OUTSOURCING STERILE PRODUCTS PREPARATION … · Principles for Use • When outsourcing. sterile...

OUTSOURCING STERILEPRODUCTS PREPARATION

CONTRACTOR ASSESSMENT TOOL

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Principles for Use • Whenoutsourcingsterileproductspreparationservices,everyhospital/healthsystem-based

departmentofpharmacyshouldtakeacomprehensiveandorganizedapproachtovendorselection.

• Departmentsofpharmacyarestronglyencouragedtoengageotherkeyhospital/healthsystemstakeholdersinthevendorselectionprocess.

• Whilethistoolisintendedtobeusefulforallhealth-system/hospital-baseddepartmentsofpharmacy,itsusewillvarybasedontheinstitution’ssize,geographiclocation,servicesprovidedandavailableresources.

• TheASHPFoundationhasattemptedtoincludetheassessmentquestionsunderthemostappropriatecategory.However,insomecasesanassessmentquestionmightbeapplicabletomultiplecategories.

• Whilethisdocumentisintendedtobehelpfultohospital/health-systemdepartmentsofpharmacyintheirselectionofasterileproductsoutsourcingorganization,itdoesnotpurporttoestablishastandardofcare.

• Hospitals/healthsystemsthatplantousethistoolasacomponentoftheirevaluationofasterileproductsoutsourcingorganizationcanalsousethetooltodevelopaRequestforProposals(RFP)fortheseservices.

• TheASHPFoundationstronglyencourageshospitals/healthsystemstousethistoolalongwithsitevisitstoensureacomprehensivereviewofpotentialsterileproductsoutsourcingorganizations.Itemsthatshouldbecloselyevaluatedduringthesitevisitareindicatedthroughoutthetool.

• Aspartofthehospital’s/healthsystem’soverallplanningforselectionofasterileproductsoutsourcingorganization,seetheASHPGuidelinesonOutsourcingSterileCompoundingServices.

• Theterm“disqualification”asusedinthistoolmeansthattheoutsourcingcontractorshouldnotbeconsideredfortheprovisionofsterileproductspreparationservices.

• Thistoolisnotintendedforuseintheevaluationofnuclearpharmacies.

Theinformationcontainedinthisself-assessmenttoolisconstantlyevolvingbecauseofongoingresearchandimprovementsintechnologyandissubjecttotheprofessionaljudgmentandinterpretationoftheinvolvedhealthcareprofessionals.TheASHPResearchandEducationFoundation,theexpertpanel,andexternalpeerreviewershavemadereasonableeffortstoensuretheaccuracyandappropriatenessoftheinformationpresented.However,anyreaderofthisinformationisadvisedthattheASHPResearchandEducationFoundation,theexpertpanel,andtheexternalreviewersarenotresponsibleforthecontinuedcurrencyoftheinformation,foranyerrorsoromissionsand/orforanyconsequencesarisingfromtheuseoftheinformationintheself-assessmenttoolinanyandallpracticesettings.AnyreaderofthisdocumentiscautionedthattheASHPResearchandEducationFoundationmakesnorepresentation,guaranteeorwarranty,expressorimplied,astotheaccuracyandappropriatenessoftheinformationcontainedinthisself-assessmenttoolandwillbearnoresponsibilityorliabilityfortheresultsorconsequencesofitsuse.

© 2011 American Society of Health-System Pharmacists Research and Education Foundation7272 Wisconsin AvenueBethesda, MD 20814301-664-8612


How to Use this Tool Step 1. Minimum Requirements for a Vendor Whenoutsourcingtheproductionofsterileproductsthefirststepinvendorevaluationistoseeifthey

meet the minimum requirements. We have developed a group of questions that can be used to qualify a vendor. There is not a score for this section. A vendor simply meets the minimum requirements or theyaredisqualified.Onceavendorhasbeenqualifiedwesuggestfurtherassessmentofthevendortodeterminewhichvendoristhebestfitforyourhospitalorhealth-system.

Step 2. Vendor Assessment The questions in this section are designed to help you objectively compare the services offered by

potentialoutsourcingvendors.Afteransweringeachquestion,theAssesmentToolprovidesascorefor the vendor and a table to interpret the score.

Step 3. Vendor Comparison The vendor scores and score legend provided in the Assessment Summary can be used to compare

potential outsourcing vendors.


