Measuring Compliance Program Effectiveness: A Resource Guide ISSUE DATE: MARCH 27, 2017 HCCA-OIG Compliance Effectiveness Roundtable Roundtable Meeting: January 17, 2017 | Washington, DC MeasuringComplianceProgramEffectiveness–AResourceGuide HCCA-OIGComplianceEffectivenessRoundtable RoundtableMeeting:January17,2017 WashingtonDC Introduction OnJanuary17,2017,agroupofcomplianceprofessionalsandstafffromtheDepartmentofHealthandHumanServices,OfficeofInspector General(OIG)mettodiscusswaystomeasuretheeffectivenessofcomplianceprograms.Theintentofthisexercisewastoprovidealarge numberofideasformeasuringthevariouselementsofacomplianceprogram.Measuringcomplianceprogrameffectivenessisrecommended byseveralauthorities,includingtheUnitedStatesSentencingCommission(see,Chapter8oftheUnitedStatesSentencingGuidelines).Thislist willprovidemeasurementoptionstoawiderangeoforganizationswithdiversesize,operationalcomplexity,industrysectors,resources,and complianceprograms. DuringthemeetingonJanuary17,theparticipantsbrokeinto4groupsof10attendeestodiscuss2elementsofacomplianceprogramatatime. Duringfoursessions,everyparticipanthadachancetosuggestideasabout“whattomeasure”and“howtomeasure”withrespecttoallseven elementsofacomplianceprogram.Weusedthefollowingcategories,fromtheHealthCareComplianceAssociation’sCHCCandidateHandbook: DetailedContentOutline,asaguidetoensurethatallelementsofacomplianceprogramwerecovered: ComplianceProgramElements: 1. Standards,Policies,andProcedures 2. ComplianceProgramAdministration 3. ScreeningandEvaluationofEmployees,Physicians,VendorsandotherAgents 4. Communication,Education,andTrainingonComplianceIssues 5. Monitoring,Auditing,andInternalReportingSystems 6. DisciplineforNon-Compliance 7. InvestigationsandRemedialMeasures Wehavelistedbelowmanyindividualcomplianceprogrammetrics.Thepurposeofthislististogivehealthcareorganizationsasmanyideasas possible,bebroadenoughtohelpanytypeoforganization,andlettheorganizationchoosewhichonesbestsuititsneeds.Thisisnota “checklist”tobeappliedwholesaletoassessacomplianceprogram.Anorganizationmaychoosetouseonlyasmallnumberoftheseinany givenyear.Usingthemallorevenalargenumberoftheseisimpracticalandnotrecommended.Theutilityofanysuggestedmeasurelistedin 1 thisreportwillbedependentontheorganization’sindividualneeds.Someofthesesuggestionsmightbeusedfrequentlyandothersonly occasionally.Thefrequencyofuseofanymeasurementshouldbebasedontheorganization’sriskareas,size,resources,industrysegment,etc. Eachorganization’scomplianceprogramandeffectivenessmeasurementprocesswillbedifferent.Somemaynotapplytotheorganization’s environmentatallandmaynotbeused. Anyattempttousethisasastandardoracertificationisdiscouragedbythosewhoworkedonthisproject;onesizetrulydoesnotfitall. Element1:Standards,Policies,andProcedures A.Conductperiodicreviewsofpolicies,procedures,andcontrols. B.Consultwithlegalresources. C.Verifythatappropriatecodingpoliciesandproceduresexist. D.Verifythatappropriateoverpaymentpoliciesandproceduresexist. E.Integratemission,vision,values,andethicalprincipleswithcodeofconduct F.Maintaincomplianceplanandprogram. G.Assurethatanonretribution/nonretaliationpolicyexists. H.Maintainpoliciesandproceduresforinternalandexternalcomplianceaudits. I.Verifymaintenanceofarecordretentionpolicy. J.Maintainacodeofconduct. K.Verifymaintenanceof: 1.Aconflictofinterestpolicy 2.Appropriateconfidentialitypolicies 3.Appropriateprivacypolicies 4.Policiesandprocedurestoaddressregulatoryrequirements(e.g.,theEmergencyMedicalTreatmentandLaborAct(EMTALA),ClinicalLaboratory ImprovementAmendments(CLIA),Anti-Kickback,research,laborlaws,Starklaw). L.Verifyappropriatepoliciesoninteractionswithotherhealthcareindustrystakeholders(e.g.,hospitals/physicians,pharma/devicerepresentatives,vendors). M.Assurepoliciesandproceduresaddressthecomplianceroleinqualityofcareissues. N.Verifymaintenanceofapolicyongiftsandgratuities. O.Verifymaintenanceofstandardsofaccountability(e.g.,incentives,sanctions,disciplinarypolicies)foremployeesatalllevels. P.MaintainaComplianceDepartmentoperationsmanual. Q.Verifymaintenanceofpoliciesonwaiversofco-paymentsanddeductibles. R.Assuregovernancepoliciesrelatedtocomplianceareappropriatelymaintained. Source:CHCCandidateHandbook:DetailedContentOutline 2 Element1:Standards,Policies,andProcedures WhattoMeasure HowtoMeasure Access: Accessibility • • • • • 1.2 ActualAccess Audithowmanyactual"hits"onpoliciesandprocedures 1.3 Accessiblelanguageforcode,standardsandpolicies FleschKincaidmeasuringstandard–nomorethan10thgradereadinglevel 1.1 1.4 • Complianceprogramawarenessandcommunication • Reviewlinktoemployeeaccessiblewebsite/intranetthatincludestheCodeofConduct Survey-Canyoureadilyaccessorreferencepoliciesandprocedures?(Yes/No/Don'tknow) Survey-Howandwheredoemployeesactuallyaccesspoliciesandprocedures? Testkeywordsearch(searchable) Auditandinterviewstafftoshowpolicies Surveyemployeestodeterminetheextenttowhichthecodeofconductandother compliancecommunicationsareavailabletoemployees Reviewtoensurethestandards,policies,andawarenessmaterialisupdatedanddistributed withinorganization’sguidelines 1.5 Impairedordisabledaccessibility Reviewaccessibilityoptions.Lookatmethodsandspeaktoindividuals. 1.6 Policycommunication Communicationstrategyofpolicies 1.7 Availabilityofpolicycontent Conductsurveysandobservation Accountability: 1.8 Accountability PolicyCoordinatordesignated Ownershipandaccountabilityofpolicies Auditprocessofhowpoliciesgetenforcedbychainofcommandwhencomplianceisnotthefinal approver.Ismanagementtakingresponsibilityforimplementingandfollowingpolicies? Routinepoliciesandprocedures Confirmthatlistedownerofeachpolicyandprocedureistheactualowner. 1.9 1.10 3 Review/ApprovalProcess: 1.11 AnnualreviewandBoardapprovalofCompliance Plan Audit:ReviewofBoardminutes 1.12 Compliancedocumentationoperationsmanual Complianceorotheroversightcommitteetoreviewannuallytoensureitisuptodate. 1.13 Maintenanceofpolicies Checklastrevieworrevision Numberofpoliciesreviewedandisthereviewtimely Processreview/audit.Usechecklisttoensureallbasicpolicyelementsareinplace,updated consistentlyandreviewed/approvedbyappropriateparties. Policyapprovals Checklistaudit.Createlistofpolicies,reviewcommitteeandboardminutestoensureall approvalshavebeenobtained. 1.16 Policyreviewprocess Auditprocessbywhichpoliciesandproceduresareprepared,approved,disseminated,etc. 1.17 Processforensuringfullorganizationalparticipation inpolicyandproceduredevelopment Reviewdocumentation/minutestoverifyinputconsideredandsolicitedforpolicyandprocedure developmentandreview 1.18 Processforreviewandapproving Checkforwrittenprocess Quality: 1.19 Arepolicies(andprocedures)asgoodasindustry practice Peerreviews 1.20 IntegrityofProcessfordevelopingandimplementing Auditpolicyandprocedureonpolicyandprocedures policiesandprocedures 1.14 1.15 1.21 1.22 1.23 Languageandreadinglevelofpolicies Arepolicieswritteninplainlanguage,appropriategradereadinglevelandwritteninapplicable languagesfororganization?Policyreview,Wordgradelevelreviewandinterviewsofstaffto makesuretheyunderstand. Languagetranslation Auditorprocessreview.Arepoliciesandthecodeofconducttranslatedintoappropriate languagesfororganization? Usefulness SURVEY-Dodepartmentpoliciesandproceduresassistyouindoingyourjobeffectively? (Yes/No/Don'tknow) 4 1.24 Needforpoliciesthatdon’texist Interviewstafftodetermineiftheyneedthecertainpoliciestostrengtheninternalcontrols. 1.25 Policiesandprocedures Requestreviewfromexternalexperts Assessment: 1.26 Assessmentofallcompanypolicies Checklistofpolicies;whicharecomplianceandwhicharebusiness 1.27 Essentialcompliancepoliciesandproceduresexist Canstaffactuallyarticulatepoliciesandprocedures;teststaff 1.28 Existenceofproceduretosupportpolicy Auditforproceduretosupportpolicy Fundamentalpoliciesandproceduresinplace Havefocusgroupsofworkunits/departmentstodeterminewhethertheyunderstandthepolicies andproceduresnecessarytodotheirjobs. Identifiability • • 1.31 Listofpoliciesareapplicabletoemployees Supervisorstoassessdirectstaff 1.32 Arethoseaffectedbypolicygiventheopportunityto Focusgroupsandinterviewsofthoseaffectedbypolicy. weighinonpolicywhendeveloped? 1.33 Listofrequiredpolicies Createchecklisttomakesureminimumpoliciesareinplaceandthenauditagainstthelist. 1.34 Effectivenessofpolicies Effectivenessofpoliciesbasedonthesubmissionhotlinecalls Policiesandproceduresthathavebeenidentifiedas partofcorrectiveaction Processreview.Conductannualmeetingwithcomplianceandlegaltolookatdatabasesand controlandprioritizereviewtoensureimplementationandongoingcompliancewithpoliciesand procedures. 1.36 Policiesforhighriskandoperationalareas Audit 1.37 Policies,standardsandproceduresarebasedon assessedrisks Riskassessment,policyexistsforeachriskidentifiedintheriskassessment(coverageofaspecific risktopic) 1.38 Policyinventorytoensurenooverlapand contradictionofpolicies Createinventoryandanalyzeinventory.Analyzeandreviewpastefforts.Lookatvarious departmentsthatmighthaveoverlappingpolicies. Policyreviewfollowinginvestigation/issue Toppoliciesimplicatedinaninvestigationarereviewedtodetermineifpolicyambiguous, complex,failstoadequatelysafeguardissues.Validatethroughaudit. 1.29 1.30 1.35 1.39 Indexofpoliciesavailableandcurrent Numberedpolicies,notjusttitles 5 1.40 Routinepoliciesandproceduresareaddressedand filterdown. Reviewdepartmentandcommitteeagendastoensurepoliciesareaddressed CodeofConduct: CodeofConduct Audit:Reviewdates,boardapprovals,distributionprocesses,attestations,surveyemployeesfor understanding,conductfocusgroups. Complianceprogramawarenessandcommunication SurveyemployeestodeterminetheextenttowhichtheyknowthecontentoftheStandardsof Conduct(SOC)andhowtoaccessit. Integratemission,vision,values,andethical principleswithcodeofconduct Comparecodewithmissionandvisionstatementstoseeifitincludeselements/statements.Check toseeifcodeisaccessibletoemployees Maintenanceofcodeofconduct Iscodewritten,postedforemployees,documentedfrequencyofreviews,andsurvey/test employeesonabilitytolocateit Distribution DocumentationofCodeofConductdistributiontrackingandresultsoverpasttwoyearsforall employees,employedphysicians,alliedhealthprofessionals,independent(contracted)physicians, volunteersandvendors/contractor/consultantsintheorganization Orientation AudittoensureallemployeesreceiveorientationtotheSOCandcompliancepolicieswithin30 daysofhire. 1.47 Staffunderstandingofcodeofconductandpolicies andprocedures • • Updates: Complianceprogramcommunicationofrulechanges Reviewperiodicallyandatrulechanges–Audittoensurethereisadequatecommunicationto employees,includingchangesinpolicy/procedure. Newandupdatedpolicydistributionandeducation ofappropriatestaff Processreview-Doesorganizationhaveformalprocesstomakeworkforceawareofnewpolicies orchangesinpolicies? Practicesimplementedafternewpolicy Auditpracticesandreviewcommitteeminutesandotherdocumentationtodeterminehownew policiesareimplemented. Understanding: 1.51 UnderstandingofPolicies/Procedures • 1.41 1.42 1.43 1.44 1.45 1.46 1.48 1.49 1.50 Reviewtestscoresaftertraining. Conductinterviews. Conductsurveysand/orfocusgroupsonspecificpolicies 6 • 1.52 Auditadherencetopolicy/procedure Orientation Ensureemployeesareprovidedinstructionbyknowledgeablepersonnelforquestions/clarity Policiesreflectpractice Usepoliciesasaudittoolandtheninterview,observeandconductdocumentreviewtoensure policiesarebeingfollowed. Questionsaskedbyemployees Systeminplacetotrackemployeequestionsandconcernstoensureconsistentguidance.Track departmentswherequestionscomefromtodeployadditionaleducationwherenecessary. Understandabletoboardandc-suite Testboardandc-suiteonlocationandunderstanding Understandabletoemployees • • • CompliancePlan: 1.57 Maintaincomplianceplanandprogram Reviewwrittenplanorwrittenscheduleofcomplianceactivities Maintaincompliancedepartmentoperationsmanual • • 1.53 1.54 1.55 1.56 1.58 Readingcomprehensiontest Situationaltests Testoflocation Auditexistenceofwrittenmanual,handbook,orreferenceguide Testwhetherthemanualiscurrent ConfidentialityStatements: 1.59 Verifymaintenanceofappropriateconfidentiality policies • • Enforcement: 1.60 Compliancewithpolicies Conductinterviews,observation. 