Biological Implant Tracking and Veteran Safety Act of 2019

I 116TH CONGRESS 1ST SESSION H. R. 547 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 Depart- ment of Veterans Affairs, and for other purposes. IN THE HOUSE OF REPRESENTATIVES JANUARY 15, 2019 Mr. DAVID P. ROE of Tennessee introduced the following bill; which was referred to the Committee on Veterans’ Affairs A BILL To amend title 38, United States Code, to direct the Sec- retary of Veterans Affairs to adopt and implement a standard identification protocol for use in the tracking and procurement of biological implants by the Depart- ment of Veterans Affairs, and for other purposes. Be it enacted by the Senate and House of Representa- 1 tives of the United States of America in Congress assembled, 2 SECTION 1. SHORT TITLE. 3 This Act may be cited as the ‘‘Biological Implant 4 Tracking and Veteran Safety Act of 2019’’. 5 VerDate Sep 11 2014 23:09 Jan 28, 2019 Jkt 089200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H547.IH H547 kjohnson on DSK79L0C42 with BILLS 2 •HR 547 IH SEC. 2. IDENTIFICATION AND TRACKING OF BIOLOGICAL 1 IMPLANTS USED IN DEPARTMENT OF VET- 2 ERANS AFFAIRS MEDICAL FACILITIES. 3 (a) IN GENERAL.—Subchapter II of chapter 73 of 4 title 38, United States Code, is amended by adding at the 5 end the following new section: 6 ‘‘§ 7330D. Identification and tracking of biological im- 7 plants 8 ‘‘(a) STANDARD IDENTIFICATION SYSTEM FOR BIO- 9 LOGICAL IMPLANTS.—(1) The Secretary shall adopt the 10 unique device identification system developed for medical 11 devices by the Food and Drug Administration under sec- 12 tion 519(f) of the Federal Food, Drug, and Cosmetic Act 13 (21 U.S.C. 360i(f)), or implement a comparable standard 14 identification system, for use in identifying biological im- 15 plants intended for use in medical procedures conducted 16 in medical facilities of the Department. 17 ‘‘(2) In adopting or implementing a standard identi- 18 fication system for biological implants under paragraph 19 (1), the Secretary shall permit a vendor to use any of the 20 accredited entities identified by the Food and Drug Ad- 21 ministration as an issuing agency pursuant to section 22 830.100 of title 21, Code of Federal Regulations, or any 23 successor regulation. 24 ‘‘(b) BIOLOGICAL IMPLANT TRACKING SYSTEM.—(1) 25 The Secretary shall implement a system for tracking the 26 VerDate Sep 11 2014 23:09 Jan 28, 2019 Jkt 089200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H547.IH H547 kjohnson on DSK79L0C42 with BILLS 3 •HR 547 IH biological implants described in subsection (a) from 1 human donor or animal source to implantation. 2 ‘‘(2) The tracking system implemented under para- 3 graph (1) shall be compatible with the identification sys- 4 tem adopted or implemented under subsection (a). 5 ‘‘(3) The Secretary shall implement inventory con- 6 trols compatible with the tracking system implemented 7 under paragraph (1) so that all patients who have re- 8 ceived, in a medical facility of the Department, a biological 9 implant subject to a recall can be notified of the recall 10 if, based on the evaluation by appropriate medical per- 11 sonnel of the Department of the risks and benefits, the 12 Secretary determines such notification is appropriate. 13 ‘‘(c) CONSISTENCY WITH FOOD AND DRUG ADMINIS- 14 TRATION REGULATIONS.—To the extent that a conflict 15 arises between this section and a provision of the Federal 16 Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) 17 or section 351 or 361 of the Public Health Service Act 18 (42 U.S.C. 262 and 264) (including any regulations issued 19 under such provisions), the provision of the Federal Food, 20 Drug, and Cosmetic Act or Public Health Service Act (in- 21 cluding any regulations issued under such provisions) shall 22 apply. 23 ‘‘(d) BIOLOGICAL IMPLANT DEFINED.—In this sec- 24 tion, the term ‘biological implant’ means any human cell, 25 VerDate Sep 11 2014 23:09 Jan 28, 2019 Jkt 089200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H547.IH H547 kjohnson on DSK79L0C42 with BILLS 4 •HR 547 IH tissue, or cellular or tissue-based product or animal prod- 1 uct— 2 ‘‘(1) under the meaning given the term ‘human 3 cells, tissues, or cellular or tissue-based products’ in 4 section 1271.3 of title 21, Code of Federal Regula- 5 tions, or any successor regulation; or 6 ‘‘(2) that is regulated as a device under section 7 201(h) of the Federal Food, Drug, and Cosmetic 8 Act (21 U.S.C. 321(h)).’’. 9 (b) CLERICAL AMENDMENT.—The table of sections 10 at the beginning of such chapter is amended by inserting 11 after the item relating to section 7330C the following new 12 item: 13 ‘‘7330D. Identification and tracking of biological implants.’’. (c) IMPLEMENTATION DEADLINES.— 14 (1) STANDARD IDENTIFICATION SYSTEM.