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National Training Programme

Open Disclosure Workshop Manual Communicating with Patients

Following Patient Safety Incidents

Reference Number NATOD-TR-001

15th January 2020 Version 5

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Table of Contents

Page

Part Contents

3

1

Introduction and Background

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2

An Overview of Open Disclosure and the Principles

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3

Open Disclosure: The Drivers

19

4

Legal Considerations and Legislation

27

5

The Patients Perspective

33

6

The Clinicians Perspective

37

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The Open Disclosure Process

43 8 Summary Evaluations and Close

44 47 50 52 54 57 61

Appendix A: Role Pay Scenarios Appendix B: List of Resources available to support staff Appendix C: State Indemnity Appendix D: Sample Language Appendix E: Summary of the HSE Open Disclosure Policy June 2019 Appendix F: Quotes from Professional, Indemnifying and Regulatory Bodies Appendix G: Patient Safety (Notifiable Patient Safety Incidents) Bill 2019: Notifiable Incidents

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Part 1: Setting the Scene: Introduction and Background

Introduction: Hello and welcome. My name is ……….. and I would like to welcome you to this 4 hour workshop on open disclosure, also known as open communication. We will be discussing how to communicate with patients/service users and their family/relevant person(s) following patient safety incidents. This revised programme has been developed by the Health Service Executive (HSE) with the support of the Medical Protection Society (MPS) as part of the national implementation of the open disclosure policy and programme across all health and social care services in the Republic of Ireland. The HSE acknowledges the strategic support provided by the State Claims Agency and their initial support over a number of years in setting up and delivering the national open disclosure programme. Please note that the term “patient” as used in this workbook includes services users, clients and residents of HSE and HSE funded services i.e. all people who access and use our services.

The HSE is dedicated and committed to providing safe and high quality health care to patients . However, as

professionals working in health and social care services we are not infallible. Our desired outcome for

patients and their families/relevant persons is not always the final outcome. There are many variables in our

work and sometimes, despite our best plans and efforts, things can go wrong. In some instances our actions

may have impacted on the end result, but not always.

It is the policy of the HSE that incidents are identified, managed, disclosed and reported and that learning is

derived from them. We want our services to support an open, timely, compassionate and consistent

approach to communicating with patients and their families/relevant persons when things go wrong in

relation to their healthcare. This is called open disclosure. Open disclosure is the professional, ethical

and human response to patients and their families involved in and/or affected by patient safety

incidents.

The national open disclosure programme has been developed to ensure that:

(i) open disclosure happens,

(ii) all persons involved in or affected by patient safety incidents are provided with adequate

support including patients, their families/relevant persons, staff and organisations.

(iii) a standardised framework is provided for the management of open disclosure discussions

(iv) all staff are aware of their professional, regulatory, legal and ethical

obligations/requirements in relation to engaging in open disclosure.

Sharing your individual experiences and learning in the safe environment provided will enhance

this programme for everyone.

Please do not hesitate to ask questions and/or seek any clarification required

Enjoy the programme !

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Programme Facilitators:

Your course facilitators today are:

1:………………………………

2:………………………………

3:………………………………

Background:

Open disclosure is not a new concept. Prior to this programme and the launch of the national documents in November 2013 the HSE did not have a national open disclosure policy or programme in place. There was little training available for staff. The practice of open disclosure was not standardised/consistent across services. There were inadequate support mechanisms in place for staff and for patients/service users involved in and/or affected by patient safety incidents. There was no protective legislation in place to protect and support staff engaging in open disclosure discussions with patients and their families. All of this has now changed.

What lead up to the development of the national open disclosure policy and subsequent implementation programme?

In January 2007, Mary Harney, Minister for Health & Children at the time, established the Commission on Patient Safety and Quality Assurance (“the Commission”) and instructed it, among other tasks, “to develop clear and practical recommendations which would ensure the safety of patients”.

In July 2008, the Commission completed its report entitled “Building a Culture of Patient Safety”. The report was published in August 2008 and approved by Government in January 2009. In her foreword to the report, chairperson Dr. Deirdre Madden states…

“When such adverse events occur there must be a system in place that ensures that all those affected are informed and cared for, and that there is analysis and learning from the error to try and prevent the recurrence of such an event”.

Dr. Madden further records the objective of the Commission, namely,

“to make recommendations for organisational, regulatory and educational reform which will create a culture of patient safety for our health system”.

Certain recommendations were made in this report in relation to open disclosure which included as follows:

National Standards on open disclosure to be developed and implemented Legislation to be enacted to provide legal protection for staff engaging in open disclosure

discussions with patients and their families Open communication/open disclosure training to be made available for all healthcare

professionals Support and counselling programmes to be provided for all parties involved in/affected by

adverse events in health care More research to be conducted into the impact of adverse events on patients and families.

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On 27th January 2009, Government approved the Commission’s report and the Minister for Health & Children at that time authorised the setting up of a Steering Group with a remit to drive the implementation of all the recommendations of the Commission’s report as effectively and efficiently as possible.

What happened next? A national open disclosure programme was commenced in October 2010 with national leads recruited – this was a joint initiative between the HSE and the SCA with the support of the MPS. A pilot programme was commenced in October 2010 in two acute hospitals – The Mater Misericordiae University Hospital, Dublin and Cork University Hospital – this pilot was completed in October 2012. Utilising the learning from the pilot programme and learning from international best practice the national documents including a national policy, national guidelines, patient information leaflet, staff support booklet and staff briefing document were developed in 2013. These documents, following wide consultation nationally, were launched officially by Health Minister at the time, Dr James Reilly, in November 2013 and are available on the open disclosure website www.opendisclosure.ie Implementation of the open disclosure policy across all health and social care services commenced in 2013 and is ongoing. Implementation has involved significant collaborative inter agency working. An independent evaluation of the pilot programme was completed and published in June 2016. This report is available to download on www.hse.ie/opendisclosure or www.opendisclosure.ie. The HSE Open Disclosure policy was revised in June 2019 to align with (i) the provisions of Part 4 of the Civil Liability (Amendment) Act 2017, (ii) the 2018 regulations accompanying Part 4 of the Civil Liability (Amendment) Act 2017, (iii) the Assisted Decision Making (Capacity) Act 2015, (iv) the HSE Incident Management Framework 2018 and (v) to meet the relevant recommendations pertaining to open disclosure in the report by Dr Gabriel Scally “Scoping Inquiry into the CervicalCheck Screening Programme” published in September 2018. Promoting HSE values during open disclosure The principles of open disclosure encompass (1) the HSE values of care, compassion, trust and learning, (ii) HSE Values in Action, (iii) #hellomynameis (iv) what matters to you and (v) nothing about me without me. Openness and transparency with patients involves empathy and compassion, an acknowledgement and apology/expression of regret, an agreed plan for ongoing care, agreed actions to address what has happened and to ensure that learning has occurred in an effort to try to reduce the likelihood of a recurrence of the adverse event. Openness, transparency and honesty instill patient trust in staff and organisations. “Compassion is the key. While empathy is the tendency to feel others’ emotions and take them on as if you were feeling them, compassion is the intent to contribute to the happiness and well-being of others. Compassion, therefore, is more proactive. A Chinese proverb says, “There is no way to compassion; compassion is the way.” Bringing compassion into any interaction you have and asking how you can be of benefit to others is the way to compassion. Compassion is something we create by applying it to every interaction we have”. (Hougaard et al 2018)

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Background

Recommendations: “Building a Culture of Patient Safety 2008” Joint HSE/SCA approach supported by MPS Pilot October 2010- March 2013 Launch of national documents November 2013 On-going roll out of policy and programme across all health and social care

services since 2013 – national training programme – area and site leads

Independent evaluation of pilot programme published in 2016

Background (continued)

QAVD audit of x 4 early adopter sites in 2016 Matters arising in Cervical Check Screening Programme 2018 and Scally

Report and Recommendations September 2018 Protective legislation: Commencement of Part 4 of the Civil Liability

Amendment Act 2017 – September 2018 Establishment of National OD Office and National Steering Committee

2018-2019 Interim Revision of HSE National Open Disclosure Policy launched in June

2019

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Part 2: An Overview of Open Disclosure and the Principles ________________________________________________________________________________ The objectives of this part of the workshop are as follows:

Attendees will have an informed knowledge of the meaning/definition of open disclosure and patient safety incidents.

