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ProficiencyTesting Manual

Table of ContentTable of ContentssSurveys & Educational Anatomic Pathology Programs Manual

1 Order Confirmation, Specimen Handling, and Customer Service 3–7

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

2 General Comments 8–9

n CompletingtheResultForm 8 n Teleforms 8 n PreprintedMethodSummaryPage 8 n ExceptionCodes 8 n IdentificationMasterLists 9 n Method/InstrumentMasterLists 9 n Handwriting 9 n DecimalPointsandBoxPositions 9 n “LessThan”or“GreaterThan”Values 9

3 e-LAB SolutionsTM 10–11

n UsingOnlineFeatures 10 n Security 10 n OnlineDataSubmission 11 n InteractiveEvaluations 11 n OnlineReports 11 4 How to Interpret the Evaluation Report 12–14

n GeneralGuidelinesforEvaluation 12 n SelectionofaTargetValue 12 n CalculationofSummaryStatistics 12 n ComparativeStatistics 14

Interlaboratory Comparison Program Cycle

5 Continuing Education 15–17

n CMECategory1 15 n CEforCytotechnologists 15 n ContinuingEducation(CE)forNonphysicianLaboratoryPersonnel 16 n EXCEL®CEProgram 16

6 Discipline-Specific Reporting Information 18–19

n HowtoCompletetheResultForm 18

7 The Evaluation and Participant Summary Reports 20–22

n YourEvaluationReport 20 n ReviewingYourEvaluationReport 20 n TheParticipantSummary 21 n HowtoPerformaSelf-Evaluation 21

8 Laboratory Legislation and Centers for Medicare and Medicaid Services (CMS) Reporting 23–28

n ProvisionofResultstoCMSandStateAgencies 25 n UseofReasonCodesforNonevaluatedSpecimens 26 n CMSPerformanceSummaryData 27

Surveys & Educational Anatomic Pathology Programs Manual

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.

1OrderConfirmation, SpecimenHandling, andCustomerService

ConfirmationAfteryourorderisreceived,anorder confirmationreportissentthatcontainsthe followinginformation:

n Shippingaddress

n Billingaddress

n Telephoneandfaxnumber

n Listofproductsordered

n Listofagenciesand/orconsultantsto whomyouhaverequestedcopiesof yourevaluationreportbesent

Pleasereviewyourlaboratoryorderconfirmationreportcarefully.Ifyouhavechanges,returntheformwithintwoweeksofreceiptto:

CustomerDataManagement CollegeofAmericanPathologists 325WaukeganRoad Northfield,Illinois60093-2750 847-832-8168(fax)

Regulatory ReportingTheCAPwillautomaticallyforwardresultsforanalytesregulatedforproficiencytestingtotheCentersforMedicareandMedicaidServices(CMS)forlaboratoriesthathaveprovidedaCLIAidentificationnumber.

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.

CollegeofAmericanPathologists ProficiencyTestingManual 4

CAP Identification NumberEachparticipantreceivesaCAPidentificationnumberthatisprintedonallresultforms.Thisnumberwillalsoappearoneachevaluationreportreceivedbyyourlaboratory.ItishelpfultohavethisnumberavailablewhencontactingtheCollege.

Replacement Specimens Thekitscontainaresultformandspecimensfor analysis.Checkthecontentsofthekitagainsttheinstructions.EXCEL®participantsshouldverifythatallmoduleslistedonthemailingpageareincludedinthekit.Ifthekitisincompleteor containsbrokenorunlabeledspecimens, contacttheCollegewithinthenumberofdaysindicatedinthekitinstructionsfollowingtheactualshippingdateforafreereplacement.Additionalreplacementspecimensmaybepurchasedwithinthesametimeframe.Becauseproficiencytestingmaterialsmustbeprocuredinadvanceofshipment,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,proficiencytesting(PT)specimensmustbetestedwiththelaboratory’sregularworkload,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.

Changing Results and CMS Reporting Instructions n Changestosubmitteddatacannotbe madeaftertheduedatelistedonthe resultform.Reviewallentriesmadeon theresultformforaccuracypriorto submission.Forresultsapprovedonline, correctionsmustalsobedoneonline. Faxedormailedcorrectionswillnotbe accepted.

n Ifyouhaveregisteredyourlabonthe CAPwebsite,youmayuse“ResultForm Verification”toverifysubmittedresults.

n Foranytestingthatyoudonotroutinely performinyourlaboratory,leaveall reportingareasforthattestblank, includingmethodinformation.Please note, a penalty will not be applied for blank responses in the case of

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educational challenges, challenges not formally graded, or the proper use of exception codes. n Ifyoudonotperformspecifictestingina Surveysprogram,pleaserefertothekit instructionsandresultformforthe appropriateinstructions.

Foranyregulatedanalytesthatyourlaboratorydoesnotreportormayhavediscontinued,youmustnotifytheCAPinwriting.PleasefaxanychangesinwritingonyourCMSreportto 847-832-8168toavoidreceivingazeroscore onyournextPTevaluation.(Yourreporting preferencesareoutlinedontheCMSAnalytesReportingSelectionsdocument,whichis availableonlineatcap.orgontheAccreditationandLaboratoryImprovementtab.)Ifyouhaveanyquestions,pleasecalltheCustomerContactCenterat800-323-4040option1.

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

nInterlaboratoryProgramsinCervicovaginal andNongynecologicCytopathology (PAP/NGC)

nFine-NeedleAspirationGlassSlideProgram

Individualresultformscanbesubmittedonline(preferredmethod)orfaxedtotheCAP.CME/CEformswillbeselfclaimedonlinethroughthe Educationtab.

Evaluation ReportsTheevaluationreportwillbepostedonlineandmailedapproximatelytwotofiveweeksaftertheshipdateofthekit.Thistimeisneededfor processingdata,establishingevaluationcriteria,andpreparingthesummaryreport.

CorrectionsOccasionally,incorrectentryofsubmitteddataoccurs.Ifthisisduetoyourtranscriptionerrororfailuretocompletetheresultformappropriately,yourentrycannotbere-evaluated.IftheerrorismadebytheCAP,pleasecontacttheCustomerContactCenterat800-323-4040option1for furtherassistance.

Customer Support

Customer Contact Center Hours

7:00 am–5:30 pm CT

ExtendedCustomerContactCenterhoursensure coverageforalltimezones.Call800-323-4040 option1tospeakwithaContactCenter representative.Forinternationalcustomers,pleasecall847-832-7000option1.

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.organdclickonthe“ContactUs”iconlocatedatthetopofthemainpage.

CAP Mail

TheCAPhasimplementedanemailnotificationservice,CAPMail,designedtokeepyouinformedofourreceiptofyourorderform(s)andresultforms.Foreachdocumenttype,theCAPwillnotifytheappropriateindividualsthatwehavereceivedyourinformation.

n Allresultformreceiptacknowledgment messagesincludearesultformreceipt.

n LinktotheCAPwebsitepagewhereyou canreviewdetailedinformationforeach kitonthenumberandspecificpages receivedandmethodofreceipt.

Totakeadvantageofthisservice,ensuretheCAPhastheappropriateemailaddressesforyourlaboratory.

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

Tochoosenottoparticipateinthisprogram, participantscancontacttheCAPCustomer ContactCenterat800-323-4040option1.



Contact the CAP via Email

GeneralinquiriesmayberoutedtotheCollegeatthefollowingemailaddress: [email protected].

Program CertificatesAfterthecompletionoftheprogramyear, participatinglaboratorieswillreceiveaprogramcertificatethatrecognizeseachinstitution’sparticipationintheCAPproficiencytestingprogramanditscommitmenttopatientcare.CertificatesaresignedbytheCAPpresidentandaresuitableforframing.

LettersAlllettersreceivedbytheCollegearereviewedand,ifappropriate,forwardedtoamedicaltechnologistorascientificresourcecommitteememberforresponse.Yourinputisencouragedandhasalwaysservedasavaluablevehicle forchangesandimprovementstothe interlaboratorycomparisonprograms.

TheCollegedoesnotrequirethatyousubmit documentationforallproficiencytesting deficiencies.However,itisrecommended thatsuchdocumentationberetainedinyour laboratory.TheCAPLaboratoryAccreditationProgramissuesaseparatereport,the “ProficiencyTestingExceptionSummary,”thataddressesproficienciesforCAP-accreditedlaboratories.Instructionsforresponsewillbeincludedwiththereport.

Limitations of Proficiency TestingDuetothemanufacturednatureofthe specimensandthelogisticsofshipping, proficiencytestingdoesnotalwayscorrelatewiththemannerinwhichfresh,clinical specimensarehandled.Aletteraddressingthesedifferencesisincludedonpage7for generalusebyyourlaboratory.

Handle With CautionProficiencytestingspecimensmustbehandledwithcaution.Eachshipmentincludesa biohazardwarningstatementexplainingproperhandling.

Laboratory AccidentsIncidentsofpersonnelexposuretoinfectiousspecimens,throughneedlesticks,contaminationofthemucousmembranesthroughsplashesoraerosolization,orcutsfromcontainers,shouldbereportedimmediatelytotheCAP.

