2014 Iowa Community‐Based Screening Services Procedures Manual
Iowa Community‐Based Screening Services Procedures Manual 2014 TableofContents 1. GeneralInformation..............................................................................................................................1 TheManual.................................................................................................................................1 ContactInformation................................................................................................................1 ImportanceofDetectingCT/GC.........................................................................................2 ChlamydiaandGonorrheaTestingatSHL....................................................................2 TestPerformanceCharacteristics.....................................................................................3 EnrollmentinCBSS..................................................................................................................4 QualityAssurance....................................................................................................................4 CBSSScreeningforCT/GC....................................................................................................7 CurrentScreeningCriteria...................................................................................................9 2. DataCollection,SpecimenCollection,PackagingandTransport.......................................10 ExplanationofDataCollection...........................................................................................10 ExplanationofDataFields....................................................................................................10 MedicaidInformation.............................................................................................................13 SampleofTestRequestForm.............................................................................................15 SpecimenCollection................................................................................................................16 PackagingandShipment.......................................................................................................18 CriteriaforRejection/Infractions.....................................................................................18 OrderingSpecimensCollectionSupplies.......................................................................19 3. TestResultsandTreatmentInformation.....................................................................................20 ReceivingTestResultsfromSHL.......................................................................................20 ContactingtheClientwithPositiveResults..................................................................20 ManagementofPartnersandFollow‐up.......................................................................21 TreatmentofChlamydia........................................................................................................22 TreatmentofGonorrhea.......................................................................................................23 PresumptiveTreatment........................................................................................................24 EPT..................................................................................................................................................24 StateReportingRequirements...........................................................................................25 4. Post‐TestandCertification.................................................................................................................27 CertificationForm....................................................................................................................28 CBSSManualPost‐Test..........................................................................................................29 5. Appendices................................................................................................................................................31 AppendixA–GenProbeAPTIMASensitivity/SpecificityCharts AppendixB–WebAccessRegistrationForms AppendixC–AdditionalResources AppendixD–Oropharyngeal/RectalSpecimenCollectionInstructionsand Recommendations 0 IowaCommunity‐BasedScreeningServices 2014 ProceduresManual 1. GeneralInformation‐AboutIowaCommunity‐BasedScreening Services(CBSS) IowaCommunity‐BasedScreeningServices(CBSS)(formerlyknownastheIowa InfertilityPreventionProject)isacollaborativeprojectbetweentheFamilyPlanning CouncilofIowa(FPCI),theIowaDepartmentofPublicHealth’s(IDPH)Family PlanningandSTDPrograms,andtheStateHygienicLaboratoryattheUniversityof Iowa(SHL).FundedbytheCentersforDiseaseControlandPrevention(CDC),testingand treatmentforchlamydiaandgonorrheaisdoneinclinicsitesacrossthestate.Data collectionisanimportantpartoftheCBSSandisusedonastateandlocalbasisexamine STDoccurrenceandtrends,guidepreventionandotherprogrammaticpriorities,and securefunding. TheManual ThepurposeofthismanualistoprovideclinicstaffattheCBSSprovidersiteswitha self‐studyguidetofamiliarizethemselveswiththepurposeandproceduresoftheprogram. Uponreceipt,thisguideshouldbereadandreviewedbyallclinicstaffinvolvedwiththe CBSS.Allnewemployeesinvolvedwiththeprogramshouldreviewthemanualwithinone monthofhire. Afterreviewingthemanual,thecliniciansandotherstaffshouldthentakethepost‐test locatedonpage29.ThistestandregistrationformshouldbereturnedtotheCBSS CoordinatorandwillserveasproofforcertificationwithintheCBSS.Thesurveymayalso betakenonSurveyMonkey. ContactInformation: ColleenBornmueller IowaCBSSCoordinator FamilyPlanningCouncilofIowa 108ThirdStreet,Suite220 DesMoines,IA50309 515‐288‐9028 [email protected] 1 IowaCommunity‐BasedScreeningServices 2014 ProceduresManual ImportanceofDetectingChlamydiatrachomatisandNeisseriagonorrhoeae* ChlamydiaisthemostcommonbacterialsexuallytransmitteddiseaseintheUnited Stateswithgonorrheabeingthesecondmostcommon.Thewideravailabilityofaffordable, cost‐effectivelaboratorydiagnostictestsforthepresenceofChlamydiatrachomatisand Neisseriagonorrhoeaehasallowedfurtherexplorationofthebroadspectrumofdisease causedbytheseorganisms. In2011,therewere1,412,791casesofchlamydiaand321,849casesofgonorrhea reportedtotheCDC.* 70%ofchlamydialinfectionsinwomenareasymptomatic,asare50%ofthe gonorrheainfections. ChlamydiaandGonorrhearatesarehighestinadolescentsandyoungadults betweentheagesof15–24. CDCestimatesthatundiagnosedanduntreatedSTDscauseatleast24,000womena yeartobecomeinfertile. Untreatedchlamydiaandgonorrheacanalsoleadtoepididymitisinmen. Ectopicpregnancyistheleadingcauseofthefirst–trimesterdeathsintheU.S. C.trachomatiscancauseneonatalpneumonia.BothC.trachomatisandN. gonorrhoeaecancauseneonatalconjunctivitis. C.trachomatisandN.gonorrhoeaeincreasesawoman’sriskofacquiringHIV,if exposedtothevirus. GonorrheaiscausedbyNeisseriagonorrhoeae,whichisgram‐negativediplococcus bacterium. TheGonococcalIsolateSurveillanceReport(GISP)continuestoshowdecreasing susceptibilityofthecephalosporinstoN.Gonorrhoeae. *CDCFactSheet,STDTrendsintheU.S.,2011 ChlamydiaandGonorrheatestingatSHL Nucleicacidamplifiedtests(NAATs)arerecommendedforthedetectionof reproductivetractinfectionscausedbyC.trachomatisandN.gonorrhoeaeinmenand women,withorwithoutsymptoms.AccordingtoCDC,optimalspecimentypesfor NAATsarefirstcatchurinefrommenandvaginalswabsfromwomen. 2 IowaCommunity‐BasedScreeningServices 2014 ProceduresManual AtSHL,chlamydiaandgonorrheatestingisperformedusingtheGen‐ProbeAPTIMA Combo2Assay,whichisaNAAT. TheGen‐ProbeAPTIMACombo2AssayisFDA‐approvedforthetestingoffemale endocervicalandvaginalswabs,maleurethralswabs,aswellasmale/femaleurine specimens.SHLhasvalidatedtheAPTIMACombo2forusewithoropharyngealand rectalspecimens. ThesensitivityoftheGen‐ProbeAPTIMACombo2Assayisgreaterthanthatof cultureortheEIAassaysforthedetectionofchlamydiaandgonorrhea. TestPerformanceCharacteristics Thereisnoperfecttest.Testinginlow‐prevalencepopulationsmayresultinsome false‐positiveresults.Positivetestresultsinalow‐prevalencepopulationshouldbe interpretedcarefullyinconjunctionwithclinicalsignsandsymptoms,clientriskprofile, andotherfindingswiththeunderstandingthatalikelihoodofafalse‐positivetestmay behigherthanatruepositive. Definitions: Sensitivity–Theprobabilityofapositivetestresultgiventhepresenceof disease.Howgoodisthetestatdetectinginfectioninthosewhohavethedisease? Specificity–Theprobabilityofanegativetestresultgiventheabsenceofthe disease.Howgoodisthetestatcallinguninfectedpeoplenegative? PredictiveValue–Theprobabilityofthepresenceorabsenceofdiseasegiven theresultsofthetest.PositivePredictiveValue(PPV)istheprobabilityofdiseasein aclientwithapositiveresult.NegativePredictiveValue(NPV)istheprobabilityof nothavingthediseasewhenthetestresultisnegative.Howpredictiveistheresult forthatparticularclient?Thisisdeterminedbythesensitivityandspecificityofthe test,andtheprevalencerateofdiseaseinthepopulationtesting. PrevalenceRate–Thenumberofcasesofillnessexistingatagiventimedivided bythepopulationatrisk. TheAPTIMACombo2C.trachomatissensitivityandspecificitycharts,theN.gonorrhoeae charts,andthePositiveandNegativePredictiveValuesbyprevalenceratesandspecimen sourcescanbefoundinAppendixA. 