Attendees will be clear that not all patient safety incidents are as a result of errors/failures in the delivery of care.

Attendees will understand the importance of communicating with patients following patient safety incidents.

Attendees will have an informed knowledge of the principles which govern the open disclosure process and how open disclosure relates and contributes to quality, risk and patient safety generally.

Attendees are clear as to why these open disclosure principles are being advocated.

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The reality of poor communication

“Our family did not get open disclosure. We felt excluded and badly

treated and none of the undertakings to give us answers were

honoured. We pursued the legal route for three years but that was fraught

with lack of conclusions and we feared for our financial security”.

Meaning of Patient Safety Incident (Civil Liability Amendment Act 2017)

“An incident which occurs during the course of the provision of a health service” which:

(a) has caused an unintended or unanticipated injury, or harm, to the patient

(b) did not result in actual injury or harm to the patient but was one which the health services

provider has reasonable grounds to believe placed the patient at risk of unintended or

unanticipated injury or harm or

(c) unanticipated or unintended injury or harm to the patient was prevented, either by “timely

intervention or by chance”, but the incident was one which the health services provider has

reasonable grounds for believing could have resulted in injury or harm, if not prevented.

Therefore a patient safety incident includes harm events, no harm events and near

miss events.

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Meaning of Open

Disclosure of a

Patient Safety Incident

(CLA Act 2017)

Meaning of Open Disclosure of a Patient Safety Incident (CLA Act 2017)

Open disclosure is where a health services provider discloses, at an open disclosure meeting, to

• a patient that a patient safety incident has occurred in the course of the provision of a health service to him or her

• a relevant person that a patient safety incident

has occurred in the course of the provision of a health service to the patient concerned, or

• a patient and a relevant person that a patient

safety incident has occurred in the course of the provision of a health service to the patient.

Definition of Open Disclosure

The HSE defines Open Disclosure as:

“an open, consistent, compassionate and timely approach to communicating with patients and, where appropriate, their relevant person following patient safety

incidents. It includes expressing regret for what has happened, keeping the patient informed and providing reassurance in relation to on-going care and treatment,

learning and the steps being taken by the health services provider to try to prevent a recurrence of the incident.”

(HSE 2019)

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• Harm events: Always disclose

• Suspected Harm Events: Always disclose

• No Harm Events: Generally

disclose . Rationale – how can you ensure that harm has not occurred if you don’t talk to the patient?

• Near Miss Events: Assess on a

case by case basis – if potential for future harm always disclose.

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The Irish National

Adverse

Event Study 2009 –

published 2016

1574 patients (53% women) – 8 hospitals The prevalence of adverse events in

admissions was 12.2% Over 70% of events were considered

preventable. Two-thirds were rated as having a mild-to-

moderate impact on the patient, 9.9% causing permanent impairment and 6.7% contributing to death.

(An adverse event is an incident that resulted in harm that may or

may not be the result of error) (Reference: The Irish National Adverse Events Study (INAES): the frequency and nature of adverse events in Irish hospitals—a retrospective record review study Natasha Rafter, Anne Hickey, Ronan M Conroy, Sarah Condell, Paul O'Connor, David Vaughan, Gillian Walsh, David J Williams)

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Principle 1: Acknowledgement Notes:……………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………… Principle 2: Truthfulness, Timeliness and Clarity of Communication Truthfulness: Notes:………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………

Timeliness: Notes:………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………

The Principles of Open Disclosure

1. Acknowledgement 2. Truthfulness, timeliness and

Clarity of communication 3. Apology/Expression of Regret 4. Recognise Patient and Carer

Expectations 5. Staff Support 6. Risk Management and Systems

Improvement 7. Multidisciplinary Approach 8. Clinical Governance 9. Confidentiality 10. Continuity of Care

CARE COMPASSION TRUST and EMPATHY

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Clarity of communication: Notes:…………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………… Principle 3: The Apology Consider the meaning of the word “Apology” Notes:…………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………… The 4 components of an apology: Notes:……………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………… Is an apology an admission of liability? Notes:………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………… Why should you avoid the terms “negligence” and “liability” during open disclosure discussions? Notes:…………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………… What is the difference between an “expression of regret” and an “apology?” Notes:………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………

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Principle 4: Recognising patient and carer expectations Notes:………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………… Principle 5: Staff Support Notes:………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………… Principle 6: Risk management and systems improvement Notes:………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………… Principle 7: Multidisciplinary Responsibility Notes………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………… Principle 8: Clinical Governance How do you ensure that open disclosure happens in your organisation/team/unit? Notes:…………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………

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Principle 9: Confidentiality Notes:………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………… Principle 10: Continuity of Care Notes:…………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………

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Open disclosure involves:

• A process of open, honest, transparent and timely communication with patients and/or their relevant person following a patient safety incident

• An acknowledgement and factual explanation in relation to what has happened and how/why it happened

• Providing a meaningful apology or expression of regret

• Demonstrating Empathy and Compassion towards all those involved in the patient

safety incident

• Listening to the patient and/or their relevant person and hearing their story

• Providing reassurance in relation to on-going care and treatment, learning and quality improvement

What does open disclosure involve?

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Exercise 1: Discussion: What are the key skills involved in Open Disclosure

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Exercise 2: Just Culture: Discussion:

What are the cultural changes required to implement effective Open Disclosure?

“A just culture is an environment which seeks to balance the need to learn from mistakes and the

need to take disciplinary action. (HSE Incident Management Framework 2018)

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Part 3: Open Disclosure: The Drivers ______________________________________________________________________________ The objective of this part of the workshop is:

To ensure that workshop attendees have an understanding of the drivers for open disclosure in the ROI outlining:

• Professional and Ethical requirements • Regulatory requirements, • Government requirements • What is expected by indemnifying bodies and • Obligations as per the HSE national policy on open disclosure and other relevant policies

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Our

Natural

Instinct

“Open disclosure represents the best of Irish healthcare. I think our instinct is to be open with patients and open disclosure guides staff to do

what they know is right even in difficult circumstances when an error has occurred”

Dr Philip Crowley: National Director of Quality Improvement HSE QID

January 2018

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• Open disclosure is the professional, ethical and human response to patients involved in/affected by patient safety incidents

• It is what patients want and expect

• It is what we would expect for ourselves or a loved one

• Learning from past experiences

Open Disclosure – The

Right Thing to Do

Open Disclosure

The Drivers

1. HSE Policy/Incident Management

Framework/YSYS

2. Professional and Regulatory

NMBI – code

Medical Council – code

HIQA – standards

CORU – code

Mental Health Commission

Pre Hospital Emergency Care

Council

Pharmaceutical Society of Ireland -

code

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Open Disclosure:

The Drivers

3. The Department of Health – Government

policy/Code of Conduct for staff 2018

4. Indemnifying Bodies:

SCA/MPS/MDU/MEDISEC

5. Royal Colleges:

RCSI/RCPI/ICO/ICGP/Faculty of

Radiologists

6. WHO

7. Media

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Part 4: Legal Considerations and Legislation

The objectives of this part of the workshop are as follows:

To identify the barriers to open disclosure

To understand why patients pursue the legislative route

To provide an update on current and pending open disclosure legislation in Ireland

To discuss the implications of this legislation for staff

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Why Disclosure can

be difficult

• Culture: Historic Medical Culture of Non- disclosure

• Institutional Barriers: “Blame and Shame” approach – no institutional support or mechanisms to facilitate disclosure

• Feelings of Shame & Embarrassment

• Fear of litigation

• Fear concerning professional

Advancement

• Fear with regard to reputation

Why do

Patients Sue?

