis patients’ support group. Worked with this group to map the renal patient pathway, as part of the unit’s quality improvement project. Adapted my practice in keeping with advice given in the latest edition of the Royal College of Physicians’ document “Consultant physicians working with patients”. (4) Collect and Analyse safety data . My colleagues and I have completed an audit of dialysis prescription errors in our unit. The Action Plan from this audit has been costed and is being implemented. (5) Learning from patient safety incidents . After a patient identification error on our unit, we implemented a similar-name alert system. The system has been shared with other units in the hospital. Strengths of the RADICAL framework The framework has foundations in schema theory, a theory of learning which hypothesises that the schema a person uses during learning will determine how the learner interprets the task to be learned, how the learner understands the information, and what knowledge the learner acquires (Anderson et al., 1977).

People use schemata (mental frameworks) to organize current knowledge and provide a framework for future understanding. RADICAL organizes knowledge and goals of risk management into a pattern that facilitates interpreting and processing information. The isolated treatment of domains in current risk management approaches promotes first order change: new processes and procedures are introduced but the system itself is relatively unchanged. The RADICAL framework should promote second order change: the thinking and attitude of staff to patient safety is proactively managed and the delivery of risk management is reconceptualised, with emphasis on integration and pursuit of defined strategic and operational objectives. The framework (see Figure 1) is akin to concentric ‘Plan, Do, Study, Act (PDSA) cycles. There has been growing use of the PDSA approach in healthcare quality improvement (Cleghorn and Headrick, 1996; Curran and Bunyan, 2012). Usability The RADICAL framework can be used easily by clinicians, administrators, service commissioners, patients, and regulators. The acronym is readily remembered and the scope of each domain is clear from the domain title. Managers who have adopted the RADICAL framework say that they can discuss their risk management activities in a structured way at formal or informal meetings, without having to refer to papers – an observation consonant with the schema theory of learning. Flexibility and adaptability It is helpful if a framework can be generic enough to be applied in different settings but also flexible enough to allow customisation to local needs. RADICAL meets this ideal. The precise content of each domain and the metrics for assessing progress in the domains can be locally defined. The RADICAL framework applies to all healthcare risk – clinical or corporate – unlike frameworks designed primarily or solely for clinical risk. Comparison with other approaches to risk management The UK National Patient Safety Agency’s (2004) framework for introducing risk management is the “Seven Steps to Patient Safety”. The “steps” – Build a safety culture; Lead and support your staff; Integrate your risk management activity; Promote reporting; Involve and communicate with patients and the public; Learn and share safety lessons; Implement solutions to prevent harm – share the domains in RADICAL but there is a focus on incident reporting. Crucially, the framework adopts a linear approach (unlike the mass integration approach of RADICAL). As emphasised previously the attributes of comprehensiveness and integration are key strengths of the RADICAL framework. Further, it is not easy to recall the seven steps without memorising them or looking at a text. The integrated framework devised by Runciman et al. (2006) is complex and, for this reason, probably unlikely to find rapid and widespread adoption. It is essentially an incident management framework. It is also a linear structure, having as its starting point a safety intervention or incident. The framework traces the process followed in logging, analysing, investigating and classifying the incident/intervention, through to the quality improvement cycle that may be undertaken as a result. There is no mention

