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Copyright © 2014 Safer Healthcare Partners, LLC. All Rights Reserved. Copyright © 2014 Safer Healthcare Partners, LLC. All Rights Reserved.
High Reliability in Healthcare What It Is. Why You Should Care. And Where to Start. Tom Brooksher and Todd Masten Safer Healthcare Partners
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High Reliability in Healthcare
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High Reliability in Healthcare
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High Reliability in Healthcare
Copyright © 2014 Safer Healthcare Partners, LLC. All Rights Reserved. 5
High Reliability in Healthcare
Copyright © 2014 Safer Healthcare Partners, LLC. All Rights Reserved. Copyright © 2014 Safer Healthcare Partners, LLC. All Rights Reserved.
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High Reliability in Healthcare
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High Reliability in Healthcare
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High Reliability in Healthcare
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High Reliability in Healthcare
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High Reliability in Healthcare
Chance of Being Killed In Plane Crash
1 in 11 million
Chance of Being Killed In Motor Vehicle Crash
1 in 5,000
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High Reliability in Healthcare
• Published in 1999 • Low limit: 44,000 deaths/year • High limit: 98,000 deaths/year • More deaths from medical
mistakes than AIDS, Breast Cancer or Car Accidents
• Epidemic proportions • $39 billion per year
Deaths From Preventable Medical Error
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High Reliability in Healthcare
• Published September, 2013 • Larger base of studies • Data 2008 to 2011 • Low limit: 210,000 deaths
per year • “True number”: 400,000+
deaths/year • “Serious harm”: 10x to 20x
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High Reliability in Healthcare
• Complex environments • Safety super-ordinate goal • NASA: 70% human error • Joint Commission: 70% human error • Highly regulated • Economic pressures • Physicians & pilots: very similar
dynamics
Industry Similarities: Healthcare & Aviation
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High Reliability in Healthcare
Ability to perform at high levels of safety over long periods of time.
Aviation: High Reliability Industry
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High Reliability in Healthcare
Healthcare High Reliability
• Dr. Mark Chassin, President, Joint Commission
• Jerod Loeb, PhD, former Exec. VP, Joint Commission
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High Reliability in Healthcare
Healthcare’s Three Critical Challenges
1. Leadership 2. Culture of Safety 3. Robust Process
Improvement
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High Reliability in Healthcare
Healthcare Crew Resource Management
• Recognizing human factors cause errors
• Acknowledging that in complex, high risk endeavors, teams are most effective operating units
• Cultivating and instilling team-based tools/practices to reduce impact of human factors
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High Reliability in Healthcare
The science of effective teamwork and communications
in high risk settings.
Healthcare Crew Resource Management
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High Reliability in Healthcare
• Team leadership • Situational awareness • Standardized communications • Conflict management • Decision making • Checklists • Briefing and Debriefing • Assertiveness
Essential Skills Crew Resource Management
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High Reliability in Healthcare
• Promotes Just Culture • Assumes humans make errors • Allows team to catch and correct errors • Promotes reporting adverse and potentially
adverse events • Makes every mistake a learning experience
Healthcare Crew Resource Management
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High Reliability in Healthcare
• 80% of the work in managing a successful Process Improvement has nothing to do with the tools and everything to do with the perceptions
• People are prisoners of their own experience – unleashing their creativity takes careful pre-planning prior to any team activity
• 90% of the time, pre-planning never happens – causing false starts and deflated demeanor
Lean Leadership Great Leaders Know
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High Reliability in Healthcare
Healthcare Six Aims for Improvement American Healthcare should be: These aims are not new….yet, American Healthcare fails far too often with respect to these aims, despite enormous cost and dedication and good efforts of millions of American Healthcare workers.
