THE ROYAL BERKSHIRE AMBULANCE NHS TRUST.
STATEMENT OF POLICY AND PROCEDURE
TO DEVELOP AND IMPLEMENT CLINICAL GUIDANCE DOCUMENTS AND GROUP PROTOCOLS
Implementation date: May 2000
Review date: September 2000
Contents
1. Purpose and scope of this policy ….………………………………….. 3
2. Background …………………………………………………………… 3
3. Guiding principles …………………………………………………….. 4
4. Developing and implementing clinical guidance documents …………. 5
5. Developing and implementing group protocols …..…………..……. 6
6. Procedure for gaining ratification for clinical guidance documents and
group protocols ……………………………………………..………… 6
7. Availability of clinical guidance documents and group protocols …….. 6
8. Members of the clinical effectiveness group……………………………… 6
9. References ……………………………………………………………… 6
Appendix a Model for clinical guidance documents 7
Appendix b Model for group protocols for the supply and administration
of drugs 10
Appendix c Flowchart showing procedure for gaining ratification of
clinical guidance documents and group protocols for the supply
and administration of drugs 14
1. PURPOSE AND SCOPE OF THIS POLICY
1.1 This policy provides guidance for managers and practitioners in terms of developing and implementing clinical guidance documents and group protocols for the supply and administration of drugs. Additionally, it sets out the procedures for gaining ratification for these documents. The aim of this is to ensure the quality, consistency and currency of such documents.
1.2 This policy covers the development and implementation of evidence based cross specialist clinical guidelines.
1.3 This policy applies to all documents that provide clinical practice guidance regardless of what term is used to describe them (for example, policy, protocol, procedure, standard, guideline, etc). The policy does not apply to non-clinical policies which are covered by the trust’s policy on policies and procedures.
1.4 This policy provides broad guidance. More detailed information about the development, implementation and audit of clinical guidance documents and group protocols for the supply and administration of drugs can be obtained through a variety of publications. Further advice and support is available from the Clinical Effectiveness group or from the Clinical Effectiveness Department.
2. BACKGROUND
2.1 Clinical guidance documents
2.1.1 Documents providing practitioners with guidance relating to clinical practice have, in recent years, become increasingly common place. This trend is likely to be maintained given the importance placed on them in the White Paper, The New NHS, Modern,Dependable1 and subsequent Department of Health direction relating to quality2,3.
2.2.2 The main purpose of clinical guidance documents is to standardise clinical practice to reflect the best available evidence thereby reducing unjustified variations in practice and hence improving quality and equality.
2.2.3 The terms policy, guideline, standard, protocol and others are often used interchangeably. The National Health Service Executive has defined clinical guidelines as “systematically developed statements which assist clinicians and patients making decisions about appropriate treatment for specific conditions4”. However, this definition is reserved for national clinical guidelines which have been developed and implemented in a very specific way4.
2.2.4 In practice, there are many definitions of guidelines. There are also numerous definitions of standards, protocols and other similar documents. Indeed, different professions tend to have different definitions.
2.2.5 In general terms, it is the level of detail contained within these various clinical guidance documents that is their main difference. There are no strict criteria as to whether a clinical guidance document should be called a policy, guideline, standard, protocol etc. However, it has been recommended to use the term protocol only when variation from any guidance is prohibited or strictly controlled4. The term protocol will, therefore, in this policy be used only in relation to group protocols for the supply and administration of drugs. All other documents providing clinical guidance to practitioners will be referred to as clinical guidance documents.
2.2.6 Section 4 of this policy provides a framework for practitioners and managers to work within when developing and implementing clinical guidance documents taking due account of Department of Health guidance4.
2.2 Group protocols for the supply and administration of drugs
2.2.1 The purpose of the group protocol is to cover the role of approved practitioners in supply and administration of medicine, providing standards and ensuring quality of care and patient safety. It outlines the responsibilities of approved practitioners with regard to their roles. It applies to all circumstances where supply and administration of drugs is not in accordance with an individually written prescription by a doctor.
2.2.2 A Group Protocol is a specific written instruction for the supply and administration of named medicines in an identified clinical situation. It is drawn up locally by doctors, pharmacists and other appropriate professionals, and approved by the employer, advised by the relevant professional advisory committees. It applies to groups of patients or other service users who may not be individually identified before presentation or treatment.5
2.2.3 The supply and administration of medicines by group protocols should be reserved for those limited situations where this offers an advantage for patient care, and where it is consistent with appropriate professional relationships and accountability.
