HIV AIDS Resource Guide/HIV-AIDS Resource Guide.iso/STAT/FEDERAL/274K.ASC

Text File | 1994-01-14 | 21KB | 484 lines

/* 42 USC 274, regarding organ transplants and bone marrow
follows. 274(e) requires standards to avoid transplantation of
organs carrying HIV. 274(k) also requires that bone marrow be
screened for HIV. */

274.  Organ procurement and transplantation network

(a) Contract authority of Secretary; limitation; available
appropriations. The Secretary shall by contract provide for the
establishment and operation of an Organ Procurement and
Transplantation Network which meets the requirements of
subsection (b). The amount provided under such contract in any
fiscal year may not exceed $2,000,000. Funds for such contracts
shall be made available from funds available to the Public
Health Service from appropriations for fiscal years beginning
after fiscal year 1984.

(b) Functions. (1) The Organ Procurement and Transplantation
Network shall carry out the functions described in paragraph
(2) and shall:

          (A) be a private nonprofit entity that has an
expertise in organ procurement and transplantation, and

          (B) have a board of directors:

               (i) that includes representatives of organ
procurement organizations (including organizations that have
received grants under section 371 [42 USC 273]), transplant
centers, voluntary health associations, and the general public;
and

               (ii) that shall establish an executive committee
and other committees, whose chairpersons shall be selected to
ensure continuity of leadership for the board.

     (2) The Organ Procurement and Transplantation Network
shall:

          (A) establish in one location or through regional
centers:

               (i) a national list of individuals who need
organs, and

               (ii) a national system, through the use of
computers and in accordance with established medical criteria,
to match organs and individuals included in the list,
especially individuals whose immune system makes it difficult
for them to receive organs,

          (B) establish membership criteria and medical
criteria for allocating organs and provide to members of the
public an opportunity to comment with respect to such criteria,
          (C) maintain a twenty-four-hour telephone service to
facilitate matching organs with individuals included in the
list,

          (D) assist organ procurement organizations in the
nationwide distribution of organs equitably among transplant
patients,

          (E) adopt and use standards of quality for the
acquisition and transportation of donated organs, including
standards for preventing the acquisition of organs that are
infected with the etiologic agent for acquired immune
deficiency syndrome,

          (F) prepare and distribute, on a regionalized basis
(and, to the extent practicable, among regions or on a national
basis), samples of blood sera from individuals who are included
on the list and whose immune system makes it difficult for them
to receive organs, in order to facilitate matching the
compatibility of such individuals with organ donors,

          (G) coordinate, as appropriate, the transportation of
organs from organ procurement organizations to transplant
centers,

          (H) provide information to physicians and other
health professionals regarding organ donation,

          (I) collect, analyze, and publish data concerning
organ donation and transplants,

          (J) carry out studies and demonstration projects for
the purpose of improving procedures for organ procurement and
allocation, [and]

          (K) work actively to increase the supply of donated
organs. [, and]

          (L) submit to the Secretary an annual report
containing information on the comparative costs and patient
outcomes at each transplant center affiliated with the organ
procurement and transplantation network.

(c) Consideration of critical comments. The Secretary shall
establish procedures forD

     (1) receiving from interested persons critical comments
relating to the manner in which the Organ Procurement and
Transplantation Network is carrying out the duties of the
Network under subsection (b); and

     (2) the consideration by the Secretary of such critical
comments.

(July 1, 1944, ch 373, Title III, Part H, 372, as added Oct.
19, 1984, P. L. 98-507, Title II, 201, 98 Stat. 2342; Nov. 4,
1988, P. L. 100-607, Title IV, 403, 102 Stat. 3115; Nov. 16,
1990, P. L. 101-616, Title II, 202(a)-(c), 104 Stat. 3283.)

274a.  Scientific registry


The Secretary shall, by grant or contract, develop and maintain
a scientific registry of the recipients of organ transplants.
The registry shall include such information respecting patients
and transplant procedures as the Secretary deems necessary to
an ongoing evaluation of the scientific and clinical status of
organ transplantation. The Secretary shall prepare for
inclusion in the report under section 376 [42 USC 274d] an
analysis of information derived from the registry.

