Duty of Candour Policy

1.0 Introduction

1.1 The introduction of Regulation 20 of the Health and Social Care Act (Regulated Activity) Regulations 2014 is a direct response to recommendation 181 of the Francis Inquiry report into Mid Staffordshire NHS Foundation Trust, which recommended that a statutory duty of candour be introduced for health and care providers.

1.2 Regulation 20 applies to providers when they are providing care and treatment to people where the service is carrying on a regulated activity. In the case of Clinical Partners, the Regulated Activity is treatment of disease disorder or injury. To meet the requirements of Regulation 20, a registered provider must make sure it acts in an open and transparent way with relevant persons in relation to care and treatment provided to people who use its services.

1.3 Regulation 20 applies to organisations as opposed to individual members of staff. Clinical Partners is required to ensure that all their staff, regardless of seniority or permanency, understand the organisation’s responsibility to be open and transparent in their communication with relevant persons in relation to a notifiable safety incident.

1.4 Individual members of staff who are professionally registered, are separately subject to the professional duty of candour, which is overseen by their professional regulatory bodies such as the General Medical Council (GMC).

Read alongside (Clinical Partners Internal Policies)

Complaints Management Policy and Procedure

Incident Reporting and Investigation Policy

Policy & Procedure for Management of Patient Caller Emergency - Risk to Life

Whistleblowing Policy

2.0 Purpose 

2.1 To ensure that Clinical Partners and its staff support the implementation of a ‘Being Open’ policy.

2.2 That patients and others accessing the service will receive open and transparent communication following a patient safety incident or complaint, including the provision of accurate information.

2.3 This policy will ensure an open and honest culture is extended to communication with all health care professionals, managers and organisations Clinical Partners works or contracts with.

3.0 Scope

3.1 All staff directly employed by or working on behalf of Clinical Partners.

4.0 Definitions

 4.1 The definitions set out below that are not defined within the regulation. In interpreting the regulation on the duty of candour Clinical Partners will use CQC’s interpretation and the definitions of openness, transparency and candour used by Robert Francis in his report. 

4.2 Openness

Enabling concerns and complaints to be raised freely without fear and questions asked to be answered.

4.3 Transparency

Allowing information about the truth about performance and outcomes to be shared with staff, people who use the service, the public and regulators.

4.4 Candour

Any person who uses the service harmed by the provision of a service provider is informed of the fact and an appropriate remedy offered, regardless of whether a complaint has been made or a question asked about it.

4.5 Apology

An ‘apology’ is an expression of sorrow or regret in respect of a notifiable safety incident; It is not an admission of guilt.

4.6 Appropriate written records

Records are complete, legible, accurate and up to date. Every effort must be made to ensure records are updated without any delays.

4.7 Cancelling treatment

Where planned treatment is not carried out as a direct result of the notifiable safety incident.

4.8 Moderate harm

‘Moderate harm’ means harm that requires a moderate increase in treatment, and significant, but not permanent, harm, for example a “moderate increase in treatment” means 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, or transfer to another treatment area (such as intensive care).

4.9 Prolonged pain

‘Prolonged pain’ means pain which a service user has experienced, or is likely to experience, for a continuous period of at least 28 days.

4.10 Prolonged psychological harm

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

4.11 Relevant person

This is the person who is receiving services or someone acting lawfully on their behalf in the following circumstances: on their death, or where they are under 16 and not competent to make a decision in relation to their care or treatment, or are 16 or over and lack the mental capacity in relation to the matter in accordance with the Mental Capacity Act 2005.

4.12 Severe harm

‘Severe harm’ means a permanent lessening of bodily, sensory, motor, physiologic or intellectual functions, including removal of the wrong limb or organ or brain damage, which is related directly to the incident and not related to the natural course of the service user’s illness or underlying condition.

4.13 Notification

A written notification is one given or sent to the relevant person in written form containing the information provided in any initial notification made in person, details of any enquiries to be undertaken by the registered person, the results of any further enquiries into the incident, and an apology (as defined above).

5.0 Process

5.1 Clinical Partners will ensure that all staff have the skills to identify a notifiable incident. That is an incident that has resulted in moderate or severe harm or death or prolonged psychological harm or pain (See Appendix A) this should be acknowledged to the person affected as soon possible. In cases where the patient or their carer identifies and informs health care staff when something untoward has happened it is essential that they are taken seriously from the outset. Their concerns should be treated with compassion and understanding by all staff.

5.2 Likewise staff raising concerns and reporting incidents are to be treated without prejudice and supported appropriately during the investigation process. This may require reference to the Whistleblowing policy. 

5.3 The staff involved in communicating with individuals and families will have the necessary skills and knowledge to be able to compassionately provide a full explanation of what went wrong and support the potentially distressed and bereaved through the investigation process. The most appropriate person will be decided on a case-by-case basis by the CEO.

