This question comes from a fellow academic (but from a paramedic, rather than a law school). The question relates to paramedic ‘Clinical Practice Guidelines’ or CPGs. My correspondent says:
I’m reading an article about developing CPGs for paramedics and the (UK) author states:
Presently, however, it is unclear whether adherence to guidelines confers immunity from liability or if non-adherence increases the likelihood of being found negligent if a patient suffers harm as a result because, in English law, guidelines carry little weight. They are considered ‘hearsay’ evidence because, unlike an expert witness, they cannot be examined and cross examined. However, it is worth noting that in the United States, legally validated guidelines have been used as a complete defence in a malpractice claim”.
From: Brown, G. (2000). Developing effective clinical practice guidelines for ambulance services. Pre-Hospital Immediate Care, 4, 136–140.
I’m not sure exactly what it entailed in ‘legally’ validating a guideline, but my primary question centres on the legal protection that is conferred on paramedics in Australia by the Clinical Practice Guidelines they work under. In relation to the quote above, would the Australian context be more similar to the English or American one, or would it be quite different in some way?
This quote misuses the term ‘hearsay’ but I shall not go into that, other than to say a CPG is not ‘hearsay evidence’.
Adherence to guidelines will not ‘confer immunity from liability’. To put it in that way suggests that if you can point to compliance that is a defence and that is all there is to it.
In Australia the relevant law will be the law of negligence and the issue there is always what was the defendant’s duty and did they act reasonably in the circumstances. We can say with confidence that a paramedic owes a duty of care to their patient. How does the ‘reasonable paramedic’ act to ensure that they provide reasonable care? They can and must comply with their training and the directions from their employer, that is they adhere to the CPGs.
So compliance with the CPGs will be evidence and almost overwhelming evidence that the care provided was reasonable in the circumstances but it’s not guaranteed. For a start there may be a case where departure from the CPG is warranted, and this is where professional judgment comes in. An example could be situations where a decision is made to ‘load and go’ rather than stabilise at the scene because of danger, some conflicting priority, the hospital is across the road etc. Mere departure will not necessarily prove negligence. Equally rigidly adhering to the protocol will not disprove negligence if it was clear that the treatment was making the situation worse (as opposed to merely not making it better).
I disagree that guidelines carry little weight particularly in this context. Paramedics gain their authority to practice from their employer (see ‘What is a paramedic’s ‘authority to practice?’ (August 19, 2014)). They have to comply with their employer’s directions so the guidelines define what it is they are to do in their practice. Guidelines can be more or less flexible. One might say ‘you should consider do x, y or z’ and all you need to do to comply is in fact ‘consider’ those things and chose to do them, or not do them, on good clinical reasons. Others are less a guideline and more a rule that say ‘you must do …’ and that leaves no room to move. In any event they define what a reasonable paramedic in the defendant’s position would have done.
One of the few cases alleging negligence by an Australian paramedic turned on the issue of the service’s protocols. In Ambulance Service of NSW v Worley [2006] NSWCA 102 the patient was given adrenaline as required by the treatment protocol but suffered a known, but rare adverse reaction). At trial the plaintiff alleged that the paramedic had been negligent as the protocol called for IV adrenaline if the patient was ‘in extremis’. It was alleged that this meant at the point of death and the paramedic did not consider whether the patient was at that stage, rather he relied on various observable symptoms related to BP, pulse and respiration rate; ‘it was accepted that the indications for administration of adrenaline were satisfied’ ([59]). At [64]-[65] Basten JA (with whom Tobias and McColl JJA agreed) said:
The trial judge found that Mr Page was negligent… The reasoning to this conclusion involved two stages. The first asked whether, properly understood, the protocol applied to Mr Worley and held that it did not. The second step asked whether the mode of administration of adrenaline “chosen” by Mr Page was reasonable and answered that it was not.
With respect, this reasoning is flawed. Mr Page did not “chose” the mode of administration, or the rate of administration. What he did was to apply Protocols 8 and 201, according to their terms. That course was in accordance with his training and the directions given by the Ambulance Service …
And, as a result, he could not be negligent unless he applied the wrong protocol or applied it in circumstances where it did not apply. It should be noted that the trial judge had said:
… recruits to the Ambulance Service obtained seven weeks training where they learn the elements of anatomy, physiology, pathophysiology and pharmacology. There follows a nine-month period of training on probation on the job. His Honour continued at [147]:
“Each officer has a set of protocols. Each set is kept up to date. Each officer is required to follow the requirements of the protocols. There is no discretion to do otherwise. Each officer who attends a patient is required to sign a completed Patient Report Form. The form must list by number the protocols that apply.”
