160222 Self-Assessment for Networks - European...

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ERNAssessmentManualforApplicants

7. Self-AssessmentChecklistforNetworksinActivePDF

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Version 1.1 April2016

ThisdocumentcontainstheSelf-AssessmentChecklistforNetworksinActivePDF.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-ASSESSMENT CHECKLIST FOR NETWORKS

INTRODUCTION

InaccordancewiththerequirementsoutlinedintheImplementingDecision2014/287/EUAnnexI(b),theapplicationtoestablishaEuropeanReferenceNetworkmustbesubmittedinresponsetoacallforinterestpublishedbytheCommissionandmustinclude:thecompletedapplicationformwiththeself-assessmentquestionnaireandthesupportingdocumentationrequiredintheassessmentmanual(Seepage23oftheERNAssessmentManualforApplicants).

Theself-assessmentprovidesNetworkswiththeopportunitytoevaluatethemselvesagainstthespecificlegislatedcriteriaandconditionsbeforesubmittingtheirapplicationtotheEuropeanCommission.

Inaddition,theself-assessmentprovidesamechanismforboththeIndependentAssessmentBodyandtheNetworktocollaborateonassessingcomplianceagainsttheOperationalCriteria.Theinformationsubmittedwillhelpsupportathoroughdocumentationreviewandplantheon-siteaudit.

DESCRIPTIONOFTHESELF-ASSESSMENTTOOL

Thefollowingself-assessmentchecklistisdividedintonine(9)distinctsections.Theseincludethefollowing:

1. EstablishmentofaEuropeanReferenceNetwork2. HighlySpecialisedHealthcare3. GovernanceandCoordination4. PatientCare5. MultidisciplinaryApproach6. GoodPractice,OutcomesMeasures,andQualityControl7. ContributiontoResearch8. ContinuousEducation,Training,andDevelopment9. NetworkingandCollaboration

Thesenine(9)sectionsarebasedontherequirementssetoutintheDelegatedDecision2014/286/EAnnexI.EachsectionincludesmultipleitemstohelptheNetworkevaluateitsreadinesstosubmitaNetworkApplication.TheseitemsarebasedonthoseOperationalCriteriathattheEuropeanCommissionandIndependentAssessmentBodywillusetoassesscompliancewiththelegislation.Notethatacompleteself-assessmentmustaccompanytheApplicationFormfortheapplicationtobeconsidered.

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INSTRUCTIONSFORCOMPLETINGTHESELF-ASSESSMENT1. EstablishateamconsistingofthedesignatedNetworkCoordinatorandrepresentationfromeachof

thepotentialHealthcareProvidersand/orrareorlowprevalencecomplexdiseaseorconditionthematicareas.

Theteamshouldbegivensufficienttimetocompletetheself-assessment.BecausetheimplementationofaNetworkcanbecomplex,completingtheself-assessmentasateamincreasesthevalueoftheprocessandaccuracyoftheinformation.Completionoftheself-assessmentisestimatedtotakeapproximatelythreetofourmeetingswithtimeallocatedbetweenmeetings,pendingvolumeofitemsrequiringfurtherinvestigationortheneedtosubmitrequireddocumentationtosupportevidenceofcomplianceinthatarea.Ateamleadershouldbeappointedtoorganizethegroup,assigntasks,andcoordinatetheself-assessmenteffort.

2. ReadandreviewtheOperationalCriteriaintheirentiretybeforebeginningtheSelf-Assessmentprocess.Ifpossible,makecopiesandsendthemtoteammembersbeforethefirstmeeting.

3. DiscusseachindividualelementintheSelf-AssessmentChecklistandevaluatetheNetwork’sprogressinimplementingit.Asnecessary,verifythelevelofimplementationwithotherindividualsoutsideoftheteam.Documentthisinformationinthe“Comments”sectionofthechecklist.

4. Onceconsensusisreached,completethetablebelowbymarkingtheboxthatmostappropriatelycapturesthecurrentstatusofcompliancewiththecriterion,usingthefollowingratingscaleandscoringguide:

Rating Guidelines0:Noactivity/NotImplemented

AllCriteria:thisratingisusedwhenthereisnoactionplaninplaceorthereisinsufficientevidencetosupportcompliance.ThisratingmayalsobeusedwhenthepracticeisnotimplementedinanyoftheHealthcareProvidersoftheNetwork(ifapplicable).

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

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

5. Repeattheprocessforeachelement.Oncecomplete,tallyuptheNetwork’sscoreforeachsectionusingthetemplateprovidedinAppendixA.Refertothoseareasinwhichyourpercentageperformanceindicatesthegreatestopportunitiesforimprovement.

