Being open policy – Rotherham Doncaster and South Humber NHS Foundation Trust (RDaSH)

1 Introduction

Being open refers to the processes for communicating adverse events with patients, families, and carers. It is the opportunity to say sorry at the onset.

Duty of candour refers to the volunteering of all relevant information to persons who have or may have been harmed by the provision of services, whether the information has been requested and whether a complaint or a report about that provision has been made.

The principles of being open and the duty of candour provide a structure and process for communicating with people in the right way when an incident has occurred. The Care Quality Commission (CQC) also set out expected standards required by healthcare providers in Regulation 20 Duty of Candour (Health and Social Care Act (2008) (Regulated Activities) Regulations, 2014).

Hard Truths (DH, 2014) acknowledges that the professional values of individual clinicians are critical in ensuring an open culture. This means that along with incidents being reported, we should act in an open and transparent way when an incident has occurred.

All Rotherham, Doncaster and South Humber NHS Foundation Trust (RDaSH) staff should be aware of their professional and statutory roles and responsibilities when an incident occurs, and this means being open and honest with the relevant people.

The trust recognises that a culture of openness and honesty creates a positive learning environment where teams and individuals can be involved in improving care and sharing those improvements. Transparency is key in producing an open-minded safety culture.

1.1 The 10 principles of being open and actions

When something goes wrong, openness and honesty is welcomed by patients and being open is the right thing to do. Being open is a process rather than a one-off event and is underpinned by 10 principles. The process should be applied in all patient safety incidents and the details of this can be found in appendix A the 10 principles of being open, for information and guidance and appendix B for the NHS resolution, saying sorry leaflet (2019).

1.2 Duty of candour, an introduction

When an incident is more serious, it is more important that the being open principles are followed, and the actions completed. It is a statutory duty for all NHS bodies to be open, honest, and candid when a patient is harmed. There is an offence of giving false or misleading information. The duty is overseen by The Care Quality Commission (CQC).

The trust has integrated the process for capturing, recording and managing the duty of candour within the on incident reporting form (incident reporting system).

The criteria that must be met to fulfil the duty are listed in appendix B, duty of candour criteria and requirements

1.3 The relevant person

The regulation defines the relevant person as the patient, the patient may also request that a suitable person acts on their behalf making them both relevant people. This person may or may not be a relative but will be a person the patient has trust in and who they have agreed to be involved in their care.

In certain situations such as when a patient dies or is incapacitated, this extends to people acting lawfully on their behalf.

2 Purpose

The purpose of this policy is to set out the arrangements and legal requirements for open and honest communication following an incident, complaint or claim in compliance with the being open principles and duty of candour requirements.

Good communication is a vital component of dealing with incidents and errors and it is a legal and professional duty of all health care professionals to communicate openly and honestly with a patient’s family and, or carer(s) when something goes wrong with care and treatment.

3 Scope

This policy applies to all clinical staff and staff who have a key role in sharing information with the relevant people following an incident.

Incidents which come under the patient safety incident investigation (PSII) criteria are investigated under the incident management policy and are therefore not specifically covered by this policy.

4 Responsibilities, accountabilities and duties

4.1 The trust

Having policies and procedures in place to support best practice, effective management, service delivery, management of associated risks and meet national and local legislation and, or requirements.

Ensuring that there are systems in place that do not obstruct anyone from exercising the duty.

4.2 Executive director, with lead responsibility

The chief nurse is the lead executive director for this policy. They are responsible for the effective management of clinical risk, by liaising with the care group directors who are responsible for the effective management of clinical risk within the trust’s clinical services.

This will include responsibility for ensuring being open principles and duty of candour are appropriately applied to the review and management of incidents, complaints, and claims.

They will also ensure that there are appropriate systems in place to share learning.

4.3 Care group directors, nurse directors, service managers and modern matrons

All care group directors, care group nurse directors, deputy care group directors, heads of corporate service and matrons are responsible for the dissemination and implementation of this policy within their departments.

They are also responsible for creating an environment within their services where open, timely and clear communication and information sharing is encouraged in line with the being open principles and duty of candour requirements. This includes ensuring staff are aware of the system for reporting incidents and ensuring that appropriate staff are trained in the principles and procedure relating to being open and the duty of candour.

4.4 Patient safety, carer and community lead (medical devices safety officer and patient safety specialist)

The patient safety, carer and community lead is responsible for providing support to directors, care group nurse directors, deputy care group directors, head of corporate services and matrons to facilitate the effective implementation and monitoring of this policy.

They will ensure that the principles of being open, and requirements of the duty of candour are discussed and embedded as part of the learning process for incidents.

Any breaches in the duty will be reported to care group directors and the integrated care board (ICB).

4.5 Duty of candour lead

When an incident has been identified, a nominated person takes responsibility for employing the principles of the duty of candour. This person is usually the manager of the team or service involved in the incident but will be decided by the modern matron or deputy care group directors, heads of corporate services. This person will remain involved throughout the process and ensure findings are fed back to the relevant people.

4.6 Lead investigator, patient safety incident investigations (PSIIs)

Any member of staff nominated to investigate an incident should comply with this policy and where appropriate, involve the patient and, or their carers and other relevant teams and organisations (for example where patient care extends beyond the trust) investigation. For further information see the trust incident management policy.

The lead investigator should maintain contact with the duty of candour lead throughout the investigation. The team manager or service manager has a key role in ensuring the findings are shared.

