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Duty of Candour

Directorate: Customer

Department: Care and Support

Approved: December 2022

Approved by: Board of Management

Review: October 2025

Purpose

This policy sets out Estuary Housing Association’s (‘Estuary’) expectations in relation to compliance with the Duty of Candour (‘the Duty’) Pursuant to the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014: Regulation 20. The purpose of the policy is to give guidance to staff on the Duty generally when it is activated and what steps Estuary must take to comply with it.

Aim

Estuary’s aim is to be fully compliant with the Duty and embrace a culture of openness in all of its dealings with customers, their relatives and / or their representatives.

Scope

This policy applies to all staff employed by and contracted to Estuary. All of these will be referred to as ‘Workers’ in this policy. This policy applies to safety incidents involving customers outlined below, and which require a more formal response and is intended to ensure that all communication with customers and/or their relatives and between staff/ other healthcare professionals and, where relevant, other healthcare organisations and/or partner agencies, when things have gone wrong to ensure Estuary is open, honest, and transparent and acting in compliance with the Duty when triggered. Failure by any Worker to comply with this Policy may lead to disciplinary action being taken against them. Any disciplinary action will be dealt with in accordance with the Disciplinary Policy.

Equality and Diversity

At Estuary Housing Association (EHA) we value inclusiveness and we are committed to embedding equality and diversity at the heart of our work. We aim to be an inclusive organisation, where individual differences are respected, where staff, people who use services, as well as their families and carers, are treated with dignity and on the basis of their merits, abilities and needs, and where everyone has a fair opportunity to fulfill their potential without suffering discrimination or disadvantage.

Introduction

1.1    This is the policy Estuary in relation to the Duty pursuant to the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014: Regulation 20. This supersedes previous Duty of Candour Guidance. 

1.2    Estuary’s aim is to be fully compliant with the Duty and embrace a culture of openness in all of its dealings with customers, their relatives and / or their representatives.

1.3    The Duty is to ensure that Estuary is open and transparent with customers who use Estuary’s services and other 'relevant persons' (people acting lawfully on their behalf) in general in relation to care and treatment. The Duty also sets out some specific requirements that Estuary must follow when things go wrong with care and treatment, including informing people about the incident, providing reasonable support, providing accurate information and an apology. As noted above, this Policy is in relation to the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014: Regulation 20 and sets out the statutory obligations of the same. This policy does not deal with the separate but linked professional duty of candour which has similar aims – to make sure that those providing care are open and transparent with the people using their services, whether or not something has gone wrong. The professional duty is overseen by regulators of specific healthcare professions such as the General Medical Council (GMC), Nursing and Midwifery Council (NMC) and the General Dental Council (GDC) as applicable. 

1.4    The Regulation applies to Estuary when they are carrying out a regulated activity within the meaning of the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014.

1.5    When things go wrong, Estuary wants to be open, transparent, and honest about what happened - discussing the incident fully, openly and compassionately - which can help all those involved cope better with the consequences, whether potential or actual, in managing the event and also in coping in the longer term. In addition, being open and candid when things go wrong ensures that the investigation gets to the root cause of the event and promotes organisational learning. Estuary understands that compliance with the Duty is a fundamental requirement, and the Care Quality Commission (‘CQC’) can prosecute for a breach of the Duty and/or take other regulatory action.

1.6    The Duty of Candour is a statutory requirement (Regulation 20) of the Health and Social Care Act 2008 (Regulated Activities) (Amendment) Regulations 2014 and is regulated by the Care Quality Commission (CQC). 

1.7    Whether anything has ‘gone wrong’ may not be known until any internal investigation has concluded or a Coroner’s inquest process has completed; by which time any opportunities to engage with and involve customers (where appropriate) and/or families and those involved in their care may be lost. Therefore, communication must start at the earliest possible opportunity. Furthermore, openness, candour and honesty towards customers are supported and actively encouraged by Estuary at all levels. This should be an integral part of the organisation along with Estuary’s commitment to being open and transparent at board level down.

1.8    Working to these principles ensures Estuary is also compliant with the requirements of the Duty. The processes relating to the management of incidents and investigation, or reviews are detailed in separate but related policies.

1.9    Estuary will also investigate any instances where a member of staff may have obstructed another in exercising the Duty. This is likely to include an investigation and escalation process that may lead to disciplinary proceedings, referral to the CQC and/or other relevant body. 

