Document Title: Duty of Candour (Being Open) Policy
Duty of Candour (Being Open) Policy
Document No. / EDRMS000102NC / Version No. / 3.0 replaces version 7Approved 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
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.
Contents
1Immediate information the Duty of Candour (Being Open) Process
2Introduction and Purpose of the Document
3Glossary/Definitions
4Main Policy Content Details
4.1Introduction
4.2Duty of Candour
4.3Notifiable Safety Incident
4.4Level of Harm
5Duty of Candour (Being Open) Process
5.1Stage 1: Incident Detection or Recognition
5.2Stage 2: Preliminary Team Discussion
5.3Stage 3: Initial Being Open Communication - Verbal and Written Notification
5.4Stage 4: Follow-up Discussions
5.5Stage 5: Process Completion
5.6Continuity of care
6Documentation
7Support during the Process
7.1Patients, Families or Carers
7.2Support and Advice for Employees Involved in Incidents
8Duties and Responsibilities of Individuals and Groups
8.1The Trust
8.2The Trust Board
8.3Chief Executive
8.4Chief Nurse
8.5Deputy Director of Quality Governance
8.6Investigation Lead
8.7Patient Quality Committee (PQC)
8.8 Senior Managers (e.g. Associate Medical Directors, Divisional Directors of Nursing, Heads of Locality)
8.9Line Managers
8.10All Employees
8.11Clinical Risk and Patient Safety Department
8.12PALS
8.13Document Author and Document Implementation Lead
8.14Target Audience – As indicated on the Cover Page of this Document.
9Monitoring Compliance and Effectiveness of Implementation
10Review Date, Arrangements and Other Document Details
10.1Review Date
10.2Regulatory Position
10.3References, Further Reading and Links to Other Policies.
10.4Consultation Process
Appendix A – Equality Impact Assessment
Appendix B – Quality Impact Assessment Tool
Appendix C– Principles of Being Open
Appendix F - Duty of Candour (Being Open) - Guidance and Frequently Asked Questions
1Immediate information the Duty of Candour (Being Open) Process
Requirement under Duty of Candour / Responsible Person/Department / TimeframeFor 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. / As soon as reasonably practicable after the incident has been detected and reported but always within 10 working days of the incident
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. / As soon as reasonably practicable after the incident has been detected and reported but always within 10 working days of the incident
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/HoLor 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 approvedby the Divisional AMD/DDON/HoLor their nominated deputy.
Shareincident 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/HoLor 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.
2Introduction and Purpose of the Document
The 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.
3Glossary/Definitions
The 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 Accidents
Being 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 Commission
EDRMS / Electronic Document and Records Management System
GMC / General Medical Council
GP / General Practitioner
IR1 / Electronic Incident Reporting Form
MDU / Medical Defence Union
MPS / Medical Protection Society
NHS / National Health Service
NHSLA / National Health Service Litigation Authority
NPSA / National Patient Safety Agency
NRLS / National Reporting and Learning System
PALS / Patient Advisory and Liaison Service
RCA / Root cause analysis
SI / Serious Incident
SWAN / South Wiltshire Advocacy Network
4Main Policy Content Details
4.1Introduction
In 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.
4.2Duty of Candour
Candour 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.
4.3Notifiable Safety Incident
The 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
(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.
4.4Level 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;
5Duty of Candour (Being Open) Process
Communicating 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).
-Acknowledgement
-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.
5.1Stage 1: Incident Detection or Recognition
The 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)
As soon as a patient safety incident is identified, the top priority is prompt and appropriate clinical careto prevent further harm. The incident should be reported in line with the Incident Management Policy.
Level of harm / ActionNo harm
(includingpreventedpatientsafety incidents) /
- 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 /
- 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.
- Communication should take the form of an open discussion between the employee providing the patient’s care and the patient and/or their carers.
- Reporting to the operational managers will occur through standard incident reporting and will be analysed centrally to detect high frequency events.
- Review will occur through aggregated trend data and local investigation.
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 /
- 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.
5.2Stage 2: Preliminary Team Discussion
The 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;
- Identify immediate support needs for the healthcare member of employeeinvolved;
- Ensure there is a consistent approach by all team members around discussions with the patient, their family and carers.
5.3Stage 3: Initial Being Open Communication - Verbal and Written Notification
The initial verbalBeing Opendiscussion 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 Opendiscussion 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 anemployee 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 Opendiscussion: