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The Management
Series
Faculty Staff
Human Resources
“Committed to understanding and delivering
value-added customer service that contributes
to our customers’ overall success”
Your NU Values Partners
Brought to you by:The Training and Development Team
Good Morning, and Welcome!
THE MANAGEMENT SERIES
UNMC Manager’s Role in
Compliance and SafetySession VII
May 12, 2005
Facilitated by:
UNMC Campus Compliance Partnership
Faculty Staff
Human Resources
“Committed to understanding and delivering
value-added customer service that contributes
to our customers’ overall success”
Your NU Values PartnersBrought to you by:
Agenda
• Welcome and Introduction
• “Just Get ‘er Done”• UNMC Regulatory
Environment and Structure
• Areas of Compliance– Human & Animal Research– Sponsored Programs
Administration– Conflict of Interest
• Break: and Class Photo• Human Resources• Environment & Safety• Contracts• Privacy/Information
Security• Manager’s Role Exercise• Session Wrap-up
“Just Geth’er Done!”
UNMC Regulatory Environment & Structure
By Sheila Wrobel, JD, MBAUNMC Compliance Officer
Privacy Officer/Research Integrity Officer
What is Compliance?
• Dictionary definitions: – Observance of official requirements – Conformity in fulfilling official requirements
• Ensuring UNMC meets regulatory requirements related to its teaching, research, patient care and outreach mission
UNMC Compliance
UNMC Regulatory Environment
Research Subjects Protection
Human Subjects o45 CFR Part 46oFDAoNIHAnimal Subjects oGuide for the Care & Use of Laboratory Animals (NRC)
Sponsored Programs
OMB Circular A-21OMB Circular A-110
False Claims ActMedicare/Medicaid
Intellectual Property & IntegrityPatentsCopyrightServicemark, Trademark/name
Safety/Environment OSHA (includes BBP)
Life Safety Code Biosafety Chemical Safety Radiation Safety EPA
Employment FLSACivil RightsADAADEAImmigration
Information Privacy & SecurityFERPAHIPAAGLBAPrivacy Act
Medical EducationAccrediting Agencies (ACGME, etc.)Several others
Tax Issues
IRC NE Regs
Interface w/ NMC & UMA
JCAHOMedicare/caid
Conflict of Interest
ResearchEmploymentIPOther
Why is Compliance Important?
• As a public institution, we have a duty towards the community we serve
• We must be good stewards of tax dollars: NE state revenue, federal grants, Medicare & Medicaid
• In alignment with NU Values: accountability • Protects research subjects from harm & injury • Ensures proper use of grant funds and other resources
Penalties for Noncompliance• Harm to others
• Fines
• Imprisonment
• Lawsuits
• Loss of certification
• Suspension of research activities
• Loss of reputation
• Bad publicity
• Loss of ability to make grant-related decisions at the University-level
Individuals can be held personally liable under
several laws applicable to UNMC
Recent Compliance Settlements • Apr 2005: UAB settles for 3.39 million for clinical
trial billing and effort reporting false claims
– Double billed Medicare & grant for same services – Didn’t properly document time spent on grant
work
• Feb 2005: Florida International settles for $11.5 million for effort reporting and grant
management issues
• Feb 2005: UPENN & CNMC settle for 500,000 each for false claims related to Jesse Gelsinger case
Evolution of Compliance Programs
• Government demands accountability of public funds– Department of Defense scandals– Securities scandals – Medicare & Medicaid fraud – Federal grant accounting– Corporate fraud scandals
FALSE CLAIMS ACT LIABILITYFALSE CLAIMS ACT LIABILITY
Those who knowingly submit, or cause another person or entity to submit, false claims for payment of government funds are liable for three times the government’s damages plus civil penalties of $5,500 to $11,000 per false claim.
Passed in Civil War era
Historically applied to defense industry
1990’s: applied to Medicare/Medicaid claims
Late 90’s: applied to federal grants:• Expenses not adequately documented as required by the terms and
conditions of the grants • Overstated time spent by researchers on federally-sponsored projects• Double-billing grant & Medicare for clinical trials
False Claims Act Liability • “Knowingly” element of FCA is met when
individuals sign certifications on claims to the
federal government (i.e. grant applications, Medicare/Medicaid claims) that information is
correct and regulations are being followed, but the government finds that erroneous charging is occurring
• No “intent to deceive” is required—ignorance of complex billing requirements is not a defense!
