01-7492. Privacy Act of 1974; System of Records

AGENCY:

Department of Veterans Affairs (VA).

ACTION:

Notice of amendment to system of records.

SUMMARY:

The Privacy Act of 1974 (5 U.S.C. 552(e)(4)) requires that all agencies publish in the Federal Register a notice of the existence and character of their systems of records. Notice is hereby given that the Department of Veterans Affairs (VA) is amending the system of records entitled “Veteran, Patient, Employee, and Volunteer Research and Development Project Records-VA” (34VA11) as set forth in the Federal Register 40 FR 38095, dated 8/26/75 and last amended in 58 FR 40852, dated 7/30/93. VA is amending the system by revising the System Number and the paragraphs on Authority to Maintain the System, Purposes, Categories of Records in the System, Routine Uses of Records Maintained in the System, and System Manager. VA is republishing the system notice in its entirety.

DATES:

Comments on the amendment of this system of records must be received no later than April 26, 2001. If no public comment is received, the amended system will become effective April 26, 2001.

ADDRESSES:

Written comments concerning the proposed new system of records may be submitted to the Office of Regulations Management (02D), Department of Veterans Affairs, 810 Vermont Avenue, NW., Washington, DC 20420. Comments will be available for public inspection at the above address in the Office of Regulations Management, Room 1158, between the hours of 8:00 a.m. and 4:30 p.m., Monday through Friday (except holidays).

FOR FURTHER INFORMATION CONTACT:

Veterans Health Administration (VHA) Privacy Act Officer, Department of Veterans Affairs, 810 Vermont Avenue, NW., Washington, DC 20420; telephone [phone].

SUPPLEMENTARY INFORMATION:

VA is renumbering the system of records from 34VA11 to 34VA12 to reflect organizational changes in the Department. The authority to maintain the records in the system has been amended to reflect current codification of the statute.

Two new routine use disclosure statements are being added to the system. One new routine use is being added to the system to allow for disclosure of information to the Department of Justice (DOJ), including U.S. Attorneys, upon its official request in order for VA to respond to pleadings, interrogatories, orders or inquiries from DOJ, and to supply DOJ with information to enable DOJ to represent the U.S. Government in any phase of litigation or in any case or controversy involving the VA. The second routine use is being added to the system to allow for disclosure of invention information with affiliated intellectual property partners to aid in the possible use, interest in, or ownership rights in VA intellectual property. Routine use number 4 is being amended to remove the Title 44 United States Code Section numbers.

The Privacy Act permits VA to disclose information about individuals without their consent for a Routine Use when the information will be used for a purpose that is compatible with the purpose for which we collected the information. In all of the Routine Use disclosures described above, the recipient of the information will use the information in connection with a matter relating to one of VA's programs, to provide a benefit to VA, or to provide disclosure as required by law.

The notice of intent to publish and an advance copy of the system notice have been sent to the appropriate Congressional committees and to the Director of the Office of Management and Budget (OMB) as required by 5 U.S.C. 552a(r) (Privacy Act) and guidelines issued by OMB (61 FR 6428), February 20, 1996.

Approved: March 1, 2001.

Anthony J. Principi,

Secretary of Veterans Affairs.

34VA12

SYSTEM NAME:

Veteran, Patient, Employee, and Volunteer Research and Development Project Records—VA.

System Location:

Records are maintained at each VA health care facility where the research project was conducted and at VA Central Office (VACO). Address locations are listed in VA Appendix 1 of the biennial Privacy Act Issuance publication. In addition, records are maintained at contractor and fieldwork sites as studies are developed, data collected and reports written. A list of locations where individually identifiable data are currently located is available from the System Manager.

Categories of Individuals Covered by the System:

The following categories of individuals will be covered by this system: (1) Veterans; (2) patients; (3) employees; or, (4) volunteers who have indicated their willingness to be a participant in medical research projects being performed by VA, by a VA contractor or by another Federal agency in conjunction with VA; and (5) research and development investigators.

