1. NEXT Being Open: Duty of Candour 2016
This detailed version is for managers, team leads and above.
If this isn’t your role, please complete either:
Being Open: Duty of Candour (overview for clinical staff) 2016 Or
Being Open: Duty of Candour (overview for non-clinical staff) 2016
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2. Being Open: Duty of Candour 2016
This training is aimed at managers, team leads and those above.
Approx. 30 mins
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7. Being Open: Duty of Candour 2016
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8. Background I I Francis Report recommendations:
The Statutory Duty of Candour is set out in Regulation 20 of the Health & Social Care Act 2008 (Regulated Activities) Regulations 2014 which came into effect in November This is supplemented by the Contractual Duty of Candour that has been in effect since 2013.
Francis Report recommendations:
181: statutory obligation to observe a duty of candour on healthcare providers who believe or suspect that treatment or care provided by it to a patient has caused death or serious injury to inform that patient…as soon as practicable and to provide such information as the patient may reasonably request.
182: statutory duty on all directors of healthcare organisations to be truthful in any information given to a healthcare regulator or commissioner, either personally or on behalf of the organisation where given in compliance of a statutory obligation to provide it. I
The Trust’s ‘Being Open’ policy is based upon this new law and subsequent guidance and underpins all Trust communication with service users, relatives and carers to ensure that the Trust meets its obligation by being open and honest about any mistakes that are made in the way we care for and treat our service users. I
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9. Introduction I I “Being Open”/ Duty of Candour involves:
Acknowledging, apologising and explaining when things go wrong.
Conducting a thorough investigation into any incident and reassurance that lesson have been learnt
Providing support for those involved
The legal Duty of Candour now requires the Trust to:
Act in an open and transparent way with service users
Notify them that a notifiable safety incident has occurred within 10 days after the event and providing them with reasonable support in relation to the incident. I
“Promoting a culture of being open in all communication is therefore a prerequisite to providing high quality healthcare and improving patient safety.”
SEPT Policy on communication patient safety events “Being Open”. I
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10. Course bjectives
To understand the legal principles behind ‘Being Open’ and the ‘Duty of Candour’.
To be competent in your knowledge and application of the Trust’s ‘Being Open’ process and documentation requirements.
To be able to implement this knowledge in your practice with different patients and encourage staff in the implementation of this.
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11. Question ‘Being Open’ involves:
Approaching, acknowledging and explaining
Acknowledging, explaining, deterring
Acknowledging, apologising and explaining
Approaching, blaming, explaining
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12. is a request for compensation.
Definitions
Duty of candour
Legal requirement for all clinicians, managers and healthcare staff to inform patient/relatives of any actions which have resulted in moderate or severe harm or death.
Patient safety event
is any unintended or unexpected incident that could have or did lead to harm for one or more patients receiving NHS funded healthcare.
Serious incident (SI)
is a serious incident or near miss which may require further investigation including those reported via Safeguarding Children and Safeguarding Adults procedures.
Definitions
Complaint
is an expression of dissatisfaction received by the Trust verbally or in writing either directly from or on behalf of existing or former service users, carers, relatives, visitors or other users of Trust facilities
Root cause analysis
is a structured approach and reporting system for investigations of patient safety events or incidents.
Claim
is a request for compensation.
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13. Question
What is:
“a structured approach and reporting system for investigations of patient safety events or incidents.”?
Serious Incident (SI)
A complaint
A claim
Root cause analysis
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14. Who has responsibility?
The Trust Board of Directors is fully committed to a culture of providing high quality healthcare and improving patient safety, this embraces the implementation of the principles of the “Being Open” Policy that is on the Trust intranet.
Directors and Senior Management will have responsibility within their own service area for:
Ensuring that the Trust complies with its legal obligations in relation to the Duty of Candour.
Monitoring the implementation of this policy via clinical audit and supervision.
Ensuring staff receive effective training and that they are competent to implement “Being Open” / Duty of Candour principles
Ensure training records are maintained
Ensure that the Risk Management Team is appropriately notified on all Patient Safety Events.
Be able to evidence that SEPT policies have been followed during any level of investigation. I
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15. Who has responsibility?
Managers and other Persons in Charge / Team Leaders / Ward Managers and Senior Sisters, where identified as the nominated Contact point for Service users their families and carers that have been involved in a Patient Safety Event will:
Ensure the procedures and principles of the ‘Being Open’ policy are followed and monitored to meet all relevant guidance.
Follow the ‘Being Open’ process as detailed later in this training. I
All staff have a responsibility to ensure that the principles contained within the ‘Being Open’ policy and associated guidelines are followed; in that they:
Must ensure that they report all patient safety events, complaints or claims to their line manager immediately.
Have an awareness of the “Being Open” Policy.
