2,654
edits
Compliance Program: Difference between revisions
no edit summary
No edit summary |
No edit summary |
||
| Line 39: | Line 39: | ||
* chair the compliance committee. | * chair the compliance committee. | ||
===Compliance Committee=== | ===Compliance Committee=== | ||
The Compliance committee shall support the Compliance Officer in meeting his/her responsibilities. | 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: | ||
* Associate General Counsel for Health Care | * Associate General Counsel for Health Care | ||
* College of Dentistry | * College of Dentistry | ||
| Line 62: | Line 62: | ||
* UNMC Physicians | * UNMC Physicians | ||
===Compliance Committee Representatives === | ===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. | 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=== | ===Compliance Hotline=== | ||
A compliance hotline has been established to provide individuals with an additional communication channel to report compliance concerns. The [http://mailto:swrobel@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]]. | A compliance hotline has been established to provide individuals with an additional communication channel to report compliance concerns. The [http://mailto:swrobel@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]]. | ||
| Line 84: | Line 84: | ||
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.<br /> | 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.<br /> | ||
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. | 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.<br /> | ||
Further information can be obtained through the UNMC IRB website at http://www.unmc.edu/irb/. | Further information can be obtained through the UNMC IRB website at http://www.unmc.edu/irb/. | ||
| Line 103: | Line 103: | ||
*'''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. | *'''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. | *'''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. | *'''Tracks Submissions and Awards by''' maintaining the grant and contract database, tracking pending and funded projects, and monitoring the processing of proposals and awards. | ||
=====[http://info.unmc.edu/dept/spaccounting/ Sponsored Programs Accounting]===== | =====[http://info.unmc.edu/dept/spaccounting/ 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. | 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. | ||
| Line 111: | Line 111: | ||
FCC is responsible for minimizing UNMC’s risk of non-compliance of the Federal government’s Cost Accounting Standards regarding sponsored programs. The areas that the Standards encompass include: direct costs, facilities and administrative (F&A) costs, effort reporting, cost sharing, cost transfers and service centers. <br /> | FCC is responsible for minimizing UNMC’s risk of non-compliance of the Federal government’s Cost Accounting Standards regarding sponsored programs. The areas that the Standards encompass include: direct costs, facilities and administrative (F&A) costs, effort reporting, cost sharing, cost transfers and service centers. <br /> | ||
FCC minimizes risks 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. | FCC minimizes risks 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.<br /> | ||
Ensures that the following proposals and reports are submitted to the Division of Cost Allocation, per OMB A-21, including: | Ensures that the following proposals and reports are submitted to the Division of Cost Allocation, per OMB A-21, including: | ||
| Line 148: | Line 148: | ||
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. | 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. | ||
====Intellectual Property==== | ====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 [https://s-edison.info.nih.gov/iEdison/ iEdison web site] 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. | 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 [https://s-edison.info.nih.gov/iEdison/ iEdison web site] 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. | ||
====Copyright==== | ====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. 6036, [http://wiki.unmc.edu/Reproducing_Copyrighted_Materials Reproduction of Copyrighted Materials]. | 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. 6036, [http://wiki.unmc.edu/Reproducing_Copyrighted_Materials Reproduction of Copyrighted Materials]. | ||
| Line 169: | Line 169: | ||
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.<br /> | 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.<br /> | ||
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. | 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 2002and 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===== | =====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.<br /> | 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.<br /> | ||
| Line 175: | Line 175: | ||
The Infection Control Specialist maintains UNMC Policy No. 2004, [http://wiki.unmc.edu/Bloodborne_Pathogens_Exposure Bloodborne Pathogen Exposure] 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/. | The Infection Control Specialist maintains UNMC Policy No. 2004, [http://wiki.unmc.edu/Bloodborne_Pathogens_Exposure Bloodborne Pathogen Exposure] 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 (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, [ | 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, [http://wiki.unmc.edu/Shipping_Hazardous_Materials Shipment of Hazardous Materials or Dangerous Goods] or the UNMC Chemical Safety website at http://www.unmc.edu/CRSO/. | ||
====Security==== | ====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.<br /> | 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.<br /> | ||
| Line 183: | Line 183: | ||
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. | 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. | ||
===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. | 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. <br /> | ||
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.<br /> | 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.<br /> | ||
| Line 192: | Line 192: | ||
! 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 | | 30 Days || E-mail/verbal notice from unit management || E-mail/verbal notice from Dean’s office | ||
|- | |- | ||
| 60 Days || Letter from Human Resources | | 60 Days || Letter from Human Resources || Letter from Vice Chancellor for Academic Affairs; records placed on hold. | ||
|} | |} | ||
==Statement of Understanding== | ==Statement of Understanding== | ||