—The 15 Secretary of Veterans Affairs shall adopt or imple- 16 ment the standard identification system for biologi- 17 cal implants required by subsection (a) of section 18 7330C of title 38, United States Code, as added by 19 subsection (a), with respect to biological implants 20 described in— 21 (A) subsection (d)(1) of such section, by 22 not later than the date that is 180 days after 23 the date of the enactment of this Act; and 24 VerDate Sep 11 2014 23:09 Jan 28, 2019 Jkt 089200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H547.IH H547 kjohnson on DSK79L0C42 with BILLS 5 •HR 547 IH (B) subsection (d)(2) of such section, in 1 compliance with the compliance dates estab- 2 lished by the Food and Drug Administration 3 under section 519(f) of the Federal Food, 4 Drug, and Cosmetic Act (21 U.S.C. 360i(f)). 5 (2) TRACKING SYSTEM.—The Secretary of Vet- 6 erans Affairs shall implement the biological implant 7 tracking system required by section 7330C(b) of title 8 38, United States Code, as added by subsection (a), 9 by not later than the date that is 180 days after the 10 date of the enactment of this Act. 11 (d) REPORTING REQUIREMENT.— 12 (1) IN GENERAL.—If the biological implant 13 tracking system required by section 7330C(b) of title 14 38, United States Code, as added by subsection (a), 15 is not operational by the date that is 180 days after 16 the date of the enactment of this Act, the Secretary 17 of Veterans Affairs shall submit to the Committee 18 on Veterans’ Affairs of the Senate and the Com- 19 mittee on Veterans’ Affairs of the House of Rep- 20 resentatives a report explaining why the system is 21 not operational for each month until such time as 22 the system is operational. 23 VerDate Sep 11 2014 23:09 Jan 28, 2019 Jkt 089200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H547.IH H547 kjohnson on DSK79L0C42 with BILLS 6 •HR 547 IH (2) ELEMENTS.—Each report submitted under 1 paragraph (1) shall include a description of the fol- 2 lowing: 3 (A) Each impediment to the implementa- 4 tion of the system described in such paragraph. 5 (B) Steps being taken to remediate each 6 such impediment. 7 (C) Target dates for a solution to each 8 such impediment. 9 SEC. 3. PROCUREMENT OF BIOLOGICAL IMPLANTS USED IN 10 DEPARTMENT OF VETERANS AFFAIRS MED- 11 ICAL FACILITIES. 12 (a) PROCUREMENT.— 13 (1) IN GENERAL.—Subchapter II of chapter 81 14 of title 38, United States Code, is amended by add- 15 ing at the end the following new section: 16 ‘‘§ 8129. Procurement of biological implants 17 ‘‘(a) IN GENERAL.—(1) The Secretary may procure 18 biological implants of human origin only from vendors that 19 meet the following conditions: 20 ‘‘(A) The vendor uses the standard identifica- 21 tion system adopted or implemented by the Sec- 22 retary under section 7330C(a) of this title and has 23 safeguards to ensure that a distinct identifier has 24 VerDate Sep 11 2014 23:09 Jan 28, 2019 Jkt 089200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\H547.IH H547 kjohnson on DSK79L0C42 with BILLS 7 •HR 547 IH been in place at each step of distribution of each bio- 1 logical implant from its donor. 2 ‘‘(B) The vendor is registered as required by 3 the Food and Drug Administration under subpart B 4 of part 1271 of title 21, Code of Federal Regula- 5 tions, or any successor regulation, and in the case of 6 a vendor that uses a tissue distribution intermediary 7 or a tissue processor, the vendor provides assurances 8 that the tissue distribution intermediary or tissue 9 processor is registered as required by the Food and 10 Drug Administration. 11 ‘‘(C) The vendor ensures that donor eligibility 12 determinations and such other records as the Sec- 13 retary may require accompany each biological im- 14 plant at all times, regardless of the country of origin 15 of the donor of the biological material. 16 ‘‘(D) The vendor agrees to cooperate with all 17 biological implant recalls conducted on the initiative 18 of the vendor, on the initiative of the original prod- 19 uct manufacturer used by the vendor, by the request 20 of the Food and Drug Administration, or by a statu- 21 tory order of the Food and Drug Administration. 22 ‘‘(E) The vendor agrees to notify the Secretary 23 of any adverse event or reaction report it provides 24 to the Food and Drug Administration, as required 25 VerDate Sep 11 2014 23:09 Jan 28, 2019 Jkt 089200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\H547.IH H547 kjohnson on DSK79L0C42 with BILLS 8 •HR 547 IH by sections 1271.3 and 1271.350 of title 21, Code 1 of Federal Regulations, or any successor regulation, 2 or any warning letter from the Food and Drug Ad- 3 ministration issued to the vendor or a tissue proc- 4 essor or tissue distribution intermediary used by the 5 vendor by not later than 60 days after the vendor 6 receives such report or warning letter. 7 ‘‘(F) The vendor agrees to retain all records as- 8 sociated with the procurement of a biological implant 9 by the Department for at least 10 years after the 10 date of the procurement of the biological implant. 