FIRSTREGULARSESSION HOUSEBILLNO.1561 103RDGENERALASSEMBLY INTRODUCEDBYREPRESENTATIVEGALLICK. 3165H.01I JOSEPHENGLER,ChiefClerk ANACT Torepealsection190.241,RSMo,andtoenactinlieuthereofonenewsectionrelatingto traumacenterdesignations. BeitenactedbytheGeneralAssemblyofthestateofMissouri,asfollows: SectionA.Section190.241,RSMo,isrepealedandonenewsectionenactedinlieu 2thereof,tobeknownassection190.241,toreadasfollows: 190.241.1.Exceptasprovidedforinsubsection4ofthissection,thedepartment 2shalldesignateahospitalasanadult,pediatricoradultandpediatrictraumacenterwhena 3hospital,uponproperapplicationsubmittedbythehospitalandsitereview,hasbeenfoundby 4thedepartmenttomeettheapplicableleveloftraumacentercriteriafordesignationin 5accordancewithrulesadoptedbythedepartmentasprescribedbysection190.185.Site 6reviewmayoccuron-siteorbyanyreasonablemeansofcommunication,orbyany 7combinationthereof.Suchrulesshallincludedesignationasatraumacenterwithoutsite 8reviewifsuchhospitalisverifiedbyanationalverifyingordesignatingbodyatthelevel 9whichcorrespondstoalevelapprovedinrule.Indevelopingtraumacenterdesignation 10criteria,thedepartmentshalluse,asitdeemspracticable,peer-reviewedandevidence-based 11clinicalresearchandguidelinesincluding,butnotlimitedto,themostrecentguidelinesofthe 12AmericanCollegeofSurgeons.Thedepartmentshallnotdenyaqualifiedhospital 13designationasalevelI,II,orIIItraumacenterbasedsolelyonthedistanceormileage 14betweentraumacenters. 15 2.Exceptasprovidedforinsubsection4ofthissection,thedepartmentshall 16designateahospitalasaSTEMIorstrokecenterwhensuchhospital,uponproperapplication 17andsitereview,hasbeenfoundbythedepartmenttomeettheapplicablelevelofSTEMIor EXPLANATION—Matterenclosedinbold-facedbrackets[thus] intheabovebillisnotenactedandis intendedtobeomittedfromthelaw.Matterinbold-facetypeintheabovebillisproposedlanguage. 18strokecentercriteriafordesignationinaccordancewithrulesadoptedbythedepartmentas 19prescribedbysection190.185.Sitereviewmayoccuron-siteorbyanyreasonablemeansof 20communication,orbyanycombinationthereof.IndevelopingSTEMIcenterandstroke 21centerdesignationcriteria,thedepartmentshalluse,asitdeemspracticable,peer-reviewed 22andevidence-basedclinicalresearchandguidelinesincluding,butnotlimitedto,themost 23recentguidelinesoftheAmericanCollegeofCardiology,theAmericanHeartAssociation,or 24theAmericanStrokeAssociation.SuchrulesshallincludedesignationasaSTEMIcenteror 25strokecenterwithoutsitereviewifsuchhospitaliscertifiedbyanationalbody. 26 3.Thedepartmentofhealthandseniorservicesshall,notlessthanonceeverythree 27years,conductasitereviewofeverytrauma,STEMI,andstrokecenterthroughappropriate 28departmentpersonneloraqualifiedcontractor,withtheexceptionoftraumacenters,STEMI 29centers,andstrokecentersdesignatedpursuanttosubsection4ofthissection;however,this 30provisionisnotintendedtolimitthedepartment'sabilitytoconductacomplaintinvestigation 31pursuanttosubdivision(3)ofsubsection2ofsection197.080ofanytrauma,STEMI,or 32strokecenter.Sitereviewsshallbecoordinatedforthedifferenttypesofcenterstotheextent 33practicablewithhospitallicensureinspectionsconductedunderchapter197.Nopersonshall 34beaqualifiedcontractorforpurposesofthissubsectionwhohasasubstantialconflictof 35interestintheoperationofanytrauma,STEMI,orstrokecenterunderreview.The 36departmentmaydeny,placeonprobation,suspendorrevokesuchdesignationinanycasein 