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ModelRequestforProposalsforEquineDrugTestingLaboratory

Preparedby:

DionneBensonPetraHartmannMikeHopkinsLynnHovdaEdMartinMaryScollay

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Theaimofthisdocumentistofacilitatetheselectionofatestinglaboratorythat1)providesanalyticservicesthatmeetorexceedindustrystandards;and,2)representsthebestvaluetotheregulatoryagencyinsupportingtheenforcementofitsregulations.

Note:RMTClaboratoryaccreditationinformstheregulatoryagencythatalaboratoryhastherequisiteanalyticcapabilities;itdoesnotestablishorinsureperformancestandardswithrespecttotheanalysisofregulatoryagencysamples.Itistherefore,theresponsibilityoftheregulatoryagencytounequivocallyrequirethelaboratorytoperformtoindustrystandardswhenanalyzingitssamples.Todootherwisesubvertsthegoalofuniformityinmedicationregulationandcreatesthe‘illusionofintegrity,’ratherthantheapplicationoffairandconsistenttestingacrossallracingjurisdictions.

Theprocessoflaboratoryselectioncallsforthoroughandaggressiveduediligencebytheregulatoryagency.Thiscanbeimmenselyproblematicgiventhatfewregulatorshavethetechnicalknowledge,northetimeand/orresourcestodevelopadequateknowledgetocriticallyevaluateacandidatelaboratory.Thisdocumentprovides,inadditiontotherequirementstobeincludedinamodelRequestForProposals(RFP),explanationandjustificationforeachrequirementinorderthatagencyofficialsunderstandtheRFPtheyrelease,andhaveconfidencethatthedocumentaccuratelyrepresentstheagency’sneeds.ThisinformationmayalsobeusefulindefendingRFPcriteriaandtestingspecificationstootherstateagenciesthatmaybeinvolvedinthelaboratoryprocurementprocess.Theevaluationshouldreconciletheneedsoftheregulatoryagency,theexpectationsoftheindustry,andavailablefunding.Thelowestpricedoesnotnecessarilyrepresentthebestvalue.Scoringthatisbasedsolelyonpricecanunderminearespondinglaboratory’sabilitytooffertestingtoindustrystandardsandpublicexpectations,UNLESS,theregulatoryagency’sRFPismeticulousindefiningitstestingandlaboratorysupportrequirements.CandidatelaboratoriesmustbeRacingMedicationTestingConsortium(RMTC)accreditedandthuscomparableanalyticcapabilities.Therefore,pricingofferedthatissubstantiallylowerthanthatinotherresponsesshouldbecloselyscrutinized.Costcuttingmeasures(declaredorhidden)arelikelytoaffectthequalityofthetestingperformed.Fortheregulatoryagencywithsubstantialbudgetaryconstraints,itmaybenecessarytocontemplatetestingfewersamplesinordertosubjectthemtoanalysisconsistentwithindustryexpectations.Itis,infact,preferabletodefinetheagency’srequirementsandsolicitpricingonaper‐samplebasis—atwhichtimetheagencycandecidehowmanysamplesitwilltest.Thealternative—identifyingthetotalsumallocatedfortestingandthenumberteststobeperformed,andthensolicitingpricing—mayactuallyrequirelaboratoriestooffertestingbelowestablishedstandards,inordertofunctionwithintheother,fixedvariables(budgetandnumberoftests).

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Index PageI. Backgroundinformationprovidedbytheissuingagency………………… 4

II. Requirementsforsamplecollection/processing/shipment………………5

III. TestBarnInventoryManagement………………………………………………….7

IV. Shipping………………………………………………………………………………………. 8

V. LaboratoryPersonnel…………………………………………………………………… 10

VI. LaboratoryFacilities…………………………………………………………………….. 11

VII. LaboratoryAccreditation……………………………………………………………… 11

VIII. QualityControlandQualityAssurance………………………………………….. 12

IX. StandardOperatingProcedures……………………………………………………. 13

X. SampleManagement/SampleRetention………………………………………. 14

XI. ScopeofTesting—StandardPost‐RaceScreeningAnalysis……………… 16

XII. ScopeofTesting—Out‐Of‐CompetitionTesting………………………………. 19

XIII. ScopeofTesting—TCO2Analysis…………………………………………………… 20

XIV. ScopeofTesting—Samplesderivedfromhorsesworkingfor

releasefromtheVets’List……………………………………………………………… 21

XV. ElectiveTesting—Targetedanalysisofadministeredsubstances…….. 22

XVI. ScopeofTesting—Confiscatedsubstances/unknowns…………………... 23

XVII. Subcontractingoroutsourcingofwork…………………………………………... 23

XVIII. ChangestoScopeofTesting…………………………………………………………… 24

XIX. Turn‐around‐times—ScreeningandConfirmatoryAnalyses…………… 25

XX. QualityControl/QualityAssurance……………………………………………….. 26

XXI. Reports/Communications/SupporttoRegulatoryAgency…………… 28

XXII. Historicalinformation…………………………………………………………………… 30

XXIII. Research…………………………………………………………………………………….… 31

XXIV. Value‐addedservices…………………………………………………………………….. 31

XXV. Disclosureofcompetingbusinessinterestsofconflictofinterest…….. 32

XXVI.Defaultoncontractualobligations…………………………………………………. 32

XXVII. Pricing……………………………………………………………………………………….… 33

XXVIII.EvaluationofResponsestoRFP……………………………………………………37

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I.Backgroundinformationprovidedbytheissuingagency

Thesolicitationshouldprovidethefollowinginformation:1. Numberofracedays(ateachtrack,ifmultipleracetracksareinvolved)

2. Racingcalendar,includingposttimes(suchthattherespondinglaboratory

canidentifyprospectiveshippingschedules)3. Copyofthecurrentmedicationregulations,(includinginformationrelevant

tofiledorpendingregulationchanges)

4. Theaddressofeachracetrackfromwhichsampleswillbesubmittedtothelaboratory,thenameandphonenumberoftheagency’scontactforeachracetrack

5. Descriptionofpreviousdrugtestingservices/activityincluding:

1. numberofsamples(post‐race,TCO2,outofcompetition,investigativeorother)submittedduringtheprevious2calendaryears;

2. frequencyof‘suspicious’samplesrequiringconfirmatoryanalysis;3. listofreportsoffindingissuedbytheagency’sofficiallaboratoryfor

theprecedingcalendaryear6. Descriptionofotherworkperformedbytheofficiallaboratory(i.e.

analysisofunknowns/confiscatedsubstances/syringeresidues,testingperformedfornon‐regulatory/intelligencegatheringpurposes)

7. Estimateofthenumberofserumandurinesamplestobetestedina12

monthperiod;provideexplanationforanychangeinsamplenumbersthatisgreaterthan10%relativetotheprevious12monthperiod.

8. EstimateofthenumberofTCO2samplestobetestedina12monthperiod;

provideexplanationforanychangeinsamplenumbersthatisgreaterthan10%relativetotheprevious12monthperiod.

9. Approximatenumberofhumansamplestobetested

IfsamplesderivedfromhorsesinGradedandListedStakesaretobesubjected toascopeofanalysisthatdiffersfromthatappliedtothestandardpost‐racesamples:10. Estimateofthenumberofserumandurinesamplesina12monthperiodto

undergoanalysisasprescribedbytheThoroughbredOwnersandBreeders’AssociationAmericanGradedStakes(TOBAAGS)Committee;provideexplanationforanychangeinsamplenumbersthatisgreaterthan10%relativetotheprevious12monthperiod.

11. Adescriptionofthesampleshipmentscheduleusedintheprevious12monthperiod.

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Comment:Itisstronglyrecommendedthatallofficialpost‐racesamplesbesubjectedtothesamescopeofanalysis.Itisdifficulttocrediblyjustifyalesserscopeoftestingfornon‐stakesraces.Wageringintegrityspansallclassesofracing,andthepublicisunlikelytoacceptthatthroughitstestingprogramtheregulatoryagencyistolerantofracingatlowerlevelsimportancebeingimpactedbytheuseofmedication(regulatedorprohibited)inawaythatisnotpermittedatotherclassesofracing.

II.Requirementsforsamplecollection/processing/shipment1a.ThelaboratoryshallprovidetotheCommissionstaffallitemsnecessarytocollect,label,process,store,andshipsamples,inclusiveof:bloodcollectiontubes,bloodcollectionneedles,liddedurinecollectioncupsofsufficientsizetocollecttherequiredsamplevolumeasestablishedbythelaboratory,primaryandsplitsampleurinespecimencontainerswithscrewcaps,urinecollectionsticks,non‐sterileexamgloves,sequentiallynumberedbarcodedsampleIDtags,tamper‐proofsecuritytape,centrifuge,refrigerator,freezer,chainofcustodydocuments,shippingcontainers,securitylocks,coolants,padding/absorbentfill,secondarywatertightreceptacles,andshippinglabels.ThelaboratoryshallbearallcostsassociatedwiththeshipmentanddeliveryofsuppliestoCommissionstaff.InitsResponsethelaboratoryshallprovidesamples,orphotographsanddescriptionsofmaterialsandequipmentdescribedabove.

OR 1b.ThelaboratoryshallprovidetotheCommissionstaffclearanddetailedspecificationsforallitemsnecessarytocollect,label,process,store,andshipsamplesinclusiveof:bloodcollectiontubes,bloodcollectionneedles,liddedurinecollectioncups,primaryandsplitsampleurinespecimencontainerswithscrewcaps,urinecollectionsticks,non‐sterileexamgloves,sequentiallynumberedbarcodedsampleIDtags,tamper‐proofsecuritytape,centrifuge,refrigerator,freezer,chainofcustodydocuments,shippingcontainers,securitylocks,coolants,padding/absorbentfill,andsecondarywatertightreceptacles.Comments:Ratherthanrequiringthelaboratorytosupplytheabove‐describedmaterialstheregulatoryagencymayelecttopurchasesomeorallthroughgovernmentcontractinordertoreducecosts.Regulatoryagenciesshouldbeawarethatarequirementfortherespondinglaboratorytoproviderefrigerators,freezers,centrifugesorotherTestBarnhardware,willaddtotheoverallcostofthecontract.Localpurchaseofrefrigerators,freezers,

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andcentrifugesmayaffordamoretimelyresponseshouldrepairorserviceberequired.(Aservicecontractisrecommendedatthetimeofpurchase.)Totheextentthatthelaboratoryisrequiredbytheregulatoryauthoritytosupplysamplingmaterials,thosematerialsshouldonlybeusedforthepurposeoftestingofsamplesbythelaboratory.Iftheregulatoryauthorityelectstocollectsamplesforotherpurposes,itshouldexpecttopayforthosematerials,andshouldrequestpricingfromthelaboratoryintheRFP.Attheendoftheday,thereshouldbeaclearunderstandingofwhichTestBarnsuppliesandequipmentwillbeprovidedbythelaboratoryandwhichbytheregulatoryauthority.ForthepurposeofcomparingRFPresponses,thelaboratory’sobligationsshouldbeincludedasrequirementsintheRFPratherthannegotiatedafterthefact.

SampleCollectionSuppliesDescribed1. Collectionmaterials

1. Bloodcollectiontubes,size(volume)andtype(i.e.serumseparator,EDTA,heparin,sodiumcitrate)tobedeterminedby1. thetestingmethodologyemployedbythelaboratory,and2. theregulatoryagency’sstatutesand/orregulations(i.e.Ifa

substanceisregulatedbyathresholdinplasma,anticoagulanttubesmustbeutilized.Theanalysisofserumwhenaregulationspecifiesathresholdinplasmamayproveproblematicwhenprosecutingcases.)

2. CollectionneedlegaugeandlengtharebestdeterminedbythepreferenceofthoseperformingphlebotomyintheTestBarn.Thelaboratoryshallbenotifiedoftheagency’sneedlepreferences.(Smallboreneedles[≥21‐gauge]mayresultbothlongerfilltimesanderythrolysiswhichcanimpactcertaintestingmethods.Largebore[≤18‐gauge]needlesincreasetheriskofhematomapost‐collection.)

3. Urinecollectioncups(16oz.)shouldbeliddedandbearatamperevidentsecurityseal(thatcanbeverifiedasintactbeforethelidisremovedtoperformsamplecollection).

4. Urineprimaryspecimencups(20‐120mldependingonthelaboratory’surinevolumerequirements)withscrewcaps

5. Urinesplitsamplespecimencups(20‐120mldependingonthelaboratory’surinevolumerequirementsandtheregulatoryagency’sstoragecapacity)withscrewcaps

6. Urinecollectionsticks7. Non‐sterileexamgloves(tobewornbyindividualsperformingurine

collection)8. Evidencetape(forsealingstopperedendsofbloodtubesandlidsof

primaryandspliturinecontainers.

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1. SampleIDtagsandchainofcustodymaterials1. SampleIDtags

1. adhesivebacked(peelandstick)sequentiallynumbered,barcodedlabels

2. sufficientnumberoflabelstoidentifyallsamples(bloodandurine)collectedonaroutinebasis

3. informationcapturerelevanttothespecificneedsoftheregulatoryauthority(i.e.track,race,date,horse,trainer,horse’smedicationstatus,gender,claimedhorse,etc.)

4. Sampleinventoryform(copyretainedinTestBarn,copytoaccompanyshipment.

2a.Thelaboratoryshallprovideon‐sitetrainingforCommissionstaffinthecollection,labeling,processing,management,packaging,andshipmentofofficialsamples.

OR2b.ThelaboratoryshallprovidetrainingmaterialsforCommissionstaffonthecollection,labeling,processing,management,packaging,andshipmentofofficialsamples.ThelaboratoryshallprovideacopyofproposedtrainingmaterialsinitsResponse.Comment:On‐sitetrainingrepresentsaddedexpense,butalsoprovidestheopportunityforanauditoftestbarnprotocols.Thedistributionoftrainingmanualsbythelaboratoryrepresentsareduced‐costoption.Eitherway,thereshouldbeaclearunderstandingbetweenthelaboratoryandtheCommission’sTestBarnstaffforallproceduresrelatedtosamplecollection,labeling,processing,packagingandshipping.Howsamplesaremanagedpriortotheirarrivalatthelaboratoryhasadirectimpactonthequalityoftheensuinganalysis.III.TestBarnsupplyinventorymanagementIf1a.(ormodificationthereof)isutilized‐‐3.ThelaboratoryshalldelivertotheaddressprovidedbytheCommissionaninventoryofmaterials(asdescribedinsection1)nolessthan24hourspriortothebeginningofeachracemeeting.Commissionstaffshallmonitordepletionoftheinventoryandsubmitrequeststothelaboratoryforreplenishmenttwoweekspriortocriticalneed,oratmutuallyagreed,predeterminedintervals.

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IV.Shipping4a.Thelaboratoryshallprovideclearinstructionsforpackagingofsamplessuchthatsamplesareshippedinaccordancewithapplicablegovernment,InternationalAirTransportAssociation(IATA)andInternationalCivilAviationOrganization(ICAO)regulations.Thelaboratoryshallprovidechainofcustodymaterials.Thelaboratoryshallbearallexpenseassociatedwithpriorityovernightshipmentofsamplesbycommercialshipperorbybondedcourier(nextdaydeliveryby10:30a.m.)andstandarddeliveryreturnofemptycoolerstoCommissionstafftoanaddressprovidedbytheCommission.Thelaboratoryshallberesponsiblefortrackingshipmentsandidentifyingandremediatingdelaysordivertedshipments.Theregulatoryagencyshallnotifythelaboratorywhensamplesshipandprovideatrackingnumber.ThelaboratoryshallappointakeycontactpersonfortheCommissionforallmattersrelatedtosampleshipping.Thekeycontactpersonshallbeaccessibleondaysduringwhichliveracingtakesplace,inclusiveofweekendsandholidays.

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4b.Thelaboratoryshallprovideclearinstructionsforpackagingofsamplessuchthatsamplesareshippedinaccordancewithapplicablegovernment,InternationalAirTransportAssociation(IATA)andInternationalCivilAviationOrganization(ICAO)regulations.Thelaboratoryshallprovidechainofcustodymaterials.TheCommissionshallbearallexpenseassociatedwithpriorityovernightshipmentofsamplesbycommercialshipperorbybondedcourier(nextdaydeliveryby10:30a.m.)andstandarddeliveryreturnofemptycoolerstoCommissionstaff.TheCommissionshallberesponsiblefortrackingshipmentsandidentifyingandremediatingdelaysordivertedshipmentsandperformingthenecessarynotificationstothelaboratory.Thelaboratoryshallprovidedetailedspecificationsforshippingcontainers,packingmaterials,absorbentfill,coolants,andsecondarywatertightreceptacles.

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Comment:Theregulatoryagencymayexpectthatshipmentofsingleracedaysamplesetswillresultinincreasedcostwhencomparedtobatchshipmentofseveraldays’samples.Schedulingofshipmentsmusttakeintoconsiderationtheracingcalendarandthelaboratory’shoursofaccession.Regulatoryagenciesmayexpectincreasedshippingcosts(andpossiblyincreasedlaboratorycosts)whensampledeliveriesarescheduledforweekendsorholidays.Willtheregulatoryagencyretainsplitsamplesorwilltheybetransportedwiththeprimarysamplestothelaboratory?Ifthelaboratoryisexpectedtoinventoryandwarehousesplitsamples,theregulatoryagencyshouldanticipateadditionalexpensethatwillvarydependinguponthedurationofthestipulatedretentionperiodofthesplitsamples.Also,ifthelaboratoryisexpectedtowarehousethesplitsamples,theRFPshouldclearlyindicatewhatparty(laboratory,regulatoryagency,ortrainer)isresponsibleforcostsassociatedwithshipmentofasplitsampletoareferencelaboratory.InSectionI,BackgroundInformation,theregulatoryagencyshoulddefinethedesiredsampleshippingschedule,andclarifywhatsamples(primary+/‐split)thatthelaboratorywillbeexpectedtoreceive,inventory,andmanage.

Shippingmaterialsdescribed:2. Containers

1. Insulatedcoolerwithrigidsides2. Sizetobedeterminedbynumberofsamples(numberofracedays)

andsizeofsamplecontainerstobeshipped3. Lighterweightcoolersarepreferableasshippingratesareweight

dependent4. Musthavelockablehasp,orbemodifiedinordertoaccommodate

securitylock3. Locks/security

1. Single‐use,uniquelynumbered,tamper‐proofdevices2. Keyedpadlocksmaybeused,butalonedonotrepresentabest

practice4. Coolants5. Padding/absorbentfill6. Secondarywatertightreceptacle

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V.LaboratoryPersonnel5.TheLaboratoryDirectorandseniorchemistsshallbeprofessionalmembersingoodstandingoftheAssociationofRacingChemists(AORC)andhave,relevanttotheirresponsibilities,ascientificdegreeinoneormoreofthefollowingfields:chemistry,pharmacology,toxicology,veterinaryscience,orpharmaceuticalscience.Therespondinglaboratoryshallproviderelevantbiographicalinformation(education,degreesachieved,experience,scientificpublications,ongoingresearch,andindustryrelations/outreach)forthelaboratorydirector,seniorchemists,anddatareviewanalysts.Therespondinglaboratoryshallprovideanorganizationalchartandjobdescriptionsforallemployeesperformingcontractedservicesrelevanttotheregulatoryagency’ssamples.Therespondinglaboratoryshallprovidedocumentationofthetrainingprogramforallemployeesperformingcontractservicesrelevanttotheregulatoryagency’ssamples.Thisdocumentationshallincludeadescriptionofongoingproficiencytestingandperformancereview—includingasummaryofinternalproficiencyperformance,anydeficienciesnoted,correctiveactionplans(CAPAs)applied,andCAPAsoutcomes.ThelaboratoryshallidentifyandprovidecontactinformationforaKeyContactPersonfortheregulatoryagency.Thisindividualshallbeavailableduringstandardbusinesshoursaswellasevenings,weekends,andholidays.Thelaboratoryshallalsoidentifyandprovidecontactinformationforadesignatedback‐upcontactfortheCommission.Thelaboratoryshalldescribeitssuccessionplanforkeylaboratorystaff.Unscheduledchangesinkeylaboratorystaff(i.e.,laboratorydirector,laboratorymanager,commissionkeycontact,qualitycontrolofficer,andseniorchemist)determinedtobeunacceptablebytheregulatoryagencymayresultinearlyterminationofthecontract.Comment:Onlyqualifiedpersonnelshouldbeincontactwithitsofficialsamples,andthelaboratory,asaroutinepractice,shouldmonitorandevaluateindividualperformance.Thelaboratoryshouldhaveclearcriteriafortheamountofexperienceandproficiencyrequiredateachlevelofinteractionwiththeagency’ssamples.Thelaboratorymustdocumentthatitemploysasufficientnumberofqualifiedpersonnel

