2015 proficiency testing manual - college of american pathologists · 4collee of aean patolosts...

2015 Proficiency Testing Manual

Table of ContentsProficiency Testing Manual

1 Order Confirmation, Specimen Handling, and Customer Service 3–8

n Confirmation 3 n RegulatoryReporting 3 n Binders/Glossaries 3 n AlertingtheMailroom 3 n CAPIdentificationNumber 4 n ReplacementSpecimens 4 n TestingInstructionsandCompletionTime 4 n SecondInstrumentReporting 4 n ChangingResultsandCMSReportingInstructions 5 n Fax-BackResponsePrograms 5 n EvaluationReports 5 n Corrections 5 n CustomerSupport 6 n ProgramCertificates 6 n Letters 6 n LimitationsofProficiencyTesting 7 n HandleWithCaution 7 n LaboratoryAccidents 7 n LimitationsofProficiencyTestingLetter 8

2 General Comments 9–10

n CompletingtheResultForm 9 n Teleforms 9 n PreprintedMethodSummaryPage 9 n ExceptionCodes 9 n IdentificationMasterLists 10 n Method/InstrumentMasterLists 10 n Handwriting 10 n DecimalPointsandBoxPositions 10 n “LessThan”or“GreaterThan”Values 10

3 e-LAB SolutionsTM 11–13

n UsingOnlineFeatures 11 n Security 11 n OnlineDataSubmission 12 n InteractiveEvaluations 12 n OnlineReports 13 4 How to Interpret the Evaluation Report 14–16

n GeneralGuidelinesforEvaluation 14 n SelectionofaTargetValue 14 n CalculationofSummaryStatistics 14 n ComparativeStatistics 16

Interlaboratory Comparison Program Cycle

5 Continuing Education 17–18

n CMECategory1 17 n ContinuingEducation(CE)forNonphysicianLaboratoryPersonnel 17 n EXCEL®CEProgram 18 n CEforCytotechnologists 18

6 Discipline-Specific Reporting Information 19–20

n HowtoCompletetheResultForm 19

7 Evaluation and Participant Summary Reports 21–23

n YourEvaluationReport 21 n ReviewingYourEvaluationReport 21 n ParticipantSummary 22 n HowtoPerformaSelf-Evaluation 22

8 Laboratory Legislation and Centers for Medicare & Medicaid Services (CMS) Reporting 24–29

n ProvisionofResultstoCMSandStateAgencies 26 n UseofReasonCodesforNonevaluatedSpecimens 27 n CMSPerformanceSummary 28 n CMSPerformanceSummaryData 28

1CAP 2 Subscriptions September–December:Yourlaboratoryplacesitsorder.

Your Laboratory 3CAP Order Processing September–December: Orderquantitiesarereserved.

Catalog Delivery September:Thecatalogissenttoyour laboratory.

4CAP 5 Kits Mailed Kitsareprepared andsentfromthe manufacturertoyour laboratory.

Surveys Mailing 6Your Laboratory Result Form Completedresultforms arereturnedviamail,fax,or onlinesubmissiontotheCAPwheredataaresummarized.

Order Confirmation September–December: Confirmationreportsaresenttoyourlaboratoryafteryourorderisprocessed.

7Scientific Resource Committee 8 Reports Mailed/

Available Online Reportsaresenttoormadeavailableonlineforyour laboratory,regulatory agency,and/orconsultants.

CAP 9Certificate Certificate of Participation AsaCAPSurveysand AnatomicPathology EducationalProgramsand EXCELsubscriber,your laboratoryisentitledtoreceive aCertificateofParticipation.Thecertificatewillbeissuedatthe beginningoftheprogramyear.

Evaluation Criteria Thescientificresource committeereviewsresultsandtheimpactofevaluationcriteria.

Proficiency Testing Manual

1OrderConfirmation, SpecimenHandling, andCustomerService

ConfirmationAfteryourorderisreceived,anorder confirmationreportissentthatcontainsthe followinginformation:

nShippingaddress

nBillingaddress

nTelephoneandfaxnumber

nListofprogramsordered

nListofagenciesand/orconsultantsto whomyouhaverequestedcopiesof yourevaluationreportbesent

Pleasereviewyourlaboratoryorderconfirmationreportcarefully.Ifyouhavechanges,returntheformwithintwoweeksofreceiptto:

CustomerDataManagement CollegeofAmericanPathologists 325WaukeganRoad Northfield,Illinois60093-2750 Fax:847-832-8168(Countrycode:001)

Regulatory ReportingTheCAPwillautomaticallyforwardresultsforanalytesregulatedforproficiencytestingtotheCentersforMedicare&MedicaidServices(CMS)forlaboratoriesthathaveprovidedaCLIA identificationnumber.

Torequestthatnoresultsbeforwardedortomakechangestoyourlaboratory’sanalyte selectionreportfortheinformationprovidedtoCMS,pleasecontacttheCustomerContact

Centerat800-323-4040option1oraccessyourreportonlineatcap.org.

Documentationwillberequestedandmaybefaxedto847-832-8168.Anexplanationof regulatoryreportingandcurrentlaboratory legislationisincludedinChapter8ofthismanual.

Binders/GlossariesPleaseseeyourcatalogforinstructionsonhowtoobtainthree-ringbindersforfilingresultsandreports.Surveysresultsareprintedonthree- hole-punchedsheetsforstorageinthebinders.

Ifyouareenrolledinhematologyand/orclinical microscopySurveyscontainingphotographsfor morphologicidentification,youwillbeabletoaccessanonlineglossaryoftermsforyour generaluse.Ifyouneedahardboundcopy,pleasecalltheCAPCustomerContactCenter.

Alerting the MailroomRefertotheshippingscheduleandadviseyour receivingdepartmentaccordingly.Ashippingscheduleisprovidedtoyourlaboratorywith theorderingcatalog,oryoucanobtaina customizedshippingcalendarthroughe-LAB Solutions™atcap.org.

Thereceivingdepartmentofyourhospitalorlaboratoryshouldbeadvisedhowtohandle theCAPkits.Insistonprompttransfertothe laboratory.(Kitsreceivedbythehospitalbut notdeliveredtothelaboratoryarenot eligibleforfreereplacement.)Unlessotherwisespecified,storethespecimensintherefrigerator.

College of American Pathologists Proficiency Testing Manual 4

CAP Identification NumberEachparticipantreceivesaCAPidentificationnumberthatisprintedonallresultforms.Thisnumberwillalsoappearoneachevaluationreportreceivedbyyourlaboratory.ItishelpfultohavethisnumberavailablewhencontactingtheCollege.

Replacement Specimens Thekitscontainaresultformandspecimensfor analysis.Checkthecontentsofthekitagainsttheinstructions.EXCEL®participantsshouldverifythatallmoduleslistedonthemailingpageareincludedinthekit.Ifthekitisincompleteor containsbrokenorunlabeledspecimens, contacttheCollegewithinthenumberofdaysindicatedinthekitinstructionsfollowingtheactualshippingdateforafreereplacement.Additionalreplacementspecimensmaybepurchasedwithinthesametimeframe.Becauseproficiencytesting(PT)materialsmustbe procuredinadvanceofshipment,onoccasion, additionalinventoryisavailableforanominalfee.TopurchasethesematerialscontacttheCustomerContactCenterat800-323-4040 option1.Allliteratureassociatedwiththis productincludingthesummarydatawouldbeprovided.This option does not replace routine proficiency testing.

Thesematerialsmaybeusedforbutnotlimitedto:

nCompetencyassessment

nInstrumenttroubleshooting

nTraining

nEducation

nResearch

Intheeventthatareplacementspecimenisrequired,retainyouroriginalresultformwhileawaitingthearrivalofthereplacement specimens.Thereplacementspecimenswill besentinthesamemannerasyouroriginal specimens.Whenyoureceivethe replacementspecimens,youwillbeallowed thesameamountoftimeforanalysisaswas allowedwiththeoriginalshipment.Youare ensuredanevaluation.

Occasionally,itmaynotbepossibleforthe manufacturertoreplaceyourspecimen(s)kit. Inthiscase,filltheexceptioncode33bubble ontheresultform.SpecimenProblemwill appearonyourevaluationreport,andyou willnotbepenalized.

Testing Instructions and Completion TimePertheFederal Register,PTspecimensmust betestedwiththelaboratory’sregular workload,usingroutinemethodsandtestingthePTspecimensthesamenumberoftimesitroutinelytestspatientspecimens.

WhenhandlingPTspecimens,laboratoriesmustnotcommunicateresultsnorshareorrefer specimensfortestsnotonthelaboratory’smenu.Ifreferralfortestingisroutinelyperformedforpatientspecimens,thepracticecannotbefollowedforPTspecimens.Referralisconsideredtobemovementofthespecimenfroma laboratorywithaCLIAidentificationnumbertoanotherlaboratorythathasadifferentCLIAidentificationnumber.LaboratoriesmustensurethatpersonneldonotshareresultsorreferPTspecimensforanyreflexortestingoutsidetheirCLIAidentificationnumber.

TheSurveysandEXCELprogramsareusedforcertificationofcertainlaboratories.Sincepromptnessisconsideredindeterminingcertification,wecannotacceptlateentries.Results are due by the date noted on the result form. Resultformsreceivedbeyondthedatenotedwillnotbeevaluated.Participantswill receiveanevaluationindicatingthattheresultswerereceivedpasttheevaluationcut-offdatealongwithaParticipantSummarythatcanbeusedforself-evaluation.

Second Instrument ReportingIn2014,theCentersforMedicare&MedicaidServices(CMS)directedallPTprovidersthatlaboratoriessubjecttoClinicalLaboratoryImprovementAmendments(CLIA)regulationsarenotallowedtotestandreportPTspecimens

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fromasecond/back-upinstrumentunlessthatishowtheyroutinelytestpatientspecimens.

Becausethesanctionsaresevereifthe regulationsarenotfollowed,theCAPPT programnolongerincludestheoptionfor secondinstrumentreportingwithyourPTresults.Tomeetyourlaboratoryneeds,theCAPnowoffersitsQuallityCrossCheckprogramfor:

n GeneralChemistryandTherapeuticDrugs

n B-TypeNatriureticPeptides

n AutomatedHematology

n BloodOximetry/CriticalCareAqueous BloodGasChemistry

SeetheSurveyscatalogfordetails.

Changing Results and CMS Reporting Instructions

n Changestosubmitteddatacannotbe madeaftertheduedatelistedonthe resultform.Reviewallentriesmadeon theresultformforaccuracypriorto submission.Forresultsapprovedonline, correctionsmustalsobedoneonline. Faxedormailedcorrectionswillnot beaccepted.

n Ifyouhaveregisteredyourlabonthe CAPwebsite,youmayviewthestatusof yourresultsontheResultFormDataEntry andReceiptVerificationscreen.

n Foranytestingthatyoudonotroutinely performinyourlaboratory,leaveall reportingareasforthattestblank, includingmethodinformation.Please note, a penalty will not be applied for blank responses in the case of educational challenges, challenges not formally graded, or the proper use of exception codes.

n Ifyoudonotperformspecifictestingina Surveysprogram,pleaserefertothekit instructionsandresultformforthe appropriateinstructions.

Foranyregulatedanalytesthatyourlaboratorydoesnotreportormayhavediscontinued,youmustnotifytheCAPinwriting.PleasefaxanychangesinwritingonyourCMSreportto 847-832-8168toavoidreceivingazero scoreonyournextPTevaluation.(Yourreporting preferencesareoutlinedontheCMSAnalytesReportingSelectionsdocument,whichis availableonlineatcap.orgontheAccredita-tionandLaboratoryImprovementtab.)Ifyouhaveanyquestions,pleasecalltheCustomerContactCenterat800-323-4040option1.

Fax-Back Response ProgramsTheCollegeoffersimmediate(fax-back) responsesforthesubmissionofthelaboratoryformsforthefollowingeducationalanatomicpathologyprograms:

n InterlaboratoryProgramsin CervicovaginalandNongynecologic Cytopathology(PAP/NGC)

n Fine-NeedleAspirationGlassSlide Program

Individualresultformscanbesubmittedonline (preferredmethod)orfaxedtotheCAP.CME/CEformswillbeselfclaimedonlinethroughthe LearningPortaltab.

Evaluation ReportsTheevaluationreportwillbepostedonlineandmailedapproximatelytwotofiveweeksaftertheshipdateofthekit.Thistimeisneededfor processingdata,establishingevaluationcriteria,andpreparingthesummaryreport.

CorrectionsOccasionally,incorrectentryofsubmitted dataoccurs.Ifthisisduetoyourtranscriptionerrororfailuretocompletetheresultform appropriately,yourentrycannotbe reevaluated.IftheerrorismadebytheCAP,pleasecontacttheCustomerContactCenterat800-323-4040option1forfurtherassistance.



Customer Support

Customer Contact Center Hours

7:00 am–5:30 pm CT

ExtendedCustomerContactCenterhours ensurecoverageforalltimezones. Call800-323-4040option1tospeakwitha ContactCenterrepresentative.For internationalcustomers,pleasecall 847-832-7000option1(Countrycode:001).

24-hour Messaging Service

TheCAP’s24-hourvoicemailsystemallowsyoutoleaveamessageafterhours.Aresponsewillbeprovidedthefollowingbusinessday.

24-hour Service Fax Hotline (800-289-1815)

Aswiththe24-hourvoicemailsystem,theServiceFaxHotlinemakesiteasyforyoutofaxrequestsanytime,dayornight.Responseisguaranteedbythenextbusinessday.

Contact the CAP via the Website

Youcansubmityourrequestorquestion convenientlyonlineviatheCAPWebpage.Logontocap.organdclickontheContactUsiconlocatedatthetopofthemainpage.

CAP Mail

TheCAPhasimplementedanemailnotifica-tionservice,CAPMail,designedtokeepyouinformedofourreceiptofyourorderform(s)andresultforms.Foreachdocumenttype,theCAPwillnotifytheappropriateindividualsthatwehavereceivedyourinformation.

n Allresultformreceiptacknowledgment messagesincludearesultformreceipt.

n LinktotheCAPwebsitepagewhereyou canreviewdetailedinformationforeach kitonthenumberandspecificpages receivedandmethodofreceipt.

Totakeadvantageofthisservice,ensurethe CAPhastheappropriateemailaddressesforyourlaboratory.

n Fordocumentacknowledgment,include theappropriateemailaddressonthefirst pageofyourorderforminthesection titled,“PTShippingContact.”

Tochoosenottoparticipateinthisprogram, participantscancontacttheCAPCustomer ContactCenterat800-323-4040option1.

Contact the CAP via Email

GeneralinquiriesmayberoutedtotheCollege atthefollowingemailaddress: [email protected].

Program CertificatesAfterthecompletionoftheprogramyear, participatinglaboratorieswillreceiveaprogramcertificatethatrecognizeseachinstitution’s participationintheCAPproficiencytesting programanditscommitmenttopatientcare.CertificatesaresignedbytheCAPpresidentandaresuitableforframing.

LettersAlllettersreceivedbytheCollegeare reviewedand,ifappropriate,forwarded toamedicaltechnologistorascientific resourcecommitteememberforresponse. Yourinputisencouragedandhasalways servedasavaluablevehicleforchanges andimprovementstotheinterlaboratory comparisonprograms.

TheCollegedoesnotrequirethatyousubmit documentationforallproficiencytesting deficiencies.However,itisrecommended thatsuchdocumentationberetainedinyourlaboratory.TheCAPLaboratoryAccreditationProgramissuesaseparatereport,the “ProficiencyTestingExceptionSummary,”thataddressesproficienciesforCAP-accredited laboratories.Instructionsforresponsewillbeincludedwiththereport.


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Limitations of Proficiency TestingDuetothemanufacturednatureofthe specimensandthelogisticsofshipping, proficiencytestingdoesnotalwayscorrelate withthemannerinwhichfresh,clinical specimensarehandled.Aletteraddressing thesedifferencesisincludedonpage8for generalusebyyourlaboratory.

Handle With CautionProficiencytestingspecimensmustbehandledwithcaution.Eachshipmentincludesa biohazardwarningstatementexplainingproperhandling.

Laboratory AccidentsIncidentsofpersonnelexposuretoinfectious specimens,throughneedlesticks,contamination ofthemucousmembranesthroughsplashesoraerosolization,orcutsfromcontainers,shouldbereportedimmediatelytotheCAP.

24-hourhotline:800-443-3244

Pleasetrytohavethefollowinginformation available:

n CAPnumber

n Phonenumber

n Nameofinstitution/city/state

n Nameofpersonaffected,ifother thancaller

n Dateandtimeofincident

n Whereandhowaffected

n Surveyandspecimennumber

n Nameandtelephonenumberof laboratorydirector

Thisinformationwillberelayedtoapathologist memberoftheappropriateresource committeewhowillcontacttheparticipant’slaboratorydirectororhospitalemployeehealthservicesphysicianwithinstructionsconcerningprophylaxis.


Limitations of Proficiency Testing Letter

TheCollegeofAmericanPathologists(CAP)Surveysprogramisthelargestexternalquality assessmentprogramintheworld.Assuch,itprovidesanunparalleledselectionofchallengesandoffersthelargestdatabaseinexistenceforinterlaboratorycomparison.TheCAPhas accumulatedsignificantexperienceinmanagingthistypeofprogramandisknowledgeable initsusesandlimitations.

PerformanceonCAPSurveysisnottobetakenasthesoleindicatorofalaboratory’sabilities. AproficiencytestingSurveyisbutoneofanumberofprogramsthatlaboratoriesshouldemploytoassess,manage,andimprovequality.InadditiontoSurveys,propermethodvalidation, qualitycontroltesting,periodiccalibrationandinstrumentmaintenance,employee competencytesting,andlaboratoryinspectionandaccreditationprovideimportanttools formeasuringlaboratoryperformanceandensuringquality.

TheSurveysprogram,althoughoutstanding,isnotaperfectmeasuringdevice.Anumber offactorslimitthistool’sabilitytomeasurelaboratoryaccuracy.Specificlimitationsinclude requisiteuseofmatrixmaterialsthatmayimpacttestsystemsdifferentlythanpatient specimens;theappropriatenessofgroupingresponsesaccordingtomethodology, instrumentation,andtestplatforms;varyingsizeofcomparisongroupswithattendant variabilityofstatisticalparameters;regulatedlimitationsinsamplingoflaboratories’testing systems;difficultiesinquantitationattheextremesofanalyteconcentration;andunsuitability ofcertainfederally-mandatedevaluationlimits.

Thus,acertainnumberofresponsesthataregradedasunacceptableinSurveyswillinfact beacceptable,andacertainnumberofresponsesgradedasacceptablewillinfactbe unacceptable.AlthoughunsuccessfulorunsatisfactorySurveysperformancemayreflect problemswithinalaboratory,itdoesnotconstituteproofofinadequateperformanceoran inabilitytomeetpatientneeds.

Sincerely,

R.BruceWilliams,MD,FCAP

Chair,CouncilonScientificAffairs

2 GeneralComments

Completing the Result FormTheresultformisapreparedformonwhichyourecordyourmethodsofanalysisandresultsoflaboratorytesting.ThecompletedresultformmustbereturnedonlineorbyfaxtotheCAPforevaluation.Prepareyourresultformcarefullyaccordingtotheinstructions.Double-checkyouranswersforaccuracyandcompleteness.

