Duty of Candour Policy

Document type: Policy Version: 4 Author (name): Emily Harrison Author (designation): Clinical Risk Manager Validated by Procedural Document Oversight Committee Date validated 14th August 2019 Ratified by: Directors Date ratified: 2nd September 2019 Name of responsible committee/individual: Clinical Governance & Quality Committee Name of Executive Lead (for policies only) Trish Armstrong-Child, Director of Nursing Master Document Controller: Governance Support Co-ordinator Date uploaded to intranet: Key words Being Open, Duty of Candour, Candour, incident, investigation Review date: August 2022

Version control

Version Type of Change Date Revisions from previous issues 1 New Policy May 2015 2 To emphasise the July 2016 Figure 1, the boxes for ‘Offer Meeting’ and ‘Send need for a meeting an apology letter with the findings’ have been or conversation to swopped around. share the findings Paragraph 15 has been amended to highlight the with the patient or need to talk to the patient / family prior to sending family. an apology with the findings.

Paragraph 18 has an additional line to emphasise To emphasise that that the authority for an exemption for Duty of authority for Candour comes from the Director of Nursing, exemptions can Medical Director or Deputy Director of Nursing only come from the Version 4 Policy Duty of Candour Policy Reviewed By: Page 1 of 21 Date July 2019 Next Review Date August 2022 E. Harrison, Clinical Risk Manager

Director of Nursing, Paragraph 40 has been amended to clarify that the Medical Director or initial approach for an exemption is made to the Deputy Director of Clinical Risk Manager, or Head of Governance, Nursing. then confirmed by the Director of Nursing, Medical Director or Deputy Director of Nursing.

To introduce the Family Liaison Person

Improve the quality

of guidance given for the verbal Appendix 2 apology discussion

Amend the Roles and Responsibilities to add in the role of Appendix 5 the Clinical Risk Manager and Family Liaison Person 3 Update roles and November responsibilities 2018 Into new format 4 Major amendments July 2019 Amendments to content of introduction and purpose to include clarity regarding statutory requirements and principles of openness and transparency. Amendments to definitions list. Minor amendment to 1s stage duty of candour process. Previously stated letter had to be issued within 10 days of identifying an incident. This is not factually correct – the statutory obligation is to notify the patient/relevant person verbally within 10 days of identification of an incident and to follow this up in writing. The deadline for this has been set as 5 working days post verbal notification. Minor amendments to process to clarify role of Duty of Candour Lead and Family Liaison Person. Amendments to specific considerations section to include HSIB investigations and provide clarity regarding responsibilities in relation to patients who lack capacity. Amendments to monitoring section in line with amendments to required timescales as described above.

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Amended EQIA.

Equality Impact

Bolton NHS Foundation Trust strives to ensure equality of opportunity for all service users, local people and the workforce. As an employer and a provider of healthcare Bolton NHS FT aims to ensure that none are placed at a disadvantage as a result of its policies and procedures. This document has therefore been equality impact assessed to ensure fairness and consistency for all those covered by it regardless of their individuality. The results are shown in the Equality Impact Assessment (EIA).

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Contents Page 1. Introduction 5 2. Purpose 5-6 3. Scope 6 4. Definitions 6-7 5. Reporting Requirements – Stage 1 7-8 6. Reporting Requirements – Stage 2 8-9 7. Communication 9-10 8. Special Considerations 10-12 9. Recording Incidents 12 10. Serious Incidents 12 11. Training and Resource 12-13 12. Monitoring Compliance 13-14 13. Associated Documents and References 14

Appendices Appendix 1: Roles and Responsibilities 15-16 Appendix 2: Draft letter template 17 Appendix 3: Document Development Checklist 18-19 Appendix 4: Equality Impact Assessment 20-22

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1 Introduction

1.1 There has been a responsibility for health care providers to be open and honest with patients since the Being Open Framework, published by the National Patient Safety Agency (NPSA) in 2009. The publication of the Francis Inquiry report in 2013 raised the profile of the principle of being open and honest, with two recommendations centred on the value of transparency with patients and/or families.

