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Duty of Candour (Being Open) Policy

Equality Impact

Great Western Hospitals 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 health care, the Trust 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 in line with current legislation to ensure fairness and consistency for all those covered by it regardless of their individuality. This means all our services are accessible, appropriate and sensitive to the needs of the individual.

Special Cases

None.

Document No. EDRMS000102NC Version No. 3.0 replaces version 7

Approved by Policy Governance Group

Date approved 17/07/2015

Ratified by Policy and Procedural Documents Governance Group

Date ratified 17/07/2015

Date Implemented 17/07/2015 Next Review Date 17/07/2018

Status Approved

Target Audience All Employees

Accountable Director Medical Director

Policy Author/Originator Clinical Risk Manager

Implementation Lead Clinical Risk Manager

If developed in partnership with another agency, ratification details of the relevant agency

Document Title: Duty of Candour (Being Open) Policy

Contents1 Immediate information the Duty of Candour (Being Open) Process......................................4

2 Introduction and Purpose of the Document............................................................................53 Glossary/Definitions...............................................................................................................5

4 Main Policy Content Details...................................................................................................64.1 Introduction............................................................................................................................6

4.2 Duty of Candour.....................................................................................................................64.3 Notifiable Safety Incident.......................................................................................................6

4.4 Level of Harm.........................................................................................................................75 Duty of Candour (Being Open) Process.................................................................................7

5.1 Stage 1: Incident Detection or Recognition............................................................................85.2 Stage 2: Preliminary Team Discussion..................................................................................9

5.3 Stage 3: Initial Being Open Communication - Verbal and Written Notification....................105.4 Stage 4: Follow-up Discussions...........................................................................................11

5.5 Stage 5: Process Completion...............................................................................................115.6 Continuity of care.................................................................................................................11

6 Documentation.....................................................................................................................127 Support during the Process..................................................................................................13

7.1 Patients, Families or Carers.................................................................................................137.2 Support and Advice for Employees Involved in Incidents....................................................13

8 Duties and Responsibilities of Individuals and Groups........................................................148.1 The Trust..............................................................................................................................14

8.2 The Trust Board...................................................................................................................148.3 Chief Executive....................................................................................................................14

8.4 Chief Nurse..........................................................................................................................148.5 Deputy Director of Quality Governance...............................................................................14

8.6 Investigation Lead................................................................................................................148.7 Patient Quality Committee (PQC)........................................................................................14

8.8. . .Senior Managers (e.g. Associate Medical Directors, Divisional Directors of Nursing, Heads of Locality)............................................................................................................................................15

8.9 Line Managers.....................................................................................................................158.10 All Employees......................................................................................................................15

8.11 Clinical Risk and Patient Safety Department.......................................................................158.12 PALS....................................................................................................................................15

8.13 Document Author and Document Implementation Lead......................................................158.14 Target Audience – As indicated on the Cover Page of this Document................................15

9 Monitoring Compliance and Effectiveness of Implementation.............................................1610 Review Date, Arrangements and Other Document Details..................................................16

10.1 Review Date.........................................................................................................................1610.2 Regulatory Position..............................................................................................................16Note: This document is electronically controlled. The master copy of the latest approved version is maintained by the owner department.

If this document is downloaded from a website or printed, it becomes uncontrolled.

Version 3.0 of 23Printed on 17/05/2023 at 06:11:13

Document Title: Duty of Candour (Being Open) Policy10.3 References, Further Reading and Links to Other Policies...................................................16

10.4 Consultation Process...........................................................................................................17Appendix A – Equality Impact Assessment.....................................................................................18

Appendix B – Quality Impact Assessment Tool...............................................................................19Appendix C– Principles of Being Open............................................................................................20

Appendix F - Duty of Candour (Being Open) - Guidance and Frequently Asked Questions...........22

Note: This document is electronically controlled. The master copy of the latest approved version is maintained by the owner department. If this document is downloaded from a website or printed, it becomes uncontrolled.



1 Immediate information the Duty of Candour (Being Open) ProcessRequirement under Duty of Candour

Responsible Person/Department Timeframe

For incidents where moderate harm, serious harm or death has occurred, the relevant person must be informed.

Senior clinician for episode of care during which the incident occurred. The Divisional Associate Medical Director (AMD)/Divisional Director of Nursing (DDON)/Head of Locality (HoL) should be made aware and if appropriate, involved.

As soon as reasonably practicable after the incident has been detected and reported but always within 10 working days of the incident

Initial notification of incident must be verbal (face-to-face, where possible) unless the relevant person declines notification or cannot be contacted in person. Sincere expression of regret or sorrow must be provided verbally. This must be recorded in the notes.

Senior clinician for episode of care during which the incident occurred. The Divisional AMD/DDON/HoL should be made aware and if appropriate, involved.


Step-by-step explanation of the known facts must be offered to the relevant person.

Provide contact details of a staff member who will maintain an ongoing relationship with the relevant person.

Senior clinician for episode of care during which the incident occurred. The Divisional AMD/DDON/HoL should be made aware and if appropriate, involved.