1.10    Estuary wants 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, and are supported to be open and honest with customers and apologise when things go wrong.

1.11    In cases where something unintended or unexpected has happened or has been reported, all staff should treat the incident seriously, immediately consider whether it is a notifiable safety incident (see below) and take appropriate action in line with this policy. 

Definitions

2.1     Apology: An expression of sorrow or regret in respect of a notifiable safety incident.

2.2     Notifiable safety incident: any incident that is unintended or unexpected that results in the death of the person using the service, an impairment of the sensory, motor or intellectual functions of the person using the service which has lasted, or is likely to last, for a continuous period of at least 28 days, prolonged pain or psychological harm, a change to the structure of their body, a shortening of their life expectancy or requirement for treatment by a health care professional in order to prevent either the death or any injury which, if left untreated, would lead to one or more of the outcomes mentioned above.

2.3     Moderate Harm: harm that requires a moderate increase in treatment (e.g. unplanned return to surgery, an unplanned readmission, 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) and which caused significant but not permanent harm.

2.4     Prolonged psychological harm: psychological harm which a person we support experiences, or is likely to experience, for a continuous period of at least 28 days.

2.5     Severe Harm: a permanent lessening of bodily, sensory, motor, physiologic 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 customer’s illness or underlying condition.

2.6    Death: a death directly related to the incident rather than to the natural course of the customer’s illness or underlying condition.

2.7     Relevant person: this is usually the customer i.e., the person who has been affected by the notifiable safety incident. This will be the customer or a person lawfully acting on their behalf (including power of attorney / attorneys for health and care) if the customer/patient has died, is under 16 and not competent to make a decision about their care and treatment or is over 16 and lacks capacity in relation to the matter. 

2.8 Customers: means our service users, clients, residents or people receiving care, support and treatment from us and to which this policy applies.

Responsibilities

3.1    All workers are responsible for following this policy when something unintended or unexpected has happened during the provision of a regulated activity and consider whether it is a notifiable safety incident (see Policy section)

Policy

4.1    The Duty applies to incidents that occur during the delivery of services that are regulated by the CQC and describes what incidents it applies to. The table below uses wording from the Duty of Candour Regulations and accompanying CQC guidance. 

4.2    A ‘Notifiable Safety Incident’ means any unintended or unexpected incident that occurred in respect of a customer during the provision of a regulated activity that in the reasonable opinion of a health care professional, appears to have resulted in one of the harm levels set out in the table below. Where the degree of harm is not yet clear but may fall into the below categories in future, the ‘relevant person’ must be informed of the notifiable safety incident in line with the requirements of the Duty. 

Notifiable Safety Incident
Harm Level Definition
Death The death relates directly to the incident rather than the natural course of the patient’s illness or underlying condition.
Severe Harm A permanent lessening of bodily, sensory, motor, physiologic 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 customer’s illness or underlying condition.
Moderate Harm  Harm that requires a moderate increase in treatment (e.g. unplanned return to surgery, an unplanned readmission, 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) and which caused significant but not permanent harm.
Impairment An impairment of the sensory, motor or intellectual functions of the customer which has lasted, or is likely to last, for a continuous period of at least 28 days.
Prolonged Psychological Harm Experiencing prolonged psychological harm
Prolonged Pain Experiencing prolonged pain 
Structure of body A customer has experienced or is likely to experience changes to the structure of their body.
Life expectancy A customer has or is likely to have a shortening of their life expectancy.
Treatment by a health care professional A customer requires treatment by a health care professional in order to prevent either the death of a customer or any injury to the customer which, if left untreated, would lead to one or more of the outcomes mentioned above. 

4.3    A notifiable safety incident must therefore meet all 3 of the following criteria:

  • 4.3.1    It must have been unintended or unexpected; 
  • 4.3.2    It must have occurred during the provision of an activity the CQC regulate; and
  • 4.3.3    In the reasonable opinion of a healthcare professional, has resulted in death, or harm as outlined in the table above to the person receiving care or treatment. 
  • If any of these three criteria are not met, it is not a notifiable safety incident (but remember that the overarching duty of candour, to be open and transparent, always applies). You should interpret "unexpected or unintended " in relation to an incident which arises in the course of the regulated activity, not to the outcome of the incident. By "regulated activity" the CQC mean the care or treatment provided. By "outcome" the CQC mean the harm that occurred. The presence or absence of fault on the part of a provider has no impact on whether or not something is defined as a notifiable safety incident. 
  •  As soon as reasonably practicable (within 5 working days is best practice but we must act promptly) after becoming aware that a notifiable safety incident has occurred Estuary must:
  • 4.3.4    Notify the ‘relevant person’ (see above) that the incident has occurred and;
  • 4.3.5    Provide reasonable support to the relevant person in relation to the incident, including when giving such notification.