1.61 Policyviolations Auditpolicyandprocedurestomakesurepracticeconsistentwithpolicy. 1.62 Adherencetopoliciesandproceduresforcases involvingpatientharmandreportingtoregulatory agency Reviewpoliciesandproceduresandcasesinvolvingpatientharmandvalidateproperreportingto regulatoryagency Auditprocedureforobtainingconfidentialitystatementsfromemployees Auditemployeefilesforsignedconfidentialitystatementsfromemployees 7 Element2:ComplianceProgramAdministration A.Maintainacompliancebudget(e.g.,contributetoplanning,preparing,andmonitoringfinancialresources). B.Reportcomplianceprogramactivitytothegovernanceboard/committee. C.Coordinateoperationalaspectsofacomplianceprogramwiththeoversightcommittee. D.Collaboratewithotherstoinstitutebestcomplianceprogram. E.Coordinateorganizationaleffortstomaintainacomplianceprogram. F.Definescopeofcomplianceprogramconsistentwithcurrentindustrystandards. G.Assurethatthecomplianceoversightcommittee’sgoalsandfunctionsareoutlined. H.Evaluatetheeffectivenessofthecomplianceprogramonaperiodicbasis. I.Maintainknowledgeofcurrentregulatorychangesandinterpretationoflaws. J.Assurethecredibilityandintegrityofthecomplianceprogram. K.Recognizetheneedforoutsideexpertise. L.Overseeacomplianceeducationprogram. M.Verifytheorganizationhasdefinedtheauthorityofthecomplianceofficeratahighlevel. N.Verifythegoverningboardunderstandsitsresponsibilityasitrelatestothecomplianceprogramandculture. O.Assurethattheroleofcounselinthecomplianceprocesshasbeendefined. P.Definetheresponsibilities,purpose,andfunctionforallcompliancestaff. Q.Assurestaffingforthecomplianceprogram. R.Verifycomplianceriskassessmentsareconductedperiodically. S.Participateinthedevelopmentofinternalcontrolsandsystemstomitigaterisk. T.Incorporaterelevantaspectsofregulatoryagencies’focusintocomplianceoperations. U.Overseeintegrationofthecomplianceprogramintooperations. V.Developanannualcomplianceworkplan. W.Demonstrateindependenceandobjectivityinallaspectsofcomplianceprogram. X.Maintainanindependentreportingstructuretothegoverningbody(e.g.,Board,PhysicianPracticeExecutiveCommittee). Source:CHCCandidateHandbook:DetailedContentOutline 8 Element2:ComplianceProgramAdministration WhattoMeasure HowtoMeasure BoardofDirectors: 2.1 • ActiveBoardofDirectors • 2.2 2.3 • Reviewoftrainingandresponsibilitiesasreflectedinmeetingminutesandotherdocuments (trainingmaterials,newsletters,etc.).Dominutesreflectboard’sunderstanding? Review/auditboardeducation–howoftenisitconducted?Conductinterviewstoassess boardunderstanding. Boardunderstandingandoversightoftheir responsibilities • Appropriateescalationtooversightbody • Reviewminutes/checklistincomplianceofficerfiles • • Reviewcomplianceprogramresources(budget,staff). Reviewdocumentationtoensurestaff,boardandmanagementareactivelyinvolvedinthe program. Conductinterviewsofboard,managementandstaff. 2.4 Commitmentfromtop • 2.5 ReviewminutesofmeetingswhereComplianceOfficerreportsin-persontotheAuditand ComplianceCommitteeoftheBoardofDirectorsonaquarterlybasis Conductinventoryofreportsgiventoboardandapplicablecommittees. Processforescalationandaccountability Processreview(documentreview,interviews,etc.).Istheretimelyreportingandresolutionof matters? ComplianceBudget: 2.6 Appropriateoversightofbudget Reviewcharterofgoverningbody(Board)toverifyitincludesapprovalofcompliancebudget 2.7 Budgetisbasedonanassessmentofriskand programimprovement/effectiveness IstheBoard’sapprovalofthebudgetbasedonidentifiedrisksandeffectiveness evaluation/programimprovement? 2.8 Sufficientcomplianceprogramresources(budget, staffing) Reviewbudgetandstaffingtoensuresignificantrisksaremanagedappropriately ComplianceCommittees: 9 2.9 Activeinvolvementofcompliancecommittee members Trackpercentageofattendanceofeachcompliancecommitteememberoverthelastyear 2.10 Assurethatthecomplianceoversightcommittee goalsandfunctionsareoutlined Reviewcharterofcommittee Committeestructure Reviewdocumentationofstructureofcommitteesaswellascharters.Ensurenoconflicting charters. 2.11 2.12 Compliancecommitteecompositionandattendance Reviewcharterandminutestoassureattendance. 2.13 Cascadeadministrationofcomplianceprogram throughouttheorganization Differentoperationalareasgivesomecertification/disclosuretothecomplianceoffice 2.14 CompositionofComplianceCommittee Revieworganizationalcharttovalidatecorrectcomposition Effectivenessofcompliancecommitteemeetings Keepexecutivereportcardbymemberqualitative/quantitativewithindicatorsofcontributionon topics Engagement Inthelasttwoyears,havethecompliancecommitteemeetingsbeenheldinaccordancewiththe charter? EngagementofDirectors/Managers Reviewcommitteestructuretoevaluatehowdirectors/managersareparticipatinginCompliance OperationalCommittee(s)meetingincludesagenda,minutes,attendanceandreportsfrom subcommittees ExecutiveLeadershipengagedinCompliance Program Reviewfrequencyofmeetings,membership,attendance,agendaandminutesoverthepastyear oftheComplianceExecutiveCommitteetoincludeallmembersoftheSeniorExecutiveteam receivinginformationdirectlyfromtheComplianceOfficer Accountability: Leadershipaccountability Auditdocumentationandconductinterviews.Someexamplesmightinclude: • Employeeeducationcompletionrates • Demonstrationofpromotionofcompliance(e.g.,townhallmeetingpresentations, newsletters,etc.) • Completionofauditorreviewactionitemswithinestablishedtimeframe Managementaccountabilityforcompliance Processanddocumentreviewandinterviews. • Isthereamappingofoperationalormanagementresponsibleforchampioningcompliance? 2.15 2.16 2.17 2.18 2.19 2.20 10 • 2.21 • Isthereamappingofmanagementresponsibleforkeyareasofcompliancetoensure accountability? Doestopmanagementsupportthecomplianceteam? • • Certification(CHC,CHPC,CHRC) Annualevaluation,coaching,correctiveaction,professionaldevelopment • Reviewparticipationofcomplianceofficerinstrategicplanningprocessandduediligence processes. • • Processreview,includingreviewoforganizationalcharttoensurecompliancecaptures enterprise-wideentities. Interviewswithcomplianceandothercommittees. Complianceindependence/compliancestructure • • Doesthereportingstructurereflectsthe"express"authorityrequired? Auditprogramcharters(complianceprogramorAuditcommittee) Complianceintegration Audittodeterminetheextenttowhichcomplianceofficerisinvolvedintraining,policy development,marketingandotheroperationalaspectsofthebusiness ComplianceOfficer: Competency 2.22 Isthecomplianceofficerakeystakeholderinthe strategicinitiativesoftheorganization 2.23 Compliancedepartmentinvolvementinenterprisewideinitiatives/entities/strategies(e.g.,involvement orpenetrationinjointventureinitiativesandother organizationalinventory) 2.24 2.25 2.26 ComplianceOfficerreportingstructureandoversight toensuredirectaccesstoCsuiteandboard • • • 2.27 • • Complianceofficer’sindependence/objectivity • • • • • Documentreview-Lookatorganizationalchartandconductinterviews. ReviewboardminutesanddocumentationthatthereareregularmeetingswithCEOandor appropriateparties. Ensurecomplianceofficerhasauthorityandiscomfortabletogotoboard. Reviewcomplianceofficer’sjobdescription.Doess/hereportdirectlytoCEO,board(notCFO orLegal)?Conductinterviews,focusedgroups,audit. Seatinglocationofcompliancewiththebusiness,seniorteamsaretogether,anddottedline onorgchart Interviewcomplianceofficertoseeiftheyfeeltheyhaveindependence,dotheydocument disagreements,isthereexecutivesessionforauditcommittee. Interviewtheboard,reviewminutes,andinterviewtheCCO Reviewofwrittenorganizationalstructure VerifytheComplianceOfficerhastheindependentauthoritytoretainoutsidelegalcounsel ReviewifthereisscreeningofcomplianceofficermaterialtotheBoardofDirectors 11 • 2.28 Credibilityofcomplianceofficer RegularexecutivesessionoftheComplianceOfficerwiththeAuditandCompliance CommitteeoftheBoard JobDescriptionreview,ongoingtrainingofcomplianceofficer,basiccompetencies,certifications, reportingstructure 2.29 • • • Haveneededchangesbeenmade,andifnot,whynot? Whatauthoritydoesthecomplianceofficerhaveandhowdoesheorsheexerciseit? Whereisthecomplianceteamwithregardstoidentifyingworkinggroupstohelpattacka newcompliancerisk? Howsupportedthecomplianceofficerfeels • • Interviewcomplianceofficer; Documentationreview. Organizationalperceptionofcomplianceofficerand corporatecomplianceprogram Surveyemployeesregarding: • Theirperceptionofthecomplianceofficerrole. • Whethertheyknowwhothecomplianceteamis,howtogettothemand,whattotellthem. • Isthecompliancestaffapproachable? • Arethecompliancestaffsolutionfacilitatorsorlookedatastheorganizationalpoliceforce? 2.32 Complianceproblemsolvingandadequacyof process Processreview Staffing: Howmuchauthoritydoesthecomplianceofficer havetostartaworkinggrouptolookatchanges? 2.30 2.31 2.33 Adequacyofstaffingandresources • • • • • • • • 2.34 Assuranceofstaffing Reviewqualificationsofstaff;ratioofcompliancestafftobusiness,compensationtothebusiness 2.35 Adequacyofcompliancestaffbasedonrisk assessment Riskassessmentconsidersthenumberandcompetencyofstaffrequiredtoaddressrisk FTEsassignedtocompliancefunction Reviewcompliancemattersandiftheyhavebeenaddressedtimely. Reviewandensurepoliciesandproceduresareimplementedandbeingfollowed. Reviewdocumentationofreportstocommittee(s)andboard. Assessstatusofworkplanandanydelays. Ensuredocumentationofriskassessment. Reviewdocumentationregardingdiscussionsatboardlevelregardingbudget. Reviewbenchmarkingdatafromsimilarentities. 12 CompliancePlan: 2.36 Complianceplanassessments • • • • • Complianceplanprocess Auditprocessfordevelopmentoftheannualcomplianceplan. Complianceorganization Assessthepositioningandeffectivenessofthecomplianceorganizationstaff,titles,organizational chart,pay,promotionrecordscomparedtootherareaswithintheorganization 2.39 Documentthatestablishestheauthorityofthe program Documentreview,meetingminutesforapproval. 2.40 Perceptionofcomplianceprogram Surveyemployees Culture: Accountability SURVEY-Doesthecompliancedepartmenthaveanimpactonhowyoudoyourjob? (Yes/No/Don'tknow) AccuracyandTrustinMonitoring SURVEY:Doyoubelievetheinformationfromyourdepartmentisreportedwithahighdegreeof integrityandaccuracy?(Yes/No/Don’tknow) Culture Conductculturalsurvey(interviews,confidentialsurveys,focusgroups,etc.)andreportfindingsto compliancecommitteeandboard.Reviewminutestoensurereportoutandactionplan established. 2.44 Effectivenessofcomplianceprograminthefield Surveyoffieldcompliancepeople 2.45 Surveys. • Whatdoescompanyincentivize? Whatiscompanydoingtodrivecomplianceculture? • Whatdoesthecompanypromoteandlookdownon? • Iscomplianceprogramtiedtomission,vision,values? 2.37 2.38 2.41 2.42 2.43 2.46 Employeecommentsfrom“Rounding” Documentreview,includingcomplianceplanandpolicies. Isthereanexternalreviewconductedperiodically? Whatistheroleofinternalauditwithregardingtocompliance? Howdoesinternalauditinteractwithcompliance? Benchmarkprogramwithsimilarsizeswithinthesameindustry Auditthetrackingofwhatemployeesreportwhenproactivelyaskedbycompliancedepartment (orleadership,etc.)andhowthisinformationismanagedandreported. 