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Clinical Governance what why how


Implemented recommendations from prospective & retrospective system analyses - Hunter ... April 1 2004. NSW Patient Safety and Clinical Quality Program October ... – PowerPoint PPT presentation

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Title: Clinical Governance what why how

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
  • Dr Sam Galbraith MO, Scotland, 1999

Clinical Governance - What
  • Aims to improve patient
  • safety
  • outcomes
  • overall quality of care by a Just Culture that
  • 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
  • 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
  • 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

  • Future enquiries inevitable
  • Unless opened and dealt with
  • Save by writing the next report now
  • Same findings recommendations
  • Change names

CASAs 10 Steps for a Safety Management System
  • Gain senior management commitment
  • Set safety management policies and objectives
  • Appoint a safety officer
  • Set up a safety committee
  • Establish a process for managing risk
  • Set up a recording system to record hazards,
    risks, actions taken
  • Train and educate staff gain their commitment
  • Audit your organisation and investigate incidents
    and accidents
  • Set up a system to control documentation and data
  • Evaluate how the system is working

1999 Clinical Quality Plan - Priority Areas
1999 Clinical Quality Plan - Priority Areas

Policies developed reflect challenges encountered
  • Resolution of Complaints / Concerns re Clinician
  • 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

  • Model Policy for RACS and NSW Health Safe
    Introduction of New Interventional Procedures
    Into Clinical Practice NSW Health Circular
  • Governance and Innovation Experience with a
    policy on the introduction of new interventional
    procedures. Spigelman AD. ANZ J Surg 2006 76

  • 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
  • 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
  • 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
  • Elective open abdominal aortic aneurysm repair a
    seven year experience. Mackenzie S, Swan J,
    DEste 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.

  • Books
  • The National Colorectal Cancer Care Survey -
    Australian Clinical Practice in 2000. Spigelman
    AD, McGrath DR. ISBN 1 876992 00 X. 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, OConnell D,
    Leong D, Spigelman A, Armstrong B. ISBN 1 86507
    073 4 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. 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.
    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 Northern Territory
    Department of Health Community Services, ISBN 0
    7245 3372 9, 2002.

Audits and Surveys
  • Incidents
  • - Near Misses
  • Adverse
  • Events

Patient Safety
Media and Coronial Reports
Complaints and Claims
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
  • 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
  • SAC 1s 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

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
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
System analysis (RCA) detected flaws not found by
medical record review or unstructured staff
System Factors
  • 1. 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
  • Fatigue
  • 5.Task Factors
  • No guidelines available

  • 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
  • Pharmacy Drug Use Evaluation, TASC project
  • 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 blunderers charter
  • (James Reason)

RCA Where does it fit?
  • Reckless
  • Unethical
  • Wilful negligence
  • Criminal

Discipline/ Prosecution
HCCC / Reg. Bd
System Improvements
Causation Statements/ Recommendations
Adverse Event
Root Cause Analysis
(No Transcript)
(No Transcript)
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

CGUs 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
  • 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 Qs
  • 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
  • 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.
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
  • 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
  • Managerial takeover
  • Bureacratization
  • Loss of trust
  • Active clinicians excluded distant from coal
  • Default to the old medical administration model
  • Failure to educate
  • Shop floor knowledge of need to change poor
  • JMOs 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
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