[Federal Register: March 13, 2008 (Volume 73, Number 50)]
[Notices]
[Page 13547-13550]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr13mr08-64]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Privacy Act of 1974; Revision to Existing System of Records;
Revised
AGENCY: Health Resources and Services Administration (HRSA), HHS.
ACTION: Notification of an Altered System of Records; revised.
-----------------------------------------------------------------------
SUMMARY: In accordance with the requirements of the Privacy Act, the
Health Resources and Services Administration (HRSA) is publishing
notice of a proposal to alter the system of records for the C.W. Bill
Young Cell Transplantation Program. This system of records is required
to comply with the implementation directives of Public Law 109-129.
Records are used for the C.W. Bill Young Cell Transplantation Program's
planning, implementation, evaluation, monitoring, and document storage
purposes.
HRSA published in the Federal Register of August 17, 2007, a
document concerning notice of a new system of records, 09-15-0068, C.W.
Bill Young Cell Transplantation Program (FR. Doc. 07-4019). This
document more fully explains the routine uses of records maintained in
the system and amends the record retention and disposal policy.
Accordingly, the notice is published below in its entirety, as amended.
DATES: Persons wishing to comment on this revised system of records
notice may do so until April 14, 2008. Unless there is a further notice
in the Federal Register, this revised system of records will become
effective on April 14, 2008.
ADDRESSES: Please address comments to Health Resources and Services
Administration Privacy Act Coordinator, Donn Taylor, 5600 Fishers Lane,
Room 14A-20, Rockville, Maryland 20857; telephone (301) 443-0204. This
is not a toll-free number. Comments received will be available for
inspection at this same address from 9 a.m. to 3 p.m., Monday through
Friday.
FOR FURTHER INFORMATION CONTACT: James F. Burdick, M.D., Director,
Division of Transplantation, HSB, HRSA, 5600 Fishers Lane, Room 12C-06,
Rockville, Maryland 20857; telephone (301) 443-7577; fax (301) 594-
6095; or e-mail: jburdick@hrsa.gov. This is not a toll-free number.
SUPPLEMENTARY INFORMATION: The Health Resources and Services
Administration published in the Federal Register of August 17, 2007,
notice of a new system of records, 09-15-0068, C.W. Bill Young Cell
Transplantation Program. The Stem Cell Therapeutic and Research Act of
2005 (the Act) establishes the C.W. Bill Young Cell Transplantation
Program (the Program) which maintains information related to patients
in need of a blood stem cell transplant and potential adult volunteer
blood stem cell donors who have agreed to be listed on the registry
maintained by the Program. Additionally, the Program maintains
information related to the outcomes of patients who have undergone
blood stem cell transplantation.
The Stem Cell Therapeutic and Research Act of 2005 authorizes the
C.W. Bill Young Cell Transplantation Program and provides for the
collection, maintenance, and distribution of human blood stem cells for
the treatment of patients and for research. The Program consists of
four interrelated components each operated under a separate contract.
The four components are: the Bone Marrow Coordinating Center; the Cord
Blood Coordinating Center; the Office of Patient Advocacy/Single Point
of Access; and the Stem Cell Therapeutic Outcomes Database. The
contracts for operation of the Bone Marrow Coordinating Center, Cord
Blood Coordinating Center, and Office of Patient Advocacy/Single Point
of Access were awarded to the National Marrow Donor Program in
September 2006. A single contract for the Stem Cell Therapeutic
Outcomes Database was awarded to the Center for International Blood and
Marrow Transplant Research (CIBMTR) at the Medical College of Wisconsin
in September 2006 as well.
As identified by the Act, the Program is charged with: Operating a
system for identifying, matching, and facilitating the distribution of
bone marrow that is suitably matched to candidate patients; operating a
system for identifying, matching, and facilitating the distribution of
donated umbilical cord blood units that are suitably matched to
candidate patients; providing a means by which transplant physicians,
other healthcare professionals, and patients can electronically search
for and access all available adult marrow donors available through the
Program; recruiting potential adult volunteer marrow donors;
coordinating with other Federal programs to maintain and expand medical
contingency response capabilities; carrying out informational and
educational activities; providing patient advocacy services; providing
case management services for potential donors; and collecting,
analyzing, and publishing blood stem cell transplantation related data,
including patient outcomes data, in a standardized electronic format.
This system of records is required to comply with the implementation
directives of the Act, Public Law 109-129. The records will be used for
the C.W. Bill Young Cell Transplantation Program's planning,
implementation, evaluation, monitoring, and document storage purposes.