ItisimportanttophotocopyorprintacopyofthecompletedformsforyourrecordsbeforemailingorsubmittingthemonlinetotheCAP.

PerdirectivefromtheCentersofMedicare &MedicaidServices(CMS),changesto submitteddatacannotbemadeaftertheduedateprintedontheresultform.Reviewallinformationonthemethodsummarypageandallentriesmadeontheresultformforaccuracypriortosubmission.Onceyouhaveoptedin,youcanusethe“ResultFormDataEntryandReceiptVerification”optionontheCAP website(undere-LABSolutions)toverifythesubmitteddata.

TeleformsTeleformsarescannableforms.Becausetheseformsarescanned,pleaserefertothekitinstructionsformoredetailedinstructionsoncompletingtheresultform.

Preprinted Method Summary PageThecomputersystemisdesignedtoenhanceresultreportingfromyourlaboratory.Once youhaveinitiallyprovidedamasterlistcode foramethod,instrument,and/orreagent,the computerwillmaintainthesecodes, endingyourneedtoreportthemthroughouttheyear.Pleasecheckeachmasterlisttoensurethecorrectcodesarelisted.Shouldyouneedtochangeacode,enteritinthe appropriateboxesontheresultform.

Exception CodesIfitisnecessaryforyoutoreportananalyticalproblemforanentiretestorindividual specimenswithinatest,leavetheresultareablankandfillthebubblefortheappropriate exceptioncode.Selecttheappropriate two-digitcodefromthoselistedandfillthe appropriatebubble.

Exception Code* Reason

11 Unabletoanalyze (documentationtobeprovided bylaboratory).

22 Resultisoutsidemethod/ instrumentreportablerange.

33 Specimendeterminedtobe unsatisfactoryaftercontacting theCAP.

*Itisthelaboratory’sresponsibilitytodocumentthe appropriateuseoftheseexceptioncodesshouldthisberequestedduringalaboratoryinspection.Pleasereferto thekitinstructionsformoreinformation.


Identification Master ListsMasterlistsofpossibleidentificationsare providedformicrobiology,bloodcell identification,urinesediment,clinical microscopy,andprovider-performed microscopy.Selectyouranswersfromthe appropriatemasterlistsprovided.Recordtheappropriatemasterlistcodeforyourchoiceontheresultform.

Forbloodcellidentification,urinesediment,clinicalmicroscopy,andprovider-performedmicroscopy,allpossibleidentificationsare includedonthemasterlists.Donotusethecode010,“Other,Specify.”Theuseofthis codewillbeevaluatedasanunacceptable response.

Method/Instrument Master ListsMethod/instrumentmasterlistsareprovidedinthekitinstructions.Choosetheappropriateinstrumentand/ormethodandprovidethisinformationontheresultform.

ItisimportantthatyounotifytheCAPandthe manufacturerifyourinstrumentormethodisnotlistedonamasterlist.Thismaybedonebylistingthisinformationinthe“UseofOther”sectionoftheresultform.YoumayalsocontacttheCAPdirectlywhilecompletingtheresultformtosee ifacodehasalreadybeenestablishedfor yourmethodand/orinstrumentbutwasnot availableintimeforprintingoftheresultform.

HandwritingTheresultformsaredesignedforquick,easy scanningbyourcomputers.Ifyoufaxyour results,theinformationonyourresultformmustbeclearlyreadable.

Decimal Points and Box PositionsThecomputerisprogrammedtoacceptonlythoseanswersconformingtotheboxesanddecimalpointsontheresultform.

Ifanumberisnotlargeenoughtofilltheboxes, insertzerointheremainingspaces.Resultsshouldberight-justified.Whensubmittingresultsonline,thiswillbedoneautomatically

Example: Correct Incorrect Glucose 73 mg/dL

Urea Nitrogen 12.8 mg N/dL

“Less Than” or “Greater Than” ValuesDonotattempttoadd“lessthan”or“greaterthan”tothevalueyousubmitunlessthisoptionisprovidedontheresultform.Whereprovisionismadetoreport“lessthan”or“greaterthan”results,youmustfillinthebubbleofthe appropriateboxtoindicateyourresponseisa“lessthan”or“greaterthan”value.Allotherresultswillbeconsidered“equalto”values.

Wherenooptiontoreport“greaterthan”or“lessthan”isgiven,referto“exceptioncodes”onpage10orinyourkitinstructions.

073. 73 .

013. 128.

GeneralComments

Using Online FeaturesPowerfulInternet-basedtoolsareavailabletogiveparticipatinglaboratoriesmanyexcitingchoices.Simpleinstructionsforuseofthesetoolsareprovided.Andasalways,CAP CustomerContactCenterrepresentativesstandreadytoofferassistance.

Inordertotakefulladvantageofthe functionalitiesavailableonline,userscan selectivelyenablelaboratoriesand personnelbyundertakingenrollment proceduresasoutlinedbelow:

Self Registration

ThisistheprocessofcreatinganaccountwiththeCollegeforonlineactivities.AllusersoftheadvancedfeaturesoftheCAPwebsitearerequiredtohaveapersonalWebaccountandbeloggedintobeabletousethesite.Thisprocessonlyneedstobedoneonceperuser;itallowstheusertoselectanIDthatcanbeeasilyrecalledandthatbelongstotheuser,regardlessoflaboratoryaffiliation.Bothmembersandnonmembersarerequiredtoberegistered,therebyallowingtheentirelabora-torycommunitytoparticipateonline.Thisreg-istrationisalsovalidforCME/CEonlinelearningactivities.

Logging In

OnceusershaveestablishedanaccountwiththeCollege,theywillbepromptedbythe systemtoentertheiruserIDandpassword.Thismustbedoneeverytimeusersvisitthesite,oruserscanchoosetohavethesystem

remembertheirlogin.Bothmembersand nonmembersutilizethesamelogin functionality.

Opting In

Auser(thelaboratoryadministrator,by default)entersaCAP#andCollege-provided PIN#,therebyenablingthelaboratoryto accessadvancedfeaturesonline.Thisprocessonlyneedstobedoneonceperlab;andonceaccomplished,thelabwillhaveaccesstoallofthefeaturescurrentlyaccessible onlineaswellasthosethatwillbeofferedinthenearfuture.

SecurityThenatureoftheindividualizedaccounts forlaboratoryusersallowsforflexibilityin determiningwhatlevelsofaccesseachusershouldhave.Becauseusersareindependententitiesfromthelaboratory,theuserscanbeassociatedwithmultiplelaboratoriesandtheirsecuritycanbeadministeredinadifferentmannerateachsite.Thisiscarriedoutby thedelegatedsecurityadministratoratthe laboratorywhoisresponsibleforoverseeingtheaccessandsiteprivilegesforeachuser associatedwiththatlab.Becauseofthechangingnatureoftheemployee-employerrelationshipinthelaboratory,thisfeature allowsthemostflexibilityfortheadministratortoadd,modify,and/orremoveusers’accessprivilegesastheadministratorseesfit.Thishastheoveralleffectofeliminatingtheneedto havetocalltheCustomerContactCenter tocarryoutsomeofthemoreroutine

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maintenanceofanaccount.Thedelegatedsecurityadministrator(s)canconferasmanyorasfewpermissionsastheyseefit,andtheadministrator(s)canconfigurepersonnel securitysothatitcloselymatchesindividuals’roleswithinthelaboratory.Thiswillenablethelabtoreplicatethesameworkflowmodelthatitemploysforpaper-basedsubmissionof results,therebyhelpingtoincreasetheintegrityandconfidenceinthedataenteredonline.

Online Data SubmissionOncethelabhasoptedinandsecurityforemployeeshasbeenadministered,oneofthefirstfeaturesalabcantakeadvantageofistheabilitytosubmititsdataresultsonline.AlabwillreceiveitsPTmaterialandpaperresultforms asusualandwilltesttheminitscustomary manner.Mostlaboratoriansmayprefertorecordtheirresultsonthepaperresultformforeaseoftranscriptiontotheonlinesystem.Theuserswilllogintothesite,navigatetotheirlabandkit,andtheywillbepresentedwithan AdobePDFversionofthesamepaperresultformtheyhaveinhand.Theformisdesignedtopreventerrantdatafrombeingsavedtotheform.Userswillbeabletoselectmethodandqualitativecodesfromdropdownlistsratherthanhavingtorefertoaseparatedocumentforthecode.Invalidcodesanddatawill preventtheuserfromsavingtheform.Userswillenterthedataintothevirtualformandsavethedataastheyfinish.ForSurveysinwhichmultiplelaboratoriansperformthetestingandresulting,theflexiblenatureofthedataentrysystemwillallowmultipleuserstologintothesystemat differenttimesandentertheirdata,soastominimizeanyinterruptiontotheirnormal laboratorywork.Dependingonthenormalworkflowwithinthelab,theadministratorhasachoicetodesignateanadditionalapproverroleforanotheruserwhosejobitistoverifythatalldatawasenteredasintendedandtosubmitthedata.Oncethisstepisfinished,thedataiscommittedtotheCollege’ssystemandisreadyfornormalprocessing.Theadvantagestothissystemlieinspeed,efficiency,andclarityoftheresultantdata.

Inadditiontothesebenefits,labswhocontinuetofaxtheirresultformsincanalsotake

advantageoftheonlineentrysincethesystemwillbeabletopresentthedataasithasbeeninterpretedbycomputerizedscanning equipment.Userscanaccesstheirinterpreteddataandwillhavetheopportunitytocorrectanyscanningerrorsthatmayhaveoccurredduetothenatureoferrorsinherentinthese media.Givingtheparticipantstheopportunitytocorrectforthesescanningerrorsalso increasestheaccuracyoftheirdatawhich,ifallowedtopropagatethroughthesystem,couldhavenegativeconsequencesintheirperformanceinterpretation.