Written notification to the relevant person. The written notification should outline the facts discussed at the notification meeting and include a sincere expression of regret or sorrow.

As above. All letters must be approved by the Divisional AMD/DDON/HoL or their nominated deputy.

As above (template letter available from Clinical Risk, for guidance only – all letters must be personalised and tailored to the individual needs of the person receiving the letter).

Maintain full written documentation of any meetings. If meetings are offered but declined this must be recorded

As above. All follow-up letters to patients/ relatives to be approved by the Divisional AMD/DDON/HoL or their nominated deputy.

Share incident investigation report (including action plans) with an accompanying letter.

Lead Investigator or other nominated person. All letters must be approved by the Divisional AMD/DDON/HoL or their nominated deputy.

As soon as reasonably practicable but always within 25 working days of report being signed off as complete and incident closed by the Serious Incident Panel.




2 Introduction and Purpose of the DocumentThe purpose of this policy is to provide a best practice framework which enables employee to apply the principles of openness, transparency and candour when communicating with patients or their family/carer after any incident which has resulted in harm to a patient.

This policy should be used in conjunction with the following Trust Policies:

Incident Management Policy(Ref 7) Complaints Policy (Ref 13) Claims Policy(Ref 14)

This policy applies to all employees including permanent and temporary employed by the Trust. The policy also applies to students, and locum workers contracted workers and volunteers. Every healthcare professional in the Trust must be open and honest with patients when something goes wrong with their treatment or care which causes, or has the potential to cause, harm or distress.

3 Glossary/DefinitionsThe following terms and acronyms are used within the document:

Apology: An expression of sorrow or regret in respect of a notifiable safety incidentAvMA Action Against Medical AccidentsBeing Open: Open communication of events (adverse incidents, complaints or claims) that result in

harm or death of a patient whilst receiving healthcare.CQC Care Quality CommissionEDRMS Electronic Document and Records Management SystemGMC General Medical CouncilGP General PractitionerIR1 Electronic Incident Reporting FormMDU Medical Defence UnionMPS Medical Protection SocietyNHS National Health ServiceNHSLA National Health Service Litigation AuthorityNPSA National Patient Safety AgencyNRLS National Reporting and Learning SystemPALS Patient Advisory and Liaison ServiceRCA Root cause analysisSI Serious IncidentSWAN South Wiltshire Advocacy Network




4 Main Policy Content Details4.1 IntroductionIn 2005, the National Patient Safety Agency (NPSA) issued a Safer Practice Notice advising NHS Trusts to develop a local Being Open Policy and to raise awareness with all health care staff.

In 2009 the NPSA published the revised Being Open Framework in order to strengthen Being Open throughout the NHS.

Following the mid-Staffordshire inquiry, which considered the poor care and high mortality rates of patients at the Stafford Hospital, Sir Robert Francis recommended the implementation of a statutory duty of candour.

On 27 November 2014, the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014, brought this into force through Regulation 20 (Ref 3). The Regulation states that (1) "A health service body must act in an open and transparent way with relevant persons in relation to care and treatment provided to service users in carrying on a regulated activity".

The Care Quality Commission ["CQC"] guidance accompanying the new duty of candour prescribes how the terms "openness", "transparency" and "candour" are to be interpreted,

• Openness – enabling concerns and complaints to be raised freely without fear and questions asked to be answered. • Transparency – allowing information about the truth about performance and outcomes to be shared with staff, patients, the public and regulators. • Candour – any patient harmed by the provision of a 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.

4.2 Duty of CandourCandour is defined in The Francis report (Ref 15) as:

“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.”

Unlike the existing professional and ethical duty which applies to all circumstances where a patient is harmed when something goes wrong, the statutory Duty of Candour only applies to incidents where a patient suffered (or could have suffered) unintended or unexpected harm resulting in moderate or severe harm or death or prolonged psychological harm.

4.3 Notifiable Safety IncidentThe regulations state that a “notifiable safety incident” means “any unintended or unexpected incident that occurred in respect of a service user during the provision of a regulated activity that, in the reasonable opinion of a health care professional, could result in, or appears to have resulted in—

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

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

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



Document Title: Duty of Candour (Being Open) Policy(b) provide reasonable support to the relevant person in relation to the incident, including

when giving such notification.

The notification to be given must:

(a) be given in person by one or more representatives of the health service body,(b) provide an account, which to the best of the health service body’s knowledge is true, of

all the facts the health service body knows about the incident as at the date of the notification,

(c) advise the relevant person what further enquiries into the incident the health service body believes are appropriate,

(d) include an apology, and(e) be recorded in a written record which is kept securely by the health service body.

This notification must be followed up in writing.

4.4 Level of Harm Incidents that result in no harm or low harm are not covered by the Duty of Candour. Patients should still be informed of such events in line with being open, but the emphasis for the Duty of Candour is on incidents that result in moderate harm, severe harm or death.

