[Code of Federal Regulations]

[Title 42, Volume 4]

[Revised as of October 1, 2006]

From the U.S. Government Printing Office via GPO Access

[CITE: 42CFR486.318]



[Page 649]

 

                         TITLE 42--PUBLIC HEALTH

 

  CHAPTER IV--CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF 

                  HEALTH AND HUMAN SERVICES (CONTINUED)

 

PART 486_CONDITIONS FOR COVERAGE OF SPECIALIZED SERVICES FURNISHED BY 

 

Subpart G_Requirements for Certification and Designation and Conditions 

              for Coverage: Organ Procurement Organizations

 

Sec.  486.318  Condition: Outcome measures.



    (a) With the exception of OPOs operating exclusively in non-

contiguous U.S. states, commonwealths, territories, or possessions, an 

OPO must meet all 3 of the 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) At least 2 out of the 3 following yield measures are no more 

than 1 standard deviation below the national mean, averaged over the 4 

years of the re-certification cycle:

    (i) The number of organs transplanted per standard criteria donor, 

including pancreata used for islet cell transplantation;

    (ii) The number of organs transplanted per expanded criteria donor, 

including pancreata used for islet cell transplantation; and

    (iii) The number of organs used for research per donor, including 

pancreata used for islet cell research.

    (b) For OPOs operating exclusively in non-contiguous U.S. states, 

commonwealths, territories, and possessions, the OPO outcome measures 

are as follows:

    (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) At least 2 out of the 3 following are no more than 1 standard 

deviation below the national mean:

    (i) The number of kidneys transplanted per standard criteria donor;

    (ii) The number of kidneys transplanted per expanded criteria donor; 

and

    (iii) The number of organs used for research per donor, including 

pancreata recovered for islet cell transplantation.

    (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.



       Organ Procurement Organization Process Performance Measures