AutomatedPTdatatransmissionlaboratorieshavetheoptiontotransmitdatathroughanautomatedproficiencytestreportingservicecallede-LAB SolutionsConnect™.Withe-LAB SolutionsConnect,theCAP’squantitative proficiencytestresultsareautomatically transmittedfromyourlaboratory’sinstrumentsorlaboratoryinformationsystemtoe-LAB Solutions.TheCAPhaspartneredwithDataInnovationsInstrumentManager™middlewaresolutiontohelpfacilitatetheconnectionandtransmission.GototheCAPwebsiteorcalltheCustomerContactCenterformoreinformation.

Interactive EvaluationsAssoonastheduedateindicatedontheresultformhaspast,thedataareprocessedandgradedaccordingtostringentgovernmentalandcommitteecriteria.Thelabresultsandgradinginterpretationsaredisplayedinanindividualizedreportthatwillbeavailabletoallusersviapaperoronline.Theonlineversionisavailableinastaticformatthatcanbe printedordownloadedandstoredlocally,therebynegatingtheneedtocreatea separatelibraryofevaluationsforfuture reference.Inaddition,theonlineevaluation willallowtheusertonavigatethroughtheevaluationandbrowsethedataanalytebyanalyte.Also,userswillbenefitbytheinclusionofdetailedimagesthatwillbehyperlinkedfromtheonlineevaluationreportonly.LaboratorymanagerswillfindausefultoolintheAllAnalyteScorecard,whichwillallowthemtofilterandcustomizethescorecarddatafortheir laboratoryasameansofidentifying deficienciesortrendsinperformance.

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Online ReportsOtherancillaryreportsthataccompanytheevaluationreportwillbeavailableonline,aswell,forreviewandtodownloadforfuturereference.Thisincludesparticipantsummaryreports,finalcritiques,andannualsummaries,whichcontainusefuldataandeducationthatcanbereviewedandaccessedbyalluserswithappropriatesecurity.Thesedocumentsmaybedownloadedandstoredlocallyforfutureuse.

Thiswillhelptoincreasethedisseminationoftheinformationcontainedinthesedocumentstomultiplepersonnel,especiallynowthatthe informationcontainedthereinisbeingused increasinglyforeducationalenhancements forwhichindividualscanobtaincontinuing medicaleducation/continuingeducation (CME/CE)credits.

Thischapterincludesgeneralinformation regardingevaluations.Asectionexplaininghowtointerpretyourindividualevaluationwillbeincludedwitheachmailing.

General Guidelines for EvaluationOnFebruary28,1992,theSecretaryofHealthandHumanServicespublishedthefinalrulesimplementingtheClinicalLaboratory ImprovementAmendments(CLIA)of1988.TheseregulationsestablishedevaluationcriterialimitsformanyoftheanalytesincludedintheCAPSurveysprograms.Thetargetvaluesaredeterminedbythescientificresource committeesoftheCAP.Forthoseanalytes notincludedintheproficiencytestingportionofCLIA,thetargetvaluesandevaluationcriteriaaredeterminedsolelybythescientificresourcecommittees.

Selection of a Target ValueTominimizetheeffectofmethoddifferencesandtoallowcomparisonofallmethods, participants’resultsarecombinedinto comparablemethod/instrumentgroupscalledpeergroups.Itisimportantforparticipantstoprovidecompleteinformationregardingthemethodorinstrumentusedinordertobe combinedintheappropriatepeergroup.

Formostanalytes,thepeergroupmeanisdesignatedasthetargetvalueforevaluation.Thepeergroupmeanisthepreferredtargetifnosingletargetvalueexiststhatcanprovide

anaccuracy-basedtargetthatistraceabletothe“truevalue”asdeterminedbyadefinitiveorreferencemethodanalysis.Thepeergroupmustconsistofgreaterthannineresultsafteroutlierexclusion,andthevariabilityofthepeergroupdatamustnotbetoogreat.

Ifpeergroupdataarenotavailableoraretoo variable,methodgroupstatisticsmaybeused.Themethodgroupmustalsoconsistofgreaterthannineresultsanddemonstrateacceptablevariabilitybeforeitisusedasthetargetgroup.

Ifpeerandmethodgroupstatisticsarenotavailable,acomparativemethodgroupmaybedesignatedasthetargetmean.The comparativemethodisnotthemethod recommendedbytheCollege.Howeveritisestablishedasahistoricallyreliablemethodandisusedforevaluatingresultsfrommethodsthathaveaninsufficientnumberofparticipantstogenerateaseparatepeergroupand/or methodgroupstatistics.Ifnocomparativemethodexistsfortheanalyte,resultswillnot beevaluated.

Forsomeanalytes,asingletargetvalueisusedinwhichconsistentresultsaredemonstratedacrossallpeergroups.

Calculation of Summary StatisticsPeer Group Results

Resultsaregroupedaccordingtothemethodusedforanalysisandscreenedforoutliers. Variousstatisticsarecalculatedfromthe

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HowtoInterprettheEvaluationReport

remainingdatathatsummarizethepeergroup’sresponses.Thesesummarystatisticsmayincludethefollowing:

n themean(theaverageofthereported results);

n thestandarddeviation(ameasureof thevariabilityoftheparticipantresults, oftenabbreviatedasSD);

n thecoefficientofvariation(CV);

n themedian(themiddlevalueinan orderedlistofthenon-outlierresults);

n thelowvalue(thelowest valuereported);

n thehighvalue(thehighest valuereported); nthefinalcountofreportedresultsthat werenotexcludedasoutliers.

Outlier Detection Technique

Outlierexclusionisnecessarybecausealargeseriesofresultsfrequentlywillincludesome aberrantvalues.Thesemayarisefrom instrumentmalfunction,technicalerrors, specimenmix-ups,misplaceddecimals, incorrectunitsofmeasure,ordataentryerrors. Ifanyresultsareexcluded,theoutlierprocess isrepeatedusingtheremainingvalues.Thesummarystatisticsthatappearonyourreportsdonotreflectresultsthatwereconsideredtobeoutliersduringeitheroutlierpass.

Quantitative Procedures/Rounding

Allquantitativeresponsesareevaluatedbaseduponarangeofacceptability.Thisrangeisdeterminedusingatargetvalueandalimit.Thelimitwillbeeitherafixedinterval(eg,±5mg/dl),apercentageofthemean(eg,±25%),anSD(eg,±3SD),oravariablerange(eg,±6mg/dL or10%,whicheverisgreater).TheParticipantSummaryincludedwithyourevaluationwilllistthecriteriausedtoevaluateyourperformance.Thefollowingsectionsprovidesspecific examplesofhowtocalculatetherangeof acceptabilitydependinguponthecriteriaused.

Fixed Range Example

Yourlaboratoryreportsasodiumresultof138mmol/L.Thepeergroupmeanis139.5mmol/L.

Theevaluationlimitforsodiumis±4mmol/L.Theacceptablerangeisdeterminedbytheformula139.5mmol/L±4mmol/L,whichis135to144mmol/L.Therefore,yourreportedresultof138mmol/Liswithinthecalculatedacceptablerangeof135to144mmol/Lwhenusingbenefit-of-the-doubtrounding.

Percentage of the Mean Example

Yourlaboratoryreportsanalbuminresultof3.1 mg/dL.Thepeergroupmeanis3.39mg/dL.Theevaluationlimitforalbuminis±10%.Tenpercentof3.39mg/dLis0.34mg/dL.Theacceptablerangeisdeterminedbytheformula3.39mg/dL±0.34mg/dL,whichis3.0to3.8mg/dLwhenusingbenefit-of-the-doubtrounding.Therefore,yourreportedresultof3.1mg/dLiswithinthecalculatedacceptablerangeof3.0to 3.8mg/dL.

Standard Deviation Example

YourlaboratoryreportsaTSHresultof 16.4µU/mL.Thepeergroupstatisticsareas follows:mean=15.7µU/mL,SD=1.5,and CV=9.6.TheevaluationlimitforTSHis±3SD. 3x1.5=4.5.Theacceptablerangeis determinedusingtheformula15.7µU/mL±4.5µU/mL,whichis11.2to20.2µU/mLwhenusingbenefit-of-the-doubtrounding.Therefore,yourresultof16.4µU/mLiswithintheacceptablerangeof11.2to20.2µU/mL.

Variable Range Example

Yourlaboratoryreportsatotalbilirubinresultof4.5mg/dL.Thepeergroupmeanis4.68mg/dL.Theevaluationlimitfortotalbilirubinis ±0.4mg/dLor20%,whicheverisgreater.Twentypercentof4.68is0.936.Sincethepercentagelimitof0.94isgreaterthantheintervallimitof0.4,thepercentagelimitisappliedtothetargetvalue.Theacceptablerangeisdetermined usingtheformula:4.68±0.936,whichis3.7to 5.7mg/dLwhenusingbenefit-of-the-doubtrounding.Therefore,yourresultof4.5mg/dL iswithintheacceptablerangeof3.7to 5.7mg/dL.


TheParticipantSummaryReportincludedwithyourevaluationreportwilllistthecriteriausedtoevaluateyourperformance.Todeterminetheacceptablerange,abenefit-of-the-doubtroundingprocedureisutilizedwhengrading. Theupperlimitofacceptabilityisobtainedbyroundinguptothenextreportableresult,whilethelowerlimitisdeterminedbytruncating.

