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SECTION 1. SHORT TITLE.

This Act may be cited as the ''Biological Implant Tracking and
Veteran Safety Act of 2015''.

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. 7330B. 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
pursuant to 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 referred to in
subsection (a) from human donor or animal source to implantation. Such
system shall be compatible with the identification system adopted or
implemented under subsection (a).
''(2) 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 of 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 sections 351 or 361 of the Public Health Service Act (42
U.S.C. 262) (including any regulations issued under such Acts), the
provision the Federal Food, Drug, and Cosmetic Act or Public Health
Service Act (including any regulations issued under such Acts) shall
apply.
''(d) Definition of Biological Implant.--In this section, the term
'biological implant' means any animal or human cell, tissue, or
cellular or tissue-based product--
''(1) under the meaning given the term 'human cells' 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.''.
(b) 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 item:

''7330B. Identification and tracking of biological implants.''.
(c) Implementation Deadlines.--
(1) Standard identification system.--
(A) In general.--With respect to biological
implants described in paragraph (1) of subsection (d)
of section 7330B of title 38, United States Code, as
added by subsection (a), the Secretary of Veterans
Affairs shall adopt or implement a standard
identification system for biological implants, as
required by subsection (a) of such section, by not
later than the date that is 180 days after the date of
the enactment of this Act.
(B) Implants regulated as devices.--With respect to
biological implants described in paragraph (2) of
subsection (d) of such section, 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 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 subsection (b) of section 7330B, 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.--If the biological implant tracking
system required by subsection (b) of such section 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 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
operational. Each such explanation shall describe each impediment to
the implementation of the system, steps being taken to remediate each
such impediment, and 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 such title
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 7330B(a)
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 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 consents to periodic inspections and
audits by the Secretary regarding the accuracy of records and
the handling of products.
''(E) The vendor agrees to cooperate with all biological
implant recalls conducted on the vendor's own initiative, 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.
''(F) 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 section 1271.3 of title 21,
Code of Federal Regulations, or any successor regulation, or of
any warning letter from the Food and Drug Administration issued
to the vendor or a tissue processor or tissue distribution
intermediary it uses by not later than 60 days after the vendor
receives such report or warning letter.
''(G) 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 implant.
''(H) 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 non-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 7330B(a)
of this title.
''(B) The vendor is registered as required by the Food and
Drug Administration under section 807.3(c) of title 21, Code of
Federal Regulations, 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.
''(C) The vendor consents to periodic inspections and
audits by the Secretary regarding the accuracy of records and
the handling of products.
''(D) The vendor agrees to cooperate with all biological
implant recalls conducted on the vendor's own initiative, 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 report it provides to the Food and Drug
Administration as required in 21 C.F.R. part 803 or any warning
letter from the Food and Drug Administration issued to the
vendor or the original product manufacturer it uses 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 five years after the date of the procurement of
the biological implant.
''(3) 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. For 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.
''(4) Section 8123 of this title shall not apply to the procurement
of biological implants.
''(5) 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.
''(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' shall have the meaning
given such term in section 7330B(d) of this title.
''(2) The term 'production 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 subsection (c)
of section 1271.290 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 such chapter is amended by adding at the end of
the items relating to such subchapter 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
subsection (b) of section 7330B 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 date may be procured by the Department
of Veterans Affairs without relabeling under the standard
identification system adopted or implemented under section 7330B of
such title, as added by section 2(a).
Biological Implant Tracking and Veteran Safety Act of 2015 Directs the Department of Veterans Affairs (VA) to: (1) adopt the unique device identification system developed for medical devices by the Food and Drug Administration (FDA), or implement a comparable standard identification system, for identifying biological implants intended for use in medical procedures conducted in VA medical facilities; (2) permit a vendor to use any of the accredited entities identified by the FDA as an issuing agency in adopting or implementing such a system; (3) implement a compatible system for tracking the implants from the human donor or animal source to implantation; and (4) implement inventory controls compatible with such tracking system so that all patients who have received, in a VA medical facility, a biological implant subject to a recall by the FDA can be notified of the recall. Sets forth requirements for vendors from which the VA may procure biological implants of human origin, and for vendors from which the VA may procure biological implants of non-human origin, including that such a vendor: uses the standard identification system adopted or implemented by VA under this Act; is registered as required byFDA procedures; consents to periodic inspections and audits by the VA regarding the accuracy of records and the handling of products; agrees to cooperate with all biological implant recalls conducted on the vendor's own initiative, on the initiative of the original product manufacturer used by the vendor, by the request of the FDA, or by a statutory order of the FDA; agrees to notify the VA of any adverse event report it provides to the FDA, or of any warning letter from the FDA issued to the vendor, by not later than 60 days after the vendor receives such report or warning letter; and agrees to retain all records associated with the procurement of a biological implant by the VA for at least five years after the date of the procurement. Requires the VA to: (1) procure such implants under General Services Administration Federal Supply Schedules if they are available under such Schedules, (2) accommodate reasonable vendor requests to undertake specified outreach efforts to educate VA medical professionals about the use and efficacy of implants that are listed on such Schedules, and (3) procure biological implants that are unavailable under such Schedules using competitive procedures in accordance with the Federal Acquisition Regulation. Makes any VA procurement employee found responsible for a biological implant procurement transaction with intent to avoid, or with reckless disregard of, the requirements of this Act 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.