Applying Failure Modes and Effects Analysis (FMEA) in ... · PDF fileApplying Failure Modes...

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. 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

¹¹ TT.. FFaarrlleeyy,, ““PPaarreennttss SSuuee CCiittyy HHoossppiittaall ffoorr $$5566 MMiilllliioonn,,”” TThhee DDaaiillyy OOkkllaahhoommaann,, MMaarrcchh 88,, 11999911 ²² LL.. AAnnkkrrmm aanndd CC.. LLeenntt,, ““CCrraaddllee RRoobbbbeerrss:: AA SSttuuddyy ooff tthhee IInnffaanntt AAbbdduuccttoorr,,”” FFBBII LLaaww EEnnffoorrcceemmeenntt BBuulllleettiinn,, SSeepptteemmbbeerr 11999955..


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

Step 1: Define the FMEA Topic

The first step is to clearly define the FMEA topic:

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


Step 2: Assemble the Team

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

FMEA Team Members:

Todd Reichert 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 WakeProcess Flow DiagramWPBP - Mainitaining Infant Security

Mother Admitted into Labor and Delivery

Unit

Start

Baby Born(ID Band Only)

SpecialCare

Needs?

Move toSpecial 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

?

BabyWashed

A

Yes

No

BabyLeaves Special Care

Nursery(SCN)

Discharge?

No, NewbornNursery or Post-Partum

EndYes

3

4

14

B

C

C


Apply HUGS BandEnter Info into

Computer System

Space Available in Post Partum

?

Delay, until space is available

Move to Post Partum

No

Yes

Problem: Sometimes HUGS bandsaren'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 ShiftCorrections 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

?FYes

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 RATING SCALE Rating Description Potential Failure Rate

10 Certain probability of occurrence

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

almost every time.

9 Failure is almost inevitable

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

days.

8 7

Very high probability of occurrence

Failure occurs frequently; or failure occurs about once

per week.

6 5

Moderately high probability of occurrence

Failure occurs about once per month.

4 3

Moderate probability of occurrence

Failure occurs occasionally; or, failure once every 3

months.

2 Low probability of occurrence

Failure occurs rarely; or, failure occurs about once per

year.

1 Remote probability of occurrence

Failure almost never occurs; no one remembers last

failure.

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


DETECTION RATING SCALE

Rating Description Definition

10

No chance of

detection

There is no known mechanism for detecting the failure.

9 8

Very Remote/Unreliable

The failure can be detected only with thorough inspection and this

is not feasible or cannot be readily done.

7 6 Remote

The error can be detected with manual inspection but no process

is in place so that detection left to chance.

5 Moderate chance of detection

There is a process for double-checks or inspection but it not automated and/or is applied only to a sample and/or relies on

vigilance.

4 3 High

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

automated.

2 Very High

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

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 Applying Failure Modes and Effects Analysis and Effects Analysis

(FMEA) in Healthcare(FMEA) in Healthcare

Preventing Infant Preventing Infant Abduction, a Case StudyAbduction, a Case Study

2004 Society for Health Systems Presentation2004 Society for Health Systems PresentationTodd A. ReichertTodd A. Reichert

Objectives of this PresentationObjectives of this Presentation

Define FMEADefine FMEAExplain the use of this tool in healthcareExplain the use of this tool in healthcareDescribe the project selection processDescribe the project selection processApply the FMEA process to Apply the FMEA process to ““Preventing Preventing Infant Abduction at WakeMedInfant Abduction at WakeMed””Report on results achieved by the project Report on results achieved by the project teamteam

WakeMed:WakeMed:A multiA multi--facility health care systemfacility health care system

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 CenterCenter68 rehabilitation beds68 rehabilitation beds55 skilled nursing beds55 skilled nursing bedsA home health agencyA home health agency

WakeMed:WakeMed:A multiA multi--facility health care systemfacility health care system

WakeMed Faculty Physicians PracticeWakeMed Faculty Physicians Practice5800 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)UNC affiliation UNC affiliation -- residency programsresidency programs

What is an FMEA?What is an FMEA?

FMEA FMEA –– Failure Modes and Effects AnalysisFailure Modes and Effects Analysisis a proactive teamis a proactive team--oriented approach to risk oriented approach to risk reductionreduction

ID what ID what ““couldcould”” go wrong at each process step?go wrong at each process step?Assign Assign ““riskrisk”” scoresscoresTeamTeam--oriented approach to focus resources on oriented approach to focus resources on priority issuespriority issues

What is an FMEA?What is an FMEA?

Since the 1960Since the 1960’’s theys 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.

TheyThey’’re now being used in Healthcare and re now being used in Healthcare and other service industries.other service industries.

Why Use FMEAs in Healthcare?Why Use FMEAs in Healthcare?

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.””

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 systemsthrough changes to healthcare systems

The report stated that most medical errors do not The report stated that most medical errors do not result from result from ““individual recklessnessindividual recklessness”” but instead but instead from from ““basic flawsbasic flaws”” in the way the healthcare in the way the healthcare system is organizedsystem 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 highand 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 highselect 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 Projectan FMEA Project

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, wrongabbreviations, wrong--site surgery, delay in site surgery, delay in treatment, etc. treatment, etc.

JCAHOJCAHO’’s Patient Safety Goalss Patient Safety GoalsOther identified highOther identified high--risk processes within the risk processes within the hospitalhospital

Choosing Infant Abduction as a Choosing Infant Abduction as a Process for an FMEA ProjectProcess for an FMEA Project

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 nonsince 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. ¹¹

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, dayresidences, day--care centers, and shopping care centers, and shopping centers.centers.¹¹

¹¹ FBIFBI’’s National Center for Violent Crime (NCAVC) and the National Cens 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 countrycountry¹¹, this crime transcends statistics due , this crime transcends statistics due to its highlyto its highly--charged naturecharged nature²²

¹¹ 7800 births annually at WakeMed (average)7800 births annually at WakeMed (average)²² 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, 1991Oklahoman, March 8, 1991


Infant abductions affect the local community Infant abductions affect the local community and beyond:and beyond:•• National news coverageNational 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

²² 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, 1991Oklahoman, March 8, 1991

What Motivates the Perpetrator?What Motivates the Perpetrator?

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 herPreventing the partner from deserting her•• Salvaging the relationshipSalvaging the relationship•• MiscarriageMiscarriage•• Inability to conceiveInability to conceive¹¹

¹¹ 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.

FMEA Project Methodology:FMEA Project Methodology:

Step 1: Step 1: Define the FMEA TopicDefine the FMEA Topic

Step 2: Assemble the TeamStep 2: Assemble the Team

Step 3: Step 3: Review the Process / Create a Process Review the Process / Create a Process FlowchartFlowchart

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

FMEA Project Methodology:FMEA Project Methodology:

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

Step 6: Calculate the Total Risk Priority Number Step 6: Calculate the Total Risk Priority Number ScoreScore

Step 7: Step 7: Create an Action PlanCreate an Action Plan

Step 8: Determine FMEA Project Success Step 8: Determine FMEA Project Success

Step 1: Define the FMEA TopicStep 1: Define the FMEA Topic

““Minimize the potential for Infant Minimize the potential for Infant Abduction at WakeMedAbduction at WakeMed’’ss

Western Wake CampusWestern Wake Campus””

Step 2: Assemble the TeamStep 2: Assemble the Team

FMEA Team Members:FMEA Team Members:

Todd ReichertTodd Reichert FMEA Team Leader, Performance ImprovementFMEA Team Leader, Performance ImprovementMonica Blochowiak Nurse Manager, WW WomenMonica Blochowiak Nurse Manager, WW Women’’s Pavilions PavilionBlair Creekmore Staff Nurse, WW Post PartumBlair Creekmore Staff Nurse, WW Post PartumMichael PrinceMichael Prince Supervisor, WW Public SafetySupervisor, WW Public SafetyBarbara WernerBarbara Werner Supervisor, WW WomenSupervisor, WW Women’’s Pavilions PavilionCheryl BakerCheryl Baker Supervisor, WW NICU Supervisor, WW NICU Sara OwensSara Owens Staff Nurse, WW Special Care Nursery Staff Nurse, WW Special Care Nursery Michael BakerMichael Baker Supervisor, Engineering, WWSupervisor, Engineering, WW

WW = Western Wake Campus (WakeMed)WW = Western Wake Campus (WakeMed)

Step 3: Review the ProcessStep 3: Review the Process

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

(Rev. 6/5/03)Western WakeProcess Flow DiagramWPBP - Mainitaining Infant Security

Mother Admitted into Labor and Delivery

Unit

Start

Baby Born(ID Band Only)

SpecialCare

Needs?

Move toSpecial 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 FlowchartFlowchart

Infant Security Precautions

Discussed with Mom, Family, Visitors

Wash Baby

?

BabyWashed

A

Yes

No

BabyLeaves Special Care

Nursery(SCN)

Discharge?

No, NewbornNursery or Post-Partum

EndYes

3

4

14

B

C

C


Apply HUGS BandEnter Info into

Computer System

Space Available in Post Partum

?

Delay, until space is available

Move to Post Partum

No

Yes

Problem: Sometimes HUGS bandsaren'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 ShiftCorrections 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

?FYes

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

At this step, we want to identify what At this step, we want to identify what ““couldcould”¹”¹go 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.

¹¹ These are referred to as These are referred to as ““Failure ModesFailure 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 Insuff icient IS info provided to mom

Forgetfulness, Training Issues, Not Assuming Responsibility

Mom Doesn't know Infant Security Precautions

3 Mom not paying attention Not the Best Time for MomMom Doesn't know Infant Security Precautions

3 Info not understood Cultural/Language BarriersMom Doesn't know Infant Security Precautions

4Baby may not be HUGS banded prior to w ashing

Caregiver Know ledge Deficit about New System

Baby may be Moved w /o HUGS Protection



5Info not entered into computer system, including name/room# Room # Changed, ?

Delayed Response to HUGS Alarm

5Delay 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



6HUGS band not applied until reaching post partum (sometimes)

SCN Transfer, Not in "Standard of Care," (See FM #2) No HUGS Protection

7 Bands looseningDiminished Sw elling of Infant's Limb HUGS Band may Fall Off

8Bands 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 5Step 5 Evaluate the Risk of Failure, or Evaluate the Risk of Failure, or Hazard ScoreHazard Score

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 OccurrenceProbability of Occurrence, and Detection Capability, and Detection Capability

–– The The ““severityseverity”” is the is the consequenceconsequence of the failure of the failure should it occurshould it occur

–– The The ““probability of occurrenceprobability of occurrence”” is the is the likelihoodlikelihood of of a failure mode occurringa failure mode occurring

–– The The ““detection ratingdetection rating”” is our is our ability to catchability to catch the the error before causing patient harmerror 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 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 i t 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 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 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 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 in g .

7 D a n g e r o u s

F a i l u r e c a u s e s m in o r t o m o d e r a t e i n ju 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 e r a t e d a n g e r

F a i l u r e c a u s e s m in o r i n ju 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 t o M o d e r a t e d a n g e r

F a i l u r e c a u s e s v e r y m in o r o r n o i n 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 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 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 .

2 S l i g 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 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 f o r m i n o r i n ju r y e x i s t s ; l i t t l e 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 l u r e c a u s e s n o i n 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 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 ; P o t e n t i a l F a i l u r e M o d e s a n d E f f e c t s A n a l y s i s , 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 i p t i o n P o t e n t i a l F a i l u r e R a t e

1 0 C e r t a in 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 lu 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 lu r e o c c u r s

a lm o s t e v e r y t im e .

9 F a i lu r e is a l m o s t in e v it a b le

F a i lu r e o c c u r s p r e d ic t a b l y ; o r , f a i lu 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 i l it y o f o c c u r r e n c e

F a i lu r e o c c u r s f r e q u e n t ly ; o r f a i lu 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 i l it y o f o c c u r r e n c e

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 c c u r r e n c e

F a i lu r e o c c u r s o c c a s io n a l l y ; o r , f a i lu r e o n c e e v e r y 3

m o n t h s .

2 L o w p r o b a b i l it y o f o c c u r r e n c e

F a i lu r e o c c u r s r a r e ly ; o r , f a i lu 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 r o b a b i l it y o f o c c u r r e n c e

F a i lu 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

f a i lu r e .

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 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 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 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 l i t y , T h e F r e e P r e s s ; P o t e n t i a l F a i lu r e M o d e s a n d E f f e c t s A n a l y s i s , A u t o m o t iv e I n d u s t r y A c t i o 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 RPNCalculating the RPNRRisk isk PPriority riority NNumber =umber =

Severity x Occurrence x DetectabilitySeverity x Occurrence x Detectability

Scores are 1Scores are 1--10; 10; The resulting number is 1The resulting number is 1--10001000

(Minor problem: RPN <= 100)(Minor problem: RPN <= 100)

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

Step Failure ModeFrequency of Failure

Degree of Severity

Chance of Detection

Risk Priority #

1 N/A ----- ----- ----- -----

2 Child not banded 7 10 5 350

3 Insuff icient 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

4Baby may not be HUGS banded prior to w ashing 9 10 3 270



Degree of Severity

Chance of Detection

Risk Priority #

5Info not entered into computer system, including name/room# 8 10 5 400

5Delay in entering info into computer system 4 10 5 200

5 "Unfounded" Alarms 3 10 10 300

5 Alarm ringing - doors not locking 2 10 10 200



Degree of Severity

Chance of Detection

Risk Priority #

6HUGS band not applied until reaching post partum (sometimes) 5 10 2 100

7 Bands loosening 9 8 6 432

8Bands not checked and/or tightened properly 3 8 8 192

9 Not checked against census 8 7 7 392

9 Transferred rooms, not updated 7 7 7 343



Degree of Severity

Chance of Detection

Risk Priority #

10

HUGS band may not be checked w hen moving to nursery, other, for blood draw s, circ., etc. 7 5 3 105

11, 12, 13 N/A ----- ----- ----- -----

14

Leaving SCN other than for discharge w /o HUGS band (may include family room visiting) 5 8 8 320


misc.


