[Code of Federal Regulations]
[Title 42, Volume 4]
[Revised as of October 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 42CFR482.98]

[Page 538-539]
 
                         TITLE 42--PUBLIC HEALTH
 
  CHAPTER IV--CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF 
                  HEALTH AND HUMAN SERVICES (CONTINUED)
 
PART 482_CONDITIONS OF PARTICIPATION FOR HOSPITALS--Table of Contents
 
             Subpart E_Requirements for Specialty Hospitals
 
Sec.  482.98  Condition of participation: Human resources.

    The transplant center must ensure that all individuals who provide 
services and/or supervise services at the center, including individuals 
furnishing services under contract or arrangement, are qualified to 
provide or supervise such services.
    (a) Standard: Director of a transplant center. The transplant center 
must be under the general supervision of a qualified transplant surgeon 
or a qualified physician-director. The director of a transplant center 
need not serve full-time and may also serve as a center's primary 
transplant surgeon or transplant physician in accordance with Sec.  
482.98(b). The director is responsible

[[Page 539]]

for planning, organizing, conducting, and directing the transplant 
center and must devote sufficient time to carry out these 
responsibilities, which include but are not limited to the following:
    (1) Coordinating with the hospital in which the transplant center is 
located to ensure adequate training of nursing staff and clinical 
transplant coordinators in the care of transplant patients and living 
donors.
    (2) Ensuring that tissue typing and organ procurement services are 
available.
    (3) Ensuring that transplantation surgery is performed by, or under 
the direct supervision of, a qualified transplant surgeon in accordance 
with Sec.  482.98(b).
    (b) Standard: Transplant surgeon and physician. The transplant 
center must identify to the OPTN a primary transplant surgeon and a 
transplant physician with the appropriate training and experience to 
provide transplantation services, who are immediately available to 
provide transplantation services when an organ is offered for 
transplantation.
    (1) The transplant surgeon is responsible for providing surgical 
services related to transplantation.
    (2) The transplant physician is responsible for providing and 
coordinating transplantation care.
    (c) Standard: Clinical transplant coordinator. The transplant center 
must have a clinical transplant coordinator to ensure the continuity of 
care of patients and living donors during the pre-transplant, 
transplant, and discharge phases of transplantation and the donor 
evaluation, donation, and discharge phases of donation. The clinical 
transplant coordinator must be a registered nurse or clinician licensed 
by the State in which the clinical transplant coordinator practices, who 
has experience and knowledge of transplantation and living donation 
issues. The clinical transplant coordinator's responsibilities must 
include, but are not limited to, the following:
    (1) Ensuring the coordination of the clinical aspects of transplant 
patient and living donor care; and
    (2) Acting as a liaison between a kidney transplant center and 
dialysis facilities, as applicable.
    (d) Standard: Independent living donor advocate or living donor 
advocate team. The transplant center that performs living donor 
transplantation must identify either an independent living donor 
advocate or an independent living donor advocate team to ensure 
protection of the rights of living donors and prospective living donors.
    (1) The living donor advocate or living donor advocate team must not 
be involved in transplantation activities on a routine basis.
    (2) The independent living donor advocate or living donor advocate 
team must demonstrate:
    (i) Knowledge of living organ donation, transplantation, medical 
ethics, and informed consent; and
    (ii) Understanding of the potential impact of family and other 
external pressures on the prospective living donor's decision whether to 
donate and the ability to discuss these issues with the donor.
    (3) The independent living donor advocate or living donor advocate 
team is responsible for:
    (i) Representing and advising the donor;
    (ii) Protecting and promoting the interests of the donor; and
    (iii) Respecting the donor's decision and ensuring that the donor's 
decision is informed and free from coercion.
    (e) Standard: Transplant team. The transplant center must identify a 
multidisciplinary transplant team and describe the responsibilities of 
each member of the team. The team must be composed of individuals with 
the appropriate qualifications, training, and experience in the relevant 
areas of medicine, nursing, nutrition, social services, transplant 
coordination, and pharmacology.
    (f) Standard: Resource commitment. The transplant center must 
demonstrate availability of expertise in internal medicine, surgery, 
anesthesiology, immunology, infectious disease control, pathology, 
radiology, blood banking, and patient education as related to the 
provision of transplantation services.

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