[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: 42CFR486.326]



[Page 651-652]

 

                         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.  486.326  Condition: Human resources.



    All OPOs must have a sufficient number of qualified staff, including 

a director, a medical director, organ procurement coordinators, and 

hospital development staff to obtain all usable organs from potential 

donors, and to ensure that required services are provided to families of 

potential donors, hospitals, tissue banks, and individuals and 

facilities that use organs for research.

    (a) Standard: Qualifications. (1) The OPO must ensure that all 

individuals who provide services and/or supervise services, including 

services furnished under contract or arrangement, are qualified to 

provide or supervise the services.

    (2) The OPO must develop and implement a written policy that 

addresses potential conflicts of interest for the OPO's director, 

medical director, senior management, and procurement coordinators.

    (3) The OPO must have credentialing records for physicians and other 

practitioners who routinely recover organs in



[[Page 652]]



hospitals under contract or arrangement with the OPO and ensure that all 

physicians and other practitioners who recover organs in hospitals with 

which the OPO has agreements are qualified and trained.

    (b) Standard: Staffing.

    (1) The OPO must provide sufficient coverage, either by its own 

staff or under contract or arrangement, to assure both that hospital 

referral calls are screened for donor potential and that potential 

donors are evaluated for medical suitability for organ and/or tissue 

donation in a timely manner.

    (2) The OPO must have a sufficient number of qualified staff to 

provide information and support to potential organ donor families; 

request consent for donation; ensure optimal maintenance of the donor, 

efficient placement of organs, and adequate oversight of organ recovery; 

and conduct QAPI activities, such as death record reviews and hospital 

development.

    (3) The OPO must provide a sufficient number of recovery personnel, 

either from its own staff or under contract or arrangement, to ensure 

that all usable organs are recovered in a manner that, to the extent 

possible, preserves them for transplantation.

    (c) Standard: Education, training, and performance evaluation. The 

OPO must provide its staff with the education, training, and supervision 

necessary to furnish required services. Training must include but is not 

limited to performance expectations for staff, applicable organizational 

policies and procedures, and QAPI activities. OPOs must evaluate the 

performance of their staffs and provide training, as needed, to improve 

individual and overall staff performance and effectiveness.

    (d) Standard: Medical director. The OPO's medical director is a 

physician licensed in at least one of the States or territories within 

the OPO's service area or as required by State or territory law or by 

the jurisdiction in which the OPO is located. The medical director is 

responsible for implementation of the OPO's protocols for donor 

evaluation and management and organ recovery and placement. The medical 

director is responsible for oversight of the clinical management of 

potential donors, including providing assistance in managing a donor 

case when the surgeon on call is unavailable.