# 42 CFR § 486.318 - Condition: Outcome measures.

(a) With the exception of OPOs operating exclusively in noncontiguous States, Commonwealths, Territories, or possessions, an OPO must meet two out of the three following outcome measures:

(1) The OPO's donation rate of eligible donors as a percentage of eligible deaths is no more than 1.5 standard deviations below the mean national donation rate of eligible donors as a percentage of eligible deaths, averaged over the 4 years of the re-certification cycle. Both the numerator and denominator of an individual OPO's donation rate ratio are adjusted by adding a 1 for each donation after cardiac death donor and each donor over the age of 70;

(2) The observed donation rate is not significantly lower than the expected donation rate for 18 or more months of the 36 months of data used for re-certification, as calculated by the SRTR;

(3) The OPO data reports, averaged over the 4 years of the recertification cycle, must meet the rules and requirements of the most current OPTN aggregate donor yield measure.

(i) The initial criteria used to identify OPOs with lower than expected organ yield, for all organs as well as for each organ type, will include all of the following:

(A) More than 10 fewer observed organs per 100 donors than expected yield (Observed per 100 donors—Expected per 100 donors <−10);

(B) A ratio of observed to expected yield less than 0.90; and

(C) A two-sided p-value is less than 0.05.

(ii) The number of organs used for research per donor, including pancreata used for islet cell research.

(4) The outcome measures described in § 486.318(a)(1) through (3) are effective until July 31, 2022.

(b) For OPOs operating exclusively in noncontiguous States, Commonwealths, Territories, and possessions, an OPO must meet two out of the three following outcome measures:

(1) The OPO's donation rate of eligible donors as a percentage of eligible deaths is no more than 1.5 standard deviations below the mean national donation rate of eligible donors as a percentage of eligible deaths, averaged over the 4 years of the re-certification cycle. Both the numerator and denominator of an individual OPO's donation rate ratio are adjusted by adding a 1 for each donation after cardiac death donor and each donor over the age of 70;

(2) The observed donation rate is not significantly lower than the expected donation rate for 18 or more months of the 36 months of data used for re-certification, as calculated by the SRTR;

(3) The OPO data reports, averaged over the 4 years of the recertification cycle, must meet the rules and requirements of the most current OPTN aggregate donor yield measure.

(i) The initial criteria used to identify OPOs with lower than expected organ yield, for all organs as well as for each organ type, will include all of the following:

(A) More than 10 fewer observed organs per 100 donors than expected yield (Observed per 100 donors—Expected per 100 donors <−10);

(B) A ratio of observed to expected yield less than 0.90; and

(C) A two-sided p-value is less than 0.05.

(ii) The number of organs used for research per donor, including pancreata used for islet cell research.

(4) The outcome measures described in § 486.318(b)(1) through (3) are effective until July 31, 2022.

(c) Data for the outcome measures.

(1) An OPO's performance on the outcome measures is based on 36 months of data, beginning with January 1 of the first full year of the re-certification cycle and ending 36 months later on December 31, 7 months prior to the end of the re-certification cycle.

(2) If an OPO takes over another OPO's service area on a date later than January 1 of the first full year of the re-certification cycle so that 36 months of data are not available to evaluate the OPO's performance in its new service area, we will not hold the OPO accountable for its performance in the new area until the end of the following re-certification cycle when 36 months of data are available.

(3) An OPO's performance on the outcome measures described in § 486.318(a)(1) through (3) and § 486.318(b)(1) through (3) is based on the data described in § 486.318(c)(1) and (2) until July 31, 2022.

(d) An OPO is evaluated by measuring the donation rate and the organ transplantation rate in their DSA.

(1) For all OPOs, except as set forth in paragraph (d)(2) of this section, for all OPOs:

(i) The donation rate is calculated as the number of donors in the DSA as a percentage of the donor potential.

(ii) The organ transplantation rate is calculated as the number of organs transplanted from donors in the DSA as a percentage of the donor potential. The organ transplantation rate is adjusted for the average age of the donor potential.