3 IowaCommunity‐BasedScreeningServices 2014 ProceduresManual EnrollmentinCBSS Allclinicsmustbeapprovedforparticipationintheprogram.CBSSclinicsinclude familyplanning,STD,orotheragenciestargetingdisproportionatelyimpactedpopulations orhighmorbidityareas.Requestswillbeconsideredbasedonfundingavailability, populationserved,andgeographiclocation. AgenciesmustsignaMemorandumofAgreement(MOA)withtheCBSStoparticipate. TheMOAisintendedtoprovideawrittenunderstandingfortheexpectationsofIDPH, CBSS,andtheparticipatingclinics.Itisnotacontract;however,butwillbesignedbythe CBSSAdministrator,IDPH,andtheparticipatingagencyprogramdirectorormanager. QualityAssurance CBSSrecommendsmethodsandsetsstandardsforassuringqualityandincludesthe followingidentifiedelements: a. Deskmonitoring; b. Facility‐specificassessments;and c. Treatment/partnerservices Consideringthesemethods,thefollowingistheQualityAssurancePlanfortheCBSS: DeskMonitoring–Thisiscarriedoutthroughanalysisofprintedreportsforthe purposeofidentifyingtrendsandissuesarising. RejectedSpecimens 1. SpecimensaremonitoredastheyaresubmittedtoSHLandfacilitiesarenotified immediatelyofspecimensthatcannotbeprocessed.TheSHLestablishesguidelines forspecimenrejectionbasedontheassaypackageinsertand/ortheregulator specifications. 2. TheSHLwillprovidemonthlyandquarterlyreportstotheCBSSCoordinatorthat includesallspecimensthatwerefoundtobeunsuitablefortestingandtheclinics wheretheyoriginated.Aquarterlyanalysisoftherejectedspecimensandthe reasonsforrejectionwillbereportedtoeachfacility.(Alistofrejectioncriteriacan befoundonpages18‐19.)Contactwillbemadewithanyfacilitywithahigher percentageofrejectedspecimensthanthestateaverageforthatquarter.Contact willbeintheformofaletter.Ifnoimprovementisshowninthenextquarter,a phonecallwillbemadebytheCBSSCoordinatortodeterminethecausesand correctiveactionneededtobetaken,suchason‐sitetraining. 4 IowaCommunity‐BasedScreeningServices 2014 ProceduresManual OutofCriteriaSpecimens Datafromthelabrequisitionformsforeachclinicwillbereviewedbylaboratorystaff forbirthdate,plustheotherinformationthatrelatestotestingsuchasinsurancestatus, signsandclinicalimpressions,symptoms,andriskhistory.Specimensfromclientsthatdo notfittheCBSSscreeningcriteriawillberejected.Ifdataareincomplete,clinicswillbe notifiedtoobtainmissinginformationastimeallows.Clinicsreceivetimelywritten notificationoftherejection. DataCollection/Accuracy TheCBSSCoordinatorauditsthetestrequestformsforappropriateandaccuratedata collection.Thelabformistheonlymeansfordatacollectionandcompletedatacollectionis necessaryforeffectiveprogramoperation.Onceamonth,theCBSSCoordinatorreceivesa spreadsheetfromSHLwiththedataforeachspecimensubmitted.Dataarereviewedfor incompletedatafields.Afieldleftblankinanexcessoffivetimesinonemonthis consideredabovethestatestandardandtheclinicsubmittingthespecimen/datawillbe contactedbylettertoadvisethemoftheproblem.Clinicsreceivingwrittennotificationfor threeconsecutivemonthswillbenotifiedbyphonebytheCBSSCoordinatortohelpsolve thedataissues. QuarterlyReports–DataAnalysis DatacollectedfromtestrequestformsiscompiledtocreatetheCBSSquarterlyand year‐endreports.Thesereportscontainthetotalnumberofspecimenssubmitted,totaland percentpositiveforchlamydiaandgonorrhea,andotherdatarelatedtofieldsreportedto theCBSS.TheCBSSCoordinatorwillprovideayearlydataanalysisfortheCBSSandeach participatingprovider. FacilityAssessments–SiteVisits Onanannualbasis,theCBSSCoordinatorwillmonitoraminimumof20%ofthe currentCBSSfacilitiesduringanin‐personsitevisitinrelationtothefourelementsfrom theIowaQualityAssurancePlan.Formostagencies,thiswillmeanaroutinesitevisitevery threeyears.However,avisitmaybedonesoonerifthereisnewstafforissuesrelatedto oneofthequalityassuranceelementslisted.Thefourelementsthatwillbecoveredduring thevisitinclude: 1. SpecimenCollectionandSubmission 2. ScreeningCriteria 3. DataCollectionandAccuracy 4. Client/PartnerTreatmentandEducation 5 IowaCommunity‐BasedScreeningServices 2014 ProceduresManual CBSSprovidersmustbeavailableforsitevisitsscheduledinadvanceduringtheclinic’s regularbusinesshours.Sitevisitstypicallylastbetween60to90minutesandareinformal innature.Thesitevisitprovidesanopportunitytoensuretheclinicisnotencounteringany difficultiesandtoprovidetechnicalassistancewhenneeded. Duringsitevisits,theCBSSCoordinatorwillcompletetheFacilityServicesAssessment (FSA)form,asrequiredbytheIowaQAPlan. InadditiontotheFSA,theCBSSCoordinatormayalso(dependingonclinictype) performamedicalrecord(chart)review.Ifachartreviewisdone,theCBSSCoordinator willspecifythechartstopull,aswellasanumberofrandomcharts. Withinsevendaysfromthedateofthesitevisit,theCBSSCoordinatorwillnotify(by letter)thefindingsofthevisitalongwithanyissuesneedingcorrectiveactionorfollow‐up. AcopyoftheFSAandchartreview,ifapplicable,willalsobemailed. LaboratoryQualityAssurance TheSHLhasbeeninspectedandlicensedunderCLIAbytheHealthCareFacilities Administration. 6 IowaCommunity‐BasedScreeningServices 2014 ProceduresManual CBSSScreeningforChlamydiaandGonorrhea Screeningiscommonlydefinedas“testinginasymptomaticpopulations.”Becauseof thefrequentasymptomaticnatureofchlamydialinfections,screeningbecomesessentialto controllingdiseaseincidenceandpreventingpotentialcomplications.Economically,itis notpossibletoscreeneveryone;therefore,individualregionsandstatesattempttofindthe bestcriteriafortheirareabasedonCDCguidelines,publishedstudies,andlocalprevalence data. TheCDCrecommendsannualchlamydiascreeningforallsexually‐activewomenwho are25yearsofageandyounger.Inadditiontheyrecommendrescreeningwomen, regardlessofage,withapreviouspositivetest.Accordingtotheirguidelines“Repeat infectionsconferanelevatedriskforPIDandothercomplicationswhencomparedwiththe initialinfection.Therefore,recentlyinfectedwomenareamajorpriorityforarepeattest forC.trachomatis.”CliniciansshouldadviseallwomenwithCT/GCinfectiontobe rescreenedapproximatelythreetofourmonthsaftertreatment. Recentdatasuggestthatscreeningsexually‐activeadolescentandyoungmalesfor chlamydiaarecost‐effectiveandthatarelativelyhighpercentageofpositivityisfoundin certainclinicsettings.http://ncc.prevent.org/products/committee‐products/file/EC_July‐ 2013.pdfRecommendationsagainstroutinescreeningofyoungmenarebaseduponan assumptionofapositivityrateoflessthanfivepercent,inwhichcasescreeningisnotcost‐ effective.However,recentstudiesindicateamuchhigherpositivityrateamongyoung malesattendingfamilyplanningclinics,evenwhencontrollingforvariablessuchas signs/symptomsandknownexposuretochlamydia.Alikelycontributingfactoristhe migrationofmalesfromtraditionalSTDclinicstofamilyplanningclinicsduetothe reductionofhoursandclosingofmanystand‐aloneSTDclinics.Localdataaffirmsimilar circumstancesforIowa.Forthesereasons,theCBSSprogramdoesrecommendroutine screeningofsexually‐activemales25yearsofageandyounger. CBSSscreeningcriteriaarethesameforfemalesandmales,includinggaymenand othermenwhohavesexwithmen(MSM).Thescreeningcriteriagenerallyreferto urogenitalspecimens.However,supplementalguidelineshavebeendevelopedfor oropharyngealandrectalspecimensbaseduponexposureandriskhistory.Regardlessof gender,sexualorientation,orspecimentype,thedeterminationofwhetheranindividual qualifiesforscreeningusingCBSStestkitsmustfirstbedeterminedusingthecriteriaof insurancestatus,age,andriskfactors.(Theincludedflowchartshouldbeusedtomakethis determinationfirst.)TheCBSSscreeningcriteriaareusedforbothchlamydiaand gonorrheatesting.Thecriteriaarebasedonacombinationofrecommendations(e.g.,CDC) andlocaldata.Theyfocusonyoungageastheprimaryriskindicator.Otherriskfactors includenewormultiplepartnersinthelast90days,reportedsymptoms,andobserved clinicfindingsatthetimeoftheexam. 7 Specimensnotmeetingthescreeningcriteriawillberejected.Clinicswillbenotifiedandmayreportadditionalinformationtojustifytesting ofthespecimen. 