What is the existing NHS contractual duty of candour?
Robert Francis QC made a series of recommendations concerning openness, transparency and candour.
In response, the Government has, to date, introduced the NHS Commissioning Board and Clinical Commissioning Groups (Responsibilities and Standing Rules) Regulations 2012 (SI 2012/2996). Regulations 16 to 18 required the duty of candour to take effect in contractual form from 1 April 2013 by way of being included in the NHS Standard Contract 2013/14, and is mirrored in the subsequent 2014/15 contract.
The NHS Standard Contract is used by all organisations commissioning NHS healthcare services, although this is subject to various exceptions. Where used, the contract requires all NHS and non NHS Providers of services to patients to comply with the duty of candour. The contractual duty of candour appears in Specific Condition 35 and operates on the following basis:
- It will apply to individual patient safety incidents that result in moderate harm (a patient safety incident that resulted in a moderate increase in treatment and which caused significant but not permanent harm), severe harm (a patient safety incident that appears to have resulted in permanent harm), or death.
- Immediately on becoming aware of the occurrence or suspected occurrence, the incident should be appropriately reported.
- As soon as practical, a full investigation should be implemented.
- Within 10 days, Relevant Persons (i.e. the Service User, family or carer for example) should be informed that the incident has occurred or is suspected to have occurred. That notification must where possible:
- Be verbal, and conducted in person by one or more representatives of the Provider, including where possible the clinician responsible for the episode of care.
- Provide all facts known about the incident.
- Include an appropriate apology.
- Be accompanied by the offer of a written notification.
- Be recorded in writing for audit purposes.
- The Service User and any other Relevant Person must be given all necessary support.
- As soon as practical the Relevant Person should be offered a step by step explanation of the events and circumstances, which should be updated regularly as the investigation proceeds. Regard should also be given to equity of access, equality and non-discrimination in this process.
- Within 10 days following the investigation being signed off as being complete, provide the Relevant Person with a copy of the investigation report.
- Record for audit purposes any refusal by the Relevant Person of a meeting, other contact or the provision of information.
- Maintain full written records of any meeting or contact.
If a complaint is received from (a) a Relevant Person, (b) a commissioner, (c) Local Healthwatch or (d) any healthcare professional involved in the care of the Service User, and makes reference to a failure to disclose a reportable patient safety incident, the P
provider must notify the commissioner in writing providing full details of the complaint.
Failure to comply with Specific Condition 35
In these circumstances the commissioner may:
- Notify the Care Quality Commission of that failure.
- Require the Provider to provide any Relevant Person with a written apology and explanation for that failure signed by the Provider's CEO, and copied to the commissioner.
- Require the provider to publish details of that failure prominently on its website.
- Where a provider is found not to have been open, the commissioner can implement the consequences set out in the contract, namely recovery of the cost of the episode of care or £10,000 if the cost is unknown.
As the NHS "Being Open" guidance also continues to apply to the communication of patient safety incidents, a lot of issues are open to interpretation.
The Health Act 2009 requires all NHS organisations to have regard to the NHS Constitution which already provides that: "The NHS also commits … when mistakes happen … to acknowledge them, apologise … and put things right quickly and effectively". From this perspective it would appear that the impact of the contractual duty of candour should be minimal. However the 2009 Health Act only requires NHS organisations to have regard to the NHS Constitution, not to mandatorily follow it. In contrast, the above duty of candour is contractual, and creates a contractual obligation.
It is anticipated that costs related to increased clinical negligence claims generated by increased awareness of patient safety incidents may be inevitable. Certainly if an organisation governed by the NHS Standard Contract in its service provision feels that the incident is such that it triggers the contractual duty of candour, then the above steps should be taken. Beyond this, there is yet no additional statutory duty or obligation.
However, there is a difficult balance to be struck between saying sorry and providing an offer of an explanation, for example by way of a meeting to discuss investigation findings; and potentially going beyond factual issues as to what happened by subsequently admitting liability without good reason. That difficult balance remains, and will be explored further in an article in our Summer edition.