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POLICY NO: 8000<br />
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EFFECTIVE DATE: 11/01/06<br />
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REVISED DATE:<br />
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REVIEWED DATE: 11/01/06<br />
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<td style="padding:0.5em; background-color:white; line-height:0.95em; border:solid 2px #A3B1BF; border-bottom:0; font-weight:bold;" width="20">[[Compliance]]</td>
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[[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]] | [[Electronic Digital Signatures and Records]]
<br /><br />
Policy No.: '''8000'''<br />
Effective Date: '''11/01/06'''<br />
Revised Date: '''07/09/24'''<br />
Reviewed Date: '''07/09/24''' <br />
<big>'''Compliance Program Policy'''</big>
<big>'''Compliance Program Policy'''</big>
== 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 ==
[[File:Compliance-flowchart-8-5-2020.jpg]]
===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:


=== Basis for Policy ===
*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.<br />


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.<br />
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==
[https://www.unmc.edu/academicaffairs/compliance/areas/ Compliance Areas]<br />
Compliance responsibilities shall be established per UNMC and/or Board of Regents policies and procedures linked and referenced below:
{| class="wikitable"
|-
|'''Research Compliance'''||
|-
| Code of Conduct || UNMC Policy No. 8006, [[Code of Conduct]]
|-
| IRB || [https://www.unmc.edu/irb/ Institutional Review Board] https://www.unmc.edu/ibc/
|-
| IACUC || [https://info.unmc.edu/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, [https://wiki.unmc.edu/index.php/Subrecipient_Policy Subrecipient], UNMC Policy No. 6110, [[On-Campus and Off-Campus Indirect Cost Rates on Federally Sponsored Projects]]
|-
| '''Environmental and Safety Compliance'''||
|-
| Safety || [https://unmc.edu/ehs/safety/ UNMC Environmental Health & Safety Department], UNMC Policy No. 2000, [[Safety]]
|-
| Radiation Safety || [https://www.unmc.edu/ehs/ UNMC Environmental Health & Safety Department]
|-
| Bloodborne Pathogens || [https://univnebrmedcntr.sharepoint.com.mcas.ms/sites/infectioncontrolepid/SitePages/Home%20Page.aspx Infection Control], UNMC Policy No. 2004, [[Bloodborne Pathogens Exposure]]
|-
| Biosafety || [https://www.unmc.edu/ibc/ Institutional Biosafety Committee], UNMC Policy No. 2005,  [https://www.unmc.edu/ehs/biosafety/biohazard-waste/index.htmlBiohazardous Waste Handling]
|-
| Chemical Safety || [https://www.unmc.edu/ehs/ UNMC Environmental Health & Safety Department], [https://www.unmc.edu/ehs/_documents/HMDGShippingPlan.pdf UNMC Hazardous Material/Dangerous Goods (HM/DG) Shipping Plan]


=== Compliance Program Structure ===
|-
 
| Security || [https://info.unmc.edu/safety/campus-security/index.html UNMC Campus Security]
'''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:
|-
 
| '''Intellectual Property''' ||
|-
* analyze laws and regulations applicable to UNMC and coordinate with subject matter experts to ensure compliance with them.
| Copyright || UNMC Policy No. 6036, [[Reproducing Copyrighted Materials]]
*  monitor day-to-day compliance activities.
|-
*    establish compliance audits of risk areas and develop corrective action plans in response to identified deficiencies.
| '''Privacy and Information Security'''||
*  oversee visits by regulatory agencies and responses to inquiries and investigations.
|-
*  make periodic reports regarding compliance matters directly to the UNMC Chancellor’s Council.
| Privacy, Confidentiality, and Information Security|| UNMC Policy No. 6045, [https://wiki.unmc.edu/index.php/Privacy/Confidentiality Privacy, Confidentiality and Information Security]
*  coordinate with the Associate General Counsel for Health Care on legal issues.
|-
*    respond to compliance hotline calls.
| Use and Disclosure of Protected Health Information|| UNMC Policy No. 6054, [[Use and Disclosure of Protected Health Information]]
*    chair the compliance committee.<br />
|-
<br />
| Retention/Destruction/Disposal of Private/Confidential Information|| UNMC Policy No. 6056, [https://wiki.unmc.edu/index.php/Retention_and_Destruction/Disposal_of_Private_and_Confidential_Information Retention and Destruction/Disposal of Private and Confidential Information]
'''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:
|-
 
