Requestedfile Hfmea Abduction Child

Applying Failure Modes and Effects
Analysis (FMEA) in Healthcare

Preventing Infant Abduction,
A Case Study
2004 Society for Health Systems Presentation

February 20-21, 2004
Todd A. Reichert
WakeMed
3000 New Bern Ave.
Raleigh, NC 27610
Objectives of this document:
Describe the WakeMed Healthcare System

Define FMEA
Explain the use of this tool in healthcare
Describe the FMEA project selection process
Explain the application of the FMEA process to Preventing Infant
Abduction at WakeMed
Report on the results achieved by the project team
Background of WakeMed
WakeMed is a multi-facility health care system consisting of 629 acute care
beds, 515 at New Bern Avenue and 114 at Western Wake Medical Center.
WakeMed employs 5800 employees and is affiliated with UNC Healthcare
through its residency programs.
What is an FMEA?
FMEA (Failure Modes and Effects Analysis) as its applied in Healthcare is a
proactive team-oriented approach to risk reduction that seeks to improve
patient safety by minimizing risk potential in high-risk processes.
Rather than focus on a problem - after its occurrence, FMEA looks at what
could go wrong at each process step, the so-called Failure Modes,
assigns a risk score to each of these possibilities, and provides for a teamoriented approach to focus resources on priority issues. Since the 1960s
theyve been used in the nuclear, military, aviation, food, and automotive
industries, now theyre 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.)
JCAHOs Patient Safety Goals
Other identified high-risk processes within the hospital
Page 3
2/2/2004
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.
83 infants were taken from hospitals and 62 were taken from other locations,
such as residences, day-care centers, and shopping centers.
While arguably statistically insignificant, given that there are 4.2 million
births per year in 3500 birthing centers throughout the country, 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.
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 conceive
T. Farley, Parents Sue City Hospital for $56 Million, The Daily Oklahoman, March 8, 1991
L. Ankrm and C. Lent, Cradle Robbers: A Study of the Infant Abductor, FBI Law Enforcement Bulletin,
September 1995.
Page 4
2/2/2004
Conducting the FMEA

In the pages that follow the FMEA process will be applied to minimizing the
potential for Infant Abduction at WakeMed:
FMEA Project Methodology:
Step 1:
Step 2:
Step 3:
Step 4:
Step 5:
Step 6:
Step 7:
Step 8:
Define the FMEA Topic

Assemble the Team
Review the Process / Create a Process Flowchart
Brainstorm Potential Failure Modes, Causes, and Effects
Evaluate the Risk of Failure, or Hazard Score
Calculate the Total Risk Priority Number Score
Create an Action Plan
Determine FMEA Project Success
Step 1: Define the FMEA Topic

The first step is to clearly define the FMEA topic:
Minimize the potential for Infant Abduction at WakeMeds
Western Wake Campus
Page 5
2/2/2004
Step 2: Assemble the Team

Next, assemble a team of process experts and those that would be involved
in any expected changes to policies, procedures, equipment, or personnel. In
our case, we chose representatives from the Womens Pavilion and
Birthplace, Public Safety, Engineering, and Performance Improvement.
FMEA Team Members:

Todd Reichert
Monica Blochowiak
Blair Creekmore
Michael Prince
Barbara Werner
Cheryl Baker
Sara Owens
Michael Baker
FMEA Team Leader, Performance Improvement

Nurse Manager, WW Womens Pavilion
Staff Nurse, WW Post Partum
Supervisor, WW Public Safety
Supervisor, WW Womens Pavilion
Supervisor, WW NICU
Staff Nurse, WW Special Care Nursery
Supervisor, Engineering, WW
WW = Western Wake Campus (WakeMed)
Page 6
2/2/2004
Step 3: Review the Process

Develop a flowchart of the existing process, listing all process steps. This
will assist in the next step of the FMEA process, when Failure Modes will
be identified.
(Rev. 6/5/03)
Western Wake
Process Flow Diagram
WPBP - Mainitaining Infant Security
Start
Mother Admitted into

