Using failure modes and effects Using failure modes and effects analysis to evaluate “home analysis to evaluate “home meds” failures in surgical meds” failures in surgical

patientspatients

Fred M. Blanchard, Pharm.D.Fred M. Blanchard, Pharm.D.Virginia Commonwealth UniversityVirginia Commonwealth UniversityPatient Safety Fellowship ProgramPatient Safety Fellowship Program

May 1, 2003May 1, 2003

PurposePurpose

Introduce FMEA methodologyIntroduce FMEA methodology Incorporate FMEA into Performance Incorporate FMEA into Performance

Improvement and Patient Safety Improvement and Patient Safety EffortsEfforts

Apply FMEA and evaluate “home Apply FMEA and evaluate “home meds” failuresmeds” failures

MethodsMethods Establish a teamEstablish a team FOCUS PDSAFOCUS PDSA FMEA TrainingFMEA Training FMEAFMEA Define, Prioritize, Measure FailuresDefine, Prioritize, Measure Failures InterveneIntervene Re-measureRe-measure

““Home Meds” TeamHome Meds” Team

Dale Bosiger, Pre-op Dale Bosiger, Pre-op EducationEducation

Debra Coulter, PACUDebra Coulter, PACU Lynn Harris, SurgicareLynn Harris, Surgicare Nadine Gilmore, Nadine Gilmore,

PharmacyPharmacy Linda Lange, Nursing Linda Lange, Nursing

Policy and ProcedurePolicy and Procedure

Sherry Payne, Sherry Payne, Orthopedic UnitOrthopedic Unit

Randall Puckett, Randall Puckett, PharmacyPharmacy

Kim Woodley, Kim Woodley, Quality Support Quality Support Services (PI)Services (PI)

Fred Blanchard, Fred Blanchard, PharmacyPharmacy

FMEAFMEA

Originally intended for prospective Originally intended for prospective identification of failuresidentification of failures

Applied retrospectively as a stand Applied retrospectively as a stand alone process in the healthcare alone process in the healthcare environmentenvironment

Also applied as a tool in FOCUS PDSAAlso applied as a tool in FOCUS PDSA

PI and FMEA SimilaritiesPI and FMEA Similarities

FOCUS PDSAFOCUS PDSA Find a ChallengeFind a Challenge Organize a TeamOrganize a Team Clarify ProcessClarify Process Understand the Understand the

Variation & Select a Variation & Select a ProcessProcess

P-D-S-AP-D-S-A

FMEAFMEA Define TopicDefine Topic Assemble TeamAssemble Team Describe ProcessDescribe Process Hazard AnalysisHazard Analysis

Action/Outcome Action/Outcome MeasuresMeasures

Graphic Description of Graphic Description of ProcessProcess

SURGEONREFERRAL FOR

SURGERY

PRE-OP TESTINGAND TEACHING

SURGICALADMISSION

SURGERYTRANSFER TO

UNIT OR FLOORS

CHANGE LEVELOF CARE

DISCHARGEHOME

1 2 3 4 5

6

7

Subsystem Steps and Subsystem Steps and CausesCauses

2A. OFFICESTAFF SCHEDPREOP VISIT

AND SURG

2B. CALL TO VBHOFFICE TOSCHEDULE

2C. SURGERYSCHEDULED

2D. OFFICE STAFFSCHEDULES PREOP

VISIT

2E. OFFICE STAFFTELL PT TO BRING

MEDS

2F. PT ARRIVES FORPREOP VISIT,COMPLETESWORKSHEET

2G. NURSETRANSCRIBES TO

ASSESSMENT FORM

2I.ANESTHESIOLOGIST

INTERVIEWSPATIENT

2H. NURSE REVIEWSMEDS WITH PATIENT

AND GIVESINSTRUCTIONS

1. didn't tell patient

2. not emphasized

3. not understood

4.office staff doesn'tunderstand importance

1. pt. doesn't show

2. didn't bring anymeds

3. didn't bring all meds

4. brought list

5. gave verbalmedication history

6. brought medswithout labels

1. illegible

2. incorrecttranscription

3. misunderstoodpatient intentionwhenpatient wrote meddirections

1. gaps in medicationhistory not clarified withphysician

1. gaps in medicationhistory not clarified withother physicians

2. ignores nurserecommnedation toadvise patient

3. not available after1530

Failure ModeFailure Mode

2g1 Nurse transcription from patient 2g1 Nurse transcription from patient form to assessment sheet is illegibleform to assessment sheet is illegible

Failure AnalysisFailure Analysis

Potential CausePotential Cause

2g1(e) Form not suitable for writing 2g1(e) Form not suitable for writing complete medication instructions complete medication instructions including drug, strength, route, and including drug, strength, route, and frequencyfrequency

Hazard Analysis 2g1(e)Hazard Analysis 2g1(e)

Severity = MajorSeverity = Major Probability = FrequentProbability = Frequent Hazard Score = 12Hazard Score = 12

Decision Tree 2g1(e)Decision Tree 2g1(e)Does the hazardwarrant control?

(Score > 8)

Is this a single pointweakness?

(Failure=System Failure)

Does an effective controlmeasure exist?

Is the hazard so obviousthat a control measure is

not warranted?

STOP

Determine Action andOutcome Measures

NO

YES

YES

NO

NO

NO

YES

Action TypeAction Type

ControlControlAcceptEliminate

Action and Outcome Action and Outcome MeasuresMeasures

Measure “error” rates at baselineMeasure “error” rates at baseline Develop a new form; combine stepsDevelop a new form; combine steps Perform a trialPerform a trial Measure post intervention “error” Measure post intervention “error”

ratesrates

PREOP

NURSE

ADMIT

RECORD

OLD

FORM

{ {

Baseline Measure of Current Baseline Measure of Current ProcessProcess

Retrospectively reviewed 94 charts-Retrospectively reviewed 94 charts-all same day surgeries over a three all same day surgeries over a three week periodweek period

Baseline MeasurementsBaseline MeasurementsBeforBeforee

Charts with “Home Meds” documented pre-opCharts with “Home Meds” documented pre-op 94%94%Charts with any order to renew “Home Meds” Charts with any order to renew “Home Meds” post-oppost-op

69%69%

Post-op “Home Meds” order “qualified”Post-op “Home Meds” order “qualified” 84%84%Post-op “Home Meds” orders “complete”Post-op “Home Meds” orders “complete” 34%34%Post-op orders that were clarifiedPost-op orders that were clarified 44%44%Average number of “Home-Meds” pre-opAverage number of “Home-Meds” pre-op 5.75.7Average number of “Home Meds” renewed Average number of “Home Meds” renewed post-oppost-op

2.72.7

Drug, Strength, Frequency, Route info pre-opDrug, Strength, Frequency, Route info pre-op 91%91%Drug, Strength, Frequency, Route info post-opDrug, Strength, Frequency, Route info post-op 98%98%Discrepancies post-opDiscrepancies post-op 22%22%

RESUME

HOME

MEDS

FORM

NEW

FORM

{

Post Intervention Utilization of Post Intervention Utilization of Combined Home Meds FormCombined Home Meds Form

Retrospectively reviewed 51 charts-Retrospectively reviewed 51 charts-all same day surgeries over a two all same day surgeries over a two week periodweek period

New form used by nursing staff 45 New form used by nursing staff 45 times (88%)times (88%)

New form used by nursing and New form used by nursing and physician staff 35 times (78%)physician staff 35 times (78%)

ResultsResultsBeforBeforee

AfterAfter

Charts with “Home Meds” documented pre-opCharts with “Home Meds” documented pre-op 94%94% 100%100%Charts with any order to renew “Home Meds” Charts with any order to renew “Home Meds” post-oppost-op

69%69% 100%100%

Post-op “Home Meds” order “qualified”Post-op “Home Meds” order “qualified” 84%84% 100%100%Post-op “Home Meds” orders “complete”Post-op “Home Meds” orders “complete” 34%34% 100%100%Post-op orders that were clarifiedPost-op orders that were clarified 44%44% 0%0%Average number of “Home-Meds” pre-opAverage number of “Home-Meds” pre-op 5.75.7 6.36.3Average number of “Home Meds” renewed Average number of “Home Meds” renewed post-oppost-op

2.72.7 4.94.9

Drug, Strength. Frequency, Route info pre-opDrug, Strength. Frequency, Route info pre-op 91%91% 99%99%Drug, Strength, Frequency, Route info post-opDrug, Strength, Frequency, Route info post-op 98%98% 99%99%Discrepancies post-opDiscrepancies post-op 22%22% 0%0%

DiscussionDiscussion

Advantages of using FMEA in the Advantages of using FMEA in the context of FOCUS PDSAcontext of FOCUS PDSA Identification of failuresIdentification of failures Greater depth of analysisGreater depth of analysis Improved prioritization of selected Improved prioritization of selected

processesprocesses LimitationsLimitations

Time consumingTime consuming Reserve for critical processesReserve for critical processes

DiscussionDiscussion

Home Meds Reorder ProcessHome Meds Reorder Process Combining pre-op medication history with post-Combining pre-op medication history with post-

op order set:op order set: Reduced process variationReduced process variation Improved pre-op documentationImproved pre-op documentation Increased frequency of post-op renewalIncreased frequency of post-op renewal Improved the completeness of post-op ordersImproved the completeness of post-op orders Reduced calls to clarify ordersReduced calls to clarify orders Increased probability that meds taken at home were Increased probability that meds taken at home were

continued post-opcontinued post-op Reduced the number of post-op order discrepanciesReduced the number of post-op order discrepancies