MECC Standard Operating Procedures Final Nov 08

8/12/2019 MECC Standard Operating Procedures Final Nov 08

1/111

StandardOperatingProceduresfor

MECCRegistries

SecondEdition

December2008

Editedby:

HodaAntonCulverPh.D.

ProfessorandChair,Departmentof

Epidemiology

UniversityofCaliforniaIrvine

224IrvineHall

Irvine,California,

92697

USA

JohnL.Young,Jr.DrPH,CTR

ProfessorofEpidemiology

SchoolofMedicine,RollinsSchoolofPublic

Health,EmoryUniversity

1462CliftonRoad,

NEAtlanta,

Georgia

30322

USA

TheSecondEditionhasbeendiscussedandamendedbythedirectorsoftheMECCRegistriesattheMECC

SteeringCommitteeMeetingofOctober,2008.


2/111

2

INTRODUCTION.5

I. ACCESSTOSOURCEDATAANDCOMPLETENESSOFREPORTING ........................................................ 6

A.STRUCTURALREQUIREMENTS..............................................................................................................6

1.LegislationandRegulations ..............................................................................................................6

2.ReportabilityDefinitions ................................................................................................................. 10

B.PROCESSSTANDARDS ......................................................................................................................... 11

1.ParticipationofAllHospitals...........................................................................................................11

2.CaseAscertainmentinNonhospitalSources .................................................................................12

3.ReportingbyPhysicians .................................................................................................................. 13

4.OutofareaCoverageandCaseSharing ......................................................................................... 14

5.InformingFacilitiesandPractitioners .............................................................................................15

6.Monitoring

Use

of

and

Changes

in

Facilities

and

Practitioners ...................................................... 16

7.ConfidentialityPoliciesandProcedures:IssuesinDataCollectionandManagement...................17

8.DeathClearance ..............................................................................................................................21

9.TraininginCaseFindingandMultiplePrimaryDetermination....................................................... 24

10.MonitoringCompletenessofReportingandEnsuringCompliancebyAllFacilitiesand

Practitioners .................................................................................................................. ...................... 24

11.CaseFindingAudits ....................................................................................................................... 26

12.PatientFollowup..........................................................................................................................27

C.OUTCOME

MEASURES ........................................................................................................................28

1.PercentDeathCertificateOnly.......................................................................................................28

2.ObservedVersusExpectedCaseCounts......................................................................................... 29

3.OtherAnalyses ................................................................................................................................31

4.TimelinessofRegistryReporting ....................................................................................................32

5.CaseFindingAuditResults ..............................................................................................................33

6.FollowupSuccessRates .................................................................................................................34

II. DATAQUALITY ....................................................................................................................................35

A.STRUCTURALREQUIREMENTS............................................................................................................35

1.DataQuality:GeneralRequirements..............................................................................................35

2.StaffingGuidelinesforDataQuality................................................................................................36

3.ProcedureManuals,CodingManuals,andOtherDocumentation.................................................37

4.EditsandDataProcessingCapabilitiesforDataQuality.................................................................38


3/111

3


1.TrainingforImprovedDataQuality ................................................................................................43

2.QualityControlActivities ................................................................................................................44

3.DisseminationofQualityControlActivityResults.......................................................................... 50

C.OUTCOME

MEASURES ........................................................................................................................51

1.ReabstractingandRecodingAudits ...............................................................................................51

2.AbstractingandCodingReliabilityStudies .....................................................................................54

3.UnknownValues .............................................................................................................................55

III. DATAANALYSISANDREPORTING................................................................................................... 57

A.STRUCTURALREQUIREMENTS............................................................................................................57

1.ConfidentialityPoliciesandProcedures:IssuesinResearch,Reporting,andReleaseofRegistry

Data ..................................................................................................................................................... 57

2.PopulationData ..............................................................................................................................61

3.StaffingGuidelinesforDataAnalysisandReporting ...................................................................... 62


1.AnalysisCategoriesandRecodedGroups.......................................................................................65

2.StatisticalMethods .........................................................................................................................67

3.Reports............................................................................................................................................ 75

IV. DATAMANAGEMENT......................................................................................................................81

A.

STRUCTURAL

REQUIREMENTS............................................................................................................81

1.DataManagement:GeneralRequirements....................................................................................81

2.StaffingGuidelinesforDataManagement .....................................................................................84


1.DataEntry .......................................................................................................................................86

2.Outputs ...........................................................................................................................................90

3.RecordLinkage ................................................................................................................................92

4.Edits................................................................................................................................................. 95

5.Record

Consolidation...................................................................................................................... 95

6.GuidelinesforProcessingFollowup,Correction,andDeletionTransactions................................96

7.LinkageswithExternalFiles ............................................................................................................ 97

8.Documentation ...............................................................................................................................97

V. APPENDICES ........................................................................................................................................99


4/111

4

A.REPORTABILITY ...................................................................................................................................99

B.MAJORMINORDISCREPANCYDEFINITIONS.....................................................................................101

C.SAMPLECASESHARINGAGREEMENT...............................................................................................103

D.ACCESSTONONCONFIDENTIALMECCDATA ..................................................................................105

E.AGREEMENT

FOR

ACCESS

TO

MECC

DATA .......................................................................................107

F.ACKNOWLEDGEMENTANDDISCLAIMER .......................................................................................... 109

INDEX ........................................................................................................................................................110


5/111

5

INTRODUCTION

Establishmentof

these

standards

is

of

major

importance

in

enhancing

the

usefulnessofcancerregistrydata.Collaborativestudiesanddatacomparisonsare

morefeasibleasdatabecomemoredirectlycomparable.Electronicsharingof

cancerdata,edits,datarecoderoutines,analysissoftware,documentation,and

trainingaidsareallincreasinglypossibleoncestandardsareestablishedand

adopted.

CancerRegistriesareintendedtoprovideabaseforepidemiologicalresearchand

casecontrolstudies.Someregistriesemphasizecancercontrolandpatient

managementconsiderations,

and

some

focus

on

end

results

and

survival.

Strictness:Thestandardspresentedvaryinhowstronglytheyarerecommended.

Therearethreelevelsofstrictnesstothestandards:

MUSTs:Therearecertainregistrycharacteristicsthatarenecessaryforthe

effectiveandefficientoperationofacancerregistry.Theseareidentifiedas

MUSTsinthestandards.Althoughsomeexistingregistriesmaybeableto

functionwithoutthesecharacteristics,itisthepresentconsensusthatany

newregistryshouldadoptthesestandards.

SHOULDs:Thereareothercharacteristicsthatexperiencehasshownare

stronglyrecommended,butperhapsnotasabsolutelyrequiredasthe

MUSTsabove.ThesearedesignatedasSHOULDsinthestandards.Someof

theproblemsaddressedbytheSHOULDscanbesolvedinalternateways

dependingonlocalconditions,needs,andresources.

MAYs:Thereareyetothercharacteristicsthatarehighlydesirablebutnot

necessary.These

are

designated

as

MAYs.


6/111

6

I. ACCESSTOSOURCEDATAANDCOMPLETENESSOF

REPORTING

A.STRUCTURALREQUIREMENTS1.LegislationandRegulations

a)DefinitionsLegislation:Legislationorstatutereferstoaformoflawenactedbya

government.

Regulation:Regulationorrulereferstoaformoflawcreatedby

administrativeagenciesofagovernment.

b)IntroductionTheauthorityofapopulationbasedcancerregistrytocollectdataon

cancerincidenceisestablishedthroughlegislationforcancerreporting

withorwithoutregulations;and/orregulations/rulesdevelopedunder

generalauthorizationforreportingnoncommunicabledisease,as

specifiedhealthauthorities.

Legislativeauthorityshouldincludespecificcomponentsrelatedto

registrydevelopmentandfunction,aswellasspecificdirectivesfor

promulgationofregulationsdetailingthesecomponents.Oftenthe

authorityisgrantedtothejurisdictionshealthdepartment,whichin

turnmaydelegatetheauthoritytoanotheragency.Inotherinstances,

theauthorityisgranteddirectlytoanotheragency,suchasauniversity.

TheguidelinesofMECCinclude:reportingrequirements,patientrecord

access,dataqualityanddatastandards,confidentialityanddisclosureof

data.


7/111

7

c)Standards(1)Standards for Reporting Requirements

GeneralConsiderations:GovernmentlegislationoraMinisterial

decreeMUST

authorize

apopulation

based

registry.

Legislation

or

decreeSHOULDdefinereportablecancers,areferencedatefor

registryoperation,residencyrequirementsofcases,whohasthe

authorityandresponsibilityforimplementingandmaintainingthe

database,whoisresponsibleforreportingthedata(i.e.,physicians,

hospitals,pathologylaboratories,etc.),whatgeographicareaistobe

covered,timelinessofreporting,thetypeandformatofdatatobe

reported,towhomandunderwhatcircumstancestheregistryhas

authoritytoreleasethedata,anditshouldaddresspenaltiesfor

noncompliance.

RequiredComponentsoftheLegislationand/orMinisterialDecreeRegardingReportingRequirements: Definitions:Allterminologyusedinthetextofthelawor

decreeMUSTclearlybedefined.

CancerSHOULD

include

all

neoplasms

in

the

most

recent

editionoftheInternationalClassificationofDiseaseforOncology

(ICDO),withabehaviorcodeof2or3(insituormalignant).PossibleexceptionstothisMAYincludemanybasalandsquamouscell

carcinomasoftheskinandinsitucarcinomaofthecervixuteri.RegistriesMAYcollectbenigntumorsandthisshouldbedefined.

Referencedatereferstotheeffectivedatecoveragestartsin

aspecifiedpopulationatrisk.Itisnotthedatetheregistryis

organizedor

actually

performs

the

work.

Cases

diagnosed

on

or

after

thereferencedateMUSTbeincluded.ThereferencedateSHOULD

beJanuary1ofacalendaryear,butMAYbeanotherdate.

