Applying Failure Modes and Effects Analysis (FMEA) in Healthcare

Transcription

Applying Failure Modes and Effects
Analysis (FMEA) in Healthcare
Preventing Infant Abduction,
A Case Study
2004 Society for Health Systems Presentation
February 20-21, 2004
Todd A. Reichert
WakeMed
3000 New Bern Ave.
Raleigh, NC 27610
Objectives of this document:
•
•
•
•
•
Describe the WakeMed Healthcare System
Define FMEA
Explain the use of this tool in healthcare
Describe the FMEA project selection process
Explain the application of the FMEA process to “Preventing Infant
Abduction at WakeMed”
• Report on the results achieved by the project team
Background of WakeMed
WakeMed is a multi-facility health care system consisting of 629 acute care
beds, 515 at New Bern Avenue and 114 at Western Wake Medical Center.
WakeMed employs 5800 employees and is affiliated with UNC Healthcare
through its residency programs.
What is an FMEA?
FMEA (Failure Modes and Effects Analysis) as its applied in Healthcare is a
proactive team-oriented approach to risk reduction that seeks to improve
patient safety by minimizing risk potential in high-risk processes.
Rather than focus on a problem - after its occurrence, FMEA looks at what
“could” go wrong at each process step, the so-called “Failure Modes,”
assigns a risk score to each of these possibilities, and provides for a teamoriented approach to focus resources on priority issues. Since the 1960’s
they’ve been used in the nuclear, military, aviation, food, and automotive
industries, now they’re being used in Healthcare and other service industries.
Todd A. Reichert, WakeMed, Raleigh, NC.
Page 2
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Why Use FMEAs in Healthcare?
Recently, JCAHO (Joint Commission on the Accreditation of Healthcare
Organizations) added a new requirement for the use of FMEA to reduce
risks, improve patient safety, and enhance patient satisfaction in high-risk
processes.
“JCAHO Standard LD.5.2 requires facilities to select at least one high-risk
process for proactive risk assessment each year. This selection is to be
based, in part, on information published periodically by the JCAHO that
identifies the most frequently occurring types of sentinel events. The
National Center for Patient Safety will also identify patient safety events and
high risk processes that may be selected for this annual risk assessment.”
Furthermore, the 1999 Institute of Medicine (IOM) report, “To Err is
Human: Building a Safer Health System,” urged health organization to
reduce medical errors by 50% over the following 5 years through changes to
healthcare systems. The report stated that most medical errors do not result
from “individual recklessness,” but instead from “basic flaws” in the way
the healthcare system is organized.
Choosing a Process for an FMEA Project
Many different processes occur within a hospital setting, each with varying
degrees of risk. So how do you choose a process to work on? The
possibilities include considering the following:
• Sentinel Event Alerts (Past alerts have covered medication
abbreviations, wrong-site surgery, delay in treatment, etc.)
• JCAHO’s Patient Safety Goals
• Other identified high-risk processes within the hospital
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Choosing Infant Abduction as an FMEA
Project at WakeMed
According to FBI statistics, 145 cases of infant abductions have been
documented since 1983 (<1 year old, taken by a non-family member), an
average of 14 infant abductions per year since 1987.¹
83 infants were taken from hospitals and 62 were taken from other locations,
such as residences, day-care centers, and shopping centers.²
While arguably “statistically insignificant,” given that there are 4.2 million
births per year in 3500 birthing centers throughout the country², this crime
transcends statistics due to its highly-charged nature. There are
approximately 7,800 births/year in the WakeMed system.
Furthermore, when these situations occur, infant abductions affect the local
community and beyond. National news coverage can be expected and these
incidents can adversely affect hospitals via the publicity generated and
liability concerns. In one case, an Oklahoma City couple filed a $56 million
suit against their city hospital.¹
What Motivates the Perpetrator?
The need to present their partners with a baby often drives the female
offender (141 of the 145 cases). Several motivating factors have been cited
in FBI statistics, including the following:
• Preventing the partner from deserting her
• Salvaging the relationship
• Miscarriage
• Inability to conceive²
¹ T. Farley, “Parents Sue City Hospital for $56 Million,” The Daily Oklahoman, March 8, 1991
² L. Ankrm and C. Lent, “Cradle Robbers: A Study of the Infant Abductor,” FBI Law Enforcement Bulletin,
September 1995.
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Conducting the FMEA
In the pages that follow the FMEA process will be applied to minimizing the
potential for Infant Abduction at WakeMed:
FMEA Project Methodology:
Step 1:
Step 2:
Step 3:
Step 4:
Step 5:
Step 6:
Step 7:
Step 8:
Define the FMEA Topic
Assemble the Team
Review the Process / Create a Process Flowchart
Brainstorm Potential Failure Modes, Causes, and Effects
Evaluate the Risk of Failure, or Hazard Score
Calculate the Total Risk Priority Number Score
Create an Action Plan
Determine FMEA Project Success
Step 1: Define the FMEA Topic
The first step is to clearly define the FMEA topic:
“Minimize the potential for Infant Abduction at WakeMed’s
Western Wake Campus”
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Step 2: Assemble the Team
Next, assemble a team of process experts and those that would be involved
in any expected changes to policies, procedures, equipment, or personnel. In
our case, we chose representatives from the Women’s Pavilion and
Birthplace, Public Safety, Engineering, and Performance Improvement.
FMEA Team Members:
Todd Reichert
Monica Blochowiak
Blair Creekmore
Michael Prince
Barbara Werner
Cheryl Baker
Sara Owens
Michael Baker
FMEA Team Leader, Performance Improvement
Nurse Manager, WW Women’s Pavilion
Staff Nurse, WW Post Partum
Supervisor, WW Public Safety
Supervisor, WW Women’s Pavilion
Supervisor, WW NICU
Staff Nurse, WW Special Care Nursery
Supervisor, Engineering, WW
WW = Western Wake Campus (WakeMed)
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Step 3: Review the Process
Develop a flowchart of the existing process, listing all process steps. This
