Applying FMEA to Prevent Infant Abduction

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

Todd A. Reichert, WakeMed, Raleigh, NC. Page 2 2/2/2004
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 team-
oriented 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.

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

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
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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: 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
The first step is to clearly define the FMEA topic:
“Minimize the potential for Infant Abduction at WakeMed’s
Western Wake Campus”

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 FMEA Team Leader, Performance Improvement
Monica Blochowiak Nurse Manager, WW Women’s Pavilion
Blair Creekmore Staff Nurse, WW Post Partum
Michael Prince Supervisor, WW Public Safety
Barbara Werner Supervisor, WW Women’s Pavilion
Cheryl Baker Supervisor, WW NICU
Sara Owens Staff Nurse, WW Special Care Nursery
Michael Baker Supervisor, Engineering, WW
WW = Western Wake Campus (WakeMed)

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
Mother Admitted into
Labor and Delivery
Unit
Start
Baby Born
(ID Band Only)
Special
Care
Needs?
Move to
Special Care
Nursery
(SCN)
Yes
No
F
Computer Info
Deleted & HUGS
Band Removed
(Locked Unit)
1
2
13
A B

Infant Security
Precautions
Discussed with Mom,
Family, Visitors
Wash
Baby
?
Baby
Washed
A
Yes
No
Baby
Leaves Special Care
Nursery
(SCN)
Discharge
?
No, Newborn
Nursery
or Post-
Partum
End
Yes
3
4
14
B
C
C

Apply HUGS Band
Enter Info into
Computer System
Space
Available in
Post Partum
?
Delay, until
space is
available
Move to
Post Partum
No
Yes
Problem: Sometimes HUGS bands
aren't applied until reaching Post Partum
D
C
5
6

Security Precautions
Reviewed w/ Mom
+
Visual Check of
Bands - Mom & Baby
D
Bands Checked and
Tightened as
Necessary Each Shift
Charge Nurse Checks
Computer Records
(against census?)
Each Shift
Corrections made,
Bands Located as
necessary
Baby
Removed
From
Room? No
Yes
7
8
9
E

ID Band Checked and
Verified, HUGS Tag
Presence Checked
Begin Discharge
Process
Check Band
Remove Info from
Computer System
Remove HUGS Band
End
Special
Care Needs
?
F
Yes
10
11
To Be
Discharged
?
Move to Circ., Nursery,
etc.
Return to Postpartum
Check ID Band, Return
baby to Mom
Yes
No
12
E
No

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.

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.
7
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.
2
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.
1 No danger Failure causes no injury and has no impact on system.
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.

OCCURRENCE RATINGSCALE
Rating Description Potential Failure Rate
10 Certain probability of occurrence
Failure occurs at least once a day; or, failure occurs
almost everytime.
9 Failure is almost inevitable
Failure occurs predictably; or, failure occurs every 3 or 4
days.
8
7
Veryhigh probability of
occurrence
Failure occurs frequently; or failure occurs about once
per week.
6
5
Moderately high probabilityof
occurrence
Failure occurs about once per month.
4
3
Moderate probabilityof
occurrence
Failure occurs occasionally; or, failure once every 3
months.
2 Low probabilityof 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: QuantumLeaps in Speed, Efficiency, and Quality, The Free
Press; Potential Failure Modes and Effects Analysis, Automotive Industry Action Group, 1993.

DETECTIONRATINGSCALE
Rating Description Definition
10
Nochanceof
detection
Thereis noknownmechanismfor detectingthe failure.
9
8
Very
Remote/Unreliable
Thefailure canbedetectedonlywiththoroughinspectionandthis
is not feasibleor cannot bereadilydone.
7
6
Remote
Theerror canbedetected withmanual inspectionbut noprocess
is inplacesothat detectionleft tochance.
5
Moderate chanceof
detection
Thereis aprocess for double-checks or inspection but it not
automatedand/or is appliedonlytoasampleand/or relies on
vigilance.
4
3
High
Thereis 100%inspectionor reviewof theprocess but it is not
automated.
2 VeryHigh
Thereis 100%inspectionof theprocess andit is automated.
1 Almost certain There are automatic“shut-offs”or constraints that prevent failure.
Adaptedfrom: TheBasics of FMEA, Productivity, Inc. Copyright 1996ResourceEngineering, Inc.;
Goodman, S.L., Designfor Manufacturabilityat Midwest Industries, HarvardBusiness School, February2,
1996Lecture; Wheelwright, S.C.; Clark, K.B., RevolutionizingProduct Development: QuantumLeaps in
Speed, Efficiency, andQuality, The Free Press.