1.2 In November 2013 the Department of Health published the ‘Hard Truths’ report, the department’s response to the Francis recommendations. This emphasised a commitment to greater openness and candour, to developing a culture dedicated to learning and improvement that continually strives to reduce avoidable harm.

1.3 The duty of candour then took effect in contractual form by way of being included in the NHS Standard . This requires all NHS and non-NHS providers of services to patients to comply with the duty of candour under contract.

1.4 An addendum to the Health and Social Care Act in November 2014 brought the statutory requirements on Duty of Candour into effect. 20 of the Health and Social Care Act 2008 (Regulated Activities) 2014 made the Duty of Candour a regulatory requirement and clearly stipulates the actions health care providers must take to be compliant. This requirement is monitored and enforced by the Care Quality Commission.

1.5 ‘The intention of this regulation is to ensure that health care providers are open and honest with people who use services and other ‘relevant persons’ (people acting lawfully on their behalf) in general in relation to care and treatment. It also sets out specific requirements health care providers must follow when things go wrong with care and treatment.’ (Guidance for providers on meeting the regulations, Care Quality Commission, 2015)

1.6 The principles of being open and honest apply to all incidents and any failure in care or treatment. Being open about what happened and discussing patient safety events promptly, fully and compassionately with patients and/or relevant persons can:

 Help patients and/or relatives cope better with the after-effects;  Ensure that a thorough investigation into the patient safety event takes place and provide assurance that lessons learned will help prevent to ensure a similar type of incident from recurring;  Provide an environment where patients and/or their carers, healthcare professionals and managers feel supported when things go wrong.

2 Purpose

2.1 The Trust is committed to the principles of duty of candour and encouraging a culture of openness and transparency at all levels of the organisation.

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2.2 This document outlines the Trust’s policy on duty of candour and the processes by which it will be encourage candour, openness and honesty at all levels. This will support the Trust to meet its obligations to patients, relatives and the public by being open and honest when communicating with patients or other relevant persons in relation to care and treatment.

2.3 This policy should be followed in conjunction with the Trust Incident Reporting Policy and Serious Incident Policy.

3 Scope

3.1 This policy is relevant to all care delivered by any of the Trust clinical services to patients and their families, both while on Trust property and when care is delivered by a member of Trust staff while working in the community.

4 Definitions

4.1 Apology – An expression of sorrow or regret in respect of a notifiable safety incident

4.2 Notifiable safety incident – Any unintended or unexpected incident that occurred in respect of a person using the service during the provision of care and treatment that appears to have resulted in:

i. The death of the person using the service, where the death relates directly to the incident rather than due to natural course of any underlying condition/illness. ii. Severe harm, moderate harm or prolonged psychological harm

4.3 Relevant person(s) – A person lawfully acting on behalf of a patient under the following circumstances: i. The patient has died ii. The patient is under 16 and not competent to make a decision in relation to their care and treatment iii. The patient is 16 and over and lacks capacity in relation to the matter.

4.4 Moderate harm – significant but not permanent harm that requires a moderate increase in treatment.

4.5 Severe harm – A permanent lessening of bodily, sensory, motor, physiological or intellectual function that is directly related to the incident and not related to the natural course of any underlying illness/condition

4.6 Prolonged psychological harm – Psychological harm which the person using the service has experienced or is likely to experience, for a continued period of at least 28 days

4.7 Candour - 'The volunteering of all relevant information to persons who have or may have been harmed by the provision of services, whether or not the information has been requested and whether or not a complaint or a report about that provision has been made’ (Francis, 2013).

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4.8 Root cause analysis (RCA) – A system based methodology used to underpin investigations in order to identify the fundamental reason (or root cause) for why an incident occurred. Following analysis an action plan can then be developed to address the identified issues and prevent recurrence.

Reporting Requirements

A summary of the Duty of Candour process is in figure 1 below:

Send summary letter including apology Stage 1: Initial notification

Provide support Notifiable safety incident occurs

Stage 2: Send 2nd apology Investigate/make Offer meeting letter with findings further enquiries and copy of report Figure 1

5 Stage 1 - Initial notification to the patient or relevant person:

 When a notifiable safety incident has occurred, the patient or relevant person must be informed as soon as reasonably practicable after the incident has been identified:

 Verbally notify and apologise to the patient or relevant person within 10 working days of it being identified that the incident has occurred.

 The lead consultant (or other identified individual with appropriate knowledge of the duty of candour process) will act as the Duty of Candour Lead. They must ensure that the patient or the relevant person is verbally informed (face to face if possible) that a suspected patient safety incident has occurred as soon as practicable following an incident. If for any reason it is not appropriate for the lead consultant to act as Duty of Candour lead, then a suitable individual must be confirmed as part of the serious incident scoping panel (see Serious Incident policy)

 This verbal notification must include a meaningful apology that expresses sorrow or regret for the occurrence of the incident. This is not an admission of liability.

 Provide the patient or relevant person with a truthful account of the facts known about the incident at that time. This account must be given in a manner the patient or relevant person can understand.

 Advise and, if appropriate, agree with the patient or relevant person what further enquiries into the incident are appropriate. Explain that additional

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information may come to light as these enquiries proceed.

 Agree how the patient or relevant person would like to be kept informed.

 A family liaison person should be identified to provide reasonable support following the incident. In the case of a serious incident, the lead clinician or Divisional Governance Lead will act as the family liaison person.

 If the patient or relevant person appears to have suffered significant psychological harm as a result of the incident, then appropriate support must be explored.

 Where psychological harm is felt to be a significant risk due to the nature of the incident, the discussion should cover whether a separate family liaison person should be assigned for regular contact, and who that might be.

 This discussion, along with the date the discussion took place and the name and designation of the Trust representative who made contact, must be recorded in the incident record on Safeguard.

Summary letter - Following the initial notification:

 Within 5 working days of verbal notification, a letter summarising the above discussion must be sent to the patient or relevant person. This letter must start with a meaningful apology that expresses sorrow or regret at the occurrence of the incident, along with details of the agreed process for providing updates to the patient or relevant person. The letter should also provide the contact details of the nominated family liaison person and advise the patient or relevant person how to raise any specific questions they may have around the incident.

 It may be advantageous at this point to agree a provision for sharing findings of the investigation (if appropriate).

 A copy of this summary letter must be logged /attached onto the incident record on the Safeguard system.

6 Stage 2 – Following further enquiries

 Once further enquiries have been concluded and any final investigation report has been signed off by the appropriate authority, the patient or relevant person should be contacted by the Duty of Candour Lead to offer to meet in order to discuss the findings.

 Any formal meetings with the patient or relevant person should be minuted.

 A second letter must then be sent to the patient that: o Reiterates the apology o Summarises the findings o Outlines the actions taken and/or planned to prevent recurrence o Invites the patient or relevant person to contact the Duty of Candour Version 4 Policy Duty of Candour Policy Reviewed By: Page 8 of 21 Date July 2019 Next Review Date August 2022 E. Harrison, Clinical Risk Manager

Lead if they would like to meet further to discuss the findings o Include a copy of the investigation report where appropriate, otherwise a suitable summary capturing relevant findings is sufficient. o This should be provided within 10 working days of the completed investigation report being signed off by the Quality Assurance Committee.

Follow-up discussions

 Any formal meeting will be arranged if requested by the patient or relevant person, at a time convenient to them.

 Before the meeting, the patient or relevant person will be advised of the identity and the role of all the people who will be attending. This allows them the opportunity to ensure that they are comfortable with all the individuals they will meet. The patient or relevant person may bring another individual with them as support if they so wish. Where there is a separate family liaison person, the Duty of Candour Lead must suggest inviting them as support for the patient or relevant person.