Labor and Delivery
Unit
F
Baby Born
(ID Band Only)
Computer Info
Deleted & HUGS
Band Removed
13
Yes
Special
Care
Needs?
Move to
Special Care
Nursery
(SCN)
(Locked Unit)
No
Page 7
2/2/2004
B
A
14
Baby
Leaves Special Care
Nursery
(SCN)
3
Infant Security
Precautions
Discussed with Mom,
Family, Visitors
Wash
Baby
?
Discharge
?
Yes
Baby
Washed
Yes
End
No, Newborn
Nursery
or PostPartum
C
No
Page 8
2/2/2004
Apply HUG S Band

Enter Info into
Com puter System
Space
Available in
Post Partum
?
No
Delay, until
space is
available
Yes
M ove to
Post Partum
Problem : Som etim es HUG S bands

aren't applied until reaching Post Partum
Page 9
2/2/2004
Security Precautions
Reviewed w/ Mom
+
Visual Check of
Bands - Mom & Baby
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
E
Page 10
2/2/2004
Special
Care Needs
?
Yes
No
10
ID Band Checked and

Verified, HUGS Tag
Presence Checked
To Be
Discharged
?
Move to Circ., Nursery,

etc.
No
Yes
Begin Discharge
Process
Return to Postpartum
11
Check Band
12
Remove Info from

Computer System
Check ID Band, Return

baby to Mom
Remove HUGS Band

End
Page 11
2/2/2004
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.
Page 12
2/2/2004
SEVERITY RATING SCALE

Rating
Description
Definition
10
Extremely
dangerous
Failure could cause death of a customer (patient, visitor, employee,

staff member, business partner) and/or total system breakdown,
without any prior warning.
9
8
Very dangerous
Failure could cause major or permanent injury and/or serious system

disruption with interruption in service, with prior warning.
Dangerous
Failure causes minor to moderate injury with a high degree of

customer dissatisfaction and/or major system problems requiring major
repairs or significant re-work.
6
5
Moderate danger
Failure causes minor injury with some customer dissatisfaction and/or

major system problems.
4
3
Low to
Moderate danger
Failure causes very minor or no injury but annoys customers and/or

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

the potential for minor injury exists; little or no effect on system.
No danger
Failure causes no injury and has no impact on system.
2
1
Adapted from: The Basics of FMEA, Productivity, Inc. Copyright 1996 Resource Engineering, Inc.; Goodman, S.L.,
Design for Manufacturability at Midwest Industries, Harvard Business School, February 2, 1996 Lecture;
Wheelwright, S.C.; Clark, K.B., Revolutionizing Product Development: Quantum Leaps in Speed, Efficiency, and
Quality, The Free Press; Potential Failure Modes and Effects Analysis, Automotive Industry Action Group, 1993.
Page 13
2/2/2004
OCCURRENCE RATING SCALE
Rating
Description
Potential Failure Rate
10
Certain probability of occurrence
Failure occurs at least once a day; or, failure occurs

almost every time.
Failure is almost inevitable
Failure occurs predictably; or, failure occurs every 3 or 4

days.
8
7
Very high probability of

occurrence
Failure occurs frequently; or failure occurs about once

per week.
6
5
Moderately high probability of

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

months.
Low probability of occurrence
Failure occurs rarely; or, failure occurs about once per

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

failure.
Adapted from: The Basics of FMEA, Productivity, Inc. Copyright 1996 Resource Engineering, Inc.; Goodman, S.L.,
Design for Manufacturability at Midwest Industries, Harvard Business School, February 2, 1996 Lecture; Wheelwright,
S.C.; Clark, K.B., Revolutionizing Product Development: Quantum Leaps in Speed, Efficiency, and Quality, The Free
Press; Potential Failure Modes and Effects Analysis, Automotive Industry Action Group, 1993.
Page 14
2/2/2004
DETECTION RATING SCALE

Rating
Description
Definition
10
No chance of
detection
There is no known mechanism for detecting the failure.
9
8
Very
Remote/Unreliable
The failure can be detected only with thorough inspection and this
is not feasible or cannot be readily done.
7
6
Remote
The error can be detected with manual inspection but no process