• Qui-Tam Relator provisions allow whistleblowers to receive a proportion of funds recovered by the govt
“Studies estimate the fraud deterred thus far by the qui tam provisions runs into the hundreds of billions of dollars. Instead of encouraging or rewarding a culture of deceit, corporations now spend substantial sums on sophisticated and meaningful compliance programs. That change in corporate culture – and in the values-based decisions that ordinary Americans make daily in the workplace --may be the law’s most enduring legacy”
-- Senator Grassley (R-IA)
Federal Compliance Guidance provides Direction
1. Federal Sentencing Guidelines: • Revised in October 2004• Organizations must “promote an organizational
culture that encourages a commitment to compliance with the law”
• Organizational leadership is responsible for compliance & understanding the organization’s compliance status
• Provides elements of an effective compliance program
2. DHHS Model Compliance Plans
• 14 model plans published for health care related entities since 1995
• DHHS plans to issue guidance for NIH grant recipients in FY05
• Contain 7 elements of an effective compliance program
7 Elements of an Effective Compliance Program
1. Compliance Officer & Compliance Committee2. Compliance Plan3. Training and education4. Effective lines of communication (hotline)5. Internal Monitoring & auditing6. Enforce standards7. Respond promptly to detected problems
2005 DHHS Office of the Inspector General Work Plan Implementation of select agent regulations by University
laboratories
Time and effort reporting compliance
Privacy of medical records of persons participating in NIH-funded clinical trials
Review of adverse event reports by IRBs
Pursue False Claims Act cases against institutions which receive grant funds from NIH & other PHS agencies
UNMC Compliance Program Structure• Compliance Officer position created in Jan 04
– Reports to Vice Chancellor of Academic Affairs
• UNMC has subject matter experts in several areas who are responsible for implementing subject-specific programs (see list)
• Compliance dept provides structure; ensures compliance risk areas are being addressed; investigates concerns
• See Compliance link on UNMC homepage • Compliance Committee created in Jun 04
UNMC Compliance Committee Members
Dr. Peter Gwilt, COP Carol Kirchner, B&FDr Susan Noble Walker, CON Deb Vetter, SP AdministrationDr Mike Molvar, COD Gail Paulsen, IRBDr Ira Fox, COM Matthew Winfrey, EppleyDr Wayne Stuberg, MMI Sharon Welna, IT ServicesJohn Russell, Human Resources Nick Combs, Facilities
Rick Spellman, Assoc. Gen Coun. Kathy Carlson, Compliance Leonard Agneta, IP Office Sheila Wrobel, Compliance
Marci Baker, UMACindy Owen, The Nebraska Medical Center
UNMC Compliance Hotline Established
• One of many channels available to communicate compliance concerns
• See UNMC Policy 6108, “Compliance Hotline Policy & “Reporting Compliance Issues” poster
• National Hotline Services; operates 24 hours a day/7 days a week
• Reports can be made anonymously • Caller can receive a response to concerns • Phone Number: 1-866-568-5430
36 Functional Areas Assessed to determine Compliance Status
• Questionnaires completed by subject matter experts – Assessed regulatory requirements– Identified oversight committees– Monitoring conducted to verify compliance
• Reviewed by Compliance Committee (in progress)
• Corrective action plans developed as needed
Conflict of Interest Committee Created
• Dr. Crouse is the chair
• He will explain more later!
Several New/RevisedPolicies & Procedures
• UNMC Compliance Program • Government Investigations• Research Integrity • Code of Conduct (draft) • Appropriate Use of Human Anatomical Material
(draft) • Contracts (draft)
Located in UNMC on-line
Policies & Procedures manual
Examples of Compliance Initiatives
• Clinical Trial Research Billing Work Group• Identified by Medicare Fiscal Intermediary as area needing
improvement• Tools developed to improve communication across continuum
so grants & third party payers are properly billed • Education & pilot of new tools in selected areas in May 05
• Sponsored Programs Work Group• Improve effort reporting, cost sharing & cost transfer systems • Develop consistency across departments• Provide education on proper procedures
Compliance Strategy • See UNMC Compliance Strategy handout • 2005-06 goals:
– Develop monitors in risk areas– Provide UNMC leadership with summary of
indicators
• Incorporate compliant systems into everyday work—make it easier for UNMC staff to do the right thing
• Provide education on complex areas
Our Responsibilities
• Understand and follow laws & regulations related to our duties
• Ask questions if we do not understand regulatory requirements
• Report conduct that may violate the law
Compliance is vital to maintain UNMC’s reputation of integrity & excellence in teaching, patient care and outreach.
Areas of Compliance
• Human and Animal Research
• Sponsored Programs Administration
• Conflict of Interest
• Panel Discussion (Questions & Answers)
Human and Animal Research Compliance
Gail A Paulsen, RN, BSN, CCRC
IRB Compliance Coordinator
Human Subject Research
HHS Definition of Human Subject
Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains (1.) data through intervention or interaction with the individual, or (2.) identifiable private information.
45 CFR 46.102(f)
HHS Definition of Research
Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.
45 CFR 46.102(d)45 CFR 46.102(d)
UNMC Institutional Review Board (IRB)
The IRB must review and approve all human subject research conducted by faculty, students, staff or others at UNMC, UNO, and The Nebraska Medical Center.
If there is any intent to present or publish outside the “walls” of this Institution, IRB approval must be obtained.
Additional Review Requirements
• Eppley Cancer Center Scientific Review Committee (SRC): Review all cancer related studies conducted by UNMC faculty.
• Pharmacy & Therapeutics (P&T) Committee: Review of all research proposals involving investigational or marketed drugs.