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.

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

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!

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.

Applying Failure Modes
Applying Failure Modes
and Effects Analysis
and Effects Analysis
(FMEA) in Healthcare
(FMEA) in Healthcare
Preventing Infant
Preventing Infant
Abduction, a Case Study
Abduction, a Case Study
Todd A. Reichert
Todd A. Reichert

Objectives of this Presentation
Objectives of this Presentation
„
„ Define FMEA
Define FMEA
„
„ Explain the use of this tool in healthcare
Explain the use of this tool in healthcare
„
„ Describe the project selection process
Describe the project selection process
„
„ Apply the FMEA process to
Apply the FMEA process to “
“Preventing
Preventing
Infant Abduction at WakeMed
Infant Abduction at WakeMed”
”
„
„ Report on results achieved by the project
Report on results achieved by the project
team
team

WakeMed:
WakeMed:
A multi
A multi-
-facility health care system
facility health care system
ƒ
ƒ 629 acute care beds: 515 at New Bern
629 acute care beds: 515 at New Bern
Avenue and 114 at Western Wake Medical
Avenue and 114 at Western Wake Medical
Center
Center
ƒ
ƒ 68 rehabilitation beds
68 rehabilitation beds
ƒ
ƒ 55 skilled nursing beds
55 skilled nursing beds
ƒ
ƒ A home health agency
A home health agency

WakeMed:
WakeMed:
A multi
A multi-
-facility health care system
facility health care system
ƒ
ƒ WakeMed Faculty Physicians Practice
WakeMed Faculty Physicians Practice
ƒ
ƒ 5800 employees; 779 medical staff at New
5800 employees; 779 medical staff at New
Bern Avenue, 506 at Western Wake (of the
Bern Avenue, 506 at Western Wake (of the
506, 411 are also on staff at NBA)
506, 411 are also on staff at NBA)
ƒ
ƒ UNC affiliation
UNC affiliation -
- residency programs
residency programs

What is an FMEA?
What is an FMEA?
ƒ
ƒ FMEA
FMEA –
– Failure Modes and Effects Analysis
Failure Modes and Effects Analysis
is a proactive team
is a proactive team-
-oriented approach to risk
oriented approach to risk
reduction
reduction
ƒ
ƒ ID what
ID what “
“could
could”
” go wrong at each process step?
go wrong at each process step?
ƒ
ƒ Assign
Assign “
“risk
risk”
” scores
scores
ƒ
ƒ Team
Team-
-oriented approach to focus resources on
oriented approach to focus resources on
priority issues
priority issues

What is an FMEA?
What is an FMEA?
ƒ
ƒ Since the 1960
Since the 1960’
’s they
s they’
’ve been used in the
ve been used in the
nuclear, military, aviation, food, and
nuclear, military, aviation, food, and
automotive industries.
automotive industries.
ƒ
ƒ They
They’
’re now being used in Healthcare and
re now being used in Healthcare and
other service industries.
other service industries.

ƒ
ƒ 1999 Institute of Medicine (IOM) report,
1999 Institute of Medicine (IOM) report, “
“To Err is
To Err is
Human: Building a Safer Health System.
Human: Building a Safer Health System.”
”
ƒ
ƒ The report urged health organization to reduce
The report urged health organization to reduce
medical errors by 50% over the following 5 years
medical errors by 50% over the following 5 years
through changes to healthcare systems
through changes to healthcare systems
ƒ
ƒ The report stated that most medical errors do not
The report stated that most medical errors do not
result from
result from “
“individual recklessness
individual recklessness”
” but instead
but instead
from
from “
“basic flaws
basic flaws”
” in the way the healthcare
in the way the healthcare
system is organized
system is organized

Recently, JCAHO (Joint Commission on the
Recently, JCAHO (Joint Commission on the
Accreditation of Healthcare Organizations)
Accreditation of Healthcare Organizations)
added a new requirement for the use of
added a new requirement for the use of
FMEA to reduce risks, improve patient safety,
FMEA to reduce risks, improve patient safety,
and enhance patient satisfaction in high
and enhance patient satisfaction in high-
-risk
risk
processes.
processes.

