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Dr Lee Gruner 2004 1
Background to Clinical Risk Management and Root Cause Analysis
Dr Lee GrunerBSc, MBBS, BHA, FRACMA,
MBA (Executive) GAICD
Dr Lee Gruner 2004 2
Major medical error studiesHarvard Medical Practice Study (1984)
Reviewed medical charts of 30,121 patients admitted to 51 acute care hospitals in New York state in 1984
In 3.7% an adverse event led to prolonged admission or produced disability at the time of discharge
69% of injuries were caused by errors
Dr Lee Gruner 2004 3
Major medical error studies Australian Quality in Healthcare study
(1995) Investigators reviewed the medical records of
14,179 admissions to 28 hospitals in New South Wales and South Australia in 1995.
An adverse event occurred in 16.6% of admissions, resulting in permanent disability in 13.7% of patients and death in 4.9%
51% of adverse events were considered to have been preventable.
Dr Lee Gruner 2004 4
Results of medical error
In Australia medical error results in 18,000 unnecessary deaths and more than 50,000 disabled patients per year
In the USA, medical error results in at least 44,000 unnecessary deaths and over 1,000,000 excess injuries per year
Dr Lee Gruner 2004 5
Origins of Clinical Risk Management “Most people view medical mistakes as an
individual provider issue rather than a failure in the process of delivering care in a complex delivery system. When asked about possible solutions to prevent medical mistakes actions rated effective by respondents were “keeping health professionals with bad track records from providing care” and “better training of health professionals”
( To Err is Human, 1999)
Dr Lee Gruner 2004 6
Developing a systems approach Research into adverse events in the aviation
industry have supported the systems approach
Don Berwick contends the “bad apples” approach is inappropriate: worst mistakes often made by the best people error provoking states of mind are the last and
least manageable in the error sequence
Dr Lee Gruner 2004 7
Developing a systems approach
A systems approach is based on: same situations lead to the same errors
regardless of who is involved no single best way to prevent error fallibility is part of being human important features are the chain of events,
actions of individuals, conditions of work and contextual issues
blame lies with the system at least 60% of the time
Dr Lee Gruner 2004 8
Why does medical error rate continue to be so high?
Lack of awareness of the extent of the problem major errors are uncommon and regarded as outliers most errors do not harm the patient
Professional staff have great difficulty in dealing with human error when it does occur powerful emphasis in medicine on perfection error is regarded as a failure of character “you weren't
careful enough” “ you didn’t try hard enough” error = negligence role models enforce concept of infallibility
Dr Lee Gruner 2004 9
Why does medical error rate continue to be so high?
Learnings are not shared errors covered up mistakes not evaluated learn from mistakes in a vacuum
Realities of medico-legal action incentives against disclosure
Dr Lee Gruner 2004 10
Standard approaches If professionals were properly trained and
motivated there would be no errors Training and/or punishment will fix the
problem The individual is at fault- “bad apple” theory Underlying causes of error not explored More emphasis on inspection and quality
control
Dr Lee Gruner 2004 11
Evidence from human factor and psychological research Human performance is classified into:
skill based rule based knowledge based
Errors are classified as: Active failures
Slips Mistakes Violations
Latent failures Provide conditions in which unsafe acts occur, usually
stemming from decisions of those not directly involved in the workplace
Dr Lee Gruner 2004 12
Evidence from human factor and psychological research
Slips: errors of action due to break in routine when attention is
diverted influenced by sleep loss, drugs, illness,
anxiety
Dr Lee Gruner 2004 13
Example of an error
Car accident while fiddling with the radioAffixing wrong drug label while talking to
someonePicking up the wrong ampoule while in a
hurry
Dr Lee Gruner 2004 14
Evidence from human factor and psychological research
Mistakes rule or knowledge based errors use the wrong rule lack of knowledge or misinterpretation of
the problem bias may play a significant part- paradigm
theory
Dr Lee Gruner 2004 15
Example of a mistakeMethotrexate prescribed for patient
admitted for elective surgery at a dosage of 15 mg per day
Prescribed by a junior doctorActual dose should have been 15 mg per
weekPatient died a week later of neutropaenia
Dr Lee Gruner 2004 16
Evidence from human factor and psychological research
Violations Deviations from safe operating practice
usually associated with motivational problems eg poor morale/ poor riole modelling/ deficient management
Dr Lee Gruner 2004 17
Example of a violation
Dr Lee Gruner 2004 18
Example of a violation
19Dr Lee Gruner 2004
Relationship to adult learning theory
LOW HIGH
Unconscious Incompetence
Conscious Incompetence
Unconscious Competence
Conscious Competence
LOW
LOWHIGH
COMPETENCE
SELF AWARENESS
LOW HIGH
Dr Lee Gruner 2004 20
Latent errorsThree Mile Island incident 1979Chernobyl 1986 / Bhopal 1984
poor system design implicated operator error only part of the explanation-
proximal cause root causes present in the system for a
