Following the scandal at Mid Staffordshire NHS Foundation Trust, where there was a gross failure to review and take action on patient safety incidents and listen to concerns raised by the public, a public inquiry (Francis, 2013) recommended that all health care providers have a statutory duty of candour (DOC) with their service users when a reportable patient safety incident has occurred that has resulted in death, severe harm, moderate harm or prolonged psychological harm. The DOC is essentially a process of talking openly and honestly with a service user and their family when harm has occurred owing to an act or omission by a health care provider. The DOC process should occur regardless of whether the service user has complained or is unaware that a patient safety incident involving them has occurred. The DOC process includes being open and honest with colleagues and employers, taking part in reviews and investigations and raising concerns where appropriate. This supports our professional responsibility as midwives under The Code (Nursing and Midwifery Council, 2015) to cooperate with all investigations and audits.
The Care Quality Commission (2015) has produced a regulation 20 document that gives guidance on the DOC for all health care providers. The DOC has three important steps:
The DOC should be documented in the service user's notes, clearly stating who had the DOC discussion and what was discussed.
It is not always clear whether a DOC discussion needs to be held. The National Patient Safety Agency (NPSA, 2009) has defined the levels of harm as follows:
For example, if a recently delivered woman returned to hospital with offensive lochia and was found to have a retained swab in her vagina that was then uneventfully removed without lasting complications, but this resulted in a readmission for intravenous antibiotics, this would be classified as a moderate harm event and would require a DOC discussion and investigation.
The NPSA clarifies the meaning of a moderate increase in treatment as a return to surgery, an unplanned readmission, a prolonged episode of care, extra time in hospital or as an outpatient, cancelling of treatment, or transfer to another area such as intensive care as a result of the incident.
Feeding back full investigations to service users may overwhelm them with the minutiae of the report, distracting from the actual incident. However, the benefits of being open and honest with service users far outweigh the risks.
Unfortunately, patient safety incidents resulting in harm to service users will happen. It is essential to be transparent and willing to learn. Lord Donaldson emphasised this point in R v Lancashire County Council Ex p. Huddleston [1986]:
‘It is not discreditable to get it wrong. What is discreditable is a reluctance to explain fully what has occurred and why… it is a process which falls to be conducted with all the cards face upwards on the table and the vast majority of the cards will start in the authority's hands.’