University of Nebraska Medical Center

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Policy No.: '''8000'''<br />
Policy No.: '''8000'''<br />
Effective Date: '''11/01/06'''<br />
Effective Date: '''11/01/06'''<br />
Revised Date: '''01/02/14'''<br />
Revised Date: '''DRAFT<br />
Reviewed Date: '''01/02/14'''<br />  
Reviewed Date: '''07/18/16'''<br />  
<br />
<br />
<big>'''Compliance Program Policy'''</big>
<big>'''Compliance Program Policy'''</big>
== Basis for Policy ==
== Basis for Policy ==
The University of Nebraska Medical Center (UNMC) shall comply with all applicable federal, state and local laws and regulations and University of Nebraska and UNMC Policies and Procedures.
The University of Nebraska Medical Center (UNMC) Compliance Program consistent with UNMC Code of Conduct, UNMC Policy No. 8006, [[Code of Conduct]], UNMC Faculty, staff, and students are expected to comply with: all applicable federal, state and local laws; all relevant regulations; and University of Nebraska and UNMC Policies and Procedures. The purpose of the Compliance Program and Committee is to identify UNMC’s compliance risks, as well as make recommendations and implement solutions, policies, procedures and standards of conduct to ensure that UNMC complies with all applicable federal, state and local laws and regulations. In support of this purpose, UNMC’s Compliance Program will designate a compliance officer and compliance committee whose responsibilities will include the following: to conduct effective training and education, develop effective lines of communication, and conduct internal monitoring and auditing for enforcement of policies and procedures.
== Compliance Program Structure ==
== Compliance Program Structure ==
===Associate Vice Chancellor for Compliance===
The Associate Vice Chancellor for Compliance reports directly to the Vice Chancellor of Academic Affairs and is responsible for overseeing the development and coordination implementation of policies, procedures and practices necessary to effect compliance with federal, state, and local laws and regulations.
===Compliance Officer===
===Compliance Officer===
The Compliance Officer is responsible for overseeing the development of and coordinating the implementation of policies, procedures and practices necessary to effect compliance with federal, state, and local laws and regulations. The compliance officer shall report to the Vice Chancellor for Academic Affairs, but has the authority to communicate directly with the Chancellor or Vice Chancellors for Business and Finance and Research on compliance matters. The Compliance Officer shall:
The Compliance Officer shall report to the Associate Vice Chancellor of Academic Affairs for Compliance, but has the authority to communicate directly with the Chancellor or Vice Chancellors for Academic Affairs, Business and Finance and Research or others on compliance matters which include, but are not limited to:  
* analyze laws and regulations applicable to UNMC and coordinate with subject matter experts to ensure compliance with them.
*analyze laws and regulations applicable to UNMC and coordinate with subject matter experts to ensure compliance;
* monitor day-to-day compliance activities.
*monitor day-to-day compliance activities;
* establish compliance audits of risk areas and develop corrective action plans in response to identified deficiencies.
*develop, initiate, maintain and revise policies and procedures for compliance with laws and regulations applicable to UNMC;
* oversee visits by regulatory agencies and responses to inquiries and investigations.
*oversee visits by regulatory agencies and responses to inquiries and investigations;
* make periodic reports regarding compliance matters directly to the UNMC Chancellor’s Council.
*report compliance matters directly to the UNMC Chancellor’s Council;
* coordinate with the Associate General Counsel for Health Care on legal issues.
*coordinate with the Associate General Counsel for Health Care on legal issues;
* respond to compliance hotline calls.
*coordinate with the Director of Internal Audit;
* chair the compliance committee.
*coordinate with the Information Security Officer;
*respond to compliance hotline calls;
*disseminate information to support compliance and training on the Compliance Program;
*chair the compliance committee.  
===Compliance Committee===
===Compliance Committee===
The Compliance committee shall support the Compliance Officer in meeting his/her responsibilities. The committee shall analyze UNMC’s risk areas and oversee the monitoring of internal audits and external investigations. The Compliance Committee shall be composed of representatives from the following departments:
The Compliance Committee assists the Compliance Officer with the above duties and helps manage the Compliance Program. The Compliance Committee shall seek to leverage the compliance efforts of each area and avoid duplication of effort.  The Compliance Committee shall analyze UNMC’s key risk areas, and monitor and promote compliance. The Compliance Committee shall serve to oversee, monitor and manage risks as identified by the Internal Audit Director’s annual audit plan as well as data generated through monitoring and individual reporting.  
