webinar series june 2019 fran griffin, rrt, mpa · 1. appreciation of a system 2. knowledge of...

New Jersey Hospital AssociationWebinar Series June 2019

Fran Griffin, RRT, MPA

1. Appreciation of a System2. Knowledge of Variation3. Theory of Knowledge4. Knowledge of Psychology

System of Profound Knowledge

W. Edwards Deming

2© Fran Griffin & Associates, LLC

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


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?


Data provided by NJHA


2. Knowledge of Variation

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Commute Time in Minutes


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Commute Time in Minutes


Assessing Performance with Data: measured over time

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Percent patients assessed for fall risk on admission

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Improving performance

Unstable performance

Deteriorating performance

Stable but unacceptable performance


OUTCOMES …falls …falls with injuries

PROCESSES …risk assessment …use of standardized prevention protocols/methods …others?

What does your data indicate for…


3. Theory of Knowledge

“Information is not knowledge. Let’s not confuse the two.”

W. Edwards Deming


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


Understanding motivation Driving out fear Freedom to speak up Supporting team work and communication

4. Knowledge of Psychology


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


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)?

© Fran Griffin & Associates, LLC 14

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


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


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


Start Collect ingredients

Measure/prep ingredients

Get pot and place on stove

First step from recipe

Lots of other steps

Eat chili

Step Failure Mode How likely?

Will I miss it?

Impact

Collect ingredients

Measure ingredients

Get pot & place on stove


Edible chili that tastes good What are the steps? What could go wrong?

Failure Modes How much might each

issue affect the outcome?




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


Pot dirty or in use







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)


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)


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


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



Will I miss it?

Impact

Collect ingredients

Select wrong item 2 5 5

Drop/spill item 1 1 8


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


Pot dirty or in use 1 1 1







• 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



Will I miss it?

Impact RPN

Collect ingredients

Select wrong item 2 5 5 12

Drop/spill item 1 1 8 10


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


Pot dirty or in use 1 1 1 3







Real Example of FMEA (from IHI website)


Screenshot from actual FMEA in interactive tool on www.ihi.org


http://www.ihi.org/

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


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


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


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


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


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


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


FMEA Info Centrewww.fmeainfocentre.com

Institute for Healthcare Improvementwww.ihi.org Downloadable PDF tool Interactive tool

FMEA Resources

http://www.fmeainfocentre.com/

http://www.ihi.org/

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


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


webinar series june 2019 fran griffin, rrt, mpa · 1. appreciation of a system 2. knowledge of...

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