,i  #aaf? ,,congress  #b;d ,session  ,h4
 ,r4 #ijcg  ,,9 ,,! ,,h\se ,,(          
,,repres5tatives  ,decemb] #bj1         
#bjbj,ms4 ,gabb>d introduc$ ! foll[+    
bill2 :i* 0 ref]r$ to ! ,committee on   
,en]gy & ,comm]ce  ,a ,,bill  ,to am5d !
 ,public ,heal? ,s]vice ,act to ensure  
transp>5cy )9 ! heal? c>e sy/em ?r\gh ! 
e/abli%m5t ( a ,national ,heal?c>e      
,acquir$ ,infection & ,m$ical ,error    
,report+ ,program4  #a4 ,%ort title ,?is
 ,act may be cit$ z ! ,national         
,heal?c>e ,acquir$ ,infection & ,m$ical 
,error ,transp>5cy ,act4  #b4 ,f9d+s    
7#a7 ,! ,c5t]s = ,disease ,control &    
,prev5tion report$ t ea* day "o 9       
?irty-"o hospital pati5ts has at lea/ "o
 heal?c>e-associat$ infection2  7#b7 #cb
 p]c5t ( all heal?c>e-acquir$ infections
 are ur9>y tract2  7#c7 #bb p]c5t ( all 
infections are surgical site infections2
  7#d7 #ae p]c5t are pneumonia 7lung    
infections72  7#e7 #ad p]c5t are        
blood/ream infections4  7#f7 ,pati5ts :o
 acquire infections f surg]y sp5d on    

av]age an additional #f4e days          
hospitaliz$2  7#g7 are five times m     
likely to be readmitt$ aft] dis*>ge2    
7#h7 & are twice z likely to die4  7#i7 
,z rec5t z #bjaf1 ,johns ,hopk9s        
,univ]sity pati5t safety exp]ts         
calculat$ t m$ical error is responsible 
= at lea/ #bej1jjj dea?s p] ye> 7! ?ird 
lead+ cause ( dea? 9 ! ,u4,s474  #c4    
,e/abli%m5t ( ,(fice ( ,pati5t ,safety &
 ,heal? ,c>e ,quality ,title ,,ix ( !   
,public ,heal? ,s]vice ,act 7#db        
,u4,s4,c4 #bii et seq47 is am5d$-- 7#a7 
by r$esignat+ "p ,e z "p ,f2  7#b7 9 "p 
,f1 z r$esignat$-- 7,a7 by r$esignat+   
sections #ida ?r\gh #idh z sections #iea
 ?r\gh #ieh1 respectively2 &  7,b7 9    
section #ieh7a71 z r$esignat$1 by /rik+ 
#8#8#ida'' & ins]t+ #8#8#iea''2 &  7#c7 
by ins]t+ aft] "p ,d ! foll[+3  ,e      
,national ,heal?c>e ,acquir$ ,infection 
& ,m$ical ,error ,report+ ,program      
#ida4 ,def9itions ,9 ?is "p3 7#a7       
,anti-retaliation ,! t]m                
anti-retaliation any pati5t or legal    

repres5tative ( a pati5t :o engages 9   
,protect$ ,activity w be %ield$ f       
retaliation4  7#b7 ,database ,! t]m     
,database means ! ,national ,pati5t     
,safety ,database e/abli%$ "u section   
#idd4  7#c7 ,heal? c>e provid] ,! t]m   
heal? c>e provid] means a p]son or      
entity lic5s$ or o!rwise au?oriz$ "u    
,/ate law to provide heal? c>e s]vices1 
includ+-- 7,a7 a hospital1 heal? plan1  
community cl9ic1 nurs+ facility1        
compreh5sive rehabilitation facility1   
home heal? ag5cy1 hospice program1 r5al 
dialysis facility1 ambulatory surgical  
c5t]1 ph>macy1 doctor's or heal? c>e    
practition]'s (fice1 long-t]m c>e       
facility1 behavior heal? resid5tial     
treatm5t facility1 cl9ical laboratory1  
or heal? c5t]2  7,b7 a doctor1 nurse1   
physician assi/ant1 nurse practition]1  
cl9ical nurse speciali/1 c]tifi$ nurse  
ane/heti/1 c]tifi$ nurse midwife1       
psy*ologi/1 c]tifi$ social work]1       
regi/]$ dietitian or nutrition          
pr(essional1 physical or occupational   

