Policy No: RM49

Version: 6.0

Name of Policy: Duty of Candour and Being Open Policy

Effective From: 19/12/2017

Date Ratified 08/11/2017 Ratified Risk and Safety Council Review Date 01/11/2019 Sponsor Director of Nursing, Quality and Midwifery Expiry Date 07/11/2020 Withdrawn Date

Unless this copy has been taken directly from the Trust intranet site (Pandora) there is no assurance that this is the most up to date version

This policy supersedes all previous issues

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Version Control

Ratified Changes Version Release Author/Reviewer by/Authorised Date (Please identify by page no.) 1.0 May 2006 Trust Policy June & July Forum & 2006 Clinical Improvement Group

2.0 01/10/2009 S A Gair, Risk PQRS 18/09/2009 Format and Facilitator Committee monitoring changes to meet NHS LA standards 2009/10

3.0 24/10/2012 S A Gair, Risk Risk 28/09/2012 Management Management Facilitator (CLIPA) Group

4.0 27/02/2014 S A Neale SafeCare 12/02/2014 Amended to include Risk Management Council the requirement for Facilitator Duty of Candour

5.0 19/08/2015 S H Winn PQRS 14/08/2015 Updated to reflect Head of Risk Committee the new legal duties Management from 27 th Nov 2014 and available advice 6.0 19/12/2017 Kate Jones Risk & Safety 08/11/2017 Updated to include Head of Corporate Council Standard Operating Risk Procedure for Duty Dr Kieran Doran, of Candour and Legal Services Being Open Manager

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Contents Page

1. Introduction and Background ...... 4

2. Policy scope ...... 5

3. Aim of policy...... 6

4. Duties – roles and responsibilities ...... 6

5. Definition of terms ...... 8

6. The Duty of candour process and Being open ...... 9 6.1 Detecting and recognising an incident ...... 10 6.2 Implementing the duty of candour requirement ...... 11 6.2.1 The notification (steps that must be taken) ...... 12 6.2.2 Written record (‘Notifiable Patient Safety Incident Record’)...... 12 6.2.3 Investigation ...... 13 6.2.4 Completion of the process ...... 13 6.3 Duty of candour non-compliance ...... 13 6.4 Legal claims and the duty of Candour ...... 13 6.5 Complaints and the duty of Candour ...... 13 6.6 Continuity of care ...... 14 6.7 External communications. The GP, community care service providers etc ...... 14 6.8 Communication of lessons learned (internally and externally) ...... 14

7. Training ………………………………………………………………………………… ...... 15

8. Diversity and inclusion ...... 15

9. Process for monitoring compliance with this policy ...... 15

10. Consultation and review ...... 15

11. Policy implementation ...... 16

12. References...... 16

13. Associated documentation ...... 16

Appendix 1 What you need to know when undertaking Duty of Candour

Appendix 2 Template – Notification letter

Appendix 3 Template – Findings letter

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Duty of Candour and Being Open Policy

1. Introduction

Gateshead Health NHS Foundation Trust is committed to the provision of high quality health care. As part of this objective, the trust has a duty to limit the potential impact of clinical and non-clinical risks and put in place robust and transparent systems to make sure that all incidents which might cause actual or potential harm to patients, visitors and staff are identified, investigated and rectified.

Promoting a culture of openness and truthfulness is a prerequisite to improving the safety of patients, staff and visitors as well as the quality of healthcare systems. It involves apologising and explaining what happened to patients who have been harmed as a result of their healthcare treatment or when in-patients or outpatients of the trust. It also involves apologising and explaining what happened to staff or visitors who have suffered harm. It encompasses communication between healthcare organisations, healthcare teams and patients and/or their carers, staff and visitors and makes sure that openness, honesty and timeliness underpins responses to such incidents. The purpose of the policy is to aid understanding of the duty of candour and outline the processes required to fulfil the duty of candour and what it means regarding ‘Being open’.

1.1 Being Open

The culture of being open should be intrinsic throughout the Trust in relationships with and between patients, the public, staff and other healthcare organisations.

This policy is based on guidance from the National Patient Safety Agency (NPSA) ‘Being open: Saying sorry when things go wrong’ (2009); the Nursing and Midwifery Council & General Medical Council Joint guidance on openness and honesty when things go wrong (2015) and the NHS Resolution communication ‘Saying sorry’ (2017).

Being open involves: • acknowledging, apologising and explaining when things go wrong; • conducting a thorough investigation into the patient safety event and reassuring patients, their families and carers that lessons learned will help prevent the patient safety event recurring; and • providing support for those involved (both patients and staff) to cope with the physical and psychological consequences of a patient safety event.