| '''Other''' ||
|-
|Clinical Compliance || See Institute or College specific policies or refer to [https://now.nebraskamed.com/policies-and-procedures-manual/ Nebraska Medicine Policies and Procedures Manual]
 
|-
Associate General Counsel for Health Care
| Computer Use and Information Security || UNMC Policy No. 6051, [https://wiki.unmc.edu/index.php/Computer_Use/Electronic_Information 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 || [https://www.unmc.edu/human-resources/index.html Human Resources]
College of Dentistry
|-
 
| Internal Audit || University of Nebraska Internal Audit Charter and [https://nebraska.edu/offices-policies/internal-audit-and-advisory-services UNMC Internal Audit and Advisory Services Webpage]
|-
| Student Success || [https://www.unmc.edu/student-success/ Student Success], [https://catalog.unmc.edu/ UNMC CourseLeaf Catalog] [https://info.unmc.edu/policies/compliance/matrix.html Compliance Matrix], [https://www.unmc.edu/student-success/academic-records/ferpa.html FERPA Information]
 
|-
College of Medicine
| Title IX || UNMC Policy No. 1099, [[Non-Discrimination and Harassment]], UNMC Policy No. 1107, [[Sexual Misconduct]]
 
|-
| Family Educational Rights and Privacy Act (FERPA) || [https://wiki.unmc.edu/index.php/Student_Policies Student Policies], [https://www.unmc.edu/student-success/academic-records/ferpa.html 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), [https://www.justice.gov/civil/false-claims-act False Claims Act 31 U.S.C. §§ 3729-3733]
College of Nursing
|-
 
| Foreign Corrupt Practices Act || Contact the Chief Compliance Officer (see also the UNMC Compliance Hotline, 1-844-384-9584 or www.nebraska.ethicspoint.com), [https://www.justice.gov/sites/default/files/criminal-fraud/legacy/2012/11/14/fcpa-english.pdf Foreign Corrupt Practices Act (FCPA) 15 U.S.C. §§ 78dd-1, et seq.]
|}
 
College of Pharmacy
 
 
Comparative Medicine
 
 
Compliance
 
 
Eppley Institute
 
 
Facilities Management
 
 
Financial Compliance
 
 
Human Resources
 
 
Information Technology Services
 
 
Institutional Animal Care and Use Committee (IACUC)
 
 
Institutional Review Board (IRB)
 
 
Intellectual Property
 
 
Munroe-Meyer Institute
 
 
Sponsored Programs Accounting
 
 
Sponsored Programs Administration
 
 
The Nebraska Medical Center


==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.


UNMC Physicians <br />
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.
<br />
==Compliance Hotline==
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.
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.


'''Compliance Hotline'''. A compliance hotline has been established to provide individuals with an additional communication channel to report compliance concerns. The Compliance Officer shall investigate concerns and take corrective action in response to identified issues.
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:


For additional information, see UNMC Policy No. 8001, Compliance Hotline Policy.<br />
{| class="wikitable" style ="text-align:center"
<br />
'''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, UNMC 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.<br />
<br />
'''False Claims Act'''.  The False Claims Act is a federal law that provides that whoever knowingly submits to the federal government a false claim for payment, or creates a false record in support of a claim for payment, or knowingly retains the proceeds of a false claim for payment submitted to the government shall be liable for a civil penalty in the amount of $5,500 to $11,000 per claim, and three times the actual damages sustained by the government.
 
The Federal False Claims Act contains qui tam, or whistleblower provisions that allow citizens with evidence of fraud against government contracts and programs to sue, on behalf of the government, in order to recover the funds. In compensation for the risk and effort of filing a qui tam case, the citizen whistleblower or “relator” may be awarded a portion of the funds recovered, typically between 15 and 25 percent.
 