• Safe • Effective • Patient-centered
• Timely • Efficient • Equitable
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High Reliability in Healthcare
Lean A Path to the Imperatives The IOM Chasm Report gave us the Vision of where to go… …and Womack’s Lean Thinking gives us
the direction (path) to get us there. • Process Improvement Framework • Tools and Problem-Solving Skills
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High Reliability in Healthcare
Lean Evolution in Healthcare
1910 1930 1940 1950 1960 1970 1980 1990 2000 2010 1920 Time & Motion Studies Methods
Improvement IE Tools, Techniques &
Mgmt Support TQM LEAN
1939 – Shewert, Statistical Method from the Viewpoint of Quality Control 1982 – Deming,
Out of Crisis 1950 – Toyoda visits Ford’s River Rouge Complex
1977 – Sugimori, Toyota Production System & Kanban Systems: Materialization of JIT & Respect-for-Human System
1951 – Juran, Quality Control Handbook
1990 – Womack, Jones & Roos, The Machine That Changed The World
1996 – Womack & Jones, Lean Thinking
1911 – Taylor, Principles of Scientific Management 1950 – Gilbreth
Management Engineering and Nursing 1916 – Gilbreth, Motion Study in Surgery
1999 2001 Healthcare
Manufacturing
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High Reliability in Healthcare
• Value-Stream Mapping • Workplace Organization (5S) • Six Sigma • Visual Management • Total Preventive Maintenance • Balanced/Lean Scorecard • Kaizen Events • Theory of Constraints • Workouts • Kanban • Reduce Waste • Improve Efficiency
The Random Acts of Lean • Heijunka Scheduling • Standard Work • Rapid Improvement Events • Operational Method Sheets • Changeover Optimization (SMED) • Case Sequencing • DMAIC • Production Preparation Process (3P) • Process Balancing Tools • Electronic Kanban Methods • Benchmarking Practices • Health Care Execution Systems
• Green Belts, Black Belts • Mixed Model Designs • Drum/Buffer/Rope • RFID/Bar Code Strategies • Flow Rate Management • Cellular Concepts • Rationalization Practices • Demand-Driven Metrics • Flexibility Practices • Process Mapping • Velocity Analysis • Mistake Proofing (Poka-Yoke)
The common problem… • Pockets of improvement are not tied to nor affect bottom line • Primarily focused on micro areas with micro results
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High Reliability in Healthcare
• Variability recognizes that processes do not produce identical results every time (inherent in nature)
• Variability may be caused by identifiable forces acting on the process or by minute fluctuations in the process itself
• Range (low to high spread), standard deviation (relative dispersion from the mean), and variance (how far a set of numbers is spread out) are common measures of variability
Stop Chasing Averages…
µ = average
σ = variation The Normal
Distribution Curve
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High Reliability in Healthcare
How Good Is Good Enough?
3,660 Patients With Misplaced Personal Items
Every Day
340 Patients With Misplaced
Personal Items Every Day
12 Patients With Misplaced
Personal Items Every Day
6 Patients With Misplaced
Personal Items Every Month
770 Coding Errors Every Day Require
Correction
72 Coding Errors Every Day
Require Correction
13 Coding Errors Every Week
Require Correction
During The Year, Only 10 Coding Errors Require
Correction
257 Calls Each Day Exceed The Two Minute On-Hold
Time
24 Calls Each Day Exceed The Two Minute On-Hold
Time
5 Calls Each Week Exceed The Two Minute On-Hold
Time
During The Year, 3 Calls Exceed The
Two Minute On-Hold Time
66,800
6,210
230
3.4
93.32000%
99.34900%
99.97700%
99.99966%
3σ
4σ
5σ
6σ
Sigma Level
Personal Items
Misplaced
Coding Processing
Errors
On-hold Time
Exceeded
Defects Per Million
Oppty % Yield
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High Reliability in Healthcare
Traditional Push Versus The Power of Pull Push Facility
vs.
Pull Facility
vs. Originally built to push or batch product
Originally built to pull
to customer demand
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High Reliability in Healthcare
• The 90/10 Rule of Value • Often, the same amount of effort applied to the non-value
added activity (the 90%) as the value-added activity (the 10%) yields significantly greater results
• However, most improvements focus solely on the 10%
• In health care, this applies to both paper process(ing) and patient process(ing)
Lean Value and Non-Value Add
10%!90%!Time!
Non-value added activity! Value added activity!
Typical NVA Ac,vi,es: • Coun,ng • Handling • Wai,ng • Stocking/Storing • Signoffs • Mul,ple Order Entry/Processing
• Moving
VA activity is defined as anything the customer is willing to pay for
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High Reliability in Healthcare
Lean Separating Waste from Value
Time Start Finish
Waiting Wait Move Wait Move/Wait = Value Added Time (VA)
= Non-Value Added Time (NVA)
Tests Treat Triage
Traditional Focus ! Improve the VA processes Process Focus ! Eliminate the NVA processes
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High Reliability in Healthcare
• Scope creep • Any change not in the original project plan • Team member adds on additional items to target area/project • Often done with the best intentions • Can cloud team focus and cause delays • Major challenge… knowing when to raise the flag
• Hope creep • Not having clear view of end state • Do not have clear understanding, so just go through the motions • Hoping someone knows what they’re doing and where they’re headed • Major challenge… waiting to catch up (procrastination)
• Effort creep • Moves project to 80%+ complete and then stalls out • Major challenge… crossing the finish line continues to push
Lean Leadership Know Your “Creeps”
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High Reliability in Healthcare
Lean Leadership Getting Started
To be completed PRIOR to getting the team assembled
Names of key people or units/departments that will have influence over or be affected
by the changes in the target area.
Stakeholders can be internal or external…senior or junior levels.
Onboarding New Staff
PeriOp 07 09 XX Mary Smith Scope: Scrub Techs – Top 20 Procedures
Team Leads Scrub Techs Dr Jones RN Johnson HR RN Staff Physicians Grp Educator Manager
Plot the numbers of each of the listed stakeholders…
…based on their level of Power and Interest
related to the transformation.