The regulations state that the Duty of Candour applies to incidents as follows:

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

(b) Severe harm means a permanent lessening of bodily, sensory, motor, physiological or intellectual functions, including removal of the wrong limb or organ or brain damage, that is related directly to the incident and not related to the natural course of the service user’s illness or underlying condition;

(c) Moderate harm means—harm that requires a moderate increase in treatment, and significant, but not permanent, harm; “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);

(d) Prolonged psychological harm to the service user; means psychological harm which a service user has experienced, or is likely to experience, for a continuous period of at least 28 days;

5 Duty of Candour (Being Open) ProcessCommunicating effectively with patients, their family/carer is a vital part of the process of dealing with notifiable safety incidents in healthcare.

Being open involves:

• Acknowledging, apologising and explaining when things go wrong;• Conducting a thorough investigation into the incident and reassuring patients, their families and carers that lessons learned will help prevent the incident recurring;• Providing support for those involved to cope with the physical and psychological consequences of what happened.

The Being Open Framework (Ref 1) describes a set of principles that employees should adhere to when communicating with patients and their family/carer following a safety incident in which a patient has been harmed (Appendix C).

- AcknowledgementNote: This document is electronically controlled. The master copy of the latest approved version is maintained by the owner department.

If this document is downloaded from a website or printed, it becomes uncontrolled.


Document Title: Duty of Candour (Being Open) Policy- Truthfulness, Timeliness and clarity of communication- Apology- Recognising patient and carer expectations- Professional support- Risk management and systems improvement- Multidisciplinary responsibility- Clinical governance- Confidentiality- Continuity of care Being Open is a process rather than a one-off event. There are a number of

stages in the process.

5.1 Stage 1: Incident Detection or RecognitionThe Being Open process begins with the recognition that a patient has suffered harm or has died as a result of a patient safety incident. Incidents may be identified by:

A member of employee at the time of the incident; A member of employee retrospectively when an unexpected outcome is detected; Outside the incident reporting process usually by way of a complaint, legal claim, Coroner’s

Officer or media interest; A patient, their family or carers who express concern or dissatisfaction with the patient’s

healthcare either at the time of the incident or retrospectively; Incident detection systems such as incident reporting or medical records review; Other sources such as detection by other patients, visitors or non-clinical staff(for example,

researchers observing healthcare employees)



Document Title: Duty of Candour (Being Open) PolicyAs soon as a patient safety incident is identified, the top priority is prompt and appropriate clinical care to prevent further harm. The incident should be reported in line with the Incident Management Policy.

Level of harm ActionNo harm(including prevented patient safety incidents)

o Patients are not usually contacted or involved in investigations and these types of incidents are outside the scope of the Duty of Candour. Openness remains best practice, but there is no requirement to follow the Duty of Candour processes.

Low harm o Unless there are specific indications or the patient requests it, the communication, investigation and analysis, and the implementation of changes will occur at local service delivery level with the participation of those directly involved in the incident.

o Communication should take the form of an open discussion between the employee providing the patient’s care and the patient and/or their carers.

o Reporting to the operational managers will occur through standard incident reporting and will be analysed centrally to detect high frequency events.

o Review will occur through aggregated trend data and local investigation.Where the trend data indicates a pattern of related events, further investigation and analysis may be needed.Openness remains best practice, but there is no requirement to follow the Duty of Candour processes for incidents that result in this level of harm. .

Moderate harm Severe harm or death

o The Duty of Candour policy is implemented.

5.1.1 Incidents that are Identified Retrospectively or that have Occurred within the care of Another Provider

On occasion, an incident that happened some time ago may be discovered, for example on receipt of a notification of a claim. The incident should be reported in the usual way on a Trust incident form, and agreement reached by the senior clinician and the Clinical Risk and Patient Safety Manager as to the most appropriate action to take. A delay in discovering an incident does not mean the Duty of Candour does not apply. The processes however may require additional consideration in order that the patient or their relatives are informed of the incident with care to avoid unexpected shock or distress.

Incidents that are discovered that relate to care delivered by another provider will be reported to a senior manager and the Clinical Risk Management Department in that organisation. That organisation is then responsible for implementing the Duty of Candour.

5.2 Stage 2: Preliminary Team DiscussionThe multidisciplinary team, including the most senior health professional involved in the patient safety incident, should meet as soon as possible after the event to:

Establish the basic clinical and other facts; Assess the incident to determine the level of immediate response; Identify who will be responsible for discussion with the patient, their family and carers. Consider the appropriateness of engaging patient support at this early stage. This includes the

use of a facilitator, a patient advocate or a healthcare professional who will be responsible for identifying the patient’s needs and communicating them back to the healthcare team;



Document Title: Duty of Candour (Being Open) Policy Identify immediate support needs for the healthcare member of employee involved; Ensure there is a consistent approach by all team members around discussions with the

patient, their family and carers.

5.3 Stage 3: Initial Being Open Communication - Verbal and Written Notification

The initial verbal Being Open discussion is the first part of an ongoing communication process. Many of the points raised here should be expanded on in subsequent meetings with the patient, their family and carers.

If for any reason it becomes clear during the initial discussion that the patient would prefer to speak to a different healthcare professional, the patient’s wishes should be respected. A substitute with whom the patient is satisfied should be provided.