37whichithasdeterminedtherehasbeenasubstantialfailuretocomplywiththeprovisionsof 38thischapteroranyrulesorregulationspromulgatedpursuanttothischapter.Centersthatare 39placedonprobationarystatusshallberequiredtodemonstratecompliancewiththeprovisions 40ofthischapterandanyrulesorregulationspromulgatedunderthischapterwithintwelve 41monthsofthedateofthereceiptofthenoticeofprobationarystatus,unlessotherwise 42providedbyasettlementagreementwithadurationofamaximumofeighteenmonths 43betweenthedepartmentandthedesignatedcenter.Ifthedepartmentofhealthandsenior 44serviceshasdeterminedthatahospitalisnotincompliancewithsuchprovisionsor 45regulations,itmayconductadditionalannouncedorunannouncedsitereviewsofthehospital 46toverifycompliance.Ifatrauma,STEMI,orstrokecenterfailstwoconsecutivesitereviews 47becauseofsubstantialnoncompliancewithstandardsprescribedbysections190.001to 48190.245orrulesadoptedbythedepartmentpursuanttosections190.001to190.245,its 49centerdesignationshallberevoked. 50 4.(1)Insteadofapplyingfortrauma,STEMI,orstrokecenterdesignationunder 51subsection1or2ofthissection,ahospitalmayapplyfortrauma,STEMI,orstrokecenter 52designationunderthissubsection.Uponreceiptofanapplicationonaformprescribedbythe 53department,thedepartmentshalldesignatesuchhospitalatastatelevelthatcorrespondstoa 54similarnationaldesignationassetforthinrulespromulgatedbythedepartment.Therules HB1561 2 55shallbebasedonstandardsofnationallyrecognizedorganizationsandtherecommendations 56ofthetime-criticaldiagnosisadvisorycommittee. 57 (2)Exceptasprovidedbysubsection5ofthissection,thedepartmentshallnot 58requirecompliancewithanyadditionalstandardsforestablishingorrenewingtrauma, 59STEMI,orstrokedesignationsunderthissubsection.Thedesignationshallcontinueifsuch 60hospitalremainscertifiedorverified.Thedepartmentmayremoveahospital'sdesignationas 61atraumacenter,STEMIcenter,orstrokecenterifthehospitalrequestsremovalofthe 62designationorthedepartmentdeterminesthatthecertificateorverificationthatqualifiedthe 63hospitalforthedesignationunderthissubsectionhasbeensuspendedorrevoked.Any 64decisionmadebythedepartmenttowithdrawitsdesignationofacenterpursuanttothis 65subsectionthatisbasedontherevocationorsuspensionofacertificationorverificationbya 66certifyingorverifyingorganizationshallnotbesubjecttojudicialreview.Thedepartment 67shallreporttothecertifyingorverifyingorganizationanycomplaintitreceivesrelatedtothe 68centerdesignatedpursuanttothissubsection.Thedepartmentshallalsoadvisethe 69complainantwhichorganizationcertifiedorverifiedthecenterandprovidethenecessary 70contactinformationshouldthecomplainantwishtopursueacomplaintwiththecertifyingor 71verifyingorganization. 72 5.Anyhospitalreceivingdesignationasatraumacenter,STEMIcenter,orstroke 73centerpursuanttosubsection4ofthissectionshall: 74 (1)Withinthirtydaysofanychangesorreceiptofacertificateorverification,submit 75tothedepartmentproofofcertificationorverificationandthenamesandcontactinformation 76ofthecenter'smedicaldirectorandtheprogrammanager;and 77 (2)Participateinlocalandregionalemergencymedicalservicessystemsforpurposes 78ofprovidingtraining,sharingclinicaleducationalresources,andcollaboratingonimproving 79patientoutcomes. 80 81AnyhospitalreceivingdesignationasalevelIIIstrokecenterpursuanttosubsection4ofthis 82sectionshallhaveaformalagreementwithalevelIorlevelIIstrokecenterforphysician 83consultativeservicesforevaluationofstrokepatientsforthrombolytictherapyandthecareof 84thepatientpost-thrombolytictherapy. 