Duty of candour and the definition of moderate harm for radiation overexposure and exposures much greater than intended in diagnostic radiology.

Abstract

On 1 April 2013, a new standard National Health Service (NHS) contract came into use for all organizations commissioning NHS healthcare services, with the exception of services commissioned under primary care contracts. The contract requires all NHS and non-NHS providers of services to NHS patients to comply with a duty of candour. This requirement arose from a recommendation of the Francis Report into the failings at Mid-Staffordshire NHS Foundation Trust.1 Under this duty of candour, if a reportable patient safety incident occurs or is suspected to have occurred, the healthcare provider must give information on the affected patient(s) about the incident and conduct an investigation within 10 days. Only incidents resulting in moderate or severe harm or death are covered by this contractual duty. Harm is defined using the definitions provided in the National Patient Safety Agency (NPSA) document “Seven steps to patient safety”.2 The question arises as to how exposures much greater than intended reported to the Care Quality Commission under the Ionising Radiation (Medical Exposure) Regulations 2000 (IRMER)3 or patient overexposures reported to the Health and Safety Executive under the Ionising Radiations Regulations 1999 (IRR)4 should be interpreted within this definition of harm, so that the duty of candour can be complied with appropriately. This article makes some pragmatic proposals for numerical patient dose thresholds that could be taken as broadly corresponding to the definition of moderate harm required to trigger the duty of candour. It is accepted that the concept of a firm link between the numerical values of radiation exposure and the actual harm is questionable, as explored by the International Commission on Radiological Protection (ICRP) when originally developing the concept of an index of harm.5 The broader question regarding the range of possibilities for causing harm by radiological misdiagnosis is not covered in this discussion, and it should be emphasized that justified high patient doses are by definition not incidents and would, therefore, never trigger the duty of candour as defined above.