art & science service development
Collins S, Patel S (2009) Development of clinical policies and guidelines in acute settings.
Nursing Standard. 23, 27, 42-47. Date of acceptance: October 13 2008.
This article outlines a model for developing policies and discusses some of the issues involved in the process of writing, approving and disseminating clinical policies and guidelines. I t does not seek to dwell on policy drafting perse because guidance is readily available that can help authors to write and implement policies using evidence-based practice, research, implementation and audit skills.
Any individual policy, however, does not exist in a vacuum, but in a network of related policies. There is relatively little practical guidance, literature or debate about the methodology that can be applied to developing an organisationai policy framework, or how an understanding of this context can help those planning to develop a policy for their organisation. The article draws on the authors' experiences of policy development from the perspective of an acute
NHS trust and discusses the challenges of developing a proactive and co-ordinated approach to policy worl<. I t concludes with a recognition of some useful internal and external checks that can help policy authors to identify the extent to which policy is translated into practice.
Sean Collins is deputy board secretary. Corporate Services, Barts and The London NHS Trust and Seraphim Patel is clinical governance co-ordinator. Central West London Community
Services, London, and formerly business and committee officer,
Barts and The London NHS Trust, London.
Email: seanp.collins@bartsandthelondon.nhs.uk
Clinical governance; Clinical guidelines; Policies and procedures; Protocols
These keywords are based on the subject headings from the British
Nursing Index. This article has been subject to double-blind review.
For author and research article guidelines visit the Nursing Standard home page at nursingstandard.rcnpublishing.co.uk. For related articles visit our online archive and search using the l<eywords.
THE RECENT HISTORY of the NHS in England is dominated by large-scale national policy initiatives, from the NHS Plan (Department of
Health (DH) 2000) and national service frameworks through to specific interventions, such as deep cleaning programmes (DH 2007).
In its attempts to address the letter and the spirit
42 march 11 :: vol 23 no 27 :: 2009 of national policy, an NHS trust or foundation trust faces several challenges to set its own course while aligning with national requirements and best practice.
Every healthcare organisation will directly or tacitly adopt, develop or promote policies to meet its statutory obligations and develop consistent approaches to patient care. An effective policy regimen can be shown to benefit patients, staff and organisations. Conversely, failure to adopt a rigorous policy approach can become a weakness for organisations under scrutiny for perceived poor performance. In the authors' experience, a review of an organisation's policies is commonly the first step taken by external agencies and inspection bodies when assessing an organisation's competence. This was illustrated recently in the criticism of gaps in organisational infection control policies in high profile
Clostridum difficile investigation reports
(Healthcare Commission 2006,2007).
Policies can be defined as 'purposeful plans of action directed toward a risk or issue of concern'
(Sudduth 1999). Also, importantly, 'a policy is what you do, not what you write' (Friedman
2007). Any policy should be evidence based wherever possible in terms of making the case for change and in evaluating its own effectiveness. However, based on the authors' experiences, policies in acute hospitals should be considered primarily as operational tools a concise and clearly understandable resource providing support and direction to staff, patients and the public.
Hospital trusts used to hold a portfolio of personnel and mandatory risk management policies, but are now expected by patients, the public, external agencies and central government to have a broad network of policies extending across a range of clinical activities. Where this includes procedures to be undertaken by healthcare professionals to achieve a high standard of care, the demands for a
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comprehensive and consistent approach become increasingly complex and difficult to capture by policy authors in a concise way.
Introducing a policy framework
Friedman (2007) recommended that, when establishing policy priorities and developing formal policies, there should be a methodological approach that is appropriate to its aims. For example, a structured research-focused approach for clinical policy appraisal and an assessment tool has been developed by the
Appraisal of Guidelines Research and Fvaluation
Collaboration of researchers based at St George's
Medical School in London (Appraisal of
Guidelines Research and Evaluation
Collaboration 2003). The policy development framework used at Barts and The London NHS
Trust, however, is primarily operationally focused (Figure 1 ). A cyclical approach to policy development activity is adopted, which recognises five distinct stages. Structuring this article around these stages provides an opportunity to separate and examine the issues that can arise when developing policies.
an understanding of the right questions to ask, the most relevant data sources as well as an understanding ofthe patients' perspective
(DePalma 2002). The nursing profession has a strong historical legacy of policy work, perhaps typified by local development ofthe Scope of
Professional Practice (United Kingdom Central
Council 1992) protocols, which extended nursing practice to carry out specific interventions previously reserved for other professions, for example the role of nurses in administering intravenous medication via a peripheral cannula in line with defined protocols.