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6. UsethisinformationtodevelopanActionPlantoimprovereadinesstosubmittheapplicationandcompletetheindependentassessmentprocess.

7. Priortofinalizingandsubmittingtheself-assessment,aprocesstovalidatetheresultsinternallyshouldbefollowed.Thepurposeoftheinternalvalidationisto:

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

ItistheNetwork’sresponsibilitytodeterminehowtheinternalvalidationwillbecompleted.TheNetworkmustensurethattheprocessusedmeetsthefollowingrequirements:

• Theprocessisfairandrobust;• TheprocessisagreedtobyallHealthcareProviders;• Accountabilityfortheself-assessmentisagreedtobytheChiefExecutiveOfficerofthe

HealthcareProvider;and• Theprocessincludespatientandfamilyinvolvement.

Attheconclusionoftheinternalvalidation,theself-assessmentteamshouldcheckandrecordanychangesintheself-assessment.

8. CompleteandsigntheDeclarationForminAppendixCoftheself-assessment.

9. SubmitthecompletedSelf-AssessmentalongwiththeApplicationFormonorbeforethedeadlineforsubmittingapplicationsinresponsetothecallforinterest.TheNetworkmusthavereadyatthetimethe application is submitted all supportingdocumentation listed inAppendix B. ThesedocumentsshouldbemadeavailabletotheIAB,attheirrequest.

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THESELF-ASSESSMENTCHECKLISTTOOLFOREUROPEANREFERENCENETWORKS

1. ESTABLISHMENT OF A EUROPEAN REFERENCE NETWORK1.1 The Network meets the minimum requirement for Healthcare Provider membership and their location to be recognised as a European Reference Network.

Measure ElementsRating(0 or 1or 2)

Comments 3*

1.1.1TheNetworkiscomprisedofaminimumof10Membersacross8MemberStates.

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2. HIGHLY SPECIALISED HEALTHCARE2.1 The Network provides highly specialised healthcare for one or more rare or low prevalence complexdiseases or conditions in the areas of diagnosis, treatment, and follow-up.

Measure Elements Comments 3*

2.1.1Thethematicgroup(s)anddisease(s)orcondition(s)withintheNetwork’sscopearedefinedanddocumented.

2.1.2TheNetwork’sareaofexpertiseishighlyspecialisedandwelldefinedandtheexpectedgainsofcentralisingcareforthesepatientscanbedemonstrated.

2.1.3TheobjectivesoftheNetworkanditsactivitiesareclearlydefinedwithinamissionand/orvisionstatementandstrategicplan.

Rating(0 or 1or 2)

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3. GOVERNANCE AND COORDINATION3.1 The Network has a clear governance and coordination structure that includes mechanisms to support oversight and evaluation.


Comments 3*

3.1.1ThereisonedesignatedrepresentativeforeachapplicantmemberoftheNetwork.

3.1.2TheNetworkisgovernedbyaBoardcomposedofonerepresentativefromeachMemberintheEuropeanReferenceNetwork.

3.1.3TheroleandresponsibilitiesoftheBoardareclearlydefinedanddocumentedinasetofgovernancepoliciesorrulesofprocedure.

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3.1.4TheBoardmonitorstheactivity,outcomes,andinitiativesoftheNetworkanditsMembersinregardstotheirspecific,predefinedrole.

3.1.5TheBoardhasestablishedmechanismstohearfromandincorporatethevoiceandopinionofpatientsandfamilies.

3.1.6TheNetworkhasadefinedstrategyforintegratingnewMembersapprovedbytheERNBoardofMemberStatesandAffiliatedPartnersdesignatedbytheCompetentNationalAuthorities.

3.1.7ThereisoneMemberwithintheNetworkdesignatedastheCoordinatingMember.OnepersonisappointedbytheCoordinatingMembertoactasthe“Coordinator”oftheNetwork.

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4. Patient Care4.1 The Network promotes good quality and safe patient care by fostering timely and pertinentdiagnosis, treatment, follow-up and management across the Network.


Comments 3*

4.1.1TheNetworkworkswithitsMemberstoestablishclearpatientpathwaysbasedontheneedsofpatients,clinicalevidence,andbestuseofresources.

4.1.2TheNetworkpromotesand/orfacilitatestheuseofinformationandcommunicationtechnology(ICT)toolstoprovidecaretopatientsandsharepertinentdatawithinitsareaofexpertise.

4.1.3TheNetworkfacilitatesthetransferofknowledgeonsafe,evidence-based,effectiveandinnovativemedicine.