That may be different today with university qualified paramedics and the use of CPGs rather than protocols. As noted a ‘guideline’ may allow much more room for professional judgement and discretion than would be expected from a protocol, but I suspect nothing turns on that. Just as the paramedic in this case was not negligent for applying the protocol, a paramedic will be able to rely on a CPG as evidence of reasonable care.
All of that assumes two things. First that the diagnosis is correct, that is that the paramedic not only followed a CPG but that he or she followed the right one. Rigid and complete adherence to the CPG for the treatment for asthma will be no defence if the person was suffering from anaphylactic shock unless it can be shown that the mistake was ‘reasonable’.
Equally it is assumed that the treatment is done reasonably. Administering a drug IV because that is what is called for is fine, but its no defence if the needle is punched through the vein and the drug is administered into the tissue instead.
Finally it is assumed that the CPG is itself reasonable and based on good science. In Worley’s case it was alleged that the ambulance service was negligent for maintaining a protocol that called for IV rather than IM adrenaline. The service was able to point to an ongoing scientific debate about the best route of administration, that they were aware of, following and contributing to the debate. The science had not come down definitively one way or the other so they were not negligent for adhering to IV administration. If the science had been concluded, maintaining an out of date protocol would have seen the service, but not the paramedic, liable for negligence.
Conclusion
Compliance with a CPG does not confer immunity and, whilst ‘non-adherence increases the likelihood of being found negligent if a patient suffers harm as a result’ it is also not definitive. The question is always ‘what was the reasonable response’. A paramedic trained in accordance with a CPG and where the CPG represents best clinical practice would be expected to adhere to that and it would be evidence of reasonable practice.
CPGs do not have a standing as law, rather they are evidence, compelling evidence but only evidence, of what can be expected in the circumstances.
See also: Treatment outside the protocol (April 2, 2012)
Hi Michael,
I teach in an undergraduate program so spend a lot of time reviewing guidelines across the different Australian states, NZ and the UK National guidelines to prepare students for employment as a paramedic, not as a paramedic for a specific service. I note quite a lot of variation in recommendations of management for specific cases and some that are no longer evidence based. I have found that some services have a comprehensive and publicly available set of guidelines that are updated regularly (every 6 months), others publish their guidelines but are certainly not comprehensive or evidence based in some areas, some just do not make their guidelines publicly available, I personally question this lack of public transparency. If no guideline is available to guide the management of a case in a particular state, one that is common in other states, and the paramedic injures the patient as a result of their actions or inaction, who is to blame?
The simple principle is that any liability for injury caused to a patient by the negligence of an employed paramedic, or the negligence of the ambulance service that employs the paramedic, belongs to the employer.
It can’t be that every situation is covered by an explicit set of directions, that is why people like paramedics are trained and employed to exercise judgement and to make decisions. Equally there must be some conduct or practices that are so axiomatic that there is no room for judgement but equally one might assume that anyone with a paramedic degree, or one day a registered paramedic, would do ‘x’ in situation ‘y’ without an express guideline. It reminds me of the evidence of Dr Lowns in Woods v Lowws when he was asked what would he have done had he attended a fitting patient when asked to do so. His evidence was to the effect that he would have administered valium and then directed the paramedics to take him to the nearest hospital – as if paramedics need to be told that. So one probably doesn’t need a specific guideline to end with ‘and then take the person to hospital’ on the basis that if you didn’t say that the paramedics wouldn’t know what to do. The point of that discussion is that the presence or absence of the guidelines will not be the definitive point. The question is always ‘what would the reasonable paramedic have done in the circumstances’.
CPG and in particular evidence based ones go a long way to answering that question and they certainly go a long way to answering ‘what would a reasonable paramedic employed by this service do in the circumstances’. If the directions to the employee require the employee to practice in a way that other services or the profession think is substandard that will be evidence that it is the employer service that is negligent. With paramedic registration, paramedics will be better equipped to tell their employer if the employer’s guidelines or practices are such that paramedics should not follow them as it would risk a finding of unsatisfactory professional conduct by that paramedic, one would hope however such situations do not arise.
It can also be noted that in Worley v Ambulance Service of NSW there was disagreement as to whether the relevant drug for the treatment of anaphylaxis should be given IV or IM. The Ambulance Service of NSW won that case because they could show that their protocol calling for IV drugs was ‘evidence based’ even though the evidence was contested.
That’s a long answer dealing with a number of issues. To return to the question – If no guideline is available to guide the management of a case in a particular state, one that is common in other states, and the paramedic injures the patient as a result of their actions or inaction, who is to blame? Answer – the ambulance service that employs the paramedic.