4.7 Medical devices and duty of candour officer (MDDCO)

The medical devices and duty of candour officer (MDDCO) is responsible for the day-to-day monitoring of the duty of candour process and will monitor the incident reporting system for incidents which trigger the duty of candour. They will produce reports and provide staff with advice about the process. See appendix L for further information.

4.8 All staff

All staff should comply with the principles of being open and the requirements of the duty of candour with patients and, or their carers as outlined in this policy.

Staff should report all incidents promptly and clearly to ensure that the appropriate actions can be taken to ensure an open and honest culture.

5 Procedure

5.1 Reporting the incident

The required process is outlined in the flow chart at appendix D duty of candour step by step and appendix E.

When any incident occurs, the members of staff involved are to complete an incident report using the incident reporting system. This report identifies whether the incident is a patient safety incident, and the level or harm that occurred as a result of the event.

In some cases, the incident may not initially involve trust staff or the incident may be reported to staff by someone else; such as a patient, visitor or other organisation. These are also to be reported on the incident reporting system, including in the report all information that is available.

5.2 Being open actions

The actions required to comply with the being open process can be found in appendix A, the 10 principles of being open.

5.3 Notifiable patient safety incident

The definition of a “notifiable safety incident” which will trigger the duty of candour, is any unintended or unexpected incident in the provision of a regulated activity which, in the reasonable opinion of a healthcare professional, could result in, or appears to have resulted in, moderate or severe harm or death or “prolonged psychological harm”. The definitions of “moderate” and “severe” harm are consistent with those used within the NHS for reporting under the national reporting and learning system and the existing contractual duty under the NHS standard contract. Near misses are not notifiable safety incidents.

Minor treatment is defined as first aid, additional therapy, or additional medication. It does not include any extra stay in hospital or any extra time as an outpatient, or continued treatment over and above the treatment already planned; nor does it include a return to surgery or readmission.
Moderate increase in treatment is defined as a 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 area such as intensive care as a result of the incident.
Permanent harm directly related to the incident and not related to the natural course of the patient’s illness or underlying condition is defined as permanent lessening of bodily functions, sensory, motor, physiological or intellectual, including removal of the wrong limb or organ, or brain damage.
The death must be related to the incident rather than to the natural course of the patient’s illness or underlying condition.

More detail can be found in the actual harm grading scale at appendix F which includes psychological harm.

The trust has integrated the process of capturing, recording and managing the duty of candour into its incident reporting system. All staff responsible for the duty of candour, or incident investigation, should be aware of how to undertake the duty of candour process using the system.

Within the incident reporting system form is a record of the perceived actual impact (harm) caused. If this is recorded as moderate harm or above for a patient safety incident, then the incident has triggered the duty of candour.

In some cases, the presence of psychological harm caused by the incident will not be recognised until after the 28-day period. In these cases, a new incident report is required documenting the presence of psychological harm from the original incident.

Moderate patient safety incidents reported as safeguarding incidents will be processed via the usual safeguarding enquiry proceedings to prioritise patient safety. Police investigations may also supersede usual duty of candour procedures when the investigation may be external to the trust.

5.4 Duty of candour actions

All patient safety incidents require the being open actions to be carried out. If, however, the incident is of such a severity that the duty of candour applies, then further actions are required. These further actions follow on from the being open actions and are:

5.4.1 As soon as possible after the incident

Offer and provide support to the relevant people after the incident, throughout the review and ongoing as required.
The duty of candour lead is to meet the relevant person, in person (if possible), and inform them that the incident has occurred, apologise, inform them what happened as far as we are aware and what actions are to be taken next.
The date and details of this contact are recorded on the incident reporting system in the duty of candour “relevant person contacted” section by the duty of candour lead.
If contact is not possible, for example, there is no relevant person or the person is clinically unwell, this is entered onto the incident reporting system.

5.4.2 First letter within 10 working days of the incident

Share with the patient and, or relevant person, in writing, the original notification and the results of any further enquiries.

This should include:

all the information given verbally during the face-to-face meeting
an apology
any further information that has come to light since the meeting
an outline of the review that is in progress
any relevant support details

The duty of candour letter template available at appendix G reflects a scenario and can be adapted to meet individual needs. These templates are guides only and the letter should be personal and relevant to the case.

The date the letter was sent or given to the relevant person should be recorded on the incident reporting system in the duty of candour “written explanation” section by the duty of candour lead. If contact is not possible, for example, there is no relevant person or the person is clinically unwell, this is entered onto the incident reporting system.

On rare occasions, it may not be possible for the letter to be sent within 10 working days. In these instances, an explanation must be given for reporting purposes and a record of the reason should be made. This will be reported to the care group directors and the integrated care board by the patient safety, carer and community lead.

5.4.3 Review and feedback within 60 working days of the incident

Feedback should be facilitated by the duty of candour lead with the lead investigator as they will have had the most recent contact with the relevant people.

Written feedback should be offered to the relevant person. The final investigation report should be concise, in an appropriate format to meet the requirements of the relevant person and should be restricted to the incident.
The findings from the review can be fed back in letter format. This is the responsibility of the duty of candour lead. A template for this is available in appendix H. If staff have not been in recent contact with the patient or family, a query letter can be used to determine if they require the report (see appendix I).
If the incident has undergone a full patient safety incident investigation (PSII) investigation, the feedback may be provided as either a full copy of the PSII report or a shorter version may be preferrable. A covering letter template is available in appendix K.
The final duty of candour report should be concise, easy to understand by the relevant person and restricted to the incident. If the patient or family have made a complaint, the duty of candour feedback may be given in the form of a complaints response to reduce duplication.
This can be a distressing time for patients, families and carers especially where a death has occurred. It is acknowledged that those involved may not wish to receive a report in any format. Where this is the case, a record of the conversation should be made, and the incident reporting system should be updated to acknowledge this.
The date actions were taken, notifications given, letters sent and outcomes are to be recorded with the initial incident on the incident reporting system form by the duty of candour lead or the lead investigator.

