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ERNAssessmentManualforApplicants

8. Self-AssessmentChecklistforHealthcareProvidersinActivePDF

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Version 1.1 April2016

ThisdocumentcontainstheSelf-AssessmentChecklistforHealthcareProvidersinActivePDF.Itispartofseriesofninedocumentsthatincludethefollowing:

1. ERNAssessmentManualforApplicants:DescriptionandProcedures2. ERNAssessmentManualforApplicants:TechnicalToolboxforApplicants3. ERNAssessmentManualforApplicants:OperationalCriteriafortheAssessmentofNetworks4. ERNAssessmentManualforApplicants:OperationalCriteriafortheAssessmentofHealthcare

Providers5. NetworkApplicationForm6. MembershipApplicationForm7. Self-AssessmentChecklistforNetworksinActivePDF8. Self-AssessmentChecklistforHealthcareProvidersinActivePDF9. SampleLetterofNationalEndorsementforHealthcareProviders

This series of documents of the Assessment Manual and Toolbox for European Reference Networks has been developed in the framework of a service contract funded under the European Union Health

Programme.

Preamble

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SELF-ASSESSMENTCHECKLISTFORHEALTHCAREPROVIDERS

INTRODUCTION

InaccordancewiththerequirementsoutlinedintheImplementingDecision2014/287/EUAnnexII(b),themembershipapplicationtojoinaNetworkmustbesubmittedinresponsetoacallforinterestpublishedbytheCommissionandmustinclude:thecompletedapplicationformwiththeself-assessmentquestionnaireandsupportingdocumentationrequiredintheassessmentmanual(Seepage23oftheERNAssessmentManualforApplicants).

Theself-assessmentprovidesHealthcareProviderswiththeopportunitytoevaluatethemselvesagainstthespecificlegislatedcriteriaandconditionsbeforesubmittingtheirapplicationtotheEuropeanCommission.

Inaddition,theself-assessmentprovidesamechanismforboththeIndependentAssessmentBodyandtheHealthcareProvidertocollaborateonassessingcomplianceagainsttheOperationalCriteria.Theinformationsubmittedwillhelpsupportathoroughdocumentationreviewandplantheon-siteaudit.

DESCRIPTIONOFTHESELF-ASSESSMENTTOOL

Thefollowingself-assessmentchecklistisdividedintonine(9)distinctsections.Theseincludethefollowing:

GeneralcriteriaandconditionsforHealthcareProviders11. PatientEmpowermentandPatientCentredCare2. Organisation,Management,andBusinessContinuity3. Research,Education,andTraining4. Expertise,InformationSystems,ande-HealthTools5. QualityandSafety

SpecificcriteriaandconditionsforHealthcareProviderswithregardtotheareaofexpertise,diseaseorcondition2

6. Competence,Experience,andOutcomesofCare7. HumanResources8. OrganisationofPatientCare9. FacilitiesandEquipment

1CommissionDelegatedDecision(2014/286/EU)–AnnexII2CommissionDelegatedDecision(2014/286/EU)–AnnexII

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Thesenine(9)sectionsarebasedontherequirementssetoutintheDelegatedDecision2014/286/EAnnexII.EachsectionincludesmultipleitemstohelptheHealthcareProviderevaluateitsreadinesstosubmitanapplication.TheseitemsarebasedonthoseOperationalCriteriathattheEuropeanCommissionandIndependentAssessmentBodywillusetoassesscompliancewiththelegislation.Notethatacompleteself-assessmentmustaccompanytheApplicationFormfortheapplicationtobeconsidered.

INSTRUCTIONSFORCOMPLETINGTHESELF-ASSESSMENT

1. EstablishamultidisciplinaryteamconsistingoftheHealthcareProvider’sRepresentativeandcareproviderrepresentation.

Theteamshouldbegivensufficienttimetocompletetheself-assessment.Completingtheself-assessmentasateamincreasesthevalueoftheprocessandaccuracyoftheinformation.Itisestimatedtotakeapproximatelythreetofourmeetingswithtimeallocatedbetweenmeetingspendingvolumeofitemsrequiringfurtherinvestigationortheneedtosubmitrequireddocumentationtosupportevidenceofcomplianceinthatarea.Ateamleadershouldbeappointedtoorganizethegroup,assigntasks,andcoordinatetheself-assessmenteffort.

