A short briefing on the Government’s proposals

1.     What is the Duty of Candour?

A statutory duty of candour will be introduced in October 2014. It will place a formal requirement on providers of health or social care to be open with their patients when they suffer harm related to care or treatment. It’s aim is to ensure that openness, transparency and candour are the norm.

While there is already a contractual duty of candour contained in NHS Standard Contracts, this new statutory duty will apply to a wider range of providers.

There is now a real commitment to greater openness and candour, to developing a culture dedicated to learning and improvement that continually strives to reduce avoidable harm.”

Norman Lamb, Minister for Care and Support

2.     Who does it apply to?

Initially the duty will only apply to NHS bodies but will be extended to cover all service providers registered with the Care Quality Commission from April 2015. Slightly different definitions will apply to NHS bodies than to other providers.

3.     When will the duty apply?

There is a general duty on all health service bodies to act in an open and transparent way in relation to care and treatment provided to service users. This will apply at all times.

In addition “…as soon as reasonably practicable after becoming aware that a notifiable safety incident has occurred” a health service body must notify the “relevant person” that that the incident has occurred.

In respect of NHS bodies, a “notifiable safety incident” means any unintended or unexpected incident that occurred in respect of a service user during the provision of regulated activity that, in the reasonable opinion of a healthcare professional, could result in, or appears to have resulted in:

  • Death
  • Severe harm
  • Moderate harm
  • Prolonged psychological harm”

Severe harm is defined as “a permanent lessening of bodily, sensory, motor, physiologic or intellectual functions, including removal of the wrong limb, or organ or brain damage.”

The definitions for both death and severe harm are qualified in that they only apply to the extent that the death or severe harm is “related directly to the incident rather than the natural course of the service user’s illness or underlying condition.

Moderate harm means:

  • “harm that requires a moderate increase in treatment; and
  • significant, but not permanent, harm.”

A moderate increase in treatment includes:

  • An unplanned return to surgery
  • An unplanned re-admission
  • A prolonged episode of care
  • Extra time in hospital or as an outpatient
  • Cancelling of treatment
  • Transfer to another area such as intensive care

It is not qualified in the same way as severe harm in terms of having to be “related directly to the incident” and could cover recognised complications if they are “unintended or unexpected”.

The definition of prolonged psychological harm is also limited, being taken from the Care Quality Commission (Registration) Regulations 2009:

“psychological harm which a service user has experienced, or is likely to experience, for a continuous period of at least 28 days.’’

4.     What is an “incident”?

The draft regulations originally defined the term “safety incident”. The final regulations have done away with that and given the term ‘notifiable safety incident’ a slightly longer definition instead. There is still no definition of “incident” and, as a result, some doubt over when the duty is actually triggered.

If we use the ordinary meaning, “an event or occurrence” we are left with the potential for all unintended or unexpected occurrences of qualifying harm to be caught by the duty, even where there has been nothing untoward in the delivery of care.

In practical terms, even if the term “incident” was defined, it is still likely to catch many instances where harm has occurred even though there was no “error” or “mistake’ in the care provided. For example, a patient may fall on the ward despite all reasonable prevention steps being taken. The fall itself would almost certainly be an “incident” on any definition and a “notifiable safety incident” if relevant harm has occurred. Only later, once enquiries are made, will it be evident that there was no failure in care.

A challenge for NHS bodies will be where to draw the line. Do you investigate every report of a recognised complication or every adverse drug reaction? Can you ignore harm where there is no obvious “incident”? CQC guidance will hopefully tackle this issue.

5.     What are the reporting requirements?

If a notifiable incident occurs, the provider must:

  • Notify the patient (in person) of the incident
  • Provide all information directly relevant to the incident
  • Provide reasonable support

The notification must:

  • Provide an account that the service provider believes to be true
  • Advise of any further enquiries
  • Include an apology
  • Be recorded in a written record
  • Be followed by written notification giving specific information

6.     What are the consequences of breach?

It is a criminal offence not to notify a service user of a notifiable safety incident or to fail to meet the requirements for such a notification. If the organisation is found guilty of the offence, they will  be liable, on conviction, to a fine not exceeding £2,500 (although that may increase to £10,000 in line with proposals to increase the sentencing powers of magistrates generally).

However, if the registered person can prove that they took all appropriate steps and exercised all due diligence to ensure that they complied with the duty, this will be a defence. A fixed penalty notice of £1,250 may be offered by the CQC as an alternative to prosecution.

7.     How should providers be prepare?

Training should be offered to staff on:

  • The types of harm that need to be reported and how to report them
  • When to report
  • What they should tell patients and relatives

Providers should also ensure that their system for reporting incidents enables them to identify all incidents to which the duty applies, including those that only become notifiable when harm is presented or after a period of time has elapsed.

Policy guidance should be issued to staff to ensure that they have a clear understanding of the reporting process; especially when they are presented with evidence of harm at a later date.

8.     What are the potential drawbacks?

There are concerns that the administrative burden will deter clinicians from reporting incidents. Equally, if clinicians feel they must report every error or “near miss” this could lead to significant administrative overheads, taking the focus away from patient care.