1. LAUNCH: 12 November 2013

2. What is Open Disclosure? An open, consistent approach to communicating with patients when things go wrong in healthcare. This includes expressing regret for what has happened, keeping the patient informed, providing feedback on investigations and the steps taken to prevent a recurrence of the adverse event.” ( Australian Commission on Safety and Quality in Health Care)

3. What is an Adverse Event? An undesired patient outcome that may or may not be the result of an error. (World Health Organisation: The conceptual Framework for the International Classification for Patient Safety: Version 1,1 2009)

4. Principles 1. Acknowledgement 2. Truthfulness, timeliness and clarity of communication 3. Apology 4. Recognising patient and carer expectations 5. Professional Support 6. Risk management and systems improvement 7. Multidisciplinary responsibility 8. Clinical governance 9. Confidentiality 10. Continuity of care

5. Open Disclosure: Why? 1.The patient/service user’s perspective 2.The staff’s perspective 3.The organisation’s perspective: Changing Culture, Patient Safety, Quality Improvement and Financial Considerations. 4.Policy, Regulatory, professional and ethical requirements 5.Learning from national and international reviews/investigations.

6. 1. The Patient/Service User’s Perspective

7. At least 98% want to be told the truth Hobgood et al 2005, Mazor et al 2004 Do patients want to know?

8. The Importance of Open Disclosure for Patients The process can assist with providing closure for the patient/family and quicker emotional recovery. It can help to rebuild trust and confidence within healthcare. OD facilitates patient involvement in decisions relating to their ongoing care. OD prevents patient misconceptions in relation to the cause of the adverse event. Patients are more willing to continue an effective relationship with the Health Care Provider. Feelings of desertion after an adverse event are a major contributor to litigious intent.

9. Why Patients Sued Patients felt rushed No explanations given Felt less time spent Felt ignored (Hickson et al 1994) 91% wanted to prevent a recurrence. 90% wanted an explanation. 68% wanted the doctor to know how they felt. 45% due to attitude of hospital staff following the error. (Vincent et al 1994)

10. HIQA and CIS Exploratory Study 2010 Study involved patients or their families who had been involved in an adverse event, on whose behalf claims were settled by the State Claims Agency. To determine an insight into Irish patients’ experiences of adverse events and the outcomes desired by patients and their families following an adverse event. To establish what prompted patients or their families to take legal action following an adverse event

11. Reasons for taking legal action: Respondents’ comments “ I consulted legal representatives to represent me and my family at the inquest into my husband’s death. As the hospital never acknowledged the two serious incidents that led to my husband’s death I felt I needed a solicitor to help me communicate with them”. “I felt that they thought that offering me compensation without acknowledging the wrong in not giving me any explanation would make it ok”

12. Reasons for taking legal action: Respondents’ comments “ I felt forced to take legal action because it was the only action open to me. I took the matter to a solicitor because I felt I had an obligation to others as well as to myself to do so” “Staff were secretly telling me that a mistake had been made! It was very obvious to the maternity hospital that a mistake had been made but they focused on closing ranks and protecting the organisation and healthcare professionals involved. I was told my daughter would be dead within 12 months…”

13. 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.”

14. 2. The Staff Perspective

15. Why disclosure is difficult Culture: Historic Medical Culture of Non disclosure Institutional Barriers: “Blame and Shame” approach – no institutional support or mechanisms to facilitate disclosure Fear of litigation Fear concerning professional advancement Fear with regard to reputation Fear of being reported to professional body

16. Why disclosure is difficult (continued) Fear of the Media Fear of the patient’s/family’s response Financial concerns Uncertainty with regard to extent of information to be disclosed Lack of training and guidance for healthcare professionals

17. The Importance of Open Disclosure for Staff Improved staff recovery. It encourages a culture of honesty and openness. Staff are more willing to learn from adverse events. It enhances management and clinician relationship. It leads to better relations with patients and their families. Maintains personal and professional integrity Lightens the burden of guilt Allows for reflective learning

18. 3. The Organisation’s Perspective: Culture, Patient Safety and Financial Considerations

19. Levels of Transparency required to change culture – Lucian Leape 2014 Transparency between clinicians and patients/service users demonstrated by open disclosure following adverse events Transparency between clinicians demonstrated by peer review and other mechanisms to share learning Transparency between healthcare organisations demonstrated by shared learning and collaborative working. Transparency between both clinicians and organisations and the public demonstrated by public reporting of patient safety data

20. Additional layers of transparency identified in Evaluation of OD in ROI Transparency between:  Clinicians and hospital management, through staff support and a protective environment to disclose  Health and social care organisations, patients and their families, and representative patients’ organisations, in development of open disclosure policies, training and practice. Transparency results in : Improved patient outcomes, fewer errors, happier patients, lower costs, increased public confidence

21. Transparency helps to: Build the will to improve care Shape the culture into one of openness, with attention to eliminating defects. Raise improvement capability through access to real time data. Engage partners and empower teams across boundaries Provide patients and community members with opportunities to participate in improvement and to motivate change. (IHI White Paper)

22. 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.

