1. In this session we will be looking at best practice for communicating with patients and carers who have been involved in a patient safety incident.
Communicating with patients and/or carers about patient safety incidents - GOLD Workshop

2. Aims To provide an overview of the Being open framework
For participants to be able to put Being open in practice
For participants to learn key skills that underpin effective communication with patients, their families and carers following a patient safety incident.
Notes to Facilitator:
Read the purpose of the session statements from the slide.
Many of the people who you train will already have a certain level of skill and experience in offering apologies and explanations to patients, their families and carers. It is important to recognize this at the outset of the workshop and to state that other participants who have attended the workshop and have previous experience of putting Being open into practice have found it a useful forum to reflect on their current approach to being open and further improve the skills they already have.
Some participants may have less or more limited experience of offering apologies and therefore the course materials along with the discussions within the whole group will enable skills to be developed.

3. Session 1: Background to Being open

4. Key actions from NPSA Patient Safety Alert: (2009)
Local policy
Leadership
Responsibilities
Training and support
Visibility
Supporting patients
Note to the Facilitator:
Explain that the NPSA’s original Being open policy was launched in September The NPSA re-launched the Being open framework, along with a Patient Safety Alert in November Being Open is a set of principles that healthcare staff should use when they communicate with a patient, their family or carer(s) following a patient safety incident where the patient was harmed. The key requirements for NHS organisations from the NPSA’s Patient Safety Alert are:
Local policy: Review and strengthen local policies to ensure they are aligned with the Being open framework and embedded with your risk management and clinical governance processes
Leadership: Make a board-level public commitment to implementing the principles of Being open
Responsibilities: Nominate executive and non-executive leads responsible for leading your local policy. These can be leads with existing responsibilities for clinical governance
Training and support: Identify senior clinical counsellors who will mentor and support fellow clinicians. Develop and implement a strategy for training these staff and provide ongoing support
Visibility: Raise awareness and understanding of the Being open principles and your local policy among staff, patients and the public, making information visible to all.
Supporting patients: Ensure PALS and other staff have the information, skills and processes in place to support patients through the Being open process

5. Being open Framework guidance (2009)
Policy
Principles
Process
Patient issues
Supporting staff
Board leadership
Note to the Facilitator:
Explain that the NPSA’s original Being open policy was launched in September The NPSA re-launched the Being open framework, along with a Patient Safety Alert in November Being Open is a set of principles that healthcare staff should use when they communicate with a patient, their family or carer(s) following a patient safety incident where the patient was harmed. The key requirements for NHS organisations from the NPSA’s Patient Safety Alert are:
Local policy: Review and strengthen local policies to ensure they are aligned with the Being open framework and embedded with your risk management and clinical governance processes
Leadership: Make a board-level public commitment to implementing the principles of Being open
Responsibilities: Nominate executive and non-executive leads responsible for leading your local policy. These can be leads with existing responsibilities for clinical governance
Training and support: Identify senior clinical counsellors who will mentor and support fellow clinicians. Develop and implement a strategy for training these staff and provide ongoing support
Visibility: Raise awareness and understanding of the Being open principles and your local policy among staff, patients and the public, making information visible to all.
Supporting patients: Ensure PALS and other staff have the information, skills and processes in place to support patients through the Being open process

6. Putting Things Right
“The underlying principle of Putting Things Right Is that whenever concerns are raised about treatment and care, whether through a complaint, claim or clinical incident, those involved can expect to be dealt with openly and honestly……..”
Note to Facilitator:
The following background information on Putting Things Right will be useful when presenting this slide:
What is Putting things Right?
From 1st April 2011, the ways in which NHS Wales organisations deal with complaints, claims and incidents (collectively known as concerns) have changed. These new arrangements are set out in the Welsh Assembly Government - NHS (Concerns, Complaints and Redress Arrangements) (Wales) Regulations 2011 and apply to all NHS Wales healthcare providers:
·        Local Health Boards,
·        NHS Trusts,
·        Primary care providers e.g. GPs, dentists, optometrists, community pharmacists and
·        Independent healthcare providers who provide NHS funded care e.g. private hospitals, residential care homes
 By introducing a single and consistent method for grading and investigating concerns, as well as more openness and involvement of the person raising the concern, the new arrangements represent a significant culture change for the NHS in Wales in the way in it manages concerns and how it deals with things that go wrong. The arrangements also introduce the concept of Redress , that is, where a  Local Health Board or NHS Trust receive an allegation that harm has or may have been caused, they have a duty to consider whether an offer of Redress should be made.  
Making the Connections launched in 2004 set out a vision for public services in Wales and made fair redress one of the key customer service core standards. The Welsh Assembly Government further strengthened this approach through the publication  and revision in April 2010 of  Doing Well, Doing Better: Standards for Health Services in Wales.  Standard  23 - Dealing with concerns and managing incidents  requires organisations to look into  concerns promptly and thoroughly and learn from all patient safety incidents. 
The Welsh Assembly Government's commitment to this approach was again outlined in November 2006 through the publication of The Healthcare Quality Improvement Plan (QUIP). In this document effective redress is identified as one of the actions required to provide a high quality health service, which continuously learns and improves.  In this context "redress" describes the fair treatment given to an individual who has suffered because of the actions of any body providing health services, whether through within the NHS or under NHS commissioning arrangements.

7. Contractual ‘duty of candour’ to drive a more open NHS culture
4 December, 2012
New rules to toughen transparency in NHS organisations and increase patient confidence have been announced following public consultation.
The government will create regulations that require NHS England to include a contractual duty of openness in all commissioning contracts from April 2013.
NHS organisations will be required to tell patients if their safety has been compromised, apologise, and ensure that lessons are learned to prevent them from being repeated. Although all NHS organisations are currently expected to be open about mistakes, there is no contractual duty to hold them to account when this does not happen.

8. The benefits of Being open
Note to Facilitator:
The learning objectives of the benefits of Being open session are to:
Teach participants why being open is important and the right thing for patients and carers.
Help participants to identify what is good practice following a patient safety incident.
The session uses a video clip of a mother whose child had a cochlear implant operation performed on the wrong ear to teach the learning objectives specified above. In the video clip the mother describes how the healthcare team involved in her child’s care reacted after it became apparent that the operation had been performed incorrectly.
As a facilitator you will need to:
Ensure that the mpeg files for the 2 video clips are saved in the same folder as your powerpoint presentation on your laptop.
Ensure that you have good quality speakers plugged into your laptop to ensure that the video clip is audible to the audience.
Ensure that there is flip chart paper and pens available for participants to write down their responses during the session.
Explain the format of the session (refer to the Facilitator’s Handbook) and read out the background information on the events that led to the child having the operation on the wrong ear.

9. Patient/carer testimony 1
Note to Facilitator:
Read out the description of the events that led to the operation being performed on the wrong ear.
Brief the participants that you will be playing them a video of a mother who is sharing her experiences of how a healthcare team responded when it became apparent that a wrong site surgery operation had been carried out on her child.
State that the video clip relates to a real incident and is the mother’s testimony.
Brief participants that you want them to watch the video clip and will then be carrying out a group exercise linked to it afterwards.
Click on the black outline of the photo on the screen to start the video clip.

10. Effects of patient safety incidents
On patients and/or carers
What would be your feelings and concerns if the patient was a member of your family?
What three things do you think patients and/or carers involved in this type of incident would want most?
On healthcare professionals
How would you feel if you had been one of the healthcare professionals involved?
What three things do you think healthcare teams involved in this type of incident would want most?
As the facilitator you need to explain the format of the group work session.
Split the group into smaller groups of six-eight people and allocate half of the groups as patients/carers and the other half as healthcare professionals.
State that the patients/carers groups have 15 minutes to discuss the two questions on the slide.
Each group should capture their responses on the flip chart paper. After fifteen minutes ask one member of each group to feedback on their groups discussion. As the facilitator you should point out:
That some of the feelings and concerns felt by healthcare teams and patients/carers are similar or the same.
That the top 3 things identified relate to common themes including an apology, explanation of what went wrong, single point of communication, investigation and systems change and information on what if anything can be done to medically redress the harm.

11. Patient/carer testimony 2
To round off this session a second video clip is played.
In this video clip, the mother in question describes how she would have liked the healthcare team involved in her son’s care to have reacted differently after it became apparent that the operation had been carried out on the wrong side.

12. What patients want The English public want:
34% an apology or explanation
23% an enquiry into the causes
17% support in coping with the consequences
Less important were:
11% financial compensation
6% disciplinary action
Source: MORI survey commissioned for the ‘Making Amends’ report, DOH, 2002
State that international research on being open/open disclosure shows that patients and carers usually want an apology, explanation of what went wrong, investigation and support in coping with the consequences of the incident.
On this slide the findings from a survey of 400 patients who had been harmed as a result of their healthcare treatment are shown. The survey was carried out as part of the Chief Medical Officers Making Amends consultation. The findings show that when asked what was most important to them in the aftermath of an incident, patients responded that it was an apology and explanation, enquiry into the causes and support in coping with the consequences of the incident. Less important were financial compensation and disciplinary action against individual healthcare professionals.
Notes to Facilitator:
Make the link between the groups responses in the video-based exercise and the findings on this slide.

13. What patients want A full apology and tangible support
(Idema et al., 2008)
Information on the nature, cause and prevention of errors and emotional support
(Gallagher et al., 2003)
Notes to Facilitator:
State that there is also a growing body of research evidence from around the world that supports the Making Amends study’s findings about what patients want. For example, Iedema et al. (2008) found that patients want full and tangible support. Similarly a study by Gallagher which compared doctors and patients expectations about open disclosure showed that patients want information on the nature, causes and prevention of errors and emotional support, and that there was a mismatch between patients expectations and what doctors thought they should discuss.
At this point you may also want to refer to research which has shown the positive impact being open has on claims and complaints. Some examples from around the world are listed below. However, please emphasise that the NPSA and other organisations endorse being open because it is the right and humane way to respond when things go wrong, not because it has a positive impact on claims and complaints.
There are also case studies which demonstrate how open disclosure and improving patient safety can have economic benefits. Examples include:
The Mater Hospitals, Brisbane, Australia – the hospitals have noticed a significant reduction in claims with savings of nearly $2 million AUD over four years, and a substantial return on investment9.
A large, academic hospital in Singapore – there has been a reduction in the number of claims after implementing their system for handling serious incidents. In the past two years, they have had no cases proceed to litigation, with estimated savings of approximately $500,000 SGD per year10.
The University of Michigan Hospital System – the full-disclosure programme has halved the number of pending lawsuits resulting in a total average annual savings of $2 US million11.
A full list of key references can be found at the back of the Facilitator’s Guide

14. Being open and legal liability
Mater Hospitals, Brisbane, Australia. Significant reduction in claims with savings of nearly $2 million AUD over four years
Singapore: large academic hospital: no cases that proceeded to litigation for 2 years. Estimated savings of $500,000 SGD
University of Michigan: full disclosure programme halved the number of pending lawsuits. Average annual saving of $US 2 million
Explain that one of the barriers to being open amongst healthcare professionals is the belief that saying sorry to patients, their families and/or carers is an admission of legal liability. This is not true and to implement being open across the NHS we need to dispel this widely held myth.

15. Endorsement for Being open by the Welsh Risk Pool
‘In Wales we have sought to explain that NHS bodies and
their clinicians can, and in many cases should, provide
apologies and explanations and that this would not
compromise their NHS indemnity in any way. When it is
clear that treatment should have been better or an adverse
outcome prevented, the patient or, where appropriate,
their relatives should receive a sincere and meaningful
apology and an honest explanation…’
John Bowles, Manager. Welsh Risk Pool (2009)
Endorsement for Being open by the Welsh Risk Pool by John Bowles, speaking at the re-launch of the NPSA’s Being open framework in 2009.
Note to Facilitators:
This slide applies to Wales only
When presenting this slide it is important to emphasise that organisations like the Welsh Risk Pool and NHSLA had issued technical circulars as far back as 2002 encouraging healthcare staff to offer apologies and explanations.

16. Organisations supporting the Being open principles

17. Key elements of the Being open framework
This part of the first session aims to give participants some background information on the NPSA’s Being open framework.
Introduce this part of the session by explaining to workshop participants that you will now give them some background information on being open

