Cytology Reference Manual2016

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Table of Contents1. INTRODUCTION 1.1PurposeandObjective .......................................................................... 3 1.2 Turnaround Time .................................................................................... 3

2. LICENSURE .................................................................................................................... 3 2.1 Quality Assurance ................................................................................... 3 2.2Proficiency ................................................................................................ 4 2.3Confidentiality ......................................................................................... 4 2.4AccreditationandLicensing ................................................................. 4 2.5 Contact ..................................................................................................... 4

3. POLICIES AND PROCEDURES ..................................................................................... 4 3.1 Returned Specimens .............................................................................. 4 3.2 Compromised Specimens ..................................................................... 4 3.3TrackingandHandling ........................................................................... 5 3.4ObtainingSupplies ................................................................................. 5 3.5BethesdaReportingSystem(GYNOnly) ........................................... 6

4. GYNECOLOGICAL SPECIMENS................................................................................... 8 4.1RequisitionRequiredInformation ....................................................... 8 4.2GYNSpecimenRequiredInformation ................................................ 10 4.3Gynecological(PapSmear)Collection................................................ 11 4.4FocalPoint™Screening(SurePath®Specimens) ................................ 17 4.5 ThinPrep®ImagingSystem(ThinPrep®Specimens) ......................... 17

5. NON-GYN SPECIMENS ................................................................................................. 17 5.1RequisitionRequiredInformation ....................................................... 17 5.2Non-GYNRequiredInformation(Specimen) .................................... 18 5.3Non-GynecologicalCollection ............................................................. 18 6. APPENDIX ............................................................................................... 26 6.1AdvanceBeneficiaryNotice ................................................................. 26 6.2PrivacyInformation ................................................................................ 27

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1. INTRODUCTION

1.1PurposeandObjective

Thismanualisdesignedforthepurposeofprovidingasimpleandeasy-to-followguidelinefor collection,transportandsubmissionofspecimensforcytologicalanalysis.

Compromisingthediagnosticintegrityofspecimensisavoidedwhentheclientandthe labfollowpropercollection,preservationandreportingprocedures.Inaddition,maintaining theseguidelineswillshortenturnaroundtime,preservenecessarypatientinformationand ensuresafe,timelytransportofthesample.

ThegoalofPAMLandProvidenceSacredHeartMedicalCenter(PSHMC)inprovidingthis manualistomaintainahighqualityofpatientcarebyobtainingspecimensintheirmost preservedstate,receivingthemostcompleteandaccuratepatientinformation,andreporting backtotheclinicianwithminimalturnaroundtime.

1.2 Turnaround Time

GynecologicalSpecimens: 2–3days Non-GynecologicalSpecimens: 1–2days

2. LICENSURE

2.1 Quality Assurance

AlltestingatPAML/PSHMCareconductedinaccordancewithcurrentlawsandgovernment regulatoryguidelines.Thecurrentqualitycontrol(QC)proceduresaredesignedtonotonly meet,butalsosurpasstheClinicalLaboratoryImprovementAct(CLIA)requirements.Reviewof thisprogramisunderthedirectionofthelaboratoryMedicalDirectorandtheTechnical Supervisors.Ingeneral,twotypesofactivityaremonitored:

2.1.1 QualityofServiceProvided •Specimenhandling •Dataprocessing •Reportingresults •Deliveryofsupplies(toclients) •Disseminationofinformation(toclients)

2.1.2 QualityofAnalyticalResults •Internalqualitycontrolprogram(QCreviewofslides) •Externalqualitycontrolprogram(CAPinterlaboratorycomparisonandASCPProficiency Testing) •VoluntaryaccreditationbytheCollegeofAmericanPathologists(CAP)

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2.2Proficiency

TheCAPandASCPperformannualproficiencyandintradepartmentalcomparisontestingon allapplicablestaff.Inaddition,allapplicablestaffisrequiredtoparticipateinongoing educationalteleconferencesofferedthroughtheAmericanCollegeofClinicalPathologists (ASCP).

2.3Confidentiality

TheHealthInformationPortabilityandAccountabilityAct(HIPAA)requiresthedevelopment andimplementationofpoliciesandprocedurestoprotectpatientrights.Accesstopatient informationisstrictlycontrolled.AcopyofPAML/PSHMCPrivacyPracticesisfoundinthe Appendix.

2.4AccreditationandLicensing

CAP-LAP#2484601 HealthCareFinancingAdministration(HCFA)-CLIA#50D0661616

2.5 Contact

PAMLClientServices–509-755-8999orTollFreeat1-800-349-8586.

3. POLICIES AND PROCEDURES

3.1ReturnedSpecimens(Unlabeled/Mislabeled/Expired)

• Specimenswithoutproperpatientidentifiers(unlabeled,mislabeled)(seesection5.2.1)willbe returnedtothesubmittingclinicianwithaletterexplainingthereasonforthereturn. • Specimenssentwithnorequisitionorsubmittedonbrokenslidesthatcannotbe reconstructedwillberejected. • Specimenswillbereturnedifthelabeling(namesandnumbers)ontherequisitionandonthe sample do not correspond. • SpecimensthatareplacedinexpiredSurePath™orThinPrep®vialswillnotbeprocessed. 3.2 Compromised Specimens

Compromisedspecimensarenotreturned.However,theyareconsiderednotoptimalfor evaluation.Factorsthatcompromisetheevaluationofthespecimenwillbenotedinthefinal report.Thesefactorsinclude,butarenotlimitedto: • Nospecimensourceidentified(requiredinformation) • Nodateofcollectionspecified(requiredinformation) • Lackofclinicalhistory • Noindicationofmenstrualstatus(LMP)

Note: Patient information and pertinent clinical history should be included on the requisition to ensure accurate and timely results.

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3.3TrackingandHandling

PRINCIPLE: Toprovideadocumentedtrackingsystemforspecimenssubmittedtothelaboratoryfrom remotesites,andtoensurethatallspecimensareactuallyreceived.Documentationshould includedateandtimeofdispatchandreceipt,aswellasdocumentationofanyissueswiththe conditionofspecimensuponreceipt.

PROCEDURE: Client’s responsibility: 1.Labeltherequisitionandspecimencontainer(s)/slidewiththepatient’snameandasecond identifier(e.g.,birthdate).Placetheseintoasealedspecimenbag. 2.Filloutthespecimenmanifest,includingallareasthatarenotshaded.Becarefulto accuratelytallythenumberofspecimensatthebottomofthemanifest.Keepthesecond copyofthemanifestforyourrecords.PAMLspecimenmanifestsmaybeusedinplaceofthe SHMCmanifest.Placetheindividualspecimenbagsintothelargetamper-proofbag.Do notoverfill.Sealthebag.Placethetopcopyofthecompletedmanifestintheouterpocket ofthetamper-proofbagwiththebar-codedtrackingnumbervisible.Ifyouneedtousemore thanoneofthelargebags,besuretoincludeaseparatemanifestforeachone.Includeall requisitionsandacopyofthemanifest(s)intheshippingbox.Sealtheboxandlabelitfor deliverytoPAML/PSHMCCytology. 3. Clientswhosendmorethanoneofthelargebags:Packagethesealed,largebagsintheblue PAMLshippingboxprovided. 4.Keepacopyofthemanifestforyourrecords.Additionalformsand/orbaggiescanbe obtainedbycallingthePAMLSupplyDepartmentat509-755-8794.

3.4ObtainingSupplies

Supplies(brushes,brooms,spatulas,fixative,requisitions,transportbags)maybeobtainedby 1.ContactingthePAMLrepresentativeinyourarea 2.CallingPAML’sSupplyDepartmentat509-755-8794 3.AccessingonlinesupplyorderingthroughPAML’swebsiteatwww.paml.com

3.4.1 SurePathTM

SurePath™orThinPrep®arethepreferredgynecologicalcollection methodsforPAML/PSHMC.

3.4.2 ThinPrep®

ThinPrep®isthepreferrednon-gynecologicalcollectionmethodfor specimensneedingapreservative.Note:Non-GYNspecimensthat neednopreservativemustberefrigerateduntiltransport.

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3.4.3 Pap-Pak®

Pap-Pak®ConventionalSmearmethod.

Note: Do not use hairspray as a fixative. Do not use cotton swabs.

Note: PAML and PSHMC prefer to receive specimens in their freshest state. Therefore, non-GYN specimens that are immediately transported to the laboratory, within hours of obtaining, need no fixative. This is especially true for body fluids. However, refrigeration is required until transport. In the event a preservative must be added, PAML/SHMC prefers CytoLyt® for Non-GYN specimens.

3.5BethesdaReportingSystem(GYNOnly)

TheBethesda2001Workshop,heldApril30-May2,2001,reviewedissuesregarding terminologyandreportingofcervicalcytology.Over400cytopathologists,cytotechnologists, clinicians,andpatientadvocatesparticipated.Forty-fiveprofessionalsocieties,includingover20 countries,sentrepresentatives.Nineforumgroupsessionscoveredtopicsincludingspecimen adequacy,non-neoplasticchanges,ASCUS,AGUS,ancillarytesting,endometrialcells,SIL, automatedcomputerreview,andrecommendations.Themeetingwascharacterizedbyenergetic exchangeofopinionsandproductivediscussions

PAML/PSHMCCytologyusestheBethesda2001ReportingsystemforallGYNsamples.The followingoutlineisabriefreferencetotheinformationthatwillbecontainedintheCytology Report.

3.5.1 Diagnosis/GeneralCategory •NegativeforIntraepithelialLesionorMalignancy •EpithelialCellAbnormality:SeeDiagnosis/Specific(‘squamous’or‘glandular’as appropriate) •Other:SeeDiagnosis/Specific(e.g.endometrialcellsinawoman>40yearsofage)

3.5.2 Diagnosis/Specific • NEGATIVEFORINTRAEPITHELIALLESIONORMALIGNANCY •Whenthereisnocellularevidenceofneoplasia,thiswillbestatedintheGeneral Categorizationaboveand/orintheDiagnosissectionofthereport,whetherornot thereareorganismsorothernon-neoplasticfindings • OTHERNON-NEOPLASTICFINDINGS(Optionaltoreport;listnotinclusive) •Reactivecellularchangesassociatedwith: §Inflammation(includestypicalrepair) §Radiation §Intrauterinecontraceptivedevice(IUD) §Glandularcellsstatusposthysterectomy § Atrophy § Bacteria • OTHER •Endometrialcells(inawoman>40yearsofage) •Specifyingifnegativefor‘squamousintraepitheliallesion’

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• EPITHELIAL(SQUAMOUS)CELLABNORMALITIES •Atypicalsquamouscellsofundeterminedsignificance(ASC-US) •AtypicalsquamouscellsofundeterminedsignificancecannotexcludeHSIL(ASC-H) •Lowgradesquamousintraepitheliallesion(LSIL)encompassing: §Milddysplasia/CINI •Highgradesquamousintraepitheliallesion(HSIL)encompassing: §Moderateandseveredysplasia §CINIIandCINIII/CIS •Highgradesquamousintraepitheliallesion(HSIL)withfeaturessuspiciousforinvasion (ifinvasionissuspected) • Squamous cell carcinoma • EPITHELIAL(GLANDULAR)CELLABNORMALITIES •Atypicalendocervicalcells(NOSorspecifiedincomments) •Atypicalendometrialcells(NOSorspecifiedincomments) •Atypicalglandularcells(NOSorspecifiedincomments) •Atypicalendocervicalcells,favorneoplastic •Atypicalglandularcells,favorneoplastic • ENDOCERVICALADENOCARCINOMAINSITU • ADENOCARCINOMA • Endocervical • Endometrial • Extrauterine •NotOtherwiseSpecified(NOS) • OTHERMALIGNANTNEOPLASTMS(specified)

