System Name: Epidemiologic Studies and Surveillance of Disease Problems, HHS/CDC/NCID.
Security Classification: None.
System Location(s):
National Center for Infectious Diseases, Bldg. 1, Rm. 6013, Centers for Disease Control and Prevention, 1600 Clifton Road, NE, Atlanta, GA 30333.
National Center for Prevention Services, Corporate Square, Bldg. 11, Rm. 2106, Centers for Disease Control and Prevention, 1600 Clifton Road, NE, Atlanta, GA 30333.
National Center for Environmental Health, Chamblee Bldg. 101, Rm. 3116, Centers for Disease Control and Prevention, 4770 Buford Highway, NE, Atlanta, GA 30341-3724.
National Center for Injury Prevention and Control, Koger Davidson Bldg., Rm. 1078, Centers for Disease Control and Prevention, 4770 Buford Highway, NE, Atlanta, GA 30341-3724.
Epidemiology Program Office, Bldg. 1, Rm. 5009, Centers for Disease Control and Prevention, 1600 Clifton Road, NE, Atlanta, GA 30333.
Public Health Practice Program Office, Executive Park, Bldg. 24, Rm. 110, Centers for Disease Control and Prevention, 1600 Clifton Road, NE, Atlanta, GA 30333.
National Center for Chronic Disease Prevention and Health Promotion, Rhodes Bldg., Rm. 4000, Centers for Disease Control and Prevention, 4770 Buford Highway, NE, Atlanta, GA 30341-3724.
National Immunization Program, Corporate Square, Bldg. 12, Rm. 5113, Centers for Disease Control and Prevention, 1600 Clifton Road, NE, Atlanta, GA 30333.
Federal Records Center, 1557 St. Joseph Avenue, East Point, GA 30344.
A list of contractor sites where individually identifiable data are currently located is available upon request to the appropriate system manager.
Categories of Individuals Covered by the System: Adults and children with diseases and other preventable conditions of public health significance; also included are control group participants. Workers employed by the Department of Energy and its predecessor agencies and their contractors are also included.
Categories of Records in the System: Case reports, medical records, questionnaires, and related documents.
Authority for Maintenance of the System: Public Health Service Act, section 301, "Research and Investigation," (42 U.S.C. 241); sections 304, 306 and 308(d) which discuss authority to grant assurances of confidentiality for health research and related activities (42 U.S.C. 242 b, k, and m(d)).
Purpose(s): This record system enables Centers for Disease Control (CDC) officials to better understand disease patterns in the United States, develop programs for prevention and control of health problems, and communicate new knowledge to the health community.
Routine Uses of Records Maintained in the System, Including Categories of Users and the Purposes of such Uses:
CDC 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 such contractors. Contractors are required to maintain Privacy Act safeguards with respect to such records.
The following routine uses apply to all records in this system except those maintained under an assurance of confidentiality provided by section 308(d) of the Public Health Service Act (unless expressly authorized in the consent form or stipulated in the Assurance Statement):
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.
Disclosure may be made to organizations deemed qualified by the Secretary to carry out quality assessment, medical audits or utilization review.
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.
Records may be disclosed 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 disclosed is relevant and necessary for that assistance.
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 Justice Department 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 to student volunteers, individuals working under a personal services contract, and other individuals performing functions for PHS who do not technically have the status of agency employees, if they need the records in the performance of their agency functions.
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: Computer tapes/disks and printouts and file folders.
Retrievability: By name of individual and by identification 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 (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 card key system, with access to the computer room controlled by a card key and security code (numeric keypad) system. Access to the data entry area is also controlled by a card key system and the hard copy records are kept in locked cabinets in locked rooms. The local fire department is located directly across the street from the Clifton Road facility. The computer room is protected by a dry pipe fire protection system, numerous automatic sensors (e.g., water, heat, smoke, etc.) are installed, and a proper mix of 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 fire proof safe. Guard service in buildings provides personal screening of visitors. Electronic anti-intrusion devices are in effect at the Federal Records Center.
3. Procedural safeguards: System security includes automatic suspension of accounts, forced password changes, and control of systems and data set access. Protection for computerized records includes programmed verification of valid user identification code, account code and password prior to acceptance of a terminal session or job submission, frequently changed passwords, and Vault Management System. When Privacy Act tapes are scratched, a special "certified" process is performed in which tapes are completely written over to avoid inadvertent data disclosure. 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 developed in accordance with Chapter 45-13, "Safeguarding Records Contained in Systems of Records," of the HHS General Administration Manual, supplementary Chapter PHS.hf: 45-13; Part 6, "Automated Information System Security," of the HHS Information Resources Management Manual; the National Bureau of Standards Federal Information Processing Standards (FIPS Pub. 41 and FIPS Pub. 31). FRC safeguards are in compliance with GSA Federal Property Management Regulations, Subchapter B--Archives and Records.
Retention and Disposal: Record copy of study reports maintained in agency from two to three years in accordance with retention schedules. Source documents for computer disposed of when no longer needed by program officials. Personal identifiers may be deleted from records when no longer needed in the study as determined by the system manager, and as provided in the signed consent form, as appropriate. Disposal methods include erasing computer tapes, burning or shredding paper materials or transferring records to the Federal Records Center when no longer needed for evaluation and analysis. Records are destroyed by paper recycling process when 20 years old, unless needed for further study.
System Manager(s) and Address(es):
Director, National Center for Infectious Diseases, Bldg. 1, Rm. 6013, MS C12, Centers for Disease Control and Prevention, 1600 Clifton Road, NE, Atlanta, GA 30333.
Director, National Center for Prevention Services, Corporate Square, Bldg. 11, Rm. 2106, MS E07, Centers for Disease Control and Prevention, 1600 Clifton Road, NE, Atlanta, GA 30333.
Director, National Center for Environmental Health, Chamblee Bldg. 101, Rm. 3116, MS F29, Centers for Disease Control and Prevention, 4770 Buford Highway, NE, Atlanta, GA 30341-3724.
Director, National Center for Injury Prevention and Control, Koger Davidson Bldg., Rm. 1078, MS F36, Centers for Disease Control and Prevention, 4770 Buford Highway, NE, Atlanta, GA 30341-3724.
Director, Epidemiology Program Office, Bldg. 1, Rm. 5009, MS C08, Centers for Disease Control and Prevention, 1600 Clifton Road, NE, Atlanta, GA 30333.
Director, Public Health Practice Program Office, Executive Park, Bldg. 24, Rm. 110, MS E20, Centers for Disease Control and Prevention, 1600 Clifton Road, NE, Atlanta, GA 30333.
Director, National Center for Chronic Disease Prevention and Health Promotion, Rhodes Bldg., Rm. 4000, MS K40, Centers for Disease Control and Prevention, 4770 Buford Highway, NE, Atlanta, GA 30341-3724.
Director, National Immunization Program, Corporate Square, Bldg. 12, Rm. 5113, MS E05, Centers for Disease Control and Prevention, 1600 Clifton Road, NE, Atlanta, GA 30333.
Policy coordination is provided by: Associate Director for Management and Operations, Bldg. 1, Rm. 2011, MS D15, 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 or may obtain information concerning participation in epidemiological studies or surveillance activities by contacting the appropriate system manager at the address listed 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 dollars 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 first 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, private physicians, State and local health departments, and other health care providers.
Systems Exempted from Certain Provisions of the Act: None.