Allcancersoccurringinthegeographicregioncoveredbythe

registrySHOULDbereportable.Toallowforsharingofcaseswith


8/111

8

otherpopulationbasedregistries,tofacilitatedeathclearanceand

otherrecordlinkages,andtoallowforthepreparationofreportsto

individualfacilitiesthatincludealltheircases,theregistrySHOULD

includeallresidentsandnonresidents.

Theregistry

MUST

be

population

based.

To

assure

maximum

coverageofthedesignatedpopulation,cancersSHOULDbereported

by,orcaseinformationobtainedfrom,allhospitalsorotherfacilities

providingscreening,diagnostic,ortherapeuticservicestopatients

withrespecttocancer;andfromphysicians,surgeons,andallother

healthcareprovidersdiagnosingorprovidingtreatmentforcancer

patients,exceptforcasesdirectlyreferredtoorpreviouslyadmitted

toahospitalorotherfacilityprovidingscreening,diagnostic,or

therapeuticservicestopatientsandreportedbythosefacilities.

ThelegislationordecreeSHOULDstatethatcancercases

SHOULDbereportedtotheregistrynomorethan180daysfromthe

dateofadmissionordiagnosisinaformatprescribedbytheregistry

(theformatitselfSHOULDbeincorporatedbyreference).

(2)Standards for Patient Record Access

GeneralConsiderations:Thelegislationand/ordecreeSHOULDprovideforaccesstorecordsofhealthcareprovidersandfacilitiesthatwouldidentifycasesofcancerorwouldestablishcharacteristics

ofthecancer,treatmentofthecancer,ormedicalstatusofany

identifiedcancercasebyauthorizedrepresentativesofthecancer

registry.Thisaccessisnecessaryformeetingbothinitialreporting

requirementsandsubsequentqualityassuranceactivities.

(3)Standards for Data Quality

Thelegislationand/ordecreeMUSTprovidethatdatareportedto

theregistrySHOULDmeetstandardsofcompletenesstimelinessand

quality.RulesSHOULDfollowstandardssetbytheMECCand

SHOULDprovidefordataqualityauditsconductedatreporting

facilitiesbythecancerregistry.


9/111


10/111

10

confidentialitypoliciesandhavetheapprovaloftheregistry

InstitutionalReviewBoard(IRB).

WillfulviolationofconfidentialityprovisionsSHOULDbe

punishable.

2.ReportabilityDefinitionsa)IntroductionPrecisedefinitionsofcasesthatarereportabletotheregistryMUSTbe

developedandpromulgated.

b)Standards(1)Standards for Reportable Diagnoses

TheregistrysreportablelistSHOULDmakereferencetothe

InternationalClassificationofDiseasesforOncology.Ataminimum,

allneoplasmswithabehaviorcodeof2or3inICDOSHOULDbe

designatedreportable.Anybenignneoplasmsorneoplasmsof

uncertainbehaviorthatarereportableSHOULDclearlybeidentified

withreferencetotheirICDOcodes(SeeReportabilityinAppendixA).

(2)Standards for Multiple Primary Rules

Tocomparecancerratesfortworegistries,itisimportantthat

identicalruleshavebeenusedforcountingmultipletumorsinthe

patientwhetherinthesameorgan,oppositesidesofpairedorgans,

differentsubsites,ordifferentsites,andwhetheratthesameor

differenttimes. RulesfordeterminingmultipleprimariesinMECC

registriesareprovidedbyIARCandIACR(seetheMECCCoding

Manual)

(3)Standards for Diagnostic Confirmation

Toobtaincompleteincidencereportingandtohavetheregistrys

dataaccuratelyreflecttheburdenofcancerinthepopulationatrisk,


11/111

11

clinicallydiagnosedcasesaswellasmicroscopicallyconfirmedcases

MUSTbedesignatedasreportable. Microscopicallyconfirmedcases

includeallcaseswithpositivehistopathology,includingexaminations

ofbonemarrowandperipheralblood;andallcaseswithpositive

cytopathology,including

peritoneal

or

pleural

fluid,

fine

needle

aspirationsofcells,andbronchialwashes. Clinicallydiagnosedcases

includethosewithoutmicroscopicconfirmation(i.e.,thosewhose

diagnosesarebasedonlyondiagnosticimaging,laboratorytests,or

otherclinicalexaminations).

(4)Standards for Ambiguous Terminology

Diagnosesanddescriptionsofpatientsconditionsoftenare

describedinthemedicalrecordwithambiguoustermssuchas

possibleandruleout.Forcomparability,theregistryMUSTadopt

rulesforinterpretingambiguousterms.Theserulesaretobe

includedintheMECCCodingManual.

(5)Standards for Distribution

AcopyofthereportablelistandotherrulesSHOULDbeprovidedto

all

reporting

facilities

or

practitioners

required

to

report;

to

all

cancer

registrarsinthecoveragearea;toallmedicalrecordsorcancer

registrartrainingprograms.

B.PROCESSSTANDARDS1.ParticipationofAllHospitals

a)IntroductionParticipation

of

all

hospitals

in

the

reporting

area

that

may

diagnose

ortreatcancerisessentialtoensurecompletenessofreporting.


12/111

12

b) GeneralStandardsTheregistrySHOULDgainaccessto100percentofthehospitalsthat

maydiagnoseortreatpatientsresidinginthereportingareato

ensurecompleteness.

Letters

of

agreement

MAY

be

useful

for

both

thehospitalandtheregistry.TheselettersSHOULDspecifythe

responsibilitiesofthehospital,theresponsibilitiesoftheregistry,

andthetimeframeforreporting.

2.CaseAscertainmentinNon-hospitalSourcesa) Introduction

Cancerpatients

can

be

seen

for

diagnosis

or

treatment

in

outpatient

settings.Capturingthesecasesthroughanextendedreporting

systemisimportanttoensurethecompletenessofcancer

registration.CancerregistriesSHOULDexpandtheircoverageinto

nonhospitalsourcestofacilitatecompletereporting.

b) Standards

TheregistryMUSTdevelopmechanismstolocateandobtain

informationon

cases

diagnosed

or

treated

entirely

outside

of

hospitalsettings.Theusefulnessofspecificsourceswillvaryacross

geographicareasandovertime.However,experiencehasshown

thatataminimum,theregistrySHOULDobtaincasesfromthe

followingtypesoffacilities:

Histopathologyandhematologylaboratories.

Ambulatorysurgerycenters.

Radiationtherapyorchemotherapycenters.

Screeningprograms.

AlthoughcancercasesMAYbeidentifiedinpathology

laboratories,thelaboratoryrecordsoftencontaininsufficient

informationforpreparingacompleteabstract.Informationonthe


13/111

13

patientsresidenceand/orhealthinsurancenumber,forexample,

rarelyispresent.ThesecasesMUSTbefollowedbacktothetreating

physicianorfacilityforadditionalinformation(seealsoSectionI.B.3.)

ifneeded. Theexpansionofcaseascertainmentproceduresintoall

typesof

nonhospital

facilities

would

ensure

complete

reporting;

however,theregistrysabilitytodosoMAYbelimitedbyitsfinancial

resources. Therefore,theregistrySHOULDconsiderthefollowing

itemswhenevaluatingtheexpansionofcasefindingintonon

hospitalfacilitiessuchaschemotherapytreatmentfacilities,

coronersoffices,privateclinics,nursinghomes,andhospices:

Thecostofaccessingeachtypeoffacilitywilldependon:

Thereportinglawandwhichtypesoffacilitiesand

practitionersarerequiredtoreport.

Thequalityofthedataandthenumberofnewincidencecases

thatwouldbeobtainedfromeachtypeoffacility.

Theimpactonthefutureuseofthedataifadecisionismade

nottocollectdatafromaspecifictypeoffacility.

Theimpactoftheserequirementsoneachtypeoffacility.

3.ReportingbyPhysiciansa)Introduction

Becausenotallpersonsdiagnosedwithcancerarehospitalizedfor

diagnosisortreatment,amechanismforregisteringcasesfrom

physiciansofficesisnecessaryforcompletecaseascertainment.The

registryMAYrelyonreportingbyphysicians,orMAYhaveitsown

staffobtain

the

data

from

physicians

offices.

The

registry

generally

willrequirecaseinformationfromanindividualphysicianonlywhen

noreportisobtainedfromahospitalorotherreportingfacility.

However,theregistryalsomightneedtoobtaindemographicor

treatmentinformationoncasesreportedinitiallybyothersources.


14/111

14

b)StandardsTheregistrySHOULDperformthefollowing:

Followbacktophysiciansofficestoobtainreportsonotherwise

unreportedcases

identified

in

pathology

laboratories,

via

consult

onlyreportsfromhospitals,orfromdeathcertificates.

Developanappropriatemethodtoidentifycasesofandobtain

informationfromoncologists,hematologists,dermatologists,

dermatopathologists,andurologists,becausethesespecialtiesare

theonesmostlikelytodiagnosemalignanciesthatwillnotbe

identifiedthroughtheactivecasefindingmethodsusedathospitals

andlaboratories.

Developregistration

methods

for

physicians.

4.Out-of-areaCoverageandCaseSharinga)GeneralStandards

TheregistrySHOULDincludeallresidentsandnonresidents

diagnosedortreatedinitscoverageareatoallowforsharingofcases

withotherpopulationbasedregistries,facilitatedeathclearanceand

otherrecord

linkages,

and

allow

for

preparation

of

reports

to

individualfacilitiesthatincludealltheircases.

TheregistrySHOULDprovidecaseinformationonanonresidentto

thepopulationbasedregistrycoveringthepatientsplaceof

residencewhentherequiredcomponentslistedbelowareinplace.

b)RequiredComponentsThe

following

components

generally

will

be

required

for

the

performanceofcasesharingbetweenregistries:

CaseSharingAgreements:Thesearewrittenagreementsbetweenregistriescoveringtheusageandconfidentialityofexchangeddata.

