Share.Care.Cure.

ERNAssessmentManualforApplicants

7. Self-AssessmentChecklistforNetworksinActivePDF

Aninitiativeofthe

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

1

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.

2

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.

3

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.

4

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.

5

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)

6

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

Measure ElementsRating(0 or 1or 2)

Comments 3*

3.1.1ThereisonedesignatedrepresentativeforeachapplicantmemberoftheNetwork.

3.1.2TheNetworkisgovernedbyaBoardcomposedofonerepresentativefromeachMemberintheEuropeanReferenceNetwork.

3.1.3TheroleandresponsibilitiesoftheBoardareclearlydefinedanddocumentedinasetofgovernancepoliciesorrulesofprocedure.

7

3.1.4TheBoardmonitorstheactivity,outcomes,andinitiativesoftheNetworkanditsMembersinregardstotheirspecific,predefinedrole.

3.1.5TheBoardhasestablishedmechanismstohearfromandincorporatethevoiceandopinionofpatientsandfamilies.

3.1.6TheNetworkhasadefinedstrategyforintegratingnewMembersapprovedbytheERNBoardofMemberStatesandAffiliatedPartnersdesignatedbytheCompetentNationalAuthorities.

3.1.7ThereisoneMemberwithintheNetworkdesignatedastheCoordinatingMember.OnepersonisappointedbytheCoordinatingMembertoactasthe“Coordinator”oftheNetwork.

8

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.

Measure ElementsRating(0 or 1or 2)

Comments 3*

4.1.1TheNetworkworkswithitsMemberstoestablishclearpatientpathwaysbasedontheneedsofpatients,clinicalevidence,andbestuseofresources.

4.1.2TheNetworkpromotesand/orfacilitatestheuseofinformationandcommunicationtechnology(ICT)toolstoprovidecaretopatientsandsharepertinentdatawithinitsareaofexpertise.

4.1.3TheNetworkfacilitatesthetransferofknowledgeonsafe,evidence-based,effectiveandinnovativemedicine.

9

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.

Measure ElementsRating(0 or 1or 2)

Comments 3*

4.2.1TheNetworkactsasasourceofinformationforrareorlowprevalenceandcomplexdiseasesforpatientsandfamilies.

4.2.2TheNetworkcollaborateswithpatientassociationstoimprovethesafetyandqualityofcare.

10

4.2.3TheNetworkdisseminatesinformationonpatientsafetystandardsandsafetymeasurestopatientsandfamiliestoreduceorpreventerrors.

4.2.4TheNetworkprovidesaccessiblemeansforpatientsandfamiliestoreportpossiblesafetyincidentsoradverseeventsandexpresstheirviewsaboutthecarereceivedandtheirexperience,includingsafetyconcerns.

4.2.5TheNetworkcollaborateswithitsMemberstoestablishastandardisedcommontoolformeasuringpatientexperience.

11

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

Measure ElementsRating(0 or 1or 2)

Comments 3*

5.1.1TheNetworkidentifiesandsharesbestpracticesforprovidingmultidisciplinarycare.

5.1.2PatientcareisdeliveredacrosstheNetworkusingmultidisciplinaryhealthcareteams.

5.1.3TheNetworkhasaprocessforofferingadviceforcomplexpatientcasesprovidedbymultidisciplinaryhealthcareteams.

12

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.

13

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

Measure ElementsRating(0 or 1or 2)

Comments 3*

6.3.1TheNetworkhasaformalprocessfordevelopingorselectinganddisseminatingclinicalguidelines.

6.3.2TheNetworkadherestoethicalcriteria,istransparent,andavoidsanyconflictofinterestwhendevelopingandimplementingclinicalguidelines,patientpathways,andotherclinicaldecisionmakingtools.

6.3.3TheNetworkdevelopscrossborderpathwaysincollaborationwithitsMembers.

6.3.4TheNetworkmonitorsimplementationofestablishedclinicalguidelinesandpatientpathwaystoencourageconsistentuseacrossitsMembersandmonitortheirappropriateness.Informationisusedtomakeongoingqualityimprovements.

14

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.

15

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

Measure Elements Rating(0 or 1 or 2)

Comments 3*

7.1.1TheNetworkidentifieswherethereareresearchgapsandcarriesoutactivitiestofulfilthesegaps.

7.1.2TheNetworkpromotesandsupportscollaborativeresearchamongstitsMembers,AffiliatedPartners,andrelevantpatient,professionalandresearchorganisations.

7.1.3TheNetworkkeepsitsMembers,partners,andpatientorganizationsinformedaboutnewresearchprojectsandclinicaltrials.

16

7.1.4TheNetworksupportsatallappropriatelevels,includingthecommunitylevel,theestablishmentofspecificdiseaseorconditioninformationnetworks,sharedregistries,anddatabases.

17

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

Measure Elements Rating(0 or 1 or 2)

Comments 3*

8.1.1TheMembersworktogethertoidentifyandfulfileducation,training,an3 dprofessionaldevelopmentgapswithintheNetwork’sareaofexpertise.

8.1.2TheNetworkfacilitatesandsupportsthedevelopmentanduseofstandardizedcontinuouseducationtrainingprogrammesandtoolsforhealthcareproviderswithinandoutsidetheNetwork.

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

18

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

Measure Elements Rating(0 or 1 or 2)

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.

19

APPENDIXA:SCORINGTABLE

Self-AssessmentScoringTable

EstablishmentofaEuropeanReferenceNetwork

TotalScoreoutofaPossible2 PercentofTotal

HighlySpecialisedHealthcare

TotalScoreoutofaPossible6 PercentofTotal

GovernanceandCoordination

TotalScoreoutofaPossible14 PercentofTotal

PatientCare

TotalScoreoutofaPossible20 PercentofTotal

MultidisciplinaryApproach

TotalScoreoutofaPossible6 PercentofTotal

GoodPractice,OutcomesMeasures,andQualityControl

TotalScoreoutofaPossible18 PercentofTotal

ContributiontoResearch

TotalScoreoutofaPossible8 PercentofTotal

ContinuousEducation,Training,andDevelopment

TotalScoreoutofaPossible6 PercentofTotal

NetworkingandCollaboration

TotalScoreoutofaPossible6 PercentofTotal

Overall

GrandTotaloutofaPossible86 PercentofTotal

20

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

21

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: