Clinical Governance what why how

Professor Allan Spigelman

Clinical Governance - What

“the framework through which health organisations are accountable for

continuously improving the quality of their services and safeguarding high

standards of care by creating an environment in which excellence in

clinical care will flourish”NHS definition, adopted by NSW Health in 1999

How not to get there

Clinical Governance – What

“corporate responsibility for clinical performance”

Dr Sam Galbraith MO, Scotland, 1999

Clinical Governance - What

Aims to improve patient:

• safety

• outcomes

• overall quality of care by a ‘Just’ Culture that encourages: – reporting– open disclosure

Clinical Governance – How• Clinical Governance Unit established in 1999• First in Australia• Reviewed in 2001

• “To support clinicians and managers in facilitating continuous, sustainable improvement in patient outcomes and the minimisation of adverse events via:

• Research & development of robust clinical policies, governance frameworks, systems and processes

Facilitating the implementation of effective & efficient clinical governance across the region

Collecting, consolidating, disseminating information & adding value/insight to clinical and related data and providing feedback to clinicians and managers”

• Multiple challenges– Cultures

• Managerial• Clinical

Management: Budget = Quality

Clinical Governance – Why• QAHCS (1995) • To Err is Human (USA) (2000)• Bristol (UK) (2001- final

report)• KEMH, Perth (2002)• RMH, Melbourne (2002)• Cam Cam, Sydney (2003)• Bundaberg, Queensland (2005)

Consistent Themes in Reports

• Poor organisational structure• Poor lines of responsibility• Absent monitoring of patient safety/quality• No adverse event reporting or response system• Poor supervision of junior staff • Poor communication skills

• between health professionals, departments, facilities, with patients & families

• Absent Board / Management input to safety

• Over emphasis on fiscal matters• Poor clinical audit systems

• Non compliance of staff re safety

• No information to families when things went wrong

• Professional silos, nurses disempowered

• Poor documentation in records

• Blame culture

• Poor credentialling

• Fragmented quality structure

• Poor recognition of concept of accountability

• Lack of will to tackle difficult issues

Hypotheses

• Future enquiries inevitable

• Unless opened and dealt with

• Save $$$$ by writing the next report now

– Same findings & recommendations

– Change names

CASA’s 10 Steps for a Safety Management System

1. Gain senior management commitment

2. Set safety management policies and objectives

3. Appoint a safety officer

4. Set up a safety committee

5. Establish a process for managing risk

6. Set up a recording system to record hazards, risks, actions taken

7. Train and educate staff & gain their commitment

8. Audit your organisation and investigate incidents and accidents

9. Set up a system to control documentation and data

10. Evaluate how the system is working

1999 Clinical Quality Plan - Priority Areas1. Adverse Event Prevention

2. Appropriateness

3. Clinical Risk Management

4. Communication Skills Training

5. Concordance with patient safety policies

6. Consumer Participation

7. Credentialling

8. Efficiency

9. Measurement

10. Quality Structure & Reporting

1999 Clinical Quality Plan - Priority Areas

• Resolution of Complaints / Concerns re Clinician

Performance*• Management of Clinical Adverse Events*• Introduction of New Interventional Procedures*• Wrong Site Clinical Interventions*• Inadvertent Use of Neuromuscular Blockers• Dealing with TGA Safety Alerts• Medical Responsibility re Patient Transfer and/ or

obtaining Specialist Advice• Emergency Telephone Orders• Dispute Resolution re Ordering &/or Interpretation

of Clinical Tests• Conduct of Patient Safety Meetings

Policies developed reflect challenges encountered

• Model Policy for RACS and NSW Health: Safe Introduction of New Interventional Procedures Into Clinical Practice – NSW Health Circular 2003/84.

• Governance and Innovation: Experience with a policy on the introduction of new interventional procedures. Spigelman AD. ANZ J Surg 2006; 76: 9-13.

