Grand Rounds Compliance:

1. Grand Rounds Compliance: So many forms – So little time – What does it all mean?

2. Objectives: As a result of participation in this activity, participants will be able to: • Understand and utilize the required forms for Grand Rounds, in accordance with the ACCME standards. • Discuss and Implement the rules for commercial support • Implement the procedures set forth by the Office of Continuing Professional Development, to help them monitor compliance • Identify resources to help you achieve these objectives once you return back to your office

3. Our Agenda Today • Introduction • Required Forms • Commercial Support • Resources • Q&A

4. Interesting Facts About OCPD • We provide credit for 49 different Regularly Scheduled Conferences • They each meet weekly, bi-weekly, monthly or quarterly • We provide credit for approximately 800-1000 CME programs each year • We received Accreditation with Commendation by the ACCME in 2002. • We are up for re-accreditation in 2008

5. ACCME Essential Areas & Elements Measurement criteria have been developed for each Element in the Essential Areas to measure whether the accredited provider meets the basic level of accreditation. A provider’s documentation of the measurement criteria will be the ACCME’s primary source of information for determining compliance with the Elements. • Element 1.1: Mission • Element 1.2: Parent Organization • Element 2.1: Planning Processes • Element 2.2: Needs Assessment • Element 2.3: Purpose and Objectives • Element 2.4: Activity Evaluation • Element 2.5: Program Evaluation • Element 3.1: Organizational Framework • Element 3.2: Business and Management Practices • Element 3.3: Disclosure and Commercial Support Non-Compliance Partial ComplianceComplianceExemplary Compliance

6. USF MSSC (OCPD)MISSION STATEMENTElement 1.1: Mission The mission of the University of South Florida Health Sciences Office of Continuing Professional Development (OCPD) is to assist healthcare professionals (physicians, nurses, pharmacists, psychologists, physical therapists, and social workers) to maintain and enhance clinical excellence through the ethical, innovative, and efficient discovery and dissemination of knowledge. The CPD program is designed to meet the needs of healthcare professionals throughout the state, nationally, and internationally. To accomplish this mission the OCPD establishes the following goals: 1. To sponsor, joint sponsor and co-sponsor CE activities which fully comply with the standards of the ACCME, ANCC, ACPE, and APA. 2. To provide qualified staff and the conference management services necessary to achieve quality CE activities. 3. To sponsor educational activities that facilitate the individual departments of the Colleges of Medicine, Nursing, and Public Health obtaining their goals for faculty recognition and clinical education. The scope of the CE effort at the University of South Florida Health Sciences Center encompasses a continuum of education beginning in the immediate post-graduate period and extending throughout the professional practice years. Individual activities vary based on the identified need and course objectives. Activities range from recurring clinical conferences to multi-day specialty symposia which include the production and presentation of seminars, conferences, technology-assisted learning courses, self-instructional materials, media presentations, printed documents and journals which promote and maintain the healthcare professionals pursuit of life-long learning and continuing education. Course directors and speakers for CE activities are primarily from the USF Health Sciences Center and affiliate hospitals who are nationally and internationally recognized experts in their specialties. Guest faculty are used to supplement local faculty and enhance the scope of the CE activity.

7. Required FormsBefore the Activity • Planning Form • Faculty Disclosure Form (s) • Disclosure to Audience • Flyer/Brochure • Speaker Letter • Commercial Support Letter of Agreement (if applicable)

8. Required FormsAfter the Activity • Original Sign-in sheets • Physician Info Forms • Evaluations • Speaker’s W9/signed T&E form