2. ReadandreviewtheOperationalCriteriainitsentiretybeforebeginningtheSelf-Assessmentprocess.Ifpossible,makecopiesandsendthemtoteammembersbeforethefirstmeeting.

3. DiscusseachindividualelementintheSelf-AssessmentChecklistandevaluatetheprogressinimplementingit.Asnecessary,verifythelevelofimplementationwithotherindividualsoutsideoftheteam.Documentthisinformationinthe“Comments”sectionofthechecklist.

4. Onceconsensusisreached,completethetablebelowbymarkingtheboxthatmostappropriatelycapturesthecurrentstatusofcompliancewiththecriterion,usingfollowingratingscaleandscoringguide:

Rating Guidelines0:Noactivity/NotImplemented

AllCriteria:thisratingisusedwhenthereisnoactionplaninplaceorthereisinsufficientevidencetosupportcompliance.ThisratingmayalsobeusedwhenthepracticeisnotimplementedinanyoftheHealthcareProvidersoftheNetwork(ifapplicable).

1:PartiallyImplemented AllCriteria:thisratingisusedwhenthereisanactionplaninplaceorthereissomeevidencetosupportcompliance.ThisratingmayalsobeusedwhenthepracticeisimplementedbysomeoftheHealthcareProvidersoftheNetwork(ifapplicable).

2:FullyImplemented AllCriteria:thisratingisusedwhenthereissufficientevidencetosupportcompliance.ThisratingmayalsobeusedwhenthepracticeisimplementedbyalloftheHealthcareProvidersoftheNetwork(ifapplicable).

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5. Repeattheprocessforeachelement.Oncecomplete,tallyupthescoreforeachsectionusingthetemplateprovidedinAppendixA.Refertothoseareasinwhichyourpercentageperformanceindicatesthegreatestopportunitiesforimprovement.

6. UsethisinformationtodevelopanActionPlantoimprovereadinesstosubmittheapplicationandcompletetheassessmentprocess.

1. Priortofinalizingandsubmittingtheself-assessment,aprocesstovalidatetheresultsinternallyshouldbefollowed.Thepurposeoftheinternalvalidationisto:

• Providealevelofqualityassurance;• Confirmthattheself-assessmentsareaccurateandthereforecanbesharedexternally;• IdentifyanyinconsistencyinpracticeacrosstheNetwork;and• IdentifyareasofbestpracticethatcouldbesharedacrosstheNetwork.

ItistheNetwork’sresponsibilitytodeterminehowtheinternalvalidationwillbecompleted.TheNetworkmustensurethattheprocessusedmeetsthefollowingrequirements:

• Theprocessisfairandrobust;• TheprocessisagreedtobyallHealthcareProviders;• Accountabilityfortheself-assessmentisagreedtobytheChiefExecutiveOfficerofthe

HealthcareProvider;and• Theprocessincludespatientandfamilyinvolvement.

7. Attheconclusionoftheinternalvalidation,theself-assessmentteamshouldcheckandrecordanychangesintheself-assessment.

8. CompleteandsigntheDeclarationForminAppendixCoftheself-assessment.

9. SubmitthecompletedSelf-AssessmentalongwiththeApplicationFormnolaterthanthedeadlineforapplicationsinresponsetotheCallforExpressionInterest.TheHealthcareProvidermusthavereadyatthetimetheapplicationissubmittedallsupportingdocumentationlistedinAppendixB.ThesedocumentsshouldbemadeavailabletotheIAB,attheirrequest.

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THESELF-ASSESSMENTCHECKLISTTOOLFORHEALTHCAREPROVIDERS

1. PATIENTEMPOWERMENTANDPATIENTCENTREDCARE

1.1 TheHealthcareProviderhasstrategiesinplacetoensurethatcareispatient-centredandthatpatients’rightsandpreferencesarerespected.

MeasureElementsRating(0or1or2)

Comments 3*

1.1.1TheHealthcareProvider’scommitmenttopatient-centredcareisformallyandconsistentlycommunicatedwithpatientsandtheirfamilies.

1.1.2Processesareinplacetoassistpatientsandtheirfamiliesinknowingwhoisprovidingtheircare,andtheroleofeachpersononthemultidisciplinarycareteam.

