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8/14/2019 FMEA anticoag worksheet empty scoring.pdf
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An tico agu lat io n Failur e Mode and Effects Analys is Ad ver se Drug Effects User Gro up --Grid fo r i nd iv id ual or gan izat io n an aly si s
Steps Failure Mode Failure Causes Failure Effects
Likelihood ofOccurrence
(1-10)
Likelihood ofDetection (1-
10)Severity(1-10)
Risk PriorityNumber(RPN)
Actions to Reduce Occurrence ofFailure
1 Is Anticoagulant Indicated?
1A Is diagnosis correct? Diagnostic tests notperformed
Anticoagulantadministered when notindicated
0 All caregivers double checkdiagnosis
No treatment given when
indicated
0
Failure of test todiagnosis.
0 Use 2 tests to diagnosis whenpossible. Repeat inconclusivetests.
Doesn't meet standards ofpracticeClinicians unaware ofstandards
Inappropriate prescribingof anticoagulants
0 Pharmacists check indicationEducate prescribersEstablish treatment guidelines.
1B Are there contraindicationsor disease interactions?
No or incomplete patientinformationNot evaluatedDiagnosis inconclusiveDidn't know patient had agiven contraindication (ieepidural)Interpretation biases
BleedingDeathThrombosis
0Pharmacists double checkEstablish treatment guidelines thatinclude information oncontraindications.
1C Are there drug or foodinteractions? Can they bemanaged?
Incomplete medicationhistoryNo computer alertsSkipped alertIncomplete alertHerbal/supplementinteractions not consideredDidn't check
BleedingDeathThrombosis
0 Use pharmacy computer systemthat screens for drug interactionsTake a complete medicationhistory including herbal/supplement information.
(Severity can range from1-10)
0
Likelihood of occurrence: 1-10, 10= Very likely to occur. Likelihood of detection: 1-10, 10=very unlikely to detect. Severity: 1-10, 10 = most severe effect. RPN= product of 3 scores. Page 1
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Steps Failure Mode Failure Causes Failure Effects
Likelihood ofOccurrence
(1-10)
Likelihood ofDetection (1-
10)Severity(1-10)
Risk PriorityNumber(RPN)
Actions to Reduce Occurrence ofFailure
2E Write orders for monitoring Omitted or incomplete
monitoring ordersOver or under monitoringfrequencyWrong time for lab testWrong lab test ordered
Dose not adjusted
appropriately.
0 Use preprinted orders
Implement standard monitoringprocessPharmacist check monitoring plan.
Likelihood of occurrence: 1-10, 10= Very likely to occur. Likelihood of detection: 1-10, 10=very unlikely to detect. Severity: 1-10, 10 = most severe effect. RPN= product of 3 scores. Page 3
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Steps Failure Mode Failure Causes Failure Effects
Likelihood ofOccurrence
(1-10)
Likelihood ofDetection (1-
10)Severity(1-10)
Risk PriorityNumber(RPN)
Actions to Reduce Occurrence ofFailure
3 Process Order 0
3A Pharmacy receives order Order not receivedNot received in a timelymanner
Delays in therapyDelays in changing dosewhen necessary
0 Use CPOE systems.Handle orders on a priority basis
3B Indication check Not done or incompleteDon't distinguish betweentreatment and prophylaxis
Potential error in givinganticoagulants when notindicated
0 Use consistent process forchecking for all orders.
Day shift 0
Evening and night shift 0
3C Contraindication check Not doneInformation not readilyavailable (eg is patient onepidural?)
BleedingDeathThrombosis
0 Use consistent process forchecking for all orders.Pharmacist needs access topatient information.
3D Dose check and doseinterval check
0 Use consistent process forchecking for all orders.
3E Dosage form selection Wrong one selected. 0 Check order entry layout
3F Enter in computer system Wrong patientComputer entry error Wrong admissionEntered on wrong profile(inpatient vs outpatient)
Wrong patient gets drug.Medication error occurs
0 Nurse double checks medicationentry.
3G Drug interaction check Don't readBypass alertDatabase not currentComputer not available tocheck.
BleedingDeathThrombosis
0
Likelihood of occurrence: 1-10, 10= Very likely to occur. Likelihood of detection: 1-10, 10=very unlikely to detect. Severity: 1-10, 10 = most severe effect. RPN= product of 3 scores. Page 4
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Steps Failure Mode Failure Causes Failure Effects
Likelihood ofOccurrence
(1-10)
Likelihood ofDetection (1-
10)Severity(1-10)
Risk PriorityNumber(RPN)
Actions to Reduce Occurrence ofFailure
3H Time dose Wrong administration times
Administration times notstandardTime not coordinated withlab draws and otherprocedures.Miscommunication with teamon appropriate time.
0 Use standardized dosing times.
Likelihood of occurrence: 1-10, 10= Very likely to occur. Likelihood of detection: 1-10, 10=very unlikely to detect. Severity: 1-10, 10 = most severe effect. RPN= product of 3 scores. Page 5
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Steps Failure Mode Failure Causes Failure Effects
Likelihood ofOccurrence
(1-10)
Likelihood ofDetection (1-
10)Severity(1-10)
Risk PriorityNumber(RPN)
Actions to Reduce Occurrence ofFailure
4 Drug Preparation and
Delivery
0
4A Select product andpreparation method
Wrong drug, doseSelect wrong productSelect wrong product forrouteWrong storage
BleedingDeathThrombosis
0 Standard ConcentrationsDon't stock heparinMinimize use of heparin
4B Prepare drug in pharmacy Wrong packagingWrong syringe needleWrong equipmentPoor techniqueIncompatibilitiesDraw up wrong dose orconcentration
Increase bleeding risk 0 Use prefilled syringesUse premixed preparations
4C Pharmacist check product Check omittedFailed to detect an error
Increase bleeding risk 0 Standard, rigorous proceduresDefine role of checkingculture of patient safety
4D Deliver product to unit Delivered to wrong unitLost in systemDelays in delivery
Delay in therapy 0 Heightened sense of delay
4E Drug available from floorstock
Wrong product selectedIncompatibility issuesNot double checked
Increase bleeding risk 0 Do not stock anticoagulants asfloor stock.No double checkEvaluate "special areas" and whatreal needs are. Limit choicesavailable.
4F Drug available fromautomated dispensing unit
Wrong drug stockedNot in dispensing unitSystem is down
Increase bleeding risk 0 Double check.
4G Nurse can over-ride No double checkPharmacist doesn't profile
Increase bleeding risk 0 Do not allow override foranticoagulants
Likelihood of occurrence: 1-10, 10= Very likely to occur. Likelihood of detection: 1-10, 10=very unlikely to detect. Severity: 1-10, 10 = most severe effect. RPN= product of 3 scores. Page 6
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Steps Failure Mode Failure Causes Failure Effects
Likelihood ofOccurrence
(1-10)
Likelihood ofDetection (1-
10)Severity(1-10)
Risk PriorityNumber(RPN)
Actions to Reduce Occurrence ofFailure
4H Drug approved for
dispensing (profiling)
Not profiled
Failed to detect an error
Delay in therapy 0
4I Ready to select fromautomated dispensing unit
Wrong product stockedCabinet not set up to preventan error Wrong bar code (ifapplicable)
Increase bleeding risk 0 Check dispensing unit set up.Check bar code set up.
Likelihood of occurrence: 1-10, 10= Very likely to occur. Likelihood of detection: 1-10, 10=very unlikely to detect. Severity: 1-10, 10 = most severe effect. RPN= product of 3 scores. Page 7
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Steps Failure Mode Failure Causes Failure Effects
Likelihood ofOccurrence
(1-10)
Likelihood ofDetection (1-
10)Severity(1-10)
Risk PriorityNumber(RPN)
Actions to Reduce Occurrence ofFailure
5 Drug Administration 0
5A Nurse checks labs ifneeded
Labs not available on timeLabs not checkedWrong lab checked (timemix up)
Dose not appropriatelyadjusted
0 Establish protocolsUse PTT statDouble checks in system
5B Nurse gets dose Dose not availableGets wrong dose or drug
Disease progresses Adverse effect ofmedication
0 Check methods of storageBar coding
5C Nurse prepares if needed Error in preparation Disease progresses Adverse effect ofmedication
0 Nurse does not prepare medication
5D Check timing Incorrect timeFailure to communicate dosedue
Therapy delayed 0 Detected but after the fact
5E Select pump Programmed wrongIncorrect useWrong tubing (heparin)Free flow pumps used
BleedingDeathThrombosis
0 Do not use free flow pumps
Alaris pumps or other"smart pumps"
0
Traditional pumps 0 Consider upgrading pumpsDon't use heparinRN double checks
5F Check compatibility Didn't checkReferences not available orpoor information
Thrombosis 0 Check compatibility references
5G Verify patient Wrong patient Thrombosis to patientnot receiving dose.
0 Bar codingDouble checking
Likelihood of occurrence: 1-10, 10= Very likely to occur. Likelihood of detection: 1-10, 10=very unlikely to detect. Severity: 1-10, 10 = most severe effect. RPN= product of 3 scores. Page 8
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Steps Failure Mode Failure Causes Failure Effects
Likelihood ofOccurrence
(1-10)
Likelihood ofDetection (1-
10)Severity(1-10)
Risk PriorityNumber(RPN)
Actions to Reduce Occurrence ofFailure
5H Check injection site andadminister drug
Site not rotatedSite not documentedIV not patentPoor techniqueLack of documentation
Administered incorrectly
HematomasFatal bleeding
0 Protocols for administrationEducation to those administeringDon't rub injection site
5I Administer Wrong route HematomasFatal bleeding
0
Likelihood of occurrence: 1-10, 10= Very likely to occur. Likelihood of detection: 1-10, 10=very unlikely to detect. Severity: 1-10, 10 = most severe effect. RPN= product of 3 scores. Page 9
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Steps Failure Mode Failure Causes Failure Effects
Likelihood ofOccurrence
(1-10)
Likelihood ofDetection (1-
10)Severity(1-10)
Risk PriorityNumber(RPN)
Actions to Reduce Occurrence ofFailure
6 Monitoring 0
6A Appropriate labs orderedand run
Ordered at wrong timeNot orderedOrdered but not drawnDrawn wrongRan wrong testWrong test orderedLab error
Dose not adjustedappropriately.
