[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.''.

[[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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