It is important to remember that saying sorry is not an admission of liability and is the right thing to do.

1.2 The Duty of Candour

The Duty of Candour is a legal duty on NHS trust to inform and apologise to patients if there have been mistakes in their care that have led to significant harm. Duty of Candour aims to help patients receive accurate, truthful information from health providers.

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Since 2013 there has been a contractual requirement by NHS Trusts to ensure compliance with the Duty of Candour within the NHS Standard for those incidents that result in moderate or severe harm, or death (utilising the National Patient Safety Agency (NPSA) definitions).

On 27th November 2014 the duty of candour became a statutory duty as defined in the Health and Social Care Act 2008 (Regulated Activities) 2014: 20. Guidance on how to comply with the legal duty was issued by the Care Quality Commission (CQC) Regulation 20: Duty of Candour, Guidance for NHS bodies (November 2014).

The statutory Duty of Candour adopted the definitions of Openness, Transparency and Candour as follows: • Openness , i.e. enabling concerns and complaints to be raised freely; • Transparency , i.e. permitting correct information on clinical performance and outcomes to be disclosed; and • Candour , i.e informing any patient harmed in a clinical incident, offering an appropriate remedy to the patient, regardless of a patient complaint being filed.

2. Policy scope

This policy relates to incidents, complaints and claims and details arrangements for communication with patients and/or their carers who have suffered harm within the trust. The same principles and process should be applied if a member of staff or visitor suffers harm as a result of an incident within the Trust’s property.

Being open is relevant to any healthcare staff member, clinical or non-clinical, responsible for making sure that the infrastructure is in place to support openness between healthcare professionals and patients and/or their carers following an incident, complaint or claim.

The trust’s Incident Reporting and Investigation policy encourages staff to report all patient safety incidents, including incidents where there was no harm or it was a ‘near miss’. This policy relates to incidents where there has been a measure of harm caused including low harm, staff are required to follow the principles of Being Open. Where an incident has or may have led to moderate harm (including psychological harm), severe harm or death the policy describes the ‘formal’ duty of candour required related to these incidents.

Incidents that are no harm/near miss are not within the scope of this policy. It should be noted however, there are some instances e.g. over exposure to radiation where no harm was caused but it would be appropriate to let the patient know of the incident.

For incidents and complaints, the process outlined in this policy will be adopted as and when the issue comes to light. If an issue reaches the stage of a claim, the duty of candour process may still need to be undertaken. Documents will be disclosed in accordance with the due legal process. (See RM23 Claims Management Policy)

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The principles of Being Open also apply to open communication between healthcare organisations, healthcare teams, staff and patient’s carers/relatives. The principles suggest that Being Open is a process rather than a one of event.

3. Aim of the policy

This policy aims to improve the quality and consistency of communication when incidents involving patients, staff or visitors occur and/or in situations which give rise to complaints. It outlines ‘Being open’.

This policy aims to outline the process required when a ‘notifiable patient safety incident’ occurs and includes detailed guidance from the Regulation 20: Duty of candour. Guidance for NHS bodies (CQC, November 2014). The policy will help to make sure that if mistakes are made, the patient and/or their carer will be given an opportunity to discuss what went wrong, that they will receive an apology and be informed of the action the trust will take to prevent it happening again.

The policy aims to provide guidance on how to ensure that the trust is compliant with the statutory requirements and ensure that staff and patients/relatives are supported in the process.

4. Duties – roles and responsibilities

Trust Board Gateshead Health NHS Foundation Trust is committed to the provision of high quality health care in all aspects of its services to patients, visitors, local community and staff. Promoting a culture of openness is a prerequisite to improving patient safety and the quality of healthcare systems. The Trust Board therefore supports this policy and a culture of openness and honesty.

Chief The Chief Executive is responsible for making sure that there remains a Board level commitment to Being open and transparent in relation to care and treatment. In conjunction with the Trust Board, the Chief Executive is responsible for actively championing the Being open and duty of candour culture and process by promoting an open, honest and fair culture that fosters peer support.

Executive directors Executive directors are responsible for promoting an open, honest and fair culture within the organisation. Each director has a duty to ensure that staff operating at all levels within the organisation operate within a culture of openness and transparency, understand their individual responsibilities in relation to the duty of candour, and are supported to be open and honest with patients and apologise when things go wrong.