• Institutional Biosafety Committee (IBC): Review all research involving recombinant DNA.
**Where applicable, IRB approval is contingent upon approval by these committees.**
Federal Regulations Guiding Human Subject Research
HHS regulations under 45 CFR 46 Subpart A (Common Rule) Subpart B (Pregnant Women & Fetuses) Subpart C (Prisoners) Subpart D (Children)
FDA regulations under: 21 CFR 50 (Informed Consent) 21 CFR 56 (IRBs) 21 CFR 11 (Electronic Records & Signatures) 21 CFR 312 (Investigational New Drugs) 21 CFR 812 (Investigational Device Exemptions) 21 CFR 814 (PMA of Devices)
Federal Agency Compliance Monitoring
• HHS Office of Human Research Protection (OHRP)
• Food and Drug Administration (FDA)• Office of the Inspector General (OIG)
Why is there increased emphasis on compliance?
Jesse Gelsinger dies September 17, 1999.
Gene Therapy Goes on Trial
Is this the future?
• Increased oversight by federal agencies.
• Increased fines and penalties for noncompliance and research misconduct.
• Increased incidents of closure of human subject research programs and loss of federal funding.
• Loss of public trust.
Questions about IRB requirements?
• Visit the IRB website at: www.unmc.edu/irb.
• Call the Office of Regulatory Affairs at:
559-6463
Research Involving the Use of Animals
Ethical “heart” of the debate
Animals are exploited by scientists in research.
vs.
Animal research is necessary for advancement
of science and human welfare.
Regulations Guiding Research with Animals
The 1989 Animal Welfare Act (AWA) regulations were issued to enforce the revised animal welfare act of 1985 (PL 99-198).
(USDA) AWA regulations require research facilities to establish Institutional Animal Care and Use Committees (IACUCs). Requirements similar to the PHS policy.
Importance of the IACUC
The IACUC helps protect the ability of investigators to use animals in research. The IACUC is society’s gatekeeper.
The IACUC Ensures
Use of a live animal model is required
Number of animals to be used is minimized
Pain, discomfort, distress is avoided or minimized
The research has sufficient scientific value
The ethical cost-benefit relationship is acceptable
Protocol approved
Federal Agency Compliance Monitoring
USDA
• Assures compliance with the Animal Welfare Act (AWA).
• Compliance is monitored by active inspection program carried out by veterinary medical officers.
• Serious noncompliance procedures include civil penalties, “cease and desist” orders, or confiscation of animals.
Office of Laboratory Animal Welfare (OLAW)
• Part of the NIH. Responsible for the PHS policy on Humane Care & Use of Laboratory Animals.
• Conducts site visits and evaluates allegations of noncompliance.
• Sanctions for continued noncompliance include exclusion of individual projects to withdrawal of approval of the institution’s Animal Welfare Assurance.
Questions about IACUC requirements?
• Visit the website at:
www.unmc.edu/iacuc
• Call the Office of Regulatory Affairs:
559-3573
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Sponsored ProgramsCompliance
Carol Kirchner
Stewart Abelbeck
Crystal Miller
Sponsored Programs Compliance
• Set up
• Management
• Closing
Life Cycle of a Grant/Contract
Set-up
• Process
• Cost Share
• Institutional Base Salary
Process
SPAdministration – Process
• Verify accuracy of documents– Award documents– Internal Budgets– IRB– IACUC– IBC
• Assign WBS#• Prepare checklist(s)• Communicate with SPAccounting and
department
SPAccounting – Process
• Entered in SAP
• Budget
• Payroll Funding Changes
• Cost Sharing
SPA Accounting - Process
• Billing
• Cost Transfer Forms
Cost Share
SPAdministration – Cost Share
• Verify cost share source
• Track cost share effort
• Discourage unnecessary cost share
• Advise department’s selection of cost share times
SPAccounting – Cost Share
• Recording and Tracking Cost Share
- Cost Share Cost Center (Companion Account)
- Cost Share Table
• Financial Reporting
Institutional Base Salary
SPAdministration – IBS
• Verify– Salaries– Employee status– Salary components
• Wage codes• UMA• VA
SPAccounting – IBS
• Payroll Charged
• Effort Reporting
Federal Regulations
• Office of Management & Budget (OMB) Circulars– A-21– A110– A-133
• Establish cost principles, administrative requirements and audit requirements
Cost Accounting Standards
• Consistent – like expenses must be treated the same in like circumstances
• Reasonable – a prudent person would have purchased this item and paid this price
• Allocable – expenses can be allocated to the activity based on benefit derived, cause and effect or other equitable relationship
• Allowable – not specified as unallowable by sponsor guidelines
Allowable
• Reasonable
• Given consistent treatment
• Conform to limitations and exclusions set forth in OMB A-21
• Does the award notice have any special limitations?