The timescales for each review will follow the standard requirements as identified in the incident management policy unless agreement to extend the timeframe has been accepted by all concerned.

See the flow chart at appendices D and E.

5.5 Mortality review

In the event of a death being logged on a mortality form, an appraisal will take place by the mortality operational group (MOG). Any incidents where the trust may have caused harm are then escalated to the weekly learn from patient safety events (LFPSE) group for discussion and duty of candour can be triggered if appropriate. If duty of candour is triggered, the mortality form will be re-entered as an incident form. The duty of candour letter is required within the usual timeframe of 10 working days from the LFPSE meeting date.

5.6 Specific guidance

5.6.1 Provide an explanation

In keeping with the principles of being open, for non-notifiable incidents the member of staff involved should provide the patient or significant other with a full explanation of what is known at the time, including what further action is to be taken. This can be given by another member of staff if it is decided that this would be more beneficial. Staff should speak to their manager for advice about how to approach this if they are unsure.

The relevant person should be kept abreast of what will happen and should be given the opportunity to be involved as much as they wish.

5.6.2 Information to be shared

Communication should be timely, informing the patient and, or their carer what has happened as soon as is practicable.

A step-by-step account of all relevant facts known about the incident at the time should be given, in person, by one or more appropriate representatives of the trust. This should:

include as much or as little relevant information as the relevant person or people want to hear
be jargon-free and explain any complicated terms in line with the accessible information standards
include an explanation of any further planned enquiries and reviews
be given in a manner that relevant person or people can understand, for example, staff should consider if appropriate interpreters, advocates, communication aids and so on, should be present, but should be conscious of any potential breaches of confidentiality in doing so

5.6.3 Review of the duty of candour incident

All relevant incidents should be reviewed by an appropriate manager using system based principles in regard to care provided, actions and lesion learned. The level and depth of the review will be in line with the seriousness of the incident and where a patient safety incident investigation is required, the incident will be reviewed by the lead investigator from the patient safety team (see incident management policy).

This appropriate manager becomes the duty of candour lead.

In many cases the review will be immediate and short with the apology, explanation and results of the review being delivered all at the same time.

In other cases these may be three distinct stages, the apology, the explanation, and the results of the review.

The process for reviewing the incident should be explained to the patient and, or their carer informing them that they will be kept up to date as any new information emerges as a result of any review.

The Investigator for the incident is responsible for liaising with and providing information in a timely, truthful and open manner to the patient and, or carer in line with the agreed investigation process.

5.6.4 De-logging patients safety incident investigations

An incident that requires review is logged on the incident reporting system. There will be occasions where the incident and report will be de-logged, for example when a patient safety incident investigation or other review finds that the trust caused no harm to the patient. Where the duty of candour process has begun, it should always be followed through with the relevant people and letter outlining the findings should be provided.

5.6.5 Provision of additional support as required

Patients and or their carers should also be provided with support in a timely manner to meet their needs. This may involve an independent advocate or an interpreter. Information on the patient advisory and liaison service (PALS) and other relevant support groups should be given as soon as possible. The offer of additional support and the outcome should be recorded. It should be borne in mind that the need for support may change throughout the review process.

There should also be recognition of the traumatic effect that adverse outcomes and their aftermath might have on NHS staff as well as patients and their relatives.

5.6.6 Patients who do not agree with the information provided

Sometimes, despite the best efforts of staff, the relationship between the patient, their family and carers and the healthcare professional breaks down.

They may not accept the information provided, may desire a higher level of review, or may not wish to participate in the process. In this case, the following strategies may assist:

where the patient consents, ensure their family and carers are involved in discussions from the beginning
write a comprehensive list of the points that the patient, their family, and carers disagree with and reassure them you will follow up these issues
offer the patient, their family and carers another contact person with whom they may feel more comfortable, this could be another member of the team or a manager from another team or service
use a mutually acceptable mediator to help identify the issues between the healthcare organisation and the patient, and to look for a mutually agreeable solution
ensure the patient, their family and carers are fully aware of the formal complaints’ procedure

5.7 Special considerations

The being open approach may need to be modified according to the individual patient or personal circumstances, for example (but not restricted to):

when a patient dies
patients who have a cognitive impairment and may lack capacity
patients with a different language or cultural considerations
patients with different communication needs
children and young people
when there is a corresponding criminal enquiry

5.7.1 When a patient dies

When an incident has resulted in a patient death it is crucial that communication is sensitive, empathetic, and open. A verbal apology will be given as soon as possible after the patient’s death. It is particularly important to consider the emotional state of bereaved relatives or carers and to involve them in deciding when it is appropriate to discuss what has happened.

A written notification and apology from the duty of candour lead should follow (see letter template, appendix G)

Usually, the being open discussion and any review will occur before the coroner’s inquest. In some circumstances the trust may consider it more appropriate to wait for the coroner’s inquest before holding the being open discussion with the family and or carers. It is important to explain that they will be kept informed as information is released from the coroner’s office.

In most instances where someone dies it can be unclear if the services provided by the trust were at fault and whether duty of candour should be applied. See below for further detail:

if death is reported to be due to natural causes, duty of candour is not applicable
the main provider of care is not the trust, duty of candour is not applicable.

