09-25-0011 SYSTEMS LISTING
SYSTEM NAME:
Clinical Research: Blood Donor Records, HHS/NIH/CC.
SECURITY CLASSIFICATION:
None.
SYSTEM LOCATION:
Transfusion Medicine Department, Clinical Center (CC), Building 10, Room 1C711, 10 Center Drive, Bethesda, MD 20892-1184.
CATEGORIES OF INDIVIDUALS COVERED BY THE SYSTEM:
Donors of blood and blood components to be used in the NIH Clinical Center for patient infusions.
CATEGORIES OF RECORDS IN THE SYSTEM:
Past donations, blood types, phenotypes. Laboratory results of infectious
disease testing, serologic reactions on all blood samples, donations
of blood or blood components.
AUTHORITY FOR MAINTENANCE OF THE SYSTEM:
"Preparation of Biological Products" of the Public Health Service Act (42 U.S.C. 263).
PURPOSE(S):
ROUTINE USES OF RECORDS MAINTAINED IN THE SYSTEM, INCLUDING CATEGORIES OF USERS AND THE PURPOSES OF SUCH USES:
b) PHS may disclose information to State or local public health departments, to assist in the notification of the subject individual's sexual and/or needle-sharing partner(s), or in the verification that the subject individual has notified such sexual or needle-sharing partner(s).
POLICIES AND PRACTICES FOR STORING, RETRIEVING, ACCESSING, RETAINING, AND DISPOSING OF RECORDS IN THE SYSTEM:
STORAGE:
Records are stored in a computer file, on donor cards, and on microfilm.
RETRIEVABILITY:
Records are retrieved by a unique control number assigned to each individual donor.
SAFEGUARDS:
Access is granted only to authorized employees in the Department of Transfusion Medicine including physicians, nurses, technologists, computer operators, and the department's administrative officer.
These practices are in compliance with the standards of Chapter 45-13 of the HHS General Administration Manual, "Safeguarding Records Contained in Systems of Records," supplementary Chapter PHS hf: 45-13, and the HHS Automated Information Systems Security Program Handbook.
RETENTION AND DISPOSAL:
Records are retained and disposed of under the authority of the NIH Records Control Schedule contained in NIH Manual Chapter 1743, Appendix 1 - "Keeping and Destroying Records" (HHS Records Management Manual, Appendix B-361), item 3000-E-50. Refer to the NIH Manual Chapter for specific conditions on disposal.
SYSTEM MANAGER(S) AND ADDRESS(ES):
Chief, Transfusion Medicine Department, Clinical Center (CC), Building 10, Room 1C711, 10 Center Drive, Bethesda, MD 20892-1184.
NOTIFICATION PROCEDURE:
Write to the System manager to determine if a record exists. The requester must also verify his or her identity by providing either a notarization of the request or a written certification that the requester is who he or she claims to be and understands that the knowing and willful request for acquisition of a record pertaining to an individual under false pretenses is a criminal offense under the Act, subject to a five thousand dollar fine.
An individual who requests notification of or access to a medical record shall, at the time the request is made, designate in writing, a responsible representative, who may be a physician, who will be willing to review the record and inform the subject individual of its contents at the representative's discretion.
RECORD ACCESS PROCEDURE:
To obtain access to a record, contact the System Manager at the address specified above. Requesters should provide the same information as is required under the Notification Procedures above. Individuals may also request listings of accountable disclosures that have been made of their records, if any.
CONTESTING RECORD PROCEDURE:
Write to the official specified under Notification Procedures above, and reasonably identify the record and specify the information being contested, the corrective action sought, and your reasons for requesting the correction, along with supporting information to show how the record is inaccurate, incomplete, untimely, or irrelevant. The right to contest records is limited to information which is incomplete, irrelevant, incorrect, or untimely (obsolete).
RECORD SOURCE CATEGORIES:
Data are collected from the individual.
SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS OF THE ACT:
None.