03-22750. Privacy Act of 1974: Revision to Existing System of Records; Correction

AGENCY:

Health Resources and Services Administration, HHS.

ACTION:

Notification of an Altered System of Records; correction.

SUMMARY:

In accordance with the requirements of the Privacy Act of 1974, the Health Resources and Services Administration published in the Federal Register of August 18, 2003, a document concerning a notice of a proposal to revise an existing system of records, 09-15-0055, Organ Procurement and Transplantation Network (OPTN) Data System. In notice FR Doc. 03-20685 on page 49491, the last line in the first paragraph of the SUPPLEMENTARY INFORMATION section states:

The notice is published below in its entirety, as amended.

The system of records notice was inadvertently omitted from the document. This document corrects that mistake. Accordingly, the notice is published below in its entirety, as amended.

FOR FURTHER INFORMATION CONTACT:

James Burdick, M.D., Director, Division of Transplantation, Office of Special Programs, Health Resources and Services Administration, Parklawn Building, Room 16C-17, 5600 Fishers Lane, Rockville, Maryland 20857.

Dated: September 2, 2003.

Jane M. Harrison,

Director, Division of Policy Review and Coordination.

09-15-0055

System Name:

Organ Procurement and Transplantation Network (OPTN)/Scientific Registry of Transplant Recipients (SRTR) Data System, HHS/HRSA/OSP/DoT.

Security Classification:

None.

System Location:

Data collected by the OPTN are maintained by the OPTN contractor and shared on a monthly basis with the contractor for the SRTR and the DoT, within HRSA, the Federal entity that oversees the OPTN and SRTR contracts.

OPTN Contractor: United Network for Organ Sharing (UNOS), P.O. Box 2484, 700 North Fourth Street, Richmond, Virginia 23218.

SRTR Contractor: University Renal Research and Education Association (URREA), 315 West Huron, Suite 260, Washtenaw County, Ann Arbor, Michigan, 48103.

Division of Transplantation: Office of Special Programs, HRSA, Parklawn Building, Room 16C-17, 5600 Fishers Lane, Rockville, Maryland 20857.

Categories of Individuals Covered by the System:

Persons from whom organs have been obtained for transplantation, persons who are candidates for organ transplantation, and persons who have been recipients of transplanted organs.

Categories of Records in the System:

Donor registration, transplant recipient registration, histocompatibility forms, and transplant recipient follow-up forms. Data items include: name, Social Security number (voluntary), identifiers assigned by OPTN and SRTR contractors, hospital and hospital provider number, State and zip code of residence, citizenship, race/ethnicity, gender, date and time of organ recovery and transplantation, name of transplant center, histocompatibility status, donor cause of death and condition, patient condition before and after transplantation, immunosuppressive medication, cause of death (if appropriate), health care coverage, employment and education level.

Authority for Maintenance of the System:

42 U.S.C. 274 requires that the Secretary, by contract, provide for the establishment and operation of an OPTN, and 42 U.S.C. 274a requires that the Secretary, by grant or contract, develop and maintain a Scientific Registry of the recipients of organ transplants. 42 CFR part 121 authorizes collection of the information included in this system by the OPTN.

Purpose(s):

To (1) match donor organs with recipients; (2) monitor compliance of member organizations with OPTN requirements; (3) review and report periodically to the public on the status of organ donation and transplantation in the United States; and (4) provide data to researchers and government agencies to study the scientific and clinical status of organ transplantation.

Routine Uses of Records Maintained in the System, Including Categories of Users and the Purpose of Such Uses:

1. Departmental contractors who have been engaged by the Department to assist in accomplishment of a departmental function relating to the purposes for this system of records and who need to have access to the records in order to assist the Department.

2. HRSA, independently and through its contractor(s), may disclose records regarding organ donors, organ transplant candidates, and organ transplant recipients to transplant centers, histocompatibility laboratories, and organ procurement organizations, provided that such disclosure is compatible with the purpose for which the records were collected including: matching donor organs with recipients, monitoring compliance of member organizations with OPTN requirements, reviewing and reporting periodically to the public on the status of organ donation and transplantation in the United States. These records consist of Social Security numbers, other patient identification information and pertinent medical information.

