[Congressional Record Volume 163, Number 1 (Tuesday, January 3, 2017)]
[House]
[Pages H31-H33]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




       BIOLOGICAL IMPLANT TRACKING AND VETERAN SAFETY ACT OF 2017

  Mr. ROE of Tennessee. Mr. Speaker, I move to suspend the rules and 
pass the bill (H.R. 28) to amend title 38, United States Code, 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 
Affairs, and for other purposes.
  The Clerk read the title of the bill.
  The text of the bill is as follows:

                                H.R. 28

       Be it enacted by the Senate and House of Representatives of 
     the United States of America in Congress assembled,

     SECTION 1. SHORT TITLE.

       This Act may be cited as the ``Biological Implant Tracking 
     and Veteran Safety Act of 2017''.

     SEC. 2. IDENTIFICATION AND TRACKING OF BIOLOGICAL IMPLANTS 
                   USED IN DEPARTMENT OF VETERANS AFFAIRS MEDICAL 
                   FACILITIES.

       (a) In General.--Subchapter II of chapter 73 of title 38, 
     United States Code, is amended by adding at the end the 
     following new section:

     ``Sec. 7330C. Identification and tracking of biological 
       implants

       ``(a) Standard Identification System for Biological 
     Implants.--(1) The Secretary shall adopt the unique device 
     identification system developed for medical devices by the 
     Food and Drug Administration under section 519(f) of the 
     Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360i(f)), or 
     implement a comparable standard identification system, for 
     use in identifying biological implants intended for use in 
     medical procedures conducted in medical facilities of the 
     Department.
       ``(2) In adopting or implementing a standard identification 
     system for biological implants under paragraph (1), 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 830.100 of title 21, Code 
     of Federal Regulations, or any successor regulation.
       ``(b) Biological Implant Tracking System.--(1) The 
     Secretary shall implement a system for tracking the 
     biological implants described in subsection (a) from human 
     donor or animal source to implantation.
       ``(2) The tracking system implemented under paragraph (1) 
     shall be compatible with the identification system adopted or 
     implemented under subsection (a).
       ``(3) The Secretary shall implement inventory controls 
     compatible with the tracking system implemented under 
     paragraph (1) so that all patients who have received, in a 
     medical facility of the Department, a biological implant 
     subject to a recall can be notified of the recall if, based 
     on the evaluation by appropriate medical personnel of the 
     Department of the risks and benefits, the Secretary 
     determines such notification is appropriate.
       ``(c) Consistency With Food and Drug Administration 
     Regulations.--To the extent that a conflict arises between 
     this section and a provision of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 301 et seq.) or section 351 or 361 of 
     the Public Health Service Act (42 U.S.C. 262 and 264) 
     (including any regulations issued under such provisions), the 
     provision of the Federal Food, Drug, and Cosmetic Act or 
     Public Health Service Act (including any regulations issued 
     under such provisions) shall apply.
       ``(d) Biological Implant Defined.--In this section, the 
     term `biological implant' means any human cell, tissue, or 
     cellular or tissue-based product or animal product--
       ``(1) under the meaning given the term `human cells, 
     tissues, or cellular or tissue-based products' in section 
     1271.3 of title 21, Code of Federal Regulations, or any 
     successor regulation; or
       ``(2) that is regulated as a device under section 201(h) of 
     the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
     321(h)).''.
       (b) Clerical Amendment.--The table of sections at the 
     beginning of such chapter is amended by inserting after the 
     item relating to section 7330B the following new item:

``7330C. Identification and tracking of biological implants.''.

       (c) Implementation Deadlines.--
       (1) Standard identification system.--The Secretary of 
     Veterans Affairs shall adopt or