9. Planning Form USF College of Medicine Continuing Medical Education Planning Form for Serial Activities (This form and the faculty disclosure form must be completed for EACH serial presentation and submitted to the CME Office PRIOR to the activity) 1. Activity Title: 2. Presentation Title: 3. Date of Presentation: 4. Location of Presentation: 5. Speaker: 6. Title: 7. Address: 8. Office Phone: 9. Office Fax: 10. Topic (s) to be Addressed:________________________________________________________________________ 11. Learner Objectives: As a result of participation in this CME activity, physicians will be able to: a. b. 12. Faculty Disclosure Form Completed: (Faculty disclosure form must be submitted to the CME Office for each activity regardless of commercial support)  Yes  No 13. How will the audience be informed of any significant financial interest or other relationship the speaker may have with a commercial company? One of the following methods MUST be checked. “Not applicable” is NOT an option!  Verbal Disclosure (you must complete a verbal disclosure form and forward it to us following the presentation)  Written Material  Slide  Other: (copies of written material, slide or other method of disclosure must be forwarded to us following the presentation) 14. Has commercial support been provided for this activity?  Yes  No If yes, list company name(s): 15. Payment instructions: i.e. speaker honorarium (amount), speaker reimbursement (amount)

10. Faculty Disclosure Form Disclosure Statement As a sponsor accredited by the Accreditation Council for Continuing Medical Education, the University of South Florida College of Medicine must insure balance, independence, objectivity and scientific rigor in all its directly or jointly sponsored educational activities. Therefore, anyone who is in a position to influence or control the content of a CME activity must disclose any financial interest or other relationship with a commercial interest producing healthcare goods or services that has a direct bearing on the subject matter of the CME activity. Significant financial interest or other relationship may include such things as grants or research support, employee, consultant, major stockholder, member of speaker’s bureau, etc. that has occurred for any dollar amount over the past 12 months. The intent of disclosure is not to prevent a speaker with a significant financial or other relationship from making a presentation, but rather to resolve any conflicts prior to the CME activity so the learner may participate in a balanced, objective, evidenced-based CME activity. TITLE OF CME ACTIVITY PROGRAM # NAME ROLE IN CME ACTIVITY Speaker Activity Director Planning Committee Author  Other TITLE OF PRESENTATION(S) Check (1) OR (2) and provide the details (Type of Affiliation/Financial Interest, Name of Corporate Organization) in the next section: (1) I, or an immediate family member, including spouse or partner, have no financial relationship(s) relevant to the content of this CME activity. (2) I, or an immediate family member, including spouse or partner, have a personal financial relationship with a commercial interest and have control over educational content about the products of the commercial interest that could be perceived as a real or apparent conflict of interest within the context of this CME activity. (Provide specific information below.) Type of Affiliation/Financial InterestName of Corporate Organization(s)RelationshipActiveTerminatedAdvisory Board or PanelConsultantGrants/Research SupportOther Financial or Material Support (royalties, patents, etc.)Salary, Contractual ServicesSpeaker’s BureauStock/Shareholder (self-managed) I intend to discuss unlabeled/investigational use(s) of a drug(s) or device(s) in my presentation. Yes No Please specify the drug/product and the use (PRINT LEGIBLY). Must be completed Before every New activity

11. Faculty Disclosure Formpage 2 In light of the relationships/affiliations you designate, WE ASK THAT YOU ATTEST THAT: 1. relationships/affiliations will not bias or otherwise influence your involvement in the CME activity 2. practice recommendations that are relevant to the companies with whom you have relationships/affiliations will be supported by the best available evidence or absent evidence will be consistent with generally accepted medical practice 3. all reasonable clinical alternatives will be discussed when making practice recommendations. Additional information may be requested to resolve a conflict of interest. All identified conflicts of interest will be resolved and disclosure made to activity participants prior to the start of the CME activity. SignatureDate

12. Flyer/Brochure {Title of Activity} Speaker: {Insert Name of Speaker} Objectives: As a result of participation in this CME activity, physicians will be able to: {objective 1} {objective 2} {objective 3} This activity has been planned and implemented in accordance with the Essential Standards of the Accreditation Council for Continuing Medical Education through the sponsorship of the University of South Florida College of Medicine.  The University of South Florida College of Medicine is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. The University of South Florida College of Medicine designates this educational activity for a maximum of 1.0 AMA PRA Category 1 Credit(s)™.  Physicians should only claim credit commensurate with the extent of their participation in the activity. This activity is supported in part through an educational grant from {commercial supporter if applicable} Department of Cardiology Grand Rounds PRESENTS