Executive directors will ensure action is taken to tackle any instances of bullying, harassment and undermining in relation to duty of candour, and will investigate any instances where a member of staff may have obstructed another in exercising their duty of candour.

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Medical Director and Director of Nursing, Midwifery and Quality The Medical Director and Director of Nursing, Midwifery and Quality have joint responsibility to lead the development, implementation and promotion of a Being open and duty of candour culture within the organisation.

Medical staff Doctors have had a professional duty of candour for many years. In its core guidance for doctors, Good medical practice (2013) paragraph 55, the GMC says: "You must be open and honest with patients if things go wrong. If a patient under your care has suffered harm or distress, you should: • put matters right (if that is possible) • offer an apology • explain fully and promptly what has happened and the likely short-term and long- term effects."

Guidance is given in section 6 as to whether an incident reaches the threshold for notification under the statutory duty. The threshold is low for the doctor's ethical duty (any harm or distress caused to the patient) while the thresholds for the contractual and statutory duties are higher and slightly different (with the inclusion of prolonged psychological harm in the statutory duty).

Where the trust’s procedures for reporting and investigating incidents are followed (RM04 Incident reporting and investigation policy) in conjunction with this policy, it is unlikely that a notifiable patient safety incident will be overlooked.

Associate Directors, Heads of Service, Clinical Leads and Service Line Managers Associate directors, heads of service, clinical leads and service line managers are responsible for promoting an open, honest and fair culture within the organisation.

They are responsible for making sure that local management arrangements are suitable and sufficient to allow for all aspects of the Duty of Candour and Being Open policy being implemented in association with the requirements of the policies: RM04 Incident Reporting and Investigation policy, RM21 Complaints and RM23 Claims management.

Associate directors, heads of service, clinical leads and service line managers are required to make all reasonable efforts to ensure that staff operating at all levels within their business units operate within a culture of openness and transparency, understand their individual responsibilities in relation to the duty of candour, and are supported to be open and honest with patients and apologise when things go wrong. Where necessary, additional support should be arranged for staff involved in the process.

Business Unit Safecare and Risk leads/risk managers and Matrons Business unit Safecare and risk leads/risk managers and matrons are responsible for supporting an open, honest and fair culture within the organisation making sure that the Duty of Candour and Being Open policy is implemented throughout their department. This includes providing advice and assistance to colleagues within the business unit regarding undertaking the notification, providing letters at each stage and maintaining appropriate records in Datix. The Safecare and risk leads/risk managers will also undertake regular

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monitoring to support processes to ensure that where the duty of candour is required, it is completed appropriately.

Head of Corporate Risk/Legal Services Manager The Head of Corporate Risk and the Legal Service Manager will act as advocates for the duty of candour and being open culture and for leading the implementation of the policy. They will provide advice and support on the process and ensure that appropriate training is available for staff through the trust training programme.

On occasion, it may become apparent that a notifiable safety incident happened some time ago, or an incident relates to care that was delivered by another provider. The Regulation requires that the provider that discovers the incident should work with others who are responsible for notifying the relevant person of the incident. The Head of Corporate Risk will act as the trust representative to work with the relevant individuals to ensure that the ‘relevant person’ (patient/next of kin) is notified.

Complaints Manager/ Patient Advice and Liaison Service Manager The Complaints Manager and PALS Manager are responsible for promoting an open, honest and fair culture within the organisation when dealing with complaints and PALS enquires and reporting any incidents which become apparent, to the risk management team.

All staff All staff must have responsibility to adhere to the trust’s policies and procedures around duty of candour, regardless of seniority or permanency.

Staff have a duty to be open and honest with patients in their care, or those close to them, if something goes wrong. Staff also have a duty to be open and honest with the organisation, and to encourage a learning culture by reporting adverse incidents that lead to harm. Any incidents or concerns should be treated with compassion and understanding by all healthcare staff.

The Nursing and Midwifery Council (NMC) has released guidance with examples of harm where the duty would apply. (This can be found at http://www.nmc.org.uk/standards/guidance/the-professional-duty-of-candour ) Joint guidance from the NMC and GMC is also available at the NMC and GMC websites.

Serious Incident Panel The Serious Incident Panel meets fortnightly to review all serious or potentially serious incidents. (See RM04 Incident/near-miss reporting and investigation policy (including Serious Incidents). The panel provides a forum for incidents which may require duty of candour to be applied, to ensure a standard approach across the Trust.

The panel also monitors and advises on duty of candour correspondence and documentation. Its purpose is also to identify themes and trends and ensure actions arising are actioned and lessons learned across the Trust.

