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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)
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To determine eligibility of petitioners to
receive compensation under the National Vaccine
Injury Compensation Program.
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To compensate successful petitioners in the
amount determined by the court.
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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.
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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.
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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.
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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.
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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.
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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.
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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:
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Storage:File
folders and disks.
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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.
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Safeguards:
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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.
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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.
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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:
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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.
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