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| [[Safety/Security]] | [[Research Compliance]] | '''[[Compliance]] ''' | [[Privacy/Information Security]] | [[Business Operations]] | [[Intellectual Property]]< br /><br />[[Compliance Program]] | [[Compliance Hotline]] | [[Investigations by Third Parties]] | [[Research Integrity ]] | [[Copyright]] | [[Export Control]] | [[Code of Conduct]] | [[Use of Human Anatomical Material]] | [[Clinical Trial Fee Billing Procedures]] | [[Contracts Policy]] | [[Conflict of Interest]]<br /><br /> POLICY NO: '''6109'''<br /> EFFECTIVE DATE: '''10/16/04'''<br /> REVISED DATE:<br /> REVIEWED DATE:<br />
== Purpose ==
Government investigators, regulatory agencies or other third parties may contact staff or arrive unannounced at UNMC or at the homes of staff members and seek interviews, documents, information or request to search the premises. The purpose of this policy is to establish procedures for an orderly response that protects the interests of UNMC and provides for appropriate cooperation. Examples of regulatory agency visits, investigations, or requests for information that are subject to this policy include but are not limited to the following:
* Routine or investigative visits by regulatory agencies such as the Department of Health and Human Services (DHHS), Food and Drug Administration (FDA), United States Department of Agriculture (USDA), Environmental Protection Agency (EPA), Office of Human Research Protections (OHRP), or Internal Revenue Service (IRS), on an announced or unannounced basis;
* Law enforcement visits, including local, state and federal
* Licensure investigations;
* Freedom of Information Act (FOIA) requests;
* Sunshine Act requests (allows citizens to request government agency meeting records);
* Subpoenas (including subpoena duces tecum for the inspection or production of documents).
== Procedures ==
#'''Regulatory Agency Visits'''
#* UNMC staff members who are notified of a visit by a regulatory agency should notify their supervisor, director and/or dean (as appropriate to the type of visit) and the Compliance Officer at 559-6767.
#* During the visit, the regulatory agency official(s) should be escorted at all times by an individual who is knowledgeable about the area(s) visited.
#* Most regulatory agency visits are permitted pursuant to state or federal law, and the regulator may request copies of documents to assess compliance without providing a subpoena. Staff who are unsure about whether documents should be provided to regulators should ask their supervisor, the Compliance Officer at 559-6767 or the Associate General Counsel for Health
Care at 559- 9801 for guidance.
#* Supervisory personnel and the Compliance Officer should be informed of any serious compliance issues that may arise during the visit as soon as possible, and shall be provided with reports of findings at the end of all visits.
#'''Investigations by Government Officials/Law Enforcement/Other Third Parties'''
#* If a UNMC staff member becomes aware of any contact by an agent, representative, investigator, auditor or attorney from any governmental agency, law enforcement agency, or other third party (hereinafter, "
Investigator"), the staff member should ask to see the Investigator's identification and business card for name and agency affiliation. If contact is by telephone, ask the Investigator to fax a business card or other identification. Ask for the investigator's agency name and phone number and call him/her back to verify identity.
#* Inquire as to the reason for the visit, if rationale has not already been provided.
#* Contact a supervisor, director or dean, and the Compliance Officer at 559-6767. If the Compliance Officer is unavailable, contact the Associate General Counsel for Health
Care at 559- 9801. The Compliance Officer and/or Associate General Counsel for Health Care shall notify the University of Nebraska Office of the Associate General Counsel of the investigation and coordinate with them as necessary.#* If the subject matter of the investigation is not in the staff member's area of responsibility, the Compliance Officer should be contacted, so the Investigator can be directed to the correct area.#* '''Subpoenas/Search Warrants'''. If the investigator asks to search a UNMC facility or obtain any documents from UNMC, ask if there is a subpoena or search warrant to be served; and if so, make a copy of the document. Immediately contact the Associate General Counsel for Health Care to review the subpoena or warrant to verify it is valid and to provide advice on responding to it. If he/she is unavailable, the University of Nebraska Office of the Associate General Counsel should be contacted to review the documents. The Compliance Officer and/or Associate General Counsel for Health Care shall escort the investigator, along with personnel familiar with the area to be searched.:If documents are subpoenaed, the records custodian for the documents shall be consulted if he/she is not already involved (i.e. Medical Records Department for patient information; Human Resources Department for employee information, Student Services for student information). The Information Technology Services Security Officer shall be contacted at 559-2545 if computer information, files or hardware is requested.:Individuals intending to serve subpoenas to employees for non-work-related matters should be instructed to report to the Human Resources Employee Relations Department to arrange service.#* '''Conditions of Search'''. If a search is conducted pursuant to a valid search warrant, the search shall be confined to the areas specified in the search warrant. If the Investigator attempts to enter areas not specified in the search warrant, staff should object. Staff shall remain with the Investigator at all times. If the search warrant is valid, the search may not be stopped. No staff member is required to speak to the Investigator other than to provide administrative assistance with the search and provide the documents specified in the warrant. Under no circumstances should staff obstruct or interfere with the search.#* '''Record of Search'''. During the search, staff shall keep a written record of areas searched and documents and items seized, including a summary of their content. Staff should ask the Investigator if he/she is willing to accept copies of documents instead of originals.#* '''Interviews'''. Staff members who shall be interviewed pursuant to an investigation may consult with the Associate General Counsel for Health Care before any requested interview. When responding to questions asked by Investigators, staff shall always tell the truth. If staff do not recall something or have no knowledge about the topic, they should say so. Staff should not guess or speculate. Staff should be very careful to answer questions completely, accurately, and concisely so that there will be no misunderstanding.#* '''Debriefing'''. After the Investigator departs the premises, staff involved in the investigation shall take part in a debriefing with the Compliance Officer and/or Associate General Counsel for Health Care. Reports of the investigation shall be provided to senior personnel as appropriate.#* '''After Hours'''. In the unlikely event that an Investigator requests information after hours, staff should contact the Associate General Counsel for Health Care or the Compliance Officer through the operator at 559-4000. <br /> For additional information, please contact the [mailto: firstname.lastname@example.org Compliance Officer].
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