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5. Definition of terms

Openness: enabling concerns and complaints to be raised freely without fear and questions asked to be answered.

Transparency : allowing information about the truth and performance and outcomes to be shared with staff, patients, the public and regulators.

Candour: Any patient harmed by the provision of healthcare service is informed of the fact and an appropriate remedy offered, regardless of whether a complaint has been made or a question asked about it.

In addition, there are other definitions relevant to the statutory Duty of Candour for Trusts as Healthcare Providers, related to a clinical incident, which are as follows:

Act in an Open and Transparent Way , i.e. clear, honest and effective communication with a Patient or the Patient’s Representative;

Apology , i.e. an expression of sorrow or regret but NOT an admission of guilt;

Appropriate Written Records , i.e. records which are complete, legible, accurate and up to date; Cancelling Treatment , i.e. where clinical treatment or procedure is cancelled;

Death, any patient safety incident that directly resulted in the death of one or more persons receiving NHS-funded care.

Low Harm, any patient safety incident that required extra observation or minor treatment and caused minimal harm, to one or more persons receiving NHS-funded care.

Moderate Harm , i.e. harm which a moderate increase in treatment, with significant but NOT permanent harm to one or more persons receiving NHS-funded care:

No harm: Impact prevented – any patient safety incident that had the potential to cause harm but was prevented, resulting in no harm to people receiving NHS-funded care. Impact not prevented – any patient safety incident that ran to completion but no harm occurred to people receiving NHS-funded care.

Prolonged Pain , i.e. pain that the Patient has experienced, or is likely to experience, lasting at least twenty eight (28) days;

Prolonged Psychological Harm , i.e. psychological harm that the Patient has experienced, or is likely to experience, lasting at least twenty eight (28) days;

Relevant Person , i.e. the Patient’s Representative acting lawfully on behalf of the Patient;

Severe Harm , i.e. a permanent lessening of bodily, sensory, motor, physiologic or intellectual functions; and

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Written Notification , i.e. given to the Patient or the Patient’s Representative, disclosed personally by a Trust Healthcare Professional including enquiries undertaken, the results of any further enquiries, and, if appropriate, an apology (as defined above).

6. The Being open and duty of candour process

This policy reflects the ‘Ten Principles of “Being open” and the revised “Being open” framework issued in November 2009.

A decision needs to be made whether an incident reaches the threshold for notification under the statutory duty. The threshold is low for the ethical duty to be open (any harm or distress caused to the patient) while the thresholds for the contractual and statutory duty of candour is higher and slightly different. Section 6.1 defines what constitutes a notifiable patient safety incident and therefore the duty of candour.

The policy also reflects the requirements of the NHS Standard Contract with particular requirements around the timing of the notification.

In litigation cases, NHS Resolution will prepare letters of apology (where the following process has not already been completed as a result of an incident or complaint giving rise to the claim).

The obligations associated with the statutory duty of candour are contained in Regulation 20 of The Health and Social Care Act 2008 (Regulated Activities) Regulations 2014. The key principles are:

• Care organisations have a general duty to act in an open and transparent way in relation to care provided to patients. This means that an open and honest culture must exist throughout an organisation. • The statutory duty applies to organisations, not individuals, though it is clear from CQC guidance that it is expected that an organisation's staff cooperate with it to ensure the obligation is met. • As soon as is reasonably practicable after a notifiable patient safety incident occurs, the organisation must tell the patient (or their representative) about it in person. • The organisation has to give the patient a full explanation of what is known at the time, including what further enquiries will be carried out. Organisations must also provide an apology and keep a written record of the notification to the patient. • A notifiable patient safety incident has a specific statutory meaning: in the reasonable opinion of a healthcare professional it applies to incidents where a patient suffered (or could have suffered) unintended harm that results in death, severe harm, moderate harm or prolonged psychological harm. Severe and moderate harm definitions are derived from the NPSA's Seven Steps to Patient Safety. Prolonged psychological harm means that it must be experienced continuously for 28 days or more. Further guidance is provided in section 6.1. • There is a statutory duty to provide reasonable support to the patient. Reasonable support could be providing an interpreter to ensure discussions are understood, or giving emotional support to the patient following a notifiable patient safety incident.

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• Once the patient has been told in person about the notifiable patient safety incident, the organisation must provide the patient with a written note of the discussion, and copies of correspondence must be kept.

