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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: ''' | Revised Date: '''08/14/20'''<br /> | ||
Reviewed Date: ''' | Reviewed Date: '''08/14/20'''<br /> | ||
<br /> | <br /> | ||
<big>'''Compliance Program Policy'''</big> | <big>'''Compliance Program Policy'''</big> | ||
== Basis for Policy == | == Basis for Policy == | ||
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 adherence to 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. | 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 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 auditing for adherence to 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 Program Structure == | ||
[[File:Compliance-Flowchart2-1-18.jpg]] | [[File:Compliance-Flowchart2-1-18.jpg]] | ||
===Senior Vice Chancellor for Academic Affairs=== | ===Senior Vice Chancellor for Academic Affairs=== | ||
The Senior Vice Chancellor for Academic Affairs is responsible for overseeing the development and implementation of policies, procedures and practices necessary to effect compliance with federal, state, and local laws and regulations. | 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. | ||
===Compliance Officer=== | ===Chief Compliance Officer=== | ||
The 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 or others on compliance matters, which include, but are not limited to: | 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 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; | *coordinate with subject matter experts to analyze laws and regulations applicable to UNMC to ensure compliance; | ||
*monitor day-to-day compliance activities; | *monitor day-to-day compliance activities; | ||
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*report 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 on legal issues; | *coordinate with the Associate General Counsel on legal issues; | ||
*coordinate with the Director of Internal Audit; | *coordinate with the Director of Internal Audit and Advisory Services; | ||
*coordinate with the Information Security Officer; | *coordinate with the Information Security Officer; | ||
*respond to compliance hotline calls; | *respond to compliance hotline calls; | ||
*disseminate information to support compliance and training on the Compliance Program; | *disseminate information to support compliance and training on the Compliance Program; and | ||
*chair the compliance committee. | *chair the compliance committee. | ||
===Compliance Committee=== | ===Compliance Committee=== | ||
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 oversee and monitor department response to identified risks as identified by the | 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 oversee and monitor department response to identified risks as identified by the Chancellor Risk AssessmentInternal Audit Director’s annual audit plan as well as data generated through monitoring and individual reporting. | ||
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: | 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: | ||
*Compliance Officer | |||
*Chief Compliance Officer | |||
*Associate General Counsel | *Associate General Counsel | ||
*Export Control Compliance Officer | *Export Control Compliance Officer | ||
*Human Resources Director | *Human Resources Director | ||
*Information Security Officer | *Information Security Officer | ||
*Chair of the Institutional Review Board | *Chair of the Institutional Review Board or Compliance designee | ||
*Executive Director, Environmental Health & Safety | *Executive Director, Environmental Health & Safety | ||
*Intellectual Property Director | *Intellectual Property Director | ||
*Internal Audit | *Director Internal Audit and Advisory Services | ||
*Nebraska Medicine Compliance Officer or Compliance Representative for Nebraska Medicine | *Nebraska Medicine Compliance Officer or Compliance Representative for Nebraska Medicine | ||
*Privacy Officer | *Privacy Officer | ||
*Controller | *Controller | ||
*Financial Compliance and Cost Analysis | |||
*Sponsored Programs Administration | *Sponsored Programs Administration | ||
*Sponsored Programs Accounting | *Sponsored Programs Accounting | ||
*Director of Procurement | *Director of Procurement | ||
*Chief Student Affairs Officer | *Chief Student Affairs Officer | ||
*Library | |||
The Compliance Committee or 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: | The Compliance Committee or 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; | *develop policies related to compliance; | ||
*establish compliance training programs; | *establish compliance training programs; | ||
*assist with identifying areas of potential compliance vulnerabilities; | *assist with identifying areas of potential compliance vulnerabilities; | ||
*assist with understanding the compliance risks and related regulations and laws; | *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 /> | *assist with response to alleged violation of rules, regulations, policies, procedures and other functions as needed to enforce this policy.<br /> | ||
Representatives would be from the following areas: | Representatives would be from the following areas: | ||
*NU Director of Internal Audit | *NU Director of Internal Audit and Advisory Services | ||
*Biosafety | *Biosafety | ||
*Child Health Research Institute (CHRI) | |||
*College of Dentistry | *College of Dentistry | ||
*College of Medicine | *College of Medicine | ||
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*College of Pharmacy | *College of Pharmacy | ||
*College of Public Health | *College of Public Health | ||
*College of Allied Health | *College of Allied Health Professions | ||
*Graduate Studies | |||
*UNMC Physicians | *UNMC Physicians | ||
*Comparative Medicine/Institutional Animal Care and Use Committee | *Comparative Medicine/Institutional Animal Care and Use Committee | ||
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*Munroe-Meyer Institute | *Munroe-Meyer Institute | ||
*Environmental Health & Safety | *Environmental Health & Safety | ||
*Student | *Student Success | ||
*Others as necessary | *Others as necessary | ||
==Compliance Responsibilities== | ==Compliance Responsibilities== | ||