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

automated and/or is applied only to a sample and/or relies on
vigilance.
4
3
High
There is 100% inspection or review of the process but it is not

automated.
Very High
Almost certain
There is 100% inspection of the process and it is automated.
There are automatic shut-offs or constraints that prevent failure.
Adapted from: The Basics of FMEA, Productivity, Inc. Copyright 1996 Resource Engineering, Inc.;
Goodman, S.L., Design for Manufacturability at Midwest Industries, Harvard Business School, February 2,
1996 Lecture; Wheelwright, S.C.; Clark, K.B., Revolutionizing Product Development: Quantum Leaps in
Speed, Efficiency, and Quality, The Free Press.
Page 15
2/2/2004
Calculating the RPN

Risk Priority Number =
Severity x Occurrence x Detectability
Since scores are 1-10, the resultant Risk Priority Number will be from
1-1000. Failure Modes with RPN scores <= 100 are generally considered
minor scores and might not be considered further by the team when an
action plan is created in step 7.
In our example, Child not banded (in L&D):

Severity of the potential effects was rated a 10 (Highest Severity
relative to providing infant security no HUGS protection at this
time)
Probability was rated a 7 (High)
Detection was rated a 5 (Moderate)
Therefore, the RPN for this failure mode is 10x7x5 = 350 (High)
Step 6 Calculate the Total RPN Score

Next, add the totals of all RPN scores for all failure modes to get a grand
total. This creates a baseline for future comparison. In our process, our
score was 4,164 (See the attached FMEA worksheet.)
Note: process scores can only be compared to themselves, not against other
processes, since they may have more or less process steps.
Page 16
2/2/2004
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
Page 17
2/2/2004
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!
Page 18
2/2/2004
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 leaders 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: Authors Edition, PAL Publications, 1998.
The Basics of Healthcare Failure Modes and Effect Analysis,
Videoconference Course, VA National Center for Patient Safety, 2001.
Understanding the Failure Modes and Effects Analysis, an on-line course,
HCProfessor.com, 2002. Phone #: 800-650-6787.
JCAHO, www.jcaho.org, Sentinel Event Alerts, Issue 9 April 9, 1999,
Infant Abductions: Preventing Future Occurrences.
Page 19
2/2/2004
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 1960s theyve been used in the
nuclear, military, aviation, food, and
automotive industries.
Theyre 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.
JCAHOs Patient Safety Goals

Other identified high-risk processes within the
hospital
Choosing Infant Abduction as a

Process for an FMEA Project
According to FBI statistics, 145 cases of
infant abductions have been documented

since 1983 (<1 year old, taken by a nonfamily member), an average of 14 infant
abductions per year since 1987.
83 infants were taken from hospitals, and 62
were taken from other locations, such as

residences, day-care centers, and shopping
centers.
FBIs 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
country, this crime transcends statistics due
to its highly-charged nature
7800 births annually at WakeMed (average)

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
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 conceive
L. Ankrm and C. Lent, Cradle Robbers: A Study of the Infant

Abductor, FBI Law Enforcement Bulletin, September 1995.
Step 1:
Define the FMEA Topic
Step 2:
Assemble the Team
Step 3:
Review the Process / Create a Process

Flowchart
Step 4:
Brainstorm Potential Failure

Modes,Causes, and Effects
Step 5:
Evaluate the Risk of Failure, or Hazard

Score
Step 6:
Calculate the Total Risk Priority Number

Score
Step 7:
Create an Action Plan
Step 8:
Determine FMEA Project Success
Step 1: Define the FMEA Topic

Minimize the potential for Infant
Abduction at WakeMeds
Western Wake Campus
Step 2: Assemble the Team

FMEA Team Members:
Todd Reichert
Monica Blochowiak
Blair Creekmore
Michael Prince
Barbara Werner
Cheryl Baker
Sara Owens
Michael Baker
FMEA Team Leader, Performance Improvement

Nurse Manager, WW Womens Pavilion
Staff Nurse, WW Post Partum
Supervisor, WW Public Safety
Supervisor, WW Womens Pavilion
Supervisor, WW NICU
Staff Nurse, WW Special Care Nursery
Supervisor, Engineering, WW
WW = Western Wake Campus (WakeMed)
Step 3: Review the Process
Develop a flowchart of the existing

process, listing all process steps
(Rev. 6/5/03)
Western Wake
Process Flow Diagram
WPBP - Mainitaining Infant Security
Start
Mother Admitted into