6.1 Detecting and recognising an incident

As soon as a patient safety incident is identified the actions required are:

• First priority: prompt and appropriate clinical care with prevention of further harm. If additional treatment is required, it should happen as soon as reasonably practicable after a discussion with the patient (or carer if the patient is unable to participate in discussion) and with appropriate consent.

• Incidents must be reported through the Datix incident reporting system in accordance with RM04 Incident Reporting and Investigation Policy.

The duty of candour process begins with the recognition and acknowledgement that a patient has suffered moderate harm*, severe harm, or has died, as a result of a notifiable safety incident*.

6.2 Implementing the duty of candour requirements (Regulation 20)

As soon as reasonably practicable after becoming aware that a notifiable safety incident has occurred a health service body must—

(a) notify the relevant person that the incident has occurred (details below), and (b) provide reasonable support to the relevant person in relation to the incident, including when giving such notification.

Care is normally provided by multidisciplinary teams. Every team member is therefore not expected to report an adverse incident and speak to the patient (relevant person) if things go wrong. Someone therefore has to take responsibility for each of these tasks. The patient (relevant person) has the right to receive an apology and explanation from the most appropriate team member, regardless of who or what may be responsible for what has happened.

The following actions are the responsibility of the most appropriate team member. This may be the clinician responsible for the episode of care during, or as a result of which the incident happened, a manager from the business unit and/or matron. It may not appropriate for others to give information to the patient. In making a decision about who is most appropriate to provide the notification and apology, consideration should be given to seniority, relationship to the patient, and experience and expertise in the type of incident that has occurred. Where incidents relate to nursing care, the most appropriate person may be the nurse looking after the patient e.g. incidents of pressure damage, harm as a result of falls.

• Where the duty of candour is relevant; moderate, severe or death incidents, including prolonged psychological harm incidents, details must be reported to the relevant person * as soon as reasonably practicable after the incident has

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been identified and within at most 10 working days of the incident Being reported on Datix, and sooner where possible.

• Where the degree of harm is not yet clear but may fall into the above categories, the relevant person must be informed of the notifiable safety incident in line with the requirements of the regulation.

The NHS body is not required by the regulation to inform a person using the service when a ‘near miss’ has occurred, and the incident has resulted in no harm to that person. No harm, near misses and prevented incidents should not routinely be communicated to patients as discussing no harm incidents with them can result in additional stress and loss of confidence in the standard of care. However, staff are reminded of the importance of reporting near misses as these are ‘free lessons’ whereby lessons can be learned although no harm occurred (see RM04 Incident Reporting, Investigation and Learning Policy).

Guidance Where necessary, advice can be taken or discussion held with the Head of Corporate Risk/ Head of Legal Services as to the facts of the event(s), to decide whether the duty of candour is required and what may be the best approach in the particular circumstances. Discussion can be held with those involved with the patient’s care and those who have been involved in the apparent incident, the consultant responsible for the patient and/or the relevant manager.

Staff are reminded that there is a ten day period in which the duty of candour must be carried out. Staff should not attempt to make a notification under the duty of candour if they are not fully prepared.

Providing reasonable support The patient (relevant person) must be provided with all reasonable support to help overcome the physical, psychological and emotional impact of the incident. This could include all or some of the following: • Treating them with respect, consideration and empathy. • Offering the option of direct emotional support during the notifications, for example from a family member, a friend, a care professional or a trained advocate. • Offering access to assistance with understanding what is being said e.g. via interpretative services, non-verbal communication aids, written information, Braille etc. • Providing access to any necessary treatment and care to recover from or minimise the harm caused where appropriate. • Providing the relevant person with details of specialist independent sources of practical advice and support or emotional support/counselling. • Providing the relevant person with information about available impartial advocacy and support services, their local Healthwatch and other relevant support groups, for example Cruse Bereavement Care and Action against Medical Accidents (AvMA), to help them deal with the outcome of the incident.

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• Arranging for care and treatment to be delivered by another professional, team or provider if this is possible, should the relevant person wish. • Providing support to access its complaints procedure. • The Being Open Framework (referenced in section 12) provides guidance on how to support patients, their families and carers when a patient safety incident has occurred.

