Failure to be aware of and to follow clinical guidelines and protocols could constitute clinical negligence, but not in all cases, and much will depend on the facts of each case. The recent case of four-year-old Charlotte who lost all four limbs because hospital staff failed to recognise and treat her properly for meningitis and sepsis forcibly brings this point home. The solicitor helping her and her family stated:
‘All these symptoms, according to NICE guidelines, should have immediately raised a red flag for sepsis (blood poisoning) in children under five. 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.’
Guidance and direction
All professions have guidelines, protocols, standards and so on – nursing and medicine are replete with these, and many healthcare staff feel overwhelmed with the amount of material and publications produced. A Care Quality Commission (CQC) report 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.’
It is clear from past judicial precedents and case law that nurses and doctors are under both a professional and a legal duty to keep up to date:
‘The reasonably skilful doctor has a duty to keep himself informed of major developments in practice, but this duty obviously cannot extend to the requirement that he should know all there is to be known in a particular area of medicine.’
The importance of professional updating
Busy nurses and doctors cannot switch off from professional updating and information on clinical negligence. Cases have gone to court on the use of guidelines. The judge would decide, after listening to all the evidence, witnesses, claimant, defendant and so on, whether the practitioner in the case was negligent in failing to keep up to date. Negligence is a legal concept. The judge would look at what would be expected of the reasonable nurse or doctor in that specialty in the circumstances of the case.
This would also apply in terms of clinical guidelines. The court would look to see whether there was negligence due to a failure to follow a protocol or guideline without good reason. If the patient's condition contraindicates the application of a clinical guideline or protocol, then it should not be applied. Much will depend on the exact circumstances of the case, but there is no substitute for the exercise of professional judgement. There is an apt saying about clinical guidelines – they are not tramlines, and your professional judgement is not suspended by them.
A recent case
A recent case looking at guidelines is that of the estate of John Berry (deceased) v Guy's and St Thomas' NHS Trust. This is case is an excellent example: it goes into a lot of detail about guideline use and the link to clinical negligence. It well worth reading in full and will provide very useful material for study days. On the difference between local, in-house and national guidelines, Judge Tindal stated:
‘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.’
Marion O'Brien (Administratrix of the Estate of Mr John Berry (Deceased)) and Guy's & St Thomas' NHS Trust, 2022: 78
Guidelines and the courts
The courts consider, among several other matters, the status, development process and application of clinical guidelines and there have been several cases over the years looking at the issues. The point is that creating guidelines and protocols has important legal implications because they could well be tested in court. They must be properly drafted, evidence based and there must be an audit trail of their creation. They must have a built-in review date for reflection. There is a need to demonstrate that guidelines are up to date, evidence based and have been regularly reviewed because how else would we know that they still reflect best clinical practice?
There is no shortage of research papers and publications on good practice in developing guidelines. Still highly relevant today are reports from Australia's National Health and Medical Research Council (1998) and University of Leeds et al (1994).
Patient safety in surgery
The frequency of certain Never Events calls into question how well clinical guidelines, protocols and standards in surgery are observed in practice (NHS England, 2023). The NHS England report states that 295 Serious Incidents appeared to meet the definition of a Never Event in the official list and had an incident date between 1 April and 31 December 2022. There were 134 wrong site surgery Never Events recorded, 71 retained foreign objects post-procedure Never Events and 30 wrong implant/prosthesis Never Events.
The Proximie report
To compound the problem of guidance and protocols not being observed, a report has been recently published by Proximie (2023) highlighting patient safety issues in surgery. The report states that patient safety standards in NHS operating rooms have been getting worse for many years and that we have now reached a critical moment in time:
‘While most NHS services experienced some detrimental impact caused by COVID-19, the pandemic is largely over, and standards should now be improving.’
The report discusses the declining situation, the percentage of surgeries with a Never Event, the experience of patients, the drivers of decline and barriers to reform. The report provides an important overview of patient safety in surgery and raises some good points for further discussion.
National Safety Standards for Invasive Procedures 2 (NatSSIPs)
The Centre for Perioperative Care (CPOC) (2023) provides important national standards to avoid confusion, misunderstandings and errors in surgery and to help staff work together properly to deliver safer care. They also apply in relation to invasive procedures carried out outside the operating department. Clearly, if these standards were followed more closely, we would see fewer Never Events and other adverse healthcare incidents. History, however, has not served NHS patient safety well. Never Event occurrence over the years has been stubbornly persistent despite excellent national standards and guidance.
To an extent, error is inevitable, we are all fallible and make mistakes. The best that we can do is to try to manage risk effectively. The CPOC (2023) National Safety Standards are detailed and work to provide a safe care environment and include the eight NatSSIPs sequential step standards:
- Consent, procedural verification, and site marking
- Team brief
- Sign in
- Time out
- Safe and efficient use of implants (where relevant)
- Reconciliation of items in the prevention of retained foreign objects
- Sign out
- Handover/debrief.
Confusing use of terminology
The use of terminology is key. There are many different titles and definitions given to quality management tools such as clinical guidelines, care pathways and so on. People use the terms interchangeably. Labels may be confusing or applied inconsistently. Renard (2022) provides a helpful focus on these care management tools and terminology:
‘Care pathways also allow the translation of clinical guidelines or evidence in other forms into local protocols. While clinical guidelines offer generic recommendations, care pathways offer one or more specific treatment recommendations based on a hierarchy of selection criteria.’
It is the idea behind the label that matters. Protocols generally are viewed as being more directive than guidelines, although applying a protocol does not suspend clinical judgement if the patient's condition contraindicates its application. National standards would appear to be in the same directive mould and then we have clinical guidelines.
A court would consider all these issues and the case of the estate of John Berry (deceased) v Guy's and St Thomas' NHS Trust (2022) is instructive on this. The exercise of a nurse or doctor's own clinical judgement is paramount. The judge stated in paragraph 80:
‘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.’
Conclusion
Nurses, doctors and other health carers have both a professional and a legal duty to keep informed about developments in their professional practice area and cannot say they were too busy to do this. This will include personal updating on clinical guidelines, protocols, standards and other care management tools in their area of practice. There are problems of terminology but the important thing to remember is that it is not the label that necessarily matters, it is the ideas behind it.