Dated: February 19, 2008.
Elizabeth M. Duke,
Administrator.
09-15-0068
SYSTEM NAME:
C.W. Bill Young Cell Transplantation Program.
SECURITY CLASSIFICATION:
None.
SYSTEM LOCATION:
Data collected by the C.W. Bill Young Cell Transplantation Program
(the Program) are maintained by the National Marrow Donor Program
(NMDP) and the Medical College of Wisconsin, contractors for the
Program. The Division of Transplantation within the
[[Page 13548]]
Health Resources and Services Administration oversees the Program and
the contracts with the NMDP and Medical College of Wisconsin.
Records associated with the C.W. Bill Young Cell Transplantation
Program are located at the National Marrow Donor Program, 3001 Broadway
Street, NE., Suite 500, Minneapolis, MN 55413.
Additional records associated with the Stem Cell Therapeutic
Outcomes Database component of the Program are located at the Medical
College of Wisconsin's Center for International Blood and Marrow
Transplant Research (CIBMTR), 8701 Watertown Plank Road, Milwaukee, WI
53226.
CATEGORIES OF INDIVIDUALS COVERED BY THE SYSTEM:
1. Volunteers whose bone marrow, peripheral blood or cord blood
donations are to be used for hematopoietic reconstitution or other
therapeutic applications on behalf of patients in need.
2. Patients searching for an unrelated donor or who are receiving
transplant or ancillary services through the C.W. Bill Young Cell
Transplantation Program.
3. Recipients of allogeneic blood stem cell transplantation.
CATEGORIES OF RECORDS IN THE SYSTEM:
Records consist of documents (printed and electronic) containing
all information necessary to manage and facilitate patient searches and
to track detailed post-transplant clinical status, including
documentation and correspondence concerning patients in need of (or
recipients of) blood stem cell transplants and volunteers listed on the
Program's registry as potential blood stem cell donors. These documents
include all information necessary to manage and facilitate patient
searches, and to track detailed post-transplant and post-donation
clinical status. The following information is maintained in the system:
individual identifiers about the recipients and donors (e.g., social
security number (voluntary), names, date of birth, etc.); recipient and
donor demographics and socio-demographics; recipients' disease, disease
history and treatment, transplant procedure details, post-
transplantation medical history, events, and complications; donor
medical history; donation procedure and blood stem cell product
details; long-term follow-up of medical outcomes and assessment of
functioning for donors and recipients; provider identifiers; transplant
and collection facility identifiers; and, donor management center
identifiers.
AUTHORITY FOR MAINTENANCE OF THE SYSTEM:
Public Law 109-129 establishes the C.W. Bill Young Cell
Transplantation Program, authorizing the Department to establish by
contract a system for identifying, matching, and facilitating bone
marrow and cord blood transplants, including recruitment, patient
advocacy and maintenance of a stem cell therapeutic outcomes database.
PURPOSE(s):
The C.W. Bill Young Cell Transplantation Program is comprised of
the Office of Patient Advocacy/Single Point of Access, the Bone Marrow
Coordinating Center, the Cord Blood Coordinating Center, and the Stem
Cell Therapeutic Outcomes Database. The purpose of the system is to
support the Program's mission to facilitate and increase access to
blood stem cell transplantation. Additionally, information in the
system will be used to advise the Secretary of the Department of Health
and Human Services and the Advisory Council on Blood Stem Cell
Transplantation on matters related to the Program and for ongoing
monitoring of the Program by the Health Resources and Services
Administration to determine the effectiveness of the Program and to
guide implementation of the policies and procedures that govern the
Program's structure. Records from this system will be used to carry out
the statutory charge of the C.W. Bill Young Cell Transplantation
Program. Specifically, records vital and attendant to the full scope of
activities involved at every stage of the process of facilitation of
blood stem cell transplantation or other therapies for recipients
suitably matched to biologically unrelated donors; analyzing factors
affecting transplant outcomes; monitoring and reporting of adverse
events; monitoring and reporting of quality, compliance, and
performance indicators; monitoring and reporting on the size and
composition of the registry of adult bone marrow donors and size and
composition of the umbilical cord blood inventory; and to provide
pertinent information to transplant programs, physicians, patients,
other entities awarded a contract under Section 379 of the Public
Health Service Act, donor registries, and cord blood banks as stated in
Public Law 109-129.