3.5.3 Specimen Adequacy •Satisfactoryforevaluation(presenceorabsenceofendocervical/transformationzone componentandanyotherqualityindicators,e.g.,partiallyobscuringblood, inflammation,etc.) •Unsatisfactoryforevaluation...(reasonspecified) •Specimenrejected/notprocessed(reasonspecified) •Specimenprocessedandexamined,butunsatisfactoryforevaluationofepithelial abnormalitybecauseof(reasonspecified)

3.5.4 Description •SpecimenType(Conventionalsmear(Papsmear)vs.liquidbasedvs.other) •AutomatedReview(Ifthecaseisexaminedbyanautomateddevice,thedevicewillbe specifiedwiththeresult.) •Pathologist’sReview •QualityControlReview •Organisms •Trichomonasvaginalis •FungalorganismsmorphologicallyconsistentwithCandidaspp •Shiftinflorasuggestiveofbacterialvaginosis •BacteriamorphologicallyconsistentwithActinomycesspp •CellularchangesconsistentwithHerpessimplexvirus

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3.5.5 Comment EducationalNotesandSuggestions(optional) •Suggestionswillbeconciseandconsistentwithclinicalfollow-upguidelinespublished byprofessionalorganizations(referencestorelevantpublicationsmaybeincluded). •AncillaryTesting •Abriefdescriptionofthetestmethodswillbeprovidedandtheresultreportedso that it is easily understood by the clinician.

4. GYNECOLOGICAL SPECIMENS

4.1RequisitionRequiredInformation Note: Patient information and pertinent clinical history must be included on the requisition to ensure accurate and timely results.

4.1.1 PhysicianInformation •Orderingphysician'sfullnameandidentificationcodenumber •Physician’sofficeaddress,phoneandFAXnumber

4.1.2 PatientInformation (Twopatientidentifiersmustbeprovidedinordertoperformthetest.) • REQUIRED INFORMATION •Patient’sfulllegalname–last,firstandmiddleifavailable.Alsoincludepreviousor maidennameifavailable •Dateofbirth •ABN–ifMedicare • OPTIONAL INFORMATION • Social security number •Gender • Address • Phone number •Patient’scompleteinsuranceinformation,includinginsurancenameandaddress, policynumberandpolicyholder’sname.Aphotocopyofthepatient’sinsurancecard, frontandbackmaybeattachedinlieuofcompletingtheinsurancesection

4.1.3 SpecimenInformation • REQUIRED INFORMATION •Collectiondate •Specimensource:cervical,endocervical,and/orvaginal •Specimentype:SurePath™,ThinPrep®PaporconventionalslidePapsmear(toinclude thenumberofslidessubmitted)

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4.1.4 PapTestOrderinformation •Selecttheappropriateriskassessmentlevelforthepatient:screeningordiagnostic.If diagnosticpleaseindicatepatient’ssigns,symptomsorhistory. •Boththelow-riskandhigh-risklevelsaredefinedbyMedicaretobescreeningtests.For Medicarepatientsreceivingthesescreeningtests,asignedAdvancedBeneficiaryNotice (ABN)shouldbesubmittedwiththerequisition.(Seeappendixforsample).

1.OrderingPapTests: PAPLQ: Usedforliquid-basedPapsthatdonotrequireHPVtestingnotincludedin thefollowingcodes(i.e.LSIL,HSIL) PAPHP: Usedforwomen30yearsandolder.PapandHPV;regardlessofPap results;reflexedto16/18GenotypeifPapresultisnegativeandHPVis positive. PAPACR: PapandreflextoHPVifPapresultisASC-US;16/18Genotype. PSHPV: HPVprimaryscreen;reflextoPAPifHPVother12positive,16/18 negative. PAPSMR: UsedforconventionalPapsmearsonly(microscopeslides).

2.OrderingHPVtestswithoutaPap: HRHPV: HPVhighriskwith16/18Genotype.

3.OrderingChlamydia/GonorrheaTesting: APTCG: CTandGC;ThinPrep®CollectionOnly APTCGT: CT,GCandTrichomonas;ThinPrep®collectiononly VIPCG: CTandGC;SurePath™collectiononly

4.OncoFISHCervicalTest: OncoFISHCervicalidentifiesASCUS/HPVPositiveorLSILresultsthatmayhavea highriskofprogression.

TheOncoFISHCervicalTestisperformedonexistingThinPrep®andSurePath™ liquidPapvials.

To order oncoFISH Cervical Testing: FONCOI: TestperformedregardlessofthePapdiagnosis. FONCOR:TestperformedifthePapdiagnosisisLSILonly. FONCAR:TestperformedifPapdiagnosisisASC-USorLSILandHPVisPositive.

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4.1.5 ClinicalInformation •Pleaseprovideanyapplicableclinicalinformationincluding: •Dateoflastmenstrualperiod(LMP) •Pregnant •Postpartum,nursing •Menopausal •Hysterectomy •Hormonetherapy •Clinicalindications/riskfactors •IUD •DESExposure •Dateoflastpapand/orbiopsy •Previousabnormalresultsandtreatmentsincludingdates.

4.1.6 HPVTesting HPVtestingcanbeorderedonPap(cervical/vaginal)specimenscollectedina SurePath™vial,orThinPrep®PreservCyt®Solution.HPVtestingwillberesultedandwill be billed separately. Note: HPV testing on cervical/vaginal specimens collected in liquid is FDA approved only if performed within 3 weeks of collection. HPV testing will not be performed if the specimen is outside the three-week date parameter.

4.1.7 Chlamydia/GonorrheaandTrichomonasTesting Chlamydia/Gonorrhea(CT/NG)TestingcanbeorderedonPap(cervical/vaginal) SurePath™ or ThinPrep®specimensoriftheyaresubmittedseparatelyonanAptima swab.TrichomonastestingcanalsobeperformedonThinPrep®specimens.Resultswill beprovidedonaseparatereportandthetestwillbebilledseparately.