!rapi/s1 ph>maci/1 or o!r individual    
heal?c>e practition]2 &  7,c7 any o!r   
heal? c>e pr(essional specifi$ 9        
regulations promulgat$ by ! ,secret>y4  
7#d7 ,heal?c>e ,acquir$ ,infection ,!   
t]m ,heal?c>e ,acquir$ ,infection7s7    
7,,hai7 means an infection t is         
contract$ :ile 9 a heal?c>e facility1   
su* z an acute c>e hospital1 skill$     
nurs+ c>e facility1 or doctor's (fice or
 cl9ic4  7#f7 ,m$ical error ,! t]m      
m$ical error means an unexpect$         
occurr5ce involv+ dea? or s]i\s physical
 or psy*ological injury1 or ! risk ( su*
 injury1 includ+ any process v>iation ( 
:i* recurr5ce may c>ry significant *ance
 ( a s]i\s adv]se outcome4  7#g7 ,(fice 
,! t]m ,(fice means ! ,(fice ( ,pati5t  
,safety & ,heal? ,c>e ,quality e/abli%$ 
"u section #idc1 :i* %all be a c]tifi$  
pati5t safety organization z def9$ "u "p
 ,c4  7#h7 ,outcomes ,! t]m outcomes    
means any result ( heal?c>e acquir$     
infection &_/or m$ical error on affect$ 
pati5ts4  7#i7 ,pati5t safety data ,!   

t]m pati5t safety data means in=mation  
reque/$ by ! ,director ( ! ,(fice to be 
submitt$ by ! pati5t safety (fic] ( a   
,program p>ticipant z describ$ 9 section
 #ide7;e74  7#f7 ,pati5t safety ev5t ,! 
t]m pati5t safety ev5t means an         
occurr5ce1 incid5t1 or process t ei!r   
contributes to1 or has ! pot5tial to    
contribute to1 a pati5t injury or       
degrades ! ability ( heal? c>e provid]s 
to provide ! appropriate /&>d ( c>e4    
7#g7 ,pati5t safety (fic] ,! t]m pati5t 
safety (fic] means ! individual         
designat$ by a ,program p>ticipant z be+
 responsible = ensur+ t ! conditions =  
p>ticipation 9 ! ,program are met4  7#h7
 ,pati5t safety organization ,! t]m     
pati5t safety organization has ! mean+  
giv5 su* t]m 9 section #iba4  7#i7      
,pati5t safety "w product ,! t]m pati5t 
safety "w product has ! mean+ giv5 su*  
t]m 9 section #iba4  7#aj7 ,program ,!  
t]m ,program means ! ,national ,heal?c>e
 ,acquir$ ,infections & ,m$ical ,error  
,report+ ,program e/abli%$ "u section   

#ide4  7#aa7 ,program p>ticipant ,! t]m 
program p>ticipant means any heal?c>e   
provid] :o reports heal?c>e acquir$     
infections &_/or m$ical errors to !     
,national ,heal?c>e ,acquir$ ,infections
 & ,m$ical ,error ,report+ ,program4    
7#ab7 ,root cause analysis ,! t]m root  
cause analysis means an exam9ation or   
inve/igation ( an occurr5ce1 ev5t1 or   
incid5t to det]m9e if a prev5table      
m$ical error took place or ! /&>d ( c>e 
0 n foll[$ & to id5tify ! causal factors
 t l$ to su* occurr5ce1 ev5t1 or        
incid5t4  7#ad7 ,:i/lebl[] ,! t]m       
:i/lebl[] means any individual or legal 
repres5tative ( an individual1 :o       
provides orig9al in=mation relat+ to a  
,heal?c>e ,acquir$ ,infection or ,m$ical
 ,error outcome4  #idb4 ,purpose & goals
 ,x is ! purpose ( ?is legislation to   
promote a culture ( safety & tru/ )9    
hospitals1 heal? sy/ems1 cl9ics1 & o!r  
sites ( heal? c>e1 ?r\gh ! e/abli%m5t ( 
a ,national ,heal?c>e ,acquir$          
,infection & ,m$ical ,error ,report+    