8 IowaCommunity‐BasedScreeningServices 2014 ProceduresManual Community‐BasedScreeningServices‐CurrentScreeningCriteria InsuranceStatus CBSStestkitsmustbeprioritizedforindividualswhocannotobtainchlamydiaandgonorrhea testingbecauseitiscostprohibitive(e.g.,lackoforinadequateinsurancecoverage.)Thisisthefirst criterion,beforeanyconsiderationofrisk(e.g.age)istakenintoaccount.Pleaseseethepreceding flowchartforguidanceonmakingthisdetermination.Duetolimitedresourcesifthecostoftesting canbecoveredbyothermeans(e.g.privateinsurance)CBSStestkitsmustnotbeused.Exceptions willbemadeforclientsrequiringconfidentialservicesandtesting. WomenandMen Specimencollectionforwomenmaybedoneusingavaginalswab(self‐collectedorclinician‐ collected,ifclientisover16andnotpregnant),acervicalswab,oraurinekit.Useofaurine collectionkitinanoutreachlocationmusthavepriorapprovalfromtheCBSSCoordinator. Specimencollectionformenmaybedonewithaurinecollectionkitorurethralswab. AllClinicTypes WomenandMen≤25yearsofage: Screenallindividuals≤25yearsofageannually o Screenallwomen≤25priortoIUDinsertion,asindicated Atanexamwithin12monthsofanegativechlamydia/gonorrheatest,screenONLYifan individualhasoneormoreofthefollowing: o Newormultiplepartnersinthelast90days o Reportedsymptomsconsistentwithchlamydiaorgonorrhea o Observedclinicalsignsconsistentwithchlamydia,gonorrheaorPID o ContacttoanSTD o IUDinsertion(women) WomenandMen26: Testallindividuals26yearsofageandolderiftheyhaveoneormoreofthefollowing: o Newormultiplepartnersinthelast90days o Reportedsymptomsconsistentwithchlamydiaorgonorrhea o Observedclinicalsignsconsistentwithchlamydia,gonorrheaorPID o ContacttoanSTD o IUDinsertion(women) Rescreen Rescreenallindividuals,regardlessofage,iftheyhavetestedpositiveforchlamydiaor gonorrheainthelast3to4months.(Thisisacheckforneworre‐infection,notatestof cure.) In order to determine whether oropharyngeal or rectal screening for gonorrhea or chlamydia is appropriate, see Appendix D. Please note that the above criteria must still be met regardless of specimen type (urogenital, oropharyngeal, or rectal). 9 IowaCommunity‐BasedScreeningServices 2014 ProceduresManual 2. DataCollection,SpecimenCollection,Packaging,andTransport Procedures ExplanationofDataCollection DatafortheCBSSissubmittedonthetestrequestformthataccompaniesthespecimen toSHL.Itisvitalthatallfieldsarecompleteoneveryform,everytime. SocialSecurityNumberand/oraclinicclientidentificationnumberaretheonly optionalfields.ALLOTHERSAREREQUIRED.Missingdatainthefieldswillbetrackedand clinicsnotifiedoftheseinfractions.Remembertoprintclearly. ExplanationofDataFieldsontheTestRequestForm SiteofCollection Checkonlyonechoicebymarkingtheboxthatidentifiesthesitefromwhichthe specimenwastaken(i.e.,cervix,oropharyngeal,rectal,urethral,urine,andvaginal). Failuretodosowilldelaytestresults. DateofSpecimenCollection Pleasewriteinthedatethespecimenwascollected.Thisinformationiscritical.The finalreportwillindicateifthedatehasbeenomittedandwillrequestthattheclinic notifythelaboratorywiththedate. ClientName Pleaseensurethatthenameonthetestrequestformandthenameonthespecimen collectiontubeareanexactmatch;otherwise,thelaboratorywillrejectthe specimen.Ifthereisnonameonthespecimentube,itwillberejected. BirthDate Thedatetheclientwasborn.Usetheformatoftwo‐digitmonth,two‐digitday,and four‐digityear(e.g.,01/02/2010).Ifthedateisnotsuppliedtheclinicwillbe contactedforthisinformation. SocialSecurityNumber Thisinformationisoptional.ItisnotrequiredbytheCBSSfordatacollection purposes.TheSHLusesthisinformationformakingdefiniteclientidentification.If yourclinicusesthisnumberforidentificationpurposes,pleaserecorditonthetest requestform. 10 IowaCommunity‐BasedScreeningServices 2014 ProceduresManual Address SHLandthestateSTDPreventionProgramusetheaddressforfurtheridentification oftheclientintheinstanceofapositivetest.Theclient’saddressmaybeusedto determinetheexactgeographicdistributionofdiseasetrends. CityofResidence Thisfieldisusedtodeterminethecountyoftheclient’sresidence.Writeoutthe client’shomecityandstateonthelineprovided. PhoneNumber ThisinformationiscollectedbySHLonalltestrequestforms.Itisusedforclient notificationbytheDiseasePreventionSpecialist(DPS)onlyintheinstanceofa diseaseinvestigationresultingfromapositivetest. Gender Indicatemaleorfemalebychecking“M”formaleor“F”forfemale.Determinationof sexismadebyobservationorthemedicalrecord. Race/Ethnicity ThecategoriesforreportingraceandethnicityfortheCBSSconformtotheOfficeof ManagementandBudget(OMB)1997RevisiontotheStandardfortheClassificationof FederalDataonRaceandEthnicity.Ifthisinformationisnotalreadyincludedinthe client’smedicalrecord,theinformationshouldbecollectedbyself‐identificationbythe client.Theclientisnowabletoself‐identifyorself‐reportmorethanoneoffiveraces categories.Thosemarkingmorethanoneracewillbecollapsedinto“Morethanone racereported”categoryinthefinalstateandregionaldata.Botharacialandethnic groupmustbemarkedoneveryform. Race White:IncludespersonsofEuropeandescent,theMiddleEast,orNorthAfrica Black:IncludespersonshavingoriginsinanyoftheblackracialgroupsofAfrica AmericanIndianorAlaskanNative:Includespersonshavingoriginsinanyofthe IndianpeoplesinNorthorSouthAmerica(includingCentralAmerica),andwho maintainstribalaffiliationorcommunityattachment;AlaskanIndian,Eskimo,and Aleutarealsoincluded. Asian:IndicatespersonshavingoriginsinanyoftheoriginalpeoplesoftheFar East,SoutheastAsia,ortheIndiansubcontinentincluding,forexample,Cambodia, China,India,Japan,Korea,Malaysia,Pakistan,thePhilippineIslands,Thailand,and VietNam. NativeHawaiianorOtherPacificIslander:Includespersonshavingoriginsinanyof theoriginalpeoplesofHawaii,Guam,Samoa,orotherPacificIslands. Unknown:Iftheclientdoesnotknowordoesnotwishtoidentifyrace. 11 IowaCommunity‐BasedScreeningServices 2014 ProceduresManual Ethnicity Hispanic:IndicatespersonshavingoriginsofCuba,Mexico,PuertoRico,Southor CentralAmerica,orotherSpanishcultureororigin,regardlessofrace.Theterm, “Spanishorigin”,canbeusedinadditionto“Hispanic”or“Latino”. Non‐Hispanic:Includesallotherpersons. Unknown:Iftheclientdoesnotknowordoesnotwishtoidentifyethnicity. ClientIdentificationNumber Thisistheclinic’sidentificationnumberfortheclient,ifyourclinicusesanumber otherthanSocialSecurityNumber. Ifyouclinicdoesnotuseaclientidentifier,itcanbeleftblank. Clinician Youmustentertheclinician’sfullname. ReasonforVisit(Checkonlyone) FP/Comprehensive:Theclientisattendingthescreeningsiteprimarilyforroutine services(i.e.,initial/annualorcontraceptivevisitsforfamilyplanningservicesor othercomprehensivehealthservices). STDScreening:TheclientisattendingthescreeningsiteprimarilyforSTDservices. Prenatal:Thisfieldisusedbytheclinicsdesignatedfortestingprenatalclientsby theCBSS.Theclientisattendingthescreeningsiteprimarilyforprenatalservices. Rescreen:Allclientstestingpositiveforchlamydiashouldberetested3to4months aftertreatment.Thisisnota“testofcure”;itisacheckforre‐infection.Notesting shouldbeperformeduntilatleast3‐4weeksfollowingthecompletionoftreatment. Pre‐IUD:Theclientisscreenedpriortoinsertionofanintrauterinedevice. RiskHistory(Checkallthatapply) NewPartner(last90days):Clientreportsanewsexualpartnerinthelast90days. MultiplePartners(last90days):Clientreportsmorethanonesexualpartnerinthe last90daysortheclientreportshavingapartnerwithmultiplepartnersinthelast 90days. ContacttoSTD:Clientreportshavingsexualcontactwithsomeonethathasbeen diagnosedwithanysexuallytransmitteddiseaseinthelastyear. MSM:Maleclientreportshehasengagedinsexualcontactwithothermeninthelast year. None:Clientdoesnotreportanyoftheabove;ifthisfieldischeckedyoumaynot checkanotherfieldwithinthissection. Symptoms Theclientreportsthatheorshehas(Yes)ordoesnothave(No)symptoms.(e.g., itching,burning,discharge,painwithintercourse,etc.) 12 IowaCommunity‐BasedScreeningServices 2014 ProceduresManual Signs/ClinicalImpressions(Checkallthatapply) Cervicitis/MucopurulentCervicitis:Aninfectionofthecervix;symptomsmay includemucopurulentvaginaldischargeandinflammation.MucopurulentCervicitis (MPC)isthepresenceofendocervicalmucopus,whichgiveyelloworgreen discolorationtoanendocervicalswabinsertedintotheos.Itisdefinedasanyofthe following: o Edema,erythema,orfollicle‐likelesionsinanareaofectopy(theextension ofcolumnarepitheliumontotheectocervix),or o Thepresenceofcervicalmucuswithtenormorepolymorphonnuclear leukocytesperx1000microscopicfield. CervicalFriability:Inflammationofthecervix;theclientmayreportpost‐coital bleeding,ortheremaybebleedingwhentheswabtouchesthecervix. PIDSuspicion:AdiagnosisofPID(PelvicInflammatoryDisease)isusuallybasedon clinicalfindings,whichisimprecise.Thefollowingareminimumcriteriawhenno othercausecanbeidentified: o Lowerabdominaltenderness o Adnexaltenderness o Cervicalmotiontenderness Urethritis:Aninflammationoftheurethracharacterizedbythedischargeof mucopurulentorpurulentmaterial,byburningduringurination,orurethralitching. NoExamperformed:Markthisfieldwhencollectingaurineorvaginalspecimenand therewasnophysicalexamination. Noneoftheabove:Anormalexamoranexamthatdoesnotincludeanyofthe aboveCT/GCrelatedsigns/clinicalimpressions. o