Where a suicide or child death has taken place, these incidents will always trigger the duty of candour. Where the child death is due to natural causes, duty of candour does not apply.

Note, in all cases, duty of candour is only applicable if the death occurs while the patient is receiving regulated care (NHS funded care) or within 6 months of them being discharged from care.

5.7.2 Where there is no identified relevant person

Where no contact details have been recorded or updated in the clinical record and, or the relevant person cannot be easily identified, staff should ask the coroner, general practitioner or other official body if they can provide contact details. This can then be recorded on the incident reporting system as “other relevant person not identified” but it should later be recorded on the incident reporting system if contact is made. A clear record should be made of the attempts to contact the relevant person along with any reasons why contact has not been made.

Where staff are unclear, they should seek advice from management.

5.7.3 Patients who have a cognitive impairment and may lack capacity

Wherever possible the patient will be involved in communications about what has happened. An advocate with appropriate skills should be available to the person to assist in the communication process.

It would be worthwhile to obtain advice from an advocate or translator before the meeting on the most sensitive way to discuss the information. Avoid using “unofficial translators” and or the patient’s and, or carers as they may distort information by editing what is communicated. Refer to the interpreters policy (provision, access and use of, for patients, service users and carers).

5.7.4 Patients with different communication needs

Some patients will have particular communication difficulties, such as a hearing impairment. Plans for the meeting should fully consider these needs. Knowing how to enable or enhance communications with a patient is essential to facilitating a process, focusing on the needs of individuals and their families and being personally thoughtful and respectful.

5.7.5 Children and young people

The trust’s Safeguarding Children team can provide advice related to assessing and managing risks in relation to children and young people and child protection, including information-sharing with other agencies See also trust safeguarding children policy and multiagency safeguarding children procedures.

The legal age of maturity for giving consent to treatment is 16. It is the age at which a young person acquires the full rights to make decisions about their own treatment and their right to confidentiality becomes vested in them rather than their parents or guardians. However, it is still considered good practice to encourage competent children and young people to involve their families in decision-making.

The courts have stated that younger children who understand fully what is involved in the proposed procedure can also give consent (known as Gillick competence). Where a child is judged to have the cognitive ability and the emotional maturity to understand the information provided, he or she should be involved directly in the being open process after an incident. The opportunity for parents to be involved should still be provided unless the child expresses a wish for them not to be present.

Where children and young people are deemed not to have sufficient maturity or ability to understand, consideration needs to be given to whether information is provided to the parents alone or in the presence of the child. In these instances the parents’ views on the issue should be sought.

5.8 Documenting all communication

A clear and contemporaneous record must be maintained of all communication. It is important throughout the being open process that records of discussions with the patient and, or their carers as well as the incident review are maintained.

The initial apology and explanation given should be documented in the incident reporting system form, and in-depth detail recorded in the patient’s record.

The incident reporting system form will be the main record repository for duty of candour processes, with copies of letters and written notes being scanned and uploaded into the system.

Once the relevant person has been informed in person about the notifiable or patient safety incident, the trust must provide the relevant person with a written note of the discussion, and copies of all correspondence must be kept by the trust, along with any enquiries or reviews, and the outcome or results of those enquiries or reviews. A record of such communications should also be included in the patient record, incident reporting system and complaints and patient safety incident investigation files where applicable.

Any routine day to day “being open” communication such as an incident outside the duty of candour and the remit of the above policies will be recorded in the patient’s health record.

Staff should make every reasonable effort to contact the relevant people through various communication means. All attempts to contact the relevant people should be documented. If the relevant person declines to contact the trust, their wishes should be respected and a record of this kept.

Good documentation is crucial. Discussions around the time of an incident should be recorded in the patient records. Any subsequent meetings should have minutes taken and followed up by letter.

The outcomes or results of any enquiries and reviews should also be provided in writing to the relevant people, should they wish to receive them. Any correspondence from relevant persons relating to the incident should be responded to in an appropriate and timely manner and a record of communications kept.

5.9 Next steps

The relevant person should be advised on what further enquires are appropriate and they should be given all reasonable opportunities to be involved as much as they wish to be in the progress of any enquiries.

New information may emerge during the course of any review into the incident, and the relevant people must be informed of new information as it arises. The trust must keep the relevant people informed about the conclusions of our enquiries, and provide them with a single point of contact for any questions and further opportunities to discuss the case:

on an ongoing basis throughout the course of their continuing recovery and, or treatment, and during any review or inquiry
at times and amounts of their choosing until they are satisfied that all relevant information has been disclosed

5.10 Continuity of care

Patients are entitled to expect they will continue to receive all usual treatment and continue to be treated with respect and compassion. If a patient expresses a preference for their healthcare needs to be taken over by another team, the appropriate arrangements should be made for them to receive the treatment elsewhere.

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

When a patient or service user 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.

5.11 Practical support

In line with the expectations of all staff regardless of any incident, patients will be provided with all reasonably practical and emotional support necessary to help overcome the physical, psychological and emotional impact of the incident. At a direct level this will include:

treating all patients and their families with respect, consideration and empathy
offering the option of immediate emotional support during the notifications, for example from a family member, a care professional or a trained advocate
offering access to help with understanding what is being said, for example, via interpretative services, non-verbal communication aids, written information, Braille
in line with the accessible information standards

In addition, staff will be supported by relevant process and individuals within the trust to:

offer access to any necessary remedial treatment to minimise the harm caused
provide information about available impartial advocacy and support services, local health watch and other relevant support groups, such as cruse bereavement care and action against medical accidents (AvMA), to help them deal with the outcome of the incident
arrange for care and treatment to be delivered by another professional or team or provider as far as reasonably practical, should the relevant people wish.

