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From the jaws of the Care Quality Commission this month comes the first ever fine issued for breach of the Duty of Candour.[1]  Bradford Teaching Hospitals NHS Foundation Trust have been given a fixed penalty notice for £1,250 for failing to apologise to a bereaved family within a ‘reasonable’ time.

A baby had been admitted to Bradford Royal Infirmary in July 2016. Delays in diagnosis and missed opportunities to admit him had been recorded as a notifiable safety incident, yet the family were not informed of this and did not receive any apology until October (writes the CQC).  

The CQC’s action does not relate to the actual care provided to the child, but rather to the fact that the NHS Trust was slow to inform the family that there had been delays and missed opportunities in his treatment.

Apparently the hospital identified and reported their breach to the CQC themselves, and have implemented an awareness-raising programme across their staff to avoid this happening again. Whilst in theory the CQC have powers of prosecution, in the circumstances, this relatively small fine seems more proportionate. 

The Duty of Candour and Inquests

This case serves as a useful reminder that the Duty of Candour has teeth, and it should be kept in mind when engaged in healthcare inquest cases. When shortcomings have led to a death documents relevant to the duty’s exercise may be informative both during the Coroner's investigation and at the inquest itself. Coroners may want to ask NHS Trusts for disclosure of their Duty of Candour letters as potentially containing relevant information, whilst those representing bereaved families in inquests will no doubt consider carefully what the inquest reveals about the Trust's previous awareness of shortcomings. Families may choose to bring matters to the attention of the CQC where significant failings, known to a Trust in advance of the coroner’s investigation, have not been frankly acknowledged to the family in accordance with the duty from the outset.

The Regulations

As a reminder, Regulation 20 of the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 (SI 2014/2936) provides that:

“(1) Registered persons must act in an open and transparent way with relevant persons in relation to care and treatment provided to service users in carrying on a regulated activity.
 
(2) As soon as reasonably practicable after becoming aware that a notifiable safety incident has occurred a registered person must
(a) notify the relevant person that the incident has occurred in accordance with paragraph (3), and
(b) provide reasonable support to the relevant person in relation to the incident, including when giving such notification.
 
(3) The notification to be given under paragraph (2)(a) must
(a) be given in person by one or more representatives of the registered person,
(b) provide an account, which to the best of the registered person's knowledge is true, of all the facts the registered person knows about the incident as at the date of the notification,
(c) advise the relevant person what further enquiries into the incident the registered person believes are appropriate,
(d) include an apology, and
(e) be recorded in a written record which is kept securely by the [registered person].”
 

The CQC have issued detailed guidance on how to comply with the duty that can be accessed here.

Notifiable Safety Incident 

What counts as a ‘notifiable safety incident’ will depend on whether the body concerned is a health service body (such as an NHS Trust), or whether it is any other registered person/body (such as a care home). Under Regulation 20(8), in relation to health service bodies, a ‘notifiable safety incident’ is any:

“….. unintended or unexpected incident that occurred in respect of a service user during the provision of a regulated activity that, in the reasonable opinion of a health care professional, could result in, or appears to have resulted in

(a) the death of the service user, where the death relates directly to the incident rather than to the natural course of the service user's illness or underlying condition, or

(b) severe harm, moderate harm or prolonged psychological harm to the service user.”

 

Whereas under Regulation 20(9), for any other registered person/body, a ‘notifiable safety incident’ is any:

 
“…. unintended or unexpected incident that occurred in respect of a service user during the provision of a regulated activity that, in the reasonable opinion of a health care professional
   (a) appears to have resulted in
(i) the death of the service user, where the death relates directly to the incident rather than to the natural course of the service user's illness or underlying condition,
(ii) an impairment of the sensory, motor or intellectual functions of the service user which has lasted, or is likely to last, for a continuous period of at least 28 days,
(iii) changes to the structure of the service user's body,
(iv) the service user experiencing prolonged pain or prolonged psychological harm, or
(v) the shortening of the life expectancy of the service user; or
   (b) requires treatment by a health care professional in order to prevent
(i) the death of the service user, or
(ii) any injury to the service user which, if left untreated, would lead to one or more of the outcomes mentioned in sub-paragraph (a).”

 

The duty of candour obligations are separate and additional to those obligations arising under Regulation 18 of the Care Quality Commission (Registration) Regulations 2009. The 2009 Regs set out an obligation on registered persons to notify the CQC of certain (adverse) incidents arising in the provision of care, and is aimed at enabling the CQC to take prompt and effective regulatory action. For more on that, take a look at the CQC’s guidance page, which can be accessed here.

If seeking disclosure of Duty of Candour letters, why not jump in fully, and seek disclosure of notifications to the CQC also? This author recently acted in an inquest where, in breach of the statutory obligations, a care home's management had failed for weeks to notify the CQC of a grade 4 pressure sore which contributed to death. This was indicative of problems in leadership and management of that home, and staff’s basic regulatory knowledge. The home had been shut down by the time of the inquest, but had it still been operating, further exploration of such issues would have been instructive in relation to the Coroner’s PFD duties.

 

[1] The regulations that require providers to be open and honest with patients or their families if there is an incident in which they suffer harm.   See our earlier blog on its application in inquests here.  If the underlying DoC documents are disclosed to coroners,  and the duty has been properly complied with, they are likely to be more candid and more contemporaneous than even SUI / SI / RCA internal investigation reports.