• To get answers

• The need for acknowledgement

and apology

• Patients felt rushed

• Felt less time spent/ignored

• The attitude of staff

• Patients wanted their perceptions

of the event/their story validated

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Why do

Patients Sue?

Impact of Open Disclosure on Litigation: The University of Michigan Health System

2002, Adopted full disclosure policy- Moved from, “Deny and defend” to “Apologise and learn when we’re wrong, explain and vigorously defend when we’re right and view court as a last resort” August 2001-August 2007 Ratio of litigated cases : total reduced from 65-27%. Average claims processing time reduced from 20.3 months to 8 months. Insurance reserves reduced by > two thirds. Average litigation costs more than halved. Savings invested into patient safety initiatives

• The experience of “second harm” – poor or no communication after the patient safety incident occurred

• To seek financial compensation

• To enforce accountability

• To correct deficient standards of care

• To try to prevent a recurrence of the

incident

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The Civil Liability (Amendment) Act 2017 and 2018 Regulations

Protective legislative provisions in Part 4 of the Civil Liability Amendment Act 2017 (CLA Act) Commenced in September 2018 1. Open disclosure: (a) shall not constitute an express or implied (b) shall not, notwithstanding any other enactment or rule of law, be admissible as evidence of fault or liability and (c) shall not invalidate insurance or otherwise affect the cover provided by such policy

2. Information provided, and an apology where it is made, shall not

(a) constitute an express or implied admission, by a health practitioner, of fault, professional misconduct, poor professional performance, unfitness to practice

(b) be admissible as evidence of fault, professional misconduct, poor professional performance, unfitness to practise, in proceedings to determine a complaint, application or allegation

Provisions of Part 4

of the CLA Act 2017

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Part 4 of the CLA Act 2017 relates to voluntary open

disclosure

There are 8 regulations that accompany Part 4 of the CLA Act

2017

Staff can opt to seek the protective provisions of the Act or

not.

To avail of the protective provisions of Part 4 of the Act open

disclosure must be managed strictly in accordance with the

procedure as set out within the Act and the regulations that

accompany Part 4 of the Act

The protections of the Act will be automatic when OD is

managed as per the procedure set out in Part 4 of the Act

What you need to know about Part 4

of the CLA Act 2017

In addition to the HSE Policy requirements:

• The relevant prescribed statements (forms) must be prepared and signed by the health services provider and provided to the patient/relevant person, as appropriate.

• A copy of all forms must be kept on record by the health services provider – in a file separate to the clinical/care record

• The name of the designated person (key contact person)

must be documented in a file separate to the healthcare record e.g. OD file/Incident Management File

What is different about managing Open Disclosure under Part 4

of the CLA Act?

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What are

the Regulations?

There are 8 regulations The regulations take the form of prescribed statements which staff are obliged to:

Complete

Sign (signed by principal health care practitioner or another person deemed appropriate by the health services provider)

Provide (relevant forms) to patients as set out in the procedure

Maintain on record in a file separate to the healthcare record e.g. OD file or incident management file

Form A - Statement of Information Provided at an Open Disclosure Meeting Form B - Statement of Non-Attendance patient or Relevant Person at open disclosure meeting Form C - Statement of Non-Attendance patient and relevant person at open disclosure meeting Form D - Refusal to accept Statement Form E - Statement of Additional Information Form F - Request for Clarification Meeting Form G - Statement of Clarification of Information Form H - Statement of Steps Taken to Establish Contact Available: https://www.hse.ie/eng/about/who/qid/other-quality-improvement-programmes/opendisclosure/open-disclosure-legislation/civil-liability-forms.html

Prescribed

Statements

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Notes: See Appendix G for more detail

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Patient Safety Bill (pending)

“A Bill to provide for mandatory open disclosure of

serious reportable patient safety incidents, notification of reportable incidents, clinical audit to improve patient care and outcomes and extend the Health Information Quality Authority remit to private health services” (Department of Health 5 July 2018)

Note: The progress of the Bill can be followed on the Oireachtas website:

https://www.oireachtas.ie/en/bills/bill/2019/100/

List of Current Notifiable Incidents in Draft Patient Safety Bill (Summary)

Unintended and unanticipated patient death which did not arise from/was a consequence of an illness/underlying condition

Following wrong patient surgery Following wrong site surgery Following wrong surgical procedure Following unintended retention of foreign object Following elective surgery Directly related to treatment Due to transfusion of incompatible blood or blood components Associated with medication error Death of a woman while pregnant or within 42 days of delivery Still born child born without foetal abnormality at prescribed gestational age/birth weight not related to underlying condition of the child. Perinatal death of a child who was alive at the onset of care in labour who had reached

A prescribed gestational age and a prescribed birth weight Suicide of patient while being cared for at a place or premises where care is being

Provided

2. Baby referred for therapeutic hypothermia or baby considered for and did not undergo therapeutic hypothermia.

NOTE: The Minister has reserved the right to make further regulations (additions to the list above)

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A person who fails to comply without a reasonable excuse

shall be guilty of an offence and shall be liable on

summary conviction to a Class A fine

(Fine may vary up to €5000)

The above relates to failure to hold an open disclosure

meeting and/or to report the patient safety incident to the

Relevant Authority e.g. HIQA, Chief Inspector, Mental

Health Commission

Patient Safety Bill 2019 Part 7 -

Offences

Written information to be provided to the

patient /relevant person

• Give the patient and/or the relevant person a copy of the statement, in writing at the meeting or not later than five days from the date on which the meeting was held.

• Health service provider to maintain a copy of this statement in a file separate to the healthcare record.

The Patient Safety Bill Communication

Record

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Part 5: The Patient’s Perspective: What do patients expect from us? ________________________________________________________________________________

The objectives of this part of the workshop are as follows:

To identify the patients’ perspectives and requirements following patient safety incidents from a practical and emotional perspective.

To establish the importance of open disclosure for patients.

To introduce the MPS ASSIST Model of communication and its application to open disclosure communication, complaints management and general communication with patients and their families.

To practice open disclosure using the ASSIST Model of communication.

__________________________________________________________________________________________

Exercise 3

Watch the DVD – (approximately 4-5 minutes)

Focus on the patient – Mrs Ling

As you are watching it think about what the patient’s needs are.

What does the patient require/expect from her GP during the consultation?

What does the patient expect following the consultation in relation to her on-going

care?

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Exercise 3: Watch the ‘Mastering Adverse Outcomes’ DVD provided by the MPS. Focus on the patient. As you are watching it think about what the patient’s needs are. What does the patient require / expect from the GP during this consultation?

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The Open Disclosure Process

using the MPS

A.S.S.I.S.T

Model of

Communication

A – Acknowledge – problem and impact

S – Sorry – express regret

S – Story – hear patient’s story and

summarise back to them

I – Inquire – seek questions to be answered,

provide answers, give information

S – Solution – seek patient’s ideas on the way

forward – agree a plan

T – Travel – avoid abandonment – continued

care - increased contact.

What do

Patients

want?

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Benefits

for Patients

Quote from

a Patient Advocate

“Open disclosure is not about blame. It is not about accepting the blame. It is not about apportioning blame. It is about integrity and being truly professional And the reason: You hold our lives in your hands and we, as patients, want to hold you in high regard.” (Mrs Margaret Murphy)

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Exercise 4: Watch the DVD. This is the same scenario as earlier but on this occasion the doctor manages the consultation using the A.S.S.I.S.T model. Record the terminology used by the doctor which applies to the various components of the A.S.S.I.S.T model as listed below. Reflect on what was different about this consultation. Acknowledge: ……………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………

Sorry: ……………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………

Story: ………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………

Inquire ………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………

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Travel ………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………

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Exercise 5

Practicing Open

Disclosure

• Read the case scenario provided. • In your allocated groups of three you will take

turns in playing the role of (a) Doctor, (b) Patient and (c) Observer

• You will be allocated 5 minutes for each role play.

• Do not be concerned if you have not completed the consultation.

• At the end of 5 minutes provide feedback on the consultation using the A.S.S.I.S.T Model.

• You will then swap roles. • There will be a general feedback session at the

end of the session when all three persons have experienced the role of the Doctor, Patient and Observer.

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Part 6: The Clinician’s Perspective ________________________________________________________________________________

The objectives of this part of the workshop are as follows:

o To identify the impact of adverse events on health and social care staff and their feelings in

relation to the same.

o To consider how staff communicate with each other.

o To explore the importance of respectful communication between health and social care staff.

o To establish why open disclosure can be difficult for staff.

o To develop an understanding in relation to staff reaction and needs following adverse

events. o To establish the link between open disclosure and claims. o To provide an update on staff support resources.

Exercise 6: Watch the DVD. Consider the feelings and emotions of the doctor whose patient is being referred to by their medical colleague. Consider that you are this doctor and write down all the feelings you may be experiencing and your possible reactions to this conversation.

Feelings/Emotions: ……………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………

Possible Immediate Reactions: ………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………… Other Considerations: ………………………………………………………………………………………………………………… ………………………………………………………………………………………………………………… ………………………………………………………………………………………………………………… ………………………………………………………………………………………………………………… ………………………………………………………………………………………………………………… ………………………………………………………………………………………………………………… …………………………………………………………………………………………………………………

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The Six Recognised

Stages of

Staff Reaction following

an Adverse Event

1. Chaos: Error realised and recognised. How and why did it happen. Care for the patient. 2. Intrusive reflections: Re-evaluate the event. Haunted re-enactments of the event. Self isolation. 3. Restoring personal integrity: Managing gossip Questioning trust. Fear.

4. Enduring the inquisition: Realisation of seriousness. Wonder about repercussions. Who can I talk to? 5. Obtaining emotional first aid: Seeking personal and professional support. Where can I turn to for help?

The Six Recognised

Stages of

Staff Reaction following

an Adverse Event

6. Moving On—Dropping Out, Surviving or Thriving: Despite a desire to move on, many professionals find it difficult to do so. This stage has three potential paths: Dropping Out—changing professional

role, leaving the profession or moving to a different practice location.

Surviving—performing at the expected

performance levels (“doing OK”) but continue to be affected by the event.

Thriving—making something good out of the adverse event.

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Benefits of

Open Disclosure

for Staff

• Improved staff recovery • It encourages a culture of honesty and

openness. • Staff are more willing to learn from patient

safety incidents • It enhances management and clinician

relationships • It leads to better relationships with patients

and their relevant persons • Maintains personal and professional

integrity • Lightens the burden of guilt • Allows for reflective learning

The ASSIST ME

Model of

Staff Support

Provides information for staff on:

• The potential normal reactions to what is an

abnormal event

• How to help yourself

• How to support a colleague /peer using the

ASSIST ME model

• Advice on when to seek professional

assistance i.e. GP/EAP/OH

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Resources:

Note: See Appendix B

of this workbook

for a list of

Resources

Employing organisation: Work Colleagues/Peers/Managers/OD Lead

GP

EAP/Occupational Health/CISM

Indemnifying bodies/Royal Colleges

The HSE Policy for Preventing and Managing Critical Incident Stress 2012 developed by the National Health and Safety Advisers Group.

The HSE and State Claims Agency staff support booklet 2013: Supporting staff following an adverse event: The “ASSIST ME” model

A – Acknowledge – what has happened and the impact on staff

Member

S – Sorry – express regret for their experience

S – Story – allow the staff member time to talk about what

has happened - listen and summarise back to

them

I – Inquire – seek questions to be answered, do not go into

investigative mode - provide answers, give

information

S – Solution – talk about next steps – the management of the

patient and event – seek their ideas/suggestions –

agree a plan – check if ok to remain at work

T – Travel – maintain communication and support – check in

regularly- avoid abandonment – continued care

M – Monitor - monitor their progress

E - Evaluate – talk to the staff about experience of the process

End - close the process when staff member feels ready

open door

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Part 7: The Open Disclosure Process ________________________________________________________________________________ The objectives of this section of the workshop are as follows: To inform attendees of the elements which are necessary to try and ensure a structure and informed approach to the open disclosure process as follows:

o Determining the level of response required o The importance of preparation o Timing o Where to disclose o What to disclose o Makeup of the Open Disclosure team and roles of team members o Venue/Location of meetings o Managing Deferral o Documentation requirements o Managing another clinician’s error

To explore some frequently asked questions i.e. attendance of solicitors at OD meetings – recording meetings, etc. To establish the pitfalls to avoid

Notes:……………………………………………………………………………………………………………

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Levels of

Open Disclosure

Criteria for determining the appropriate level of response Low level Response: A low level response is usually initiated for patient safety Incidents where there has been no harm to the patient or the harm to the patient is minimal – this level of response may involve just one meeting with the patient (i.e. Category 3 incidents as per the HSE Risk Impact Table ). High Level Response: A high level response involves the full open disclosure process and will usually be initiated for patient safety incidents where the patient has suffered a moderate or higher level of harm (i.e. Category 1 and Category 2 Incidents as per HSE Risk Impact Table)

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Preparation

for

Open

Disclosure

A preliminary MDT discussion with all necessary stakeholders to establish the known facts

Consider if the protections of the CLA Act are being sought and refer to CLA open disclosure procedure

To establish the facts takes time, not all facts need to be

established prior to meeting the patient/relevant person

Think ahead and plan responses to questions that may arise

Consider if an apology is required and the wording of such Apology

Consider who will make the open disclosure and who the open disclosure will be made to

Agree OD Team

Appointment of the designated person /key contact person– name documented

Consider if additional supports are required? e.g. interpreter,

assisted decision making, patient advocate

Prepare documentation e.g. checklist, (CLA forms if legal protections sought)

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Notes:……………………………………………………………………………………………………………

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Considerations Does the CEO/GM know that a disclosure meeting is happening? Should they be there? Are there any other members of the healthcare team that need to know e.g.

• Clinical Director • Director of Nursing • Allied Healthcare • Public Health • Microbiologist/Radiologist

The

Open Disclosure

Team

Lead Discloser – Ideally the principal healthcare practitioner involved e.g. Consultant or another staff member deemed appropriate by the health services provider

Deputy Discloser – To assist, ensure patient/

relevant person understands – e.g. Registrar, Director of Nursing, CNM

Designated Person/Key Contact

Links with patient/ relevant person Keeps them informed Helps patient/relevant person prepare for meeting Meet and Greet Follow up after meeting

Scribe – Confidential minutes of meeting

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Where to

Disclose

• Preparation again essential

• Designated person to liaise with patient/family

• Meet and greet patient/relevant person at pre-

determined location

• Consideration given to off site meeting

• Informal surroundings – consider room layout

• Well ventilated room

• Refreshments

• Bleeps, mobiles off.

Summary of Information to be provided at the Open Disclosure Meeting

A description of the patient safety incident – an acknowledgement of what happened, when it happened and when/how the patient safety incident came to the attention of the health services provider

The facts available at the time of the open disclosure meeting – how/why /any known contributing factors.

A description of the actions being taken and the timeframe expected by the health

services provider to establish further information

The impact of the patient safety incident on the patient and any known or likely consequences for the patient going forward as a result.

A sincere and meaningful apology

Factual responses to questions/clarifications sought by the patient/their relevant

person.

The actions/measures taken or planned by the health services provider to manage the incident.

The learning identified and the actions taken or planned by the health services

provider to try to prevent a recurrence of the incident.

Agreed next steps to include the planned communication process with the patient and/or their relevant person.

The details of the support services available to the patient and/or their relevant

person.