* Associate General Counsel for Health Care
* College of Dentistry
* College of Medicine
* College of Nursing
* College of Pharmacy
* College of Public Health
* Comparative Medicine/Institutional Animal Care and Use Committee (IACUC)
* Compliance
* Eppley Institute
* Facilities Management
* Financial Compliance
* Human Resources
* Information Technology Services
* Institutional Review Board (IRB)
* Intellectual Property
* Munroe-Meyer Institute
* Sponsored Programs Accounting
* Sponsored Programs Administration
* Student Services
* The Nebraska Medical Center
* UNMC Physicians
===Compliance Committee Representatives ===
Compliance Committee representatives shall assist the Compliance Office with communicating compliance policies and procedures and other information within their respective units. The Compliance Committee shall meet no less than quarterly. The Compliance Office shall complete meeting minutes and maintain them on file for no less than seven years. The meeting minutes shall be confidential. Meeting minutes shall be distributed to committee members, vice chancellors, college deans and executive directors to inform UNMC leadership about compliance activities.
===Compliance Hotline===
A compliance hotline has been established to provide individuals with an additional communication channel to report compliance concerns. The [http://mailto:tscrogin@unmc.edu Compliance Officer] shall investigate concerns and take corrective action in response to identified issues. For additional information, see UNMC Policy No. 8001, [[Compliance Hotline]].


The Compliance Committee shall meet no less than quarterly. The Compliance Committee shall be composed of at least the following representatives who shall be responsible for the overseeing compliance and assist the Compliance Officer with managing the Compliance Program:
*Compliance Officer
*UNMC Legal Counsel
*Human Resources Director
*Information Security Officer
*Institutional Review Board
*Intellectual Property Director
*Internal Audit Director
*Nebraska Medicine Compliance Officer
*Controller
*Sponsored Programs Administration
*Director of Procurement
The Compliance Committee or Compliance Officer may expect reports at a minimum annually from certain representatives and/or others to address compliance issues as necessary, to develop policies related to compliance, establish compliance training programs, assist with identifying areas of potential compliance vulnerabilities, assist with understanding the compliance risks and related regulations and laws, assist with response to alleged violation of rules, regulations, policies, procedures and other functions as needed to enforce this policy. Those representatives would be from the following areas: NU Director of Internal Audit, Biosafety, Chemical Safety, College of Dentistry, College of Medicine, College of Nursing, College of Pharmacy, College of Public Health, College of Allied Health, Comparative Medicine/Institutional Animal Care and Use Committee, Eppley Institute/Fred & Pamela Buffett Cancer Center, Facilities Management, Munroe-Meyer Institute, Radiation Safety, Safety, Student Services, or other as necessary. <br />
==Compliance Responsibilities==
[[http://www.unmc.edu/academicaffairs/compliance/areas/ Compliance Areas]]
Compliance responsibilities shall be established per UNMC and/or Board of Regents policies and procedures linked and referenced below:
{| class="wikitable sortable"
|-
! Research Compliance Header text
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| Example || Example
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| Example || Example
|-
| Example || Example
|-
| Example || Example
|-
| Example || Example
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| Example || Example
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| Example || Example
|}
===Code of Conduct===
===Code of Conduct===
The UNMC Code of Conduct applies to all UNMC faculty, staff, and students, and guides them in carrying out daily activities within appropriate ethical and legal standards. UNMC Policy No. 8006, [[Code of Conduct]], codifies UNMC’s commitment to full compliance with all federal, state, and local regulatory requirements and mandates that the UNMC Community abide by the Code.
The UNMC Code of Conduct applies to all UNMC faculty, staff, and students, and guides them in carrying out daily activities within appropriate ethical and legal standards. UNMC Policy No. 8006, [[Code of Conduct]], codifies UNMC’s commitment to full compliance with all federal, state, and local regulatory requirements and mandates that the UNMC Community abide by the Code.
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