Calculation of the Standard Deviation Index (SDI)

Thecomputer-printedevaluationreportlistsyourresultsandtheevaluationstatisticsforyourpeergroup.ItalsolistsyournormalizedresultsasanSDI.ThisvalueisobtainedbysubtractingthegroupmeanfromyourresultandthendividingbytheSD.

TheSDIisexpressedintermsofthenumberofSDsfromthemean,withanarithmeticsignindicatingthedirectionofthedifference.ThecalculationoftheSDInormalizesyourresultand,therefore,allowsforacomparisonofresults fromspecimensofdifferentconcentrationsof ananalyte.

Whenacomparativemethodhasbeen designatedforSurveysanalysis,asecondset ofstatisticsislistedontheprintoutcomparingyourresultswiththoseobtainedusingthe comparativemethod.ThefiguresshownarethemeanandSDforthecomparativemethodandyourresultasanSDIusingthesestatistics.Itispossibleforyourresulttobedefinedas“good”performanceinyourmethodgroupandyetproduceacomparativeSDIgreaterthantwo.ThiswilloccurifyourmethodhasalargeanalyticbiasoralargeSD.Itispossibletoreceivea comparativeSDIlowerthanthemethodgroupSDI,althoughthisrarelyoccurs.Inpractice,mostparticipantsreceivesimilarmethodgroupandcomparativeSDIs.

Comparative Statistics

Quantitative Procedures

Yourevaluationreportwilldisplayplotsofthe relativedistanceofyourreportedresultsasa percentageofallowabledeviationfromthe targetvalue.Thenumericdigitindicatesthe numberofresultsataplotlocation.Thealloweddeviationmaybecalculatedasfollows:

Ifyourresultisgreaterthanthetargetmean:

Ifyourresultislessthanthetargetmean:

Qualitative Procedures

Forqualitativeresponses,consensusagreementofrefereeorparticipatinglaboratoriesisusedforevaluation.Generally,80%agreementisrequired.

HowtoInterprettheEvaluationReport

Percentage ofAcceptable Deviation=100 x

your result-target ______________________upper limit-target mean

Percentage ofAcceptable Deviation=100 x

your result-target ______________________target mean-lower limit

CME Category 1TheCollegeofAmericanPathologists(CAP)isaccreditedbytheAccreditationCouncilfor ContinuingMedicalEducation(ACCME)toprovidecontinuingmedicaleducationfor physicians.

TheCAPdesignatestheseeducationalactivitiesforamaximumofthestatednumberofAMA PRA Category 1 Credits™.Physiciansshouldonlyclaimcreditscommensuratewiththeextentoftheirparticipationintheactivity. TheAmericanMedicalAssociationhasdeterminedthatphysiciansnotlicensedintheUSwhoparticipateintheseCMEactivitiesareeligibleforAMA PRA Category 1 Credit™.

SeethecurrentSurveyscatalogforavailableCMEprograms.

5 ContinuingEducation

Continuing Education (CE) for Nonphysician Laboratory PersonnelThisactivityisacceptabletomeetthecontinuingeducationrequirementsfortheASCPBoardofRegistryCertificationMaintenanceProgram.Thisactivityisapprovedfor continuingeducationcreditinthestatesofCaliforniaandFlorida.

AllnonphysicianlaboratoryprofessionalsinyourlaboratorymaynowearnindividualCEcreditsbycompletingtherelatededucationreadingandonlinelearningassessment questionsontheCAPwebsite.

Surveys CE ProgramsDiscipline Maximum CE CreditsChemistry

Coagulation

Hematology

Histology(HistoQIP)

Immunology

Microbiology

TherapeuticDrugMonitoring/Endocrinology

Toxicology

The number of credits are specific to the program mailing.

Please go to cap.org for up-to-date activity listings.


EXCEL CE ProgramFortheEXCELprogram,eachindividualmayreceivecontinuingeducation(CE)creditsforparticipatingintheeducationactivities. SelectedmailingsofEXCELwillincludean educationactivitydesignedtoprovide technicalandnontechnicalinformationto keepyourstaffontheleadingedgetoensurequalitypatientcare.Theeducationactivityconsistsofarelatedreadingfoundinthe ParticipantSummaryandlearningassessmentquestionsonlineatcap.org.

DesignedbytheCAPPoint-of-CareTestingCommittee,eachactivitycombinestheuniqueperspectiveofthecommittee’spathologist, clinician,andmedicaltechnologistmembers.Theeducationactivitiesaredesignedto challengeandeducatewhileprovidingtheconvenienceofearningfreeCEcreditsandfulfillinglicensureandeducationrequirementswithoutleavingyourlaboratory.Theeducationactivitiesarealsovaluabletoolsforin-housecontinuingeducationprograms.

Learning Cycle Information

Eacheducationactivityprovidesinformation oncommontechnicalandnontechnical issuesencounteredinalllaboratorysettings.Toreceivecontinuingeducationcredit,youmustcompletetheeducationreadingprovidedinyourParticipantSummaryandanswerthe onlinelearningassessmentquestions.Each educationactivitywillbeavailablefor12monthsandmustbecompletedwithinthattimeframe.Continuingeducationcreditwillbeappliedtowardtheyearinwhichtheactivityiscompleted.Detailedinformationonhowto accesstheonlinecomponentswillbeincludedineachParticipantSummary.

CE for CytotechnologistsCytotechnologistsmayapplythecreditsfromthegynecologic(FOVandPAPeducation)andnongynecologic(FNA,FNAG,NGC,andTICP)programstowardtherequirededucational activitiesfortheAmericanSocietyfor Cytopathology(ASC)ContinuingEducationCreditProgram.

Online Virtual Microscopy Education Programs

TheCAPoffersonlineeducationprogramsthatuseadvancedimagingtechnologytopresentimagesfromactualglassslidesforavarietyofsitesandspecimentypes.Thistechnology simulatesamicroscope,allowingyoutoscantheimageandusemultiplemagnificationstoviewthematerial.Fromtheimagesandclinicalinformationprovided,youselectadiagnosis,answerlearningassessmentquestions,and receiveimmediatefeedbackonline.

SeethecurrentSurveyscatalogforavailableonlinevirtualmicroscopyeducationprograms.

ContinuingEducation

How to Complete the Result FormToensurestatisticallyvaliddata,itisessential thatparticipantsprovideallnecessaryunitofmeasure,method,reagent,and/orinstrumentinformationasrequired.Pleaseremember,onceyouhaveprovidedaccurateinformation,ourcomputersystemwillretainthisinformation.

Verifythatthecorrectunitofmeasure,method,reagent,and/orinstrumentcodeisnotedonthepreprintedmethodsummarypageincludedwithyourresultformorlistedontheonlineresultform. Ifacodeisnotnotedoryou’vechanged instruments,youmustenterthecorrectcode ontheresultform.

Hematology

Toreportyourbloodcellidentification,selectthebestidentificationcodefromtheHematologyBloodCellIdentificationMasterListprovidedinthekitinstructions.Toassistyouwithbloodcellidentification,theHematology,Clinical Microscopy,andBodyFluidsGlossaryisavailiableonlineatcap.org.

Ifresultsarereportedforbothbloodcell identificationandautodifferentials,thebloodcellidentificationwillbereportedtoCMS.

TheHematologyBloodCellIdentification MasterListchoice,“Immaturecellor abnormalcell,wouldreferforidentification,”mustbereservedforcellsyourarelyencounterandareunabletospecificallyidentify.GradingofthisresponsewillfollowtheguidelinessetforthintheJuly26,1993,Federal RegisterNotice.

Coagulation

Forplasma-basedcoagulationtesting(PT,APTT, Fibrinogen),aninstrumentandreagentcodearerequiredforproperevaluation.Participantsenrolledinwholebloodproficiencytesting forPTneedonlyindicateaninstrument (ifrequested)andtheirresults.Forall prothrombintimemodules,reportingof InternationalNormalizedRatio(INR)resultsis optional.Plasma-basedandwholebloodINR areevaluated.

Urinalysis

Thereisaseparateurinalysisandspecific gravitymethodmasterlistandinstrumentmasterlist.Toensureanaccuratepeergroupevaluationofyourresults,itiscriticaltoprovideaccuratemethodandinstrumentinformation.

Aspecificlistofreportingoptionsisprovided foreachurinalysisprocedure.Itisnotfeasible toprovidealistofreportingchoicesspecific foreverypossibledipstickbeingmarketedtolaboratories.Subsequently,theresultrangeslistedmaynotexactlycorrelatewiththerangesusedwithyourinstrument/dipstick.Inthesefewcases,choosetherangethatmostcloselymatches yourintendedresult.Toensureanaccurate peergroupevaluationofyourresults,itis criticaltoselectanappropriateresultthatthemethodallows.

Toreporturinesediment,clinicalmicroscopy,orprovider-performedmicroscopy,selectthebest identificationcodefromtheUrineSediment/ ClinicalMicroscopyMasterListprovided.To assistwithidentification,theHematology, ClinicalMicroscopy,andBodyFluidsGlossary isavailableonlineatcap.org.

6 Discipline-Specific ReportingInformation


Urinalysis Dipstick Tests

Forqualitativeproceduresinurinalysis,evaluationisbasedonparticipantconsensusbymethodandinstrument.Foreachanalyte,aminimumoftwo,butnotmorethanfour,responseswillbegivenapassingscore.Analyteresultsgraded“good” performancemusthave80%participant consensus.Eightypercentparticipantconsensuscanbedeterminedbygroupingthemodewiththenextoneortwomostfrequentresponses.Thisgroupwillbegiven“good”performance.“Acceptable” performancewillbegiventoadditionalresponsesuntilaminimumof90%ofparticipantresultsaregivenapassingscore.Inthecaseofanegativespecimen,negativeresponsesmustconstitute90%participantconsensus.Specimenswithresultsforoneormoremethodsdistributedoverboth negativeandpositiveresponse(nonconsesus) willnotbeevaluated.Specimensforwhichthereisgreaterthan90%ofparticipantresponses distributedovermorethanfourresponseswillbegradedasnonconsensus.