It should be recognised that patients, their families and carers may be anxious, angry and frustrated even when the Being Open discussion is conducted appropriately.

The content of the initial Being Open discussion with the patient, their family and carers should cover the following:

An expression of sympathy, regret and a meaningful apology for the harm that has occurred. The facts that are known as agreed by the multidisciplinary team. Where there is

disagreement, communication about these events should be deferred until after the investigation has been completed.

The patient, their family and carers are informed that an incident investigation is being carried out and more information will become available as it progresses.

The patient’s, their family’s and carers’ understanding of what happened is taken into consideration, as well as any questions they may have.

An explanation about what will happen next in terms of the short and long-term treatment plan and incident analysis findings.

An offer of practical and emotional support for the patient, their family and carers. This may involve getting help from third parties such as charities and voluntary organisations, as well as offering more direct assistance. Information about the patient and the incident should not normally be disclosed to third parties without consent.

Contact details of an employee who will maintain an ongoing relationship with the patient, using the most appropriate method of communication from the patient’s, their family’s and carers’ perspective. Their role is to provide both practical and emotional support in a timely manner.

It is essential that the following does not occur during the Being Open discussion:

Speculation; Attribution of blame; Denial of responsibility; Provision of conflicting information from different individuals.

The verbal notification (Being Open discussions) must be followed by a written notification, confirming information provided.

Template letters (to be used as guidance) are available on the intranet and from the Clinical Risk and Patient Safety Department.

The Relevant Person Cannot be Contacted or Declines to Have Further Information



Document Title: Duty of Candour (Being Open) PolicyIf, after discussion, the patient says they do not want more information, then the possible consequences must be explained to them. It should be made clear that they can change their mind and have more information at any time.

All Duty of Candour conversations must be recorded in the notes including instances when the patient has declined the offer of further information.

Where a relevant person cannot be contacted, a clear written record must be kept of the attempts made to contact or speak to the relevant person. This should evidence that every reasonable effort was made to contact the person by stating how many attempts were made, who by and when.

5.4 Stage 4: Follow-up DiscussionsFollow-up discussions with the patient, their family and carers are an important step in the Being Open process. Depending on the incident and the timeline for the investigation there may be more than one follow-up discussion before the investigation has been completed.

5.5 Stage 5: Process CompletionCommunication with the Patient, Their Family and Carers

After completion of the incident investigation, feedback should take the form most acceptable to the patient. Whatever method is used, the communication should include:

The chronology of clinical and other relevant facts; Details of the patient’s, their family’s and carers’ concerns and complaints; A repeated apology for the harm suffered and any shortcomings in the delivery of care that led

to the patient safety incident; A summary of the factors that contributed to the incident; Information on what has been and will be done to avoid recurrence of the incident and how

these improvements will be monitored.

It is expected that in most cases there will be a complete discussion of the findings of the investigation and analysis. In some cases information may be withheld or restricted, for example, in the rare instances where communicating information will adversely affect the health of the patient; where investigations are pending review by the Coroner; or where specific legal requirements preclude disclosure for specific purposes. In these cases the patient must be informed of the reasons for the restrictions.

5.6 Continuity of careWhen a patient has been harmed during the course of treatment and requires further therapeutic management or rehabilitation, they should be informed, in an accessible way, of the ongoing clinical management plan. This may be encompassed in discharge planning policies addressed to designated individuals, such as the referring GP, when the patient safety incident has not occurred in primary care.

Patients, their families and carers need to 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 prefer.

When the patient is discharged, the discharge letter should also be forwarded to the GP or appropriate community care service. It should contain summary details of:

The nature of the patient safety incident and the continuing care and treatment; The current condition of the patient;



Document Title: Duty of Candour (Being Open) Policy Key investigations that have been carried out to establish the patient’s clinical condition; Recent results; Prognosis

6 DocumentationThroughout the Duty of Candour (Being Open) process it is important to record discussions with the patient, their family and carers as well as the incident investigation. A summary of communication should be documented in the Duty of Candour section of the corresponding incident form.

With specific relation to the Being Open/Duty of Candour records must:

Record the sharing of any facts that are known and agreed with the relevant person;

Record how it has been agreed that the relevant person will be kept informed of the progress and results of that investigation;

Record, where appropriate, a full apology to the patient and their family/carers;

Record any explanation given of the likely short and long-term effects of the incident;

Contain copies of any letters sent to the relevant person;

Record an offer of appropriate practical and emotional support.




7 Support during the Process7.1 Patients, Families or CarersPatients, their families and carers may need considerable practical and emotional help and support after experiencing a patient safety incident. The most appropriate type of support may vary among different patients, their families and carers. It is therefore important to discuss with the patient, their families and carers their individual needs. Support may be provided by patients’ families, social workers, religious representatives and healthcare organisations such as PALS, South Wiltshire Advocacy Network (SWAN) and Community of health care councils in Wales. Where the patient needs more detailed long-term emotional support, advice should be provided on how to gain access to appropriate counselling and support services.