1.1.3Patienteducationmaterialsappropriateforreadersofvaryingliteracylevelsandforspeakersofdifferentnativelanguagesareavailable.

1.1.4TheHealthcareProviderprovidespatientsandtheirfamilieswithwritteninformationaboutthefacility,theorganization,anditsspecificareaofexpertise.

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1.1.5TheHealthcareProvidergivespatientsandtheirfamilieswritteninformationabouttheirrightsandresponsibilities.

1.1.6Thereisapolicyandprocedureinplacetodiscloseunanticipatedoutcomesandcomplicationstopatientsandtheirfamilies,asappropriate.

1.2 TheHealthcareProviderprovidespatientswithclearandtransparentinformationaboutthecomplaintsproceduresandremediesandformsofredressavailableforbothdomesticandforeignpatients.


Comments 3*

1.2.1Patientsandtheirfamiliesaregiveninformationabouthowtofileacomplaint,reportviolationsoftheirrights,andraiseconcernsabouttheircareand/orsafety.

1.3 TheHealthcareProviderregularlycollectsinformationonpatientcareexperiencewithintheNetwork’sareaofexpertiseandusesthisinformationtomakeongoingimprovements.


Comments 3*

1.3.1TheHealthcareProviderroutinelymeasuresorfacilitatesthemeasurementofpatientandfamilyexperienceusingastandardisedvalidatedquestionnaire.Thisinformationisperiodicallyreportedtoallhealthcareprofessionalsandmanagersinvolvedindeliveringcare,patientsandfamilies,andthegeneralpublic.

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1.4 TheHealthcareProviderprotectstheprivacyandconfidentialityofpatienthealthinformation.


Comments 3*

1.4.1TheHealthcareProviderensuresaccesstomedicalrecordsandclinicalinformationisincompliancewithEUdataprotectionprovisionsandnationalimplementingmeasures,inparticular,Directive95/46/EC.

1.5 PatientinformedconsenttosharepersonalhealthinformationcomplieswiththerequirementssetoutinArticle2(e)oftheDirective2014/286/EU.


Comments 3*

1.5.1Ifpatientpersonalhealthinformationisexchanged,patientsareinformedoftheirrightsundertheapplicabledataprotectionrulesandinformedconsentisobtained.TheHealthcareProviderhasapolicyandstandardprocedureforobtaininginformedconsent.TheInformedconsentisdocumentedinthepatient’smedicalrecord.

1.6 TheHealthcareProvidermaintainstransparencybyprovidinginformationtopatientsandthegeneralpublicaboutclinicaloutcomes,treatmentoptions,andqualityandsafetystandardsthatareinplace.


Comments 3*

1.6.1TheHealthcareProviderpresentspatientsandtheirfamilieswithreliableinformationonclinicaloutcomesinaformthatisusefultothem.

1.6.2Allrelevantinformationmustbeprovidedtopatientsinananonymizedformat,includingclaimsdata,patientregistrydata,clinicaldata,andpatient-reportedoutcomes.

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1.6.3Everypatientisprovidedwithafulldescriptionoftheavailablealternativesfortestsandtreatments,aswellastheprosandconsforeach,andthepotentialrisksandbenefits.

1.6.4TheHealthcareProviderdisseminatesinformationtopatientsandtheirfamiliesonpatientsafetystandardsandsafetymeasurestoreduceorpreventerrors.

1.7 TheHealthcareProvideristransparentaboutallpossibleconflictsofinterestrelatedtotreatmentand/orresearchactivities.


Comments 3*

1.7.1TheHealthcareProviderensuresdisclosureofallfinancialandnon-financialconflictsofinterestrelatedtotreatmentand/orresearchactivities.

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2. ORGANISATION,MANAGEMENT,ANDBUSINESSCONTINUITY

2.1 TheorganizationfollowsadocumentedsetoforganizationandmanagementrulesandproceduresforservicesprovidedwithintheNetwork’sareaofexpertise.


Comments 3*

2.1.1Managementandstaffand/orclinicianrolesandresponsibilitiesspecifictotheareaofexpertiseareclearlydefinedinanorganizationchart.

2.1.2TheHealthcareProviderestablishesandmaintainsasetofpoliciesandproceduresaddressingaspectsofmanagementandactivitiesorserviceswithintheNetwork’sareaofexpertise.