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4.1.4TheNetworkpromotesthesafeuseofhighlyspecializeddiagnostictechniquesandservicesandtheapplicationofrecognizedinternationalqualitystandards,certification,andaccreditationschemes.

4.1.5TheNetworkimplementsguidelinesand/orprotocolstosupporttransitionandcontinuityofcarefromchildhood,throughadolescence,andintoadulthood,whereapplicable.

4.2 The Network empowers and involves patients in order to improve the safety and quality of care.


Comments 3*

4.2.1TheNetworkactsasasourceofinformationforrareorlowprevalenceandcomplexdiseasesforpatientsandfamilies.

4.2.2TheNetworkcollaborateswithpatientassociationstoimprovethesafetyandqualityofcare.

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4.2.3TheNetworkdisseminatesinformationonpatientsafetystandardsandsafetymeasurestopatientsandfamiliestoreduceorpreventerrors.

4.2.4TheNetworkprovidesaccessiblemeansforpatientsandfamiliestoreportpossiblesafetyincidentsoradverseeventsandexpresstheirviewsaboutthecarereceivedandtheirexperience,includingsafetyconcerns.

4.2.5TheNetworkcollaborateswithitsMemberstoestablishastandardisedcommontoolformeasuringpatientexperience.

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5. Multidisciplinary approach5.1 The Network promotes and follows a multidisciplinary approach to care for rare or low prevalencecomplex diseases or conditions.


Comments 3*

5.1.1TheNetworkidentifiesandsharesbestpracticesforprovidingmultidisciplinarycare.

5.1.2PatientcareisdeliveredacrosstheNetworkusingmultidisciplinaryhealthcareteams.

5.1.3TheNetworkhasaprocessforofferingadviceforcomplexpatientcasesprovidedbymultidisciplinaryhealthcareteams.

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6. Good Practice, Outcome Measures, and Quality Control6.1 The Network offers specialised clinical expertise and produces good practice guidelines for rare orlow prevalence complex diseases or conditions.

Measure ElementsRating(0 or 1 or 2)

Comments 3*

6.1.1TheNetworkgathers,exchanges,anddisseminatesknowledge,bestpracticeevidence,andclinicalexpertisewithinandoutsideoftheNetwork.

6.1.2RepresentativesfromeachMembermeetperiodicallytoreviewandsharebestpractices,anddiscussnewevidence-basedtreatments,therapies,andhealthcaretechnologies.

6.2 The Network collaborates with its Members and other relevant partners to bring healthcare withinits area of expertise closer to its patients.

Measure Elements Rating(0 or 1 or 2)

Comments 3*

6.2.1TheNetworksharesexpertiseandsupportshealthcareprovidersinordertobringlocal,regionalandnationalprovisionofcaretopatientsclosertohome.

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6.3 The Network develops and/or implements clinical guidelines and cross border patient pathways.


Comments 3*

6.3.1TheNetworkhasaformalprocessfordevelopingorselectinganddisseminatingclinicalguidelines.

6.3.2TheNetworkadherestoethicalcriteria,istransparent,andavoidsanyconflictofinterestwhendevelopingandimplementingclinicalguidelines,patientpathways,andotherclinicaldecisionmakingtools.

6.3.3TheNetworkdevelopscrossborderpathwaysincollaborationwithitsMembers.

6.3.4TheNetworkmonitorsimplementationofestablishedclinicalguidelinesandpatientpathwaystoencourageconsistentuseacrossitsMembersandmonitortheirappropriateness.Informationisusedtomakeongoingqualityimprovements.

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6.4 The Network implements quality controls and monitors clinical outcome measures of care for rare orlow prevalence complex diseases or conditions.

Measure ElementsRating(0 or 1 or 2)

Comments 3*

6.4.1TheNetworkdevelopsandregularlymonitorsperformanceandoutcomeindicators.Theinformationisusedtosupportongoingqualityimprovement.

6.4.2TheNetworkdevelopsandmaintainsaquality,patientsafety,andevaluationframework.

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7. Contribution to Research7.1 The Network provides evidence of ongoing research for rare or low prevalence complex diseases orconditions.


Comments 3*

7.1.1TheNetworkidentifieswherethereareresearchgapsandcarriesoutactivitiestofulfilthesegaps.

7.1.2TheNetworkpromotesandsupportscollaborativeresearchamongstitsMembers,AffiliatedPartners,andrelevantpatient,professionalandresearchorganisations.

7.1.3TheNetworkkeepsitsMembers,partners,andpatientorganizationsinformedaboutnewresearchprojectsandclinicaltrials.

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7.1.4TheNetworksupportsatallappropriatelevels,includingthecommunitylevel,theestablishmentofspecificdiseaseorconditioninformationnetworks,sharedregistries,anddatabases.