 All questions (relating to the patient safety incident) raised by the patient or relevant person as part of the initial notification, should be addressed.

 Notes (minutes) should be taken at the meeting and typed up to provide a summary record of the discussion and any actions agreed. A final copy of these minutes must be attached and saved on the incident record on the Safeguard system*.

*All documents relevant to Duty of Candour, including letters of apology and any minutes of meetings, must be uploaded to the incident record on Safeguard as of compliance with contractual and statutory requirements.

7 Communication

 The patient or relevant person should have been asked (as part of the initial verbal notification) how they would like to be kept updated and an appropriate method of communication should have been agreed as part of the discussion. The agreed method of communication should have been included within the summary letter. Any communication with the patient or relevant person should be recorded on or attached to the incident record on Safeguard.

 The family liaison person should, where possible, remain the single point of contact for the patient or relevant person. This person need not be the same as the Duty of Candour Lead who makes the formal apology, but can be a separate individual who is also able to provide support. Having a separate family liaison person should be considered where the incident was psychologically traumatic. This person could be changed if the patient or relevant person felt this was not a helpful relationship.

 Every reasonable attempt must be made to contact the patient or relevant person through all available means of communication. All attempts to contact

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the patient or relevant person must be documented in the incident record on Safeguard.

 Where a patient or relevant person’s first language is not English, all reasonable attempts should be made to communicate in a format/using a means that will assist them in fully understanding the process and subsequent findings.

 Consideration should also be given to alternative forms of communication such as the use of visual aids or easy read documentation to support patients or relevant persons in understanding the apology and the reason for it.

 If the patient or relevant person does not wish to communicate with the Trust, their wishes should be respected and this should be recorded in the patient’s medical notes and incident record on Safeguard.

 If the patient has died and there is no relevant person to act lawfully on their behalf this should be recorded in the incident record on Safeguard.

8 Specific considerations

 The approach to the Duty of Candour may need to be modified according to the patient’s personal circumstances. Where any modifications conflict with the Duty of Candour process and pose a risk of a breach by the Trust this must be escalated to the Clinical Risk Manager and Head of Quality Governance, who would then seek to confirm any exemption with the Director of Nursing (or in their absence, the Medical Director or Deputy Director of Nursing). The reason for any delay or agreed exception to Duty of Candour must be documented on the incident record on the Safeguard system.

 Where compliance with Duty of Candour is considered to be psychologically harmful to the patient, again this must be discussed with the Clinical Risk Manager or Director of Quality Governance, and where agreed, would seek authority to delay or exempt Duty of Candour from the Director of Nursing (or in their absence, the Medical Director or Deputy Director of Nursing). Once confirmation has been received, an explanatory note must be placed on the incident record on Safeguard.

 Where the patient is under 16 and is not competent to make a decision in relation to their care and treatment, the duty of candour process should be followed with the person lawfully acting on their behalf (such as an individual with parental responsibility).

 Where the patient is 16 or over and lacks capacity in relation to the matter (i.e. lacks capacity specifically in relation to the incident and subsequent process), the duty of candour process should be followed with the person lawfully acting on their behalf (such as a person appointed by way of Lasting Power of Attorney for health and welfare, or the person to be consulted in the service user's best interests under the Mental Capacity Act 2005 and the Mental Capacity (Amendment) Act 2019). The trust is not required to liaise with all potential persons identified who could meet the ‘best interests’ role, but should Version 4 Policy Duty of Candour Policy Reviewed By: Page 10 of 21 Date July 2019 Next Review Date August 2022 E. Harrison, Clinical Risk Manager

identify key persons.

 Where the patient has been assessed as not having capacity (in accordance with the Mental Capacity Act 2005 and the Mental Capacity (Amendment) Act 2019), a verbal apology should still be made to the patient (unless it is believed that this would cause unnecessary psychological harm or distress), and noted in the incident record. It is recognised that the patient may not retain knowledge of the apology.

When an incident occurs in another organisation

 If the incident happened in another organisation, for example when a patient has been transferred into the trust from another healthcare provider, the individual who first identifies the possibility of an earlier notifiable safety incident must notify the corporate governance team and contact their equivalent at the organisation where the incident occurred to establish whether:

o The patient safety incident has already been recognised o The Duty of Candour has commenced o An incident investigation is underway

Healthcare Safety Investigation Branch (HSIB) maternity investigations

 The Healthcare Safety Investigation Branch (HSIB) was established by an expert advisory group following recommendations from a government inquiry into clinical incident investigations. HSIB became operational on 1 April 2017. Their purpose is to conduct effective investigations, and improve patient safety, raise standards and support learning across the healthcare system in England.

 HSIB maternity investigations have replaced the trust’s internal maternity serious incident investigations where they meet specified criteria. HSIB involve the trust and share the investigation reports as they are completed. Trusts continue to investigate maternity events that fall outside the specified criteria.

 If the incident meets the criteria of a serious incident in accordance with the Serious Incident Framework (2015) the trust is still responsible for the Duty of Candour process. However, it is recognised that the 60 working day deadline for completion of the full investigation report may not be met and this will be highlighted to the Clinical Commissioning Group when completing the 72 hour briefing report.

 Once a referral has been made to HSIB, the Trust will provide the family with some initial information explaining who HSIB are and what will happen next. HSIB investigators will contact the family to assess how they want to be involved.

Delayed Discovery of an incident

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Sometimes incidents can come to light as a result of a specific review or audit, e.g. mortality reviews or structured judgement reviews. Where this happens it is important to look at the resultant investigation and the time that has lapsed since the initial incident. In most cases, the Duty of Candour process will still apply. However, consideration should be given to the impact the information may have on the patient, patient’s family /carers or relevant person and if the Duty of Candour requirement would be appropriate. This decision must be made at a senior level i.e. Medical Director /Director of Nursing on a case by case basis.

9 Recording Incidents

9.1 Details of how to record an incident on the Safeguard system can be found in the Incident Reporting Policy and Serious Incident Policy.

9.2 It is essential that all incidents are fully recorded at the time and any discussion is also detailed to ensure clarity and a robust audit trail regarding supporting information, actions taken and forward plans (if appropriate). As a minimum, these records must include:

 Date/time of the incident and any discussions held with the patient or relevant person  Name of person discussing the incident with the patient and their professional grade  Details of the incident  Actions taken at the time of the incident and on-going actions where appropriate  Outcome of any interventions and any further discussions  Copy of any investigation reports and action plans

9.3 To evidence compliance with Duty of Candour, this record should include, under the ‘Duty of Candour’ tab:

 Whether an apology was given, and, if not, an explanation as to why  Uploaded letters of apology  Any minutes of formal meetings with the patient or relevant person.

10 Serious Incidents

10.1 All serious incidents will be investigated in line with the Serious Incident Policy.

10.2 It is important to ensure that any actions immediately required have been under taken and any immediate on going risk is addressed.

Roles and Responsibilities

Roles and Responsibilities can be found at Appendix 1.

11 Training and Resources

11.1 Information will be provided to staff on the expectations placed upon them in respect of being open and honest. This is in line with Royal College guidance. There is specific training for staff that are required to complete incident reports, Version 4 Policy Duty of Candour Policy Reviewed By: Page 12 of 21 Date July 2019 Next Review Date August 2022 E. Harrison, Clinical Risk Manager

review clinical incidents, undertake investigations and develop action plans.

11.2 Risk management and Duty of Candour training will be provided by the corporate Risk and Assurance team on a quarterly basis (minimum).

11.3 Support will be provided for all serious incidents by Trust managers. Staff also have access to the Health and Well Being Service and KESS Team. KESS – Keeping Everyone Safe and Supported is a group of voluntary staff committed to providing additional confidential support for staff involved in incidents and associated investigations. The team can be contacted on [email protected]

12 Monitoring Compliance

12.1 The implementation of this policy will be monitored by the Clinical Risk Manager.

12.2 A report* will be pulled each quarter from the Safeguard system for any patient safety incident reported as moderate or above and a random sample of 20% will be reviewed to ensure the following standards have been achieved:

Standard Compliance Person Measure Responsible Details of initial 100% Clinical Risk 20% of all patient notification to the Manager - Risk safety incidents patient or relevant and Assurance recorded as person recorded Team moderate harm or on Safeguard above per quarter within 10 working days 1st stage Duty of 100% Clinical Risk 20% of all patient Candour Manager - Risk safety incidents summary letter, and Assurance recorded as appropriately Team moderate harm or dated, uploaded above (where an to Safeguard agreed exception within 5 working has not been days of initial noted) verbal notification 2nd stage Duty of 90% Clinical Risk 20% of all patient Candour letter Manager - Risk safety incidents detailing the and Assurance recorded as findings of the Team moderate harm or investigation above (where an within 10 working agreed exception days of the has not been investigation noted) report being approved by Quality Assurance Committee

*The accuracy of this report is dependent of managers and staff using the system correctly.

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12.3 Feedback from patients following an incident subject to the duty of candour process may also be used where available to ensure that they felt informed, supported and understood the outcomes.

12.4 Performance is reported by the Divisions via the quarterly integrated governance reports presented to Clinical Governance and Quality Committee. Escalation of concerns in respect of compliance with this policy will be taken to the Clinical Governance & Quality Committee as and when required. The Quality Assurance Committee will review the performance of the metric which measures DoC dialogue as a ratio against the total number of moderate or above harm incidents, as described in the duties of the Director of Quality Governance.

13 Associated Documents and References

The following policies should be read in conjunction with this document:

 Incident Reporting Policy  Raising Concerns Policy  Serious Incident Policy  Mortality Review Policy

References

Care Quality Commission (2014) Regulation 20: Duty of Candour: NHS Bodies, adult social care, primary medical and dental care, and independent healthcare Dalton, D and Williams, N (2014) Building a culture of candour: A review of the threshold for the duty of candour and of the incentives for care organisations to be candid Department of Health (2013) Patients First and Foremost: The Initial Government Response to the Report of the Mid Staffordshire NHS Foundation Trust Public Inquiry Francis, R (2013) Report of the Mid Staffordshire NHS Foundation Trust Public Inquiry National Patient Safety Agency (NPSA) (2009) Being Open: Saying sorry when things go wrong Royal College of Surgeons (2015) Duty of Candour: Guidance for Surgeons and Employers National Quality Board (2018) Learning from deaths: Guidance for NHS trusts on working with bereaved families and carers Healthcare Safety Investigation Branch (2018) Healthcare Safety Investigation Branch (HSIB) Maternity Investigations Trust Information Pack NHS England (2018) NHS Standard Contract 2017/19 and 2018/19 Service Conditions (Full Length) May 2018 Edition

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Appendix 1

Roles and Responsibilities

Chief Executive

The Chief Executive on behalf of the Trust Board is responsible for ensuring that there is a robust system in place for reporting and managing such events, which includes supporting staff in being open and transparent with persons directly involved in an incident or other relevant persons.

Director of Nursing

The Director of Nursing is nominated by the Trust Board to lead on quality and ensure patients are safe. They should be actively involved in supporting/mentoring senior lead officers in implementing this policy.

Medical Director

In exceptional circumstances where there has been a delay in an incident coming to light through a mortality review, the Medical Director will consider the action to be taken, the impact of the information for the patient’s family and whether this policy is to be applied.

