Review of the Douglas Inquiry into King Edward Memorial Hospital Perth, WA. Dec 2001

1. Review of the Douglas Inquiry into King Edward Memorial Hospital Perth, WA. Dec 2001 A Presentation to The Health Roundtable by Dr Michael Walsh, Chief Executive, Bayside Health 7 August 2002

2. Overview of Discussion • Background to Inquiry • Summary of Findings • Lessons for Health Care Institutions: • operational/clinical management • governance • Lessons for: • System and Policy-makers • Health Roundtable hospitals

3. King Edward Profile • WA’s only tertiary referral services for obstetrics and gynaecology • 250 inpatient beds, neonatal intensive care, outpatients and specialist emergency services • 5,000 births per year • 5,000 gynaecology operations • 8,000-10,000 emergency presentations • High and increasing case complexity

4. Lead-up to Inquiry • Organisational, Governance Change • merger with children’s hospital (1993) • two new chief executives • devolved management (1996) • Reviews, Reviews, Reviews: • review WA O&G (1990,1998) • Chief executive “whistleblowing” • review by retired clinician (1999) • Child and Glover review (1999) • Strong public debate about future of KEMH • Four Corners • The West Australian

5. METHODOLOGY

6. Inquiry’s Brief • Established under Hospitals and Health Services Act • Examine management and clinical practices, policies and processes from 1990 to 2000 • Focus to “identify and assess the deficiencies” (1) • Recommend changes to improve short-comings 1.Executive Summary, Inquiry into KEMH 1990 to 2000, Final Report, Vol.1, November 2001

7. Inquiries Scope • Extended over 18 Months • Accessed information from 1600 patient files • Analysed 605 patient files • Analysed ninety-six medico-legal cases • Compared KEMH clinical performance data with 13 similar Australian services (Consortium) • Reviewed 293 written submissions • Interviewed 70 former KEMH patients • Read 106 transcripts, reports & other documents • Resource intensive (expensive)

8. Clinical File Review • Consultant Panel • Case Selection • cases at increased risk of poor outcomes • Focus of Review • clinician knowledge, skill, experience, documentation, care planning • Safety and Clinical Error Rating • failure to recognise serious, unstable situation • failure by senior staff to assess

9. Clinical File Review • Contributing factors • delay in providing care • lack of adequate policy/practice guidelines • lack of adequate supervision and support • Protective Factors • adequate staffing levels/skill mix • evidence-based clinical policies • written care plans • access to senior clinical staff

10. Consortium Benchmarking • Comparative analysis of perinatal, obstetric and gynaecological information • KEMH Casemix • high proportion of women <20 years • more indigenous women • 1.7 times as many premature and low birth weight live births

11. FINDINGS

12. Strengths of KEMH • Many examples of exemplary care & service • Concerted effort by some to address or improve long-standing problems

13. Management Management failed to: • make & act on important decisions • create an open, transparent, positive culture • monitor & improve safety & quality • clarify accountability, responsibility & reporting • ensure staff were properly trained & supervised • address serious clinical issues adversely affecting care & clinical outcomes

14. CASE: Credentialling • No formal credentialling process to June 2000 • Subject raised often as a serious issue since 1991 • “We just have a feel for these people” (junior doctors) • ACHS recommendations on credentialling in 1991 and 1994 • Many discussions, many recommendations, no action • Credentialling list was to be drawn up in 1995 - published 1997 and never updated • Cases of clinicians scheduled to operate with no privileges -Director would give approval by phone to theatre staff • New Credentialling Committee met Aug 2000, endorsed credentialling application form in September; no reference in TOR to junior doctor credentialling • Failed to meet again until March 2001

15. Senior Doctors • Insufficient involvement in complex cases • Inadequate, delayed or absent decisions • Inadequate credentialing, appointment, re-appointment, admitting privileges processes • Inadequate performance management • Inadequate supervision/training of juniors • Failed to provide timely, detailed analysis of staffing needs

16. Junior Doctors • Left to do much of the complex work • Unreasonably burdened with difficult cases • Inadequately supervised/supported • Requests for help often delayed or ignored • Blamed for errors - “sink or swim” • Inadequate orientation & training • Supported more by midwives than senior doctors

17. CASE: Cardiotocography • Papers and reviews emphasized importance of CTG training • Misinterpretation/incorrect action in 51 of 372 high-risk cases • Numerous adverse events over many years • Many discussions, many recommendations, no action • Problems with CTG training for junior doctors: • infrequent, ad hoc, non-compulsory • senior doctors unavailable to train juniors • no registry of attendance • no skills assessment • inconsistent with midwifery training in CTG • no linkage with 2001 credentialling program • No mandatory training at July 2001

18. Clinical Practice Ineffective or absent: • care planning, coordination, documentation • policies & practicesbased on best evidence Poor management of: • complex & emergency cases • women needing intensive care services • incidents& adverse events Poor clinical & emotional outcomes for women & families