4.2GYNSpecimenRequiredInformation 4.2.1 Identifiers PSHMCdoesnotacceptunlabeledspecimens.Allspecimenssubmittedtothelaboratory mustbeindividuallylabeledandmustincludetwopatientidentifiers: •Thepatient’sfirstandlastnameasitappearsontherequisition–donotusenicknames orinitials. •Asecondidentifier,eitherthepatient’sdateofbirth,socialsecuritynumberoraunique patientidentificationnumber. Note: For conventional smears the patient identifier must appear in pencil on the frosted label end of the slide. For SurePath™ and ThinPrep® Pap vials this information must be labeled on the vial itself not on the vial cap.

4.2.2 VialExpiration SpecimenscollectedinSurePath™solutionandThinPrep®PreservCyt®solutionmustbe collectedandprocessedbeforetheexpirationdateonthevial.Specimensreceivedinan expiredvialwillnotbeprocessed.

4.2.3 TransportBag Specimensmustbesubmittedonespecimenandrequisitionperbag.Thespecimen shouldbesealedinsidethebagandtherequisitionplacedsecurelyintheouterpocket.

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4.3Gynecological(PapSmear)Collection

4.3.1 PatientPreparation Itisrecommendedthatpatientsnotusevaginallubricants,vaginalmedications,vaginal contraceptives,ordoucheswithin48hoursbeforetheexam.Thepatientshouldnot engageinsexualactivity24hoursbeforethesmeariscollected.Inmenstruatingwomen theoptimaltimeforcellcollectionisatovulation.Patientsshouldnotbescheduledduring theirmenstrualcycle.Bleedingoraheavyexudatemaymakeaspecimenunsatisfactory forevaluationofepithelialcellabnormality.

4.3.1.1 SurePath™ Option1: SurePath™ Sample Collection with Broom-Type Device with Detachable Head 1. Recordthepatient’sfirstandlastnameandoneotheridentifieronthevial. 2. Completealaboratoryrequisitionformwithcompletepatientinformationand medical history. Clients submitting computer-generated requisitions must include patient’s full name, date of birth, date of collection, specimen source, client and physician information. 3. Insertthecervix-brushintotheendocervicalcanal.Applygentlepressureuntil thebristlesformagainstthecervix.Maintaininggentlepressure,holdthestem betweenthethumbandforefinger.Rotatethebrushfivetimesinaclockwise direction. 4. Placeyourthumbagainstthebackoftheremovablecollectiondevicetipand disconnecttheentiretipfromthestemandplaceintheSurePath™preservative vial. 5. Thecollectiondevicetipshouldbetransferredinthevial.Uptothreedifferent collectiondevicescanbeleftintheSurePath™vial.Placethecaponthevialand tighten.Shakethecontainervigorouslytoremovecellsfromcollectiondevice. 6. Placethevialandrequisitioninaspecimenbagfortransporttothelaboratory. Option2: SurePath™ Sample Collection with Combination Brush/Plastic Spatula Device with Detachable Heads 1. Recordthepatient’sfirstandlastnameandoneotheridentifieronthevial. 2. Completealaboratoryrequisitionformwithcompletepatientinformationand medical history. Clients submitting computer-generated requisitions must include patient’s full name, date of birth, date of collection, specimen source, client and physician information. 3. Insertthecontouredendoftheplasticspatulaandrotate360°aroundentire exocervix. 4. Snapthedevicehandleanddropthedetachableheadofthedeviceintothe SurePath®vial.

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5. InsertCytobrushintotheendocervixuntilonlythebottom-mostbristlesare exposedattheos.Slowlyrotate¼to½turninonedirection.Toreduce unnecessarybleeding,donotover-rotatebrush. 6. Snapthedevicehandleanddropthedetachableheadofthedeviceintothe SurePath®vial.Placethecaponthevialandtighten.Shakethecontainer vigorouslytoremovecellsfromcollectiondevice. 7. Placethevialandrequisitioninaspecimenbagfortransporttothelaboratory.

4.3.1.2THINPREP®

Option1: Endocervical Brush/Spatula Protocol 1. Recordthepatient’sfirstandlastnameandoneotheridentifieronthevial. 2. Clientssubmittingcomputer-generatedrequisitionsmustincludepatient’sfull name,dateofbirth,dateofcollection,specimensource,clientandphysician information. 3. Obtainanadequatesamplingfromtheexocervixusingaplasticspatula. 4. RinsethespatulaasquicklyaspossibleintothePreservCyt®Solutionvialby swirlingthespatulavigorouslyinthevial10times.Discardthespatula. 5. Obtainanadequatesamplingfromtheendocervixusinganendocervicalbrush device.Insertthebrushintocervixuntilonlythebottommostfibersare exposed.Slowlyrotateone-fourthortheone-halfturninonedirection.Donot over-rotate. 6. RinsethebrushasquickaspossibleinthePreservCyt®Solutionbyrotating thedeviceinthesolution10timeswhilepushingagainstthePreservCyt®vial wall.Swirlthebrushvigorouslytofurtherreleasematerial.Discardthebrush. 7. Tightenthecapsothatthetorquelineonthecappassesthetorquelineonthe vial. 8. Placethevialandrequisitioninaspecimenbagfortransporttothelaboratory.

Option2: Broom-Like Device Protocol 1. Recordthepatient’sfirstandlastnameandoneotheridentifieronthevial. 2. Completealaboratoryrequisitionformwithcompletepatientinformationand medical history. Clients submitting computer-generated requisitions must include patient’s full name, date of birth, date of collection, specimen source, client and physician information. 3. Obtainanadequatesamplingfromtheexocervixusingabroom-likedevice. Insertthecentralbristlesofthebroomintotheendocervicalcanaldeepenough toallowtheshorterbristlestofullycontacttheectocervix.Pushgently,and rotatethebroominaclockwisedirectionfivetimes. 4. RinsethebroomasquicklyaspossibleintothePreservCyt®Solutionvialby pushingthebroomintothebottomofthevial10times,forcingthebristles apart.Asafinalstep,swirlthebroomvigorouslytofurtherreleasematerial. Discardthecollectiondevice.

