,i #aafth ,,congress #ast ,session ,h4 ,r4 #edg ,,in ,,the ,,house ,,of ,,representatives ,january #ae1 #bjai,mr4 ,david ,p4 ,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 #bjai4 #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;,d4 ,identification and tracking of biological implants 7a7 ,standard identification system for biological implants 7#a7 ,the ,secretary shall adopt the unique device identification system developed for medical devices by the ,food and ,drug ,administration under 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 7#b7 ,in adopting or implementing a standard identification system for biological implants under paragraph 7#a71 the ,secretary shall permit a vendor to use any of the accredited entities identified by the ,food and ,drug ,administration as an issuing agency pursuant to section #hcj4ajj of title #ba1 ,code of ,federal ,regulations1 or any successor regulation4 7b7 ,biological implant tracking system 7#a7 ,the ,secretary shall implement a system for tracking the biological implants described in subsection 7a7 from human donor or animal source to implantation4 7#b7 ,the tracking system implemented under paragraph 7#a7 shall be compatible with the identification system adopted or implemented under subsection 7a74 7#c7 ,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 can be notified of the recall if1 based on the evaluation by 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 section #cea or #cfa of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb and #bfd7 7including any regulations issued under such provisions71 the provision of the ,federal ,food1 ,drug1 and ,cosmetic ,act or ,public ,health ,service ,act 7including any regulations issued under such provisions7 shall apply4 7d7 ,biological implant defined ,in this section1 the term biological implant means any human cell1 tissue1 or cellular or tissue-based product or animal product-- 7#a7 under the meaning given the term human cells1 tissues1 or cellular or tissue-based products in section #abga4c of title #ba1 ,code of ,federal ,regulations1 or any successor regulation2 or 7#b7 that is regulated as a device under section #bja7;h7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cba7;h774 4 7b7 ,clerical amendment ,the table of sections at the beginning of such chapter is amended by inserting after the item relating to section #gccj;,c the following new item3 #gccj;,d4 ,identification and tracking of biological implants4 4 7c7 ,implementation deadlines 7#a7 ,standard identification system ,the ,secretary of ,veterans ,affairs shall adopt or implement the standard identification system for biological implants required by subsection 7a7 of section #gccj;,c of title #ch1 ,united ,states ,code1 as added by subsection 7a71 with respect to biological implants described in-- 7,a7 subsection 7d77#a7 of such section1 by not later than the date that is #ahj days after the date of the enactment of this ,act2 and 7,b7 subsection 7d77#b7 of such section1 in compliance with the compliance dates established by the ,food and ,drug ,administration under 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 section #gccj;,c7b7 of title #ch1 ,united ,states ,code1 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 7#a7 ,in general ,if the biological implant tracking system required by section #gccj;,c7b7 of title #ch1 ,united ,states ,code1 as added by subsection 7a71 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 submit to the ,committee on ,veterans' ,affairs of the ,senate and the ,committee on ,veterans' ,affairs of the ,house of ,representatives a report explaining why the system is not operational for each month until such time as the system is operational4 7#b7 ,elements ,each report submitted under paragraph 7#a7 shall include a description of the following3 7,a7 ,each impediment to the implementation of the system described in such paragraph4 7,b7 ,steps being taken to remediate each such impediment4 7,c7 ,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 title #ch1 ,united ,states ,code1 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 of human origin 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;,c7a7 of this title and has safeguards to ensure that a distinct identifier has been in place at each step of distribution of each biological implant from its donor4 7,b7 ,the vendor is registered as required by 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 a tissue distribution intermediary or a tissue processor1 the vendor provides assurances that the tissue distribution intermediary or tissue processor is registered as required by 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 agrees to cooperate with all biological implant recalls conducted on the initiative of the vendor1 on the initiative of the original product manufacturer used by the vendor1 by the request of the ,food and ,drug ,administration1 or by a statutory order of the ,food and ,drug ,administration4 7,e7 ,the vendor agrees to notify