24-hourhotline:800-443-3244

Pleasetrytohavethefollowinginformationavailable:

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 andMedicaidServices(CMS),changesto submitteddatacannotbemadeaftertheduedateprintedontheresultform.Reviewallinformationonthemethodsummarypageandallentriesmadeontheresultformforaccuracypriortosubmission.Onceyouhaveoptedin,youcanusethe“ResultFormDataEntryandReceiptVerification”optionontheCAPwebsite(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.

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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”onpage8orinyourkitinstructions.

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,therebyallowingtheentirelaboratorycommunitytoparticipateonline.ThisregistrationisalsovalidforCME/CEonlinelearningactivities.

Logging In

OnceusershaveestablishedanaccountwiththeCollege,theywillbepromptedbythe systemtoentertheiruserIDandpassword.Thismustbedoneeverytimeusersvisitthesite,oruserscanchoosetohavethesystem remembertheirlogin.Bothmembersand nonmembersutilizethesamelogin functionality.

Opting In

Auser(thelaboratoryadministrator,by default)entersaCAP#andCollege- providedPIN#,therebyenablingthe laboratorytoaccessadvancedfeatures online.Thisprocessonlyneedstobedoneonceperlab;andonceaccomplished,thelabwillhaveaccesstoallofthefeatures currentlyaccessibleonlineaswellasthosethatwillbeofferedinthenearfuture.

SecurityThenatureoftheindividualizedaccounts forlaboratoryusersallowsforflexibilityindeterminingwhatlevelsofaccesseachusershouldhave.Becauseusersareindependententitiesfromthelaboratory,theuserscanbeassociatedwithmultiplelaboratoriesandtheirsecuritycanbeadministeredinadifferentmannerateachsite.Thisiscarriedoutby thedelegatedsecurityadministratoratthe laboratorywhoisresponsibleforoverseeingtheaccessandsiteprivilegesforeachuser associatedwiththatlab.Becauseofthechangingnatureoftheemployee-employerrelationshipinthelaboratory,thisfeature allowsthemostflexibilityfortheadministratortoadd,modify,and/orremoveusers’accessprivilegesastheadministratorseesfit.Thishastheoveralleffectofeliminatingtheneedto havetocalltheCustomerContactCenter tocarryoutsomeofthemoreroutine maintenanceofanaccount.Thedelegatedsecurityadministrator(s)canconferasmanyorasfewpermissionsastheyseefit,andtheadministrator(s)canconfigurepersonnel securitysothatitcloselymatchesindividuals’roleswithinthelaboratory.Thiswillenablethelabtoreplicatethesameworkflowmodelthatitemploysforpaper-basedsubmissionof results,therebyhelpingtoincreasetheintegrityandconfidenceinthedataenteredonline.

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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.

Interactive EvaluationsAssoonastheCollegereceivesastatisticallysignificantpopulationoftheresultsfromkitsmailedforeachSurveymailing,thedataareprocessedandgradedaccordingtostringentgovernmentalandcommitteecriteria.Thelabresultsandgradinginterpretationsaredisplayedinanindividualizedreportthatwillbeavailabletoallusersviapaperoronline.Thepaperreportthatlabsareusedtoseeinghasanupdatedgraphicalformat.Thenewformatalsoallowsformoredatatobedisplayedperpage,therebycuttingdownontheamountofpaperthatmustbestoredforfutureretrieval.Theonlineversionisavailableinastaticformatthatcanbe printedordownloadedandstoredlocally,therebynegatingtheneedtocreatea separatelibraryofevaluationsforfuture reference.Inaddition,theonlineevaluation willallowtheusertonavigatethroughtheevaluationandbrowsethedataanalytebyanalyte.Also,userswillbenefitbytheinclusionofdetailedimagesthatwillbehyperlinkedfromtheonlineevaluationreportonly.LaboratorymanagerswillfindausefultoolintheAllAnalyteScorecard,whichwillallowthemtofilterandcustomizethescorecarddatafortheir laboratoryasameansofidentifying deficienciesortrendsinperformance.

Online ReportsOtherancillaryreportsthataccompanytheevaluationreportwillbeavailableonline,aswell,forreviewandtodownloadforfuturereference.Thisincludesparticipantsummaryreports,finalcritiques,andannualsummaries,whichcontainusefuldataandeducationthatcanbereviewedandaccessedbyalluserswithappropriatesecurity.Thesedocumentsmaybedownloadedandstoredlocallyforfutureuse.Thiswillhelptoincreasethedisseminationoftheinformationcontainedinthesedocumentstomultiplepersonnel,especiallynowthattheinformationcontainedthereinisbeingusedincreasinglyforeducationalenhancements forwhichindividualscanobtaincontinuing medicaleducation/continuingeducation (CME/CE)credits.