Step 1: Minimum Requirement QuestionsPart 1: Regulatory Compliance

1. Doestheoutsourcerhaveastatepharmacylicenseavailablewherethecompoundingcenterresides?

2. Istheoutsourcerlicensedtoshiptomystate?

3. Iftheoutsourcerpreparesasignificantnumberofnonpatient-specificpreparations(e.g.,>5%oftheoutsourcer’svolume),istheoutsourcerregisteredasadrugmanufacturerwiththeFDA,ifrequired?

4. Iftheoutsourcerpreparesnonpatient-specificcontrolledsubstancepreparations,istheoutsourcerregisteredasadrugmanufacturerwiththeDEA?

5. Areallpharmacistsworkingfortheoutsourcerlicensedinthestateinwhichtheyarepracticing?

6. Ifrequired,arealloftheoutsourcer’spharmacytechnicianslicensedorregisteredinthestatewheretheyarepracticing?

7. Does the outsourcer meet or exceed state required pharmacist-to-pharmacy technician ratios for the stateinwhichthecompoundingcenterislocated?

8. IfanFDA-approvedproductiscommerciallyavailable(notonbackorder),doestheoutsourcer compoundthesamedrugformulationusingnon-sterilepowders?

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

No

No N/A

N/A

N/A

N/A

No

No

No

No

No

No

N/A


9. Whennocommercialsourceexiststoprepareadmixtures,doestheoutsourceruseUSPgradebulkingredientsobtainedfromacGMPcompliantsupplier?Ifyes,cantheoutsourcerprovideacertificate ofanalysisandpotencytestingofallbulkingredientsused?

10. Does the outsourcer have the required minimum amount of product liability insurance as outlined bymyinstitution?

11. Willmyinstitutionbecoveredbythisinsuranceintheeventthatthereisnowrittencontract withtheoutsourcer?

Part 2: Quality and Patient Safety Measures

12. Cantheoutsourcerprovidedocumentationthatconfirmsstaffcompetency(garbingandhandhygiene,aseptic technique and related practices, and cleaning and disinfection procedures) is evaluated prior to compoundingofactualdrugpreparations?

13. CantheoutsourcerprovidedocumentationthatconfirmsthattheoutsourcertestsaseptictechniquesbypreparingmediafillunitsperUSPchapter<797>standards?

14. Cantheoutsourcerprovidedocumentationthatconfirmsthatpharmacistsandpharmacytechniciansarepre-qualifiedusingmediafillsbeforecompoundingofactualdrugpreparations?

15. Howoftenareoutsourcingstaffrequiredtoundergore-qualificationusingmediafills?

16. Ifapositivemediafilloccurs,doestheoutsourcerperformacomprehensiveinvestigationtoidentifyrootcause?

Yes

Yes

Yes

Yes

Yes

Yes

More than once per year Annually Less than annually or never

No

No

No

No

No

No

Yes No


17. Ifapositivemediafilloccurs,doestheoutsourcerinstitutecorrectiveandpreventiveaction?

18. Doestheoutsourcerprovidecustomerswithsubstantialevidencethatsupportsextendedexpiration datingforcompoundedsterilepreparationswhenthisevidenceexists?

19. Does the outsourcer perform studies to determine extended expiration dates, using evidence-based andvalidatedstabilitytestingprocedures,forcompoundedsterilepreparationsforwhichnoextendedexpirationevidenceexists?

20. Doestheoutsourcerverifythatstaffmembersarecomplyingwithgowning,gloving,andglove-tip processesthatareconsistentwithUSPchapter<797>standards?

21. Does the outsourcer perform routine surface microbiological environmental monitoring to minimize microbiologiccontamination?

22. Doestheoutsourcerperformcomprehensiveinvestigationsofout-of-limitfindings,asrecommendedbyUSPchapter<797>,todeterminerootcause,followedbycorrectiveandpreventativeactions?

23. Howfrequentlydoestheoutsourcerperformnonviableandviableparticletestinginprimary engineeringcontrols(e.g.,laminarflowworkbench,biologicalsafetycabinet)androomair accordingtoUSPchapter<797>standards?

