,,ii #aag? ,,congress #b;d ,session ,s4 #dhbg ,,9 ,,! ,,s5ate ,,( ,,! ,,unit$ ,,/ates ,septemb] #ac1 #bjbb,mr4 ,cassidy 7= himself & ,mr4 ,casey7 introduc$ ! foll[+ bill2 :i* 0 read twice & ref]r$ to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ,a ,,bill ,to au?orize ! ,secret>y ( ,heal? & ,human ,s]vices to e/abli% a national sepsis data tru/1 & to fund ,/ate-bas$ pilots & programs to e/abli% int]op]able ,/ate-bas$ sepsis data tru/s4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,national ,sepsis ,data ,tru/1 ,outcomes1 & ,innovation ,act or ,lu,lu's ,law4 #b4 ,treat+ & elim9at+ ! burd5 ( sepsis ,"p ,p ( title ,,iii ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bhj;g et seq47 is am5d$ by add+ at ! end ! foll[+3 #cii,v-#g4 ,treat+ & elim9at+ ! burd5 ( sepsis 7a7 ,def9ition2 designation 7#a7 ,def9ition ( sepsis ,n lat] ?an #abj days aft] ! date ( enactm5t ( ! ,national ,sepsis ,data ,tru/1 ,outcomes1 & ,innovation ,act1 ! ,secret>y %all issue a rule specify+ a def9ition ( sepsis4 ,su* def9ition may specify t sepsis is a life-?reat5+ organ dysfunction caus$ by a dysregulat$ ho/ response to infection4 ,su* def9ition %all be /&>diz$ across dep>tm5ts1 ag5cies1 & o!r entities )9 ! ,dep>tm5t ( ,heal? ( ,human ,s]vices4 7#b7 ,nationally notifiable disease ,! ,secret>y1 act+ ?r\gh ! ,director ( ! ,c5t]s = ,disease ,control & ,prev5tion1 %all take su* /eps z may be necess>y to include sepsis on ! li/ ( nationally notifiable diseases publi%$ by ! ,c5t]s = ,disease ,control & ,prev5tion4 7b7 ,national /rategy 7#a7 ,9 g5]al ,! ,secret>y %all develop a national /rategy-- 7,a7 to treat & elim9ate ! burd5 ( sepsis1 ) ! specific goals (1 ) respect to sepsis-- 7i7 coord9at+ data 7includ+ ?r\gh ! data tru/ e/abli%$ "u subsection 7d772 7ii7 spurr+ rese>*2 & 7iii7 develop+ diagno/ic tools & treatm5ts2 7,b7 to decrease in/ances ( sepsis & mitigate long-t]m heal? effects ( sepsis2 & 7,c7 t includes specific actions to be tak5 to treat & elim9ate ! burd5 ( sepsis among at-risk populations id5tifi$ pursuant to p>agraph 7#c74 7#b7 ,coord9ation ,9 develop+ ! /rategy "u p>agraph 7#a71 ! ,secret>y may coord9ate among ag5cies )9 ! ,dep>tm5t ( ,heal? & ,human ,s]vices & o!r ,f$]al ag5cies1 academic in/itutions1 & non-pr(it organizations4 7#c7 ,at-risk populations ,! ,secret>y %all id5tify population gr\ps ! ,secret>y det]m9es to be at a high] risk = contract+ sepsis1 :i* %all include-- 7,a7 *ildr52 7,b7 pregnant wom5 or wom5 9 ! "o ye> po/p>tum p]iod2 7,c7 active memb]s ( ! ,arm$ ,=ces & vet]ans2 7,d7 disabl$ & eld]ly individuals2 7,e7 individuals resid+ on f$]ally-recogniz$ ,tribal l&s2 & 7,f7 su* o!r gr\ps z ! ,secret>y det]m9es to be at high] risk = contract+ sepsis4 7c7 ,/ate-,bas$ sepsis data tru/ pilot programs 7#a7 ,9 g5]al ,subject to ! availability ( appropriations1 ! ,secret>y %all aw>d grants to n m ?an #e ,/ates to e/abli% pilot programs-- 7,a7 to collect into ,/ate-bas$ sepsis data tru/s t use /&>diz$ data =mats & cod+ 7z det]m9$ by ! ,secret>y7 de-id5tifi$ pati5t data conc]n+-- 7i7 demographic in=mation ab\t ea* case ( sepsis 9 ea* su* ,/ate2 7ii7 adm9i/rative in=mation ) respect to ea* su* case1 includ+ ! date ( diagnosis & ! s\rce ( in=mation2 7iii7 pa?ological & g5etic mat]ial *>act]iz+ ea* su* case 7includ+ deoxyribonucleic acids 7,,dna71 ribonucleic acids 7,,rna71 s+le cell ,,rna1 g5es1 *romosomes1 g5otype1 alleles1 epig5etic alt]ation or modifications to ,,dna or ,,rna1 s+le nucleotide polymorphisms 7,s,n,ps71 un9t]pret$ data t results f analysis ( a biological sample f a diagnos$ sepsis pati5t or o!r s\rce1 & any in=mation extrapolat$1 d]iv$1 or inf]r$ !refrom72 7iv7 cl9ical in=mation1 includ+ relevant diagnoses1 treatm5t1 & pati5t-report$ outcomes ( ! individuals ) sepsis & sepsis survivors2 7v7 ) respect to ea* case ( sepsis 9 ea* su* ,/ate1 ! numb] ( /aff work+ 9 ! relevant unit ( ! heal? c>e provid] involv$2 7vi7 provid] paym5ts t result f a sepsis diagnosis2 & 7vii7 o!r elem5ts det]m9$ appropriate by ! ,secret>y2 & 7,b7 to comb9e & connect data s collect$ among su* ,/ates4 7#b7 ,data tru/ guidel9es 7,a7 ,9 g5]al ,! ,secret>y %all e/abli% gov]nance guidel9es1 data access requirem5ts1 privacy & security protocols1 & o!r su* /&>ds z may be requir$ to support ! e/abli%m5t ( int]op]able ,/ate-bas$ sepsis data tru/s = purposes ( ! national sepsis data tru/ to be e/abli%$ "u subsection 7d74 7,b7 ,data %>+ ,! guidel9es e/abli%$ "u subp>agraph 7,a7 %all specify t-- 7i7 no entity p>ticipat+ 9 ! data tru/ may %>e pati5t data ) any entity n p>ticipat+ 9 ! data tru/2 & 7ii7 an entity %all agree1 z a condition on p>ticipation 9 ! data tru/ to n %>e any pati5t data ) any entity n p>ticipat+ 9 ! data tru/4 7#c7 ,selection crit]ia ,9 review+ applications submitt$ by ,/ates = grants "u ?is section1 ! ,secret>y %all consid] :e!r ! ,/ates submitt+ su* applications demon/rate e/abli%$ p>tn]%ips ) a range ( public & private /akehold]s4 ,( ! ,/ates t demon/rate su* p>tn]%ips1 ! ,secret>y %all select-- 7,a7 at lea/ "o ,/ate t has a dea? rate f septicemia ( great] ?an #ae p p] #ajj1jjj p p] ye> & #a1ejj dea?s p] ye> = ! #e cal5d> ye>s prec$+ ! decl>ation ( ! public heal? em]g5cy ) respect to ,,covid-#ai2 7,b7 at lea/ "o rural ,/ate ) above av]age sepsis mortality rate2 7,c7 a selection ( o!r ,/ates 9 su* a mann] z to ensure div]sity ( population d5sity1 geographic location1 & g5]al heal? c>e access & infra/ructure2 & 7,d7 o!r ,/ates 9 su* a matt] z to ensure geographic & population div]sity4 7#d7 ,alt]native crit]ia ,if no ,/ate meet+ ! crit]ia specifi$ 9 p>agraph 7#c7 e/abli%es a pilot program 9 coord9ation ) ! ,secret>y )9 #c ye>s ( ! date ( enactm5t ( ! ,national ,sepsis ,data ,tru/1 ,outcomes1 & ,innovation ,act1 ! ,secret>y may id5tify alt]native requirem5ts = su* ,/ates4 7#e7 ,report+ ,n lat] ?an #ah mon?s aft] ! date on :i* a ,/ate successfully 7z det]m9$ by ! ,secret>y7 e/abli%es a ,/ate-bas$ sepsis data tru/ us+ funds receiv$ ?r\gh a grant "u ?is subsection1 ! ,/ate %all submit to ! ,secret>y a report4 ,su* report %all include1 ) respect to ! ,/ate-bas$ sepsis data tru/ involv$-- 7,a7 ! process by :i* ! ,/ate e/abli%$ ! data tru/1 includ+ gov]nance & data access rules2 7,b7 ! process by :i* data 0 collect$1 de-id5tifi$1 & /&>diz$ across multiple data sy/ems2 7,c7 implem5tation b>ri]s exp]i5c$ & ! c\rse ( corrective action tak5 to address ^! b>ri]s2 & 7,d7 lessons le>n$ ?r\gh ! e/abli%m5t ( ! data tru/4 7#f7 ,au?orization ( appropriations ,!re are au?oriz$ to be appropriat$ to c>ry out ?is subsection #e1jjj1jjj = ea* ( fiscal ye>s #bjbc ?r\gh #bjbh4 7d7 ,national ,sepsis ,data ,tru/ 7#a7 ,9 g5]al ,! ,secret>y %all e/abli% a national sepsis data tru/ to improve rese>*1 outcomes1 & innovation 9 support ( ! national /rategy develop$ "u subsection 7b7 7includ+ ! actions to be tak5 pursuant to p>agraph 7#a77;,c7 ( su* subsection74 ,su* national sepsis data tru/ %all-- 7,a7 accel]ate innovation t seeks to improve sepsis prev5tion1 diagnosis1 treatm5t1 outcomes1 & survivor support1 includ+ ?r\gh-- 7i7 advanc+ ! pace ( academic rese>*2 & 7ii7 catalyz+ m inve/m5t 9 me*anisms t provide promise 9 ! e>ly recognition & exp$iti\s treatm5t ( sepsis2 7,b7 support public heal? ef=ts to improve sepsis c>e1 p>ticul>ly 9 und]s]v$ geographic areas & among at-risk & und]s]v$ communities2 7,c7 improve ! t>get+ ( antimicrobial drugs & o!r sub/ances = ! treatm5t ( sepsis1 promot+ bo? bett] c>e & improv$ antimicrobial /ew>d%ip2 7,d7 coord9ate & integrate ! developm5t ( ,/ate-bas$ sepsis data tru/s1 includ+ by def9+ data elem5ts to be includ$ 9 ,/ate-bas$ sepsis data tru/s1 includ+ self-report$ data on age1 race1 e?nicity1 prim>y language1 memb]%ip 9 a f$]ally-recogniz$ ,tribe1 /atus z a memb] ( ! ,arm$ ,=ces1 /atus z a vet]an1 /atus z pregnant or rec5tly pregnant1 & any o!r data ! ,secret>y det]m9es appropriate2 7,e7 provide = appropriate privacy & security ( de-id5tifi$ data 9 ! data tru/ by-- 7i7 prohibit+ any entity p>ticipat+ 9 ! data tru/ f %>+ pati5t data ) any entity n p>ticipat+ 9 ! data tru/2 & 7ii7 ensur+ t an entity agrees1 z a condition on p>ticipation 9 ! data tru/ to n %>e any pati5t data ) any entity n p>ticipat+ 9 ! data tru/2 & 7,f7 all[ access to data de-id5tifi$ data 9 ! data tru/ by heal? c>e provid]s & o!r entities p>ticipat+ 9 ! data tru/4 7#b7 ,/ate grants & contracts 7,a7 ,9 g5]al ,9 addition to aw>d+ grants "u subsection 7c71 ! ,secret>y may aw>d grants directly to ,/ates to support ! developm5t & op]ation ( ,/ate-bas$ sepsis data tru/s 7or aw>d grants or contracts to academic or nonpr(it organizations designat$ by a ,/ate to op]ate ! ,/ate-bas$ sepsis data tru/ involv$7 to comb9e & connect data collect$ by ! ,/ate conc]n+-- 7i7 demographic in=mation ab\t ea* case ( sepsis 9 ea* su* ,/ate2 7ii7 adm9i/rative in=mation ) respect to ea* su* case1 includ+ ! date ( diagnosis & ! s\rce ( in=mation2 7iii7 pa?ological & g5etic data *>act]iz+ ea* su* case2 7iv7 cl9ical in=mation1 includ+ relevant diagnoses1 treatm5t1 & pati5t-report$ outcomes ( ! individuals ) sepsis & sepsis survivors2 & 7v7 o!r elem5ts1 z ! ,secret>y det]m9es appropriate4 7,b7 ,mat*+ funds ,! ,secret>y may aw>d a grant or contract "u p>agraph 7#b7 only if ! ,/ate involv$ 7or ! academic or nonpr(it private organization designat$ by a ,/ate to op]ate ! ,/ate-bas$ sepsis data tru/ involv$7 agrees1 ) respect to ! co/s ( ! program to be fund$ ?r\gh ! aw>d1 to make available 7directly or ?r\gh donations f public or private entities7 non-,f$]al contributions t[>d su* co/s 9 an am\nt t is n less ?an #be p]c5t ( su* co/s4 7,c7 ,data tru/ guidel9es ,! guidel9es develop$ "u subsection 7c77#b7 %all apply ) respect to ,/ate-bas$ sepsis data tru/s e/abli%$ "u ?is p>agraph 9 ! same mann] & to ! same ext5t z su* guidel9es apply ) respect to ,/ate-bas$ sepsis data tru/s e/abli%$ "u subsection 7c7 7includ+ ! data %>+ limitations specifi$ 9 p>agraph 7#b77;,b7 ( su* subsection74 7#c7 ,report on gov]nm5t sepsis data activities & res\rces ,n lat] ?an #ahj days aft] ! date ( enactm5t ( ! ,national ,sepsis ,data ,tru/1 ,outcomes1 & ,innovation ,act1 ! ,secret>y %all submit to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives a report conta9+ ! foll[+3 7,a7 ,an outl9e ( exi/+ ,f$]al ef=ts to collect & make available data on sepsis & its associat$ conditions1 includ+ exi/+ ,f$]al repositories ( sepsis-relevant de-id5tifi$ pati5t data4 7,b7 ,a summ>y ( ! use ( ^! sepsis data by ?ird p>ties1 includ+ public heal? pr(essionals1 physicians & nurses1 & rese>*]s4 7,c7 ,a description ( ,f$]al ef=ts to improve c>e relat$ to sepsis & infection 9 und]s]v$ populations & communities t exp]i5ce disproportionately poor heal? outcomes4 7e7 ,def9itions ,9 ?is section3 7#a7 ,de-id5tifi$ ,! t]m de-id5tifi$ means1 ) respect to data 9 a data tru/ e/abli%$ "u or pursuant to ?is section1 in=mation t has be5 de-id5tifi$ 7& rema9s de-id5tifi$7 9 accordance ) ! applicable requirem5ts ( section #afd4ead ( title #de1 ,code ( ,f$]al ,regulations 7or any successor regulation74 7#b7 ,national sepsis data tru/ ,! t]m national sepsis data tru/ means an int]op]able1 de-id5tifi$1 privacy-protect$ collection1 curation1 & /orage sy/em t conta9s de-id5tifi$ data f a v>iety ( s\rces e/abli%$ by individual ,/ates1 ) data made available to entities & individuals approv$ by ! ,secret>y4 4