Microbiology

Whereappropriate,aclinicaldiagnosis,age,andsourcearelistedtosimulateatrueclinicalsituationandtoallowlaboratorypersonneltoselect appropriatemediaormethodsforprocessingthesespecimens.However,asthepathogenicbacteriapresentinanyofthesesamplesmaybeisolatedfrommultiplesourcesofthebody,allparticipantsshouldattemptidentificationoftheorganisms presentinallthesespecimens.

PertheFederal Register,aSurveymustgradealaboratory’sabilitytodistinguishbetweena pathogenandacontaminant.Culturechallengeswillbedesignatedintheinstructionstobehandledas“identifyprincipalpathogen”or“identifyall organisms”challenges.Participantsmustreportinthismannerevenwhenthisdiffersfromtheir laboratory’sroutinepractice.Forexample,aurinespecimencontainsKlebsiella pneumoniaeand Staphylococcus epidermidis.Iftheinstructions indicateto“Identifyallorganisms,”both organismsshouldbereported.Iftheinstructionsindicateto“identifyprincipalpathogen,”onlytheKlebsiella pneumoniaeshouldbereported.IftheStaphylococcus epidermidisisreported,itwouldbepenalized.

Specimenresultswillbeevaluatedif80%ormore oftheparticipantlaboratoriesagreeonthe identificationofthetestorganism(s)togenusortogenusandspecies.Intheabsenceofparticipantconsensus,refereelaboratorieswillbeused.

TheCLIAregulationsstatethatalaboratorymustperformaminimumoffivespecimensineach testingeventforthesubspecialtyofbacteriology.Thefivechallengescanincludeacombinationofthefollowingspecimens:

nbacterialantigendetection nbacterialidentification(culture) nGramstain nantimicrobialsusceptibility

Pleasenotethatproceduresassayedwithwaivedmethodologieswillnotcounttowardthefive- challengeminimum.Thelaboratoryisresponsibleformaintainingthefivespecimenspertestingeventforitsremainingnonwaivedtestsinthe subspecialtywhenatestiswaivedbythe FDAmidyear.

Antimicrobial Susceptibility Testing

Participantswillbeaskedtoperform susceptibilitytestsusingtheantimicrobialagentsandtechniquesinroutineuseintheirindividuallaboratories.Thelaboratoriesshouldreportonlyantibioticsappropriatefortherapyofinfectionsatthesiteindicatedinthepatienthistory.SeecurrentClinicalandLaboratoryStandardsInstitute(CLSI)documentsM2,M7,M100,orotherappropriatedocumentsforguidance.

Interpretationresults(susceptible,intermediate,andresistant)willbepenalizedfor:

n Agentsthatarenotclinicallyappropriate forthesiteofinfection(meningitis, pneumonia,urinarytract,etc)

nUseofmethodsCLSIadvisesagainst

nUseofmethodsthatthemanufacturer recommendsagainstusing,duetopoor performance

Selectivereportingforthepresumedsiteof infectionhelpsimproveclinicalrelevance, encouragesappropriatetherapy,andhelpstominimizeselectionofresistance.

Discipline-SpecificReportingInformation

7 EvaluationandParticipantSummaryReports

Your Evaluation ReportShortlyafteryousubmityourproficiencytestingresultstotheCAP,anevaluationreport evaluatingyoursubmittedresultswillbe availableonlineormailedbacktoyou.Yourevaluationreportcanbeusedasaqualityassurancetooltoassesshowyouperformedcomparedtootherparticipants.Tobenefitfromthisreport,itisimportantthatyoureviewandunderstandtheinformationpresented.Hereisareviewoftheinformationcontainedonyourevaluationreport:

n DemographicInformation:Provides informationaboutyourlaboratory, includingthenameofyourinstitution, yourCAPIdentificationNumber,andany agenciesorconsultantsyouhave designatedtoreceivecopiesofyour evaluation.

n ResultArea:Containsallresultsreported foraparticularmailingandstatistical datausedforevaluationpurposes.A detaileddescriptionofevaluationdata specificforeachdisciplineispresented ineachParticipantSummary.

n CMSPerformanceSummaryReport: Includesinformationoncurrentand cumulativeperformanceforregulated analytestobesenttotheCMS.

Reviewing Your Evaluation ReportTotrulyrealizethebenefitofproficiencytesting,itisimportantthatyoutakethetimetocarefullyreviewyourevaluation.Youcangainvaluableinsightintoyourlaboratory’soverallprocessesbyfollowingtheseeasystepsinreviewingthisreport.

1. Reviewthedemographicinformationon theevaluationreport.Ifanyinformation isincorrectorhaschanged,contactthe CAPat800-323-4040option1.

2. Compareinformationonyour evaluationreportwithresultsonyour photocopyorprintedcopyoftheresult form.Ifanyofyourdatawasenteredby theCAPincorrectly,contactus immediately.Correctionsdueto dataentryerrorsmadebytheCAPmust berequestedwithinfourweeksafterthe firstevaluationwasmailed.

3. Lookforanyunacceptableresults. Common,easilycorrectedreasonsfor unacceptableresultsinclude:

nIncorrectorincompletemethod/ instrumentdata

nClericalerror

nDecimalpointplacement

nSpecimenhandlingerror

Remember,whateverthecause,CLIA statesthatallPTdeficienciesmustbe


documentedandcorrectiveaction takentoresolvethedeficiency.

4. Althoughtheresultsmaynotbeformally evaluated,youcancompareyour resultswiththedataprovidedinthe ParticipantSummary.Youcanusethe “allmethodmean”ormedian,low,and highvaluestocompareyourresultsfora self-assessmentofyourperformance.

5. Forquantitativedata,justknowingthat youare“withinlimits”doesnottellyou ifyouareexperiencingaslowly developingbiasthatmayresultinfuture failures.Thekeytooptimaluseofyour evaluationdataistolookatthecolumn wherestandarddeviationindexes(SDI) arereported.Ifyounoteanyofthe followingtendencies,itmaybe advantageoustoexamineyour laboratoryprocessesfurther:

n TheaverageSDIismorethan+/-1.5: thismayindicateasignificant systematicerror.Reviewcalibration dataandtechnique.Review expirationdatesofcalibratorsand reagents.

nOneofyourSDIsisgreaterthan+/-3 ortotalSDIisgreaterthan4(oneSDI is-2andoneis+2.5foratotalof4.5): thismayindicateasignificant randomerror.Reviewyourprocedure todeterminewhereanyunwanted imprecisionmaybeoccurring.

6. Whentheevaluationreporthasa nonevaluationcodelisted,refertoyour ParticipantSummaryforvaluable information.

7. Verifythatallregulatedanalytesfor whichyoureportedresultsareincluded ontheCMSPerformanceSummary Report.

8. Makesurethelaboratorydirector reviewsandsignsallproficiency testingevaluations.

Participant Summary Inadditiontoyourevaluationreport,eachlaboratoryreceivesaParticipantSummaryforthatmailingthatlistsresultsfromallparticipantsforeachanalytegroupedbythemethodology.Thisreportprovidesvaluableinformationtotheparticipantintheformofcomparativedataandeducationactivities.

Program Update

ThissectionoftheParticipantSummarycontains informationaboutevaluationcriteriainusefor thatmailing.Italsohighlightsimportantmethod, manufacturer,andspecimeninformationthat pertainstothatmailing.

Quantitative Data

TheParticipantSummaryprovidesthestatisticaldataneededtoreviewyourproficiencytesting(PT)results.Thereportliststhemean,standarddeviation(SD),andcoefficientofvariation(CV)forpeergroupsconsistingof10ormore laboratories.

Qualitative Data

Qualitativedataevaluationisbasedon consensusofparticipantand/orreferee responses.TheParticipantSummaryliststhe participantresponsesalongwiththe percentagereportingthatresponse.Whereavailable,refereedataisalsoincluded.Thispracticeprovideshigher-quality,evaluatedchallengestoourparticipants.

How to Perform a Self-EvaluationAsmentionedpreviously,occasionallyaPTchallengecannotbeevaluatedforavarietyofreasons:

nLackofparticipantconsensus

n Insufficientdata(<10responsesfora givenmethod)

nPerceivedcompatibilityissues

InordertocomplywiththequalityassuranceaspectofproficiencytestingasoutlinedinCLIA,

TheEvaluationandParticipantSummaryReports

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youmusthavesomemechanismtoevaluateyourproficiencytestingresults.Hereareafewexam-plesofhowthedatapresentedinthe ParticipantSummarycanassistwiththistask.

Quantitative Results

Ifyouperformatestandtherearefewerthannineotherlaboratoriesreportingresultsforthattest,yourresultwillnotbeevaluated.Youcande-terminehowwellyouperformedcomparedtoallparticipantswhoreportedresultsbyusingthe“allinstrumentmethod”datapresentedinthePartici-pantSummary(ifprovided).For example,youperformhemoglobinanalysis usingtheCoulterS-plusIV.Therearean insufficientnumberofresultstoformapeergroup(<10);therefore,yourresultsarenot graded.NotethatintheParticipantSummarythereisanall-instrumentmean,standard deviation,andcoefficientofvariation,whichcanbeusedasareferencevalue.ByapplyingthepublishedCMSevaluationlimits(±7%)to thismean,youcandeterminehowwellyou performedcomparedtothisreferencevalue. Forexample:

Your result: 13.8 g/dL

All Instrument Mean: 13.77 g/dL

Range of Acceptability: 12.8–14.8 g/dL

Inthisexample,yourresultwouldbeconsideredwithinrangewhencomparedtotheall-instrumentmean.Documentthisself-assessmentonyour evaluationreport.Whenyouperformthisself- assessment,anyunacceptableresultshouldbedocumentedandinvestigatedandcorrective actionshouldbetakenaswouldbedonefor formallyevaluatedresults.Thissametechniquecanbeusedwhenonlyamedian,low,andhighvaluearereportedforananalyte.