2.1.3TherearepoliciesandproceduresformanagingcrossborderpatientswithintheNetwork’sareaofexpertise.

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2.2 TheHealthcareProvidersharesinformationwithpatientsandtheirfamiliesaboutanytariffsthatmaybeinplaceforthereimbursementofcare,includinghowthesearecalculated.


Comments 3*

2.2.1TheHealthcareProviderprovidespatientsandtheirfamilieswitheasyaccesstoinformationregardinganytariffsthatmaybeinplace,services,andbenefits.

2.3 TheHealthcareProviderhasabusinesscontinuityplan.

MeasureElements Rating Comments 3*

2.3.1Theplanincludestheprovisionofessentialmedicalcareinthecaseofunexpectedresourcefailure,orreferraltoalternativeresources,ifnecessary;andmaintainingstability,technicalcapacityandexpertiseoftheprovider,suchasaplanforhumanresourcesandupdatingtechnology.

2.4 TheHealthcareProviderestablishesproceduresand/orinter-agencyorsharedcareagreementstosupporteaseofaccessandcoordinationwithotherresources,specificunits,orservicesnecessaryformanagingpatients.


Comments 3*

2.4.1Thereareproceduresforemergenciesandpatientspresentingoutsidenormalworkinghours.PatientswithintheNetwork’sareaofexpertisecanbeadmittedwithoutdelaytoasuitablehospitalwardservicearea,wherenecessary.

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2.4.2Whennecessary,theHealthcareProviderhaseasyaccesstoothercentresorhighlyspecialisedunitsoutsideitsownfacilitiesnecessaryfordiagnosis,treatment,anddeliveryofcaretopatients.

2.5 TheHealthcareProviderhasavailableandmaintainsgoodgeneralfacilitiesinaccordancewithitsareaofexpertise.


Comments 3*

2.5.1Treatmentofpatientstakesplaceindedicatedclinicalareasthatareeasilyaccessible,clean,comfortable,quietandappropriatelyequipped.

2.6 Therearepoliciesandproceduresinplacetocommunicatewithclinicianspostdischarge,includingcrossborder.


Comments 3*

2.6.1TheHealthcareProviderprovideslocalclinicianswithcompletedischargesummariespostdischargeforallpatients.

2.6.2Wherepossible,theHealthcareProviderusesinformationandcommunicationtechnologies,suchaseHealthtools,telemedicine/tele-expertise,andcasemanagementtoolstofollow-uppostdischarge.

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3. RESEARCH,EDUCATIONANDTRAINING

3.1 TheHealthcareProviderparticipatesineducationandtrainingactivities,suchascontinuingmedicaleducationanddistancelearning,aimedatstaff,students,andothercareprofessionals.


Comments 3*

3.1.1TheHealthcareProviderdeliversuniversity,post-graduate,orspecialisedlevelofeducationandtrainingintheNetwork’sareaofexpertise.

3.1.2TheHealthcareProviderhasadefinedsetofobjectivesforitseducationandtrainingactivities.

3.1.3TheHealthcareProviderprovidesevidencethatresourcesareavailable,i.e.human,technical,orphysicalstructure,tosupporteducationandtrainingactivities.

3.1.4EducationandtrainingactivitiesaredeliveredtoprovidersinvolvedinthesamechainofcarewithinandoutsidetheHealthcareProviderfacility.

3.1.5TheHealthcareProviderevaluatestheeffectivenessofitseducationandtrainingactivitiesonanannualbasis.

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3.2 TheHealthcareProviderhasthecapacitytocarryoutresearchactivitiesanddemonstratedresearchexperience.


Comments 3*

3.2.1TheHealthcareProviderprovidesevidencethatadequateresourcesareavailable,i.e.human,technical,orphysicalstructure,tosupportresearchactivities.

3.2.2TheHealthcareProviderleadsand/orparticipatesinresearchactivitiesandclinicaltrials,atbothanationalandinternationallevel,withintheNetwork’sareaofexpertise.

3.2.3TheHealthcareProviderfollowsasetofStandardOperatingProcedures(SOPs)thatgovernresearchactivities.

3.2.4Thereisaproceduretoreviewtheethicalimplicationsofresearchactivities.