5.12 Support for staff

During the course of their duties, trust staff may find themselves involved in an incident. This can be distressing, and staff may require support. This should be provided via the team manager who will identify the relevant level of support and assist the staff member to access this in a timely manner. This could be via occupational health, or informal arrangements within the trust.

6 Training implications

Whilst there are no mandatory training needs in relation to this policy, the Care Quality Commission set out expected standards required by healthcare providers in Regulation 20 Duty of Candour (Health and Social Care Act 2008 (Regulated Activities) Regulations, 2014). Training is required for:

lead investigators who will have contact with patients, their families and carers during the course of their review
any other individual or group with a responsibility for implementing the contents of this policy
all clinical staff who during the course of their work will have direct contact with patients their carers

Training sessions will be delivered through the learning and development department to raise awareness of the duty of candour for managers, including how to record duty of candour compliance on the incident reporting system. All training attended should be recorded on the NHS electronic staff record (ESR).

As a trust policy, all staff need to be aware of the key points that the policy covers. Staff can be made aware through a variety of means such as:

one to one or supervision
team brief
weekly newsletter
team meetings
trust wide email notices
group supervision

7 Monitoring arrangements

7.1 Number of duty of candour incidents

How: safeguard output report.
Who by: medical devices and duty of candour officer (MDDCO).
Reported to: trust patient safety, carer and community report to Quality Committee.
Frequency: monthly.

7.2 Open duty of candour incidents

How: email feedback.
Who by: medical devices and duty of candour officer (MDDCO).
Reported to: care group directors.
Frequency: monthly.

8 Equality impact assessment screening

To access the equality impact assessment for this policy, please email rdash.equalityanddiversity@nhs.net to request the document.

8.1 Privacy, dignity and respect

The NHS Constitution states that all patients should feel that their privacy and dignity are respected while they are in hospital. High Quality Care for All (2008), Lord Darzi’s review of the NHS, identifies the need to organise care around the individual, “not just clinically but in terms of dignity and respect”.

As a consequence the trust is required to articulate its intent to deliver care with privacy and dignity that treats all service users with respect. Therefore, all procedural documents will be considered, if relevant, to reflect the requirement to treat everyone with privacy, dignity and respect, (when appropriate this should also include how same sex accommodation is provided).

8.1.1 How this will be met

No issues have been identified in relation to this policy.

8.2 Mental Capacity Act (2005)

Central to any aspect of care delivered to adults and young people aged 16 years or over will be the consideration of the individual’s capacity to participate in the decision-making process. Consequently, no intervention should be carried out without either the individuals informed consent, or the powers included in a legal framework, or by order of the court.

Therefore, the trust is required to make sure that all staff working with individuals who use our service are familiar with the provisions within the Mental Capacity Act (2005). For this reason all procedural documents will be considered, if relevant to reflect the provisions of the Mental Capacity Act (2005) to ensure that the interests of an individual whose capacity is in question can continue to make as many decisions for themselves as possible.

8.2.1 How this will be met

All individuals involved in the implementation of this policy should do so in accordance with the guiding principles of the Mental Capacity Act (2005).

9 Links to any other associated documents

10 References

Hard Truths (2014) Department of Health.
NHS Resolution (NPSA) (2017) Saying sorry when things go wrong: being open.
The 10 principles of being open adapted From National Patient Safety Agency (NPSA) (2009).
NPSA (2009) Being open: communicating patient safety incidents with patients their families and carers following a patient safety incident.
Report of the Mid Staffordshire NHS Foundation Trust Public Enquiry (2013).
Care Quality Commission (CQC) guidance regulation 5 and regulation 20, November 2014.

11 Appendices

11.1 Appendix A 10 principles of being open

11.1.1 Acknowledgement

All patient safety incidents should be acknowledged and reported as soon as they are identified. Notify and apologies to the patient or relevant person, verbally or face to face where possible unless the person cannot be contacted or declines notification. In cases where the patient, their family and carers inform healthcare staff when something untoward has happened, it must be taken seriously from the outset. Any concerns should be treated with compassion and understanding by all healthcare professionals.

11.1.2 Truthfulness, timeliness and clarity of communication

Information about a patient safety incident must be given to patients, their families, and carers in a truthful and open manner by an appropriately nominated, person. Patients should be provided with a step-by-step explanation of what happened, that considers their individual needs and is delivered openly. Communication should also be timely; patients, their families and carers should be provided with information about what happened as soon as practicable. It is also essential that any information given is based solely on the facts known at the time. Healthcare professionals should explain that new information may emerge as an incident investigation is undertaken, and that patients, their families and carers will be kept up to date with the progress of an investigation. Patients, their families, and carers should receive clear, unambiguous information and be given a single point of contact for any questions or requests they may have. They should not receive conflicting information from different members of staff, and the use of medical jargon, which they may not understand, should be acknowledged.

11.1.3 Apology

Patients, their families, and carers should receive a meaningful apology, one that is a sincere with expression of sorrow or regret for the harm that has resulted from a patient safety incident. This should be in the form of an appropriately worded and agreed manner of apology as early as possible. Where the death or injury of a person has occurred, an apology does not constitute an admission of liability or unsatisfactory professional performance.

