Clinical Governance what why how

1
Clinical Governance what why how

• Professor Allan Spigelman

2

3

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

4

• Clinical Governance What
• corporate responsibility for clinical
  performance
• Dr Sam Galbraith MO, Scotland, 1999

5
Clinical Governance - What

• Aims to improve patient
• safety
• outcomes
• overall quality of care by a Just Culture that
  encourages
• reporting
• open disclosure

6
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

7
Management Budget Quality
8

• 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)

9
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

10

• 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

11
Hypotheses

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

12
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

13
1999 Clinical Quality Plan - Priority Areas
14
1999 Clinical Quality Plan - Priority Areas
15

Policies developed reflect challenges encountered

• 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

16

• 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.

17
Papers

• 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,
  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.

18

• 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, OConnell 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.

19
CLINICAL RISK SOURCES MANAGEMENT
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
20
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 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)

21
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

22
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
23
Despite the clinical risky environment, most care
is delivered safely
24
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

25
Sun Herald, Sydney September 14, 2003
26
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
interviews
27
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
  level
• Fatigue
• 5.Task Factors
• No guidelines available

28

• 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

29

• 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

30
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)

31
RCA Where does it fit?

• Reckless
• Unethical
• Wilful negligence
• Criminal

Discipline/ Prosecution
HCCC / Reg. Bd
Complaint
Area
Litigation
Coroner
System Improvements
Causation Statements/ Recommendations
Adverse Event
Root Cause Analysis
32
(No Transcript)
33
(No Transcript)
34
April 1 2004
35
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

36
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

37
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
  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
•  

38
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
  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

39
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.
40
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

41
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
• 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