[[Page H32]]

     implement the standard identification system for biological 
     implants required by subsection (a) of section 7330C of title 
     38, United States Code, as added by subsection (a), with 
     respect to biological implants described in--
       (A) subsection (d)(1) of such section, by not later than 
     the date that is 180 days after the date of the enactment of 
     this Act; and
       (B) subsection (d)(2) of such section, in compliance with 
     the compliance dates established by the Food and Drug 
     Administration under section 519(f) of the Federal Food, 
     Drug, and Cosmetic Act (21 U.S.C. 360i(f)).
       (2) Tracking system.--The Secretary of Veterans Affairs 
     shall implement the biological implant tracking system 
     required by section 7330C(b) of title 38, United States Code, 
     as added by subsection (a), by not later than the date that 
     is 180 days after the date of the enactment of this Act.
       (d) Reporting Requirement.--
       (1) In general.--If the biological implant tracking system 
     required by section 7330C(b) of title 38, United States Code, 
     as added by subsection (a), is not operational by the date 
     that is 180 days after the date of the enactment of this Act, 
     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 
     operational.
       (2) Elements.--Each report submitted under paragraph (1) 
     shall include a description of the following:
       (A) Each impediment to the implementation of the system 
     described in such paragraph.
       (B) Steps being taken to remediate each such impediment.
       (C) Target dates for a solution to each such impediment.

     SEC. 3. PROCUREMENT OF BIOLOGICAL IMPLANTS USED IN DEPARTMENT 
                   OF VETERANS AFFAIRS MEDICAL FACILITIES.

       (a) Procurement.--
       (1) In general.--Subchapter II of chapter 81 of title 38, 
     United States Code, is amended by adding at the end the 
     following new section:

     ``Sec. 8129. Procurement of biological implants

       ``(a) In General.--(1) The Secretary may procure biological 
     implants of human origin only from vendors that meet the 
     following conditions:
       ``(A) The vendor uses the standard identification system 
     adopted or implemented by the Secretary under section 
     7330C(a) 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 donor.
       ``(B) The vendor is registered as required by the Food and 
     Drug Administration under subpart B of part 1271 of title 21, 
     Code of Federal Regulations, or any successor regulation, and 
     in the case of a vendor that uses a tissue distribution 
     intermediary or a tissue processor, the vendor provides 
     assurances that the tissue distribution intermediary or 
     tissue processor is registered as required by the Food and 
     Drug Administration.
       ``(C) The vendor ensures that donor eligibility 
     determinations and such other records as the Secretary may 
     require accompany each biological implant at all times, 
     regardless of the country of origin of the donor of the 
     biological material.
       ``(D) The vendor agrees to cooperate with all biological 
     implant recalls conducted on the initiative of the vendor, on 
     the initiative of the original product manufacturer used by 
     the vendor, by the request of the Food and Drug 
     Administration, or by a statutory order of the Food and Drug 
     Administration.
       ``(E) The vendor agrees to notify the Secretary of any 
     adverse event or reaction report it provides to the Food and 
     Drug Administration, as required by sections 1271.3 and 
     1271.350 of title 21, Code of Federal Regulations, or any 
     successor regulation, 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 60 days after the vendor receives 
     such report or warning letter.
       ``(F) The vendor agrees to retain all records associated 
     with the procurement of a biological implant by the 
     Department for at least 10 years after the date of the 
     procurement of the biological implant.
       ``(G) 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 implants.
       ``(2) The Secretary may procure biological implants of 
     nonhuman origin only from vendors that meet the following 
     conditions:
       ``(A) The vendor uses the standard identification system 
     adopted or implemented by the Secretary under section 
     7330C(a) of this title.
       ``(B) The vendor is registered as an establishment as 
     required by the Food and Drug Administration under sections 
     807.20 and 807.40 of title 21, Code of Federal Regulations, 
     or any successor regulation (or is not required to register 
     pursuant to section 807.65(a) of such title, or any successor 
     regulation), and in the case of a vendor that is not the 
     original product manufacturer of such implants, the vendor 
     provides assurances that the original product manufacturer is 
     registered as required by the Food and Drug Administration 
     (or is not required to register).
       ``(C) The vendor agrees to cooperate with all biological 
     implant recalls conducted on the initiative of the vendor, on 
     the initiative of the original product manufacturer used by 
     the vendor, by the request of the Food and Drug 
     Administration, or by a statutory order of the Food and Drug 
     Administration.
       ``(D) The vendor agrees to notify the Secretary of any 
     adverse event report it provides to the Food and Drug 
     Administration as required under part 803 of title 21, Code 
     of Federal Regulations, or any successor regulation, 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 60 days after the vendor 
     receives such report or warning letter.
       ``(E) The vendor agrees to retain all records associated 
     with the procurement of a biological implant by the 
     Department for at least 10 years after the date of the 
     procurement of the biological implant.
       ``(3)(A) The Secretary shall procure biological implants 
     under the Federal Supply Schedules of the General Services 
     Administration unless such implants are not available under 
     such Schedules.
       ``(B) With respect to biological implants listed on the 
     Federal Supply Schedules, 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 implants.
       ``(C) In the case of biological implants that are 
     unavailable for procurement under the Federal Supply 
     Schedules, the Secretary shall procure such implants using 
     competitive procedures in accordance with applicable law and 
     the Federal Acquisition Regulation, including through the use 
     of a national contract.
       ``(4) In procuring biological implants under this section, 
     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 
     830.100 of title 21, Code of Federal Regulations, or any 
     successor regulation.
       ``(5) Section 8123 of this title shall not apply to the 
     procurement of biological implants.
       ``(b) Penalties.--In addition to any applicable penalty 
     under any other provision of law, 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 officer, contracting officer, or purchase card 
     holder.
       ``(c) Definitions.--In this section:
       ``(1) The term `biological implant' has the meaning given 
     that term in section 7330C(d) of this title.
       ``(2) The term `distinct identifier' means a distinct 
     identification code that--
       ``(A) relates a biological implant to the human donor of 
     the implant and to all records pertaining to the implant;
       ``(B) includes information designed to facilitate effective 
     tracking, using the distinct identification code, from the 
     donor to the recipient and from the recipient to the donor; 
     and
       ``(C) satisfies the requirements of section 1271.290(c) of 
     title 21, Code of Federal Regulations, or any successor 
     regulation.
       ``(3) The term `tissue distribution intermediary' means an 
     agency that acquires and stores human tissue for further 
     distribution and performs no other tissue banking functions.
       ``(4) The term `tissue processor' means an entity 
     processing human tissue for use in biological implants, 
     including activities performed on tissue other than donor 
     screening, donor testing, tissue recovery and collection 
     functions, storage, or distribution.''.
       (2) Clerical amendment.--The table of sections at the 
     beginning of chapter 81 is amended by inserting after the 
     item relating to section 8128 the following new item:

``8129. Procurement of biological implants.''.

       (b) Effective Date.--Section 8129 of title 38, United 
     States Code, as added by subsection (a), shall take effect on 
     the date that is 180 days after the date on which the 
     tracking system required under section 7330C(b) of such 
     title, as added by section 2(a), is implemented.
       (c) Special Rule for Cryopreserved Products.--During the 
     three-year period beginning on the effective date of section 
     8129 of title 38, United States Code, as added by subsection 
     (a), 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 7330C of such 
     title, as added by section 2(a).

     SEC. 4. FUNDING.

       No additional funds are authorized to carry out the 
     requirements of this Act and the amendments made by this Act. 
     Such requirements shall be carried out using amounts 
     otherwise authorized.

  The SPEAKER pro tempore. Pursuant to the rule, the gentleman from 
Tennessee (Mr. Roe) and the gentleman from California (Mr. Takano) each 
will control 20 minutes.
  The Chair recognizes the gentleman from Tennessee.

[[Page H33]]

  



                             General Leave

  Mr. ROE of Tennessee. Mr. Speaker, I ask unanimous consent that all 
Members have 5 legislative days in which to revise and extend their 
remarks.
  The SPEAKER pro tempore. Is there objection to the request of the 
gentleman from Tennessee?
  There was no objection.
  Mr. ROE of Tennessee. I yield myself such time as I may consume.
  Mr. Speaker, I rise today in support of my bill, H.R. 28, the 
Biological Implant Tracking and Veteran Safety Act of 2017.
  Two years ago this month, the Government Accountability Office, GAO, 
released a startling report detailing a failure on the part of the 
Department of Veterans Affairs to follow requirements for documenting 
open-market purchases of surgical implants and the lack of a 
standardized process for tracking biological tissue from cadaver donors 
to living veteran recipients.
  Currently, there is no requirement for VA to systematically identify 
or track biological implants used in the VA medical facilities. Due to 
this oversight, if a given biological implant was identified as 
potentially contaminated or made the subject of a recall, it would be 
impossible for VA to identify which patients receive the impacted 
material and, therefore, take steps to inform at-risk patients and 
address contamination concerns.
  That same GAO report also found that VA did not consistently ensure 
that the vendors that the Department purchases biological implants from 
are registered with the Food and Drug Administration, and that VA did 
not maintain an inventory system to prevent expired tissues from 
remaining in storage alongside unexpired tissues. Needless to say, each 
of these findings poses a serious and unacceptable risk to veterans' 
health and safety.
  Veterans seeking care through the VA healthcare system deserve a 
quality standard that is second to none, especially within a system 
which prides itself on data collection and its electronic health 
record. The Biological Implant Tracking and Veteran Safety Act would 
provide a high-quality standard for surgical implants that is now 
sorely missing.
  By requiring VA to implement a standard identification tracking 
system for biological implants used in the VA medical facilities and 
requiring VA to procure biological implants only from approved vendors, 
H.R. 28 would address the deficiencies GAO identified and provide VA a 
necessary tool to ensure accountability and patient safety. Mr. 
Speaker, I would say the VA just should do this for quality of care for 
patients.
  I urge all of my colleagues to join me in supporting this important 
legislation.
  Mr. Speaker, I reserve the balance of my time.
  Mr. TAKANO. Mr. Speaker, I yield myself such time as I may consume.
  I rise today in support of the Biological Implant Tracking and 
Veteran Safety Act. This bill will require the VA to implement a 
standard identification system for biological implants that is 
consistent with the Food and Drug Administration's unique device 
identification system. This system will allow for the tracking of 
implants from donor to recipients. This bill will also require VA to 
procure biological implants only from vendors using the system and only 
through competitive procurement processes.
  The GAO has testified that the Veterans Health Administration is one 
of the largest purchasers of surgical implants, which include 
biological implants such as skin and bone grafts, and nonbiological 
implants such as cardiac pacemakers and artificial joints. The GAO has 
raised valid concerns regarding VA medical centers complying with VHA 
requirements for documenting surgical implants purchased from the open 
market and VHA's ability to identify veterans who received an implant 
that is being recalled by the manufacturer or the Food and Drug 
Administration.
  Patient safety is our number one concern. We all want to ensure that 
VA policies are fully followed in this regard. The legislation will 
continue to protect veterans while they receive the best care 
available.
  Mr. Speaker, before I close, I would like to extend my public 
congratulations to my good friend, Dr. Phil Roe, for being named by the 
majority as the chairman of the Committee on Veterans' Affairs. I can 
tell you that Members on my side of the aisle are looking very much 
forward to working with Dr. Roe. He has a splendid reputation.
  I don't want to ruin his reputation by saying that we absolutely 
embrace him because that would make his side of the aisle, I think, a 
little worried, but the fact is we believe that Chairman Roe is someone 
that we can work with and who has a genuine, sincere concern for 
veterans. He is a veteran himself. He is a medical doctor. As we try to 
gain the trust of veterans and gain the trust of Americans in VA health 
care and the veterans department, we are very much looking forward to 
working with him. I offer him my congratulations.
  Mr. Speaker, I yield back the balance of my time.

                              {time}  1800

  Mr. ROE of Tennessee. Mr. Speaker, I appreciate those kind words. 
Certainly, Mr. Speaker, this particular committee is a bipartisan 
committee. For the veterans out there who are watching this and for the 
American citizens who are watching this, this is truly a committee 
where we check our political affiliations at the door and try to do 
what is right and best for America's heroes. I am not talking about the 
committee, but I am saying in the country that has not always been 
done. I am a Vietnam-era veteran, and that wasn't done for my 
generation to begin with.
  There is a real commitment on both sides of the aisle, the staffs of 
both committees and the members of both committees. I am excited to get 
to work with my friend, Mr. Takano. We have been to Afghanistan 
together and gotten to know each other very well and worked on many 
issues together. I look forward to doing this. I appreciate his kind 
comments and also his support for this bill.
  Mr. Speaker, I encourage all Members to support this legislation.
  I yield back the balance of my time.
  The SPEAKER pro tempore. The question is on the motion offered by the 
gentleman from Tennessee (Mr. Roe) that the House suspend the rules and 
pass the bill, H.R. 28.
  The question was taken; and (two-thirds being in the affirmative) the 
rules were suspended and the bill was passed.
  A motion to reconsider was laid on the table.

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