(July 1, 1944, ch 373, Title III, Part H, 373, as added Oct.
19, 1984, P. L. 98-507, Title II, 201, 98 Stat. 2342; Nov. 4,
1988, P. L. 100-607, Title IV, 404, 102 Stat. 3116; Nov. 16,
1990, P. L. 101-616, Title I, 101(b) 104 Stat. 3282.)

274b.  General provisions respecting grants and contracts

(a) Application requirement. No grant may be made under this
part [42 USC 273 et seq.] or contract entered into under
section 372 or 373 [42 USC 274 or 274a] unless an application
therefor has been submitted to, and approved by, the Secretary.
Such an application shall be in such form and shall be
submitted in such manner as the Secretary shall by regulation
prescribe.

(b) Special considerations and priority; planning and
establishment grants. (1) A grant for planning under section
371(a)(1) [42 USC 273(a)(1)] may be made for one year with
respect to any organ procurement organization and may not
exceed $100,000.

     (2) Grants under section 371(a)(2) [42 USC 273(a)(2)] may
be made for two years. No such grant may exceed $500,000 for
any year and no organ procurement organization may receive more
than $800,000 for initial operation or expansion.

     (3) Grants or contracts under section 371(a)(3) [42 USC
273(a)(3)] may be made for not more than 3 years.

(c) Determination of grant amount; terms of payment; record-
keeping; access for purposes of audits and examination of
records. (1) The Secretary shall determine the amount of a
grant or contract made under section 371 or 373 [42 USC 273 or
274a]. Payments under such grants and contracts may be made in
advance on the basis of estimates or by the way of
reimbursement, with necessary adjustments on account of
underpayments or overpayments, and in such installments and on
such terms and conditions as the Secretary finds necessary to
carry out the purposes of such grants and contracts.
     (2) (A) Each recipient of a grant or contract under
section 371 or 373 [42 USC 273 or 274a] shall keep such records
as the Secretary shall prescribe, including records which fully
disclose the amount and disposition by such recipient of the
proceeds of such grant or contract, the total cost of the
undertaking in connection with which such grant or contract was
made, and the amount of that portion of the cost of the
undertaking supplied by other sources, and such other records
as will facilitate an effective audit.

          (B) The Secretary and the Comptroller General of the
United States, or any of their duly authorized representatives,
shall have access for the purpose of audit and examination to
any books, documents, papers, and records of the recipient of a
grant or contract under section 371 or 373 [42 USC 273 or 274a]
that are pertinent to such grant or contract.

(d) "Transplant center" and "organ" defined. For purposes of
this part [42 USC 273 et seq.]:

     (1) The term "transplant center" means a health care
facility in which transplants of organs are performed.

     (2) The term "organ" means the human kidney, liver, heart,
lung, pancreas, and any other human organ (other than corneas
and eyes) specified by the Secretary by regulation and for
purposes of section 373 [42 USC 274a], such term includes bone
marrow.

(July 1, 1944, ch 373, Title III, Part H, 374, as added Oct.
19, 1984, P. L. 98-507, Title II, 201, 98 Stat. 2342; Nov. 4,
1988, P. L. 100-607, Title IV, 402(b), 102 Stat. 3114; Nov. 16,
1990, P. L. 101-616, Title II, 203, 104 Stat. 3284.)


274c.  Administration

The Secretary shall designate and maintain an identifiable
administrative unit in the Public Health Service to:

     (1) administer this part and coordinate with the organ
procurement activities under title XVIII Of the Social Security
Act,

     (2) conduct a program of public information to inform the
public of the need for organ donations,

     (3) provide technical assistance to organ procurement
organizations, the Organ Procurement and Transplantation
Network established under section 372 [42 USC 274], and other
entities in the health care system involved in organ donations,
procurement, and transplants, and

     (4) provide information:
          (i) to patients, their families, and their physicians
about transplantation; and

          (ii) to patients and their families about the
resources available nationally and in each State, and the
comparative costs and patient outcomes at each transplant
center affiliated with the organ procurement and
transplantation network, in order to assist the patients and
families with the costs associated with transplantation.

(July 1, 1944, ch 373, Title III, Part H, 375, as added Oct.
19, 1984, P. L. 98-507, Title II, 201, 98 Stat. 2342; Nov. 4,
1988, P. L. 100-607, Title IV, 405, 102 Stat. 3116; Nov. 16,
1990, P. L. 101-616, Title II, 204, 104 Stat. 3285.)

