Schedule23CONFormsSpecificto

AllProjectsIncorporatingHealthIT

Contents:

Instructions

  • Background
  • Schedule23
  • VendorContractLanguageforCONApplicants

DOH155-ESchedule23Cover(10/7/2016)

CertificateofNeed(CON)InteroperableHealth IT Requirements

Instructions:Thisself-descriptionandcertificationshouldbeutilizedforALLprojectsincorporatinghealthITaspartoftheirapplication.HealthITrefersbroadlytoelectronicmethodsforstoringandprocessingclinicalandotherdata,and“interoperable”referstotheabilitytoexchangedatainastandardizedmannerwithotherITsystems.

Applicantsareaskedtoreviewandcompleteeachofthesectionsbelow.

Background

HealthITplaysasignificantroleinhealthcarereformbyensuringthatclinicalinformationisinthehandsofcliniciansandNewYorkerssothatitguidesmedicaldecisionsandsupportsthedeliveryofcoordinated,patientcentered,highqualitycare.OneoftheprincipalhealthcarereforminitiativesNewYorkhasengagedinisthedevelopmentandimplementationofahealthinformationinfrastructure.NewYork’splanincludesthetechnologicalbuildingblocks,clinicalcapacity,andmechanismsforgovernanceandpolicydevelopment,thatarenecessarytoadvancehealthITinaconsistentandmeaningfulwaythatsupportsimprovementsinhealthcarequality,affordabilityandoutcomes.

ThroughtheStatewideCollaborationProcess,facilitatedbytheNewYorkeHealthCollaborative,acomprehensivesetofinformationpolicies,standards,protocolsandothertechnicalapproachesfortheStatewideHealthInformationNetworkforNY(SHIN-NY)andHealth IT Systems hasbeendevelopedandreleasedwiththecurrentversionoftheStatewidePolicyGuidance.AllCONhealthITprojectsarerequiredtocomplywiththeStatewidePolicyGuidance andarestronglyencouragedtoparticipateinthegovernanceprocess.

Forquestionsabouttherequirementsorcompletionoftheself-certificationform,youmaycontacttheOfficeofQualityandPatientSafety,Bureau of Health Information Exchange at(518)474-4987.

InsubmittingaNewYorkStateDepartmentofHealthCertificateofNeed(CON) applicationwithahealthITcomponent,youareaskedtoaddressanumberoftechnical,organizationalandclinicalareasrelatedtotheNewYork’shealthIT strategydedicatedtosupportingimprovementsinhealthcarequality,affordabilityandoutcomesforallNewYorkers.Indoingso,youwillbealigningwiththeDepartment’sstrategyinfourarenas:

1.Technical:Atechnicalarchitecturaldesignandimplementationplanforconnectinginstitutionalsystems(inpatientandoutpatient)totheStatewideHealthInformationNetworkforNewYork(SHIN-NY),ensuringsuchsystemsareinteroperableandpatients’healthinformationisavailabletoallauthorizedclinicianswhenandwhereitisneeded,regardlessofwherethepatientreceivescare,toimprovecarecoordination,managementandquality.ThisincludesplansforgrantingprovidersutilizingHealth IT Systemsaccesstoclinicaldatagatheredviainstitutionalinpatientsystems,consistentwiththeState’sarchitecturaldesign,whileensuringseamlessintegrationamongprovidersusingdisparateHealth IT Systems ininpatientandoutpatientcaresettings.

2.Organizational:Agovernanceplanincludingadescriptionofparticipationwith a Qualified Entity (QE) toensurecompliancewithcurrenthealthinformationpolicy,standardsandtechnicalapproaches,collectivelyreferredtoasStatewidePolicyGuidance.

3.Clinical:Twocomponents:(i)AhealthITadoptionandsupportplanexplaininghowimplementationserviceswillbeprovidedandsustainedtosupportcliniciansinachievingqualitygoalsfromHealth IT SystemsadoptionandintegrationtotheSHIN-NY.(ii)AqualitymeasurementandreportingplanindicatinghowthesystemorfacilitywillreportandsubmitinformationonclinicalqualitymeasuresandothermeasuresinaformandmannerspecifiedbytheNYSDOHoratthefederallevelbytheSecretaryofHealthandHumanServices(HHS).

Schedule23 –InteroperableHealthITRequirements

SectionOne:ExecutiveSummary–PleaseprovideanexecutivelevelsummaryofyourhealthITproject.

SectionTwo:NarrativeDescriptions–PleasedescribehowyourhealthITprojectwillcomplywitheachofthefollowingrequirements.

1.PleaseidentifywhichQualified Entities(QE) yourorganizationhasalignedwithandyourspecificinvolvementinthegovernanceprocessandstructure.FormoreinformationaboutQEsinNYS,pleasereferto

2.InpatientandoutpatientHealth IT SystemsmustbeinteroperablewithotherprovidersystemstosupportimprovementsinpatientcareandbeinteroperablewithpublichealthsystemstosupportqualityandpopulationhealthreportingutilizingtheStatewideHealthInformationNetworkforNewYork(SHIN-NY).InpatientandoutpatientHealth IT SystemsmustcomplywithStatewidePolicyGuidancerequirementspromulgatedbytheNewYork’sStatewideCollaborativeProcessfacilitatedbytheNewYorkeHealthCollaborative(NYeC)andapprovedbytheNYSDOH.Policy guidance can be found at:

a.PleasedescribeyourplanforcomplyingwiththecurrentandsubsequentrequirementsspecificallyrelatedtointeroperableHealth IT Systems andtheStatewideHealthInformationNetworkforNewYork(SHIN-NY).

b.Pleaselistthevendor(s)youwillbeutilizingandthespecificproduct(s)youwillbeimplementing.

3.SeamlessintegrationbetweenprovidersusingdisparateHealth IT Systems ininpatientandoutpatientcaresettingsiscriticalforhighqualitycosteffectivepatientcare.Pleasedescribeyourorganization’splansforexchanginghealthinformationbetweendisparateinpatientandoutpatientHealth IT SystemsutilizingtheSHIN-NY.

4.Pleasedescribeyourplansforintegrationofyourorganization’sancillaryclinicalsystems(eg.radiology,PACs,laboratory,pharmacy,etc.)into your Health IT Systems.

5.Integratedhospitalpharmacysystems,electronicmedicationadministrationrecord/chartdocumentationandcomputerizedphysicianorderentry,patientbarcodingandmedicationidentificationareallimportantcomponentstomedicationsafety.Clinicaldecisionsupportandordersetsthatincludebestpracticeandclinicalalertscanallbeeffectivemethodstoleverageinformationsystemstoimprovepatientsafety.Withoutstrongphysicianparticipationinthedesignandimplementationprocess,thereisriskinimplementationifnotplannedcarefully.

Ifapplicable,pleasedescribeyourinstitution’splansforimprovingpatientmedicationsafety(e.g.,computerizedphysicianorderentry,patientbarcoding,automateddispensing,medicationadministration,etc.),includingyourplansforphysicianparticipationinthedesignandimplementationofthesesystems.

6.Ifelectronicprescribingtooutsidepharmacies using your Health IT System isincludedaspartofyourimplementation,pleaseidentifywhatsourcesofmedicationhistorywillbeprovidedtotheproviders.

a.Pleaseidentifywhatsourcesofmedicationhistorywillbeprovidedtotheproviders.

b.Pleasedescribehowproviderconnectivityformedicationmanagementwillbeprovided.

c.Pleasedescribehowmedicationhistorieswillbereconciledtogiveandaccuratelistofcurrentmedicationsasthepatientmovesbetweencaresettings.

7.PleasedescribeyourhealthITadoptionandsupportplanexplaininghowimplementationserviceswillbeprovidedandsustainedtosupportcliniciansinachievingqualitygoalsfromHealth IT SystemadoptionandintegrationtotheSHIN-NY.

SectionThree:TechnicalandClinicalRequirements

StatewidePolicyGuidanceRequirements.CompliancewithcurrentandsubsequentversionsoftheinteroperabilityrequirementsaspromulgatedthroughtheStatewideCollaborationProcessisrequiredforCONapproval.

Requirement / WillComply / WillNotComply
  1. Vendors are contractually obligated to comply with the Statewide Policy Guidance requirements as described here:

Inpatient and outpatient Health IT Systems must be interoperable to facilitate safe, efficient, high quality patient care. These systems must also be interoperable with public health systems to support quality and population health reporting through the Statewide Health Information Network for New York (SHIN-NY). Inpatient and outpatient Health IT Systems must be certified as described in the Federal Department of Health and Human Services(HHS) Standards and Certification Criteria, and must make, at a minimum, the “common clinical dataset” available. This information must be made available as a structured document, using the Consolidated Clinical Document Architecture described by Office of the National Coordinator for Health IT certification requirements in 45 CFR 170.205(a)(3).

Information on HHS health IT certification can be found here:

A description of the common clinical dataset can be found here:

Requirement / WillComply / WillNotComply
  1. Vendorsarecontractuallyobligatedtomaintaincertificationforbothinpatientandoutpatientelectronichealthrecordsasdescribedabove.

  1. Ambulatory and inpatient Health IT Systems will make, at a minimum, the common clinical data set available to the SHIN-NY in the format specified.

  1. Providers are able to access data available from the SHIN-NY via a qualified entity.

Clinical Requirements:ClinicalinformaticsservicesarerequiredtofacilitatequalityandpopulationhealthmeasurementandreportingthroughutilizationofHealth ITandtheSHIN-NY.TheNewYorkStateDepartmentofHealthinconjunctionwiththeStatewide CollaborativeProcessmaydeterminethemethodologytoassessandevaluateexternalentityorentitiesthatareinvolvedinthecollection,aggregationandanalysisofqualitymetricinformationderivedfromproviderhealthinformationsystems.CompliancewitheachofthefollowingisrequiredforCONapproval.Ifyoucheck“willnotcomply”pleaseprovideanexplanationastothereasonandaplanwhenyouwillbeincompliance(ifapplicable).PleaseindicateN/Aifnotapplicabletoyourapplication.

Requirement / WillComply / WillNotComply
1.Health IT Systemsmustbecapableofextractingde-identifiedhealthinformationinaccordancewithmeasuresspecifications,asdeterminedbytheStatewideCollaborationProcess.
2. Health IT Systems mustbecapableofextractinghealthinformationincludingphysicianidentifiers(utilizingtheSHIN-NY)inastandardizedelectronicformatforperformancemeasurementasdeterminedbythestatewidecollaborationprocess
3.Health IT Systems mustbecapableofelectronictransmissionofextractedde-identifiedandidentifiedhealthinformationforperformancemeasurementincludingphysicianidentifiers(utilizingtheSHIN-NY)inastandardizedelectronicformattoanexternalentityorentitiesthatareinvolvedinthecollection,aggregationandanalysisofqualitymetricinformationfromhealthinformationsystemsasdeterminedbytheStatewideCollaborationProcess
4.Health IT systemsarerequiredtoeitherdisplayimportedperformanceassessmentresults[importedthroughtheSHIN-NYwhenappropriate]orhaveanembeddedlinktoaqualitymeasuredataaggregationandreportingservice,whichpresentsperformancecomparisondataandotherappropriateinformationtoparticipatingproviderstoallowopportunities forclinicalprocessimprovement
5.Health IT Systemsmustensurethatdataimportedfromanexternalsource/interfacewillretaindataintegritywhenimportedintoaproviders’electronicmedicalrecordasdeterminedbytheStatewideCollaborationProcess

SectionFour:ApplicantCertification

IcertifythattheabovedescribedinformationisatrueandaccuratereflectionofthehealthITprojectrequestedaspartofthissubmission.Ifurthercertifytotheproject’scurrentandongoingcompliancewiththeStatewidePolicyGuidanceRequirementsasdevelopedbytheStatewideCollaborationProcess.

