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H H S Department of Health and Human Services
U.S. Department of Health and Human Services
Health Resources and Services Administration

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System of Record Notice 09-15-0056

System name: National Vaccine Injury Compensation Program, HHS/ HRSA/BHPr.

Security classification: None.

System location: Bureau of Health Professions (BHPr), Health Resources and Services Administration (HRSA), 5600 Fishers Lane, Room 8A-35, Rockville, Maryland 20857.

Categories of individuals covered by the system: Persons filing claims (petitioners) under the National Vaccine Injury Compensation Program (NVICP).

Categories of records in the system: Petition for compensation, including petitioner’s name and name of person vaccinated if different from petitioner, and all relevant medical records, (including autopsy reports and slides, radiological films, and home videos, if any), appropriate assessments, evaluations, prognoses, and such other records and documents as are reasonably necessary for the determination of eligibility for and the amount of compensation to be paid to, or on behalf of, the person who suffered such injury or who died from the administration of the vaccine.

Authority for maintenance of the system: 42 U.S.C. 300aa-ll and Executive Order 9397 regarding the Use of Social Security Number.

Purpose(s)

  1. To determine eligibility of petitioners to receive compensation under the National Vaccine Injury Compensation Program.
  2. To compensate successful petitioners in the amount determined by the court.
  3. To evaluate vaccine safety through research programs. Routine uses of records maintained in the system, including categories of user and the purposes of such uses: 1. Disclosures 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 written request of the individual. 2. 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 (DOJ) has agreed to represent such employee, for example in defending against a claim based upon an individual’s mental or physical condition and alleged to have risen because of activities of the Public Health Service in connection with such individual, the Department may disclose such records as it deems desirable or necessary to the DOJ to enable that Department to present an effective defense, provided that such disclosure is compatible with the purpose for which the records were collected.
  4. HRSA will contract with expert medical consultants for the purpose of obtaining advice on petitioner’s eligibility for compensation. Relevant records may be disclosed to such consultants. The consultants shall be required to maintain Privacy Act safeguards with respect to such records and return all records to HRSA.
  5. HRSA will release the petitioner’s complete medical file and may release consultants’ report to the DOJ and the Special Master of the U.S. Court of Federal Claims for adjudication of the compensation claim.
  6. HRSA will disclose for publication in the Federal Register the name of the petitioner, the name of the person vaccinated, if not the petitioner, the city and State where the vaccine was administered and the U.S. Court of Federal Claims’ Docket Number as required by the National Childhood Vaccine Injury Act. Records may be disclosed to organizations deemed qualified by the Secretary for the purpose of evaluating the administration, process, or outcomes of the National Vaccine Injury Compensation Program (as required by Congress). The purpose of the disclosure is to document the extent to which the National Vaccine Compensation Program is satisfying the goals and objectives of its authorizing legislation, i.e., maintaining a system for compensating those who have been injured by a vaccine that is fair and expeditious. Organizations to which information is disclosed for this use shall be required to maintain Privacy Act safeguards with respect to such records.
  7. A record may be disclosed to annuity brokers and to employees of life insurance companies for the purposes of obtaining financial advice and for the purchase of contracts to provide benefits to recipients of benefits under the Program. Organizations to which information is disclosed for this use will be required to maintain Privacy Act safeguards with respect to such records.
  8. A record may be disclosed to contractors for the purpose of providing medical review, analysis and determination as to whether petitions meet the medical requirements for compensation. Contractors will be required to maintain Privacy Act safeguards with respect to such records.
  9. A record may be disclosed for a research purpose when the Department:
    (A) Has determined that the 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) Is consistent with the purpose for which the program was formed, which includes but is not limited to evaluating the safety of vaccines covered under the Program, (2) Cannot be reasonably accomplished with information in statistical form, and must be provided in an identifiable form to accomplish the research purpose, and
    (3) 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 of the record except: (a) In emergency circumstances affecting the health or safety of any individual,
    (b) 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 (c) When required by law; and
    (D) Has secured a written statement attesting to the recipient’s understanding of and willingness to abide by these provisions.

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

  • Storage: File folders and disks.
  • Retrievability: Retrieval is by (1) docket number assigned by the U.S. Court of Federal Claims, and (2) the petitioner and/or name of person vaccinated.
  • Safeguards:
  1. Authorized users: Access is limited to the System Manager and authorized HRSA/BHPr personnel responsible for administering the program. HRSA/BHPr will maintain a current list of authorized users.
  2. Physical safeguards: All files are stored in an electronic carriage filing system which can be locked and secured during non-work hours; disk packs and computer equipment are retained in areas where fire and safety codes are strictly enforced. All automated and non-automated documents are protected on a 24-hour basis in security areas. Security guards perform random checks of the physical security of the record storage area.
  3. Procedural safeguards: HRSA/BHPr has established stringent safeguards in line with the sensitivity of the records. These include: Transmitting records to consultants by Federal Express, United Parcel Service, or other courier service to ensure that a signature is required upon receipt of the records; escorting visitors into areas where records are maintained; utilizing passwords for computer access; and securing areas where records are stored. A password is required to access the terminal and the data set name controls the release of data only to authorized users. All users of personal information in connection with the performance of their jobs protect information from public view and from unauthorized personnel entering an unsupervised office.

Retention and disposal: The records shall be disposed of by shredding twenty-five years after the termination of all administrative and judicial proceedings, determined by a final adjudication. Upon written notification to the Government, the petitioner shall have the right to reclaim the original medical records submitted to the Government, after the final adjudication.

System manager(s) and address:

Associate Administrator for Health Professions, Bureau of Health Professions, Health Resources and Services Administration, 5600 Fishers Lane, Room 8-05, Rockville, MD 20857.

Notification procedure: Requests must be made to the System Manager at the above address.

Request in person: A subject individual who appears in person seeking access or disclosure of records relating to him/her shall provide his/her name, current address, and at least one piece of tangible identificaUon such as a driver’s license, passport, voter registration card, or union card. Identification papers with current photographs are preferred but not required. Additional identification may be requested when there is a request for access to records which contain an apparent discrepancy between information contained in the records and that provided by the individual requesting access to the record. No verification of identity shall be required where the record is one which is required to be disclosed under the Freedom of Information Act.

Requests by mail: To determine if a record exist about you, write to the System Manager. The request must contain the name and address of the individual, assigned court docket number (if known), and a written statement that the requester is the person he/she claims to be and that he/she understands that the request or acquisition of records pertaining to another individual, under false pretenses, is a criminal offense subject to a $5000 fine.

Requests by telephone: Since positive identification of the caller cannot be established, telephone requests are not honored.

Record access procedure: Same as notification procedures. Individuals may also request an accounting of disclosures that have been made of their records, if any.

Contesting record procedure: Contact the appropriate official at the address specified under Notification Procedures above and reasonably identify the record, specify the information being contested, and state the corrective action sought and the reason(s) for requesting the correction, along with supporting justification to show how the record is inaccurate, incomplete, untimely, or irrelevant.

Record source categories: Petitioner, petitioner’s legal representative, health care providers, and other interested persons.

Systems exempted from certain provisions of the Act: None.