3. In the event of litigation where the defendant is (a) the Department, any component of the Department, or any employee of the Department in his or her official capacity; (b) the United States where the Department determines that the claim, if successful, is likely to affect directly the operation of the Department or any of its components; or (c) any Department employee in his or her individual capacity where the Department of Justice has agreed to represent such employee, for example, in defending a claim against the Public Health Service in connection with such individual, disclosure may be made to the Department of Justice to enable the Department to present an effective defense.

4. 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.

5. A record may be disclosed for a research purpose, 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 HRSA 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, magnetic tapes, and disc packs.

Safeguards:

1. Authorized users: Access is limited to authorized HRSA and contract personnel responsible for administering the program. Authorized personnel include the System Manager and Project Officer, and the HRSA Automated Information System (AIS) Systems Security Officer; and the program managers/program specialists who have responsibilities for implementing the program. Both HRSA and its contractor(s) shall maintain current lists of authorized users.

2. Physical safeguards: Magnetic tapes, disc packs, computer equipment, and hard-copy files are stored in areas where fire and life safety codes are strictly enforced. All automated and nonautomated documents are protected on a 24-hour basis in locked storage areas. Security guards perform random checks on the physical security of the records storage area. The OPTN and SRTR contractors are required to maintain off site a complete copy of the system and all necessary files to run the computer organ donor-recipient match and update software.

3. Procedural safeguards: A password is required to access the terminal and a data set name controls the release of data to only authorized users. 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 office. All authorized users must sign a nondisclosure statement. Access to records is limited to those staff members trained in accordance with the Privacy Act and Automated Data Processing (ADP) security procedures. The contractor(s) is required to assure that the confidentiality safeguards of these records will be employed and that it complies with all provisions of the Privacy Act. All individuals who have access to these records must have the appropriate ADP security clearances. Privacy Act and ADP system security requirements are included in the contracts. The HRSA Project Officer(s) and the System Manager(s) oversee compliance with these requirements. The HRSA authorized users will make visits to the contractors' facilities to assure security and Privacy Act compliance. The contractor(s) is/are required to adhere to a HRSA approved system security plan.

Retention and Disposal:

Each donor, candidate, and recipient record shall be retained for 25 years beyond the known death of the organ recipient.

System Manager and Address:

Chief, Operations and Analysis Branch, Division of Transplantation, HRSA, Parklawn Building, Room 16C-17, 5600 Fishers Lane, Rockville, MD 20857.

Notification Procedure:

Requests by mail: To determine if a record about you exists, write to the OPTN contractor (see System Location). The request should contain the name and address of the individual; the Social Security number if the individual chooses to provide it; the name of his/her transplant center, a notarized written statement that the requester is the person he/she claims to be and that he/she understands that the request or acquisition of records pertaining to another individual under false pretenses is a criminal offense subject to a $5,000 fine. These procedures are in accordance with the Department's regulations (45 CFR part 5b).

Requests in person: The individual must meet all the requirements stated above for a request by mail, providing the information in written form, or provide at least one piece of tangible identification. The individual should recognize that in order to maintain confidentiality, and thus the accuracy of data released through repeated internal verification, securing the information by request in person will be time consuming. These procedures are in accordance with the Department's regulations (45 CFR part 5b).

Requests by telephone: Since positive identification of the caller cannot be established, telephone requests are not honored.

Record Access Procedures:

Same as notification procedures. Requestors should also provide a reasonable description of the record being sought. Requestors also may request an accounting of disclosures that have been made of their records, if any. A parent or guardian who requests notification of, or access to, a minor's/incompetent person's medical 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. These procedures are in accordance with the Department's regulations (45 CFR part 5b).

Contesting Records Procedures:

Contact the official at the address specified under notification procedure above and reasonably identify the record, specify the information being contested, and 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.

Record Source Categories:

Organ procurement organizations, histocompatibility laboratories, and organ transplant centers.

Systems Exempted from Certain Provisions of the Act:

None.