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8. Continuous education, training, and development8.1 The Network, in collaboration with partners, organises continuous education, training, anddevelopment activities.


Comments 3*

8.1.1TheMembersworktogethertoidentifyandfulfileducation,training,an3 dprofessionaldevelopmentgapswithintheNetwork’sareaofexpertise.

8.1.2TheNetworkfacilitatesandsupportsthedevelopmentanduseofstandardizedcontinuouseducationtrainingprogrammesandtoolsforhealthcareproviderswithinandoutsidetheNetwork.

8.1.3TheNetwork,incollaborationwithpartners,provideseducationandtrainingtohealthcareprofessionals,alliedhealthprofessionals,andnon-healthcareprofessionalswithinitsareaofexpertise.

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9. Networking and Collaboration9.1 The Network collaborates closely with other Centres and Networks at both a national and international level.


Comments 3*

9.1.1TheNetworkexchangesanddisseminatesknowledgeandbestpracticeswithotherNetworksandCentresofExpertise.

9.1.2TheNetworkdevelopsacommunicationplanandestablishescommunicationtoolstosupportcollaborationwithotherorganizations.

9.1.3TheNetworkcollaborateswithAffiliatedPartners,i.e.AssociatedNationalCentres,CollaborativeNationalCentresorNationalCoordinationHubs,chosenbyMemberStates.

* 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 the IAB.See Appendix B for the full listing of supporting documentation required.

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APPENDIXA:SCORINGTABLE

Self-AssessmentScoringTable

EstablishmentofaEuropeanReferenceNetwork

TotalScoreoutofaPossible2 PercentofTotal

HighlySpecialisedHealthcare


GovernanceandCoordination


PatientCare


MultidisciplinaryApproach


GoodPractice,OutcomesMeasures,andQualityControl


ContributiontoResearch


ContinuousEducation,Training,andDevelopment


NetworkingandCollaboration


Overall

GrandTotaloutofaPossible86 PercentofTotal

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APPENDIXB:LISTOFSUPPORTINGDOCUMENTATIONFORNETWORKS

ATTACHMENTA–STRATEGICPLANNINGANDGOVERNANCE

ATTACHMENTB––PATIENTEMPOWERMENT

ATTACHMENTC–ORGANISATIONOFCARE

ATTACHMENTD–QUALITYANDINFORMATIONSYSTEM

ATTACHMENTE-RESEARCHANDTRAINING

⋅ Measure2.1.3Mision,Vision,InitialStrategicPlan⋅ Measure3.1.1 NetworkOrganogramandWrittenStatementsofMembers’Roleand Responsibilities

⋅ Measure3.1.2BoardTermsofReference⋅ Measure9.1.2CommunicationStrategyandPlan⋅ Measure 9.1.2 Collaboration Strategy with Affiliated Partners

⋅ Measure4.2.1Sampleofinformationprovidedtopatientsandfamilies,i.e.Brochures,Web-site⋅ Measure4.2.5PatientExperienceSurvey(s)and/orplannedactivitiesandtimelinestoestablish a

commontool

⋅ Measure4.1.1PatientPathwaysand/orPlannedActionsandTimelines⋅ Measure5.1.2Guides/RecommendationsonMultidisciplinaryTeams⋅ Measure6.3.1ClinicalGuidelinesand/orplannedactivitiesandtimelinesfordeveloping Guidelines⋅ Measure6.3.2Policyonthedeclarationandmanagementofconflictofinterestregarding clinical

guidelines,patientpathways,andclinicaldecisionmakingtools⋅ Measure6.3.3CrossBorderPathwaysand/orplannedactionsandtimelinestodevelopcross border

pathways

⋅ Measure 4.1.4 List of Diagnostic Technologies and Services Certified or Accreditedthrough National,European,and/orInternationalProgramsprovidedbyNetworkMembers

⋅ Measure 4.2.3 Published Annual Reports and/or Planned actions and Timelines forPatient SafetyDataCollectionandReporting

⋅ Measure6.4.1Listofperformanceandoutcomeindicatorsandtheirdefinitions⋅ Measure6.4.2 QualityandSafetyFramework(includingAdverseEventsReportingSystem)

⋅ Measure7.1.2StrategicResearchPlan⋅ Measure7.1.3AnnualReportonResearchProjectsandClinicalTrialsand/orplannedactions and

timelinestodeveloptheReport

⋅ Measure8.1.1AnnualEducationWorkplan

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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)

SignatureoftheNetworkCoordinator

Signature:

Declaration

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

160222 Self-Assessment for Networks - European...

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