fmea applied to the phenomenon of retained objects after surgery project managers dr. joan burtner...

FMEA Applied to the FMEA Applied to the Phenomenon of Phenomenon of

Retained Objects After SurgeryRetained Objects After Surgery

Project ManagersProject ManagersDr. Joan Burtner and Dr. Laura Dr. Joan Burtner and Dr. Laura

MoodyMoody

Mercer University School of Mercer University School of EngineeringEngineering

IIE/ASQ 'Quality Drives Lean' Conference Oct 2006 Dr. Joan Burtner, Presenter Slide 2

Presentation OverviewPresentation Overview

IntroductionIntroduction Motivation for the StudyMotivation for the Study Healthcare Failure Modes and Healthcare Failure Modes and

Effects Analysis Case StudyEffects Analysis Case Study Typical ResultsTypical Results Select RecommendationsSelect Recommendations Questions/CommentsQuestions/Comments


IntroductionIntroduction

To Err is HumanTo Err is Human – Call for action with – Call for action with respect to reducing medical errorsrespect to reducing medical errors

Case study courses at Mercer Case study courses at Mercer University School of Engineering University School of Engineering emphasize real-world projects emphasize real-world projects

Clients: MD and RN responsible for Clients: MD and RN responsible for administering Quality programs at a administering Quality programs at a hospital in the southeasthospital in the southeast


What is an FMEA?What is an FMEA? Failure Modes and Effects AnalysisFailure Modes and Effects Analysis ““FMEA is a team-based problem-solving FMEA is a team-based problem-solving

tool intended to help users identify and tool intended to help users identify and eliminate, or reduce the negative eliminate, or reduce the negative effects of, potential failures before they effects of, potential failures before they occur in systems, subsystems, product occur in systems, subsystems, product or process design, or the delivery of a or process design, or the delivery of a service.” service.” The Certified Quality Engineer The Certified Quality Engineer HandbookHandbook, page 233, page 233

CQE Body of Knowledge (Reliability and Risk CQE Body of Knowledge (Reliability and Risk Management)Management)


What is a Healthcare FMEA?What is a Healthcare FMEA? Motivation for the HFMEAMotivation for the HFMEA

Joint Commission on the Accreditation of Healthcare Joint Commission on the Accreditation of Healthcare Organizations (JCAHO) Standard LD.5.2 requires facilities Organizations (JCAHO) Standard LD.5.2 requires facilities to select at least one high-risk process for proactive risk to select at least one high-risk process for proactive risk assessment annuallyassessment annually

FMEA vs HFMEAFMEA vs HFMEA HFMEA combines the detectability and criticality steps of HFMEA combines the detectability and criticality steps of

a traditional FMEAa traditional FMEA HFMEA uses a hazard score in place of the risk priority HFMEA uses a hazard score in place of the risk priority

number (RPN) that is associated with a traditional FMEAnumber (RPN) that is associated with a traditional FMEA Hazard Score obtained from the Hazard Matrix Table Hazard Score obtained from the Hazard Matrix Table

developed by the Department of Veteran’s Affairs developed by the Department of Veteran’s Affairs National Center for Patient SafetyNational Center for Patient Safety


Project Timeline 2005-2006Project Timeline 2005-2006

Preliminary researchPreliminary research Journal articles and booksJournal articles and books Materials provided by southeastern hospitalMaterials provided by southeastern hospital

Operating room observationsOperating room observations Process flow and documentationProcess flow and documentation

High-LevelHigh-Level Detailed counting proceduresDetailed counting procedures

Healthcare Failure Modes and Effects Healthcare Failure Modes and Effects AnalysisAnalysis

Consultation with MD and RNConsultation with MD and RN


Project TeamProject Team Clients: Upper level administrators at a Clients: Upper level administrators at a

southeastern hospitalsoutheastern hospital Chief Quality Officer (Physician)Chief Quality Officer (Physician) Performance Improvement Coordinator of Performance Improvement Coordinator of

Surgical Services (Registered Nurse)Surgical Services (Registered Nurse) Faculty at Mercer UniversityFaculty at Mercer University

Dr. Joan Burtner – Certified Quality EngineerDr. Joan Burtner – Certified Quality Engineer Dr. Laura Moody – Human Factors EngineerDr. Laura Moody – Human Factors Engineer

Students enrolled at Mercer UniversityStudents enrolled at Mercer University Industrial Engineering SeniorsIndustrial Engineering Seniors Industrial Management SeniorsIndustrial Management Seniors


Preliminary ResearchPreliminary Research Factors associated with retained objectsFactors associated with retained objects

Emergency surgeryEmergency surgery Unplanned change in surgical procedureUnplanned change in surgical procedure Patient obesity (higher mean body-mass-Patient obesity (higher mean body-mass-

index)index) Most likely causes for discrepancies in Most likely causes for discrepancies in

countscounts Intensity/complexity of the environment Intensity/complexity of the environment Non-standardized methods for Non-standardized methods for

performing countsperforming counts Poor communication among the Poor communication among the

Operating Room (OR) team membersOperating Room (OR) team members


Site-Specific ObservationsSite-Specific Observations

Forms used by southeastern hospitalForms used by southeastern hospital Qualitative assessment of processQualitative assessment of process

Two people have to witness the count Two people have to witness the count for it to be validfor it to be valid

Lap sponges are mainly lost in cases Lap sponges are mainly lost in cases with obese people and/or abdominal with obese people and/or abdominal surgeriessurgeries

Sponges will do more damage to the Sponges will do more damage to the patient than instruments if left inside patient than instruments if left inside the body, due to decompositionthe body, due to decomposition


Healthcare FMEA Step #1Healthcare FMEA Step #1

Define the process that will be Define the process that will be examined and define the scopeexamined and define the scope Process - Counting of surgical tools and Process - Counting of surgical tools and

sponges prior to, during and after sponges prior to, during and after operationsoperations

Goal - Provide client with possible Goal - Provide client with possible recommendations for performing this task recommendations for performing this task that will attempt to prevent surgical tools that will attempt to prevent surgical tools and sponges from being left inside patientsand sponges from being left inside patients



Assemble the TeamAssemble the Team ISE StudentsISE Students ISE ProfessorsISE Professors IDM StudentsIDM Students MD MD RNRN

ExpertiseExpertise Subject-matterSubject-matter Process ImprovementProcess Improvement



Graphically represent the processGraphically represent the process Two flows generatedTwo flows generated

High-Level process flowHigh-Level process flow Detailed counting procedure process Detailed counting procedure process

flowflow Only partial graphics will be Only partial graphics will be

presented due to proprietary presented due to proprietary reasonsreasons



Conduct a hazard analysisConduct a hazard analysis Define potential failures at each step in each Define potential failures at each step in each

processprocess Define causes for failures at each step in processDefine causes for failures at each step in process Assign severity rating:Assign severity rating:

catastrophic, major, moderate, minor catastrophic, major, moderate, minor Determine probability scoreDetermine probability score Determine hazard scoreDetermine hazard score Eliminate, control, or accept failure mode Eliminate, control, or accept failure mode Actions for eliminate or controlActions for eliminate or control Who is responsible?Who is responsible?


Process Flow and Process Flow and DocumentationDocumentation

High-Level ProcessHigh-Level Process Highlights overall operating room Highlights overall operating room

proceduresprocedures Reviewed and approved by RNReviewed and approved by RN

Detailed Counting ProceduresDetailed Counting Procedures Highlights the specific counting procedures Highlights the specific counting procedures

for sponges, sharps, and instrumentsfor sponges, sharps, and instruments Reviewed and approved by RNReviewed and approved by RN


High-Level Process Flow ExcerptHigh-Level Process Flow Excerpt

Is there a shift change

?

Yes

6) Completio

n of surgical

procedure

3a) Possible

introduction of

additional equipment

No1)

Equipment kits are brought into the

OR

2) Sterile table is

prepared for

operation by scrub

nurse

3) Pre-

surgical count of

instruments and

sponges is conducted

4) Incisions

are made

5a) Change

in end-of-shift

nurse

5b) Possible change

in surgeon

5c) Possible addition of new surgical

staff members


Sponge Decision Tree ExcerptSponge Decision Tree Excerpt

Is the sponge count

exactly the same as the

package label states?

YesAre only X-

ray detectable sponges

being used?

Use sponges that are not X-ray detectable only for dressings.

Yes

No

No


Healthcare Analysis WorksheetHealthcare Analysis Worksheet11 Process StepProcess Step

22 Potential Failure ModePotential Failure Mode

33 Potential CausePotential Cause

44 SeveritySeverity

55 ProbabilityProbability

66 Hazard ScoreHazard Score

77 Decision (Proceed or Stop)Decision (Proceed or Stop)

88 Action (Eliminate, Control or Accept)Action (Eliminate, Control or Accept)

99 Description of ActionDescription of Action

1010 Outcome MeasureOutcome Measure

1111 Person responsiblePerson responsible

1212 Management ConcurrenceManagement Concurrence


Sterile Table Preparation ExampleSterile Table Preparation Example11 2) Sterile table is prepared for operation by scrub 2) Sterile table is prepared for operation by scrub

techniciantechnician

22 Sterile table is not set up exactly the same by every nurseSterile table is not set up exactly the same by every nurse

33 There is no standard procedureThere is no standard procedure

44 Moderate SeverityModerate Severity

55 Frequent OccurrenceFrequent Occurrence

66 Hazard Score = 8 (Hazard Scoring Matrix)Hazard Score = 8 (Hazard Scoring Matrix)

77 Decision : StopDecision : Stop

88 Action : Control Action : Control

99 Initiate standard procedure for sterile table setupInitiate standard procedure for sterile table setup

1010 Percent of nurses conforming to new procedurePercent of nurses conforming to new procedure

1111 Nursing administratorNursing administrator

1212 Management concurrence undetermined at this pointManagement concurrence undetermined at this point


Results Results (High-Level)(High-Level)

AcceptAccept Step 1 - Equipment is brought into the Step 1 - Equipment is brought into the

operating roomoperating room ControlControl

Step 3 - Pre-surgical count of the Step 3 - Pre-surgical count of the sponges and instrumentssponges and instruments

EliminateEliminate Step 6 - Completion of surgical processStep 6 - Completion of surgical process

Instruments, sponges, or sharps are left Instruments, sponges, or sharps are left inside of a patientinside of a patient


ResultsResults(Detailed Counting Procedures)(Detailed Counting Procedures)

AcceptAccept Step 2a - Sponges are not completely Step 2a - Sponges are not completely

separated during the countseparated during the count

ControlControl Step 11 - Object has left sterile field, Step 11 - Object has left sterile field,

circulator must retrieve and verify with the circulator must retrieve and verify with the scrub nursescrub nurse

EliminateEliminate Step 10 - The scrub nurse continually Step 10 - The scrub nurse continually

counts needles during the procedurecounts needles during the procedure


Recommendations for FutureRecommendations for Future

Review FMEA worksheets Review FMEA worksheets Institute recommendations and testInstitute recommendations and test Continue to monitor process flow Continue to monitor process flow

periodicallyperiodically Revise as necessaryRevise as necessary


The project managers would like to The project managers would like to acknowledge the exceptional efforts of acknowledge the exceptional efforts of the members of the student team as the members of the student team as

well as the professionalism of our well as the professionalism of our community partners at a hospital in community partners at a hospital in

the southeast.the southeast.

AcknowledgementsAcknowledgements


Questions or Comments?Questions or Comments?

Dr. Joan BurtnerDr. Joan BurtnerASQ Certified Quality EngineerASQ Certified Quality Engineer

Associate Professor of Industrial EngineeringAssociate Professor of Industrial EngineeringMercer University Macon, GAMercer University Macon, GA

(478) 301-4127(478) [email protected][email protected]

fmea applied to the phenomenon of retained objects after surgery project managers dr. joan burtner...

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