
From the U.S. Code Online via GPO Access
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[Laws in effect as of January 23, 2000]
[Document not affected by Public Laws enacted between
  January 23, 2000 and December 4, 2001]
[CITE: 42USC274k]

 
                 TITLE 42--THE PUBLIC HEALTH AND WELFARE
 
                    CHAPTER 6A--PUBLIC HEALTH SERVICE
 
                SUBCHAPTER II--GENERAL POWERS AND DUTIES
 
               Part I--National Bone Marrow Donor Registry
 
Sec. 274k. National Registry


(a) Establishment

    The Secretary shall by contract establish and maintain a National 
Bone Marrow Donor Registry (referred to in this part as the 
``Registry'') that has the purpose of increasing the number of 
transplants for recipients suitably matched to biologically unrelated 
donors of bone marrow, and 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 meeting the following 
requirements:
        (1) Each member of the board shall serve for a term of 2 years, 
    and each such member may serve as many as 3 consecutive 2-year 
    terms, except that such limitations shall not apply to the Chair of 
    the board (or the Chair-elect) or to the member of the board who 
    most recently served as the Chair.
        (2) A member of the board may continue to serve after the 
    expiration of the term of such member until a successor is 
    appointed.
        (3) In order to ensure the continuity of the board, the board 
    shall be appointed so that each year the terms of approximately one-
    third of the members of the board expire.
        (4) The membership of the board shall include representatives of 
    marrow donor centers and marrow transplant centers; recipients of a 
    bone marrow transplant; persons who require or have required such a 
    transplant; family members of such a recipient or family members of 
    a patient who has requested the assistance of the Registry in 
    searching for an unrelated donor of bone marrow; persons with 
    expertise in the social sciences; and members of the general public; 
    and in addition nonvoting representatives from the Naval Medical 
    Research and Development Command and from the Division of Organ 
    Transplantation of the Health Resources and Services Administration.

(b) Functions

    The Registry shall--
        (1) establish a system for finding marrow donors suitably 
    matched to unrelated recipients for bone marrow transplantation;
        (2) carry out a program for the recruitment of bone marrow 
    donors in accordance with subsection (c) of this section, including 
    with respect to increasing the representation of racial and ethnic 
    minority groups (including persons of mixed ancestry) in the 
    enrollment of the Registry;
        (3) carry out informational and educational activities in 
    accordance with subsection (c) of this section;
        (4) annually update information to account for changes in the 
    status of individuals as potential donors of bone marrow;
        (5) provide for a system of patient advocacy through the office 
    established under subsection (d) of this section;
        (6) provide case management services for any potential donor of 
    bone marrow to whom the Registry has provided a notice that the 
    potential donor may be suitably matched to a particular patient 
    (which services shall be provided through a mechanism other than the 
    system of patient advocacy under subsection (d) of this section), 
    and conduct surveys of donors and potential donors to determine the 
    extent of satisfaction with such services and to identify ways in 
    which the services can be improved;
        (7) with respect to searches for unrelated donors of bone marrow 
    that are conducted through the system under paragraph (1), collect 
    and analyze and publish data on the number and percentage of 
    patients at each of the various stages of the search process, 
    including data regarding the furthest stage reached; the number and 
    percentage of patients who are unable to complete the search 
    process, and the reasons underlying such circumstances; and 
    comparisons of transplant centers regarding search and other costs 
    that prior to transplantation are charged to patients by transplant 
    centers; and
        (8) support studies and demonstration projects for the purpose 
    of increasing the number of individuals, especially minorities, who 
    are willing to be marrow donors.

(c) Recruitment; priorities; information and education

                     (1) Recruitment; priorities

        The Registry shall carry out a program for the recruitment of 
    bone marrow donors. Such program shall identify populations that are 
    underrepresented among potential donors enrolled with the Registry. 
    In the case of populations that are identified under the preceding 
    sentence:
            (A) The Registry shall give priority to carrying out 
        activities under this part to increase representation for such 
        populations in order to enable a member of such a population, to 
        the extent practicable, to have a probability of finding a 
        suitable unrelated donor that is comparable to the probability 
        that an individual who is not a member of an underrepresented 
        population would have.
            (B) The Registry shall consider racial and ethnic minority 
        groups (including persons of mixed ancestry) to be populations 
        that have been identified for purposes of this paragraph, and 
        shall carry out subparagraph (A) with respect to such 
        populations.