18. 10 Principles of Being open
The Being open policy is based on the ten key principles listed on this slide. P 14 of guidance
Read the principles from the slide. Full information on what each principle means is found in the Facilitator’s Guide. See a briefer summary of each principle below:
Principle of acknowledgement All patient safety incidents should be acknowledged and reported as soon as they are identified. In cases where the patient, their family and/or their 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 staff. Denial of a patient’s concerns will make future open and honest communication more difficult.
Principle of truthfulness, timeliness and clarity of communication Information about a patient safety incident must be given to patients, their families and/or their carers in a truthful, timely 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. Patients and/or their 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 medical jargon, which they may not understand, should be avoided.  
Principle of apology Patients and/or their carers should receive a meaningful apology –one that is a sincere expression of sorrow and 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. Both verbal and written apologies should be given. Verbal apologies are essential because they allow face-to-face contact between the patient, their families and/or their carers and the healthcare team. They should be given as soon as staff are aware an incident has occurred. A written apology, which clearly states that the Trust is sorry for the suffering and distress resulting from the incident, must also be given.
Principle of recognising patient and carer expectations Patients and/or their 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 hospital. They should be treated sympathetically, with respect and consideration. Confidentiality must be maintained at all times. Patients and/or their carers should also be provided with support in a manner appropriate to their needs, such as an independent patient advocate or a translator.
Principle of professional support Staff must feel supported throughout the incident investigation process because they too may have been traumatised by being involved. They must not be exposed to punitive disciplinary action, increased medico-legal risk or any threat to their professional registration. Where there is reason to believe a member of staff has committed a punitive or criminal act, the Trust will take steps to preserve its position, and advise the member(s) of staff at an early stage to enable them to obtain separate legal advice and/or representation. Staff may seek support from relevant professional bodies such as the General Medical Council, Royal Colleges, the Medical Protection Society, the Medical Defence Union and the Nursing and Midwifery Council.
Principle of risk management and systems improvement Root cause analysis (RCA or similar systematic incident investigation techniques) should be used to uncover the underlying causes of a patient safety incident. Investigations should focus on improving systems of care, which will then be reviewed for their effectiveness. The Being Open policy must be integrated into local incident reporting and risk management policies and processes.
Principle of multidisciplinary responsibility Any local policy on openness applies to all staff who have key roles in patient care. Most healthcare provision involves multidisciplinary teams. This should be reflected in the way that patients, their families and carers 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. To ensure multidisciplinary involvement in the Being Open process, it is important to identify clinical, nursing and managerial staff who will champion it. Both senior managers and senior clinicians must participate in incident investigation and clinical risk management.
Principle of 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. The findings will be disseminated to staff so that they can learn from patient safety incidents.
Principle of confidentiality Policies and procedures for being open should give full consideration of, and respect for, the privacy and confidentiality of patients, their carers and staff. 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.
Principle of continuity of care Patients are entitled to expect that 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 treatment elsewhere.

19. Overview of Being open process
P 18 of guidance The Being open process involves:
Detecting that a patient safety incident has occurred and determining the level of being open response required, which is assessed using the known or expected severity of patient harm.
Holding a preliminary team discussion (i.e. a meeting between healthcare professionals to plan the initial Being open meeting with the patient and/or carer). Emphasise that it is important to seek advice from Senior Clinical Counsellors and/or the Governance Department/Risk Management Team before the preliminary team discussion takes place because they can provide advice and guidance.
The initial Being open discussion between the selected healthcare professional(s), the patient, their family and/or carer(s) that should take place at the earliest opportunity. The initial being open discussion should include a verbal and written apology, a summary of the facts known to date, an offer of practical and emotional support and decisions about what the next steps are to keep patient, their family and/or carer informed about the progress of the incident investigation.
Being open is not a one off event: it is a process which takes account of the needs of the patient, their family and/or carers.
The follow-up being open discussion with the patient, their family and/or carer(s) that emphasises that the Being open process is not a one-off event and provides an opportunity to provide the patient, their family and/or carer with an update on known facts and answer questions and concerns they have raised at agreed intervals/timescales.
Completing the being open process by ensuring that the main findings from the incident investigation are shared and information on continuity of care is provided to the patient, their family and/or carers.
Completing the being open process also involves actions for healthcare teams in terms of ensuring action plans that are developed on the basis of incident investigation findings are monitored and that the key findings are shared with all relevant stakeholders to ensure lessons are learnt to prevent a recurrence of the incident as far as possible.
Documenting being open discussions with patients, their family and/or carers and ensuring that incident investigation reports are stored appropriately.

20. Grading of patient safety incidents to determine level of response
P 21 of guidance
In the NPSA’s 2009 Being open framework, the level of being open response required is determined by the known or expected level of harm to the patient. In the figure shown on this slide note that the levels of harm shown are NPSA classifications and that the Trust’s own terminology may be different.
A Patient safety incident: any unintended or unexpected incident that could have or did lead to harm for one or more patients receiving NHS funded healthcare. The terms ‘patient safety incident’ and ‘prevented patient safety incident’ are used to describe ‘adverse events’/‘clinical errors’ and ‘near misses’ respectively.
Note to facilitator:
Explain that the NPSA’s being open framework places no formal requirement on healthcare staff to have being open discussions with patients, their families and/or carers where no harm occurred. Case by case judgement should be used to determine the benefits of being open.
Where low harm occurred, the being open discussion should be managed locally by the healthcare team and the principles of being open applied during the discussion.
Where moderate, severe harm or death occurred a more formal type of being open discussion is required which involves setting up a formal meeting with the patient, their family and/or carers. This involves applying the Being open process.

