Inspections/Investigations by Third Parties - Revision history

Mhurlocker at 15:21, March 7, 2025

2025-03-07T15:21:09Z

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	<br />		<br />
	[[Compliance Program]] \| [[Compliance Hotline]] \| [[Inspections/Investigations by Third Parties]] \| [[Research Integrity]] \| [[Export Control]] \| [[Code of Conduct]] \| [[Use of Human Anatomical Material]] \| [[Clinical Research and Clinical Trial Professional and Technical Fee Billing]] \| [[Contracts]] \| [[Conflict of Interest]] \| [[Red Flag Identity Theft Prevention Program]] \| [[Principles of Financial Stewardship]] \| [[Human Tissue Use and Transfer]] \| [[Disclosing Foreign Support and International Activities]] \| [[Health Care Vendor Interactions]] \| [[Credit Hour Definition]] \| [[Whistleblower]] \| [[Electronic Digital Signatures and Records]] \| [[Utilizing Generative AI]]		[[Compliance Program]] \| [[Compliance Hotline]] \| [[Inspections/Investigations by Third Parties]] \| [[Research Integrity]] \| [[Export Control]] \| [[Code of Conduct]] \| [[Use of Human Anatomical Material]] \| [[Clinical Research and Clinical Trial Professional and Technical Fee Billing]] \| [[Contracts]] \| [[Conflict of Interest]] \| [[Red Flag Identity Theft Prevention Program]] \| [[Principles of Financial Stewardship]] \| [[Human Tissue Use and Transfer]] \| [[Disclosing Foreign Support and International Activities]] \| [[Health Care Vendor Interactions]] \| [[Credit Hour Definition]] \| [[Whistleblower]] \| [[Electronic Digital Signatures and Records]] \| [[Utilizing Generative AI\|UNMC AI Use Guidelines]]
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Mhurlocker at 19:41, March 6, 2025

2025-03-06T19:41:19Z

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	</table>		</table>
	<br />		<br />
	[[Compliance Program]] \| [[Compliance Hotline]] \| [[Inspections/Investigations by Third Parties]] \| [[Research Integrity]] \| [[Export Control]] \| [[Code of Conduct]] \| [[Use of Human Anatomical Material]] \| [[Clinical Research and Clinical Trial Professional and Technical Fee Billing]] \| [[Contracts]] \| [[Conflict of Interest]] \| [[Red Flag Identity Theft Prevention Program]] \| [[Principles of Financial Stewardship]] \| [[Human Tissue Use and Transfer]] \| [[Disclosing Foreign Support and International Activities]] \| [[Health Care Vendor Interactions]] \| [[Credit Hour Definition]] \| [[Whistleblower]] \| [[Electronic Digital Signatures and Records]]<br />		[[Compliance Program]] \| [[Compliance Hotline]] \| [[Inspections/Investigations by Third Parties]] \| [[Research Integrity]] \| [[Export Control]] \| [[Code of Conduct]] \| [[Use of Human Anatomical Material]] \| [[Clinical Research and Clinical Trial Professional and Technical Fee Billing]] \| [[Contracts]] \| [[Conflict of Interest]] \| [[Red Flag Identity Theft Prevention Program]] \| [[Principles of Financial Stewardship]] \| [[Human Tissue Use and Transfer]] \| [[Disclosing Foreign Support and International Activities]] \| [[Health Care Vendor Interactions]] \| [[Credit Hour Definition]] \| [[Whistleblower]] \| [[Electronic Digital Signatures and Records]] \| [[Utilizing Generative AI]]
			<br />
	<br />		<br />
	Policy No.: '''6109'''<br />		Policy No.: '''6109'''<br />

Mhurlocker: /* Additional Information */

2024-08-19T19:43:48Z

Additional Information

← Older revision		Revision as of 14:43, August 19, 2024
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	This page maintained by [mailto:~~dpanowic~~@unmc.edu ~~dkp~~].		This page maintained by [mailto:mhurlocker@unmc.edu mh].

Mhurlocker at 13:44, July 11, 2024

2024-07-11T13:44:23Z

← Older revision		Revision as of 08:44, July 11, 2024
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	Effective Date: '''10/16/04'''<br />		Effective Date: '''10/16/04'''<br />
	Revised Date: '''01/20/23'''<br />		Revised Date: '''01/20/23'''<br />
	Reviewed Date: '''01/20/23'''<br /><br \>		Reviewed Date: '''07/09/24'''<br /><br \>
	'''<big>Inspections and Investigations by Government Officials, Regulatory Agencies and Other Third Parties</big>'''<br />		'''<big>Inspections and Investigations by Government Officials, Regulatory Agencies and Other Third Parties</big>'''<br />
	== Purpose ==		== Purpose ==