Unallowable Costs
• UNMC Unallowable Costs Policy #6013
• Two Categories:– Typical Unallowable Expenses
• Alcohol• Food• First-class airfare
– Typical Unallowable Activities• Fund-raising• Parties and entertainment
Effort Reporting
• Committed Effort
• Managed Effort
• Expenditures
• PARS
• Effort Certification
SPAdministration – Effort Reporting
• Committed Effort– As promised in the application
• Managed Effort– Change during the course of the award
• >25%• <25%
SPA Accounting – Effort Reporting
• Salary Expenditures
• PARS
• Effort Certification
Close Out and F&A Costs
• Revenue• Residual Funds• Approval of F&A waivers or reductions• Allowable Charges• Balancing accounts• Final Reports
– Technical– Financial
• Closing in SAP
SPAdministration - Revenue
• Revenue– Reporting
• Board of Regents• Public Relations • Strategic Plan Reporting
• Process– Reduction or Additional Funds Budgets– Close in SPAdmin. Database and forward to
SPAccounting– Terminal Close-outs only
SPAccounting - Revenue
• Reasonable
• All Revenue Billed & Recorded
• Balance to Budget
SPAccounting – Expenditures
• All charges recorded
• Reasonable
• Allowable– Major Project Designation– Review Charges for Unallowable– Cost Element Group– Cost Transfer Form
SPAdministration – Residual Funds
• Residual Funds– Sponsor guidelines – 25% rule– Approval in excess of rule
SPAccounting – Residual Funds
• Move residual funds minus F&A to 37 accounts
• Return residual funds to sponsor if required
SPAdministration – Final Technical Reports
• Final Reports– Technical reports– Final Invention Statements
SPAccounting – Final Financial Reports
• Financial Status Reports
• Other forms of financial reports
PotentialConflicts of Interest (COI)
and Consultingin Biomedical Research
David Crouse, Ph.D.
May 12, 2005
Why is Conflict of InterestSuch a BIG DEAL?
Pharmaceutical Industry FACTSJAMA 283:373-380, 2000
> Pharmaceutical Industry spends $11 billion/yr on promotion and marketing (1999-2000)
> Nearly $5 billion/yr of that spent by sales reps
> This represented $8,000 - $13,000 per physician in 1999 - 2000
W H Y ???
TO HAVE INFLUENCE!!!
“Financial Indigestion”JAMA 284:2156-7, 2000
“Deans of medical schools and training programdirectors must do a better job of addressing
conflict of interest.
Where professionalism is concerned,they must teach that there is no free lunch.
No free dinner.Or textbooks.
Or even a ballpoint pen.”
Jerome Kassirer, MD - former Editor of JAMA
Entire Issue of May 31, 2003devoted to the relationships
between
“Doctors and theDrug Industry”
The Cover of the JournalDepicts
“Pigs and Reptiles”(including one sick lookingGuinea Pig with an IV line)
British Medical Journal“BMJ”
NEJM 351: 1891-1899, Oct 28, 2004
“The past two years have witnessed extraordinaryregulatory ferment in the area of conflicts of interestinvolving physicians, especially conflicts arising inrelationships with the pharmaceutical industry.Professional regulatory bodies, the pharmaceuticalindustry, and the government have all decided thatphysicians and drug manufacturers need strongeradvice bout appropriate relationships.”
Opening Paragraph
Where do you think that this will go?
What is usually NOT a Financial COI?
1. A fair market wage for the time, effort and skill required to conduct the study.
2. Sponsor coverage of the actual cost of the study.
3. Owning “mutual funds” that have holdings related to the sponsor(s)
4. Some situations of consultation with a sponsor of your research.
Conflict of Interest - NIH Policy
“ … require institutions to:
maintain a written, enforced policy on financial conflictof interest; (UNMC Policy now in REVISION)
inform research investigators of that policy, theassociated reporting responsibilities, and related federalregulations;
report to awarding offices the existence of anyconflicting interest(s) and assure that the interest(s) havebeen managed, reduced, or eliminated in accordance withthe regulations.”
http://grants.nih.gov/grants/guide/notice-files/not95-179.htmlRestated as OD-00-040 in the June 5, 2000 NIH Guide
Conflict of Interest Policy - UNMC
Revised Statutes of Nebraska, Section 49-14, 101
“No … public employee shall use that person’s officeor any confidential information … to obtain financial gain,other than compensation provided by law, for himself orherself, a member of his or her immediate family or abusiness with which the individual is associated…” and,“No … public employee shall use personnel, resources,property, or funds under that individual’s official care andcontrol, other than in accordance with prescribedconstitutional, statutory, and regulatory procedures,or use such items, other than compensation providedby law, for personal financial gain …”
Conflict of Interest Policy - UNMC
RP-3.2.8 Conflict of Interest (RP 54-65)
Section 1: “… the University, while striving to promote
research internally and transfer technology externally,
must safeguard against the use of public funds for private
gain, conflicts of interest, conflicts of commitment, or
interference with university duties in situations involving
faculty, staff, students and the institution itself. The
University must also prevent violation of the tenets of
fundamental fairness.”
Confidential Disclosure of Interest
Submitted withALL
grant and contractapplications
Evaluated by:
Chair, Dean or Director,Vice Chancellor,
& possiblyCOI Committee
Disclosure of Interest Policy
Series of Nine “YES or NO” Questions (expand answer if YES):
> Consulting arrangements with Sponsor [Describe]> Financial remuneration from Sponsor [Amount, Period]> Personal loans from Sponsor or employee of Sponsor [Amount]> Other rewards from Sponsor (gifts, honorarium, etc.) [Describe]> Other relationships with Sponsor (boards, travel, etc.) [Describe]
> Direct or indirect financial benefit to you or immediate familyas a result of agreement with Sponsor [Describe, Amount]
> Ownership by you and immediate family, in aggregate greaterthan 5% or greater than $2,000 in equity of Sponsor’scompany OR a competitor [Describe, Amount]
> Sponsor ownership or rights to IP [Describe]
> Restrictions on dissemination of results [Describe]
Outside Employment Policy
Full time faculty are “... encouraged to engage in
professional activities outside the University
as a means of broadening their experience and
keeping them abreast of the latest developments
in their specialized fields; provided such activities
do not interfere with their regular duties at the
University, or represent a conflict of interest.”
BOR Bylaws 3.4.5
Permission to Engage inProfessional Activity Outside the University
SubmittedPRIOR TO
participationin outsideactivity.
Evaluated by:
Chair,Dean or Director,Vice Chancellor
& possiblyBOR
Outside Activity Permission NOT REQUIRED for:
> Honoraria for speaking engagements at professional meetings or in other academic settings
> Payment of expenses for travel to professional meetings, CME sessions, study sections, etc.
> Serving on the Advisory Board, Editorial Board, etc., for a professional organization, journal or academic institution
> Royalties for books or similar products of your academicprofessional activity
> Incidental and minor use of university facilities and resources (receiving e-mail or calls, library access, etc.)
> Unpaid volunteer professional activities
Outside Activity Permission IS REQUIRED for:
> Honoraria for speaking/consulting activity at the workplace of a pharmaceutical company
> Payment of expenses for travel to a pharmaceutical company workplace
> Serving on a Scientific Advisory Board or Governing Board of a pharmaceutical company
> Recurring and major use of university facilities and resources (sending e-mail, mail or making calls; copying at University cost; assigning a secretary/technician to support your consulting related work without compensation)
> Paid professional activities: Expert witness; running an editorial office at the University; industry CONSULTANT)
Outside Activity Requiring BOR ApprovalPRIOR to Engaging in the Activity
(a) Accept retainer fees or other remuneration on permanent or yearly basis as a professional consultant;
(b) Accept professional employment requiring more than an average of 2 days/month during their full-time employment;
(c) Charge fees for work performed in University buildings with University equipment and materials;
(d) Provide professional services for remuneration to departments or agencies of state government.
Personal Consulting Contracts
> Obviously allowed, even encouraged
> Disclosed on “Professional Outside Employment” form
> Hard for UNMC to fully oversee
> Language in such contracts is FACULTY responsibility
> Vice Chancellor’s Office or IP Office will review if asked
> Income from such contracts is YOUR responsibilitywith respect to tax implications
Conflict of Interest or CommitmentThe focus of many agencies
Recent Reports and Recommendations from:
> Food and Drug Administration; Mar, 2001
> Association of American Universities; Oct, 2001
> Intl. Committee of Medical Journal Editors; Oct, 2001
> US Gen Acctg Office; Nov, 2001 & Nov, 2003
> Assoc of American Med Colleges; Dec, 2001 & Oct 2002
> National Institutes of Health (Draft Rpt): May 5, 2004
> University of Nebraska; Fifth Version in Review now
• PHS Regs on COI at 42 CFR, Part 50, Subpart F & 45 CFR, Part 94
http://grants.nih.gov/grants/policy/emprograms/overview/ep-coi.htm
• FDA Regs on COI at 21 CFR 54,312,314,320,330,601,807,814,860
www.fda.gov/oc/guidance/financial(dis.html)
• NSF Policy on COI at 60 FR.132,35809, July 11, 1995
www.nsf.gov/nsf/nsfpubs/gpm95/ch5.htm#ch5-6
• AAU Report and Recommendations on COI , October 2001
www.aau.edu/research/COI.01.pdf
• GAO Report on COI to US Senate, November 2001
www.gao.gov/new.items/d0289
• AAMC Policy and Guidelines on COI, December 2001
www.aamc.org/members/coitf/
COI on the Web
Break
• Refreshments
• Class of 2005 Photo Shoot
Human Resources
Compliance Role
• Compliance Supports Strategic Objectives
– Employee Satisfaction and Commitment– Reducing Turnover– Increasing campus diversity (under-
represented minorities)
Major Federal Employment Laws
• Equal Pay Act• Title VII, Civil Rights Act• Executive Orders 11246, 11375• Age Discrimination in Employment Act• Vocational Rehabilitation Act• Pregnancy Discrimination Act• Americans with Disabilities Act• Homeland Security Act• Immigration Reform & Control Act• Fair Labor Standards Act
Immigration Reform & Control Act
• Authorization for Employment• Form I-9 Receipt and Maintenance Procedure
– Review of Bold Font on Procedure
Obligation:• Timely and Complete forms• Follow-up with contacts from Staffing• Exposure from violations is significant
Fair Labor Standards Act
• Establishes guidelines and rules for those jobs which are “non-exempt” from the regulations:– the keeping of time records– the payment of overtime – the minimum wage
• New rules published April 23rd
– Defining who is “exempt” and who is “non-exempt” from the regulations
Summary of Changes
• Modified Salary Test– An increase in the “threshold” annual salary level to
$23,660, which, if below, the employee must be classified as non-exempt from the FLSA regulations
• Revised “Duties” test– Hire and fire, and/or, make significant
recommendations– Discretion and independent judgment exercised with
respect to matters of significance– Enhanced examples of activities
Implications?