6.2.2 Written record of the notification

The notification of the incident must be followed by a written notification given or sent to the relevant person. Where the relevant person does not want to receive a written notification, this must be recorded with the other information in Datix. Where the written notification is not declined, it must contain —

1. The information provided about the facts and all that is known about the incident,

2. Details of any enquiries to be undertaken, e.g. incident investigation/Root Cause Analysis (RCA) to be undertaken

3. The results of any further enquiries into the incident, and

4. An apology.

To assist in complying with regulatory (legal) requirements example template letters have been developed which can be completed by the staff member providing the verbal notification or lead investigator. (A copy of the template is shown in appendix 1.) The ‘Duty of Candour Notification Letter’ must be stored electronically as a document attached to the incident record within the Datix system, immediately at the time of the notification. The template notification letter can be downloaded by clicking into Datix, ‘Duty of Candour Notification Letter’ on the trust intranet. The template may be found either on the login screen of Datix, or once logged in, under section 5 ‘Documents, templates and linked records’.

A standard letter has also been created for use where the incident concerns pressure damage of grade 3 or grade 4. (See the Datix system)

As soon as possible after the verbal notification and following authorisation by the associate director or through the Serious Incident Panel, the letter should be sent to the patient/relevant person. This should be accompanied by the duty of candour patient information leaflet, ‘Being open and the duty of candour’.

Staff should also ensure they have a clear indication as to whether or not the patient/relevant person wishes to receive information on the findings of the investigation and in what format. This may be documentation of the findings

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and lessons learned sent in a letter and possibly a copy of the investigation report. It may be verbal communication if preferred.

6.2.3 Investigation

The incident investigation/RCA should be completed and documented as described in RM 04 Incident Investigation Policy.

6.2.4 Completion of the process; sharing the findings

Following the incident investigation, where the patient/relevant person wishes to receive written follow up, the ‘Duty of candour findings letter’ will be completed by the lead/handler for the incident. This includes a summary of the findings of the investigation, lessons learned and actions taken.

The letter should be reviewed within the same process as for the notification letter; either by the business unit associate director, or if part of the serious incident process at the next SI Panel meeting. Should the relevant person wish to receive a copy of the RCA investigation report, his must be reviewed by the same process.

On completion of this process, the ‘Duty of candour findings letter’ and possibly the RCA report should be forwarded to the patient (relevant person). A letter template has been produced to assist with this (See appendix 3). This should be done within 10 days following authorisation of the documents. Please note, any documentation produced as part of the process, such as the minutes of any meetings held or queries raised by the patient/relevant person, must be stored in Datix.

If meetings are offered but declined this should be recorded.

6.4 Legal claims and the duty of candour

Where an issue reaches a claim, NHS Resolution will agree the terms of formal admissions (if appropriate) within or before litigation. This policy relates to the earlier, more informal apologies and explanations required by patients and their families. Any queries regarding this should be referred to the Legal Services Manager or Head of Risk Management.

Where an incident or error has come to light though a legal claim the requirements of the RM23 Claims Management Policy will be followed by the Legal Services Manager.

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6.5 Complaints and the duty of candour

Where an incident or error has come to light through a complaint, the Complaints Policy which encourages “ Being open ” will be implemented. Meetings with patients and their carers are recorded and full explanations given both verbally and in writing. Should the incident involve the possibility of harm that invokes the duty of candour that has not already been undertaken, the formal process as described in this policy must be followed. The lead for the complaint within the relevant business unit will be responsible for ensuring the process is undertaken, within the timescales. The ten day period to make the notification and apology will commence as soon as harm has been verified and the incident reported immediately in Datix.

6.6 Continuity of care

When a patient has been harmed during the course of treatment and requires further therapeutic management or rehabilitation, they should be informed of the ongoing clinical management plan. This may be included in discharge documentation addressed to designated individuals such as the referring GP, attending district nursing service or healthcare organisation if the patient is being transferred.

Patients and/or their carers should be reassured that they will continue to be treated according to their clinical needs even in circumstances where there is a dispute between them and the healthcare team. They should also be informed that they have the right to continue their treatment elsewhere if they have lost confidence in the healthcare team involved in the patient safety incident.

6.7 External communications

The GP, other community care service providers and NHS organisations

Wherever possible, it is advisable to send a brief communication to the patient’s GP, before discharge, describing what happened.

When the patient leaves the care of the trust, a discharge letter should also be forwarded to the GP or appropriate community care service (a copy being sent with the patient should they be transferred) with a brief summary of:

• the nature of the patient safety incident and the continuing care and treatment requirements; and • the current condition of the patient, key investigations with results and prognosis.

6.8 Communication of lessons learned (internally and externally)

Lessons learned from incidents, complaints and claims and the “Being open” and duty of candour process will be shared:

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Internally In accordance with RM04 Incident reporting and investigation policy, RM51 Learning from experience policy and RM21 Complaints policy, RM23 Claims Management including at a local level through ward/department team meetings and trust wide through the Safecare and governance arrangements. A trust integrated learning report is produced on a quarterly basis which ensures shared learning across the organisation.