More information and advice on support for patients, families and carers can be obtained from the Trust’s PALS service or from Patient UK on www.patient.co.uk

Useful contacts:Patient Advice and Liaison Service (PALS) 01793 604031 Bereavement and Mortuary Services 01793 604392

7.2 Support and Advice for Employees Involved in IncidentsIt is very rare for healthcare employees to go to work with the intention of causing harm or failing to do the right thing. While we do all we can to minimise risks, it will never be possible to eliminate them fully. It should be acknowledged from the outset that many ‘human factors’ can increase the risk of incidents occurring such as:

Workload

Distractions

Physical environment

Physical demands

Device/product design

It is uncommon for any single action or ‘failure’ to be wholly responsible. The focus following an incident should always be on learning and prevention rather than individual blame. Involvement in an incident and particularly a serious incident can have profound consequences on employees who may experience a range of reactions. Different individuals will have differing responses to the same incident and support should always therefore be tailored to the individual. The Human Resources team is able to advise on resources available in the Trust, but the support of close team members and managers is invaluable for the employees involved, and for taking forward learning from the event.

The initial level of support is provided by line managers for employees involved in a patient safety incident.

The second level of support is provided by appropriate Senior Managers, Occupational Health and the Human Resources Department.




8 Duties and Responsibilities of Individuals and Groups

8.1 The Trust8.2 The Trust Board

The Board fully endorses the principles of being open and actively promotes an open, honest and fair culture. The Trust Board will seek assurances that the principles and processes set out in this policy work effectively to support the commitment to implementing the Duty of Candour.

Employees involved in patient safety incidents in which a patient has been harmed can be traumatised by the event. The Board ensures that systems are in place to provide support to employees in these circumstances.

8.3 Chief ExecutiveThe Chief Executive has overall responsibility for Duty of Candour (Being Open) processes within the Trust, ensuring that the principles and policy are embedded in the organisation The Chief Executive will fulfil this responsibility by leading by example in fostering a culture of fair blame and promotion of incident reporting within the Trust.

8.4 Chief NurseThe Chief Nurse has executive responsibility to ensure that all incidents are managed appropriately and in accordance with the Duty of Candour.

8.5 Deputy Director of Quality GovernanceThe post holder maintains an overview of all incidents and ensures a robust monitoring and reporting system is in place.

The post holder has responsibility for ensuring that incidents are managed, external reports made as necessary and investigations undertaken appropriately and that the Duty of Candour (Being Open) policy is implemented and forms part of the incident management process.

The post holder also oversees and ensures Serious Incident reports inform the Patient Quality Committee

8.6 Investigation Lead The Investigation Lead could be the point of contact throughout an investigation between the patient, the family and the Trust if it is agreed that this is the most appropriate approach. This communication role can be undertaken by another person such as the lead clinician or senior manager if this is more appropriate, but whoever the contact is must be recorded in the clinical notes and the RCA documentation.

The Investigation Lead is responsible for ensuring the robust investigation of an incident and for ensuring that Duty of Candour and Being Open forms an integral part of the incident management process.

8.7 Patient Quality Committee (PQC)

The Patient Quality Committee is chaired by the Chief Nurse. The Committee reviews all Serious Incidents reported to ensure the quality of the investigation is of a high standard, and that associated action plans are comprehensive. The Committee will monitor Root Cause Analysis reports to determine whether the principles of being open and the Duty of Candour have been followed appropriately in each case.



Document Title: Duty of Candour (Being Open) Policy8.8 Senior Managers (e.g. Associate Medical Directors, Divisional Directors of Nursing,

Heads of Locality)On notification of an incident the senior line manager, must ensure that all appropriate steps have been taken and that the situation has been made safe. They must ensure that the Incident Management Policy(Ref 7) and Duty of Candour (Being Open) policies are followed within their Division and that employees are adequately supported to implement the polices effectively.

Responsible for ensuring that employees within the Division are provided opportunity to access short term and long term support following an incident.

8.9 Line ManagersOn notification of an incident the line manager, must ensure that the situation has been made safe and that the incident is managed in line with the Incident Management Policy.

They are responsible for ensuring that the Being Open process described within this policy is followed for all low and moderate harm incidents.

As a line manager they have responsibility for ensuring that all employees reportable to them have adequate immediate and on-going support following a patient safety incident, complaint or claim.

8.10 All EmployeesThe Being Open policy applies to all employees that have key roles in patient’s care.

8.11 Clinical Risk and Patient Safety DepartmentResponsible for advising on and ensuring compliance with the Incident Management and Duty of Candour (Being Open) policies throughout the organisation.

8.12 PALSResponsible for highlighting patient safety incidents to the clinical risk, litigation and health and safety teams which are uncovered through the complaints procedures.

Ensuring that the principles and processes described in the Duty of Candour (Being Open) policy are considered as part of the management of complaints. See Also Trust Complaints Policy.

8.13 Document Author and Document Implementation LeadThe document Author and the document Implementation Lead are responsible for identifying the need for a change in this document as a result of becoming aware of changes in practice, changes to statutory requirements, revised professional or clinical standards and local/national directives, and resubmitting the document for approval and republication if changes are required.

