,,ii #aaf? ,,congress #b;d ,session ,s4 #ceab ,,9 ,,! ,,s5ate ,,( ,,! ,,unit$ ,,/ates ,m>* #ag1 #bjbj,mr4 ,paul introduc$ ! foll[+ bill2 :i* 0 read twice & ref]r$ to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ,a ,,bill ,to cl>ify ! au?ority = regulat+ laboratory-develop$ te/+ proc$ures4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,v]ifi$ ,innovative ,te/+ 9 ,am]ican ,laboratories ,act ( #bjbj or ! ,,vital ,act ( #bjbj4 #b4 ,laboratory-develop$ te/+ proc$ures 7a7 ,f9d+s ,congress f9ds ! foll[+3 7#a7 ,laboratory te/+ s]vices are an integral "p ( m$ical decision mak+1 heal? managem5t1 & public heal? surveillance4 7#b7 ,provision ( laboratory s]vices is a pr(essional heal? c>e activity1 :i* is regulat$ "u ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bja et seq474 7#c7 ,z witness$ ) ! #bjbj ,,covid-#ai p&emic1 undue regulation ( laboratory-develop$ te/+ proc$ures may hamp] ! m$ical managem5t & public heal? response to infecti\s disease outbreaks & p&emics1 lead+ to delays 9 access to te/+ & ! ability to meet ne$$ capacity to /em community spread4 7b7 ,s5se ( ,congress ,x is ! s5se ( ,congress t-- 7#a7 ! ,f$]al ,gov]nm5t %\ld "w to-- 7,a7 ensure t pati5ts receive ! mo/ appropriate te/s & proc$ures = m$ical evaluations or treatm5t ( cl9ical conditions2 7,b7 ensure t laboratory-develop$ te/+ proc$ures are accurate1 precise1 cl9ically-relevant1 & monitor$ = cont9u$ quality p]=mance2 7,c7 enable laboratory pr(essionals to provide pr(essional s]vices )\t undue re/rictions2 7,d7 ensure t regulatory ov]sight ( laboratory te/s does n limit pati5t access1 imp$e innovation1 con/ra9 flexibility or adaptability1 or limit a te/'s su/a9ability z a result ( be+ unduly burd5some or beyond ! fiscal capacity ( ! laboratory to reasonably validate & p]=m1 or ! heal? c>e sy/em to f9ancially support2 7,e7 pres]ve ! ability ( ! laboratory community to provide surge capacity 9 public heal? em]g5cies1 includ+ biological1 *emical1 radiological1 & nucle> ?reats1 infecti\s disease outbreaks1 or o!r em]g5t situations2 & 7,f7 safegu>d1 /r5g!n1 & exp& ! exi/+ ,laboratory ,response ,network1 includ+ public heal? laboratories1 s5t9el laboratories1 national laboratories1 comm]cial ref]5ce laboratories1 academic m$ical c5t] laboratories1 & hospital-bas$ laboratories2 & 7#b7 laboratories us+ laboratory-develop$ te/+ proc$ures %\ld adh]e to p]sonnel requirem5ts requir$ "u section #cec ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfc;a71 includ+ su* requirem5ts relat+ to qualifi$ pr(essionals :o direct & sup]vise laboratories & consult on diagnosis1 treatm5t1 & managem5t ( pati5t c>e1 & r5d] op9ions to cli5ts conc]n+ diagnosis1 treatm5t1 & managem5t ( pati5t c>e requir$ "u su* section #cec4 7c7 ,au?ority ov] laboratory-,develop$ te/+ proc$ures ,all aspects ( a laboratory-develop$ te/+ proc$ures %all be regulat$ by ! ,secret>y ( ,heal? & ,human ,s]vices "u section #cec ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfc;a71 & no aspects ( laboratory-develop$ te/+ proc$ures %all be regulat$ "u ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cja et seq471 includ+ dur+ a public heal? em]g5cy decl>$ "u section #cai ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bdg;d74 7d7 ,def9ition ,9 ?is section1 ! t]m laboratory-develop$ te/+ proc$ure means a pr(essional m$ical s]vice t utilizes a laboratory exam9ation 9 ! context ( cl9ical c>e or public heal? s]vices & t meets ! /&>ds = e/abli%m5t ( p]=mance specifications e/abli%$ by regulation "u section #cec7;f7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfc;a7f77 applicable to-- 7#a7 laboratory modifications ( te/ sy/ems approv$1 cle>$1 or au?oriz$ by ! ,food & ,drug ,adm9i/ration "u section #eaj7k71 #eac1 #eae1 or #efd ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj7k71 #cfj;c1 #cfj;e1 #cfj;bbb-#c72 7#b7 me?ods develop$ or p]=m$1 & results produc$ & int]pret$1 )9 a laboratory or laboratories "u common own]%ip or )9 ! same organization1 c]tifi$ z requir$ "u section #cec7;c7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfc;a7c772 7#c7 /&>diz$ me?ods su* z ^? t are available 9 textbooks & pe]-review$ publications2 or 7#d7 me?ods 9 :i* p]=mance specifications are n provid$ by ! manufactur] ( te/ sy/ems or compon5ts4 7e7 ,public meet+ ,n lat] ?an #ij days aft] ! date ( enactm5t ( ?is ,act1 ! ,adm9i/rator ( ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices %all hold a public meet+ to solicit recomm5dations on updat+ ! regulations "u section #cec ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfc;a74 7f7 ,report to ,congress ,n lat] ?an #ahj days aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices %all report to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives1 ! foll[+3 7#a7 ,recomm5dations to update section #cec ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfc;a7 & ! regulations promulgat$ "u su* section1 tak+ into consid]ation input & recomm5dations f ! ,cl9ical ,laboratory ,improvem5t ,advisory ,committee1 to reflect ! curr5t /ate ( ! field ( cl9ical laboratory te/+4 7#b7 ,an assessm5t ( ! availability & utilization ( laboratory-develop$ te/+ proc$ures dur+ ! #bjbj ,,covid-#ai p&emic response t includes-- 7,a7 validation crit]ia & process1 & av]age l5g? ( "t f validation to a*iev+ em]g5cy use au?orization "u section #efd ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb-#c7 be=e1 & aft]1 ,febru>y #bi1 #bjbj2 7,b7 ! numb] ( pati5ts & samples te/$ by laboratories us+ su* te/+ proc$ures2 & 7,c7 recomm5dations to ensure t dur+ future infecti\s disease outbreaks1 ! public heal? sy/em & cl9ical laboratories d n enc\nt] delays to te/+4