Director of Quality Governance

The Director of Quality Governance is responsible for ensuring there is a policy which supports staff and the Trust to meet their statutory obligations in the respect of the Duty of Candour. They are also responsible for ensuring that the duty of candour is integrated in governance processes.

The Director of Quality Governance will ensure that investigations of serious incidents and complaints have been quality checked in the line with the policy.

Clinical Risk Manager

The Clinical Risk Manager is the responsible author for the Duty of Candour Policy, and for ensuring that the Trust is kept up to date with any significant developments, national changes or implications to the Duty of Candour process.

The Clinical Risk Manager is responsible for ensuring the Board dashboard is populated with the percentage of Duty of Candour metrics (initial notification, 2nd Duty of candour letters) completed within the month.

The Clinical Risk Manager is responsible for providing training, guidance and quality assuring Duty of Candour letters on request, to maintain the standard set by the Trust.

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Heads of Division, Divisional Nurse Directors, Divisional Directors of Operations, Governance Leads, Matrons and Operational Business Managers

The Heads of Division are accountable for compliance with Duty of Candour in their division.

The aforementioned are responsible for ensuring that all events are reported as and when they are identified. They must ensure this process is monitored through their divisional governance structures. In addition they must work with key members of the corporate governance team to ensure that this policy is fully complied with.

Specifically Divisional Nurse Directors, Governance Leads and Matrons must ensure:

 Events that occur within their areas of responsibility are reported in line with the Trust’s Incident Reporting Policy  In the case of a notifiable safety incident, the patient’s consultant must be informed of the event  In the event of a serious incident involving a patient, the Head of Division must be informed  Staff involved in implementing this policy have attended Duty of Candour awareness sessions

Managers must also be aware that any staff member who is involved in an event which results in another person being harmed will also need support.

Family Liaison Person

The Family Liaison Person could be the Duty of Candour Lead, Divisional Governance Lead or a separate individual employed by the Trust. It is recommended that this person be a separate individual where the event was psychologically traumatic to the patient or family, and there may be issues of anger or trust with the management team who are addressing the incident and the apology.

The Family Liaison Person would be expected to contact the patient or relevant person to offer support, be willing to listen to their concerns, and, where appropriate, share these with the investigator or management team. The Family Liaison Person would keep the patient or relevant person updated on the progress of the investigation and offer to attend any meetings during the investigation or on receipt of the report. Where the patient or relevant person has unresolved concerns following the investigation, the Family Liaison Person should listen, and direct the patient or relevant person to the Patient Advisory Liaison Service (PALS) where appropriate.

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Appendix 2

Draft Letter Template

Telephone: E-mail: Please ask for:

Bolton NHS Foundation Trust Minerva Road Date Farnworth Bolton BL4 OJR www.boltonft.nhs.uk

Dear ……………..

Following on from our discussion on …… regarding the recent incident involving (name of patient) (category of incident and incident number), on behalf of the Trust I want to express our sincere apologies for the harm caused as a result of this incident.

Add details of discussion including details of the agreed process for providing updates and preferred method of communication.

We want to assure you that this is currently being looked at and the following measures have already been taken as a result of this incident.

The Trust will share the outcome of our investigation with you.

If you feel you require further support or have any further questions as a result of this incident please contact ……

Yours ……….

Copy to be included in patient notes Copy attached to incident form on Safeguard

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Appendix 3

Document Development Checklist

Type of document Policy Lead author: Emily Harrison Is this new or does it replace an existing This replaces the Being Open Policy document? What is the rationale/ Primary purpose for Ensuring patients receive appropriate communication the document (Motivation for developing where harm has occurred the document)? Duty of Candour introduced 27 November 2014, CQC monitoring framework for Regulation 20 on Duty of Candour What evidence/standard is the document Given in the reference section: based on? CQC Guidance on Regulation 20 Royal College of Surgeons guidance on Duty of Candour NHS Contract Mental capacity Act 2005 Mental Capacity (Amendment) Act 2019 Is this document being used anywhere No else, locally or nationally? Who will use the document? All Trust staff