3.2.5TheHealthcareProvidermaintainsandmanagesrecordsofresearchactivitiesandclinicaltrialsinaccordancewithinstitutionalpoliciesandsetlawsandregulations.

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3.2.6TheHealthcareProvidersharestheresultsofitsresearchactivitiesandclinicaltrialsthroughscientificpublications.Theresultsshouldbedisseminatedtoothercentresandprofessionalandpatientassociations.

3.2.7TheHealthcareProviderevaluatestheeffectivenessofresearchactivities.

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4. EXPERTISE,INFORMATIONSYSTEMS,ANDE-HEALTHTOOLS

4.1 TheHealthcareProviderisabletoexchangeexpertisewithotherprovidersandprovidesupporttothem.


Comments 3*

4.1.1TheHealthcareProvideroffersanadvisoryservicetoexchangeexpertisewithotherprofessionalsandcaregiversinvolvedinthepatients’treatment.

4.1.2TheHealthcareProvidermaintainsanaccuratedatabaseofpatientsunderitscarewithintheNetwork’sareaofexpertise.

4.2 TheHealthcareProvidersafeguardstheuseofmedicaldatawithintheNetwork’sareaofexpertise.


Comments 3*

4.2.1TheHealthcareProviderfollowsestablishedprocedurestomanage,safeguard,andexchangemedicaldata.TheseproceduresareinaccordancewiththeEUdataprotectionlegislation,inparticular,withDirective95/46/ECandwithArticle2(e)oftheDelegatedDecision2014/286/EU.

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4.3 TheHealthcareProviderfosterstheuseoftelemedicineandothere-healthtoolswithinandoutsideitsfacility.

4.3.1Tosupporttheuseoftelemedicineandothere-healthtools,theHealthcareProviderfulfilstheminimuminteroperabilityrequirementsandwhenpossible,usesagreedtostandardsandrecommendations.

4.4 TheHealthcareProviderscodingandinformationsystemisinlinewithnationallyandinternationallyrecognisedsystems.


Comments 3*

4.4.1TheHealthcareProviderusesastandardisedinformationandcodingsystemforrareorlowprevalencecomplexdisease(s)orconditions(s).

4.4.2TheHealthcareProviderhasproceduresinplacetomonitorandmaintaindataquality.

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5. QUALITYANDSAFETY

5.1 TheHealthcareProviderregularlymonitorsthequalityandsafetyofthecareitprovidestopatientswithrareorlowprevalencecomplexdiseasesorconditions.


Comments 3*

5.1.1TheHealthcareProviderhasaqualityassuranceormanagementsysteminplacethatincludesprocessestoregularlymonitorthequalityofitsperformancewithintheNetwork’sareaofexpertise.Theinformationitcollectsisusedtomakeongoingqualityimprovements.

5.1.2TheHealthcareProviderregularlycollectsandmonitorsprocessandoutcomeindicators.

5.1.3TheHealthcareProviderhasapatientsafetyprogrammeorplaninplaceadaptedtotheNetwork’sareaofexpertise.

5.1.4Thereisaprocedureinplacetoreport,document,investigate,andlearnfromadverseeventsandcomplications.TheHealthcareProviderusesthisinformationtomakeongoingimprovements.

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5.1.5TheHealthcareProvidercontributesperformanceandoutcomedatatoevaluatetheNetwork,asawhole.

5.2 TheHealthcareProviderdemonstratesacommitmenttousingbestpracticeknowledgeandevidencebasedhealthtechnologiesandtreatments.


Comments 3*

5.2.1Thereisaprocesstoperiodicallyreviewandsharebestpractices,reviewtheresultsofclinicalaudits,reviewnewevidence-basedtreatmentsandtherapies,anddiscussdifficultcases.

5.3 TheHealthcareProviderdevelopsand/orusesclinicalpracticeguidelinesintheirareaofexpertise.


Comments 3*

5.3.1TheHealthcareProvidercollaborateswithothermembersoftheNetworkorcentresofexpertisetodevelopand/orselectclinicalpracticeguidelinesfollowingastandardevidence-basedprocedure.

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5.3.2TheHealthcareProviderimplements,wherepossible,clinicalpracticeguidelinesagreedtoordevelopedbytheNetwork.