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whowillbeassignedtotheagency’ssamplessuchthatturn‐around‐timerequirementscanbeexpectedtobereliablymet.Itisimportantthatthelaboratoryhasasuccessionplaninplace.Illnessoraccidentcanoccurwithoutwarning,andalackofsuccessionplancouldrenderthelaboratoryincapableofmeetingitscontractualobligationsforanunspecifiedperiodoftime.VI.LaboratoryFacilities6.Thelaboratoryshalldemonstratethatitsfacilitiesaresecurefromaccessbyunauthorizedindividualsandthatsample‐handlingareasareuser‐specificandaccessibleonlybymanualkeyorelectronic/digitizeddevice.Thelaboratoryfacilityshallaffirmthatishasapower‐failurenotificationsystemandanalternativepowersourcetopreventcompromiseofsamplesintheeventofapoweroutage.Thelaboratoryshalldemonstratethatithasadequatelaboratoryworkspaceandstoragecapabilitiestomeettheanticipatedsampleloadtobesubmittedbytheregulatoryagencyandthelaboratory’sotherclients.ThelaboratoryshallprovidedocumentationthatitsfacilityisOSHA,ISO17025,andRacingMedicationandTestingConsortium(RMTC)compliant;andlocalcodecompliant.Comment:RequirementsdefinedinSectionVIcanbeconsideredfulfilledifthelaboratoryhasreceivedfullRMTCaccreditation.(Seebelow)VII.LaboratoryAccreditation7.ThelaboratoryshallprovidedocumentationthatithasISO17025andfullRMTCaccreditation,andthatitsaccreditationisingoodstanding.Thelaboratoryshalldiscloseanydeficienciesnotedonthemostrecentaccreditation(orre‐accreditation)siteinspectionandprovidedocumentationthatsaiddeficiencieshavebeenremedied.Thelaboratoryshalldiscloseifitsaccreditationhaseverbeensuspended,revoked,orotherwisesanctioned.Thelaboratoryshallprovidethedetailsofanysanctionanditsresolution.

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Comments:ISO17025accreditationdoesnotaddressalaboratory’stestingsensitivityorrequirespecificanalyticmethods.Thisaccreditationestablishesthatthelaboratorycanperformtheworkthatitsaysitcan,andthatitcanprovideconsistentresults—eitherthroughtherepeatanalysisofasinglesample,ortheanalysisofmultiplesamplesovertime.ISO17025accreditationaloneshouldnotbeinferredtomeanthatalaboratoryhasthecapabilitiesrequiredtoprovideanalyticsupporttotheagency’smedicationregulations.RMTCaccreditation,throughitsexternalqualityassuranceprogram,isintendedtoestablishthatthelaboratoryhastheanalyticmethodsinplacetodetectsubstancesofregulatoryinterestatrelevantconcentrations.Unfortunately,aregulatoryagencyhastheabilitytorequirethatitslaboratoryperformitscontractualworkatsubstantiallylowerstandards—oftenasacostsavingmeasure—andconstrainthelaboratoryfromdoingtheworkofwhichitiscapable.Suchadecisionnegatesallvalueassociatedwithlaboratoryaccreditationandpreventstheagencyfromfulfillingitsregulatorymandates.Itistheresponsibilityoftheissuingregulatoryagencytorequirethattestingbeperformedtothecurrentindustrystandards,suchthatuniformrulescanbesupportedbyuniformtesting.VIII.QualityControlandQualityAssurance8.ThelaboratoryshallparticipateinAORCandRMTCexternalqualityassuranceprograms(EQAP).Theresultsofthelaboratory’sanalysisofsingle‐ordouble‐blindedproficiencysamplesshallbedisclosedtotheregulatoryagencywithin30daysofitsreceiptoftheEQAP’sreport.Foranytestingdeficiencies,thelaboratoryshallprovidedocumentationofthecorrectionplantobeimplemented,andatimelineforimplementation.ForanyotherEQAP(s)inwhichthelaboratoryparticipates,thelaboratoryshallprovideallresults,andcorrectiveactionplansasrequired.ThelaboratorymaynotsubstituteotherEQAPsfortheAORCand/orRMTCprograms.Thelaboratoryshallroutinelyperformanalysisofinternalblindsamplesofsubstancesofregulatoryinterestatrelevantconcentrations.Thelaboratoryshallnotifytheregulatoryagencywithin5businessdaysofafailedanalysis,andprovideacorrectiveactionplan(andtimeline)forremedyingthedeficiency.ThelaboratoryshallprovidetheregulatoryagencywithquarterlyreportsofEQAPandInternalBlindsampleanalysis,inclusiveoftheanalytesdetected.Thelaboratoryshallprovidethepreceding90day’shistoryofinternalblindsampleanalysisinitsResponse.ThelaboratoryshallprovideafulldescriptionofitsinternalqualitycontrolmeasuresinitsResponseandaffirmthatithasadesignated,qualifiedQualityAssurance/QualityControlofficerhavingtherequisiteauthoritytoremedydeficienciesidentified.

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Comment:ForalaboratorytomaintainitsaccreditationitisrequiredtoparticipateinEQAP.Aregulatorisrarelyinthepositiontoaccuratelyassessalaboratory’stechnicalcapabilitiesorperformance.However,theregulatoryagencyshouldbeveryinterestedinhowmanyinternalblindsamplesareanalyzed,howmanyexternalqualityassurancesamplesareanalyzed,andhowthelaboratoryperformedonthosesamples.Otherthansplitsampleanalysis,thisisthebestavailableauditofthelaboratory’sperformance.Theclientshouldexpectastrongcommitmentfromthelaboratorywithrespecttoquality,andthewillingnesstoendurescrutinyofitsQualityControlandQualityAssuranceprograms.Alaboratory’sreluctancetodiscloseQA/QCprogramsandperformanceshouldbearedflagtoapotentialclient.IX.StandardOperatingProcedures9.ThelaboratoryshallhaveStandardOperatingProcedures(SOPs)forallprocessesandmethods.SOP’sshouldbe,wereapplicable,baseduponmethodsthatwilldetectsubstancesatorbelowtheregulatorythresholdsrequiredbytheagency’sregulations.ThelaboratoryshallarchivecopiesofretiredSOPsinsuchamannerthattheproceduresthatwereusedtotesteachspecificsamplecanbeidentified.TheSOPsshallbeaccessibletolaboratorystaff.SOPsshallbereviewedandupdated,aswarranted,onaregularbasis.Comment:Historically,someregulatoryagencieshaverequestedcopiesoftherespondinglaboratory’sSOPmanuals.Thisisproblematicinthatthecontentsareproprietary,butmaythenbesubjectedtoopenrecordslawsafterbeingtransferredtothesolicitingagency.ISO17025accreditationrequiresthatthelaboratoryhaveSOPs,thattheSOPsareutilized,andappropriatelymaintained.ISO17025accreditationsiteinspectionsincludereviewofSOPsbyqualifiedindividuals.ThereviewofanSOPbyunqualifiedindividuals(i.e.regulatoryagencypersonnel)doesnotaddvaluetotherespondinglaboratory’sapplication.

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X.SampleManagement/SampleRetention10.ThelaboratoryshallhaveaLaboratoryInformationManagementSystem(LIMS)inwhichallinteractionswitheachsamplearedocumented‐‐fromaccessionthroughtheissuanceofafinalreport,anduntilsuchtimeasthesampleundergoesdisposal.Allsamplesshallbeassigneduniquelaboratoryidentificationnumbers.Assignmentofinternallaboratoryidentificationnumbersshallbeperformedbysampleaccessionpersonnelinadedicatedsamplereceivingareathatissegregatedfromareaswhereanalysesareperformedordrugreferencestandardsareused.Priortotheinitiationofanyanalysis,samplesandtheircorrespondingdocumentsshallbeinspectedwithanyirregularitiespromptlyreportedtotheregulatoryagency.Theregulatoryagencyshallthenprovidethelaboratoryguidancewithrespecttotheanalysisoftheaffectedsample.WiththeexceptionofTCO2analysis,allotheranalysesshallbeinitiatedwithin24hoursofthesamples’arrivalatthelaboratory.AnalysisofTCO2samplesshallbeinitiatedpromptlyuponthesamples’arrivalatthelaboratory.TCO2testingshallnotbeperformedonsamplesthatwerecollected120ormorehourspriortoanalysis.Thelaboratoryshallpromptlynotifytheregulatoryagencywhentestingisabortedduetosampleage.Fromtimeofaccessionthroughtheissuanceofafinalreport,allprimarybloodsamplesshallberetainedinasecuredrefrigeratorandallprimaryurinesamplesretainedinasecuredfreezer.Long‐termstoragefreezersshalllikewisebesecuredandaccessibleonlytoauthorizedlaboratorypersonnel.Negative(passed)samplesshallberetainedinarefrigerated(blood)orfrozen(urine)conditionforaperiodof____________(days/months).Suspicious,butsubsequentlypassed,samples(bloodandurine)shallberetainedinafrozenconditionforaperiodof____________(months).Positive(failed)samples(bloodandurine)shallberetainedinafrozencondition(‐80oC)for__________________(months/years).Theregulatoryagencymustauthorizethedisposalofpositive(failed)samples,regardlessofthedesignatedretentioninterval.