Qualitative Results

Ifaqualitativeresultisnotevaluatedduetolack ofrefereeorparticipantconsensus,youcanstill evaluatehowwellyourlaboratory’sresultagreedwiththecorrectresponsebyusingthedataintheParticipantSummary.Forexample,oneoftheGramstainchallengescouldnotbegradeddue

tolackofparticipantconsensus(77%reportedgram-negative,23%reportedgram-positive).TheParticipantSummaryindicatesthattheorganismwasPseudomonas aeruginosa,agram-negativerod/bacilli.Compareyourresultwiththecorrectresult.Investigateanddocumentanycorrectiveactiontaken.Reviewtheeducationalcritique accompanyingtheresultforhelpfulsuggestions onlaboratorytechnique.

TheEvaluationandParticipantSummaryReports

8 LaboratoryLegislationandCMSReporting

OnFebruary28,1992,theSecretaryofHealthandHumanServices(HHS)publishedthefinalrulesimplementingCLIA.TheCLIAregulationsreplacedtheMedicare,Medicaid,andCLIA’67standardswithasinglesetofrequirementsthatapplytoalmostalllaboratoriestestinghumanspecimens.Standardsforlaboratorypersonnel,qualitycontrol,andqualityassurancearebasedontestcomplexityandriskfactors.TheregulationsalsoestablishapplicationproceduresandfeesforCLIAcertification,aswellasenforcement proceduresandsanctionsapplicablewhen laboratoriesfailtomeetstandards.

CLIAappliestoalllaboratories,physicianoffices,orotherentitiesperformingtestingonhumanspecimensforthepurposeofproviding informationforthediagnosis,prevention,or treatmentofdiseaseorimpairmentofhumanbeings.Laboratoriesthatconducttestingforthepurposeofassessingthehealthofindividuals(eg,testingforinsurancepurposes)arealsosubjecttoCLIA.ThefollowinglistscertainlaboratoriesthatarenotsubjecttoCLIA:

n Laboratoriesconductingonlyforensic testing

n Researchlaboratoriesthatdonotreport patientresults

n Componentsorfunctionsoflaboratories certifiedbytheSubstanceAbuseand MentalHealthServicesAdministration

n Laboratorieslocatedinastateinwhich thelicensureprogramisapprovedby theCMSasmeetingCLIAstandards

n Internationallaboratoriesnotperforming testsonUnitedStatescitizens

UnderCLIA,allclinicallaboratories,regardlessof location,size,ortype,mustmeetstandardsbasedonthecomplexityoftheteststheyperform.Threelevelsoftestingcomplexityaredefinedintheregulations:waived,provider-performed microscopy,andnonwaived.Laboratories performingprovider-performedmicroscopyornonwaivedtestingmustmeetrequirementsforproficiencytesting(PT),patienttestmanagement,qualitycontrol,qualityassurance,andpersonnel.Thesespecificrequirementsdonotapplytotestsinthewaivedcategory.

Theuniformproficiencytestingprogram regulationsmandatethatyourlaboratorymustenrollinaPTprogramapprovedbythe DepartmentofHealthandHumanServices,theCMSparentregulatoryagency,foreachofthespecialtiesandsubspecialtiesforwhichitseekscertification.Allanalytesthatareregulatedforproficiencytestingappearinboldtypeinthe SurveysandAnatomicPathologyEducation ProgramsorEXCELcatalogs.

YourlaboratorymustnotifyCMSoftheapproved program(s)inwhichyouparticipateand authorizethePTprogramtoreleasealldatatotheCMS.Yourlaboratorymustparticipateinan approvedPTprogramforoneyearbefore designatingadifferentprogram.CMSmustbenotifiedbeforeyourlaboratorychangesPT programs.ForteststhatarenotsubjecttoPTintheseregulations,yourlaboratorymuststill establishtheaccuracyandreliabilityofitstestproceduresatleasttwiceayear.

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PTspecimensmustbetestedwiththeregular patientworkloadbypersonnelwhoroutinelyperformtesting.Yourlaboratory’sroutinetestingmethodsmustbeused.Theindividualtesting thespecimensandthelaboratorydirector mustattesttotheroutineintegrationof specimensusingaformprovidedbythePT program.Laboratoriesthatperformtestsonproficiencytestingsamplesmustnotengageininterlaboratorycommunicationspertainingtotheresultsofproficiencytestingsample(s)untilafterthedatebywhichthelaboratorymustreportproficiencytestingresultstotheprogramforthetestingeventinwhichthesamplesweresent. Laboratorieswithmultipletestingsitesor separatelocationsmustnotparticipatein communicationsordiscussionsconcerning proficiencytestingsampleresultsuntilafterthedatebywhichthelaboratorymustreport proficiencytestingresultstotheprogram.Yourlaboratorymustalsomaintainacopyofall records,includingtheformusedtorecordthePTresults(includingtheattestationsignatures),foraminimumoftwoyears.

YourlaboratorymustsuccessfullyparticipateinaPTprogramapprovedbyCMS.“Unsuccessfulproficiencytestingperformance”isa “conditionlevel”deficiencyandmayresultinlaboratorysanctionssuchassuspensionoftheCLIAcertificateandMedicarepaymentsforthespecialty,subspecialty,andanalyteinvolved.Fail-uretoachieveasatisfactoryoveralltestingeventperformancefortwoconsecutivetestingeventsortwooutofthreeconsecutivetestingeventsisconsideredunsuccessfulperformance.

Pleasenotethatproceduresassayedwithwaivedmethodologieswillnotcounttowardthefive- challengeminimum.

Failuretoattainanoveralltestingeventscoreofatleast80%isunsatisfactoryperformancefor analytesinallspecialtiesandsubspecialties exceptABOgroup,D(Rh)typing,and compatibilitytestingforwhich100%isrequired.

FailuretoreturnPTresultsforatestingeventis unsatisfactoryperformanceandwillresultina scoreof“0.”Foranyunsatisfactorytestingeventforreasonsotherthanfailuretoparticipate,your laboratorymustundertakeappropriatetrainingandemploythetechnicalassistancenecessaryto

correcttheproblem.Allremedialactionmustbedocumentedandsuchdocumentationkeptfortwoyearsatyourlaboratoryforpossiblereferencebyinspectionandaccreditationteams.

Aspartoftheseregulations,criteriahavebeen establishedbywhichaPTprovider’sprogrammaybeevaluatedforapprovalbyHHS.TheCAPhasmadeeveryefforttoensurethattheSurveysprogramhasmettherequirementssetforthbytheFebruary28,1992,FinalRule.

Special Considerations for the Regulatory Requirements for the Specialty of Immunohematology

TheSpecialtyofImmunohematologycomprisesfoursubspecialitiesasfollows:

n ABO/Rh

n Unexpectedantibodydetection

n Compatibilitytesting

n Antibodyidentification

A100%scoreisrequiredtoachievesatisfactory performanceforABO/RhandCompatibility Testing.

Forunexpectedantibodydetectionandantibodyidentification,an80%scoreisrequired.The consensuspercentagerequiredtoestablishagradedchallengeissetat95%participantor100%refereeconsensusforABO/Rhandcompatibilitytestingand95%refereeorparticipantconsensusforunexpectedantibodyorantibody identificationchallenges.

Special Consideration for the Regulatory Requirements for the Specialty of Microbiology

TheCLIAregulationsstatethatalaboratorymusttestaminimumoffivespecimensineach testingeventforthesubspecialtiesof bacteriology,mycobacteriology,mycology, parasitology,andvirology.Withineachof thesesubspecialties,varioustypesoftesting arerequired.

LaboratoryLegislationandCMSReporting


Forbacteriology,thefivechallengesmay includeacombinationofthefollowing specimens:

n Bacterialantigendetection

n Bacterialidentification

n Gramstain

n Antimicrobialsusceptibility

Chlamydia trachomatisresultsareaggregatedunderthesubspecialtyofbacteriology.

Formycobacteriology,thefivechallenges mayincludeacombinationofthefollowing specimens:

n Acid-faststain

n Mycobacterialidentification

n Antimycobacterialsusceptibility

Formycology,fiveidentificationsarerequired.

Forparasitology,fiveidentificationsarerequired andmayconsistoftestingbyfecalsuspension, Giemsa-stainedbloodsmear,antigen detection,and/orPVAslide.

Forvirology,thefivechallengesmayincludea combinationofthefollowingspecimens:

n Viralantigendetection

n Viralidentification(culture)

Important Note: In order to meet the regulatory requirements for microbiology subspecialties, carefully follow the kit instructions included with each Surveys mailing.

Regulatory Requirements for the Specialty of Cytology: Gynecologic Examinations

Forcytology,theexaminationconsistsoften slidesfromfourdiagnosticcategories,including Unsatisfactory,NegativeorBenign,LSILand HSILorcarcinoma.Tobesuccessfulin cytology,ascoreof90%mustbeachieved.Detailedinstructionswillbeprovidedwiththetestmaterials.

