FMEA (19) - Unlocked

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

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
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.

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
Start Process Flow Diagram
WPBP - Mainitaining Infant Security
Mother Admitted into

1 Labor and Delivery
Unit
F
2 Baby Born
Computer Info
(ID Band Only)
Deleted & HUGS
Band Removed
13
Special Yes Move to

Care Special Care (Locked Unit)
Needs? Nursery
(SCN)
No
A B

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

C
Apply HUG S Band

5
Enter Info into
Com puter System
Space Delay, until

Available in No space is
Post Partum available
?
Yes
6 M ove to Problem : Som etim es HUG S bands

Post Partum aren't applied until reaching Post Partum

D
7 Security Precautions
Reviewed w/ Mom
+
Visual Check of
Bands - Mom & Baby
Bands Checked and

8 Tightened as
Necessary Each Shift
Charge Nurse Checks

Computer Records
(against census?)
9 Each Shift
Corrections made,
Bands Located as
necessary
Baby
Removed
From
Room? No
Yes

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

12 Computer System Check ID Band, Return
baby to Mom
Remove HUGS Band
End

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
Failure could cause death of a customer (patient, visitor, employee,

Extremely
staff member, business partner) and/or total system breakdown,
10 dangerous
without any prior warning.
9
Very dangerous Failure could cause major or permanent injury and/or serious system
8
disruption with interruption in service, with prior warning.
Failure causes minor to moderate injury with a high degree of

Dangerous customer dissatisfaction and/or major system problems requiring major
7 repairs or significant re-work.
6 Failure causes minor injury with some customer dissatisfaction and/or

Moderate danger
5 major system problems.
Failure causes very minor or no injury but annoys customers and/or

4 Low to
results in minor system problems that can be overcome with minor
3 Moderate danger
modifications to system or process.
Failure causes no injury and customer is unaware of problem however

Slight danger
2 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 RATING SCALE
Rating Description Potential Failure Rate
Failure occurs at least once a day; or, failure occurs

10 Certain probability of occurrence
almost every time.
Failure occurs predictably; or, failure occurs every 3 or 4

9 Failure is almost inevitable
days.
8 Very high probability of Failure occurs frequently; or failure occurs about once
7 occurrence per week.
6 Moderately high probability of

Failure occurs about once per month.
5 occurrence
4 Moderate probability of Failure occurs occasionally; or, failure once every 3

3 occurrence months.
Failure occurs rarely; or, failure occurs about once per

2 Low probability of occurrence
year.
Remote probability of Failure almost never occurs; no one remembers last

1
occurrence 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.

DETECTION RATING SCALE
Rating Description Definition
No chance of
10 There is no known mechanism for detecting the failure.
detection
9 Very The failure can be detected only with thorough inspection and this
8 Remote/Unreliable is not feasible or cannot be readily done.
7 The error can be detected with manual inspection but no process

Remote
6 is in place so that detection left to chance.
There is a process for double-checks or inspection but it not

Moderate chance of
5 automated and/or is applied only to a sample and/or relies on
detection
vigilance.
4 There is 100% inspection or review of the process but it is not

High
3 automated.
There is 100% inspection of the process and it is automated.

2 Very High
1 Almost certain 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.

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
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 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.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)
• Preventing the partner from deserting her

• Salvaging the relationship
• Miscarriage
• Inability to conceive¹
¹ L. Ankrm and C. Lent, “Cradle Robbers: A Study of the Infant

Abductor,” FBI Law Enforcement Bulletin, September 1995.
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

“Minimize the potential for Infant

Abduction at WakeMed’s
Western Wake Campus”
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
(Rev. 6/5/03)
Western Wake Infant
Start Process Flow Diagram
WPBP - Mainitaining Infant Security Security
Process
Mother Admitted into
Flowchart
1 Labor and Delivery
Unit
F
2 Baby Born
Computer Info
(ID Band Only)
Deleted & HUGS
Band Removed
13
Special Yes Move to