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5. Tightenthecapsothatthetorquelineonthecappassesthetorquelineonthe vial.

6. Placethevialandrequisitioninaspecimenbagfortransporttothelaboratory.

4.3.1.3 PAP-PAK®ConventionalSmear

PapSmearSpecimenCollectionUsingFastSmearTechnique

1. Printthefirstandlastnameofthepatientonthefrostedendoftheslide(use #2pencil)andoneotheruniqueidentifier.

2. Clientssubmittingcomputer-generatedrequisitionsmustincludepatient’sfull name,dateofbirth,dateofcollection,specimensource,clientandphysician information.

3. Obtaincervicalmaterialfromexocervixandsquamo-columnarjunctionby rotatingthespatula360degreeswhilescrapingvigorously.

4. Placecervicalmaterialonslidenearthelabeledendasathickdrop.Donot smear.

5. Obtainendocervicalsampleusingacytobrush.Donotusecytobrushifthe patientispregnant;inthiscasefollowstep2.

6. Mixontheslidewiththeexocervicalsampledrop.Donotsmear.

7. Holdingtheslidewiththumbandforefingersmearthesamplewithone lengthwisestrokeofthespatula.Donotusecircularorzigzagmotion,asthis wouldincreasethechanceofair-drying.

8. Immediatelysprayslidewithfixative.

9. Note: Be careful to coat the slide until wet with fixative. However, do not spray the fixative so closely that cells are displaced or frozen.

10.Onlyonespecimenfromonepatientperpackage.Pleaselabelpackagewith patient'snameandoneotheridentifier(birthdate).

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4.4BDFocalPoint™GSImagingSystem(SurePath™Specimens) FocalPoint™(formerlyAutoPap),manufacturedbyBD/TriPath,isanautomatedslidereading systemthathasbeenapprovedbytheFDAforprimaryscreeningandrescreeningofPap smears.TheFocalPoint™technologyusesastatisticalclassifieralgorithmtocalculatethe likelihoodthataslidecontainsabnormalities.Afterscanning,thecomputerproducesaQC score,whichreflectsanaggregatemeasureofnumerouscytologicalabnormalities.Asthescore increases,thelikelihoodofabnormalcellsincreases. TheslideinformationisretrievedbythecytotechnologistusingtheBDFocalPoint™GSReview Station.TheReviewStationretrievestheslideprocessingresultsdatafromtheSlideProfilerand presentsthedatatoassistintheinterpretationoftheslide. Additionally,theBDFocalPoint™SlideProfileralsoselects15%ofthehighestscoring‘Negative’ slidesforqualitycontrolreview. CurrentlyatPAML/PSHMCallSurePath® specimens are screened by the FocalPoint™ system andbyaqualifiedcytotechnologist.Anotationismadeonthefinalreportthattheslidewas screenedbyanautomatedintelligencedevice.Thisaddsanotherlayerofqualityassuranceto thescreeningprocess.

4.5 ThinPrep®ImagingSystem(ThinPrep®Specimens) ThinPrep®ImagingSystem,manufacturedbyHologic,isasystemforimagingandanalyzing ThinPrep®cervicalcytologysampleslides.Cellsofinterestarehighlightedforthe cytotechnologists’review,helpinghim/hertobetterfocushis/herinterpretiveskills. CurrentlyatPAML/PSHMCallThinPrep®specimensareanalyzedbytheThinPrep®Imaging Systemandscreenedbyaqualifiedcytotechnologist.Anotationismadeonthefinalreportthat theslidewasscreenedbyanautomatedintelligencedevice.

5. NON-GYN SPECIMENS

5.1RequisitionRequiredInformation Note: Patient information and pertinent clinical history must be included on the requisition to ensure accurate and timely results. 5.1.1 PhysicianInformation •Orderingphysician'sfullnameandidentificationcodenumber •Physician’sofficeaddress,phoneandFAXnumber

5.1.2 PatientInformation • REQUIRED INFORMATION • Patient’sfullname–last,firstandmiddleifavailable.Alsoincludepreviousormaiden nameifavailable •Dateofbirth •Gender • OPTIONAL INFORMATION • Social security number • Address • Phone number

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• Patient’scompleteinsuranceinformation,includinginsurancenameandaddress, policynumberandpolicyholder’sname.Aphotocopyofthepatient’sinsurancecard, frontandback,maybeattachedinlieuofcompletingtheinsurancesection.

5.1.3 SpecimenInformation(Required) •Collectiondate •Specimentype:i.e.FNAbreast,pleuralfluid,urine(voidedorcatheterized),bronchial washing,etc. •Specimensourceorlocation:i.e.rightbreast,leftureter,leftlowerlobeoflung,etc.

5.1.4 ClinicalInformation •Pleaseprovideanyapplicableclinicalinformationincludingrecentrelatedinfectionsor illnessesandsignsorsymptomsexperienced. •Alsoindicateanyapplicablepatienthistory:i.e.historyofthyroidnodule,historyof melanoma,historyofbladderlesions,previoushysterectomy,etc.Pleasebeasspecific as possible

5.1.5 TestOrderInformation All non-GYN specimens are ordered using RSHCYO. •Indicateclinicaldiagnosiswithsignsandsymptoms. •Ifrequestingspecialstainspleaseindicatethisontherequisition.