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AND

10a.Attheendofthespecifiedretentionperiod,thelaboratoryshallautomaticallydisposeofthepassedandsuspicioussamples

OR

10b.Attheendofthespecifiedretentionperiod,theregulatoryagencywill,uponrequestbythelaboratory,authorizedisposalofthepassedandsuspicioussamples.Ifthelaboratoryistoinventoryandretainsplitsamples….10.1Splitsamples(bloodandurine)shallberetainedinafrozencondition(‐80oC)for__________(months/years).Theregulatoryagencymustauthorizethedisposalofsplitsamplesattheendofthedesignatedretentioninterval.Ifthelaboratoryistoinventoryandretainuntestedsamples….10.2Untestedsamples(bloodandurine)shallberetainedinafrozenconditionfor________(months/years).Theregulatoryagencymustauthorizethedisposalofuntestedsamplesattheendofthedesignatedretentionperiod.Comment:Theinternal‐use,Laboratory‐assignedidentificationnumberisakeyintegritymeasuretoinsurethatspecificsamplescannotbeattributedtospecifichorsesorindividualsduringtheanalyticprocess.Thissystemeffectivelyblindsthesampleandthusunauthorizedcontactoflaboratorypersonnelbyexternalindividualscannotresultinsamplemanipulationorthedisclosureofanalyticresultspendingtheissuanceofafinalreport.Itisimportantthatanyirregularitiesassociatedwithasample(i.e.hemolysis,unusualodor,otherevidenceofsampledegradation,absenceof,ordamageto,securitytape,orerrorsinassociateddocuments)beidentifiedandaddressedpriortotheinitiationofanytesting.Forexample,theabsenceofasecuritysealmaycompromisedefenseofchainofcustodyandrenderafindingnon‐prosecutable.Inconsiderationofthat,theregulatoryagencymayelecttoexcludethatsamplefromanalysis.Iftheanalysisofa

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sampleweretoproceedwithoutthelaboratoryconsultingitsclient,theclientmayfinditselfintheuntenablepositionofanon‐actionablepositivetest.Thedurationofsampleretentionwillimpactthecosttotheregulatoryauthority.Positivesamples(andsplitsamples)shouldalwaysberetainedpendingfinalcaseresolution.Theretentionperiodfornegativesamplesshouldbedeterminedinconsiderationofpotentialusesofthosesamplesforresearchorintelligencegatheringpurposes.RegulatoryagencieshavingbudgetaryconstraintsmayfindbenefitinshorterretentionperiodsforNegativesamples.Therequirementthatthelaboratorysecurepermissionfromtheregulatoryagencyforsampledisposalallowsfortheselectivelong‐termretentionofspecificsamplesofinterest(i.e.thoseassociatedwithatrainerhavinganexceptionallyhighwinningpercentage)suchthattheycouldbesubjectedtonewlydevelopedtestsatalaterdateforthepurposeofintelligencegathering.Inordertoreducethecostassociatedwithsampleretention,theregulatoryagencymayelecttoauthorizetheautomaticdisposalofTCO2samplesimmediatelyfollowinganalysisandthedeterminationofregulatorycomplianceinthesamples.

XI.ScopeofTesting—StandardPost‐RaceScreeningAnalysis11.1a.Allpost‐racesamplesshallbesubjectedtoinstrumentalscreening analysisasdescribedinsection11.3.

AlimitednumberofELISAtests,forsubstanceslackingavalidatedinstrumentalscreeningmethod,mayalsobeproposed.

ThelaboratoryshallprovidejustificationforeachELISAtestit intendstoapplytotheregulatoryagency’ssamples. Thelaboratorymustdemonstratethatthesensitivityof proposedELISAtestkitsisrelevanttotheagency’sregulationof thelistedsubstances. ELISAtestsmaynotberotated;allproposedtestsmustbe appliedtoallpost‐racesamples. Theuseofthin‐layerchromatographyisnotpermitted. Samplesmaynotbepooled.

Allsamplesshallbesubjectedtothesamescopeofanalysiswithrespecttothresholdsubstances.

OR

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11.1b.Allpost‐racesamplesidentifiedfortestingshallbesubjectedto instrumentalscreeninganalysisasdescribedbelow.Theprocessfor identifyingsamplestobesubjectedtoanalysisisdescribedinsection 11.2.

AlimitednumberofELISAtests,forsubstanceslackingavalidatedinstrumentalscreeningmethod,mayalsobeproposed.

ThelaboratoryshallprovidejustificationforeachELISAtestit intendstoapplytotheregulatoryagency’ssamples. Thelaboratorymustdemonstratethatthesensitivityof proposedELISAtestkitsisrelevanttotheagency’sregulationof thelistedsubstances. ELISAtestsmaynotberotated;allproposedtestsmustbe appliedtoallpost‐racesamples. Theuseofthin‐layerchromatographyisnotpermitted. Samplesmaynotbepooled.

Allsamplestestedshallbesubjectedtothesamescopeofanalysiswithrespecttothresholdsubstances.

Comment:Regulatoryauthoritiesarecautionedthatonaper‐substancebasis,whenlarge‐scalescreeningisbeingdoneonmultiplesamples,EnzymeLinkedImmunoassay(ELISA)testingcanrepresentasignificantlyhighercostwhencomparedtoinstrumentalscreening.InstrumentalscreeningofferseconomyofscalethatcannotbeachievedbyELISAtesting.Withrespecttothenumberofsamplestobetested,perthe1991McKinseyReport,“BuildingAWorld‐ClassDrugDetectionSystemfortheRacingIndustry:ANationalStrategicPlan,(AppendixA)”thereismeritincollectingmoresamplesthanaretobesubjectedtotesting.Individualsassociatedwithasampledhorsedonotknowwhetherornotthesamplewillbetested,andthisknowledge,orlackthereof,servesasalow‐costdeterrent.Thetestingofasubsetofsamplescollectedcanrepresentsubstantialcostsavingswithoutreducingregulatoryefficacy.Poolingofsamplessubvertsmedicationregulationandshouldbeexpresslyprohibited.Poolingisthepracticeofcombiningsamplesandperformingasingleanalysisonthecompositesample.However,thispracticesubstantiallycompromises

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thelaboratory’sabilitytodetectregulatedorprohibitedsubstances.Forexample,iffoursamplesaremixed,oneofwhichcontainsaprohibitedsubstanceandtheotherthreedonot,theprohibitedsubstance’sconcentrationhasbeenreducedby75%.Atthatloweredconcentration,thesubstancemaynotbedetectable,orifdetected,determinedtobeanirrelevantfinding.Forsubstanceshavingspecifiedregulatorythresholds,thisdilutioneffectmeansthatanexcessiveconcentrationinasinglesampleislikelytogoundetected.Itisfarbettertotestfewersampleswell,thanamultitudeofsamplespoorly.If11.1aisselected,gotosection11.3If11.1bisselectedselecteither11.2aor11.2b11.2a Asubsetofeachday’ssampleswillbeidentifiedbytheregulatoryagency,oritsdesignee,ascandidatesamples,eligibletobetesting.Allothernon‐‘candidate’sampleswillbetested.Ofthecandidatesamples,thelaboratoryshallrandomlyselectxx%fortesting,andretaintheremainingyy%accordingtotheprovisionsofSectionXofthisRFP.

OR11.2bTheregulatoryagency,oritsdesignee,willdesignatesamplestobetested,andthosetoberetained,nolaterthanthetimeofsamplesubmissiontothelaboratory.Comment:IfaregulatoryagencyelectstoemploytheMcKinsey‐recommendedsampling/testingapproach,itispreferablethatthedeterminationofthosesamplestobetested,andthoseretained,bedoneunder‘blinded’conditionsatthelaboratoryratherthanbyon‐trackpersonnel.Thiseliminatesanyperception(oropportunity)forindividualstobeaffordedpreferentialtreatmentorsubjectedtoharassmentthroughthetestingprocess.Stewards,orindividualsassignedwithmakingsampledesignations(mandatorytesting,orcandidatesample—eligibletoeitherbetestedorretained)shouldbeprovidedguidanceasdescribedintheMcKinseyreport.Theregulatoryagencymustalsodetermine:1)Howlongtheretainedsamplesmustbekeptbythelaboratory;2)Iftheycansubsequentlybeanalyzedforregulatory

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purposes;and/or3)Iftheycanbeusedforother,non‐regulatorypurposes(research,intelligencegathering,etc.

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Theretentionofsamplesrepresentsanaddedcost.Thelongertheretentionperiod,thegreatertheassociatedcost.Samplesretainedlong‐term(>6months)shouldbemaintainedatorbelow‐80oC.Evenatthislowertemperature,somesubstancesdemonstrateinstability,ortheirstabilityovertimeissimplyunknown.Retentionofsamplesbeyond6monthsmaybeofquestionablevaluewhensubjectedtoacost‐benefitanalysis.Iftheregulatoryagencyelectstoretainsampleslong‐term,thelaboratoryshouldberequiredtoprovideaffirmationthatitpossessessuitablestoragefacilities.11.3Thepost‐racetestingmenuforalltestedsamplesshallincludeinstrumentalscreeninganalysiswithascopeoftestingencompassingallControlledTherapeuticMedications(aspublishedintheRacingCommissionersInternational[RCI]ModelRulesChapter11)withtestingsensitivitiesatorbelowregulatorythresholds,andtheThoroughbredOwnersandBreeders’Association(TOBA)AmericanGradedStakesCommittee(AGS)requirements.Comment:CurrentcombinedRCIandTOBAAGSrequirementsshouldbeappliedtoallsamples.Thereisnocrediblejustificationforapplyinglessertestingstandards,andthusmorepermissivemedicationpolicy,tonon‐GradedStakesraces.Competition,particularlywhenwageringisinvolved,cannotlegitimatelybeconductedundervarying‘degrees’ofintegrity.AsRCIandTOBAAGSrequirementsarereviewedandupdatedonaregularbasis,aregulatoryagency’sscopeofrequiredtestingmayrequireamendmentduringacontractperiod.Thiswillrequireflexibilityfromtheregulatoryauthoritywithrespecttopricinginordertocontinuetestingwiththedesiredscopeofanalysis.XII.ScopeofTesting—Out‐of‐CompetitionTesting12.Sampleswillbetestedtoascopeofanalysisasdescribedin(insertagency’soutofcompetitionregulation).Samplesmaynotbepooled.Thelaboratoryshalldescribethevalidatedmethodologyitemploysforscreeningandforconfirmatoryanalyses.

