42 U.S.C. § 273 — Organ procurement organizations

(a) The Secretary can give grants for planning a qualified organ procurement organization, and for setting up, starting, merging, or expanding one. (b) (1) To be "qualified" for these grants, an organization must — as the Secretary decides — perform the functions listed in paragraph (2), and it must: (A) be nonprofit; (B) have proper accounting and financial procedures, as the Secretary specifies, to stay financially stable; (C) have an agreement with the Secretary to be reimbursed under Medicare for procuring kidneys; (D) have met this section's other requirements and been certified or recertified within the past four years — either because a certification already in effect on January 1, 2000 stayed in effect through January 1, 2002 or until recertification, or under regulations the Secretary had to issue by January 1, 2002, which recertify organizations no more than once every four years, using outcome and process measures based on real evidence of organ-donor potential, multiple outcome measures, and a way to appeal a decertification; (E) have procedures to get paid for non-kidney organs given to transplant centers; (F) have a service area large enough for effective organ procurement and fair distribution, that either fully includes or fully excludes each metropolitan statistical area; (G) have a director and enough staff — including donation coordinators and procurement specialists — to effectively get organs from donors in its area; and (H) have a board of directors or advisory board that: includes hospital administrators, ICU or ER staff, tissue banks, and health charities from its service area; includes members representing the public in that area; includes a physician or doctorate-holder with histocompatibility expertise; includes a physician with neurology expertise; and includes, from each transplant center it works with, a surgeon who practices there and does transplant surgery. That board can recommend organ-procurement policies and the other functions listed below, but has no authority over anything else the organization does. (2) (A) Within 90 days of November 16, 1990, the Secretary had to propose rules defining when an organization meets requirement (1)(E). (B) Within one year of that date, the Secretary had to finalize those rules. (3) An organ procurement organization must: (A) have working agreements with most hospitals and health facilities in its area that could have organ donors, to help identify potential donors; (B) run outreach and education efforts to get all usable organs from potential donors; (C) arrange for collecting and preserving donated organs, following quality standards set by the national Organ Procurement and Transplantation Network — including testing organs for HIV; (D) arrange proper tissue typing of donated organs; (E) have a system for fairly allocating donated organs among transplant patients, based on established medical criteria; (F) provide or arrange transportation of donated organs to transplant centers; (G) coordinate its work with transplant centers in its area; (H) take part in the national Organ Procurement Transplantation Network; (I) work with tissue banks to retrieve, process, preserve, store, and distribute usable tissue from potential donors; (J) evaluate every year how well it's doing at acquiring available organs; and (K) help hospitals set up routine procedures for asking potential donors' families about organ donation. (c) Pancreases collected by an organ procurement organization and used for islet cell transplants or research still count toward the organization's certification or recertification under subsection (b).