While the False Claims Act covers fraud involving any federally funded contract or program, in the health care area it has been applied to the Medicare and Medicaid programs, and also to federal research grants. Examples of health care-related False Claims Act violations are: 1) a health care provider bills Medicare for services that were not performed or that were unnecessary; and 2) a federal grant recipient charges the Government for costs not related to the grant.
 
In addition to the Federal False Claims Act, Nebraska has a False Medicaid Claims Act (Neb. Rev. Statute 68-1073) that provides that any person who presents a false Medicaid claim is subject to civil penalties of not more than ten thousand dollars and damages in the amount of three times the amount of the false claim submitted to the state. The Nebraska False Medicaid Claims Act does not contain qui tam relator provisions.
 
Any individual who suspects that potential False Claims Act violations may have occurred at UNMC should contact the Compliance Officer or contact the compliance hotline at 1-866-568-5430. See UNMC Policy No. 8001, Compliance Hotline. Individuals are encouraged to report concerns. Retribution against individuals raising concerns is prohibited.<br />
<br />
Compliance areas impacting the UNMC mission include but are not limited to the following:
 
A)  '''Research Compliance'''
 
Human Subjects: Institutional Review Board (IRB)
 
The UNMC IRB shall review and approve all human subject research conducted by the faculty, students, staff, or other representatives of the University of Nebraska Medical Center and The Nebraska Medical Center, when the research is part of their institutional responsibilities. In addition, the UNMC IRB shall review and approve all human subject research conducted by anyone on the premises of UNMC and the Nebraska Medical Center, including its community based clinics.
 
The UNMC IRB, which is administratively housed within the Office of Regulatory Affairs (ORA), exercises its authority in compliance with DHHS regulations at 45 CFR 46, and FDA regulations at 21 CFR 50 and 56.  This authority includes review and approval of exempt research under 45 CFR 46.101 (b); research which qualifies for expedited review under 45 CFR 46.110 and 21 CFR 56.110; and research which requires review by the full IRB.
 
Further information can be obtained through the UNMC IRB website at http://www.unmc.edu/spa/index.cfm?L1_ID=12&CONREF=149.
 
 
Animal Care: Institutional Animal Care and Use Committee (IACUC)
 
The UNMC IACUC shall review and approve all animal subject research conducted by the faculty, students, staff, or other representatives of the University of Nebraska Medical Center and University of Nebraska at Omaha, when the research is part of their institutional responsibilities. In addition, the UNMC IACUC shall review and approve all animal subject research conducted by anyone on the premises of UNMC and UNO.
 
The UNMC IACUC, which is administratively housed within the Office of Regulatory Affairs (ORA), exercises its authority in compliance with the Animal Welfare Act Regulations at 9 CFR 1-2, and the Public Health Service Policy on Humane Care and Use of Laboratory Animals, and the Guide for the Care and Use of Laboratory Animals.
 
Further information can be obtained through the UNMC IACUC website at http://www.unmc.edu/iacuc/.<br />
<br />
B)    '''Sponsored Programs'''
 
UNMC, through its Sponsored Programs offices, is responsible for ensuring that the institution is in compliance with the Federal Regulations of the Office of Management and Budget (OMB) Circulars A-21, A-110, and A-133 to maintain the integrity of accounting and administrative information.
 
The Project Director/Principal Investigator of a sponsored project is responsible for ensuring the integrity of the financial, administrative and technical information provided to the Sponsored Programs offices and/or the General Accounting Office.
 
Sponsored programs management involves both Sponsored Programs Administration (pre-award) and Sponsored Programs Accounting (post-award).
 
i)    Sponsored Programs Administration (SPA)
 
SPA is the official signature authority of UNMC for sponsored program grants and contracts (Contracts with the State of Nebraska require signature of the Vice Chancellor Business and Finance). SPA offers guidance and assistance from proposal development through award closeout. SPA performs the following functions in support of compliance:
 
Supports Pre-Award Activities by advising and assisting faculty and administrators in completing external applications based on the policies and procedures of the university and sponsors, negotiating final terms for government and non-profit grants, contracts and subcontracts, supporting, reviewing and approving budgets and applications to outside sponsors.
 