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Comment:Manyexistingoutofcompetitionregulationsreferencesubstancesforwhichcurrenttestingmethodsdonotexist.Whilethismayresultinlimitedenforcementopportunities,itisnotunreasonabletoidentifythesesubstancesasbanned.However,itisimportantthattheregulatoryagencyunderstandanylimitationswithrespecttotestingforthosesubstances.Whiletheregulatoryauthoritymaynotwishtoperformpublicnotificationwithrespecttobannedsubstancesforwhichvalidatedtestingmethodsareunavailable,itisimportantthattheagencyhasaclearunderstandingofthelaboratory’sanalyticcapabilitiesandlimitationsastheyrelatetoenforcementoftheagency’sregulations.Forjurisdictionshavingoutofcompetitionsamplescollectedatsitesotherthanlocationswithongoingliveracemeets,itisnecessarytodefinewhichparty(laboratoryorregulatoryagency)isresponsibleforcostsassociatedwithsampleshipment.Thisexpenseislikelytobevariableandassuchcannotbereliablyprojected.Thecostassociatedwithovernightshipmentofasingleoutofcompetitiontestsamplecanexceedthepriceofsampleanalysis.Costassociatedwithshipmentofsamplesetsotherthanthoseoriginatingfromtrackswithongoingracemeetsshouldrepresentanindependentexpense.XIII.ScopeofTesting—TCO2(TotalCarbonDioxide)Testing12.BloodsamplesidentifiedforTCO2testingshallbesubjectedtoanalysisonaBeckmanEL‐ISEinstrumentusingvalidatedmethodology.Ifthelaboratoryproposestoemployadifferentinstrument,itmustdemonstratetheproposedinstrumentisequivalentto,andprovidesresultsconsistentwith,Beckmanequipment.Samplesshallbesubjectedtoanalysiswithin120hoursofcollectionfromthehorse.Thelaboratoryshallnotanalyzesamples>120hourspost‐collection.Thelaboratoryshallpromptlynotifytheregulatoryagencyofanysamplesexcludedfromanalysisduetosampleage.Comment:Theregulatorythresholdof37.0mmol/lwasdevelopedthroughresearchstudiesinwhichtheBeckmanEL‐ISEinstrumentwasutilized.AnalysisperformedwithotherinstrumentsmayresultinthereportingofsubstantiallydifferentconcentrationsofTCO2RatherthanrequireregulatorstoadapttheirTCO2thresholdtotheinstrument,itistheobligationofthelaboratorytodemonstratethattheinstrumentitemploysforTCO2testingperformsconsistentlywiththeinstrumentthatwasusedtoestablishtheregulatorythreshold.

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XIV.ScopeofTesting—SamplesderivedfromhorsesworkingforreleasefromtheVets’List14.1.a.Samples(blood+/‐urine)shallbesubjecttocompletescreeningconsistentwithanalysesperformedonpost‐racesamplesasdescribedinSection11.Samplesmaynotbepooled.

OR

14.1.b.Samples(blood+/‐urine)shallbesubjectedtotargetedscreeninganalysis(consistentwithanalyticmethodsappliedtopost‐racesamplesasdescribedinSectionlI)for:________________(e.g.NSAIDs,corticosteroids,localanesthetics,anabolicsteroids,bronchodilators).Samplesmaynotbepooled.

AND14.2.aAllsuspiciousfindingsshallbesubjectedtoconfirmatoryanalysisconsistentwiththerequirementsofSection11.

OR14.2.bSuspiciousfindingsshallbereportedtotheregulatoryagency’skeycontactwhowillauthorizeconfirmatoryanalysisonanadhocbasis.Comment:HorsesworkingforreleasefromtheVeterinarians’Listshouldbesubjectedtotestingtoverifythattheactualconditionofthehorsewasnotobscuredbytheuseofmedication.Inmostcases,bloodistheonlysamplematrixavailable.SomejurisdictionsmaydiverthorsestoastaffedTestBarnforsamplecollection,inwhichcasepairedsamplescanbeacquired.TheRFPshouldspecifythesamplematrixtobesubmittedforpost‐worktesting:bloodonly,orbloodandurine.Itisdesirablethatturn‐around‐timeonthesetestsbeasrapidasisreasonablypossiblewithoutcompromisingthequalityoftesting.Inconsiderationofitsregulations,theagencymustdecideifscreeningresults(andtheestimatedconcentrationsgenerated)aresufficientforunderstandingthemedicationloadcarriedbyahorseduringtheobservedworkout.Ifso,confirmatoryanalysismaynotbenecessary,andturn‐around‐timecanremainconsistentwiththatforscreeningofpost‐racesamples.Iftheresultsofpost‐workdrugtestingmaybeusedtodeterminethatamedicationviolationhasoccurred,confirmatoryanalysis(asrequiredinSection

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11)mustbeperformed.Theregulatoryagencyshouldbeawarethatthiswillincreasecostandturn‐around‐time.Note:Afterthesuccessfulrespondantlaboratoryhasbeenidentified,itisadvisablethathorsemenareinformedoftheprojectedturnaroundtimeforthistypeofsampletoassisttheminplanningofworksandselectingracesinwhichtoentertheirhorses.Thelaboratorycannotbeexpectedtoexpediteasampleorsamplesinordertoaccommodateatrainer’sschedule.XV.ElectiveTesting—Targetedanalysisforadministeredsubstances15.Atthediscretionoftheregulatoryagency,samplesmaybesubmittedfortargetedanalysisforthedeterminationofoneormorespecificsubstance(s).Thematrix(bloodand/orurine)submittedshallberelevanttotheagency’sregulationswithrespecttothesubstance’sthresholdinbloodand/orurine.Allsamplessubmittedfortargetedanalysiswillbesubmittedthroughtheregulatoryagency.Thelaboratoryshallnotacceptprivatelyorindependentlysubmittedsamplesforanalysiswithoutthepriorconsentoftheregulatoryagency.Forsubstancesassociatedwitharegulatorythresholdotherthanthelaboratory’slimitofdetection,quantitativeanalysisshallbeperformed.Forsubstancesassociatedwitharegulatorythresholdatthelimitofdetection,qualitativeanalysisshallbeperformed.Thecostfortargetedanalysiscanbesubstance‐specificandmayappropriatelybeaddressedonaper‐samplebasis.Therefore,thelaboratoryshallestablishpricingafterreceivingnotificationofthedesignatedsubstanceandinformtheregulatoryagencyinadvanceofsamplesubmission.Thecostfortargetedanalysisshallnotexceedthelaboratory’spricingforanalysisofapost‐racesampleofthesamematrixabsentlaboratoryjustificationfortheincreasedcostandregulatoryagencyapproval.Thelaboratoryshallprovideitsreporttotheregulatoryagency.Anycommunicationsregardinganyandallaspectsoftheanalysisshallbebetweentheregulatoryagencyandthelaboratory.Thelaboratoryshallnotconsultdirectlywiththesubmittingveterinarian,trainer,orownerwithoutthepriorconsentoftheregulatoryagency.Thelaboratoryshallnotacceptsamplesforanalysisrelatedtodopingcontrol(regulatedtherapeuticmedicationsorbannedsubstances)fromanyindividualoragency,otherthanthosewithwhichithascontractualagreements,withoutthepriorconsentofthe(insertnameofregulatoryagency).

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Comment:Theabilitytoofferclearancetestingforregulatedsubstancesprovidesstakeholdersassistanceintheircompliancewithregulations.However,thereisriskthatthisservicecouldbeusedtotitratedosesoralteradministrationtimesinordertosubvertregulations.(Theregulatoryagencyshouldrequirespecificinformationpertainingtodoseandrouteofadministrationwhenacceptingthesesamplesforanalysis.)Whileitisreasonableforlaboratoriestoacceptexternalsamplesforanalysisunrelatedtodopingcontrol(i.e.pre‐orpost‐purchasetesting),itisimportanttoconstrainthelab’sabilitytoacceptofexternalsampleswhereanalyticresultscouldbeutilizedtosubverttheregulatoryagency’sregulations.XVI.ScopeofTesting—Substances/unknowns16.Forsubstancesbearingcontentlabels,thelaboratoryshallperformanalysisconsistentwiththeRMTCProtocol for Verification of Label Ingredients. (Appendix B) Forsubstanceslackingalistoflabelingredients,thelaboratoryshallperformanalysisconsistentwiththeRMTCUnknownSampleProtocol.(AppendixC)XVII.Subcontractingoroutsourcingofwork17.Thelaboratorymaynotoutsource,orengagesubcontractorsfor,anyworkrelatedtotheregulatoryagency’ssamplesforanyreasonwithoutthepriorwrittenconsentoftheregulatoryagency.Anysuchrequestmustbefullyjustifiedandincludedocumentationofthequalificationsofthecontractor,affirmationthattheanalyticrequirementsoftheregulatoryagencywillbemet,andthatchainofcustodyprocedureswillremainintact.Theproposedcontractlaboratoryshallaffirmitswillingnesstoaccepttheagency’ssamples.Thedurationofservicetobeprovidedbythecontractorshallbedefined.TheuseofacontractorbytheofficiallaboratoryshallnotjustifyanyincreaseincosttotheregulatoryagencyUNLESStheworktobeperformedbythecontractorrepresentsanagency‐initiatedchangeinitsrequiredscopeoftesting.

