1. Safety Management Systems & Reliability
Chris W. Hayes, MD
CPSOC
April 12, 2011

2. Overview How safe is healthcare? What is Safety Management System
System defences
“Swiss Cheese” model
Reliability
Group exercise
Summary

3. How Safe is Healthcare?

4. How Safe is Healthcare? Canadian Adverse Events Study
7.5% of admission suffer an AE
9250 to preventable deaths/yr
Death from AE in 1/165 admissions
Baker R. The Canadian Adverse Events Study. CMAJ 2001.

5. How Safe is Healthcare?
Health Care

6. 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

7. 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

8. Why Is This So?
AND…
Safe and quality outcomes (for the most part) dependent on healthcare providers [humans]
Is that a problem?

9. Why Is This So? Strengths Limitations Gets worse with: -fatigue
-stress
-lack of knowledge
-lack of confidence
-lack of supportive work environment
Strengths
Large memory capacity
Large repertory of responses
Flexibility in applying responses to information
Ability to react creatively to the unexpected
Limitations
Difficulty in multitasking
Difficulty in recalling detailed information quickly
Poor computational ability
Limited short term memory
Perception
Compassionate / caring

10. Where Should We Be?
Health Care
Blood Transfusion
Anesthesia

11. 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

12. 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

13. 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

14. Safety Management Systems?

15. 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

16. 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

17. 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
Culture Of
Safety

18. System Defences Redundancy and Diversity 2 Types of defences
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

19. System Defences Hazardous domains (nuclear power) Healthcare defences
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.

20. 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

21. Reason’s “Swiss Cheese” Model
Defences are only as strong as their weakest link!
Some holes due
to active failures
Hazards
Other holes due to
latent conditions
Losses
A System Model of Accident Causation

22. Reason’s “Swiss Cheese” Model
Defences are only as strong as their weakest link!
Some holes due
to active failures
Hazards
Other holes due to
latent conditions
Losses
A System Model of Accident Causation

23. 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

24. An Example

25. Reason’s “Swiss Cheese” Model
Manufacturer
Medication organization
Hazards
Sound-alike look-alike drug
Purchasing
Losses CHF/MI
RN/MD Double-check

26. 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

27. Making Your System Safer
“We cannot change the human condition
But…
we can change the conditions under which humans work”
James Reason

28. 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 processes
reliable

29. Reliability

30. 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

31. 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.

32. Reliability
Three-step model for applying principles of reliability to health care systems:
Prevent failure
Identify and Mitigate failure
Redesign the process based on the critical failures identified.

33. 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

34. 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

35. 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

36. Roll Out - The Usual Way B O A R D Initial M Plan IDEA R E A L W O D
Discuss
&
Revise B O A R D M
Discuss
&
Revise
Discuss
&
Revise
Initial
Plan
IDEA R E A L W O D

37. Roll Out - The Better WayD M
Initial
Plan
IDEA R E A L W O D

40. 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

41. 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

42. Thank You!
Questions?