Dr Lee Gruner 20041 Background to Clinical Risk Management and Root Cause Analysis Dr Lee Gruner BSc, MBBS, BHA, FRACMA, MBA (Executive) GAICD

Dr Lee Gruner 2004 1

Background to Clinical Risk Management and Root Cause Analysis

Dr Lee GrunerBSc, MBBS, BHA, FRACMA,

MBA (Executive) GAICD


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


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.


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


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)


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


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


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


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


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


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


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


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



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


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



Violations Deviations from safe operating practice

usually associated with motivational problems eg poor morale/ poor riole modelling/ deficient management


Example of a violation


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


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


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


Systems changes to reduce hospital injuries

Discovery of errorsPrevention of errorsAbsorption of errorsPsychological precursors


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


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


Turn the swiss cheese into a solid cheddar


Absorption of errors

Impossible to prevent all errorsNeed to build barriers into the system to

prevent harm to patients


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


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


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


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


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


Lessons from King Edward Memorial Hospital

Clinical practice issues: Little best practice Poor outcomes No benchmarking


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


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


Elements of clinical governance

Human resource systemsReview of clinical practiceExternal assessment of practiceCommitment to ongoing education


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


Review of clinical practice

Clinical auditEvidence based clinical practice Implementation of clinical effectiveness

evidenceRisk management


Commitment to ongoing education

Continuing education for all clinical staffDevelopment of clinical leadership skillsContinuing professional development

for all staff


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


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


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

Documents

Dr Lee Gruner 20041 Background to Clinical Risk Management and Root Cause Analysis Dr Lee Gruner BSc, MBBS, BHA, FRACMA, MBA (Executive) GAICD