Labor and Delivery
Unit
F
Baby Born
(ID Band Only)
Computer Info
Deleted & HUGS
Band Removed
13
Yes
Special
Care
Needs?
Move to
Special Care
Nursery
(SCN)
No
(Locked Unit)
Infant
Security
Process
Flowchart
Infant
Security
Process
Flowchart
B
A
14
Baby
Leaves Special Care
Nursery
(SCN)
3
Infant Security
Precautions
Discussed with Mom,
Family, Visitors
Wash
Baby
?
No
Discharge
?
Yes
Baby
Washed
Yes
No, Newborn
Nursery
or PostPartum
C
End
Infant
Security
Process
Flowchart
Apply HUGS Band

Enter Info into
Computer System
Space
Available in
Post Partum
?
No
Delay, until
space is
available
Yes
Move to
Post Partum
Problem: Sometimes HUGS bands

aren't applied until reaching Post Partum
Infant
Security
Process
Flowchart
Reviewed w/ Mom
+
Visual Check of
Bands - Mom & Baby
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?
Yes
E
No
Infant
Security
Process
Flowchart
Special
Care Needs
?
Yes
No
10
ID Band Checked and

Verified, HUGS Tag
Presence Checked
To Be
Discharged
?
No
Move to Circ., Nursery,

etc.
Yes
Begin Discharge
Process
Return to Postpartum
11
Check Band
12
Remove Info from

Computer System
Remove HUGS Band
End
Check ID Band, Return

baby to Mom
Step 4: Brainstorm Potential Failure

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

Step
1
Failure Mode
N/A
Cause of Failure
Effect of Failure
-----
-----
Not in Policies & Procedures,

Not in Standard of Care,
Not Emphasized,
Not Understood
Child not banded
No HUGS Protection
Forgetfulness,
Training Issues,
Insufficient IS info provided to mom Not Assuming Responsibility
Mom not paying attention
Not the Best Time for Mom
Info not understood
Cultural/Language Barriers
Mom Doesn't know Infant

Baby may not be HUGS banded

prior to w ashing
Caregiver Know ledge Deficit

about New System
Baby may be Moved w /o

HUGS Protection

Step
5
5
Failure Mode
Cause of Failure
Info not entered into computer

system, including name/room#
Room # Changed, ?
Delay in entering info into computer
system
Workload issues
Effect of Failure
Delayed Response to
HUGS Alarm
Delayed Response to
HUGS Alarm
"Unfounded" Alarms
Too Close to Sensor(s),

Baby Kicking,
Family Tampering w / HUGS
Tag
Alarm ringing - doors not locking
Mechanical Failure,
Fire
Alarm,
Door
Open During Alarm
Compromised IS Protection
Staff Desensitization

Step
Failure Mode
HUGS band not applied until

reaching post partum (sometimes)
Bands loosening
Bands not checked and/or

tightened properly
Not checked against census
Transferred rooms, not updated
Cause of Failure
SCN Transfer,
Not in "Standard of Care,"
(See FM #2)
Diminished Sw elling of
Infant's Limb
Effect of Failure
No HUGS Protection
HUGS Band may Fall Off

HUGS Band may Fall Off,
Not Emphasized,
or may already have fallen
Workload Issues
off
Not on Charge Nurse Flow
Erroneous Computer
Sheet,
Records,
Know ledge Issue,
Delayed Response to
Workload Issue
HUGS Alarm
Erroneous Computer
Records,
Delayed Response to
Line of Responsibility Unclear HUGS Alarm

Step
10
Failure Mode
Not Emphasized,
Workload Issues,
HUGS band may not be checked
Training Issues,
w hen moving to nursery, other, for Nurse may perform ID Check
blood draw s, circ., etc.
Only
11, 12, 13 N/A
14
misc.
misc.
Cause of Failure
Leaving SCN other than for

discharge w /o HUGS band (may
include family room visiting)
Side door not reactivating properly
Other entrance issues related to
cameras and other security
features
----"Not Part of Routine,"

Limited Staff to Cover SCN "Can't leave,"
No
Computer/No HUGS
Bands/Supplies
Effect of Failure
Possible Lack of HUGS

