3.0.0 2334 2023-01-11T13:32:32Z 2023-01-11T13:32:32Z Senate S 2015-11-30 114 ssva00 Veterans' Affairs Committee Senate Standing Referred to 2015-11-30T22:59:16Z Biological Implant Tracking and Veteran Safety Act of 2015 114 1016 HR 2015-04-21 Forwarded by Subcommittee to Full Committee in the Nature of a Substitute (Amended) by Voice Vote . Related bill CRS Veterans First Act 114 2921 S 2016-05-16 Placed on Senate Legislative Calendar under General Orders. Calendar No. 467. Related bill CRS Veterans Information Modernization Act 114 2256 HR 2015-07-22 Received in the Senate and Read twice and referred to the Committee on Veterans' Affairs. Related bill CRS 2015-11-30 ssva00 Veterans' Affairs Committee Senate Read twice and referred to the Committee on Veterans' Affairs. IntroReferral 2015-11-30 Introduced in Senate IntroReferral 10000 9 Library of Congress C001075 Sen. Cassidy, Bill [R-LA] Bill Cassidy R LA N T000464 Sen. Tester, Jon [D-MT] Jon Tester D MT 2016-01-27 False Armed Forces and National Security Business records Cell biology and embryology Congressional oversight Department of Veterans Affairs Drug safety, medical device, and laboratory regulation Government ethics and transparency, public corruption Health information and medical records Health technology, devices, supplies Licensing and registrations Organ and tissue donation and transplantation Product safety and quality Public contracts and procurement Veterans' medical care Armed Forces and National Security 00 2015-11-30 Introduced in Senate 2016-01-07T19:37:05Z Biological Implant Tracking and Veteran Safety Act of 2015

This bill directs the Department of Veterans Affairs (VA) to:

  • 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 VA medical facilities;
  • permit a vendor to use any of the accredited entities identified by the FDA as an issuing agency;
  • implement a compatible system for tracking implants from human donor or animal source to implantation; and
  • implement inventory controls compatible with such tracking system so that patients who have received a biological implant in a VA medical facility subject to FDA recall can be appropriately notified.

The bill also prescribes 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. Such a vendor must:

  • use the standard identification system adopted or implemented by VA under this Act;
  • be registered as required by FDA procedures;
  • consent to periodic VA inspections and audits regarding records and product handling;
  • agree 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, or by FDA request or statutory order;
  • agree to notify the VA within 60 days of any adverse event report it provides to the FDA, or of any FDA warning letter issued to the vendor; and
  • agree to retain all records associated with the procurement of a biological implant by the VA for at least 10 years.

The VA shall: (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, and (3) procure biological implants that are unavailable under such Schedules using competitive procedures in accordance with the Federal Acquisition Regulation.

Any VA procurement employee responsible for a biological implant procurement transaction with intent to avoid, or with reckless disregard of, the requirements of this Act 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.

Certain biological implants may be temporarily procured by the VA without relabeling under the standard identification system.

]]> Biological Implant Tracking and Veteran Safety Act of 2015 Display Title Biological Implant Tracking and Veteran Safety Act of 2015 Official Title as Introduced A bill 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. Introduced in Senate IS Short Titles as Introduced Biological Implant Tracking and Veteran Safety Act of 2015 Introduced in Senate 2015-11-30T05:00:00Z https://www.govinfo.gov/content/pkg/BILLS-114s2334is/xml/BILLS-114s2334is.xml 2015-11-30 Read twice and referred to the Committee on Veterans' Affairs. text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain. Congressional Research Service, Library of Congress This file contains bill summaries and statuses for federal legislation. A bill summary describes the most significant provisions of a piece of legislation and details the effects the legislative text may have on current law and federal programs. Bill summaries are authored by the Congressional Research Service (CRS) of the Library of Congress. As stated in Public Law 91-510 (2 USC 166 (d)(6)), one of the duties of CRS is "to prepare summaries and digests of bills and resolutions of a public general nature introduced in the Senate or House of Representatives". For more information, refer to the User Guide that accompanies this file.