E9-26527. Privacy Act of 1974; Report of an Altered System of Records

AGENCY:

Department of Health and Human Services (HHS), Health Resources and Services Administration (HRSA).

ACTION:

Notice of an altered system of records (SOR).

SUMMARY:

In accordance with the requirements of the Privacy Act of 1974, the Health Resources and Services Administration (HRSA) is publishing notice of a proposal to alter the system of records for the Organ Procurement and Transplantation Network (OPTN)/Scientific Registry of Transplant Recipients (SRTR) Data System, HHS/HRSA/HSB/DoT, system of records number 09-15-0055. The purpose of this alteration is to add a new routine use for this system of records. In addition, this notice clarifies system location, how the records are stored, retrieved, and disposed.

DATES:

HRSA filed an altered system report with the Chair of the House Committee on Government Reform and Oversight, the Chair of the Senate Committee on Homeland Security and Governmental Affairs, and the Administrator, Office of Information and Regulatory Affairs, Office of Management and Budget (OMB) on October 27th, 2009. To ensure all parties have adequate time in which to comment, the altered system, including the routine uses, will become effective 30 days from the publication of the notice or 40 days from the date it was submitted to OMB and Congress, whichever is later, unless HRSA receives comments that require alterations to this notice.

ADDRESSES:

Please address comments to the Chief of the Operations and Analysis Branch, Division of Transplantation, HSB/HRSA, Parklawn Building, Room 12C-06, 5600 Fishers Lane, Rockville, MD 20857. Comments received will be available for inspection at this same address from 9 a.m. to 5 p.m., (Eastern Standard Time Zone), Monday through Friday.

FOR FURTHER INFORMATION CONTACT:

Chris McLaughlin, Chief, Operations and Analysis Branch, Division of Transplantation, HSB/HRSA, Parklawn Building, Room 12C-06, 5600 Fishers Lane, Rockville, MD 20857, Telephone [phone]. This is not a toll-free number.

SUPPLEMENTARY INFORMATION:

HRSA is adding a new routine use (number 6) to permit disclosures 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.

In addition HRSA is clarifying system location and how records are:

• Stored (under storage); records are maintained both electronically and via hardcopy in file folders, magnetic tapes, and disc packs,
• Retrieved (under retrievability); records in the system are retrieved by more than one data element including name, date of birth, and social security number,
• Disposed (under retention and disposal); each donor, candidate, and recipient record stored within the OPTN/SRTR Data System shall be retained for no more than 25 years beyond the known death of the candidate or the organ recipient. Paper media is placed in locked destruction bins and is shredded by a third-party vendor and electronic media is logged and degaussed before leaving the building.

Dated: October 13, 2009.

Mary K. Wakefield,

Administrator.

SYSTEM NUMBER:

09-15-0055.

SYSTEM NAME:

Organ Procurement and Transplantation Network (OPTN)/Scientific Registry of Transplant Recipients (SRTR) Data System, HHS/HRSA/HSB/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: Arbor Research Collaborative for Health, 315 West Huron, Suite 360, Washtenaw County, Ann Arbor, Michigan 48103.

Division of Transplantation: Healthcare Systems Bureau, HRSA, Parklawn Building, Room 12C-06, 5600 Fishers Lane, Rockville, Maryland 20857.

CATEGORIES OF INDIVIDUALS COVERED BY THE SYSTEM:

1. Living and deceased persons from whom organs have been obtained for transplantation.

2. Persons who are candidates for organ transplantation.

3. Persons who have been recipients of transplanted organs.

CATEGORIES OF RECORDS IN THE SYSTEM:

Donor registration, transplant candidate registration, transplant recipient registration, histocompatibility, transplant recipient follow-up and living donor follow-up, forms and other non-registry operational information. Data items include: Name, Social Security number, 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 medical information and, if donor is deceased, cause of death, patient medical information before and after transplantation, immunosuppressive medication, cause of death (if recipient is deceased), 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) FOR RECORDS IN THIS SYSTEM:

To (1) facilitate organ placement and match donor organs with recipients; (2) monitor compliance of member organizations with Federal laws and regulations and with OPTN requirements; (3) review and report periodically to the public on the status of organ donation and transplantation in the United States; (4) provide data to researchers and government agencies to study the scientific and clinical status of organ transplantation; (5) perform transplantation-related public health surveillance including possible transmission of donor disease.

ROUTINE USES OF RECORDS MAINTAINED IN THE SYSTEM, INCLUDING CATEGORIES OF USERS AND THE PURPOSES OF SUCH USES:

1. Departmental contractors and/or their subcontractors 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 require 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, organ procurement organizations, the Transplant Transmission Sentinel Network and other public health agencies such as SEER registries, NCI contractors, State cancer registries and other State health agencies, 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 Federal laws and regulations and OPTN requirements, reviewing and reporting periodically to the public on the status of organ donation and transplantation in the United States, and transplantation-related public health surveillance. 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 data recipient to: (1) Establish strict limitations concerning the receipt and use of patient-identified or center-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 or center at the earliest time at which removal or destruction can be accomplished consistent with the purpose of the research project, unless the data 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 data recipient's understanding of, and willingness to abide by these provisions.

6. 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:

1. Storage: Records are maintained both electronically and via hardcopy in file folders, magnetic tapes, and disc packs.

2. Retrievability: Records in the system are retrieved by more than one data elements including name, date of birth, and social security number.

3. Safeguards:

a. 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.

b. 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.

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 stored within the OPTN/SRTR Data System shall be retained for no more than 25 years beyond the known death of the candidate or the organ recipient. Paper media is placed in locked destruction bins and is shredded by a third-party vendor and electronic media is logged and degaussed before leaving the building.

SYSTEM MANAGER(S) AND ADDRESS:

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

SRTR Contractor: Greg Levine, Arbor Research Collaborative for Health, 315 West Huron, Suite 360, Washtenaw County, Ann Arbor, Michigan 48103.

Division of Transplantation: Healthcare Systems Bureau, HRSA, Parklawn Building, Room 12C-06, 5600 Fishers Lane, Rockville, Maryland 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; date of birth; the name of his/her transplant center, a notarized written request or a certification 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.

RECORDS ACCESS PROCEDURES:

These are the 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:

To contest a record in the system, 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 PRIVACY ACT:

None.