13 2.47 Measuringeffectivenessofexecutivecommunication Trackon-lineengagement(clicks)andsurveyaudience oncompliance Incentives: 2.48 Aligningperformancemanagementsystem (promotionsystem)withethicsandcompliance objectives Auditcriteriaofpromotion,bonusesandassignments 2.49 ComplianceandEthicsRole/participationfor developingtheincentivesystem Haveanoutsideindependentexpertaudittheincentivesystemandcomplianceofficer's participation 2.50 Isincentivesystemconsistentwithcompliance program EmployeeSurvey PerformanceEvaluations: 2.51 Properalignmentofcomplianceobjectiveswith organizationalperformanceincentives (promotions/performanceappraisals/bonuses) 2.52 • Auditdisciplinaryrecordsandperformanceevaluationsforconsistencywithcompliance • Audit/Reviewofprocessforperformanceincentives(promotions/performance appraisals/bonuses)criteriatoincludecompliancecomponents • “Compliance”asaperformanceappraisalelement • • • 2.53 2.54 2.55 Auditperformanceappraisals.Someoptionsinclude: o Acknowledgmentofnodisciplinaryaction o Educationcompletion o Documentationofpromotionofcompliance Aremeritincreasestiedtoperformance? Doescompletionofcomplianceeducation,promotionofcompliancethroughwords,actions ornodocumenteddisciplinaryactionand/or,completionofcorrectiveactionplanswithinthe duedatesplayaroleintothecalculationofmeritincrease? ComplianceispartoftheannualperformanceevaluationandHRknowshowtoevaluate issuesforcompliance Managerperformanceevaluations Managershaveopendoorpolicy,communicatecompliancedirectives/initiatives,address compliancemattersandeffectivenessisnotedinperformanceevaluation. Iscompliancetakenintoaccountinpromotion decisions? Reviewpromotionlistsanddocumentationtosupportpromotion.Didtheindividualactively promotecompliance? OrganizationalRetaliation Trackwhistleblowerpromotion,bonuses,sickdays,disciplinary,correctiveactionmeasuresand exitinterviewoverlongterm 14 2.56 2.57 RiskAssessments: ComplianceResourceknowledgeandcompetence Survey,focusgroupsandinterviews Compliancestaffknowledgeofcurrentregulatory changesandlaws Documentreviewandinterviews.Reviewcertificatesofattendanceatconferences/other educationalevents,“tools”usedtokeepcompliancestaffcurrent,compliancebudget(tosupport accesstocurrentregulatorychangesandlaws). Monitoringofregulationsthatimpactthe organization Documentandprocessreview,interviews. • Isthereapolicyandprocedure? • Isthereevidencethatregulations,etc.aredisseminatedandimplemented? • Aretheredesignatedindividual(s)thatmonitorlaws,regulations,policiesthatimpact organization? • Howdotheygettheinformationandwhatdotheydowithittomakesureitgetstotheright people? 2.58 2.59 2.60 • • RiskAssessmentCycle Auditadherencetoriskassessmentcycle Annualdocumentedriskassessmenthasbeencommunicatedtooversightcommittee Riskbasedworkplanthatcoverscomplianceplan elementswithboardapprovalandregularreporting onthoseprojectstoboard ComplianceCommitteeandboardminutesreview. 2.61 Workplandevelopmentbasedonriskassessment Processanddocumentreview. 2.62 Prioritizationofriskandconsultationwithapplicable riskpartners(i.e.,legal,HR,IT,riskmanagement, Documentationandprocessreview.Isthereariskbasedplan?Howwasitdeveloped? etc.) 2.63 Exitinterview Complianceconcernsthatcomeupinexitinterviewsareaddressed ComplianceWorkPlan: 2.64 Complianceworkplan Audittoensuretheworkplanisdevelopedandimplementedanditisfollowed-throughand outcomesarereportedtocompliancecommitteeortogoverningbody 15 2.65 Effectivenessofcomplianceprogram Writtenannualworkplanthatincludesminutes LegalCounsel'sRole: 2.66 Roleofcounselincomplianceprocess Interviewcounselregardingtheirinvolvement. • Whentheyarebroughtintomatters? • Whereiscounselsituatedinrelationtocomplianceofficeronorganizationalchart? 2.67 Existenceandadherencetopolicyoninvolvementof Reviewpolicyandsampleareasthatwerereferredtolegalfollowedthepolicy legalinhandlingmattersunderprivilege Other: 2.68 Jobdescriptionsofmanagement Reviewofmanagementjobdescriptions.Domanagershaveconcretecompliancedeliverables otherthantrainingandabidingbyCodeofConduct? Element3:ScreeningandEvaluationofEmployees,Physicians,VendorsandotherAgents A.Assureorganizationhasprocessesinplacetoidentifyanddiscloseconflictsofinterest. B.Assureinclusionofcomplianceobligationsinalljobdescriptions. C.Assureinclusionofcomplianceaccountabilitiesasanelementofperformanceevaluation. D.Verifybackground/sanctionchecksareconductedinaccordancewithapplicablerulesandlaws(e.g.,employment,promotions,credentialing). E.Assurecompliance-sensitiveexitinterviewsoccur. F.Monitorgovernmentsanctionlistsforexcludedindividuals/entities(e.g.,OIG,GSA,SDN,SDGT). G.Verifyduediligenceisconductedonthirdparties(e.g.,consultants,vendors,acquisitions). H.Assurecorrectiveactionistakenbasedonbackground/sanctioncheckfindings. Source:CHCCandidateHandbook:DetailedContentOutline 16 Element3:ScreeningandEvaluationofEmployees,Physicians,VendorsandotherAgents WhattoMeasure HowtoMeasure Accountabilityforscreening: 3.1 Theindividual(s)responsibleforexclusionscreening hasclearaccountabilityforthescreeningfunction. • • Auditthejobdescription,trainingmaterial,orientationmaterial,andannualperformance evaluationoftheindividual(s)responsibleforexclusionscreeningtoensurethisresponsibility isclearlyarticulatedandperformanceismeasured. Annuallyreview/discusstheexclusionscreeningprocessindividuallywitheachperson responsibleforsanctioncheckscreening;reviewthedocumentretentionprocessestoensure documentationofthescreeningfunction,responsetofindings,andcorrectiveactionsare adequatelymaintained. ConflictofInterest: 3.2 Potentialconflictsofinterestaredisclosed. Audittheconflictofinterestdisclosuresforcompletenessandtheextenttowhichthosewho completethedisclosureinformation. 3.3 Theorganizationconductseffectiveeducationon ConflictofInterest(COI) • • Employeeaccountability: 3.4 Theextenttowhichemployeesaremadeawareof complianceexpectations. Conductfocusedinterviewswithemployeesandaudittheperformancereviewprocesstoensure complianceexpectationsarewellunderstoodandemployeesareheldaccountableforthese expectations. 3.5 3.6 Reviewtrainingmaterialsandinterviewstafftodeterminetheeffectivenessoftheeducation. Auditcompletedattestationsordisclosurestoensueindividualsaredisclosingconflicts accordingtoeducationprovided. Accountabilityforcomplianceisclearlyarticulatedin Auditperformanceevaluationstoensurecomplianceobligationsareclearlyarticulatedand employeeperformanceevaluations. performanceagainsttheserequirementsismeasured. Accountabilityforcomplianceisclearlyarticulatedin Auditjobdescriptionstoensurecomplianceobligationsareclearlyarticulated. employeejobdescriptions. 17 3.7 3.8 3.9 3.10 3.11 3.12 3.13 Employeesareprovidededucationregardingtheir complianceobligationsandtheyunderstandthese requirements. • Employeedisclosure: Theorganizationhasestablishedapolicythat requiresprospectiveandcurrentemployees,and prospectiveandcurrentvendorstodisclosetothe organizationiftheyareormaybeexcluded. • Auditandconductadocumentreviewtoensuredisclosurerequirementsareclearly articulatedinthepolicyanddisclosuresarebeingmadeasrequired. • Conductapolicyreviewtoensurethatthatimmediatereportingisarequirementfor employeesandaprovisioninvendoragreements. Employeescreening: Allemployeesarescreenedpriortohire. Audithumanresourcefilestoensuredocumentationsupportsthatnewlyhiredemployeeswere screenedpriortotheirfirstdayworked. Screeningconsidersothernames/aliasandStates usedbyaprospectiveemployee. Reviewapplicationsforeachtypeofscreening(criminal,OIG,SAM,State,SSN,etc.)andauditto determineifscreeningwascompletedagainstothernames/statesusedbytheprospective employee. Theorganizationhasdefinedwhichemployees, vendors,medicalstaff,andotherswillundergo criminal,financialand/orotherbackgroundchecks priortohire. • Theorganizationhasdefinedcriteriaforreviewof criminal,financial,and/orotherbackgroundchecks andhiringdecisionaremadebasedonthis establishedcriteria. Performassessment/audittoensuretheorganizationhasestablishedcriteriatoevaluatethe acceptabilityofacandidatebasedonfindingsofcriminal,financial,orotherbackgroundcheck(s) usedbytheorganization. Employeesareprovidededucationregardingthe organization’sscreeningprocess. Interviewemployeesandconductdocumentationreviewstoconfirmthatemployeesunderstand theimportanceofnotlettinglicensesexpireandtheeffectofexclusion. • • • Auditemployeeeducationfilestoensureeducationisbeingprovidedaccordingtothe organizationstrainingplansand/orpoliciesandprocedures. Reviewpost-teststoconfirmunderstanding. Interviewemployeestoconfirmtheirunderstandingoftheircomplianceobligationsand responsibilities. Performassessment/audittoensuretheorganizationhadidentifiedwhichindividualsreceive criminal,financial,SocialSecuritytrace,drugscreening,orotherbackgroundchecks. Audittoensuresuchbackgroundchecksarebeingperformedandreviewedpriorto employment. 18 3.14 3.15 3.16 3.17 3.18 3.19 Theorganizationensuresthatapplicantsfor employmentunderstanddisclosurerequirements. Reviewemploymentapplicationstoensuredisclosureismadetoprospectiveemployees,including exclusionandbackgroundscreeningrequirements,andthesescreeningsarecompleted. Theorganizationhasestablishedapolicyregarding thefrequencyofscreening. • Performadocumentreviewtoensurethefrequencyofscreeningisbeingdoneinaccordance withpolicy. • Auditthescreeningprocesstoensurescreeningisbeingcompletedaccordingtopolicy. • Audit,performdocumentreview,interviewsstaffandvendors,andconductdataminingto determineifsufficientcontrolsareinplacetopreventtheorganizationfromhiringan “ineligible”individualorentity. • Usedata-miningtocomparelistsofnewemployeeswithduediligencelists. • Ensurethevendormasterfileisupdatedwithvendorsthathavebeenscreened. Theorganizationhasestablishedsufficientcontrols inthehiringprocessandvendorengagement processtopreventtheorganizationfromhiringan ineligibleindividualorentity. Theorganizationhasestablishedascreening programthatisconsistentwithalllawsand regulations. Conductalegalreviewandanalysisofscreeningprocesstoensureitisbeingadministeredina mannerconsistentwithfederalandstatelaws. Theorganizationhasestablishedaprocesstoscreen employeesandotherrelevantindividualsatleast monthly. Auditscreeningprocesstoensurescreeningofemployeesandotherrelevantindividualsisbeing conductedatleastmonthlyandaccordingtopolicy. Theorganizationhasestablishedapolicyand • procedurewhichdefinesthescreeningrequirements foremployees,vendors,medicalstaffandothers. • Thepoliciesincludedescriptionofthedatabasesthat individualswillbescreenedagainstandthe • frequencyofscreening. 3.20 Theorganizationhasaprocesstodeterminewhen additionalscreeningmaybenecessarybasedon findingsfromcomplianceinvestigations.