5.3.3Clinicalpracticeguidelinesareregularlyreviewedtoensuretheyreflectcurrentresearchandbestpracticeinformation.

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6. COMPETENCE,EXPERIENCE,ANDOUTCOMESOFCARE

6.1 TheHealthcareProvidermaintainsitscompetenceintheNetwork’sareaofexpertise.


Comments 3*

6.1.1TheHealthcareProviderregularlymonitorsanddocumentsitspatientactivityspecifictotheNetwork’sareaofexpertise,diseaseorcondition.

6.1.2Tomaintainitscompetencyandexpertise,theHealthcareProviderservestheminimum/optimalnumberofpatientsand/orproceduresperyearasdefinedbytheNetworkbasedonprofessional/technicalstandardsorrecommendations.

6.2 TheHealthcareProviderdemonstratesgoodclinicalcareandoutcomes.


Comments 3*

6.2.1Thereisevidencethatthetreatmentsandadviceofferedarerecognizedbyinternationalmedicalscienceintermsofsafety,value,and/orpotentialpositiveclinicaloutcome.

6.2.2TheHealthcareProvidershowsevidenceofgoodclinicalcareandoutcomesaccordingtoavailablestandards,indicators,andknowledgeasdefinedbytheNetwork.

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7. HUMANRESOURCES

7.1 TheHealthcareProviderhasateamoftrainedprofessionalswiththerequiredcompetencieswithintheNetwork’sareaofexpertise.


Comments 3*

7.1.1TheHealthcareProvideridentifiesanddocumentstheskillsandprofessionalqualificationsrequiredforthestaffperformingactivitiescriticaltothequalityofpatientcare.

7.1.2Thereisasufficientnumberofstaffwiththenecessaryqualificationstoperformthespecializedfunction.

7.1.3Eachcoreteammembershouldundertakeaminimumnumberofproceduresand/orcareforaminimumnumberofpatientsinagivenyearasdefinedbytheNetwork.Themultidisciplinaryteamshoulddiscussaminimumnumberofpatientsperyear.

7.1.4TheHealthcareProviderretainsrecordsofstafftraining,professionaldevelopment,andmaintenanceofcompetencies.Thereisaprocesstoroutinelyassessstaffskilltoensureadequateperformanceofspecializedtasks.

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8. ORGANIZATIONOFPATIENTCARE8.2 Comprehensivecareisdeliveredbyamultidisciplinaryandspecialisedcareteam.


Comments 3*

8.2.1TheHealthcareProviderdocumentsthecharacteristicsofthemultidisciplinaryteam.

8.2.2Thereisadesignatedleaderandchairofthemultidisciplinaryteam.

8.2.3Therearedocumentedprocedurestosupporttheorganisationandfunctioningofthemultidisciplinarycareteam.

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8.2.4Thereareregularstructuredmeetingsbetweenmultidisciplinaryteammembers.

8.2.5Patientsreceiveaperiodicclinicalormultidisciplinaryreview.Thetimeframeisdefinedbasedontheareaofexpertise,diseaseorcondition;anditsseverity.

8.2.6Themultidisciplinaryteamevaluatesitsperformanceonanannualbasis.

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9. FACILITIESANDEQUIPMENT

9.3 TheHealthcareProviderhasthenecessaryfacilitiesandequipmenttoattendtopatientsspecifictotheareaofexpertise,disease,orconditionasdefinedbytheNetwork.


Comments 3*

9.3.1TheHealthcareProviderhasavailablewithinthecentreoreasyaccesstothenecessaryequipmentandfacilitiestoprovidegoodqualitypatientcare.

9.3.2Thereisaccesstoaspecialisedlaboratoryservicecapableofcarryingoutalltestsrequiredtodiagnosetherareorlowprevalencecomplexdisease(s)orcondition(s)asdefinedbytheNetwork.

9.3.3Thereisaccesstoarangeofdiagnostictechnologiesasappropriatetotherareorlowprevalencecomplexdisease(s)orcondition(s)asdefinedbytheNetwork.

9.3.4Basedontheareaofexpertise,theHealthcareProviderhasthecapacitytoprocess,manage,andexchangeinformationandbiomedicalimages,orclinicalsampleswithexternalproviders.

* TheSymbol3 indicates the requirement to have ready at the time of the application a specific

document as evidence of compliance. These documents are to be submitted at the request of theIAB. See Appendix B for the full listing of supporting documentation required.