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

Choosing a Process for
Choosing a Process for
an FMEA Project
an FMEA Project
ƒ
ƒ Sentinel Event Alerts (Published by JCAHO)
Sentinel Event Alerts (Published by JCAHO)
•
• Issue 9
Issue 9 –
– April 9, 1999, Infant Abductions:
April 9, 1999, Infant Abductions:
Preventing Future Occurrences
Preventing Future Occurrences
•
• Past alerts have covered medication
Past alerts have covered medication
abbreviations, wrong
abbreviations, wrong-
-site surgery, delay in
site surgery, delay in
treatment, etc.
treatment, etc.
ƒ
ƒ JCAHO
JCAHO’
’s Patient Safety Goals
s Patient Safety Goals
ƒ
ƒ Other identified high
Other identified high-
-risk processes within the
risk processes within the
hospital
hospital

Choosing Infant Abduction as a
Process for an FMEA Project
ƒ
ƒ According to FBI statistics, 145 cases of
According to FBI statistics, 145 cases of
infant abductions have been documented
infant abductions have been documented
since 1983 (<1 year old, taken by a non
since 1983 (<1 year old, taken by a non-
-
family member), an average of 14 infant
family member), an average of 14 infant
abductions per year since 1987.
abductions per year since 1987. ¹
¹
ƒ
ƒ 83 infants were taken from hospitals, and 62
83 infants were taken from hospitals, and 62
were taken from other locations, such as
were taken from other locations, such as
residences, day
residences, day-
-care centers, and shopping
care centers, and shopping
centers.
centers.¹
¹
¹
¹ FBI
FBI’
’s National Center for Violent Crime (NCAVC) and the National Cen
s National Center for Violent Crime (NCAVC) and the National Center for
ter for
Missing and Exploited Children (NCMEC)
Missing and Exploited Children (NCMEC)

While arguably
While arguably “
“statistically insignificant,
statistically insignificant,”
”
given that there are 4.2 million births per
given that there are 4.2 million births per
year in 3500 birthing centers throughout the
year in 3500 birthing centers throughout the
country
country¹
¹, this crime transcends statistics due
, this crime transcends statistics due
to its highly
to its highly-
-charged nature
charged nature²
²
¹
¹ 7800 births annually at WakeMed (average)
7800 births annually at WakeMed (average)
²
² T. Farley,
T. Farley, “
“Parents Sue City Hospital for $56 Million,
Parents Sue City Hospital for $56 Million,”
” The Daily
The Daily
Oklahoman, March 8, 1991

ƒ
ƒ Infant abductions affect the local community
Infant abductions affect the local community
and beyond:
and beyond:
•
• National news coverage
National news coverage
•
• Adversely affect hospitals via the publicity
Adversely affect hospitals via the publicity
generated and liability concerns. In one
generated and liability concerns. In one
case, an Oklahoma City couple filed a
case, an Oklahoma City couple filed a
$56 million suit against their city hospital
$56 million suit against their city hospital
²
² T. Farley,
T. Farley, “
“Parents Sue City Hospital for $56 Million,
Parents Sue City Hospital for $56 Million,”
” The Daily
The Daily

ƒ
ƒ The need to present their partners with a
The need to present their partners with a
baby often drives the female offender (141 of
baby often drives the female offender (141 of
the 145 cases)
the 145 cases)
•
• Preventing the partner from deserting her
Preventing the partner from deserting her
•
• Salvaging the relationship
Salvaging the relationship
•
• Miscarriage
Miscarriage
•
• Inability to conceive
Inability to conceive¹
¹
¹
¹ L. Ankrm and C. Lent,
L. Ankrm and C. Lent, “
“Cradle Robbers: A Study of the Infant
Cradle Robbers: A Study of the Infant
Abductor,
Abductor,”
” FBI Law Enforcement Bulletin, September 1995.
FBI Law Enforcement Bulletin, September 1995.

ƒ
ƒ Step 1:
Define the FMEA Topic
ƒ
ƒ Step 2: Assemble the Team
ƒ
ƒ Step 3:
Step 3: Review the Process / Create a Process
Review the Process / Create a Process
Flowchart
Flowchart
ƒ
ƒ Step 4:
Step 4: Brainstorm Potential Failure
Brainstorm Potential Failure
Modes,Causes, and Effects
Modes,Causes, and Effects

ƒ
ƒ Step 5: Evaluate the Risk of Failure, or Hazard
Step 5: Evaluate the Risk of Failure, or Hazard
Score
Score
ƒ
ƒ Step 6: Calculate the Total Risk Priority Number
Step 6: Calculate the Total Risk Priority Number
Score
Score
ƒ
ƒ Step 7:
Step 7: Create an Action Plan
Create an Action Plan
ƒ
ƒ Step 8: Determine FMEA Project Success
Step 8: Determine FMEA Project Success

“
“Minimize the potential for Infant
Minimize the potential for Infant
Abduction at WakeMed
Abduction at WakeMed’
’s
s
Western Wake Campus
Western Wake Campus”
”