13. Accreditation Statement & Designation of Credit This activity has been planned and implemented in accordance with the Essential Standards of the Accreditation Council for Continuing Medical Education through the sponsorship of the University of South Florida College of Medicine.  The University of South Florida College of Medicine is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. The University of South Florida College of Medicine designates this educational activity for a maximum of 1.0 AMA PRA Category 1 Credit(s)™.  Physicians should only claim credit commensurate with the extent of their participation in the activity. This activity is supported in part through an educational grant from {commercial supporter if applicable}

14. Commercial Support Letter of Agreement (pg.1) UNIVERSITY OF SOUTH FLORIDA COLLEGE OF MEDICINE COMMERCIAL SUPPORT LETTER OF AGREEMENT FOR A CONTINUING MEDICAL EDUCATION ACTIVITY This Letter of Agreement between the University of South Florida College of Medicine (institution) CPD Office (sponsor) and (company) contains the purposes, terms and conditions for which an educational grant in support of continuing medical education (CME) activities is made. (This form must be typed or printed legibly) Title of CME Activity: Location: Commercial Supporter (Company Name/Branch): Address: City, State, Zip: Telephone: Fax: Contact Person: The above company wishes to provide support for the named continuing medical education activity by means of (indicate which option): 1. Unrestricted educational grant for support of the CME activity in the amount of $ 2. Restricted grant to reimburse expenses for: A. Speaker(s) 1. 2. To include: All expenses _______ Travel only _______ Honorarium Only _______ Honorarium amount $ (Determined by the Program Director) B. Support for catering functions (specify): in the amount of $ C. Other (e.g., equipment loan, brochure distribution, etc.) CONDITIONS 1. Statement of Purpose: Program is for scientific and educational purposes only and will not promote the company’s products, directly or indirectly. 2. Control of Content & Selection of Presenters & Moderators: Sponsor is responsible for control of content and selection of presenters and moderators. The Company agrees not to direct the content of the program. The Company, or its agents, will respond only to Sponsor initiated requests for suggestions of presenters or sources of possible presenters. The Company will suggest more than one name (if possible); will provide speaker qualifications; will disclose financial or other relationships between Company and speaker, and will provide this information in writing. Sponsor will record role of Company, or its agents, in suggesting presenter(s); will seek suggestions from other sources, and will make selection of presenter(s) based on balance and independence. 3. Disclosure of Financial Relationships: Sponsor will ensure meaningful disclosure to the audience, at the time of the program, of (a) Company funding and (b) any significant relationship between the Sponsor and the Company (e.g., grant recipient) or between individual speakers or moderators and the Company.

15. Commercial Support Letter of Agreement(pg. 2) 4. Involvement in Content: There will be no “scripting”, emphasis, or direction of content by the Company or its agents. 5. Ancillary Promotional Activities: No promotional activities will be permitted in the same room as the educational activity. No product advertisements will be permitted in the program room. 6. Objectivity & Balance: Sponsor will make every effort to ensure that data regarding the Company’s products (or competing products) are objectively selected and presented, with favorable and unfavorable information and balanced discussion of prevailing information on the product(s) and /or alternative treatments. 7. Limitations on Data: Sponsor will ensure, to the extent possible, meaningful disclosure of limitations on data, e.g., ongoing research, interim analyses, preliminary data, or unsupported opinion. 8. Discussion of "Off-Label" or Unapproved Uses: Sponsor will require that presenters disclose when a product is not approved in the United States for the use under discussion. 9. Opportunities for Debate: Sponsors will ensure meaningful opportunities for questioning or scientific debate. 10. Independence of Sponsor in the use of Contributed Funds: a. Funds should be in the form of an educational grant made payable to USF MSSC (USF Medical Service Support Corporation). Tax ID # 59-2944-683. Checks should be mailed to: USF COM, Office of Continuing Professional Development, 12901 Bruce B. Downs Blvd., MDC 46, Tampa, FL 33612. b. All other support associated with the CME activity (e.g., distributing brochures, preparing slides, etc.) must be given with the full knowledge and approval of the CPD Office. c. No other funds from the commercial company will be paid to the Program Director, faculty or others involved with the CME activity (additional honoraria, extra social events, etc.) The Commercial Supporter agrees to abide by all requirements of the ACCME Standards for Commercial Support of Continuing Medical Education (appended). The Accredited Sponsor agrees to: 1) abide by the ACCME Standards for Commercial Support of Continuing Medical Education; 2) acknowledge educational support form the commercial company in program brochures, syllabi, and other program materials, and 3) upon request, furnish the commercial supporter a report concerning the expenditure of the funds provided. AGREED Commercial Company Representative (name) SignatureDate Associate Dean for USF COM OCPD: Deborah Sutherland, Ph.D. Signature Date:

16. Sign-In • EVERYONE attending the activity must sign in, even those not requesting credit (i.e. nurses, medical students, residents, etc) • Utilizing the bar code sheet will ensure accuracy and expediency of your files – which will be most important when your physicians get their transcripts (January & June) • If the individual is not on the bar code sheet, please have them complete the physician information form. We will add them to the bar code sheet for next time.

17. Maintaining your Sign-In Sheet is Easy! • Delete names by crossing them off the bar code sheet or writing “please delete” next to the name • Add names by sending a new physician information form • Merchal will create a new, updated bar code sheet for you and email it to you. • Save the bar code sheet on your desktop! Unless there are any changes, you can re-print it from your computer each time. Photocopying your barcode sheet repeatedly causes the bar code to blur and not useable.

18. Physician Information Form University of South Florida College of Medicine Office of Continuing Professional Education Physician Information Form The USF Office of Continuing Medical Education provides continuing education category 1 credit to physicians who attend approved activities. The Office of Continuing Medical Education is responsible for maintaining accreditation though the Accreditation Council for Continuing Medical Education, and to uphold USF College of Medicine policies for CME activities. Please complete the following information to assist the Office of Continuing Medical Education in providing quick responses and more accurate service. Please PRINT LEGIBLY OR TYPE LAST 4 DIGITS OF Social Security Number _________ (required for credit tracking) Name:____________________________________________Degree(s)________ First MI Last Academic Position: Professor Assoc. Professor Asst. Professor Instructor Department:____________________________ Specialty______________________ Sub-specialty___________________ Affiliation: ______ USF _____ Moffitt _____ TGH _____ ACH ______ VA OTHER______ Private Practice ______ Fellow/Resident Address: ___________________________________________ __________________________________________________ City/ST/Zip ____________________________________________________ Phone #: (______) _______ - ______________ Fax #: ( ) - Email: __________________@________________________________________________ Signature:____________________________________Date:_____________________

19. Evaluations • USF OCPD Grand Rounds Training • Date:___9/29/06______________ Speaker:____JANINE HARTFIELD_____________________________ • Presentation Title:__GRAND ROUNDS COMPLIANCE: SO MANY FORMS – SO LITTLE TIME – • WHAT DOES IT ALL MEAN? • EVALUATION • Objectives At the conclusion of this activity, the participant will be able to: • Understand and utilize the required forms for Grand Rounds, in accordance with the ACCME standards. • Discuss and Implement the rules for commercial support • Implement the procedures set forth by the Office of Continuing Professional Development, to help them monitor compliance • Identify resources to help you achieve these objectives once you return back to your office • 1. Degree to which presentation met the above objectives • [ ] Poor [ ] Fair [ ] Good [ ] Very Good [ ] Excellent • Activity Rating: • Please evaluate the PHYSICAL FACILITIES • [ ] Poor [ ] Fair [ ] Good [ ] Very Good [ ] Excellent • 3. Please evaluate the USEFULNESS OF INFORMATION TO YOUR JOB • [ ] Poor [ ] Fair [ ] Good [ ] Very Good [ ] Excellent • 4. Please evaluate the CATERING • [ ] Poor [ ] Fair [ ] Good [ ] Very Good [ ] Excellent • 5. Was commercial support provided? • [ ] Yes X No • 6. If yes, indicate supporting company: N/A • Speaker Rating: • 7. Knowledge of Subject • [ ] Poor [ ] Fair [ ] Good [ ] Very Good [ ] Excellent • 8. Overall Presentation • [ ] Poor [ ] Fair [ ] Good [ ] Very Good [ ] Excellent • 9. Responsiveness to questions • [ ] Poor [ ] Fair [ ] Good [ ] Very Good [ ] Excellent • 10. Use of audiovisual aids • [ ] Poor [ ] Fair [ ] Good [ ] Very Good [ ] Excellent • 11. Presentation was free of commercial bias • [ ] Poor [ ] Fair [ ] Good [ ] Very Good [ ] Excellent • Needs Assessment: Suggestions for future presentations

