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 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
cbornmueller@fpcouncil.com
1 IowaCommunity‐BasedScreeningServices 2014
ProceduresManual
ImportanceofDetectingChlamydiatrachomatisandNeisseriagonorrhoeae*
ChlamydiaisthemostcommonbacterialsexuallytransmitteddiseaseintheUnited
Stateswithgonorrheabeingthesecondmostcommon.Thewideravailabilityofaffordable,
cost‐effectivelaboratorydiagnostictestsforthepresenceofChlamydiatrachomatisand
Neisseriagonorrhoeaehasallowedfurtherexplorationofthebroadspectrumofdisease
causedbytheseorganisms.
In2011,therewere1,412,791casesofchlamydiaand321,849casesofgonorrhea
reportedtotheCDC.*
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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)
WomenandMen26:
 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
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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
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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
cbornmueller@fpcouncil.com
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‐eveland@uiowa.eduor
o JeffBenferatjeff‐benfer@uiowa.edu
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
cbornmueller@fpcouncil.com
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: ask-shl@uiowa.edu
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 ask-shl@uiowa.edu .
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 ask-shl@uiowa.edu .
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.