23. 4. Policy, Regulatory, Professional and Ethical requirements

24. Agencies Endorsing Open Disclosure Statutory: HSE including non statutory organisations funded by the HSE Government: DOH Indemnifying: SCA/CIS Medical Protection Society (MPS) Professional: The Nursing and Midwifery Board of Ireland (Previous ABA) Regulatory: The Medical Council of Ireland HIQA CORU PHECC Mental Health Commission WHO

25. Recommendations by the Patient Safety Commission National Standards to be developed and implemented Legislation to provide legal protection Open communication training for all healthcare professionals Support and counselling programmes Research in to the impact on patients and families.

26. HSE “ A Patient can expect open and appropriate communication throughout your care especially when plans change or if something goes wrong.” (You and Your Health Service, 2010 - Revised 2012.) “Safety Incident Management occurs within the framework of the principles of open disclosure, integrated risk management, just culture and fair procedures. This policy must be read within the context of the HSE/SCA Open Disclosure National Guidelines 2013.” (HSE Safety Incident Management Policy 2014)

27. 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 when something goes wrong”. (Ciarán Breen, Director of the SCA 2015)

28. Medical Protection Society

29. National Standards for Safer Better Healthcare 2012 Standard: 3.5: “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.”

30. CORU: “If a service user suffers harm, speak openly and honestly to them as soon as possible about what happened, their condition and their ongoing care plan” (The Codes for Dietitians 2014, Speech and Language Therapists 2014 and Occupational Therapists 2014)

31. PHECC (April 2015) PHECC wholly endorses the HSE principles of open disclosure. The Pre-Hospital Emergency Care Council (PHECC) in its commitment to protecting the public recognises that despite the best intentions of the highly qualified and committed responders and practitioners occasionally things may go wrong. 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.

32. Mental Health Commission 2015 “ The Mental Health Commission fully endorses Open Disclosure and communicating with service users and their families following adverse events in healthcare. As Open Disclosure is now national policy, the Commission will be making it a requirement in its revised Code of Practice on the Notification of Deaths and Incident Reporting “. Statement from the Mental Health Commission May 2015

33. Medical Council of Ireland “Patients and their families are entitled to honest, open and prompt communication with them about adverse events that may have caused them harm.” (Medical Council’s Guide to The Professional Conduct and Ethics for Registered Medical Practitioners 2009)

34. The Nursing and Midwifery Board of Ireland “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 Registered Midwives December 2014 )

35. WHO “The inclusion of open disclosure processes in many hospitals today reflects the increasing importance of professionalism and honesty with patients and their carers. This in turn is increasing opportunities for partnerships with patients”. http://(www.who.int/patientsafety/education/curriculum/who_mc_topic-8.pd

36. 5: Action on Learning from national and international reviews/investigations

37. National Open Disclosure Policy 2013 Requirements

38. National Policy Requirements 1. Incidents are identified, managed, disclosed and reported and that learning is derived from them. The service user must be informed in a timely manner of the facts relating to the incident and an apology provided, where appropriate. 2: Suspected Adverse Event: The service user should also be informed if an adverse event is suspected but not yet confirmed. 3: No Harm Events: “No harm events” should generally be disclosed. 4: Near Miss Events: Near miss events should be assessed on a case by case basis, depending on the potential impact it could have had on the service user. If, after consideration of the near miss event, it is determined that there is a risk of/potential for future harm from the event then this should be discussed with the service user.

39. National Policy Requirements 5. The HSE will provide an environment in which staff feel supported in the identification and reporting of adverse events and also during the open disclosure and review process following an adverse event. 6: The HSE and SCA will provide and facilitate training in open disclosure for health and social care staff. 7: When a clinician makes a decision, based on his/her clinical judgement, not to disclose to the service user that an adverse event has occurred, the rationale for this decision must be clearly documented in the service user’s healthcare record and this decision may need to be reviewed by the clinician at a later date, depending on the circumstances involved.

40. National Policy Requirements 8: The salient points discussed with service users during open disclosure meetings, including the details of any apology provided, should be documented in the service user’s healthcare record in accordance with the National Guidelines on Open Disclosure 2013. 9: All health and social care services must have the required governance processes in place to ensure that open disclosure occurs and to address situations where there is a difference of opinion as to whether open disclosure should occur or not. 10: All health and social care staff have an obligation under the National Standards for Safer Better Healthcare 2012 to “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.

41. Resources

42. Fact: Things go wrong and will continue to go wrong …….. Adverse events happen to the best people in the best places – none of us are immune. We must be honest with our patients, our colleagues and with ourselves. Learning is difficult where transparency is absent. Transparency must involve an empathetic approach to the patients, families and staff involved In adverse events.

43. In Summary: “To err is human, to cover up is unforgivable and to fail to learn is inexcusable” (Sir Liam Donaldson (CMO UK)

44. Contact Details:

45. Thank you for your time and attention….any questions ?