will assist in the next step of the FMEA process, when “Failure Modes” will
be identified.
(Rev. 6/5/03)
Western Wake
Process Flow Diagram
WPBP - Mainitaining Infant Security
Start
1
Mother Admitted into
Labor and Delivery
Unit
F
2
Baby Born
(ID Band Only)
Computer Info
Deleted & HUGS
Band Removed
13
Yes
Special
Care
Needs?
Move to
Special Care
Nursery
(SCN)
(Locked Unit)
No
A
B
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B
A
14
Baby
Leaves Special Care
Nursery
(SCN)
3
Infant Security
Precautions
Discussed with Mom,
Family, Visitors
4
Wash
Baby
?
Discharge
?
Yes
Baby
Washed
Yes
End
No, Newborn
Nursery
or PostPartum
C
No
C
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C
5
Apply HUG S Band
Enter Info into
Com puter System
Space
Available in
Post Partum
?
No
Delay, until
space is
available
Yes
6
M ove to
Post Partum
Problem : Som etim es HUG S bands
aren't applied until reaching Post Partum
D
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D
7
Security Precautions
Reviewed w/ Mom
+
Visual Check of
Bands - Mom & Baby
8
Bands Checked and
Tightened as
Necessary Each Shift
9
Charge Nurse Checks
Computer Records
(against census?)
Each Shift
Corrections made,
Bands Located as
necessary
Baby
Removed
From
Room?
No
Yes
E
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E
Special
Care Needs
?
Yes
F
No
10
ID Band Checked and
Verified, HUGS Tag
Presence Checked
To Be
Discharged
?
Move to Circ., Nursery,
etc.
No
Yes
Begin Discharge
Process
Return to Postpartum
11
Check Band
12
Remove Info from
Computer System
Check ID Band, Return
baby to Mom
Remove HUGS Band
End
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Step 4: Brainstorm Potential Failure Modes,
Causes, and Effects
At this step, we want to identify what “could” go wrong at each of the
process steps, these are referred to as “Failure Modes,” “why it might
happen,” the causes of those failures, and the effects of those failures. (Refer
to the attached FMEA worksheet.)
Step 5 Evaluate the Risk of Failure, or
Hazard Score
The relative risk of a failure and its effects are composed of three factors in
an FMEA: Severity, Probability of Occurrence, and Detection Capability.
– The “severity” is the consequence of the failure should it occur
– The “probability of occurrence” is the likelihood of a failure mode occurring
– The “detection rating” is our ability to catch the error before causing patient
harm
Various scoring guidelines exist, below is a scoring guideline from the “The
Basics of FMEA” by S.L. Goodman. You may wish to adapt the scoring
guidelines to suit the process under study. Scores for this case study can be
found on the attached FMEA worksheet.
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SEVERITY RATING SCALE
Rating
Description
Definition
10
Extremely
dangerous
Failure could cause death of a customer (patient, visitor, employee,
staff member, business partner) and/or total system breakdown,
without any prior warning.
9
8
Very dangerous
Failure could cause major or permanent injury and/or serious system
disruption with interruption in service, with prior warning.
Dangerous
Failure causes minor to moderate injury with a high degree of
customer dissatisfaction and/or major system problems requiring major
repairs or significant re-work.
6
5
Moderate danger
Failure causes minor injury with some customer dissatisfaction and/or
major system problems.
4
3
Low to
Moderate danger
Failure causes very minor or no injury but annoys customers and/or
results in minor system problems that can be overcome with minor
modifications to system or process.
Slight danger
Failure causes no injury and customer is unaware of problem however
the potential for minor injury exists; little or no effect on system.
No danger
Failure causes no injury and has no impact on system.
7
2
1
Adapted from: The Basics of FMEA, Productivity, Inc. Copyright 1996 Resource Engineering, Inc.; Goodman, S.L.,
Design for Manufacturability at Midwest Industries, Harvard Business School, February 2, 1996 Lecture;
Wheelwright, S.C.; Clark, K.B., Revolutionizing Product Development: Quantum Leaps in Speed, Efficiency, and
Quality, The Free Press; Potential Failure Modes and Effects Analysis, Automotive Industry Action Group, 1993.
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OCCURRENCE RATING SCALE
Rating
Description
Potential Failure Rate
10
Certain probability of occurrence
Failure occurs at least once a day; or, failure occurs
almost every time.
9
Failure is almost inevitable
Failure occurs predictably; or, failure occurs every 3 or 4
days.
8
7
Very high probability of
occurrence
Failure occurs frequently; or failure occurs about once
per week.
6
5
Moderately high probability of
occurrence
Failure occurs about once per month.
4
3
Moderate probability of
occurrence
Failure occurs occasionally; or, failure once every 3
months.
2
Low probability of occurrence
Failure occurs rarely; or, failure occurs about once per
year.
1
Remote probability of
occurrence
Failure almost never occurs; no one remembers last
failure.
Adapted from: The Basics of FMEA, Productivity, Inc. Copyright 1996 Resource Engineering, Inc.; Goodman, S.L.,
Design for Manufacturability at Midwest Industries, Harvard Business School, February 2, 1996 Lecture; Wheelwright,
S.C.; Clark, K.B., Revolutionizing Product Development: Quantum Leaps in Speed, Efficiency, and Quality, The Free
Press; Potential Failure Modes and Effects Analysis, Automotive Industry Action Group, 1993.
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DETECTION RATING SCALE
Rating
Description
Definition
10
No chance of
detection
There is no known mechanism for detecting the failure.
9
8
Very
Remote/Unreliable
The failure can be detected only with thorough inspection and this
is not feasible or cannot be readily done.
7
6
Remote
The error can be detected with manual inspection but no process
is in place so that detection left to chance.
5
Moderate chance of
detection
There is a process for double-checks or inspection but it not
automated and/or is applied only to a sample and/or relies on
vigilance.
4
3
High
There is 100% inspection or review of the process but it is not
automated.
2
Very High
1
Almost certain
There is 100% inspection of the process and it is automated.
There are automatic “shut-offs” or constraints that prevent failure.
Adapted from: The Basics of FMEA, Productivity, Inc. Copyright 1996 Resource Engineering, Inc.;
Goodman, S.L., Design for Manufacturability at Midwest Industries, Harvard Business School, February 2,
1996 Lecture; Wheelwright, S.C.; Clark, K.B., Revolutionizing Product Development: Quantum Leaps in
Speed, Efficiency, and Quality, The Free Press.
Page 15
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Calculating the RPN
Risk Priority Number =
Severity x Occurrence x Detectability
Since scores are 1-10, the resultant Risk Priority Number will be from
1-1000. Failure Modes with RPN scores <= 100 are generally considered
minor scores and might not be considered further by the team when an
action plan is created in step 7.
In our example, “Child not banded (in L&D)”:
Severity of the potential effects was rated a “10” (Highest Severity
relative to providing infant security – no HUGS protection at this
time)
Probability was rated a “7” (High)
Detection was rated a “5” (Moderate)
Therefore, the RPN for this failure mode is 10x7x5 = 350 (High)
Step 6 Calculate the Total RPN Score
Next, add the totals of all RPN scores for all failure modes to get a grand
total. This creates a baseline for future comparison. In our process, our
score was 4,164 (See the attached FMEA worksheet.)
Note: process scores can only be compared to themselves, not against other
processes, since they may have more or less process steps.
Page 16
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Step 7 Create an Action Plan
• Identify the failure modes that have an RPN Score of 100 or higher.
These are the items that require the greatest attention. (In our
example, we decided to address all failure modes, regardless of score.)
• Develop an action plan to address each of these high-hazard score
failure modes. The action plan should include who?, what?, when?,
why?, etc.
Items Included in the Action Plan:
Policy Update: All normal newborns will be banded ASAP, do not wait for
bathing to be completed
Policy Update: L&D Nurse will obtain the HUGS Band and Patient ID Bands
simultaneously
Policy Update: Transferring & Receiving Nurse will confirm patient ID & HUGS
bands, documenting on the Post Partum flow sheet
Policy Update: L&D Nurse will be responsible for activating the HUGS tag and
ensuring that the info is entered correctly into the computer system (personally
inputting or contacting the Clinical Secretary.)
Training: HUGS computer system entry training will be provided to the Clinical
Secretaries
Checklists: Create infant security & safety sheet to be shared with mom in
L&D, and signed by mom (in Spanish also? Include pictures for universal
understanding?) Obtain approval by Forms Committee and Risk Management
Checklists: Create checklist/script for education of patient & SO (significant
other) by staff re: doors, sensors, band tightness, band tampering, etc.
Alarms: Isolate Women's Pavilion from "testing alarms" in other areas,
"Strobes only," Install badge reader & Mag Lock on back stairwell and exterior
exit door. Remove auto sensor from WP -> Telemetry door, and install badge
reader, "Authorized Personnel Only" sign. Add badge & mag lock at stairwell.
Policy Update: Update Code Pink Policy (Infant Abduction). Require
monitoring of all egress points during Code Pink by hospital personnel &
provide staff education
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Policy Update: Create/Review roles & responsibilities in Code Pink policy
Alarms: Conduct Quarterly Code Pink Drills (per policy)
HUGS System: Ask HUGS representative about other band options to deal
with ankle swelling reduction & chafing concerns
HUGS System: Ask HUGS rep. if pre-printed instructions are available
Checklists: Add “HUGS band check/tightening” to the Nurse assessment
flowsheet & educate staff
Checklists: Add “HUGS check against census” to the L&D Charge Nurse
checklist
Checklists: Add “HUGS check against census” to the Post Partum Charge
Nurse checklist
Policy Update: Post Partum Nurse to check HUGS band presence before
accepting infant, otherwise infant is to be returned for tagging
Policy Update: All infants leaving the Special Care Nursery (except for direct
discharge) must be immediately HUGS banded. Update questionnaire / audit
form.
Training: Conduct HUGS system refresher for Special Care Nursery Nurses
Security: Have the supplier check/repair Physician & Employee entrance to
ensure proper reactivation after the door closes
Security: Budget for, and provide additional security cameras and other
security features around area perimeters
Step 8 Determine FMEA Project Success
Recalculate the RPN scores after implementation of the action plan, and
compare with the first FMEA analysis. Address any items with a
recalculated RPN Score of 100 or higher. See the attached worksheet for
our scoring after implementation of the action plan. In our case, our score
was reduced from 4,164 to 1,372 – a 67% improvement!
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Lessons Learned
Although conducting an FMEA can be a time consuming process, the results
can be very worthwhile. However, be sure to obtain management support
for the project, and a team leader’s skills in keeping a team motivated and
progressing through the project is essential to ensure the completion of a
successful project.
In Conclusion
FMEA is a tool for proactive risk assessment that is now being used in
healthcare. Infant Security was chosen as the 2003 FMEA project at
WakeMed because of the high volume of births in the WakeMed system and
the significance of this concern to the hospital and the community that we
serve. Through the use of FMEA, significant reductions in scored risk have
been realized.
References:
ISMP Website, Example of a Health Care Failure Mode and Effects
Analysis for IV Patient Controlled Analgesia (PCA), ISMP.Com
McDermott, Robin E., The Basics of FMEA, PRODUCTVITY, 1996.
Palady, Paul, FMEA: Author’s Edition, PAL Publications, 1998.
The Basics of Healthcare Failure Modes and Effect Analysis,
Videoconference Course, VA National Center for Patient Safety, 2001.
Understanding the Failure Modes and Effects Analysis, an on-line course,
HCProfessor.com, 2002. Phone #: 800-650-6787.
JCAHO, www.jcaho.org, Sentinel Event Alerts, Issue 9 – April 9, 1999,
Infant Abductions: Preventing Future Occurrences.
Page 19
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Applying Failure Modes
and Effects Analysis
(FMEA) in Healthcare
Preventing Infant
Abduction, a Case Study
2004 Society for Health Systems Presentation
Todd A. Reichert
Objectives of this Presentation