FMEA Team Members:
FMEA Team Members:
Todd Reichert
Todd Reichert FMEA Team Leader, Performance Improvement
FMEA Team Leader, Performance Improvement
Monica Blochowiak Nurse Manager, WW Women
Monica Blochowiak Nurse Manager, WW Women’
’s Pavilion
s Pavilion
Michael Prince
Michael Prince Supervisor, WW Public Safety
Supervisor, WW Public Safety
Barbara Werner
Barbara Werner Supervisor, WW Women
Supervisor, WW Women’
’s Pavilion
s Pavilion
Cheryl Baker
Cheryl Baker Supervisor, WW NICU
Supervisor, WW NICU
Sara Owens
Sara Owens Staff Nurse, WW Special Care Nursery
Staff Nurse, WW Special Care Nursery
Michael Baker
Michael Baker Supervisor, Engineering, WW
Supervisor, Engineering, WW

Develop a flowchart of the existing
Develop a flowchart of the existing
process, listing all process steps
process, listing all process steps

(Rev. 6/5/03)
Western Wake
Process Flow Diagram
WPBP - Mainitaining Infant Security
Mother Admitted into
Labor and Delivery
Unit
Start
Baby Born
(ID Band Only)
Special
Care
Needs?
Move to
Special Care
Nursery
(SCN)
Yes
No
F
Computer Info
Deleted & HUGS
Band Removed
(Locked Unit)
1
2
13
A B
Infant
Infant
Security
Security
Process
Process
Flowchart
Flowchart

Infant Security
Precautions
Discussed with Mom,
Family, Visitors
Wash
Baby
?
Baby
Washed
A
Yes
No
Baby
Leaves Special Care
Nursery
(SCN)
Discharge
?
No, Newborn
Nursery
or Post-
Partum
End
Yes
3
4
14
B
C
C
Infant
Infant
Security
Security
Process
Process
Flowchart
Flowchart

Apply HUGS Band
Enter Info into
Computer System
Space
Available in
Post Partum
?
Delay, until
space is
available
Move to
Post Partum
No
Yes
Problem: Sometimes HUGS bands
aren't applied until reaching Post Partum
D
C
5
6
Infant
Infant
Security
Security
Process
Process
Flowchart
Flowchart

Reviewed w/ Mom
+
Visual Check of
Bands - Mom & Baby
D
Bands Checked and
Tightened as
Necessary Each Shift
Charge Nurse Checks
Computer Records
(against census?)
Each Shift
Corrections made,
Bands Located as
necessary
Baby
Removed
From
Room? No
Yes
7
8
9
E
Infant
Infant
Security
Security
Process
Process
Flowchart
Flowchart

ID Band Checked and
Verified, HUGS Tag
Presence Checked
Begin Discharge
Process
Check Band
Remove Info from
Computer System
Remove HUGS Band
End
Special
Care Needs
?
F
Yes
10
11
To Be
Discharged
?
Move to Circ., Nursery,
etc.
Return to Postpartum
Check ID Band, Return
baby to Mom
Yes
No
12
E
No
Infant
Infant
Security
Security
Process
Process
Flowchart
Flowchart

Modes, Causes, and Effects
At this step, we want to identify what
At this step, we want to identify what “
“could
could”¹
”¹
go wrong at each of the process steps,
go wrong at each of the process steps, “
“why it
why it
might happen,
might happen,”
” the causes of those failures,
the causes of those failures,
and the effects of those failures.
and the effects of those failures.
¹
¹ These are referred to as
These are referred to as “
“Failure Modes
Failure Modes”
”

Step Failure Mode Cause of Failure Effect of Failure
1 N/A ----- -----
2 Child not banded
Not in Policies & Procedures,
Not in Standard of Care,
Not Emphasized,
Not Understood No HUGS Protection
3 Insufficient IS info provided to mom
Forgetfulness,
Training Issues,
Not Assuming Responsibility
Mom Doesn't know Infant
3 Mom not paying attention Not the Best Time for Mom
3 Info not understood Cultural/Language Barriers
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

5
Info not entered into computer
system, including name/room# Room # Changed, ?
Delayed Response to
HUGS Alarm
5
Delay in entering info into computer
system Workload issues
Delayed Response to
HUGS Alarm
5 "Unfounded" Alarms
Too Close to Sensor(s),
Baby Kicking,
Family Tampering w / HUGS
Tag Staff Desensitization
5 Alarm ringing - doors not locking
Mechanical Failure, Fire
Alarm, Door
Open During Alarm Compromised IS Protection

6
HUGS band not applied until
reaching post partum (sometimes)
SCN Transfer,
Not in "Standard of Care,"
(See FM #2) No HUGS Protection
7 Bands loosening
Diminished Sw elling of
Infant's Limb HUGS Band may Fall Off
8
Bands not checked and/or
tightened properly
Not Emphasized,
Workload Issues
HUGS Band may Fall Off,
or may already have fallen
off
9 Not checked against census
Not on Charge Nurse Flow
Sheet,
Know ledge Issue,
Workload Issue
Erroneous Computer
Records,
Delayed Response to
HUGS Alarm
9 Transferred rooms, not updated Line of Responsibility Unclear
Erroneous Computer
Records,
Delayed Response to
HUGS Alarm

10
HUGS band may not be checked
w hen moving to nursery, other, for
blood draw s, circ., etc.
Not Emphasized,
Workload Issues,
Training Issues,
Nurse may perform ID Check
Only
Possible Lack of HUGS
Protection
11, 12, 13 N/A ----- -----
14
Leaving SCN other than for
discharge w /o HUGS band (may
include family room visiting)
"Not Part of Routine,"
Limited Staff to Cover SCN -
"Can't leave," No
Computer/No HUGS
Bands/Supplies Lack of HUGS Protection
misc. Side door not reactivating properly
misc.
Other entrance issues related to
cameras and other security
features

Step 5
Step 5 Evaluate the Risk of Failure, or
Evaluate the Risk of Failure, or
Hazard Score
Hazard Score
ƒ
ƒ The relative risk of a failure and its effects is
The relative risk of a failure and its effects is
composed of three factors in an FMEA: Severity,
composed of three factors in an FMEA: Severity,
Probability of Occurrence
Probability of Occurrence, and Detection Capability
, and Detection Capability
–
– The
The “
“severity
severity”
” is the
is the consequence
consequence of the failure
of the failure
should it occur
should it occur
–
– The
The “
“probability of occurrence
probability of occurrence”
” is the
is the likelihood
likelihood of
of
a failure mode occurring
a failure mode occurring
–
– The
The “
“detection rating
detection rating”
” is our
is our ability to catch
ability to catch the
the
error before causing patient harm
error before causing patient harm

S E V E R I T Y R A T I N G S C A L E
R a t i n g D e s c r i p t i o n D e f i n i t i o n
1 0
E x t r e m e l y
d a n g e r o u s
F a i lu 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 is it o r , e m p lo y e e ,
s t a f f 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 t o 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 in g .
9
8
V e r y d a n g e r o u s F a i lu 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 in ju 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 in t e r r u p t io n in s e r v ic e , w it h p r io r w a r n in g .
7
D a n g e r o u s
F a i lu r e c a u s e s m in o r t o m o d e r a t e in ju r y w it h a h ig 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 le m s r e q u ir in g m a jo r
r e p a ir s o r s ig n i f ic a n t r e - w o r k .
6
5
M o d e r a t e d a n g e r
F a i lu r e c a u s e s m in o r in ju r y w it h s o m e 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 le m s .
4
3
L o w t o
M o d e r a t e d a n g e r
F a i lu 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 in m in 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 in o r
m o d if ic a t io n s t o s y s t e m o r p r o c e s s .
2
S lig h t d a n g e r
F a i lu r e c a u s e s n o in ju 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 fo r m in o r in ju r y e x is t s ; l it t le o r n o e f f e c t o n s y s t e m .
1 N o d a n g e r F a i lu 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 .
A d a p t e 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 t i v it y , I n c . C o p y r i g h t 1 9 9 6 R e s o u r c e E n g i n e e r i n g , I n c . ; G o o d m a n , S . L . ,
D e s i g 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 t r i e 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 t u 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 l i t y , 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 t s A n a l y s is , A u t o m o t i v e I n d u s t r y A c t i o n G r o u p , 1 9 9 3 .