Externally The incident reports of patient safety incidents are fed through the National Reporting Learning Service to NHS England and the Care Quality Commission.

NHS England will publish patient safety alerts, safer practice notices and patient safety information notices through the Safety Alert Broadcast System to highlight common factors that cause patient safety incidents, and to publicise its advice and solutions to the service. The primary aim will be to help reduce the risk of such incidents recurring.

Duty of candour reports will be shared with the Commissioners through the North of England Commissioning Support Unit.

7. Training

Specific training on the policy will be provided. The Head of Corporate Risk and the Legal Services Manager will be available to provide training on an ongoing basis as required.

The following training will include the culture, legal principles and logistical requirements of ‘Being Open and the Duty of Candour: • Risk management mandatory and corporate induction training • Medical education programmes during clinical placement.

8 Diversity and Inclusion

The Trust is committed to ensuring that, as far as is reasonably practicable, the way we provide services to the public and the way we treat staff reflects their individual needs and does not unlawfully discriminate against individuals or groups on the grounds of any protected characteristic (Equality Act 2010). This policy aims to uphold the right of all staff to be treated fairly and consistently and adopts a approach. This policy has been appropriately assessed.

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9. Process for monitoring compliance with this policy

Monitoring and evaluation of the policy and any resulting action plans will be by:

Standard / process / Monitoring and Audit issue Method By Committee Frequency The identification of Audit of all DoC Patient Risk and Safety Bi-monthly moderate, serious and incidents recorded Safety team Council death incidents, on Datix to ensure notification to compliance with all patients/NOK within 10 steps of the process. day timescale.

The identification of Written update Legal Risk and Safety Quarterly moderate, serious and relating to Trust Services Council death incidents, compliance Manager notification to Quality patients/NOK within 10 Governance day timescale. Committee

Clinical Commissioning Group

10. Consultation and review

This policy has been reviewed against Being open and duty of candour guidance. Comments from the Medical Director, Director of Nursing, Midwifery and Quality, senior doctors, associate directors and service line managers, heads of service, risk managers, clinical leads, modern matrons, Communications, Complaints PALs and Legal Services Manager have been invited.

11. Policy implementation

This policy will be implemented in accordance with policy OP27 “Policy for the development, management and authorisation of policies and procedures”

12. References

Being Open Framework provides guidance on communicating about patient safety incidents with patients, families and carers (November 2009) http://www.nrls.npsa.nhs.uk/beingopen/?entryid45=83726

“7 Steps to Patient Safety” National Patient Safety Agency, 2005 www.nrls.npsa.ns.uk

“Involving and Communicating with Patients and the Public” National Patient Safety Agency, 2005

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GMC Good Practice Guide 2013

“Striking the Balance” The NHS Litigation Authority

“Making Amends” Chief Medical Officer

NMC The Code: Standards of conduct, performance and ethics for nurses and midwives (March 2015).

“Apologies and explanations” NHS Litigation Authority 1 May 09

NPSA Patient Safety Alert: Being open (2009)

NHS Standard Contract 2015/16: NHS Commissioning Board - February 2015 (updated annually)

Regulation 20 Duty of candour. Guidance for NHS bodies November 2014

13. Associated documentation

This policy links with:

RM01 Risk Management Policy RM04 Incident reporting and investigation policy RM21 Complaints Policy RM22 Consent Policy OP6a Information Security Policy RM23 Claims Management Policy RM51 Learning from Experience Policy PP01 Disciplinary Policy

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What you need to know when undertaking Duty of Candour Appendix 1

Key Message Detail Review Incident - You are made aware of/involved in an incident involving a patient? - Datix Verbal Duty of Do you suspect there is a possibility that the patien t has suffered from harm? Candour OR Being Open YES NO Provide an apology to patient (or Provide a n apology to patient (or relatives) and explain that an Initial relatives) for any aspect of poor investigation will be undertaken to find patient experience, and provide out what has occurred and that can be contact details for PALS team if shared with the patient/relative - Datix required.

Document Document clearly in the patient notes the following: • Reference Datix number for tracking purposes • Identify who was present • Detail of apology made to patient/relative(s) • Explanation of investigation process (if potential of harm) • Explanation of written follow up (if potential of harm) • of provision of contact details • Any questions raised and answers provided

Confirmation of 72 hour review will be undertaken by appropriate specialist/clinician to moderate harm/SI/ confirm severity of incident Formal Duty of Candour

Written Duty of Within 10 working days of SI being declared –written apology and outline of Candour process of Serious Incident Investigation to be sent to patient/relative, with confirmed offer of sharing the outcome of the investigation upon completion and approval by the CCG.