TheseMAYbeinformalagreementssimplyrequestingdataand


15/111

15

affirmingtheconfidentialnatureofthedataortheymaybelonger,

moreformallegaldocuments,dependinguponthelawsgoverning

releaseofdata.

ExchangeMedia:DataMAYbeexchangedbetweenregistriesacrossavariety

of

media.

In

order

of

preference,

they

are:

electronic

files

ofdataondiskette,CDRom,ortape;electronicfilesofdata

transferredviaemail,orWebsite;copiesofpaperabstracts;or

printedreportsgeneratedfromcomputersystems.

5. InformingFacilitiesandPractitionersa)Introduction

Toencourage

compliance

with

cancer

reporting

requirements,

the

registrySHOULDnotifyfacilitiesandpractitionersthatarerequired

toreportoftheirobligations.

b)StandardsContentofNotices

ThenotificationSHOULDinclude:

Abriefdescriptionoftheregistryshistoryandpurpose

Adescriptionofandcopyofthecancerreportinglaw

Therationalefortheregistrysaccesstothesourcedata

Thedataitemstobecollected

Theproceduresforreporting

Allrelevantconsiderationsfordatahandlingandensuring

confidentiality.

OtherConsiderations:

Supportoftheregistryanditsreportingmethodsfrom

appropriategroupsMAYbesought.Examplesincludemedical

societies,specialtycollegesorboards,communitygroups.

Citingsuchsupportorendorsementsinthevarious


16/111

16

communicationstomedicalprofessionalsmayencourage

theircompliance.

AnnouncementsMAYbemadeviaprofessionalorganizations

orsocietiesregardingtheirmemberscancerreporting

responsibilities.Mechanisms

MAY

include

newsletters,

direct

mailings,journalarticles,andpresentationsatscheduled

meetings.

Inaddition,theexactdetailsofallexpectationsofandoptions

availabletothefacilitiesandpractitionersSHOULDbe

communicatedviatargetedcontacts.

Meansforaccomplishingthesestepsinclude:

Directmailingstoindividuals

Meetingswithgroups,suchasstaffoflargeclinicsorspecialty

laboratories

Presentationsatscheduledmeetings,suchashospitalstaff

meetingsorlocalmedicalsocietymeetings

Regionalpresentationsandorientationworkshopsorganized

bytheregistry.

Allrelevant

physicians

(e.g.,

pathologists,

medical

oncologists,

dermatologists,generalsurgeonsandsurgicalspecialists,and

radiationoncologists)

Allrelatedfacilitypersonnel(e.g.,hospitaladministrators,

healthinformationserviceadministrators,andcancerregistry

managers).

6.MonitoringUseofandChangesinFacilitiesandPractitioners

a)IntroductionRegistriesMUSTbeabletodocumentthattheycapturecasesfrom

theentirepopulationatriskfortheirarea.Todoso,theyMUSTbe

abletodocumentwhereresidentsoftheirpopulationreceivecancer


17/111

17

diagnosesandhowthosecancercasesareidentifiedbytheregistry.

RegistriesSHOULDmonitorchangesinthenumberandlocationof

facilitiesandpractitionersandwheretheirareaspatientsarebeing

diagnosedandtreated.Facilityopenings,closings,andmergersand

theestablishment

of

new

screening

programs

all

can

impact

workloadandproceduresfortheregistrybyinfluencingthenumber

ofcasesdiagnosedandthenumberandlocationofsourcesthe

registryneedstocover.

b)StandardsTheregistryMUSTbeawareoftheflowofcancerpatientsoutside

theregistrycoverageareasbordersfordiagnosisandtreatment;the

closingofhospitalsandclinicsandtheopeningofnewones,

includingscreeningandtreatmentcenters;mergersoffacilitiesthat

impacttheoperationofhospitalregistriesandthecentralregistry;

andshiftsinutilizationofscreening,diagnostic,ortreatment

facilitiesthatwouldimpactwherecasesarediagnosedandtreated.

TheregistryMAYobtaininformationfromgovernmentallicensing

agenciesandalsoSHOULDconductperiodicsurveysandreview

telephonedirectories,

local

newspapers,

professional

association

publications,andtheInternet.

7.ConfidentialityPoliciesandProcedures:IssuesinDataCollectionandManagement

a)IntroductionConfidentialitypoliciesandproceduresarerequiredinallphasesof

theregistry

operations

to:

Protect

the

privacy

of

the

individual

patientProtecttheprivacyofthefacilitiesreportingthecases

ProvidepublicassurancethatthedatawillnotbeabusedAbideby

anyconfidentialityprotectinglegislationoradministrativerulesthat

mayapply. Althoughthecancerreportingregulationsunderwhich

theregistryoperatesmaydefineonlypatientspecificdataas


18/111

18

confidential,registriesalsoSHOULDtreatanyinformationthat

specificallyidentifiesahealthcareprofessionaloraninstitutionas

confidential.Informationthatcharacterizesthecaseloadofaspecific

institutionorhealthcareprofessionalalsoSHOULDbeconsidered

proprietaryand

confidential.

TheRegistrysResponsibilities Itistheresponsibilityofeveryregistrytoprotectitsdatafrom

unauthorizedaccessandrelease.ThecancerregistryMUSTmaintain

thesamestandardsofconfidentialityascustomarilyapplytothe

doctorpatientrelationship;thisobligationextendsindefinitely,even

afterapatientsdeath. Ifdataaremaintainedbothonpaperandin

electronicformats,datasecuritypoliciesandproceduresMUST

addressbothtypesofdataformats.

b)Standards(1) Standards for Policies and Procedures for Data Security

Thefollowingcomponentsgenerallywillberequiredtoassuredata

security:

ThedirectoroftheregistryMUSTberesponsiblefordata

security.

SuitablelocksandalarmsystemsMUSTbeinstalledtocontrol

accesstotheregistry,andalistofpersonsauthorizedtoenter

theregistrySHOULDbemaintainedbythedirector.

RegistrystaffMUSTberesponsiblefortheconfidentialityofall

dataencounteredduringthecollectionofcancerdata.

ConfidentialdataMUSTNOTbetransmittedbyanymeans

(mail,telephone,fax,electronic)withouttheexplicitauthority


19/111

19

fromthedirectororastaffmembertowhomsuchauthority

hasbeendelegated.

RegistriesSHOULDconsidertheuseofregisteredmail,

overnightmail,

or

courier

services

for

confidential

data

and

SHOULDconsiderseparatingnamesfromotherdatafor

transmission.Whenusingmailservices,registriesSHOULD

considerusingdoubleenvelopes,withtheconfidential

informationinaseparateenvelopemarkedconfidential,

includingacontacttelephonenumber,andenclosedinthe

mailingenvelope.RegistriesSHOULDconsiderusingtearfree

envelopesmarkedconfidential.

PrecautionsMUSTbetakenforboththephysicaland

electronicsecurityofconfidentialdatasentviamagneticor

electronicmedia.

ComputeruseofconfidentialdataMUSTbecontrolledby

electronicand,ifpossible,physicalmeasurestoenhancethe

security

of

the

data,

including

the

use

of

a

separate

room,

use

ofpasswords,automaticloggingofallattemptstoenterthe

system,anddifferentlevelsofaccesstothedata.

TraininganddemonstrationsofthecomputersystemSHOULD

beperformedwithseparatefictitiousoranonymousdatasets.

ConsiderationMUSTbegiventoobtainingexpertadviceon

securityagainst

unauthorized

remote

electronic

access,

ifit

is

impossibletouseisolateddataprocessingsystems.

MeasuresMUSTbetakentoensurethephysicalsecurityof

confidentialdatastoredonpaper,microfilm,microfiche,etc.


20/111

20

ApolicyMUSTbedevelopedforthesafedisposalof

confidentialwaste.Ifaprivatedocumentdestructioncompany

isused,theregistryMUSThavedocumentedproceduresfor

disposalandthesecuritymeasuresusedforthecompanys

employees.Data

stored

on

laptops

or

other

portable

media

MUSTbeencrypted.

(2)Standards for Personnel Policies and Procedures

RegistryStaffMembers/Employees:

TheregistrystaffMUSTsign,aspartoftheiremployment

agreement,adeclarationthattheywillnotreleaseconfidential

informationto

unauthorized

persons.

This

declaration

SHOULD

remainineffectaftercessationofemployment.Thedirector

SHOULDmaintainalistofstaffmembersindicatingthenatureand

extentoftheiraccesstoregistrydata.

ThetrainingofallregistrystaffMUSTincludea

comprehensivesessionconcerningtheconfidentialityofdata.

FailuretoobservetheconfidentialitypoliciesMUSTresultin

firmdisciplinaryactionordismissal.SomecircumstancesMAY

warrantlegal

action

against

staff

members

who

fail

to

comply

with

theregistrysconfidentialitypolicies.Dependingonthejurisdiction,

therealsoMAYbecriminalpenaltiesforfailuretomaintainthe

requiredconfidentiality.

RegistrystaffSHOULDberemindedannuallyabout

confidentialitypolicies.

Non

registry

Staff:

Nonregistrystaff,especiallymedicalinvestigators,MAY

requestaccesstoconfidentialregistrydata.SuchrequestsMUSTbe

inwriting.Allnonregistrystaffwhorequestaccesstotheserecords

MUST,ataminimum,agreetoadheretothesameconfidentiality

safeguardspracticedbyregistrystaff.


21/111

21

RequestsMAYbeadequatelyaddressedwithoutthereleaseof

confidentialinformation.Wheneverpossible,itispreferableto

respondtorequestswithouttheuseofconfidentialinformation. The

registryisnotresponsiblefordisclosureofindividualclinical

informationto

unauthorized

requestors.