Papers1. Large bowel cancer: guidelines and beyond. Thomas R, Spigelman A, Armstrong B. Med J Aust 1999; 171: 284-5. 2. Does more equal less or does less equal more? Spigelman AD. J Qual Clin Practice 2000; 20: 55. 3. A survey of surgical audit in Australia: whither clinical governance? Eno LM, Spigelman AD. J Qual Clin Practice 2000; 20: 2-4.4. An audit of open and laparoscopic inguinal hernia repair. Eno L, Spigelman AD. J Qual Clin Practice 2000; 20: 56-9.5. The intention to hasten death: a survey of attitudes and practices of surgeons in Australia. Douglas CD, Kerridge IH, Rainbird KJ,

McPhee JR, Hancock L, Spigelman AD. Med J Aust 2001; 175: 511-515.6. Prevention of orthopaedic wound infections – a quality improvement project. Swan J, Douglas P, Asimus M, Spigelman AD. J Qual

Clin Practice 2001; 21: 149-153. 7. A novel strategy to stop cigarette smoking in surgical patients. Haile MJ, Wiggers JH, Spigelman AD, Knight J, Considine RJ,

Moore K. ANZ J Surg 2002; 72; 618-622. 8. Adverse events in surgical patients in Australia. Kable A, Gibberd R, Spigelman AD. Int J Quality in Health Care 2002; 14: 269-

276. Overview of the National Colorectal Cancer Care Survey - Australian Clinical Practice in 2000. McGrath DR, Spigelman AD. Colorectal Disease 2003; 5: 588-589.

9. Audit of surgeon awareness of readmissions with venous thrombo-embolism. Swan J, Spigelman AD. Internal Medicine 2003; 33: 578-580.

10. Titanic waiting lists - what lies beneath? Spigelman AD. ANZ J Surg 2003; 73: 781. 11. Why are are we waiting? Spigelman AD. ANZ J Surg 2003; 73: 873.12. Measuring clinical audit and peer review practice in a diverse health care setting. Spigelman AD, Swan JR. ANZ J Surg 2003; 73:

1041-1043. 13. Management of colorectal cancer patients in Australia: the National Colorectal Cancer Survey. McGrath DR, Leong DC, Armstrong

BK, Spigelman AD. ANZ J Surg 2004; 74: 55-64. 14. Complications after discharge for surgical patients. Kable A, Gibberd R, Spigelman AD. ANZ J Surg 2004; 74: 92-97.15. People with colorectal cancer – can we help them do better? Spigelman AD. ANZ J Surg 2004; 74: 401-402. 16. Elective open abdominal aortic aneurysm repair: a seven year experience. Mackenzie S, Swan J, D’Este C, Spigelman AD.

Therapeutics and Clinical Risk Management 2005; 1: 27-31. 17. A programme for reducing smoking in preoperative surgical patients: a randomized controlled trial. Wolfenden L, Wiggers J, Knight

J, Campbell E, Rissel C, Kerridge R, Spigelman AD, Moore K. Anaesthesia 2005; 60(2): 172-9.18. Skin antiseptics and the risk of operating theatre fires. Swan J, Spigelman AD. ANZ J Surg 2005; 75: 556 - 558.19. A review of the Australian Incident Monitoring System. Spigelman AD, Swan J. ANZ J Surg 2005; 75: 657 - 661.20. Increasing smoking cessation care in a preoperative clinic: a randomized controlled trial. Wolfenden L, Wiggers J, Knight J,

Campbell E, Spigelman AD, Kerridge R, Moore K. Preventive Medicine 2005; 41: 284-290.21. Surgeon and hospital volume and the management of colorectal cancer patients in Australia. McGrath DR, Leong DC, Gibberd R,

Armstrong B, Spigelman AD. ANZ J Surg 2005; 41: 901-910.22. Surgical accountability: a framework for trust and change. Thompson A, Stonebridge P, Spigelman A. MJA 2005; 183: 500.23. Governance and Innovation: Experience with a policy on the introduction of new interventional procedures. Spigelman AD. ANZ J

Surg 2006; 76: 9-13. 24. Patient Safety. Spigelman AD. Clinical Risk. In press.

Books:• The National Colorectal Cancer Care Survey - Australian Clinical Practice

in 2000. Spigelman AD, McGrath DR. ISBN 1 876992 00 X. www.ncci.org.au National Cancer Control Initiative for the Commonwealth Department of Health and Aged Care, 2002.

• The NSW Colorectal Cancer Care Survey 2000. Part 1. Surgical Management. Armstrong K, O’Connell D, Leong D, Spigelman A, Armstrong B. ISBN 1 86507 073 4 www.cancercouncil.com.au The Cancer Council NSW April 2004.

• The New South Wales Colorectal Cancer Care Survey 2000 Part 2. Chemotherapy Management. Armstrong K, O'Connell DL, Leong D, Yu XQ, Spigelman AD, Armstrong BK. ISBN 1 86507 078 8. www.cancercouncil.com.au The Cancer Council NSW July 2005.

• The New South Wales Colorectal Cancer Care Survey 2000 Part 3. Chemotherapy Management. Armstrong K, Kneebone A, O'Connell D, Leong D, Yu XQ, Spigelman AD, Armstrong BK. www.cancercouncil.com.au The Cancer Council NSW in press.

Chapter:• Clinical Governance – An approach to delivering safer care. Spigelman A,

in (eds) Emslie S, Williams S, Barraclough B. Enhancing the Safety of Care, Australian Safety & Quality Council www.safetyandquality.org & Northern Territory Department of Health & Community Services, ISBN 0 7245 3372 9, 2002.

Media and Coronial Reports

Complaintsand Claims

Patient Safety

Audits and Surveys

Risk Assessment Risk Assessment Root Cause AnalysisRoot Cause Analysis

Risk Register/Action PlanRisk Register/Action PlanCost Benefit AnalysisCost Benefit Analysis

Incidents- Near Misses-Adverse Events

CLINICAL RISK

SOURCES & MANAGEMENT

Communicate Risks & Investigation Outcomes

Clinical Incident Detection

Limited Adverse Occurrence Screening (LAOS)• objective measure of potentially preventable adverse events

• periodic sampling of 40% medical records

• 6 defined criteria (death, transfer to HDU / ICU, non fatal cardiac arrest or MET call, return to theatre, unplanned readmission, extended stay)

• retrospective

• attuned to objective measurement = a performance indicator

• rate = 1.7 – 2.2%

Incident Information Monitoring System (IIMS), AIMS, Riskman• incidents risk rated using Severity Assessment Coding (SAC)

• based on likelihood of recurrence and potential consequences

• SAC 1’s = the most serious – lead to Root Cause Analysis (RCA)

• prospective

• attuned to improvement opportunities

• 21,482 Incidents - September 02 to December 04 (HAHS Pilot Study)

Incident Information Monitoring

• 88,000 Incidents - NSW Health - 05/06

• Falls 26%

• Errors in medications / intravenous fluids 20%

• Clinical management issues 13%

• Aggressive patient behaviour 8%

• Human performance 7%

• Documentation 6%

• Occupational Health & Safety 5%

FLOW CHART: CLINICAL INCIDENTS & COMPLAINTS

Incident / Complaint

Rated with a Severity Assessment Code (SAC)

(based on seriousness of matter and likelihood of recurrence)

SAC 1: Extreme SAC 2: High SAC 3: Medium SAC 4: Low

Eg. unexpected death Eg. unexpected major Eg. unexpected injury Eg. no injury

loss of function increased level of care

Investigated by Investigated by Investigated by Investigated by

CGU using CGU or line management line management line management

Root Cause Analysis

Despite the clinical risky environment,

most care is delivered safely

Adverse events

• Our ‘swamps’ include:

* High workload

* Poor communication

* Financial & human resource issues

* Absent safeguards

* Faulty equipment design

* System analysis and change are necessary to minimise future risks

Sun Herald, Sydney

September 14, 2003

70 System Factors Contributed to 3 Preventable Deaths average age = 39 years

4%9%

10%

14%

20%

43%

Patient

Organisational

Task

WorkEnvironment

Staff

Communication& Team

System analysis (RCA) detected flaws not found by medical record review or unstructured staff interviews

System Factors1. Institutional and Organisational Factors– Bed availability

2. Work Environment

– Equipment not maintained or unavailable

3.Communication and Team Factors– Poor understanding of role of retrieval team– Poor communication in and between clinical teams, wards &

hospitals– Poor documentation in medical records– Low level of clinical supervision

4.Individual (Staff) Factors– Lack of skills and training at an individual level– Fatigue

5.Task Factors– No guidelines available

6. Patient Characteristics – Co-morbidities

Implemented recommendations from prospective & retrospective system analyses - Hunter

• Improved system for informing doctors of abnormal results

• PC based interactive Foetal Monitoring Programme

• Clinical Skills Training Centre

• Resuscitation

• Communication Skills

• Team-working

• Informed Consent

• CPI projects

• reduced hysterectomy rates

• reduced diabetes admission rates

• Advanced Life Support Course Attendance – Obstetrics

• Pharmacy Drug Use Evaluation, TASC project officers

• Evidence for new equipment – CT Scanner, image intensifier, foetal monitors, neurosurgery operating microscope, replacement of 10 ageing anaesthetic monitors

• Primary prevention of adverse events – prospective approach re critical care retrieval to tertiary care

System / Individual Balance

• Problems arise because of flaws in the system but

• Too much reliance on system being protective learned helplessness

• A systems approach is not a blunderer’s charter

(James Reason)

RCA – Where does it fit?