Incident Process of investigation of Serious Incident follows Incident Reporting and investigation Investigation Policy RM04

Duty of Candour – Within 10 working days of the Trust approving the report as closed – written sharing the report letter offering the opportunity to review the report, providing the opportunity to meet to discuss the report, and to provide any additional support required.

Meeting Facilitate meeting with patient/relative(s) to review the report, where this offer has been taken up, to ensure a clear understanding of the outcome and offer the opportunity to come back to evidence practice changes.

Document Ensure that outcome of the meeting is documented with an entry into the patient’s medical records. All documentation relating to DoC to be upl oaded to Datix.

Evidence of Quarterly compliance updates are tabled at Quality Governance Committee, Compliance which are evidenced by Datix, then shared with CCG.

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Template - Notification Letter Appendix 2

Gateshead Health NHS Foundation Trust Datix Ref: Trust Headquarters Queen Elizabeth Hospital Date Sheriff Hill Gateshead NE9 6SX Patient/relative address

Re incident on (date)

Dear Patient/relative (name as appropriate),

I am writing to you following the discussion held with me/ ………………….(staff member name ) on xxxxxx (date) in relation to the incident whereby (describe here e.g. you/your relative sustained a fractured hip following a fall).

Once again, I wish to express my sincere apology that this incident has occurred. As part of the Trust’s Duty of candour and Being Open policy we aim to make sure that patients/relatives are fully informed of events. Below you will find a record of the facts of the incident known at the time that were explained to you. I hope that this will reassure you that patient safety at Gateshead Health NHS Foundation Trust is our priority and it is our duty to work with patients/relatives in an open and transparent manner. The trust aims to provide a quality service to you/your relative (delete as appropriate) and we will promptly investigate such adverse events and share findings with those involved. The trust aims to learn from patient safety incidents, so that harm can be avoided wherever possible.

The facts explained to you include:

Brief list of an account of the notification An investigation into the incident has been arranged. This is intended to clarify the circumstances surrounding the incident and identify any actions that can be taken to prevent anything similar from happening in future. Once completed, I /Staff member XXXXX is (delete as appropriate) will write to you with a record of the findings. Should you wish to attend a meeting to discuss further the circumstances of the incident or the findings of the investigation, this can be arranged.

I am/ Staff member XXXXX is (delete as appropriate) acting as your lead contact for this incident. I/they (delete as appropriate) can be contacted on telephone number xxxx xxxxxxx should you have any questions in the meantime.

Yours sincerely

Name xxxxxx

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Designation xxxxxx Gateshead Health NHS Foundation Trust

Enc. Duty of Candour patient information leaflet

Chairman: Mrs J E A Hickey Chief Executive: Mr I D Renwick

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Letter template for the Investigation Findings Report Appendix 3

Gateshead Health NHS Foundation Trust Trust Headquarters Datix Ref: Queen Elizabeth Hospital Sheriff Hill Date Gateshead NE9 6SX Patient/relative address

Re incident on (date)

Dear Patient/relative (name as appropriate), Further to my previous letter relating to the safety incident which involved you, I am writing to share the details of the investigation.

In the previous letter, I sent you details of the incident that were known at the time, as part of the Trust’s Duty of Candour and Being Open policy. The letter outlined the main points of the discussion of the incident and included details of the planned investigation. The purpose of the investigation was to understand what happened and whether anything could have been done to prevent (state the incident). As part of the process we look at any changes we need to make or training or support our staff need in order to reduce the risk of something like this happens again. I am pleased to inform you that the investigation has been completed and I can now share the findings with you. The findings are as follows:

Brief list of findings including brief details of any lessons learned or actions taken as a result of the incident investigation.

I am sorry that the incident happened and I hope that this will reassure you that patient safety is a priority at Gateshead Health NHS Foundation Trust and we will always seek to learn lessons from patient safety incidents so that any risk to patients in future can be avoided where possible.

If you have any queries that weren’t answered in this letter you can discuss with us by telephone or even arrange a face to face meeting by calling XXXXXXX (telephone number)

Yours sincerely

Name Designation Gateshead Health NHS Foundation Trust

Chairman: Mrs J E A Hickey Chief Executive: Mr I D Renwick

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