Individuals

requesting

personalinformationfromtheRegistrySHOULDbereferredtothe

diagnosisand/ortreatingfacility.

(3)Standards for Policies and Procedures for Release of Registry Data

Releaseofcancerregistrydataforclinicalpurposes,forresearch,and

forhealthcareplanningiscentraltotheutilityoftheregistry,and

theregistryMUSTdevelopproceduresfordatareleasethatensures

themaintenanceofconfidentiality.SeeSectionIII.A.1.foradetailed

discussionofconfidentialityissuesinresearch,reporting,andrelease

ofregistrydata. Forthepurposeofcompletecaseascertainment,

thecancerregistryMAYexchangeconfidentialdatawithother

registriesifreciprocalcasesharingagreementsthatinclude

confidentialityprovisionsareimplemented. ThecancerregistryMAY

permitthereleaseofconfidentialdatatotreatinghospitalsintheir

own

region

for

the

purpose

of

patient

follow

up.

It

is

recommended

thatplansbemadeforthepossiblecessationofregistryactivityto

maintainthesubsequentutilityofthedatabasewhilesafeguarding

theconfidentialityofitsdata.

8.DeathClearancea) Introduction

Death

clearance

is

an

essential

step

in

achieving

complete

populationbasedreporting.Itservesasacheckonthecompleteness

ofreportingfromothersourcesandoftenidentifiescasesthatshould

havebeenreportedfromthosesourcesbutwerenot.Italso

identifiespatientsknownonlytothephysician.Furthermore,cases

thatremainasdeathcertificateonly(DCO)casesafterfollowback


22/111

22

MUSTbeincludedasincidentcasesbytheregistry.Deathclearance

forthispurposemeansidentificationofalldeaths,withcancergiven

asacauseofdeath,thatarenotaccountedforintheregistrysfiles.

Deathclearanceforthepurposesofobtainingfollowuponcases

alreadyregistered

is

not

addressed

by

this

section.

b)Standards(1)Standards for Frequency and Timing

DeathclearanceforthepurposesofcaseidentificationSHOULDbe

performedwhenthedeathfilesarecompleteforthecalendaryear

beingcleared,andwithenoughtimeforfollowbacktobecompleted

andthe

results

incorporated

in

the

registrys

database

before

the

registrypublishescancerincidenceratesforthecalendaryear.

Timingmustcarefullybeplanned.Thegoalsaretolinkeverycancer

fromthetimeperiodagainsteverydeathfromthatperiod,avoiding

unnecessaryfollowbackbutdistributingthefollowbackworkload

acrossareasonabletime. Inpractice,deathclearanceusuallyis

performedmorethanonceforcasesinagiventimeperiod.The

deathfileforagivenyearmaynotbecompletedsoonenoughto

meetthe

registrys

needs,

either

because

of

coding

delays

at

the

vital

statisticsofficeorbecausenotalldeathsofastates/provinces

residentsoccurringinotherstateshavebeenincorporated

(states/provincesexchangedeathrecordsonresidentsofother

states/provincesviathetranscriptexchangeprogram).Theregistrys

filesalsomaybeincompleteatthetimeoftheinitiallinkage.Early

linkagesMAYbeperformedwithincompletedeathorregistryfiles.

AdditionallinkageorlinkagesthenMUSTbeperformedwhenthe

registryconsidersitscasefiletobecompleteandthedeathfileis

consideredcompletefortheyearbythevitalstatisticsoffice.


23/111

23

(2)Required Components

Thefollowingcomponentsgenerallywillberequiredforthe

performanceofdeathclearance:

Theregistry

SHOULD

establish

aformal

agreement

with

the

appropriatevitalstatisticsofficecoveringaccesstocomputer

recordsandpaperfiles,subsequentuseofdeathrecord

information,andcosts.

TheregistryMUSThavetheabilitytoperformrecordlinkage

betweenthedeathfilesandcancercasesandidentify

matches,nonmatches,andpotentialmatcheswithcancerasa

causeofdeath.

Theregistry

MUST

have

staff

adequate

in

number

and

trained

incasefindingandabstractingtoperformfollowback.Arough

estimateforstaffingisonefulltimeemployeeper10,000

annualcasesforaregistrythathasbeenperformingdeath

clearanceforseveralyears.Itisimportanttokeepinmindthat

thismayrepresentapercentageoftimeforseveraldifferent

staff.

TheregistrySHOULDhaveasystemfortrackingprogressand

resultsof

follow

back.

This

system

SHOULD

preferably

be

automated,butMAYbemanual.

(3)Other Standards

TheregistryalsoSHOULD:

Includeatumorlinkagecomparisoninitsdeathclearance(i.e.,

verifythat,forpatientsinboththeregistryfileandthedeath

file,thecancersareofthesameprimarysites),andifthereare

discrepancies,followbackasnecessarytodetermineifthe

patientshadadditionalreportablecancersthatshouldbe

registered.

Analyzetheresultsofdeathclearance,monitorthemregularly,

andusetheinformationasfeedbackinthequalitycontrol


24/111

24

cycletoimprovecasefindingandcompletenessofreporting

fromhospitalsandothersources.

9.TraininginCaseFindingandMultiplePrimaryDetermination

a)IntroductionToensurethatthepersonnelactuallyperformingcaseascertainment

andabstractingareawareofthereportingrulesandmethods,itis

importanttomaketrainingavailable.

b)StandardsBeforedatacollectionfortheregistrybegins,theregistrySHOULD

providetraininginthefollowingareastoallpersonnelwhowillbe

responsibleforcancercaseidentificationandabstracting:

Allcriteriaforcasereportability Rulesformultipleprimarydetermination.

TrainingSHOULDbeprovidedtoregistrystaffandtostaffin

hospitals,laboratories,

clinics,

physicians

offices,

and

all

other

facilitieswherethestaffmaybeidentifyingcasesfortheregistry.

TrainingMAYbeofferedviaappropriateprofessionalassociation

meetingsoratworkshopsscheduledbytheregistry.Professional

publicationsandcentralregistrynewsletterarticlesalsoMAYbe

usedtodealwithreportingproblems.

10.MonitoringCompletenessofReportingandEnsuringCompliance

by

All

Facilities

and

Practitioners

a) IntroductionMonitoringthecompletenessofcasefindingisarequired

componentofthecentralregistrysqualitycontrol.Evenwherethe

reportingfacilitiesareperformingthecasefinding,itultimatelyisthe


25/111

25

centralregistrysresponsibilitytoverifythatthefacilitiesare

reportingallappropriatecasesandtotakecorrectiveactionwhen

problemsarediscovered.

b)StandardsTheregistrySHOULDmonitortheprocessingofthecasefinding

sourcesonaregularbasis.Frequentmonitoringenablestheregistry

toquicklyidentifyproblemsandtakecorrectiveaction.Theregistry

SHOULDprepareandreviewvariousmanagementreportssuchas

thefollowingtomonitorthestatusofreporting:

Completenessofreportingforeachfacility,eachcounty,and

the

entire

coverage

area

Thestatusofscreeningofthecasefindingsources,suchas

eachtypeofpathologyreport(i.e.,surgicalspecimens,

cytologies,autopsies,bonemarrows,etc.),diseaseand

operationsindices,andradiationtreatmentlogsforeach

facility

Statusofdeathclearanceprocessing

Foreachapplicablefacilityandfortheentirecoveragearea,

countsof

cases

for

primary

sites

often

diagnosed

and/or

treatedinanoutpatientsettingtoidentifypotential

underreportingfromnonhospitalsources

Areportofthepercentofhistologicallyconfirmedcancersfor

eachreportingfacilitytoidentifypotentialunderreportingdue

tolackofscreeningnonpathologicalsources. Whenthe

numberofreportedcasesdeviateswidelyfromthenumber

expected,theregistrySHOULDundertaketodeterminethe

possiblereasons.

Cancer

reporting

may

be

late

or

incomplete,

orthenumbersmayaccuratelyreflectchangesinoccurrence

ordistributionofcancer.Ahospitalscensusmaybedown,

casesmayhaveshiftedtoanotherhospitalorclinic,or

expectedgrowthinpopulationmaynothaveoccurred. Ifthe


26/111

26

reportinglawprovidesforameansofenforcingthereporting

byfacilitiesandpractitioners,thecentralregistryMUST

undertakethenecessaryprocedurestoobtaincomplete

reportingandcompliancefromallfacilities.

11.CaseFindingAuditsa)IntroductionPurposeandDefinitions

AlthoughDCOpercentages,observedtoexpectedratios,and

incidenceto mortalityratioscanprovidesomeestimatesofthelevel

ofcompletenessofregistration,theyonlyreflecthowtheregistry

performsas

compared

to

an

average.

Cancer

incidence

and/or

the

diagnosticpracticesinaregistrysareamayormaynotbethesame

astheaverage.Theonlywaytodocumentthetruelevelof

completenessofascertainmentisthroughspecialstudies,oraudits,

toidentifyanddocumentdeficienciesintheascertainmentsystem.

Thedesignofanauditwilldependonthedefinitionofcancer,the

reportingpracticesoftheinstitutionsinthearea,thereporting

requirementsandpolicies,andtheascertainmentmethodsusedby

theregistry. CancerregistriesSHOULDperformanindependent

reviewofcasefindingsourcesinreportingfacilitiestodetermine

reportingcompleteness.

b)Standards(1)Standards for Frequency of Audits

AtleastoneaudittoassesscompletenessofascertainmentSHOULD

beperformed

per

year.


27/111

27

(2)Standards for Types of Audits

MorethanonetypeofauditSHOULDbeusedtoassess

completeness.ArotatingscheduleMAYbesetupforperforming

various

types

of

audits.

12.PatientFollow-upa)Introduction

Registriesintendingtoprovideendresults(survival)dataMUST

followallregisteredpatientsforlife(often,carcinomasinsituofthecervixuteriandbasalandsquamousskincancers,whentheyare

registered,

are

not

followed).

