Following newly-published analysis from the Department of Health, this briefing examines the practicalities and implications of a contractual “duty of candour” for commissioners and providers.

Consultation outcome

On 30 November 2012 the DH published the analysis of the consultation responses on a new contractual duty on providers. This relates to the consultation that took place between October 2011 and January 2012.

Readers will recall that the proposal was for a contractual requirement, implemented through the NHS standard contract, covering NHS Acute, ambulance, community and mental health care providers. (There is no reference to it covering primary care providers).

The contract would require secondary care providers to be open with patients when things go wrong with their healthcare, and give them information about any investigations that have taken place or any lessons learned.

The DH explain how the Government’s proposal to use the standard contract sought to place the power to hold providers to account with the people who are most likely to learn of a failure to be open – the clinicians who treat people and the CCGs they belong to and who commission care. Enforcing the proposed duty would be the responsibility of commissioners.

Interesting points to note are as follows:

  • 122 responses were received to the consultation which seems low given the importance of the topic
  • The consultation did not explicitly seek views on a statutory (rather than a contractual) requirement but comments were received on that too
  • The NHSLA commented that the practice outlined is already required by virtue of professional duties and published guidance, such as their circular on Apologies and Explanations and their Risk Management Standards
  • The NHSLA also commented that there is a danger that failure to adhere to the proposed duty might open up a fresh avenue for claims/litigation
  • The MDU did not think that the duty should be extended to GPs
  • An NHS employee felt that most poor practice happens in primary care and that reporting to a CCG might not be the most appropriate way of getting concerns in primary care addressed by an independent body, as the majority there will be partners of the GP involved
  • Equalities issues were highlighted for those for whom English is not a first language or for those with reduced literacy or learning disabilities. It was suggested that this would be another duty for CCGs to mitigate this effect
  • The Royal College of GPs expressed concern that if CCGs in particular do not have sufficient resources to fulfil these functions they may be placed under intolerable strain which will not be beneficial for patient care
  • A local authority asked how this will affect social care commissioners. They were concerned to ensure there was not a two-tier system where users of social care get less protection than healthcare users  

The Government have analysed the results and remain of the opinion that a contractual duty appears to have the greatest chance of being enforceable and therefore effective. They are planning to push ahead with the implementation of a contractual duty of candour in the NHS Standard Contract in 2013/14. They have now issued the National Health Service and Clinical Commissioning Groups (Responsibilities and Standing Rules) Regulations 2012. Regulations 16-18 require the NHS Commissioning Board to include the duty in the contract.

They have also explained that they are committed to giving full consideration to the findings of the Mid Staffordshire Inquiry so that if it finds that a statutory duty is preferable to a contractual one (and the Government are convinced by the arguments made), then they will respond accordingly.  

Watch this space …  

Impact assessment

This is contained in the link provided above. We set out below the key points made in it which we think will make interesting reading/a helpful aide memoire:  

  • The policy will be public sector specific and will have no impact on the private sector unless a private sector provider chooses to enter into a contractual agreement with an NHS body using the NHS Standard Contract
  • Currently 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, explain what went wrong and put things right quickly and effectively.”
  • It highlights the professional codes for doctors, nurses and NHS managers. It refers to NPSA policy guidance, CQC registration requirements and the NHSLA’s letter on apologies and openness
  • There may be costs related to increased clinical negligence claims generated by increased awareness of patient safety incidents. The evidence on this is conflicting and any potential costs are difficult to quantify. There may be decreased clinical negligence claims due to patients not needing to pursue claims simply to receive an apology and explanation. Research from various states in the USA in connection with this are set out at paragraphs 2.13 – 2.26
  • In terms of a statutory provision there is a current lack of a suitable enforcement body. The CQC have made it clear that they are unable to enforce this duty and no other national body seems to be better placed to enforce this requirement. On a practical basis, the Government are of the view that instead of a single national body potentially having to examine hundreds or thousands of cases to determine if openness has occurred, individual CCGs will have the much more manageable task of examining only their own local providers and taking action where they find openness does not occur.

How will it work?

This is contained within the above document. We are told that the final details of the contractual duty of candour will be for the NHS Commissioning Board to determine. The Government, however, assume that:  

  • It will apply to individual patient safety incidents which result in moderate harm, severe harm or death (using NSPA definitions)
  • The patient, family or carer would be informed that the incident had occurred within ten working days of it being reported to local systems. This should be face to face where possible
  • An apology should be provided where harm was caused
  • A step-by-step explanation of what happened should be provided. This may be an initial view pending findings of an investigation
  • Full written documentation of meetings must be maintained separately from medical records and be shared
  • Appropriate investigations, as set out in the current schedules of the NHS Standard Contract should be undertaken
  • Any investigation reports should be shared within ten days of being signed off as complete
  • Where a provider is found to have failed to be open the commissioner shall implement the consequences set out in the contract. Those are likely to be:
    • Direct written apology and explanation for the breach to the individual affected from the provider’s Chief Executive and copied to the commissioner
    • Publication of the fact of a breach prominently on the provider’s website
    • Notification by the commissioner to CQC
  • Discretionary powers are also likely such as:
    • Recovery of the cost of the episode of care or £10,000
    • Agreement and implementation of a Remedial Action Plan
    • Full independent investigation of provider’s policy and practices in relation to openness paid for by the provider and reporting to the commissioner
    • Implementation of actions set out in the NHS Standard Contract
  • As “Being Open” leaves a number of issues open to local interpretation, separate guidance on expectations will be issued to support this
  • GPs and clinicians can take up issues with CCGs. CCGs should advertise a single point of contact for concerns relating to possible breaches of the contractual requirement. Providers should notify commissioners when a complaint they receive includes reference to a failure to disclose a patient safety incident. Notifications should prompt the commissioner to investigate to determine if the circumstances do represent a breach. This will involve determining if there is in an incident recorded on the provider’s risk management system and whether there are records of communications with the patient
  • The document accepts that where an incident is alleged to have taken place but has not been reported it will be difficult to confirm whether or not it has occurred. Commissioners are told that if they believe that an incident has not been reported they should undertake an independent review of case notes and further investigations. They are told that they will need to balance the importance of enforcing the contractual duty with other burdens placed on them when deciding how vigorously to investigate an allegation. It is suggested that repeated allegations from different sources should prompt greater scrutiny
  • Any dispute about a commissioner’s decision as to whether there has been a breach would be dealt with through the normal complaints procedure and could go to the Parliamentary and Health Service Ombudsman
  • Leading up to 1 April 2013, information for commissioners and providers will be developed to assist them in preparing for and implementing the policy. In addition, information for patients, the public, clinicians and relevant advocacy groups will be developed and made available. Robust communication of the policy to those with reduced capacity to receive or utilise this information will be developed in advance of and during implementation  

Yet more for both commissioners and providers to get to grips with before 1 April 2013.