Anyotherclinicalimpressionsshouldnotbeconsideredwhencompleting thisfield. Insurancestatus(Checkonlyone) Uninsured:thepatientisnotcoveredbyanyinsurance,publicorprivate Underinsured:thepatienthasinsurancebutitisinadequateorinsufficienttocover theirhealthcareneeds,suchasSTDtesting Insured,patientrefusestouse:thepatientmayrefusetousetheirinsurancedueto reasonstoprotectconfidentiality Insured,clinicincapableofprocessinginsurance:theprovidersitedoesnothave thecapacitytobillorprocessthepatient’sinsuranceorthisisafacilitythatwould notroutinelybillforthisservice(correctionalfacilities,school‐basedclinics,etc.). Medicaid/Waiverinformationsupplied:thepatienthasMedicaidortheFamily PlanningWaiverandtheinformationisprovidedonthetestrequestform. Medicaid/IowaFamilyPlanningNetworkInformation(IFPN) RequiredInformation ClientMedicaid,MedicaidHMOorIowaFamilyPlanningWaiver Number ICD9Code 13 IowaCommunity‐BasedScreeningServices 2014 ProceduresManual PleasecompletethisinformationiftheclienthasaMedicaid,MedicaidHMOorthe IowaFamilyPlanningNetworknumber. o IFPNinformationshouldbereportedonlyifthechlamydia/gonorrheatest waspartofafullcontraceptivevisit. IfaclientiscoveredbyMeridian,itisconsideredMedicaidandthelabcanbill. Pleasewritein“Meridian”nexttothepatient’sMedicaid#onthetestrequestform. Besuretoprovidetheclient’sICD‐9code,especiallyinthecaseoftheIFPN.Without it,thelab’srequestsaredeniedastheprocessingofthespecimenmustbelinkedto theserviceprovided.(PleaseNote:CodeswillchangetoICD‐10inOctober2014.New codingwillbenecessaryatthattimeandyouwillbenotified.) Possiblecodesatthistimeareasfollows: o IFPNClients V25.01–relatedtotheprescriptionoforalcontraceptives V25.02–initiationofothercontraceptivemeasures V25.09–otherfamilyplanningadvice V25.40–contraceptivesurveillanceunspecified V25.41‐contraceptivepill V25.49–othercontraceptivemethod o MedicaidClients V73.88–specialscreeningexaminationforotherspecifiedchlamydial disease V74.5–screeningexaminationforvenerealdisease Ifyoudonothaveaclient’sIFPNnumberatthetimeofsubmittingthespecimenyou shoulddosowhenthatinformationisavailable: o PreferredmethodwouldbetofaxacopyoftheDHSNoticeofDecisionthat willprovidelabstaffwiththeclientnameandclient#.Thelabstaffcanthen lookupthespecimenfortherestoftheinformation. o Ifthisformisnotavailableoryouprefernottosendit,thenfaxtheassigned numberalongwiththeclientname,yourclinicname,andifpossible,theSHL labnumberforthatclient. o SubmittheinformationtoJohnNegleyatSHL.Hisfaxnumberis319‐335‐ 4171. o Donotemailthisinformation.AdditionalquestionscanbedirectedtoJohnat 319‐335‐4442. AsampleSHLtestrequestformfollowsonthenextpage. 14 IowaCommunity‐BasedScreeningServices 2014 ProceduresManual 15 IowaCommunity‐BasedScreeningServices 2014 ProceduresManual SpecimenCollectionandTransport PackageinsertswithinstructionsforGEN‐PROBEAPTIMACollectionKits–APTIMA SpecimenCollectionGuidesareavailableuponrequest. FemaleEndocervicalSpecimenCollection* Removeexcessmucusfromcervicalosandsurroundingmucosausingcleaning swab(whiteshaftswabinpackagingwithredprinting).Discardthisswab! Insertspecimencollectionswab(blueshaftswabinpackagewithgreenprinting) intotheendocervicalcanal. Gentlyrotateswabclockwisefor10to30secondsinendocervicalcanaltoensure adequatesampling. Withdrawtheswabcarefully;avoidanycontactwithvaginalmucosa. Removecapfromswabspecimentransporttubeandimmediatelyplacespecimen collectionswabintospecimentransporttube. Carefullybreakswabshaftatscoreline;usecaretoavoidsplashingcontents. Re‐capswabspecimentransporttubetightly. MaleUrethraSwabCollection* Clientshouldnothaveurinatedforatleast1hourpriortospecimencollection. Insertspecimencollectionswab(blueshaftswabinpackagewithgreenprinting)2 to4cmintotheurethra. Gentlyrotatetheswabclockwisefor2to3secondsinurethratoensureadequate sampling. Withdrawtheswabcarefully. Removecapfromswabspecimentransporttubeandimmediatelyplacespecimen collectionswabintospecimentransporttube. Carefullybreakswabshaftatscoreline;usecaretoavoidsplashingcontents. Re‐capswabspecimentransporttubetightly. UrineSpecimenCollection(MaleorFemale)** Clientshouldnothaveurinatedforatleast1hourpriortospecimencollection Directclienttoprovidefirst‐catchurine(approximately20to30mLofinitialurine stream)intourinecollectioncup,freefromanypreservatives.Collectionoflarger volumesmayresultinspecimendilutionthatmayreducetestsensitivity.Female clientsshouldnotcleanselabiaareapriortoprovidingspecimen. Removecapfromurinespecimentransporttube,andtransfer2mLofurineinto urinespecimentransporttubeusingdisposablepipetteprovided.Thecorrect volumehasbeenaddedwhenfluidlevelisbetweenblackfilllinesonurine specimentransporttubelabel.(Thislevelisveryimportant!) Re‐capurinespecimentransporttubetightly.Thisisnowknownasthe“processed urinespecimen.” 16 IowaCommunity‐BasedScreeningServices 2014 ProceduresManual VaginalSpecimenCollection*(Non‐pregnantwomen16yearsofageandolder) Specimenmustbecollectedinaclinicalsetting.Thespecimenmaybeclinicianorclient (self)collected.Self‐collectedvaginalspecimensareanoptionforscreeningasymptomatic women.Thefollowinginstructionsareforself‐collectedswabs.ClientsmustreadthePatient CollectionInstructionsbeforeprovidingthemwithacollectionkit.Forclinician‐collected specimens,thevaginalspecimenshouldbecollectedbeforeinsertingaspeculumifanexamis tooccur. Washhandsbeforestarting. Partiallypeelopenswabpackage.Donottouchsofttiporlayswabdown.Ifsofttipis touched,swabislaiddown,orswabisdropped,requestanewAPTIMAVaginalSwab SpecimenCollectionKit. Removeswab. Holdswabbyplacingthumbandforefingerinthemiddleoftheswabshaft. Carefullyinsertswabintotheinsideopeningofthevagina,abouttwoinchesand gentlyrotateswabfor10to30seconds.Makesuretheswabtouchesthewallsof thevaginasothatmoistureisabsorbedbytheswab. Withdrawtheswabwithouttouchingskin. Whileholdingswabinthesamehand,unscrewthetubecap.Donotspilltube contents.Iftubecontentsspill,requestanewcollectionkit. Immediatelyplaceswabintothetransporttubesothetipoftheswabisvisible belowthetubelabel. Carefullybreakswabshaftagainstthetopsideofthetube. Re‐capswabspecimentransporttubetightly. Instructionsforcollectingoropharyngeal/rectalspecimenscanbefoundin AppendixD. *Specimentransportandstorage‐‐Aftercollection,transportandstoreswabinswab specimentransporttubeat2⁰Cto30⁰Cuntiltested.Specimensmustbeassayedwiththe GEN‐PROBEAPTIMAAssayforCTand/orGCwithin60daysofcollection.Iflongerstorage isneeded,freezeat‐20⁰Cto‐70⁰Cforupto90daysaftercollection. **Specimentransportandstorage–Aftercollection,transportandstoretheprocessed urinespecimenintheGEN‐PROBEAPTIMAurinespecimentransporttubeat2⁰Cto30⁰C untiltested.ProcessedurinespecimensshouldbeassayedwiththeAPTIMAAssayforCT and/orGCwithin30daysofcollection.Iflongerstorageisneeded,freezeat‐20⁰Cto‐70⁰C forupto90daysaftercollection. 17 IowaCommunity‐BasedScreeningServices 2014 ProceduresManual PackagingandShipmentofSwabandUrineSpecimens Labeleachspecimentubewithclient’snameand/oruniqueidentifier. o UNLABELEDSPECIMENSWILLNOTBETESTED AcompleteCT/GCTestRequestFormmustaccompanyeachspecimen. Besurethelidistightenedonthetransporttube. Useonebiohazardbagperspecimen. Wrapthespecimentransporttubeintheabsorbentmaterialprovidedandplace intobiohazardbag.Sealthebiohazardbag.Donotuserubberbands! Checktomakesurethetestrequestformiscompletelyfilledout.Foldthetest requestforminhalfandplaceinthewhiteplasticcircularmailers.Uptofour specimenscanbeplacedinthewhitemailingtubes. Whenshippingalargenumberofspecimens,asturdycardboardboxcanbeused insteadoftheplasticmailers.Thiswillsavepostage. Usethepreaddressedlabelprovided. TransportspecimenstoSHLassoonaspossibleaftercollection. Transportat2⁰Cto27⁰C(roomtemperature). CriteriaforRejection/InfractionsforSpecimenCollectionandTransport Specimenunsuitablefortestingduetotheuseofanimproperswab.Donotusethe whiteshaftedcleaningswabforspecimencollection. Specimenunsuitablefortestingduetotransportbufferorurineleakedduring transit.Thetransporttubecapwasnotsecurelytightenedpriortoshipment. Specimenunsuitablefortestingduetotheswabtransporttubewasreceived withoutaswab. Specimenunsuitablefortestingduetoimproperspecimen.TheGEN‐PROBE APTIMACombo2Assayisonlyvalidforfemaleendocervicalorvaginalswabs,male urethralswabs,male/femaleurine,oropharyngealswabs,orrectalswabs. Specimenunsuitablefortestingduetotheuseofanimproperspecimencollection kit.SubmitonlytheGEN‐PROBEAPTIMACombo2Assayspecimencollection system. Specimenunsuitablefortestingduetotheclient’snameonthetransporttubedoes notcorrespondtothenameonthetestrequestform. Specimenunsuitablefortesting.Noclientidentificationwasonthetransporttube. Specimenunsuitablefortesting.Thetestrequestformwasreceivedwithouta specimen. Specimenunsuitablefortesting.Notestrequestformwasreceivedwiththe specimen. 