Provision of Results to CMS and State AgenciesToassistincomplyingwiththerequirementthatyourlaboratoryresultsbereleasedtoHHS,theCAPwilltransferdatatotheCMSifyouhaveprovidedaCLIAidentificationnumber.Wewillforwardpaperorelectroniccopiesofyour resultstoyourstatedepartmentofhealth, actingonbehalfoftheCMS,ifyouauthorizeustodoso.Toauthorizereleaseofresultstostateagencies,indicateyourrequestontheorderconfirmationreportsentafteryourSurveysorderisprocessed,orsendalettertotheCAP.YourSurveysevaluationwillthenreflectthenameoftheagencytowhichtheinformationwasprovided.AnyquestionsregardingrequirementsforforwardingyourproficiencytestingresultsmaybeansweredviayourstatedepartmentofhealthoroneoftheCMSregionaloffices.

Consultwithyourstatedepartmentofhealth foradditionallawsorregulationsconcerninginspection,accreditation,andproficiency testingrequirementsthatmayaffectthe licensingofyourlaboratoryanditspersonnel.

CopiesoftheFebruary28,1992,CLIA regulationscanbeobtainedbycontactingtheGovernmentPrintingOfficebytelephoneat202-512-1800orbyfaxat202-512-2250andrequestingCFRTitle42Parts400-429and 430-End.Youmayalsoaccessdocuments onlineataccess.gpo.gov/su–docs/.

Ifyouhaveanyquestionsregardingthe automatictransferofresultstoCMSoryour performancesummaries,pleasecontacttheCollegeat800-323-4040option1.


800-323-4040 | 847-832-7000 Option 1 | cap.org 27

Use of Reason Codes for Nonevaluated SpecimensSomeindividualresultsarenotevaluatedforcertainlaboratoriesforavarietyofreasons.Areasoncodeexplainingthespecificcircumstancewillappearonindividualevaluationreports,alongwithabriefexplanationofwhatthatcodemeans.Belowisaledgerofpossiblereasoncodesthatcanbeassigned.

Reason Code Description or Explanation11 Unabletoanalyze(documentationtobeprovidedbylaboratory).

20 Noappropriatetarget/responsecouldnotbegraded.

21 Specimenproblem.

22 Resultisoutsidethemethod/instrumentreportablerange.

24 Incorrectresponseduetofailuretoprovideavalidresponsecode.

25 Inappropriateuseofantimicrobial.

26 Educationalchallenge.

27,31 Lackofparticipantorrefereeconsensus.

28 Responsequalifiedwitha“greaterthan”or“lessthan”sign;orunabletoquantitate.

29 Inappropriateresponse.

30 Scientificcommitteedecision.

33 SpecimendeterminedtobeunsatisfactoryaftercontactingtheCAP.

35 Testingnotperformedonthisspecimentype.

40 Resultsforthiskitwerenotrecieved.

41 Resultsforthiskitwererecievedpasttheduedate.

42 Nocreditassignedduetoabsenceofresponse.

43 Theorderforthiskitwascanceled;resultsnotevaluated.

44 Thisdrugisnotincludedinourtestmenu.Useofthiscodecountsasacorrectresponse.

46 Quantitationnotappropriate.

55 Exemptiongrantedduetoanaturaldisaster.

77 Improperuseofexceptioncodeforthismailing.

88 Labdoesnotperformtestsfromthissourceordoesnotperformthistestonpatients.

91 Therewereaninsufficientnumberofcontributingchallengesto establishacompositegrade.

92 Compositegradecouldnotbeestablishedduetotheuseofmultiplenongradedreasoncodesfortheindividualchallenges.

Itisthelaboratory’sresponsibilitytodocumenttheappropriateuseoftheseexceptioncodesshouldthisberequestedduringalaboratoryinspection.



CMS Performance Summary

2 35

8

6

7

1a. Kit ID:definesthecustomer’suniquekit numberforeachmailing.

1b. Kit Mailed:liststhedatetheSurveys mailingwasshipped.

1c. Original Evaluation:liststhedate theevaluationreportwasoriginally generated.

2. Regulated Analyte: listsallregulated testsincludedinthespecialty/ subspecialtyasdefinedbytheCLIA regulationsforthemodulesinwhich youareenrolled.

3. Summary of Your Previous Responses: liststhetotalnumberofspecimensyou havetestedandthenumberof acceptableresponsesforprevious testingevents.

4. CAP Number and Kit:definestheCAP numberandkitsequence.

5. Test Event:identifiestheproduct fulfillmentgroupandshipment.

6. Summary of Your Current Responses:lists thetotalnumberofspecimensyouhave testedandthenumberofacceptable responsesforthattestingevent.

CMS Performance Summary Data


Proficiency Testing Manual

www.cap.org 27

CMS Performance Summary

Subspecialty :31D0696246 ToxicologyProficiency Event

2008 3

Regulated Analyte Test Event Score %

Proficiency Event2009 1

Proficiency Event2009 2 Cumulative CLIA

'88 PerformanceInterpretation

Current EventPerformanceInterpretationTest Event Score % Test Event Score %

CMS Peformance Summary for Analytes Regulated Under the Clinical Laboratory Improvement Amendments of 1988

CLIA ID #:

Satisfactory100AL1-C 100AL1-B100AL1-AEthanol Successful/ / /555 5 5 5

100BL-C 100BL-ABlood Lead Successful/ /55 5 5

Satisfactory100Z-C 100Z-B100Z-ACarbamazepine Successful/ / /555 5 5 5

Satisfactory100Z-C 100Z-B100Z-ADigoxin Successful/ / /555 5 5 5

Satisfactory100Z-C 100Z-B100Z-AGentamicin Successful/ / /555 5 5 5

Satisfactory100Z-C 100Z-B60Z-ALithium Successful <1>/ / /555 3 5 5

Satisfactory100Z-C 100Z-B100Z-APhenobarbital Successful/ / /555 5 5 5

Satisfactory100Z-C 100Z-B100Z-APhenytoin Successful/ / /555 5 5 5

Satisfactory100Z-C 100Z-B100Z-APrimidone Successful/ / /555 5 5 5

100Z-C 0Z-AQuinidine Unsuccessful <3>/ /55 0 5*

Satisfactory100Z-C 100Z-B100Z-ATheophylline Successful/ / /555 5 5 5

Satisfactory100Z-C 100Z-B100Z-ATobramycin Successful/ / /555 5 5 5

Satisfactory100Z-C 100Z-B100Z-AValproic Acid Successful/ / /555 5 5 5

Toxicology 65/65 100 58/65 89 55/55 Satisfactory Successful

<1> Currently successful - At risk for the next mailing.<3> Currently unsuccessful.<*> Per your reporting preferences, this analyte is currently identified as being tested by your laboratory. A score of zero has been given due to the lack of response.

100

0002

The College of American Pathologists recommends that the result of this interlaboratory comparison not be used as a sole criterion for judging the performance of any individual clinical laboratory.

Page 6 of 6

CAP Number:Institution:

Attention:City / State:

Quest Diagnostics IncWilliam Tarr JR MDTeterboro NJ 07608-1070

1204101-01 Kit# 1 Kit ID: Kit Mailed:

Original Evaluation:

21876162

6/1/2009

7/10/2009

Z-B 2009 Therapeutic Drug MonitoringE V A L U A T I O N

ORIGINAL

CAP Number: 1234567-01 Kit# 1 Kit ID: 87654321 Institution: Community Hospital Kit Mailed: 6/1/0000 Attention: Lab Director Original Evaluation: 7/10/0000 City / State: Anytown, USA 12345

1a1b

1c

4

2 35

8

6

7

1a. Kit ID: defines the customer’s unique kit number for each mailing.

1b. Kit Mailed: lists the date the Surveys mailing was shipped.

1c. Original Evaluation: lists the date the evaluation report was originally generated.

2. Regulated Analyte: lists all regulated tests included in the specialty/subspecialty as defined by the CLIA regulations for the modules in which you are enrolled.

3. Summary of Your Previous Responses: lists the total number of specimens you have tested and the number of acceptable responses for previous testing events.

4. CAP Number and Kit: defines the CAP number and kit sequence.

5. Test Event: identifies the product fulfillment group and shipment.

6. Summary of Your Current Responses: lists the total number of specimens you have tested and the number of acceptable responses for that testing event.

CMS Performance Summary Data

Laboratory Legislation and CMS Reporting

800-323-4040 | 847-832-7000 Option 1 | cap.org 29

7. Current Event Performance Interpretation: indicateseithersatisfactory(≥80%)or unsatisfactory(<80%)performancefor eachanalyteandtheoverallperformance forthespecialty/subspecialty.ForABO group,D(Rho)type,andcompatibility testing,ascoreof100%isrequired.When resultshavenotbeenreceivedfromyour laboratoryforashipment,thisareawill beblank.

Ascoremaynotappear(fieldisblank)duetothefollowingreasons:

nLabhasindicatedtotheCollegethat theregulatedanalyteshouldnotbe reportedtoagencies

nChallengeswerenotgraded,using reasoncodesthatarenotreportedon thescorecard

nThemethodreportedfortheanalyteis waivedbyCMS

nNoresultswerereported

8. Cumulative Performance Interpretation: indicatessuccessful(≥80%)orunsuccessful (<80%)performanceforeachanalyteand forthespecialty/subspecialty.ForABO group,D(Rho)type,andcompatibility testing,ascoreof100%isrequired. A<1>symboldenotesthatyour performanceissuccessful;however, becauseyouhadlessthan80%onthe previousmailing,youarestillatrisktobe unsuccessfulforthenextmailing.A<2> denotesyouarecurrentlysuccessfulbut atriskforthenexttwomailingsasyouwere unsatisfactoryforthismailing.Thesecodes areapplicabletoboththeanalyteandthe overallspecialty/subspecialtyscores.A<3> denotescurrentlyunsuccessful performance.A<4>denotesthat scorecardperformanceispendingafuture evaluationormaynotbeapplicabledue todiscontinuedtestingortheuseofa waivedmethod.


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