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The Science of Patient Safety
Dr. Mohamed Mosaad Hasan
MD, MPH, CPHQ, CPPS, GBSS
Objectives
• Outline major principles for systems
thinking and reliable design
• Describe human error categories and
explain ways in which human factors
engineering impacts safe process design
• Differentiate improvement models that
have been utilized outside and inside of
the healthcare industry
CASE #1
• 35 year old male
• Seeking opthamology referral
• Lab results for a different patient were
reviewed
CASE #2
• 52 year old patient
• History of GI bleeds
and ulcers
• Prescribed an
NSAID
System
Hazards
• Hazard activities
(i.e., behaviors)
or conditions
that pose threat
of harm
• Sometimes
hazards lie
hidden in the
system, and
sometimes they
are quite
obvious
44,000- 98,0000
Healthcare World before 1999-
2000
• Quality/safety assumed to be excellent.
• No business case to improve
safety/quality.
• No local expertise, research or best
practices.
• Little concerted effort by board, C-suite or
physicians to improve quality/safety
• Combination of wrong mental model and
no incentive leads to predictable results
Healthcare World Now
• Growing business case for safety/quality
• Steady progression from relatively weak pressures
(social pressure, accreditation w/ low chance to fail,
transparency), eventually settling on “all of the above”
plus payment changes
• Capacity building: people, tools, measures and IT
• Transition from quality/safety to value
• Recognition of need to remake delivery system to
survive/succeed in new healthcare world
Why Is This So Hard?
• Medicine is complex
• High degree of
uncertainty
• Care across the
continuum is challenging
• Diversity of workforce
and
complexity of patients
Definition of Insanity
• Insanity: doing the same thing over and over again and
expecting different results.
Albert Einstein
Error Causation and Prevention
• Most preventable harm to patients
receiving healthcare today is caused by
the unsafe acts of the various Practitioners
who are trying to help them.
Human Error – James Reason
Systems Thinking
 Refers to thinking in terms of:
 Interdependencies
 Interactions
 Sequences
Systems Thinking
 Provides a conceptual framework to help
see and understand relationships
 Helps to avoid simplistic solutions to
complex problems
 Focus on interdependencies
Reliability Science
Definition of Reliability:
“the extent to which an experiment, test, or
measuring procedure yields the same
results on repeated trials”
By Institute for Healthcare Improvement
“Failure free operation over time”
Relation to IOM’s aims: effectiveness,
timeliness, and patient-centeredness.
High Reliability Organization (HRO)
• Organizations despite functioning in
complex, hazardous environments,
have very low error rates
• Examples: airline industry, nuclear
power, chemical plants, aircraft carriers.
One small error can lead to catastrophic
consequences for not only the
employees but also for the general
public.
PRINCIPLES OF RELIABILITY
SCIENCE
• Anticipation: used to detect an error
before it occur.
• Containment: control the consequences
of errors
Checklists and other Systems
Let me read your
order Back to you.
The Culture of Low
Expectations
“We suspect that these physicians and nurses had
become accustomed to poor communication and
teamwork. A ‘culture of low expectations’
developed in which participants came to expect a
norm of faulty and incomplete exchange of
information [which led them to conclude] that
these red flags signified not unusual, worrisome
harbingers but rather mundane repetitions of the
poor communication to which they had become
inured.”
Drs. Mark Chassin and Elise Becher
Annals of Internal Medicine, 2002
Human Factors
• Human factors engineering focuses on
human beings and their interaction with
each other, products, equipment,
procedures, and the environment.
• Human factors leverages what we know
about human behavior, abilities,
limitations, and other characteristics to
ensure safer, more reliable outcomes.
Sleep Deprivation
Interruptions
Memory Issues
Forcing Functions
• Be more
careful,
or….
• Redesign
the breaks
Error Proofing
1. Simplification
2. Standardization
3. Reduce reliance on memory
4. Improve access to information
5. Use forcing functions and constraints
Error Proofing
6. Use visual controls
7. Leverage high-performance teams
8. Deploy redundancies
9. Eliminate environmental factors
10. Make errors more visible
PI approaches
Common Characters
Planned
Systematic
Collaborative
Organization-wide
Planned
ORGANIZED
DOCUMENTED
Systematic
PLANNING
PRIORITIZATION
ASSESSMENT
IMPLEMENTING
MAINTENANCE
ORGANIZATION WIDE
ALL LEADERS
ENTIRE ORGANIZATION
IMPORTANT FUNCTIONS
COLLABORATIVE
DEPARTMENTS
SETTINGS
DISCIPLINES
Model for Improvement
Three Questions
1) What is the aim?
