Medico-legal: The legal status of clinical guidelines

Dr Sally Old discusses the legal status of guidance from national and local organisations, and how to apply it in clinical practice.

There is a large - and growing - amount of guidance for GPs covering clinical decision making, legal and ethical practice and local policies and procedures. However, there may be circumstances where guidance conflicts with your own clinical judgement. In these circumstances, it pays to know the legal status of guidance and how to apply it to your situation.

Ignorance is no defence. The starting point is to be aware of the relevant guidance. For GPs this includes:

  • national organisations such as the RCGP, NICE and the Scottish Intercollegiate Guidelines Network (SIGN)
  • regulators such as the GMC and CQC
  • local organisations such as your local clinical commissioning group or health board

The GMC expects you to be 'familiar with guidelines and developments that affect your work'; 'to keep up to date with, and follow, the law, our guidance and other regulations relevant to your work’ and to 'provide effective treatments, based on the best available evidence’.1

Departing from guidelines

Guidelines are intended to inform clinical practice and uphold consistent standards, rather than replace the knowledge and skills of clinicians or the wishes of patients.

You can make a conscious and justifiable decision to depart from guidelines in specific situations when you consider it is in the patient’s interests, and after discussion with your patient. NICE says that while 'health and social care professionals are actively encouraged to follow our recommendations to help them deliver the highest quality care… our recommendations are not intended to replace the professional expertise and clinical judgement of health professionals, as they discuss treatment options with their patients'.2

In seeking consent from the patient (or their legal representative), explain why you believe it is in their best interests to depart from the relevant guidance, outlining the alternatives and possible outcomes.

You should record the discussion, your reasons for departing from guidance and their consent in their clinical records. You must be prepared to explain and justify your decisions and actions.

Degrees of certainty

In some cases, it will be more difficult to depart from established guidance, particularly when it has been produced by a nationally recognised body or regulator, or reinforces legislation. For example, the CQC has produced extensive guidance for providers on how they can meet their legal obligations under the Health and Social Care Act 2008. Failure to adhere to its guidance could lead to enforcement action.

Some organisations acknowledge that not all guidance will be appropriate in a given situation and you will need to use your clinical judgement to determine the best way forward. Both the GMC and NICE have developed their own terminology to reflect this.

GMC guidance uses the following terms:

  • 'you should’, to cover a duty or principle that 'will not apply in all situations or where there are factors outside your control that affect whether or how you can follow the guidance’
  • 'you must’, to reflect `an overriding duty or principle’.

NICE says 'some recommendations can be made with more certainty than others’ and uses the following terms:3

  • 'consider', to reflect an intervention where there is less certainty about benefit
  • 'offer’, 'advise’, 'ask about’ or similar directive terms, where an intervention should (or should not) be used
  • 'must’ and 'must not’, where there is a legal duty to follow a recommendation, or the consequences of not doing so are extremely serious.

Medico-legal consequences

If you depart from guidance, be prepared to justify your actions as there may be medico-legal consequences. The GMC warns that 'serious or persistent failure to follow [its] guidance will put your registration at risk.’

Doctors are also right to be concerned about what might happen if there is a clinical negligence claim following treatment where it was necessary to depart from guidelines.

It can help towards the successful defence of a claim if you can demonstrate you followed widely accepted guidance, supported by expert opinion. However, it is equally possible to mount a successful defence of a GP who has not followed guidelines because it is not in their patient’s interest, especially if this involves the patient’s informed consent and there is a clear and contemporaneous record of what happened.

It is advisable to talk to your medical defence organisation or a senior colleague if you are considering departing from current guidance. Discussing the specific situation should help you clarify the issues and ensure your decision is justifiable.

Learning points
  • Guidance is intended to inform your clinical practice and decision-making
  • You need to be aware of current guidance relevant to your clinical practice, especially guidance from national bodies and regulators
  • Recognise when you ‘must follow’ guidance and where it reinforces an existing legal obligation
  • You can depart from guidelines when you consider it is in the patient’s interests and after discussion with your patient
  • Explain to the patient why you believe it is in their best interests to depart from the relevant guidance, explaining the alternatives and possible outcomes
  • If you depart from guidance, make a record of your reasons and of the patient’s consent
  • Talk to your medical defence organisation or a senior colleague if you are considering departing from current guidance
  • Dr Sally Old is a medico-legal adviser at the MDU

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References

  1. General Medical Council Good Medical Practice, paragraphs 11, 12 and 16b. GMC, 2013
  2. NICE NICE Charter. [accessed 27 April 2017] https://www.nice.org.uk/Media/Default/About/Who-we-are/NICE_Charter.pdf
  3. Chapter 9, Developing NICE guidelines: the manual, NICE, October 2014 https://www.nice.org.uk/media/default/about/what-we-do/our-programmes/developing-nice-guidelines-the-manual.pdf

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