A decision should be made as to who is the most appropriate member of staff to give both verbal and written apologies to patients, their families, and carers. The decision should consider seniority, relationship to the patient, and experience and expertise in the type of patient safety incident that has occurred. Verbal apologies are essential because they allow face-to-face contact between the patient, their family and carers and the healthcare team. This should be given as soon as staff are aware an incident has occurred. A written apology, which clearly states the healthcare organisation is sorry for the suffering and distress resulting from the incident, must also be given. It is important not to delay giving a meaningful apology for any reason,

including: setting up a more formal multidisciplinary being open discussion with the patient, their family and carers if required; fear and apprehension; or lack of staff availability. Delays are likely to increase the patient’s, their families and their carers’ sense of anxiety, anger or frustration.

11.1.4 Recognising patients, families, and carers expectations

Patients, their families and carers can reasonably expect to be fully informed of the issues surrounding a patient safety incident, and its consequences, in a face-to-face meeting with representatives from the healthcare organisation. They should be treated sympathetically, with respect and consideration. They should also be provided with support if they require it, in a manner appropriate to their needs.

When communicating with relatives and when appropriate, the issue of consent should also be considered and any discussion in relation to the patient wishes should be clearly documented.

11.1.5 Professional support

All staff, whether directly employed or independent contractors, should report patient safety incidents and staff should feel supported throughout the incident. They should not be unfairly exposed to punitive disciplinary action, increased medico-legal risk, or any threat to their registration.

The Just Culture Guide (NHS Improvement, 2018) supports a conversation between managers about whether a staff member involved in a patient safety incident requires specific individual support or intervention to work safely.

11.1.6 Risk management and systems improvement

The trust investigation process will be used to identify any causes of a patient safety incident.

11.1.7 Multidisciplinary responsibility

Most healthcare provision is through multidisciplinary teams. This should be reflected in the way that patients, their families, and other relevant people are communicated with when things go wrong. This will ensure that the being open process is consistent with the philosophy that incidents usually result from systems failures and rarely from the actions of an individual.

11.1.8 Clinical governance

Being open requires the support of patient safety and quality improvement processes through clinical governance frameworks in which patient safety incidents are investigated and analysed to find out what can be done to prevent their recurrence. These findings should be disseminated to healthcare professionals so that they can learn from patient safety incidents.

Within the trust, monitoring and reporting is carried out through the incident reporting system.

11.1.9 Confidentiality

Being open should give full consideration of, and respect for, the patient’s, their families and other relevant people’s and staff privacy and confidentiality. Details of a patient safety incident 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, in line with the Care Quality Commission’s guidance for outcome 20. Where this is not practical, or an individual refuses to consent to the disclosure, it may still be lawful if justified in the public interest, or where those investigating the incident have statutory powers for obtaining information.

Communications with parties outside the clinical team should also be on a strict need to know basis and, where practicable, records should be anonymous. In addition, it is good practice to inform the patient, their family and carers about who will be involved in the investigation before it takes place and give them the opportunity to raise any objections.

11.1.10 Continuity of care

Patients are entitled to expect that they will continue to receive all usual treatment and continue to be treated with dignity, respect and compassion. If a patient expresses a preference for their healthcare needs to be taken over by another team or person, the appropriate arrangements should be made for them to do so.

Please note, the being open approach may need to be modified according to the individual patient or personal circumstances, for example (but not restricted to):

when a patient dies
when there is no identified ‘relevant person’
patients in the community
patients who have a cognitive impairment and may lack capacity
patients with a different language or cultural considerations
patients with different communication needs
children and young people
when there is a corresponding criminal enquiry (see section 5.7 special considerations)

11.2 Appendix B duty of candour criteria and requirements

In order to meet this duty the trust must:

act in an open and transparent way with relevant persons in relation to care and treatment provided to people who use our services in carrying on a regulated activity
tell the relevant person, in person, as soon as reasonably practicable after becoming aware that a notifiable patient safety incident (PSI) has occurred and provide support to them in relation to the incident, including when giving the notification
provide an account of the incident, which to the best of its knowledge is true, of all the facts that it knows about the incident as at the date of notification
advise the relevant person what further enquiries it believes are appropriate
offer an apology
follow this up by giving the same information in writing and providing an update on the enquiries
keep a written record of all communication with the relevant person.
the Care Quality Commission will monitor compliance with the key requirements with respect to the duty of candour
there should be a board-level commitment to being open and transparent in relation to care and treatment
candour, openness and honesty should be encouraged at all levels, as an integral part of a culture of safety that supports organisational and personal learning
providers should take action to tackle bullying, harassment and undermining, and must investigate any instances where a member of staff may have obstructed another in exercising their duty of candour
staff should receive appropriate training, and there should be arrangements in place to support staff who are involved in a notifiable patient safety incident
there is no formal deadline under the regulation for notifying the relevant person of an incident, but the guidance refers to the NHS standard contract provision which requires notification within ten working days of the incident being reported and sooner where possible
where the degree of harm is not yet clear but may fall within the criteria in the regulation (death, severe harm, moderate harm or prolonged psychological harm) the relevant person must still be informed of the incident in line with the regulations
although there is a requirement to investigate incidents which “could result in” harm as described above, the Care Quality Commission state that there is no need to inform a person under the regulation when a “near miss” has occurred, resulting in no harm to that person
where the incident relates to care delivered by another provider, the trust would work with others, and that provider would then be responsible for notifying the relevant person of the incident
there is guidance as to what constitutes “reasonable support”, for example, third party emotional or advocacy support, arranging further treatment, where necessary by a different team or provider, and providing support to access the trust complaints procedure
where, despite reasonable attempts, the relevant person cannot be contacted, or does not wish to communicate with the provider (including historic incidents) a written record should be kept of the attempts to contact or speak with them