Define FMEA
Explain the use of this tool in healthcare
Describe the project selection process
Apply the FMEA process to “Preventing
Infant Abduction at WakeMed”
Report on results achieved by the project
team
WakeMed:
A multi-facility health care system
629 acute care beds: 515 at New Bern
Avenue and 114 at Western Wake Medical
Center
68 rehabilitation beds
55 skilled nursing beds
A home health agency
WakeMed:
A multi-facility health care system
WakeMed Faculty Physicians Practice
5800 employees; 779 medical staff at New
Bern Avenue, 506 at Western Wake (of the
506, 411 are also on staff at NBA)
UNC affiliation - residency programs
What is an FMEA?
FMEA – Failure Modes and Effects Analysis
is a proactive team-oriented approach to risk
reduction

ID what “could” go wrong at each process step?
Assign “risk” scores
Team-oriented approach to focus resources on
priority issues
What is an FMEA?
Since the 1960’s they’ve been used in the
nuclear, military, aviation, food, and
automotive industries.
They’re now being used in Healthcare and
other service industries.
1999 Institute of Medicine (IOM) report, “To Err is
Human: Building a Safer Health System.”
The report urged health organization to reduce
medical errors by 50% over the following 5 years
through changes to healthcare systems
The report stated that most medical errors do not
result from “individual recklessness” but instead
from “basic flaws” in the way the healthcare
system is organized
Recently, JCAHO (Joint Commission on the
Accreditation of Healthcare Organizations)
added a new requirement for the use of
FMEA to reduce risks, improve patient safety,
and enhance patient satisfaction in high-risk
processes.

“JCAHO Standard LD.5.2 requires facilities to
select at least one high-risk process for proactive
risk assessment each year. This selection is to be
based, in part, on information published
periodically by the JCAHO that identifies the most
frequently occurring types of sentinel events. The
National Center for Patient Safety will also
identify patient safety events and high risk
processes that may be selected for this annual risk
assessment.”
Choosing a Process for
an FMEA Project

Sentinel Event Alerts (Published by JCAHO)
• Issue 9 – April 9, 1999, Infant Abductions:
Preventing Future Occurrences
• Past alerts have covered medication
abbreviations, wrong-site surgery, delay in
treatment, etc.

JCAHO’s Patient Safety Goals
Other identified high-risk processes within the
hospital
Choosing Infant Abduction as a
Process for an FMEA Project
According to FBI statistics, 145 cases of
infant abductions have been documented
since 1983 (<1 year old, taken by a nonfamily member), an average of 14 infant
abductions per year since 1987. ¹
83 infants were taken from hospitals, and 62
were taken from other locations, such as
residences, day-care centers, and shopping
centers.¹
¹ FBI’s National Center for Violent Crime (NCAVC) and the National Center for
Missing and Exploited Children (NCMEC)
While arguably “statistically insignificant,”
given that there are 4.2 million births per
year in 3500 birthing centers throughout the
country¹, this crime transcends statistics due
to its highly-charged nature²
¹ 7800 births annually at WakeMed (average)
² T. Farley, “Parents Sue City Hospital for $56 Million,” The Daily
Oklahoman, March 8, 1991
Infant abductions affect the local community
and beyond:
• National news coverage
• Adversely affect hospitals via the publicity
generated and liability concerns. In one
case, an Oklahoma City couple filed a
$56 million suit against their city hospital
² T. Farley, “Parents Sue City Hospital for $56 Million,” The Daily
Oklahoman, March 8, 1991
What Motivates the Perpetrator?
The need to present their partners with a
baby often drives the female offender (141 of
the 145 cases)
•
•
•
•
¹
Preventing the partner from deserting her
Salvaging the relationship
Miscarriage
Inability to conceive¹
L. Ankrm and C. Lent, “Cradle Robbers: A Study of the Infant
Abductor,” FBI Law Enforcement Bulletin, September 1995.

