Privacy Act System Notice 09-20-0089

System name: Studies of Treatment of Tuberculosis and other Mycobacterioses. HHS/CDC/NCHSTP.

Security classification: None.

System location: Division of Tuberculosis Elimination, National Center for HIV, STD and TB Prevention, Coordinating Center for Infectious Diseases, Corporate Square, Bldg. 11, Rm. 2106, Centers for Disease Control and Prevention, 1600 Clifton Road, NE, Atlanta, GA 30333.

and

Federal Records Center, 4712 Southpark Blvd., Ellenwood, GA  30294. A list of contractor sites where individually identified data are currently located is available upon request to the system manager.

Categories of individuals covered by the system: Adults and children with tuberculosis or other mycobacterial diseases having been or currently being treated or observed by a limited number of participating local or county health departments, clinics, and hospitals (from 1959 until the present time), including those individuals in selected areas receiving preventive therapy with isoniazid therapy and/or other changes or BCG vaccinations, and patients for whom routine tuberculosis treatment is ineffective. Also included are contacts to tuberculosis patients, adults with inactive tuberculosis, and controls.

Categories of records in the system: Abstracts of medical data pertaining to clinical trials, including medical history, skin tests, physical examinations, laboratory test results, X-ray results, medications prescribed, smoking habits, etc.

Authority for maintenance of the system: Public Health Service Act, Section 301, "Research and Investigation" (42 U.S.C. 241).

Purpose(s): To determine the effectiveness and safety of a variety of treatments and preventive measures for tuberculosis and other mycobacterial diseases, to determine the best measures against drug resistant tuberculosis, and to monitor incidence of complications among individuals who have received preventive therapy, including isoniazid.

Routine uses of records maintained in the system, including categories of users and the purposes of such uses: Records may be disclosed to health departments and other public health or cooperating medical authorities in connection with program activities and related collaborative efforts to deal more effectively with diseases and conditions of public health significance.

A record may be disclosed for a research purpose, when the Department:

(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 the research purpose (1) cannot be reasonably accomplished unless the record is provided in individually identifiable form, and (2) warrants the risk to the privacy of the individual that additional exposure of the record might bring;

(C) has required the recipient to: (1) establish reasonable administrative, technical, and physical safeguards to prevent unauthorized use or disclosure of the record, (2) remove or destroy 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 (3) make no further use or disclosure of the record except (a) in emergency circumstances affecting the health or safety of any individual, (b) for use in another research project, under these same conditions, and with written authorization of the Department, (c) for disclosure to a properly identified person for the purpose of an audit related to the research project, if information that would enable research subjects to be identified is removed or destroyed at the earliest opportunity consistent with the purpose of the audit, or (d) when required by law;

(D) has secured a written statement attesting to the recipient's understanding of, and willingness to abide by these provisions.

The Department is under contract with private firms for the purpose of collating, analyzing, aggregating or otherwise refining records in this system. Relevant records are maintained by the contractors. The contractors are required to maintain Privacy Act safeguards with respect to such records. 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.

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 directly affect the operations 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 based upon an individual's mental or physical condition and alleged to have arisen because of activities of the Public Health Service in connection with such individual, disclosure may be made to the Department of Justice to enable that Department to present an effective defense, provided that such disclosure is compatible with the purpose for which the records were collected.

Records may be disclosed by CDC in connection with public health activities to the Social Security Administration for sources of locating information to accomplish the research or program purposes for which the records were collected.

Policies and practices for storing, retrieving, accessing, retaining, and disposing of records in the system:

Storage: File folders, computer tapes/disks, and CD-ROMs.

Retrievability: Records are retrieved by the participant's name and/or study I.D. number.

Safeguards:

1. Authorized Users: A database security package is implemented on CDC's mainframe computer to control unauthorized access to the system. Attempts to gain access by unauthorized individuals are automatically recorded and reviewed on a regular basis. Access is granted to only a limited number of physicians, scientists, statisticians, and designated support staff of the Centers for Disease Control and Prevention (CDC), or its contractors, as authorized by the system manager to accomplish the stated purposes for which the data in this system have been collected.