11.4 Appendix C duty of candour staff flow diagram

Duty of candour applies where incidents cause moderate or severe harm, or death (via learn from patient safety events group) (being open policy appendix G for actual harm grading scale).
For all other incidents, even if they are no harm or low harm, an apology or “being open” should be given to the patient or relevant person and details of the event should be.
Being open: discussion with patient or relevant person within 48 hours of incident occurring or in case of delayed identification, as soon as possible after identification. Record the disclosure or discussion with patient, or relatives in records and incident form.
Initial duty of candour: ideally face to face, or by phone must take place and then followed up in writing within 10 days (DOC1) of incident by agreed lead professional. The sharing of appropriate leaflets is part of the written process.
Communication: agreed professional will give information, support and outline the review process or timescale to patient or family. Identify if and when they would like to meet and anything they may wish to be included as part of the review. Agree method or frequency of communication. Should patient or family prefer not to engage please record in notes and on incident form.
Documentation: record decision or communication in patient’s records and on incident form duty of candour (DOC) tab. DOC1 letter templates are available in being open policy (appendix G and H).
Final duty of candour: following the review, if there has not been recent contact with patient or family, a query letter can be sent to see if feedback is required (appendix J). The final report or DOC2 letter is shared with patient or family with an opportunity for them to feedback. Templates are available in being open policy (appendix I and K). Incident form duty of candour tab is updated. The duty of candour is now closed.

11.4 Appendix D duty of candour step by step

Provide initial verbal apology and explanation of what happened as far as is known at that time.
Complete incident reporting system and record the conversation in the relevant section of the form.
Inform manager as soon as practicable.
Offer patient or relevant person support during and after the process, including, but not limited to, interpreters, advocates, counselling, self-help groups, transfer of care to another team, and so on.

11.4.1 Within 10 working days the manager must

Nominate a lead to comply with the duty of candour.
Notify patient that incident has occurred, this must be:
- in person (if possible)
- include an apology, what happened and what is going to happen next, review
- be delivered by a suitable manager from the service involved
- be followed by written notification
- be recorded in the duty of candour section on the incident reporting system form

Within 60 working days of the incident (extend if patient safety incident investigation or similar) the line manager must:

carry out a review and provide a explanation of the events and circumstances which resulted in the incident
provide and maintain written records of the interactions with the patient or relevant person
provide a copy of the review report to the patient or relevant person, this report has to be approved for release and suitably redacted if required
offer patient or relevant person support after the process, including, but not exclusively, counselling, self-help groups, transfer of care to another team, and so on, also the patient feedback and complaints process

11.5 Appendix E process flowchart

Patient safety incident occurs.
Being open at the time of the Incident.
Ensure the safety of those involved and the area, assist as required.
Provide verbal apology and explanation of what happened as far as is known at that time.
Advise and, if possible, agree with the patient what further enquiries are appropriate.
Report as an incident on the incident reporting system and record the conversation in the relevant section of the form.
Provide reasonable support to the patient or service user, their families, or carers.
Was the severity of harm moderate, major, catastrophic or death? or psychological harm over 28 days?
No, duty of candour does not apply, but being open initiative applies to all patient safety incidents.
Yes, Within 10 working days the allocated manager must Notify patient that incident has occurred. This should be:
- delivered by a suitable manager from the service involved
- in person
- include all known facts about the incident
- include a repeat apology
- include next steps
- be followed by written notification
- be recorded in the duty of candour section of the incident reporting system
- commence an investigation into the incident
Within 60 working days (If the incident is being reviewed as a patient safety incident investigation, or an external review, then the 60-day limit may be exceeded) of the incident the manager must:
- carry out a review to provide a explanation of the events and circumstances which resulted in the incident
- keep the patient or relevant person informed of progress during the review
- provide and maintain written records of the interactions with the patient or relevant person
- provide an explanation and offer a copy of the investigation report to the patient or relevant person, this report has to be approved for release and suitably redacted if required
- offer patient or relevant person support during and after the process, including, but not exclusively, counselling, self-help groups, transfer of care to another team, and so on. Also the patient feedback and complaints process, incident is now complete

11.6 Appendix F actual harm grading scale

11.6.1 Actual harm grading scale: physical harm

11.6.1.1 No harm (1)

Incident prevented, any patient safety incident that had the potential to cause harm but was prevented, and no harm was caused to patients receiving NHS-funded care.
Incident not prevented, any patient safety incident that occurred, but no harm was caused to patients receiving NHS-funded care.
Minimal injury requiring no or minimal intervention or treatment.
No time off work.

11.6.1.2 Minor (2)

Minor injury or illness, requiring minor intervention.
Minor treatment is defined as first aid, additional therapy, or additional medication.
Increase in length of hospital stay by 1 to 3 days.
Requiring time off work for greater than 3 days.

11.6.1.3 Moderate (3)

Injury requiring a 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 area such as intensive care as a result of the incident.
Semi-permanent injury taking up to 12 months to recover.
Increase in length of hospital stay by 4 to 15 days.
Reporting of injuries, diseases and dangerous occurrences regulations (RIDDOR) reportable incident.
Requiring time off work for 4 to 14 days.

11.6.1.4 Major (4)

Major injury leading to long-term incapacity or disability.
Increase in length of hospital stay by greater than 15 days.
Requiring time off work for greater than 14 days.

11.6.1.5 Catastrophic (5)

Permanent harm directly related to the incident and not related to the natural course of the patient’s illness or underlying condition is defined as permanent lessening of bodily functions, sensory, motor, physiological or intellectual, including removal of the wrong limb or organ, or brain damage.
Multiple permanent injuries or irreversible health effects.