0 Use protocols
6B Check labs Not available in a timely
fashionNo one checksNo action taken to critical labMisreadNot flagged as critical valueMisinterpreted
Dose not adjusted
appropriately.Bleeding
0 Protocols
Use alerts (computerized)
6C Check patient status: signsof bleeding and diseaseprogression
Patient not evaluatedOccult bleeding not detectedNo standard evaluationNot reported to caregiver Patient not informed
Accountability for monitoringunclear
Bleeding 0 ProtocolsUse alerts (computerized)Involve patient in care--have themalert care giver immediately if anysymptoms
6D Adjust dose or drug asneeded
Adjusted incorrectlyFailure to adjustOngoing dose adjustmentsnot doneOrders not processedNot adjusted appropriate forchanges in renal, hepatic,platelet or allergy status
Dose not appropriatelyadjusted
0 Use protocolsIdentify heparin inducedthrombocytopenia (HIT)appropriately.Use alertsNotify patient if allergic
Likelihood of occurrence: 1-10, 10= Very likely to occur. Likelihood of detection: 1-10, 10=very unlikely to detect. Severity: 1-10, 10 = most severe effect. RPN= product of 3 scores. Page 10
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Steps Failure Mode Failure Causes Failure Effects
Likelihood ofOccurrence
(1-10)
Likelihood ofDetection (1-
10)Severity(1-10)
Risk PriorityNumber(RPN)
Actions to Reduce Occurrence ofFailure
7 Patient Education 0
7A Educate patient andcaregiver
Materials varyMisunderstandingLanguage and literacybarriersnot providedincompletevariations in practice
Accountability unclear Caregiver not available
Injury prevention notincluded
BleedingDeathThrombosis
0 Systematic process for educatingpatients on anticoagulants.
Failure to educatepatient on disease andefficacy
0
Failure to educatepatient on ADRsincluding HIT
0
No education receivedby patient 0
7B Assess understanding Lack of formal assessmentof understanding
Active assessmentmechanisms not used
Use drug inappropriatelyIncrease risk of bleeding
0 Formalize options when patientand or caregiver do not understandeducation
Likelihood of occurrence: 1-10, 10= Very likely to occur. Likelihood of detection: 1-10, 10=very unlikely to detect. Severity: 1-10, 10 = most severe effect. RPN= product of 3 scores. Page 11
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Steps Failure Mode Failure Causes Failure Effects
Likelihood ofOccurrence
(1-10)
Likelihood ofDetection (1-
10)Severity(1-10)
Risk PriorityNumber(RPN)
Actions to Reduce Occurrence ofFailure
8 Discharge 0
8A Duration of therapyestablished
Not establishedVariation in standards andguidelinesPhysician variationNot communicated to patient
Exposed to drug longerthan neededProgression of disease
0 Use protocolsDocument clearly disease beingtreated and duration of therapyCommunicate information tooutside caregivers
8B Follow-up appointment setif indicated
No follow-up appt set Appt or place notcommunicated to patient
Pt or family does notunderstand
Patient hascomplications andunclear where to go
Develops drug ordisease interactions
0 Use protocolsDischarge documentation processestablished
Communicate with outsidecaregiversFollow-up that patient went tofollow-up appt.
8C Follow-up with primary careprovider
Communication doesn'thappenCommunication not received
Patient hascomplications andunclear where to goDevelops drug ordisease interactions
0 Establish process to communicatewith outside caregivers
8D Get prescription filled Payment or reimbursementissues not addressedPharmacy doesn't carryDon't get script filledVariations in counseling.Conflicts with otherinformation received
Patient hascomplications andunclear where to goDevelops drug ordisease interactions
0 Establish process to work withpatient/caregiver to address theseissues prior to leaving the hospitaland as part of the follow-up.
depending on system,
can vary in frequencyfrom 3-7
0
08E Patient attends follow-up
appointmentTransportation problemsPatient reschedulesNo follow-up on missedappointments
BleedingDeathThrombosis
0 Use follow-up protocol.
Likelihood of occurrence: 1-10, 10= Very likely to occur. Likelihood of detection: 1-10, 10=very unlikely to detect. Severity: 1-10, 10 = most severe effect. RPN= product of 3 scores. Page 12