O C C U R R E N C E R A T I N G S C A L E
R a t i n g D e s c r ip t i o n P o t e n t ia l F a il u r e R a t e
1 0 C e r t a in p r o b a b ilit y o f o c c u r r e n c e
F a ilu r e o c c u r s a t le a s t o n c e a d a y ; o r , fa ilu r e o c c u rs
a lm o s t e v e r y t im e .
9 F a ilu r e is a lm o s t in e v it a b le
F a ilu r e o c c u r s p r e d ic t a b ly ; o r , fa ilu r e o c c u r s e v e r y 3 o r 4
d a y s .
8
7
V e r y h ig h p r o b a b ilit y o f
o c c u r r e n c e
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
p e r w e e k .
6
5
M o d e r a t e ly h ig h p r o b a b ilit y o f
o c c u r r e n c e
F a ilu 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 ro b a b ilit y o f
o c c u r r e n c e
F a ilu r e o c c u r s o c c a s io n a lly ; o r , fa ilu r e o n c e e v e r y 3
m o n t h s .
2 L o w p ro b a b ilit 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
y e a r .
1
R e m o t e p ro b a b ilit y o f
o c c u r r e n c e
F a ilu r e a lm 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 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 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 I O N R A T I N G S C A L E
R a t i n g D e s c r i p t i o n D e f i n i t i o n
1 0
N o c h a n c e o f
d e t e c t i o n
T h e r e i s n o k n o w n m e c h a n i s m f o r d e t e c t i n g t h e f a i l u r e .
9
8
V e r y
R e m o t e / U n r e l i a b l e
T h e f a i l u r e c a n b e d e t e c t e d o n l y w i t h t h o r o u g h i n s p e c t i o n a n d t h i s
i s n o t f e a s i b l e o r c a n n o t b e r e a d i l y d o n e .
7
6
R e m o t e
T h e e r r o r c a n b e d e t e c t e d w i t h m a n u a l i n s p e c t i o n b u t n o p r o c e s s
i s i n p l a c e s o t h a t d e t e c t i o n l e f t t o c h a n c e .
5
M o d e r a t e c h a n c e o f
d e t e c t i o n
T h e r e i s a p r o c e s s f o r d o u b l e - c h e c k s o r i n s p e c t i o n b u t i t n o t
a u t o m a t e d a n d / o r i s a p p l i e d o n l y t o a s a m p l e a n d / o r r e l i e s o n
v i g i l a n c e .
4
3
H i g h
T h e r e i s 1 0 0 % i n s p e c t i o n o r r e v i e w o f t h e p r o c e s s b u t i t i s n o t
a u t o m a t e d .
2 V e r y H i g h
T h e r e i s 1 0 0 % i n s p e c t i o n o f t h e p r o c e s s a n d i t i s a u t o m a t e d .
1 A l m o s t c e r t a i n T h e r e a r e a u t o m a t i c “ s h u t - o f f s ” o r c o n s t r a i n t s t h a t p r e v e n t f a i l u r e .
A d a p t e d f r o m : T h e B a s i c s o f F M E A , P r o d u c t i v i t y , I n c . C o p y r i g h t 1 9 9 6 R e s o u r c e E n g i n e e r i n g , I n c . ;
G o o d m a n , S . L . , D e s i g n f o r M a n u f a c t u r a b i l i t y a t M i d w e s t I n d u s t r i e 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 t u r e ; W h e e l w r i g h t , S . C . ; C l a 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 l i t y , T h e F r e e P r e s s .

Calculating the RPN
Calculating the RPN
R
Risk
isk P
Priority
riority N
Number =
umber =
Scores are 1
Scores are 1-
-10;
10;
The resulting number is 1
The resulting number is 1-
-1000
1000
(Minor problem: RPN <= 100)
(Minor problem: RPN <= 100)

Step 5
Step 5 Evaluate the Risk of Failure,
Evaluate the Risk of Failure,
or Hazard Score
or Hazard Score
Step Failure Mode
Frequency
of Failure
Degree of
Severity
Chance of
Detection
Risk
Priority #
1 N/A ----- ----- ----- -----
2 Child not banded 7 10 5 350
3 Insufficient IS info provided to mom 4 5 8 160
3 Mom not paying attention 8 5 8 320
3 Info not understood 2 5 8 80
4
prior to w ashing 9 10 3 270

Step 5
or Hazard Score
or Hazard Score
Step Failure Mode
Frequency
of Failure
Degree of
Severity
Chance of
Detection
Risk
Priority #
5
system, including name/room# 8 10 5 400
5
system 4 10 5 200
5 "Unfounded" Alarms 3 10 10 300
5 Alarm ringing - doors not locking 2 10 10 200

Step 5
or Hazard Score
or Hazard Score
Step Failure Mode
Frequency
of Failure
Degree of
Severity
Chance of
Detection
Risk
Priority #
6
reaching post partum (sometimes) 5 10 2 100
7 Bands loosening 9 8 6 432
8
tightened properly 3 8 8 192
9 Not checked against census 8 7 7 392
9 Transferred rooms, not updated 7 7 7 343

Step 5
or Hazard Score
or Hazard Score
Step Failure Mode
Frequency
of Failure
Degree of
Severity
Chance of
Detection
Risk
Priority #
10
blood draw s, circ., etc. 7 5 3 105
11, 12, 13 N/A ----- ----- ----- -----
14
include family room visiting) 5 8 8 320
misc.
features
4164
Total RPN (Baseline)

Calculating the RPN
Calculating the RPN
ƒ
ƒ In our example,
In our example, “
“Child not banded (in
Child not banded (in
L&D)
L&D)”
”:
:
Severity of the potential effects was rated a
Severity of the potential effects was rated a “
“10
10”
”
(Highest Severity)
(Highest Severity)
Probability was rated a
Probability was rated a “
“7
7”
” (High)
(High)
Detection was rated a
Detection was rated a “
“5
5”
” (Moderate)
(Moderate)
RPN for this failure mode: 10x7x5 = 350 (High)
RPN for this failure mode: 10x7x5 = 350 (High)

Prioritized Failure Mode RPN Scores
Prioritized Failure Mode RPN Scores
Step Failure Mode
Risk Priority #
(Before)
7 Bands loosening 432
5 Info not entered into computer system, including name/room# 400
9 Not checked against census 392
2 Child not banded 350
9 Transferred rooms, not updated 343
3 Mom not paying attention 320
14
Leaving SCN other than for discharge w/o HUGS band (may
include family room visiting) 320
5 "Unfounded" Alarms 300
4 Baby may not be HUGS banded prior to washing 270
5 Delay in entering info into computer system 200
5 Alarm ringing - doors not locking 200
8 Bands not checked and/or tightened properly 192
3 Insufficient IS info provided to mom 160
10
HUGS band may not be checked when moving to nursery, other,
for blood draws, circ., etc. 105
6 HUGS band not applied until reaching post partum (sometimes) 100
3 Info not understood 80
misc.
Other entrance issues related to cameras and other security
features
4164

Add the totals of all RPN scores to
Add the totals of all RPN scores to
get a grand total
get a grand total
4,164 in this example
4,164 in this example

Step 7 Determine an Action Plan
Step 7 Determine an Action Plan
ƒ
ƒ Identify the failure modes that have an RPN
Identify the failure modes that have an RPN
Score of 100 or higher. These are the items
Score of 100 or higher. These are the items
requiring the greatest attention.
requiring the greatest attention.
ƒ
ƒ Develop an action plan to address each of
Develop an action plan to address each of
these high
these high-
-hazard score failure modes. The
hazard score failure modes. The
action plan should include who, what, when,
action plan should include who, what, when,
why, etc.
why, etc.

ƒ
ƒ Policy Update
Policy Update: All normal newborns will be banded
: All normal newborns will be banded
ASAP, do not wait for bathing to be completed.
ASAP, do not wait for bathing to be completed.
ƒ
ƒ Policy Update
Policy Update: L&D Nurse will obtain the HUGS Band
: L&D Nurse will obtain the HUGS Band
and Patient ID Bands simultaneously.
and Patient ID Bands simultaneously.
ƒ
ƒ Policy Update
Policy Update: Transferring & Receiving Nurse will
: Transferring & Receiving Nurse will
confirm patient ID & HUGS band, documenting this
confirm patient ID & HUGS band, documenting this
info on the Post Partum flow sheet.
info on the Post Partum flow sheet.

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

ƒ
ƒ Checklists
Checklists:
: Create infant security & safety
Create infant security & safety
sheet to be shared with mom in L&D, and
sheet to be shared with mom in L&D, and
signed by mom (in Spanish also? Include
signed by mom (in Spanish also? Include
pictures for universal understanding?) Obtain
pictures for universal understanding?) Obtain
approval by Forms Committee and Risk
approval by Forms Committee and Risk
Management.
Management.
ƒ
ƒ Checklists
Checklists:
: Create checklist/script for
Create checklist/script for
education of patient & SO (significant other)
education of patient & SO (significant other)
by staff re: doors, sensors, band tightness,
by staff re: doors, sensors, band tightness,
band tampering, etc.
band tampering, etc.

ƒ
ƒ Alarms
Alarms: Conduct Quarterly Code Pink Drills (as per
: Conduct Quarterly Code Pink Drills (as per
policy.)
policy.)
ƒ
ƒ HUGS System
HUGS System:
: Ask HUGS representative about
Ask HUGS representative about
other band options to deal with ankle swelling
other band options to deal with ankle swelling
reduction & chafing concerns.
reduction & chafing concerns.

ƒ
ƒ HUGS System
HUGS System: Ask HUGS rep. if pre
: Ask HUGS rep. if pre-
-printed
printed
instructions are available.
instructions are available.
ƒ
ƒ Checklists
Checklists:
: Add “HUGS band check/tightening” to
Add “HUGS band check/tightening” to
the Nurse Assessment flowsheet & educate staff.
the Nurse Assessment flowsheet & educate staff.