Manias and Street (2000) noted that nurses tended to communicate their knowledge with reference to policies and protocols. Nurses also often work in a complex, active environment, and need to have timely information and resources in their work areas to assist them to provide high quality patient care and to participate in and share professional nursing practice development (Scharfe-Pretino and
Von Bacho 2006). This background offers nurses an advantage when assuming a co-ordinating role, overseeing the development and approval process for organisational policies.
Nurses'contribution
Because of their experience and knowledge, nurses often provide useful insight on and challenges to policy. Effective challenge involves
Developing a policy
Stage 1: The policy author consults stakeholders and the NHS trust's policy co-ordinator to develop a policy An important
FIGURE 1
Barts and the London NHS Trust policy development process
Stage 1
The policy author consults stakeholders and the NHS trust's policy co-ordinator to develop a policy
Stage 5
The policy is reviewed after three years (or sooner if necessary)
stage 2
The policy is submitted for consideration and approval by relevant trust committees
Stage 4
The policy is disseminated via the intranet, the in-house publication and policy liaison officers
(Adapted from Barts and The London NHS Trust 2008a)
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Stage 3
The policy is considered and approved by the policies working group march 11 :: vol 23 no 27 :: 2009 4 3

art & science service development first obstacle facing an organisation's policy coordinator or individual author is defining the difference between policies, guidelines and standard operating procedures. The author should consider this context and decide whether it needs to be a departmental or organisationwide guideline or policy. Without any attempt to draw a distinction between a highly specific procedural document primarily aimed at department or specialty level and a broader policy affecting a wider group of staff and/or patients, an organisation or policy author may find it difficult to avoid 'policy fatigue'. Such fatigue can be a risk if a resource-intensive centralised policy approach is uniformly adopted for all proposed policies and guidelines, given that this inevitably involves senior clinicians and managers in consultation, approval and implementation. This risk can be reduced by differentiating the approach taken for policies and guidelines; by identifying the highly specialised nature of some clinical guidelines, the scope of consultation and dissemination can be targeted in a more appropriate way.
At Barts and The London NHS Trust, attempting to distinguish between what should constitute a policy and what should be a guideline on the basis of a subjective view of importance has been avoided, as priorities in health care change rapidly. Instead, the designation of a document is derived from its scope and application.
In this model:
• A core policy sets out the mandatory requirements with which everyone working in the organisation must comply. A standard application including possible sanctions applies.
• A core guideline sets out the expected or best practice for a particular issue, or principles, or frameworks to be followed.
• A local policy, guideline or standard operating procedure sets out the requirements or best practice for staff in one discrete specialty, department or professional group.
This designation is relevant to ensuring that each stage of design, consultation and approval is differentiated to ensure it is appropriate and manageable. It is, perhaps, not as important to identify how such boundaries are drawn up as it is to recognise that they need to exist somewhere.
For those involved in writing clinical policies or guidelines, the collection of reliable data that underpins the need for a specific policy proposal
44 march 11 :: vol 23 no 27 :: 2009 is an important step. For example, a sequence of serious untoward incidents related to patients with known allergies could demonstrate a gap in policy for the use of patient identification and colour coded bands to act as a visual reminder for staff to consult health records before prescribing or administering medication.
Even at an early stage in policy development, ensuring key steps are taken, such as discussion with a relevant lead clinician or director, can be helpful to ensure that the the policy fits with the organisation's strategic direction and requirements. At Barts and The London NHS
Trust this includes the drafting of a short briefing paper to the trust's policies working group to outline why the policy is required, the issue it seeks to address and how the policy will meet this need. An organisational memory for policy development work is developed in this way.