• NACUA suggest the DOL “targeting” academic institutions
• DOL has established audit teams
• NACUA and other professional/legal firms and services advise immediate attention and action to assure compliance
FLSA Record keeping
• All non-exempt employees must complete weekly time sheets
• All hours worked must be recorded– Authorized or Unauthorized
• Hours worked over 40 in one pay week must be paid– Overtime premium, or– Compensatory Time
• Covered employees must accurately account for the overtime hours worked, even if compensatory time will be taken
• Overtime =– OTD– CME– CMU
• Significant liability exposure to the campus
FLSA Record keeping (Continued)
FLSA: New Campus Developments
• Student Scholars– Not exempt from FICA taxes
• Other Hourly Workers
• Other Monthly Workers
• Graduate Assistants– Research– Teaching– Other
FLSA: New Campus Developments• Audits will be conducted beginning this year• Resources are available to answer questions
you may have
Where to go…
• Recruiting/Selection Actions– Rod Kelly 5905; Sandra McKenzie 5906
• Compensation Actions– Rod Kelly 5905; Alice Weyant 5913; Jen Maly
4102;
• Career opportunities decisions– Rod Kelly 5905; Sandra Leslie 5910
• Reduction-In-Force– Sandra Leslie 5910; Rod Kelly 5905
• Hostile Work Environment– Sandra Leslie 5910
• FLSA– Rod Kelly 5905; Alice Weyant 5913; Jen Maly
4102
• Discrimination– Sandra Leslie 5910
Where to go…
Environment and Safety
Occupational Safety & Health Administration • OSHA does not have jurisdiction related to the
University but it does for the Hospital.Means that UNMC is not subject to OSHA fines “They have ways of assuring compliance”
• Under state regulations we are required to comply with OSHA regulations.
• Many grants and federal funding is subject to compliance with OSHA and EPA regulations
Safety
Safety
OSHA’s General Duty ClauseEach employer shall furnish to each of their employees employment and a place of employment which are free from recognized hazards that are causing or are likely to cause death or serious physical harm to their employees.
• Safety Concerns– Do not ignore - it does not go away it only gets worst– New Employees need to know who and how to report
concerns
• Risk loss of accreditation (JCAHO, CAP, etc.) • Risk loss of governmental contracts & grants
– As a part of the approval process we certify that we are in compliance with local, state and federal regulations
Reporting
Managers Safety Officer
Safety Committee Regulatory Compliance Officer
Safety
We want to know about concerns so they can be addressed - remember to not shoot the messenger.
Section 11(c) of the OSH Act provides protection for employees against In many cases the employee is protected against discrimination because of their involvement in protected safety and health related activity. No person shall discharge or in any manner discriminate against any employee because such employee has filed a complaint or exercised their rights afforded by the Occupational Safety and Health Act
Safety
Nebraska Statute 48-443 Safety committee; when required; membership; employee rights and remedies
• An employee shall not be discharged or discriminated against by his or her employer because he or she makes any oral or written complaint to the safety committee or any governmental agency having regulatory responsibility for occupational safety and health, and any employee so discharged or discriminated against shall be reinstated and shall receive reimbursement for lost wages and work benefits caused by the employer's action.
Safety
Hazardous Communications Standard (a.k.a. Employee Right to know)All employers with hazardous chemicals in their workplaces must have labels and MSDSs for their exposed workers, and train them to handle the chemicals appropriately All employees have a right to know about the hazards associated with the material they are working with.
The MSDS = Material Safety Data Sheet is the place to find this information.
Safety
Lockout/tagout - refers to specific practices and procedures to safeguard employees from the unexpected energization or startup of machinery and equipment, or the release of hazardous energy during service or maintenance activities
Ergonomics – program to reduce and prevent workplace ergonomic injuries, often called musculoskeletal disorders (MSDs). OSHA will conduct inspections for ergonomic hazards and issue citations under the General Duty Clause and issue ergonomic hazard alert letters where appropriate.
Safety
• Indoor Air Quality - work area is making them sick– Ignoring it will not make it go away– “This building makes me sick”
– Have a process that includes IAQ questionnaire to be completed by all in the area.