e-LABSolutions

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.Thepeergroupmeanisthepreferredtargetifnosingletargetvalueexiststhatcanprovideanaccuracy-basedtargetthatistraceabletothe“truevalue”asdeterminedbyadefinitiveorreferencemethodanalysis.Thepeergroupmustconsistofgreaterthannineresultsafter

outlierexclusion,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 remainingdatathatsummarizethepeergroup’sresponses.Thesesummarystatisticsincludethefollowing:

n themean(theaverageofthereported results);

n thestandarddeviation(ameasureof thevariabilityoftheparticipantresults, oftenabbreviatedasSD);

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n thecoefficientofvariation(CV);

n themedian(themiddlevalueinan orderedlistofthenon-outlierresults);

n thelowvalue;

n thehighvalue;

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/dLwhen

usingbenefit-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-thedoubtroundingprocedureisutilizedwhengrading.Theupperlimitofacceptabilityisobtainedbyroundinguptothenextreportableresult,whilethelowerlimitisdeterminedbytruncating.

Calculation of the Standard Deviation Index (SDI)

Thecomputer-printedevaluationreportlistsyourresultsandtheevaluationstatisticsforyourpeergroup.ItalsolistsyournormalizedresultsasanSDI.ThisvalueisobtainedbysubtractingthegroupmeanfromyourresultandthendividingbytheSD.

TheSDIisexpressedintermsofthenumberofSDsfromthemean,withanarithmeticsignindicatingthedirectionofthedifference.ThecalculationoftheSDInormalizesyourresultand,therefore,allowsforacomparisonofresultsfromspecimensofdifferentconcentrationsofananalyte.

HowtoInterprettheEvaluationReport


Whenacomparativemethodhasbeen designatedforSurveysanalysis,asecondsetofstatisticsislistedontheprintoutcomparingyourresultswiththoseobtainedusingthecomparativemethod.ThefiguresshownarethemeanandSDforthecomparativemethodandyourresultasanSDIusingthesestatistics.Itispossibleforyourresulttobedefinedas“good”performanceinyourmethodgroupandyetproduceacomparativeSDIgreaterthantwo.ThiswilloccurifyourmethodhasalargeanalyticbiasoralargeSD.Itis possibletoreceiveacomparativeSDIlower thanthemethodgroupSDI,althoughthisrarelyoccurs.Inpractice,mostparticipantsreceive similarmethodgroupandcomparativeSDIs.

Comparative StatisticsQuantitative Procedures

Yourevaluationreportwilldisplayplotsofthe relativedistanceofyourreportedresultsasa percentageofallowabledeviationfromthe targetvalue.Thenumericdigitindicatesthe numberofresultsataplotlocation.Thealloweddeviationmaybecalculatedasfollows:

Ifyourresultisgreaterthanthetargetmean:

Ifyourresultislessthanthetargetmean:

Qualitative Procedures

Forqualitativeresponses,consensusagreementofrefereeorparticipatinglaboratoriesisusedfor evaluation.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

15

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

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

SeethecurrentSurveyscatalogforavailableCMEprograms.

CE for CytotechnologistsCytotechnologistsmayapplythecreditsfromtheFNAG,FNA,PAPCE1/PAPJE1/PAPKE1/PAPME1, PAPPTandNGCprogramstowardtherequirededucationalactivitiesfortheAmericanSocietyforCytopathology(ASC)ContinuingEducationCreditProgram.

Online Virtual Microscopy Education Programs

TheCAPoffersonlineeducationprogramsthatuseadvancedimagingtechnologytopresentimagesfromactualglassslidesforavarietyofsitesandspecimentypes.Thistechnology simulatesamicroscope,allowingyoutoscantheimageandusemultiplemagnificationstoviewthematerial.Fromtheimagesandclinicalinformationprovided,youselectadiagnosis,answerlearningassessmentquestions,andreceiveimmediatefeedbackonline.

SeethecurrentSurveyscatalogforavailableonlinevirtualmicroscopyeducationprograms.

5 ContinuingEducation


Surveys CE ProgramsDiscipline Maximum CE CreditsChemistry

Coagulation

Hematology

Histology(HistoQIP)

Immunology

Microbiology

TherapeuticDrugMonitoring/Endocrinology

Toxicology

TransfusionMedicine

Continuing Education (CE) for Nonphysician Laboratory Personnel

The number of credits are specific to the program mailing.

Please go to cap.org and click on the Education tab for

up-to-date activity listings.

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

All laboratory professionals in your lab may now earn individual CE credits by completing the related education reading and online learning assessment questions on the CAP website.Uponcompletionoftheeducationactivity,youwillreceiveaCAPcontinuing educationcertificate.