Step 1:
Define the FMEA Topic

Step 2:
Assemble the Team

Step 3:
Review the Process / Create a Process
Flowchart

Step 4:
Brainstorm Potential Failure
Modes,Causes, and Effects

Step 5:
Evaluate the Risk of Failure, or Hazard
Score

Step 6:
Calculate the Total Risk Priority Number
Score

Step 7:
Create an Action Plan

Step 8:
Determine FMEA Project Success
Step 1: Define the FMEA Topic
“Minimize the potential for Infant
Abduction at WakeMed’s
Western Wake Campus”
Step 2: Assemble the Team
FMEA Team Members:
Todd Reichert
Monica Blochowiak
Blair Creekmore
Michael Prince
Barbara Werner
Cheryl Baker
Sara Owens
Michael Baker
FMEA Team Leader, Performance Improvement
Nurse Manager, WW Women’s Pavilion
Staff Nurse, WW Post Partum
Supervisor, WW Public Safety
Supervisor, WW Women’s Pavilion
Supervisor, WW NICU
Staff Nurse, WW Special Care Nursery
Supervisor, Engineering, WW
WW = Western Wake Campus (WakeMed)
Step 3: Review the Process
Develop a flowchart of the existing
process, listing all process steps
(Rev. 6/5/03)
Western Wake
Process Flow Diagram
WPBP - Mainitaining Infant Security
Start
1
Mother Admitted into
Labor and Delivery
Unit
F
2
Baby Born
(ID Band Only)
Computer Info
Deleted & HUGS
Band Removed
13
Yes
Special
Care
Needs?
Move to
Special Care
Nursery
(SCN)
No
A
B
(Locked Unit)
Infant
Security
Process
Flowchart
Infant
Security
Process
Flowchart
B
A
14
Baby
Leaves Special Care
Nursery
(SCN)
3
Infant Security
Precautions
Discussed with Mom,
Family, Visitors
4
Wash
Baby
?
No
C
Discharge
?
Yes
Baby
Washed
Yes
No, Newborn
Nursery
or PostPartum
C
End
Infant
Security
Process
Flowchart
C
5
Apply HUGS Band
Enter Info into
Computer System
Space
Available in
Post Partum
?
No
Delay, until
space is
available
Yes
6
Move to
Post Partum
D
Problem: Sometimes HUGS bands
aren't applied until reaching Post Partum
D
7
Infant
Security
Process
Flowchart
Reviewed w/ Mom
+
Visual Check of
Bands - Mom & Baby
8
Bands Checked and
Tightened as
Necessary Each Shift
9
Charge Nurse Checks
Computer Records
(against census?)
Each Shift
Corrections made,
Bands Located as
necessary
Baby
Removed
From
Room?
Yes
E
No
Infant
Security
Process
Flowchart
E
Special
Care Needs
?
Yes
F
No
10
ID Band Checked and
Verified, HUGS Tag
Presence Checked
To Be
Discharged
?
No
Move to Circ., Nursery,
etc.
Yes
Begin Discharge
Process
Return to Postpartum
11
Check Band
12
Remove Info from
Computer System
Remove HUGS Band
End
Check ID Band, Return
baby to Mom
Step 4: Brainstorm Potential Failure
Modes, Causes, and Effects
At this step, we want to identify what “could”¹
go wrong at each of the process steps, “why it
might happen,” the causes of those failures,
and the effects of those failures.
¹ These are referred to as “Failure Modes”
Step
1
Failure Mode
N/A
Cause of Failure
Effect of Failure
-----
-----
Not in Policies & Procedures,
Not in Standard of Care,
Not Emphasized,
Not Understood
2
Child not banded
No HUGS Protection
3
Forgetfulness,
Training Issues,
Insufficient IS info provided to mom Not Assuming Responsibility
3
Mom not paying attention
Not the Best Time for Mom
3
Info not understood
Cultural/Language Barriers
Mom Doesn't know Infant
4
Baby may not be HUGS banded
prior to w ashing
Caregiver Know ledge Deficit
about New System
Baby may be Moved w /o
HUGS Protection
Step
5
5
5
5
Failure Mode
Cause of Failure
Info not entered into computer
system, including name/room#
Room # Changed, ?
Delay in entering info into computer
system
Workload issues
Effect of Failure
Delayed Response to
HUGS Alarm
Delayed Response to
HUGS Alarm
"Unfounded" Alarms
Too Close to Sensor(s),
Baby Kicking,
Family Tampering w / HUGS
Tag
Alarm ringing - doors not locking
Mechanical Failure,
Fire
Alarm,
Door
Open During Alarm
Compromised IS Protection
Staff Desensitization
Step
Failure Mode
6
HUGS band not applied until
reaching post partum (sometimes)
7
Bands loosening
8
Bands not checked and/or
tightened properly
9
Not checked against census
9
Transferred rooms, not updated
Cause of Failure
SCN Transfer,
Not in "Standard of Care,"
(See FM #2)
Diminished Sw elling of
Infant's Limb
Effect of Failure
No HUGS Protection
HUGS Band may Fall Off
HUGS Band may Fall Off,
Not Emphasized,
or may already have fallen
Workload Issues
off
Not on Charge Nurse Flow
Erroneous Computer
Sheet,
Records,
Know ledge Issue,
Delayed Response to
Workload Issue
HUGS Alarm
Erroneous Computer
Records,
Delayed Response to
Line of Responsibility Unclear HUGS Alarm
Step
10
Failure Mode
Not Emphasized,
Workload Issues,
HUGS band may not be checked
Training Issues,
w hen moving to nursery, other, for Nurse may perform ID Check
blood draw s, circ., etc.
Only
11, 12, 13 N/A
14
misc.
misc.
Cause of Failure
Leaving SCN other than for
discharge w /o HUGS band (may
include family room visiting)
Side door not reactivating properly
Other entrance issues related to
cameras and other security
features
----"Not Part of Routine,"
Limited Staff to Cover SCN "Can't leave,"
No
Computer/No HUGS
Bands/Supplies
Effect of Failure
Possible Lack of HUGS
Protection
-----
Lack of HUGS Protection
Step 5