Manage Closely Keep Satisfied Keep Informed
Monitor
Onboarding New Staff
PeriOp 07 09 XX Mary Smith Scope: Scrub Techs – Top 20 Procedures
1
2
3
4
5 6
7
8 9
Team Leads Scrub Techs Dr Jones RN Johnson HR RN Staff Physicians Grp Educator Manager
List the primary (key) activities for the project down the left side.
Then indicate the appropriate designation
for the individuals from the stakeholder list:
Responsible Accountable Consulted Informed
Onboarding New Staff
PeriOp 07 09 XX Mary Smith Scope: Scrub Techs – Top 20 Procedures
1
2
3
4
5 6
7
8 9
Team Leads Scrub Techs Dr Jones RN Johnson HR RN Staff Physicians Grp Educator Manager
Identify Top Procedures
Select Software Vendor
Take Supply Pictures
Solidify Curriculum
Determine Training Sched
Create Rounding ?s
R A R
C R A
C A C I I I I C I I I I
R I A R C I R I I R R A C C C C I I R C A I C I I I I R R A C C I R I I
Use this Communication Grid to detail the various communication methods required
throughout the transformation.
Onboarding New Staff
PeriOp 07 09 XX Mary Smith Scope: Scrub Techs – Top 20 Procedures
1
2
3
4
5 6
7
8 9
Keep Satisfied
Manage Closely
Keep Informed
10min weekly
10min Weekly
Tammy Face-to- Face
No Surprises
Major Milestones Manager
Manager Dr Jane Face-to- Face Alignment Milestones
Obstacles
Huddle Susie Scrub
Face-to- Face Update Top 3
Activities Manager
Team Leads Scrub Techs Dr Jones RN Johnson HR RN Staff Physicians Grp Educator Manager
Identify Top Procedures
Select Software Vendor
Take Supply Pictures
Solidify Curriculum
Determine Training Sched
Create Rounding ?s
R A R
C R A
C A C I I I I C I I I I
R I A R C I R I I R R A C C C C I I R C A I C I I I I R R A C C I R I I
What is the specific name or number of the element or issue(s) under review?
Be as specific as possible so as to allow
others to easily identify this element.
Anticoagulation Patient Management Process
PeriOp 08 27 XX Mary Smith
Review Dose Amount
What is the specific manner in which a component, system or function could
possibly fail while being used?
Essentially, ask the question: “How can this element fail?”
Anticoagulation Patient Management Process
PeriOp 08 27 XX Mary Smith
Review Dose Amount
Dose change made when not needed
Patient took wrong dose
amount
For each mode of failure, what will the likely effect be? How would the failure affect
different stakeholders? What will be the likely outcomes if the system or component
fails?
An individual failure more may have many possible effects.
Anticoagulation Patient Management Process
PeriOp 08 27 XX Mary Smith
Review Dose Amount
Dose change made when not needed
Bleeding, clot
Patient took wrong dose
amount Bleeding, clot, adverse event
Each failure effect can be judged for it’s potential seriousness. This value should be discussed and
negotiated by all members of the team.
Severity Rating: 1 – low impact (minor event – patient unharmed) 3 – med impact (moderate event – stay extends) 9 – high impact (major event – surgical intervention)
Anticoagulation Patient Management Process
PeriOp 08 27 XX Mary Smith
Review Dose Amount
Dose change made when not needed
Bleeding, clot X
X
X
Patient took wrong dose
amount Bleeding, clot, adverse event X
X
X
Each failure mode will have an underlying root cause. Thus, it is important to spend time
to establish the potential root causes or mechanisms of failure.
Ask… “what is the likely cause of the failure
mode?”
Anticoagulation Patient Management Process
PeriOp 08 27 XX Mary Smith
Review Dose Amount
Dose change made when not needed
Bleeding, clot X Patient did not
communicate diet on day of test
X Lab error in calibration
X Patient went to
different lab then usual
Patient took wrong dose
amount Bleeding, clot, adverse event X Wrote down
wrong dose
X Selected the wrong pills
X Forgot they took
dose already that day
Assign a value of the likelihood of the potential failure occurring. The entire team
should agree as to the probability.
Occurrence Rating: 1 – low likelihood (remote – once per 5yrs) 3 – med likelihood (occasional – 2+ per2yrs) 9 – high likelihood (frequent – 5+ per 6mos)
Anticoagulation Patient Management Process
PeriOp 08 27 XX Mary Smith
Review Dose Amount
Dose change made when not needed
Bleeding, clot X Patient did not
communicate diet on day of test
X
X Lab error in calibration X
X Patient went to
different lab then usual
X
Patient took wrong dose
amount Bleeding, clot, adverse event X Wrote down
wrong dose X
X Selected the wrong pills X
X Forgot they took
dose already that day
X
Indicate here if there are any specific design controls which can reduce or eliminate the
potential failure.
These could include labels, barriers, work instructions or a total redesign of a given
process.
Anticoagulation Patient Management Process
PeriOp 08 27 XX Mary Smith
Review Dose Amount
Dose change made when not needed
Bleeding, clot X Patient did not
communicate diet on day of test
X INR test
X Lab error in calibration X INR test
X Patient went to
different lab then usual
X Different than
listed in system, INR test
Patient took wrong dose
amount Bleeding, clot, adverse event X Wrote down
wrong dose X INR test
X Selected the wrong pills X INR test
X Forgot they took
dose already that day
X INR test
Rate the likelihood that the design controls listed will enable the detection of the potential
failure.
Occurrence Rating: 1 – high likelihood (almost certain it will occur) 3 – med likelihood (moderate chance) 9 – low likelihood (very remote chance)
Anticoagulation Patient Management Process
PeriOp 08 27 XX Mary Smith
Review Dose Amount
Dose change made when not needed
Bleeding, clot X Patient did not
communicate diet on day of test
X INR test X
X Lab error in calibration X INR test X
X Patient went to
different lab then usual
X Different than
listed in system, INR test
X
Patient took wrong dose
amount Bleeding, clot, adverse event X Wrote down
wrong dose X INR test X
X Selected the wrong pills X INR test X
X Forgot they took
dose already that day
X INR test X
Follow through is essential and identifying specific actions to reduce the impact or
likelihood of the potential failure are essential.
These actions should be specific and measurable. Attentions should be given to
actions that address the root cause and not just the symptoms.
Anticoagulation Patient Management Process
PeriOp 08 27 XX Mary Smith
Review Dose Amount
Dose change made when not needed
Bleeding, clot X Patient did not
communicate diet on day of test
X INR test X Standardize questions to patient, training
X Lab error in calibration X INR test X Weekly sample
checks
X Patient went to
different lab then usual
X Different than
listed in system, INR test
X Patient training
Patient took wrong dose
amount Bleeding, clot, adverse event X Wrote down
wrong dose X INR test X Patient repeats dose to care practitioner
X Selected the wrong pills X INR test X Pills are color
coded
X Forgot they took
dose already that day
X INR test X Pill dispenser container by day
All actions should be unambiguously assigned or allocated to an individual, department and/or
an organization.
A date should be assigned by which time all assigned actions have been accomplished and
approved.
Anticoagulation Patient Management Process
PeriOp 08 27 XX Mary Smith
Review Dose Amount
Dose change made when not needed
Bleeding, clot X Patient did not
communicate diet on day of test
X INR test X Ron Black 10/10/XX Standardize questions
to patient, training
X Lab error in calibration X INR test X Jane
Brown 09/16/XX Weekly sample checks
X Patient went to
different lab then usual
X Different than
listed in system, INR test
X Sue Jones 11/23/XX Patient training
Patient took wrong dose
amount Bleeding, clot, adverse event X Wrote down
wrong dose X INR test X Ron Smith 10/10/XX Patient repeats dose
to care practitioner
X Selected the wrong pills X INR test X Jane
Brown 09/16/XX Pills are color coded
X Forgot they took
dose already that day
X INR test X Mary Gomez 11/23/XX Pill dispenser
container by day
Multiply the scores from the “Severity,” “Occurrence” and “Detection” columns to
create an objective measure of potential risk.
The higher the Risk Priority Score, the higher the assumed risk that needs to be mitigated.
Conduct another FMEA on same process once actions are completed to calculate risk mitigation %.
Anticoagulation Patient Management Process
PeriOp 08 27 XX Mary Smith
Review Dose Amount
Dose change made when not needed
Bleeding, clot X Patient did not
communicate diet on day of test
X INR test X 81 Ron Black 10/10/XX Standardize questions
to patient, training
X Lab error in calibration X INR test X 27 Jane
Brown 09/16/XX Weekly sample checks
X Patient went to
different lab then usual
X Different than
listed in system, INR test
X 9 Sue Jones 11/23/XX Patient training
Patient took wrong dose
amount Bleeding, clot, adverse event X Wrote down
wrong dose X INR test X 243 Ron Smith 10/10/XX Patient repeats dose
to care practitioner
X Selected the wrong pills X INR test X 81 Jane
Brown 09/16/XX Pills are color coded
X Forgot they took
dose already that day
X INR test X 81 Mary Gomez 11/23/XX Pill dispenser
container by day
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High Reliability in Healthcare
Lean Leadership Communication
The single biggest problem with communication is the illusion that it has taken place.
George Bernard Shaw
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High Reliability in Healthcare
Tom Brooksher Email: [email protected] Todd Masten Email: [email protected]