Difference between revisions of "Compliance Program"
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REVIEWED DATE: '''11/01/06'''<br />
REVIEWED DATE: '''11/01/06'''<br />
Revision as of 10:19, July 26, 2012
Compliance Program | Compliance Hotline | Investigations by Third Parties | Research Integrity | Copyright | Export Control | Code of Conduct | Use of Human Anatomical Material | Clinical Trial Fee Billing Procedures | Contracts Policy | Conflicts of Interest
POLICY NO: 8000
EFFECTIVE DATE: 11/01/06
REVIEWED DATE: 11/01/06
Basis for Policy
The University of Nebraska Medical Center (UNMC) shall comply with all applicable federal, state and local laws and regulations and University of Nebraska and UNMC Policies and Procedures.
Compliance Program Structure
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:
- analyze laws and regulations applicable to UNMC and coordinate with subject matter experts to ensure compliance with them.
- monitor day-to-day compliance activities.
- establish compliance audits of risk areas and develop corrective action plans in response to identified deficiencies.
- oversee visits by regulatory agencies and responses to inquiries and investigations.
- make periodic reports regarding compliance matters directly to the UNMC Chancellor’s Council.
- coordinate with the Associate General Counsel for Health Care on legal issues.
- respond to compliance hotline calls.
- chair the compliance committee.
Compliance Committee. The Compliance committee shall support the Compliance Officer in meeting his/her responsibilities. The committee shall analyze UNMC’s risk areas and oversee the monitoring of internal audits and external investigations. The Compliance Committee shall be composed of representatives from the following departments:
Associate General Counsel for Health Care
College of Dentistry
College of Medicine
College of Nursing
College of Pharmacy
Information Technology Services
Institutional Animal Care and Use Committee (IACUC)
Institutional Review Board (IRB)
Sponsored Programs Accounting
Sponsored Programs Administration
The Nebraska Medical Center
Compliance Committee representatives shall assist the Compliance Office with communicating compliance policies and procedures and other information within their respective units. The Compliance Committee shall meet no less than quarterly. The Compliance Office shall complete meeting minutes and maintain them on file for no less than seven years. The meeting minutes shall be confidential. Meeting minutes shall be distributed to committee members, vice chancellors, college deans and executive directors to inform UNMC leadership about compliance activities.
Compliance Hotline. A compliance hotline has been established to provide individuals with an additional communication channel to report compliance concerns. The Compliance Officer shall investigate concerns and take corrective action in response to identified issues.
For additional information, see UNMC Policy No. 8001, Compliance Hotline Policy.
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.
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.
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/.
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.
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.
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
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.
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.
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.
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).
K) Environmental and Safety Compliance
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 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/.
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.
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/.
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.
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:
|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||Letter from Human Resources||Letter from Vice Chancellor for Academic Affairs; records placed on hold.|
|90 Days||Letter from Chancellor||Letter from Chancellor|
9) 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: non-discrimination, including sexual harassment; privacy and information security; and drug-free workplace.
For additional information, please contact the Compliance Officer.
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