Protection
-----
Lack of HUGS Protection
Step 5
Evaluate the Risk of Failure, or

Hazard Score
The relative risk of a failure and its effects is

composed of three factors in an FMEA: Severity,
Probability of Occurrence, and Detection Capability
The severity is the consequence of the failure
should it occur
The probability of occurrence is the likelihood of
a failure mode occurring
The detection rating is our ability to catch the
error before causing patient harm
S E V E R IT Y R A T IN G S C A L E
R a tin g
D e s c r ip tio n
D e f in itio n
10
E x tre m e ly
d ang ero u s
F a i l u r e c o u ld c a u s e d e a t h o f a c u s t o m e r ( p a t ie n t , v i s it o r , e m p lo y e e ,
s t a ff m e m b e r , b u s in e s s p a r t n e r ) a n d /o r to t a l s y s t e m b r e a k d o w n ,
w it h o u t a n y p r io r w a r n i n g .
9
8
V ery d a ng ero u s
F a i l u r e c o u ld c a u s e m a jo r o r p e r m a n e n t i n j u r y a n d / o r s e r io u s s y s t e m
d is r u p t io n w it h i n t e r r u p t io n i n s e r v i c e , w it h p r io r w a r n i n g .
D ang ero u s
F a i l u r e c a u s e s m i n o r t o m o d e r a t e i n j u r y w it h a h i g h d e g r e e o f
c u s t o m e r d is s a t is f a c t io n a n d / o r m a jo r s y s t e m p r o b l e m s r e q u ir i n g m a jo r
r e p a ir s o r s ig n i f i c a n t r e - w o r k .
6
5
M o d erate d ang er
F a i l u r e c a u s e s m i n o r i n j u r y w it h s o m e c u s t o m e r d i s s a t is f a c t io n a n d / o r
m a jo r s y s t e m p r o b le m s .
4
3
L o w to
M o d erate d ang er
F a ilu r e c a u s e s v e r y m in o r o r n o in ju r y b u t a n n o y s c u s t o m e r s a n d /o r
r e s u lt s i n m i n o r s y s t e m p r o b le m s t h a t c a n b e o v e r c o m e w it h m i n o r
m o d i f i c a t io n s t o s y s t e m o r p r o c e s s .
S lig h t d a n g e r
F a i l u r e c a u s e s n o i n j u r y a n d c u s t o m e r is u n a w a r e o f p r o b le m h o w e v e r
t h e p o t e n t ia l f o r m i n o r i n ju r y e x i s t s ; l it t l e o r n o e f f e c t o n s y s t e m .
N o danger
F a ilu r e c a u s e s n o in ju r y a n d h a s n o im p a c t o n s y s t e m .
2
1
A d a p te d f r o m : T h e B a s ic s o f F M E A , P r o d u c tiv it y , I n c . C o p y r ig h t 1 9 9 6 R e s o u r c e E n g in e e r i n g , I n c .; G o o d m a n , S .L .,
D e s ig n f o r M a n u f a c tu r a b ilit y a t M id w e s t I n d u s tr ie s , H a r v a r d B u s in e s s S c h o o l, F e b r u a r y 2 , 1 9 9 6 L e c tu r e ;
W h e e l w r i g h t , S .C .; C la r k , K .B ., R e v o l u t i o n i z i n g P r o d u c t D e v e l o p m e n t : Q u a n t u m L e a p s i n S p e e d , E f f i c i e n c y , a n d
Q u a lity , T h e F r e e P r e s s ; P o t e n t ia l F a ilu r e M o d e s a n d E f f e c ts A n a ly s is , A u to m o t iv e I n d u s t r y A c tio n G r o u p , 1 9 9 3 .
O C C U R R E N C E R A T IN G S C A L E
R a tin g
D e s c r ip tio n
P o te n tia l F a ilu r e R a te
10
C e r t a i n p r o b a b i l it y o f o c c u r r e n c e
F a i l u r e o c c u r s a t le a s t o n c e a d a y ; o r , f a i l u r e o c c u r s
a lm o s t e v e r y t im e .
F a i l u r e is a l m o s t i n e v it a b l e
F a i l u r e o c c u r s p r e d ic t a b l y ; o r , f a i l u r e o c c u r s e v e r y 3 o r 4