Categories of Records in the System:

Records, or information contained in records, vary according to the specific medical research involved and may include: (1) Research on biomedical, prosthetic and health care services; (2) research stressing spinal cord injuries and diseases and other disabilities that tend to result in paralysis of the lower extremities; and (3) morbidity and mortality studies on former prisoners of war. VACO records contain (4) a merit review of the project; and (5) a review and evaluation of the research and development investigators and of the participants in the program. The review and evaluation information concerning the research and development investigators may include personal and educational background information as well as specific information concerning the type of research conducted. Invention records contain: a certification page, describing the place, time, research support related to the invention and co-inventors; Technology Transfer Program Invention Evaluation Sheet Internal or External Invention Assessment reports; Research and Development Information System (RDIS) reports on research support related to the invention; Correspondence; and the Office of General Counsel Letter of Determination.

Authority for Maintenance of the System:

Title 38, United States Code, Section 7301.

Purpose(s):

The records and information may be used to determine eligibility for research funding, to determine handling of intellectual properties, and to manage proposed and/or approved research endeavors.

Routine Uses of Records Maintained in the System, Including Categories of Users and the Purposes of Such Uses:

1. Transfer of statistical and other data to Federal, State, and local government agencies and national health organizations to assist in the development of programs.

2. In the event that a system of records maintained by this agency to carry out its functions indicates a violation or potential violation of law, whether civil, criminal or regulatory in nature, and whether arising by general statute or particular program statute, or by regulation, rule or order issued pursuant thereto, the relevant records in the system of records may be referred, as a routine use, to the appropriate agency, whether Federal, State, local or foreign, charged with the responsibility of investigating or prosecuting such violation or charged with enforcing or implementing the statute or rule, regulation or order issued pursuant thereto.

3. Disclosure may be made to a congressional office from the record of an individual in response to an inquiry from the congressional office made at the request of that individual.

4. Disclosure may be made to National Archives and Records Administration (NARA), General Services Administration (GSA) in records management inspections conducted under authority of 44 United States Code.

5. Disclosure of medical record data, excluding name and address (unless name and address is furnished by the requester) for research purposes determined to be necessary and proper, to epidemiological and other research facilities approved by the Under Secretary for Health.

6. In order to conduct Federal research necessary to accomplish a statutory purpose of an agency, at the written request of the head of the agency, or designee of the head of that agency, the name(s) and address(es) of present or former personnel of the Armed Services and/or their dependents may be disclosed (a) to a Federal department or agency or (b) directly to a contractor of a Federal department or agency. When a disclosure of this information is to be made directly to the contractor, VA may impose applicable conditions on the department, agency and/or contractor to ensure the appropriateness of the disclosure to the contractor.

7. Upon request for research project data, the following information will be released to the general public, including governmental and non-governmental agencies and commercial organizations: Project title and number; name and educational degree of principal investigator; Veterans Health Administration (VHA) medical center location; type (initial, progress, or final) and date of last report; name and educational degree of associate investigators; and project summary. In addition, upon specific request, keywords and indexing codes will be included for each project.

8. Upon request for information regarding VA employees conducting research, the following information will be released to the general public, including governmental agencies and commercial organizations: Name and educational degree of investigator; VHA title; academic affiliation and title; hospital service; primary and secondary specialty areas and subspecialty.

9. Records from this system of records may be disclosed to a Federal agency or to a State or local government licensing board and/or to the Federation of State Medical Boards or a similar nongovernment entity which maintains records concerning individuals' employment histories or concerning the issuance, retention or revocation of licenses, certifications, or registration necessary to practice an occupation, profession or specialty, in order for the agency to obtain information relevant to an agency decision concerning the hiring, retention or termination of an employee or to inform a Federal agency or licensing boards or the appropriate nongovernment entities about the health care practices of a terminated, resigned or retired health care employee whose professional health care activity so significantly failed to conform to generally accepted standards of professional medical practice as to raise reasonable concern for the health and safety of patients in the private sector or from another Federal agency. These records may also be disclosed as part of an ongoing computer matching program to accomplish these purposes.