8.14 Target Audience – As indicated on the Cover Page of this Document.The target audience has the responsibility to ensure their compliance with this document by:

Ensuring any training required is attended and kept up to date. Ensuring any competencies required are maintained. Co-operating with the development and implementation of policies as part of their normal

duties and responsibilities.




9 Monitoring Compliance and Effectiveness of ImplementationThe arrangements for monitoring compliance are outlined in the table below: -

Measurable policy objectives

Monitoring / audit method

Monitoring responsibility (individual / group /committee)

Frequency of monitoring

Reporting arrangements (committee / group to which monitoring results are presented)

What action will be taken if gaps are identified?

For all incidents resulting in harm, staff should acknowledge, apologise, and explain when things go wrong and record communication appropriately.

Monthly audit of all incidents resulting in moderate harm, severe harm or death

Clinical Risk Monthly Monthly reports to Divisional Quality Facilitators – divisional quality dashboards

Monthly reports on compliance to Patient Quality Committee

10 Review Date, Arrangements and Other Document Details

10.1 Review DateThis document will be fully reviewed every three years in accordance with the Trust’s agreed process for reviewing Trust -wide documents. Changes in practice, to statutory requirements, revised professional or clinical standards and/or local/national directives are to be made as and when the change is identified.

10.2 Regulatory PositionLegislation which applies in relation to the requirements of the document.

Health and Social Care Act 2008 (Regulated Activities) Regulations 2014: Regulation 20

10.3 References, Further Reading and Links to Other Policies.The following is a list of other policies, procedural documents or guidance documents (internal or external) which staff should refer to for further details:

Ref. No. Document Title Document Location

1 NPSA – Being Open – Communicating Patient Safety Incidents With Patients And Their Carers

www.nrls.npsa.nhs.uk

2 Code of Practice on Openness in the NHS www.cfoi.org.uk

3 Health and Social Care Act 2008 (Regulated Activities) Regulations 2014: Regulation 20

http://www.cqc.org.uk

4 Medical Defence Union. MDU encourages doctors to say sorry if things go wrong. MDU, May 2009

www.the-mdu.com

5 NHS Litigation Authority. Apologies and Explanations. NHSLA, London. May 2009

www.nhsla.com




Ref. No. Document Title Document Location

6 Welsh Risk Pool. Technical Note 23: Apologies and Explanations. WRP, July 2001.

howis.wales.nhs.uk

7 Incident Management Policy Intranet

8 Whistle Blowing Policy Intranet

9 Data Protection Policy Intranet

10 Code of Confidentiality for Employees in Respect of Confidentiality

Intranet

11 Information Disclosure Policy Intranet

12 The Caldecott Principles, Intranet

13 Complaints Policy Intranet

14 Claims Management Policy and Procedure Intranet

15 Report of the Mid Staffordshire NHS Foundation Trust Public Inquiry

www.gov.uk/government/

10.4 Consultation ProcessThe following is a list of consultees in formulating this document and the date that they approved the document:

Job Title / Department Date Consultee Agreed Document Contents

Deputy Director Quality Governance 15.07.2015

Divisional Director of Nursing Womens and Childrens Division 01.07.2015

Divisional Quality Facilitator Diagnostics and Outpatients 29.06.2015

Legal Services Manager 16.07.2015

Lead Nurse Practitioner for Infection Prevention and Control 07.07.2015

Education Lead for Quality and Safety 17.07.2015

Any comments on this policy should, in the first instance be addressed to the author.




Appendix A – Equality Impact Assessment



Trust Equality and Diversity Objectives

Better health

outcomes for all

Improved patient

access and experience

Empowered engaged

and included

staff

Inclusive leadership at all levels

Age

Disability

Gender Re- assignment

Marriage and Civil

Partnership

Pregnancy and

Maternity

Race - including

Nationality and

Ethnicity

Religion or Belief

Sex

Sexual Orientation

Are we Treating Everyone Equally?Define the document. What is the document about? What outcomes are expected?

Consider if your document/proposal affects any persons (Patients, Employees, Carers, Visitors, Volunteers and Members) with protected characteristics? Back up your considerations by local or national data, service information, audits, complaints and compliments, Friends & Family Test results, Staff Survey, etc.

If an adverse impact is identified what can be done to change this? Are there any barriers? Focus on outcomes and improvements. Plan and create actions that will mitigate against any identified inequalities.

If the document upon assessment is identified as having a positive impact, how can this be shared to maximise the benefits universally?

9 Protected Characteristics

Our Vision

Great Western Hospitals NHS Foundation Trust wants its services and opportunities to be as accessible as possible, to as many people as possible, at

the first attempt.

Equality Impact Assessment


Appendix B – Quality Impact Assessment ToolPurposeTo assess the impact of individual policies and procedural documents on the quality of care provided to patients by the Trust both in acute settings and in the community.

ProcessThe impact assessment is to be completed by the document author. In the case of clinical policies and documents, this should be in consultation with Clinical Leads and other relevant clinician representatives.Risks identified from the quality impact assessment must be specified on this form and the reasons for acceptance of those risks or mitigation measures explained.