The name and contact details for the designated person whom the patient/relevant person can contact directly should they require further information/clarification of any information provided

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Documentation Essential to ensure continuity and consistency Imperative that details of the patient safety incident

are documented in the clinical record including the details of clinical care provided.

The salient points of the open disclosure meeting

must be documented in the patient record including the exact wording and context of any apology given.

Documentation of open disclosure on NIMS

Non-clinical communications to be kept in a separate

file i.e. risk reviews, minutes of meetings, CLA forms Refer to pre-during and post documentation checklist

in guidelines and on website

Disclosing another

Clinician’s Error

Consider ethical duty/responsibility

Patients and their relevant persons come first rights to honest, open and transparent communication compassion difficulties in disclosure should not stand in the way ensuring correct clinical management of the patient’s condition

Explore – Do not ignore!

turn towards involved colleague colleague to colleague discussion obtain the facts – do not rush to judgement frame the conversation to minimize defensiveness – curiosity opposed to accusations manner – body language – tone establish what happened

discuss and agree the way forward - clinical management/reporting/ disclosure, etc. seek assistance from the organisation if necessary.

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Deferring

Open

Disclosure

Only in rare and exceptional circumstances would open disclosure not occur – open disclosure is the expected HSE response to patient safety incidents Circumstances when OD may need to be deferred:

• The patient and/or their relevant person cannot be contacted. • The patient and/or relevant person refuses open disclosure. • The patient is extremely ill and is unable to participate in an open

disclosure meeting. • The clinician has concerns that initiating open disclosure with the

patient may put the patient at risk of causing harm to themselves or to others

Consideration must be given in the above circumstances to initiating open disclosure with the patient’s relevant person, where appropriate, taking into consideration matters relating to patient confidentiality and patient consent. The escalation processes outlined in the HSE policy must be adhered to

Common Pitfalls

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Part 8: Summary, Evaluation and Close _____________________________________________________________________________

Summary of the HSE Policy

A summary of the HSE Policy on Open Disclosure June 2019 is available in Appendix E of this workbook. Further Information and Resources: Further information and resources

visit our website on www.opendisclosure.ie where you can access the national documents, resources for clinicians, organisations and trainers and information and contact details for the open disclosure leads in your area.

Join our Yammer group - Yammer.com

Email the National Open Disclosure Office on opendisclosure.office@hse.ie Open Disclosure in Specific Circumstances: To access open disclosure guidelines for Radiologists follow the link below:

Faculty of Radiology: Open disclosure guidelines for radiologists 2016 available at http://www.radiology.ie/wp-content/uploads/2012/05/Open-Disclosure-Faculty-of-Radiologists-V1.2-April-20161.pdf To access open disclosure guidelines relating to HCAI follow the link below. Open Disclosure of Health Care Acquired Infections (HCAI s) 2018 developed by CPE Expert Group available at http://www.hpsc.ie/a-z/microbiologyantimicrobialresistance/strategyforthecontrolofantimicrobialresistanceinirelandsari/carbapenemresistantenterobacteriaceaecre/guidanceandpublications/Discussing%20HCAI_AMROs%20with%20patients_final_2July18.pdf

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Appendix A: Sample Case Scenarios for Role Play

Scenario A: Acute Hospital: Wrong Site Surgery The Patient Jim, a 65 year old patient presented with a left detached retina which required urgent surgical repair. In preparation for the surgery the left eye was inadvertently taped. Surgery commenced on the right eye. It became apparent following surgical examination that there was no problem with the right eye. The surgeon then realized the error and commenced surgery on the correct eye i.e. the left eye. Post Surgery Following surgery Jim woke up to discover that both eyes had protective bandaging and eye shields applied. Prior to going on holidays that evening, the consultant surgeon met briefly with Jim in recovery and informed him that the ‘right’ eye had been ‘examined’. 24hours later Jim met with the surgeon’s registrar who explained that the wrong eye had been operated on. He informed Jim that he was not told of the error immediately as the consultant did not want to cause him undue stress at that time. Jim met his consultant at an out-patient appointment some 38days later; he was then informed by the consultant that an error had been made. Jim felt he had been misled. The Hospital Following discharge Jim requested a meeting with the hospital to establish how the error occurred. No one in authority would meet with him. He subsequently requested his consent form, following which he was told he would have to write in for it. He was now angry with the hospital as he felt there was a cover up, a significant delay in informing him of the error and an inability to communicate with him in a timely and honest manner. He proceeded to take a case against the hospital, which was subsequently settled out of court. Role Play The disclosure meeting: Open disclosure meeting 38 days later between the patient’s consultant and the patient Lead discloser: Patient’s Consultant Present: Jim (the patient) Observer: Observe the disclosure process using the A.S.S.I.S.T model.

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Scenario B: Community Setting: Community Hospital Scenario: Mary is an 84 year old lady with severe cognitive impairment. She was transferred from the acute hospital to her local community hospital for rehabilitation and convalescence following a right total hip replacement. Mary has complex health problems and was discharged from the acute hospital on several medications including Zantac for acid reflux. The discharge letter which included a list of Mary’s current medications was handwritten and was difficult to read. Dr A who is a locum GP working in the GP out of hours service, was asked, while attending another patient in the unit, to write up Mary’s prescription chart. After reviewing the discharge letter he prescribed Xanax (a drug used to treat anxiety and panic disorders) for Mary instead of Zantac. Nurse B, a staff nurse on the unit, administered Xanax to Mary as prescribed. Mary was cared for at home by her daughter Margaret and family prior to her admission to the acute hospital for her surgery. Mary’s husband is deceased for 8 years. While visiting her Mum that evening, Margaret observes her Mum to be drowsy and questions the staff nurse as to whether her Mum has been sedated. She is angry that her Mum may have been sedated without her knowledge. Nurse B advises Margaret that her Mum has not been sedated and reports the concerns raised to the sister in charge. Margaret is unhappy with the response from Nurse B and she feels that there is a cover up as she has never witnessed her Mum to be drowsy prior to this. Following a review of Mary’s medications as prescribed by the locum GP and the discharge letter from the acute hospital Nurse B and the sister in charge established that an error occurred and that Mary had been prescribed and was administered Xanax instead of Zantac. Visiting time was over and Margaret had left the building when the error was realised. The director of nursing was informed and Margaret was contacted and asked to come in to meet with her to discuss Mary’s medications. Role Play The disclosure meeting: Lead discloser: Director of Nursing, Community Hospital Present: Margaret (Mary’s daughter) Observer: Observe the disclosure process using the A.S.S.I.S.T model.

Scenario C: Acute Hospital Scenario Margaret, a 56 year old lady is found to have a retained swab after a life-saving laparotomy. It is discovered 3 weeks after the initial surgery when she is re-admitted for investigation of on-going abdominal pain and fever. She needs to return to theatre for removal of the swab. A different surgical unit is now looking after Margaret. Margaret is advised by this team that a swab had been retained during her previous surgery i.e. the surgical laparotomy and a meeting is arranged for her to discuss this with her previous consultant who has been informed of the findings. Margaret has had no other abdominal surgery prior to the abdominal laparotomy. Role Play The disclosure meeting: Lead discloser: Patient’s Consultant at time of initial surgery i.e. laparotomy Present: Margaret (the patient) Observer: Observe the disclosure process using the A.S.S.I.S.T model.

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Scenario D: Community Scenario John is an 87 year old man who suffers from Alzheimer’s disease. He is an in-patient in the Alzheimer’s Unit in a community hospital awaiting a bed in a nursing home as his wife is no longer able to care for him at home. John is assessed as being at high risk of absconding during his admission assessment. John absconds from the community hospital during the third week of his stay there. The Director of Nursing informed the Gardaí, senior management, John’s GP and John’s next of kin immediately when he was noticed to be missing and he organised a search of the local area. John was found by a passer-by 23 hours later. He was lying in a wood and suffering from severe hypothermia. He was admitted as an emergency admission to the acute hospital and died later the same day. The Director of Nursing initiated a review of the incident and established that John had left the unit 2 hours prior to him being reported as missing. He walked out with another patient’s visitors. Role Play: The disclosure meeting: Lead discloser: General Manager PCCC Present: John’s son James. (John’s wife is elderly and too upset to attend) Observer: Observe the disclosure process using the A.S.S.I.S.T model.