DesignedbytheCAPPoint-of-CareTestingCommittee,eachactivitycombinestheuniqueperspectiveofthecommittee’spathologist,

clinician,andmedicaltechnologistmembers.Theeducationactivitiesaredesignedto challengeandeducatewhileprovidingtheconvenienceofearningfreeCEcreditsandfulfillinglicensureandeducationrequirementswithoutleavingyourlaboratory.Theeducationactivitiesarealsovaluabletoolsforin-housecontinuingeducationprograms.

Learning Cycle Information

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

ContinuingEducation

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ContinuingEducation

Overall Learning Objective

Uponcompletionoftheseeducationactivities,thelearnerwillbeableto:

1. Listpreanalytic,analytic,and postanalyticvariablesthataffect patienttesting.

2. Identifyqualityimprovement opportunitieswithinhis/herown laboratorysetting.

3. Applyappropriatequalityassurance measurestoensureaccuratepatient results.

CE (Continuing Education)

Thisactivityisacceptabletomeetthe continuingeducationrequirementsfortheASCPBoardofRegistryCertification MaintenanceProgram.

Thisactivityisapprovedforcontinuing educationcreditinthestatesofCalifornia andFlorida.

How to Complete the Result FormToensurestatisticallyvaliddata,itisessentialthatparticipantsprovideallnecessarymethod,reagent,and/orinstrumentinformationasrequired.Pleaseremember,onceyouhaveprovidedaccurateinformation,ourcomputersystemwillretainthisinformation.

Verifythatthecorrectmethod,reagent,and/or instrumentcodeisnotedonthepreprintedmethodsummarypageincludedwithyour resultformorlistedontheonlineresultform. Ifacodeisnotnotedoryou’vechanged instruments,youmustenterthecorrectcode ontheresultform.

Hematology

Toreportyourbloodcellidentification,selectthebestidentificationcodefromthe HematologyBloodCellIdentificationMaster Listprovidedinthekitinstructions.Toassistyouwithbloodcellidentification,theHematology, ClinicalMicroscopy,andBodyFluidsGlossary isavailiableonlineatcap.org.

Ifresultsarereportedforbothbloodcell identificationandautodifferentials,thebloodcellidentificationwillbereportedtoCMS.

TheHematologyBloodCellIdentificationMasterListchoice,“Immaturecellorabnormalcell,wouldreferforidentification,”mustbereservedforcellsyourarelyencounterandareunabletospecificallyidentify.GradingofthisresponsewillfollowtheguidelinessetforthintheJuly26,1993,Federal RegisterNotice.

Coagulation

Forplasma-basedcoagulationtesting(PT,APTT, Fibrinogen),aninstrumentandreagentcodearerequiredforproperevaluation.Participantsenrolledinwholebloodproficiencytesting forPTneedonlyindicateaninstrument (ifrequested)andtheirresults.Forall prothrombintimemodules,reportingof InternationalNormalizedRatio(INR)resultsisoptional.Plasma-basedandwholebloodINRareevaluated.

Urinalysis

Thereisaseparateurinalysisandspecific gravitymethodmasterlistandinstrumentmasterlist.Toensureanaccuratepeergroupevaluationofyourresults,itiscriticaltoprovideaccuratemethodandinstrumentinformation.

Aspecificlistofreportingoptionsisprovided foreachurinalysisprocedure.Itisnotfeasible toprovidealistofreportingchoicesspecific foreverypossibledipstickbeingmarketedtolaboratories.Subsequently,theresultrangeslistedmaynotexactlycorrelatewiththerangesusedwithyourinstrument/dipstick.Inthesefewcases,choosetherangethatmostcloselymatchesyourintendedresult.Toensurean accuratepeergroupevaluationofyourresults,itiscriticaltoselectanappropriateresultthatthemethodallows.

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

6 Discipline-SpecificReportingInformation

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Urinalysis Dipstick Tests

Forqualitativeproceduresinurinalysis, evaluationisbasedonparticipantconsensus bymethodandinstrument.Foreachanalyte, aminimumoftwo,butnotmorethanfour,responseswillbegivenapassingscore.Analyteresultsgraded“good”performancemusthave80%participantconsensus.Eightypercent participantconsensuscanbedeterminedby groupingthemodewiththenextoneortwomostfrequentresponses.Thisgroupwillbe given“good”performance.“Acceptable” performancewillbegiventoadditional responsesuntilaminimumof90%ofparticipantresultsaregivenapassingscore.Inthecaseofanegativespecimen,negativeresponsesmustconstitute90%participantconsensus.Specimenswithresultsforoneormoremethodsdistributedoverbothnegativeandpositiveresponse(nonconsensus)willnotbeevaluated.Specimensforwhichthereisgreaterthan90%ofparticipantresponsesdistributedovermorethanfourresponseswillbegradedas nonconsensus.