– Complaints may result from other causes. These may include an illness contracted outside the building, acute sensitivity (e.g., allergies), job related stress or dissatisfaction, and other psychosocial factors
Safety
Personal Protective Equipment
Use PPE appropriate to task
GLOVES
Safety
FIRE CODES • Requirements are vary between types of occupancies• Storage in corridor is not allowed
• File cabinets• Equipment
• Flammable outside of approved storage cabinets of flammable liquids storage rooms limited to a one day working supply.
• Decorations• Not on doors• Not on or attached to fire alarm, sprinkler
heads, etc.• No live trees
Safety
SafetyProof that flammable liquids cabinets work
Safety• Emergency Procedures
– UNMC uses the incident command system of emergency management
– Fire – what to do – Severe Weather – notification and shelter
areas– Evacuation
• “Muster Point” -a predesignated meeting place where staff can check in and be accounted for during emergencies
Latex Allergy
THE SENSITIZATI
ON
• Only powder free latex gloves are allowed– Glove box should say
“powder free”
– If is says “wipe powder after donning gloves” it’s not powder free
• No latex balloons• Latex alternatives
Safety
Incident Reports• When do I complete a
form?
• Where do I go for treatment?
Safety
Environmental
Waste disposal
•A place for everything and everything in it’s place
• If you don’t know – don’t throw
UNMC/Hospital Waste Streams
Collected
Collected at site, removal
contractor notified
Mixed paper,
cardboard, aluminum cans and
scrap metal
collected
Placed in appropria
te container
s
Collected at site in
marked containers
Chemical Safety Office (CSO) notified
Placed in dumpsters/compact
or for landfill
Disposed via predetermin
ed regulatory methods
Picked up and
disposed via predetermined methods by licensed contractor
Disposed through
contractor
Pick up by appropria
te contracto
r
Picked up and
disposed via predetermined methods by licensed contractor
Ordinary
rubbish* 9-
4073
Radiological waste 9-6356
Recycled waste 9-4100
*Includes unregulated fluorescent bulbs and unregulated batteries. **Universal waste includes mercury containing lamps, mercury containing thermostats, batteries (Ni-Cad, mercuric oxide, lithium and lead acid) and certain pesticides. ***Hazardous waste includes chemicals regulated by the EPA, including unwanted aerosol cans and all other mercury containing devices.
Note1: For disposal of all electronic equipment including computers at UNMC, call 9-5899. For disposal information in the hospital, call Purchasing at 2-3340 for non-computer electronic equipment and IT at 2-3294 for computer disposal questions.
Chemical Safety Office
(CSO) notified
Picked up and
disposed via predetermined methods by licensed contractor
Computers &
electronic equipment containing
circuit boards and monitors
Disposed through
computer /
electronic equipment recycler
EPA Regulated
chemotherapy
waste 9-6356
Hazardous
waste *** 9-6356
Universal Waste ** 9-6356
Computer/ electronic
equipment See note 1
Regulated Medical Waste 9-7315
Dangerous Goods“INCLUDES ANYTHING WITH DRY ICE”
• Biohazard or chemical capable of posing significant harm, offered for shipping• “Shipper” needs training
• Includes diagnostic specimens
• YOU ARE NOT QUALIFIED TO PACKAGE OR TRANSPORT
Chemical Handling
• Labeling
• Storage
• Disposal
Mercury SpillPink Lemonade
Case Studies
InformationSafety Inspections
– Patient Care Areas– Laboratories
• Pre survey questionnaire– Office/General (under development)
• Resources (Phonebook, ID Reference Cards – Coming in the future –EPM)
Emergency / Safety Tab (RED)
Telephone directory
ID Badge reference card
Emergency Procedures
Manual
Resources
Safety Staff
John Hauser
Safety Officer
9-7315
Larry Nelson
Safety Specialist
9-6690
Robert Huffman
Safety Specialist
2-3411
Contracts
Sheila Wrobel, JD, MBA
UNMC Compliance Officer
What is a Contract?
• An agreement between 2 or more persons which creates an obligation to do or not to do a particular thing (Black’s Law Dictionary)
• 3 basic required elements: offer, acceptance, consideration (benefit accruing to one party)
• Contracts can be called different things: agreement, memorandum of understanding, etc-- it’s the substance of the arrangement that counts.
• Contracts can be oral or in writing; but some oral contracts are not enforceable.
• Get it in writing!