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Appendix B: List of resources available to support staff

_______________________________________________________________________________

• For information on the HSE Employee Assistance Programme visit

https://www.hse.ie/eng/staff/workplace-health-and-wellbeing-unit/employee-assistance-and-counselling-service/

• For information on Occupational Health visit https://www.hse.ie/eng/staff/workplace-health-and-wellbeing-unit/occupational-health/

• For information on Critical Incident Stress Management visit https://www.hse.ie/eng/staff/workplace-health-and-wellbeing-unit/employee-assistance-and-counselling-service/applications-for-cism.html

• The National HR Helpdesk Telephone: 1850444925 or email ask.hr@hse.ie Note: The national Employee Helpdesk at HSE HR provides individual employee support

• The HSE Dignity at Work policy 2009

http://www.hse.ie/eng/staff/Resources/hrppg/Dignity_at_Work_Policy.html

• The HSE Good Faith Reporting Policy 2011

http://www.hse.ie/eng/staff/Resources/hrppg/Good_Faith_Reporting.html

• The Integrated Employee Wellbeing and Welfare Strategy

http://www.hse.ie/eng/staff/Resources/hrppg/Integrated%20Employee%20Wellbeing%20and%20Welfare%20Strategy.pdf

• The HSE Employee Resource Pack

http://www.hse.ie/eng/staff/Resources/Employee_Resource_Pack/

• HSE Policy for the Prevention and Management of Stress in the Workplace 2012

http://www.hse.ie/eng/staff/Resources/hrppg/Policy_for_Preventing_Managing_Stress_in_the_Workplace_.pdf

• HSE Policy for the Prevention and Management of Critical Incident Stress 2012

http://www.hse.ie/eng/staff/Resources/hrppg/Policy_for_Preventing_and_Managing_Critical_Incident_StressDecember_2012.pdf

• HSE Policy on Work Related Aggression and Violence 2014

http://www.hse.ie/eng/staff/Resources/hrppg/aggpol.html

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• HSE Stress management Information Sheet

https://www.hse.ie/eng/staff/safetywellbeing/2015campaign/Identification%20bulletin.pdf

• HSE: Supporting staff following an adverse event: The ASSIST ME Model

http://www.hse.ie/eng/about/Who/qualityandpatientsafety/nau/Open_Disclosure/opendiscFiles/bookletSuppStaffadverseevent.pdf

• HSA Work-Related Stress: A Guide for Employers

http://www.hsa.ie/eng/Publications_and_Forms/Publications/Occupational_Health/Work_Related_Stress_A_Guide_for_Employers.pdf

• HSA: Work Related Stress : Information sheet for employees

http://www.hsa.ie/eng/Publications_and_Forms/Publications/Occupational_Health/Work_Related_Stress_Information_Sheet.pdf

• HSE Protected Disclosures of Information in the Workplace(Whistleblowing) 2009

http://www.hse.ie/eng/staff/Resources/hrppg/Protected_Disclosures_of_Information_in_the_Workplace_.html

• HSE Trust in Care Policy 2004

http://www.hse.ie/eng/staff/Resources/hrppg/Trust_in_Care.html

• HSE Absence Management Policy and related documents https://www.hse.ie/eng/staff/benefitsservices/Timeoff/Sick_Leave.html

Please visit http://www.hse.ie/eng/staff/Resources/hrppg/ to access a list and links to HSE HR policies and procedures

Additional Resources for Medical Staff:

Practitioner Health: The Practitioner Health Matters Programme (PHMP) in Ireland offers a strictly confidential service to doctors, dentists and pharmacists. They have a confidential telephone line and email contact point for an expert clinical advice service. They welcome contact from any individual whether you are the person in need of help, a family member, a colleague or a friend. To make an enquiry or seek support please email them on confidential@practitionerhealth.ie

or call them on (01) 297-0356.

MPS: The MPS offer their members access to a 24/7 confidential counselling service if you are suffering from stress and anxiety as a result of situations such as complaints, claims, or disciplinary or a Medical Council investigation. It is an independent service tailored to your requirements and delivered by fully trained, qualified and registered psychologists and counsellors.

https://www.medicalprotection.org/ireland/help-advice/counselling-service

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Medisec: Medisec’s team of medico-legal advisers are available 24/7 to guide, direct and support you in relation to any patient safety incident that may occur in your practice.

https://medisec.ie/Guidance-And-Advice/Guidance-And-Advice

ICGP: About the ICGP Doctors' Health in Practice Programme

The ICGP Doctors' Health in Practice Programme was established in March 2000. It aims to promote and support the good physical health, occupational health, psychological health and wellbeing of GPs. It encourages primary health care for doctors' healthcare in the first instance and supports the aim that every GP should have a GP. The healthcare networks and helpline can also be accessed by GPs' families so that GPs can avoid treating their own family members, and the email service can be accessed by practice staff, for example for health and safety issues.

Visit www.icgp.ie/DoctorsHealth for more details.

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Appendix C: State Indemnity

Government Departments and other State agencies, whose claims are delegated for management by the State Claims Agency (SCA), do not have conventional insurance cover. Instead, these State bodies operate under State indemnity, a self-insurance model whereby the State bears the financial risk associated with the costs of claims.

This approach to insurance is set out in the Public Financial Procedures (Department of Finance, 2008, C8, Section 11): ‘the general rule is that no insurance should be effected against the risk of any loss which, if it arose would fall wholly and directly on public funds. This is based on the understanding that the risks for which the Government is liable are innumerable and widely distributed, and that losses maturing in any one year are never so large as to materially disturb the financial position of the year, so that it is cheaper in the long term for the Exchequer to ‘carry its own insurance.’

Scope of State indemnity

State indemnity, as operated by the SCA, is provided to delegated State authorities and delegated healthcare enterprises, in respect of personal injury, third-party property damage and clinical negligence liabilities.

State indemnity is provided by the Minister for Finance under legislation and a State authority does not have authority to extend this indemnity to cover the risk(s) of other organisations.

Who is covered by State Indemnity?

All Government departments; Other specified State bodies and authorities. All HSE facilities, public hospitals and other agencies providing clinical services; Non-consultant hospital doctors, nurses and other clinical staff employed by health

agencies whether permanent, locum or temporary; Consultant hospital doctors are covered with effect from 1 February 2004 in respect of

alleged clinical negligence incidents on or after that date; Clinical support staff in pathology and radiology services; Public health doctors, nurses and other community-based clinical staff in respect of

clinical activities; Dentists providing public practice; Certain other ancillary healthcare providers. Participating enterprises are specified in

Schedule 1, Part 1 of the National Treasury Management Agency (Delegation of Functions) Orders 2003 and 2007 (SIs No. 63 of 2003 and 628 of 2007);

Mount Carmel Hospital, Dublin with respect to midwifery/obstetrics practices.

What is covered by State indemnity?

Activities that are directly controlled, substantially funded and are wholly run by the indemnified State body, authority or enterprise;

Good Samaritan acts within the jurisdiction of the State; Representation for agencies or individual practitioners at Coronial Inquiries.

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Exclusions from State indemnity

The following classes of claim are expressly excluded from the SCA’s remit under the enacting legislation:

Applications for compensation made under the Garda Compensation Acts; Claims made under the Criminal Injuries Compensation Scheme; Claims involving a question as to the validity of any law having regard to the provisions

of the Constitution; Claims made in respect of infection, directly or indirectly, with Hepatitis C or the human

immunodeficiency virus (HIV), or both, through the administration of blood or blood products or in respect of related matters;

Claims in respect of certain torts not within the SCA’s remit.