Microbiology

Whereappropriate,aclinicaldiagnosis,age,andsourcearelistedtosimulateatrue clinicalsituationandtoallowlaboratory personneltoselectappropriatemediaor methodsforprocessingthesespecimens. However,asthepathogenicbacteriapresent inanyofthesesamplesmaybeisolatedfrommultiplesourcesofthebody,allparticipantsshouldattemptidentificationoftheorganismspresentinallthesespecimens.

PertheFederal Register,aSurveymustgradealaboratory’sabilitytodistinguishbetweenapathogenandacontaminant.Culture challengeswillbedesignatedintheinstructionstobehandledas“identifyprincipalpathogen”or“identifyallorganisms”challenges. Participantsmustreportinthismannerevenwhenthisdiffersfromtheirlaboratory’sroutinepractice.Forexample,aurinespecimen containsKlebsiella pneumoniaeand Staphylococcus epidermidis.Iftheinstructionsindicateto“Identifyallorganisms,”both organismsshouldbereported.Iftheinstructionsindicateto“identifyprincipalpathogen,”onlytheKlebsiella pneumoniaeshouldbereported.IftheStaphylococcus epidermidisisreported,itwouldbepenalized.

Specimenresultswillbeevaluatedif80%ormoreoftheparticipantlaboratoriesagreeontheidentificationofthetestorganism(s)to genusortogenusandspecies.Intheabsenceofparticipantconsensus,refereelaboratorieswillbeused.

TheCLIAregulationsstatethatalaboratorymustperformaminimumoffivespecimensineachtestingeventforthesubspecialtyofbacteriology.Thefivechallengescanincludeacombinationofthefollowingspecimens:

nbacterialantigendetection

nbacterialidentification(culture)

nGramstain

nantimicrobialsusceptibility

Pleasenotethatproceduresassayedwithwaivedmethodologieswillnotcounttowardthefive-challengeminimum.ThelaboratoryisresponsibleformaintainingthefivespecimenspertestingeventforitsremainingnonwaivedtestsinthesubspecialtywhenatestiswaivedbytheFDAmidyear.

Antimicrobial Susceptibility Testing

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

Interpretationresults(susceptible,intermediate,andresistant)willbepenalizedfor:

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

nUseofmethodsCLSIadvisesagainst

nUseofmethodsthatthemanufacturer recommendsagainstusing,duetopoor performance

Selectivereportingforthepresumedsiteofinfectionhelpsimproveclinicalrelevance,encouragesappropriatetherapy,andhelpstominimizeselectionofresistance.

Discipline-SpecificReportingInformation

7 TheEvaluationand ParticipantSummaryReports

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

nDemographicInformation:Provides informationaboutyourlaboratory, includingthenameofyourinstitution, yourCAPIdentificationNumber,andany agenciesorconsultantsyouhave designatedtoreceivecopiesofyour evaluation.

n ResultArea:Containsallresultsreported foraparticularmailingandstatistical datausedforevaluationpurposes.A detaileddescriptionofevaluationdata specificforeachdisciplineispresentedin eachParticipantSummary.

nCMSPerformanceSummaryReport: Includesinformationoncurrentand cumulativeperformanceforregulated analytestobesenttoCMS.

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.

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5. Forquantitativedata,justknowingthatyou are“withinlimits”doesnottellyouifyou areexperiencingaslowlydevelopingbias thatmayresultinfuturefailures.Thekeyto optimaluseofyourevaluationdataisto lookatthecolumnwherestandard deviationindexes(SDI)arereported.Ifyou noteanyofthefollowingtendencies,itmay beadvantageoustoexamineyour laboratoryprocessesfurther:

n TheaverageSDIismorethan+/-1.5: thismayindicateasignificantsystematic error.Reviewcalibrationdataand technique.Reviewexpirationdatesof calibratorsandreagents.

n OneofyourSDIsisgreaterthan+/-3 ortotalSDIisgreaterthan4(oneSDIis -2andoneis+2.5foratotalof4.5):this mayindicateasignificantrandomerror. Reviewyourproceduretodetermine whereanyunwantedimprecisionmay beoccurring.

6. Whentheevaluationreporthasa nonevaluationcodelisted,refertoyour ParticipantSummaryforvaluable information.

7. Verifythatallregulatedanalytesforwhich youreportedresultsareincludedonthe CMSPerformanceSummaryReport.

8. Makesurethelaboratorydirectorreviews andsignsallproficiencytestingevaluations.

The 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,youmusthavesomemechanismtoevaluateyourproficiencytestingresults.Hereareafewexamplesofhowthedatapresentedinthe ParticipantSummarycanassistwiththistask.

