[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: 42CFR486.324]



[Page 650-651]

 

                         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.  486.324  Condition: Administration and governing body.



    (a) While an OPO may have more than one board, the OPO must have an 

advisory board that has both the authority described in paragraph (b) of 

this section and the following membership:

    (1) Members who represent hospital administrators, either intensive 

care or emergency room personnel, tissue banks, and voluntary health 

associations in the OPO's service area.

    (2) Individuals who represent the public residing in the OPO's 

service area.

    (3) A physician with knowledge, experience, or skill in the field of 

human histocompatibility, or an individual with a doctorate degree in a 

biological science and with knowledge, experience, or skills in the 

field of human histocompatibility.

    (4) A neurosurgeon or other physician with knowledge or skills in 

the neurosciences.

    (5) A transplant surgeon representing each transplant hospital in 

the service area with which the OPO has arrangements to coordinate its 

activities. The transplant surgeon must have practicing privileges and 

perform transplants in the transplant hospital represented.

    (6) An organ donor family member.

    (b) The OPO board described in paragraph (a) of this section has the 

authority to recommend policies for the following:

    (1) Procurement of organs.

    (2) Effective agreements to identify potential organ donors with a 

substantial majority of hospitals in its service area that have 

facilities for organ donation.

    (3) Systematic efforts, including professional education, to acquire 

all useable organs from potential donors.



[[Page 651]]



    (4) Arrangements for the acquisition and preservation of donated 

organs and provision of quality standards for the acquisition of organs 

that are consistent with the standards adopted by the OPTN, including 

arranging for testing with respect to preventing the acquisition of 

organs that are infected with the etiologic agent for acquired 

immunodeficiency syndrome (AIDS).

    (5) Appropriate tissue typing of organs.

    (6) A system for allocation of organs among transplant patients that 

is consistent with the rules and requirements of the OPTN, as defined in 

Sec.  486.320 of this part.

    (7) Transportation of organs to transplant hospitals.

    (8) Coordination of activities with transplant hospitals in the 

OPO's service area.

    (9) Participation in the OPTN.

    (10) Arrangements to cooperate with tissue banks for the retrieval, 

processing, preservation, storage, and distribution of tissues as may be 

appropriate to assure that all useable tissues are obtained from 

potential donors.

    (11) Annual evaluation of the effectiveness of the OPO in acquiring 

organs.

    (12) Assistance to hospitals in establishing and implementing 

protocols for making routine inquiries about organ donations by 

potential donors.

    (c) The advisory board described in paragraph (a) of this section 

has no authority over any other activity of the OPO and may not serve as 

the OPO's governing body or board of directors. Members of the advisory 

board described in paragraph (a) of this section are prohibited from 

serving on any other OPO board.

    (d) The OPO must have bylaws for each of its board(s) that address 

potential conflicts of interest, length of terms, and criteria for 

selecting and removing members. (e) A governing body must have full 

legal authority and responsibility for the management and provision of 

all OPO services and must develop and oversee implementation of policies 

and procedures considered necessary for the effective administration of 

the OPO, including fiscal operations, the OPO's quality assessment and 

performance improvement (QAPI) program, and services furnished under 

contract or arrangement, including agreements for these services. The 

governing body must appoint an individual to be responsible for the day-

to-day operation of the OPO.

    (e) A governing body must have full legal authority and 

responsibility for the management and provision of all OPO services and 

must develop and oversee implementation of policies and procedures 

considered necessary for the effective administration of the OPO, 

including fiscal operations, the OPO's quality assessment and 

performance improvement (QAPI) program, and services furnished under 

contract or arrangement, including agreements for these services. The 

governing body must appoint an individual to be responsible for the day-

to-day operation of the OPO.

    (f) The OPO must have procedures to address potential conflicts of 

interest for the governing body described in paragraph (d) of this 

section.

    (g) The OPO's policies must state whether the OPO recovers organs 

from donors after cardiac death.