Evaluate the Risk of Failure, or
Hazard Score
The relative risk of a failure and its effects is
composed of three factors in an FMEA: Severity,
Probability of Occurrence, and Detection Capability
– The “severity” is the consequence of the failure
should it occur
– The “probability of occurrence” is the likelihood of
a failure mode occurring
– The “detection rating” is our ability to catch the
error before causing patient harm
S E V E R IT Y R A T IN G S C A L E
R a tin g
D e s c r ip tio n
D e f in itio n
10
E x tre m e ly
d ang ero u s
F a i l u r e c o u ld c a u s e d e a t h o f a c u s t o m e r ( p a t ie n t , v i s it o r , e m p lo y e e ,
s t a ff m e m b e r , b u s in e s s p a r t n e r ) a n d /o r to t a l s y s t e m b r e a k d o w n ,
w it h o u t a n y p r io r w a r n i n g .
9
8
V ery d a ng ero u s
F a i l u r e c o u ld c a u s e m a jo r o r p e r m a n e n t i n j u r y a n d / o r s e r io u s s y s t e m
d is r u p t io n w it h i n t e r r u p t io n i n s e r v i c e , w it h p r io r w a r n i n g .
D ang ero u s
F a i l u r e c a u s e s m i n o r t o m o d e r a t e i n j u r y w it h a h i g h d e g r e e o f
c u s t o m e r d is s a t is f a c t io n a n d / o r m a jo r s y s t e m p r o b l e m s r e q u ir i n g m a jo r
r e p a ir s o r s ig n i f i c a n t r e - w o r k .
6
5
M o d erate d ang er
F a i l u r e c a u s e s m i n o r i n j u r y w it h s o m e c u s t o m e r d i s s a t is f a c t io n a n d / o r
m a jo r s y s t e m p r o b le m s .
4
3
L o w to
M o d erate d ang er
F a ilu r e c a u s e s v e r y m in o r o r n o in ju r y b u t a n n o y s c u s t o m e r s a n d /o r
r e s u lt s i n m i n o r s y s t e m p r o b le m s t h a t c a n b e o v e r c o m e w it h m i n o r
m o d i f i c a t io n s t o s y s t e m o r p r o c e s s .
S lig h t d a n g e r
F a i l u r e c a u s e s n o i n j u r y a n d c u s t o m e r is u n a w a r e o f p r o b le m h o w e v e r
t h e p o t e n t ia l f o r m i n o r i n ju r y e x i s t s ; l it t l e o r n o e f f e c t o n s y s t e m .
N o danger
F a ilu r e c a u s e s n o in ju r y a n d h a s n o im p a c t o n s y s t e m .
7
2
1
A d a p te d f r o m : T h e B a s ic s o f F M E A , P r o d u c tiv it y , I n c . C o p y r ig h t 1 9 9 6 R e s o u r c e E n g in e e r i n g , I n c .; G o o d m a n , S .L .,
D e s ig n f o r M a n u f a c tu r a b ilit y a t M id w e s t I n d u s tr ie s , H a r v a r d B u s in e s s S c h o o l, F e b r u a r y 2 , 1 9 9 6 L e c tu r e ;
W h e e l w r i g h t , S .C .; C la r k , K .B ., R e v o l u t i o n i z i n g P r o d u c t D e v e l o p m e n t : Q u a n t u m L e a p s i n S p e e d , E f f i c i e n c y , a n d
Q u a lity , T h e F r e e P r e s s ; P o t e n t ia l F a ilu r e M o d e s a n d E f f e c ts A n a ly s is , A u to m o t iv e I n d u s t r y A c tio n G r o u p , 1 9 9 3 .
O C C U R R E N C E R A T IN G S C A L E
R a tin g
D e s c r ip tio n
P o te n tia l F a ilu r e R a te
10
C e r t a i n p r o b a b i l it y o f o c c u r r e n c e
F a i l u r e o c c u r s a t le a s t o n c e a d a y ; o r , f a i l u r e o c c u r s
a lm o s t e v e r y t im e .
9
F a i l u r e is a l m o s t i n e v it a b l e
F a i l u r e o c c u r s p r e d ic t a b l y ; o r , f a i l u r e o c c u r s e v e r y 3 o r 4
d a ys.
8
7
V e r y h i g h p r o b a b i l it y o f
o ccu rrence
F a ilu r e o c c u r s fr e q u e n t ly ; o r fa ilu r e o c c u r s a b o u t o n c e
per w eek.
6
5
M o d e r a t e l y h i g h p r o b a b i l it y o f
o ccu rrence
F a i lu r e o c c u r s a b o u t o n c e p e r m o n t h .
4
3
M o d e r a t e p r o b a b i l it y o f
o ccu rrence
F a i l u r e o c c u r s o c c a s io n a l l y ; o r , f a i l u r e o n c e e v e r y 3
m o nths.
2