Mhurlocker at 17:06, August 14, 2023

2023-08-14T17:06:17Z

← Older revision		Revision as of 12:06, August 14, 2023
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	</table>		</table>
	<br />		<br />
	[[Compliance Program]] \| [[Compliance Hotline]] \| [[Inspections/Investigations by Third Parties]] \| [[Research Integrity]] \| [[Export Control]] \| [[Code of Conduct]] \| [[Use of Human Anatomical Material]] \| [[Clinical Research and Clinical Trial Professional and Technical Fee Billing]] \| [[Contracts]] \| [[Conflict of Interest]] \| [[Red Flag Identity Theft Prevention Program]] \| [[Principles of Financial Stewardship]] \| [[Human Tissue Use and Transfer]] \| [[Disclosing Foreign Support and International Activities]] \| [[Health Care Vendor Interactions]] \| [[Credit Hour Definition]] \| [[Whistleblower]]<br />		[[Compliance Program]] \| [[Compliance Hotline]] \| [[Inspections/Investigations by Third Parties]] \| [[Research Integrity]] \| [[Export Control]] \| [[Code of Conduct]] \| [[Use of Human Anatomical Material]] \| [[Clinical Research and Clinical Trial Professional and Technical Fee Billing]] \| [[Contracts]] \| [[Conflict of Interest]] \| [[Red Flag Identity Theft Prevention Program]] \| [[Principles of Financial Stewardship]] \| [[Human Tissue Use and Transfer]] \| [[Disclosing Foreign Support and International Activities]] \| [[Health Care Vendor Interactions]] \| [[Credit Hour Definition]] \| [[Whistleblower]] \| [[Electronic Digital Signatures and Records]]<br />
	<br />		<br />
	Policy No.: '''6109'''<br />		Policy No.: '''6109'''<br />

Afaylor: updated Compliance Department link from dev1 to www

2023-03-30T20:12:04Z

updated Compliance Department link from dev1 to www

← Older revision		Revision as of 15:12, March 30, 2023
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	:* '''After Hours'''. In the unlikely event that an investigator requests information after hours, staff should contact the Office of the General Counsel, Varner Hall, 402-472-1201 or the Chief Compliance Officer through the operator at 402-559-4000.		:* '''After Hours'''. In the unlikely event that an investigator requests information after hours, staff should contact the Office of the General Counsel, Varner Hall, 402-472-1201 or the Chief Compliance Officer through the operator at 402-559-4000.
	==Additional Information==		==Additional Information==
	*[mailto:sarah.glodencarlson@unmc.edu Chief Compliance Officer], [https://~~dev1~~.unmc.edu/academicaffairs~~-lave~~/compliance/index.html Compliance Department], 402-559-9576 or 402-559-6767		*[mailto:sarah.glodencarlson@unmc.edu Chief Compliance Officer], [https://www.unmc.edu/academicaffairs/compliance/index.html Compliance Department], 402-559-9576 or 402-559-6767
	*[mailto:privacy@nebraskamed.com Privacy Officer], 402-559-5136		*[mailto:privacy@nebraskamed.com Privacy Officer], 402-559-5136
	*University General Counsel, Varner Hall, 402-472-1201		*University General Counsel, Varner Hall, 402-472-1201

Dpanowic at 18:40, January 20, 2023

2023-01-20T18:40:45Z

← Older revision		Revision as of 13:40, January 20, 2023
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	Policy No.: '''6109'''<br />		Policy No.: '''6109'''<br />
	Effective Date: '''10/16/04'''<br />		Effective Date: '''10/16/04'''<br />
	Revised Date: '''~~DRAFT 11~~/10/22'''<br />		Revised Date: '''01/20/23'''<br />
	Reviewed Date: <br /><br \>		Reviewed Date: '''01/20/23'''<br /><br \>
	'''<big>Inspections and Investigations by Government Officials, Regulatory Agencies and Other Third Parties</big>'''<br />		'''<big>Inspections and Investigations by Government Officials, Regulatory Agencies and Other Third Parties</big>'''<br />
	== Purpose ==		== Purpose ==

Dpanowic at 16:36, November 10, 2022

2022-11-10T16:36:55Z

← Older revision		Revision as of 11:36, November 10, 2022
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	Policy No.: '''6109'''<br />		Policy No.: '''6109'''<br />
	Effective Date: '''10/16/04'''<br />		Effective Date: '''10/16/04'''<br />
	Revised Date: '''DRAFT'''<br />		Revised Date: '''DRAFT 11/10/22'''<br />
	Reviewed Date: <br /><br \>		Reviewed Date: <br /><br \>
	'''<big>Inspections and Investigations by Government Officials, Regulatory Agencies and Other Third Parties</big>'''<br />		'''<big>Inspections and Investigations by Government Officials, Regulatory Agencies and Other Third Parties</big>'''<br />