    (2) Information and education regarding recruitment; testing 
                               and enrollment

        (A) In general

            In carrying out the program under paragraph (1), the 
        Registry shall carry out informational and educational 
        activities for purposes of recruiting individuals to serve as 
        donors of bone marrow, and shall test and enroll with the 
        Registry potential donors. Such information and educational 
        activities shall include the following:
                (i) Making information available to the general public, 
            including information describing the needs of patients with 
            respect to donors of bone marrow.
                (ii) Educating and providing information to individuals 
            who are willing to serve as potential donors, including 
            providing updates.
                (iii) Training individuals in requesting individuals to 
            serve as potential donors.

        (B) Priorities

            In carrying out informational and educational activities 
        under subparagraph (A), the Registry shall give priority to 
        recruiting individuals to serve as donors of bone marrow for 
        populations that are identified under paragraph (1).

               (3) Transplantation as treatment option

        In addition to activities regarding recruitment, the program 
    under paragraph (1) shall provide information to physicians, other 
    health care professionals, and the public regarding the 
    availability, as a potential treatment option, of receiving a 
    transplant of bone marrow from an unrelated donor.

(d) Patient advocacy; case management

                           (1) In general

        The Registry shall establish and maintain an office of patient 
    advocacy (in this subsection referred to as the ``Office'').

                        (2) General functions

        The Office shall meet the following requirements:
            (A) The Office shall be headed by a director.
            (B) The Office shall operate a system for patient advocacy, 
        which shall be separate from mechanisms for donor advocacy, and 
        which shall serve patients for whom the Registry is conducting, 
        or has been requested to conduct, a search for an unrelated 
        donor of bone marrow.
            (C) In the case of such a patient, the Office shall serve as 
        an advocate for the patient by directly providing to the patient 
        (or family members, physicians, or other individuals acting on 
        behalf of the patient) individualized services with respect to 
        efficiently utilizing the system under subsection (b)(1) of this 
        section to conduct an ongoing search for a donor.
            (D) In carrying out subparagraph (C), the Office shall 
        monitor the system under subsection (b)(1) of this section to 
        determine whether the search needs of the patient involved are 
        being met, including with respect to the following:
                (i) Periodically providing to the patient (or an 
            individual acting on behalf of the patient) information 
            regarding donors who are suitability matched to the patient, 
            and other information regarding the progress being made in 
            the search.
                (ii) Informing the patient (or such other individual) if 
            the search has been interrupted or discontinued.
                (iii) Identifying and resolving problems in the search, 
            to the extent practicable.

            (E) In carrying out subparagraph (C), the Office shall 
        monitor the system under subsection (b)(1) of this section to 
        determine whether the Registry, donor centers, transplant 
        centers, and other entities participating in the Registry 
        program are complying with standards issued under subsection 
        (e)(4) of this section for the system for patient advocacy under 
        this subsection.
            (F) The Office shall ensure that the following data are made 
        available to patients:
                (i) The resources available through the Registry.
                (ii) A comparison of transplant centers regarding search 
            and other costs that prior to transplantation are charged to 
            patients by transplant centers.
                (iii) A list of donor registries, transplant centers, 
            and other entities that meet the applicable standards, 
            criteria, and procedures under subsection (e) of this 
            section.
                (iv) The posttransplant outcomes for individual 
            transplant centers.
                (v) Such other information as the Registry determines to 
            be appropriate.

            (G) The Office shall conduct surveys of patients (or family 
        members, physicians, or other individuals acting on behalf of 
        patients) to determine the extent of satisfaction with the 
        system for patient advocacy under this subsection, and to 
        identify ways in which the system can be improved.

                         (3) Case management

        (A) In general

            In serving as an advocate for a patient under paragraph (2), 
        the Office shall provide individualized case management services 
        directly to the patient (or family members, physicians, or other 
        individuals acting on behalf of the patient), including--
                (i) individualized case assessment; and
                (ii) the functions described in paragraph (2)(D) 
            (relating to progress in the search process).

        (B) Postsearch functions

            In addition to the case management services described in 
        paragraph (1) for patients, the Office may, on behalf of 
        patients who have completed the search for an unrelated donor, 
        provide information and education on the process of receiving a 
        transplant of bone marrow, including the posttransplant process.

(e) Criteria, standards, and procedures

    Not later than 180 days after November 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 for the system for patient advocacy operated under 
    subsection (d) of this section, including standards requiring the 
    provision of appropriate information (at the start of the search 
    process and throughout the process) to patients and their families 
    and physicians;
        (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.

(f) 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) of this 
section and complying with the criteria, standards, and procedures 
described in subsection (e) of this section.

(g) 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.

(h) 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.

(i) Eligibility

    Entities eligible to receive a contract under this section shall 
include private nonprofit entities.

(j) Records

                          (1) Recordkeeping

        Each recipient of a contract or subcontract under subsection (a) 
    of this section 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.

(k) Penalties for disclosure

    Any person who discloses the content of any record referred to in 
subsection (e)(5)(A) of this section 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 
(e)(5)(B) of this section, shall be imprisoned for not more than 2 years 
or fined in accordance with title 18, or both.

(l) Annual report regarding pretransplant costs

    The Registry shall annually submit to the Secretary the data 
collected under subsection (b)(7) of this section on comparisons of 
transplant centers regarding search and other costs that prior to 
transplantation are charged to patients by transplant centers. The data 
shall be submitted to the Secretary through inclusion in the annual 
report required in section 274l(c) of this title.

(July 1, 1944, ch. 373, title III, Sec. 379, as added Pub. L. 101-616, 
title I, Sec. 101(a)(2), Nov. 16, 1990, 104 Stat. 3279; amended Pub. L. 
105-196, Sec. 2(a), (b)(1), (c)-(g), July 16, 1998, 112 Stat. 631-635.)


                               Amendments

    1998--Subsec. (a). Pub. L. 105-196, Sec. 2(a), substituted 
``(referred to in this part as the `Registry') that has the purpose of 
increasing the number of transplants for recipients suitably matched to 
biologically unrelated donors of bone marrow, and that meets'' for 
``(referred to in this part as the `Registry') that meets'' and 
substituted ``under the direction of a board of directors meeting the 
following requirements:'' and pars. (1) to (4) for ``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.''
    Subsec. (b)(2) to (8). Pub. L. 105-196, Sec. 2(b)(1), added pars. 
(2) to (7), redesignated former par. (7) as (8), and struck out former 
pars. (2) to (6) which read as follows:
    ``(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''.
    Subsecs. (c), (d). Pub. L. 105-196, Sec. 2(c), (d), added subsecs. 
(c) and (d). Former subsecs. (c) and (d) redesignated (e) and (f), 
respectively.
    Subsec. (e). Pub. L. 105-196, Sec. 2(c), redesignated subsec. (c) as 
(e). Former subsec. (e) redesignated (g).
    Subsec. (e)(4). Pub. L. 105-196, Sec. 2(e), added par. (4) and 
struck out former par. (4) which read as follows: ``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;''.
    Subsec. (f). Pub. L. 105-196, Sec. 2(c), (g)(1), redesignated 
subsec. (d) as (f) and substituted ``subsection (e)'' for ``subsection 
(c)''. Former subsec. (f) redesignated (h).
    Subsecs. (g) to (i). Pub. L. 105-196, Sec. 2(c), redesignated 
subsecs. (e) to (g) as (g) to (i), respectively. Former subsecs. (h) and 
(i) redesignated (j) and (k), respectively.
    Subsec. (j). Pub. L. 105-196, Sec. 2(c), redesignated subsec. (h) as 
(j) and struck out heading and text of former subsec. (j). Text read as 
follows: ``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.''
    Subsec. (k). Pub. L. 105-196, Sec. 2(c), (g)(2), redesignated 
subsec. (i) as (k) and substituted ``subsection (e)(5)(A)'' for 
``subsection (c)(5)(A)'' and ``subsection (e)(5)(B)'' for ``subsection 
(c)(5)(B)''.
    Subsec. (l). Pub. L. 105-196, Sec. 2(f), added subsec. (l).


                    Effective Date of 1998 Amendment

    Pub. L. 105-196, Sec. 7, July 16, 1998, 112 Stat. 637, provided 
that: ``This Act [see Short Title of 1998 Amendment note set out under 
section 201 of this title] takes effect October 1, 1998, or upon the 
date of the enactment of this Act [July 16, 1998], whichever occurs 
later.''