2. Physical Safeguards: Access to the CDC Clifton Road facility where the mainframe computer is located is controlled by a cardkey system. Access to the computer room is controlled by a cardkey and security code (numeric keypad) system. Access to the data entry area is also controlled by a cardkey system. The hard copy records are kept in locked cabinets in locked rooms. The local fire department is located nearby. The computer room is protected by an automatic sprinkler system, automatic sensors (e.g., water, heat, smoke, etc.) are installed, and portable fire extinguishers are located throughout the computer room. The system is backed up on a nightly basis with copies of the files stored off site in a secure fireproof safe. Security guard service in  buildings provides personnel screening of visitors.

3. Procedural Safeguards: Protection for computerized records both on the mainframe and the National Center Local Area Network (LAN) includes programmed verification of valid user identification code and password prior to logging on to the system, changed mandatory password changes, limited log-ins, virus protection, and user rights/file attribute restrictions. Password protection imposes user name and password log-in requirements to prevent unauthorized access. Each user name is assigned limited access rights to files and directories at varying levels to control file sharing. There are routine daily backup procedures and secure off-site storage is available for backup files. To avoid inadvertent data disclosure, ”degaussing” is performed to ensure that all data are removed from Privacy Act computer tapes and/or other magnetic media. Additional safeguards may be built into the program by the system analyst as warranted by the sensitivity of the data.

CDC and contractor employees who maintain records are instructed to check with the system manager prior to making disclosures of data. When individually identified data are being used in a room, admittance at either CDC or contractor sites is restricted to specifically authorized personnel. Privacy Act provisions are included in contracts, and the CDC Project Director, contract officers and project officers oversee compliance with these requirements. Upon completion of the contract, all data will be either returned to CDC or destroyed, as specified by the contract.

4. Implementation Guidelines: The safeguards outlined above are in accordance with the HHS Information Security Program Policy and FIPS Pub 200, “Minimum Security Requirements for Federal Information and Information Systems.” Data maintained on CDC’s Mainframe and the National Center LAN are in compliance with OMB Circular A-130, Appendix III. Security is provided for information collection, processing, transmission, storage, and dissemination in general support systems and major applications.

Retention and disposal: Records are retained and disposed of in accordance with the CDC Records Control Schedule.  Records are maintained in agency for five years. Disposal methods include erasing computer tapes and burning or shredding paper materials or transferring records to the Federal Records Center when no longer needed for evaluation and analysis. Records destroyed by paper recycling process when 20 years old, unless needed for further study.

System manager(s) and address: Director, Division of Tuberculosis Elimination, National Center for HIV, STD and TB Prevention, Coordinating Center for Infectious Diseases, Corporate Square, Bldg. 11, Rm. 2106, MS E10, Centers for Disease Control and Prevention, 1600 Clifton Road, NE, Atlanta, GA 30333.

Notification procedure: An individual may learn if a record exists about himself or herself by contacting the system manager at the address above. Requesters in person must provide driver's license or other positive identification. Individuals who do not appear in person must either: (1) submit a notarized request to verify their identity; or (2) certify that they are the individuals they claim to be and that they understand that the knowing and willful request for or acquisition of a record pertaining to an individual under false pretenses is a criminal offense under the Privacy Act subject to a $5,000 fine.

An individual who requests notification of or access to medical records shall, at the time the request is made, designate in writing a responsible representative who is willing to review the record and inform the subject individual of its contents at the representative's discretion.

A parent or guardian who requests notification of, or access to, a child'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 child by means of a birth certificate or court order, as well as verify that he or she is who he or she claims to be.

The following information must be provided when requesting notification: (1) full name; (2) the approximate date and place of the study, if known; and (3) nature of the questionnaire or study in which the requester participated.

Record access procedures: Same as notification procedures. Requesters should also reasonably specify the record contents being sought. An accounting of disclosures that have been made of the record, if any, may be requested.

Contesting record procedures: Contact the official at the address specified under System Manager above, reasonably identify the record and specify the information being contested, the corrective action sought, and the reasons for requesting the correction, along with supporting information to show how the record is inaccurate, incomplete, untimely, or irrelevant.

Record source categories: Individuals, State and local health departments, hospitals, laboratories, clinics, and family members of study participants.

Systems exempted from certain provisions of the act: None.

[Federal Register: November 24, 1986 (Volume 51, Number 226)] [Notices] [Page 42457-42458] (PDF - 917Kb)