18 IowaCommunity‐BasedScreeningServices 2014 ProceduresManual SpecimennottestedduetotheclientnotmeetingtheCBSSscreeningcriteria. Specimenunsuitablefortestingduetospecimenintransporttubecontainstwo swabs.(Besuretodisposeofthewhiteshaftcleaningswab.) Specimenunsuitablefortestingduetoimproperquantityofurine.Thefluidlevelin theurinetransporttubemustfallbetweenthetwoblackindicatorlinesonthetube level. Specimennottested.Swabscutabovethebreakpointcannotbeprocessed.Swabsmustbe brokenoffattheindicatedbreak‐pointontheswab.Failuretodosocancause contaminationintheclinicandatthelaboratory. OrderingSpecimenCollectionSupplies Testkits,testrequestforms,andallotherCT/GCsuppliesaretobeorderedthroughthe CBSSCoordinatororAdministrativeAssistantat: Community‐BasedScreeningServices FamilyPlanningCouncilofIowa 108–3rdStreet,Suite220 DesMoines,IA50309 Phone:515‐288‐9028 [email protected] Collectionkitscaninclude: o Unisexswabkits,vaginalswabkitsorurinekits o Testrequestforms o Biohazardbags o Absorbentmaterial o Whitemailingtubes o Mailinglabels Individualcomponentsmaybeorderedseparately.Swabandurinekitscomeinboxes of50.Youmayspecifyaquantitylessthan50,butonlyinlotsof50iforderingmore(e.g., 50,100,150,etc.)TheorderisforwardedtoSHL. Orderwellinadvance,beforeyourunoutofsupplies.Itcantakeupto10to14days toreceiveyourtestkits. Itisimportanttoavoidhavingtestkitsexpire.Besuretorotatestockoftestkits often,watchingexpirationdates.Practice“Firstin–Firstout”policy. Supplyordersshouldbebasedonanapproximatesupplyfora3‐monthtimeperiod. (Exceptinthecaseofurinetestkits–thelimitis100perorder.) Formsarepre‐printedwiththeclinicnameandaddress.Pleasecheckthenameand addressatthebottomofthetestrequestformswhenyoureceivethem.Iftheform isnotcorrect,theclienttestresultswillbesenttothewrongclinic. 19 IowaCommunity‐BasedScreeningServices 2014 ProceduresManual 3. TestResultsandTreatmentInformation ReceivingTestResultsfromSHL SHLnowofferschlamydiaandgonorrheatestresultsviathewebonthePublicHealth InformationManagementSystem(PHIMS).Testresultsareavailableassoonastheyare completedandreleased,improvingturn‐aroundtime.Resultsareinaprintableformat resemblingreportsthataremailed.Providerscancheckthestatusandthedatespecimens werereceivedatSHL.Uptothreeindividualsateachclinicsitemaysignupandreceivea passwordtogainaccesstotheresults.Oncethestaffhascompletedtrainingandbecomes comfortablewiththesystem,aseparaterequestshouldbesubmittedtogo“paperless.” (Theresultswillnolongerbemailed.)SHLshouldbenotifiedimmediatelyifastaffperson leavestheclinicsothataccessisterminated.Registration/enrollmentformscanbefound inAppendixB. AfulldescriptionoftheWebAccessReportingSystemisfoundat: http://www.shl.uiowa.edu/kitsquotesforms/phimswebaccessbrochure.pdf Questionsregardingtestresultsshouldbedirectedto: o KrisEvelandatkristofer‐[email protected] o JeffBenferatjeff‐[email protected] Ifitisnotpossibletoemail,youmaycallthemat319‐335‐4500. ReceivingTestResultsintheClinic Assoonasapositivetestresultisreceived,itshouldbeplacedinthemedical record. ContactingtheClient Anattempttocontacttheclientshouldbemadewithin24hoursofreceivinga positivetestresultandmustbedonewithin3workingdays. Eachattempttocontacttheclientshouldberecordedinthemedicalrecord. Whenpermissible,thefirstattempttocontacttheclientshouldbemadeby telephone.Aphysician,physician’sassistant,nurse,nursepractitioner,oran appropriatelytrainednon‐medicalpersonshouldmakethiscall. Medicalinformationisconfidential,andtheclientshouldberemindedofthis.Dueto confidentiality,iftheclientisnothome,askthatthephonecallbereturned.Donot giveoutmedicalinformationtoanyonebuttheclient. Theclientshouldbealertedtotheseriousnatureoftheinfectionandremindedthat medicalattentionisneededimmediately.Explaintotheclientthattheinfectionis 20 IowaCommunity‐BasedScreeningServices 2014 ProceduresManual easilytreatedandlong‐termconsequencescanbeavoidedifmedicationisreceived inatimelymanner. Makeanappointmentwiththeclientforcounselingandtreatmentassoonas possible. Ifthereisnowaytocontacttheclientbytelephone,orattemptsattelephone contacthavebeenunsuccessful,acertifiedletterwithareturnrequestshouldbe senttotheclient. Thislettershouldnotcontainalarminglanguage.Theconfidentialnatureofthe contentmustnotberevealed.Thelettershouldencouragetheclienttocallwith questions.Thelettershouldstatethatthisisthelastattempttocontacttheclient. Iftheclinicisunabletocontactaclientwithapositivechlamydiaorgonorrheatest result,thestateorlocalsexuallytransmitteddiseaseprogrammustbenotified. StateandlocalDPShelplocateandcontactclients.Asstaffofstateorcountypublic healthdepartments,theyhavetherighttoclientinformationrelatedtoreportable infectionslikechlamydiaorgonorrhea.ForthenameoftheDPSforyourareagoto http://www.idph.state.ia.us/IDPHChannelsService/file.ashx?file=4AB90493‐4617‐ 46A6‐A89D‐88E1BF53EF7B TreatmentdrugsforchlamydiaandgonorrheaareavailableforallCBSSproviders throughIDPH.Forenrollmentandorderinginformation,contacttheSTDProgram Managerat515‐281‐4936. ManagementofSexPartnersandFollow‐up Apartnerreferralsystemforassuringtheexaminationandtreatmentofsex partnersmustbeinplace. Clientsshouldbeinstructedtorefersexpartnersforevaluation,testing,and treatment. o Notificationandreferralcanbeaccomplishedinanyofthreeways: Bytheclient Bytheclinicorprovider BythestateorlocalDPS(Pleasenote:Duetothehighvolumeof cases,clientsdiagnosedwithchlamydiawillonlybeofferedpartner services/referraluponclinicianrequesttoyourlocalDPSortheIDPH STDProgram.) Sexpartnersshouldbeevaluatedandtreatediftheyhadsexualcontactwiththe clientduringthe60daysprecedingonsetofsymptomsorthediagnosisof chlamydiaorgonorrhea. Themostrecentsexpartnershouldbeevaluatedandtreatedevenifthetimeofthe lastsexualcontactwasgreaterthan60daysbeforesymptomsordiagnosis. Arescreeninthreemonthsisrecommendedforallindividualstestingpositivefor chlamydiatocheckfornewinfection.Ifnotseenwithinthreemonths,retestthose whopresentforcarewithin12months. 21 IowaCommunity‐BasedScreeningServices 2014 ProceduresManual TreatmentofChlamydia Personstreatedforchlamydiashouldbeinstructedtoabstainfromsexualintercourse for7daysaftersingle‐dosetherapyoruntilcompletionofa7‐dayregimen. Recommended o Azithromycin1gramorallysingledose,directlyobservedOR o Doxycycline100mg.orally2timesadayfor7days Alternative o Erythromycinbase500mg.orally4timesadayfor7daysOR o Erythromycinethylsuccinate800mg.orally4timesadayfor7daysOR o Levofloxacin500mg.orallyonceadayfor7daysOR o Ofloxacin300mg.orally2timesadayfor7days PregnantFemales‐Recommended o Azithromycin1gramorallysingledose,directlyobservedOR o Amoxicillin500mgorally3timesadayfor7days PregnantFemales–Alternative o Erythromycinbase500mg.orally4timesadayfor7daysOR o Erythromycin250mgorally4timesadayfor14daysOR o Erythromycinethylsuccinate800mg.orally4timesadayfor7daysOR o Erythromycinethylsuccinate400mg.4timesadayfor14days Youshouldcounselpatientstoabstainduringtreatment,usebarriersand contraceptionforprevention,andtorescreenin3–4months. YouarestronglyencouragedtoreadthecompletecurrentCDCSexuallyTransmitted DiseasesTreatmentGuidelinesformoredetailedfindingsregardingscreening,treatment andfollow‐upofchlamydia.Formoreinformationonthetreatmentguidelines,pleasevisit www.cdc.gov/std/treatment 22 IowaCommunity‐BasedScreeningServices 2014 ProceduresManual TreatmentofGonorrhea Personstreatedforgonorrheashouldbeinstructedtoabstainfromsexualintercourse for7daysaftersingle‐dosetherapyoruntilcompletionofa7‐dayregimen. Recommendedforuncomplicatedurogenital,anorectal,andpharyngealgonococcal infections o Ceftriaxone250mg.IMinasingledose PLUS o Azithromycin1gramorallyinasingledose SeetheCDCSTDTreatmentGuidelinesforadditionaloptionsifthereareallergiesor otherconcerns. Whentreatingusingtherecommendedtherapy,test‐of‐cureisunnecessary.Test‐of‐ cureisonlynecessarywhenusingoneofthealternativeregimens(e.g.,cefixime)orwhen thepatientmeetsoneoftheothercriterialistedonpage16oftheCephalosporin‐Resistant NeisseriagonorrhoeaePublicHealthResponsePlan. http://www.cdc.gov/std/treatment/Ceph‐R‐ResponsePlanJuly30‐2012.pdf Fortestrequestformsandtest‐ofcurekitscall:319/335‐4500.Foradditionalforms,go tohttp://www.shl.uiowa.edu/kitsquotesforms.Anyquestionspertainingtopatienttest resultsshouldbedirectedtothebacteriologysectionat319‐335‐4448. GonorrheaTreatmentIssues o Whenapatientisdiagnosedwithgonorrhea,dualtherapyforgonorrheaand chlamydiaisrequired.Dualtherapyslowsthedevelopmentofantimicrobial resistanceandenhancesoropharyngealeradication.(Sathia2007,Golden2009) o Suspectedcephalosporintreatmentfailuresshouldbecultured,andifpositive: Performantimicrobialsusceptibilitytesting Consultaspecialistfortreatmentguidance ReportcasetoCDCthroughstateandlocalhealthdepartments HealthDepartmentshouldprioritizepartnernotification o TheCDCwebsiteortheIowaDepartmentofPublicHealthcanprovidethemost currentinformation.SHLcanalsoprovideinformationregardingadditional testingthatmaybeneeded. 