Monitoring the Level of RiskThe mitigating actions and level of risk should be monitored by the author of the policy or procedural document or such other specified person.High Risks must be reported to the relevant Executive Lead.

Impact AssessmentPlease explain or describe as applicable.

1. Consider the impact that your document will have on our ability to deliver high quality care.

To support safe practice and openness

2. The impact might be positive (an improvement) or negative (a risk to our ability to deliver high quality care).


3. Consider the overall service - for example: compromise in one area may be mitigated by higher standard of care overall.


4. Where you identify a risk, you must include identify the mitigating actions you will put in place. Specify who the lead for this risk is.

none

Impact on Clinical Effectiveness & Patient Safety5. Describe the impact of the document on clinical effectiveness.

Consider issues such as our ability to deliver safe care; our ability to deliver effective care; and our ability to prevent avoidable harm.

Promote safety culture

Impact on Patient & Carer Experience6. Describe the impact of the policy or procedural document on

patient / carer experience. Consider issues such as our ability to treat patients with dignity and respect; our ability to deliver an efficient service; our ability to deliver personalised care; and our ability to care for patients in an appropriate physical environment.

Supporting openness and transparency

Impact on Inequalities7. Describe the impact of the document on inequalities in our

community. Consider whether the document will have a differential impact on certain groups of patients (such as those with a hearing impairment or those where English is not their first language).

No equality concerns perceived



Document Title: Being Open Policy

Appendix C– Principles of Being Open

1. Principle of acknowledgementAll events should be acknowledged and reported to the Risk Management, Legal Services or Patient and Customer Services Department as soon as they are identified. Any concern by a patient or their carer must be taken seriously from the outset and treated with compassion and understanding by all healthcare employees . Denial of a patient’s concerns will make future open and honest communication more difficult.

2. Principle of truthfulness, timeliness and clarity of communicationInformation about any event must be given to patients and/or their carers in a truthful and open manner, by an appropriately nominated individual and should be based solely on facts known at the time.

Such information should be delivered as soon as practicable, with an explanation that new information may emerge as the investigation is undertaken, and patients and /or their carers will be kept up to date with the progress of an investigation.

A single point of contact for patients and/or their carers should be identified, from whom they can receive clear, unambiguous information, without the use of medical jargon, which may not be understood. Other healthcare workers should direct all questions and requests regarding the event through that contact in order to avoid the possible issue of conflicting information.

3. Principle of apologyA sincere expression of regret for harm as a result of any event, should be given to patients and/or their carers as soon as possible, and should not be delayed for any reason, even for the setting up of a more formal Being Open discussion. A delay in the delivery of an apology is likely to increase patients’ and/or their carers’ anxiety, anger and frustration and is more likely to prompt them to seek medico-legal advice. In the first instance, a verbal apology must be given, but must be followed by a written apology, clearly stating that Portsmouth Hospitals NHS Trust is sorry for any suffering and distress resulting from the event. The decision on which employee should give the apology must take into account seniority, relationship to the patient, and experience and expertise in the type of event that has occurred.

4. Principle of recognising patient and carer expectationsPatients and/or their carers can reasonably expect to be fully informed of issues surrounding the event and its consequences in a face-to-face meeting. They must be treated sympathetically, with respect and consideration, and confidentiality must be maintained. Patients and/or their carers should also be provided with support in a manner appropriate to their needs. This may include an independent patient advocate, a bereavement councillor or an interpreter, as well as the provision of information on the Patient Advisory and Liaison Service (PALS) and other relevant support groups such as Action against Medical Accidents (AvMA).

5. Principle of professional supportThe Trust’s open and fair culture seeks to create an environment in which all healthcare employees are encouraged to report events that may be considered adverse events and/or may lead to a complaint or claim. Managers should ensure that employees feel supported throughout the investigation process as it is recognised that they too, may have been traumatised by their involvement in the event. They should not feel unfairly exposed to punitive disciplinary action, increased medico-legal risk, or any threat to their registration.




Where there is reason for the Trust to believe that an employee has committed a punitive or criminal act, it will take steps to preserve its position. It will advise the employee of its belief at an early stage, to enable them to obtain legal advice and/or representation. Staff will also be actively encouraged to seek support from relevant professional bodies such as the General Medical Council, Royal Colleges, and Medical Protection Society.

6. Principle of risk management and systems improvement Root Cause Analysis (RCA) will be used to uncover the underlying cause/s of a patient

safety incident and complaints and claims will be investigated in accordance with the relevant policies. Investigations will focus on improving systems of care, which will then be reviewed for their effectiveness.

7. Principle of multi-disciplinary responsibility This Being Open policy applies to all employees with key roles in the patient’s care. Most

healthcare provision involves multidisciplinary teams and communication with patients and/or their carers should reflect this. This will ensure that the philosophy that adverse incidents, complaints or claims usually result from systems failures and rarely from the actions of one individual.

