Developing a Centralized Ethics and Compliance Program in a Decentralized and Defunded Environment
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1 Developing a Centralized Ethics and Program in a Decentralized and Defunded Environment SCCE Conference on Effective Systems in Higher Education June, 2009 DRAFT 3/08DRAFT 1
2 Presenters Lynda Hilliard, MBA, RN, CHC, CCEP Deputy Officer Ethics and Department University of California Luanna Putney, Ph.D., CHC, CCEP Director of Research Ethics and Department University of California DRAFT 3/08 2
3 Presentation Outline Establishment of a Systemwide Program Decentralized Roles Tying it Together: the Communication Plan For Example: Research, Privacy and Healthcare DRAFT 3/08 3
4 Presentation Goals Identify important elements of an effective systemwide compliance program in the decentralized model Learn how to leverage decentralized activities to improve compliance program efficiencies DRAFT 3/08 4
5 Establishment of the Systemwide UC Ethics and Program Why? Good business practice Required by Federal Acquisition Regulation (FAR ) Provides efficiencies in processes and communication Reduces/prevents civil/criminal enforcement by regulatory agencies Enhances public trust Meets expectations of external constituents and The Regents When? Program was approved by The Regents July 2008 DRAFT 3/08 5
6 Systemwide Program: Getting Started Determine scope of Ethics and Program ( Program ) Reduce compliance silos Model from the Federal Sentencing Guidelines Identify and understand compliance risks within organization Determine scope of services provided Identify applicable rules and regulations governing the operations of the business, i.e., research, health care, education, financial aid, sports (NCAA), title IX, ADA, etc. Outline and understand the business processes and their inter-campus relationships Gain leadership commitment for a Program based on strong tone from the top DRAFT 3/08 6
7 Defining the Communication Plan The Board of Regents Ethics and Program Locations UCB UCD UCI UCOP UCR UCSB UCSC UCM UCSF LBNL ANR UCSD UCLA Northern Campuses Central Units Southern Campuses DRAFT 3/08 7
8 Building the Structure Locations System Office The Board of Regents UC Chief and Audit Officer Systemwide Ethics & Risk Council* (co-chaired by President and SVP/Chief Officer) Chancellor Campus Oversight and Accountability Campus Ethics & Risk Committee* (co-chaired by EVC and CECO) Campus Ethics & Officer (CECO) Employee Training (Vice Chancellor or above level) Reporting Policies & Procedures Monitoring & Auditing Stakeholder Collaboration Corrective Action *Membership to include representation from academic senate and administrative leaders of compliance risk areas; campus refers to UC locations including LBNL, UCOP and ANR *Academic Medical Centers are included in campus definition DRAFT 3/08 8
9 Systemwide Program: Mission and Roles The Regents UC Ethics and Program Locations UCB UCD UCI UCOP UCR UCSB UCSC UCM UCSF ANR LBNL UCSD UCLA Northern Campuses Central Units Southern Campuses DRAFT 3/08 9
10 Mission Statement The UC Ethics and Program enhances the University s duty to perform its public responsibilities in an ethics and compliance-based environment where applicable legal, regulatory, Regental and UC Policy are followed and in which the public trust is maintained. Sample of Obligations including but not limited to the below Anti-kickback/ Sponsorship Laws Equal Employment Opportunity Grants and Contracts Rules Human Subjects Protection Conflicts of Interest Anti-trust/ Competition Laws Pricing & Reimbursement Promotional Activities Affirmative Action Sexual Harassment Benefits Fiduciary Obligations NCAA Animal Research Environmental Health & Safety Import/Export Controls HIPAA Privacy Good Clinical/Lab Practices (GCP) Licensure Compensation & Tax (IRS) Information Security DRAFT 3/08 10
11 Tenets of a Systemwide Program Demand individual accountability and responsibility as key tenets of an effective Program Educate key stakeholders on the role of compliance as differentiated from legal and/or risk management and outilne the benefits of having a strong Program Gain consensus from key stakeholders from both the administrative and academic functions Develop a Program that is efficient and leverages current policies/procedures, internal controls, training and education, human resource protocols and audit/monitoring activities that meet regulatory requirements DRAFT 3/08 11
12 Tenets of a Systemwide Program (cont) Identify informal and formal communication structures and key stakeholders in the organization Establish Program communication plan that includes frequent updates and status reports on Program development, activities, etc. to key stakeholder communities Solicit feedback from stakeholders on process questions, i.e., communication methodologies to other constituencies within the organization Establish trust by following through on tasks, etc in a timely manner. DRAFT 3/08 12
13 Structure of the Systemwide Program The Board of Regents UC President Mark Yudof Sheryl Vacca SVP/CCAO Lynda Hilliard Deputy CCO Luanna Putney Director, Research Claudia White Spec Asst to SVP/CCAO Jon Good Interim HIPAA Security Officer UC Privacy Officer (VACANT) John Lohse Director, Investigations Senior Analyst, Research/Privacy (VACANT) Teresa Alvarez Admin Analyst Meg Carter Senior Analyst, Investigations Admin Assistant (VACANT) Peter Cataldo Director, Ethics & (South) Linda Buffet Senior Analyst, Education Rachelle Jeppson Director, Ethics & (North) Nancy Capell University Policy Coordinator DRAFT 3/08 13