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| IACUC || [http://www.unmc.edu/iacuc/ Institutional Animal Care and Use Committee], BOR Policy 3.2.8 | | IACUC || [http://www.unmc.edu/iacuc/ Institutional Animal Care and Use Committee], BOR Policy 3.2.8 | ||
|- | |- | ||
| Conflict of Interest || UNMC Policy No. 8010, [[Conflict of Interest]] | | 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]] | | Clinical Trial Billing || UNMC Policy No. 8008, [[Clinical Trial Professional and Technical Fee Billing]] | ||
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| Research Integrity || UNMC Policy No. 8003, [[Research Integrity]] | | Research Integrity || UNMC Policy No. 8003, [[Research Integrity]] | ||
|- | |- | ||
| Sponsored Programs Administration and Sponsored Programs Accounting || UNMC Policy No. 3001, [[Sponsored Programs]], UNMC Policy 6100, [[Direct Cost]], UNMC Policy 6101, [https://wiki.unmc.edu/index.php/Facilities_and_Administrative_Cost Facilities and Administrative, F&A) Cost], UNMC Policy 6102, [[Institutional Base Salary]], UNMC Policy 6103, [https://wiki.unmc.edu/index.php/Unallowable_Cost_Policy Unallowable Cost], UNMC Policy 6104, [[Sponsored Project Cost Share]], UNMC Policy 6105, [[Effort Certification]], UNMC Policy 6106, [[Cost Transfer]], UNMC Policy 6107, [[Service Center]], UNMC Policy 6108, [https://wiki.unmc.edu/index.php/Subrecipient_Policy Subrecipient] | | Sponsored Programs Administration and Sponsored Programs Accounting || UNMC Policy No. 3001, [[Sponsored Programs]], UNMC Policy 6100, [[Direct Cost]], UNMC Policy 6101, [https://wiki.unmc.edu/index.php/Facilities_and_Administrative_Cost Facilities and Administrative, F&A) Cost], UNMC Policy 6102, [[Institutional Base Salary]], UNMC Policy 6103, [https://wiki.unmc.edu/index.php/Unallowable_Cost_Policy Unallowable Cost], UNMC Policy 6104, [[Sponsored Project Cost Share]], UNMC Policy 6105, [[Effort Certification]], UNMC Policy 6106, [[Cost Transfer]], UNMC Policy 6107, [[Service Center]], UNMC Policy 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'''|| | | '''Environmental and Safety Compliance'''|| | ||
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| 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] | | 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]] | | 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/about/contact-hr.html Human Resources] | | Human Resources || [https://www.unmc.edu/human-resources/about/contact-hr.html Human Resources] | ||
|- | |- | ||
| Internal Audit || UNMC | | Internal Audit || University of Nebraska Internal Audit Charter and UNMC Internatl Audit and Advisory Services Webpage | ||
|- | |- | ||
| Student Services || | | Student Services || Student Success, [https://www.unmc.edu/studentservices/_documents/Handbook.pdf Student Handbook] [https://www.unmc.edu/academicaffairs/compliance/matrix.html Compliance Matrix], [https://www.unmc.edu/studentservices/academic-records/ferpa/ FERPA Information] | ||
|- | |- | ||
| Title IX || UNMC Policy No. 1099, [[Non-Discrimination and Harassment]], UNMC Policy No. 1107, [[Sexual Misconduct]] | | Title IX || UNMC Policy No. 1099, [[Non-Discrimination and Harassment]], UNMC Policy No. 1107, [[Sexual Misconduct]] | ||
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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. | 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== | ==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 Compliance Officer shall investigate concerns and take corrective action in response to identified issues. For additional information, see UNMC Policy No. 8001, [[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== | ==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 as determined by the Compliance Officer and Compliance Committee. | All University of Nebraska Medical Center employees (including visitors), students (including visiting students and visitors), and faculty (including but not limited to courtesy, adjunct faculty, visitors, 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 must complete all mandatory compliance training required of UNMC staff and students. It is the individual's responsibility to complete the compliance training requirements at http://www.unmc.edu/academicaffairs/compliance/training-requirements/index.html. 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: | Mandatory compliance training is required of UNMC staff and students. All UNMC invited visitors on campus for seven (7) or greater days must complete all mandatory compliance training required of UNMC staff and students. It is the individual's responsibility to complete the compliance training requirements at http://www.unmc.edu/academicaffairs/compliance/training-requirements/index.html. 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: | ||
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*For a complete listing of Contacts and Compliance Topics see the [https://www.unmc.edu/academicaffairs/compliance/matrix.html Compliance Matrix] for details. | *For a complete listing of Contacts and Compliance Topics see the [https://www.unmc.edu/academicaffairs/compliance/matrix.html Compliance Matrix] for details. | ||
*UNMC Policy No. 1003, [[Drug Free Campus]] | *UNMC Policy No. 1003, [[Drug Free Campus]] | ||
*UNMC Policy No. 1049, [[Outside Employment]] | |||
*UNMC Policy No. 1099, [[Non-Discrimination and Harassment]] | *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. 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. 2004, [[Bloodborne Pathogens Exposure]] | ||
*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. 6036, [[Reproducing Copyrighted Materials]] | ||
*UNMC Policy No. 6045, [https://wiki.unmc.edu/index.php/Privacy/Confidentiality Privacy, Confidentiality and Information Security] | *UNMC Policy No. 6045, [https://wiki.unmc.edu/index.php/Privacy/Confidentiality Privacy, Confidentiality and Information Security] | ||
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*UNMC Policy No. 8006, [[Code of Conduct]] | *UNMC Policy No. 8006, [[Code of Conduct]] | ||
*UNMC Policy No. 8010, [[Conflict of Interest]] | *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]] | |||
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