Once approved for development, the author should draft the policy drawing on national policy and examples of policy used elsewhere, and acknowledging any advice or comments made by stakeholders. Important stakeholders can include other professional groups, patients, members of the public, social workers, practice managers and others with relevant expertise or personal experience.
The authors' experience suggests that the most effective policies separate policy statements and principles from detailed procedures, distilling key requirements into one document and having detailed procedural material available separately or in appendices.
A template-driven approach can reinforce a consistent policy structure to help users to navigate documents and ensure authors address key questions by, for example, requiring sections to be completed about monitoring compliance with the policy. The NHS Litigation
Authority's website (www.nhsla.com/home.
htm) section on risk management standards is a good starting point for organisations that are attempting to identify what such policy templates might look like.
When establishing an evidence base for a policy, it is important for prospective authors to recognise the benefits that can accrue from using existing local evidence, such as patient survey data. An organisation should also recognise its unique place in this context; in the authors' example, this includes the ethnicity of the local population and continuing health inequalities in east London. However, local policy authors should also note that the evidence base of national policy can often have additional strengths, such as use of meta-analysis, which involves collating the results of numerous local trials to generate a greater mass of evidence. This supports the approach of adapting national
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An example of ar impact assessment form to be completed by the policy author
Area for consideration
Description of issue Guidance material
Trust contact
Financial impact for the NHS trust
Impact on private finance initiative
Does the policy impose an additional direct or indirect cost and how will this be managed?
How will the poiicy affect the volume or cost of services provided by the hospital's partner companies
How will the policy affect other partners?
[This column to be completed by the policy author]
[This column to be completed by the policy author]
Impact on other partner organisations
Race equality
Disability discrimination
Does the policy take account of race equality legislation and the trust's race equality scheme?
Does the policy take account of the Disability
Discrimination
Act 2005?
Age discrimination Does the policy take account of relevant legislation?
Gender discrimination
Does the policy take account of relevant legislation?
{Barts and The London NHS Trust 2008b)
Policy author description of how the issue has been addressed in the policy or guideline
[This column to be completed by the policy author] policy to local needs as well as a reduced reliance on laborious local data collection exercises.
Policy content should reference available evidence but avoid detailed debate or a literature review-style approach if this risks sending mixed messages to users seeking clear direction. This is a typical tension between the development of a comprehensive policy - with accompanying rationale - and the objective of producing a concise user-friendly policy.
The principles for developing new policies are the same as those for policies being revised.
However, the advantages of completed monitoring and audit of revised policies should be captured to refine the revised policy
(Figure 1, Stage 5).
Stage 2: The policy is submitted for consideration and approval by relevant trust
committees This stage outlines the consultation and collaborative work required to ensure policies reflect the views of local experts and end users. This can include a formal local specialist or departmental committee stage. For example,
NURSINQ STANDARO a policy for the presence of relatives at resuscitation attempts would be submitted initially to the trust resuscitation committee.
Submitting policies and guidelines to trust committees in this way allows expert views on aspects of clinical practice to be ascertained and provides an initial internal check on proposed policy.
At Barts and The London NHS Trust, authors are expected to carry out an impact assessment to identify that statutory and other key cost, access and quality requirements have been considered and addressed in policies (Table 1 ). This reflects the significant attention paid by external agencies to policies when assessing organisational effectiveness, as well as specific national requirements, such as the need for all policies to be assessed in relation to compliance with equality legislation.
Stage 3: The policy is considered and approved by
the policies working group In the authors' experience there is often an expectation of external agencies that policies should be approved march 11 :: vol 23 no 27 :: 2009 45

art & science service development by each NHS trust board. Given the number and nature of organisation policies now in existence, this has been delegated at Barts and The London
NHS Trust to a committee comprising members who are suited to reviewing the operational detail and the principles of policies. This committee - the policies working group - has delegated authority to oversee the development and approval process for trust policies and guidelines on behalf of the
NHS trust board.