Authorizes Awards by establishing accounts and setting up budgets for all federal, non-profit and for-profit awarded grants and contracts based on sponsor regulation, processing budget revisions, no-cost extension requests and grant transfers.
 
Tracks Submissions and Awards by maintaining the grant and contract database, tracking pending and funded projects, and monitoring the processing of proposals and awards.
 
   
 
ii)    Sponsored Programs Accounting
 
Sponsored Programs Accounting is responsible for the post-award administration of grants and contracts. After an award is received, Sponsored Programs Accounting sets up the WBS account and inputs the budget. All cash collections related to grants, contracts, donations, wills or trusts are recorded by Sponsored Programs Accounting. The department reviews the reasonableness and appropriateness of expenditures for sponsored program activities and approves Cost Transfer Forms. The Personnel Activity Reporting for federal programs is administered by Sponsored Programs Accounting and involves the set up of cost sharing cost centers for tracking cost sharing on grants. Other responsibilities include: preparing financial reports for sponsoring agencies, reporting for annual financial audit under Generally Accepted Accounting Principles, compliance and reporting for the annual A-133 audit, and sub-recipient review of subcontractors.<br />
<br />
C)  '''Financial Controls and Compliance coordinates campus cost accounting standards (CAS)'''. 
 
Financial Controls and Compliance is responsible for minimizing UNMC’s risk of non-compliance of the Federal government’s Cost Accounting Standards regarding sponsored programs. The Cost Accounting Standards are found in OMB Circular A-21. The areas that the Standards encompass include direct costs, facilities and administrative (F&A) costs, effort reporting, cost sharing, cost transfers and service centers.
 
Financial Controls and Compliance minimizes this risk by creating policies and procedures, educating the campus to these policies and procedures, monitoring for compliance and taking corrective action when instances of noncompliance are discovered. Other responsibilities include completing the Federal Facilities and Administrative rate proposal and negotiation and monitoring and revising UNMC’s Disclosure Statement (DS-2).
 
D)  '''Conflict of Interest'''
 
Conflicts of interest may arise when an individual’s duty to UNMC conflicts with his/her own personal interests or when the financial interests of UNMC conflict with its responsibility to make prudent business decisions.
 
Potential conflicts of interest must be identified, analyzed, managed, or eliminated when warranted to maintain the public’s trust in UNMC’s teaching, research and service missions. A Conflict of Interest Committee has been established to review and address potential conflicts of interest.
 
For additional information, see UNMC Policy 8010, Conflict of Interest.<br />
<br />
E)    Human Resources
 
The Human Resources department is responsible for staff employment activities; payroll, records and benefits administration; employee relations; compensation and salary administration activities; and administration of Human Resources Policies. In conjunction with these core functions, compliance responsibility includes adherence to and enforcement of law, regulation and policy pertaining to the following:
 
* Equal Employment Opportunity and Affirmative Action
* Immigration and employment eligibility
* Military service and leave
* Labor legislation and related regulations (such as)
 
# Fair Labor Standards Act
# Family Medical Leave Act
# Americans with Disabilities Act
# Child labor legislation
# Taxation and withholding
# Records retention and protection<br />
<br />
Compliance in these areas requires ongoing coordination with the General Counsel's Office and the Central Administration Human Resources Office in order to assure consistency across all campuses of the University.
 
For additional information, contact Human Resources or see the Human Resources section of the UNMC Policy Manual.<br />
<br />
 
F)    '''Privacy and Information Security'''
'''Health Insurance Portability and Accountability Act (HIPAA)'''
 
The Privacy Officer and the Information Security Officer are responsible for Health Insurance Portability and Accountability Act (HIPAA) compliance to safeguard protected health information (PHI).
 
For additional information, see the HIPAA website, contact the above offices or see the Privacy and Information Security section of the UNMC Policy Manual.
 