Have responsibility to ensure as part of continuing professional development they acquire, maintain and disseminate knowledge and skills to carry out where required the principles of “Being Open”.
Through, clinical supervision and post event reviews, can expect to receive support tailored to their individual need. I
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16. The ‘Being Open’ policy and procedures are only relevant to directors.
Question
The ‘Being Open’ policy and procedures are only relevant to directors.
TRUE
FALSE
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17. Notifiable Safety Incidents
A notifiable safety incident is any unintended or unexpected incident that could have, or did, lead to harm for one or more patients receiving NHS funded healthcare.
The Duty of Candour applies where a notifiable safety incident, in the reasonable opinion of a healthcare professional, could result in, or appears to have resulted in:
the death of a service user, where the death relates directly to the incident rather than to the natural course of the service users illness or underlying condition; or
severe harm, moderate harm or prolonged psychological harm to the service user.
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18. Harm Thresholds
Severe harm: permanent lessening of bodily, sensory, motor, physiologic or intellectual functions, including the removal of the wrong limb or organ or brain damage that is directly related to the incident and not related to the service user’s illness or underlying condition
Moderate harm: harm that requires a moderate increase in treatment and significant but not permanent harm.
Prolonged psychological harm: psychological harm which a service user has experienced, or is likely to experience , for a continuous period of at least 28 days
Moderate increase in treatment: unplanned return to surgery, extra time in hospital as an outpatient, cancelling of treatment, or transfer to another treatment area (such as intensive care)
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19. 1 2 3 Ten key Principles Navigation Toolbar Acknowledgement
All notifiable safety incidents should be acknowledged and reported as soon as identified to the person in charge of the area. The person in charge or line manager will agree with the Clinical Manager the person nominated to communicate with the service user, relatives and or carers. 1
Truthfulness, Timeliness and Clarity of Communication
Information must be given in a truthful and open manner by the nominated person who should give a step-by-step explanation of what happened. Communication must be timely and information must be based solely on the facts known at that time and updated with any new information as it emerges. Information must be clear and unambiguous with the nominated person as the single point of contact.
Service user should be given formal notification as soon as reasonably-practicable but within 10 days
And told what further inquiries into the incident are appropriate 2
Apology
A sincere expression of sorrow or regret for any harm that has resulted from an incident must be communicated by a nominated staff member; consideration of the use of an MDT discussion to compliment the apology. Both verbal and written apologies should be given as early as possible by the nominated member of staff. The most important consideration here is not to delay in giving a meaningful apology for any reason, (service users are more likely to seek medico-legal advice if verbal and written apologies are not promptly communicated). 3
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20. 4 5 6 7 Navigation Toolbar Recognising Patient and Carer Expectations
Service users and or carers should be fully informed of the issues surrounding an incident and its consequences, in a face to face meeting with a representative from the Trust. They should be treated sympathetically, with respect and consideration, and provided with support where required to met their needs such as an independent advocate and or translator. Where appropriate, information on the Patient Advisory and Liaison Service (PALS) and other relevant support groups such as Cruse Bereavement Care should be given, as soon as it is possible. 4
Professional Support
The Trust aims to create a culture where all incidents are reported and where staff feel supported throughout the incident investigation process. To this end the NPSA incident decision tree (IDT) as detailed in SI Policy Corporate Procedural Guidelines CP3 is used. Where there is a reason to believe a member of staff has committed a criminal act the Trust will advise staff at an early stage to obtain legal advice and or representation, relevant Trust policies in this process must be followed. 5
Risk Management and Systems Improvement
Root Cause Analysis (RCA) investigations will be used to investigate a patient safety event as per Trust Adverse Incident Policy CP3 and Trust Complaints policy CP2. 6
Multi-disciplinary Responsibility (MDT)
It is important to identify senior managers and senior clinicians to participate in incident investigation and clinical risk management as per Trust Adverse Incident Policy CP3 and complaint investigation as per Trust policy CP2. 7
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21. 8 9 10 Continue Recap 10 Key Principles Navigation Toolbar
Clinical Governance
Findings from investigations are analysed and are disseminated so that continuous learning programmes and audits are developed to allow monitoring of the implementation of changes in practice. A system of accountability is set out within the policy. 8
Confidentiality
Full consideration in respect of confidentiality and privacy must be appropriately maintained. Details of a patient safety incident should at all times be considered confidential. Consent of the individual concerned should be sought prior to disclosing information beyond the clinicians involved in treating the service user. The service user, relatives and or carers will be informed who will be conducting and involved in the investigation before the investigation takes place to give an opportunity to raise any objections. 9
Continuity of Care
Service users 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 service user expresses a preference for their healthcare needs to be taken over by another team appropriate arrangements will be made for them to receive treatment elsewhere. 10
Recap 10 Key Principles
Continue
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22. What response is appropriate?
INCIDENT
LEVEL OF RESPONSE
Patients are not usually contacted or involved in investigations and these types of incidents are outside the scope of the Being open policy.
Individual healthcare organisations decide whether ‘no harm’ events (including prevented patient safety incidents) are discussed with patients, their families and carers, depending on local circumstances and what is in the best interest of the patient.
No harm (including prevented patient safety incident)
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.
Reporting to the risk management team will occur through standard incident reporting mechanisms and be analysed centrally to detect high frequency events. Review will occur through aggregated trend data and local investigation. Where the trend data indicates a pattern of related events, further investigation and analysis may be needed.
Communication should take the form of an open discussion between the staff providing the patient’s care and the patient, their family and carers.
Apply the principles of Being open
LOW HARM
Moderate harm, severe harm or death
A higher level of response is required in these circumstances. The risk manager or equivalent should be notified immediately and be available to provide support and advice during the Being open process if required.
Follow being open principles and the duty of candour process
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23. The Pr cess
“ ‘Being Open’ is a process rather than a one off event…”
SEPT Policy on communication patient safety events “Being Open”.
It is essential that the following DOES NOT occur during the discussion/process:
Speculation
Attribution of blame
Denial of responsibility
Provision of conflicting information from different individuals
Stage 1
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24. Incident detection or recognition
The Pr cess 1
STAGE 1
Incident detection or recognition
The process begins with recognition that a service user has suffered moderate/severe harm or has died as a result of a patient safety event.
Detection and notification through appropriate systems
Prompt and appropriate clinical care to prevent further harm
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25. Preliminary Team discussions
The Pr cess 2
STAGE 2
Preliminary Team discussions
The Multidisciplinary team (MDT), including the most senior health professional involved in the patient safety event should meet as soon as possible after the event.
Initial assessment
Establish timeline
Choose who will lead communication
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26. The initial “Being Open” discussion
The Pr cess 3
STAGE 3
The initial “Being Open” discussion
The initial discussion with the service user, their family and carers should occur as soon as possible after recognition of the patient safety event.
Verbal and written apology
Provide known facts to date
Offer practical and emotional support
Identify next steps for keeping informed
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27. Written Communication
The Pr cess 4
STAGE 4
Written Communication
For cases of moderate, severe harm or death, written notification must follow the initial discussion as outlined in stage 3. The member of staff identified to take this forward should contact the Serious Incidents Department who are responsible for supporting this stage of the process.
This written correspondence must be provided within 10 working days of the incident.
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28. 5 STAGE 5 The Pr cess Follow up discussions
Follow up discussions with the service user, their family and carers are an important step in the process. Depending on the seriousness of the incident and the timeline for the investigation there may be more than one follow up discussion.
Provide update on known facts at regular intervals
Respond to queries
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29. Recap the 6 stage process
The Pr cess 6
STAGE 6
Process completion
After completion of the incident investigation, feedback should take the form most acceptable to the service user. It is expected that in most cases there will be a complete discussion of the findings of the investigation and analysis.
Discuss findings of investigation and analysis
Inform on continuity of care
Share summary with relevant people
Monitor how action plan is implemented
Communicate learning with staff
Recap the 6 stage process
Continue
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30. Further Info The Pr cess
If you have questions regarding this and/or require further guidance, please contact the Serious Incident team:
For a more detailed explanation of the process, please refer to the Being Open Procedure CP36.
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31. Documenting and Recording
All communication surrounding any incident must be recorded within appropriate documentation using Trust guidance.
This will include:
Service user case notes
Ward report book
Complaint files
Claims files
Incident report forms
It is important to record discussions with the patient, their family and carers.
The required patient safety event documentation includes:
A copy of the relevant medical information
Incident reports
Records of the investigation and analysis process I
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32. Documenting and Recording
Written records of the ‘Duty of Candour’ discussions should consist of:
The time, place and date of the meeting
Name and relationships of all attendees
The plan for providing further information to the service user, their family and carers
Offers of assistance and the response from the service user, their family and carers
Questions raised by the family and carers and the answers given
Plans for follow up meetings
Progress notes relating to the clinical situation and an accurate summary of all the points explained to the service user, their family and carers
Copies of letters sent to the service user, their family, carers and GP
Copies of any statements taken in relation to the patient safety event
A copy of the incident report
A copy of the original complaint (where appropriate)
A copy of the original claim (where appropriate)
Failure to make and keep a written record of the notification process could expose the Trust to risk of criminal prosecution.
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33. Question
All communication surrounding any incident must be recorded within appropriate documentation using Trust guidance.
