[Code of Federal Regulations]
[Title 42, Volume 1]
[Revised as of October 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 42CFR121.9]

[Page 656-657]
 
                         TITLE 42--PUBLIC HEALTH
 
    CHAPTER I--PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES
 
PART 121_ORGAN PROCUREMENT AND TRANSPLANTATION NETWORK--
Table of Contents
 
Sec. 121.9  Designated transplant program requirements.

    (a) To receive organs for transplantation, a transplant program in a 
hospital that is a member of the OPTN shall abide by these rules and 
shall:
    (1) Be a transplant program approved by the Secretary for 
reimbursement under Medicare; or
    (2) Be an organ transplant program which has adequate resources to 
provide transplant services to its patients and agrees promptly to 
notify the OPTN and patients awaiting transplants if it becomes inactive 
and which:
    (i) Has letters of agreement or contracts with an OPO;
    (ii) Has on site a transplant surgeon qualified in accordance with 
policies developed under Sec. 121.4;
    (iii) Has on site a transplant physician qualified in accordance 
with policies developed under Sec. 121.4;
    (iv) Has available operating and recovery room resources, intensive 
care resources and surgical beds and transplant program personnel;
    (v) Shows evidence of collaborative involvement with experts in the 
fields of radiology, infectious disease, pathology, immunology, 
anesthesiology, physical therapy and rehabilitation medicine, 
histocompatibility, and immunogenetics and, as appropriate, hepatology, 
pediatrics, nephrology with dialysis capability, and pulmonary medicine 
with respiratory therapy support;
    (vi) Has immediate access to microbiology, clinical chemistry, 
histocompatibility testing, radiology, and blood banking services, as 
well as the capacity to monitor treatment with immunosuppressive drugs; 
and
    (vii) Makes available psychiatric and social support services for 
transplant candidates, transplant recipients, and their families; or
    (3) Be a transplant program in a Department of Veterans Affairs, 
Department of Defense, or other Federal hospital.

[[Page 657]]

    (b) To apply to be a designated transplant program, transplant 
programs shall provide to the OPTN such documents as the OPTN may 
require which show that they meet the requirements of Sec. 121.9(a) 
(1), (2), or (3).
    (c) The OPTN shall, within 90 days, accept or reject applications to 
be a designated transplant program.
    (d) Applicants rejected for designation may appeal to the Secretary. 
Appeals shall be submitted in writing within 30 days of rejection of the 
application. The Secretary may:
    (1) Deny the appeal; or
    (2) Direct the OPTN to take action consistent with the Secretary's 
response to the appeal.

[63 FR 16332, Apr. 2, 1998, as amended at 64 FR 56660, Oct. 20, 1999]