4164Total RPN (Baseline)

Calculating the RPNCalculating the RPNIn 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 ““1010””(Highest Severity)(Highest Severity)

Probability was rated a Probability was rated a ““77”” (High)(High)

Detection was rated a Detection was rated a ““55”” (Moderate)(Moderate)

RPN for this failure mode: 10x7x5 = 350 (High)RPN for this failure mode: 10x7x5 = 350 (High)

Prioritized Failure Mode RPN ScoresPrioritized Failure Mode RPN ScoresStep Failure Mode

Risk Priority # (Before)

7 Bands loosening 4325 Info not entered into computer system, including name/room# 4009 Not checked against census 3922 Child not banded 3509 Transferred rooms, not updated 3433 Mom not paying attention 320

14Leaving SCN other than for discharge w/o HUGS band (may include family room visiting) 320

5 "Unfounded" Alarms 3004 Baby may not be HUGS banded prior to washing 2705 Delay in entering info into computer system 2005 Alarm ringing - doors not locking 2008 Bands not checked and/or tightened properly 1923 Insufficient IS info provided to mom 160

10HUGS 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) 1003 Info not understood 80


misc.Other entrance issues related to cameras and other security features

4164

Step 6 Calculate the Total RPN ScoreStep 6 Calculate the Total RPN Score

Add the totals of all RPN scores toAdd the totals of all RPN scores toget a grand totalget a grand total

4,164 in this example4,164 in this example

Step 7 Determine an Action PlanStep 7 Determine an Action Plan

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.

Develop an action plan to address each of Develop an action plan to address each of these highthese 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.

Items Included in the Action Plan:Items Included in the Action Plan:Policy UpdatePolicy 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.

Policy UpdatePolicy 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.

Policy UpdatePolicy 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.

Items Included in the Action Plan:Items Included in the Action Plan:

Policy UpdatePolicy 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.)

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


ChecklistsChecklists:: 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.

ChecklistsChecklists:: 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.


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

HUGS SystemHUGS 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.


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

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


Policy UpdatePolicy 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.

Policy UpdatePolicy 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.

TrainingTraining:: Conduct HUGS system refresher for SCN Conduct HUGS system refresher for SCN Nurses.Nurses.


SecuritySecurity:: 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.

SecuritySecurity: 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 8Step 8 Determine FMEA Project SuccessDetermine FMEA Project Success

Recalculate the RPN scores after Recalculate the RPN scores after implementing the action planimplementing the action plan

Compare with the first FMEA analysisCompare with the first FMEA analysis

Address any items with a recalculated RPNAddress any items with a recalculated RPNScore of 100 or higher Score of 100 or higher

Step 8 Determine FMEA Project SuccessStep 8 Determine FMEA Project Success


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

4Baby may not be HUGS banded prior to w ashing 9 10 3 270 1 10 2 20

After Implementing Action PlanBefore Implementing Action Plan

Step 8 Determine FMEA Project SuccessStep 8 Determine FMEA Project Success


Degree of Severity

Chance of Detection

Risk Priority #


Degree of Severity

Chance of Detection

Risk Priority #

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

5Delay in entering info into computer 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



Degree of Severity

Chance of Detection

Risk Priority #


Degree of Severity

Chance of Detection

Risk Priority #

6HUGS band not applied until reaching post partum (sometimes) 5 10 2 100 1 10 2 20

7 Bands loosening 9 8 6 432 5 8 3 120

8Bands not checked and/or 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




Degree of Severity

Chance of Detection

Risk Priority #


Degree of Severity

Chance of Detection

Risk Priority #

10

HUGS band may not be checked w hen moving to nursery, other, for blood draw s, circ., etc. 7 5 3 105 4 5 3 60

11, 12, 13 N/A ----- ----- ----- ----- ----- ----- ----- -----

14

Leaving SCN other than for discharge w /o HUGS band (may include family room visiting) 5 8 8 320 1 8 3 24


misc.


4164 1372

67.05%


Percent Improvement

Total RPN (Baseline) Total RPN (After)

Lessons LearnedLessons Learned

FMEA can be a time consuming processFMEA can be a time consuming processBe sure to obtain management supportBe sure to obtain management supportKeep the team motivatedKeep the team motivatedThe results are worthwhileThe results are worthwhile

In ConclusionIn Conclusion

FMEA is a tool for proactive risk assessment now FMEA is a tool for proactive risk assessment now used in healthcareused in healthcareInfant 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 toolrealized through the use of this tool

QuestionsQuestions??

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 Failure Modes and Effects Analysis (FMEA) in ... · PDF fileApplying Failure Modes...

Documents

Transcript of Applying Failure Modes and Effects Analysis (FMEA) in ... · PDF fileApplying Failure Modes...