Care Special Care (Locked Unit)
Needs? Nursery
(SCN)
No
A B
B Infant
A
Security
Process
14 Baby
Leaves Special Care
Flowchart
Nursery
(SCN)
3
Infant Security
Precautions
Discussed with Mom,
Family, Visitors Discharge Yes End
?
No, Newborn
Nursery
or Post-
4 Partum
Wash Yes Baby
Baby Washed
C
?
No
C
C Infant
Security
5
Apply HUGS Band Process
Enter Info into
Computer System Flowchart
Space Delay, until

Available in No space is
Post Partum available
?
Yes
6 Move to Problem: Sometimes HUGS bands

Post Partum aren't applied until reaching Post Partum
D
D
Infant
7 Security Precautions Security
Reviewed w/ Mom
+ Process
Visual Check of
Bands - Mom & Baby Flowchart
Bands Checked and
8 Tightened as
Necessary Each Shift
Charge Nurse Checks

Computer Records
(against census?)
9 Each Shift
Corrections made,
Bands Located as
necessary
Baby
Removed
From
Room? No
Yes
E
E
Infant
Security
Special
Care Needs
Yes
F Process
?
Flowchart
No
ID Band Checked and
Verified, HUGS Tag
10
Presence Checked
To Be
No Move to Circ., Nursery,
Discharged
etc.
?
Yes
Begin Discharge
Process Return to Postpartum
11
Check Band
Remove Info from

12 Computer System Check ID Band, Return
baby to Mom
Remove HUGS Band
End
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 Failure Mode Cause of Failure Effect of Failure

1 N/A ----- -----
Not in Policies & Procedures,

Not in Standard of Care,
Not Emphasized,
2 Child not banded Not Understood No HUGS Protection
Forgetfulness,
Training Issues, Mom Doesn't know Infant
3 Insufficient IS info provided to mom Not Assuming Responsibility Security Precautions
Mom Doesn't know Infant
3 Mom not paying attention Not the Best Time for Mom Security Precautions
Mom Doesn't know Infant
3 Info not understood Cultural/Language Barriers Security Precautions
Baby may not be HUGS banded Caregiver Know ledge Deficit Baby may be Moved w /o
4 prior to w ashing about New System HUGS Protection

Info not entered into computer Delayed Response to
5 system, including name/room# Room # Changed, ? HUGS Alarm
Delay in entering info into computer Delayed Response to
5 system Workload issues HUGS Alarm
Too Close to Sensor(s),

Baby Kicking,
Family Tampering w / HUGS
5 "Unfounded" Alarms Tag Staff Desensitization
Mechanical Failure, Fire

Alarm, Door
5 Alarm ringing - doors not locking Open During Alarm Compromised IS Protection

SCN Transfer,
HUGS band not applied until Not in "Standard of Care,"
6 reaching post partum (sometimes) (See FM #2) No HUGS Protection
Diminished Sw elling of
7 Bands loosening Infant's Limb HUGS Band may Fall Off
HUGS Band may Fall Off,
Bands not checked and/or Not Emphasized, or may already have fallen
8 tightened properly Workload Issues off
Not on Charge Nurse Flow Erroneous Computer
Sheet, Records,
Know ledge Issue, Delayed Response to
9 Not checked against census Workload Issue HUGS Alarm
Erroneous Computer
Records,
Delayed Response to
9 Transferred rooms, not updated Line of Responsibility Unclear HUGS Alarm
Not Emphasized,
Workload Issues,
HUGS band may not be checked Training Issues,
w hen moving to nursery, other, for Nurse may perform ID Check Possible Lack of HUGS
10 blood draw s, circ., etc. Only Protection
11, 12, 13 N/A ----- -----
"Not Part of Routine,"
Limited Staff to Cover SCN -
Leaving SCN other than for "Can't leave," No
discharge w /o HUGS band (may Computer/No HUGS
14 include family room visiting) Bands/Supplies Lack of HUGS Protection
misc. Side door not reactivating properly