14 Priority Functional Areas of the Systemwide Program Response/Prevention Oversight/Leadership Construction Human Resources Policies/Procedures Crime Enforcement/Discipline Legal Financial Athletics Healthcare Reporting/Investigating Privacy New Legislation Research Academic Affairs Student Affairs Facilities Monitoring/Auditing Training/Education DRAFT 3/08 14
15 Roles of the Systemwide Office Responsible for coordinating and reporting overall activities and performance metrics to the and Audit Committee of the Board of Regents Assist locations in establishing effective Ethics and Risk Committees, i.e., provide tools, performance metrics, benchmarking, etc. Coordinate/collaborate with locations on identification of compliance risks and mitigation efforts Develop mandatory training (i.e., Sexual Harassment, /COI Briefings, HIPAA) Facilitate accountability through development of central policy statements (i.e., enforcement policies) DRAFT 3/08 15
16 Decentralized Program: Roles of the Locations The Regents UC Ethics and Program Locations UCB UCD UCI UCOP UCR UCSB UCSC UCM UCSF ANR LBNL UCSD UCLA Northern Campuses Central Units Southern Campuses DRAFT 3/08 16
17 Roles of the Locations Chancellor accountable for compliance on campus and appointment of EVC as CECC Chairperson Designate location Campus Ethics and Officer as liaison to Systemwide Ethics and Program Identify, address and mitigate high risk compliance areas at specific location Ensure completion of location-specific mandatory compliance training (100% compliance) Facilitate accountability through development of applicable local policies/procedures (i.e., enforcement policies) Report overall location-specific activities and performance metrics to the Systemwide Ethics and Program DRAFT 3/08 17
18 Tying it Together: The Communication Plan The Board of Regents Ethics and Program Locations UCB UCD UCI UCOP UCR UCSB UCSC UCM UCSF ANR LBNL UCSD UCLA Northern Campuses Central Units Southern Campuses DRAFT 3/08 18
19 Communication is Key Participation by Chief and Audit Officer (CCAO) CCAO participates in location committee meetings CCAO conveys first-hand information from The Board of Regents and UC President directly to location leadership Integration of full-time Systemwide Directors of Ethics and in location committees Directors provide written and verbal systemwide updates at each location committee meeting, and report information from locations back to Systemwide Program leadership One Director for Northern locations and one for Southern locations Fluid communication between Northern and Southern Directors to ensure consistency in messaging Systemwide Program Office facilitates frequent meetings and standing calls to discuss and mitigate specific high risk priority areas among location stakeholders and leadership DRAFT 3/08 19
20 The Communication Plan: Research Example The Board of Regents Ethics and Program Other Research Healthcare Privacy Locations UCB UCD UCI UCOP UCR UCSB UCSC UCM UCSF ANR LBNL UCSD UCLA Northern Campuses Central Units Southern Campuses DRAFT 3/08 20
21 Research Communication Office of Research The Board of Regents Legal Finance, HR, Bus Ops, etc. Systemwide Research Program System Office External Regulators Research Advisory Committee Local Committees IACUCs & Vets Local Research Program Location IRBs SPO DRAFT 3/08 21 EFM
22 The Communication Plan: Privacy Example The Board of Regents Ethics and Program Other Research Healthcare Privacy Locations UCB UCD UCI UCOP UCR UCSB UCSC UCM UCSF ANR LBNL UCSD UCLA Northern Campuses Central Units Southern Campuses DRAFT 3/08 22
23 Privacy Communication Security The Board of Regents Legal Student Affairs, HR, Bus Ops, etc. Systemwide Privacy Program System Office External Regulators Privacy Officers Local Committees Security Offices Local Privacy Program Location Research/Healthcare Student Health DRAFT 3/08 23 Electronic Records Groups
24 Adding Value in Decentralized and Defunded Environment Leverage locations existing organizational structure, training, policies/procedures and monitoring efforts already in place/being conducted Mandatory training pushed out centrally could be incorporated into location-specific training already being offered If dispersed compliance leadership/committee activity already exists in area, suggest locations pull together outcomes/status of those efforts for reporting Provide centralized assistance to bring locations together and facilitate communication Offer to do the leg-work and/or fund (if office has $$) information gathering and workgroup formation (i.e., scheduling, hosting meetings, etc.) to focus on high risk systemwide compliance issues Provide infrastructure support for value-added compliance training (i.e., webinars, listservs for education sharing, hosting in-person training, etc.) Provide personnel to participate in location meetings and campus workgroups Personnel act as information gatherers saving time and effort on part of location leadership Personnel provide direct, timely and accurate information to location leadership about systemwide compliance risks DRAFT 3/08 24
25 Thank You!! Lynda Hilliard, MBA, RN, CHC, CCEP Luanna Putney, Ph.D., CHC, CCEP DRAFT 3/08 25
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