[Federal Register Volume 74, Number 212 (Wednesday, November 4, 2009)]
[Notices]
[Pages 57184-57186]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-26527]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration


Privacy Act of 1974; Report of an Altered System of Records

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

ACTION: Notice of an altered system of records (SOR).

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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 (301) 443-0036. 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

[[Page 57185]]

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:

[[Page 57186]]

    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.

[FR Doc. E9-26527 Filed 11-3-09; 8:45 am]
BILLING CODE 4160-15-P