Other entrance issues related to
cameras and other security
misc. features
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
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 ,
E x tre m e ly
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 ,
10 d ang ero u s
w it h o u t a n y p r io r w a r n i n g .
9
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
8
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 .
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
D ang ero u s 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
7 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 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 o d erate d ang er
5 m a jo r s y s t e m p r o b le m s .
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
4 L o w to
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
3 M o d erate d ang er
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 .
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
S lig h t d a n g e r
2 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 .
1 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 .
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
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
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
a lm o s t e v e r y t im 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
9 F a i l u r e is a l m o s t i n e v it a b l e
d a ys.
8 V e r y h i g h p r o b a b i l it y o f 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
7 o ccu rrence per w eek.
6 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
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 .
5 o ccu rrence
4 M o d e r a t e p r o b a b i l it y o f 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
3 o ccu rrence m o nths.
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
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
year.
R e m o t e p r o b a b i l it y o f 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
1
o ccu rrence 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
N o chance o f
1 0 T h e r e is n o k n o w n m e c h a n is m fo r d e t e c t in g t h e fa ilu r e .
d e t e c t io n
9 V ery 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
8 R e m o t e /U n r e lia b le 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 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
R e m o te
6 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 .
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
M o d e rate c h a n c e o f
5 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
d e t e c t io n
v ig ila n c e .
4 T h e r e is 1 0 0 % 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
H ig h
3 a u to m a te d .
T h e r e is 1 0 0 % 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 .
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 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 Evaluate the Risk of Failure,
or Hazard Score
Frequency Degree of Chance of Risk

Step Failure Mode 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 Mom not paying attention 8 5 8 320
3 Info not understood 2 5 8 80
Baby may not be HUGS banded

4 prior to w ashing 9 10 3 270
or Hazard Score

Info not entered into computer
5 system, including name/room# 8 10 5 400
Delay in entering info into computer
5 system 4 10 5 200
5 "Unfounded" Alarms 3 10 10 300
5 Alarm ringing - doors not locking 2 10 10 200

or Hazard Score
HUGS band not applied until

6 reaching post partum (sometimes) 5 10 2 100
7 Bands loosening 9 8 6 432
Bands not checked and/or

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

or Hazard Score
HUGS band may not be checked

w hen moving to nursery, other, for
10 blood draw s, circ., etc. 7 5 3 105
11, 12, 13 N/A ----- ----- ----- -----
Leaving SCN other than for

discharge w /o HUGS band (may
14 include family room visiting) 5 8 8 320

misc. features
Total RPN (Baseline) 4164
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
Risk Priority #
Step Failure Mode (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
Leaving SCN other than for discharge w/o HUGS band (may
14 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
HUGS band may not be checked when moving to nursery, other,
10 for blood draws, circ., etc. 105
6 HUGS band not applied until reaching post partum (sometimes) 100
3 Info not understood 80

Other entrance issues related to cameras and other security
misc. 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 After Implementing Action Plan
Frequency Degree of Chance of Risk Frequency Degree of Chance of Risk

Step Failure Mode of Failure Severity Detection Priority # of Failure Severity Detection 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
Baby may not be HUGS banded

4 prior to w ashing 9 10 3 270 1 10 2 20

Info not entered into computer
5 system, including name/room# 8 10 5 400 5 10 3 150
Delay in entering info into computer
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


HUGS band not applied until

6 reaching post partum (sometimes) 5 10 2 100 1 10 2 20
7 Bands loosening 9 8 6 432 5 8 3 120
Bands not checked and/or

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


HUGS band may not be checked

w hen moving to nursery, other, for
10 blood draw s, circ., etc. 7 5 3 105 4 5 3 60
11, 12, 13 N/A ----- ----- ----- ----- ----- ----- ----- -----
Leaving SCN other than for

discharge w /o HUGS band (may
14 include family room visiting) 5 8 8 320 1 8 3 24

misc. features
Total RPN (Baseline) 4164 Total RPN (After) 1372
Percent Improvement 67.05%
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

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Applying Failure Modes and Effects

Analysis (FMEA) in Healthcare

Preventing Infant Abduction,

2004 Society for Health Systems Presentation

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

“JCAHO Standard LD.5.2 requires facilities to select at least one high-risk

Furthermore, the 1999 Institute of Medicine (IOM) report, “To Err is

Choosing a Process for an FMEA Project

• Sentinel Event Alerts (Past alerts have covered medication

Todd A. Reichert, WakeMed, Raleigh, NC. Page 3 2/2/2004

What Motivates the Perpetrator?

