webinar series june 2019 fran griffin, rrt, mpa · 1. appreciation of a system 2. knowledge of...
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New Jersey Hospital AssociationWebinar Series June 2019
Fran Griffin, RRT, MPA
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1. Appreciation of a System2. Knowledge of Variation3. Theory of Knowledge4. Knowledge of Psychology
System of Profound Knowledge
W. Edwards Deming
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What is a system? A set of interacting or interdependent things working together as parts of a larger whole and purpose
Typically complex, with inter-related components, multiple stakeholders, competing goals
Quality: optimization of performance of the components of a system Individual components of a system should reinforce, not compete with, other components to accomplish
overall system goals
Clearly defined and commonly understood purpose with all actions and roles designed to support this goal
Safety is a dimension of quality
1. Appreciation of a System (“Systems Thinking”)
Adapted from W. Edwards Deming and The Improvement Guide, 2nd ed, by Langley et al
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Map the processes Essential to know the steps, sequence
and decision points Observe the processes directly
Not the policy & procedure as may be happening differently
Collect data on the processes
How do you know what the system is for fall prevention at your hospital?
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Data provided by NJHA
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2. Knowledge of Variation
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Commute Time in Minutes
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Commute Time in Minutes
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Assessing Performance with Data: measured over time
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Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec
Percent patients assessed for fall risk on admission
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Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec
Percent patients assessed for fall risk on admission
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Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec
Percent patients assessed for fall risk on admission
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Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec
Percent patients assessed for fall risk on admission
Improving performance
Unstable performance
Deteriorating performance
Stable but unacceptable performance
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OUTCOMES …falls …falls with injuries
PROCESSES …risk assessment …use of standardized prevention protocols/methods …others?
What does your data indicate for…
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3. Theory of Knowledge
“Information is not knowledge. Let’s not confuse the two.”
W. Edwards Deming
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The PDSA Cycle
Act• What changes
are to be made?• Next cycle?
Plan• Objective• Questions and
predictions (why)• Plan to carry out the cycle (who, what, where, when)
Study• Complete analysis of data
• Compare data to predictions
• Summarize learning
Do• Carry out the plan• Document problems &
unexpected observations• Begin analysis of data
Also known as:
• Shewhart Cycle
• Deming Cycle
• Learning and Improvement Cycle
• PDCA Cycle (C = Check)
Four equally important stepsPlan, Do, Study, Act
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Understanding motivation Driving out fear Freedom to speak up Supporting team work and communication
4. Knowledge of Psychology
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Clinical Issue: A hospital is opening a new wing of hospital with long hallways, single patient rooms, and new electronic fall risk notification system. They want to ensure that the new design does not put patients at increased risk of falling.
QI process: how to assess for potential fall risk factors in a new clinical setting using a FMEA.
NJHA Case Study: Fall Prevention
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A systematic, proactive method for evaluating a process Identifies where and how failures may occur and relative impact to identify the parts of the
process that are most in need of change. Developed in industry – primarily with technology products. It can be used with any
process. Adopted in health care to assess risk of failure and harm to patients in processes and to
identify the most important areas for process improvements. The Joint Commission requires accredited hospitals to conduct a type of “proactive process
analysis” annually.
What is Failure Modes & Effects Analysis (FMEA)?
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Evaluate processes for possible failures before they occur. Prevent failures or minimize consequences by correcting processes
proactively rather than reacting after failures have occurred. Emphasis is on prevention and risk reduction. Particularly useful for:
evaluating a new process prior to implementation assessing the impact of a proposed change to an existing process
Uses & Benefits
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Define steps in the process Identify
Failure modes (What could go wrong?)NOTE: Most steps have more than 1 possible failure mode
Failure causes (Why would the failure happen?) Failure effects (What would be the consequences of each failure?)
FMEA Review
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Assumptions: Recipe selected and in-
hand Ingredients available or
purchased
FMEA Questions What is the outcome?
Edible chili that tastes good What are the steps?
Example: using a new recipe for chili
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Start Collect ingredients
Measure/prep ingredients
Get pot and place on stove
First step from recipe
Lots of other steps
Eat chili
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Step Failure Mode How likely?
Will I miss it?
Impact
Collect ingredients
Measure ingredients
Get pot & place on stove
FMEA Questions What is the outcome?
Edible chili that tastes good What are the steps? What could go wrong?
Failure Modes How much might each
issue affect the outcome?
Example: using a new recipe for chili
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Step Failure Mode How likely?
Will I miss it?
Impact
Collect ingredients
Select wrong item
Drop/spill item
Item expired or no good
Measure ingredients
Measure too little of itemNot enough of itemMeasure too much of item
Get pot & place on stove
Pot dirty or in use
FMEA Questions What is the outcome?
Edible chili that tastes good What are the steps? What could go wrong?
Failure Modes How much might each
issue affect the outcome?
Example: using a new recipe for chili
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Numeric estimate of the overall risk Helps prioritize areas of focus and assess opportunities for improvement. RPN is calculated at 3 levels:
1. For each failure mode2. For each step (sum of failure mode scores)3. For the entire process (sum of all)
Risk Priority Number (RPN)
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Three key questions for calculating failure mode RPN
Likelihood of occurrence: How likely is it that this will occur? Likelihood of detection: If this occurs, how likely is it that the failure
will be missed (not detected)? Severity: If this occurs, how likely is it that harm
(negative impact) will occur?