(iii) The numerator for the donation rate is the number of donors in the DSA. The numerator for the organ transplantation rate is the number of organs transplanted from donors in the DSA. The numbers of donors and organs transplanted are based on the data submitted to the OPTN as required in § 486.328 and § 121.11 of this title. For calculating each measure, the data used is from the same time period as the data for the donor potential.

(iv) The denominator for the outcome measures is the donor potential and is based on inpatient deaths within the DSA from patients 75 or younger with a primary cause of death that is consistent with organ donation. The data is obtained from the most recent 12-months data from state death certificates.

(2) For the OPO representing the Hawaii DSA:

(i) The donation rate is calculated as the number of donors in the DSA as a percentage of the donor potential.

(ii) The kidney transplantation rate is calculated as the number of kidneys transplanted from kidney donors in the DSA as a percentage of the donor potential.

(iii) The numerator for the donation rate is the number of donors in the DSA. The numerator for the kidney transplantation rate is the number of kidneys transplanted from kidney donors in the DSA. The numbers of donors and kidneys transplanted are based on the data submitted to the OPTN as required in § 486.328 and § 121.11 of this title. For calculating each measure, the data used is from the same time period as the data for the donor potential.

(iv) The denominator for the outcome measures is the donor potential and is based on inpatient deaths within the DSA from patients 75 or younger with a primary cause of death that is consistent with organ donation. The data is obtained from the most recent 12-months data from state death certificates.

(e) An OPO must demonstrate a success rate on the outcome measures in accordance with the following parameters and requirements:

(1) For each assessment period, threshold rates will be established based on donation rates during the 12-month period immediately prior to the period being evaluated:

(i) The lowest rate among the top 25 percent in DSAs, and

(ii) The median rate among the DSAs.

(2) For each assessment period, threshold rates will be established based on the organ transplantation or kidney transplantation rates during the 12-month period prior to the period being evaluated:

(i) The lowest rate among the top 25 percent, and

(ii) The median rate among the DSAs.

(3) The 95 percent confidence interval for each DSA's donation and organ transplantation rates will be calculated using a one-sided test.

(4) Tier 1—OPOs that have an upper limit of the one-sided 95 percent confidence interval for their donation and organ transplantation rates that are at or above the top 25 percent threshold rate established for their DSA will be identified at each assessment period.

(5) Tier 2—OPOs that have an upper limit of the one-sided 95 percent confidence interval for their donation and organ transplantation rates that are at or above the median threshold rate established for their DSA but is not in Tier 1 as described in paragraph (e)(4) of this section will be identified at each assessment period.

(6) Tier 3—OPOs that have an upper limit of the one-sided 95 percent confidence interval for their donation or organ transplantation rates that are below the median threshold rate established for their DSA will be identified at each assessment period. OPOs that have an upper limit of the one-sided 95 percent confidence interval for their donation and organ transplantation rates that are below the median threshold rate for their DSA are also included in Tier 3.

(7) For the OPO exclusively serving the DSA that includes the non-contiguous state of Hawaii and surrounding territories, the kidney transplantation rate will be used instead of the organ transplantation rate. The comparative performance and designation to a Tier will be the same as in paragraphs (e)(4), (5), and (6) of this section except kidney transplantation rates will be used.

(f)

(1) An OPO's performance on the outcome measures is based on an evaluation at least every 12 months, with the most recent 12 months of data available from the OPTN and state death certificates, beginning January 1 of the first year of the agreement cycle and ending December 31, prior to the end of the agreement cycle.

(2) An assessment period is the most recent 12 months prior to the evaluation of the outcome measures in which data is available.

(3) If an OPO takes over another OPO's DSA on a date later than January 1 of the first year of the agreement cycle so that 12 months of data are not available to evaluate the OPO's performance in its new DSA, we will hold the OPO accountable for its performance on the outcome measures in the new area once 12 months of data are available.