Methods

of

obtaining

follow

up

will

varyduetolocalconsiderations,suchasthenumberofcasesbeing

followedbyhospitalcancerprogramsandtheavailabilityof

databasesagainstwhichtheregistryfilescanbelinked.Thegoalisto

achievethehighestpossiblesuccessratesandavoidbiasesinthe

losttofollowupgroup(seeSectionI.C.6.foradiscussionof

measuringsuccessrates).Methodsgenerallyareclassifiedasactive

orpassive,withactivemeaningadirectcontactwiththepatient,the

patientsfamily,

or

the

patients

physician;

and

passive

referring

to

methodsthatdonotrequiresuchcontact.Centralregistriesusually

willneedtoemployacombinationofcomplementarymethodsto

achieveacceptablelevelsofsuccessandavoidbiasinthelostto

followupgroup.

b)StandardsThechoiceofmethodsorsourcesforobtainingpatientfollowup

SHOULDbe

driven

by:

Theavailabilityofthemethodorsourcetothecentralregistry.

Theeffectivenessofthemethodorsource.

Theprimarysourcesusuallyare:


28/111

28

HospitalRegistries:ThecentralregistrySHOULDobtainreportson

theresultsoftheiractivefollowupactivitiesfromhospitalregistries.

ThecentralregistrySHOULDestablishastandardizedelectronic

formatfor

the

submission

of

follow

up

records.

Follow

up

is

more

of

acollaborativeactivityifthecentralregistryalsoprovideshospital

registrieswiththeresultsofitsownfollowupactivities,especially

theresultsofdeathclearance.

DeathClearance:ThecentralregistrySHOULDclearitscasefiles

againstfilesofregistereddeathstoobtainvitalstatus,datesof

death,andcausesofdeath.

C.OUTCOMEMEASURES1.PercentDeath-Certificate-Only

a) IntroductionThepercentofcasesinaregistryfileforwhichthedeathcertificateis

theonlyreportingsourcetraditionallyhasbeenusedasameasureof

registrycompleteness.

In

long

standing

registries

with

very

complete

coverage,itisprobablymoreameasureofassiduousnessoffollow

back.Amoreusefulmeasuremightbetheproportionofcases

initiallyidentifiedthroughdeathcertificatesthatwouldotherwise

havebeenunreported,regardlessoftheireventualtypeofreporting

source,butthisisnotameasureforwhichthereisanyconsensuson

codesoranyhistoryofcollection.Registriescontinuetousepercent

deathcertificateonlybecauseitissimpleandidentifiesregistries

thatclearlyareincomplete,althoughitdoesnotdiscriminatewell

amongrelativelycompleteregistries.


29/111

29

b)StandardsIntheMECCregistriesDCOisanessentialfunction.Basedonthe

experienceoftheIARCProgram,arateof5percentorlessDCOis

acceptable.If

0percent

are

DCO,

death

clearance

has

not

been

performed,andifthepercentDCOisgreaterthan5,thereprobably

isunderreportingfromothersources,orfollowbackisincomplete,

orboth.

2.ObservedVersusExpectedCaseCountsa)Introduction

Incompleteascertainment

of

cancer

cases

can

result

in

artificially

low

incidenceratesandcanleadtoincorrectconclusionsaboutthe

cancerburdeninthepopulation.Thereareanumberofwayscancer

registrystaffcandeterminethelevelofdatacompletenessinthe

cancerregistry:calculatingthepercentageofcasesidentifiedby

deathcertificateonly;analyzingcollecteddatatobesuretheyfollow

knownpatterns(e.g.,incidence>mortality);and,mostimportantly,

conductingspecialstudiesoraudits.Additionally,thecomparisonof

theexpected

number

of

cancer

cases

for

agiven

population

with

the

observednumberofunduplicatedcasesreportedtotheregistryover

aspecifiedtimeperiodisveryusefulindeterminingwhether

standardsofcaseascertainmentarebeingmetandwhetherthedata

collectedbytheregistryarecompleteenoughforanalysis.

MethodologyforCalculatingObservedVersusExpectedCases

ManymethodsMAYbeusedtocalculateexpectednumbersofcases,

fromthe

simple

to

the

very

sophisticated.

It

is

preferable

that

estimatesbebasedonactualincidencedataforthepopulationat

risk,orifthosedataarenotavailable,onincidencedatafora

populationsimilarinracialcomposition.Useofmortalityratesisless

useful.Forthemostaccurateestimateofexpectednumbers,some


30/111

30

methodofadjustingfortimetrendsMAYbeincluded,althoughthis

addstothecomplexityofthecalculations. Onemethodthathas

beenusedistomultiplyage andsexspecificestimatesofthe

populationintheyearofinterestbythemostrecentlypublishedage

andsex

specific

incidence

rates

for

all

cancers

in

the

population

covered.Thismethodassumesthattheregistryhasratesfrom

previousyearsandthattheseratesareunbiased(basedoncomplete

andaccurateinformation).Ifthisisnotacorrectassumption,rates

fromanother,highqualityregistrycoveringapopulationwhose

demographicsaresimilartothoseintheregistrysarea,especiallyin

itsracialdistribution,MAYbeused.Age andsexspecificnumbers

thenaresummedtodeterminetheoverallexpectedvaluesforall

cancers.Allcalculationsandanalysesaddressedinthissectionandin

SectionI.C.3.assumethatduplicaterecordsforpersonsandtumors

havebeeneliminated,thateachcaseiscountedonlyonce,andthat

allpatientandtumorinformationhasbeenconsolidated.

b)Standards TheregistrySHOULDcompareobservedandexpectednumbersat

regularintervals

during

the

year.

Ifthesizeofthepopulationislargeenoughtoyieldstablenumbers,

expectedcasecountsSHOULDbecomparedtoobservedcountsby

countyand/orregionofthecoveragearea,byrace/ethnicityif

minoritiesmakeupanimportantpartofthepopulation,andby

cancersite.Sitescomprisingthegreaterproportionofcancers

reportedtotheregistrySHOULDincludebreast,colonandrectum,

lung,andprostate.

Theexpected

number

of

cases

SHOULD

be

evaluated

and

revised

annuallybasedonactualnumbersofcasesandotherconsiderations,

suchasknowntrendstowardincreasingordecreasingratesofcancer

ofspecificsitesorchangesinthepopulationduetoin or

outmigration.


31/111

31

Interpretationofobservedversusexpectedcountsrequiresa

thoroughknowledgeoftheunderlyingpopulation.ThereMAYbe

specificreasonsotherthanproblemsindatacollectionastowhy

observednumbersarehigherorlowerthanexpected.

Calculatingand

interpreting

observed

versus

expected

counts

SHOULDnotsupplantotherqualitycontrolactivities,particularly

casefindingaudits.

3. OtherAnalysesa)Introduction

Experiencehasshownthatcertainpatternsoccurincancerdata.

Nonconformancewith

one

or

more

of

these

patterns

may

indicate

incorrectdata.TheregistrySHOULDassignaqualifiedpersonto

evaluateayearsdataandusehisorherjudgmenttodetermine

whetherornotdatathatdeviatefromthesestandardsornormsare

accurate.

b)StandardsDataSHOULDbeanalyzedforthefollowingpatterns:

IncidenceratesandfrequenciesSHOULDbegreaterthanmortality

ratesandfrequencies.Ifmortalityexceedsincidenceforcancerof

anysite,thedataforthatsiteMUSTbeverified.

Lung,liver,andpancreasaretypicalsitesforDCOcases.Investigation

isrequirediftherearenoDCOcasesforthesesites.

Primarysiteofthecancerisunknownforabout5percentofall

cases.

Cancersof

the

male

breast

account

for

0.5

to

1percent

of

all

breast

cancers.


32/111

32

4.TimelinessofRegistryReportinga)Introduction

Timelyreportingofcancerinformationisanimportantgoalfora

registry.Epidemiology,cancercontrol,andclinicalusesbenefitfrom

speedyaccesstothemostcurrentinformation.However,

completenessandaccuracyofdataalsoareessentialgoals.Reports

basedonincompleteorinaccuratedatacanmisinformscientistsand

thepublicaboutthetruepictureofcancerintheregistrysarea. The

speedwithwhichregistrydatacanbecollected,processed,analyzed,

andreporteddependsonmanyfactors,someofwhicharewithinthe

registrys

control

and

others

of

which

are

not.

Efficient

data

collectionmethods,useofcomputersandtelecommunications,and

adequatenumbersofwelltrainedstaffallcaninfluencethe

timelinessofreportingofcasesfromhospitals,withinlimits.

However,italsoistruethatthediagnosticworkupandtreatment

canoccuroverseveralmonths.Oncecaseshavebeenreceivedby

theregistry,awidevarietyofactivitiestakeplace,asoutlinedin

SectionsII,III,andIVofthemanual.Alloftheseprocessingstepstake

time,and

some

of

them

notably

death

clearance,

sharing

of

cases

withotherregistries,andestablishmentofpopulationdenominators,

imposeexternaldelaysontheregistry.

b)StandardsCasesMUSTbeabstractedwithin6monthsofinitialdiagnosis.

Within12monthsofthecloseofthediagnosisyear,90percentof

expected,unduplicatedcasesSHOULDbeavailabletobecountedas

incidentcases

at

the

registry;

and,

within

24

months

of

the

close

of

thediagnosisyear,95percentofexpected,unduplicatedcases

SHOULDbeavailabletobecountedasincidentcasesattheregistry.


33/111

33

5.CaseFindingAuditResultsa)Introduction

Casefindingauditsarestudiesinvolvingindependentre

ascertainmentofcancercases,usuallyinasampleoffacilitiesand,

withineachfacility,asampleoftimeperiods.Casesidentifiedduring

theauditareenumeratedandmatchedagainsttheregistrysfiles.