4.4    The Regulations (at 20 (2) – (3) (a) (Health and Social Care Act 2008 (Regulated Activities) Regulations 2014) outline that the notification should be given (a) in person and followed up (b) in writing (unless either step is expressly declined which should be recorded in writing – see below). It is therefore a two-stage notification process.

4.5    The notification referred to above must:

  • 4.5.1    Be given in person (i.e. face to face) by one or more members of staff;
  • 4.5.2    Provide a true account of all the facts known about the incident to date. This will include a step-by-step account of all relevant facts known about the incident at the time. This should include as much or as little information as the ‘relevant person’ wants to hear, be jargon free and staff should explain any complicated terms. The account must be given in a manner that the ‘relevant person’ can understand. For example, staff should consider whether interpreters, advocates, or other communication aids should be used, while being conscious of any potential breaches of confidentiality in doing so.
  • 4.5.3    Advise the relevant person what further enquiries or investigations into the incident will be appropriate and undertaken;
  • 4.5.4    Include an apology, a sincere expression of sorrow or regret (to fulfil the Duty, we must apologise for the harm caused, regardless of fault, as well as being open and transparent about what has happened), and;
  • 4.5.5    Be securely recorded in writing in the notes. This notification must be followed up in in writing by way of a follow up letter to the relevant person.

4.6    The Duty (both in respect of the meeting and follow up letter), will require:

  • 4.6.1    the account, which to the best of our knowledge is true, of all the facts we know about the incident as at the date of the notification;
  • 4.6.2    details of any further enquiries or investigations to be undertaken into the incident we believe are appropriate;
  • 4.6.3    the results or update on any further enquiries or investigations into the incident, and
  • 4.6.4    an apology, a sincere expression of sorrow or regret. 

4.7    Estuary must make every reasonable attempt to contact the relevant person through all available means of communication to provide the notification outlined above. All attempts to contact the relevant person must be documented. If the ‘relevant person’ cannot be contacted or declines to speak to one or more members of staff then paragraphs 4.6 – 4.7 above are not to apply, and a written record is to be kept of the attempts made to contact them or to speak to the ‘relevant person’. If the ‘relevant person’ does not wish to communicate with Estuary, their wishes must be respected and a record of this must be kept.

4.8    If the relevant person has died and there is nobody who can lawfully act on their behalf, a record of this should be kept along with the steps taken in an attempt to identify the same We must still report the incident through the appropriate notifications system and investigate it in order to prevent harm occurring to others.

4.9    Subject to 4.8 and 4.9 above, Estuary must ensure that the written notification is given to the ‘relevant person’ following the notification that was given in person, even though enquiries may not yet be complete.

4.10    The written notification must contain all the information that was provided in person, including an apology, as well as the results of any enquiries that have been made since the notification in person. The outcomes or results of any further enquiries and investigations must also be provided in writing to the relevant person through further written notifications if they wish to receive them.

4.11    Estuary must keep a copy of all correspondence with the ‘relevant person’. 

4.12    In addition to the notification requirements outlined above Estuary must also give the ‘relevant person’ and, if the ‘relevant person’ is not the customer, then the customer themselves all reasonable support necessary to help overcome any physical, psychological and emotional impact of the incident. This could include all or some of the following:

  • 4.12.1    Treating the ‘relevant person’ (and customer if they are not the same person) with respect, consideration and empathy;
  • 4.12.2    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 (if the relevant person consents) – indeed the CQC expects that Estuary would have involved family members and carers in any discussions subject to consent;
  • 4.12.3    Offering help to understand what is being said, for example, through an interpreter, non-verbal communication aids, written information, Braille etc (i.e. information in accessible formats and environmental adjustments for someone who might have a disability);
  • 4.12.4    Providing access to any necessary treatment and care to recover from or minimise the harm caused where appropriate;
  • 4.12.5    Providing the relevant person with details of specialist independent sources of practical advice and support or emotional support/counselling (i.e, signposting to mental health or other services);
  • 4.12.6    Providing the relevant person with information about available impartial advocacy and support services, their local Healthwatch and/or other relevant support groups to help them deal with the outcome of the incident (i.e. the support of an advocate);
  • 4.12.7    Arranging for care and treatment from another professional, team or provider if this is possible, if the relevant person wishes;
  • 4.12.8    Providing support to access the complaints procedure and drawing their attention to other sources of independent help and advice;
  • 4.12.9    Provide information on any planned investigation/ review and ask whether they would like to be involved and how; identify any additional support and/or information needed and clarify what communication they would like and how and provide a single point of contact for communication.
     

Miscellaneous

5.1      It should be noted that Estuary is not required by the Duty to inform a person using the service when a 'near miss' has occurred, and the incident has resulted in no harm to the customer (unless this was as a result of treatment by a health care professional to prevent either the death or one of the harm outcomes outlined above in which case the Duty is still triggered).

5.2      In addition to keeping a record of the written notification in line with the above, staff must also keep a written record of any enquiries and investigations and the outcome or results of the enquiries or investigations.

5.3      Any correspondence from the ‘relevant person’ relating to the incident must be responded to in an appropriate manner and a record of communications should be kept.

5.4     Other than where the ‘relevant person’ is not the customer outlined above, information should only be disclosed to family members or carers where the person using the service has given consent.

5.5     In relation to the notification process outlined above, this should be carried out by one or more staff members (where possible) who are:

  • 5.5.1   Known to, and trusted by, the patient/relatives/carers;
  • 5.5.2   Have a good grasp of the known facts relevant to the incident;
  • 5.5.3   Be senior enough or have sufficient experience and expertise in relation to the type of incident to be credible;
  • 5.5.4  Have excellent compassionate interpersonal skills, avoiding use of medical and other jargon;
  • 5.5.5   Ensure interpreters, non-verbal communication aids, written information, Braille etc.is used as appropriate;
  • 5.5.6   Be willing and able to offer an expression of sorrow or regret.

5.6     Consideration must be given to the confidentiality of all customers, carers and staff, and information disclosure and sharing will be subject to the usual confidentiality and information governance restrictions. Advice can be sought from the Data Protection Officer. Details of an adverse incident or complaint should at all times be considered confidential. The consent of the individual concerned must be sought prior to disclosing identifiable information beyond the teams involved in providing care, unless safeguarding adult, child, legal or criminal concerns are raised. Confidential information may be disclosed to a person acting lawfully on the customer’s behalf under certain circumstances.

5.7      Upon the Duty being engaged, the following bodies should also be notified:

Monitoring and Review

6.1      This policy will be reviewed every 3 years or sooner if changes in legislation require. The process will be led and initiated by the Director of Customer Services.

Support Documentation and Relevant Legislation

7.1      Supporting policies/procedures and documentation:

Corporate Safeguarding Policy

Safeguarding Adults Procedure – Care and Support

Skills for Care Code of Conduct for Healthcare Support Workers and Adult Social Care Workers in England

EHA Code of Conduct for Employees

Health & Safety Policy

Service User Involvement and Consultation Procedure

Data Protection Policy

Complaints and Customer Feedback Policy

Openness and Transparency Policy

  • 7.1.1   Health and Social Care Act 2008 (Regulated Activities) Regulations 2014: Regulation 20;
  • 7.1.2   Regulation 20: Duty of candour, Care Quality Commission Guidance;
  • 7.1.3   The Care Act 2014;
  • 7.1.4   The Health and Social Care Act 2008 (Regulated Activities) Regulations 2014;
  • 7.1.5   The Health and Social Care Act 2008 (Regulated Activities) (Amendment) Regulations 2015;
  • 7.1.6   Mental Capacity Act 2005;
  • 7.1.7   Mental Capacity Act Code of Practice;
  • 7.1.8   Care Act 2014 (Social Care Institute for Excellence);
  • 7.1.9   Care and support statutory guidance, issued under the Care Act 2014;
  • 7.1.10 Mental Capacity Act 2005 Code of Practice;