[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: 42CFR486.348]



[Page 655]

 

                         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.  486.348  Condition: Quality assessment and performance improvement



(QAPI).



    The OPO must develop, implement, and maintain a comprehensive, data-

driven QAPI program designed to monitor and evaluate performance of all 

donation services, including services provided under contract or 

arrangement.

    (a) Standard: Components of a QAPI program. The OPO's QAPI program 

must include objective measures to evaluate and demonstrate improved 

performance with regard to OPO activities, such as hospital development, 

designated requestor training, donor management, timeliness of on-site 

response to hospital referrals, consent practices, organ recovery and 

placement, and organ packaging and transport. The OPO must take actions 

that result in performance improvements and track performance to ensure 

that improvements are sustained.

    (b) Standard: Death record reviews. As part of its ongoing QAPI 

efforts, an OPO must conduct at least monthly death record reviews in 

every Medicare and Medicaid participating hospital in its service area 

that has a Level I or Level II trauma center or 150 or more beds, a 

ventilator, and an intensive care unit (unless the hospital has a waiver 

to work with another OPO), with the exception of psychiatric and 

rehabilitation hospitals. When missed opportunities for donation are 

identified, the OPO must implement actions to improve performance.

    (c) Standard: Adverse events.

    (1) An OPO must establish written policies to address, at a minimum, 

the process for identification, reporting, analysis, and prevention of 

adverse events that occur during the organ donation process.

    (2) The OPO must conduct a thorough analysis of any adverse event 

and must use the analysis to affect changes in the OPO's policies and 

practices to prevent repeat incidents.



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