Adequacy of patient consent for interventional radiological procedures [QSI Refs: XR-502, IR-801]
Descriptor
Suboptimal or deficient processes for obtaining consent prior to a procedure have been identified as a major factor leading to litigation.
Background
Competent adult patients have a fundamental right to give or to withhold their consent to an examination, an investigation or a treatment. Successful relationships between patients and doctors depend on trust. Patients are becoming increasingly well informed and are rightly engaging in decisions relating to their medical care [1].
The Cycle
The standard:
All patients undergoing interventional or invasive radiological procedures for diagnostic or therapeutic purposes should give express consent. ‘In a planned procedure the patient should receive information verbally or in writing in sufficient time before the procedure to consider it, and to consult others if they so wish. The patient should have their informed consent confirmed at a separate discussion with the radiologist performing the procedure' [1]. The “prudent doctor, prudent patient” principle should apply.
Target:
95%
Assess local practice
Indicators:
The percentage of patients who have undergone an interventional procedure who are able to answer ‘yes’ to every question on the audit questionnaire (see Questionnaire in Resources).
Data items to be collected:
Patients will be asked to complete the questionnaire (see Questionnaire in Resources) within 48 hours of having the procedure. If the patient has had sedation, then the questionnaire should not be given until 24 hours after the procedure.
Suggested number:
30 patients randomly chosen by the departmental nursing staff from the interventional case lists occurring over a period of four consecutive weeks.
Suggestions for change if target not met
• Construct a departmental check-sheet relating to consent that has to be completed and signed by the doctor at the end of each ‘consenting episode’
• Arrange for the requirements for adequate consent to be printed on a laminated sheet in the consent pack for use at the time of discussion with the patient
• Arrange for training in the medico-legal aspects of consent, consenting technique and the possible consequences resulting from inadequate arrangements
• Repeat date for commencing the next audit (following change): three months and/or six months
• Identify staff member responsible for introducing change
• Indicate date for reporting on the repeat audit
Resources
• Departmental nurse to distribute and collect the questionnaires
• Audit assistant to collate the results
• Nurse: five minutes per patient (total should be less than three hours)
References
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Standards for patient consent particular to Radiology, Second Edition. London the Royal College of Radiologists 2012.
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General Medical Council. Consent: patients and doctors making decisions together. London: GMC, 2008 http://www.gmc-uk.org/guidance/ethical_guidance/consent_guidance_index.asp
Editor’s comments
The format of this audit is illustrative and is not intended to suggest that these are the only areas in which consent needs to be obtained. For example, consent to a plain radiographic examination is required but is usually accepted as implicit when the patient arrives for the study. It is reasonable to assume that (competent) adults understand what a plain radiographic examination entails.
• There are many misconceptions regarding consent. This occurs particularly in relation to children, parental and partner rights, and in respect of patients with a limited ability to give consent.
• This audit could be carried out across the whole department and cover the work of all the radiologists. The results could contribute to the contents of an individual’s revalidation folder as a personal audit.
Submitted by
Adapted from Clinical Governance and Revalidation 2000 RCR, updated by Dr D Remedios 2012, updated by Dr A L Chang 2017