Storage

   Retrievability

   Authorized Users

   Physical Safeguards

   Procedural Safeguards

   Implementation Guidelines

 

System name:  Specimen Handling for Testing and Related Data.  HHS/CDC/NCID.

Security classification:  None.

System location:  Material, Data and Specimen Handling Section, Scientific Resources Program, National Center for Infectious Diseases, Bldg. 4, Rm. B35, Centers for Disease Control and Prevention, 1600 Clifton Road, NE, Atlanta, GA  30333.

San Juan Laboratories, National Center for Infectious Diseases, Centers for Disease Control and Prevention, Calle Casia 2, San Juan, Puerto Rico  00921.

Division of Vector-Borne Infectious Diseases, National Center for Infectious Diseases, Centers for Disease Control and Prevention, Foot Hills Campus, Fort Collins, CO  80522.

Arctic Investigations Program, National Center for Infectious Diseases, Centers for Disease Control and Prevention, 4055 Tudor Centre Drive, Anchorage, Alaska  99508.

and

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 whose specimens have been submitted to the Centers for Disease Control and Prevention (CDC) for testing.

Categories of records in the system:  Results of diagnostic tests involving microbiology, clinical chemistry, hematology, immunology, genetics and pathology.

Authority for maintenance of the system:  Public Health Service Act, Section 301, "Research and Investigation," (42 U.S.C. 241); and 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):  For documentation of test results which are returned to submitter.  Used between specialty units for research purposes; and for epidemiological investigations, for epidemic causes, prevention, family groupings of diseases, and geographical location of specific diseases; also, used by epidemiologist and researchers in determining drug resistance of specific organisms.

Routine uses of records maintained in the system, including categories of users and the purposes of such uses:  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):

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

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.

To individuals and 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.

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.

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

Storage:  Original Form - file folders; microfilm copies and computer tapes/disks and printouts.

Retrievability:  Retrieved by name or designated number furnished by the submitter, CDC identifying number, and/or microfilm 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 directly next door to the Clifton Road buildings.  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.  The 24-hour guard service in buildings provides personnel screening of visitors.  Electronic anti-intrusion devices are in effect at the Federal Records Center.

3. Procedural Safeguards:  Protection for computerized records both on the mainframe and the CIO Local Area Network (LAN) includes programmed verification of valid user identification code and password prior to logging on to the system, 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 is routine daily backup procedures and secure off-site storage is available for backup tapes.  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 developed in accordance with Chapter 45-13, "Safeguarding Records Contained in Systems of Records," of the HHS General Administration Manual; and Part 6, "Automated Information System Security," of the HHS Information Resources Management Manual.  FRC safeguards are in compliance with GSA Federal Property Management Regulations, Subchapter B--Archives and Records.  Data maintained in CDC Atlanta’s Processing Center 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.  The CIO LANs currently operate under Novell Netware v 4.11 and are in compliance with “CDC & ATSDR Security Standards for Novell File Servers.”

Retention and disposal:  Records are maintained in agency for five years.  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 destroyed by paper recycling process when 10 years old, unless needed for further study.

System manager(s) and address:  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.

Chief, Dengue Branch, Division of Vector-Borne Infectious Diseases, San Juan Laboratories, National Center for Infectious Diseases, Centers for Disease Control and Prevention, 2 Calle Casia, San Juan, Puerto Rico  00921-3200.

Director, Division of Vector-Borne Infectious Diseases, National Center for Infectious Diseases, Centers for Disease Control and Prevention, Post Office Box 2087 (Foot Hills Campus), PO2, Fort Collins, CO  80522.

Director, Arctic Investigations Program, National Center for Infectious Diseases, Centers for Disease Control and Prevention, 4055 Tudor Centre Drive, Anchorage, Alaska 99508.

Policy coordination is provided by:  Associate Director for Management and Operations, Bldg. 16, Rm. 5117, 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 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:  Approved public health laboratories, Federal medical facilities, private physicians.

Systems exempted from certain provisions of the act:  None.