5.2Non-GYNRequiredInformation(Specimen) 5.2.1 Identifiers PAML/PSHMCCytologydoesnotacceptunlabeledspecimens.Allspecimenssubmittedtothe laboratorymustbeindividuallylabeledandmustincludetwoidentifiers: •Thepatient’sfirstandlastnameasitappearsontherequisition–donotusenicknames •Asecondidentifier,eitherthepatient’sdateofbirth,socialsecuritynumberoraunique patientidentificationnumber. Note: For specimens submitted on a slide, label the frosted end of the slide using a #2 pencil. For specimens submitted in cytology fixative or other specimen container, this information should be written in permanent ink on the container itself not on the container cap.

5.2.2 Accepted and Processed Allspecimensmustbesubmittedtothelaboratoryusingthecollectionproceduresandthe specimen requirements included in this manual in order to be accepted and processed. Any questionsorconcernsrelatedtothesecriteriashouldbedirectedtothelaboratory.

5.3Non-GynecologicalCollection Note: Samples for microbiological and/or hematological studies should be provided in separate sterile containers. Note: Formalin should never be used for cytology specimens as this renders the specimen unsatisfactory for cytology processing.

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5.3.1 BodyCavityFluid(Aspirated)includingPleuralFluid,PeritonealFluid,PericardialFluid 1. Collectspecimeninaclean/sterilecontainerthatislabeledwiththepatientsfirstand lastnameandauniquepatientidentifier. 2. Ifatallpossible,atleast50ccoffluidshouldbecollectedforpropercytological preparation.Thevolumeneednotexceed200mLoffluid. 3. Donotaddfixative.Iftransporttothelabwillbedelayed,thespecimenshouldbe refrigeratedorkeptonice.Ifadelayinprocessingbeyond24hoursisanticipated,the specimenshouldbemixedwithanequalamountofCytoLyt®fixative(availablefrom thePAMLSupplyDepartment). 4. SendspecimenandcompletedrequisitiontoCytology.

5.3.2BodyCavityFluid(Washings)includingPelvic/Peritoneal,gutter,Etc. 1. Normalsalineistherecommendedwashingfluid. 2. Collectspecimeninaclean/sterile,containerthatislabeledwiththepatientsfirstand lastnameandauniquepatientidentifier. 3. Ifatallpossible,atleast50ccoffluidshouldbecollectedforpropercytological preparation.Thesizeofthesampleneednotexceed200mLoffluid. 4. Donotaddfixative.Iftransporttothelabwillbedelayed,thespecimenshouldbe refrigeratedorkeptonice.Ifadelayinprocessingbeyond24hoursisanticipated,the specimenshouldbemixedwithanequalamountofCytoLyt®fixative(availablefrom thePAMLSupplyDepartment). 5. SendspecimenandcompletedrequisitiontoCytology. Note: Formalin should never be used for cytology specimens as this renders the specimen unsatisfactory for cytology processing.

5.3.3Bronchial/BronchoscopySpecimens 1. Collectspecimeninaclean/sterile,containerthatislabeledwiththepatientsfirstand lastnameandauniquepatientidentifier. 2. Donotaddfixative.Iftransporttothelabwillbedelayed,thespecimenshouldbe refrigeratedorkeptonice.Ifadelayinprocessingbeyond24hoursisanticipated,the specimenshouldbemixedwithanequalamountofCytoLyt®fixative(availablefrom thePAMLSupplyDepartment). 3. SendspecimenandcompletedrequisitiontoCytology.

5.3.4BronchialBrushings Slides 1. Rollthecontentsofthebrushontoaclean,labeledglassslideandfiximmediatelywith sprayfixative(withinonetotwoseconds)or,immediatelydropslide(s)intoacoplinjar containing95%alcohol. 2. SendspecimenandcompetedrequisitiontoCytology.

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Container • Rinsethebrushinfixative(CytoLyt®)solutionbyrotatingthebrushinthesolution10 timeswhilepushingagainstthevialwall.Swirlthebrushvigorouslyinsolutionto further release cells.

• Note:Salinemaybeusedinplaceoffixativeiftransporttothelabisimmediate; however,thisisnotrecommended.Formalinshouldneverbeusedforcytology specimensasthisrendersthespecimenunsatisfactoryforcytologyprocessing.

• Cutoffbrushleavingapproximatelyoneandone-halfinchesofwireanddropbrush intothetubeofcytologyfixativeobtainedfromthelaboratory.

• Replacecaptightlyandlabelcontainerwithpatientnameandanotheridentifier(birth date).

• SendspecimenandcompletedrequisitiontoCytology. Note: Specimens submitted for culture studies, molecular studies, and other special studies must be submitted in separate sterile containers.

5.3.5BronchoalveolarLavage 1. Collectspecimeninaclean/sterile,containerthatislabeledwiththepatientsfirstand lastnameandauniquepatientidentifier.

2. Donotaddfixative.Iftransporttothelabwillbedelayed,thespecimenshouldbe refrigeratedorkeptonice.Ifadelayinprocessingbeyond24hoursisanticipated,the specimenshouldbemixedwithanequalamountofCytoLyt®fixative(availablefrom thePAMLSupplyDepartment).

3. SendspecimenandcompetedrequisitiontoCytology.

Note: Fixative may be added to the specimen if a delay in transport is expected. Cytology fixative (CytoLyt®) may be obtained from the laboratory. Fixative is added to BAL samples upon arrival to the lab. Formalin is never used as a cytology fixative.

5.3.6 Sputum Note: Fresh sputum samples must be sent immediately to the laboratory refrigerated. Fixed sputum samples have no transport time limit.

Inpatientsputum 1. Forthemostadequatesputumspecimen,besurespecimencollectedisanearly morning,deepcoughspecimen(preferablybeforebreakfast)andnotsaliva.

2. Havepatientcoughintoaclean,labeledspecimencontainer.Donotaddfixative.

3. Sendspecimenwithcompletedcytologyrequisitiontothelaboratory.

Outpatientsputum 1. SpecimenmustbecollectedinlabeledcontainerwithCytoLyt®fixative.CytoLyt® fixativeisavailablefromPAMLSupplyDepartment.

