MAXIMIZING FAILURE MODE &
EFFECTS ANALYSIS AS AN EFFECTIVE
RISK MANAGEMENT TOOL
Sandra Thompson
Administrator, Quality Resources/Compliance
Laurens County Health Care System
Clinton, SC
Thursday, May 31, 2012
TODAY’S GOALS

Discuss establishing a “Culture of Safety”

Describe the linkage between and importance of FMEA
to RM

Identify the TJC FMEA requirements

Discuss the basics of failure mode and effects analysis

Identify tools and resources for further information &
study
A GROWING CONCERN FOR PATIENT SAFETY….

1995: “The year that medicine went to Hell in
a handbasket” - Dennis O’Leary, JCAHO President, 9/01
 Tampa:
Wrong site surgery
 Dana Farber: Chemo event
 Martin Memorial: Anesthesia event

These events helped drive a consensus for
change
“CULTURE OF SAFETY”

Imperative driven by IOM reports
“To Err is Human” – 1999
 “Crossing the Quality Chasm” – 2000


Culture of Safety is owned by ALL


Not physicians, Administration, or a single department
Requires new tools, new thinking, new information
not traditionally utilized in healthcare

FMEA, RCA, Six Sigma, Lean, Systems Engineering,
????
NEW TOOLS/NEW THINKING

Root cause analysis

Lean






Forcing functions (poke yoke)
Standardization (5S)
Customer focus (value stream mapping)
Front-line staff involvement (observation – “going to the gemba”,
spaghetti diagrams)
Push/pull systems (patient flow)
High-reliability organizations

“Going for Zero”

Electronic health record

Proactive risk assessment

Healthcare FMEA!
TOOLS OF CHANGE
Proactive
Proactive Risk Assessment
(FMEA, HFMEA)
Automation,
Computerization
Standardization
Protocols, PrePrinted Orders
Checklists
Least
Effective
Effectiveness Scale
Forcing
Functions
Most
Effective
Rules & DoubleChecking
Information
Inspection
Education
Reactive
Auditing
HFMEA is a proactive
means of assessing &
decreasing risk in your
organization!
FMEA VS. HFMEA

FMEA
 Failure
Mode & Effect Analysis
 Traditionally used in industry
 Looks at a device or a component

HFMEA
 Healthcare
Failure Mode & Effect Analysis
 Looks at a process
HFMEA

Process developed by VA Pt. Safety Center

Online tutorial at:
 http://www.patientsafety.gov/CogAids/HFMEA/ind
ex.html#page=page-1
FAILURE MODE & EFFECT ANALYSIS

Do you take actions to prevent yourself from being late to work?
Yes or No

Do you “take the shortcut” when you see traffic building up in a
familiar place?
Yes or No

Do you try to distinguish “big problems” from “little problems”?
Yes or No

Do you see the possibility of eliminating some problems, but
need a better way to show that to people?
Yes or No
FAILURE/FAILURE MODE

Failure
 When
process begins to produce undesired
results/effects

Failure Mode
 Weakness/vulnerability
in any part of process
 Chain of events that has potential to cause safety
problem
RISK MANAGEMENT PERSPECTIVE

Assists RMs to favorably impact the patient care environment

Another tool in the box of RM strategies to understand and
reduce medical error

Assists RMs & others in driving change before it can do harm

Proactively forecasts potential failures

Applies risk /loss control techniques to those potential
failures
WHERE TO START: FOUNDATION

What philosophy ?

“Blame free” vs. “Just Culture”

Do we see systems or individuals?

Are the right tools & resources available for the job?

What is an incident to be reported at your facility?




Close call/near miss/”good catches”?
Only adverse events (e.g., “harm”)?
Sentinel events?
Where do willfully unsafe acts fit in? Disruptive behavior?
WHERE TO START: FOUNDATION

Design/redesign incident reporting systems to
capture near misses
Predictive – show patterns around a process –
100:10:1
 Rich source of information
 Reward/encourage near miss reporting
 Follow up on near misses and trend
 Don’t forget the narrative! Important details found here
 Close the loop – report back to staff on trends, patterns
noted, solicit suggestions for improvement

WHERE TO START: FOUNDATION
Must filter the tidal wave!
WHERE TO START: FOUNDATION
For each reported incident:
Assign Severity
Catastrophic
Failure could cause death or serious
injury (Sentinel Events)
Major
Permanent lessening of bodily
functioning, disfigurement, surgical
intervention required, additional
treatment required (3 or more
patients)
Moderate
Increased LOS, increased level of care
(1-2 patients)
Minor
No injury, no increased LOS, no
increased level of care
WHERE TO START: FOUNDATION
Assign Frequency:
Frequent: Likely to occur immediately or within a short period (may
happen several times in one year)
Occasional: Probably will occur (may happen several times in 1-2 years)
Uncommon: Possible to occur (may happen sometime in 2-5 years)
Remote: Unlikely to occur (may happen sometime in 5-30 years)
CULTURE OF SAFETY: FOUNDATION
Apply the risk management equation
 Severity
x Frequency = RISK
 What resources per level of risk?
 Examine trends/patterns
Severity
Probability

Catastrophic
Major
Moderate
Minor
Frequent
3
3
2
1
Occasional
3
2
1
1
Uncommon
3
2
1
1
Remote
3
2
1
1
GETTING STARTED: SELECT A HIGH-RISK
PROCESS

Sources:



Your incident report data
Loss runs/claims data
Brainstorm list of HR processes for your organization








Consider physical resources, environment, staffing, etc.
Worker’s Compensation reports
Literature
Sentinel Event Alerts
Infection Control data
IHI
Joint Commission
Organizational strategic quality goals/objectives
ASSEMBLE A TEAM

Multidisciplinary group who have hands-on
experience with the selected
process/procedure
 Include

physicians!
RM role
 May
be multifaceted
 CAUTION: Leader/Facilitator
DIAGRAM THE PROCESS

ABSOLUTE MUST:


Tools:




Direct observation of process (Lean)
“Process Mapping” vs. Flowcharting
Fishbone (Cause & Effect Diagram)
Current State Stream Maps (Lean)
Differentiate - need TWO maps!


“The way things were intended to work”
“The way things are actually working”
PROCESS MAPPING
Process Step
Process Step
Process Step
1
2
3
Medication
ordered
Auto electronic
transfer to
Pharmacy
system
Pharmacy fills
scipt; sends to
floor
Process Step
4
Nurse
administers
Sub-Processes
Sub-Processes
A.
B.
A.
B.
Dummy terminal
PCs
Dummy terminal
PCs
Sub-Processes
A.
B.
C.
D.
E.
Check drug
allergies
Check drug
interactions
Check proper
dosages
Orders labs
Order sent to
auto dispensing
Sub-Processes
A.
B.
C.
D.
Automatically
fills orders
checked
Drugs pulled
and script filled
Med cart filled
Cart sent to
floor
Sub-Processes
A.
B.
C.
D.
E.
F.
Log on to
laptop
Medcart
Medications
scanned
Patient band
scanned
Medication
given to pt.
Pt. record
updated
IDENTIFY POTENTIAL FAILURE MODES

Compare “ideal” vs. “reality”

May be multiple failure modes – list all

Each failure mode can have multiple possible effects

Tool: Brainstorming

Ask:



What could fail with this step? (i.e., failure modes)
Why would this failure occur? (i.d., causes)
What could happen if this failure occurred? (i.e., effects)
ASSESS FAILURE MODES-IDENTIFY CAUSES

Assess risk – severity/probability

Tools:
Fishbone (C&E) Diagram
 Hazard Scoring Matrix (HFMEA)

Probability
Severity
Catastrophic
Major
Moderate
Minor
Frequent
16
12
8
4
Occasional
12
9
6
3
Uncommon
8
6
4
2
Remote
4
3
2
1
ADDITIONAL STEPS

Decision (proceed or stop)
 If
score 8 or higher & decision to stop, document
rationale
 Tools:
 Decision
Tree (HFMEA)
 HFMEA Worksheet

Develop action plan for change
 Include
outcome measures, management
concurrence
PROTECTING THE PROCESS

Concerns re: discoverability

Could provide potent evidence for plaintiff if all potential
failures not addressed & mishap occurs involving that
failure point

Follow current procedures under state law relative to
peer review protection



Must be produced under guidance of medical staff &
reviewed in “medical staff committee”
Include “disclaimer” on document
Seek guidance from legal counsel
REMEMBER…..

Seek support from senior leadership


Include physicians


Executive/Administrative Sponsor?
Physician Champion
Seek out trained facilitator OR get training in facilitation

Important to open communication

Involve front-line staff; give them ownership

Look for best practices already identified for the process
being assessed
QUESTIONS?
RESOURCES

VA Center for Patient Safety
HFMEA Toolkit
 http://www.patientsafety.gov/CogAids/HFMEA/index.ht
ml#page=page-1


Institute for Healthcare Improvement
Online tool for conducting FMEA; can be shared
 Tutorials, journal articles
 Completed examples
 http://www.ihi.org/knowledge/Pages/Tools/FailureMod
esandEffectsAnalysisTool.aspx

OTHER RESOURCES
http://www.patientsafety.gov/SafetyTopics/HFMEA
/FMEA2.pdf
 http://psnet.ahrq.gov/resource.aspx?resourceID=
1531
http://www.patientsafety.gov/SafetyTopics/HFMEA
/HFMEAIntro.pdf
 http://intranet.uchicago.edu/quality/FailureMode
sandEffectsAnalysis_FMEA_1.pdf
 http://www.patientsafety.gov/SafetyTopics/HFMEA
/HFMEA_JQI.pdf