Is a pilot run of the document required? No (optional) Has an evaluation taken place? What are No the results? (optional) What is the implementation and A briefing note will be sent to the divisional management dissemination plan? (How will this be teams, matrons and ward managers shared?) How will the document be reviewed? Reviewed in 3 years by the Clinical Risk Manager (unless (When, how and who will be responsible?) amendment is required sooner) Are there any service implications? (How This should already be in practice will any change to services be met? Resource implications?) Keywords (Include keywords for the Being Open, Duty of Candour, Candour, incident, document controller to include to assist investigation searching for the policy on the Intranet)

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Staff/stakeholders consulted Divisional Governance Teams, Procedural Document Oversight Committee, Clinical Governance & Quality Committee EIA yes Signed and dated By validator ...... 14th August 2019 Procedural Document Oversight Committee

Signed and dated By ratifying officer

...... 2nd September 2019 Executive Directors

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Appendix 4 Equality Impact Assessment Tool

To be completed and attached to any procedural document when submitted to the appropriate committee for consideration and approval.

Yes/No Comments

1. Does the document/guidance affect one group less or more favourably than another on the basis of:

 Race No

 Ethnic origins (including gypsies and Yes The policy emphasises the need travellers) to communicate with patients/ relevant persons in their preferred method to assist them in fully understanding the process and subsequent findings. Patients/relevant persons from travelling communities may be difficult to contact as a permanent address is required. In such instances a preferred means of communication is to be agreed.

 Nationality Yes Patients/relevant persons for whom English is not the first language - Where a patient or relevant person’s first language is not English, all reasonable attempts should be made to communicate in a format/using a means that will assist them in fully understanding the process and subsequent findings.

 Gender (including gender reassignment) No

 Culture No

 Religion or belief No

 Sexual orientation No

 Age Yes Where the patient is under 16 and is not competent to make a decision in relation to their care and treatment, the duty of candour process should be followed with the person lawfully acting on their behalf (such as an individual with parental responsibility). However, it should not be assumed that because a person is under 16 that they automatically lack capacity (as per Consent process and Gillick competence standards)

Version 4 Document Duty of Candour Policy Page 20 of 22 Date July 2019 Next Review Date July 2022

 Disability - learning disabilities, physical Yes Consideration as to the disability, sensory impairment and mental requirements of the MCA 2005 health problems and MCA (Amendment) 2019 must be given as outlined in the policy to ensure that the relevant person is still informed when capacity may be an issue. Consideration should also be given to the use of alternative forms of communication such as visual aids and easy read documents to aid patient understanding. The policy reinforces the need to communicate with patients/ relevant persons in their preferred format as part of the investigation and to feedback. Every effort will be made to make reasonable adjustments to ensure patients remain central to the process. Patients and relevant persons can request meetings at their convenience and as needed.

2. Is there any evidence that some groups are Yes As outlined under the Special affected differently? Considerations section. Communication considerations will need to given when supporting people for whom English is not their first language i.e. ethnic groups and people with disabilities

3. If you have identified potential discrimination, are Yes As outlined under the special there any valid exceptions, legal and/or consideration section: justifiable? Delayed identification of an incident particularly following a patient’s death – to contact the family may be distressing and should be reviewed on a case by case basis with the medical Director.

4. Is the impact of the document/guidance likely to No be negative?

5. If so, can the impact be avoided? N/A

6. What alternative is there to achieving the N/A document/guidance without the impact?

7. Can we reduce the impact by taking different N/A action?

If you have identified a potential discriminatory impact of this procedural document, please refer it to the Equality and Diversity Co-ordinator, together with any suggestions as to the action required to avoid/reduce this impact. Version 4 Document Duty of Candour Policy Page 20 of 22 Date July 2019 Next Review Date July 2022