ROUTINE USES OF RECORDS MAINTAINED IN THE SYSTEM, INCLUDING CATEGORIES
OF USERS AND THE PURPOSES OF SUCH USES:
Disclosure of records from this system of records may be made as
provided in the Privacy Act, 5 U.S.C. 552a(b), and to the following
recipients for the purposes stated:
1. Departmental contractors who have been engaged by the Department
to assist in accomplishment of a departmental function related to the
purposes of this system of records and who have a need to access the
records in order to carry out that function.
2. Transplant centers, physicians and staff, and NMDP participating
organizations, for the purpose of searching for donors or products and/
or facilitating transplants, matching donor blood stem cells with
recipients, monitoring participant outcomes, and monitoring compliance
of member organizations with contractor requirements.
3. Personnel involved in the care of volunteer blood stem cell
donors and management of their participation in the Program.
Disclosures of clinically relevant de-identified information contained
in certain donor records may be made to transplant physicians, patients
or their designated representatives for purposes of facilitating
searches for blood stem cell donors or products and/or facilitation of
unrelated donor transplants.
4. Disclosures may be made by the contractors for the Office of
Patient Advocacy/Single Point of Access, the Bone Marrow Coordinating
Center, the Cord Blood Coordinating Center, the Stem Cell Therapeutic
Outcomes Database, NMDP and CIBMTR participating centers to one another
as well as participating umbilical cord blood banks to carry out the
purposes of the C.W. Bill Young Cell Transplantation Program.
5. Disclosure may be made to the Department of Justice when: (a)
The agency or any component thereof; or (b) any employee of the agency
in his or her official capacity; (c) any employee of the agency in his
or her individual capacity where agency or the Department of Justice
has agreed to represent the employee; or (d) the United States
Government, is a party to litigation or has an interest in such
litigation, and by careful review, the agency determines that the
records are both relevant and necessary to the litigation and the use
of such records by the Department of Justice is therefore deemed by the
agency to be for a purpose that is compatible with the purpose for
which the agency collected the records.
6. Disclosure may be made to a court or adjudicative body in a
proceeding when: (a) The agency or any component thereof; or (b) any
employee of the agency in his or her official capacity; (c) any
employee of the agency in his or her individual capacity where agency
or the
[[Page 13549]]
Department of Justice has agreed to represent the employee; or (d) the
United States Government, is a party to litigation or has an interest
in such litigation, and by careful review, the agency determines that
the records are both relevant and necessary to the litigation and the
use of such records is therefore deemed by the agency to be for a
purpose that is compatible with the purpose for which the agency
collected the records.
7. Disclosure may be made to a congressional office from the record
of an individual in response to a verified inquiry from the
congressional office made at the written request of that individual.
8. Disclosure may be made for research purposes. Rarely, with the
appropriate safeguards and consistent with the applicable provisions of
the Privacy Act and the Common Rule (45 CFR Part 46), disclosure for
research purposes may be made when the Department, independently or
through its contractor(s): (a) Has determined that the use or
disclosure does not violate legal or policy limitations under which the
record was provided, collected, or obtained; (b) has determined that a
bona fide research/analysis purpose exists; (c) has required the
recipient to: (1) Establish strict limitations concerning the receipt
and use of patient-identified data; (2) establish reasonable
administrative, technical, and physical safeguards to protect the
confidentiality of the data and to prevent the unauthorized use or
disclosure of the record; (3) remove, destroy, or return the
information that identifies the individual at the earliest time at
which removal or destruction can be accomplished consistent with the
purpose of the research project, unless the recipient has presented
adequate justification of a research or health nature for retaining
such information; and (4) make no further use or disclosure of the
record except as authorized by HHS or its contractor(s) or when
required by law; (d) has determined that other applicable safeguards or
protocols will be followed; and (e) has secured a written statement
attesting to the recipient's understanding of, and willingness to abide
by these provisions.
POLICIES AND PRACTICES FOR STORING, RETRIEVING, ACCESSING, RETAINING,
AND DISPOSING OF RECORDS IN THE SYSTEM:
STORAGE:
Records are maintained in file folders and in computer data files.
RETRIEVABILITY:
Patient and donor records may be retrieved by a unique ID assigned
by the system or through the use of other identifying information
(e.g., names, date of birth, social security number, or address).
SAFEGUARDS:
1. Authorized Users: Access is limited to authorized personnel
responsible for administering the program, including program managers
and program specialists who have responsibilities for implementing the
program and the HRSA Information Systems Security Officer. The
contractor(s) shall maintain current lists of authorized users.
Retrieval of donor or patient records will be limited to authorized
users for search, outcomes data collection and data auditing, or
transplant management purposes.