d a ys.
8
7
V e r y h i g h p r o b a b i l it y o f
o ccu rrence
F a ilu r e o c c u r s fr e q u e n t ly ; o r fa ilu r e o c c u r s a b o u t o n c e
per w eek.
6
5
M o d e r a t e l y h i g h p r o b a b i l it y o f
o ccu rrence
F a i lu r e o c c u r s a b o u t o n c e p e r m o n t h .
4
3
M o d e r a t e p r o b a b i l it y o f
o ccu rrence
F a i l u r e o c c u r s o c c a s io n a l l y ; o r , f a i l u r e o n c e e v e r y 3
m o nths.
L o w p r o b a b i l it y o f o c c u r r e n c e
F a ilu r e o c c u r s r a r e ly ; o r , fa ilu r e o c c u r s a b o u t o n c e p e r
year.
R e m o t e p r o b a b i l it y o f
o ccu rrence
F a i l u r e a l m o s t n e v e r o c c u r s ; n o o n e r e m e m b e r s la s t
fa ilu r e .
A d a p te d f r o m : T h e B a s ic s o f F M E A , P r o d u c tiv it y , I n c . C o p y r ig h t 1 9 9 6 R e s o u r c e E n g in e e r in g , I n c .; G o o d m a n , S .L .,
D e s ig n f o r M a n u f a c tu r a b ilit y a t M id w e s t I n d u s tr ie s , H a r v a r d B u s in e s s S c h o o l, F e b r u a r y 2 , 1 9 9 6 L e c tu r e ; W h e e lw r ig h t,
S . C . ; C la r k , K . B . , R e v o l u t i o n iz i n g P r o d u c t D e v e l o p m e n t : Q u a n t u m L e a p s i n S p e e d , E f f i c i e n c y , a n d Q u a li t y , T h e F r e e
P r e s s ; P o te n t ia l F a ilu r e M o d e s a n d E f f e c ts A n a ly s is , A u to m o t iv e I n d u s tr y A c tio n G r o u p , 1 9 9 3 .
D E T E C T IO N
R A T IN G
S C A L E
R a tin g
D e s c r ip tio n
D e fin itio n
1 0
N o chance o f
d e t e c t io n
9
8
V ery
R e m o t e /U n r e lia b le
T h e f a i lu r e c a n b e d e t e c t e d o n ly w it h t h o r o u g h in s p e c t io n a n d t h is
is n o t fe a s ib le o r c a n n o t b e r e a d ily d o n e .
7
6
R e m o te
T h e e r r o r c a n b e d e t e c t e d w it h m a n u a l in s p e c t io n b u t n o p r o c e s s
is in p la c e s o t h a t d e t e c t io n le f t t o c h a n c e .
M o d e rate c h a n c e o f
d e t e c t io n
T h e r e is a p r o c e s s f o r d o u b le - c h e c k s o r in s p e c t io n b u t it n o t
a u t o m a t e d a n d / o r is a p p l ie d o n ly t o a s a m p le a n d / o r r e lie s o n
v ig ila n c e .
4
3
H ig h
V e r y H ig h
A lm o s t c e r t a in
T h e r e is n o k n o w n m e c h a n is m
T h e r e is 1 0 0 %
T h e r e is 1 0 0 %
fo r d e t e c t in g t h e fa ilu r e .
in s p e c t io n o r r e v ie w o f t h e p r o c e s s b u t it is n o t
a u to m a te d .
in s p e c t io n o f t h e p r o c e s s a n d it is a u t o m a t e d .
T h e r e a r e a u t o m a t ic s h u t - o f f s o r c o n s t r a in t s t h a t p r e v e n t f a i lu r e .
A d a p te d f r o m : T h e B a s ic s o f F M E A , P r o d u c tiv it y , I n c . C o p y r ig h t 1 9 9 6 R e s o u r c e E n g in e e r in g , I n c .;
G o o d m a n , S .L ., D e s ig n f o r M a n u f a c t u r a b ilit y a t M id w e s t I n d u s tr ie s , H a r v a r d B u s i n e s s S c h o o l, F e b r u a r y 2 ,
1 9 9 6 L e c tu r e ; W h e e lw r ig h t, S .C .; C la r k , K .B ., R e v o lu tio n iz in g P r o d u c t D e v e lo p m e n t: Q u a n tu m L e a p s in
S p e e d , E ffic ie n c y , a n d Q u a lity , T h e F r e e P re s s .
Calculating the RPN

Risk Priority Number =
Severity x Occurrence x Detectability
Scores are 1-10;

The resulting number is 1-1000
(Minor problem: RPN <= 100)
Step 5
Step
Evaluate the Risk of Failure,

or Hazard Score
Failure Mode
Frequency Degree of Chance of

Risk
of Failure Severity Detection Priority #
N/A
-----
-----
-----
Child not banded
10
350
Insufficient IS info provided to mom
160
320
Info not understood
80

prior to w ashing
10
270
-----
Step 5
Step

or Hazard Score
Failure Mode

Risk

system
"Unfounded" Alarms
10
10
300
10
10
200
10
400
10
200
Step 5

or Hazard Score
Risk
Step
Failure Mode

10
100
Bands loosening
432

tightened properly
192
392
343
Step 5

or Hazard Score
Step
Failure Mode
10

w hen moving to nursery, other, for
11, 12, 13 N/A
14
misc.
misc.


Risk
7
-----
5
-----
3
-----
105
-----
320
Total RPN (Baseline)
4164

features
Calculating the RPN
In our example, Child not banded (in

L&D):
Severity of the potential effects was rated a 10
(Highest Severity)
Probability was rated a 7 (High)
Detection was rated a 5 (Moderate)
RPN for this failure mode: 10x7x5 = 350 (High)
Prioritized Failure Mode RPN Scores

Step
7
5
9
2
9
3
Failure Mode
10
Bands loosening
Info not entered into computer system, including name/room#
Child not banded
Leaving SCN other than for discharge w/o HUGS band (may
"Unfounded" Alarms
Baby may not be HUGS banded prior to washing
Delay in entering info into computer system
Bands not checked and/or tightened properly
HUGS band may not be checked when moving to nursery, other,
for blood draws, circ., etc.
6
3
HUGS band not applied until reaching post partum (sometimes)

Info not understood
14
5
4
5
5
8
3
misc.
misc.
Risk Priority #
(Before)
432
400
392
350
343
320
320
300
270
200
200
192
160
105
100
80

Other entrance issues related to cameras and other security
features
4164
Step 6 Calculate the Total RPN Score
Add the totals of all RPN scores to

get a grand total
4,164 in this example
Step 7 Determine an Action Plan
Identify the failure modes that have an RPN

Score of 100 or higher. These are the items
requiring the greatest attention.
Develop an action plan to address each of

these high-hazard score failure modes. The
action plan should include who, what, when,
why, etc.
Policy Update: All normal newborns will be banded

ASAP, do not wait for bathing to be completed.
Policy Update: L&D Nurse will obtain the HUGS Band

and Patient ID Bands simultaneously.
Policy Update: Transferring & Receiving Nurse will

confirm patient ID & HUGS band, documenting this
info on the Post Partum flow sheet.
Policy Update: L&D Nurse will be responsible for

activating the HUGS tag and ensuring that the info is
entered correctly into the computer system
(personally inputting or contacting the Clinical
Secretary.)
Training: HUGS computer system entry training will

be provided to the Clinical Secretaries.
Checklists: Create infant security & safety

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

education of patient & SO (significant other)
by staff re: doors, sensors, band tightness,
band tampering, etc.
Alarms: Conduct Quarterly Code Pink Drills (as per

policy.)
HUGS System: Ask HUGS representative about

other band options to deal with ankle swelling
reduction & chafing concerns.
HUGS System: Ask HUGS rep. if pre-printed

instructions are available.
Checklists: Add HUGS band check/tightening to

the Nurse Assessment flowsheet & educate staff.
Policy Update: Post Partum Nurse to check HUGS

band presence before accepting infant, otherwise
infant is to be returned for tagging.
Policy Update: All infants leaving the SCN (except for

direct discharge) must be immediately HUGS
banded. Update questionnaire / audit form.
Training: Conduct HUGS system refresher for SCN

Nurses.
Security: Have supplier check/repair Physician &

Employee entrance to ensure proper reactivation
after door closes.
Security: Budget for, and provide additional security

cameras and other security features around area
perimeters.
Recalculate the RPN scores after

implementing the action plan
Compare with the first FMEA analysis
Address any items with a recalculated RPN