'''Family Educational Rights and Privacy Act (FERPA)'''
 
Student Services ensures compliance with federally mandated student privacy issues. The Family Educational Rights and Privacy Act (FERPA) (20 U.S.C. § 1232g; 34 CFR Part 99) is a Federal law that protects the privacy of student education records. The Registrar at UNMC is responsible for FERPA compliance.  The written policy and adopted procedures are provided to all students annually in the Policies section of the UNMC Student Handbook. The handbook is available on line at https://net.unmc.edu/care/docs/handbook.pdf.
 
'''Gramm-Leach Bliley Act (GLBA – 16 CFR Part 314)'''
 
Information Services is responsible for compliance with the federally mandated student financial information safeguards. Privacy of student information is regulated via FERPA. <br />
<br />
G)  '''Information Technology and Security'''
 
Information Services is responsible for implementing technical controls to ensure confidentiality, integrity and availability of electronic data. In addition, Information Services provides training for end users regarding best practices for helping to protect the technical environment.
 
For additional information, see the Information Security Plan.
 
H)  '''Intellectual Property'''
 
The Intellectual Property Office is responsible for ensuring compliance with the Bayh Dole Act (37 CFR 401). The Bayh Dole Act requires organizations receiving federal research funds to report any resulting inventions to the federal funding agencies. At UNMC, all inventions are reported to the IPO which in turn reports all federally funded inventions to the appropriate federal funding agencies. The IPO provides the federal funding agencies with updates as patent protection is sought. Inventions are continually monitored and reported to ensure the government is aware of the progress of each invention. The majority of the reporting to these agencies is done through the iEdison web site (http://iedison.gov) and allows the University to retain title to materials and products invented with federal funding. The website, established by the NIH and used by almost all agencies involved, captures the necessary information regarding the reporting required to meet federal funding agency/Bayh-Dole Act.  A copy of the Bayh-Dole Act and guidance along with iEdisons history is also provided at the iEdison web site.
 
I)    '''Copyright'''
 
Copyright is a form of protection provided by federal law to the author of “original works of authorship” including literary, dramatic, musical, artistic, and certain other intellectual works. Unauthorized reproduction or use of copyrighted works is illegal, and is called copyright infringement. Court decisions over the years have developed a doctrine called “fair use” that permits reproduction of certain works under limited circumstances without the permission of the author.
 
For additional information, see UNMC Policy No. 8004, Copyright Policy (under construction).
 
J)      '''Export Control'''
 
Export control regulations prohibit the export of certain materials (including select agents) and information for reasons of national security or protection of trade unless approval is received from the federal government in the form of a license before the export takes place. Two major export control regulations are the Department of Commerce Export Administration regulations (EAR) and the State Department International Traffic in Arms (ITAR) regulations. The term “export” under these regulations includes “deemed exports” that occur when a controlled technology is disclosed to a foreign person in the United States, including university students and employees.
 
For additional information, see UNMC Policy No. 8005, Export Control (under construction).<br />
<br />
K)    '''Environmental and Safety Compliance'''
 
'''Safety'''
 
The Safety Officer is responsible for developing, implementing and directing a comprehensive safety and fire prevention program designed to minimize risk of injury to patients, visitors, staff and students at The Nebraska Medical Center and UNMC.
 
The Safety Office maintains a library that includes a complete set of National Fire Protection Association Standards and pamphlets. Material Safety Data Sheets are available electronically via the internet and chemical safety server.
 
Organizational Safety Committees – The Nebraska Medical Center and UNMC Safety Committees work to establish and maintain a safe and healthful environment for all employees, students, patients, and visitors. In addition they monitor each organization’s compliance with local, state, and federal requirements.
 
For more information on safety, see the Safety website or contact Safety Operations at Extension 9-7315. The UNMC Safety Policy Index can be found at http://info.unmc.edu/safety/policies/policies%20index.htm.
 