(Relevant event(situational)screening(R.E.S.)) Conductadocumentreviewtoverifythepolicyandprocedurehasbeenestablished,is complete,andaudittoensurescreeningisbeingconductedconsistentwithpolicy. Performassessment/audittoensureorganizationhasidentifiedwhichliststocheckandhow ofteneachischeckedandthescreeningsarebeingcheckedperpolicy. Performassessment/audittoensureallrelevanttypesofindividualsandentities(employees, temps,vendors,etc.)arebeingscreenedperpolicy. Conductareviewofcomplianceinvestigationfilestodetermineifconsiderationforadditional screeningiswarrantedandreviewtheresultsofadditionalscreeningcompletedaspartofthe investigationprocess(situational)whenapplicable 19 3.21 3.22 3.23 3.24 3.25 3.26 Theorganizationhasapolicyandprocedurewhich Conductdocumentationreviewandaudittoensurescreeningisbeingcompletedaccordingto articulatestheprocessforscreening,investigationof policyrequirementsandthatallprocesselementsrelatedtoinvestigation,resolution,tracking, potential“hits,”actionstakeninresponsetoa andcommunicationarebeingmanagedaccordingtopolicyrequirements. positivefinding,trackingexclusions,and communicationtoappropriatestakeholders. ExitInterviews: Employeeawarenessoforganization’scompliance program. Revieworganization’semployeeterminationprocesssuchasexitinterviews,surveys,and/or questionnairestotestforemployeeawarenessoftheorganization’scomplianceprogram. Employeeexitinterviewsareconductedand • employeesareaskedaboutthecomplianceprogram andanyconcerns,risks,violationsorfailuresofthe complianceprogram. • rd Revieworganization’semployeeterminationprocesssuchasexitinterviews,surveys,and/or questionnairestoensurecomplianceprogramquestionsareincorporatedintoexitinterviews andtheexitinterviewsarereviewedandevaluated. Audittoensureallterminated/separatingemployeeshavecompletedanexitinterviewand thatcompliancequestionsareincludedandevaluated. Vendorsandother3 partiesareinterviewedatthe terminationoftheengagementandaskedabout theirawarenessofthecomplianceprogramandany concerns,risks,violations,orfailuresofthe complianceprogram. Revieworganization’svendortermination/off-boardingprocesssuchasinterviews,surveys, and/orquestionnairestoensurecomplianceprogramquestionsareincorporatedintotheprocess andinterviews/resultsarereviewedandevaluated. Theorganizationhasestablishedapolicyand procedureforconductingexitinterviewsfor employeesleavingtheorganization.Theexit interviewprocessincludesquestionsrelatedto complianceobligationsandanyknownviolationsof law,policies,orprocedures. Reviewpolicyandproceduretoensuretheorganizationhasanestablishedprocess.Auditexit interviewfilestoensureinterviewsarebeingconductedaccordingtopolicy.Reviewtoensure thatanyidentifiedviolationsoflaw,policyorprocedurearethoroughlyinvestigated. HighRiskScreening: Theorganizationhasestablishedapolicyidentifying highriskpositionsintheorganizationthatmay requireadditionalscreening. Conductpolicyreviewtoensurehighriskpositions(e.g.,cliniciansworkingwithchildrenor mentalhealth,cashhandlers)areidentifiedinpolicy,andthepolicyincludesadescriptionofany 20 additionalscreeningrequirements(fingerprinting,financialbackgroundchecks,etc.).Review employmentandvendorfilestoensuretheadditionalscreeningisoccurringaccordingtopolicy. 3.27 3.28 3.29 3.30 3.31 3.32 3.33 Licensure: Theorganizationhasaprocesstoensurethat individualswhotransferpositionswithinthe organizationareappropriatelylicensedand credentialedforthejobtheywillbeperforming. Auditandconductadocumentreview,audittoensureaprocessforexaminationoflicensesand credentialsisestablishedforemployeestransferringpositionswithintheorganization.Auditto confirmprocessisbeingfollowedandindividualstransferredhaveappropriatelicenseand credentialsforthepositiontheyareassuming. Theorganizationhasestablishedapolicyand Performdocumentreviewandaudittoensureapolicyforverificationandreviewoflicenseand procedureforlicensureandcertificationreviews, certification,includingsourceverification,existsandlicensesandcertificationsareconsistently includingreviewuponhire,upontransfer,andduring reviewedaccordingtopolicy. renewalperiods. ResponsetoExclusion: Appropriateactionistakeninresponsetopotential andidentifiedexclusion Audittoensurerefundsareinitiatedifrequiredandemployment,contract,ormedicalstaffaction istakenupondiscovery(includingvendors). ResponsetoScreening: Theorganizationtakesactionontheresultsof screening. Performadocumentreviewtoensurescreeningresultsarebeingevaluatedandappropriate actionistakenwherenecessary. Theorganizationhasestablishedaprocessfor investigationandresolutionofpositive"hits." Auditprocesstoensure“hits”areinvestigatedandthatfalsepositivesareresolvedwhenthereis confirmationthattheindividualdoesnotmatchtheexcludedindividual. Theorganizationhasapolicyandprocedureinplace Conductdocumentandprocessreviewandauditrecentidentifiedsanctionstoensurethe thatarticulateshowpotentialsanctionswillbe evaluationandresolutionisconsistentwithpolicy. evaluatedandresolved. Vendor: Vendorsandother3rdpartiesadequatelysatisfy complianceobligations Conductauditofvendorsandother3rdpartiestoensuretheyhavedocumentedevidenceof requiredcompliancetraining,orientationtotheorganizationsStandardsofConduct,orientation toapplicablecompliancepoliciesandprocedures. 21 3.34 3.35 3.36 3.37 3.38 3.39 Theorganizationhasestablishedaprocesstoensure Conductadocumentreviewandinterviewstoensurethereiscommunicationbetweenlawyers vendorandotherthirdpartyagreementsare whodeveloptheagreementsandfacilitylevelpersonnelmanagingtheengagementtomakesure managedconsistentwiththetermsofthe itisimplementedandbeingmanagedaccordingtothetermsoftheagreement. agreement. Theorganizationrequiresvendorsandotherthird partiestocertifyscreeninghasbeencompletedas requiredbytheagreement. Audittodeterminethatvendorsrespondtorequestforcertification.Reviewprocessto determinethatactionstakenforfailuretorespondorproviderequiredcertificationsare consistentwiththeagreement.Ensurethatresponsetocertificationisreviewedbyan appropriateindividualandcommunicatedtofacilityoperations.Audittoensurethatrenewal decisionsconsidercompliancewithcertificationrequirements. Theorganizationhasestablishedapolicyoutlining Conductdocumentreviewandperformauditstoensurevendorsmeetthecomplianceobligations thecomplianceobligationsofvendorsandother required. thirdparties(includingadherencetotheStandards ofConduct).Vendoragreementsincludetherightto auditthevendortoensurecompliancewiththeir obligations. Theorganizationhasestablishedapolicyprohibiting Auditexclusionstoensurepolicyisbeingadheredto. vendorsthatareexcludedfromworkinginthe organization. VendorScreening: rd Vendorsandother3 partiesareadequately screenedforexclusion. Theorganizationhasaneffectiveprocesstoreview thirdpartyvendors. • Auditvendorrecordsandcrosschecktoensurethevendorisadequatelyscreened,in accordancewithagreementand/orentityrequirements. • Developchecklistofcriteriaforvendorcompliancereviewandauditagainstthatlistfor vendorscreeningrequirements. • Surveypeerorganizationstoensuretheorganization’svendorand3 partyscreeningprocess isconsistentwithindustrypractice. rd Auditandconductadocumentreviewtoensure: • Thirdpartycontractsallowfororganizationtoreviewvendorfilesforcompliancewith screeningrequirements. 22 3.40 Theorganizationhasrequirements,viapolicyor contractualterms,forscreeningoffirst-tier, downstreamandrelatedentities(contractors) • Theorganizationhasrequestedthethirdparty’spolicyandprocedurerelatedtovendor screeningofemployees. • Theorganizationconductsreviewsofthirdpartycontracts. • Theorganizationhasestablishedapolicyonhowoftenscreeningsarerequiredtobedoneby thethirdparty. • Theorganizationhasestablishedapolicyrequiringthirdpartiestoproduceproofthatthey arecheckingtheiremployees. • Theorganizationhasestablishedapolicyestablishingwhichdatabasesthirdpartiesare checking,especiallyregardingpractitioners,includinggeographicspecifics(statedatabases). • Theorganizationhasestablishedaprocessforindependentevaluationofwhatscreeningthe vendorissupplying. Audittoverityevidencethatcontractorsarebeingscreenedpursuanttocontractual requirements. Element4:Communication,Education,andTrainingonComplianceIssues A.Disseminateregulatoryguidancematerial. B.Communicatecomplianceinformationthroughouttheorganization. C.Assurecompliancetrainingoccurs. D.Distillcomplexlawsandregulationsintoaformatemployeescanunderstand. E.Assureworkforcestaffareeducatedoncompliancepolicies. F.Assureamechanismexiststoevaluateemployeeunderstandingofcomplianceresponsibilities. G.Promoteacultureofcompliancethroughouttheorganization. H.Encourageemployeestoseekguidanceandclarificationwhenindoubt. I.Participateincontinuingeducationtomaintainprofessionalcompetence. J.Verifyparticipationinongoingcompliancetrainingprogramsistracked. K.Assuregeneralcompliancetrainingisconductedforallemployees,physicians,vendors,andotheragents. L.Assurerisk-specifictrainingisconductedfortargetedemployees. M.ProvideHRandmanagementwithtrainingtorecognizecomplianceriskassociatedwithemployeemisconduct. Source:CHCCandidateHandbook:DetailedContentOutline 23 Element4:Communication,Education,andTrainingonComplianceIssues WhattoMeasure HowtoMeasure Training: 4.1 • Theorganizationprovidesriskareaspecifictraining • toemployeesdesignatedtobeinhighriskpositions. • 4.2 Theorganizationhasestablishedacompliance trainingplan.Theorganizationassuresthattraining iscompletedaccordingtotheestablishedplan.The trainingplanisperiodicallyupdatedorrefreshed. 4.3 Theorganizationdefinestheappropriateaudience foreachtypeofcompliancetraining(general,issue specific,highrisk,etc.). 4.4 TheorganizationoffersCEU’s,whenappropriate,for itscomplianceeducationandtraining. 4.5 4.6 Theorganizationhasestablishedaprocess,policy and/orproceduretocommunicateandprovide trainingtoemployeesonnewlaws,regulations, policies,andprocedures. • • • Audittoensuretheorganizationhasdesignatedthepositionsdeemedtobehighrisk(coding, billing,physicians,etc.)andestablishedtrainingrequirementsforthesehighriskpositions. Comparerisksposedbythesepositionsagainsttrainingmaterialstoensurespecificrisksare addressed. Audithighrisktrainingcompletionrates. Conductdocumentreviewtoensurethetrainingplanexistsandincludesrequiredtraining, expectedaudience,topicscovered,andmethodfordeployment. Auditsign-insheetsorothertrackingtoolstoensureindividualsareattendingrequired training. Reviewtoensuretrainingplanisperiodicallyupdated. • • Auditjobcodestoensurethecorrecttraininghasbeenassigned. Reviewjobcodestoensuretraining,includingjobspecificjobtrainingisbeingconducted accordingtotheestablishedtrainingplan. • Performadocumentationreviewtodeterminetheextenttowhichtheorganizationoffers CEUsforcompliancetraining. EvaluatetheeffectofofferingCEUsontrainingcompletionrates. • Conductadocumentreviewtoensureaprocessforcommunicatingandtrainingemployeeson newlaws,regulations,policies,andprocedureshasbeenestablishedandsuchcommunicationand trainingisbeingconductedconsistentwiththeestablishedprocess. Theorganizationhasestablishedapolicyrequiring • compliancetrainingandeducation.Theorganization Conductadocumentreviewtoensureapolicyhasbeenestablishedanditisperiodically updated. 24 regularlyupdatestheeducationpolicyandmonitors compliancewithtrainingrequirements. 4.7 4.8 4.9 Complianceeducation/informationisincludedinall educationdeployedthroughoutorganization. Theorganizationhascreatedtheircompliance trainingprogramaroundjobfamiliestoaddress specificrisksidentifiedwithinajobfamily. Confirmbyauditthatemployeesarecompletingeducationalrequirementsaccordingtothe policy. Conductadocumentationreviewtoverifythatatleastonecompliancerelatedtopic/slideis includedineveryeducationalpresentation,program,ormoduledeployedthroughoutthe organization. Theorganizationbasestrainingforindividualswho aredesignatedtobeinhigh-riskpositionsona • formalprocessforassessingriskandevaluating controlvulnerabilities.Theorganizationdevelops • issue-specifictrainingbasedontheresultsoftherisk assessmentandidentifiedinternalcontrol weaknesses. 4.10 4.11 • • • • Conductareviewoftheprocesstheorganizationhasforassessingriskandevaluating controlweaknesses. Reviewthetrainingplanandtrainingmaterialstoensurethetrainingaddressesthoseissues thatareofsignificantriskandthattheorganizationmaybevulnerableto. Auditthecompliancetrainingprogramtodetermineiftrainingistailoredtotherisks identifiedandassociatedwithspecificjobfamilies. Audittoensuretrainingisassignedbasedonjobfamilies. Theorganizationevaluatespolicyandcompliance • failuresandprovidesre-educationtoapplicablestaff. • Auditfilesofknownpolicyorcompliancefailurestoensurere-trainingisconsideredaspartof correctiveaction. Audittoensurethere-trainingiscompleted. Trackforreoccurrencestodeterminetheeffectivenessofthere-trainingandemployee understanding. Theorganizationtracksdisclosurereports(hotline calls,directcontactstothecompliancedepartment) followingemployeeeducationtodeterminethe extenttowhichtheeducationwaseffectiveat raisingemployeeawarenessofspecificareasof vulnerability. Monitor,auditandreviewdisclosuretrackinglogstoevaluatetheeffectofeducationon disclosures. Trackhowemployeesbecomeawareofissuestoanalyzetheeffecttraininghasonemployee awarenessandreporting. 4.12 • • • Theorganizationmaintainsdocumentationofall educationprovided. • Conductdocumentreviewandaudittoensureallcompliancerelatededucationis documented,includingmaterialcovered,attendees,anddeploymentmethod. Audittoensuredocumentationofpost-trainingtestsismaintainedtoevaluateemployee levelofunderstanding. 