10. Identifying information in this system, including name, address, social security number and other information as is reasonably necessary to identify such individual, may be disclosed to the National Practitioner Data Bank at the time of hiring and/or clinical privileging/reprivileging of health care practitioners, and other times as deemed necessary by VA, in order for VA to obtain information relevant to a Department decision concerning the hiring, privileging/reprivileging, retention or termination of the applicant or employee.

11. Relevant information from this system of records may be disclosed to the National Practitioner Data Bank and/or State Licensing Board in the State(s) in which a practitioner is licensed, in which the VA facility is located, and/or in which an act or omission occurred upon which a medical malpractice claim was based when VA reports information concerning: (a) Any payment for the benefit of a physician, dentist, or other licensed health care practitioner which was made as the result of a settlement or judgment of a claim of medical malpractice of an appropriate determination is made in accordance with agency policy that payment was related to substandard care, professional incompetence or professional misconduct on the part of the individual; (b) a final decision which relates to possible incompetence or improper professional conduct that adversely affects the clinical privileges of a physician or dentist for a period longer than 30 days; or, (c) the acceptance of the surrender of clinical privileges or any restriction of such privileges by a physician or dentist either while under investigation by the health care entity relating to possible incompetence or improper professional conduct, or in return for not conducting such an investigation or proceeding. These records may also be disclosed as part of a computer matching program to accomplish these purposes.

12. Information concerning individuals who have submitted research program proposals for funding, including the investigator's name, social security number, research qualifications and the investigator's research proposal, may be disclosed to qualified reviewers for their opinion and evaluation of the applicants and their proposals as part of the application review process.

13. Any information in this system may be disclosed to the Department of Justice (DOJ), including U.S. Attorneys, upon its official request in order for VA to respond to pleadings, interrogatories, orders or inquiries from DOJ and to supply DOJ with information to enable DOJ to represent the U.S. Government in any phase of litigation or in any case or controversy involving VA.

14. Any invention information in this system may be disclosed to affiliated intellectual property partners to aid in the possible use, interest in, or ownership rights in VA intellectual property.

Policies and Practices for Storing, Retrieving, Accessing, Retaining, and Disposing of Records in the System:

Storage:

(1) Paper documents. (2) Microscope slides. (3) Magnetic tape or disk. (4) Photographs. (5) Microfilm.

Retrievability:

Records are retrieved by individual identifiers and indexed by a specific project site or location, project number, or under the name of the research or development investigator.

Safeguards:

Physical Security: Access to VA working space and medical record storage areas is restricted to VA employees on a “need to know” basis. Generally, VA file areas are locked after normal duty hours and protected from outside access by the Federal Protective Service. Employee file records and file records of public figures or otherwise sensitive medical record files are stored in separate locked files. Strict control measures are enforced to ensure that disclosure is limited to a “need to know” basis. Access to a contractor's records and their system of computers used with the particular project are available to authorized personnel only. Records on investigators stored on automated storage media are accessible by authorized VACO personnel via terminals which are dedicated to this research and development information system.

Retention and Disposal:

The project records are held five (5) years after completion of the research project and/or publication of a final report unless they become part of the patient's individual medical history file in which case the record would remain 75 years after the last activity of care. At the end of a study, records maintained by a contractor are returned to VA for appropriate disposition.

System Manager(s) and Address:

Director of Operations, Research and Development (12C), Department of Veterans Affairs, 810 Vermont Ave, NW., Washington, DC 20420.

Notification Procedure:

Interested persons should write to: Director of Operations, Research and Development (12C), Department of Veterans Affairs, 810 Vermont Ave, NW., Washington, DC 20420. All inquiries must reasonably identify the project and site location; date of project and team leader.

Record Access Procedures:

Interested persons desiring access to and contesting of research records should write to the address in Notification Procedure above.

Contesting Record Procedures:

(See Notification Procedure above.)

Record Source Categories:

(1) Patients and patient records; (2) employees and volunteers; (3) other Federal agencies; (4) National Institutes of Health; (5) Centers for Disease Control (Atlanta, Georgia); (6) individual veterans; (7) other VA systems of records; and, (8) research and development investigators.