,program4 ,x %all be a goal ( ! ,program
 to-- 7#a7 e/abli% /&>diz$ proc$ures =  
,/ates to provide reports detail+       
heal?c>e acquir$ infection & m$ical     
error disclosure & report+2  7#b7       
require all ,/ate dep>tm5ts ( heal? to  
use ! data provid$ by hospitals = error 
report+ to analyze tr5ds & id5tify be/  
practices2  7#c7 r$uce rates (          
prev5table m$ical errors2 &  7#d7 ensure
 pati5ts h access to in=mation = m$ical 
injury or illness due to m$ical error1  
neglig5ce1 or malpractice4  #idc4 ,(fice
 ( ,pati5t ,safety & ,heal? ,c>e        
,quality  7a7 ,9 ,g5]al ,! ,secret>y    
%all e/abli% )9 ! ,(fice ( ! ,secret>y1 
an ,(fice ( ,pati5t ,safety & ,heal?    
,c>e ,quality to collaborate ) !        
,director ( ! ,ag5cy = ,heal? ,c>e      
,rese>* & ,quality to improve pati5t    
safety & r$uce m$ical error across !    
heal? c>e sy/em4 ,! ,(fice %all be head$
 by a ,director to be appo9t$ by !      
,secret>y4  7b7 ,activities ,!          
activities ( ! ,(fice %all be deem$     

pati5t safety activities1 z def9$ 9     
section #iba4  7c7 ,duties ,! ,director 
( ! ,(fice %all-- 7#a7 e/abli% & adm9i/]
 ! ,program2  7#b7 det]m9e :o is        
eligible = p>ticipation 9 ! ,program 9  
accordance ) section #ide2  7#c7        
contract ) an indep5d5t entity = !      
purpose ( evaluat+ ! ,program at lea/   
once e two ye>s1 ) ! results ( su*      
evaluations be+ dissem9at$ to ,program  
p>ticipants1 ,congress1 & ! public2     
7#d7 e/abli% & ma9ta91 9 consultation ) 
pati5t safety organizations1 heal? c>e  
quality organizations1 heal? c>e        
provid]s1 & ! heal? in=mation te*nology 
indu/ry1 a ,national ,pati5t ,safety    
,database z provid$ = 9 section #idd to 
receive nonid5tifiable pati5t safety "w 
product z describ$ 9 ! report+          
requirem5ts = ,program p>ticipants "u   
section #ide7;c77#aj72  7#e7 det]m9e &  
adopt a /&>diz$ pati5t safety taxonomy1 
necess>y elem5ts1 common & consi/5t     
def9itions1 & /&>diz$ =mats = !         
electronic report+ ( pati5t safety data 

to ! ,database z describ$ 9 section     
#idd7;e72  7#f7 survey ,f$]al1 ,/ate1 & 
local requirem5ts = ! report+ ( pati5t  
safety data & "w to /reaml9e & r$uce    
duplication ( su* requirem5ts2  7#g7    
grant pati5t safety organizations1      
rese>*]s1 & o!r qualifi$ individuals &  
in/itutions access to ! ,database z     
det]m9$ appropriate ?r\gh ! evaluation (
 complet$ applications submitt$ to !    
,(fice = su* purpose2  7#h7 analyze1    
directly or ?r\gh a contract ) a pati5t 
safety organization1 all data ent]$ into
 ! ,database & provide ,program         
p>ticipants1 ,congress1 & ! public )    
heal?c>e acquir$ infection & m$ical     
error tr5d reports & o!r analyses z     
det]m9$ appropriate by ! ,director on a 
qu>t]ly basis2  7#i7 develop1 directly  
or ?r\gh a contract ) a pati5t safety   
organization1 safety & tra9+            
recomm5dations = heal? c>e provid]s t   
focus on ! r$uction ( m$ical errors1    
improv$ pati5t safety1 & increas$       
quality ( c>e on at lea/ a ye>ly basis2 

7#aj7 ma9ta9 a publicly accessible      
int]net website to provide pati5ts &    
heal? c>e provid]s ) in=mation conc]n+ !
 ,program & ! ,database2 &  7#aa7 p]=m  
any o!r duties = ! adm9i/ration ( !     
,program z det]m9$ necess>y by !        
,secret>y4  7d7 ,au?orization (         
,appropriations ,!re are au?oriz$ to be 
appropriat$ su* sums z may be necess>y =
 ea* fiscal ye> to c>ry out ! activities
 ( ! ,(fice4  #idd4 ,national ,pati5t   
,safety ,database  7a7 ,9 ,g5]al ,!     
,director ( ! ,(fice %all1 9 accordance 
) section #idc7;c77#f71 e/abli% a       
,national ,pati5t ,safety ,database t   
%all-- 7#a7 adopt /&>diz$ pati5t safety 
taxonomy 9 consultation ) ! ,jo9t       
,commission on ,accr$itation ( !        
,heal?c>e ,organizations & o!r entities 
) relevant exp]tise2  7#b7 include      
necess>y elem5ts1 common & consi/5t     
def9itions1 & a /&>diz$ electronic      
int]face = ! entry & process+ ( ! data  
by ,program p>ticipants1 z develop$ by !
 ,director 9 consultation ) pati5t      