Risk Priority Number (RPN)
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Score each failure mode for each of the 3 questions:a) Likelihood of occurrence:
1 = “very unlikely to occur” and 10 = “very likely to occur”
b) Likelihood of detection:1 = “very unlikely to be missed” and 10 = “very likely to be missed/not detected”
c) Severity:1 = “very unlikely that harm (negative impact) will occur” and 10 = “very likely that severe harm (negative impact) will occur”
NOTE: Scoring occurs at level of failure mode – not the step
Calculating RPN
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Calculating RPNLikelihood of occurrence1 5 10 Rare Frequent
Likelihood of being “missed” (not detected)1 5 10 Very visible Easily missed
Likelihood of harm / adverse outcome1 5 10 Little harm or consequence Severe harm
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Step Failure Mode How likely?
Will I miss it?
Impact
Collect ingredients
Select wrong item 2 5 5
Drop/spill item 1 1 8
Item expired or no good
5 2 9
Measure ingredients
Measure too little of item
2 8 5
Not enough of item
5 1 7
Measure too much of item
2 5 8
Get pot & place on stove
Pot dirty or in use 1 1 1
FMEA Questions What is the outcome?
Edible chili that tastes good What are the steps? What could go wrong?
Failure Modes How much might each
issue affect the outcome?
Example: using a new recipe for chili
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• Multiply or add the three scores for each failure mode. • Lowest possible score = 1 (multiplication) or 3 (addition)• Highest = 1,000 (multiplication) or 30 (addition)
• RPN for a step = sum of all RPN’s for all failure modes in step.
• RPN for entire process - add up all of the individual RPNs.
Calculating RPN
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Step Failure Mode How likely?
Will I miss it?
Impact RPN
Collect ingredients
Select wrong item 2 5 5 12
Drop/spill item 1 1 8 10
Item expired or no good
5 2 9 16
Measure ingredients
Measure too little of item
2 8 5 15
Not enough of item 5 1 7 13
Measure too much of item
2 5 8 15
Get pot & place on stove
Pot dirty or in use 1 1 1 3
FMEA Questions What is the outcome?
Edible chili that tastes good What are the steps? What could go wrong?
Failure Modes How much might each
issue affect the outcome?
Example: using a new recipe for chili
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Real Example of FMEA (from IHI website)
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Screenshot from actual FMEA in interactive tool on www.ihi.org
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Start with failure modes that have highest RPNs – these represent greatest risk.
Failure modes with very low RPNs are not likely to affect the overall process very much, even if eliminated completely, and they should therefore be at the bottom of the list of priorities.
RPN can never be “zero”. All risk of failure can never be removed.
Using as Improvement Tool
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If the failure mode is likely to occur: Evaluate the causes and see if any or all of them can be eliminated. Consider adding a forcing function (a physical constraint that makes
committing an error impossible) Add a verification step, such as independent double-checks, bar
coding or alert screens. Modify other processes that contribute to causes.
Actions to prevent failure
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If the failure is unlikely to be detected: Identify other events that may occur prior to the failure mode and can
serve as “flags” that the failure mode might happen. Add a step to the process that intervenes at the earlier event to
prevent the failure mode. Consider technological alerts such as devices with alarms to alert
users when values are approaching unsafe limits.
Actions to improve identification
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If the failure is likely to cause severe negative impact: Identify early warning signs that a failure mode has occurred, and
train staff to recognize them for early intervention. For example, use drills to train staff by simulating events that lead up to failure, to improve staff ability to recognize these early warnings.
Provide information and resources at points of work for events that may require immediate action.
Actions to mitigate when failure occurs
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Use FMEA to evaluate the potential impact of changes under consideration. Discuss and analyze each change under consideration and calculate the
change in RPN if the change were implemented. This allows for “verbal simulation” of the change to evaluate its impact in a
safe environment, prior to testing in actual work. Some ideas that seem like great improvements can turn out to be changes
that would actually increase the estimated RPN.
Use FMEA to monitor and track improvement over time. Calculate a total RPN for the process. Set a goal for improvement, such as decreasing the total RPN for the
process by 50% from the baseline.
Using FMEA for Improvement
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1. Map out the process with all steps (use a flowchart)2. Identify what could go wrong at each step (failure modes)3. Calculate RPN for each failure mode then steps and process4. Sort by RPN and focus on highest scores5. Set a goal for improvement (never zero)6. When considering a change, “predict” impact by recalculating RPN
a) Test changes using PDSA cyclesb) Adjust RPN when change is made permanentc) Track RPN over time
FMEA Process: Recap
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1. Prevent primary failure
2. Identify failures that occur none-the-less less (to err is human!) and mitigate impact
3. Learn from failures, continuously improve system
Reliable Design
Prevent Failures
Identify /mitigate that failure
Redesign to prevent future failures
80%
15%
5%
3-tiered model (all 3 legs important):
35Slide courtesy of James Benneyan, PhD, Northeastern University
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FMEA Info Centrewww.fmeainfocentre.com
Institute for Healthcare Improvementwww.ihi.org Downloadable PDF tool Interactive tool
FMEA Resources
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Every system is perfectly designed for the results that it gets. If patients are experiencing injuries
from falls in your hospital, your system is perfectly designed to cause this outcome.
All improvement is change. You must change the design of your
system (not your people) to achieve a different result.
Not all change is improvement. Testing is important to learn whether a
change leads to improvement or requires adaptation (or doesn’t work) without major consequences.
Essential Considerations in ImprovementSubject Matter Knowledge
ProfoundKnowledge
From W. Edward Deming’s System of Profound Knowledge
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To reduce injuries from falls: Understand your systems – processes, response systems and data Identify risk points with prospective analysis Test changes to learn what might result in improvement
Summary
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