Unmatchedcasesarefollowedbacktoverifytheirreportability,and

thepercentofcasesactuallymissedthatshouldhavebeenreported

iscalculated. Studiesaredesignedforavarietyofpurposesandwith

varyingdegreesofstatisticalrigor.Moststudiesfocusonhospital

reporting,

and

thus

provide

an

estimate

of

the

completeness

of

reportingforhospitalsonly,andnotatrueregistrycompleteness

estimate.Thefollowingsourcesareproblematictoreviewina

systematicway,andusuallyhavenotbeenincorporatedintoaudit

protocols:

Physiciansoffices

Clinicsandoutpatientfacilities,includingradiationtherapyand

surgerytreatmentcenters

Freestanding

pathology

laboratories

Welldesignedprotocolswithcarefulsamplingplansandformal

analysisplansareimportantwhencalculatinganestimateofthe

registryscompletenessthatwillbemadepublicorusedtoassess

registrycompleteness.Ifthegoalistoidentifypossible

ascertainmentproblemsinfacilitiesandtotakecorrectiveaction,

moreinformalmethodsMAYbeappropriate;however,thereare

otheradvantages

to

aformal

well

documented

protocol

and

written

findings.Itwillallowrepetitionofthestudyatalatertimeorin

anotherareaorgroupoffacilities,andfindingscanbecompared

overtimeandacrosssamplesifthesamestudydesignisusedand

resultsarewelldocumented.


34/111

34

b)StandardsStandardshavenotbeenestablishedforthedesignofcasefinding

studiesorthestatisticalanalysisoftheresults.However,itis

importantthat

such

studies

be

designed

by

astatistician

or

epidemiologistfamiliarwithcancerregistriesaswellassampling

methods.

6.Follow-upSuccessRatesa) Introduction

Thereareatleastsixdifferentformulaeusedtocalculatethepercent

successfulfollow

up.

They

vary

by

whether

deceased

individuals

are

includedinthenumeratorand/ordenominatorandwhetherthe

monthoffollowupisconsideredoronlytheyear.Anystandard

establishedMUSTspecifytheformulatobeused. Forthe

populationbasedregistryspurposeofcalculatingpatientsurvival

basedonaccumulatedfollowupdata,thepercentofcases

successfullyfollowedSHOULDbeashighaspossibleandthatthe

caseslosttofollowupbeanunbiasedgroup.

b)StandardsTherequirementisforasuccessrateofatleast90percent,

preferably95percentorgreater.Theformulaforcalculating

successfulfollowup,appliedseparatelytoinvasiveandinsitucancers,isasfollows: AssumethatYisthecalendaryearending19

monthspriortotheduedateforanAugustdatasubmission.The

percentofpatientsdiagnosedduringtheyearspriortoandwhohave

currentfollow

up

is

defined

as:

P=100(D+A)/T

WhereDisthenumberdead,Aisthenumberalivewithfollowup

datesonorafterJanuary1,Y+1,andTisthetotalnumberof

patientsbeingfollowed.Pcanbecalculatedforindividualyearsof


35/111

35

diagnosisupthroughY1andforallyearscombinedpriortoY.

Systematicannualfollowupofpatientsisanimportantcancer

registryfunction.Asuccessfulfollowuprateof90percentis

requiredtouseregistrydataforsurvival(outcome)analysis.The

requiredrate

for

follow

up

is

calculated

separately

and

is

set

at

80

percent.Casesaredelinquent(lost)ifthefollowupintervalexceeds

15months. TheregistrySHOULDapplythecalculationstosubgroups

ofpatientstoevaluateforbias.Forexample,calculationoffollowup

ratesbysexforthreeagegroups,thoseunder15,15to64,and

those65andover,MAYshowthat,althoughtheoverallrateisvery

high,theregistryisnotsuccessfullyfollowingitspediatriccancers,

especiallyamongfemales.Ananalysisbyethnicgrouporgeographic

areamightidentifyothergroupsthathavepoorfollowup.

II. DATAQUALITYA.STRUCTURALREQUIREMENTS

1.DataQuality:GeneralRequirementsa)Introduction

Allaspectsoftheregistrysoperationsimpactdataquality,including

thelawsandregulationsunderwhichtheregistryoperates,relations

withhospitalsandphysiciansintheregistryscoveragearea,howthe

datacollectionsystemisdesigned,staffqualificationsandtraining,

reviewofdataforanalysisandreporting,andthecapabilitiesofthe

computersystem.Thefunctionusuallytermedqualitycontrolis

limitedto

those

personnel

and

activities

that

are

directly

focused

on

assessmentofanimprovementofqualityofthedata,butthequality

controlactivitycannotfunctiononitsown.


36/111

36

b)StandardsTheregistryMUSThaveanoverallprogramofqualityassuranceinto

whichthespecificactivitiesfit.QualitycontrolactivitiesMUSTbe

partof

aplanned

whole,

and

not

just

aseries

of

unrelated,

sporadic

activities.ThequalityassuranceprogramSHOULDbeformally

defined,includingtheassignmentofaspecificresponsibleindividual,

thescheduleforroutineeditsandreports,andstepstobetaken

whenprespecifiedconditionsarenotmet.TheregistrySHOULD

carefullydocumenteachoftheseactivities,aswellasprocedural

changesandanynonroutinedatasetevaluationsundertaken. The

registrysbudgetSHOULDprovidespecifiedandadequatefunding

forquality

control

staff

and

activities.

The

registry

SHOULD

prepare

writtenrulesforidentifyingwhenactionorfurtherinvestigationis

neededbasedonresultsofqualitycontrolactivities,andSHOULD

havepredeterminedprocedurestofollowunderthoseconditions.

2.StaffingGuidelinesforDataQualitya)Introduction

Adequateregistrystaffingrequiresboththeskillsandtheavailable

personneltoconductregistrybusinessinatimely,competent

manner.Staffcompetenciesnecessaryforqualitycontrolinaregistry

includecontentknowledge,analyticknowledge,trainingknowledge,

andorganizationalskills.Thenumbersofpersonsrequiredwill

dependonthesizeofthegeographicarea,thecaseloadofthe

registry,thenumberanddetailofitemscollected,themethodof

datacollection,

and

registry

staff

organization.

b)StandardsThefollowingskillsMUSTberepresentedonacentralregistrystaff

foradequatequalitycontrolactivities:TumorRegistrar(TR):Oneor


37/111

37

moreTRsSHOULDbedirectlyinvolvedinmonitoringabstractreview,

trainingthepersonswhoabstractoreditdata(bothregistry

employeesandstaffatreportingfacilities),andconductingquality

controlactivities.Inparticular,TRscancontributeexpertisewith

respectto

diagnostic

and

treatment

data,

case

finding,

and

follow

up.StatisticalAnalyst:Bothsystematicanalysisandspecificdesigned

studiesMUSTbedesignedandevaluatedwiththeactive

participationofanindividualwhoisknowledgeableinstatistical

methodologyandanalysis,especiallyfordeterminingappropriate

samples,appropriatestatisticalmeasures,andcriteriafortaking

remedialaction.ThepersonMUSTbefamiliarwithbiostatistical,

qualitycontrol,andsamplingtechniques. AbstractorsandCoders:If

theregistryemploysabstractorsorcodersintheoffice(for

abstractingorroutineediting)orinthefield,theyMUSTbefamiliar

withallitemdefinitionsandcodinginstructionsusedbythecentral

registry,andwelltrainedinabstractingcancerdatafrompatient

records. QualityControl:OnepersononthestaffSHOULDbe

identifiedasresponsibleformaintainingoverallqualitycontrolfor

theregistry.Oftenthiswillbethepersoninchargeoftrainingboth

registrystaff

and

staff

at

contributing

facilities.

This

is

the

person

primarilyresponsibleforinterpretingtheresultsofqualitycontrol

auditing. ComputerExpertise:TheregistryMUSThave

knowledgeablecomputerstaffavailabletobeinvolvedinthedesign

andimplementationofeditsandcarryingoutstudies.

3.ProcedureManuals,CodingManuals,andOtherDocumentation

a)IntroductionPermanent,current,widelydistributedwrittendocumentationofall

aspectsoftheregistrysdefinitionsandmethodsisessentialto

establishstandardization,maintaincontinuityofmeaning,document

changesovertime,developtraining,andinformdatausers.The


38/111

38

documentationusuallyisintheformofproceduremanuals,coding

manuals,andothermanuals.

b)StandardsAdequatestaffandtimeMUSTbeprovidedtoprepareandmaintain

highquality,uptodatedocumentationormanuals. Theregistry

MUSTformallydocumentitsdatasetdefinitions,codes,codingrule

interpretations,procedures,anddecisionsorrecommendationsofits

medicaladvisors.TheregistryMUSThaveamechanismforupdating

thedocumentationandkeepingitcurrent.TheregistryMUST

incorporatestandardmanuals,suchasMECCmanualswhenever

appropriatetoensurecomparability. DocumentationMUSTbe

providedtoallregistryemployeesinvolvedindatacollection,data

management,anddataanalysis,andalsotoemployeesofhospitals

andfacilitiesthatarereportingdatatotheregistry.Appropriate

portionsofthedocumentationSHOULDbeprovidedtoinvestigators

andusersofthedatatoexplaindefinitionsandmethods.

Traditionally,documentationhasbeenintheformofprinted

manuals,includingdatadictionaries,codingmanuals,andprocedure

manuals.Online

electronic

documentation

is

becoming

increasingly

important.TheregistrysdocumentationMAYbeinprintedform,

online,orinacombinationofmedia.

4.EditsandDataProcessingCapabilitiesforDataQualitya)IntroductionandDefinitions

Softwareengineeringidentifiesrepetitivemanualprocessesthatmay

bebetter

performed

by

acomputer

program.

Over

the

years,

cancer

registrysoftwarehasbeendevelopedtoaddressanincreasing

numberofregistrytasks,enablingstafftofocusontasksthatrequire

humanjudgment,analysis,orinteraction,andinmostcasesbringing

increasedqualitytothedata.Thispatternmaybeexpectedto

continueforsometime.Centralregistrycomputersoftwaresystems


39/111

39

MUSTnotonlyprovidearepositoryfordataandthetoolsto

generateincidencereports,researchdata,orotherregistryend

products,butalsoareamajorfocalpointforqualitycontrol

processes.Afundamentalrequirementofregistrysoftwareisthat

thesystem

maintains

data

integrity,

through

careful

and

effective

datamanagementandadequatesystemsecurity.Thesefunctionsare

coveredinthismanual,titledDataManagement.Thepresentsection

coversaspectsofthecomputersystemthataredirectlyrelatedto

qualitycontrolactivitiesoftheregistry.Routinequalitycontrol

functionsthatSHOULDbebuiltintoregistrycomputersystems

include:

Edits:Dataeditsarelogicalrules,typicallyembodiedinacomputer

algorithm,thatevaluatetotrue,false,ormaybe,forany

value(s)ofdataitem(s).Inthecancerregistry,editsareappliedtoall

recordstocheckforitemvalidity,internalconsistency,andinter

recordconsistency.Dataeditsmayinvolveasinglefield,multiple

fieldsinasinglerecord,multiplefieldsindifferentrecordswithinone

database,ormultiplefieldsinmultipledatabases.

ProcessControls:Wheninformationfromeditproceduresis

retained,it

SHOULD

be

analyzed

on

aregular

basis

to

identify

trouble

spots,forexample,withdatasources,coders,itemcodestructure,or

clarityofinstructionsinthemanuals.ThecomputersystemSHOULD

containflagssettoreflectthenatureanddispositionofeditfailures

andanalyticroutinesforevaluatingtheircontents.Thedataare

summarizedacrosstimeforindividualdatasourcesoritemcodes.

ItemsSHOULDincludedateseachcasewasaccessionedintothe

registryandlaterupdatedtoevaluatedelaysbetweencasereporting

andaccession.

CapabilitiesforAuditsandDesignedStudies:ThesystemSHOULD

supporttheconductofauditsanddesignedstudiesbyfacilitatingthe

drawingofappropriatesamples,efficientdataentryforcasesinthe

field,automatedcomparisonsoforiginalandreabstractedor

recodeddata,andanalysisofresults.


40/111

40

StandardizedEditsAsubtlebutimportantprincipleisthatdatathat

areediteddifferentlywillbestatisticallydifferent,andnon

comparable.Toachievecomparabledata,editsneedtobestandard

acrossallregistriesforthefollowingreasons:

Theutility

of

any

local

data

collection

effort

is

substantially

compromisedwhenthecategorizationofdatacollectedisnot

statisticallycomparabletoothercollections.

Astandardeditservesasreminderandenforcerofstandards;

however,whenaneditisnonstandard,itenforcesnoncomparable

data.

Additionalsubsequenteditsgenerallycannotremedytheeffectof

earlier,suboptimaledits.

b)Standards(1)Required Components

Thefollowingcomponentsgenerallywillberequiredforautomated

qualitycontrolprocedures:

ComputerEdits

Theregistry

MUST

have

asystem

of

computerized

data

edits

with

the

followingcharacteristics:

Usesstandardprogramcodeoralgorithmwhereverpossible

Performssinglefield,multifield,multirecord,andmulti

databaseeditsasappropriate

Isflexibleenoughtoallowforchanges

Producesreportsanderrormessagesthataremeaningfulto

those

correcting

errors

and

to

everyone

interpreting

the

data

Isthoroughlydocumentedastologicandperformance,with

documentationandalltablesusedintheeditsavailableand

understandabletothosecorrectingerrorsandeveryoneusing

thedata


41/111

41

ProvidesforeditoutputthatMAYbepassedbacktoindividual

facilitiesforresolutionifnecessary.

ProcessControls:TheregistrySHOULDprovidethecapacityfor

processcontrols.

The

data

items

necessary

to

identify

and

store

qualitymeasuresandtheanalyticroutinesforsystematically

evaluatingthemSHOULDbebuiltintothecomputersystem.These

include:

Amethodofsummarizingeditoutcomessystematically.

Routineevaluationofeditoutcomes,preferablypresentedincontrol

chartsorothereasilyinterpretableformssuchasgraphs.

DesignedStudies/Audits:TheregistrysystemSHOULDallowdrawing

ofsamplesforqualitycontrolstudiesbyanydesiredcharacteristic.

Staff:TheregistryMUSThavesufficientstafftrainedinabstracting

andcodingtotrackandcorrecteditfailures.

(2)Standards for Data Entry, Data Definition, Data Representation, Datasets,

and Record Layout

StandardizationofDataEntry:Standardizationofoutputisfacilitated

bystandardizationofasmanyaspectsaspossibleoftheintervening

stepsincollectingandprocessingthedata.

Standardizationofthefollowingaspectsofregistrysoftware

applicationsmayimprovedatacomparability:

Prompts

Codingchoicelists

Onlinehelp

Edits:

single

field,

multi

field,

multi

record,

or

multi

database

Errormessages. Althoughconvenient,autocodingcanbea

dangerousfeature,especiallyforvariablessuchashistologywhere

modifierstoarootwordchangesthecode. Registrieswillvaryinthe

extenttowhichtheyhavecontrolovertheseaspects,becausesome

registrieswillobtaindatacollectedbyhospitalsusingavarietyof


42/111

42

softwareapplications.However,registriesSHOULDencourage

mechanismsfordefinitionandpromulgationofadditionalstandards.

StandardizationofCodeDefinitions:Historicalcontinuityofthe

definitionof

data

categories

is

required

for

trend

analysis.

Representationofmeaningmaybeallowedtochangeovertime,

providedthattranslationtablesarepreserved.Whencertain

categoriesmustbediscontinued,continuityofmeaningmaybe

preservedinsomecasesbyanoverlapincollectionofthenewand

theoldcategories.Whenadditionaldetailisdesired,ensurethat

collapseintostandardcategoriesisfeasible.Inchoosingadataset,it

isessentialtoidentifythepurposetobeservedandthentochoose

appropriatesubsetsofitems.Examplesofspecificpurposesinclude:

Patientcareevaluation

Descriptiveepidemiologyandsurveillance

Cancercontrol

Research.

Codingofdataanddatatranslations

Itemsequenceandrecordlayout

Electronic

media

specifications.

StandardizationofDataExchangeFormat:Standardizationofthe

electronicformatfordataexchangeimprovesthequalityofmerged

files.

(3)Standards for Frequency and Timing of Data Edits

EditsSHOULDbeasphysicallyclosetotheinformationsourceas

possibleto

allow

immediate

verification/review

upon

edit

failure.

EditsSHOULDbeastemporallyclosetotheeventaspossible,to

improvesuccessofobtainingaccurateclarification,andminimize

permanentinformationloss.Thisalsoincreasesthevalueofthedata.

Item,internalconsistency,andinterreporteditsSHOULDbeapplied

routinelyasorbeforenewrecordsareaddedtothedatabase,with


43/111

43

seriouseditfailuresbeingwithheldfromincorporationintothe

analyticdatabaseuntiltheyareresolved. Analysisofeditfailures

SHOULDbeperformedcontinuouslywithspecialattentiontoresults

fornewstaff,newhospitals,newvendors,newproceduresorother

datacollection

conditions

that

are

not

stabilized.

(4)Standards for Record Consolidation

Recordconsolidationisanimportantfunctionofcancerregistries.It

ensuresthatallsubmittedcancercasesarecountedonlyonce.When

recordsarenotconsolidated,overcountsofcancerincidenceoccur.

B.PROCESSSTANDARDS1.TrainingforImprovedDataQuality

a)IntroductionTrainingisanessentialcomponentforapopulationbasedregistryto

assurethatthedatacollectedareaccurate,consistent,and

complete.

b)Standards(1)Required Components

TrainingMUSTbeprovidedtoemployeesofthecentralregistrywho

areinvolvedindatacollectionandqualitycontrolandtothe

employeesofhospitalsandotherfacilitiesthatarereportingdatato

theregistry.Trainingactivitiesinthefollowingareasare

recommended:Reporting

Requirements:

Instruction

on

reporting

requirementsincludingfrequencyofreporting,mechanismof

reporting,andrequireddataitems.DocumentationMUSTbe

providedthatdefinesthereportingrequirements. DataCollection:

Instructiononreportableneoplasms,casefindingprocedures,

abstractingrequirements,ICDOcoding,staging,and,where


44/111

44

appropriate,treatmentcodingMUSTbeprovided.Theinstruction

MUSTbebasedonthestandardizedreferencemanualsthatthe

registryofficiallyadopts. QualityControl:Instructioninvisualand

computereditsandfeedbackregardingeditresultsSHOULDbe

providedto

the

data

collection

staff

and

other

staff

from

reporting

facilities. DataProcessing:Instructionregardingtheuseofcomputer

softwareSHOULDbeprovidedifcomputerizedreportingis

mandatory.

(2)Standards for Training Methods

AvarietyofmethodsMAYbeutilized,including:

FormalPrograms:Theseincludeintroductorytrainingclasses,

workshops,educationalprogramsandsymposia,plusregularly

scheduledinservicetraining.

Audits:Identifyareasthatneedadditionaltrainingthroughthe

useofaudits.

Feedback:Providetimelyfeedbacktodatacollectorsonthe

typesandpatternsoferrorsidentifiedduringqualitycontrol

activities.