2.2.4 While group protocols have been in existence for some time, the legality of the arrangements under which medicines are supplied and administered under group protocols has recently been called into question. A review team, led by Dr June Crown, has produced recommendations for future practice5. Section 5 of this policy, developing and implementing group protocols for the supply and administration of drugs, takes account of these recommendations.
3. GUIDING PRINCIPLES
3.1 Clinical guidance documents provide a framework to guide clinical decision making. They seek to standardise practice by reducing unjustified variations in practice. Valid clinical guidance documents, when appropriately disseminated and implemented can lead to changes in practice and improvements in care6.
3.2 Notwithstanding this, clinical guidance documents of all kinds can only assist practitioners’ decision making. They do not replace clinical judgement nor can they mandate, authorise or outlaw treatment options. Regardless of the strength of evidence, it remains the responsibility of the practitioner to interpret the application of guidance to local circumstances and the needs and wishes of the individual patient.
3.3 Where variations from guidance do occur, it is important to document the variations and the reasons for them.
4. DEVELOPING AND IMPLEMENTING CLINICAL GUIDANCE DOCUMENTS
4.1 While the content and format of clinical guidance documents will vary, a high quality document should include:
· the rationale for development
· the aims/objectives
· details of the process of development (of the document)
· clear, unambiguous, evidence based guidance for practitioners (making explicit the sources of evidence, whether from research, clinical expertise or patients’ views)
· details as to how the clinical guidance document will be implemented (dissemination alone is insufficient)
· implementation and review dates
4.2 A model for clinical guidance documents providing more detail can be found at appendix a. The model has been designed to provide a framework to guide the development and implementation of such documents while at the same time allowing for some flexibility in approach and documentation. This model should be used by anyone developing or reviewing a clinical guidance document.
4.3 All clinical guidance documents should use the front page format as suggested in the model to aid consistency and recognition.
5. DEVELOPING AND IMPLEMENTING GROUP PROTOCOLS FOR THE SUPPLY AND ADMINISTRATION OF DRUGS
5.1 The content and format of group protocols will vary. However, all group protocols must meet minimum criteria as set out in the model for group protocols for the supply and administration of drugs (see appendix b).
5.2 The model for group protocols should be used by anyone developing or reviewing a group protocol supplemented by referring directly to the Crown Report5 for more information if necessary.
5.3 All group protocols should use the front page format as suggested in the model to aid consistency and recognition.
6. PROCEDURE FOR GAINING RATIFICATION FOR CLINICAL GUIDANCE DOCUMENTS AND GROUP PROTOCOLS FOR THE SUPPLY AND ADMINISTRATION OF DRUGS (see flow chart at appendix c)
6.1 Once a practice guidance document has been drafted, gaining ratification includes the following stages:
6.1.1 Obtain local agreement from the Clinical Effectiveness Group
6.1.2 Present draft clinical guidance document to the LAAPs for discussion and comment (as appropriate).
6.1.3 Send amended draft clinical guidance document to the Operations Committee for inclusion on the agenda of the next meeting
6.1.4 Send amended draft clinical guidance document to the Clinical governance and Risk Management Committee for inclusion on the agenda of the next meeting
6.1.5 Finalise clinical guidance document.
6.1.6 Send finalised clinical guidance document (hard copy and an electronic copy in WORD format) to the to the Operations Director who will circulate to the members as necessary before presenting it to the Trust Board for ratification.
6.2 6.1.2, 6.1.3 and 6.1.4 can take place in any order, which best suits the expedition of the guideline
7. AVAILABILITY OF CLINICAL GUIDANCE DOCUMENTS AND GROUP PROTOCOLS FOR THE SUPPLY AND ADMINISTRATION OF DRUGS
7.1 Eventually, all clinical guidance documents and group protocols will be available electronically throughout the Trust via networked computer links.
7.2 In the meantime, after going through the ratification procedures detailed in sections 6 and 7, clinical guidance documents and group protocols will be kept in the Clinical effectiveness department both on hard copy and in WORD format on disc.
8. MEMBERS OF THE CLINICAL EFFECTIVENESS GROUP
Members are as follows:
9. REFERENCES
1. Department of Health (1997). The New NHS: Modern, Dependable. London: Department of Health.
2. Department of Health (1998). A First Class Service: Quality in the NHS. London: Department of Health.
3. National Health Service Executive (1999). Clinical governance: Quality in the new NHS. London: Department of Health.
4. National Health Service Executive (1996). Clinical guidelines: Using clinical guidelines to improve patient care within the NHS. London: Department of Health
5. Crown J (1998). Review of prescribing, supply and administration of medicines. A report on the supply and administration of medicines under Group Protocols. Department of Health.
6. Davis D, Thomson M, Oxman M, Haynes B (1995). Changing physician performance. A systematic review of the effect of continuing medical education strategies. Journal of the American Medical Association, 274(9): 701-705.
APPENDIX A Royal Berkshire Ambulance NHS Trust
Model for clinical guidance documents
Introduction
The terms policy, guideline, standard, protocol, care pathway and others are often used interchangeably.
The National Health Service Executive has defined clinical guidelines as “systematically developed statements which assist clinicians and patients making decisions about appropriate treatment for specific conditions[1]”. However, this definition is reserved for national clinical guidelines which have been developed and implemented in a very specific way1.
In practice, there are many definitions of guidelines. There are also numerous definitions of standards, protocols and other similar documents. Indeed, different professions have different definitions.
In general terms, the level of detail these various practice guidance documents contain is the main difference between them. However, there are no strict criteria as to whether a practice guidance document should be called a policy, guideline, standard, protocol etc.
Given the numerous definitions that exist, the term guidance document will be used here to refer to guidelines, standards, policies and any other document that contains guidance for practice.
Use of this model
This model has been developed using guidance published by the National Health Service Executive1 and is intended for use by anyone developing or reviewing a guidance document for use at Royal Berkshire Ambulance NHS Trust.
While the content of a guidance document will of course vary, a high quality guidance document should include the information detailed in the model overleaf. An example front page is also provided to aid consistency.
Eventually, all clinical guidance documents will be available electronically throughout the Trust via networked computer links thus making them easily accessible.
Procedure for gaining ratification for a clinical guidance document
Once a practice guidance document has been drafted, gaining ratification includes the following stages:
· Obtain local agreement from the Clinical Effectiveness Group
· Present draft guidance document to the LAAPs for discussion and comment (as appropriate).
· Send amended draft guidance document to Operations Committee, for inclusion on the agenda.
· Send amended draft guidance document to the Clinical Governance and Risk Management Committee, for inclusion on the agenda.
· Finalise guidance document.
· Send finalised guidance document (hard copy and an electronic version in WORD format) to the Director of Operations who will circulate to the members as necessary before presenting it to the Trust Board for ratification.
· Ratified guidance document will then be placed on the Intranet to ensure that all such documents are widely available.
1
D:\Temp\RBATG'linesPolicy2002.doc
Developed by the Clinical Effectiveness Group May 2000
Royal Berkshire Ambulance NHS Trust
Model for clinical guidance documents
Rationale for developmentThe reasons why the guidance document was developed should be stated and appropriate.
Consider whether this is an area where new research or other evidence is available or whether it is an area associated with high variations in practice, known or suspected problems, high risk, high volume, or high cost.
Aims/objectives
The aims/objectives of the guidance document should be clearly stated.Consider whether it is clear what the guidance document is attempting to achieve.
The aims/objectives should be appropriate.
Consider whether the aims/objectives are about assuring or improving the quality of care?
Development of the guidance document
It should be clear which people/professional groups have been involved in developing the guidance document.NB All relevant professional groups should be involved/consulted about the development of guidance documents.
It should be clear who is responsible overall for the development of the guidance document and this person(s) must be sufficiently senior.
NB If the practice guidance document involves more than one professional group, it should be clear who is taking overall responsibility within each professional group.
The way in which the guidance document was developed should be described and should be appropriate.
Consider whether it was developed using evidence from the literature, consensus methods etc
Content of guidance document
The guidance contained in the document should be clear, unambiguous and appropriate.
Consider whether people who have not been involved in the development of the guidance document can understand it.
It should be clear to whom the practice guidance is applicable.
NB State what is the target population.
When appropriate, there should be an adequate description of the circumstances when exceptions might be made to using various aspects of the stated guidance.
Evidence base
Is should be clear what the evidence base is for different elements of the guidance document.References should be given.
Where databases are used, it should be clear which ones were searched.
Currency of the guidance document
The guidance document should have a date indicating when it becomes live.The guidance document should include a review date.
Implementation
The guidance document should include details of how it will be implemented.
NB Dissemination alone is unlikely to be successful. Consider training and education, audit and “marketing”.
Royal Berkshire Ambulance NHS Trust