long time i.e. accidents waiting to happen
Dr Lee Gruner 2004 21
Accident Prevention Must focus on:
Root causes- systems errors in design and implementation
don’t develop solutions to the unsafe acts themselves developing methods of error reduction at each stage
of system development design features that correct for human and
mechanical errors and minimise errors simplification, use of constraints, standardisation
Dr Lee Gruner 2004 22
Systems changes to reduce hospital injuries
Discovery of errorsPrevention of errorsAbsorption of errorsPsychological precursors
Dr Lee Gruner 2004 23
Discovery of errors
Efficient routine identification of errors as part of normal practice
Routine investigation of all errors that cause injury
Collect relevant data as this will reduce expenses in the longer term
Dr Lee Gruner 2004 24
Error prevention in hospitals Reduce reliance on memory
check lists/ protocols/ decision aids Improve information access
creative ways to provide information where and when needed
Error proofing “forcing functions”
Standardisation Training
How to prevent errors/ problem solving techniques Better supervision of junior staff Safe practice is as important as effective practice
Dr Lee Gruner 2004 25
Turn the swiss cheese into a solid cheddar
Dr Lee Gruner 2004 26
Absorption of errors
Impossible to prevent all errorsNeed to build barriers into the system to
prevent harm to patients
Dr Lee Gruner 2004 27
Psychological precursors
Assess work schedules, division of responsibilities,task descriptions, management decisions These can lead to time pressure and
fatigue with an impact on safetyDevelop a supportive environmentEliminate fear
Dr Lee Gruner 2004 28
Lessons from King Edward Memorial Hospital Issues relating to poor child and maternal
outcomes dating back over 10 years Three reviews in 3 years culminating in the
Douglas Enquiry in 1999 Douglas Enquiry focused on areas for
improvement and high risk cases Findings related to management / medical
staff and clinical practice issues
Dr Lee Gruner 2004 29
Lessons from King Edward Memorial Hospital Management failed to:
Make important decisions Create an open and transparent culture Monitor safety and quality Ensure proper supervision/ training of staff Define accountability and reporting responsibility Address serious issues relating to adverse pt
outcomes Respond adequately to complaints
Dr Lee Gruner 2004 30
Lessons from King Edward Memorial Hospital Senior doctor procedures deficient:
Insufficient involvement in complex cases Inadequate decisions Inadequate credentialling and appointment
procedures Inadequate performance management Inadequate supervision of junior staff Failed to provide timely analysis of staffing needs
Dr Lee Gruner 2004 31
Lessons from King Edward Memorial HospitalJunior doctor work practices:
Did much of the complex work Poorly supervised Requests for help ignored Blamed for errors Sink or swim culture Inadequate orientation and training
Dr Lee Gruner 2004 32
Lessons from King Edward Memorial Hospital
Clinical practice issues: Little best practice Poor outcomes No benchmarking
Dr Lee Gruner 2004 33
Clinical governance
A framework through which organisations are accountable for continually improving the quality of services and safeguarding standards of care by creating an environment in which clinical care will flourish
Dr Lee Gruner 2004 34
Clinical governance
Aims to ensure that:systems to monitor the quality of clinical
practice are in place and functioning properly
clinical practices are reviewed and improved
clinical practitioners meet standards set by regulatory bodies
Dr Lee Gruner 2004 35
Elements of clinical governance
Human resource systemsReview of clinical practiceExternal assessment of practiceCommitment to ongoing education
Dr Lee Gruner 2004 36
Human resource systems
Medical appointments and credentialing systems
Effective management of poorly performing colleagues
Management of the clinical performance of colleagues , developing guidelines and protocols
Dr Lee Gruner 2004 37
Review of clinical practice
Clinical auditEvidence based clinical practice Implementation of clinical effectiveness
evidenceRisk management
Dr Lee Gruner 2004 38
Commitment to ongoing education
Continuing education for all clinical staffDevelopment of clinical leadership skillsContinuing professional development
for all staff
Dr Lee Gruner 2004 39
Use of root cause analysisTo uncover latent errors (errors of
system design) underlying an adverse (sentinel) event
Structured, process focused approachAvoids individual blame Identifies and addresses systems and
organisational issues
Dr Lee Gruner 2004 40
Limitations of RCA Impossible to know if the root cause
established by the analysis is the actual cause of the incident
May be tainted by hindsight biasMay be bias relating to prevailing
concerns in the organisation Time consuming and labour intensiveQualitative rather than quantitative
Dr Lee Gruner 2004 41
Use of RCA Needs to be regular enough for staff to develop
skills Decision to conduct an RCA depends on
organisational leadership Needs to be conducted for all DHS reportable
sentinel events Only one detailed study of regular use of RCA
and its outcomes RCA and follow up of serious drug events over 12
month period led to a 45% decline in ADEs attributed to blame free RCA and changes in policy and process
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