2.QualityControlActivitiesa)Introduction

Whileitisappropriateandnecessarytodesignaqualitycontrol

programtofittheneedsofaparticularcancerregistryanditsusers

totheextentthatregistriesadheretothevariousstandards

addressedinthisdocument,certainqualitycontrolactivitieswillbe

universallyapplicable.Theseactivitiescanbedividedintothree

classes:inspectionoracceptancesampling,processcontrol,and

designedstudies.Inspectionoracceptancesamplingencompasses

anyformofregular,ongoingreviewtodeterminewhetherindividual

caseabstractsorbatchesofcaseabstractsmeetminimumstandards


45/111

45

ofacceptability.Processcontrolscompriseallformsofmonitoring

theoutcomeofinspectiontodetectshiftsfromtheincontroltoan

outofcontrolstate.Designedstudiesareplannedstudiesand

generallyareundertakentoaddressaparticularproblem,toexamine

thefeasibility

of

change,

or

to

independently

quantify

acomplex

registrycharacteristic. Thethreeclassesofactivityarerelated

hierarchically,withinspectionbeingthesimplestformofquality

control,andthemostappropriateforveryyoungregistries.Process

controlscanonlybeeffectivelyimplementedafterthereporting

processhasstabilizedanditisreasonablyclearthattheregistry

systemisincontrol.Similarly,designedstudieswillnotprovide

reliableresultsuntilastablereportingsystemisinplace.

Definitions

QualityAssuranceSampling:Inspectionistheprocessofmeasuring,

examining,orotherwisecomparingtheunitwiththeapplicable

requirements.Inspectionsbecomequalityassurancesamplingif

failuretomeettherequirementsleadstorejectionoftheunit.There

areseveral

forms

of

quality

assurance

sampling

of

varying

practical

importanceincancerregistries:

Automatededitchecks:highimportance

Visualreviewoftextandcodes:highimportance

Duplicatecoding:minimalimportance

Duplicateabstracting:minimalimportance. ProcessControl:

Statisticalprocesscontrolinvolvestheprospectivemonitoringof

rationallyaggregated

results

of

inspection.

Process

controls

can

involvebothoutcomesofacceptancesamplingwhereerrorsincase

abstracts(orbatches)aredetected(e.g.,editrejectionrates)aswell

asotheraspectsofregistrydataandoperationthatdonot

necessarilyrepresenterrors,butthatshouldexhibitstabilityover

timeoracrossregions(e.g.,percentunknownprimaries).Process


46/111

46

controldesignrequiresstatisticalexpertise,includingspecificationof

anappropriateprobabilitymodel,selectionofasamplingplanand

rationalsubgroups,selectionofappropriatecontrolcharting

procedures,andspecificationofcontrollimits.

DesignedStudies:Twotypesofdesignedstudiesareappropriatefor

cancerregistries:optimization/feasibilitystudiesandestimation

studies.First,thefeasibilityorutilityofsubstantivechangesto

registrydesignandoperation(e.g.,newforms,dataitems,sourcesof

reporting,etc.)SHOULDformallybeevaluated.Second,thekey

registryqualityattributesofcompleteness(seealsoSectionI)and

accuracySHOULDperiodicallybeevaluatedbyaformallydesigned

study.Ifthesestudiescanbestandardizedandareexecutedona

routinebasis,theybecomeaformofacceptancesamplingandthe

resultsSHOULDbemonitoredbyappropriatelydesignedprocess

controls.

ReabstractingAudits:Reabstractingauditsdescribestheprocessof

independentlyreabstractingcancercasesfromthesourcepatient

records,coding

the

data,

and

comparing

the

abstracted

and

coded

datatothedataalreadyintheregistry.Thistypeofstudyhistorically

hasbeenusedincancerregistries,andthemethodsarewell

developed.

RecodingAudits:Recodingauditsinvolveindependentlyreassigning

codestoabstractedtextinformationbutnotreviewingthesource

documents.Thistypeofstudyisdonefrequently,andisveryuseful

intraining

new

coders.

It

is

easier

and

less

expensive

to

perform

than

reabstracting,butthemethodcannotdetectproblemswith

abstracting.


47/111

47

b)Standards(1)Standards for Acceptance Sampling

GeneralConsiderations:Notallformsofacceptancesamplingwillbe

applicableto

all

registries.

For

example,

duplicate

data

entry

would

notbeappropriateforregistriesreceivingdataelectronically.

Regardlessofwhichmethodsareused,theprocedures,sampling

plan,andintensitySHOULDbedocumented,andtheresultsof

inspectionSHOULDberetrievable,eithermanuallyorpreferably

fromanautomatedtrackingsystem.TherealsoSHOULDbeasystem

tomonitorprogressinresolvingerrors.Unacceptablereports

SHOULDbecorrectedandreinspected.Ifinspectionisonasampling

basis,documentationSHOULDincludedetailsofthesamplingplan

andspecificationsforbatchrejection.

AutomatedEditChecks

Application:Allregistries.

Sampling:SHOULDbe100percent.

Comment:RegistriesSHOULDattempttoimplementallapplicable

standardedit

checks

and

to

develop

additional

edit

checks

to

address

dataitemsanddatastructuresuniquetotheregistry.ErrorsSHOULD

bedocumentedandcorrected.

Sampling:SHOULDbeappliedbroadlyinyoungregistriesand

selectivelyinwellestablishedregistries.

Comment:ErrorsSHOULDbedocumentedandMUSTbecorrected.

Ifreviewisdoneonasamplingbasis,thenreportsSHOULDbe

batchedorstratifiedrationally,withentirebatchesbeingrejected.

Someforms

of

errors

MAY

only

be

identified

through

visual

review

(or,reviewoftheoriginalmedicalrecords).Forexample,systematic

misapplicationofcodingrulesmayonlybedetectablethrough

comparisonofcodesandtext.


48/111

48

Application:Registriesperformingdataentry,especiallythose

usingkeytodiskratherthaninteractivescreenorienteddataentry

(thelattermaynotlenditselftocosteffectiveduplicatedataentry).

Sampling:Ifused,either100percentorasufficientlylarge

sample/batchto

allow

detection

of

error

rates

in

excess

of

1to

2

percent.


Ifduplicateentryisdoneonasamplingbasis,thenrecordsSHOULD

bebatchedorstratifiedrationally,withentirebatchesbeingrejected.

Application:Registriesreceivingbackupdocumentationof

submittedcodes(e.g.,computerizedtext,paperabstracts,or

pathologyreports).

Sampling:SHOULDbeappliedselectively,ifatall.

Comment:ErrorsSHOULDbedocumented,categorizedasto

keyingorcodingerrors,andMUSTbecorrected.Ifdoneona

samplingbasis,recordsSHOULDbebatchedorstratifiedrationally,

withentirebatchesbeingrejected(routineduplicatecodingis

differentfromspecialstudiesorrecodingaudits).

Application:Registriesreceivingabstractsandhavingadequate

accessto

source

documents.

Sampling:AsanacceptancesamplingtechniqueSHOULDbe

appliedselectively,ifatall(butseeStandard(3)below).


Ifdoneonasamplingbasis,thenrecordsSHOULDbebatchedand

stratifiedrationally,withentirebatchesbeingrejected(routine

duplicateabstractingisdifferentfromspecialstudiesorre

abstractingaudits).

VisualReview

of

Text

and

Codes

Application:

Registries

receiving

backupdocumentationofsubmittedcodes(e.g.,computerizedtext,

paperabstracts,orpathologyreports).DuplicateDataEntry

DuplicateCodingDuplicateAbstracting


49/111

49

(2)Standards for Process Controls

Processcontrolsrepresentanadditionallevelofsophistication,in

whichtheaggregatedresultsofinspectionaretracked,usuallyover

time,

and

used

to

determine

objectively

whether

a

process

is

in

controlornot.Designofstatisticalprocesscontrolsrequirethe

specificationofasamplingplan,selectionofrationalsubgroups,

computationofcontrollimits,selectionofachartingstrategy(if

controlchartswillbeused),andspecificationoffrequencyof

updates.TheseissuesaswellasactionstobetakenSHOULDbefully

documented.Measuresofcancerregistryqualitythatshouldbenefit

fromformaldevelopmentofprocesscontrolsinclude,butarenot

limitedto,

the

following:

Visualreviewrejectionrates

Duplicateentry/coding/abstractrejectionrates

Editcheckfailureratesoveralland/orfailureonthemost

importantdataitems

Missingdataanduseofunknownorilldefinedcodesfordataitems

consideredcriticaltoanalysisbytheregistry

Numbersofcasesreported

Lagtime

in

reporting

Percentdeathcertificateonly

Reabstractingagreementrates.Automatedsupportforprocess

controlsisstronglyrecommended.Forexample,thecomputercan

assistintheacquisition,managementandchartingofprocesscontrol

dataandthesefunctionscanbebuiltintoregistrysoftwaresystems.

(3)Standards for Designed Studies

Cancerregistries

SHOULDperiodicallyplanandexecutecasefinding

auditstoassessoverallcompletenessofreportingandreabstracting

auditsorrecodingauditstoassessoveralldatareliability.Re

abstractingandrecodingstudieshavealonghistoryincancer

registries.Themethodologiesarewelldefined,andcomparisondata


50/111

50

maybeavailable.AdditionalstudiesMAYbeundertakentoaddress

specificcancers,problemareas,orfeasibilityofproposedchanges.

AlldesignedstudiesSHOULDbeplannedandexecutedaccordingtoa

formal,writtenprotocol.Ataminimum,theprotocolSHOULD

addressthe

following:

Introductionandrationale

Statementofpurpose

Samplingplan,includingsamplesizeconsiderations,stratifications,

andrandomization

Eligibilitycriteriaandstudypopulation

Procedurestobefollowedforstudyexecution

Analysisplan,includingdatamanagement,statisticalanalysisand

summarystatisticstobecomputed.CompletedstudiesSHOULDbe

analyzedandtheresultscommunicatedtomanagement,data

suppliers,anddatausers.

3.DisseminationofQuality-Control-ActivityResultsa)Introduction

Identifyingandcorrectingdataerrorsisreq

Documents

MECC Standard Operating Procedures Final Nov 08