UNMC Contracts Policy
• Authority to Approve & Execute Contracts – Executive Memoranda 13 & 14 procedures specify UNMC
signature authorities by type of contract – Do not sign contracts if you do not have the authority to
sign them– Many contractual provisions are required or recommended
to protect UNMC interests– Subject matter experts in functional area of contract should review complex contracts prior to signature; obtain legal
counsel review as necessary
• Contract Repositories• Independent contractor template
Privacy & Information Security
Sharon Welna Information Security Officer
&Sheila Wrobel
Privacy Officer
Regulatory Overview An alphabet soup of acronyms: (F-G-H)
FERPA -- GLBA -- HIPAA
1. FERPA: Family Education Rights & Privacy Act – Federal law that protects the privacy of student
education records – Directory information considered public and may be
disclosed without authorization• Name, current address, permanent address, year at the
University, and academic major field of study• Campus security or police reports considered public• Source: NU Board of Regents Bylaws 5.6
– Questions??: contact Student Services
Regulatory Overview
2. GLBA: Gramm-Leach-Bliley Act
• Governs financial institutions, including universities that manage student financial aid
• Covers student financial information: Information that the university obtains from the student in the process of offering a financial product or service
• Policy: NU Executive Memorandum 26: GLBA Compliance
• Privacy & security procedures implemented in departments with access to student financial information to meet GLBA requirements
Regulatory Overview
3. HIPAA: Health Insurance Portability and
Accountability Act • 3 Areas:
– Privacy – Security – Electronic Transactions & Code Sets:
governs electronic billing and payment between health care providers and third party payers (10 separate regulations)
Information Privacy & Security Manager’s Responsibilities
• Ensure staff knows that confidential information may only be accessed on a “need to know” basis to perform assigned duties
• Ensure physical environment is secure– Is confidential information visible to visitors? – Are recycling bins available, convenient &
used? – Are departments secure when staff is not
present?
Information Privacy & Security Manager’s Responsibilities
• Respond appropriately to privacy & security issues when staff raise them– Implement corrective action when necessary – Report privacy & security incidents to
Privacy/Security Officer– Coordinate with Employee Relations when
employees breach confidentiality – Use security & privacy articles in UNMC
Today as a department training tool
Information Privacy & Security Manager’s Responsibilities
• Be aware of what data is maintained in your department & how it is safeguarded
• Review who has access and how it is used
• Do you really need the data???
Privacy & Information Security Policies• NU Executive Memorandum 16: Responsible
Use of University Computers & Information Systems
– UNMC 6045: Privacy & Information Security – UNMC 6051: Computer Use & Electronic
Information Security – Employees sign annual confidentiality
statement; network traffic monitored
• NU Executive Memorandum 26: Information
Security Plan: GLBA Compliance
• NU Executive Memorandum 27: HIPAA
UNMC Efforts to Protect Employee Identity
Reduced use of Social Security Number• October 2003 survey • 234 line items identified• Removed from:
• Absence Form• Many reports• Benefit cards effective with new benefit year• Travel Expense form • Evaluate databases within your area
• Exception request form must be completed for all SSN existing or proposed use
Information Security in a Nutshell
• UNMC’s Information Security Strategy:
Protect all confidential information
• Implement uniform information security policies
• Follow best practices of industry
Manager’s Role Exercise
Managers and Leaders• Manager
– Promotes stability and smooth operations– Often maintains the status quo– Focuses on processes (the “how”)
• Leader– Articulates a mission or a goal (the “what”) and
knows how to bring everyone on board to get it accomplished
– Is a “Partner” in the dance, influencing the outcome
Valued Behaviors
• AccountabilityAccepts responsibility for own actions and decisions and demonstrates commitment to accomplish work in an ethical, efficient and cost-effective manner.
• AdaptabilityAdjusts planned work by gathering relevant information and applying critical thinking to address multiple demands and competing priorities in a changing environment.
Valued Behaviors
• Communication Effectively conveys information and expresses thoughts and facts. Demonstrates effective use of listening skills and displays openness to other people's ideas and thoughts.
• Customer and Quality Focus Anticipates and meets the needs of customers and responds to them in an appropriate manner. Demonstrates a personal commitment to identify customers' apparent and underlying needs and continually seeks to provide the highest quality service and product to all customers.
Valued Behaviors
• InclusivenessInteracts appropriately with all business and community partners and members of and visitors to the campus community, without regard to individual characteristics. Demonstrates a personal commitment to create a hospitable and welcoming environment. Fosters respect for all individuals and points of view.
Valued Behaviors
• Occupational Knowledge and Technology OrientationDemonstrates the appropriate level of proficiency in the principles and practices of one's field or profession. Demonstrates a commitment to continuous improvement, to include understanding and application of technology (hardware, software, equipment and processes).
Valued Behaviors
• Team FocusWorks cooperatively and effectively with others to achieve common goals. Participates in building a group identity characterized by pride, trust and commitment.
• LeadershipCommunicates personal vision and the university's vision in ways that gain the support of others. Mentors, motivates and guides others toward goals.
Questions Asked
…Covered
Wrap-up
Wrap-up
• UNMC Regulatory Environment and Structure
• Manager’s Role and Accountability
• Break
• Areas of Compliance– Human & Animal Research– Sponsored Programs
Administration– Conflict of Interest
• Human Resources• Contracts• Privacy/Information
Security• Environment & Safety• Session Wrap-up
The Management SeriesSession VIII
UNMC Manager’s JourneyMay 26, 2005
Thomson Alumni House
3:00 p.m. to 5:00 p.m.
Supervisors Invited
Faculty Staff
Human Resources
“Committed to understanding and delivering
value-added customer service that contributes
to our customers’ overall success”
Your NU Values PartnersBrought to you by:
Reminder! Celebrating…