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2. Besurespecimencollectedisanearlymorning,deepcoughspecimen(preferably beforebreakfast)andnotsaliva. 3. Afterpatientexpectoratesintocontainer,replacelidandshakecontainertodistribute fixative. 4. Sendspecimenwithcompletedcytologyrequisitiontothelaboratory.

Post-bronchoscopysputum(24-hourpost-bronchialsputum) 1. CollectONEgood,deepcoughspecimenatanytimeduringthe24hoursfollowing bronchoscopy.Pooled24-hourcontinuouslycollectedsputaarenotsuitablefor cytology. 2. Sendspecimenwithcompletedcytologyrequisitiontothelaboratory.

InducedSputum 1. Aheatedaerosolizedsolutionof15percentNaCland20percentPropyleneGlycolis inhaledbythepatientfor20minutes. 2. Havepatientcoughintoaclean,labeledspecimencontainer.Donotaddfixative. 3. Sendspecimenwithcompletedrequisitiontothelaboratory. 5.3.7CerebrospinalFluid 1. Collectspecimeninaclean/sterilecontainerthatislabeledwiththepatientsfirstand lastnameandauniquepatientidentifier. 2. Filloutrequisitionindicatingsiteoftap(lumbar,ventricle,omayareservoir)and relevantclinicalinformation. 3. SendspecimenrefrigeratedandcompletedrequisitiontoCytology. Note: If transport to the lab will be delayed, the specimen should be refrigerated or kept on ice. Fixative is not added to CSF. 5.3.8FineNeedleAspiration(SuperficialSites) Aspirationofsuperficial,generallypalpable,lesionsofthebreast,thyroid,salivarygland, lymphnode,subcutaneous,skin,orothersitecanbeperformedinadoctor’sofficeor patientroom.LymphnodeaspiratesforflowcytometryrequireRPMIfixativeavailable fromCytologyorHistology.IfyouwouldliketoarrangeforaCytotechnologisttoassist withinthehospital,pleasecall509-474-4437.

GeneralProcedureforSuperficialSites 1. Labeltwoormorecleanglassslidesorlabelcytologycollectionbottle(tube)withthe patient'sfirstandlastnameandauniquepatientidentifier. 2. Wipetheskinoverthelesionwithanalcoholswab.Localanestheticisnotusually needed. 3. Attacha22gauge(or25gaugeincertainsitessuchasthyroid)needletoa10-20cc syringe. 4. Ifpossible,fixthelesioninplaceusingthethumbandforefingerofthelefthand(if righthanded). 5. Passtheneedlethroughtheskinandintothelesion.

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6. Aftertheneedleisinthelesion,drawbacktheplungerofthesyringetocreatesuction (negativepressure).Movetheneedlebackandforthseveraltimesinthelesion.A"jack hammer"motionisofteneffective. Note: With solid lesions, material should be aspirated only into the needle and not into the syringe. Once material appears in the hub of the needle, aspiration should be discontinued. Blood is undesirable. In the case of cystic lesions, the syringe may be filled with fluid. This fluid may be submitted for cytological examination. 7. Onceaspirationiscompleted,releasetheplungerandallowittofallbacktoa"neutral" position. 8. Removetheneedleandsyringefromthepatient.

To Make Slides 1. Removetheneedlefromthesyringe. 2. Drawairintothesyringe. 3. Replacetheneedleontothesyringe. 4. Withthebevelpointeddown,expressthematerialintheneedleontothecenterofa slideusingfirmbutnotexcessivepressureontheplunger.Onlyoneortwodropsof fluidarenecessary. 5. Immediatelyplaceasecondslideovertheslidewiththesample. 6. Allowthesampletospreadbetweenthetwoslideswithoutanysmearingmotion (othersmearingmethodscanbeusedbutrequireexperience). 7. Immediatelyfixtheslidesusingasprayfixativeorbyplacingtheslidein95%alcohol. Note: Alternatively, Allow only one slide to air dry particularly with suspected lymphoma or hematopoetic cancer (label it as ‘air dried’). Air-dried slides have no time limit on transport. However, rinsed material should be transported immediately or fixed if a delay in transport is expected. Cytology fixative (CytoLyt®) may be obtained from the laboratory or the PAML Supply Department. 8. Theremainderofthematerialintheneedlecanbeexpressedintoaclean,labeled tubebydrawingupsterilesalineandforcingitbackoutuntilthesprayisdry. 9. Theproceduremayberepeatedseveraltimes. 10.Applypressuretotheaspiratedsitetominimizehematoma.

TosendinaContainer(NoSlides) 1. Specimenswithneedlesattachedarenotacceptedandshouldnotbetransported.If transportingspecimeninasyringe(notrecommended),theneedleshouldberemoved andthesyringeshouldbecapped.Itisrecommendedthatifnoslidesarebeing smearedatthetimeofcollection,thesamplebeexpressedfromthesyringetoaclean, labeledcontainer(cytospintube)usingsterilesaline. 2. Obtainthesampleusingthegeneralprocedure. 3. Drawupsterilesalineintosyringe. 4. Forcethesalineoutintothetubethroughtheneedleuntilthesprayisdry.

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5.Theproceduremayberepeatedseveraltimes. 6.Note:Rinsedmaterialshouldbetransportedimmediately.Ifadelayintransport isexpected,thespecimenshouldbefixed.Cytologyfixative(CytoLyt®)maybe obtained from the laboratory. 7. Cap the tube for transport. 8.Applypressuretotheaspiratedsitetominimizehematoma. 9.Disposeofthesyringeandneedleinthepropercontainer.

5.3.9 FineNeedleAspirations(DeepSites) Deepsitesareaspiratedunderradiologicalguidanceusingatechniquesimilartothat forsuperficialsites(seeabove).Theradiologistexpressesthesampleontoasterileslide orrinsesthespecimenwithsalineintoacollectiondevice(tubeorcup).Apathologist, cytotechnologist,ortechnicianspreadsthesamplebetweentwoslidesandfixesand/or air-driestheslides.