safety organizations1 heal? c>e         
provid]s1 & ! heal? in=mation te*nology 
indu/ry2  7#c7 all[ = ! compreh5sive    
collection & analysis ( ! pati5t safety 
data requir$ to be submitt$ by all      
,program p>ticipants "u section #ide2 & 
7#d7 include pati5t safety data requir$ 
to be submitt$ by ,program p>ticipants  
"u section #ide z nonid5tifiable pati5t 
safety "w product & privileg$ &         
confid5tial 9 accordance ) section #ibb4
  7b7 ,limitation ,in=mation submitt$ to
 ! ,database %all be confid5tial &      
protect$ f disclosure 9 accordance ) !  
regulations promulgat$ "u section       
#bfd7;c7 ( ! ,heal? ,insurance          
,portability & ,acc\ntability ,act (    
#aiif 7#db ,u4,s4,c4 #acbj;d-#b note74  
7c7 ,access ,access to ! pati5t safety  
data conta9$ )9 ! ,database %all only be
 provid$ ?r\gh application to & approval
 by ! ,director4  #ide4 ,national       
,heal?c>e ,acquir$ ,infection & ,m$ical 
,error ,report+ ,program  7a7           
,e/abli%m5t ,! ,secret>y1 act+ ?r\gh !  

,director ( ! ,(fice1 %all e/abli% a    
,national ,heal?c>e ,acquir$ ,infection 
& ,m$ical ,error ,report+ ,program to   
provide = ! confid5tial disclosure (    
m$ical errors & pati5t safety ev5ts 9   
ord] to improve pati5t safety & heal?   
c>e quality1 r$uce prev5table m$ical    
errors1 ensure pati5t access to data &  
reports = m$ical injury due to m$ical   
error1 neglig5ce1 or malpractice4  7b7  
,eligible ,p>ticipants ,to be eligible  
to p>ticipate 9 ! ,program an entity    
%all-- 7#a7 7,a7 be a heal?c>e provid]2 
or  7,b7 be any o!r entity det]m9$ to be
 eligible by ! ,director2  7#b7         
designate a pati5t safety (fic] to      
ensure t ! conditions ( p>ticipation    
describ$ 9 subsection 7c7 are met2  7#c7
 submit a complet$ application to !     
,(fice at su* "t1 9 su* mann]1 & conta9+
 su* in=mation z ! ,director may        
require2 &  7#d7 agree to comply ) !    
conditions ( p>ticipation "u subsection 
7c74  7c7 ,conditions ( ,p>ticipation ,a
 ,program p>ticipant %all1 directly or  

indirectly-- 7#a7 submit a compreh5sive 
plan1 z "p ( ! application =            
p>ticipation 9 ! ,program1 to r$uce !   
incid5ce ( m$ical errors & improve      
pati5t safety 9 ! case ( a ,program     
p>ticipant t is a heal? c>e provid]1    
activities t result 9 ! r$uction (      
m$ical errors or t o!rwise improve      
pati5t safety2  7#b7 require heal? c>e  
provid]s includ$ 9 ! ,program by !      
,program p>ticipant & z outl9$ 9 !      
,program p>ticipant application1 to     
submit to ! pati5t safety (fic] a report
 ( any incid5t or occurr5ce involv+ a   
pati5t t is ?\ght to ei!r be a m$ical   
error or pati5t safety ev5t2  7#c7      
ensure t ! reports fil$ "u p>agraph 7#b7
 are submitt$ to ! ,database 9 a /&>diz$
 =mat z designat$ by ! ,director2  7#d7 
:]e appropriate1 ensure t a root cause  
analysis ( any report submitt$ to !     
pati5t safety (fic] "u p>agraph 7#b7 is 
p]=m$ )9 #ij days ( ! fil+ ( a report "u
 su* p>agraph2  7#e7 ensure t if a      
pati5t 0 h>m$ or injur$ z ! result ( a  