Yes

Yes

Yes

Yes

PerformsMorethanWeekly

ExceedsUSP<797>Guidelines(Performsmorethanweekly)

MeetsUSP<797>Guidelines(Performsweekly)

Does not meet USP797 Guidelines

PerformsWeekly

DoesNotPerformWeekly

No

No

No

No

ExceedsUSP<797>Guidelines(Performsmorethansemiannually)

MeetsUSP<797>Guidelines(Performssemiannually)

Does not meet USP797 Guidelines


24. Doestheoutsourcerhaveapolicythatrequiresvalidationofneworchangedfacilities,equipment,processes,containertypes,forsterility,andrepeatability?

Part 3: Medication Administration Safety Features

25. Doestheoutsourcerprovidereadilyaccessibleinformationregardingstatusoflatex,DEHPand preservativesinthepreparationstheyprepare?

Part 4: Service Excellence

26. Doestheoutsourcercompoundproductsinavarietyofcontainers(e.g.,syringes,minibags, pump-specificcassettes)tomeettheneedsofmyinstitution?

27. Does the outsourcer have business continuity plans in place in the event of a natural or man-made disasterorpublichealthemergency?

Minimum Requirement Assessment Results

Yes

Yes

Yes

No

No

No

Yes No


PART I: REGULATORY COMPLIANCE (20% of Total Score)

Section One: Current Registration and Licensure

1. Whatpercentageoftheoutsourcer’spharmacytechnicianstaffarecertifiedbyanauthoritativeboard(e.g.,PharmacyTechnicianCertificationBoard)?

2. Does the outsourcer provide pedigree information that documents that they do not purchase productsoutsideoftraditionaldrugdistributionnetworksorthroughsecondarywholesalers?

3. Ifacommercialproductcomponentofapreparationisonbackorder,cantheoutsourcerprovideacertificateofanalysis,potencytesting,andproofthatallotherrequirementsaremet(e.g.,higherlevelcleanroom)forHighRiskLevelCompounding?

4. DoestheoutsourcermeetASHPguidelinesforhandlingofhazardousagents?

5. DoestheoutsourcermeetNIOSHguidelinesforhandlingofhazardousagents?

6. DoestheoutsourcermeetUSPchapter<797>guidelinesforhandlingofhazardousagents?

Step 2. Vendor Assessment Thefollowingquestionsaredesignedtohelpyouobjectivelycomparetheservicesofferedbypotential

outsourcingvendors.Afteransweringeachquestion,theAssessmenttoolprovidesascoreforthevendor and a table to interpret the score.

<50%

Yes, all available Some or no Pedigree Information available

50-94% ≥95%

Yes

Yes

Yes

No

No

No N/A

Yes No N/A


Section Two: Availability of Reports and Technical Summaries

7. Hastheoutsourcerdisclosedanydisciplinaryorpunitiveactionbyanyregulatoryagency.(e.g.,FDAwarningletter,stateboardofpharmacy)withinthepast36months?

8. Does the outsourcer provide quality control history and quality assurance trend reports on a regular basisanduponrequest?

PART 2: QUALITY AND PATIENT SAFETY MEASURES (50% of Total Score)

Section One: Personnel Competency Through Media Fills

9. Cantheoutsourcerprovidedocumentationthatconfirmsthatsterilemediausedarecertifiedbythe manufacturertobesterileandguaranteedtopromotegrowth?

10. Can the outsourcer provide detailed reports on the incidence of positive media test results and the follow-upretestsaftercorrectiveactioniscompleted?Duringongoingmediamonitoring,howmanytimesinthelastyearwerepositivemediafillsreportedonrequalifications?

Part 1 Score

Yes, stillunresolved

All available Some or noneavailable

Yes, resolved No

Yes

Never Once More than once

No


Section Two: Availability of Reports and Technical Summaries

11. Inassigningexpirationandbeyond-usedating,doestheoutsourcerfollowevidence-basedandvalidatedstabilitytestingprocedurestoevaluateeachpreparation’s(drug,diluentanddevice/container)potencyatroomtemperatureorrefrigeratedtemperatureasapplicable?

12. Inassigningexpirationandbeyond-usedating,doestheoutsourcerfollowevidence-basedandvalidatedstabilitytestingprocedurestoevaluateeachpreparation(drug,diluentanddevice/container), based on a range of extreme temperatures, to ensure stability and determine the impact onthepreparation(e.g.evaporation,precipitation,degradation,concentration)?

13. Inassigningexpirationandbeyondusedating,doestheoutsourcerfollowevidence-basedand validatedstabilitytestingprocedurestoevaluateeachpreparation(drug,diluentanddevice/container)forchemicalcharacteristicssuchaspH,particulatematter,color,sterility(containerclosureintegritytesting)?