L o w p r o b a b i l it y o f o c c u r r e n c e
F a ilu r e o c c u r s r a r e ly ; o r , fa ilu r e o c c u r s a b o u t o n c e p e r
year.
1
R e m o t e p r o b a b i l it y o f
o ccu rrence
F a i l u r e a l m o s t n e v e r o c c u r s ; n o o n e r e m e m b e r s la s t
fa ilu r e .
A d a p te d f r o m : T h e B a s ic s o f F M E A , P r o d u c tiv it y , I n c . C o p y r ig h t 1 9 9 6 R e s o u r c e E n g in e e r in g , I n c .; G o o d m a n , S .L .,
D e s ig n f o r M a n u f a c tu r a b ilit y a t M id w e s t I n d u s tr ie s , H a r v a r d B u s in e s s S c h o o l, F e b r u a r y 2 , 1 9 9 6 L e c tu r e ; W h e e lw r ig h t,
S . C . ; C la r k , K . B . , R e v o l u t i o n iz i n g P r o d u c t D e v e l o p m e n t : Q u a n t u m L e a p s i n S p e e d , E f f i c i e n c y , a n d Q u a li t y , T h e F r e e
P r e s s ; P o te n t ia l F a ilu r e M o d e s a n d E f f e c ts A n a ly s is , A u to m o t iv e I n d u s tr y A c tio n G r o u p , 1 9 9 3 .
D E T E C T IO N
R A T IN G
S C A L E
R a tin g
D e s c r ip tio n
D e fin itio n
1 0
N o chance o f
d e t e c t io n
9
8
V ery
R e m o t e /U n r e lia b le
T h e f a i lu r e c a n b e d e t e c t e d o n ly w it h t h o r o u g h in s p e c t io n a n d t h is
is n o t fe a s ib le o r c a n n o t b e r e a d ily d o n e .
7
6
R e m o te
T h e e r r o r c a n b e d e t e c t e d w it h m a n u a l in s p e c t io n b u t n o p r o c e s s
is in p la c e s o t h a t d e t e c t io n le f t t o c h a n c e .
5
M o d e rate c h a n c e o f
d e t e c t io n
T h e r e is a p r o c e s s f o r d o u b le - c h e c k s o r in s p e c t io n b u t it n o t
a u t o m a t e d a n d / o r is a p p l ie d o n ly t o a s a m p le a n d / o r r e lie s o n
v ig ila n c e .
4
3
H ig h
2
V e r y H ig h
1
A lm o s t c e r t a in
T h e r e is n o k n o w n m e c h a n is m
T h e r e is 1 0 0 %
T h e r e is 1 0 0 %
fo r d e t e c t in g t h e fa ilu r e .
in s p e c t io n o r r e v ie w o f t h e p r o c e s s b u t it is n o t
a u to m a te d .
in s p e c t io n o f t h e p r o c e s s a n d it is a u t o m a t e d .
T h e r e a r e a u t o m a t ic “ s h u t - o f f s ” o r c o n s t r a in t s t h a t p r e v e n t f a i lu r e .
A d a p te d f r o m : T h e B a s ic s o f F M E A , P r o d u c tiv it y , I n c . C o p y r ig h t 1 9 9 6 R e s o u r c e E n g in e e r in g , I n c .;
G o o d m a n , S .L ., D e s ig n f o r M a n u f a c t u r a b ilit y a t M id w e s t I n d u s tr ie s , H a r v a r d B u s i n e s s S c h o o l, F e b r u a r y 2 ,
1 9 9 6 L e c tu r e ; W h e e lw r ig h t, S .C .; C la r k , K .B ., R e v o lu tio n iz in g P r o d u c t D e v e lo p m e n t: Q u a n tu m L e a p s in
S p e e d , E ffic ie n c y , a n d Q u a lity , T h e F r e e P re s s .
Calculating the RPN
Risk Priority Number =
Severity x Occurrence x Detectability
Scores are 1-10;
The resulting number is 1-1000
(Minor problem: RPN <= 100)
Step 5
Step
Evaluate the Risk of Failure,
or Hazard Score
Failure Mode
Frequency Degree of Chance of
Risk
of Failure Severity Detection Priority #
1
N/A
-----
-----
-----
2
Child not banded
7
10
5
350
3
Insufficient IS info provided to mom
4
5
8
160
3
8
5
8
320
3
Info not understood
2
5
8
80
4
prior to w ashing
9
10
3
270
-----
Step 5
Step
or Hazard Score
Failure Mode
Risk
5
system
5
"Unfounded" Alarms
3
10
10
300
5
2
10
10
200
5
8
10
5
400
4
10
5
200
Step 5
or Hazard Score
Risk
Step
Failure Mode
6
5
10
2
100
7
Bands loosening
9
8
6
432
8
tightened properly
3
8
8
192
9
8
7
7
392
9
7
7
7
343
Step 5
or Hazard Score
Step
Failure Mode
10
w hen moving to nursery, other, for
11, 12, 13 N/A
14
misc.
misc.
Risk
7
-----
5
-----
5
3
-----
8
105
-----
8
320
Total RPN (Baseline)
4164
features
Calculating the RPN

