PI Brief Update

How to Assess Medical Records for Validity of Consent - Dr Mark Burgin

21/09/16. Dr. Mark Burgin BM BCh (oxon) MRCGP explains how generalist experts can find evidence of the consent process in medical records.

The law on consent is moving faster than clinical practice with the result that many practitioners are inadvertently failing to document valid consent.

There are three processes that can be recognised when reviewing medical records; management plan, explanation given and patient responses.

Where there is evidence of all three processes in the records it is relatively straight forward to confirm that consent was valid.

The less that is written in the GP records the more important it is to determine usual practice by a duty of candour request before litigation.

The medical records should include 5 elements; what the doctor thinks might be wrong with patient, what the patient thinks, the steps that need to be taken, what to expect and what follow up is required.

For example – URTI, ‘is it an infection?’ fluids, if not better 1 week see as required.

Management Plan

The management plan and especially the diagnosis and the steps that need to be taken may be formally documented or implied from the records.

The GMC (GMP) states that clinical records should include the decisions made and actions agreed, the information given to patients and any drugs prescribed or other investigation or treatment.

Where the doctor has not followed GMP the expert may imply what the diagnosis was and what steps the doctor thought was necessary from other evidence such as the medication prescribed.

At present no clinical reasoning or diagnosis is required when prescribing a medication and there are times when the treatment is equivocal for instance antibiotics where there is more than one possible source of infection.

The more confused, vague and illogical the management plan appears the more likely an expert would determine the doctor did not explain the plan properly and any consent was not valid.

Explanation Given

The explanation can be formalised in a patient information leaflet or on a consent form or be informal and either not recorded or briefly noted.

Where the consent was written on a consent form it is evidence of what the explanation was intended to cover.

There is a significant difference in the type of explanation given under good medical practice and discussing all options in consent.

The challenge for the doctor is to ensure that the explanation is both sufficient and at the same time proportionate so that the patient has the capacity to understand the explanation.

The reading age can be measured for written materials and any lengthy complex document is likely to be challenged unless the doctor records patient responses to show that understanding has occurred.

Patient Responses

There is often a discrepancy between the patient and the doctor in what the patient said at the time of the consultation.

Absence of a record does not confirm the patient did not mention an issue as most doctors continue to inconsistently document patient responses.

The previous consultations are evidence as to whether patient responses are routinely recorded in the practice.

Even a single quote as above confirms that there was a meeting of minds at the time of this consultation.

Considering the example above, the question ‘is it an infection?’ confirms that the doctor listened to the patient, was aware of the issue of infection.

Further in the example the doctor is likely to be of the habit of recording the patient’s ideas, concerns and expectations.

The example can support evidence that the doctor had assessed the patient’s capacity during a discussion of the nature of viral infections.

Conclusions

Bolam has been overruled in two important consent cases Bolitho and Montgomery confirming that a doctor will be criticised for not following the law on consent.

Failure to follow the law could potentially be used more widely to overturn the presumption that a doctor’s word will be preferred over the patient’s.

At worst a doctor could refuse a duty of candour request, made inadequate records, not discuss options, not consider capacity and not record patient responses.

A judge faced with a doctor who has broken several laws may find it difficult to find as fact that the consent was valid.

Doctor Mark Burgin, BM BCh (oxon) MRCGP is on the General Practitioner Specialist Register.
Dr. Burgin can be contacted This email address is being protected from spambots. You need JavaScript enabled to view it. and 0845 331 3304 website drmarkburgin.co.uk

1. Bolam v Friern Hospital Management Committee [1957] 1 WLR 582

2. Bolitho v. City and Hackney Health Authority [1996] 4 All ER 771

3. Duty of Candour. The Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 No. 2936

4. GMC (GMP) Good medical practice (2013) gmc-uk.org

5. Montgomery v Lanarkshire Health Board (Scotland) [2015] UKSC 11

Image ©iStockphoto.com/dra_schwartz