1. New Faculty Orientation
Office of the General Counsel
Anne K. Garcia
Senior Associate General Counsel
Executive Director of Billing and Research Compliance

2. New Faculty Orientation
Office of the General Counsel
Provides legal guidance and services
Saint Louis University provides coverage for:
Faculty
Fellows
Residents
Medical Students
Other Staff

3. New Faculty Orientation
Coverage is provided for all occurrences that happened during the course and scope of your employment with Saint Louis University.
NOT COVERED:
If injuries result from acts or omissions while under the influence of drugs or alcohol
Criminal or intentional acts
Outside the normal course and scope of your employment

4. New Faculty Orientation
Failure to Cooperate with OGC or Defense Counsel
Insurance:
University is self insured up to $2 million
Excess commercial insurance is provided up to $25 million per year.

5. New Faculty Orientation
Reporting of Incidents
Please report promptly (within hours)
Methods of Reporting
977-URPT (8778)
Slucareincident.slu.edu
Username: INCIDENT
Password: SLUCARE1!
Call the OGC at

6. New Faculty Orientation
Other Helpful Tips
If an attorney calls, please direct them to the OGC at Do not speak with the attorney.
If you receive a BHA or AG complaint direct it to the OGC
Direct any process servers to the OGC
If you are named in a lawsuit, OGC will appoint defense counsel and will notify you of your assigned counsel.

7. New Faculty Orientation
Other Helpful Tips (Continued)
Complete and Timely Documentation
Limit Communications (Discoverable)
Please discuss patient care in the appropriate setting
Need assistance handling a difficult issue/family involve Risk Management

8. New Faculty Orientation
Questions???

9. Office of University Compliance
Physician Billing Compliance
Privacy/HIPAA
Research Compliance
Export Controls

10. Billing Compliance Routine audits of billing records Education
Repayments to CMS and insurance companies
Sanction checks for HSC employees and vendors

11. Privacy/HIPAA Ensure SLU’s compliance with HIPAA privacy regulations
Provide HIPAA education to SLU workforce
Establish and maintain policies regarding privacy
Provide incident response to issues of privacy
Advise staff and management regarding privacy matters
Collaborate with IT to address appropriate safeguarding of information
Privacy Officer: Ron Rawson,

12. Research Compliance Audits/Reviews of Research Divisions
IACUC, IRB, OEHS, etc.
Clinical Trial reviews
Sunshine Act
Research misconduct investigations
Education

13. Reporting Saint Louis University Compliance Hotline
Available and answered 24/7
Caller / reporter may remain anonymous
Protection provided

14. the highest standards of ethical, moral,
The Saint Louis University Office of University Compliance is committed to excellence in corporate integrity and responsibility. This commitment is realized through the integration of education, leadership, and service. Through collaboration the Department promotes
the highest standards of ethical, moral,
and lawful practices. These efforts are
guided by the mission of Saint Louis
University and the Jesuit tradition.
Read Slide
Resource!
Additionally, numerous resources are available at the University to assist with questions, projects, issues and concerns.

15. Questions?

16. Michael Reeves Export Control Officer
Export Controls
Michael Reeves
Export Control Officer

17. Export Controls
Federal Export Control regulations restrict the following exports:
Tangible goods: technology, letters, software, or packages
Communication: and phone conversations
International travel

18. Definitions
“U.S. Person”-Any person who is a citizen of the United States, a lawful permanent resident alien of the United States, a refugee or someone here under amnesty.
“Foreign National”- Any individual or organization that is not a U.S. person.
“Technology Control Plan”-Plan used to manage Export Control restrictions during research project.

19. “Deemed Export”
“Deemed Export”- Discussion with a “Foreign National” or providing them access to controlled research within the borders of the United States.

20. Regulated by 3 federal agencies:
Department of Commerce
Department of State
Department of the Treasury

21. Department of Commerce
Export Administration Regulations (EAR)
15 CFR
“Dual-use” items- commercial goods, services, and technologies that also have military or proliferation possibilities. (i.e. GPS, UAV)
Maintain Commerce Control List

22. Department of State International Traffic in Arms Regulations (ITAR)
22 CFR
Defense items-products specifically designed for military applications (i.e. missiles)
Maintain Munitions list
Recently updated category XV
“Defense Services”
Defense services-The furnishing of assistance (including training) to foreign persons, whether in the US or abroad in the design, development, engineering, manufacture, production, assembly, testing, repair, maintenance, modification, operation, demilitarization, destruction, procession or us of defense articles.

23. Department of the Treasury
Office of Foreign Assets Control (OFAC)
31 CFR
Regulates countries, organizations, and individuals. Targets terrorists, drug traffickers, WMD proliferators, human rights violators, anti-boycott and narcotics (i.e. Marion, IL golf course, )
Maintain sanction lists for the above groups
Independence Day

24. Export restricted and embargoed countries
All three federal agencies maintain lists of restricted and embargoed countries
Comprehensive Sanctioned Countries T-5 (Cuba, Iran,, N. Korea, Syria, Sudan)
Most countries have commodity or information exchange specially restricted (i.e. China, Russia)
China is the highest risk country for the US….most foreign national students from China. We also have students from Iraq, Iran.

25. Fundamental Research Exclusion
Ordinarily published and shared broadly within the scientific community
Generally accessible to the interested public in any form
Applies only to information, not tangible goods

26. Educational
General science, math and engineering commonly taught at schools and universities (ITAR)
Information conveyed in courses listed in course catalogues and in their associated teaching labs of any academic institution (EAR)

27. Bona Fide Employee Is a full-time, bona fide employee;
Is not a national of certain countries;
Has a permanent residence in the US while employed; and
Is advised in writing not to share covered technical data with foreign nationals.

28. Licenses
Current process requires us to seek license for highest level of restriction;
ITAR
EAR
OFAC-Travel to all T-5 and most D-1 countries

29. Areas of Concern for SLU
Downloading software on a restricted computer
Providing technology/technical data via , fax or during a phone conversation or a meeting to a foreign national
Provision of defense services to a foreign person; wherever the services take place
Re-export
Shadowing into restricted spaces

30. Travel Traveling with SLU equipment Temporary Export Certificate
Clean computer
Traveling with personal technology
All technology is on CCL
No research on personal devices while traveling

31. Penalties for Violations
ITAR: Civil Penalties-Up to $500,000 fine
ITAR: Criminal Penalties-Up to $1 million fine, up to 10 years in prison
EAR: Civil Penalties-Up to $250,000 fine
EAR: Criminal Penalties-Up to $1 million fine, 20 years in prison.
OFAC: Civil Penalties-Up to $250,000 fine
OFAC: Criminal Violations-Up to $1 million fine, 10 years in prison.

32. Examples of Violations
Professor J. Reece Roth, University of Tennessee
Guilty of 18 counts of conspiracy, fraud, and violating the Arms Export Control Act
Sentenced to 48 months
UT escaped fine because of cooperation and policy
UM-Lowell- Failed to screen company- $100,000 fine.
ITT-leading producer of night vision goggles -$100 million fine
Boeing $4.2 million and $15 million fines

33. Contact information
Michael Reeves, University Export Control Officer

34. Questions?