Quantitative Results

Ifyouperformatestandtherearefewerthannineotherlaboratoriesreportingresultsforthattest,yourresultwillnotbeevaluated.Youcandeterminehowwellyouperformedcomparedtoallparticipantswhoreportedresultsbyusingthe“allinstrumentmethod”datapresentedintheParticipantSummary(ifprovided).For example,youperformhemoglobinanalysis usingtheCoulterS-plusIV.Therearean insufficientnumberofresultstoformapeergroup(<10);therefore,yourresultsarenotgrad-ed.NotethatintheParticipantSummarythere

TheEvaluationandParticipantSummaryReports


isanall-instrumentmean,standarddeviation,andcoefficientofvariation,whichcanbeusedasareferencevalue.ByapplyingthepublishedCMSevaluationlimits(±7%)tothismean,youcandeterminehowwellyouperformedcomparedtothisreferencevalue.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,oneoftheGramstainchallengescouldnotbegradedduetolackofparticipantconsensus(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,andqualityassuranceare basedontestcomplexityandriskfactors.The regulationsalsoestablishapplicationproceduresandfeesforCLIAcertification,aswellas enforcementproceduresandsanctions applicablewhenlaboratoriesfailtomeet standards.

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

n Laboratoriesconductingonlyforensic testing

n Researchlaboratoriesthatdonotreport patientresults

n Componentsorfunctionsoflaboratories certifiedbytheSubstanceAbuseand MentalHealthServicesAdministration

n Laboratorieslocatedinastateinwhich thelicensureprogramisapprovedby theCentersforMedicareandMedicare Services(CMS)asmeetingCLIA standards

n Internationallaboratoriesnotperforming testsonUnitedStatescitizens.

UnderCLIA,allclinicallaboratories,regardlessof location,size,ortype,mustmeetstandardsbasedonthecomplexityoftheteststhey perform.Threelevelsoftestingcomplexityaredefinedintheregulations:waived,provider- performedmicroscopy,andnonwaived. Laboratoriesperformingprovider-performed microscopyornonwaivedtestingmust meetrequirementsforproficiencytesting(PT),patienttestmanagement,qualitycontrol, qualityassurance,andpersonnel.Thesespecificrequirementsdonotapplytotestsinthewaivedcategory.

Theuniformproficiencytestingprogram regulationsmandatethatyourlaboratorymustenrollinaPTprogramapprovedbythe DepartmentofHealthandHumanServices,CMS’sparentregulatoryagency,foreachofthespecialtiesandsubspecialtiesforwhichitseekscertification.AllanalytesthatareregulatedforproficiencytestingappearinboldtypeintheSurveysandEducationalAnatomicPathologyProgramsorEXCELcatalogs.

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


PTspecimensmustbetestedwiththeregularpatientworkloadbypersonnelwhoroutinelyperformtesting.Yourlaboratory’sroutinetestingmethodsmustbeused.Theindividualtestingthespecimensandthelaboratorydirectormustattesttotheroutineintegrationofspecimens usingaformprovidedbythePTprogram.Laboratoriesthatperformtestsonproficiencytestingsamplesmustnotengagein interlaboratorycommunicationspertainingtotheresultsofproficiencytestingsample(s)untilafterthedatebywhichthelaboratorymustreportproficiencytestingresultstotheprogramforthetestingeventinwhichthesamplesweresent.Laboratorieswithmultipletestingsitesor separatelocationsmustnotparticipatein communicationsordiscussionsconcerning proficiencytestingsampleresultsuntilafterthedatebywhichthelaboratorymustreport proficiencytestingresultstotheprogram.Yourlaboratorymustalsomaintainacopyofall records,includingtheformusedtorecordthePTresults(includingtheattestationsignatures),foraminimumoftwoyears.

YourlaboratorymustsuccessfullyparticipateinaPTprogramapprovedbyCMS.“Unsuc-cessfulproficiencytestingperformance”isa“conditionlevel”deficiencyandmayresultinlaboratorysanctionssuchassuspensionoftheCLIAcertificateandMedicarepaymentsforthespecialty,subspecialty,andanalyteinvolved.Failuretoachieveasatisfactoryoveralltestingeventperformancefortwoconsecutivetestingeventsortwooutofthreeconsecutivetestingeventsisconsideredunsuccessfulperformance.

Pleasenotethatproceduresassayedwithwaivedmethodologieswillnotcounttowardthefive-challengeminimum.

Failuretoattainanoveralltestingeventscoreofatleast80%isunsatisfactoryperformanceforanalytesinallspecialtiesandsubspecialtiesexceptABOgroup,D(Rh)typing,and compatibilitytestingforwhich100%isrequired.