8. Principle of governance The Trust’s Governance Framework supports patient safety and quality improvement

processes and ensures adverse incidents, complaints and claims are investigated, analysed and steps taken to prevent their recurrence: those findings being disseminated to employees to enable them to learn. The Framework also involves a system of accountability through the Chief Executive to the Board to ensure these steps are implemented and their effectiveness reviewed.

9. Principle of confidentialityFull respect will be given to the privacy and confidentiality of employees, patients and/or their carers. Details of any event should at all times be considered confidential. The consent of the individual concerned should be sought prior to disclosing information beyond the clinicians involved in treating the patient. Where this is not practicable or an individual refuses to consent to the disclosure, disclosure may still be lawful if justified in the public interest, or where the investigating panel has statutory powers for obtaining information. Communications with parties outside of the clinical team will be strictly on a need to know basis and, where practicable, records will be anonymous. Patients and/or their carers should be informed of who will be involved in the investigation before it takes place, allowing them the opportunity to raise any objections.

10. Principle of continuity of carePatients are entitled to expect that they will continue to receive all usual treatment and be treated with respect and compassion following an adverse incident, complaint or claim. Should such patients express a preference for their healthcare needs to be taken over by another team every effort will be made to accommodate their wishes.




Appendix F - Duty of Candour (Being Open) - Guidance and Frequently Asked Questions

Following the mid-Staffordshire inquiry, which considered the poor care and high mortality rates of patients at the Stafford Hospital, Sir Robert Francis recommended the implementation of a statutory duty of candour. From November 2014, NHS provider bodies registered with the Care Quality Commission (CQC) are required to comply with a new Statutory Duty of Candour (DOC).

This involves giving patients accurate, truthful, prompt information when mistakes are made and treatment does not go to plan.

• Openness – enabling concerns and complaints to be raised freely without fear and questions asked to be answered. • Transparency – allowing information about the truth about performance and outcomes to be shared with employees patients, the public and regulators. • Candour – any patient harmed by the provision of a 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.

What is candour?

Recognising when an incident occurs that impacts on a patient in terms of harm. Notifying the patient something has occurred. Apologising to the patient. Supporting the patient further. Following up with the patient as your investigations evolve. Documenting the above discussions and steps.

When might it arise?

Whilst the patient is an in-patient, i.e. at the "bedside". When a patient is back at home following discharge or via community based care. Following a patient's death.

What triggers the statutory duty of candour?

The death of a patient when due to treatment received or not received (not just their underlying condition).

Severe harm - in essence permanent serious injury as a result of care provided. Moderate harm - in essence non-permanent serious injury or prolonged psychological

harm.

What does candour look like?

Open discussions between the patient and the healthcare provider when things go wrong. Acceptance by healthcare employees that open conversations will take place at an early

stage. Reduction in overly defensive approaches to information sharing about incidents in

relation to the patient in question. Engaging the patient with the outcome of investigations; and An apology in relation to the incident.




What is an apology?

Clinical employees may worry that being open with patients may compromise the ability to deal with a claim if one is subsequently made by the patient. In reality candour is all about sharing accurate information with patients and should be encouraged. The facts are the facts and employees should be encouraged and supported to help patients understand what has happened to them.

Where employees should be more cautious is where the facts are not yet know or where they are being asked to speculate beyond what is known. It can be more damaging to a relationship with the patient to speculate inaccurately than to investigate and find the facts and then provide the extra information.

Saying Sorry

Duty of Candour Example - Uterine perforation during ablation

A 44-year old woman was admitted to hospital for uterine endometrial ablation. Following the procedure she was transferred back to the ward but deteriorated over the next 12 hours with abdominal pain and sepsis.

Her surgeon suspected a uterine perforation and immediately spoke with the patient. He told her what he thought had happened, apologised that it had occurred, and explained that he hoped to oversew the perforation. However, he warned her that he might need to carry out an emergency hysterectomy and obtained the patient's consent for this. The patient returned to theatre where the doctor's diagnosis was confirmed and a hysterectomy was eventually required.

The surgeon reported the incident through the hospital's risk management reporting procedures for patient safety incidents. As the incident had resulted in moderate harm to the patient, the hospital's clinical governance lead and departmental manager decided that it met the threshold for the contractual duty of candour.

The hospital began a root cause analysis under its clinical governance procedures and now he had the full facts the surgeon spoke to the patient again. He described in more detail what had gone wrong, again expressing his regret at the outcome. He explained that the hospital was formally investigating the incident and would keep her updated.

The investigation found that perforation was a recognised complication of the procedure and that the patient had been informed about this before she consented to the operation. It also concluded that the surgeon had followed accepted technical practice in carrying out the ablation therapy and acted appropriately when the complication came to light. The report recommended changes to post-operative review procedures, to allow for earlier identification of perforations, and these were later put into practice by the trust. A copy of the report was sent to the patient within 10 days and she was invited to a further meeting with the trust to discuss the findings. She eventually told the trust she was happy with the way the incident had been managed and that she had no plans to make a formal complaint.

The incident was also reported to the CQC via the National Reporting and Learning System (NRLS) because it had resulted in injury to the patient.

Being Open Record completed



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