The Bolam test requires doctors to provide reasonable care, consistent with the practice of a responsible body. The task of experts is often to advise the court as to where the limits of reasonable care lie. In considering that standard, what role do national or local guidelines play? Is care given in line with guidelines necessarily adequate? Is failing to comply necessarily a breach of duty? What happens when different guidelines conflict? In short, how are guidelines and negligence related?
The question arose in O’Brien v Guy’s & St Thomas’ NHS Trust.
Mr Berry had undergone a nephrectomy, was suffering from end-stage renal failure and was on dialysis. In February 2017, he had a heart attack. He was admitted to St Thomas’ Hospital. Mr Berry underwent left coronary artery stenting but deteriorated and was considered to be at risk of sepsis. He was transferred to ICU and prescribed gentamycin. The gentamycin caused ototoxicity and balance problems.
A claim was brought on his behalf alleging that his management with gentamycin was negligent. In fact, by the time it was brought, Mr Berry had died, although not as a result of the alleged negligence. The focus of the claim was on whether he had been managed correctly in the light of applicable guidelines. Causation and damages were agreed, subject to a finding of breach of duty, which was disputed.
The GMC’s 2021 guidance on ‘Keeping up to date and prescribing safely’ requires doctors to ‘follow the advice in the BNF on prescription writing’ and ‘take account of the clinical guidelines published by NICE…’ These were not in force in 2017.
NICE and BNF guidelines set out a daily dose of gentamycin but said that, where there was impairment of renal function, the intervals between doses should be increased and where the renal impairment was severe, the dose itself should be reduced. The Trust had similar guidelines applicable outside of ICU. However, its guidelines for gentamycin use in ICU did not recommend the lower dose in cases of severe renal impairment.
Mr Berry had undergone stenting on the morning of 2 March 2017. By midday on 3 March 2017, he was at high risk of sepsis. He was given 80mg of gentamycin (less than the 422.5 mg to 591.5 mg recommended by NICE and BNF), a ‘surprisingly conservative dose’. Then, 90 minutes later, he was admitted to ICU and put on continuous veno-venous haemodialysis. By the morning of 4 March 2017, it was clear that Mr Berry’s infection was progressing. He was started on fast dialysis and prescribed 400mg of gentamycin. This accorded with the Trust’s own ICU guidelines – although it was higher than its guidelines for gentamycin use in renally impaired patients outside ICU. It was also a much higher dose than recommended by NICE and BNF in cases of renal impairment.
Was the treatment negligent?
The judge was critical of the Trust’s guidelines but found the doctor not negligent for a number of reasons:
He had not blindly followed the guidelines but appropriately balanced managing a potentially life-threatening situation with Mr Berry’s poor renal function.
The local guidelines were insufficiently nuanced but not themselves negligent.
ICU needs one, simple, clear guideline applicable to everyone and not a confusion of guidelines.
The balance of risk in ICU is different from outside ICU and justified a different approach.
The previous low dose of 80mg had failed and the doctor only had only ‘one shot’ to stem the rising infection, justifying a high dose.
The role of local guidelines
The judge made some helpful comments on the status of local guidelines. Under the Bolam test, an action is only negligent if there is no responsible body who would have done the same. In other words, the presence of a responsible body is normally a defence. One would normally expect the presence of guidelines supporting that approach to represent, at the very least, a reasonable body.
The judge held that, while relying on having followed national guidelines may well be a defence to allegations of negligence, local guidelines had a different status. Relying on local guidelines was not necessarily a defence. He gave three reasons:
If an in-house guideline could in effect create a ‘responsible body of clinical opinion’, a Trust would in effect be able to determine its own standard of care.
The resources available to a Trust are different from those available to NICE or the BNF authors.
In-house guidelines would not necessarily generate regulatory obligations under GMC guidance in the same way as NICE and other national guidelines.
The judge reviewed the authorities on the relationship between national guidelines and negligence and summarised the following principles:
Even national guidelines are not a substitute for clinical judgement.
Where a court is considering breach of duty, reference to guidelines is not a substitute for expert evidence. However, guidelines may inform expert evidence. The content of guidelines may be evidence that a particular practice complies with that of a responsible body. This may be the case even where guidelines post-date an action.
Departure from a national guideline does not necessarily indicate negligence but it is likely to call for explanation. In other words, it may be appropriate to depart from a guideline, but there needs to be a reason for doing so.
Compliance with a national guideline may be inconsistent with negligence if it constitutes a Bolam-compliant body of opinion or practice. The same does not apply to in-house guidelines, which have a different status.
The question for the court is ultimately whether conduct was Bolam compliant (and capable of logical analysis). Guidelines may be relevant to that issue.
Experts giving evidence on what amounts to reasonable care will often need to consider any relevant guidelines and cite them in support of their views. However, there is often a need for nuance. It is not necessarily the case that complying with guidelines amounts to reasonable care, although it often will be. Similarly, it is not necessarily the case that failing to comply with guidelines is a breach of duty, although it may be. O’Brien v Guys and St Thomas’ NHS Trust provides some helpful analysis of the role of guidelines in assessing the standard of care.