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The RADICAL framework for


implementing and monitoring
healthcare risk management
Leroy C. Edozien

The RADICAL
framework

165

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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166

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,

The RADICAL
framework

167

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.

168

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 units 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 organisations 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 organisations 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

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

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170

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 organisations 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).

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 Womens 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
Womens 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 patients 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 Kings 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 physicians 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
units 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 Agencys (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.
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Corresponding author
Leroy C. Edozien can be contacted at: Leroy.Edozien@manchester.ac.uk

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