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U.S. Department of Health and Human Services
Health Resources and Services Administration

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System of Record Notice 09-15-0068

SYSTEM NUMBER: 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 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 and Time Warner Telecom, 5488 Feltl Road, Minnetonka, MN 55343.

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), 9200 W. Wisconsin Avenue, 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 and their subcontractors (so long as such subcontractors are contractually bound to comply with the Privacy Act) 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 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. 
  9. To appropriate federal agencies and Department contractors that have a need to know the information for the purpose of assisting the Department’s efforts to respond to a suspected or confirmed breach of the security or confidentiality of information maintained in this system of records, and the information disclosed is relevant and necessary for that assistance.

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 by electronic mail or facsimile cannot be honored.

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.