Dpanowic at 16:27, November 10, 2022

2022-11-10T16:27:27Z

Dpanowic at 16:49, October 27, 2022

2022-10-27T16:49:44Z

← Older revision		Revision as of 11:49, October 27, 2022
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	</table>		</table>
	<br />		<br />
	[[Compliance Program]] \| [[Compliance Hotline]] \| [[Investigations by Third Parties]] \| [[Research Integrity]] \| [[Export Control]] \| [[Code of Conduct]] \| [[Use of Human Anatomical Material]] \| [[Clinical Research and Clinical Trial Professional and Technical Fee Billing]] \| [[Contracts]] \| [[Conflict of Interest]] \| [[Red Flag Identity Theft Prevention Program]] \| [[Principles of Financial Stewardship]] \| [[Human Tissue Use and Transfer]] \| [[Disclosing Foreign Support and International Activities]] \| [[Health Care Vendor Interactions]] \| [[Credit Hour Definition]] \| [[Whistleblower]]<br />		[[Compliance Program]] \| [[Compliance Hotline]] \| [[Inspections/Investigations by Third Parties]] \| [[Research Integrity]] \| [[Export Control]] \| [[Code of Conduct]] \| [[Use of Human Anatomical Material]] \| [[Clinical Research and Clinical Trial Professional and Technical Fee Billing]] \| [[Contracts]] \| [[Conflict of Interest]] \| [[Red Flag Identity Theft Prevention Program]] \| [[Principles of Financial Stewardship]] \| [[Human Tissue Use and Transfer]] \| [[Disclosing Foreign Support and International Activities]] \| [[Health Care Vendor Interactions]] \| [[Credit Hour Definition]] \| [[Whistleblower]]<br />
	<br />		<br />
	Policy No.: '''6109'''<br />		Policy No.: '''6109'''<br />

← Older revision		Revision as of 11:27, November 10, 2022
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	#* Any requests for information related to a patient, patient’s care or billing, also known as protected health information (PHI) pursuant to an investigation by a regulatory agency require notification of the Privacy Officer at 402-559-5136 or [mailto:privacy@nebraskamed.com Privacy Officer] prior to providing patient information.		#* Any requests for information related to a patient, patient’s care or billing, also known as protected health information (PHI) pursuant to an investigation by a regulatory agency require notification of the Privacy Officer at 402-559-5136 or [mailto:privacy@nebraskamed.com Privacy Officer] prior to providing patient information.
	#* 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.		#* 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 Chief Compliance Officer at 402-559-9576 or 402-559-6767 or the ~~Associate General Counsel '''''for Health Sciences (care~~ of the ~~University’s~~ General ~~Counsel’s office at~~ Varner Hall at 402-472-1201~~)'''''~~ for guidance.		#* 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 Chief Compliance Officer at 402-559-9576 or 402-559-6767 or the Office of the General Counsel, Varner Hall, 402-472-1201, for guidance.
	#* Supervisory personnel and the Chief 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.		#* Supervisory personnel and the Chief 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.
	#'''Inspections/Investigations by Government Officials/Law Enforcement/Other Third Parties'''		#'''Inspections/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 them back to verify identity.		#* 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 them back to verify identity.
	#* Inquire as to the reason for the visit if rationale has not already been provided.		#* Inquire as to the reason for the visit if rationale has not already been provided.
	#* Contact a supervisor, director or dean, and the Chief Compliance Officer at 402-559-9576 or 402-559-6767. If the Chief Compliance Officer is unavailable, contact the ~~Associate General Counsel '''''for Health Sciences (care~~ of the ~~University’s~~ General ~~Counsel’s office at~~ Varner Hall at 402-472-1201~~)'''''~~. The Chief Compliance Officer ~~and/or Associate General Counsel '''''for Health Sciences'''''~~ shall notify the ~~University of Nebraska~~ Office of the ~~Associate~~ General Counsel of the investigation and coordinate with them as necessary. Notify Nebraska Medicine when a patient care area is involved or could be involved.		#* Contact a supervisor, director or dean, and the Chief Compliance Officer at 402-559-9576 or 402-559-6767. If the Chief Compliance Officer is unavailable, contact the Office of the General Counsel, Varner Hall, 402-472-1201, for guidance. The Chief Compliance Officer shall notify the Office of the General Counsel, Varner Hall, 402-472-1201, of the investigation and coordinate with them as necessary. Notify Nebraska Medicine when a patient care area is involved or could be involved.
	#* In the case of a possible concern for safety or compliance investigation disruption, ~~Compliance~~ may contact public safety for assistance at 402-559-5111.		#* In the case of a possible concern for safety or compliance investigation disruption, compliance may contact public safety for assistance at 402-559-5111.
	#* If the subject matter of the investigation is not in the staff member's area of responsibility, the Chief Compliance Officer should be contacted, so the investigator can be directed to the correct area.		#* If the subject matter of the investigation is not in the staff member's area of responsibility, the Chief 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 Sciences'''''~~ to review the subpoena or warrant to verify it is valid and to provide advice on responding to it~~. If they are unavailable, the University of Nebraska Office of the Associate General Counsel should be contacted to review the documents~~. The Chief Compliance Officer and/or Associate General Counsel ~~'''''for Health Sciences'''''~~ shall escort the investigator, along with personnel familiar with the area to be searched.		#* '''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 Office of the General Counsel, Varner Hall, 402-472-1201, to review the subpoena or warrant, to verify it is valid and to provide advice on responding to it. The Chief Compliance Officer and/or Associate General Counsel shall escort the investigator, along with personnel familiar with the area to be searched.<br>