274d.  Report

Not later than February 10 of 1991 and of each second year
thereafter, the Secretary shall publish, and submit to the
Committee on Energy and Commerce of the House of
Representatives and the Committee on Labor and Human Resources
of the Senate. [,] a report on the scientific and clinical
status of organ transplantation. The Secretary shall consult
with the Director of the National Institutes of Health and the
Commissioner of the Food and Drug Administration in the
preparation of the report.

(July 1, 1944, ch 373, Title III, Part H, 376, as added Oct.
19, 1984, P. L. 98-507, Title II, 201, 98 Stat. 2342; Nov. 4,
1988, P. L. 100-607, Title IV, 406, 102 Stat. 3116; Nov. 16,
1990, P. L. 101-616, Title II, 205, 104 Stat. 3285.)

274e.  Prohibition of organ purchases

(a) Prohibition. It shall be unlawful for any person to
knowingly acquire, receive, or otherwise transfer any human
organ for valuable consideration for use in human
transplantation if the transfer affects interstate commerce.

(b) Penalties. Any person who violates subsection (a) shall be
fined not more than $50,000 or imprisoned not more than five
years, or both.

(c) Definitions. For purposes of subsection (a):

     (1) The term "human organ" means the human (including
fetal) kidney, liver, heart, lung, pancreas, bone marrow,
cornea, eye, bone, and skin or any subpart thereof and any
other human organ (or any subpart thereof, including that
derived from a fetus) specified by the Secretary of Health and
Human Services by regulation.

     (2) The term "valuable consideration" does not include the
reasonable payments associated with the removal,
transportation, implantation, processing, preservation, quality
control, and storage of a human organ or the expenses of
travel, housing, and lost wages incurred by the donor of a
human organ in connection with the donation of the organ.

     (3) The term "interstate commerce" has the meaning
prescribed for it by section 201(b) of the Federal Food, Drug
and Cosmetic Act [21 USC 321(b)].

(Oct. 19, 1984, P. L. 98-507, Title II, 301, 98 Stat. 2346;
Nov. 4, 1988, P. L. 100-607, Title IV, 407, 102 Stat. 3116.)


274k.  National Registry

(a) Establishment. The Secretary shall by contract establish
and maintain a National Bone Marrow Donor Registry (referred to
in this part [42 USC 274k et seq.] as the "Registry") that
meets the requirements of this section. The Registry shall be
under the general supervision of the Secretary, and under the
direction of a board of directors that shall include
representatives of marrow donor centers, marrow transplant
centers, persons with expertise in the social science, and the
general public.

(b) Functions. The Registry shall:

     (1) establish a system for finding marrow donors suitably
matched to unrelated recipients for bone marrow
transplantation;

     (2) establish a system for patient advocacy, separate from
mechanisms for donor advocacy, that directly assists patients,
their families, and their physicians in the search for an
unrelated marrow donor;

     (3) increase the representation of individuals from racial
and ethnic minority groups in the pool of potential donors for
the Registry in order to enable an individual in a minority
group, to the extent practicable, to have a comparable chance
of finding a suitable unrelated donor as would an individual
not in a minority group;

     (4) provide information to physicians, other health care
professionals, and the public regarding bone marrow
transplantation;

     (5) recruit potential bone marrow donors;

     (6) collect, analyze, and publish data concerning bone
marrow donation and transplantation; and

     (7) support studies and demonstration projects for the,
purpose of increasing the number of individuals, especially
minorities, who are willing to be marrow donors.

(c) Criteria, standards, and procedures. Not later than 180
days after the date of enactment of this part [enacted Nov. 16,
1990], the Secretary shall establish and enforce, for entities
participating in the program, including the Registry,
individual marrow donor centers, marrow donor registries,
marrow collection centers, and marrow transplant centers:

     (1) quality standards and standards for tissue typing,
obtaining the informed consent of donors, and providing patient
advocacy;

     (2) donor selection criteria, based on established medical
criteria, to protect both the donor and the recipient and to
prevent the transmission of potentially harmful infectious
diseases such as the viruses that cause hepatitis and the
etiologic agent for Acquired Immune Deficiency Syndrome;

     (3) procedures to ensure the proper collection and
transportation of the marrow;

     (4) standards that require the provision of information to
patients, their families, and their physicians at the start of
the search process concerning:

          (A) the resources available through the Registry;

          (B) all other marrow donor registries meeting the
standards described in this paragraph; and

          (C) in the case of the Registry:

               (i) the comparative costs of all charges by
marrow transplant centers incurred by patients prior to
transplantation; and

               (ii) the success rates of individual marrow
transplant centers;

     (5) standards that:

          (A) require the establishment of a system of strict
confidentiality of records relating to the identity, address,
HLA type, and managing marrow donor center for marrow donors
and potential marrow donors; and

          (B) prescribe the purposes for which the records
described in subparagraph (A) may be disclosed, and the
circumstances and extent of the disclosure; and

     (6) in the case of a marrow donor center or marrow donor
registry participating in the program, procedures to ensure the
establishment of a method for integrating donor files,
searches, and general procedures of the center or registry with
the Registry.

(d) Comment Procedures. The Secretary shall establish and
provide information to the public on procedures, which may
include establishment of a policy advisory committee, under
which the Secretary shall receive and consider comments from
interested persons relating to the manner in which the Registry
is carrying out the duties of the Registry under subsection (b)
and complying with the criteria, standards, and procedures
described in subsection (c).
(e) Consultation. The Secretary shall consult with the board of
directors of the Registry and the bone marrow donor program of
the Department of the Navy in developing policies affecting the
Registry.

(f) Application. To be eligible to enter into a contract under
this section, an entity shall submit to the Secretary and
obtain approval of an application at such time, in such manner,
and containing such information as the Secretary shall by
regulation prescribe.

(g) Eligibility. Entities eligible to receive a contract under
this section shall include private nonprofit entities.

(h) Records. (1) Recordkeeping. Each recipient of a contract or
subcontract under subsection (a) shall keep such records as the
Secretary shall prescribe, including records that fully
disclose the amount and disposition by the recipient of the
proceeds of the contract, the total cost of the undertaking in
connection with which the contract was made, and the amount of
the portion of the cost of the undertaking supplied by other
sources, and such other records as will facilitate an effective
audit.

     (2) Examination of records. The Secretary and the
Comptroller General of the United States shall have access to
any books, documents, papers, and records of the recipient of a
contract or subcontract entered into under this section that
are pertinent to the contract, for the purpose of conducting
audits and examinations.

(i) Penalties for disclosure. Any person who discloses the
content of any record referred to in subsection (c)(5)(A)
without the prior written consent of the donor or potential
donor with respect to whom the record is maintained, or in
violation of the standards described in subsection (c)(5)(B),
shall be imprisoned for not more than 2 years or fined in
accordance with title 18, United States Code, or both.

(j) Authorization of appropriations. There are authorized to be
appropriated to carry out this section $15,000,000 for fiscal
year 1991 and such sums as may be necessary for each of fiscal
years 1992 and 1993.

(July 1, 1944, ch 373, Title III, Part I, 379, as added Nov.
16, 1990, P. L. 101-616, Title I, 101(a)(2), 104 Stat. 3279.)

274l.  Study by the General Accounting Office

(a) In general. The Comptroller General of the United States
shall conduct a study that evaluates:

     (1) the costs and benefits of the search process for an
unrelated bone marrow donor among different marrow donor
registries;
     (2) the extent to which marrow donor registries protect
donor confidentiality;

     (3) the relationship between the Registry, individual
marrow donor centers, and other marrow donor registries;

     (4) the effectiveness and appropriateness of policies and
procedures of marrow donor centers, marrow transplant centers,
and marrow donor registries, including:

          (A) the process of donor recruitment, including the
policy of asking each donor whether the donor would want to
donate more than one time;

          (B) the maintenance and updating of donor files; and

          (C) the policy of initially typing donors for A/B
antigens only instead of initially typing for both A/B and D/R
antigens;

     (5) the ability of the marrow donor registries to
incorporate changes in medical research and clinical practice;
and

     (6) the costs associated with tissue typing.

(b) Report. Not later than 1 year after the date of enactment
of this part [enacted Nov. 16, 1990], the Comptroller General
shall complete the study required under subsection (a) and
submit to the Committee on Energy and Commerce of the House of
Representatives and the Committee on Labor and Human Resources
of the Senate a report describing the findings made by the
study and recommendations for legislative reform.

(July 1, 1944, ch 373, Title III, Part I, 379A, as added Nov.
16, 1990, P. L. 101-616, Title I, 101(a)(2), 104 Stat. 3282.)