23 IowaCommunity‐BasedScreeningServices 2014 ProceduresManual PresumptiveTreatmentCriteria–ExpeditedPartnerTherapy Presumptivetreatmentoccursbeforetestresultsareavailablewhenaclient presentswithoneormorecomplaints.Treatmentmayoccurwithoutactually testingtheclient. Criteriaforpresumptivediagnosisandtreatmentofchlamydiaorgonorrhea: o Males Historyofurethraldischarge Historyand/orexamconsistentwithurethritis,epididymitis,ornon‐ gonococcalurethritis Historyofsexualpartnerwithchlamydialinfection Historyofsexualpartnerwithgonococcalinfection Symptomaticpartner HistoryofpartnerwithmucopurulentcervicitisorPID Rapevictim o Females Physicalexamconsistentwithmucopurulentcervicitis,friablecervix orpositiveswabtest SignsorsymptomsofPID Historyofsexualpartnerwithchlamydialinfection Historyofsexualpartnerwithgonococcalinfection Symptomaticpartner Historyofpartnerwithurethritis,epididymitis,ornon‐gonococcal urethritis Rapevictim ExpeditedPartnerTreatment/Therapy(EPT)istheclinicalpracticeoftreating thesexpartnersofpatientsdiagnosedwithchlamydiaand/orgonorrheaby providingprescriptionsormedicationstothepatienttotaketohis/her partner(s)withoutthehealthcareproviderfirstexaminingthepartner(s).EPT canbeaccomplishedintwoways.Patient‐DeliveredPartnerTherapy(PDPT) occurswhenapatientdeliverstheprescriptionsormedicationstoherorhis partner(s).Field‐DeliveredTherapy(FDT)isapracticethatissimilartoDirectly ObservedTherapy(DOT).FDToccurswhenapublichealthprofessional,suchas aDiseasePreventionSpecialist(DPS),deliverstheprescriptionormedicationto thepartner(s). Thegoldstandardforinterruptingthetransmissionofsexuallytransmitted diseases(STDs)istoexamine,test,andappropriatelytreatallsexpartnersof personsdiagnosedwithanSTD.EPThasbeendemonstratedtobeeffectivein accomplishingthelastpartofthisstandard.EPTisusefulwhenpartnersare deemedunlikelytoaccesshealthcarethemselves,andwhenapatientpresents withre‐infection(s). 24 IowaCommunity‐BasedScreeningServices 2014 ProceduresManual ThefollowingistheIowacoderegardingEPT: 139A.41CHLAMYDIAANDGONORRHEANotwithstandinganyotherprovisionoflaw, aphysician,physicianassistant,oradvancedregisterednursepractitionerwhodiagnosesa sexuallytransmittedChlamydiaorGonorrheainfectioninanindividualpatientmay prescribe,dispense,furnish,orotherwiseprovideprescriptionoralantibioticdrugstothat patient’ssexualpartnerorpartnerswithoutexaminationofthatpatient’spartneror partners.Iftheinfectedindividualpatientisunwillingorunabletodeliverthemedication toasexualpartnerorpartners,aphysician,physicianassistant,oradvancedregistered nursepractitionermaydispense,furnish,orotherwiseprovidetheprescriptionoral antibioticdrugtothedepartmentorlocaldiseasepreventioninvestigationstafffor deliverytothepartnerorpartners. TheinstructionsonhowtouseEPTinCBSSProviderSitescanbefoundontheIDPH websiteat:http://www.idph.state.ia.us/IDPHChannelsService/file.ashx?file=CDA25C68‐ F6DA‐4471‐8C1C‐016C2CA44C81 StateReportingRequirements–ChlamydiaandGonorrhea Iowaisadualreportingstate.Boththeclinicianthatdiagnosestheinfectionand thelaboratorythatprocessesthespecimenarerequiredtoreporteacheventofa reportableinfectiontoIDPH.Thefollowinginformationoffersguidanceonhowto reportinfections,includingthetimeframeinwhichtheymustbereported. ForSTDinfections,cliniciansandlaboratoriesmustreporteacheventofinfection withinthreedaysofapositivetestresult.Iowacode139A.32statesthatapersonincharge ofapublic,private,orhospitalclinicallaboratoryshallreport“allspecimenswhichyield evidenceoforarereactiveforthosediseasesdefinedassexuallytransmitteddiseasesor infections.”ThereportableSTDsinIowaarechlamydia,gonorrhea,syphilis,andHIV. Chlamydia o Confirmedpositiveresultsonanyqualitativepolymerasechainreaction(PCR) test,nucleicacidamplificationtest(NAAT),nucleicacidhybridization(DNA probe)test,enzyme‐linkedimmunosorbentassay(ELISA,EIA),direct fluorescentantibodytest(DFA),orculture. Gonorrhea o Confirmedpositiveresultsonanyqualitativepolymerasechainreaction(PCR) test,nucleicacidamplificationtest(NAAT),nucleicacidhybridization(DNA probe)test,enzyme‐linkedimmunosorbentassay(ELISA,EIA),bacterial culture,orGramstain.(Gramstainisonlyvalidasaconfirmatoryteston urethralspecimensfromsymptomaticmales). 25 IowaCommunity‐BasedScreeningServices 2014 ProceduresManual Syphilis o Confirmedpositiveresultsbyatreponemaltest(e.g.TPPA,FTA,andIgG). Thenon‐treponemaltest(e.g.,RPRorVDRL),withaquantitativetiter,must alsobereported. Onlyreportthesetoflabs(RPR/VDRL+TPPA/FTA)whenthe TPPA/FTAispositive.YoudonotneedtoreportreactiveRPRswhen theTPPAisnegative.However,whentheTPPAispositive,please reporttheRPRnomatterwhetheritisreactiveornot.IfaTPPA/FTA isnotrun,thenreportpositiveRPR/VDRLbyitself. ThefollowingsectionofIowaAdministrativeCode641describeswhatmustbeincluded ineacheventreportedtotheIowaDepartmentofPublicHealth: 641–1.4(2)Whattoreport.Eachreportshallcontainallofthefollowinginformation: a.Thepatient’sname. b.Thepatient’saddress. c.Thepatient’sdateofbirth. d.Thesexofthepatient. e.Theraceandethnicityofthepatient. f.Thepatient’smaritalstatus. g.Thepatient’stelephonenumber. h.Thenameandaddressofthelaboratory. i.Thedatethetestwasfoundtobepositiveandthecollectiondate. j.Thenameandaddressofthehealthcareproviderwhoperformedthetest k.Ifthepatientisfemale,whetherthepatientispregnant. l.Thenameofthereportabledisease. STDreportingformscanbeorderedonlinefromtheClearinghouseat http://healthclrhouse.drugfreeinfo.org/cart.php?target=category&category_id=303 and followingtheorderinginstructions.Postage‐paidenvelopestomailthereportingformsto IDPHmaybeorderedfromtheClearinghouseaswell.Alternatively,youmaycalltheIDPH STDProgramat515‐281‐30103or515‐281‐4936tohaveaPDFofthemostup‐to‐date reportingformemailedorfaxedtoyou. ThereisadditionalinformationandresourcesregardingSTDsandforfurtherclient referralsinAppendixC. 26 IowaCommunity‐BasedScreeningServices 2014 ProceduresManual 4. Post‐TestandCertification AllstaffinvolvedwiththeCBSSshouldreviewthismanualandtakethepost‐test includedhere.Newstaff,within30daysofhire,shouldalsoreadthemanualandcomplete thetest.Acopyofthepost‐testisincludedherewhichyoucancompleteandsendtothe CBSSCoordinator.Alternatively,thesurveycanbeaccessedandcompletedonSurvey Monkeyathttp://www.surveymonkey.com/s/cbssposttest2014 Acompletioncertificatewillbemailedtotheparticipantswhenapassinggradeof70% isachieved. 27 IowaCommunity‐BasedScreeningServices 2014 ProceduresManual Community‐BasedScreeningServicesManualCertification CompletingtheCommunity‐BasedScreeningServicespost‐testverifiesthatIhaveread andunderstandtheIowaCommunity‐BasedScreeningServicesProceduresManual.Ihave includedthepost‐testandIwillbenotifiedoftheresults.IfIreceiveapassinggradeof 70%orabove,IwillreceiveaCertificateofParticipation. Name__________________________________________________________________ ClinicName______________________________________________________________ ClinicStreetAddress_______________________________________________________ ClinicCity,State,andZipcode_________________________________________________ Emailaddress______________________________________________________________ Pleasechooseone: LPN RN CMA NursePractitioner Physician(MDorDO) Physician’sAssistant Other_______________________________ ___________________________________________ Signature ___________________________________________ Date Pleasereturnto: ColleenBornmueller,CBSSCoordinator FamilyPlanningCouncilofIowa 1083rdStreet,Suite220 DesMoines,IA50309 Fax:515‐288‐4048 [email protected] 28 IowaCommunity‐BasedScreeningServices 2014 ProceduresManual2014 CBSSManualPostTest Name________________________________________________ Pleasecirclethecorrectanswerforeachquestionbasedonthismanual.Chooseonly oneanswerperquestion.Youmayalsotakethispost‐testonlineatSurveyMonkey http://www.surveymonkey.com/s/cbssposttest2014 1. AccordingtotheCDC,whatisthepercentageofchlamydiainfectionsinwomenthat areasymptomatic? a. 30% b. 50% c. 70% d. 100% 2. OptimalspecimencollectiontypeswhenusingNucleicAcidAmplifiedTesting (NAATs)formenarefirstcatchurineandvaginalswabsforwomen. a. True b. False 3. WhichprogramelementwillbeaddressedduringaCBSSFacilityAssessmentsite visit? a. Specimencollectionandsubmission b. ScreeningCriteria c. Client/Partnertreatmentandeducation d. Alloftheabove 4. NewCBSSscreeningcriteriaapplytobothmaleandfemaleclients. a. True b. False 5. WhatmustbeconsideredfirstwhendecidingtouseaCBSStestkitforspecimen collection? a. Age b. Sexualorientation c. Insurancestatus d. Multiplepartners 6. Forclients26yearsofageandolder,whichofthefollowingwouldnotbe consideredariskfactorandqualifyfortheuseofaCBSStestkit: a. Multiplepartnersinthelast90days b. Onenewpartnerinthelastyear c. ContactwithanotherindividualthatwasdiagnosedwithanSTD d. Symptomsreportedbythepatient 29 IowaCommunity‐BasedScreeningServices 2014 ProceduresManual 7. Gen‐ProbeAPTIMACombo2Unisextestkitsareusedtocollectoropharyngealand rectalspecimens. a. True b. False 8. WhichofthefollowingreasonscouldcauseSHLtorejectandnotprocessa specimen? a. Specimenunsuitablefortestingduetotheuseofanimproperswab. b. Specimenunsuitablefortestingduetotransportbufferorurineleaked duringtransit. c. Specimenunsuitablefortestingduetotheclient’snameonthetransport tubedoesnotcorrespondtothenameonthetestrequestform. d. Alloftheabove 9. Whatistheonlyrecommendedtreatmentregimenforadiagnoseduncomplicated gonorrheainfection? a. Doxycycline100mg.orally,2timesadayfor7days b. Ceftriaxone250mgIM,singledose c. Azithromycin,1gramorally,singledose d. Ceftriaxone250mgIM,singledoseplusAzithromycin1gramorally,single dose. 10. ForSTDinfections,laboratoriesandcliniciansmustreporteacheventofinfection withinhowmanydaysofapositivetestresult? a. 3days b. 4days c. 7days d. 10days 11. Iftheclinicorproviderisnotabletocontactaclientandheorshehasnotreturned totheclinicfortreatment,whoshouldbecontacted? a. Theemergencyroomatalocalhospital b. Anotherclinician c. Thepartneroftheinfectedindividual d. Thestateorlocalsexuallytransmitteddiseaseprogram(e.g.,DPS) 12. ExpeditedPartnerTherapy(EPT)istheclinicalpracticeoftreatingthesex partner(s)ofpatientsdiagnosedwithchlamydiaand/orgonorrheabyproviding prescriptionsormedicationstothepatienttotaketohisorherpartner(s)without thehealthcareproviderfirstexaminingthepartner(s). a. True b. False 30 IowaCommunity‐BasedScreeningServices 2014 ProceduresManual Appendices AppendixA–Gen‐probeAPTIMASensitivity/SpecificityCharts AppendixB‐WebAccessRegistrationForms–RegistrationandPaperless AppendixC–AdditionalResourcesandContactInformation AppendixD–OropharyngealandRectalSpecimenCollectionInstructionsand ScreeningRecommendations 31 AppendixA C.trachomatisSensitivityandSpecificity APTIMA Combo 2 Assay Specimens vs. Patient Infected Status Specimen Symptoms Status N TP FP TN FN Sensitivity (95% C.I.) Specificity (95% C.I.) MS Symp Asymp All 676 388 1065 190 70 260 15 5 20 464 309 774 7 4 11 96.4% (92.8-98.6) 94.6% (86.7-98.5) 95.9% (92.9-98.0) 96.9% (94.9-98.2) 98.4% (96.3-99.5) 97.5% (96.1-98.5) MU Symp Asymp All 694 400 1095 199 77 276 8 4 12 484 316 801 3 3 6 98.5% (95.7-99.7) 96.3% (89.4-99.2) 97.9% (95.4-99.2) 98.4% (96.8-99..3) 98.8% (96.8-99.7) 98.5% (97.4-99.2) FS Symp Asymp All 819 569 1389 133 61 195 22 6 28 653 501 1154 11 1 12 92.4% (86.7-96.1) 98.4% (91.3-100) 94.2% (90.1-97.0) 96.7% (95.1-97.9) 98.8% (97.4-99.6) 97.6% (96.6-98.4) FU Symp Asymp All 821 569 1391 136 60 197 8 5 13 668 502 1170 9 2 11 93.8% (88.5-97.1) 96.8% (88.8-99.6) 94.7% (90.7-97.3) 98.8% (97.7-99.5) 99.0% (97.7-99.7) 98.9% (98.1-99.4) Total Swab Symp Asymp All 1495 957 2454 323 131 455 37 11 48 1117 810 1928 18 5 23 94.7% (91.8-96..8) 96.3% (91.6-98.8) 95.2% (92.9-96.9) 96.8% (95.6-97.7) 98.7% (97.6-99.3) 97.6% (96.8-98.2) Total Urine Symp Asymp All 1515 969 2486 335 137 473 16 9 25 1152 818 1971 12 5 17 96.5% (94.0-98.2) 96.5% (92.0-98.8) 96.5% (94.5-98.0) 98.6% (97.8-99.2) 98.9% (97.9-99.5) 98.7% (98.2-99.2) N=Negative; TP= True Positive; FP= False Positive; TN=True Negative; FN= False Negative MS= male Urethral Swab; MU= Male Urine; FS= Female Endocervical Swab; FU= Female Urine Specimen PVS CVS Symptom Status N TP FP1 TN FN 1 Asymp 628 60 18a 549 All 1423 168 32b 1217 Symp Asymp 809 636 111 59 25c 16d 669 559 All 1445 170 41e 1228 Sensitivity (95% C.I.) Specificity (95% C.I.) 98.4% (91.2–100) 96.8% (95.0–98.1) 6 96.6% (92.6–98.7) 97.4% (96.4–98.2) 2 96.5% (91.3–99.0) 96.7% (88.7–99.6) 96.4% (94.7–97.7) 97.2% (95.5–98.4) 6 96.6% (92.7–98.7) 96.8% (95.6–97.7) 4 N = Negative; TP = True Positive; FP = False Positive; TN = True Negative; FN = False Negative. PVS = Asymptomatic Patient-Collected Vaginal Swab; CVS = Clinician-Collected Vaginal Swab. 1 CT TMA Alternate Amplification results represent # positive results/# specimens tested: a: 15/18, b: 28/32, c: 17/25, d: 15/16, and e: 32/41. AppendixA N.gonorrhoeaeSensitivityandSpecificity APTIMA Combo 2 Assay Specimens vs. Patient Infected Status N TP FP TN FN Sensitivity (95% C.I.) Specificity (95% C.I.) Symp Asymp 724 378 304 15 5 12 412 351 3 0 99.0% (97.2-99.8) 100% (78.2-100) 98.8% (97.2-99.6) 96.7% (94.3-98.3) All 1103 319 17 764 3 99.1% (97.3-99.8) 97.8% (96.5-98.7) MU Symp Asymp All 750 383 1134 311 13 324 1 2 3 433 368 802 5 0 5 98.4% (96.3-99.5) 100% (75.3-100) 98.5% (96.5-99.5) 99.8% (98.7-100) 99.5% (98.1-99.9) 99.6% (98.9-99.9) FS Symp Asymp All 881 596 1479 94 31 126 15 2 17 772 562 1335 0 1 1 100% (96.2-100) 96.9% (83.8-99.9) 99.2% (95.7-100) 98.1% (96.9-98.9) 99.6% (98.7-99.9) 98.7% (98.0-99.3) FU Symp Asymp All 883 599 1484 87 28 116 7 3 10 782 564 1347 7 4 11 92.6% (85.3-97.0) 87.5% (71.0-96.5) 91.3% (85.0-95.6) 99.1% (98.2-99.6) 99.5% (98.5-99.9) 99.3% (98.6-99.6) Total Swab Symp Asymp All 1605 974 2582 398 46 445 20 14 34 1184 913 2099 3 1 4 99.3% (97.8-99.8) 97.9% (88.7-99.9) 99.1% (97.7-99.8) 98.3% (97.4-99.0) 98.5% (97.5-99.2) 98.4% (97.8-99.2) Total Urine Symp Asymp All 1633 982 2618 398 41 440 8 5 13 1215 932 2149 12 4 16 97.1% (94.9-98.5) 91.1% (78.8-97.5) 96.5% (94.4-98.0) 99.3% (98.7-99.7) 99.5% (98.8-99.8) 99.4% (99.0-99.7) Specimen MS Symptoms Status N=Negative; TP= True Positive; FP= False Positive; TN=True Negative; FN= False Negative .MS= male Urethral Swab; MU= Male Urine; FS= Female Endocervical Swab; FU= Female Urine Specimen PVS CVS Symptom Status FP1 TN FN Sensitivity (95% C.I.) Specificity (95% C.I.) N TP Asymp 629 21 3a 605 0 100% (83.9–100) 99.5% (98.6–99.9) All 1423 74 8b 1341 0 100% (95.1–100) 99.4% (98.8–99.7) Symp Asymp 807 637 51 21 7c 4d 747 611 2 1 96.2% (87.0–99.5) 95.5% (77.2–99.9) 99.1% (98.1–99.6) 99.3% (98.3–99.8) All 1444 72 11e 1358 3 96.05 (88.8–99.2) 99.2% (98.6–99.6) N = Negative; TP = True Positive; FP = False Positive; TN = True Negative; FN = False Negative. PVS = Asymptomatic Patient-Collected Vaginal Swab; CVS = Clinician-Collected Vaginal Swab 1 GC TMA Alternate Amplification results represents # positive results/# specimens tested: a: 3/3, b: 8/8, c: 6/7, d: 3/4, and e: 9/11 Appendix B Data Access Application for the State Hygienic Laboratory Individuals requiring access to data must submit an application for authorization by the SHL. The SHL will issue a user ID and password for each individual upon approval of this application. By submitting this application, you acknowledge that you have read, understood, and agree to the Terms of Use specified below and on our web site at http://www.shl.uiowa.edu. This application must be filled in its entirety in order for the request to be processed. Please keep a copy of this application for your records. Please type or print the requested information. Return this application form to: State Hygienic Laboratory – Web Access University of Iowa Research Park 2490 Crosspark Road Coralville, Iowa 52241-4721 Phone: 319-335-4358 Fax: 319-335-4555 E-Mail: [email protected] For further information, please contact Web Access. You may e-mail, fax, or mail this application. : Terms of Use (1) SHL will make all reasonable efforts to ensure the accuracy of the information provided through this service, but will not be held liable for errors and/or omissions of any content. (2) Tampering, reverse engineering or unlawful use of the content is strictly prohibited. (3) When a user’s access to data is to be discontinued, it is the responsibility of the agency to notify the SHL 14 days prior to the date of termination of access for the said user. Access will be removed within a reasonable amount of time of the request, but no later than the last day of allowed access. (4) Initial passwords will be supplied by SHL. Users must change passwords as necessary but are responsible for the integrity and safe keeping of their password. (5) Violation of said terms will result in immediate termination of access to SHL data, investigation, and possible legal action. Organization Information Organization Name: ________________________________________________________________________ Department: ______________________________________________________________________________ Address1: ________________________________________________________________________________ Address2: ________________________________________________________________________________ City: ____________________________________ State: ________ Zip: ___________ Applicant Information (Required) First Name: _________________________________ Email: _______________________________________ Middle Name: _______________________________ Phone: (_____)_______-________ ext. _________ Last Name: _________________________________ Fax: (_____)_______-__________ Title: ______________________________________ By accessing and using our web site and these services, you acknowledge that you have read, understood, and agreed to the Terms of Use. Signature of Applicant Date Authorizing Representative Information (Please complete if different from Applicant) First Name: _________________________________ Email: _______________________________________ Middle Name: _______________________________ Phone: (_____)_______-________ ext. _________ Last Name: _________________________________ Fax: (_____)_______-__________ Title: ______________________________________ Signature of Authorizing Representative Date Appendix B State Hygienic Laboratory The University of Iowa Request for Paperless Result Delivery You must have access to the SHL web reporting system BEFORE you can request paperless result delivery. If you would like access to the SHL web reporting system, please call Web Access at 319-335-4358 or e-mail [email protected] . By submitting this form, you are agreeing to receive electronically available SHL laboratory test results by accessing the SHL Internet site. Test results available electronically will no longer be mailed. Request for Paperless Result Delivery To ensure legibility, please type or print clearly all requested information. Please print, sign, and fax the completed form to the State Hygienic Laboratory at 319-335-4555 or e-mail it to [email protected] . Facility Information Facility Name: ____________________________________________________________________________ Address: ________________________________________________________________________________ ________________________________________________________________________________ City: ____________________________________ State: ________ Zip: ________ Phone: (_____) ______-_________ ext. ________ Authorizing Representative Information Name: _____________________________________ Title: ______________________________________ Phone: (_____) _______-__________ ext. ________ Signature: __________________________________ Date: ______________________________________ For questions or concerns, contact Web Access at 319-335-4358. SHL USE ONLY State Hygienic Laboratory University of Iowa Research Park 2490 Crosspark Road Coralville, Iowa 52241-4721 (319) 335-4500 Fax: (319) 335-4555 SHL Client # _______________________________ http://www.shl.uiowa.edu Ankeny Laboratory 2220 S. Ankeny Blvd. Ankeny, IA 50023-9093 (515) 725-1600 Fax: (515) 725-1642 AppendixC AdditionalSourcesofInformation NATIONALTELEPHONEHOTLINESANDTREATMENTLOCATORS AmericanSocialHealthAssociation’sSTIResourceCenter 1‐800‐227‐8922or919‐361‐8488 Talktoaninformationspecialist9a.m.to6p.m.onMonday‐Friday 919‐361‐4848 Pre‐recordedtelephoneinformationmessages24/7 EmergencyContraceptionHotline(NOT‐2‐LATE) http://ec.princeton.edu/ DrugandAlcoholTreatmentLocator www.findtreatment.samhsa.gov NationalDomesticViolenceandAbuseHotline 1‐800‐799‐SAFE NationalGayandLesbianYouthHotline 1‐800‐347‐TEEN NationalHelplineNetwork 1‐800‐SUICIDE SOURCESOFSTDINFORMATIONTODISTRIBUTETOPATIENTS CentersforDiseaseControlandPrevention(CDC) http://www.cdc.gov/std/chlamydia/ www2a.cdc.gov/nchstp_od/piweb/stdorderform.asp TheCentersforDiseaseControlandPreventionprovidesfacts,statistics,andtreatments optionsforpatientswithsexuallytransmittedinfections. AmericaSocialHealthAssociation www.ashastdwebstore.org TheAmericanSocialHealthAssociation(ASHA)isatrusted,non‐profitorganizationthat hasadvocatedonbehalfofpatientstohelpimprovepublichealthoutcomessince1914. ASHAoffershigh‐qualitypatienteducationmaterialsonawiderangeofsexually transmittedinfections. AdvocatesforYouth www.advocatesforyouth.org AdvocatesforYouthwasestablishedin1980astheCenterforPopulationOptions.Their goalistohelpyoungpeoplemakeinformedandresponsibledecisionsabouttheir AppendixC reproductiveandsexualhealth.Advocatesbelievesitcanbestservethefieldbyboldly advocatingforamorepositiveandrealisticapproachtoadolescentsexualhealth. GetYourselfTestedCampaign www.gytnow.org TheGYTcampaignseekstocreateasocialmovementaroundgettingtestedforSTDs. Servingastheinformationhubforthecampaign,www.GYTnow.orgprovidesfactsonSTDs, tipsonhowtobringuptestingwithpartnersandhealthcareproviders,andaneasy‐to‐use testingcenterlocator,providedbytheCDC. SexualityInformationandEducationCounciloftheUnitedStates www.siecus.org SexualityInformationandEducationCounciloftheUnitedStateswasfoundedin1964to provideeducationandinformationaboutsexualityandsexualandreproductivehealth. SIECUSeducates,advocates,andinforms. GENERALSTDINFORMATIONANDREFERRALTOLOCALCLINICSFOR SERVICES http://hivtest.cdc.gov/STDTesting.aspx CDC‐INFOContactCenter 1‐800‐CDC‐INFO(800‐232‐4636) TTY:1‐888‐232‐6348,InEnglish&enEspañol CDC‐INFOisavailable24/7,365daysayearforSTDinformationandreferralstoSTD clinics AppendixD Oropharyngeal/RectalSpecimenCollectionInstructions RectalSwabs UsingtheAPTIMACombo2UnisexSwab,insertspecimencollectionswab(blue shaftswabinpackagewithgreenprinting)intotherectumapproximately4‐6cm androtateagainstrectalwallseveraltimes. Withdrawtheswabcarefully;avoidfecalcontaminationandincaseofgross contaminationdiscardtheswabandrecollect. Removecapfromswabspecimentransporttubeandimmediatelyplacespecimen collectionswabintospecimentransporttube. Carefullybreakswabshaftatscoreline;usecaretoavoidsplashingcontents. Re‐capswabspecimentransporttubetightly. OropharyngealSwabs Usingatonguedepressor,ifnecessary,andtheAPTIMACombo2UnisexSwab, insertspecimencollectionswab(blueshaftswabinpackagewithgreenprinting) intothepharynxandrotateagainstanyinflammationandaroundthetonsillararea. Havethepatientsay“ah”foraccesstothepharynxandavoidtouchingthetongue, teeth,cheeks,etc.withtheswab. Withdrawtheswabcarefully,againavoidingtouchinganythingintheoralcavity. Removecapfromswabspecimentransporttubeandimmediatelyplacespecimen collectionswabintospecimentransporttube. Carefullybreakswabshaftatscoreline;usecaretoavoidsplashingcontents. Re‐capswabspecimentransporttubetightly. AppendixD Testing Recommendations with Rectal/Pharyngeal Specimens Asexualhistoryofthepatientmustbetakeninordertoassessriskanddeterminethe appropriatenessoftesting.Pleasenote:Oropharyngealandrectaltestsaresubjectto thesamescreeningcriteriaestablishedforurogenitalspecimensPleaseseethe screeningcriteriaandflowchart(page9)first,inordertodeterminewhethera patientiseligibleforuseofaCBSStestkit. Testingrectalspecimensforgonorrheaandchlamydiaisrecommendedwhen: ThepatientisMSM(manwhohassexwithmen)andhashadreceptiveanal intercoursewithinthepastyear,regardlessofcondomuse. TestingwomenforgonorrheaandchlamydiaattheanorectalsiteisgenerallyNOT recommended.Womenshouldbescreenedaturogenitalsitesaspreviouslyrecommended. Studiesindicatethatitisrareforawomantobeinfectedwithgonorrheaorchlamydiaonly attheanorectalsite.Averyhighpercentageofwomenwhohaveananorectalgonococcal orchlamydialinfectionarealsoinfectedaturogenitalsites;thereforegonorrheaand chlamydiawillbedetectedwhentestingurogenitalspecimens.Furthermore,anorectal infectionsinwomenarenotwellcorrelatedwithreportedhistoryofanalintercourse. Testingoropharyngealspecimensforgonorrhea*andisrecommendedwhen: Thepatient(maleorfemale**)hasperformedoralintercourseonamanwithinthe pastyear. Thepatienthasperformedoralintercourseonapartnerwhohastestedpositivefor gonorrhea. *AccordingtoCDC’sSTDTreatmentGuidelines,2010,“[Screening]forChlamydia trachomatispharyngealinfectionisnotrecommended…Theclinicalsignificanceand transmissibilityofC.trachomatisdetectedatoropharyngealsitesisunclear,andthe efficacyofdifferentantibioticregimensinresolvingoropharyngealchlamydiaremains unknown.”Becausedataonoropharyngealchlamydiaareverylimited,thistestshouldnot beusedforthepurposeofscreeningpatientsfororopharyngealchlamydialinfection. **Femalepatientswithahistoryofmultipletypesofsexualintercourse Ifapatientreportsahistoryofmultipletypesofsexualintercourse(e.g.,vaginal,oral,or anal),collectingspecimensfrommultiplesitesisunnecessaryandnotrecommended. Anytimeafemalepatientreportsvaginalintercourseinadditiontoothertypesof intercourse,onlyaurogenitalspecimenshouldbecollectedandscreenedforgonorrhea andchlamydia.Thereisnobenefittotestingadditionalsiteswhenthepatientreports vaginalintercoursewithherpartner(s)becauseifthetreatmentguidelinesarefollowed correctly,themedicationsusedforurogenitalinfectionwillalsoeradicatetheorganism(s) fromotherbodysites.Furthermore,NeisseriagonorrhoeaeandChlamydiatrachomatis havethehighestaffinityforurogenitalsites,thereforeifapatienthasengagedinmultiple typesofintercourseandbeenexposedtogonorrheaorchlamydia,apositiveresultwillbe obtainedfromtheurogenitalspecimen.
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