14. Doestheoutsourcerprovideminimumguaranteedshelflifeupondelivery?

Section Three: Maintenance of Sterility and Environmental Monitoring

Site Visit Question15. Doestheoutsourcerdocumentthatcleaningmethodsandagentsareeffectiveinpreventing

contaminationofthesterilepreparationsarea?

Site Visit Question16. Aresporicidalagentsusedtosanitizevialsandportstopreventsporegrowth?

17. Doestheoutsourcerhaveactionandalertlimitsforenvironmentalmonitoring?

Followsprocedures

Followsprocedures

Followsprocedures

Doesnotfollowprocedures



Yes

Yes

Yes

Yes

No

No

No

No


18. For systems that require validation, does the outsourcer initiate corrective and preventive actions basedonaformalreviewprocess?

19. Doestheoutsourcerhaveachangecontrolprocessfortimeswhenpreventivemaintenanceis completedorequipmentorsoftwareupgradesareinstalled?

20. Doestheoutsourcerhavedocumentedprocessesandprocedures(includingshippingvalidationstudies)toensurethatpreparationsleavingthesiteretaintheirintegrityandstabilitythroughtheshippingcycle?

PART 3: MEDICATION ADMINISTRATION SAFETY FEATURES (20% of Total Score)

Section One: Quality Label

21. DoestheoutsourcerusedrugnamedifferentiationintheformofTALLMANletteringasdefinedbyanauthoritativebodyforsound-alikeandlook-alikedrugs?

22. Does the outsourcer use visual cues on the label to differentiate drug names and drug concentrations withinatherapeuticclass?

23. Doestheoutsourcer’slabelingprovidetotaldrugamountandconcentration(e.g.,mg/mL)toensureadministrationofthecorrectdose?

Part 2 Score

Yes

Yes

Yes

Yes

Yes

Yes

No

No

No

No

No

No


24. Doestheoutsourcerprovideauxiliarycautionarylabelingtoindicatecontraindicatedroutesofadministration?

25. DoestheoutsourceruseASTM(AmericanSocietyforTestingandMaterials)colorcodingfor anesthesiasyringepreparations?

26. Doestheoutsourcerhavethecapabilitytoprovideadditionalriskcuesonanesthesiasyringesto differentiatedrugswithinatherapeuticclassand/orconcentration?

27. Does the outsourcer provide access to information on latex, DEHP and preservative free products 24 hoursperday,7daysperweek?

28. Doestheoutsourcerprovidebarcodesonallofitslabels?

29. Doestheoutsourcerprovidecomprehensivebarcodingthatincludesthenationaldrugcode(whenavailable)number,lotnumber,andexpirationdate?

30. Doestheoutsourcerprovidelabelformatsandbarcodeplacementthatallowvisualizationofdrugnameandconcentrationwhenusedintheinstitution’sautomatedinfusionpumpsorsyringepumps?

Section Two: Tamper Evidence

31. Doestheoutsourceroffertamper-evidentoptionswhichmayincludeoverwrap,shrinkwrap, tamper-evidentfoil,and/ortamper-evidentcaps?

Part 3 Score

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

No

No

No

No

No

No

No

No


PART 4: SERVICE EXCELLENCE (10% of Total Score)

Section One: Product Availability and Breadth of Line

32. Cantheoutsourcerprovideconcreteexamplesoftheirabilitytoprovidenewservicestomeettheevolvingpatientcareneedsofmyinstitution?

33. Doestheoutsourcercompoundmedicationsforepiduraladministration?

34. Doestheoutsourcercompoundmedicationsforintrathecaladministration?

35. Doestheoutsourcercompoundcontrolledsubstances?

36. Doestheoutsourcercompoundpatientcontrolledanalgesiasolutions?

37. Doestheoutsourcercompoundanesthesiasyringes?

38. Doestheoutsourcercompoundsolutionsforcontinuousnerveblocks?

39. Doestheoutsourcercompoundantibiotics?

40. Doestheoutsourcercompoundelectrolytesolutions?

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

No

No

No

No

No

No

No

No

No


41. Doestheoutsourcercompoundtotalparenteralnutrition?

42. Doestheoutsourcercompoundcardioplegiasolutions?

43. Doestheoutsourcercompoundsolutionsforuseinthecriticalcaresetting?

44. DoestheoutsourcercompoundCRRT(ContinuousRenalReplacementTherapy)preparations?

45. Doestheoutsourcercompoundoxytocinsolutions?

46. Doestheoutsourcercompoundchemotherapy?

47. Doestheoutsourcerfillelastomericcontainers/pumps?

48. Doestheoutsourcercompoundmedicationsforuseinpediatricpatients?

Section Two: Ease of Ordering

49. Doestheoutsourcerprovideeasy,convenientandreliableweb-basedordering?

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

No

No

No

No

No

No

No

No

No


50. DoestheoutsourcerofferE-222“CSOS”orderingforcontrolledsubstancepurchases?

51. Doestheoutsourcerofferareal-time,onlinereportingtool(e.g.,shipmenttracking,orderhistory,invoices)?

Section Three: Order Turnaround Time

52. Doestheoutsourcerprovideguaranteeddeliverytimeframesforcompoundedsterilepreparations?

53. Doestheoutsourcerprovidesame-daydelivery?

54. Doestheoutsourcerprovidenext-daydelivery?

Section Four: Storage and Space

Site Visit Question55. Doestheoutsourcer’scurrentproductioncapacitymeettherequirementsoftheorganization?

56. Istheoutsourcerwillingtoworkwiththeorganizationonsuggestionsforimprovementinstorage solutions(e.g.,customizedpackaging)?

57. Hastheoutsourcerincorporatedgreenprograms(e.g.,wastereductioninitiatives)intotheirservices?

Site Visit Question58. Iftheoutsourcerpreparescompoundedsterileproductsusingcontrolledsubstances,isthestorage

areaforthesesecureandisstaffidentificationrequiredpriortoentryintothearea?

Yes No

Yes No

Yes No

Yes No

Yes No

Yes No

Yes No

Yes No

Yes No


Section Six: Service Considerations

59. Doestheoutsourcernegotiatepriceswithgrouppurchasingorganizations?

60. Does the outsourcer have a mechanism to respond to customer service issues or questions 24 hours aday,7daysaweek?

61. Doestheoutsourcerhavetheclinicalexpertiseintheareaofproductsprovided(e.g.,TPN)?

62. Doestheoutsourcerhavestaffmemberswhoareknowledgeableinthenecessaryclinicalpharmacyareastothesupporttheeffortsofitscustomersindrivingchangewithinthehospital?

63. Doestheoutsourcerhavestaffmemberswhoareknowledgeableinthenecessaryclinicalpharmacy areaswhocanensurethatanorderreceivedfromahospitalisclinicallyandtherapeuticallyappropriate?

64. Cantheoutsourcerprovideconsultationservicesregardingpotentialcompoundingefficienciesandpracticechangesthatcanresultfromanalysisofcompoundingpatterns?

65. Doestheoutsourcerhaveatrackrecordforinnovationandprocessevolutionasevidencedby customertestimonials?

Part 4 Score

Yes No N/A

Yes No

Yes No

Yes No

Yes No

Yes No

Yes No


Step 3: Assessment Summary

20%

50%

20%

10%

100%

371 - 412Excellent

309 - 370Good

285 - 308Consider Other Sterile Products Outsourcing Options

This outsourcing contractor should not be considered for the provision of sterile products preparation services as this outsourcer was unable to meet one or more of the minimum requirments.

Interpret Your Score:Contractor AssessmentTool Score:

27

Interpret Your Score:412-371Excellent

370-330Good

329-301Consider other options

300Vendor is disqualified due to an unacceptable response to one or more minimum requirement questions.

≤

Contractor Assessment Tool Score:

*AzerointheTotalPointssectionunderVendorQualificationindicatesthatthevendorisdisqualifiedduetoanunacceptableresponsetooneormoreminimumrequirement questions.

Part 1: Regulatory

Part 2: Quality and Patient Safety

Part 3: Medication Administration Safety Features

Part 4: Service Excellence

Vendor Assessment Number of Questions

TotalRawScore

SectionWeight

WeightingMultiplier

TotalPoints

8

12

11

34

65

Number of Questions

TotalRawScore

TotalPointsVendor Qualification*

Part 1-4

Total

Sterile Products Outsourcing Tool (SPOT)

OUTSOURCING STERILE PRODUCTS PREPARATION … · Principles for Use • When outsourcing. sterile...

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