OUTSOURCING STERILE PRODUCTS PREPARATION
Transcript of OUTSOURCING STERILE PRODUCTS PREPARATION
OUTSOURCING STERILEPRODUCTS PREPARATION
CONTRACTOR ASSESSMENT TOOL
Developed with support from PharMEDium Services, LLC.
TM
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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
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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.
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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-sterilepowdersorothercomponents?
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
No
No N/A
N/A
N/A
N/A
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No
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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
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Yes No
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17. Ifapositivemediafilloccurs,doestheoutsourcerinstitutecorrectiveandpreventiveaction?
18. Doestheoutsourcerprovidecustomerswithsubstantialevidencethatsupportsextendedexpiration datingforcompoundedsterilepreparationswhenBUDlimitsinUSP<797>areexceeded?
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 and fungal environmental monitoring to minimizecontamination?
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
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No
No
No
ExceedsUSP<797>Guidelines(Performsmorethanweekly)
MeetsUSP<797>Guidelines(Performsweekly)
Does not meet USP797 Guidelines
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24. Doestheoutsourcerhaveapolicythatrequiresvalidationofneworchangedfacilities,equipment,processes,containertypes,forsterility,andrepeatability?
Part 3: Medication Administration Safety Features
25. Doestheoutsourcerprovidereadilyaccessibleinformationregardingstatusoflatex,DEHPand preservativesinthepreparationstheyprepare?
Part 4: Service Excellence
26. Doestheoutsourcercompoundproductsinthecontainerstypes(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
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Yes No
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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)forHighRiskLevelCompoundingperUSP<797>?
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
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Yes No N/A
N/A
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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?
Yes, stillunresolved
All available Some or noneavailable
Yes, resolved No
Yes
Never Once More than once
No
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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),basedonarangeofextremetemperaturesperUSPchapter<797>guidelines,toensurestabilityand determinetheimpactonthepreparation(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
Doesnotfollowprocedures
Doesnotfollowprocedures
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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?
Yes
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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. Doestheoutsourcerprovidesmachine-readablebarcodesonallofitslabels?
29. Doestheoutsourcerprovidecomprehensivebarcodingthatincludesthenationaldrugcode(whenavailable)number,lotnumber,andexpirationdate?
30. Doestheoutsourcerprovidelabelformatsandbarcodeplacementthatallowvisualizationofdrugnameandconcentrationwhenusedintheinstitution’sautomatedinfusionpumpsorsyringepumps?
Section Two: Tamper Evidence
31. Doestheoutsourceroffertamper-evidentoptionswhichmayincludeoverwrap,shrinkwrap, tamper-evidentfoil,and/ortamper-evidentcaps?
Yes
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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
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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
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N/A
N/A
N/A
N/A
N/A
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N/A
N/A
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50. DoestheoutsourcerofferE-222“CSOS”orderingforcontrolledsubstancepurchases?
51. Doestheoutsourcerofferareal-time,onlinereportingtool(e.g.,shipmenttracking,orderhistory,invoices)?
Section Three: Order Turnaround Time
52. Doestheoutsourcerprovideguaranteedtimeframesthatmeetyourorganization’sneedsfor compoundedsterilepreparations?
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 N/A
Yes No
Yes No
Yes No
Yes No
Yes No
Yes No
Yes No
Yes No
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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?
Yes No N/A
Yes No
Yes No
Yes No
Yes No
Yes No
Yes No
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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:90-100%Excellent
80-89%Good
70-79%Consider other options
69%Vendor 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
TotalRawPoints
SectionWeight
Available Points
SectionScore
8
12
11
34
65
Number of Questions
TotalRawScore
TotalPointsVendor Qualification*
Part 1-4
Total
Sterile Products Outsourcing Tool (SPOT)