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Ten steps to the perfect protocol

Helen Caulfield
LLB (Law) MA (Medical Ethics and Law) MSc (Health Economics)
RCN Solicitor and Policy Advisor
T:020 7409 3333

It is useful to set out what a protocol is in the context of other types of rules, standards, guidance and guidelines that exist in nursing practice today.

What is a rule?
In health law, a rule is made by Parliament and is a form of legislation. Statutory instruments are also known as rules and can set out in more detail the requirements that are contained in Acts of Parliament. The Medicines Act (1968) sets out who can prescribe medicines, but the detail of what is a prescription-only medicine is contained in a statutory instrument that can be amended and updated as decisions are made about which medicines can be obtained over the counter. There may be criminal penalties for individuals who do not follow these rules.
What is a standard?
The Healthcare Commission (the new Commission for Health Improvement) will be setting "core" and "developmental" standards for the NHS in England. The "developmental" standards represent aspirations for the future. The "core" standards set out the quality of care that patients can expect from all NHS settings under seven domains: safety, clinical and cost- effectiveness, governance, patient focus, accessible and responsible care, care environment and amenities, and public health. In the independent sector in England and Wales, standards for care are supported by national minimum standards that are now being taken forward by the newly created Commission for Social Care Inspection, which took over from the National Care Standards Commission. Where these standards are not followed, there may be financial penalties for the organisation that falls below them. 
The Nursing and Midwifery Council (NMC) has a responsibility to set standards for nursing in relation to conduct, practice and education. The Code of Professional Conduct is a set of standards that has to be followed by all registrants.(1) The NMC also sets standards for midwives that apply to local supervising authorities. A nurse who falls below the standards in the Code may be investigated as an individual by the NMC, and, in serious cases, they may be removed from the register.

What is a guideline?
The National Institute for Clinical Excellence (NICE) is the organisation responsible for producing clinical guidelines for the NHS in England and Wales. These clinical guidelines recommend treatment and care in a range of diseases and conditions. NICE expects that all health professionals will follow their guidelines, but these do not override the individual responsibility of health professionals to exercise their judgement in relation to the individual patient. In the context of risk management, it would mean that clinicians have a duty to keep up-to-date with the developments from NICE, but if they do not feel that these should apply to their patients, they will not be penalised for this.
The NMC has produced guidelines for the administration of medicine that set out an explanation in some detail of what is expected of registrants.(2) This also gives details of how the NMC would regard errors made in relation to administration.
What is guidance?
Guidance can be issued by government departments, such as the Department of Health (DH), to set out their interpretation of what is meant by legislation or by court decisions. This is intended to show how the DH interprets this law and what standards of procedure it expects from NHS bodies.

Why protocols are important
Two key purposes are achieved with protocols. They can ensure clear lines of accountability, and they can create active risk management in practice. Where practice nurses are working in autonomous settings, running their own clinics and taking on a wider range of sophisticated activity, it is important that there are clear routes for all those in the practice to know who is taking on what responsibilities in what particular tasks. It is a tool of clinical governance to ensure that staff are clear about the limits placed on their practice.   
Once the protocol is up and running in your practice, it will become an implicit part of your job description. The advantage of this is that, in any situation you are asked to do something that goes outside your competence or the limits of the protocol, you will be able to rely on both your professional code of conduct and your job description to justify your actions.   

Ten pointers for protocols

1. What's the point?
Why do you want a protocol? Make sure that the reason for investing time in creating a protocol is clear before you get involved. Is it because the insurance company has asked for this as part of risk management? Is it because you are extending your practice and want security about the limits on your competence? Once you are clear about the purpose of the protocol, you reduce the chance that different members of the team will have conflicting agendas. Make sure that this purpose is written into the protocol as a reminder to everyone what it is about.

2. Don't reinvent the wheel
Do not waste your precious time and energy trying to reinvent the wheel. Does a protocol already exist?  Check national websites to see whether work has been done in the area you are considering, whether the PCT has any standards that are being used, and what your professional organisation has done in the area. Where practice nurses in a local area or through a national body are able to create templates for protocols, this will cut down on duplication of effort. 

3. Have you got the time? 
Beware of agreeing to take on too much. While you may be the expert on the procedure to be used, make sure that you build in time and other resources that you will need to take time out to work on the protocol. Remember that when you say "yes" in committing your time, you will be saying "no" to some other activity. Be honest with yourself about what you will give up in order to spend time on this. If you are going to be involved in the implementation, staff training and review of the protocol, build in this time from the start. 

4. What style are you going to use?  
There may be different protocols that vary in quality, depending on the extent to which they have been formed based on a review of scientific literature, opinion, anecdote or a mixture of any of these factors. What are you going to use in your protocol? Be clear about the style, and set this out in the protocol so that anyone reading it will understand which style you are using and the reasons for this.   

5. Who is on your team?    
Identify the clinicians and administrative staff who will be affected by the protocol. Do you need the cooperation of the pharmacist, social services, the outpatient department or local walk-in centre? Make sure you involve every member from the outset; otherwise, you may find that you spend time developing a protocol that is ignored by a key individual. This can create a lack of motivation for those involved in the development of further protocols. Create an environment that encourages support from the team as soon as possible. 

6. Keep it simple
Do not make the protocol complicated. This is not an essay; it is essentially a process tool. If you want to refer to literature, make sure you give a summary of what the literature says and your reasons for including it in the protocol. This will make the literature more appropriate to the protocol. At your review date, decide whether that literature is still relevant or needs to be updated with further research. 

7. Must is not may
Decide what parts of the process must be carried out in every case. Decide what may be carried out, and make sure you separate the two. If you say the process must be followed in every case, then patients (and their lawyers) will argue that you have failed them if you miss out even one step of the protocol. Make sure your protocol has different statements that distinguish "you must" statements from "you may" statements. Insurance companies have a tendency to favour protocols that have fewer steps because this reduces the chances of staff forgetting to carry out a particular part of the protocol.   

8. Phone a friend
When you have a finished draft of the protocol, show it to a colleague. Do they understand it? Do they think any parts are ambiguous or contradictory? Does it make sense? Have you missed out anything obvious? This will give you an unbiased and friendly critique of the draft. This will reduce the chance that when the protocol is active you will find you have missed some important aspect.   

9. When is your review date?
All protocols must have a start date and a review date, to guarantee that there is less chance that the protocol will be left on a shelf to gather dust. Make sure the review date does not fall on a Sunday or Bank Holiday.  Give yourself time and space to carry out a review, and put that on the agenda at staff meetings.
Think about making space at the end of the protocol for staff to write comments about how easy or difficult they found the protocol to use, as this will make the review process much easier. For a first protocol, plan a first review within three months so you can iron out any issues arising very quickly and demonstrate your commitment to the protocol. This is also more likely to reinforce its importance to other staff.  

10. Don't suffer in silence
If you have complicated working relationships that are affecting the way protocols are being used, talk to someone about it. A problem shared is very often a problem solved. You are too precious as a nurse to spend time being distressed about promoting good practice that improves patient care. Use your professional organisation and other support networks. If you get really stuck, and have no one to turn to, ring me.  We'll get it sorted together.  

The future for protocols in nursing practice
The increase in responsibility for practice nurses will mean that there is greater pressure to take on more technically demanding tasks. It is likely that more sophisticated templates for protocols will be developed as part of clinical governance in the future. Until that time arrives, however, the steps set out in this article will guide you in the areas of accountability and risk management.


  1. Nursing and Midwifery Council. Code of professional conduct. London: NMC; 2002.    
  2. Nursing and Midwifery Council. Guidelines for the administration of medicine. London: NMC; 2002.

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