2) How will we know a change is an
improvement?
3) What changes can we make that will
result in
an improvement?
SHEWHART (PDCA) AND DEMING
MODEL (PDSA)
 P = PLAN
 D = DO (PILOT)
 CHECK OR STUDY
 ACT
36
Shewhart Cycle
Plan
Do
Check
Act
1. Identify customer
needs/expectations
2. Describe the
current process
3. Measure and
analyze data
4. Identify improvement
opportunities
5. Identify root causes
of problems
6. Generate and choose
solutions
7. Plan and implement
a pilot of the solutions
8. Evaluate results of pilot9. Draw conclusions
10. Standardize the change
11. Monitor the change
and hold the gains
The Tradiotnal PDCA Model
FOCUS – PDCA MODEL
 F = FIND A PROBLEM
 O = ORGANIZE TEAM
 C = CLARIFY YOUR KNOWLEDGE ABOUT THE PROCESS
 U = UNDERSTAND SOURCES OF VARIATION
 S = SELECT THE PROCESS IMPROVEMENT
 PLAN THE NECESSARY STEPS
 DO ALL NECESSARY TO IMPLEMENT
 CHECK THE RESULT OF ACTION
 ACT FULLY IMPLEMENT
(Useful for REDESIGN of a new process or QI)
F.O.C.U.S.
→Find an improvement project
(initiative):
– Review related standards & documents
– Analysis of collected data
– Identify problems & desired outcomes
39
F. O .C.U.S.
→Organize ad hoc (task force) team:
– Identify & involve stakeholders (e.g.
physicians, nurses, administrative …etc)
– Cover all related departments to the
improvement initiative
– Select team members who best do or know
the process to be improved
40
O
F.O.C.U.S.
→ Clarify current process & desired
outcomes:
– Fully understand the current process by
all team member
– Draw flow chart to clarify the process
variation/problem
– Collect data from all affected areas
relevant to process & desired outcomes
41
C
F.O.C.U.S.
Understand Process Variation, Root
Causes & Desired Outcomes
F.O.C.U.S.
→Select the best practice procedure:
– Analyze alternative solutions related to
process improvement
– Choose the best solution that will achieve
desired outcome
– Develop approval with a summary of
required information about expected
outcomes, resources needed, time-frame,
responsibilities ..etc
43
S
P.D.C.A.
Plan the improvement project:
P.D.C.A.
Do the improvement project:
P.D.C.A.
Check the results:
P.D.C.A.
Act to hold gains or re-adjust
FOCUS_PDCA
Lean Methodology
• LEAN: An effective
approach for
improving patient
safety by process
design that improves
reliability through
standard work,
mitigation, and
continuous
improvement
Focus Area of Lean
Lean:
 Lean pioneered by Toyota, focuses on the
efficient operation of the entire value chain.
 Focus areas:
– Remove non-value added steps to:
 Reduce cycle time
 Improve quality
– Align production with demand
– Reduce inventory
– Improve process safety and efficiency
Six Sigma
Core Attributes for Safe, Reliable
Systems
• Well-defined workflows
• Mistake-proofing principles
• Measurement strategy
• Team members who share responsibility
to provide safe, reliable care
The Science of Patient Safety
• New concepts: science of error
causation (“systems thinking”), complex
systems, human factors, cognitive
psychology, applied informatics…
• New attitudes: teamwork, discipline,
professionalism, balancing “no blame”
with accountability, disclosure…
• New skills: error analysis, leadership,
change management...
“We think that the anxiety, demoralization, and
sense of loss of control that afflict too many
healthcare professionals today directly come not
from finding themselves to be participants in
systems of care, but rather from finding
themselves lacking the skills and knowledge to
thrive as effective, proud, and well-oriented
agents of change in those systems…. A physician
equipped to help improve healthcare will be not
demoralized, but optimistic; not helpless in the
face of complexity, but empowered; not frightened
by measurement, but made curious and more
interested; not forced by culture to wear the mask
of the lonely hero, but armed with confidence to
make a better contribution to the whole.”
