Sec. 3. Procurement of biological implants used in Department of Veterans Affairs medical facilities
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Subchapter II of chapter 81 of title 38, United States Code, is amended by adding at the end the following new section: The Secretary may procure biological implants of human origin only from vendors that meet the following conditions: 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.
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. 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.
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. 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.
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. 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. The Secretary may procure biological implants of nonhuman origin only from vendors that meet the following conditions:
The vendor uses the standard identification system adopted or implemented by the Secretary under section 7330C(a) of this title. 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).
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. 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.
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. 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. 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.
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. 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.
Section 8123 of this title shall not apply to the procurement of biological implants. 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.
In this section: The term biological implant has the meaning given that term in section 7330C(d) of this title. The term distinct identifier means a distinct identification code that— relates a biological implant to the human donor of the implant and to all records pertaining to the implant; 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 satisfies the requirements of section 1271.290(c) of title 21, Code of Federal Regulations, or any successor regulation.
The term tissue distribution intermediary means an agency that acquires and stores human tissue for further distribution and performs no other tissue banking functions. 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. . 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. . 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. 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).