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Comment:Theremaybeanumberofreasonsfortheuseofacontractlaboratory,somegood,somenot.Whatisimportantisthatifacontractlaboratoryistobeused,thatthereisnovulnerabilitytotheregulatoryagencyintermsofthequalityoftestingandthedefensibilityofanyactionablefindingthatmightresultfromoutsourcedwork.Insomecases,theneedforacontractlaboratoryisknownatthetimetheRFPresponseissubmitted.Quantitativeanalysisforcobaltisperformedoninstrumentsrarelypossessedbydrugtestinglaboratories.Itisanticipatedthatfortheforeseeablefuture,inmostcasescobaltanalysiswillbeoutsourced.Laboratorieslackingtheabilitytoperformconfirmatoryanalysisforerythropoietinordarbepoetinwillhaveestablishedrelationshipswithlaboratorieshavingavalidatedconfirmatorymethod.Inthesecircumstances,thecontractlaboratoryshallbeidentifiedintheRFPresponse.Intheeventthattheneedtooutsourceanalyseswasnotpredetermined,itisimportantthattheselectedlaboratoryaffirmitswillingnesstoacceptthesamplesandperformitsworktotheagency’sspecificationsanddesiredturn‐around‐time.XVIII.ChangestoScopeofTesting18.Thelaboratorymaynotamendthescopeoftestingforanysample(s),withoutsecuringpriorpermissionfromtheregulatoryagency.Theregulatoryagencymayrequestchangestothescopeoftestingduringtheperiodoftheservicecontract.CostsassociatedwithmethodvalidationforimplementationofthresholdsestablishedbytheARCIandadoptedbytheregulatoryagencyshallbeabsorbedbythelaboratory.CostsassociatedwithmethodvalidationforthresholdsotherthanthoseestablishedbytheARCIshallbebornebytheregulatoryauthorityestablishingthethreshold.Forotherrequestsbytheregulatoryagencyforchangestothescopeoftesting,theregulatoryagencyandlaboratoryshallidentifycostsassociatedwiththeprojectedwork.Priortothecommencementofmethoddevelopmentandvalidation,theregulatoryagencyandlaboratoryshall,tothesatisfactionofbothparties,determinehowthemethoddevelopment,validationandsubsequenttestingwillbefundedandthatadequatefundingexists.Comment:Itisimportantthattheregulatoryagencyunderstandwhattestingis,andisnot,beingperformed.ThisshouldbeclearlyestablishedthroughtheRFPprocess.Achangeinthescopeoftesting—whetheritappliestoallsamplesorasinglesample—mustneverbeimplementedwithouttheknowledgeandconsentoftheregulatoryagency.

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Thisrequirementalsoservesasaqualitycontrolmeasuretoinsurethatthebloodand/orurinecollectionprocessobtainsspecimensinvolumesthatdonotconstrainthelaboratory’swork,andthatsamplesarebeingconsistentlysubjectedtothescopeofanalysisasprescribedbytheregulatoryagency.XIX.Turn‐around‐times—ScreeningandConfirmatoryAnalyses19.Thelaboratoryshallelectronicallyissuescreeningreports(inclusiveofpost‐race,pre‐raceTCO2,post‐work,andoutofcompetitiontests)within________(business/calendardays)ofitsreceiptofsamplestoadistributionlistprovidedbytheregulatoryauthority.Intheeventthelaboratorydeterminesthatascreeningreportcannotbereportedasscheduled,thelaboratoryshallpromptlynotifytheregulatoryauthority,provideajustificationforthedelayandrequesttheregulatoryagencyforanextension.Extensionsshallbeforadefinedperiodaswarrantedbytheeventthatresultedinthedelay.Confirmatoryanalysis,whenwarranted,shallbecompletedwithin___________(business/calendar)daysoftheissuanceofthescreeningreport.Intheeventthelaboratorydeterminesthatafinalreportcannotbereportedasscheduled,thelaboratoryshallpromptlynotifytheregulatoryauthority,provideajustificationforthedelayandrequesttheregulatoryagencyforanextension.Extensionsshallbeforadefinedperiodaswarrantedbytheeventthatresultedinthedelay.Comment:Generally,screeningreportsshouldbeproducedtotheregulatoryagencywithin4‐7daysofthelab’sreceiptofsamples.Confirmatoryanalysesforcontrolledtherapeuticsubstancesshouldbereportedwithinanadditional5‐7businessdays.Othersubstancesmayrequireadditionaltimebasedontheavailabilityofreferencestandardsand/orvalidatedtestingmethods.Inthesecases,turn‐around‐timewill,outofnecessity,belonger.Intheseinstances,thelaboratoryshouldpromptlycommunicatetotheregulatoryagencyananticipatedtimelineforcompletionoftherequiredwork.Foranalysisofconfiscatedmaterials,targetedanalysisformedicationclearance,andanalysisofsampleotherthanthosedescribed,turn‐around‐timemaybedifficulttodefineinadvanceofthework’sactuallyhavingbeenperformed.Itislikelythatthesematterswillneedtobeaddressedatthetimeofsamplesubmissionandinconsiderationofthecircumstancessurroundingtheneedfortheanalysis.Note:Acontractualrequirementformorerapidturn‐around‐timesisassociatedwithincreasedcost.Forjurisdictionsunderbudgetaryconstraints,flexibilitywithrespect

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toturn‐around‐timerequirementsmayrepresentanopportunitytoconservelimitedfunding.XX.QualityControl/QualityAssurance20.Thelaboratoryshallhave,andidentifytotheregulatoryauthority,adesignatedqualitycontrolofficerwhoisresponsibleforimplementationofaninternalproficiency‐testingprogramcomprisedofanalysisofsingleblindsamplesandroutineperformancereviewsofallindividualshavingcontactwiththeregulatoryauthority’sofficialsamples.Internalblindsamplesshallcontainsubstancesofcurrentinterestatrelevantconcentrations.Theinternalproficiency‐testingprogramshallhave,asaminimum,ascopeofcoveragethatencompassesroutinescreeningtests.Resultsofinternalproficiencytestingshallbeprovidedtotheregulatoryauthorityona(quarterly/semi‐annual/annual)basis.Theregulatoryagencyshouldbepromptlynotifiedbythelaboratorykeycontactwhenanalysisofaninternalblindsamplefailstodetecttheanalytepresent.Thelaboratory’scorrectiveactionprocessshouldbedocumentedandprovidedtotheclientuponrequest.Thelaboratoryshallparticipateinexternalqualityassuranceprograms(EQAP),asrequiredthroughRMTCandISO17025accreditation.InitsresponsetotheRFP,thelaboratoryshallinformtheregulatoryauthorityoftheprogramsinwhichitparticipates,thenumberofEQAPsamplesitreceivesina12‐monthperiodandprovidejustificationfortheEQAPsinwhichitisenrolled.ThelaboratorykeycontactshallprovidetheregulatoryauthoritytheEQAP‐issuedreportofthelaboratory’sperformancewithin7workingdaysofreceiptoftheresultsofthetests.Thelaboratoryshallprovideitsclient(s),within30days,awrittenplantoremedyanydeficienciesidentifiedthroughtheEQAPprocess.OPTIONAL20a.Thelaboratoryshallparticipateinapassed‐sampleexchangeprogramwithoneormoreRMTC(ortheinternationalequivalent)accreditedlaboratories.(number)setsof(bloodand/orurine)shouldbeexchangedona(quarterly/semi‐annual/annual)basis.Resultsshallbeprovidedtotheregulatoryauthorityinatimelymanner.Comment:Qualityassuranceprogramsarecriticaltoassessinglaboratorycapabilities.ExternalQualityAssuranceProgram(EQAP)providersselectsubstances

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thatarerelevanttotheneedsofracingregulators.Whiletheclientmaynotbefamiliarwiththesubstance,oritseffect,theclientdoesneedtoknowifthelaboratoryiscapableofitsdetection.TheclientmustbenotifiedinatimelymanneroftheresultsofEQAPparticipation.EventhebestEQAPcurrentlyavailableusesasingleblindsystem—inwhichtheEQAPsamplesareclearlyindicatedassuch.Thisthenresultsinatestofthelaboratory’scapabilities,butdoesnotclarifythatthesecapabilitiesarefullyappliedtotheregulatoryauthority’ssamples.ThepassedsampleexchangeisausefuladjuncttotheEQAPinthatthesamplesarederivedfromactualracehorses,andthesub‐thresholdmedicationloadismorereflectiveofthatwhichisroutinelyseenbythelaboratory.Assumingconsistencyinmethodologyandsensitivity,thereshouldbegoodagreementbetweenthetwolaboratories.Recognizingthatthesesampleswillalsobeidentifiedtothelaboratory,itispossiblethatthey,liketheEQAPsamples,couldbesubjectedtoahigherlevelofscrutinythanthatappliedtothelab’sroutinework.Werethistobethecase,substancesidentifiedbythesecondlab,butnotbytheprimarylab,maybeidentifiedforadditiontothescopeofanalysisorrefinementinthelaboratory’ssensitivity.Pricingforapassed‐sampleexchangeprogramcanbeestablishedonaper‐samplebasisindependentofthecostsassociatedwiththeanalysisofofficialsamples,oritcanbepro‐ratedandaddedtotheperpost‐racesamplecost.Eitherway,thisprogramwillresultinsomeincreaseincosttotheregulatoryauthority.However,itismoneywellspent.Ifthereisconcernaboutdisclosureofresultsvis‐a‐vissamplesoriginatingfromanotherlaboratory,itmaybeprudenttoexecuteanMOUestablishingconfidentialityanddefiningtheuseoftheinformationgenerated.Note:Passedsampleexchangeprogramscanbeimpactedbydifferencesinmedicationregulationsbetweenjurisdictions.Fortheresultsofasampleexchangetobemeaningful,itisimportantfortheregulatoryagencytodetermineifasamplereportedaspassedinonejurisdiction,butfailedinanother,isindicativeofanalyticdifferencesORdifferencesintherespectiveagencies’regulationofthatsubstance.

