,i  #aacth ,,congress  #b;d ,session    
,h4 ,r4 #dcgd  ,,in ,,the ,,house ,,of  
,,representatives  ,april #b1 #bjad ,mr4
 ,roe of ,tennessee introduced the      
following bill2 which was referred to   
the ,committee on ,veterans' ,affairs   
,a ,,bill  ,to amend title #ch1 ,united 
,states ,code1 to direct the ,secretary 
of ,veterans ,affairs to adopt and      
implement a standard identification     
protocol for use in the tracking and    
procurement of biological implants by   
the ,department of ,veterans ,affairs1  
and for other purposes4  #a4 ,short     
title ,this ,act may be cited as the    
,biological ,implant ,tracking and      
,veteran ,safety ,act of #bjad4  #b4    
,identification and tracking of         
biological implants used in ,department 
of ,veterans ,affairs medical facilities
  7a7 ,in general ,subchapter ,,ii of   
chapter #gc of title #ch1 ,united       
,states ,code1 is amended by adding at  
the end the following new section3      
#gccj;,b4 ,identification and tracking  

of biological implants  7a7 ,standard   
identification system for biological    
implants ,the ,secretary shall adopt the
 unique device identification system    
developed for medical devices by the    
,food and ,drug ,administration pursuant
 to section #eai7;f7 of the ,federal    
,food1 ,drug1 and ,cosmetic ,act 7#ba   
,u4,s4,c4 #cfj;i7f771 or implement a    
comparable standard identification      
system1 for use in identifying          
biological implants intended for use in 
medical procedures conducted in medical 
facilities of the ,department4  7b7     
,biological implant tracking system     
7#a7 ,the ,secretary shall implement a  
system for tracking the biological      
implants referred to in subsection 7a7  
from donor to implantation4 ,such system
 shall be compatible with the           
identification system adopted or        
implemented under subsection 7a74  7#b7 
,the ,secretary shall implement         
inventory controls compatible with the  
tracking system implemented under       

paragraph 7#a7 so that all patients who 
have received1 in a medical facility of 
the ,department1 a biological implant   
subject to a recall by the ,food and    
,drug ,administration can be notified of
 the recall1 if based on the evaluation 
of appropriate medical personnel of the 
,department of the risks and benefits1  
the ,secretary determines such          
notification is appropriate4  7c7       
,consistency with ,food and ,drug       
,administration regulations ,to the     
extent that a conflict arises between   
this section and a provision of the     
,federal ,food1 ,drug1 and ,cosmetic    
,act 7#ba ,u4,s4,c4 #cja et seq47 or    
sections #cea or #cfa of the ,public    
,health ,service ,act 7#db ,u4,s4,c4    
#bfb7 7including any regulations issued 
under such ,acts71 the provision the    
,federal ,food1 ,drug1 and ,cosmetic    
,act or ,public ,health ,service ,act   
7including any regulations issued under 
such ,acts7 shall apply4  7d7           
,definition of biological implant ,in   

this section1 the term biological       
implant means any human cell1 tissue1 or
 cellular or tissue-based product--     
7#a7 under the meaning given the term   
human cells in section #abga4c of title 
#ba1 ,code of ,federal ,regulations1 or 
any successor regulation2 or  7#b7 that 
is regulated as a device under subpart  
,a of part #hja of title #ba1 ,code of  
,federal ,regulations1 or any successor 
regulation4  4  7b7 ,clerical amendment 
,the table of sections at the beginning 
of such chapter is amended by adding at 
the end of the items relating to such   
subchapter the following new item3      
#gccj;,b4 ,identification and tracking  
of biological implants4  4  7c7         
,implementation deadlines  7#a7         
,standard identification system  7,a7   
,in general ,with respect to biological 
implants described in paragraph 7#a7 of 
subsection 7d7 of section #gccj;,b of   
title #ch1 ,united ,states ,code1 as    
added by subsection 7a71 the ,secretary 
of ,veterans ,affairs shall adopt or    

implement a standard identification     
system for biological implants1 as      
required by subsection 7a7 of such      
section1 by not later than the date that
 is #ahj days after the date of the     
enactment of this ,act4  7,b7 ,implants 
regulated as devices ,with respect to   
biological implants described in        
paragraph 7#b7 of subsection 7d7 of such
 section1 the ,secretary of ,veterans   
,affairs shall adopt or implement such  
standard identification system in       
compliance with the compliance dates    
established by the ,food and ,drug      
,administration pursuant to section     
#eai7;f7 of the ,federal ,food1 ,drug1  
and ,cosmetic ,act 7#ba ,u4,s4,c4       
#cfj;i7f774  7#b7 ,tracking system ,the 
,secretary of ,veterans ,affairs shall  
implement the biological implant        
tracking system required by subsection  
7b7 of section #gccj;,b1 as added by    
subsection 7a71 by not later than the   
date that is #ahj days after the date of
 the enactment of this ,act4  7d7       

