safety management systems & reliability chris w. hayes, md cpsoc april 12, 2011
TRANSCRIPT
Overview
How safe is healthcare? What is Safety Management System System defences “Swiss Cheese” model Reliability
– Group exercise
Summary
How Safe is Healthcare?
Canadian Adverse Events Study– 7.5% of admission suffer an AE
– 9250 to 23750 preventable deaths/yr
– Death from AE in 1/165 admissions
Baker R. The Canadian Adverse Events Study. CMAJ 2001.
Why Is This So?
“Medicine used to be simple, ineffective and relatively safe.
Now it is complex, effective and potentially dangerous.”
Sir Cyril Chantler
Chairman, King’s Fund
Why Is This So?
Clinical medicine has become extremely complex:– Increased patient volume, acuity
– Growing therapeutic options
– Expanding knowledge, evidence
– Surprises, uncertainty
– Many sources of (incomplete) information
– Interruptions and multitasking
Why Is This So?
AND… Safe and quality outcomes (for the most part)
dependent on healthcare providers [humans] Is that a problem?
Why Is This So?
StrengthsLarge memory capacityLarge repertory of responsesFlexibility in applying responses to informationAbility to react creatively to the unexpected
LimitationsDifficulty in multitaskingDifficulty in recalling detailed information quicklyPoor computational abilityLimited short term memoryPerception
•Compassionate / caring
Gets worse with:-fatigue-stress-lack of knowledge-lack of confidence-lack of supportive workenvironment
How Do We Get There?
Healthcare needs to become more like an ultra-safe industry– Learn from other ultra-safe industries
– Learn from components of medicine that have achieved high degree of safety
– Develop a strong Culture of Safety
Safety Management Systems?
Safety Management System, SMS– Taken from ultra-safe, HROs
– An organizational approach to safety
– Focuses on the system not the person
A systematic, explicit and comprehensive process for managing safety risks
Safety Management Systems?
SMS origins from aviation industry– In response to major airline disasters in the 1960’s
– Initial focus on “safety system”• Made department / individuals responsible for safety
Safety Management Systems?
SMS origins from aviation industry– In response to major airline disasters in the 1960’s
– Initial focus on “safety system”• Made department / individuals responsible for safety
– Realization that to achieve full scale safety goals need whole organization approach
Safety Management Systems?
Main objectives:– Detecting and understanding the hazards and risks
in your environment
– Proactively making changes to minimize risks
– Learning from errors that occur in order to prevent their reoccurrence
Safety Management Systems?
With the understanding that:– Safety is everyone’s job
– Embedded at all levels
– Humans are fallible
– System defences need to be designed / redesigned to protect patients
CultureOf
Safety
System Defences
Redundancy and Diversity– Need for multiple layers
– Need for multiple approaches
2 Types of defences– Hard defences – engineered features, forcing functions,
constraints
– Soft defences – rules, policies, double-checks, signoffs, auditing, reminders
System Defences
Hazardous domains (nuclear power)– activities are stable and predictable
– heavy reliance on engineered safety features.
Healthcare defences– most of the defences are human skills.
– sharpenders (nurses, junior MDs) are the ‘glue’ that holds these defences together.
System Defences
Disaster happens when:– There are initiating disturbances, AND
– The defences fail to detect and/or protect
– often necessary for several defences to fail at the same time.
Incidence of error (losses) depends on:– The frequency of initiating disturbance (hazards)
– The reliability of the system defences
Reason’s “Swiss Cheese” Model
Defences are only as strong as their weakest link!
Some holes dueto active failures
Other holes due to
latent conditions
HazardsHazards
LossesLosses
A System Model of Accident Causation
Reason’s “Swiss Cheese” Model
Defences are only as strong as their weakest link!
Some holes dueto active failures
Other holes due to
latent conditions
A System Model of Accident Causation
HazardsHazards
LossesLosses
An Example
SMH ICU– Patient with CVA has seizure in ICU
– MD orders 1g Dilantin over 20 minutes
– MD called to reassess patient for severe hypertension and ST changes
– Metoprolol given with bradycardia but little BP effect
– Pt suffers large MI and CHF
Reason’s “Swiss Cheese” Model
HazardsHazardsSound-alikeSound-alikelook-alike look-alike drugdrug
LossesLossesCHF/MICHF/MI RN/MD Double-check
Medicationorganization
Purchasing
Manufacturer
Making Your System Safer
Accept that errors will be made Incorporate features of Ultra-safe SMS
– Actively seek hazards (FMEA, Walk-Rounds) and learn from errors that have occurred (RCA)
– Create multiple defense layers to prevent error (hard and soft as appropriate)
– Make safety everyone’s job
Making Your System Safer
“We cannot change the human condition
But…
we can change the conditions under which humans work”
James Reason
Making Healthcare Reliable
How do you close the hole’s in the Swiss Cheese– Design strong defences
• Engineer problem away
– Include human factors design (later)
– Build in reliable processesreliable
Reliability
Measured as the inverse of the system’s failure rate Failure free operation over time
– Chaotic: failure in greater than 20% of events
– 10-1: 1 or 2 failures out of 10
– 10-2: <5 failures per 100
– 10-3 : <5 failures per 1000
– 10-4 : <5 failures per 10000
Reliability
Reliability principles, used to design systems that compensate for the limits of human ability, can improve safety and the rate at which a system consist-ently produces desired outcomes.
Reliability
Three-step model for applying principles of reliability to health care systems:
1. Prevent failure
2. Identify and Mitigate failure
3. Redesign the process based on the critical failures identified.
Table Exercises – The case
As your organization’s PSO your are made aware of several patients who received cardiopulmonary resuscitation following Code Blue calls despite known advance directives stating the patients’ wishes were to be DNR
In both cases the DNR order was in the chart but were not easily located nor were the assigned nurses aware of the order
You were aware that No Resuscitation Policy that contained a standardized order form was created, approved by senior management and MAC and was available for use
POLICY PRACTICE
Group Exercise
Identify a process to make more reliable Describe the current process (flow chart) Identify where the defects occur in the current
system Set a reliability goal for the segment
Roll Out - The Usual Way
IDEA
Discuss&
Revise
Discuss&
ReviseDiscus
s&
Revise
Discuss&
Revise
Discuss&
Revise
Discuss&
ReviseInitialPlan
InitialPlan
BOARDROOM
REAL
WORLD
Applying Reliability
Understand the process Find the defects, bottlenecks and workarounds Plan process improvements Test them…small scale, front-line
involvement….until they work Look for failures and …redesign
Summary
Healthcare has high error rate Understanding hazards and learning from errors
vital Defences that rely on more than human vigilance
need to be in place Need a strong culture of safety Need to build reliable processes Start small….involve frontline Safety improvement is everyone’s job