TRUE
FALSE
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34. Healthcare organisations & teams
Benefits of being open
Healthcare organisations & teams
Patients
A reputation of respect and trust for the organisation and/or team
Receive a meaningful apology and explanation when things go wrong
Know that lessons learned from incidents will help prevent them from happening again
Feel their concerns and distress have been acknowledged
Reinforces a culture of openness and gives staff confidence in how to communicate effectively when things go wrong
Reduce the trauma felt when things go wrong
Have greater respect and trust for the organisation
A reputation for supporting staff when things go wrong, with staff feeling supported in apologising and explaining to patients, their families and carers
Reassured that the organisation will learn lessons to prevent harm happening to someone else
Improves the patient experience and satisfaction with the organisation
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35. Patient issues to be considered
A patients death
It is even more crucial that communication is sensitive, empathetic and open. Involve the family and carers in deciding when it is appropriate to discuss what has happened as well as considering the role of a family liaison officer to support this.
An apology should be issues as soon as possible, together with an explanation that the coroners’ process has been initiated. Give a realistic time frame for when more information may be available. I
Patients with cognitive impairment
Where a service user has a condition(s) that limits their ability to understand what is happening to them and they have an authorised person to act on their behalf (Power of Attorney), then the being open discussion should be held with them.
If there is no POA, refer to the Trust Policy MCP01 Mental Capacity Act 2005 to determine the most appropriate person to hold the discussion with. Where possible the patient should still be involved. I
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36. Patient issues to be considered
Patients with learning difficulties
Where a service user has difficulties expressing their opinions verbally and they are not cognitively impaired then in the “Being Open“ process they should be supported by alternative communication methods, (writing questions down etc.) and an advocate should be appointed. These can include carer’s family or friends of the service user. I
Service users with different language or cultural considerations
Before discussing a patient safety event, it would be worthwhile to obtain advice from an advocate or translator on the most sensitive way to discuss the information. The service user’s family or friends should not be used to translate and the employment of professional translators is required. I
Service users with different communication needs
A number of service users will have particular communication difficulties, such as hearing impairment. Plans for the “Being Open” meetings should fully consider these needs. I
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37. Patient issues to be considered
Children
At the age of 16 a child has the right to make decisions about their treatment and their right to confidentiality is vested in them rather than their parents or guardians. It is however considered good practice to encourage children to involve their families in decision making.
Where a child is judged to have cognitive ability and emotional maturity they should be involved directly in the “Being Open” process. Where children are deemed not, consideration needs to be given to whether information is provided to the parents alone. In these instances the parents’ views on the issue should be sought.
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38. Patient issues to be considered
Patients who do not agree with the information provided
Sometimes, despite the best efforts, the relationship can break down. Patients may not accept the information provided or may not wish to participate in the “Being Open” process. In this case, the following strategies may assist:
Deal with the issue as soon as it emerges and where appropriate and the service user agrees involve family and carers from the beginning of “Being Open” discussions;
Write a comprehensive list of the points that the service user; their family and carers disagree with and reassure them you will follow up these issues
Ensure the Line managers and the MDT are made aware of the difficulties at all times
Offer another contact person with whom they may feel more comfortable with
Ensure the service user; their family and carers are fully aware of the formal complaints procedures
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39. What happens if we get this wrong?
Legal Duty of Candour requires openness and specifically requires the notification process to take place in a particular way
If not then the CQC may take regulatory action for breach of a fundamental standard
In extreme cases the Trust could be prosecuted under the criminal law and fined
Individuals who fail to comply may face disciplinary action from their employer or regulatory action from their professional body
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40. serious.incident@sept.nhs.uk 01268 407739
Associated Documents
The Trusts documents of Policy and Procedural Guidance associated with this policy are:
CP2 and CPG2 Complaints Policy and Guidelines.
CP10 Negligence and Insurance Claims Policy.
Adverse Incident Reporting including Serious Incident Policy CP3
Clinical Risk Assessment and Management CLP28
CPG53 (Procedure for Staff on Dealing with Issues of Concern about Health Care Matters)
CP53 (Policy for Staff on Whistle Blowing – Public Concern about Health Care Matters)
Mental Capacity Act 2005 Policy MCP01
These documents can be found on the SEPT intranet site and under the ‘Policies’ tab.
If you have questions regarding this and/or require further guidance, please contact the Serious Incident team:
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41. Remember, if you want to find more information / evidence about this subject or anything else which is relevant to your work or study, join your local healthcare library.
For staff in Essex contact Basildon Healthcare Library.
EX3594 
It may be that you work in a different area,
for example Luton.
Details of all the Health Libraries in the East of England can be found at this site…
You are welcome to join any of these.
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For information on locations, dates, times, availability
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43. Review of Objective(s)
Before completing the test, please ensure you have acquired the relevant knowledge against the modules objective(s) below:
“To understand the principles of ‘Being Open’ and the policies that accompany this.
To be competent in your knowledge and application of the Trust’s being open procedures.”
If not, please take this opportunity to revisit the presentation content.
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