Appropriate representation of professions, managers, patients and partners on this committee is the key to its success. This representation enables the committee to analyse effectively the proposed policy or guideline and to provide a 'helicopter view' of the policy, looking down to see how this fits into the context of other policies and practice in the organisation.
The role of nursing representation is particularly important to ensure there is a holistic view of clinical service delivery, as the continuity of nursing care - being involved throughout all stages of treatment of many patients - offers a unique professional perspective. Having considered the policy, the policies working group then considers the opportunities, implications, risks and constraints of its scope and decides whether to approve it.
As stated earlier, policies and protocols do not exist in isolation but in a network of related policies and, in acute settings, alongside complex professional and managerial relationships.
Policy development can therefore create tensions in clinical practice. It is important that authors recognise the balance between using policies and protocols to support and provide direction, while avoiding the perception of 'issuing diktats'.
Achieving such a balance preserves flexibility and clinical freedom, which help to generate good patient care.
Stage 4: The policy is disseminated via the intranet, in-house publication and policy liaison
officers To practice evidence-based and effective health care, research must be translated into actions and usable tools that can be implemented in care delivery at local level (Coopey 2006). The comparative advantages of tools available for disseminating policies are well-rehearsed, with the use of in-house intranet resources cited elsewhere
(Wolford and Hughes 2001).
With the increased use of computer-based dissemination of information, as well as improved 'version control' (safeguarding which version is in active use), staff are able to access policies and guidelines with greater ease than with
46 march 11 :: vol 23 no 27 :: 2009 more traditional hard copies. However, this does assume that staff have ready access to personal computers and relevant computer networks. This access is not always guaranteed and therefore it is important to consider alternative back-up hard copy systems. This may be important for contingency planning in the case of a computer systems failure or similar incident.
Ploeg et al (2007) suggested that implementation of policies and guidelines was often fragmented and inconsistent in clinical settings. Policy launches, introduction of arrangements to monitor compliance and the development of accompanying action plans help to translate policies into daily operational reality.
However, factors influencing effective implementation remain poorly understood, and developing a better understanding of the 'barriers' and 'enablers' is important for producing targeted implementation strategies. Effective targeting of communication to staff and patients most affected by any changes to policy is a factor in achieving compliance with policies.
An organisation's communications department can be a valuable resource to support authors in how best to launch policies and progress towards translating policy into practice.
Announcing any change to policy, preferably reinforced through staff briefings, is an essential first step for raising awareness. Audit and anecdotal evidence has reinforced the message that ease of use is the most important factor to the perceived relevance and eventual use of policies by clinical staff.
At the point of policy approval, the means of monitoring compliance should also be established.
Without this step, the prospects of effectively
'closing the loop' (by learning the lessons arising during the implementation stage and understanding the required policy refinements) gradually diminish and the opportunity to improve policy and practice is wasted.
Stage 5: Policy review after three years, or
sooner if necessary At Barts and The London
NHS Trust a three-year review period was set as the standard for trust policies and guidelines. It is recognised that certain events can necessitate an earher review than this standard timescale, particularly when national legislation or guidance is revised or where an active monitoring and audit process has been implemented and possible refinements have been identified.
Policies and guidelines should be redefined continuously, acknowledging feedback from those most directly involved in implementation and assessment internally or by external agencies, such as the Healthcare Commission.
It is often a sign of a good policy that it is regularly updated, signalling that it is a
'living' document.
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Conclusion
This article outlines an organisational policy model using five stages of a policy cycle to highlight issues that arise during policy development. In the organisation-wide policy model described above, the senior nurse administrator is pivotal to a comprehensive and consistent approach to policy development.
The authors hope this article has outlined risks associated with focusing too narrowly on the needs of one clinical area without considering the wider context. This highlights the need for policy authors to recognise the complex and sometimes conflicting challenges faced by the organisation as a whole.
Ultimately, a successful author or organisation will be that which has the ability to adopt a methodical approach and keep sight of the overriding objective of clinical policies and guidelines, which is to deliver high quality care in a safe environment for patients NS
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