System Name: Medical and Laboratory Studies, HHS/CDC/NIOSH.
Security Classification: None.
System Location(s):
Division of Respiratory Disease Studies, National Institute for Occupational Safety and Health, 1095 Willowdale Road, Morgantown, WV 26505-2845.
A list of contractor sites where individually identifiable data are currently located is available upon request to the system manager.
Also, occasionally data may be located at the facilities of collaborating researchers where analyses are performed, data collected and reports written. A list of these facilities is available upon request to the system manager. Data may be located only at those facilities that have an adequate data security program and the collaborating researcher must return the data to NIOSH or destroy individual identifiers at the conclusion of the project.
Categories of Individuals Covered by the System: Individuals who have had examinations at Division of Respiratory Disease Studies (DRDS) staff or submitted medical information in cooperation with a DRDS study.
Categories of Records in the System: Analyses of biochemical data, occupational and medical histories, and results of medical tests. The specific types of records collected and maintained are determined by the needs of the individual study.
Authority for Maintenance of the System: Federal Mine Safety and Health Act of 1977, Section 501, "Research" (30 U.S.C. 95l); Occupational Safety and Health Act, Section 20, "Research and Related Activities" and Section 22(d), "Authority of Director, National Institute for Occupational Safety and Health" (29 U.S.C 669, 671(d)).
Purpose(s): The purpose of this system is to perform medical and epidemiological research, statistical analysis, and to identify early indicators of occupationally related diseases (biochemical indices); data is given to other NIOSH units for biochemical and epidemiological studies.
Routine Uses of Records Maintained in the System, Including Categories of Users and the Purposes of such Uses:
Data may be sent to State Vital Statistics Divisions to obtain death certificates and to missing person location agencies to find those individuals who cannot otherwise be located.
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 subject to the Privacy Act are disclosed to private firms for data entry, computer systems analysis and computer programming services. The contractors promptly return data entry records after the contracted work is completed. The contractors are required to maintain Privacy Act safeguards.
Certain communicable diseases may be reported to State and/or local health departments where the State has a legally constituted reporting program for communicable diseases and which provides for the confidentiality of the information.
In the event of litigation initiated at the request of NIOSH, the Institute may disclose such records as it deems desirable or necessary to the Department of Justice and to the Department of Labor, Office of the Solicitor, where appropriate, to enable the Departments to effectively represent the Institute, provided such disclosure is compatible with the purpose for which the records were collected. The only types of litigative proceedings that NIOSH is authorized to request are: (1) enforcement of a subpoena issued to an employer to provide relevant information; or (2) contempt citation against an employer for failure to comply with a warrant obtained by the Institute.
Disclosure may be made to NIOSH collaborating researchers (NIOSH contractors, grantees, cooperative agreement holders, or other Federal or State scientists) in order to accomplish the research purpose for which the records are collected. The collaborating researchers must agree in writing to comply with the confidentiality provisions of the Privacy Act and NIOSH must have determined that the researchers' data security procedures will protect confidentiality.
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.
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.
Policies and Practices for Storing, Retrieving, Accessing, Retaining, and Disposing of Records in the System—
Storage: Computer tapes/disks and printouts, CD ROM; microfiche, and manual files.
Retrievability: Name and case number are the indices used to retrieve records from this system.
Safeguards:
1. Authorized users: Access is granted to only a limited number of physicians, scientists, statisticians, and designated support staff of the Centers for Disease Control (CDC), as authorized by the system manager to accomplish the stated purposes for which the data in this system have been collected.
2. Physical safeguards: Records are kept in locked cabinets in locked rooms. Guard service in buildings provides screening of visitors. Electronic anti-intrusion devices are in operation at the Federal Records Center.
3. Procedural safeguards: Users of individually identified data protect information from public scrutiny, and only specifically authorized personnel may be admitted to the record storage area. CDC employees who maintain records are instructed to check with system manager prior to making disclosures of data.
4. Implementation guidelines: HHS Chapter 45-13 and supplementary Chapter PHS.hf: 45-13 of the General Administration Manual. FRC safeguards are in compliance with GSA Federal Property Management Regulations, subchapter B--Archives and Records.
Retention and Disposal: Master records for completed studies are maintained in agency until transferred to the National Archives, which will occur within five years of completion. Source documents for computer data are disposed of 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. Electronic records are maintained according to the provisions of the Records Control Schedule for NIOSH Electronic Records, which is consistent with the records maintenance requirements for other forms of records. Copies of notifications to workers/private physicians of needed medical attention and/or medical treatment are destroyed when no longer needed for administrative purposes, but may be retained for as long as seventy years. Paper records are destroyed by paper recycling process when 20 years old, unless needed for further study.
System Manager(s) and Address(es):
Administrative Officer, Division of Respiratory Disease Studies (DRDS), National Institute for Occupational Safety and Health (NIOSH), 1095 Willowdale Road, MS 217, Morgantown, WV 26505-2845.
Health Science Administrator, Clinical Investigations Branch, DRDS, NIOSH, 1095 Willowdale Road, MS 245, Morgantown, WV 26505-2845.
Policy coordination is provided by: Director, Division of Respiratory Disease Studies, National Institute for Occupational Safety and Health, 1095 Willowdale Road, MS 220, Morgantown, WV 26505-2845.
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 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.
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: Information is obtained directly from the individual.
Systems Exempted from Certain Provisions of the Act: None.