25 4.13 Theorganizationstrainingplanisregularlyupdated toaddressnewlawsandregulations. 4.14 Obtainfromcounsellistofnewlawsandregulationsandauditagainsttrainingplantoensurenew lawsareadequatelyaddressed. • Theorganizationhasconsideredthemosteffective methodforcomplianceeducationdeployment. • 4.15 Theorganizationhasestablishedaformalmethod fororientingnewemployeestothecompliance programandtheirobligationsandresponsibilities. 4.16 4.17 • Audittoensureemployeeshavereceivedtheircomplianceorientationconsistentwiththe orientationpolicy. Reviewnames,datesandmaterialsusedtoorientnewemployeestothecomplianceprogram overthepast2years Theorganizationhasconsideredtheaccessibilityof complianceeducationtoindividualswithdisabilities orlanguagebarriersandprovideseducationin variousformatstoaccommodateindividualswith disabilitiesorlanguagebarriers. Surveyemployeeswithcommunicationissuesordisabilitiestoensuretheeducationwas accessibleandunderstandable. Employeesoftheorganizationperceivecompliance educationasusefulandsufficienttoaddressthe compliancerequirementsintheirjob. Surveyemployeestounderstandtheirperceptionofcompliancetrainingusefulnessand sufficiency. 4.18 Theorganizationhasestablishedamethod(s)to evaluatetheeffectivenessofcomplianceeducation. 4.19 Theorganizationmeasurestheeffectivenessof trainingthoughtheuseofpost-trainingtestsor evaluations. 4.20 • Reviewthetrainingplantoensuretheorganizationhasconsideredthemosteffectivemethod ofdisseminatingtrainingtoemployees,medicalstaff,contractors,leadership,Board,and others(on-line,written,in-person,smallorlargegroup,etc.). Audittrainingrecordstodetermineiftraininghasbeendeployedaccordingtoplan. • • • • • Conductdocumentreviewtodetermineiftheorganizationhasestablishedamethodfor evaluatingtheeffectivenessofcompliancetraining. Auditincidentlogsandhotlinereportstoevaluatetheeffecttraininghashadonbehavior. Conductdocumentreviewtoevaluatetheexistenceofpost-trainingtestsorevaluations. Reviewtoconfirmtheresultsofpost-trainingtestsorevaluationsareevaluatedandtracked. Reviewtoconfirmmodificationstotrainingmaterialsconsidersfeedbackfrompost-training testsorevaluations. Theorganizationintegratesspecificrisksidentified Compareriskassessmenttotrainingplantoensurethehighriskissuesidentifiedareincludedin throughtheriskassessmentprocessintocompliance thetrainingplan. training. 26 4.21 4.22 Theorganizationsolicitsfeedbackfromemployees oncompliancetrainingneeds.Employee recommendationsareincludedintrainingmodules disseminated. • Theorganizationhasestablishedapolicyregarding thefrequencyofrequiredcompliancetraining. Audittraininglogstoensurecompliancerelatedtrainingisdisseminatedandcompletedas requiredbypolicy. 4.23 Theorganizationupdatescompliancetrainingbased onnewpolicies,procedures,processes,laws,and regulations. 4.24 4.25 4.26 4.27 4.28 • • • • Conductdocumentreviewtoensureemployeessurveyedfortheirtraining/educationneeds andwhatfeeltheyneedtrainingon. Interviewstafftoassesseffectivenessoftrainingplan Confirmthattrainingconsidersemployeefeedback. Revieweducationupdateprocess. Verifyissuesidentifiedthroughtheriskassessment,issuetrackingsystem,andotherinternal andexternaltrackingsystemsareconsideredandevaluatedastrainingprogramsare updated. Theorganizationevaluatestrainingeffectiveness. Conductknowledgesurvey6monthsaftertrainingisdeployed. Accountability: Theorganizationhasestablishedanincentive programthatties,inpart,meetingcompliance objectivestoincentivepaymentsandotherperks. Reviewperformanceevaluationstoensuretheyincludecomplianceelementsaspartof performance,merit,andincentivereview. Theorganizationhasestablishedmechanismsto • ensurethatemployeesareheldaccountablefortheir • complianceobligations. Reviewjobdescriptionsandperformanceevaluationsforspecificcompliancemetrics. ReviewStandardsofConductandotherawarenessinformationtoensurecompliance obligationsareclearlyarticulated,includingtherequirementtoreportcomplianceconcerns. Theorganizationhasamechanisminplaceto evaluatetheextenttowhichemployeesunderstand theircomplianceresponsibilities. Surveyemployeestotesttheirunderstandingoftheircomplianceobligationsandresponsibilities. Theorganizationholdsmanagementemployees accountableforensuringtheiremployees understandtheStandardsofConductand compliancerelatedresponsibilities Reviewdepartmentmeetingminutesandconductrandomstaffinterviewstodetermineiffirstlinemanagersdiscusscomplianceobligationswiththeirdirectreportsandthatstaffunderstand specificcompliancerequirementsassociatedwiththeirjob. 27 4.29 4.30 4.31 4.32 Theorganizationhasestablishedapolicyregarding sanctionsforthoseemployeeswhodon’tcomplete requiredcompliancetrainingandsanctions employeesaccordingtotheestablishedguidelines. Awareness: • Documentreviewandaudittoensureapolicyexistsrelatedtosanctionsforfailureto completecompliancetraining. Audittoensurepolicyisbeingfollowedasdescribed. Employeesareawareofandunderstandthe organization’scomplianceprogramandunderstand theirresponsibilitiesundertheprogram. Surveyemployees. Theorganizationpromotescompliancethrough activitiessuchasComplianceAwarenessWeek, ComplianceFairs,orotheremployeeinvolvement activities. Reviewifandhowtheorganizationengagesinactivitiesdesignedtopromotecompliance awareness. Board: Theorganizationhasestablishedspecificcompliance PerformadocumentreviewtoensuresufficientcompliancecompetenciesexistwithintheBoard competenciesformembersoftheBoard andappropriategoverningcommitteemembership. Compositionandappropriategoverningcommittees. 4.33 Theorganizationhasestablishedaformalprogram toorientnewBoardmembersandseniorleadersto thecomplianceprogramandtheirobligationsand responsibilities. 4.34 • Theorganization’strainingplanprovidesforspecific educationthatwillbeprovidedtotheBoardand seniorexecutives.Theplanincludesthetopicsthat willbecovered,thefrequencyoftraining,includes currentindustrydevelopmentsandresources,and provideseducationontheirresponsibilitiesfor compliance. • • • Conductdocumentreviewtodetermineiftheorganizationhasformalizedacompliance orientationprogramfornewexecutivesandnewBoardmembers. Conductanaudittoensureorientationisprovidedasrequiredbytheorientationpolicy. Reviewnames,datesandmaterialsusedtoorientnewmembersoftheBoardofDirectors andseniorleaderstothecomplianceprogramoverthepast2years. ReviewtrainingmaterialsprovidedtotheBoardandseniorexecutivesandconductpersonal interviewstoensuretrainingisprovidedpursuanttotheplanandthelevelofunderstandingof thematerialpresented. 28 4.35 Theorganizationprovidesseniorleadershipand boardmembercomplianceeducationandthey adjuststrategyandoperationsinresponsetothe trainingandotherinformationprovidedtothem. 4.36 Theorganization’sperformanceappraisalsandjob descriptionsincludetherequirementforemployees topromotecompliance.Employeesatalllevelsof theorganizationcananddoarticulatethe compliance/ethicsmessage.Thereisarequirement thatmanagersinsertcompliancemessagesinto meetingsandothercommunicationswithstaff. Performadocumentreview,conductemployeepersonalfileaudits,andintervieworsurvey employeestoensuretheorganization’scomplianceprogram,includingexpectationsand responsibilitiesareformallyandinformallycommunicatedtotheemployeepopulation. • Acomplianceprogramcommunicationplanis developedandimplemented. 4.39 • • Conductadocumentreviewtodeterminetheresponses/questionsposedbyseniorleaders andBoardmembersaftertraining. Evaluateeffectoftrainingontheorganization’soperationsandstrategy. TrackquestionsposedbyseniorleadersandBoardmemberstodeterminelevelof understandingofmaterialpresented. Communication: 4.37 4.38 • Thecompliancedepartment/staffregularlypresent complianceprograminformationandupdatesat staffmeetings,otherdepartmentmeetings,board meetings,townhalls,andotherforums. Theorganizationrequirescompliance representativestobepresentateverysenior managementandgovernance-levelmeeting. 4.40 Theorganizationprovidescomplianceinformation, training,andupdatesinamannerthatis understandableforemployees(readinglevel, languages,casestudies,verbalcommunication) • • • • • • • • Reviewtheorganization’scommunicationplantoensuretheplanaddresseskeymessaging foremployees. Conductfocusgroupdiscussionsandsurveyemployeesontheeffectivenessofthis messaging. Conductadocumentreviewtoensurethecompliancedepartment/staffregularlyprovide updatestotheorganizationandisavisiblepresenceatvariousmeetings. Confirmtheorganizationdocumentsandtracksallsuchpresentations. Conductadocumentationreviewtoverifythereisanexpectationforcompliancetobe representedatallseniormanagementandgovernance-levelmeeting. Confirmbyauditthatacompliancerepresentativehasattendedallsuchmeetings. Surveyemployeestodeterminetheeffectivenessandlevelofunderstandingbyemployeesto thematerialpresented. Conductpost-trainingevaluations. Reviewandtrackquestionsanddisclosuresmadefollowingthedisseminationofinformation andeducation. 29 4.41 4.42 4.43 4.44 Theorganizationensuresthereisadequatetwo-way communicationbetweenthecompliance departmentstaffandemployeessuchasperiodic check-inswithemployeesandfollow-upwith employeeswhoreportconcerns. Surveyemployeestodetermine: Competency: Theorganizationhasdefinedthecompetencies requiredforthecompliancestaffincluding requirementsforcertificationorotherspecific skills/expertise. Reviewjobdescriptionsandpersonnelfilesforallcompliancestafftoensurespecificcompliance competenciesandcertificationrequirementsaredesignatedandthestaffpossesstherequired competencies/certifications. • Theorganizationrequiresallcompliancestaffto maintaintheircompetencybyattendingappropriate • educationalsessions. • Theorganizationprovidesfocusededucationto compliancestaffmemberstoensuretheyare competentinevaluatingandinvestigatingissues. 4.45 • • • • • Conductadocumentationreviewtoverifythatrequirementsforcompliancestaffeducation, includingprofessionaldevelopment,areestablished. Audittoverifythatcompliancestaffattendeducationasrequired. Reviewcompliancedepartmentbudgettoensuresufficientresourcesaredevotedto providingappropriateeducation(includingconferences)tothecompliancestaff. Conductdocumentreviewtoevaluatetheeducationprovidedtocompliancestaff. Reviewtoensurecompliancestaffbeingtrainedonconductinginternalinvestigations,audits, performingriskassessments,vulnerabilityanalysis,etc. Developmentplanforcompliancestaff Reviewdocumentationofdevelopmentplanandmonitortoensurethatplanrequirementsare completedannuallyorasotherwisespecifiedintheplan Culture: 4.46 • Theorganizationhasestablishedacultureof compliance. • theirperceptionofhowaccessiblethecompliancestaffis, iftheyknowtoreportconcerns,and iftheybelievetheirconcernsaretakenseriouslyandareadequatelyaddressed. Incentives: Surveyallemployeestodeterminetheextenttowhichemployeesbelievethereisacultureof complianceintheorganizationandemployeeunderstandingofthecomplianceculture. Reviewtheorganization’scompliancetrainingmaterialtodetermineifscenariobased trainingand/orotherinteractivetrainingmethodsareusedtopromoteunderstanding. 