FailuretoreturnPTresultsforatestingeventis unsatisfactoryperformanceandwillresultina scoreof“0.”Foranyunsatisfactorytestingeventforreasonsotherthanfailuretoparticipate,your laboratorymustundertakeappropriatetrainingandemploythetechnicalassistancenecessarytocorrecttheproblem.Allremedialactionmustbedocumentedandsuchdocumentationkeptfortwoyearsatyourlaboratoryforpossible referencebyinspectionandaccreditationteams.

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/RhandCompatibilityTesting.

Forunexpectedantibodydetectionand antibodyidentification,an80%scoreisrequired.Theconsensuspercentagerequiredtoestablishagradedchallengeissetat95%participant or100%refereeconsensusforABO/Rhand compatibilitytestingand95%refereeor participantconsensusforunexpectedantibody orantibodyidentificationchallenges.

Special Consideration for the Regulatory Requirements for the Specialty of Microbiology

TheCLIAregulationsstatethatalaboratorymusttestaminimumoffivespecimensin eachtestingeventforthesubspecialtiesofbacteriology,mycobacteriology,mycology,parasitology,andvirology.Withineachofthesesubspecialties,varioustypesoftestingare required.

Forbacteriology,thefivechallengesmay includeacombinationofthefollowing specimens:

n Bacterialantigendetection

n Bacterialidentification

n Gramstain

n Antimicrobialsusceptibility

Chlamydia trachomatisresultsareaggregatedunderthesubspecialtyofbacteriology.

LaboratoryLegislationandCMSReporting

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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,theCAPwilltransferdatatoCMSifyouhaveprovidedaCLIAidentificationnumber.Wewillforwardpaperorelectroniccopiesofyour resultstoyourstatedepartmentofhealth,actingonbehalfofCMS,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.



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.


800-323-4040|847-832-7000Option1|cap.org 27

CMS Performance Summary

2 35

8

6

7

1a.Kit ID:definesthecustomer’suniquekit numberforeachmailing.

1b.Kit Mailed:liststhedatetheSurveysmailing wasshipped.

1c.Original Evaluation:liststhedatethe evaluationreportwasoriginallygenerated.

2. Regulated Analyte: listsallregulatedtests includedinthespecialty/subspecialtyas definedbytheCLIAregulationsforthe modulesinwhichyouareenrolled.

3. Summary of Your Previous Responses:lists thetotalnumberofspecimensyouhave testedandthenumberofacceptable responsesforprevioustestingevents.

4. CAP Number and Kit:definestheCAP numberandkitsequence.

5. Test Event:identifiestheproductfulfillment groupandshipment.

6. Summary of Your Current Responses:liststhe totalnumberofspecimensyouhavetested andthenumberofacceptableresponses forthattestingevent.

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


7. Current Event Performance Interpretation: indicateseithersatisfactory(≥80%)or unsatisfactory(<80%)performanceforeach analyteandtheoverallperformanceforthe specialty/subspecialty.ForABOgroup, D(Rho)type,andcompatibilitytesting,a scoreof100%isrequired.Whenresultshave notbeenreceivedfromyourlaboratoryfor ashipment,thisareawillbeblank.

Ascoremaynotappear(fieldisblank)duetothefollowingreasons:

n LabhasindicatedtotheCollegethat theregulatedanalyteshouldnotbe reportedtoagencies

n Challengeswerenotgraded,using reasoncodesthatarenotreportedon thescorecard

n Themethodreportedfortheanalyteis waivedbyCMS

n Noresultswerereported

8. Cumulative Performance Interpretation: indicatessuccessful(≥80%)orunsuccessful (<80%)performanceforeachanalyteand forthespecialty/subspecialty.ForABO group,D(Rho)type,andcompatibility testing,ascoreof100percentisrequired. A<1>symboldenotesthatyourperformance issuccessful;however,becauseyouhadless than80%onthepreviousmailing,youarestill atrisktobeunsuccessfulforthenextmailing. A<2>denotesyouarecurrentlysuccessfulbut atriskforthenexttwomailingsasyouwere unsatisfactoryforthismailing.Thesecodesare applicabletoboththeanalyteandthe overallspecialty/subspecialtyscores.A<3> denotescurrentlyunsuccessfulperformance. A<4>denotesthatscorecardperformanceis pendingafutureevaluationormaynotbe applicableduetodiscontinuedtestingorthe useofawaivedmethod.


Download - CAP Proficiency Testing Manual - Home - College of ... Folders...College of American4 Pathologists Proficiency Testing Manual CAP Identification Number Each participant receives a

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