Berwick and Finkelstein, Acad Med, 2010
1 the science of patient safety

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1 the science of patient safety

  • 1. The Science of Patient Safety Dr. Mohamed Mosaad Hasan MD, MPH, CPHQ, CPPS, GBSS
  • 2. Objectives • Outline major principles for systems thinking and reliable design • Describe human error categories and explain ways in which human factors engineering impacts safe process design • Differentiate improvement models that have been utilized outside and inside of the healthcare industry
  • 3. CASE #1 • 35 year old male • Seeking opthamology referral • Lab results for a different patient were reviewed
  • 4. CASE #2 • 52 year old patient • History of GI bleeds and ulcers • Prescribed an NSAID
  • 6. Hazards • Hazard activities (i.e., behaviors) or conditions that pose threat of harm • Sometimes hazards lie hidden in the system, and sometimes they are quite obvious
  • 8. Healthcare World before 1999- 2000 • Quality/safety assumed to be excellent. • No business case to improve safety/quality. • No local expertise, research or best practices. • Little concerted effort by board, C-suite or physicians to improve quality/safety • Combination of wrong mental model and no incentive leads to predictable results
  • 9. Healthcare World Now • Growing business case for safety/quality • Steady progression from relatively weak pressures (social pressure, accreditation w/ low chance to fail, transparency), eventually settling on “all of the above” plus payment changes • Capacity building: people, tools, measures and IT • Transition from quality/safety to value • Recognition of need to remake delivery system to survive/succeed in new healthcare world
  • 10. Why Is This So Hard? • Medicine is complex • High degree of uncertainty • Care across the continuum is challenging • Diversity of workforce and complexity of patients
  • 11. Definition of Insanity • Insanity: doing the same thing over and over again and expecting different results. Albert Einstein
  • 12. Error Causation and Prevention • Most preventable harm to patients receiving healthcare today is caused by the unsafe acts of the various Practitioners who are trying to help them.
  • 13. Human Error – James Reason
  • 14.
  • 15. Systems Thinking  Refers to thinking in terms of:  Interdependencies  Interactions  Sequences
  • 16. Systems Thinking  Provides a conceptual framework to help see and understand relationships  Helps to avoid simplistic solutions to complex problems  Focus on interdependencies
  • 17. Reliability Science Definition of Reliability: “the extent to which an experiment, test, or measuring procedure yields the same results on repeated trials” By Institute for Healthcare Improvement “Failure free operation over time” Relation to IOM’s aims: effectiveness, timeliness, and patient-centeredness.
  • 18. High Reliability Organization (HRO) • Organizations despite functioning in complex, hazardous environments, have very low error rates • Examples: airline industry, nuclear power, chemical plants, aircraft carriers. One small error can lead to catastrophic consequences for not only the employees but also for the general public.
  • 19. PRINCIPLES OF RELIABILITY SCIENCE • Anticipation: used to detect an error before it occur. • Containment: control the consequences of errors
  • 20. Checklists and other Systems Let me read your order Back to you.
  • 21. The Culture of Low Expectations “We suspect that these physicians and nurses had become accustomed to poor communication and teamwork. A ‘culture of low expectations’ developed in which participants came to expect a norm of faulty and incomplete exchange of information [which led them to conclude] that these red flags signified not unusual, worrisome harbingers but rather mundane repetitions of the poor communication to which they had become inured.” Drs. Mark Chassin and Elise Becher Annals of Internal Medicine, 2002
  • 22. Human Factors • Human factors engineering focuses on human beings and their interaction with each other, products, equipment, procedures, and the environment. • Human factors leverages what we know about human behavior, abilities, limitations, and other characteristics to ensure safer, more reliable outcomes.