5.4 In the case of a Serious Incident investigation, Clinical Partners' CEO or Chief Medical Officer will appoint a lead investigator to communicate with the person/s involved to arrange a meeting and agree the terms of reference of the investigation and how the report and findings will be shared at its conclusion. Root Cause Analysis will be used to uncover the underlying causes of a serious incident.

5.5 The Board of Clinical Partners has a duty to encourage an open culture between organisations, healthcare teams, staff, patients and /or carers. When things go wrong Clinical Partners will:

• Tell the relevant person, in person, as soon as reasonably practicable after becoming aware that a notifiable safety incident has occurred and provide support to them in relation to the incident, including when giving the notification.

• Provide an account of the incident which, to the best of the provider’s knowledge, is true of all the facts the body knows about the incident as at the date of the notification.

• Advise the relevant person what further enquiries the provider believes are appropriate.

• Offer an apology.

• Follow up the apology by giving the same information in writing and providing an update on the enquiries.

• Keep a written record of all communication with the relevant person.

5.6 Those affected by the incident should be signposted to independent advocacy services when required and be given a single point of contact for any further questions or requests and to keep them updated with the progress of the investigation.

6.0 Completing the process

6.1 Following the completion of the investigation, feedback to those involved should take the form most acceptable to them. Whatever method used the communication will include:

• Reference to the chronology of clinical and other relevant facts.

• Reference to details of any concerns and complaints raised.

• An apology for the harm suffered and any shortcomings in the delivery of services.

• A summary of the factors that contributed to the incident.

• Information on what has been and will be done to avoid repetition.

• How these improvements will be monitored.

6.2 It is expected that in most cases there will be complete disclosure of the findings of the investigation and analysis. In some cases, information may be withheld or restricted e.g. where disclosure of information will adversely affect the health of the person; where investigations are pending coroner processes or where specific legal requirements preclude disclosure for specific purposes. In these cases, the person will be informed of the reasons for the restrictions.

7.0 Documentation

7.1 The open disclosure of incidents must be properly recorded. Documentation should include:

• a copy of all correspondence

• incident reports

• records of the investigation including the names of people involved

• records of meetings and notes

• the analysis process

• recommendations for improvement

• how staff have been informed of any changes to practice, policy or operational procedure

• a copy or record of any notifications made.

7.2 Records will be kept online in the Company file.

8.0 Notifications

8.1 Regulations 16, 17 and 18 of the Care Quality Commission (Registration) Regulations 2009 require all providers to have systems in place to handle notifiable safety incidents in accordance with Regulation 20 and the other regulatory requirements in relation to such incidents. Clinical Partners will fulfil its obligation to notify CQC about certain incidents.

8.2 Where an incident has occurred that is reportable under RIDDOR Clinical Partners will inform the Health and Safety Executive.

8.3 When working under NHS contract arrangements Clinical Partners will ensure that they inform the Commissioning Body in accordance with the Serious Incident Framework 2015.

8.4 Individual members of staff who are professionally registered, are separately subject to the professional duty of candour, which is overseen by the professional regulatory bodies such as the General Medical Council (GMC). If any breaches of the professional duty of candour by staff who are professionally registered are identified this is likely to include an investigation and escalation process, which may lead to referral to their professional regulator or other relevant body.

9.0 References

Report of the Mid Staffordshire NHS Foundation Trust Public Inquiry

https://www.cqc.org.uk/guidance-providers/regulations-enforcement/regulation-20-duty-candour

NHS England » Serious Incident framework

The Health and Social Care Act 2008 (Regulated Activities) Regulations 2014

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Appendix: Illustrative examples of incidents that trigger the thresholds for duty of candour

These examples have been developed with stakeholders to illustrate examples of notifiable safety incidents that trigger the threshold for the duty of candour regulation. Some examples, particularly those relating to mental health and prolonged psychological harm have been developed de novo by CQC through a process of engagement with external stakeholders and professional colleagues.

Example 1

A 9 year old boy was prescribed methylphenidate for the treatment of ADHD. At no point was an assessment made of his cardiac status nor enquiry into a family history of cardiac problems. He suffered several episodes of syncope thought to be due to extreme anxiety before collapsing with an arrhythmia, resulting in cardiac arrest and resultant permanent cognitive impairment.

This would be an example where an incident appeared to have resulted in severe harm (regulation 20 (8)(b).

Example 2

A 71-year-old woman with apathy and memory loss is diagnosed with dementia. She is treated for several months in the memory service before she is re-evaluated and diagnosed with depression which responds to antidepressant treatment.

This would be an example of an incident leading to prolonged psychological harm (regulation 20 (8)(b).