30 4.47 4.48 4.49 Theorganizationhasestablishedmethodsfor Reviewincentive,rewards,andrecognitionsprogramstoensuresuccessfulachievementof rewardingandrecognizingemployeesforcompliance compliancemetricsareconsideredwhenrecognizingandrewardingemployeesandleadership. activities. VendorsandVolunteers: • Theorganizationhasestablishedthetraining requirementsforvendors. Theorganizationhasestablishedthecompliance trainingrequirementsforvolunteers. • • • • Conductdocumentreviewtoensuretheorganizationhasestablishedtrainingrequirements forvendors. Reviewfilestoensurevendorshavecompletedtrainingasrequired. Conductsitevisitstoreviewvendoremployeecompletionofrequirededucation. Conductdocumentreviewtoensuretheorganizationhasestablishedtrainingrequirements forvolunteers. Reviewfilestoensurevolunteershavecompletedtrainingasrequired. Element5:Monitoring,Auditing,andInternalReportingSystems A.Protectanonymityandconfidentialitywithinlegalandpracticallimits. B.Publicizethereportingsystemtoallworkforcemembers,vendors,andagents. C.Assuremonitoringoccursforviolationsoflawsandregulations. D.Conductorganizationalriskassessments. E.Developworkplanbasedonriskassessment. F.Maintainreportingsystem(s)toenableemployeestoreportanynoncompliance(e.g.,hotline). G.Respondtocomplianceconcernsexpressedbyemployeesthroughinternalreporting. H.Assuretheexistenceofproceduresformonitoringadherencetocompliancepoliciesandprocedures. I.Conductcomplianceaudits. J.Analyzecomplianceauditresults(e.g.,track,trend,benchmark). K.Developanannualcomplianceauditplan. L.Evaluateresultsofauditsconductedbyexternalentities. M.Monitorthatretaliationforreportingcomplianceconcernshasnotoccurred. N.Recognizeneedforattorneyconsultationintheauditing/monitoringprocess. O.Employauditingmethodologiesthatareobjectiveandindependent. P.Determinesamplingmethodologyconsistentwithcircumstances. Q.Assureatimelyresponseismadetoreportedcomplianceconcerns. 31 R.Monitormanagement’simplementationofcorrectiveactionplans. S.Providetimelyfeedbacktomanagementoncomplianceconcernsbasedonauditresults. Source:CHCCandidateHandbook:DetailedContentOutline Element5:Monitoring,Auditing,andInternalReportingSystems WhattoMeasure HowtoMeasure ReportingSystem: Accessibilityofreportingsystem Interviews.Surveys.Askemployeesandmanagersifthereportingsystemisaccessibletothem. Isitavailableinlanguagesthataremostspokenintheorganization? Adherenceto60-dayoverpaymentrule Reviewincidenttracker;ensuredaystoopenordaystoclosedonotexceedthattimeframe.Track effortstoidentify;statusbenchmarksspecificdaystocompletion. Trustinthesystem Survey-Doyoufeelyoucanfreelyreportethicsandcomplianceissueswithoutfearofretaliation frommanagers?(Yes/No/Don'tKnow). ReportingandInvestigationProcess Reviewexternalbenchmarkingreports(#ofcalls,timeittakestoclosecases,anonymous,etc.). Reportingsystem–complianceresponseto reporters Documentreview.Focusedgroupsandspeakingwithemployeesabouthotline. • Arecallsmadethroughreportingsystemresponsivetoreporters? • Arepoliciesfollowedregardingtheresponsetoreportsreceived? • Arereportsrespondedtoonregularintervalsandupdatedappropriately? ReportingSystem:Hotline/Directcontacts Documentreview,audit. • Arehotlinecallsormattersbroughttotheattentionofthecompliancedepartment (directcontacts)categorized,trended,andreportedtothecompliancecommitteeand boardlevelcommittee? • Aretheretracking,trendingandreportingofhowthesemattershavebeenresolved? Reportingtocompliance(hotline,reporttothe complianceofficers,etc.) Reportsreflectcommunicationmethods(call,anonymous,email,direct,etc.)? 5.1 5.2 5.3 5.4 5.5 5.6 5.7 32 5.8 Thoroughnessofinvestigationfiles Review5investigationfilesforsummaryofissue,interviewsconductedandsummaryof interviews,investigationsummaryandresults/conclusionandcorrectiveaction(asapplicable). Timetorespondtoincidentreport Reviewdatereported,dateresponded,dateinvestigationclosed. Promotionofreportingsystem Documentationreview.Interviews,visualwalk-throughs. • Arehotlinepostershanginginconspicuousareas? • Interviewstaff–dotheyknowhowtoreport? • Audituseofreportingsystem(howfrequentlyisitused)?Considerinternalorexternal reportingbenchmarks. Publishedreportingsystem Survey. • Isthereahotline,complianceofficer? • Howtoreport? • Howtofindinformation? Demonstrationofaformalcomplianceprogram Documentreview.Isthereidentificationofprioritizationofkeycomplianceindicators;reporting andescalatingtocomplianceoversightcommittee? Documentationtosupportresolutionofreported matters. Audit.Documentreview. Effectivenessofcompliancedepartment Documentreview,surveys,interviews,focusgroups. • Isthereareportcardonassociates’comfortlevel? • Dotheyknowwhotogotowithconcerns? • Dotheyknowwhomtotrust? • Istherefollow-through? • Whatisthetrustandintegrityaroundmembersofcompliancedepartment? 5.15 Disciplinefornon-compliance Documentreview,interviews.Monitortoensuredisciplinepoliciesarefollowed. 5.16 EffectivenessofFollow-uptoComplianceConcerns Interview/surveycallerforsatisfactionwithfollow-upofconcern. CultureSurvey Documentreview,assessmentofresponses.Doculturesurveysincludequestionssuchas: • Doyouknowhowtoreportconcerns? • Areyouwillingtoreportconcerns? 5.9 5.10 5.11 5.12 5.13 5.14 5.17 33 • Doyoutrustthatconcernswillbeaddressedfairlywhenreported? 5.18 Awarenessandeffectivenessofinternalreporting system Reviewsystemuse.Looktomakesureemployees,vendors,contractorscanreport;gaugethe levelofretaliation;individualcomfortofreportingsystems;survey.Conductinterviews. 5.19 Awarenessofthediscipline Survey. Hotlinereportingsystem/vendor Monitor. • Aretestcallsofthesystemconducted? • Arethecallsanswered? • Ifexternalvendor,aretheyfollowingtheorganization’sdocumentednotification protocol? Internalreportingfrombusinesspartners, contractors,etc. Contractreviewandinterviews. • Iscompliancedepartmentawareofthecontractswithbusinesspartners,contractors, etc.? • Isthereaninventoryofpartners? • Dotheyknowhowtocontactcompliancedepartmentwithissues? Investigationresolutionandtimeliness Documentationreview. • Arereportsclosedtimely? • Aretherecompletionnotesanddatesmattersandsubmittedtoboard? PresenceofInternalReportingSystem Reviewpoliciesandproceduresandmechanismsforinternalreporting.Aremattersbeing reportedaccordingtopolicy?Whatshouldbereportedupinregardstocompliance?Checktosee ifithasbeenreportedupappropriately. Processofhowaconcernishandled Reviewdocumentationthatreflectsthisprocess;auditcasefilestodemonstratethisdecision processwasfollowed.Isitamanagementissue,legalissue,other?Isthereatriagetree? Subordinateconduct Interviews.Documentreviews.Doesorganizationmeasurewhetherlinemanagersare monitoringtheconductoftheirsubordinates? Writtenescalationprocess Documentationreview.Isthereawrittenproceduretodetermineatwhatpointamattermustbe reportedtotheboard,committee,orgovernmentagency? RiskAssessments: RiskAssessment Documentation/processreview. • Isthereadocumentedenterprise-wideriskassessment? 5.20 5.21 5.22 5.23 5.24 5.25 5.26 5.27 34 • • • • 5.28 Whatistheworkplancreationprocess? Isinternalauditincluded? Isafraudriskassessmentconducted? Isthisinformationusedasabasisforcreatingtheauditingandmonitoringplanorwork plan? RiskAssessmentProcess Processmapofriskassessmentprocess. • Whoparticipates? • Howaretopicsprioritized? • Whatistheprocess? • Howaremitigationstepsdetermined? • Iseducationprovided? • Howaretheresultsreported? Riskbasedwork/auditplan Documentreview.Isthecompliancework/auditplanbasedonadocumentedriskassessmentand isitriskbased? Follow-uptoRiskAssessment Reviewprocessforfindingsofriskassessmentandwhetherimplemented;auditormonitor implementation;auditandmonitorasnecessaryafterimplementationtomitigaterisk(closingthe loop). 5.31 Frequencyofriskassessment,scopeandcoverage andtoolsusedforriskassessment Audittheriskassessmentprocessfortheseareas. 5.32 Informationflowfrombusinessunitstocompliance departmentfortheriskassessmentprocess Interviews. Internalauditdepartment’srelationshipwith compliancedepartment Documentreview,interviews. • Isriskassessmentutilizedtocreateannualauditplan? • Whoparticipatesintheriskassessment? • Arethereroutineinteractionsbetweencomplianceandinternalaudit? • Howmanyinternalaudithoursaredesignatedforcompliancerelatedwork? • Or,howareauditsdelegatedtointernalauditorcomplianceafterriskassessmentis completed? Isauditingandmonitoringbasedonriskareas identifiedinriskassessmentprocess Reviewriskassessmentprocessandwhatauditsandmonitoringareonworkplans. 5.29 5.30 5.33 5.34 35 5.35 Monitoringeffectiveness Documentreview.Isthemonitoringplanlinkedtoriskassessmentstomakesurehighestrisk areasarecovered? 5.36 Verifythatriskreportingisgoingtobusinessleadership;routineinclusionofrisksatcompliance committee;assessmentofeffectivefollow-upwhenriskresolutionisoff-track. Participationofbusinessleadershipinriskresolution MonitoringandAuditingWorkPlan: Methodtocreateauditplan Document/processreview. • Whatinternallyandexternallyareusedtocreatetheriskbasedplan? • Isareviewofsubmittedcorrectiveactionplansincludedinthereviewandplanning process? 5.38 Auditandmonitoringbasedonriskassessment Documentreviewcomparisonofaudit/monitoringplan. 5.39 Approvalprocessofworkplans ReviewminutesofBoardandComplianceCommitteemeetings. 5.40 Auditingandmonitoringprocess Documentandprocessreview.Howisannualworkplandeveloped?Whoisresponsibleforit? Aretheresufficientauditsconducted? Documentationreview.Lookatauditplan,including“adhoc”auditsthatwereunplanned,but conductedinresponsetoamatter. Auditinventory Documentreview.Isthereaninventoryofallauditsbeingconductedeitherbyinternalstaffor externalconsultantsintheorganization? 5.43 Compliancedepartmentroleinestablishingaudit plan Reviewofauditplanandprocesstoensurecomplianceiskeystakeholderandpartoftheprocess. 5.44 Definedprocesstohireoutsideexpertstoconduct audit/investigationandreview Reviewpolicyandproceduresandinterviewdecisionmakersontheprocessandcriteriatotrigger thehiringofoutsideexpertstoconductaudit/investigationandreview. Completionrateforcomplianceworkplan Auditordocumentreview. • Weretheitemsontheworkplancompletedbytheduedate? • Ifnot,docompliancecommitteeandboardlevelcommitteeminutesreflectdiscussion aboutthis? • Ifworkplanwaschanged,istherecompliancecommitteeandboardcommittee documentationtosupportthis? 5.37 5.41 5.42 5.45 36 5.46 Periodicreviewsofmonitoringandauditingplan Documentreview.Ismonitoringandauditingplanreviewedperiodicallyatthecompliance committeeandboardlevelcommitteetomakesureitisstillfitforpurposeandfocusedonhighriskareasfortheorganization? 5.47 Randomauditingisconductedtoidentifyunknown risks Portionoftheauditplanisbasedonrandomselection. 5.48 Effectivenessofgiftpolicyandprocedure SurveyongiftpolicyawarenessandauditgiftregistryorsystemforcompliancewithP&P. AuditProcess: 5.49 Theneedfortheadviceofcounselrelatedtoaudits Reviewofreferralprocesstotrackattorneyreferral.Isorganizationtrackingthatattorneyis consultedwhenauditfindingsnoteissues? 5.50 Validatetheorganizationisconductingaudits Processreview. 5.51 Auditresultsandactionsinresponsetoauditis reportedtothegoverningbody Reviewofminutes. 5.52 Auditresultsarepartofperformancereportsand/or Documentationreview. incentives 5.53 5.54 5.55 5.56 Authoritytoinitiateaudit Documentreview.Interviews.Audit. • Istheredocumentationoutliningwhoisauthorizedtoinitiateanaudit,includingthe engagementofoutsideconsultants? • Howisthisdone? • Howthoroughisit? Auditprocess Processreview.Documentationreview.Areauditsdefinedwithissue,scope,objectives,and resources? Accountability Createauditreportsforcomplianceauditsidentifyingpurpose,scope,sampleselection(if applicable),findings,conclusion,andrecommendations. Auditbenchmarks Auditofauditsforbenchmarking-Aretheauditfindingsactionable? Complianceauditresults Processreviewanddocumentreview. • Areauditresultsbeinganalyzed,tracked,trendedandreported? • Forexample,howoftenareeducationorpoliciesandprocedurechangesneeded? • Ismanagement(notcompliance)responsibleforcorrectiveactionplans? 5.57 37 • 5.58 Iscompliancemonitoringcorrectiveactionplanstocompletionandthenconducting follow-upauditstoensuretheactionsremaininplace? Meaningfulnessofaudits Reviewofaudittool. Reportresults Documentationreview. • Howisresolutionofdeficiencydocumented? • Howdoesthedepartmentdocument?Howdoesthedepartmenttrackwhatwas accomplished(metric:spreadsheet-database)? Reportingofauditresults Processreview.Documentationreview. • Areauditresultsarereportedtooperations? • ComplianceCommittee? • Governingbody? CorrectiveActionPlans: Depthandbreadthofrootcauseanalysis Auditandinterviewprocesstodetermineifproperdepthandbreadthofrootcauseofconcern andproperincorporationintocorrectiveactionplan. 