2. Assign Responsibility for Security: Responsibility is assigned
to a management official knowledgeable of the nature of the information
and processes supported by the C.W. Bill Young Cell Transplantation
Program and in the management, personnel, operational, and technical
controls used to protect it.
3. Perform Risk Assessment: A risk assessment was conducted in
conjunction with the development of the system. The system design
ensures vulnerabilities, risks, and other security concerns are
identified and addressed in the system design and throughout the life
cycle of the project. This is consistent with the HHS Automated
Information Systems Security Program Handbook.
4. Certification and Accreditation: The Program's electronic data
systems are certified under the auspices of HRSA's Office of
Information Technology Certification and Accreditation system.
5. Physical Safeguards: All computer equipment and files and hard
copy files are stored in areas where fire and life safety codes (e.g.,
OSHA standards) are strictly enforced. All automated and non-automated
documents are protected on a 24-hour basis. Perimeter security includes
intrusion alarms, key/passcard/combination controls, and receptionist
controlled area. Most hard copy files are maintained in a file room
used solely for purposes of the Program with access limited by
combination lock to authorized users identified above. Computer files
are password protected and are accessible only by use of computers
which are password protected. Servers are password protected and
protected in locked rooms, with access restricted to specific
authorized staff using controls specified in the certification and
accreditation process.
6. Procedural Safeguards: A password is required to access computer
files. All users of personal information in connection with the
performance of their jobs protect information from public view and from
unauthorized personnel entering an unsupervised area. All authorized
users sign a nondisclosure statement. All passwords, keys and/or
combinations are changed when a person leaves or no longer has
authorized duties. Access to records is limited to those authorized
personnel trained in accordance with the Privacy Act and automated data
processing (ADP) security procedures. The transmission of records is
protected using secure protocols. Individuals with access to the system
have User IDs and passwords and must be granted access to the system.
External access to the data requires two-factor authentication. The
safeguards described above were established in accordance with NIST
800-53 and OMB Circular A-130 Appendix III.
RETENTION AND DISPOSAL:
HRSA is working with the National Archives and Records
Administration (NARA) to obtain the appropriate retention value of
these records.
SYSTEM MANAGER AND ADDRESS:
Director, Blood Stem Cell Transplantation Program, HRSA, Parklawn
Building, Room 12C-06, 5600 Fishers Lane, Rockville, MD 20857.
NOTIFICATION PROCEDURE:
Requests must be made to the System Manager.
Requests by Mail: Requests for information and/or access to records
received by mail must contain information providing the identity of the
writer, and a reasonable description of the record desired, and whom it
concerns. Written requests must contain the name and address of the
requester, his/her date of birth and his/her signature. Requests must
be notarized to verify the identity of the requester, or the requester
must certify that (s)he is the individual who (s)he claims to be and
that (s)he understands that to knowingly and willfully request or
acquire a record pertaining to another individual under false pretenses
is a criminal offense under the Privacy Act subject to a $5,000 fine
(45 CFR 5b.5(b)(2)(ii)).
Requests in person or by telephone, electronic mail or facsimile
cannot be honored.
[[Page 13550]]
REQUESTS IN PERSON:
No requests in person at the system location will be honored.
REQUESTS BY TELEPHONE:
Since positive identification of the caller cannot be established,
telephone requests are not honored.
RECORD ACCESS PROCEDURES:
Record access procedures are the same as notification procedures.
Requesters should also provide a reasonable description of the contents
of the record being sought. A parent or guardian who requests
notification of, or access to, a minor's/incompetent person's record
shall designate a family physician or other health professional (other
than a family member) to whom the record, if any, will be sent. The
parent or guardian must verify relationship to the minor/incompetent
person as well as his/her own identity. Records will be mailed only to
the requester's address that is on file, unless a different address is
demonstrated by official documentation.
CONTESTING RECORD PROCEDURES:
To contest a record in the system, contact the official at the
address specified above and reasonably identify the record, specify the
information being contested, and state the corrective action sought and
the reason(s) for requesting the correction, along with supporting
documentation to show how the record is inaccurate, incomplete,
untimely, or irrelevant.
RECORD SOURCE CATEGORIES:
Sources of records include, but are not limited to, patients,
donors, and/or their representatives under the C.W. Bill Young Cell
Transplantation Program and any other sources of information or
documentation submitted by any other person or entity for inclusion in
a request for the purpose of facilitating and monitoring blood stem
cell transplantation (e.g., transplant center healthcare
professionals).
SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS OF THE ACT:
None.
[FR Doc. E8-5056 Filed 3-12-08; 8:45 am]
BILLING CODE 4165-15-P