A high court case considering the principles of the Bolam test, where negligence was claimed regarding the treatment and antibiotic administration to the now deceased Mr Berry. 

The claimant, an executor for Mr Berry’s estate, claimed non-compliance with clinical guidelines amounts to negligence. The trust Doctors’ defence was his compliance with in-house clinical policies. The High Court judge presiding examined whether such use of in-house clinical guidelines is a shield and protection to not following the NICE/BNF and nationally accepted guidelines.

The NICE/BNF procedure for Gentamicin administration gave specific guidance for IV Gentamicin administration to adults with significant infection, particularly those with renal impairment. The rate of creatinine clearance should determine gentamicin dosage. Specifically, a patient’s impaired renal function would require a reduced dose of Gentamicin with greater intervals between.

The trust worked to a similar policy to NICE/BNF for non-ICU patients differentiating the dosage of Gentamicin for those with renal impairment. However, the judge noted an odd difference in the trusts guideline for patients within ICU, such that there was no practical difference in the recommended dosage between patients with or without renal impairment.

Background to Mr Berry’s Case

Mr Berry, whilst a patient at the hospital, was initially placed using the NEWS score at medium risk of infection and sepsis, but this increased to high risk by the following day. Both parties agreed that Mr Berry was a sepsis risk. 80mg of Gentamicin was administered to Mr Berry in the hospital ward. The judge noted that this dose, whilst not negligent, was significantly lower than the in-house and international dosage rates. The patient was later transferred to ICU due to his risk of increased sepsis risk and general clinical presentation, at which point he was treated with a further 400mg dose of Gentamicin. This led to ototoxicity and balance problems. Both parties accepted Gentamicin as the cause. However, it was in dispute as to whether the dose subsequently caused Mr Berry to lose hearing.

The defence

The trust stated that using its in-house guidelines was the ‘shield’ that protected them. However, the claimant relied on the trust’s other protocols, and national policies were the sword that should break down the defence of reliance on following in-house protocol.

Such that the rate of administration should be directly related to the rate at which the body’s kidneys can clear creatinine. When renal function is impaired, the dose should be lowered and administration intervals extended. NICE/BNF guides practitioners in using Gentamicin when hospitalising patients with severe infections such as septicaemia.

Whilst the trust held similar guidelines for non-ICU patients, the judge noted the trust’s policy for ICU patients was the odd one out, in that there was no practical difference in the dose recommended for patients with or without renal impairment.

The fundamental flaws in the trust’s policy and their differentiation from the NICE guidelines, and the trust policy not meeting the primary goal of antibiotic administration within their Renal Impairment guidelines were given as an argument for negligence.

Conclusion

The judge ruled that the doctor was not negligent in following the trust’s in-house guidelines. Stating that the doctor had noted Mr Berry’s intolerances and had felt that pursuing a mixed clinical approach would balance the potentially life-threatening infection with the patient’s impaired renal function. Also, under cross-examination, the claimant’s expert agreed the trust ICU guidelines were not themselves negligent, simply nuanced insufficiently. The trust’s expert emphasised the need for a similar approach to patients in ICU, as the ICU is a hectic environment that needs simple, clear guidelines applicable to all patients to protect patient welfare.

Dr Meyer had just one chance to stem the rising infection. Such infection presented a far greater risk than the risk of ototoxicity; as such, the level of Gentamicin was necessary to reduce infection risk.

The Bolam test as a shield using NICE/BNF guidelines can be relied upon. However, using in-house policies as a shield could enable trusts to determine their own level of care, which is principally wrong. 

Whilst a divergence from national guidelines is not necessarily negligent, a full explanation of why divergence was necessary must be satisfactory to prevent a claimant from using non-compliance as a sword.