the ,secretary of any adverse event or reaction report it provides to the ,food and ,drug ,administration1 as required by sections #abga4c and #abga4cej of title #ba1 ,code of ,federal ,regulations1 or any successor regulation1 or any warning letter from the ,food and ,drug ,administration issued to the vendor or a tissue processor or tissue distribution intermediary used by the vendor by not later than #fj days after the vendor receives such report or warning letter4 7,f7 ,the vendor agrees to retain all records associated with the procurement of a biological implant by the ,department for at least #aj years after the date of the procurement of the biological implant4 7,g7 ,the vendor provides assurances that the biological implants provided by the vendor are acquired only from tissue processors that maintain active accreditation with the ,american ,association of ,tissue ,banks or a similar national accreditation specific to biological implants4 7#b7 ,the ,secretary may procure biological implants of nonhuman origin 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;,c7a7 of this title4 7,b7 ,the vendor is registered as an establishment as required by the ,food and ,drug ,administration under sections #hjg4bj and #hjg4dj of title #ba1 ,code of ,federal ,regulations1 or any successor regulation 7or is not required to register pursuant to section #hjg4fe7;a7 of such title1 or any successor regulation71 and in the case of a vendor that is not the original product manufacturer of such implants1 the vendor provides assurances that the original product manufacturer is registered as required by the ,food and ,drug ,administration 7or is not required to register74 7,c7 ,the vendor agrees to cooperate with all biological implant recalls conducted on the initiative of the vendor1 on the initiative of the original product manufacturer used by the vendor1 by the request of the ,food and ,drug ,administration1 or by a statutory order of the ,food and ,drug ,administration4 7,d7 ,the vendor agrees to notify the ,secretary of any adverse event report it provides to the ,food and ,drug ,administration as required under part #hjc of title #ba1 ,code of ,federal ,regulations1 or any successor regulation1 or any warning letter from the ,food and ,drug ,administration issued to the vendor or the original product manufacturer used by the vendor by not later than #fj days after the vendor receives such report or warning letter4 7,e7 ,the vendor agrees to retain all records associated with the procurement of a biological implant by the ,department for at least #aj years after the date of the procurement of the biological implant4 7#c7 7,a7 ,the ,secretary shall procure biological implants under the ,federal ,supply ,schedules of the ,general ,services ,administration unless such implants are not available under such ,schedules4 7,b7 ,with respect to 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 ,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 ,regulation1 including through the use of a national contract4 7#d7 ,in procuring biological implants under this section1 the ,secretary shall permit a vendor to use any of the accredited entities identified by the ,food and ,drug ,administration as an issuing agency pursuant to section #hcj4ajj of title #ba1 ,code of ,federal ,regulations1 or any successor regulation4 7#e7 ,section #habc of this title shall not apply to the procurement of biological implants4 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 has the meaning given that term in section #gccj;,c7d7 of this title4 7#b7 ,the term distinct identifier means a distinct identification code that-- 7,a7 relates a biological implant to the human 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 section #abga4bij7;c7 of title #ba1 ,code of ,federal ,regulations1 or any successor regulation4 7#c7 ,the term tissue distribution intermediary means an agency that acquires and stores human tissue for further distribution and performs no other tissue banking functions4 7#d7 ,the term tissue processor means an entity processing human tissue for use in biological implants1 including activities performed on tissue other than donor screening1 donor testing1 tissue recovery and collection functions1 storage1 or distribution4 4 7#b7 ,clerical amendment ,the table of sections at the beginning of chapter #ha is amended by inserting after the item relating to section #habh 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 section #gccj;,c7b7 of such title1 as added by section #b7;a71 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 effective date may be procured by the ,department of ,veterans ,affairs without relabeling under the standard identification system adopted or implemented under section #gccj;,c of such title1 as added by section #b7;a74 #d4 ,funding ,no additional funds are authorized to carry out the requirements of this ,act and the amendments made by this ,act4 ,such requirements shall be carried out using amounts otherwise authorized4