Ifnoslidesarebeingmade,thepathologist,cytotechnologist,ortechniciancapsthe collectiondevicefortransport.Fixedslideshavenotimelimitontransport.Air-dried slideshavenotimelimitontransport.However,rinsedmaterialshouldbetransported immediatelyorfixed,ifadelayintransportisexpected.Cytologyfixative(CytoLyt®)may beobtainedfromthelaboratoryorthePAMLSupplyDepartment.

Slides can be immediately stained and interpreted for adequacy. The procedure can be repeatedifinadequatematerialisobtained.Cytocentrifugepreparations,ThinPrep® Slides,andcellblockcanbepreparedfromneedleandtubewashings.

Coresoftissuecanbefixedforhistologicsectioning.Immunohistochemistry(forestrogen receptor,prostatespecificantigen,leukocytecommonantigen,keratin,etc.)canbe performedoncellblockandcoresoftissue.Particlescanbesavedforelectron microscopy.LymphnodeaspiratesforflowcytometryrequireRPMIfixativeavailablefrom CytologyorHistology.

IfyouwouldliketoarrangeforaCytotechnologisttoassistwithinthehospital,pleasecall 509-474-4437.

5.3.10MostCommonDeepSites • Breast • Liver • Lung • LymphNode • Pancreas • SalivaryGland • Thyroid • Mediastinum • Kidney • AdrenalGland • Softtissue

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5.3.11GastrointestinalBrushings Slides 1.Rollthecontentsofthebrushontoaclean,labeledglassslideandfiximmediatelywith sprayfixative(withinonetotwoseconds).Alternatively,slidesmaybeplacedintoa bathof95%alcoholfortransport. 2.SendimmediatelytoCytologyLabwithcompletedrequisition. Container 1.Rinsethebrushinfixativesolutionbyrotatingthebrushinthesolution10timeswhile pushingagainstthevialwall.Swirlthebrushvigorouslyinsolutiontofurtherrelease cells. 2.Cutoffthebrushanddropitinthefixative. 3.Replacecaptightlyandlabelcontainer. 4.SendimmediatelytoCytologyLabwithcompletedrequisition.

5.3.12NippleDischarge 1.Expresssecretionbygentlycompressingthefullcircumferenceoftheareolabetween thumbandindexfinger.Whenamassispalpable,theareabetweenthemassand nipple may be compressed. 2.Smearsecretiononaclean,labeled,glassslide.Ifsecretionisscanty,theslidemay betouchedtothenipple.Ifsecretionisthick,itmaybesmearedbetweentwoslides. Sprayfixslide(s)immediately(holdaerosolsprayfourtosixinchesfromslideandapply foronetotwoseconds).(Alternatively,placetheslideimmediatelyintoabathof95% alcoholtofixcells.) 3.PlaceslidesincarrierandsendtoCytologyLabwithcompletedrequisition.

5.3.13Skin(TzanckSmear) 1.Identifyafreshtypicalvesicle. 2.Unroofthevesicle. 3.Scrapethemarginofthevesiclewithascalpelblade. 4.Spreadthecellsanddebrisadherenttothebladeonaclean,labeled,glassslide. 5.Fiximmediatelywithsprayfixative(Holdaerosolsprayfourtosixinchesfromslideand applyforoneortwoseconds.)orplacetheslideintoabathof95%alcohol. 6.Placeslidesincarrier,andsendslidesandrequisitiontothelaboratory.

5.3.14Urine,RenalPelvicWashings&bladderWashings Urinespecimenswithoutfixativeshouldbesentdirectlytothelaboratoryorrefrigerated ifanydelayisanticipated.Unfixedrefrigeratedurineissuitableforcytological examinationfor24hours.Ifspecimenscannotberefrigeratedorifalongdelayin transportisanticipated,thespecimenshouldbecollectedinanequalvolumeofcytology fixative(CytoLyt®)availablefromthePAMLSupplyDepartment.

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VoidedUrine 1.Patientcollectsspecimen.Besureallspecimensarecollected"cleancatch"andin properly labeled containers. Makesuretonotethatspecimenisvoidedurine. 2.Foroptimalcytologicalevaluationofurine,first-voidedmorningspecimensshould not be used. 3.Sendimmediatelytothecytologylaboratorywithcompletedrequisition.Ifspecimen cannotbesentimmediatelytothecytologylaboratory,pleaserefrigerate. 4.Analternative(especiallyifadelayintransporttothelaboratoryisanticipated)isto collectthespecimeninanequalvolumeofcytologyfixative(CytoLyt®)availablefrom thePAMLSupplyDepartment.Formalinisneveranappropriatecytologyfixative.

CatheterizedUrine 1.Specimeniscollectedbyphysicianornursingstaffinaclean,properlylabeled containerandsentimmediatelytotheCytologyLaboratorywithcompletedrequisition. Makesuretonotethatspecimeniscatheterizedurine. 2.Analternative(especiallyifadelayintransporttothelaboratoryisanticipated)isto collectthespecimeninanequalvolumeofcytologyfixative(CytoLyt®)availablefrom thePAMLSupplyDepartment.Formalinisneveranappropriatecytologyfixative.

RenalPelvicandBladderWashings 1.Usingnormalsaline,thewashingspecimeniscollectedbyaphysicianinaclean specimen container. 2.Labelcontainerwithname,andbodysite(specificallydesignaterightorleftpelvic washing). 3.Sendimmediatelytothelaboratorywithacompletedrequisition.Indicatethatthe specimenisawashing. 4.Ifadelayintransportisexpected,addanequalvolumeofCytoLyt®(obtainablefrom thePAMLSupplyDepartment)tothespecimen.Formalinisneveranappropriate cytologyfixative.

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