11.6.1.6 Death (6)

The death must be related to the incident rather than to the natural course of the patient’s illness or underlying condition.
Death as a result of an incident classified as a “never event”.

11.6.2 Specific harm grading scale

11.6.2.1 Minor (2)

Pressure ulcers:

patient develops trust acquired pressure ulcer category 1 or 2 or a moisture lesion

Falls:

fall causing harm that resolves within one month, for example, scalp laceration

Medication errors:

medication error resulting in patient harm which resolves within 1 month, for example, increased dose of antihypertensive administered in error which requires additional BP monitoring

11.6.2.2 Moderate (3)

Pressure ulcers:

trust acquired category 3 or 4 pressure ulcer, multiple trust acquired category 2 pressure ulcers causing significant affects judged to be moderate

Falls:

fall causing harm that takes 1 to 12 months to resolve, for example, fractured humerus, seriousness of the incident or affects is judged to be moderate

Medication errors:

medication error resulting in patient harm that takes 1 to 12 months to resolve seriousness of the incident or affects is judged to be moderate

11.6.2.3 Major (4)

Pressure ulcers:

multiple trust acquired category 3 or 4 pressure ulcer

Falls:

as moderate, but judged to be a major harm

Medication errors:

as moderate, but judges to be a major harm

11.6.2.4 Catastrophic (5)

Pressure ulcers:

pressure ulcer resulting in sepsis and sepsis recorded on death certificate

Falls:

fall causing an injury which contributes to patient death, for example, recorded on part 2 of death certificate or causes permanent harm or permanent disability, for example, fractured neck of femur

Medication errors:

medication error which contributes to patient death, for example, failure to reconcile cardiac medication contributing to patient death

11.6.2.5 Death (6)

Falls:

fall leading to injury that directly causes death of patient

Medication errors:

medication incident directly resulting in patient death, for example, medication administered to which the patient had a known allergy and administration results in death

11.6.3 Psychological harm

No psychological harm: distress is inherent in being involved in any patient safety incident, but please select this option if there is no specific psychological harm over and above this.

Low psychological harm: low psychological harm is when at least one of the following apply:

distress that did not, or is unlikely to affect the patient’s normal activities for more than a few days
distress that did not, or is unlikely to need extra treatment beyond a single GP, community healthcare professional, emergency department or clinic visit
distress that did not or is unlikely to result in a new mental health diagnosis or a significant deterioration in an existing mental health condition

Moderate psychological harm: moderate psychological harm is when at least one of the following apply:

distress that did or is likely to affect the patient’s normal activities for more than a few days but is unlikely to affect the patient’s ability to live independently for more than six months
distress that did or is likely to need a course of treatment or therapy sessions that extends for less than six months
distress that did or is likely to result in a new mental health diagnosis, or a significant deterioration in an existing mental health condition, but where recovery is expected within six months

Severe psychological harm: severe psychological harm is when at least one of the following apply:

distress that did or is likely to affect the patient’s normal activities or ability to live independently for more than six months
distress that did or is likely to need a course of treatment or therapy sessions that continues for more than six months
distress that did or is likely to result in a new mental health diagnosis, or a significant deterioration in an existing mental health condition, and recovery is not expected within six months

11.11 Appendix K cover letter for patient safety incident investigation report template

Refer to appendix K: cover letter for patient safety incident investigation report template (staff access only).

11.12 Appendix L monitoring and management process

Day numbers refer to days after the incident is reported.

Incident is reported.
System emails manager, patient safety, carer and community lead (PSCCL), and medical devices and duty of candour officer (MDDCO).
Manager moderates the incident report.
Duty of candour (DOC) incident added to duty of candour monitoring spreadsheet (MDPO). Exceptions to be raised with patient safety, carer and community lead (PSCCL).
If duty of candour section on incident reporting system is not commenced, notification email to be sent to duty of candour lead or manager to inform that it is a duty of candour and what is required (MDDCO).
Day 10 incident marked as “RED” on spreadsheet if no contact or letter. Phone to remind manager or duty of candour lead if no contact and, or letter recorded on the incident reporting system (MDDCO). Reason for delay is recorded. If still not completed, this would be escalated to care group director and integrated care board (PSCCL):
- patient safety incident investigation (or external report), patient safety incident investigation report due date entered onto the incident reporting system as target date for report (MDDCO). Once known, patient safety incident investigation investigator is entered on incident reporting system as duty of candour lead for the incident (MDDCO). Weekly check of live patient safety incident investigation cases to confirm progress of report (MDDCO). Once patient safety incident investigation report completed and reviewed by integrated care board, email patient safety incident investigation investigator to chase up final feedback to patient or family (MDDCO). If report is not forthcoming escalate to PSCCL (MDDCO). Escalate to PSCCL, care group director, or head of quality and promises in monthly report
- not patient safety incident investigation, after action review or SWARM et cetera day 60 email duty of candour lead to remind about report (MDDCO). Chase on a monthly basis (MDDCO). Escalate to PSCCL, care group director, or head of quality and promises in monthly report (MDPO)

Assistance and advice can be called for at any time in this process from the patient safety, carer and community lead (PSCCL) or medical devices and duty of candour officer (MDDCO).

Document control

Version: 9.
Unique reference number: 319.
Ratified by: risk management group.
Date ratified: 5 August 2025.
Name of originator or author: patient safety, carer and community lead.
Name of responsible individual: chief nurse.
Date issued: 11 August 2025.
Review date: August 2028.

Page last reviewed: August 21, 2025
Next review due: August 21, 2026

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