The following guidelines regarding the response to government inquiries are
intended to avoid providing inaccurate or incomplete information to government
officials and to prevent unauthorized disclosure of information that may, among
other things, jeopardize our patients' rights to privacy.
Two agencies by statute are entitled to immediate access to information; the
Office of Inspector General of the United States Department of Health and Human
Services and state Medicaid Fraud Control Units. Proper identification must be
presented by officials of either of these agencies before access would be provided.
In all cases, when a request by personnel of either agency is made, the Compliance
Officer and the Office of Legal Management must be notified immediately and access
to the requested information should be delayed pending that notification and an
opportunity to take appropriate action.
Inspectors of the United States Food and Drug Administration (FDA) must present
appropriate credentials and a written note, but do not need a warrant in order
to inspect equipment, containers and so forth in facilities where food, drugs
and devices are held.
However, such inspection must be conducted at reasonable times, within reasonable
limits and in a reasonable manner.
FDA inspectors may also inspect records and files pertaining to prescription
drugs or restricted devices under certain circumstances, including, upon request
of an FDA official, all records and reports required to be kept or maintained
in connection with scientific investigation of the safety and effectiveness of
drugs and medical devices, including records relating to reports of adverse effects.
Upon notice that the FDA has reason to suspect the submission or maintenance
of improper records, including that adequate informed consent was not obtained,
investigators are required to permit FDA officers to inspect any copy records
that identify subjects. Authorized representatives or the FDA may also inspect
and copy records that identify subjects. Authorized representatives of the FDA
may also inspect and copy all records required to be prepared and maintained by
UMDNJ's IRB. In addition, if requested by an FDA officer or employee, UMDNJ must
permit that FDA officer or employee at all reasonable times and in a reasonable
manner to have access to, and to copy and verify, all records that UMDNJ must
maintain under the medical devices provisions of the Food, Drug and Cosmetics
Act relating to information that reasonably suggests that a device has or may
have caused or contributed to the death or serious illness of, or serious injury
to a patient, or other significant adverse device experience.
Other governmental agencies, including the Federal Bureau of Investigation,
the Drug Enforcement Administration, the United State Postal Inspector, the state
Attorney General, the county prosecutor, and local police departments, may look
at UMDNJ documents and other materials only by UMDNJ's consent or by proper legal
process.
Any UMDNJ employee who is approached by any other federal or state law enforcement
agency seeking information about any aspect of the operations of UMDNJ or the
job-related activities of any of UMDNJ's officers, employees or agents must notify
the Compliance Officer and Office of Legal management before turning over any
information. Upon receipt of any request for information, prior to providing the
information, you should (in addition to notifying the Compliance Officer), obtain
the name and organizational affiliation of all persons from whom a request for
access to information is received or to whom access is permitted. You should also
maintain a written record of each document to which access is given and keep a
detailed record of all telephone contacts made, including specifically the name
and affiliation of the parties to each conversation, the information requested,
and the response given during the conversation.
Specific federal and state confidentiality laws relating to medical records
pertaining to HIV/AIDS and substance abuse (controlled drugs and alcohol) and
to psychiatric records may limit the general authority of government investigators.
Employees should be certain that any disclosure of such records complies with
UMDNJ's policies and procedures.
