University of Nebraska Medical Center

Compliance Program

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Policy No.: 8000
Effective Date: 11/01/06
Revised Date: 07/09/24
Reviewed Date: 07/09/24
Compliance Program Policy

Basis for Policy

The purpose of the Compliance Program and Committee is to identify UNMC’s key 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; and University of Nebraska and UNMC Policies and Procedures. In support of this purpose, UNMC’s Compliance Program will designate a chief compliance officer and a compliance committee whose responsibilities will include the following: to provide for or conduct effective training and education, develop effective lines of communication, and conduct internal monitoring and reviews for adherence to compliance training and conflict of interest policies and procedures. The University of Nebraska Medical Center (UNMC) Compliance Program consistent with UNMC Policy No. 8006, Code of Conduct, mandates that all UNMC faculty, staff, and students comply with: all applicable federal, state and local laws; all relevant regulations; and University of Nebraska and UNMC Policies and Procedures.

Compliance Program Structure

 

Senior Vice Chancellor for Academic Affairs

The Senior Vice Chancellor for Academic Affairs is responsible for overseeing the development and implementation of the policies, procedures and practices necessary to effect compliance with federal, state, and local laws and regulations; and University of Nebraska and UNMC Policies and Procedures.

Chief Compliance Officer

The Chief Compliance Officer shall report to the Senior Vice Chancellor for Academic Affairs, but has the authority to communicate directly with the Chancellor or Vice Chancellors for Academic Affairs, Business and Finance, Research, Deans, the Audit, Risk and Compliance Committee of the Board of Regents or others on compliance matters, which include, but are not limited to:

  • coordinate with subject matter experts to analyze laws and regulations applicable to UNMC to ensure compliance;
  • monitor day-to-day compliance activities;
  • 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;
  • report compliance matters directly to the UNMC Chancellor’s Council;
  • coordinate with the Associate General Counsel on legal issues;
  • coordinate with the Director of Internal Audit and Advisory Services;
  • coordinate with the Information Security Officer;
  • coordinate with the University Compliance Officer and other campus compliance officers;
  • respond to compliance hotline calls;
  • participate on the University Compliance Council;
  • disseminate information to support compliance and training on the Compliance Program; and
  • chair the Compliance Committee.

Compliance Committee

The Compliance Committee assists the Chief 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 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 Chief Compliance Officer with managing the Compliance Program:

  • Chief Compliance Officer
  • Associate General Counsel
  • Export Control Compliance Officer
  • Human Resources Director
  • Information Security Officer
  • Chair of the Institutional Review Board or Compliance designee
  • Executive Director, Environmental Health & Safety
  • Intellectual Property Director
  • Director Internal Audit and Advisory Services
  • Nebraska Medicine Compliance Officer or Compliance Representative for Nebraska Medicine
  • Privacy Officer
  • Controller
  • Financial Compliance and Cost Analysis
  • Sponsored Programs Administration
  • Sponsored Programs Accounting
  • Procurement
  • Chief Student Affairs Officer
  • Library
  • Comparative Medicine/IACUC Director
  • Institutional Biosafety Administration

The Compliance Committee or Chief Compliance Officer may request reports annually from certain representatives and others to address compliance issues as necessary. The purpose of the reports will be 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; and
  • assist with response to alleged violation of rules, regulations, policies, procedures, and other functions as needed to enforce this policy.

Representatives would be from the following areas:

  • NU Director of Internal Audit and Advisory Services
  • Biosafety
  • Child Health Research Institute (CHRI)
  • College of Dentistry
  • College of Medicine
  • College of Nursing
  • College of Pharmacy
  • College of Public Health
  • College of Allied Health Professions
  • Graduate Studies
  • UNMC Physicians
  • Comparative Medicine/Institutional Animal Care and Use Committee
  • Eppley Institute/Fred & Pamela Buffett Cancer Center
  • Facilities Management
  • Munroe-Meyer Institute
  • Environmental Health & Safety
  • Student Success
  • Others as necessary

Compliance Responsibilities

Compliance Areas
Compliance responsibilities shall be established per UNMC and/or Board of Regents policies and procedures linked and referenced below:

Research Compliance
Code of Conduct UNMC Policy No. 8006, Code of Conduct
IRB Institutional Review Board https://www.unmc.edu/ibc/
IACUC Institutional Animal Care and Use Committee, BOR Policy 3.2.8
Conflict of Interest UNMC Policy No. 1049, Outside Employment, UNMC Policy No. 8010, Conflict of Interest, UNMC Policy No. 8015, Health Care Vendor Interactions
Clinical Trial Billing UNMC Policy No. 8008, Clinical Trial Professional and Technical Fee Billing
Research Integrity UNMC Policy No. 8003, Research Integrity
Sponsored Programs Administration, Sponsored Programs Accounting and Financial Compliance & Cost Analysis UNMC Policy No. 3001, Sponsored Programs, UNMC Policy No. 6100, Sponsored Programs Costing, UNMC Policy No. 6102, Institutional Base Salary, UNMC Policy No. 6104, Sponsored Project Cost Share, UNMC Policy No. 6105, Effort Certification, UNMC Policy No. 6106, Cost Transfer, UNMC Policy No. 6107, Service Center, UNMC Policy No. 6108, Subrecipient, UNMC Policy No. 6110, On-Campus and Off-Campus Indirect Cost Rates on Federally Sponsored Projects
Environmental and Safety Compliance
Safety UNMC Environmental Health & Safety Department, UNMC Policy No. 2000, Safety
Radiation Safety UNMC Environmental Health & Safety Department
Bloodborne Pathogens Infection Control, UNMC Policy No. 2004, Bloodborne Pathogens Exposure
Biosafety Institutional Biosafety Committee, UNMC Policy No. 2005, Waste Handling
Chemical Safety UNMC Environmental Health & Safety Department, UNMC Hazardous Material/Dangerous Goods (HM/DG) Shipping Plan
Security UNMC Campus Security
Intellectual Property
Copyright UNMC Policy No. 6036, Reproducing Copyrighted Materials
Privacy and Information Security
Privacy, Confidentiality, and Information Security UNMC Policy No. 6045, Privacy, Confidentiality and Information Security
Use and Disclosure of Protected Health Information UNMC Policy No. 6054, Use and Disclosure of Protected Health Information
Retention/Destruction/Disposal of Private/Confidential Information UNMC Policy No. 6056, Retention and Destruction/Disposal of Private and Confidential Information
Other
Clinical Compliance See Institute or College specific policies or refer to Nebraska Medicine Policies and Procedures Manual
Computer Use and Information Security UNMC Policy No. 6051, Computer Use and Electronic Information Security
Export Control UNMC Policy No. 8005, Export Control, UNMC Policy No. 8014, Disclosing Foreign Support and International Activities
Human Resources Human Resources
Internal Audit University of Nebraska Internal Audit Charter and UNMC Internal Audit and Advisory Services Webpage
Student Success Student Success, UNMC CourseLeaf Catalog Compliance Matrix, FERPA Information
Title IX UNMC Policy No. 1099, Non-Discrimination and Harassment, UNMC Policy No. 1107, Sexual Misconduct
Family Educational Rights and Privacy Act (FERPA) Student Policies, FERPA Information
False Claims Act Contact the Chief Compliance Officer (see also the UNMC Compliance Hotline, 1-844-384-9584 or www.nebraska.ethicspoint.com), False Claims Act 31 U.S.C. §§ 3729-3733
Foreign Corrupt Practices Act Contact the Chief Compliance Officer (see also the UNMC Compliance Hotline, 1-844-384-9584 or www.nebraska.ethicspoint.com), Foreign Corrupt Practices Act (FCPA) 15 U.S.C. §§ 78dd-1, et seq.

Compliance Committee Meetings

The purpose of Compliance Committee meetings shall be to analyze, assess, manage, coordinate, and develop corrective action(s) related to compliance risks identified for the purpose of compliance with UNMC’s Code of Conduct, University of Nebraska and UNMC Policies and Procedures.

The Compliance Office shall complete meeting minutes and maintain them on file for no less than seven years. The draft 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 UNMC compliance hotline (1-844-384-9584 or www.nebraska.ethicspoint.com) has been established to provide individuals with an additional communication channel to report compliance concerns. The Chief Compliance Officer shall investigate concerns and take corrective action in response to identified issues. For additional information, see UNMC Policy No. 8001, Compliance Hotline.

Compliance Training

All University of Nebraska Medical Center employees (including visitors and non-faculty volunteers), students (including visiting students and visitors), and faculty (including but not limited to courtesy, adjunct faculty, visitors and volunteers) must be knowledgeable of and comply with laws and regulations related to their duties or field of study as determined by the Chief Compliance Officer and Compliance Committee.

Mandatory compliance training is required of UNMC staff and students. All UNMC invited visitors on campus for seven (7) or greater days (does not have to be consecutive), have access to UNMC software/databases or access to the UNMC Campus (ID Badge) must complete all mandatory compliance training required of UNMC faculty, staff and students. It is the individual's responsibility to complete the compliance training requirements listed at https://info.unmc.edu/policies/compliance/training-requirements/index.html and assigned via the UNMC Learning Platform. Failure to complete the training requirements will be grounds for corrective action up to and including dismissal or termination of employment. Delinquency notices will be sent according to the guidelines below:

Days Overdue (days past deadline date) Employees Students
30 Days E-mail/verbal notice from unit management E-mail/verbal notice from Dean’s office
60 Days Communication from Human Resources Records placed on hold
90 Days Notification to Dean, access removed from all UNMC resources except Canvas until training has been completed

Statement of Understanding

All employees and students shall sign a Statement of Understanding at the beginning of employment/start of school and annually thereafter, documenting that they have read, understand and agree to adhere to policies on: code of conduct, non-discrimination, sexual harassment; privacy and information security; and drug-free workplace.

Additional Information


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