• Reckless• Unethical• Wilful negligence• Criminal

Adverse Event

Discipline/ Prosecution

Complaint

HCCC / Reg. Bd

Area

Litigation

Coroner

Causation Statements/

Recommendations

System Improvements

Root Cause Analysis

April 1 2004

NSW Patient Safety and Clinical Quality Program October 2004

Clinical Governance • “While the patient safety initiatives in NSW Health have begun to

address many patient safety and quality issues, following the events identified in the Macarthur Health Service, there is a need to ensure patient safety is a high priority and is comprehensively and uniformly well managed across the health system”

 • “Actual complaint and incident reporting rates in NSW are

substantially lower than would be expected based on retrospective medical record studies from the US and Australia. This suggests underreporting, undetected incidents and immature systems for reporting, responding to and learning from failures in care. A more mature system will deliver an increase in the numbers of incident reports so that effective action can be taken”

 • “There is also significant variation in the extent to which

recommended strategies and structures are being implemented across all Health Services. A major change across the health system is needed so that effective measures can be implemented uniformly and consistently”

“Major Change”

• NSW Health– set uniform core standards and expected outcomes re patient

safety and clinical quality• CEC (evolved from ICE)

– Evaluate implementation of the standards– Deal with systems– Refer individual performance issues to HCCC

• HCCC– Deal with complaints

• AHSs – CGUs in all– Oversight the implementation of patient safety and clinical

quality standards by line management and clincians– Provide advice, support & facilitation to management &

clinicians regarding the standards and issues arising

CGU’s to ensure that:

1. Health services have systems in place to monitor and review patient safety

2. Health Services have developed and implemented policies and procedures to ensure patient safety and effective clinical governance

3. An incident management system is in place to effectively manage incidents that occur within health facilities and risk mitigation strategies are implemented to prevent their reoccurrence

4. Complaints management systems are in place and complaint information is used to improve patient care

5. Systems are in place to periodically audit a quantum of medical records to assess core adverse events rates

6. Performance review processes have been established to assist clinicians maintain best practice and improve patient care

7. Audits of clinical practices are carried out and, where necessary, strategies for improving practice are implemented

 

Annual Hunter Clinical Audit & Peer Review Survey• Robust audit & peer review are needed to channel AIMS & RCA data to clinicians

Sample Q’s:• Does Unit conduct clinical audit and peer review? • If YES, are meetings held to discuss findings and what is their frequency?

• Are relevant indicators reported to these meetings?

• Is management engaged to address issues arising?

• Are meetings multi-disciplinary?

• Do meetings address system issues?

• Are mechanisms in place to prevent recurrence of adverse events / near misses?

• Are points for action minuted and do they identify responsibility for follow up?• Units scored according to responses

• 10 points for each “Yes”; 0 points for each “No”

Clinical Audit Surveys: more points = more robust process Median score increased significantly from 91 to 101 (p = 0.016)

Measuring clinical audit and peer review practice in a diverse health care setting. Spigelman AD, Swan JR. ANZ J Surg 2003; 73: 1041-1043.

• Leadership (support from the top)

• Current clinical experience and credibility in the CGU

• Just Culture (with clear rules for competence issues)

• Risk reporting mechanisms (robust, timely with open disclosure)

• Appropriate structure and line of reporting

• Resources to provide advice & assistance (adequate number of trained staff)

• Feedback to staff (outcomes of investigations)

• Corrective actions implemented and monitored

Clinical Governance - Critical Success Factors

Risks to success of Clinical Governance

• Managerial takeover • Bureacratization• Loss of trust• Active clinicians excluded distant from coal face• Default to the old medical administration model• Failure to educate

– Shop floor knowledge of need to change poor– JMO’s – never heard of Bristol, Shipman, Cam Cam

• Failure to feedback• Failure to prevent errors and poor performance• Reliance on voluntary incident reporting• Size of new Area Health Services (NSW)• Secrecy