'''Radiation Safety'''
 
Radiation Safety approves all uses of radioactive material on campus. The Radiation Safety Officer ensures that the State Radioactive Material License is current and that all conditions of the license are met. Radiation Safety routinely performs compliance audits on all authorized users. Radiation Safety manages the personnel radiation monitoring program.
 
Radiation Safety is the point of contact for inspections performed by the State Radioactive Materials Program and the Nuclear Regulatory Commission. The Radiation Safety Committee meets quarterly to review all issues involving radioactive material.
 
Information on the Radiation Safety program can be found at: http://www.unmc.edu/CRSO/.
 
'''Biosafety'''
 
The general biosafety program on campus is regulated by the Institutional Biosafety Committee (IBC) in coordination with the Campus Biosafety Officer. The Biosafety Officer is available to consult on any issues pertaining to biosafety. This includes routine laboratory inspections for those laboratories utilizing biohazardous agents, as well as a resource concerning the environment and biohazardous agent exposure.
 
The UNMC IBC reviews and approves all research involving the use of biohazardous agents conducted by the faculty, students, staff, or others representing the University of Nebraska Medical Center and The Nebraska Medical Center.  Biohazardous materials are defined as "materials of biological origin that have the capacity to produce a deleterious effect on humans or animals". The UNMC IBC exercises its authority in compliance with the NIH Guidelines for Research Involving Recombinant DNA Molecules, April 2002 and 42 CFR Part 73, Possession, Use, and Transfer of Select Agents and Toxins.
 
Additional information can be obtained through the UNMC IBC website at http://unmc.edu/ibc.
 
'''Bloodborne Pathogens'''
 
Infection Control services are provided by an Infection Control Specialist from The Nebraska Medical Center. The Infection Control Specialist, housed in the Department of Healthcare Epidemiology identifies methods to minimize the risk of infectious diseases among patients, health care providers, employees, students, and volunteers to prevent transmission, detect epidemics and reduce risks of exposure to infectious agents (e.g., bloodborne pathogens). The Infection Control Specialist serves as a resource to provide current information and education regarding infection control issues, safer medical devices, and best practices to ensure compliance with infection control standards.
 
The Infection Control Specialist maintains UNMC Policy No. 2004, Bloodborne Pathogen Exposure Policy and provides required annual training in bloodborne pathogens to individuals who require training according to the OSHA Bloodborne Pathogen Standards.
 
For additional information, see the UNMC Infection Control web site at http://www.unmc.edu/infectioncontrol/.
 
'''Chemical Safety (RCRA and DOT Shipping)'''
 
Chemical Safety is responsible to analyze regulations and ensure compliance in the areas of EPA hazardous waste and FAA / DOT shipment of dangerous goods. Chemical Safety routinely performs compliance audits on all areas which generate hazardous waste or which ship dangerous goods. Chemical Safety is the point of contact for inspections performed by the EPA, State NDEQ, and FAA/DOT. The Chemical Safety Committee meets quarterly to review all issues involving hazardous waste and dangerous goods.
 
For additional information, see UNMC Policy No. 2002, Shipment of Hazardous Materials or Dangerous Goods or the UNMC Chemical Safety website at http://www.unmc.edu/CRSO/.
 
L)    '''Security'''
 
Campus Security is coordinated by the UNMC Security Department. Security Officers undergo continuous on-the-job training to upgrade their skills.  Members of the UNMC Security Department are not armed. They conduct foot and vehicular patrols of the campus 24 hours a day in an effort to deter criminal acts.  Unsafe conditions noted by UNMC Security Officers during campus patrol are reported to Facilities Management and Planning.
 
On campus, the UNMC Security Department enforces University regulations. The UNMC Security Department also works very closely with the Omaha Police Department and county, state and federal authorities. Students, faculty and staff members are encouraged to make accurate and prompt reports to the UNMC Security Department and external law enforcement agencies. The department may assist students who choose to ask for help in notifying other appropriate authorities of offenses committed.
 