11 ‘‘(G) The vendor provides assurances that the 12 biological implants provided by the vendor are ac- 13 quired only from tissue processors that maintain ac- 14 tive accreditation with the American Association of 15 Tissue Banks or a similar national accreditation spe- 16 cific to biological implants. 17 ‘‘(2) The Secretary may procure biological implants 18 of nonhuman origin only from vendors that meet the fol- 19 lowing conditions: 20 ‘‘(A) The vendor uses the standard identifica- 21 tion system adopted or implemented by the Sec- 22 retary under section 7330C(a) of this title. 23 ‘‘(B) The vendor is registered as an establish- 24 ment as required by the Food and Drug Administra- 25 VerDate Sep 11 2014 23:09 Jan 28, 2019 Jkt 089200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\H547.IH H547 kjohnson on DSK79L0C42 with BILLS 9 •HR 547 IH tion under sections 807.20 and 807.40 of title 21, 1 Code of Federal Regulations, or any successor regu- 2 lation (or is not required to register pursuant to sec- 3 tion 807.65(a) of such title, or any successor regula- 4 tion), and in the case of a vendor that is not the 5 original product manufacturer of such implants, the 6 vendor provides assurances that the original product 7 manufacturer is registered as required by the Food 8 and Drug Administration (or is not required to reg- 9 ister). 10 ‘‘(C) The vendor agrees to cooperate with all bi- 11 ological implant recalls conducted on the initiative of 12 the vendor, on the initiative of the original product 13 manufacturer used by the vendor, by the request of 14 the Food and Drug Administration, or by a statu- 15 tory order of the Food and Drug Administration. 16 ‘‘(D) The vendor agrees to notify the Secretary 17 of any adverse event report it provides to the Food 18 and Drug Administration as required under part 19 803 of title 21, Code of Federal Regulations, or any 20 successor regulation, or any warning letter from the 21 Food and Drug Administration issued to the vendor 22 or the original product manufacturer used by the 23 vendor by not later than 60 days after the vendor 24 receives such report or warning letter. 25 VerDate Sep 11 2014 23:09 Jan 28, 2019 Jkt 089200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\H547.IH H547 kjohnson on DSK79L0C42 with BILLS 10 •HR 547 IH ‘‘(E) The vendor agrees to retain all records as- 1 sociated with the procurement of a biological implant 2 by the Department for at least 10 years after the 3 date of the procurement of the biological implant. 4 ‘‘(3)(A) The Secretary shall procure biological im- 5 plants under the Federal Supply Schedules of the General 6 Services Administration unless such implants are not 7 available under such Schedules. 8 ‘‘(B) With respect to biological implants listed on the 9 Federal Supply Schedules, the Secretary shall accommo- 10 date reasonable vendor requests to undertake outreach ef- 11 forts to educate medical professionals of the Department 12 about the use and efficacy of such biological implants. 13 ‘‘(C) In the case of biological implants that are un- 14 available for procurement under the Federal Supply 15 Schedules, the Secretary shall procure such implants using 16 competitive procedures in accordance with applicable law 17 and the Federal Acquisition Regulation, including through 18 the use of a national contract. 19 ‘‘(4) In procuring biological implants under this sec- 20 tion, the Secretary shall permit a vendor to use any of 21 the accredited entities identified by the Food and Drug 22 Administration as an issuing agency pursuant to section 23 830.100 of title 21, Code of Federal Regulations, or any 24 successor regulation. 25 VerDate Sep 11 2014 23:09 Jan 28, 2019 Jkt 089200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6201 E:\BILLS\H547.IH H547 kjohnson on DSK79L0C42 with BILLS 11 •HR 547 IH ‘‘(5) Section 8123 of this title shall not apply to the 1 procurement of biological implants. 2 ‘‘(b) PENALTIES.—In addition to any applicable pen- 3 alty under any other provision of law, any procurement 4 employee of the Department who is found responsible for 5 a biological implant procurement transaction with intent 6 to avoid or with reckless disregard of the requirements of 7 this section shall be ineligible to hold a certificate of ap- 8 pointment as a contracting officer or to serve as the rep- 9 resentative of an ordering officer, contracting officer, or 10 purchase card holder. 11 ‘‘(c) DEFINITIONS.—In this section: 12 ‘‘(1) The term ‘biological implant’ has the 13 meaning given that term in section 7330C(d) of this 14 title. 15 ‘‘(2) The term ‘distinct identifier’ means a dis- 16 tinct identification code that— 17 ‘‘(A) relates a biological implant to the 18 human donor of the implant and to all records 19 pertaining to the implant; 20 ‘‘(B) includes information designed to fa- 2 [Text truncated for display. Full text available on Congress.gov.]