Other insurable risks which are not covered by State indemnity are:

State property, including buildings and contents; State-owned vehicles; personal accident insurance;

Theft of or criminal damage to third party property; Accidental damage or loss to third party property; and Business interruption; Professional indemnity not involving personal injury or property damage (HSE

professionals are covered in respect of clinical negligence under the Clinical Indemnity Scheme);

Defamation; Marine; Computer engineering insurance for plant and statutorily required inspections; Overseas travel on State business; Directors and officers liability, administrative negligence etc.; Crime/fidelity guarantee insurance – embezzlement, fraud, theft, involving State

authority employees and/or others; Other matters not coming under the remit of State indemnity as defined by the SCA.

Other exclusions

Representation at disciplinary proceedings or before professional regulatory bodies; Representation for agencies or individual practitioners at inquiries, other than Coronial

Inquiries; Good Samaritan Acts outside the jurisdiction of the island of Ireland.

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Appendix D: Sample Language

Stage of Process Sample Phrases

Acknowledgement

“We are here to discuss the harm that you have experienced/the complications with your

surgery/treatment”

“I realise that this has caused you great pain/distress/anxiety/worry”

“I can only imagine how upset you must be”

“ I appreciate that you are anxious and upset about what happened during your surgery

– this must have come as a big shock for you”

“I understand that you are angry/disappointed about what has happened”

“I think I would feel the same way too”

Sorry “ I am so sorry this has happened to you”

“ I am very sorry that the procedure was not as straightforward as we expected and that

you will have to stay in hospital an extra few days for observation”

“I truly regret that you have suffered xxx which is a recognised complication associated

with the x procedure/treatment”. “I am so sorry about the anxiety this has caused you”

“ A review of your case has indicated that an error occurred – we are truly sorry about

this”

Story Their Story

“Tell me about your understanding of your condition”

“Can you tell me what has been happening to you”

“What is your understanding of what has been happening to you”

Your understanding of their Story: (Summarising)

“I understand from what you said that” xxx “and you are very upset and angry

about this” Is this correct? (I.e. summarise their story and acknowledge any

emotions/concerns demonstrated.

“Am I right in saying that you ……………………………………..”

Your Story

“Is it ok for me to explain to you the facts known to us at this stage in relation to what has

happened and hopefully address some of the concerns you have mentioned?”

“Do you mind if I tell you what we have been able to establish at this stage?”

“We have been able/unable to determine at this stage that ……………………….”

“We are not sure at this stage about exactly what happened but we have established

that ……………………….. We will remain in contact with you as information unfolds”

“You may at a later stage experience xx if this happens you should …………………”

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Inquire “Do you have any questions about what we just discussed?”

“How do you feel about this?

“Is there anything we talked about that is not clear to you?

Solutions “What do you think should happen now?”

“Do you mind if I tell you what I think we should do “

“I have reviewed your case and this is what I think we need to do next”

What do you think about that?

“These are your options now in relation to managing your condition, do you want to have

a think about it and I will come back and see you later?”

“I have discussed your condition with my colleague Dr x we both think that you would

benefit from xx. What do you think about that?”

Travel “Our service takes this very seriously and we have already started an investigation into

the incident to see if we can find out what caused it to happen”

“We will be taking steps to learn from this event so that we can try to prevent it

happening again in the future”

“I will be with you every step of the way as we get through this and this is what I think we

need to do now”

“We will keep you up to date in relation to our progress with the investigation and you will

receive a report in relation to the findings and recommendations of the investigation

team”.

“Would you like us to contact you to set up another meeting to discuss our progress with

the investigation?

“I will be seeing you regularly and will see you next in ….. Days/weeks.

“You will see me at each appointment”

“Please do not hesitate to contact me at any time if you have any questions or if there

are further concerns – you can contact me by ………………….”

“If you think of any questions write them down and bring them with you to your next

appointment”.

“Here are some information leaflets regarding the support services we discussed – we

can assist you if you wish to access any of these services”

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Appendix E: Summary of the HSE Policy on Open Disclosure June 2019

It is the policy of the HSE that we:

1. communicate with our patients in an open, honest, transparent and empathic manner following patient safety incidents,

2. provide our patients with a sincere and meaningful apology when they are harmed as a result of a patient safety incident, and

3. begin the communication process within 24 – 48 hours of the incident occurring or becoming known to the health services provider or as soon as possible after the incident happens.

This policy replaces the HSE Open Disclosure Policy 2013. The revised policy is aligned with the provisions of

Part 4 of the Civil Liability Amendment Act, 2017, the Civil Liability (Open Disclosure) (Prescribed Statements) Regulations 2018, the Assisted Decision Making Act 2015, and the HSE Incident Management Framework 2018.

Summary of Policy Requirements:

No. Policy Section Summary

1 Open Communication

Patients have the right to full knowledge about their healthcare and to be informed when things go wrong during their health care journey.

2 Presumption of Capacity

A person whose decision-making capacity is in question is entitled to open disclosure on an equal basis with others.

3 Provision of appropriate medical care and treatment

Treat patients with compassion and empathy. Our focus must first be on the physical needs of the patient. Provide appropriate medical treatment or other care to manage any harm that has occurred, to relieve suffering and minimise the potential for further harm to occur.

4 Events that trigger Open Disclosure

There are three types of patient safety incidents, these are: harm or suspected harm no harm near miss

We must disclose all harm and suspected harm incidents. We should generally disclose no harm incidents. Assess near miss incidents on a case by case basis. We must inform patients of a near miss or no harm event if there is potential for it to become a harm event in the future.

5 Timing of open disclosure

We must start the open disclosure process within 24 to 48 hours or as soon as is practical after an incident occurs.

6 Assessing the Level of response required to Patient Safety Incident

Our response can vary from low level to high level. The level chosen will depend on the harm which has occurred and the expectations of the patient. The member of staff who discovers the incident will assess it, consult with the principal healthcare practitioner and determine the level of response needed.

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No. Policy Section Summary

7 Preparation for an Open Disclosure meeting

You must prepare for an open disclosure meeting by giving due consideration to:

what has happened, the facts available, the stakeholders involved, the membership of the open disclosure team, who the disclosure will be made to any additional supports this person(s) will require, the apology to be provided and the preparation of any necessary paperwork.

Consider whether the protections of Part 4 of the Civil Liability Amendment Act 2017 are being sought. Manage open disclosure as per the procedure set out in the Act and regulations.

8 Information to be provided at an Open Disclosure meeting

We must inform the patient of all the facts available to us at the time of the open disclosure meeting about the patient safety incident. (See Table 2 in policy for full details of information to be provided)

9 The Apology When we identify a failure or error in the delivery of care/treatment we must provide the patient with a sincere and meaningful apology in a timely manner which is personal to the patient and to the given situation.

10 Providing additional information

We must provide any extra relevant information obtained after the first open disclosure discussion to the patient in a timely and supportive manner.

11 The assignment of a designated person

To maintain personal contact between the patient and ourselves we must give the patient the name and contact details of a designated staff member as a point of contact for them as soon as possible. This will help ensure the patient feels supported, listened to and included in the open disclosure process.

12 Clarification of Information provided

We must quickly respond to all questions and requests received by the designated staff member, after an open disclosure meeting, with factually correct information

13 Providing a safe, supportive environment for staff

The HSE will provide a safe, supportive and caring environment for staff involved in or affected by patient safety incidents. We will ensure that staff have access to relevant training on the open disclosure policy.

14 Deferral of Open Disclosure

The HSE can only defer open disclosure of a patient safety incident in rare or exceptional cases. Staff members must always base the decision to defer on the safety and well-being of the patient. Section 3.16 of the policy sets out detailed requirements about deferring open disclosure and escalation processes. All staff members must adhere to these requirements.