NOTE:Theselfcertificationformshouldbecompletedforallprojectsinvolvingtheimplementationofclinicalinformationsystems,EMRs,CPOE,radiologysystems,laborderingsystemsorotherhealthinformationsystemsimpactingpatientcare.Ifyour projectdoesnotfallintoanyoftheseareasand youbelievethatthis certificationformisNOTApplicabletoyourproject,pleasechecktheboxbelowandsignanddatetheform.

Ihavereviewedtheinformationcontainedintheselfcertificationform andbelieveitisNOTApplicabletotheprojectsubmittedforCONapproval.Pleaseincludeabriefdescription(oneortwosentences)astowhytherequirementsarenotapplicableintheboxbelow.

CEO/COO/CFO/CIOSignature Date

Applicant (Print Name)

Title

Organization

SectionFour:Qualified EntityCertification

IcertifythatIhavecollaboratedwiththeapplicantsubmittingthisapplicationandamsupportiveoftheirunderstandingofStatewidePolicyGuidanceRequirements.TheapplicanthasagreedtobecomeanactivecollaboratingmemberofthisQEandparticipateintherelevantassociatedprocesses.Iamcollaboratingwiththisapplicanttohelpensureinteroperabilityoftheirsystemscontainingpersonalhealthinformationandwillworkwiththemtofacilitatethesharingofthisinformation.

QE RepresentativeSignature Date

(Print Name)

Title

QE

VendorContractLanguageforCONApplicants

1.StatewideCollaborativeProcessrequirements andongoingrequirement:

(Vendor)and(Project)willworktogethertoconfiguretheProgramPropertyinamannerthatconformsinallmaterialrespectswiththeStatewidePolicyGuidancepriorto(Project’s)FirstLiveUseoftheProgramProperty.(Vendor)anditsstaffregularlymonitortheactivitiesof,andoftenparticipatein,varioushealthcareinformationtechnologygroups,commissionsandnational standards-settingbodies.(Vendor)and(Project)willcontinuetodeployresourcesseekingtokeepabreastofsuchstandards,includingstandardsadoptedthroughtheStatewideCollaborationProcessandincorporatedintotheStatewidePolicyGuidance.Moreover,if(Project)orotherNewYorkcustomersnotify(Vendor)ofanSPGRequirement,(Vendor)willmeetwith(Project)andotheraffectedcustomerstoconsiderpossiblemodificationstotheProgramPropertyandotheroptionsforaddressing theissue.Uponexecutionof amutuallyagreeable ChangeOrder, (Vendor)will developat(Vendor)StandardRatesanymodificationsaddressingsuchStatewidePolicyGuidanceRequirement.Ifmorethanone(Vendor)customerswillbenefitfromthemodificationstoaddresstheSPGRequirement,(Vendor)agreestousegoodfaitheffortstospreadthecostoftheChangeOrderequallyamongthoseelectingtoreceivethebenefitofthechange.An“SPGRequirement”isarequirementoftheStatewidePolicyGuidancedevelopedandadoptedthroughtheStatewideCollaborationProcessthatrelatesdirectlytothefunctionalityoftheProgramPropertyasitisdescribedintheDocumentationManualsandisnecessaryfor(Project)tocomplywiththeStatewidePolicyGuidancetoexchangehealthinformationwithaRegionalHealthInformationOrganization(RHIO)forparticipationintheStatewideHealthInformationNetworkforNewYork(SHIN-NY).(Project)understandsthatachievingcompliancewiththeStatewidePolicyGuidancemayrequire(Project) to payfeesorcosts for thirdpartyproductsor services.