In our example, “Child not banded (in
L&D)”:
Severity of the potential effects was rated a “10”
(Highest Severity)
Probability was rated a “7” (High)
Detection was rated a “5” (Moderate)
RPN for this failure mode: 10x7x5 = 350 (High)
Prioritized Failure Mode RPN Scores
Step
7
5
9
2
9
3
Failure Mode
10
Bands loosening
Info not entered into computer system, including name/room#
Child not banded
Leaving SCN other than for discharge w/o HUGS band (may
"Unfounded" Alarms
Baby may not be HUGS banded prior to washing
Delay in entering info into computer system
Bands not checked and/or tightened properly
HUGS band may not be checked when moving to nursery, other,
for blood draws, circ., etc.
6
3
HUGS band not applied until reaching post partum (sometimes)
Info not understood
14
5
4
5
5
8
3
misc.
misc.
Risk Priority #
(Before)
432
400
392
350
343
320
320
300
270
200
200
192
160
105
100
80
Other entrance issues related to cameras and other security
features
4164
Step 6 Calculate the Total RPN Score
Add the totals of all RPN scores to
get a grand total
4,164 in this example
Step 7 Determine an Action Plan

Identify the failure modes that have an RPN
Score of 100 or higher. These are the items
requiring the greatest attention.

Develop an action plan to address each of
these high-hazard score failure modes. The
action plan should include who, what, when,
why, etc.

Policy Update: All normal newborns will be banded
ASAP, do not wait for bathing to be completed.

Policy Update: L&D Nurse will obtain the HUGS Band
and Patient ID Bands simultaneously.

Policy Update: Transferring & Receiving Nurse will
confirm patient ID & HUGS band, documenting this
info on the Post Partum flow sheet.

Policy Update: L&D Nurse will be responsible for
activating the HUGS tag and ensuring that the info is
entered correctly into the computer system
(personally inputting or contacting the Clinical
Secretary.)

Training: HUGS computer system entry training will
be provided to the Clinical Secretaries.

Checklists: Create infant security & safety
sheet to be shared with mom in L&D, and
signed by mom (in Spanish also? Include
pictures for universal understanding?) Obtain
approval by Forms Committee and Risk
Management.

Checklists: Create checklist/script for
education of patient & SO (significant other)
by staff re: doors, sensors, band tightness,
band tampering, etc.

Alarms: Conduct Quarterly Code Pink Drills (as per
policy.)

HUGS System: Ask HUGS representative about
other band options to deal with ankle swelling
reduction & chafing concerns.

HUGS System: Ask HUGS rep. if pre-printed
instructions are available.

Checklists: Add “HUGS band check/tightening” to
the Nurse Assessment flowsheet & educate staff.

Policy Update: Post Partum Nurse to check HUGS
band presence before accepting infant, otherwise
infant is to be returned for tagging.

Policy Update: All infants leaving the SCN (except for
direct discharge) must be immediately HUGS
banded. Update questionnaire / audit form.

Training: Conduct HUGS system refresher for SCN
Nurses.

Security: Have supplier check/repair Physician &
Employee entrance to ensure proper reactivation
after door closes.

Security: Budget for, and provide additional security
cameras and other security features around area
perimeters.

Recalculate the RPN scores after
implementing the action plan

Compare with the first FMEA analysis

Address any items with a recalculated RPN
Score of 100 or higher
Before Implementing Action Plan
Step
Failure Mode
After Implementing Action Plan
Risk
Frequency
of Failure Severity Detection Priority # of Failure
-----
-----
-----
Degree of Chance of
Risk
Severity Detection Priority #
1
N/A
-----
2
Child not banded
7
10
5
350
3
10
2
60
3
4
5
8
160
2
5
4
40
3
8
5
8
320
6
5
6
180
3
Info not understood
2
5
8
80
2
5
6
60
4
prior to w ashing
9
10
3
270
1
10
2
20
-----
-----
-----
-----
Step
Failure Mode
Risk
Frequency
Degree of Chance of
Risk
5
system
5
"Unfounded" Alarms
3
10
10
300
2
10
10
200
5
2
10
10
200
2
10
8
160
5
8
10
5
400
5
10
3
150
4
10
5
200
3
10
3
90
Risk
Frequency
Degree of Chance of
Risk
Step
Failure Mode
6
5
10
2
100
1
10
2
20
7
Bands loosening
9
8
6
432
5
8
3
120
8
tightened properly
3
8
8
192
2
8
3
48
9
8
7
7
392
4
7
4
112
9
7
7
7
343
2
7
2
28
Step
Failure Mode
10
w hen moving to nursery, other, for
11, 12, 13 N/A
14
misc.
misc.
Risk
Frequency
7
-----
5
-----
5
3
-----
8
Degree of Chance of
Risk
4
105
-----
-----
8
320
Total RPN (Baseline)
4164
5
-----
1
3
-----
8
60
-----
3
24
features
Percent Improvement
Total RPN (After)
67.05%
1372
Lessons Learned
FMEA can be a time consuming process
Be sure to obtain management support
Keep the team motivated
The results are worthwhile

In Conclusion

FMEA is a tool for proactive risk assessment now
used in healthcare
Infant Security was chosen as the 2003 FMEA
project because of the high volume of births in the
WakeMed system (approx. 7800 births/year) and
the significance of this issue.
Significant reductions in scored risk have been
realized through the use of this tool
Questions?
References:
ISMP Website, Example of a Health Care Failure
Mode and Effects Analysis for IV Patient Controlled
Analgesia (PCA), ISMP.Com
McDermott, Robin E., The Basics of FMEA,
PRODUCTVITY, 1996.
Palady, Paul, FMEA: Author’s Edition, PAL
Publications, 1998.
References:
The Basics of Healthcare Failure Modes and Effect
Analysis, Videoconference Course, VA National
Center for Patient Safety, 2001.
Understanding the Failure Modes and Effects Analysis,
an on-line course, HCProfessor.com, 2002. Phone #:
800-650-6787.
JCAHO, www.jcaho.org, Sentinel Event Alerts, Issue 9
– April 9, 1999, Infant Abductions: Preventing Future
Occurrences