21. Key learning points - session 1
Being open is what patients, their families and carers want to happen when an incident occurs
Organisations like the NHSLA, WRP, MDU, MPS, GMC, RCN and others all support Being open
Offering an apology is not an admission of legal liability
There are ten Being open principles
The level of Being open response is determined by an initial assessment of the severity of patient harm
Read the key learning points from this slide

22. Session 2: Putting Being open into practice
State that the remainder of the workshop will focus on the practical aspects of being open.

23. Bill and the wrong prescription
This section is based on a video clip that demonstrates both good and not-as-good aspects of an initial Being open discussion with the family of deceased patient, Bill. The first scene, which you will be using now, shows a consultant gastroenterologist, Dr Moore informing the family of Bill’s death and opening an initial being open discussion with the family ten days later.

24. Nick Oliver and the blood transfusion

25. Key learning points - session 2
Most patients want:
Acknowledgment that there has been an error
An apology (sincere, verbal and written)
An explanation
Information on what, if anything, can be done to repair the harm
Reassurance that, as far as possible, you will try to prevent recurrence
Choose an appropriate lead; Consider being accompanied
Establish a relationship
Ask what people are feeling and need; Don’t assume
Don’t be afraid to say you don’t know yet
Offer and arrange a key contact
Read the key learning points for the session from the slide. These learning points consolidate what participants have been taught throughout the session.

26. Session 3: Discussing the incident, outlining the next steps and completing the process
Introduce Session 3 by explaining that you will be focusing on how to discuss the incident and outline the next steps in this session.

27. Bill and the wrong prescription
The video clip continues the Being open conversation with Bill’s family. For this session, the conversation is focused on phase two of the overall Being open conversation, which is ‘discussing the incident’.

28. Tom Slater and the laryngectomy
This exercise involves actors role playing a conversation between a ambulance manager and a lady called Mrs Slater, whose husband, Tom Slater, has died as a result of a patient safety incident.
In the scenario, you will see the actors role play the discussing the incident and outlining the next steps part of a being open conversation.
As the facilitator you will need to read out the script which describes the background to this incident and forum theatre piece. You will also need to:
Explain how the forum theatre exercise works
Advise the participants to watch the actors role play the script and to identify what goes well and what needs to be improved in the being open conversation between Mrs Slater and the ambulance manager.
Advise participants that their role in the forum theatre is to act as ‘directors’ directing the actor who plays the healthcare professional how to improve the non-verbal and verbal elements of the conversation.

29. Process completion 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
Notes to Facilitator:
The being open process is completed when the actions on the slide have been carried out. Note that some of the bullet points mentioned on this slide will have been discussed in the Tom Slater scenario because workshop participants tend to bring them up as this scenario is delivered. Where this has occurred, refer back to the Tom Slater scenario to make links between what the trainees have directed the actors to do and the key points listed on this slide.
Key points to note when presenting this slide are:
Discuss findings of investigation and analysis (i.e. that if further being open discussions take place, the same format should be used to carry out these discussions). All further being open discussions should be documented in line with the requirements of the trust’s local Being open policy.
Inform on continuity of care (i.e. if the healthcare team has not already done so, they should discuss continuity of care with the patient)
Share summary with relevant people (for example, other healthcare providers treating the patient or the coroner when a patient has died).
Monitor how action plan is implemented (i.e. where an incident has occurred the Trust will develop an action plan and it is important that this is monitored over time.
Communicate learning with staff (i.e. it is important that the learning from the incident investigation and being open process is shared with other members of the healthcare team).

30. Key learning points - session 3
Being open helps patients / carers deal with the effects of a patient safety incident
Being open is a process, not a one off event
Avoid making assumptions about what people are feeling and thinking. Ask; Use open ended questions
Stick to the facts as they are known
Document Being open discussions
Speak to patients, families and carers as you would wish to be spoken to yourself, i.e. openly and honestly
Read the key learning points for the session from the slide. These learning points consolidate what participants have been taught throughout the session.

31. Any questions?
Further information can be found at:
Notes to Facilitator:
As you close the session and signpost workshop participants to further information, state that the workshop workbook has a summary of the Being open process on the back page.