85 6.Hospitalsdesignatedasatraumacenter,STEMIcenter,orstrokecenterbythe 86departmentshallsubmitdatabyoneofthefollowingmethods: 87 (1)Enteringhospitaldataintoastateregistry;or 88 (2)Enteringhospitaldataintoanationalregistryordatabank.Ahospitalsubmitting 89datapursuanttothissubdivisionshallnotberequiredtocollectandsubmitanyadditional 90trauma,STEMI,orstrokecenterdataelements.Nohospitalsubmittingdatatoanationaldata 91registryordatabankunderthissubdivisionshallwithholdauthorizationforthedepartmentto HB1561 3 92accesssuchdatathroughsuchnationaldataregistryordatabank.Nothinginthissubdivision 93shallbeconstruedasrequiringduplicativedataentrybyahospitalthatisotherwise 94complyingwiththeprovisionsofthissubsection.Failureofthedepartmenttoobtainaccess 95todatasubmittedtoanationaldataregistryordatabankshallnotbeconstruedashospital 96noncomplianceunderthissubsection. 97 7.Whencollectingandanalyzingdatapursuanttotheprovisionsofthissection,the 98departmentshallcomplywiththefollowingrequirements: 99 (1)Namesofanyhealthcareprofessionals,asdefinedinsection376.1350,shallnot 100besubjecttodisclosure; 101 (2)Thedatashallnotbedisclosedinamannerthatpermitstheidentificationofan 102individualpatientorencounter; 103 (3)Thedatashallbeusedfortheevaluationandimprovementofhospitaland 104emergencymedicalservices'trauma,stroke,andSTEMIcare;and 105 (4)Trauma,STEMI,andstrokecenterdataelementsshallconformtonational 106registryordatabankdataelements,andincludepublisheddetailedmeasurespecifications, 107datacodinginstructions,andpatientpopulationinclusionandexclusioncriteriatoensuredata 108reliabilityandvalidity. 109 8.Thedepartmentshallnothaveauthoritytoestablishadditionaleducation 110requirementsforphysicianswhoareemergencymedicineboard-certifiedorboard-eligible 111throughtheAmericanBoardofEmergencyMedicine(ABEM)ortheAmericanOsteopathic 112BoardofEmergencyMedicine(AOBEM)andwhoarepracticingintheemergency 113departmentofafacilitydesignatedasatraumacenter,STEMIcenter,orstrokecenterbythe 114departmentunderthissection.Thedepartmentshalldeemtheeducationrequirements 115promulgatedbyABEMorAOBEMtomeetthestandardsfordesignationsunderthissection. 116Educationrequirementsfornon-ABEMornon-AOBEMcertifiedphysicians,nurses,and 117otherproviderswhoprovidecareatafacilitydesignatedasatraumacenter,STEMIcenter,or 118strokecenterbythedepartmentunderthissectionshallmirrorbutnotexceedthose 119establishedbynationaldesignatingorverifyingbodiesoftraumacenters,STEMIcenters,or 120strokecenters. 121 9.Thedepartmentofhealthandseniorservicesmayestablishappropriatefeesto 122offsetonlythecostsoftrauma,STEMI,andstrokecentersurveys. 123 10.NohospitalshallholditselfouttothepublicasaSTEMIcenter,strokecenter, 124adulttraumacenter,pediatrictraumacenter,oranadultandpediatrictraumacenterunlessit 125isdesignatedassuchbythedepartmentofhealthandseniorservices. 126 11.Anypersonaggrievedbyanactionofthedepartmentofhealthandseniorservices 127affectingthetrauma,STEMI,orstrokecenterdesignationpursuanttothischapter,including 128therevocation,thesuspension,orthegrantingof,refusaltogrant,orfailuretorenewa HB1561 4 129designation,mayseekadeterminationthereonbytheadministrativehearingcommission 130underchapter621.Itshallnotbeaconditiontosuchdeterminationthatthepersonaggrieved 131seekareconsideration,arehearing,orexhaustanyotherprocedurewithinthedepartment. ✔ HB1561 5