• Preventing the partner from deserting her

Todd A. Reichert, WakeMed, Raleigh, NC. Page 4 2/2/2004

FMEA Project Methodology:

Step 1: Define the FMEA Topic

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

Todd A. Reichert, WakeMed, Raleigh, NC. Page 5 2/2/2004

FMEA Team Members:

WW = Western Wake Campus (WakeMed)

Todd A. Reichert, WakeMed, Raleigh, NC. Page 6 2/2/2004

Mother Admitted into

Special Yes Move to

Todd A. Reichert, WakeMed, Raleigh, NC. Page 7 2/2/2004

Todd A. Reichert, WakeMed, Raleigh, NC. Page 8 2/2/2004

Apply HUG S Band

Space Delay, until

6 M ove to Problem : Som etim es HUG S bands

Todd A. Reichert, WakeMed, Raleigh, NC. Page 9 2/2/2004

Bands Checked and

Charge Nurse Checks

Todd A. Reichert, WakeMed, Raleigh, NC. Page 10 2/2/2004

Remove Info from

Todd A. Reichert, WakeMed, Raleigh, NC. Page 11 2/2/2004

Step 5 Evaluate the Risk of Failure, or

– The “severity” is the consequence of the failure should it occur

– The “probability of occurrence” is the likelihood of a failure mode occurring

Todd A. Reichert, WakeMed, Raleigh, NC. Page 12 2/2/2004

Rating Description Definition

Failure could cause death of a customer (patient, visitor, employee,

Failure causes minor to moderate injury with a high degree of

6 Failure causes minor injury with some customer dissatisfaction and/or

Failure causes very minor or no injury but annoys customers and/or

Failure causes no injury and customer is unaware of problem however

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

Todd A. Reichert, WakeMed, Raleigh, NC. Page 13 2/2/2004

Rating Description Potential Failure Rate

Failure occurs at least once a day; or, failure occurs

Failure occurs predictably; or, failure occurs every 3 or 4

6 Moderately high probability of

4 Moderate probability of Failure occurs occasionally; or, failure once every 3

Failure occurs rarely; or, failure occurs about once per

Remote probability of Failure almost never occurs; no one remembers last

Todd A. Reichert, WakeMed, Raleigh, NC. Page 14 2/2/2004

Rating Description Definition

7 The error can be detected with manual inspection but no process

There is a process for double-checks or inspection but it not

4 There is 100% inspection or review of the process but it is not

There is 100% inspection of the process and it is automated.

Todd A. Reichert, WakeMed, Raleigh, NC. Page 15 2/2/2004

In our example, “Child not banded (in L&D)”:

WakeMed Faculty Physicians Practice

ID what “could” go wrong at each process step?

Since the 1960’s they’ve been used in the

They’re now being used in Healthcare and

1999 Institute of Medicine (IOM) report, “To Err is

The report urged health organization to reduce

The report stated that most medical errors do not

“JCAHO Standard LD.5.2 requires facilities to

Sentinel Event Alerts (Published by JCAHO)

According to FBI statistics, 145 cases of

83 infants were taken from hospitals, and 62

Infant abductions affect the local community

Step 1: Define the FMEA Topic

Step 2: Assemble the Team

Step 3: Review the Process / Create a Process

Step 4: Brainstorm Potential Failure

Step 5: Evaluate the Risk of Failure, or Hazard

Step 6: Calculate the Total Risk Priority Number

Step 7: Create an Action Plan

Step 8: Determine FMEA Project Success