Transcript Preventing litigation: the role of clinical governance

Clinical Governance
what why how
Professor Allan Spigelman
How not to get there
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
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
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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 Areas
1. Adverse Event Prevention
2. Appropriateness
3. Clinical Risk Management
4. Communication Skills Training
5. Concordance with patient safety
policies
1999 Clinical Quality Plan - Priority Areas
6. Consumer Participation
7. Credentialling
8. Efficiency
9. Measurement
10. Quality Structure & Reporting
Policies developed reflect challenges encountered
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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
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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.
Papers
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Large bowel cancer: guidelines and beyond. Thomas R, Spigelman A, Armstrong B. Med J Aust 1999; 171: 284-5.
Does more equal less or does less equal more? Spigelman AD. J Qual Clin Practice 2000; 20: 55.
A survey of surgical audit in Australia: whither clinical governance? Eno LM, Spigelman AD. J Qual Clin Practice 2000; 20:
2-4.
An audit of open and laparoscopic inguinal hernia repair. Eno L, Spigelman AD. J Qual Clin Practice 2000; 20: 56-9.
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.
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.
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.
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.
Audit of surgeon awareness of readmissions with venous thrombo-embolism. Swan J, Spigelman AD. Internal Medicine
2003; 33: 578-580.
Titanic waiting lists - what lies beneath? Spigelman AD. ANZ J Surg 2003; 73: 781.
Why are are we waiting? Spigelman AD. ANZ J Surg 2003; 73: 873.
Measuring clinical audit and peer review practice in a diverse health care setting. Spigelman AD, Swan JR. ANZ J Surg
2003; 73: 1041-1043.
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.
Complications after discharge for surgical patients. Kable A, Gibberd R, Spigelman AD. ANZ J Surg 2004; 74: 92-97.
People with colorectal cancer – can we help them do better? Spigelman AD. ANZ J Surg 2004; 74: 401-402.
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.
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.
Skin antiseptics and the risk of operating theatre fires. Swan J, Spigelman AD. ANZ J Surg 2005; 75: 556 - 558.
A review of the Australian Incident Monitoring System. Spigelman AD, Swan J. ANZ J Surg 2005; 75: 657 - 661.
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.
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.
Surgical accountability: a framework for trust and change. Thompson A, Stonebridge P, Spigelman A. MJA 2005; 183: 500.
Governance and Innovation: Experience with a policy on the introduction of new interventional procedures. Spigelman AD.
ANZ J Surg 2006; 76: 9-13.
Patient Safety. Spigelman AD. Clinical Risk. In press.
Books:
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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.
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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.
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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.
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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:
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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.
CLINICAL RISK
SOURCES & MANAGEMENT
Audits and
Surveys
Incidents
- Near Misses
-Adverse
Events
Patient
Safety
Complaints
and Claims
Media and
Coronial Reports
Risk Assessment
Root Cause Analysis
Risk Register/Action Plan
Cost Benefit Analysis
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
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incidents risk rated using Severity Assessment Coding (SAC)
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based on likelihood of recurrence and potential consequences
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SAC 1’s = the most serious – lead to Root Cause Analysis (RCA)
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prospective
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attuned to improvement opportunities
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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
Eg. unexpected death
Investigated by
CGU using
Root Cause Analysis
SAC 2: High
SAC 3: Medium
Eg. unexpected major
Eg. unexpected injury
loss of function
increased level of care
Investigated by
CGU or line management
SAC 4: Low
Eg. no injury
Investigated by
Investigated by
line management
line management
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
Patient
4%
9%
Organisational
10%
43%
14%
Task
Work
Environment
Staff
20%
Communication
& Team
System analysis (RCA) detected flaws not found by medical
record review or unstructured staff interviews
System Factors
1. Institutional and Organisational Factors
– Bed availability
2. Work Environment
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Equipment not maintained or unavailable
3.Communication and Team Factors
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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
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Lack of skills and training at an individual level
Fatigue
5.Task Factors
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No guidelines available
6. Patient Characteristics
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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
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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?
Discipline/
Prosecution
• Reckless
• Unethical
• Wilful negligence
• Criminal
HCCC / Reg. Bd
Complaint
Area
Litigation
Coroner
Adverse
Event
Root Cause Analysis
Causation
Statements/
Recommendations
System
Improvements
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
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Robust audit & peer review are needed to channel AIMS & RCA data to clinicians
Sample Q’s:
• Does Unit conduct clinical audit and peer review?
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If YES, are meetings held to discuss findings and what is their frequency?
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Are relevant indicators reported to these meetings?
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Is management engaged to address issues arising?
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Are meetings multi-disciplinary?
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Do meetings address system issues?
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Are mechanisms in place to prevent recurrence of adverse events / near misses?
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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.
Clinical Governance - Critical Success Factors
• 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
Risks to success of Clinical Governance
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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
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Failure to feedback
Failure to prevent errors and poor performance
Reliance on voluntary incident reporting
Size of new Area Health Services (NSW)
Secrecy