Source: https://www.govregs.com/regulations/title42_chapterI_part121_section121.8
Timestamp: 2020-07-06 18:21:20
Document Index: 552886858

Matched Legal Cases: ['§ 121', '§ 121', '§ 121', '§ 121', '§ 121', '§ 121', '§ 121']

42 CFR 121.8 - Allocation of organs. § 121.8 - Allocation of organs.
§ 121.8 - Allocation of organs.
(a) Policy development. The Board of Directors established under § 121.3 shall develop, in accordance with the policy development process described in § 121.4, policies for the equitable allocation of cadaveric organs among potential recipients. Such allocation policies:
(b) Allocation performance goals. Allocation policies shall be designed to achieve equitable allocation of organs among patients consistent with paragraph (a) of this section through the following performance goals:
(c) Allocation performance indicators. (1) Each organ-specific allocation policy shall include performance indicators. These indicators must measure how well each policy is:
(d) Transition patient protections - (1) General. When the OPTN revises organ allocation policies under this section, it shall consider whether to adopt transition procedures that would treat people on the waiting list and awaiting transplantation prior to the adoption or effective date of the revised policies no less favorably than they would have been treated under the previous policies. The transition procedures shall be transmitted to the Secretary for review together with the revised allocation policies.
(2) Special rule for initial revision of liver allocation policies. When the OPTN transmits to the Secretary its initial revision of the liver allocation policies, as directed by paragraph (e)(1) of this section, it shall include transition procedures that, to the extent feasible, treat each individual on the waiting list and awaiting transplantation on October 20, 1999 no less favorably than he or she would have been treated had the revised liver allocation policies not become effective. These transition procedures may be limited in duration or applied only to individuals with greater than average medical urgency if this would significantly improve administration of the list or if such limitations would be applied only after accommodating a substantial preponderance of those disadvantaged by the change in the policies.
(e) Deadlines for initial reviews. (1) The OPTN shall conduct an initial review of existing allocation policies and, except as provided in paragraph (e)(2) of this section, no later than November 16, 2000 shall transmit initial revised policies to meet the requirements of paragraphs (a) and (b) of this section, together with supporting documentation to the Secretary for review in accordance with § 121.4.
(f) Secretarial review of policies, performance indicators, and transition patient protections. The OPTN's transmittal to the Secretary of proposed allocation policies and performance indicators shall include such supporting material, including the results of model-based computer simulations, as the Secretary may require to assess the likely effects of policy changes and as are necessary to demonstrate that the proposed policies comply with the performance indicators and transition procedures of paragraphs (c) and (d) of this section.
(g) Variances. The OPTN may develop, in accordance with § 121.4, experimental policies that test methods of improving allocation. All such experimental policies shall be accompanied by a research design and include data collection and analysis plans. Such variances shall be time limited. Entities or individuals objecting to variances may appeal to the Secretary under the procedures of § 121.4.
(h) Directed donation. Nothing in this section shall prohibit the allocation of an organ to a recipient named by those authorized to make the donation.