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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