19. CASE: Ectopic Pregnancy • Ruptured ectopic pregnancies from 1995-2000 • ED Residents managed potential ectopic pregnancies • Often no review by a senior clinician • No clinical management policy or guideline - ongoing • Slow ectopic pregnancy testing and delays of up to 3 days for results review - some ruptured • Outdated clinical management 1998 - laparotomies • Registrars and residents sent numerous memos - no policy • Draft policy 1999 - never endorsed • Problem considered too complex to overcome • Litigation for ruptured ectopic April 2000- still no policy or guideline

20. CASE: Bladder Care • Cases post-epidural bladder dysfunction • Policy took 2 years to develop • Inhibitors: ad hoc formulation process; desire for consensus • Numerous emails, numerous drafts; numerous delays • No reference to best available evidence • No evidence of literature review • No clinical trials

21. Clinical Review & Reporting Inconsistencies in: • review and report of deaths to the Coroner • report, review and response to incidents & adverse events • management of complaints and medico-legal cases • review & compare clinical performance & respond to performance issues

22. Clinical File Review; Obstetrics • Of 372 high risk cases, 47% at least one clinical error. Of these, 57% very serious clinical error • Error free care • consultants 72% cases, Snr Reg 66%, Level 3/4 Reg 60%, Level 1/2 Reg 36%, residents 24%, Midwives 40% • Staff at Crucial Times • 71% errors outside business hours • Consultants involved at crucial times 21% cases; midwives and Level 3/4 Regs same

23. Consortium Benchmarking • Obstetric and Perinatal Outcomes • high proportion of pre-term births • excess stillbirths • high rates induced labour • high rates 3rd and 4th degree peri. Tears • Gynaecology Outcomes • relatively high number of post-op deaths • relatively high number of post-op transfers to adult special care

24. Internal Policies and Processes Absent or inadequate: • quality improvement program • incident/adverse event monitoring & follow-up • complaints & medico-legal case management • committee functioning & review • policy development, deployment, review • recruitment, employment, performance management, training

25. Policy Compliance Issue • Inquiry found many examples of non-compliance • cord blood pH testing • Oxytocin policy • unnecessary CTGs for low-risk patients • Prostaglandin E2gel • Residents signing consent form

26. Policy Compliance Monitoring Issue • No distinction between mandatory & discretionary • 1997 ACHS review gave “moderate achievement” • Monitoring methods: • “we rely on peer pressure” • midwives as “watchdogs” • “I tell them not to” (non-compliance with handbook) • memos in pigeon-holes • follow-up if problem arose • Reasons for not auditing compliance: • handbook content not meant to be strict rules • guidelines “meant to be interpreted intelligently” • no database; requires manual chart review • Responsibility:in Unit Medical Director’s job description

27. Women & Families • Often excluded from decisions about care • Concerns ignored or overlooked • Treated poorly as complainants • Given untimely and inadequate information, particularly when things went wrong • Rarely involved in policy decisions

28. COMPARISONS

29. Bristol Royal Infirmary • Heart surgery on babies in Britain’s Bristol Infirmary from 1988 to 1994 • Deaths following arterial switch operation • Excessive time take to do procedure • Concerns raised repeatedly by an anaesthetist (whistleblower) • Senior doctors and chief executive eventually faced prosecution

30. Common Themes In both cases, management’s failed to: • respond to important issues raised repeatedly • ensure clinicians were properly trained • build a culture of transparency/open disclosure • establish effective quality systems • give patients & families adequate information about risks, care & problems with care • effectively manage complaints/medico-legal cases

31. LESSONS

32. Clinical governance 1. Leadership & Culture 2. Accountability & Responsibility 3. Safety & Quality Systems 4. Staff Support & Development 5. Concern for Consumer & Families

33. Health Service Issues Institutional Governance • Role of Board, Management in Patient Safety • Importance of Benchmarking and Comparative Data • Importance of Incident Monitoring, Reporting, Management and Review • Importance of Mortality Review • Importance of Periodic External Review of Management Policies, Procedures and Practices

34. System Issues System Governance • Role of Regulatory/Statutory Authorities • Mortality Committees; • Coroner • Role and Function of External Accreditation • Standards of practice (incl credentialling) • Role and Structure of “Special Inquiries” • Importance of Comparative Data • voluntary versus mandatory • clinical privilege (Immunity) • public disclosure

35. CONCLUSIONS

36. The Douglas Inquiry • landmark in the evolution of health care safety and quality policy and practice in Australian hospitals; • ACS&QHC Summary and Implications document should be required reading for all hospital managers and Boards • We should learn from the Inquiry findings and limitations to develop better ways of monitoring and reporting safe patient care environments.

37. What Does it Mean for HRT Members? • To what extent do Douglas findings apply to us? • Management, Board leadership and decision-making? • Senior and Junior relationships, workload and credentialling • recruitment, appointment, performance management • safety and quality protection systems • attitudes to patients and families, complainants

38. What Should We Do About It? • System Responses • Australian Health Ministers • National Safety and Quality Council • Victorian Quality Council • Health Roundtable CEOs • Review of the Role of the Board • Self Assessment • Awareness-raising • Managers • Defining the role of managers, staff • Self Assessment • awareness and education