,reporting requirement ,if the          
biological implant tracking system      
required by subsection 7b7 of such      
section is not operational by the date  
that is #ahj days after the date of the 
enactment of this ,act1 the ,secretary  
of ,veterans ,affairs shall provide to  
the ,committees on ,veterans' ,affairs  
of the ,senate and ,house of            
,representatives a written explanation  
for each month until such time as the   
system is operational4 ,each such       
explanation shall describe each         
impediment to the implementation of the 
system1 steps being taken to remediate  
each such impediment1 and target dates  
for a solution to each such impediment4 
#c4 ,procurement of biological implants 
used in ,department of ,veterans        
,affairs medical facilities  7a7        
,procurement  7#a7 ,in general          
,subchapter ,,ii of chapter #ha of such 
title is amended by adding at the end   
the following new section3  #habi4      
,procurement of biological implants  7a7

 ,in general  7#a7 ,the ,secretary may  
procure biological implants only from   
vendors that meet the following         
conditions3  7,a7 ,the vendor uses the  
standard identification system adopted  
or implemented by the ,secretary under  
section #gccj;,b7a7 of this title and   
has safeguards to ensure that a         
production identifier has been in place 
at each step of distribution of each    
biological implant from its donor4  7,b7
 ,the vendor is registered with the     
,food and ,drug ,administration under   
subpart ,b of part #abga of title #ba1  
,code of ,federal ,regulations1 or any  
successor regulation1 and in the case of
 a vendor that uses tissue distribution 
intermediaries1 the vendor uses only    
tissue distribution intermediaries that 
are appropriately registered with the   
,food and ,drug ,administration4  7,c7  
,the vendor ensures that donor          
eligibility determinations and such     
other records as the ,secretary may     
require accompany each biological       

implant at all times1 regardless of the 
country of origin of the donor of the   
biological material4  7,d7 ,the vendor  
consents to periodic inspections and    
audits by the ,department of ,veterans  
,affairs regarding the accuracy of      
records and the handling of products4   
7,e7 ,the vendor agrees to cooperate    
with all biological implant recalls     
conducted on the vendor's own           
initiative1 by the request of the ,food 
and ,drug ,administration1 or by a      
statutory order of the ,food and ,drug  
,administration4  7,f7 ,the vendor      
agrees to provide to the ,secretary any 
adverse event report or warning letter  
of the ,food and ,drug ,administration  
issued to the vendor by not later than  
#cj days after the vendor receives such 
report or warning letter4  7,g7 ,the    
vendor agrees to retain all records     
associated with the procurement of a    
biological implant by the ,department   
for at least five years after the date  
of the procurement of the biological    

implant4  7,h7 ,the vendor maintains    
active accreditation with the ,american 
,association of ,tissue ,banks or a     
similar national accreditation specific 
to biological implants4  7#b7 ,the      
,secretary shall procure biological     
implants under the ,federal ,supply     
,schedules of the ,general ,services    
,administration1 unless such implants   
are not available under such ,schedules4
 ,for biological implants listed on the 
,federal ,supply ,schedules1 the        
,secretary shall accommodate reasonable 
vendor requests to undertake outreach   
efforts to educate medical professionals
 of the ,department about the use and   
efficacy of such biological implants4   
7#c7 ,section #habc of this title shall 
not apply to the procurement of         
biological implants4  7#d7 ,in the case 
of biological implants that are         
unavailable for procurement under the   
,federal ,supply ,schedules1 the        
,secretary shall procure such implants  
using competitive procedures in         

accordance with applicable law and the  
,federal ,acquisition ,regulation4  7b7 
,penalties ,in addition to any          
applicable penalty under any other      
provision of law1 any procurement       
employee of the ,department who is found
 responsible for a biological implant   
procurement transaction with intent to  
avoid or with reckless disregard of the 
requirements of this section shall be   
ineligible to hold a certificate of     
appointment as a contracting officer or 
to serve as the representative of an    
ordering officer1 contracting officer1  
or purchase card holder4  7c7           
,definitions ,in this section3  7#a7    
,the term biological implant shall have 
the meaning given such term in section  
#gccj;,b7d7 of this title4  7#b7 ,the   
term production identifier means a      
distinct identification code that--     
7,a7 relates a biological implant to the
 donor of the implant and to all records
 pertaining to the implant2  7,b7       
includes information designed to        

facilitate effective tracking1 using the
 distinct identification code1 from the 
donor to the recipient and from the     
recipient to the donor2 and  7,c7       
satisfies the requirements of subsection
 7c7 of section #abga4bij of title #ba1 
,code of ,federal ,regulations1 or any  
successor regulation4  4  7#b7 ,clerical
 amendment ,the table of sections at the
 beginning of such chapter is amended by
 adding at the end of the items relating
 to such subchapter the following new   
item3  #habi4 ,procurement of biological
 implants4  4  7b7 ,effective date      
,section #habi of title #ch1 ,united    
,states ,code1 as added by subsection   
7a71 shall take effect on the date that 
is #ahj days after the date on which the
 tracking system required under         
subsection 7b7 of section #gccj;,b of   
such title1 as added by section #b7;a7  
is implemented4  7c7 ,special rule for  
cryopreserved products ,during the      
three-year period beginning on the      
effective date of section #habi of title

 #ch1 ,united ,states ,code1 as added by
 subsection 7a71 biological implants    
produced and labeled before that date   
may be procured by the ,department of   
,veterans ,affairs without relabeling   
under the standard identification system
 adopted or implemented under section   
#gccj;,b of such title1 as added by     
section #b7;a74