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XXI.Reports/Communications/SupporttoRegulatoryAgency21.Screeningreports,finalreports,reportsofadversefindings,anddata(litigation)packetsshallmeetallISO17025‐2005andRMTCcriteria.Reportsshallbedistributedelectronicallytoadistributionlistprovidedbytheregulatoryauthorityorviafacsimiletoalocationdesignatedbythecommission.HardcopyreportsbearingoriginalsignatureswillbeproduceduponrequestanddeliveredbyFirstClassUSmailunlessotherwiserequested.Costsassociatedwithexpeditedoralternativedeliverymethodswillbeassumedbytheregulatoryauthority.Data(litigation)packetsshallbedeliveredtotheregulatoryauthorityelectronicallyorviaexpressmailnolaterthan7businessdaysaftertheregulatoryagencysubmitsitsrequestforthelaboratorytocompilethepacket.Onlyuponpriorauthorizationbytheregulatoryagencymaythelaboratorydiscussordiscloseanymethods,testingsensitivities,limitsofdetectionorotherinformationrelevanttothetestingoftheagency’ssamples.Shoulddataderivedfromtheregulatoryauthority’ssamplesbeintendedforuseinascientificpublication,thelaboratoryshallsolicitpermissionfromtheregulatoryauthorityandexecuteanappropriatenon‐disclosureagreementpriortosubmissionofamanuscripttoajournalforreview.Thelaboratorydirectorshallserveasexpertwitnessonbehalfoftheregulatoryagency,andprovideconsultation,oraltestimony,andscientificreferencesaswarranted,intheadjudicationofcasesarisingfromalaboratoryreportoffinding.

AND21.aCostsassociatedwithtravelandtimeforupto_____appearances,bythelaboratorydirectororotherlaboratorypersonnelintestimonyandtestimonypreparation,willbebornebythelaboratory.

OR21.bCostsassociatedwithtravelandtime,consumedbythelaboratorydirectororotherlaboratorypersonnelintestimonyandtestimonypreparation,willbereimbursedbytheregulatoryagencyatratescurrentatthetimeoftravelasestablishedbystategovernment.

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Comment:Screeningreportsshouldincludethefollowinginformation:Dateofreportissuance,originofsamples(racetrack),collectiondate,datereceived,dateanalysiswasinitiated,conditionofsamples,shippingsealnumber,agencysampleIDnumber,laboratoryinternalsamplereferencenumber,sampletype,analyticresult,totalnumberofsamplesandanalyticmethodsperformed.Ifallsamplesarepassedasaresultofscreeninganalysisperformed,thereportshouldindicate“Noviolationsdetected”orcomparableverbiage.Forsamplesidentifiedforfurtheranalysis,thereshouldbeanindicationof“Pending”orcomparableverbiage.Reportsoffailedsamplesshouldalsoincludetheexactfinding.Forsubstanceshavingregulatorythresholdsabovethelaboratory’slimitofdetect,thereportshouldcontaintheconcentrationdetermined,andthelaboratory’smeasurementuncertainty.(Forasubstancetobereportedbythelaboratoryasdetectedinaconcentrationinexcessoftheregulatorythreshold,thedetectedconcentrationmustexceedthethresholdplusthemethod’suncertaintymeasurement.)Themethodusedforconfirmatoryanalysisshouldbeidentified.Opinions,totheextentthattheyarerequired,mustbeclearlyidentifiedassuch.Casepreparationandtestimonybykeylaboratorypersonnel(mostoftentheLaboratoryDirector)canbeimportanttoanagency’sprosecutionofregulationviolations.Recognizethatin‐personappearancesathearingsrepresentsubstantialexpense,aswellastimeawayfromthelaboratoryandtheperformanceofotherduties.Skypeorvideoconferencingmayrepresentcost‐effective,andlegallyacceptable,alternativesfordepositionsandtestimony.ConfidentialityisimportantANDofficialdrugtestingresultscangenerateuseful,andrelevantresearch.Thebalancetobeachievedisthatifdataderivedfromanagency’ssamplesaretobeacomponentofresearch,thelaboratoryshallberequiredtoredactorrefrainfrompublishinganyinformationthatidentifiestheregulatoryauthority,theracetrack,date,orspecificrace.

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XXII.Historicalinformation22.Thelaboratoryshallprovideahistoryofitsexperienceinanalyticworkrelevanttothescopeofworkrequiredbytheregulatoryagency.Thelaboratoryshallprovidecontactinformationforthreeclientshavingsimilarservicerequirementstothoseoftheissuingagency.Forlaboratoriesperformingequinedrugtestingservicesforlessthanfiveyears,thelaboratoryshall,initsresponsetotheRFP,agreetoprovideaperformancebondfortheperiodofthecontract.Thelaboratoryshallprovideinformationrelatedtothedismissalofanyanalyticfindingsrelatedtofailureinchain‐of‐custody,erroneousorinadequatelydocumentedanalyticmethods,dataanalysiserror,orothereventattributabletothelaboratory.Thelaboratoryshallprovideinformationrelatedtothedismissalofanyanalyticfindingsrelatedtoareferencelaboratory’ssplitsampleanalysisfailingtosupporttheprimarylaboratory’sfinding.Thelaboratoryshallprovideinformationrelatedtothedeterminationbyanyhearingofficerorquasi‐judicialofficialthattestimonyprovidedbylaboratorypersonnelwasnotcredible.Thelaboratoryshalldiscloseifacontractwitharegulatoryagencyhaseverbeenterminatedduringtheperiodofthecontract,andifso,thelaboratoryshalldescribethecircumstancesresultingintheearlyterminationofservice.Comment:Theclientneedstoknowthatthelaboratory’sworkwillwithstandthedegreeofscrutinythatmaybeexpectedinalegalchallenge.Previousfailings,whilenotnecessarilyjustifyingalaboratory’sexclusionfromtheselectionprocess,shouldbenotedandadequatelyresearched.

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XXIII.Research23.Thelaboratoryshallprovideasummaryofitsongoingandcompletedresearchrelevanttoequinedrugtesting,theregulationoftherapeuticmedications,orthedetectionofbannedsubstancesinracehorsesamples.Thelaboratoryshalldocumenttheactivitiesofseniorstaffrelevanttomeetingsandoutreachwithindustryrepresentatives,stakeholders,andlicensees.Thelaboratoryshalldescribeitsongoingeffortstomonitoranalyticaltrends,gatherintelligence,andidentifysubstancesrepresentingemergingthreatstotheintegrityofthesportandthesafetyofitsparticipants.Comment:ResearchisarequirementforRMTCaccreditation.Itisworthknowingifcompletedresearchisrelevanttotheneedsoftheregulatoryagency,ortheracingindustryatlarge.Further,itwillbehelpfultoknowifthelaboratoryiswilling/abletoinvestigatequestionsidentifiedbyitsclients.Iftheregulatoryagencyhastheinclinationandabilitytofundresearch,theRFPcouldalsoincludelanguagedescribingtheprocessforthedeterminationofpricing,worktimelinesandresearchworkproduct.Alternatively,thiscouldbeaseparateagreement,independentofthedrugtestingcontract.ForregulatoryagenciesalsohavingjurisdictionoverGreyhoundracingorotheranimalsport,theabovelanguagemaybeexpandedtoreflecttheadditionalresearchinterests.XXIV.Value‐addedservices24.Thelaboratoryshalldescribeanyvalue‐addedservicesitintendstoprovidebeyondthoserequiredinthisRFP.Comment:Theavailabilityofthelaboratorydirectorforregularlyscheduledconferences(inpersonorviatelephone)todiscussaspectsoftheregulatoryagency’stestingprogram,attendanceatagency‐hostedmeetingswithstakeholders,orprovidingadditionalintelligencederivedfromtheagency’ssamplesrepresentexamplesofvalue‐addedservicethatmaybeofsubstantialbenefittotheclient.ItisworthaskingthelaboratorywhatsetsitapartfromotherRMTCaccreditedlaboratories.

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XXV.Disclosureofcompetingbusinessinterestsorconflictofinterestinkeylaboratorypersonnel25.TheRFPresponseshallincludedisclosureofanycompetingbusinessinterestsorconflicts‐of‐interestinanylaboratorypersonnelhavingpurchasingauthorityortheabilitytodetermineanalyticpractices.Comment:Theregulatoryagencymusthaveconfidencethatdecisionsmadewithinthelaboratoryareinthebestinterestsoftheanalyticneedsoftheirclients.Ifachemistisalsoassociatedwithacompanythatmanufacturestestkitsthatareutilizedintheanalysisofaclient’ssamples,thereisanobligationtoacknowledgeanddefendsuchuse.XXVI.Defaultoncontractualobligations

26.Thelaboratory'sfailuretoperforminaccordancewithalltermsofthecontractshallprovidethestateracingauthoritycertainrights.Insuchanevent,theracingauthoritymayrequire:

1)Ameetingbetweenrepresentativesoftheracingauthorityandlaboratorymanagement;

2)Acorrectiveactionplanbythelaboratorytobringthelaboratoryintocompliancewiththetermsofthecontract.Theplanmustinclude:

A.Identificationofareasinwhichthelaboratoryisinbreachof thecontract;

B.Clarificationastothecause(s)ofdeficienciesandadetailed plantopreventsaiddeficienciesinthefuture;C.Alistofspecificactionsanddeadlinesforfulfillmentofthose obligationsinarrears;and,D.Abondpayabletothestateracingauthorityinanamount agreedbetweentheparties.