	If documents are subpoenaed, the records custodian for the documents shall be consulted if they are not already involved (i.e. [https://www.nebraskamed.com/patients/medical-records Medical Records Department] for patient information; Human Resources Department for employee information, Student Success for student information). The Information Technology Security Office shall be contacted at [https://support.security.unmc.edu https://support.security.unmc.edu] if computer information, files or hardware is requested.<br />		If documents are subpoenaed, the records custodian for the documents shall be consulted if they are not already involved (i.e. [https://www.nebraskamed.com/patients/medical-records Medical Records Department] for patient information; Human Resources Department for employee information, Student Success for student information). The Information Technology Security Office shall be contacted at [https://support.security.unmc.edu https://support.security.unmc.edu] if computer information, files or hardware is requested.<br />

	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.		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.		:* '''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 they are willing to accept copies of documents instead of originals. Staff should coordinate closely with General Counsel for direction, and specifically with the ~~'''''~~Director of University of Records~~'''''~~.		:* '''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 they are willing to accept copies of documents instead of originals. Staff should coordinate closely with General Counsel for direction, and specifically with the [mailto:jklintoe@nebraska.edu, Associate General Counsel and Director of University Records], 402-472-1201.
	:* '''Interviews'''. Staff members who shall be interviewed pursuant to an investigation may consult with the ~~Associate~~ General Counsel ~~'''''~~for ~~Health Sciences'''''~~ 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.		:* '''Interviews'''. Staff members who shall be interviewed pursuant to an investigation may consult with the Office of the General Counsel, Varner Hall, 402-472-1201, for guidance 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 Chief Compliance Officer and/or ~~Associate~~ General Counsel ~~'''''for Health Sciences'''''~~. Reports of the investigation shall be provided to senior personnel as appropriate.		:* '''Debriefing'''. After the investigator departs the premises, staff involved in the investigation shall take part in a debriefing with the Chief Compliance Officer and/or Office of the General Counsel, Varner Hall, 402-472-1201. 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 Sciences'''''~~ or the Chief Compliance Officer through the operator at 402-559-4000.		:* '''After Hours'''. In the unlikely event that an investigator requests information after hours, staff should contact the Office of the General Counsel, Varner Hall, 402-472-1201 or the Chief Compliance Officer through the operator at 402-559-4000.
	==Additional Information==		==Additional Information==
	*[mailto:sarah.glodencarlson@unmc.edu Chief Compliance Officer], 402-559-9576 or 402-559-6767		*[mailto:sarah.glodencarlson@unmc.edu Chief Compliance Officer], [https://dev1.unmc.edu/academicaffairs-lave/compliance/index.html Compliance Department], 402-559-9576 or 402-559-6767
	*[mailto:privacy@nebraskamed.com Privacy Officer], 402-559-5136		*[mailto:privacy@nebraskamed.com Privacy Officer], 402-559-5136
	*~~Associate~~ General Counsel ~~'''''for Health Sciences~~, ~~(care of the University’s General Counsel’s office at~~ Varner Hall at 402-472-1201~~)'''''~~		*University General Counsel, Varner Hall, 402-472-1201
	~~'''~~*Director of University of Records~~??'''~~		*[mailto:jklintoe@nebraska.edu, Associate General Counsel and Director of University Records], 402-472-1201
	*[https://support.security.unmc.edu Office of Information Security]		*[https://support.security.unmc.edu Office of Information Security]
	*[https://nebraska.edu/-/media/unca/docs/offices-and-policies/policies/executive-memorandum/policy-on-records-requests-and-contacts-by-law-enforcement.pdf University of Nebraska Executive Memorandum 43], Policy on Records Requests and Contacts by Law Enforcement		*[https://nebraska.edu/-/media/unca/docs/offices-and-policies/policies/executive-memorandum/policy-on-records-requests-and-contacts-by-law-enforcement.pdf University of Nebraska Executive Memorandum 43], Policy on Records Requests and Contacts by Law Enforcement