APPENDIX A: SCORING TABLE

Self-Assessment Scoring Table GENERAL CRITERIA AND CONDITIONS

Patient Empowerment and Patient Centred Care

Total Score out of a Possible 30 Percent of Total

Organisation, Management, and Business Continuity


Research, Education and Training


Expertise, Information Systems, and E-health Tools


Quality and Safety


SPECIFIC CRITERIA AND CONDITIONS

Competence, Experience, and Outcomes of Care


Human Resources


Organization of Patient Care


Facilities and Equipment


OVERALL Subtotal Score for General Criteria Percent of Total

Subtotal Score for Specific Criteria Percent of Total

GRAND TOTAL SCORE out of a Possible 140 Percent of Total

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Percent of Total

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APPENDIXB:LISTOFSUPPORTINGDOCUMENTATIONFOR HEALTHCARE PROVIDERS

ATTACHMENTA–STRATEGICPLANNINGANDGOVERNANCE

⋅ Measure1.1.1Misionand/orCoreValues (English_Summary). Measure2.1.1Organizationchart (English_Summary)⋅ Measure 1.7.1 Conflict of Interest Policy (English_Summary) . Measure 2.3.1 Business continuity plan (English_Summary)

ATTACHMENTB–PATIENTEMPOWERMENT (English_Summary of all B measures)

⋅ Measure1.1.3SampleofPatientEducationMaterials⋅ Measure1.1.5WrittenMaterialDescribingPatientandFamilyRightsandResponsibilities. Measure1.3.1PatientExperienceSurveyandSamplePatientExperienceReports⋅ Measure1.5.1InformedConsentPolicyandProcedure ( English translation of one sample + documents in original language)

ATTACHMENTC–ORGANISATIONOFCARE (English_Summary of all C measures)

. Measure 2.1.3 Policies and Procedures for Managing Cross Border Patients or planned actions andtimelinesfordevelopingpoliciesandprocedures (English_Summary) ⋅ Measure2.6.1DischargeprocedureandDischargeTemplate (English_Summary) ⋅ Measure5.3.1ClinicalPracticeGuidelines

ATTACHMENTD–QUALITYANDINFORMATIONSYSTEM (English_Summary of all D measures) ⋅ Measure 2.5.1 Third party reports and/or inspections on the quality care environments (English_Summary)

⋅ Measure5.1.1QualityImprovementPlan⋅ Measure 5.1.2 Process and Outcome Indicators (Dashboard) and their definitions

⋅ Measure5.1.3PatientSafetyPlan⋅ Measure5.1.4DetailedExampleofRootCauseAnalysisandDescriptionofProcessImprovement

⋅ATTACHMENTE–RESEARCHANDTRAINING (English_Summary of all E measures)

⋅ Measure3.1.2Listofteachingobjectives (English_Summary) ⋅ Measure3.1.3ListofTeachingStaffandQualifications (English_Summary) ⋅ Measure3.2.2Listofgrantsandresearchprojectsoverthelast5years (English_Summary) ⋅ Measure3.2.3ListofStandardOperatingProcedures(SOPs)thatgovernresearchactivities (English_Summary)

⋅ Measure3.2.4ResearchPolicyandProcedure

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APPENDIXC:DECLARATIONFORM

TOBECOMPLETEDBYTHEPERSONLEADINGTHESELF-ASSESSMENT

PersonLeadingtheSelf-Assessment

Name:

Title:

ContactEmail:

AssessmentPurpose

ApplicationType InitialApproval

Networkand/orHealthcareProviderRenewal

SelfAssessment

Date:

Outcome FullCompliancewiththeOperationalCriteria

PartialCompliancewiththeOperationalCriteria

NotYetCompliantwiththeOperationalCriteriaNotesRelevanttotheSelf-Assessment(ifany)

SignatureoftheHealthcare Provider Representative

Signature:

Declaration of the Network Coordinator

Iconfirmthatthisself-assessmentisanaccurateandtruereflectionofthecompliancestatusoftheHealthcareProvideragainsttheOperationalCriteriaandthatallsupportingdocumentationlistedinAppendixBarepreparedandreadyforsubmission,attheIAB’srequest.Signature: Name: Date:

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