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Doctors have an ethical duty to be open with patients and their families if something goes wrong. Now you also need to be aware of your employer's duty of candour guidance and procedures.
Doctors are expected to play a major role in supporting their organisation's new contractual 'duty of candour' to patients. Under the new NHS standard contract all NHS healthcare providers, and private providers serving NHS patients, must disclose errors in treatment that result in moderate or severe harm, or death.
Any reportable or suspected patient safety incident falling within these categories must be investigated and reported to the patient, and any other 'relevant person', within 10 days. The organisations have a duty to provide patients and their families with information and support when a reportable incident has, or may have occurred.
When services are provided under the new NHS standard contract, if a provider breaches the contractual duty of candour, the commissioning body can recover either the cost of the episode of care, or up to £10,000 if the cost is unknown, from the provider.
Dr Michael Devlin, head of advisory services at the MDU, said: "The duty of candour falls on the organisation, not on individual doctors. But doctors already have an ethical duty to comply with investigations into actual or suspected patient safety events. Doctors must be open and honest and tell patients when something has gone wrong. Their account of the incident will be crucial and they will usually be the ones who tell the patient what happened."
Clause SC35 of the NHS contract specifies how the patient and any other relevant person should be notified of the incident. First, there is a duty to speak with the patient and this should be done by the provider's representative/s and, if possible, the clinician responsible. The explanation must include all the known facts and an appropriate apology. The patient or relevant person should be offered a written account, and the meeting minuted for audit purposes.
The National Patient Safety Authority (NPSA) defines the three levels of harm in Seven Steps to Patient Safety as:
An example of a moderate incident is described as perforation of the bowel during surgery that is not picked up and results in septicaemia and repair surgery. A severe incident would be bowel perforation that results in a temporary colostomy and further major operations.
Service providers are expected to use these definitions to create their own guidance. The MDU advises that if your organisation does not already produce guidance on classification of patient safety incidents and investigating and reporting procedures, it will need to do so to ensure that all staff are aware when the duty of candour applies. It will also need to ensure that the guidance complies with the new duty of candour requirements.
The GMC's Good Medical Practice places an ethical duty on doctors to act to put matters right if a patient they are responsible for suffers harm or distress. This includes giving the patient an apology, and a full and prompt explanation, setting out what has happened and the short- and long-term effects.
"The contractual duty of candour doesn't conflict with or restrict your ethical duty in any way," says Dr Devlin. "The ethical duty is much wider and applies to individual doctors. In practice, this means that you will need to continue to inform patients any time something goes wrong. But you must also bear in mind your organisation's duty of candour guidance and follow their procedures."
A 44-year old woman was admitted to hospital for uterine endometrial ablation. Following the procedure she was transferred back to the ward but deteriorated over the next 12 hours with abdominal pain and sepsis.
Her surgeon suspected a uterine perforation and immediately spoke with the patient. He told her what he thought had happened, apologised that it had occurred, and explained that he hoped to oversew the perforation. However, he warned her that he might need to carry out an emergency hysterectomy and obtained the patient's consent for this. The patient returned to theatre where the doctor's diagnosis was confirmed and a hysterectomy was eventually required.
The surgeon reported the incident through the hospital's risk management reporting procedures for patient safety incidents. As the incident had resulted in moderate harm to the patient, the hospital's clinical governance lead and departmental manager decided that it met the threshold for the contractual duty of candour.
The hospital began a root cause analysis under its clinical governance procedures and now he had the full facts the surgeon spoke to the patient again. He described in more detail what had gone wrong, again expressing his regret at the outcome. He explained that the hospital was formally investigating the incident and would keep her updated.
The investigation found that perforation was a recognised complication of the procedure and that the patient had been informed about this before she consented to the operation. It also concluded that the surgeon had followed accepted technical practice in carrying out the ablation therapy and acted appropriately when the complication came to light. The report recommended changes to post-operative review procedures, to allow for earlier identification of perforations, and these were later put into practice by the trust. A copy of the report was sent to the patient within 10 days and she was invited to a further meeting with the trust to discuss the findings. She eventually told the trust she was happy with the way the incident had been managed and that she had no plans to make a formal complaint.
The incident was also reported to the CQC via the National Reporting and Learning System (NRLS) because it had resulted in injury to the patient.
This is a fictional case compiled from actual cases in the MDU files.
This page was correct at publication on . Any guidance is intended as general guidance for members only. If you are a member and need specific advice relating to your own circumstances, please contact one of our advisers.
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