heal?c>e acquir$ infection or m$ical    
error1 or z a result ( ! relevant /&>d (
 c>e n be+ foll[$1 an acc\nt ( ! incid5t
 or occurr5ce1 z describ$ 9 p>agraph    
7#b7 %all be disclos$ to ! pati5t n lat]
 ?an #e bus9ess days aft] ! completion (
 root cause analysis2  7#f7 disclose    
in=mation conta9$ 9 any report submitt$ 
to ! pati5t safety (fic] "u p>agraph    
7#b7 ^u ! reque/ ( ! pati5t ) respect to
 :om ! report has be5 fil$2  7#g7 (f]1  
at ! "t ( disclosure ( an incid5t or    
occurr5ce 9 :i* x 0 det]m9$ t a pati5t 0
 h>m$ or injur$ z a result ( m$ical     
error or z a result ( ! relevant /&>d ( 
c>e n be+ foll[$1 to %>e1 :]e           
practicable1 any ef=ts ! heal? c>e      
provid] w und]take to prev5t            
reoccurr5ce2 &  7#h7 prep>e & submit    
entries to ! ,database z requir$ by !   
,director ( ! ,(fice & 9 accordance )   
subsection 7d74  7d7 ,submission (      
,pati5t ,safety ,data  7#a7 ,9 ,g5]al   
,all entries into ! ,database %all--    
7,a7 conta9 only non-id5tifiable pati5t 

safety "w product2  7,b7 be 9 a /&>diz$ 
electronic =mat to be det]m9$ by !      
,director2 &  7,c7 if relat$ to a s+le  
occurr5ce or incid5t1 be giv5 a common  
id5tifi] to l9k entries ( relat$ data4  
7#b7 ,report+ requirem5ts ,! pati5t     
safety (fic] ( a ,program p>ticipant    
%all be requir$ to prep>e & ent] into ! 
,database-- 7,a7 reports1 conta9+ only  
nonid5tifiable pati5t safety "w product1
 fil$ by a heal? c>e provid] "u         
subsection 7c77#d7 & a summ>y ( ! f9d+s 
( ! root cause analysis ) respect to su*
 report )9 #e bus9ess days ( !          
completion ( ! root cause analysis2     
7,b7 any discipl9>y actions tak5 aga9/ a
 heal? c>e provid] z a result (         
involvem5t 9 any incid5t or occurr5ce   
involv+ a pati5t t is ?\ght to be a     
m$ical error or pati5t safety ev5t1 or  
legal action = :i* a report "u          
subsection 7c77#d7 0 fil$2 or  7,c7 o!r 
data z det]m9$ appropriate by !         
,director4  7#c7 ,privilege &           
confid5tiality ,! provisions ( section  

#ibb %all apply to pati5t safety data   
submitt$ "u ?is subsection4  #idf4 ,!   
,national ,heal?c>e ,acquir$ ,infection 
& ,m$ical ,error ,report+ ,acc\ntability
 ,/udy  7a7 ,9 ,g5]al ,! ,director ( !  
,(fice %all conduct1 directly or ?r\gh a
 contract ) pati5t safety organizations 
or qualifi$ individuals or in/itutions1 
an analysis ( ! pati5t safety data 9 !  
,database & o!r available data to       
det]m9e p]=mance & sy/ems /&>ds1 tools1 
& be/ practices 7includ+ pe] review7 =  
doctors & o!r heal? c>e provid]s        
necess>y to prev5t m$ical errors1       
improve pati5t safety1 & increase       
acc\ntability )9 ! heal? c>e sy/em4 ,su*
 analysis %all also consid] ! value (   
increas+ ! transp>5cy ( ! pati5t safety 
data to include ! id5tity ( heal? c>e   
provid]s & provide recomm5dations =     
improvem5ts to ! pe] review process4    
7b7 ,report & ,recomm5dations ,n lat]   
?an #b ye>s aft] ! date ( enactm5t ( ?is
 section1 ! ,director ( ! ,(fice %all   
submit to ,congress & make available to 

,/ates1 ,/ate m$ical bo>ds1 & ! public a
 report t describes ! results ( ! /udy  
c>ri$ out "u subsection 7a7 & conta9s   
recomm5dations = ,congress bas$ on !    
f9d+s ( ! report4  4