5.62 Accountabilityofcorrectiveaction Reviewagendas,minutesandreportstocompliancecommitteeoncorrectiveactionplans. 5.63 Actionplansinresponsetoanauditfinding Auditofauditstoensureactionplansaredocumented. 5.64 Areidentifiedrefundstracked,documentedand returnedtimely? Auditandreviewofdocumentationtoensurecheckwentout. Auditandinvestigationtrending Validationreviewsofcorrectiveactionplans.Areauditandinvestigationfindingstrackedfor trends?Rootcauseanalysis?Fixforentiresystem? CorrectiveActionPlans Documentreview.Audit. • Isthereadocumentedfollowupprocesstomakesuremanagementhascompleteditems incorrectiveactionplans? • Werethecorrectiveactionssuccessfulincorrectingthedeficiency? • Arefollowupauditsconductedtoensurecorrectiveactionsdonotlapse? Reportingofuntimelycorrectiveactions Validationaudits/follow-upaudits.Ifthereareun-timelycorrectiveactions,aretheyreportedto thecompliancecommitteeandgoverningbody? Timelycorrectiveactions(newsafeguards/controls) Audittoensureauditshavecorrectiveactiondocumentedinatimelyfashion. 5.59 5.60 5.61 5.65 5.66 5.67 5.68 38 Auditors: 5.69 Auditingtheauditors Hirethirdpartytoauditauditorsorindividualcontributors;validateauditresults. 5.70 Auditorsdevelopauditinstructions Documentreview.Arethereguidelinesinplace? 5.71 Auditorsskillsetandcompetencytoaudittheissue Reviewauditworkproduct,personnelfiles,etc. Independence AuditforIndependence-Reviewtoensurenovestedinterestinoutcomes,meetindependence requirementasdefinedbyyellowbook. 5.73 Processtoevaluateauditorskillsettoensurethe rightauditresourcesareselected(internalaudit, outsideauditor,etc.) Reviewofauditorbackgroundandskillset. 5.74 Standardizationofauditprocess-auditorsapproach Auditreviewtomonitorforconsistency. auditsinthesameway Non-Retaliation: 5.75 Monitoringforretaliation Exitinterviews/employeesurveys. 5.76 Retaliation Surveys,focusgroups,individualquestioning,exitinterviews. Vendoroversight: 5.72 5.77 • Vendoroversight • Reviewvendorcertifications;trackconsequencesforvendorsnotadheringtocompliance program. Ensureallvendorcontractsincludeconsistentcompliancelanguage. 39 Element6:DisciplineforNon-Compliance A.Recommenddisciplinaryactionwhennoncomplianceissubstantiated. B.Promotedisciplineproportionatetoviolation. C.Promotedisciplineconsistentwithpoliciesandprocedures. D.Verifythatdisciplineisenforcedconsistentlythroughoutalllevelsoftheorganization. E.Monitorforconsistentdocumentationofdisciplinaryaction. F.Recommendactionforindividualsandentitiesthathavebeenexcludedfromgovernmentprograms. G.Verifythatcompliance-relatedviolationsareaddressedindisciplinarypolicies. H.Coordinatewithmanagementthattimelydisciplinaryactionistaken. I.Verifythatdisciplinaryactionisreportedtoregulatorybodywhenrequired. Source:CHCCandidateHandbook:DetailedContentOutline Element6:DisciplineforNon-Compliance WhattoMeasure Consistency: 6.1 HowtoMeasure Fairnessandconsistencyindisciplinaryprocess Sample–audit. • Isthedisciplinaryactionpolicyconsistentlyfollowed? • Doesthecompliancecommitteereviewandmeasurefairnessandconsistencyinpolicy application? • Auditdisciplinepersonnelfiles–considercreatingpredefineddisciplinematricesand auditagainstthese. • Interviewonperceptionofdisciplineapplied,surveyonperception. • Isdisciplinaryactioninproportiontomatter? • Isthereconsistencyforsimilarmatters? Approachtodeterminingtypeofdisciplinaryaction ReviewofP&P. • Auditing/testingtodeterminewhetherthereisacommonapproachtoanalyzingthe disciplineaspectofresolution. • Aretherestepsembeddedintoprotocol? 6.2 40 6.3 Complianceofficerinputintodisciplinaryaction decisions 6.4 Decision-makingparties InterviewCCO,outcomesreview,andaudit.Arecomplianceofficer’srecommendationstaken seriously? • • • • 6.5 Auditpersonnelfiles. Policyreview. Isthereadisciplinaryactioncommitteeapproachtoreviewresultsofinvestigationand previousactionsandtomakedecisions? Aretheappropriateparties(e.g.Legal,HR,Compliance,etc.)partofdisciplineactiondecisionmakingprocess? ThoroughnessofdisciplinaryP&P Reviewcriteriaofincludingcomplianceviolationsandwell-definedsanctionsforconsistent applicationofdisciplinarypolicies. 6.6 Timelinessofdisciplinaryaction HRauditoffiles.Istimelydisciplineandactioncarriedout? Awareness: Understanding Survey-Ispoorperformanceoncomplianceresponsibilitiesgroundsfordisciplinaryaction? Accuracy Verifyingthatpersoncompletedthecomplianceexpectationsthatwereattestedto. Compliancegoals Documentationreview.Isthereconsiderationofcomplianceactivitiesindailyactivities?Review performanceevaluations-Weregoalsaccomplished? Complianceincentives Processreview;interviewsofleadershipandstaffinterviews.Whatistheroleofcompliance whenitisimplemented? Incentivepolicy Documentreview,interviews,andfocusgroups. • Doestheorganizationdistributebadgesforcenters,ordepartmentsforparticipationin compliancetraining? • Aretherecontestsforcompliancetrainingandpublishingoftestscores? Distinctionbetweendisciplinaryactionandnonretaliation Interviews,reviewsofpolicies,etc.Assesstheeffectivenessoftheorganizationaldistinction betweendisciplineandnon-retaliationandmakesurethereareappropriateprotectionsregarding non-retaliation. 6.7 6.8 6.9 6.10 6.11 6.12 41 6.13 Educationtoensureemployeesknowexpectations Auditcommunicationsregardingexpectationsanddisciplinepossible.Comparepolicyand StandardsofConducttoensuretheyareclearregardingdisciplinaryaction. Employeeawarenessofdisciplinaryactionpolicy Interviews,surveys,etc.Doemployeesunderstandtherearedisciplineconsequencesfornoncompliance? Employee,vendor,contractorknowledgeofcodeof conductandtheircomplianceresponsibilities Auditdocumentation. • Doemployees,vendors,andcontractorsknowtheirresponsibilitiesregardingcodeof conduct? • Dotheysignannualattestations? Transparencyregardinglessonslearned Documentreview.Arethelessonslearnedfromdisciplinaryactionconveyedandusedasan educationaltoolfororganization? 6.17 Culture Survey-Doyoufeelemployeeswhoengageinimproperwork-relatedactivitieswillbecaught? 6.18 Non-retaliationforgoodfaithreporting Reviewdemotions,terminationsandconductemployeesurveys. 6.19 Proactiveeducationonviolationanddiscipline Reviewpolicyandprocedureandeducationandtraining Recognitionandappreciation Focusgroups,interviews. • Arethererecognitionandappreciationprogramsthatdonotincludeincentivizingwith money? • Forexample,aretherenewsletters,reportstogoverningbody,websiteannouncements torecognizethoseforexhibitingcomplianceandethicalbehaviorsandactions? Documentation: Disciplinetransparency Documentationreview.Arehigh-levelresultsfromdisciplinaryactionpublished(e.g.,#of terminations,#ofcounseling,#ofsuspensions,and#ofcorrectiveactionplans)? Oversight ReviewminutesfornumberofdisciplinaryactionsforcomplianceandHIPAAviolationsinlastyear reportedtotheComplianceCommittee(dashboard) Adequatedocumentation Review/auditdisciplinaryfilesforsupportingdocumentationofdisciplinaryaction. Complianceinbusinessplans Document,processreview. • Istherealeadershipscorecardthatincludescompliancemetrics? • Aretherecomplianceincentivesbuiltintobusinessplans? 6.14 6.15 6.16 6.20 6.21 6.22 6.23 6.24 42 6.25 Notificationoflicensingboards HRfileaudit-beforeissueisclosed,isdocumentationpresentandincludedintrackingsystem? 6.26 Policy Documentreview.Audit.Isthereadocumentedpolicyaddressingdisciplinefornon-compliance? Policyexceptions Filereviewofexceptions.Areexceptionstracked,documented,andevaluated?Whogetsto makethedecisionregardingexceptions?Isthisprocessdocumented? Reportingtoregulatoryauthorities Audit.Documentreview. • Lookatcriteriaforreportingandtimelinessachieved. • Auditcasesandtrack. • Ensuretimelyreportingtoregulatoryauthoritiesofpotentialviolationsanddisciplineto demonstrateorganization’scommitmenttocompliance. Scopeandinclusionofdisciplinaryactionpertaining totheculture Investigatebreadthofdisciplineandinclusion,auditdisciplinaryfiles,andconductinterview. Doesdisciplineincludethosewhoknowaboutitanddidn'treportitorcausedittohappenbutdid notactuallydoit? 6.30 Scopeofdisciplinaryaction Audittoverify-Aretheredisciplinaryactions/consequencesfornotreporting? 6.31 Systemallowsfordocumentationofcompliance issues Document/Systemreview.DoesHRsystemhavemechanismforrecordingandtracking complianceoffenses? PromotionCriteria: PromotionCriteria Reviewifcomplianceconsiderationswereincludedinpromotionprocessandcriteria. Seniorexecutiveperformancereviews Process,documentreview. • Beforepromotion,doescomplianceconductinterviewtoidentifyordiscusscompliance issues? • Doesheadofcomplianceparticipateinthereviewsofseniorexecutives? • Istheretalkaboutcomplianceinitiativeswithregardstoseniorexecutiveperformance reviews? Performancereviews Documentreview. • Isthererecognitionofcomplianceeffortsinperformancereviews? • Iscompliancebuiltintotheperformanceevaluationforrewardingemployeesand disciplinaryaction? 6.27 6.28 6.29 6.32 6.33 6.34 43 Element7:InvestigationsandRemedialMeasures A. Communicatenoncompliancethroughappropriatechannels. B. Assuredevelopmentofcorrectiveactionplansinresponsetononcompliance. C. Monitortheeffectivenessofcorrectiveactionplansinresponsetononcompliance. D. Assureremedialeffortsareimplementedtoreducerisk. E. Cooperatewithgovernmentinquiriesandinvestigations. F. Investigatemattersrelatedtononcomplianceinafair,objective,anddiscretemanner. G. Assurerecordsaremaintainedoncomplianceinvestigations. H. Participateinnegotiationwithregulatoryagencies. I. Assurethatoverpaymentstopayersarerefundedinatimelymanner. J. Collaboratewithlegalcounselregardingvoluntarydisclosures. K. Coordinateinvestigationstopreserveprivileges,asapplicable. L. Facilitateindependentinvestigationswhennecessary. M. Recommendmodificationofcorrectiveactionplans. N. Recognizeneedforsubjectmatterexperts. O. Assuredocumentsrelevanttoaninvestigationarepreserved. P. Assureinvestigationpersonnelhavethenecessaryskillsets. Q. Instituteimmediatemeasuresasnecessarytomitigateongoingharm. R. Recommendmeasurestoaddresssubstantiatedincidenceofretaliation. Source:CHCCandidateHandbook:DetailedContentOutline 44 Element7:InvestigationsandRemedialMeasures WhattoMeasure HowtoMeasure GuidelinesforConductinganInvestigation: 7.1 Theorganizationhasguidelinesestablishedto ensurethorough,credible,andcomplete investigationsaredoneinaconsistentmanner Reviewguidelines,policyandprocedureand/orprotocolonconductinganinvestigation. 7.2 Effectivenessofinvestigativeprocess Reviewprocessforcommonstepstoembedintoaprotocol.Conductabaselinereviewto understandwhatthemandatorypartsoftheinvestigationframeworkareandwhatmaychange duetosituationorcircumstance. • Istheoverallinvestigationprocessdrivenbyapolicyandprocedure,subjectmatterresource involvement,objectivereviewer? • Istheprocesstransparent(noteverythingplacedunderattorneyclientprivilege)? • Isthereadocumentedinvestigationsprocessorprocedure? • Areinvestigationsbeingconductedconsistentwithwrittenprocedures? • Istheresomethingthattriggersasentinelevent,immediatereporting,theneedforexternal consultantsorattorneys? • Whatistheapprovalprocess? • Whataretimelineswithregardsto60-dayrule? • Isthereacentralizedprocessforkeepingupwithallinvestigationsinprocess? • Howmuchflexibilityduetosituationorcircumstancesisappropriateandhowmuchneedsto becontrolled? • Nextyear,istheprocesstightenedupgoingforward? 7.3 Individualaccountabilityaspartofinvestigativeplan. Audit.Documentreview.Interviews. • Isthereabaselineinvestigativeplanthatoutlinescommunicationplanforinterviewing currentorprioremployees? • Doestheinvestigativeprocessincludespecialattentiontoindividualaccountability? • Isthereinvestigativemappingandoutlinetoaskquestionsaboutwhomaybeintheloopso compliancecanbesuretheyarenotpartofreportinggroup? • Arethereappropriateprotectionsforpeoplebeinginterviewedandtherepresentationof organization? 