Score of 100 or higher

Before Implementing Action Plan
Step
Failure Mode
After Implementing Action Plan

Risk
Frequency
of Failure Severity Detection Priority # of Failure
-----
-----
-----
Degree of Chance of
Risk
Severity Detection Priority #
N/A
-----
Child not banded
10
350
10
60
160
40
320
180
Info not understood
80
60

prior to w ashing
10
270
10
20
-----
-----
-----
-----

Step
Failure Mode

Risk
Frequency
Degree of Chance of
Risk

system
"Unfounded" Alarms
10
10
300
10
10
200
10
10
200
10
160
10
400
10
150
10
200
10
90

Risk
Frequency
Degree of Chance of
Risk
Step
Failure Mode

10
100
10
20
Bands loosening
432
120

tightened properly
192
48
392
112
343
28

Step
Failure Mode
10

w hen moving to nursery, other, for
11, 12, 13 N/A
14
misc.
misc.


Risk
Frequency
7
-----
5
-----
3
-----
Degree of Chance of
Risk
105
-----
-----
320
Total RPN (Baseline)
4164
5
-----
3
-----
60
-----
24

features
Percent Improvement
Total RPN (After)

67.05%
1372
Lessons Learned
FMEA can be a time consuming process
Be sure to obtain management support
Keep the team motivated
The results are worthwhile
In Conclusion
FMEA is a tool for proactive risk assessment now

used in healthcare
Infant Security was chosen as the 2003 FMEA
project because of the high volume of births in the
WakeMed system (approx. 7800 births/year) and
the significance of this issue.
Significant reductions in scored risk have been
realized through the use of this tool
Questions?
References:
ISMP Website, Example of a Health Care Failure
Mode and Effects Analysis for IV Patient Controlled
Analgesia (PCA), ISMP.Com
McDermott, Robin E., The Basics of FMEA,
PRODUCTVITY, 1996.
Palady, Paul, FMEA: Authors 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

2004 Society for Health Systems Presentation

Objectives of this document:

Describe the WakeMed Healthcare System

Todd A. Reichert, WakeMed, Raleigh, NC.

Why Use FMEAs in Healthcare?

Choosing a Process for an FMEA Project

Todd A. Reichert, WakeMed, Raleigh, NC.

Choosing Infant Abduction as an FMEA

What Motivates the Perpetrator?

Todd A. Reichert, WakeMed, Raleigh, NC.

Conducting the FMEA

Define the FMEA Topic

Step 1: Define the FMEA Topic

Todd A. Reichert, WakeMed, Raleigh, NC.

Step 2: Assemble the Team

FMEA Team Members:

FMEA Team Leader, Performance Improvement

WW = Western Wake Campus (WakeMed)

Todd A. Reichert, WakeMed, Raleigh, NC.

Step 3: Review the Process

Mother Admitted into

Todd A. Reichert, WakeMed, Raleigh, NC.

Todd A. Reichert, WakeMed, Raleigh, NC.

Apply HUG S Band

Problem : Som etim es HUG S bands

Todd A. Reichert, WakeMed, Raleigh, NC.

Bands Checked and

Charge Nurse Checks

Todd A. Reichert, WakeMed, Raleigh, NC.

ID Band Checked and

Move to Circ., Nursery,

Remove Info from

Check ID Band, Return

Remove HUGS Band

Todd A. Reichert, WakeMed, Raleigh, NC.

Step 4: Brainstorm Potential Failure Modes,

Step 5 Evaluate the Risk of Failure, or

Todd A. Reichert, WakeMed, Raleigh, NC.

SEVERITY RATING SCALE

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

Failure could cause major or permanent injury and/or serious system

Failure causes minor to moderate injury with a high degree of

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

Failure causes no injury and has no impact on system.

Todd A. Reichert, WakeMed, Raleigh, NC.

OCCURRENCE RATING SCALE

Potential Failure Rate

Certain probability of occurrence

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

Failure is almost inevitable

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

Very high probability of

Failure occurs frequently; or failure occurs about once

Moderately high probability of

Failure occurs about once per month.

Failure occurs occasionally; or, failure once every 3

Low probability of occurrence

Failure occurs rarely; or, failure occurs about once per

Failure almost never occurs; no one remembers last

Todd A. Reichert, WakeMed, Raleigh, NC.