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of user involvement or explicit coverage of the role of the individual practitioner (other than as a loop in quadruple loop learning). RADICAL is a much simpler framework while also covering more domains. Attention to the balance between “person” and “system” – a central tenet of the Raise Awareness domain – is unique to RADICAL. The Department of Health in Western Australia produced a five-step framework (Office of Safety and Quality in Health Care, 2005) for managing clinical risk: Establish the context; Identify the risks; Analyse the risks; Evaluate and prioritise the risks; Treat the risks. Two additional processes flow across the five steps: “Communication and Consultation” and “Monitoring and Review”. Both are implemented simultaneously at each level of the five-step process. This framework does not have the breadth captured by RADICAL; learning does not stand out as a key objective, and user engagement is not explicit. Further development Formal evaluation of the RADICAL framework – its implementation and impact across organisations – is planned. The elements of each domain can be further defined, without adding complexity to the main framework. For example, an incident management protocol can be incorporated under the “Collect and Analyse” domain. Conclusion The RADICAL framework provides a simple but comprehensive approach to the implementation, monitoring and reporting of healthcare risk management. It is designed to facilitate learning and accountability at both individual and organisational levels, advocating a balance between “person” and “system”. It covers all domains of patient safety while also being flexible to allow local customisation of the content and metrics for each domain. Presented as a grid rather than a linear structure, the emphasis is not just on the domains but on integration between domains. As a catchy acronym that also serves as a mnemonic, RADICAL appeals to staff. There is scope for further development and application of this framework. References Anderson, R.C., Reynolds, R.E., Schallert, D.L. and Goetz, E.T. (1977), “Frameworks for comprehending discourse”, American Educational Research Journal, Vol. 14 No. 4, pp. 367-81. Armitage, G. (2009), “Human error theory: relevance to nurse management”, Journal of Nursing Management, Vol. 17 No. 2, pp. 193-202. Cleghorn, G.D. and Headrick, L.A. (1996), “The PDSA cycle at the core of learning in health professions education”, The Joint Commission Journal on Quality Improvement, Vol. 22 No. 3, pp. 206-12. Curran, E.T. and Bunyan, D. (2012), “Using a PDSA cycle of improvement to increase preparedness for, and management of, norovirus in NHS Scotland”, Journal of Hospital Infection, Vol. 82 No. 2, October, pp. 108-13. Davies, H., Powell, A. and Rushmer, R. (2007), Healthcare Professionals’ Views on Clinician Engagement in Quality Improvement. A Literature Review, The Health Foundation, London.

Davis, R.E., Jacklin, R., Sevdalis, N. and Vincent, C.A. (2007), “Patient involvement in patient safety: what factors influence patient participation and engagement?”, Health Expectations, Vol. 10 No. 3, pp. 259-67. Edozien, L.C. (2009), “Gynaecological risk management”, in Mahmood, T., Templeton, A. and Dhillon, C. (Eds), Models of Care in Women’s Health, RCOG Press, London. Kingston, M.J., Evans, S.M., Smith, B.J. and Berry, J.G. (2004), “Attitudes of doctors and nurses towards incident reporting: a qualitative analysis”, The Medical Journal of Australia, Vol. 181 No. 1, pp. 36-9. National Patient Safety Agency (2004), Seven Steps to Patient Safety. The Full Reference Guide, National Patient Safety Agency, London. National Reporting and Learning System (2011), National Reporting and Learning System, available at: www.nrls.npsa.nhs.uk/report-a-patient-safety-incident/about-reportingpatient-safety-incidents/ (accessed 4 March 2011). Office of Safety and Quality in Health Care (2005), Clinical Risk Management Guidelines for the Western Australian Health System, Department of Health, Government of Western Australia, East Perth, available at www.safetyandquality.health.wa.gov.au/docs/clinical_ risk_man/Clinical_risk_man_guidelines_wa.pdf (accessed 6 September 2012). Runciman, W.B., Williamson, J.A.H., Deakin, A., Benveniste, K.A., Bannon, K. and Hibbert, P.D. (2006), “An integrated framework for safety, quality and risk management: an information and incident management system based on a universal patient safety classification”, Quality and Safety in Health Care, Vol. 15, Supplement I, pp. i82-i90. Weingart, S.N., Wilson, R.M., Gibberd, R.W. and Harrison, B. (2000), “Epidemiology of medical error”, BMJ, Vol. 320 No. 7237, pp. 774-7. Corresponding author Leroy C. Edozien can be contacted at: [email protected]

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