45 • Istheredocumentationthattheindividualisnotgivenassurancesthatthereareno repercussionsforhim/her? 7.4 Typeofdocumentationrequiredforremedial measuresandinvestigation Reviewpoliciesandproceduresonrecordretentionandtypesofdocumentation ContentofInvestigationFiles: 7.5 Assurerecordsaremaintainedoninvestigation Audittoask: • Isthereapolicyandprocedurefordocumentationthatneedstobemaintained? • Doinvestigativefilesmatchthepolicyrequirements(determinewhatshouldbeinthe attorneyfileversustheinvestigationfile)? 7.6 Qualityofthedocumentation Assesswhetherthewho,what,whenandhowisansweredineveryinvestigation;samplelog entries 7.7 Assuredocumentsrelevanttoaninvestigationare preserved Readwrittenpolicyandprocedureforinvestigationrecords;readinvestigationfilesofHR, compliance,and/orlegaltoconfirmcompliancewithretentionperiod QualityandConsistencyofInvestigations: 7.8 Qualityandeffectivenessofinvestigations Auditinvestigationstolookat: • qualityofquestionsaskedandcontentconsidered,involvedparties,andreportoutof findings; • didtheyinvolvetheappropriatepartsoftheorganization; • aretheybroadenough;and • didtheyuseinternalorexternalauditors? 7.9 Thoroughness,timelinessandconsistencyof investigationprocessamonginvestigators Auditinvestigationfiles 7.10 Triageprocess • • 7.11 ConsistencyofInvestigations Multipleanonymous(mock)reportsondifferentissuestotestprocess Auditprocesstoreviewwhetherallegationswereappropriatelyandtimelyhandled Dryrun,test,mockreport 46 7.12 Credibilityofinvestigationandremediationprocess tothirdparties Demonstratingitbymockpresentation(devil’sadvocate)-roleplayingwhataregulatormightask regardingtheinvestigationandremediationprocess. TrackingandTrendingInvestigations 7.13 Investigationcategorizationprocessandtrending Documentationreviewandaudittrackingsystem.Areinvestigationsbeingcategorizedsothey canbetracked,trendedandreportedtocompliancecommittee,seniormanagementandboard? 7.14 Retainingdocumentationofinvestigationsinrecords Reviewofdocumentationinsystem managementsystem(tracking,trending,review) 7.15 Documentingwhenissueissubstantiatedornotand Reviewreports/process reporting/trending 7.16 Compliancelog(logandtrackinvestigations) • • • EscalationofInvestigations 7.17 Ensureadequateandtimelyescalationof investigationoutcomes Auditsampleofinvestigationfiles 7.18 Significantinvestigationsarereportedtothe governingbody Reviewboardminutes,reviewpoliciesrelatedtoboardreportingrequirements. 7.19 Investigationreportingtoseniorleadershipand board Documentreview,interviews.Areinvestigationsbeingreportedtoseniorleadershipandthe board? CommunicationofInvestigationOutcomes 7.20 Theappropriatecommunicationoftheinvestigation outcomes(education) • • Doesalogexist; Doesithaveinvestigationsandactionstaken;and Aretheresupportingfilesforeachentrysothattheycanbereportedon(HR,Billing)toreport thetrends? Conductanassessmentattheconclusionofaninvestigationofadditionalcommunicationto theorganizationfororganizationallearningandcultureofcompliance Documentreviewofmeetingminutesand/orinterimreports.Wereinvestigationsresults reportedtoseniorleadershipandboard?Howweretheresultscommunicated? 47 • Reviewhowresultsofinternalinvestigationsaresharedwiththeorganization'sgoverning body,leadershipandrelevantdepartments. 7.21 Culture Surveyforwhetheremployeesbelievethatmanagementand/orthecomplianceofficerfollowsup onreportsofcomplianceconcernsandtakesappropriateactionwhenevernecessary? (Yes/No/Don'tknow) 7.22 Perceptionofinvestigationresultsbyemployeesand Focusgroupsorsurveyofemployees stakeholders 7.23 Communicatenoncompliancethroughappropriate channels Readworkgroupmeetingminutesoremailstodeterminedistributionlistincludesappropriate individuals(stakeholders,decisionmakers) TrainingofInvestigators 7.24 Staffwhoconductinternalinvestigationshavethe educationnecessarytoconductinvestigations Peerreviewonsimilarorganizations.Reviewofcertificationsandeducationprovided. 7.25 Numberofemployeeswithappropriatecertifications Reviewlistofinvestigatorsandtheircertifications thatareconductinginvestigations 7.26 Investigatorshavetheskillset Interviewinvestigatorsandlookatworkproductforfacts 7.27 Training/competencyofinvestigators • • ProfessionalismandCompetencyofinvestigators 7.28 Ensuringinvestigatorsareconductinginvestigationin Interviewsubjects professionalandrespectfulmanner 7.29 Professionalismandeffectivenessofinvestigators Conductandobservemockinterviews 7.30 Strengthandcredibilityofinvestigationprocess Roleplayofinvestigationprocess 7.31 Investigatemattersinafairmatter,objectiveand discreetmanner Peerbenchmarkingtoevaluate: • thetimeitshouldtaketoconductaninvestigation; Evaluatetrainingtranscripts,trainthemoninvestigationtechniques; Reviewthetypeoftraininganyoneconductinginvestigationshasreceivedoverthepast2 years 48 • whatpeersdotomakesureinvestigationsoccurdiscreetlyandtimely Independenceofinvestigator 7.32 Objectivityofinvestigator Interviewsbyexternalsourcewithgoaltoensurenointernalorganizationalpressureonthe investigatorsthatisimproper. 7.33 Assessinguniformityofusingoutsidecontractorsand Reviewpoliciesandproceduresandauditfilesforcompliance expertsintheinvestigationprocess 7.34 IndependenceandObjectivityofInvestigation Reviewpoliciesandprocedures,surveyemployeeperception,qualitycontrolprocess,etc. 7.35 Independenceofinvestigation(nointimidationis occurring) Workproductandinterviews;qualityofprocess(avoidreportingstructureconflictsofinterest; direct-report) InvolvementofLegalCounsel 7.36 Coordinatinginvestigationstoprotectprivilegewhen Auditagainstpoliciesandprocedurestodetermineappropriateattachmentofprivilege necessary 7.37 Collaboratingwithlegal • • • Lookatworkproducttodeterminequality; Ensurecomplianceleadstheinvestigation(unlessinvestigationisbeingconductedunder privilege); Interviewcomplianceofficerandlegalcounseltodeterminethelevelofcollaboration. TimelinessofResponse 7.38 Areimmediateactionstakenimmediately Auditinvestigationoutcomestoseeiftimely 7.39 Complianceofficerauthority Interviews,documentreviews.Ifconcernisraisedanditisharmful,managementneedsabilityto reactimmediatelyevenifitisbeforeinvestigationiscomplete.Doesthecomplianceofficerhave theabilityandauthoritytostopanaction(e.g.,billing)? 7.40 Timetoinvestigationclosure • • Tracktimelinessagainstbenchmarkestablishedbyorganization; Documentationreview.Islengthtocloseinvestigationsbeingdocumented,tracked,trended andreported? 49 • Areresolutionactions(e.g.,education,newpolicy/procedure,correctiveactionplan, disclosure,repayment,etc.)beingdocumented,tracked,trendedandreported? 7.41 Timelyprocessingofrefunds,self-disclosures Audit,monitor,documentreviewofinvestigationsthatresultedinrefunds,disclosurestoensure theywereprocessedinatimelyfashion. 7.42 Self-Disclosureguidelines Documentreview,interviews. • Aretherewrittenguidelinesforself-disclosures? • Dotheyaddressmembersimpacted,informationtobesharedwithregulators? CorrectiveActionPlans/RemedialMeasures 7.43 Businessleadersareaccountableforfollow-upto investigations • • • 7.44 Effectivenessofcorrectiveactions Documentationreviewofcorrectiveactionstimeframesmet,issuesclosedout,effective resolution. 7.45 Structure Reviewhowcorrectiveactionplansarecreated 7.46 Validatethatcorrectiveactionplansareappropriate, Review3correctiveactionplanstoensureidentifiedallissuesandconductvalidationvisits implementedandeffective 7.47 Accountability • • 7.48 Ensureremedialmeasureforlikefindingsare consistentlyimplemented Audit 7.49 Measuringsufficiencyofcorrectiveactionplansthat aredeveloped Samplecasesthatweresubstantiatedandreviewthecorrespondingcorrectiveactionplansto ensuretheyrespondtoissuesidentifiedininternalandexternalauditsandinvestigations 7.50 Remedialactions-Appropriateremedialaction occurred Reviewinvestigationdocumentation,PowerPoint,trainingattestationisinthefile. Verificationthatinvestigativereportissharedwiththoseresponsibleforfollow-up. ClosurereportsareprovidedtoComplianceCommittee. Auditpostinvestigationtoensureresolutionismaintained. Reviewhowcorrectiveactionplansaretracked; ReviewhowcorrectiveactionplansarereportedtoComplianceExecutiveCommittee 50 7.51 Ensureremedialeffortsareestablishedtoreduce risk Basedontheoutcomeoftheinvestigation;deficiencywasfixed,evidenceitwasfixed,thereare otheritemstoreview(ex.Chargemaster)lookatthedownstreamimpact-employees,systemic issues(beyonddisciplinaryaction) Rootcauseanalysis 7.52 Conductrootcauseanalysistodetermineiffindings needtobeaddressedinotherpartsofthe organization Auditdocumentation 7.53 Resolutionofinvestigations Audit.Wasrootcauseresolved? 7.54 Accountability/Structure Obtainalistofadhoccommitteesformedaroundspecificcomplianceissueoverthelast2years Adherencetonon-retaliationpolicy 7.55 Monitoringhowthereporterfeelsabouthaving reported Interview 7.56 Ensureconfidentialityofinvestigationprocess Surveyorfocusedgroups,interviewparticipantsininvestigations 7.57 Exitinterviewprocessqueriesforretaliation Reviewofexitinterviewprocess 7.58 Culture:Retaliation Surveys,interviews,exitinterviews. • Isthereapolicystatementinnewemployeeorientation? • Aretherecommunications? • Doemployeesknowhowtoreportpotentialinstances? • Doestheorganizationconductculturesurveys? • Isthereapolicystatementregardingnoobstructionofinvestigation? 7.59 Adherencetonon-retaliationpolicy Surveyparticipatesininvestigationtodetermineiftheyfeltorfearedretaliation 7.60 Substantiatedretaliation Audit GovernmentInquires/Investigations 51 7.61 Cooperatewithgovernmentinquiries/investigations • • 7.62 Strategicrelationshipwithregulators Interviews. • Isthereafocusedapproachtobuildingrelationshipswithregulators? • Doesstaffseekoutregulatorsatconferences,etc.tobuildrelationships? 7.63 Mockpresentations Documentationreview.Interviews. • Doestheorganizationconductmockpresentations(e.g.,in-houseattorney“acts”as governmententity? • Compliancepresentsadisciplinepartofcomplianceprogramtoin-houseattorneyfor his/herreviewandcomment.) MonitoringResults 7.64 Validationthatinvestigationsarecomplete Auditcreditreceivedforcooperation; Readrecordsthatcontaingovernmentcorrespondencewithentity.Reviewandconfirm appropriateresponsesweresubmittedonorbeforerequesteddate. • • • Auditing,documentationreview,interviewsafterinvestigationsarecomplete. Isthereadocumented(3-6-9months)timingintervaltoassesswhether“actionhastraction?” Isthereaprocesstogobackandprioritizeorverifythatplansorworkunitsarefollowing throughonrecommendedactions? Documentationreview. Isthereananalysisofinvestigationstohelpinformfutureworkplans? 7.65 Reviewofinvestigationsinfutureworkplanning • • 7.66 Longtermeffectivenessofremedialmeasures Audit-oneyearofremedialmeasureswhereactivemonitoringended6monthspriortovalidate thatremediationstillinplace 7.67 Howlargerlessonscanbeconveyedtothe organization COcouldreviewannuallythereportstotheboardorbroadercommunicationstotheentire organization;revieweducationontrendsandthemes. AwarenessofInvestigationProcess 7.68 Educationoninvestigationsprocess 7.69 Strategicrelationshipwithriskpartners(i.e.,Legal, HR,riskmanagement,etc.) • • Audit,monitortrainingrecordsandeducationalcontent. Istrainingregardingtheinvestigationsprocessprovidedathireandongoingsoemployees knowwhattoexpectregardingtheinvestigationsprocess? Interviewriskpartnerstodetermineinteraction,involvement,knowledge. 52 ContractProvisionsregardingInvestigations 7.70 Thirdpartyandnon-employedcliniciancontractsto ensuretheyhaveanobligationtocooperatein investigations. 7.71 Inventoryofrequirementsincontracts • Contractreview. • Inventoryofagreementswith3rdpartiesandnon-employedclinicianstomakesurethey understandtheirobligationtocooperatewithinvestigations. Audit.Documentreview.Aretherestandardtermsthatmustbeincludedincontracts?A templatecanbeusedtoensureallrequirementsareincontracts. 53
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