                            Savings Provision

    Section 102 of title I of Pub. L. 101-616 provided that:
    ``(a) In General.--This title [enacting this section and section 
274l of this title and amending section 274a of this title], and the 
amendments made by this title, shall not affect any legal document, 
including any order, regulation, grant, or contract, in effect on the 
date of enactment of this Act [Nov. 16, 1990], or any administrative 
proceeding or lawsuit pending on the date, that relates to the bone 
marrow registry established under section 373(b) of the Public Health 
Service Act [section 274a(b) of this title] (as it existed before the 
amendment made by section 101(b) of this Act).
    ``(b) Continued Effect.--A legal document described in subsection 
(a) or an order issued in a lawsuit described in subsection (a) shall 
continue in effect until modified, terminated, or revoked.
    ``(c) Proceedings.--In any administrative proceeding or lawsuit 
described in subsection (a), parties shall take appeals, and officials 
shall hold proceedings and render judgments, in the same manner and with 
the same effect as if this title had not been enacted.''


    Report of Inspector General; Plan Regarding Relationship Between 
                       Registry and Donor Centers

    Pub. L. 105-196, Sec. 2(b)(2), July 16, 1998, 112 Stat. 632, 
provided that: ``The Secretary of Health and Human Services shall ensure 
that, not later than 1 year after the date of the enactment of this Act 
[July 16, 1998], the National Bone Marrow Donor Registry (under section 
379 of the Public Health Service Act [this section]) develops, 
evaluates, and implements a plan to effectuate efficiencies in the 
relationship between such Registry and donor centers. The plan shall 
incorporate, to the extent practicable, the findings and recommendations 
made in the inspection conducted by the Office of the Inspector General 
(Department of Health and Human Services) as of January 1997 and known 
as the Bone Marrow Program Inspection.''


                   Study by General Accounting Office

    Pub. L. 105-196, Sec. 5, July 16, 1998, 112 Stat. 636, provided 
that:
    ``(a) In General.--During the period indicated pursuant to 
subsection (b), the Comptroller General of the United States shall 
conduct a study of the National Bone Marrow Donor Registry under section 
379 of the Public Health Service Act [this section] for purposes of 
making determinations of the following:
        ``(1) The extent to which, relative to the effective date of 
    this Act [Oct. 1, 1998], such Registry has increased the 
    representation of racial and ethnic minority groups (including 
    persons of mixed ancestry) among potential donors of bone marrow who 
    are enrolled with the Registry, and whether the extent of increase 
    results in a level of representation that meets the standard 
    established in subsection (c)(1)(A) of such section 379 [subsec. 
    (c)(1)(A) of this section] (as added by section 2(c) of this Act).
        ``(2) The extent to which patients in need of a transplant of 
    bone marrow from a biologically unrelated donor, and the physicians 
    of such patients, have been utilizing the Registry in the search for 
    such a donor.
        ``(3) The number of such patients for whom the Registry began a 
    preliminary search but for whom the full search process was not 
    completed, and the reasons underlying such circumstances.
        ``(4) The extent to which the plan required in section 2(b)(2) 
    of this Act [set out as a note above] (relating to the relationship 
    between the Registry and donor centers) has been implemented.
        ``(5) The extent to which the Registry, donor centers, donor 
    registries, collection centers, transplant centers, and other 
    appropriate entities have been complying with the standards, 
    criteria, and procedures under subsection (e) of such section 379 
    [subsec. (e) of this section] (as redesignated by section 2(c) of 
    this Act).
    ``(b) Report.--A report describing the findings of the study under 
subsection (a) shall be submitted to the Congress not later than October 
1, 2001. The report may not be submitted before January 1, 2001.''


     Compliance With New Requirements for Office of Patient Advocacy

    Pub. L. 105-196, Sec. 6, July 16, 1998, 112 Stat. 636, provided 
that: ``With respect to requirements for the office of patient advocacy 
under section 379(d) of the Public Health Service Act [subsec. (d) of 
this section], the Secretary of Health and Human Services shall ensure 
that, not later than 180 days after the effective date of this Act [Oct. 
1, 1998], such office is in compliance with all requirements 
(established pursuant to the amendment made by section 2(d) [amending 
this section]) that are additional to the requirements that under 
section 379 of such Act [this section] were in effect with respect to 
patient advocacy on the day before the date of the enactment of this Act 
[July 16, 1998].''

                  Section Referred to in Other Sections

    This section is referred to in section 274l of this title.