Theracingauthorityisnotrequiredtoallowanycorrectiveactionandshallreservetherighttoterminatethecontractinaccordancewithitsterms.Comment:Mostcontractscontainprovisionsforterminationoftheagreementshouldeitherpartydefaultonitsobligations.However,simplyterminatingarelationshipwithalaboratorymaynotbeapracticaloptionfortheclientwhoseregulatorydutiescannotbesuspendedpendingtheidentificationofanalternate

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laboratory.Thissectionestablishesanincentivefortheremediationofdeficiencies,andanalternativetounscheduledterminationoftherelationship.XXVII.PricingHistoricallythecostofconfirmatoryanalysisofsampleshasbeenincludedinthepersamplepricingofferedbythelaboratory.Iftherealcostofaconfirmatoryanalysisis$1000andthesuspiciousrateis2%,thenthecostperpairedbloodandurineisincreasedby$20tocoverthecostofthetesting(2x$1000/100pairedsamples=$20perpairedsample).Thispro‐ratedinclusionofconfirmatoryanalysiscostsishelpfultoregulatoryagenciesforbudgetplanningpurposesbutisonlybeneficialtoclientsandlaboratorieswhentheoccurrenceofsuspicioussamplesisaccuratelyprojected.Iftheactualoccurrenceofsuspicioussamplesfallsbelowtheprojectedrate,theclientispayingforunusedtestingservices.Ifthenumberofsuspiciousfindingsincreaseswhencomparedtotheprojectedrate(e.g.,whennewthresholdsareadopted,orsubstancesareaddedtothescopeofanalysis),thelaboratory’sexpensesassociatedwithtestingcanbemuchgreater.Iftheprojectedrateofsuspicioussamplesis2%,buttheactualsuspiciousrateis7%‐12%,thenthecostperpairedbloodandurinewouldneedtobeincreasedby$50‐100tocovertheadditionalcostsofanalysis.Absentafeeadjustment,thelaboratoryperformstestingataloss,andthebusinessmodelisunsustainable.Anunanticipatedincreaseinworkloadmaybeexpectedtoresultindelaysinturn‐around‐timeunacceptabletotheregulatoryauthority.Further,thebusinessmodelthatdoesnotdesignatespecificpaymentfortestingofsuspicioussamplesestablishesdisincentivesforalaboratorytoexpanditsscopeoftestingortopursueandconfirmsuspiciousfindings.Apreferablebusinessmodelmaybeoneinwhicheachconfirmatoryanalysisisbillableatanestablishedrate.Thiswouldincentivizelaboratoriestoexpandthescopeoftestingandtopursuefindings,andalsoincentivizeregulatoryagenciesandracetrackstoreducefindingsthrougheducationalprogramsandstakeholderoutreach.

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27.Thelaboratoryshallofferper‐samplepricing,inclusiveoftheprovisionsofSectionsII‐XXVIofthisRFP,asfollows:

ANDPaired‐postracesamples27a1.A.Paired(bloodandurine)post‐racesamplesubjectedtoscreening analysisasdescribedinSectionXI,and B.Confirmatoryanalysisofpost‐racesample(onapermatrixbasis) identifiedassuspiciousthroughscreeninganalysis,asrequired forissuanceofafinalreport.

OR27a2.Paired(bloodandurine)post‐racesamplesubjectedtoanalysisas describedinSectionXI,andinclusiveofallanalysesrequiredfortheissuanceofafinalreport.

ANDBlood‐onlypost‐racesamples27b1.A.Singlematrix(bloodonly)post‐racesamplesubjectedtoscreening analysisasdescribedinSectionXI,and; B.Confirmatoryanalysisofsinglematrixpost‐racesample, identifiedassuspiciousthroughscreeninganalysis,asrequiredforissuanceofafinalreport.

OR

27b2.Singlematrix(bloodonly)post‐racesamplesubjectedtoanalysisas describedinSectionXI,inclusiveofallanalysesrequiredfortheissuanceofafinalreport.

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AND

Out‐of‐competitiontesting27c1.A.Singlematrix(bloodonly)outofcompetitionsamplesubjectedto screeninganalysisasdescribedinSectionXII,and; B.Confirmatoryanalysisofsinglematrixout‐of‐competitionsample identifiedassuspiciousthroughscreeninganalysis,asrequiredfor theissuanceofafinalreport.

OR27c2.Singlematrix(bloodonly)out‐of‐competitionsamplesubjectedtoanalysisasdescribedinSectionXII,inclusiveofallanalysesrequiredfortheissuanceofafinalreport.Comment:Currentlymostoutofcompetitionsamplesarebloodonly,singlematrix.Asoutofcompetitionsamplingisusuallyperformedabsentadvancenotification,thecollectionofaurinesamplecanbeproblematicandisrarelyattempted,letaloneachieved.However,forjurisdictionscontemplatingexpandedscopesofanalysesforoutofcompetitionsamples,itisadvisabletosolicitadditionalpricing,comparabletothatdescribedabovein26c1or26c2,forpairedsamples.

AND

TCO2Testing27d.Singlematrix(bloodonly)pre‐orpost‐racesampledesignatedforTCO2analysisasdescribedinSectionXII,andinclusiveofallanalysesrequiredfortheissuanceofafinalreport.

AND

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AnalysisofSamplesDerivedFromHorsesworkingforReleasefromtheVeterinarians’List27e1.A.Singlematrix(bloodonly)post‐exercisesamplesubjectedto screeninganalysisasdescribedinSectionXIV,and; B.Confirmatoryanalysisofsinglematrixpost‐exercisesample identifiedassuspiciousthroughscreeninganalysis,asrequiredfor theissuanceofafinalreport.Comment:Jurisdictionsforwhichthedetectionofacontrolledtherapeuticmedicationorabannedsubstanceinapost‐exercise(non‐race)samplewouldnotconstituteaviolation,mayelectnottosolicitBpricingasdescribedabove.Thepricingdescribedabovewouldbeapplicabletothosejurisdictionsinwhichconfirmatoryanalysisisperformedatthediscretionoftheregulatoryagency.

OR

27e2.Singlematrix(bloodonly)post‐exercisesamplesubjectedtoanalysisasdescribedinSectionXII,inclusiveofallanalysesrequiredfortheissuanceofafinalreport.Comment:Asthesesamplesarederivedfromhorsesfollowingscheduled,observedexercise,urinesamplecollectionmaybepossible.Forthosejurisdictionsintendingtoperformurinecollection,pricingforpaired(bloodandurine)samples,comparabletothatdescribedin26e1and26e2,shouldalsobesolicited.

AND

Analysisofconfiscated,orotherwiseacquired,substances27f.A.AnalysisofsubstanceswithlistoflabeledingredientsasdescribedintheRMTCProtocolforVerificationofLabelIngredients,and;B.Analysisofsubstanceslackingalistoflabelingredients,asdescribed intheRMTCUnknownSampleProtocol.

AND

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Miscellaneous27g.Pricingoflaboratory‐sourcedmaterials,intendedforusesotherthantheanalysisofofficialsamples,asfollows:(Insertitemizedlist—i.e.bloodcollectiontubes,needles,urinesamplecups,etc.)XXVIII.EvaluationofProposalsReceivedinResponsetoRFPComment:InadditiontotheRFP,theissuingagencymayalsoconsiderrequiringpresentationsfromrepresentativesoftherespondinglaboratoriesand/ortheanalysisofblindsamplesprovidedbytheissuingagency.Anoralpresentationbykeylaboratorypersonnelmaybehelpfulindetermininghowthelaboratoryinteractswithclientsandindustrystakeholders,and/orcommunicatesinformationinhearings.Theanalysisofblindsamplesmaybehelpfulindeterminingthelaboratory’sfamiliaritywiththeagency’sregulations,andinevaluatingproposedmethodsofcommunicationbetweenthelaboratoryandtheregulatoryauthority.TheRFPrequestsalargeamountofinformationthattheregulatoryagencymustevaluaterelevanttoitsneeds.Itishelpfultouseaconsistentformatwhenevaluatinglaboratories’responsesinordertorecognizeandconsidertheimpactofsubstantivedifferences.Costcomparisonsareusefulonlyiftheproposedwork

1)meetsthestandardsoftheregulatoryagency;and,2)isconsistentbetweenlaboratories’responses.

AdescriptionoftheevaluationcriteriaandselectionprocessshouldbedistributedwiththeRFP.Thefollowingevaluationformmaybeusedasatemplateforobjectiveassessmentandcomparisonoflaboratories’responses.Theregulatoryagencymustdeterminewhichcriteriashouldbeassignedpass/failstatus.Failuretoachieve‘Pass’statusonanyofthesecriteriarenderstheproposalunresponsiveandexcludedfromfurtherconsideration.Othercriteriamaybeevaluatedonapointssystem,similartothatdescribedbelow.

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RFPEVALUATIONFORMPass/FailCriteria:

1. Proposalreceivedonorbeforesubmissiondeadline Yes No2. LaboratoryisRMTCaccredited Yes No3. Laboratoryappliesvalidatedmethodologiesforthe

detectionofallControlledTherapeuticSubstancesatthresholdconcentrations(asexistinRCIModelRuleseffectiveatthetimeoftheissuanceoftheRFP) Yes No

EvaluationFactors:1. Qualificationsandcapabilitiesofvendor(25pointsmaximum)

a. Proposedstaffingforthemanagementandanalysisoftheagency’ssamples

b. Chemists/analystswithadvanceddegree(s)/analyticexperiencec. Laboratorydirectordegree/experienced. Staffavailableforconsultation;availabilityoutsideofnormalbusiness

hourse. Descriptionofotherclients

i. Currentii. Previous

f. Performancehistory—meetingcontractualdeadlines;outcomeofsplitsampleanalyses;defenseoffindingsinhearings,etc.

g. Experienceinequinetestingh. Identificationofperson(s)withAORCmembership

2. Deliverablesandworkplan(30pointsmaximum)a. Samplemanagementb. Turn‐around‐times—screeningandconfirmatoryanalysesc. Communicationswithregulatoryagencyd. Testimony/Supporttoregulatoryagencye. Valueaddedservices(notrequestedbyRFP)

3. Totalproposedcost(25pointsmaximum)a. Costforblood/urinesamplesb. CostforTCO2samplesc. Costforout‐of‐competitionsamplesd. Costfor“special”services

Comment:#3shouldbecustomizedtobeconsistentwithpricingrequestedinSectionXXVIIoftheRFP.

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4. Equipmentandmethodsoftesting(10pointsmaximum)

a. Equipmentdesignatedfortestingoftheagency’ssamplesb. Testingmethodologyc. Qualityassurance/qualitycontrolprogramd. Developmentofnew/advancedtestingprocedures

5. Industryleadership(10pointsmaximum)a. Publishedarticlesb. Presentationsc. Stakeholderinteraction/communicationd. Collaborationwithotherlaboratories

Comment:Iftheregulatoryagencyelectstorequireblindedsampleanalysis, ororalpresentations,pointsshouldberedistributedtoincludetheadditional evaluationcriteria.