Patient safety, clinical guidelines, and the law

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John Tingle explores the interface between patient safety, clinical guidelines, and the law

John Tingle

There is guidance, statements of expectation on the proper, professional, safe way of doing things in all professions. This emanates from regulatory authorities, education, training organisations, and from many other sources.

Myriad sources of information

In the NHS there are a myriad source of statements, guidance on best, safe professional practice. This can take the form of clinical guidelines, care pathways, protocols, standards, procedures and so on. The use of terminology can be confusing. The terms used to describe these care management tools can be seen to be used interchangeably, inconsistently by health care staff and others.

The label is not determinative

I would argue that in terms of the focus and effect it is not necessarily the label, term that matters but the ideas behind it. Protocols for example are generally regarded as being more directive than guidelines. These all do not suspend the clinical judgment of the doctor or nurse should the patient’s condition contra-indicates their application. His Honour Judge Tindal stated in O’Brien (administratrix of the estate of John Berry (deceased) ) v Guy’s and St Thomas ‘NHS Trust [2022] EWHC  2735 (KB):

“However, none of this is to say that even a national guideline relieves any clinician of their responsibility to exercise their own clinical judgement. No guideline, however comprehensive, can ever be a substitute for clinical judgement in the particular circumstances of the particular patient at the particular time.” (Para 80)

So much information

There is now so much information on patient safety, regulation, quality, clinical guidelines out in the health care environment that many health carers feel swamped by it all. This information can be contradictory and emanating from various national and international stake holders with varying agendas. It can be difficult for health care staff and others to work out which guidelines, other care tools to follow and which to disregard. The independent regulator of health and social care in England, the CQC , (Care Quality Commission) stated:

“Staff are struggling to cope with large volumes of safety guidance, they have little time and space to implement guidance effectively, and the systems and processes around them are not always supportive. (p43)”

Clinical Negligence

Ignorance of, not applying a clinical guideline properly could constitute negligence in appropriate circumstances. The recent case involving, Charlotte, the four-year-old girl who suffered catastrophic injuries including losing four limbs emphasises the importance of health carers keeping up to date with clinical guidelines and applying them properly. Charlotte’s symptoms should have been recognised, there are NICE   ( National Institute for Health and Care Excellence) guidelines covering her symptoms, condition. Nadel states:

“In the hospital’s own Serious Incident Report, a treating doctor said he was not aware that limb pain was associated with meningococcal sepsis and had therefore not reported it to a senior doctor.”

The report states that the case was settled with an admission of liability for around £39 Million.

Cases have gone to court

Several cases have gone to court on the issue of clinical guidelines and health care staff professional updating. A recent case  mentioned above on the use and status of clinical guidelines in negligence actions is O’Brien (administratrix of the estate of John Berry (deceased) ) v Guy’s and St Thomas ‘NHS Trust [2022] EWHC  2735 (KB).

There is a detailed discussion of clinical guidelines, Bolam-negligence in the case. His Honour Judge Tindal makes an important distinction between local, national guidelines and their status.

“Nevertheless, in my judgement, an ‘in-house guideline’ – even spanning several hospitals and tens, if not hundreds, of clinicians – is not of the same status as a national guideline. Of course, it may (indeed, quite often will) reflect a wider reasonable ‘Bolam-compliant’ body of clinical opinion, but it is unlikely by itself to constitute one.” (Para 78).

This is an interesting judgment for health lawyers and clinicians as it is an in-depth analysis of key issues:

“If an in-house guideline could itself amount to a ‘responsible body of clinical opinion’ without more, a defendant trust could effectively determine their own standard of care, which would seem wrong in principle.” (Para 78).


Clinical guideline use is often a central issue in clinical negligence maternity cases where babies have been born brain damaged or otherwise harmed. Cases concerning clinical guidelines also appear in other clinical areas. It is good to see judges addressing issues here. Clinical guidelines are essential to the delivery of safe care. They are also not without controversy and are so pervasively used in health care.

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