  • 26. Forcing Functions • Be more careful, or…. • Redesign the breaks
  • 27. Error Proofing 1. Simplification 2. Standardization 3. Reduce reliance on memory 4. Improve access to information 5. Use forcing functions and constraints
  • 28. Error Proofing 6. Use visual controls 7. Leverage high-performance teams 8. Deploy redundancies 9. Eliminate environmental factors 10. Make errors more visible
  • 32. ORGANIZATION WIDE ALL LEADERS ENTIRE ORGANIZATION IMPORTANT FUNCTIONS
  • 34. Model for Improvement Three Questions 1) What is the aim? 2) How will we know a change is an improvement? 3) What changes can we make that will result in an improvement?
  • 35. SHEWHART (PDCA) AND DEMING MODEL (PDSA)  P = PLAN  D = DO (PILOT)  CHECK OR STUDY  ACT
  • 36. 36 Shewhart Cycle Plan Do Check Act 1. Identify customer needs/expectations 2. Describe the current process 3. Measure and analyze data 4. Identify improvement opportunities 5. Identify root causes of problems 6. Generate and choose solutions 7. Plan and implement a pilot of the solutions 8. Evaluate results of pilot9. Draw conclusions 10. Standardize the change 11. Monitor the change and hold the gains The Tradiotnal PDCA Model
  • 37.
  • 38. FOCUS – PDCA MODEL  F = FIND A PROBLEM  O = ORGANIZE TEAM  C = CLARIFY YOUR KNOWLEDGE ABOUT THE PROCESS  U = UNDERSTAND SOURCES OF VARIATION  S = SELECT THE PROCESS IMPROVEMENT  PLAN THE NECESSARY STEPS  DO ALL NECESSARY TO IMPLEMENT  CHECK THE RESULT OF ACTION  ACT FULLY IMPLEMENT (Useful for REDESIGN of a new process or QI)
  • 39. F.O.C.U.S. →Find an improvement project (initiative): – Review related standards & documents – Analysis of collected data – Identify problems & desired outcomes 39
  • 40. F. O .C.U.S. →Organize ad hoc (task force) team: – Identify & involve stakeholders (e.g. physicians, nurses, administrative …etc) – Cover all related departments to the improvement initiative – Select team members who best do or know the process to be improved 40 O
  • 41. F.O.C.U.S. → Clarify current process & desired outcomes: – Fully understand the current process by all team member – Draw flow chart to clarify the process variation/problem – Collect data from all affected areas relevant to process & desired outcomes 41 C
  • 42. F.O.C.U.S. Understand Process Variation, Root Causes & Desired Outcomes
  • 43. F.O.C.U.S. →Select the best practice procedure: – Analyze alternative solutions related to process improvement – Choose the best solution that will achieve desired outcome – Develop approval with a summary of required information about expected outcomes, resources needed, time-frame, responsibilities ..etc 43 S
  • 47. P.D.C.A. Act to hold gains or re-adjust FOCUS_PDCA
  • 48. Lean Methodology • LEAN: An effective approach for improving patient safety by process design that improves reliability through standard work, mitigation, and continuous improvement
  • 49. Focus Area of Lean Lean:  Lean pioneered by Toyota, focuses on the efficient operation of the entire value chain.  Focus areas: – Remove non-value added steps to:  Reduce cycle time  Improve quality – Align production with demand – Reduce inventory – Improve process safety and efficiency
  • 51. Core Attributes for Safe, Reliable Systems • Well-defined workflows • Mistake-proofing principles • Measurement strategy • Team members who share responsibility to provide safe, reliable care
  • 52. The Science of Patient Safety • New concepts: science of error causation (“systems thinking”), complex systems, human factors, cognitive psychology, applied informatics… • New attitudes: teamwork, discipline, professionalism, balancing “no blame” with accountability, disclosure… • New skills: error analysis, leadership, change management...
  • 53. “We think that the anxiety, demoralization, and sense of loss of control that afflict too many healthcare professionals today directly come not from finding themselves to be participants in systems of care, but rather from finding themselves lacking the skills and knowledge to thrive as effective, proud, and well-oriented agents of change in those systems…. A physician equipped to help improve healthcare will be not demoralized, but optimistic; not helpless in the face of complexity, but empowered; not frightened by measurement, but made curious and more interested; not forced by culture to wear the mask of the lonely hero, but armed with confidence to make a better contribution to the whole.” Berwick and Finkelstein, Acad Med, 2010