ƒ
ƒ Policy Update
Policy Update: Post Partum Nurse to check HUGS
: Post Partum Nurse to check HUGS
band presence before accepting infant, otherwise
band presence before accepting infant, otherwise
infant is to be returned for tagging.
infant is to be returned for tagging.
ƒ
ƒ Policy Update
Policy Update:
: All infants leaving the SCN (except for
All infants leaving the SCN (except for
direct discharge) must be immediately HUGS
direct discharge) must be immediately HUGS
banded. Update questionnaire / audit form.
banded. Update questionnaire / audit form.
ƒ
ƒ Training
Training:
: Conduct HUGS system refresher for SCN
Conduct HUGS system refresher for SCN
Nurses.
Nurses.

ƒ
ƒ Security
Security:
: Have supplier check/repair Physician &
Have supplier check/repair Physician &
Employee entrance to ensure proper reactivation
Employee entrance to ensure proper reactivation
after door closes.
after door closes.
ƒ
ƒ Security
Security: Budget for, and provide additional security
: Budget for, and provide additional security
cameras and other security features around area
cameras and other security features around area
perimeters.
perimeters.

Step 8
Determine FMEA Project Success
ƒ
ƒ Recalculate the RPN scores after
Recalculate the RPN scores after
implementing the action plan
implementing the action plan
ƒ
ƒ Compare with the first FMEA analysis
Compare with the first FMEA analysis
ƒ
ƒ Address any items with a recalculated RPN
Address any items with a recalculated RPN
Score of 100 or higher
Score of 100 or higher

Step Failure Mode
Frequency
of Failure
Degree of
Severity
Chance of
Detection
Risk
Priority #
Frequency
of Failure
Degree of
Severity
Chance of
Detection
Risk
Priority #
1 N/A ----- ----- ----- ----- ----- ----- ----- -----
2 Child not banded 7 10 5 350 3 10 2 60
3 Insufficient IS info provided to mom 4 5 8 160 2 5 4 40
3 Mom not paying attention 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
After Implementing Action Plan
Before Implementing Action Plan

Step Failure Mode
Frequency
of Failure
Degree of
Severity
Chance of
Detection
Risk
Priority #
Frequency
of Failure
Degree of
Severity
Chance of
Detection
Risk
Priority #
5
system, including name/room# 8 10 5 400 5 10 3 150
5
system 4 10 5 200 3 10 3 90
5 "Unfounded" Alarms 3 10 10 300 2 10 10 200
5 Alarm ringing - doors not locking 2 10 10 200 2 10 8 160
Before Implementing Action Plan After Implementing Action Plan

Step 8
Step Failure Mode
Frequency
of Failure
Degree of
Severity
Chance of
Detection
Risk
Priority #
Frequency
of Failure
Degree of
Severity
Chance of
Detection
Risk
Priority #
6
reaching post partum (sometimes) 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 Not checked against census 8 7 7 392 4 7 4 112
9 Transferred rooms, not updated 7 7 7 343 2 7 2 28

Step 8
Step Failure Mode
Frequency
of Failure
Degree of
Severity
Chance of
Detection
Risk
Priority #
Frequency
of Failure
Degree of
Severity
Chance of
Detection
Risk
Priority #
10
blood draw s, circ., etc. 7 5 3 105 4 5 3 60
11, 12, 13 N/A ----- ----- ----- ----- ----- ----- ----- -----
14
include family room visiting) 5 8 8 320 1 8 3 24
misc.
features
4164 1372
67.05%
Percent Improvement
Total RPN (Baseline) Total RPN (After)

Lessons Learned
Lessons Learned
„
„ FMEA can be a time consuming process
FMEA can be a time consuming process
„
„ Be sure to obtain management support
Be sure to obtain management support
„
„ Keep the team motivated
Keep the team motivated
„
„ The results are worthwhile
The results are worthwhile

In Conclusion
In Conclusion
„
„ FMEA is a tool for proactive risk assessment now
FMEA is a tool for proactive risk assessment now
used in healthcare
used in healthcare
„
„ Infant Security was chosen as the 2003 FMEA
Infant Security was chosen as the 2003 FMEA
project because of the high volume of births in the
project because of the high volume of births in the
WakeMed system (approx. 7800 births/year) and
WakeMed system (approx. 7800 births/year) and
the significance of this issue.
the significance of this issue.
„
„ Significant reductions in scored risk have been
Significant reductions in scored risk have been
realized through the use of this tool
realized through the use of this tool

References:
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:
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

Applying FMEA to Prevent Infant Abduction

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