15 Open Disclosure to the patient’s relevant person

Disclosing information to an adult patient’s relevant person must only be done with the consent of the patient, where possible. Section 3.17 of the policy gives details on managing open disclosure to the patient’s relevant person in all circumstances, including when a patient dies.

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No. Policy Section Summary

16 Record keeping We must document the most important points of the open disclosure meeting, including details of any apology, in the patient’s clinical/care record. Store other documentation, for example: prescribed statements, checklists, minutes of meetings, in a separate file to the health care record, for example an incident management file or an open disclosure file.

17 Follow up care Send the patient the minutes of the formal open disclosure meeting after it has happened. The designated staff member should contact the patient on an agreed date and time.to talk to them about their experience of the meeting.

18 Governance Open disclosure is an integral component of the incident management process. Primary responsibility and accountability for the effective management of patient safety incidents, including the open disclosure process, is at the organisational level where the patient safety incident occurs. We must ensure that the correct governance structures are in place, at service level, to support timely and effective open disclosure.

19 Implementation HSE services will develop an implementation plan to support the roll out of the open disclosure policy – see section 12.0 of the policy

20 Evaluation and Audit

The Senior Accountable Officer is responsible for the monitoring of performance in relation to open disclosure and verification of compliance with this policy.

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Appendix F: Quotes from Professional, Indemnifying and Regulatory Bodies

HSE

“A Patient can expect open and appropriate communication throughout your care especially when plans change

or if something goes wrong.”

(National Healthcare Charter: You and Your Health Service, 2010 - Revised 2012.)

“Open and honest communication (Open Disclosure) is initiated as soon as practicable after the incident has

been identified. The planned review process has been described and communicated to all persons affected”.

(HSE Incident Management Framework 2018)

Department of Health

“Open Disclosure can be viewed as an integral element of patient safety incident management and it is

government policy that a system of open disclosure is in place and supported across the health system” (2018)

State Claims Agency

“At the heart of open disclosure lies the concept of open, honest and timely communication. Patients and

relatives must receive a meaningful explanation following an adverse event”.

(Ciarán Breen, Director of the SCA 2015)

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MEDISEC

"At Medisec, we welcome and support the principles of Open Disclosure, and encourage our members to

engage with patients in an open, honest and transparent manner when things go wrong. We believe that timely

and clear communication with a patient about an adverse event benefits all parties. Patients are facilitated by

understanding what occurred and receiving an apology, if appropriate. Open disclosure also represents a vital

learning opportunity for the doctor concerned, leading to safer and more robust practice going forward." (

2018)

Medical Council

“Patients and their families, where appropriate, are entitled to honest, open and prompt communication with

them about adverse events that may have caused them harm.”

(Guide to The Professional Conduct and Ethics for Registered Medical Practitioners 2016)

Nursing and Midwifery Board of Ireland (NMBI)

“Safe quality practice is promoted by nurses and midwives actively participating in incident reporting, adverse

event reviews and open disclosure”

(Code of Professional Conduct and Ethics for Registered Nurses and Midwives December 2014)

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Health Information and Quality Authority (HIQA)

“Service providers fully and openly inform and support service users as soon as possible after an adverse event

affecting them has occurred, or becomes known and continue to provide information and support as needed.”

(Standard: 3.5: Safer Better Healthcare Standards 2012)

CORU

“If a service user suffers harm, speak openly and honestly to them as soon as possible about what happened,

their condition and their on-going care plan”

(The Codes for Dietitians 2014, Speech and Language Therapists 2014 and Occupational Therapists 2014)

Pre Hospital Emergency Care Council (PHECC)

PHECC wholly endorses the HSE principles of open disclosure. PHECC is committed to the process of open

disclosure as included in the Education and Training Standards since 2007. We believe that the open disclosure

process encourages the reporting of adverse events which leads to a manifestation of the patients’ autonomy

and ultimately leads to opportunities for systems improvement and delivery of the highest standards of care

delivery. In addition PHECC is committed to information being available following the incident review as being

an essential component of an open disclosure policy.

(Statement from PHECC April 2015)

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Mental Health Commission

“The Mental Health Commission fully endorses Open Disclosure and communicating authentically,

compassionately and respectfully with service users, families and staff involved in patient safety incidents. The

Commission and HIQA jointly developed National Standards for the Conduct of Reviews of Patient Safety

Incidents (2017). The National Standards cover reviews of patient safety incidents which fit into a service’s

overall incident management process; this includes reporting, open disclosure and notification to external

bodies.” (2018)

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Appendix G: Patient Safety (Notifiable Patient Safety Incidents) Bill 2019: Notifiable Incidents

1.1: Surgery performed on the wrong patient resulting in unintended and unanticipated death which did not arise from, or was a consequence of, an illness, or an underlying condition, of the patient, or having regard to any such illness or underlying condition, was not wholly attributable to that illness. 1.2: Surgery performed on the wrong site resulting in unintended and unanticipated death which did not arise from, or was a consequence of, an illness, or an underlying condition, of the patient, or having regard to any such illness or underlying condition, was not wholly attributable to that illness. 1.3: Wrong surgical procedure performed on a patient resulting in an unintended and unanticipated death which did not arise from, or was a consequence of, an illness, or an underlying condition, of the patient, or having regard to any such illness or underlying condition, was not wholly attributable to that illness. 1.4: Unintended retention of a foreign object in a patient after surgery resulting in an unanticipated death which did not arise from, or was a consequence of, an illness, or an underlying condition, of the patient, or having regard to any such illness or underlying condition, was not wholly attributable to that illness. 1.5: Any unintended and unanticipated death occurring in an otherwise healthy patient undergoing elective surgery in any place or premises in which a health services provider provides a health service where the death is directly related to a surgical operation or anaesthesia (including recovery from the effects of anaesthesia) and the death did not arise from, or was a consequence of (or wholly attributable to) the illness of the patient or an underlying condition of the patient. 1.6: Any unintended and unanticipated death occurring in any place or premises in which a health services provider provides a health service that is directly related to any medical treatment and the death did not arise from, or was a consequence of (or wholly attributable to) the illness of the patient or an underlying condition of the patient. 1.7:Patient death due to transfusion of ABO incompatible blood or blood components and the death was unintended and unanticipated and which did not arise from, or was a consequence of (or wholly attributable to) the illness of the patient or an underlying condition of the patient. 1.8: Patient death associated with a medication error and the death was unintended and unanticipated as it did not arise from, or was a consequence of (or wholly attributable to) the illness of the patient or an underlying condition of the patient. 1.9: An unanticipated death of a woman while pregnant or within 42 days of the end of the pregnancy from any cause related to, or aggravated by, the management of the pregnancy, and which did not arise from, or was a consequence of (or wholly attributable to) the illness of the patient or an underlying condition of the patient. 1.10: An unanticipated and unintended stillborn child where the child was born without a fatal foetal abnormality and with a prescribed birthweight or has achieved a prescribed gestational age and who shows no sign of life at birth, from any cause related to or aggravated by the management of the pregnancy, and the death did not

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arise from, or was a consequence of (or wholly attributable to) the illness of the patient or an underlying condition of the child. 1.11: An unanticipated and unintended perinatal death where a child born with, or having achieved, a prescribed gestational age and a prescribed birthweight who was alive at the onset of care in labour, from any cause related to, or aggravated by, the management of the pregnancy, and the death did not arise from, or was a consequence of (or wholly attributable to) the illness of the child or an underlying condition of the child. 1.12: An unintended death where the cause is believed to be the suicide of a patient while being cared for in or at a place or premises in which a health services provider provides a health service whether or not the death was anticipated or arose from, or was wholly or partially attributable to, the illness or underlying condition of the patient.

2.1: A baby who— (a) in the clinical judgment of the treating health practitioner requires, or is referred for, therapeutic hypothermia, or (b) has been considered for, but did not undergo therapeutic hypothermia as, in the clinical judgment of the health practitioner, such therapy was contraindicated due to the severity of the presenting condition.