In accordance with the Student Right to Know and Campus Security Act of 1990, 20 U.S.C., Section 1092, Campus Security posts Daily Security Summary Reports, Security Alerts, and other security and personal safety related information on the Intranet at http://info.unmc.edu/security. Employees and students are encouraged to review the information on a routine basis and contact Campus Security with any questions or concerns.<br />
<br />
8)    '''Compliance Training'''
 
All University of Nebraska Medical Center employees, students (including visiting students), and faculty (including but not limited to courtesy, adjunct, volunteers) must be knowledgeable of and comply with laws and regulations related to their duties or field of study.   
 
Mandatory compliance training has been established to educate UNMC staff and students and meet regulatory requirements. A summary of these compliance training requirements and directions for accessing and completing this training can be found on the UNMC Intranet Compliance Training web page.
 
It is the individual's responsibility to complete the compliance training requirements. 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: <br />
<br />
{| class="wikitable"
|-
|-
! Days Overdue (days past deadline date) !! Employees !! Students
! 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  
| 30 Days || E-mail/verbal notice from unit management || E-mail/verbal notice from Dean’s office
|-
|-
| 60 Days || Letter from Human Resources || Letter from Vice Chancellor for Academic Affairs; records placed on hold.
| 60 Days || Communication from Human Resources || Records placed on hold
|-
|-
| 90 Days || Letter from Chancellor  || Letter from Chancellor
| 90 Days || Notification to Dean, access removed from all UNMC resources except Canvas until training has been completed ||
|-
|-
| 120 Days || Termination  || Dismissal
|}
|}<br />
==Statement of Understanding==
<br />
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.
9)    '''Statement of Understanding'''
==Additional Information==
 
*Contact the [mailto:sarah.glodencarlson@unmc.edu Chief Compliance Officer]
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: non-discrimination, including sexual harassment; privacy and information security; and drug-free workplace.
*For a complete listing of Contacts and Compliance Topics see the [https://info.unmc.edu/policies/compliance/matrix.html Compliance Matrix] for details.
*[https://nebraska.edu/-/media/unca/docs/offices-and-policies/policies/executive-memorandum/sexual-misconduct-minimum-training-standards.pdf Sexual Misconduct Minimum Training Standards - Executive Memo No. 44]
*UNMC Policy No. 1003, [[Drug Free Campus]]
*UNMC Policy No. 1049, [[Outside Employment]]
*UNMC Policy No. 1099, [[Non-Discrimination and Harassment]]
*UNMC Policy No. 2002, [https://wiki.unmc.edu/index.php/Shipping_Hazardous_Materials Shipment of Hazardous Materials or Dangerous Goods]
*UNMC Policy No. 2004, [[Bloodborne Pathogens Exposure]]
*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, [https://wiki.unmc.edu/index.php/Subrecipient_Policy Subrecipient]
*UNMC Policy No. 6110, [[On-Campus and Off-Campus Indirect Cost Rates on Federally Sponsored Projects]]
*UNMC Policy No. 6036, [[Reproducing Copyrighted Materials]]
*UNMC Policy No. 6045, [https://wiki.unmc.edu/index.php/Privacy/Confidentiality Privacy, Confidentiality and Information Security]
*UNMC Policy No. 6051, [https://wiki.unmc.edu/index.php/Computer_Use/Electronic_Information Computer Use and Electronic Information Security]
*UNMC Policy No. 8001, [[Compliance Hotline]]
*UNMC Policy No. 8005, [[Export Control]]
*UNMC Policy No. 8006, [[Code of Conduct]]
*UNMC Policy No. 8010, [[Conflict of Interest]]
*UNMC Policy No. 8014, [[Disclosing Foreign Support and International Activities]]
*UNMC Policy No. 8015, [[Health Care Vendor Interactions]]


For additional information, please contact the Compliance Officer.


This page maintained by dkp.
This page maintained by [mailto:mhurlocker@unmc.edu mh]

Latest revision as of 13:29, July 26, 2024

Human Resources   Safety/Security   Research Compliance   Compliance   Privacy/Information Security   Business Operations   Intellectual Property   Faculty


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 | Electronic Digital Signatures and Records

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

Compliance-flowchart-8-5-2020.jpg

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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