20. W9, Signed T&E, Original Receipts • We can’t pay honorarium for non-USF faculty without a completed W9 form • We can’t reimburse expenses without a signed T&E form and original receipts

21. ACCME Standards for Commercial Support STANDARD #1 INDEPENDENCE The CME Provider must ensure that decisions were made free of the control of a commercial interest. • CME Needs • Educational Objectives • Selection and presentation of content • Selection of all persons and organizations that will be in a position to be in control of the content of the CME • Selection of education methods • Evaluation of the activity

22. ACCME Standards for Commercial Support STANDARD #2 Resolution of Personal Conflicts of Interest The CME Provider must be able to show that everyone who is in a position to control the content of an education activity has disclosed all relevant financial relationships. The ACCME defines “relevant” as financial relationships in ANY amount occurring within the past 12 months that create a conflict of interest

23. ACCME Standards for Commercial Support • STANDARD #3 • Appropriate Use of Commercial Support • The provider must make all decisions regarding the disposition and disbursement of commercial support • 2. The provider cannot be required by a commercial interest to accept advice or services concerning teachers, authors, or participants or other education matters, including content. • 3. All commercial support associated with a CME activity must be given with the full knowledge and approval of the provider

24. ACCME Standards for Commercial Support • STANDARD #3 • Appropriate Use of Commercial Support • Written agreement documenting terms of support • The terms, conditions and purposes of the commercial support must be documented in a written agreement, signed by both the commercial supporter and the provider. • (OCPD can’t deposit the grant check without a signed CSLOA)

25. ACCME Standards for Commercial Support • STANDARD #3 • Appropriate Use of Commercial Support • Expenditures • The provider must pay directly any teacher or author honoraria or expense reimbursement • 2. No other payment shall be given to the director of the activity, planning committee members, teachers or authors, joint sponsor, or any others involved with the supported activity • 3. Social events or meals at CME activities cannot compete with or take precedence over the educational events

26. Common Disclosure Pitfalls • Getting, but not sharing faculty relationships with learners • Not informing faculty of commercial supporters so that disclosure of these relationships can occur • Not disclosing the nature of faculty’s relationships

27. Methods of Disclosure • Written disclosure-Complete the Disclosure of Significant Relationships with Commercial Companies Form and provide a copy to each participant. • Verbal disclosures – (i.e when introducing the speaker), you must still provide us with written documentation that disclosure occurred. Use the Verbal Disclosure Form • Power Point Slide – a slide can be projected prior to the beginning of the lecture that provides the disclosure information. You will need to provide a copy of the slide to us as documentation that this option was used.

28. Frequently Asked Questions about Commercial Support Can a Pharmaceutical Company Pay a Speaker Directly? No. If this happens, CME credit will not be provided for That presentation

29. Frequently Asked Questions about Commercial Support Can a commercial supporter pay directly for food Associated with my activity? No. All Commercial Support must be in the form of a Grant to the provider.

30. Frequently Asked Questions about Commercial Support Can I use a letter of agreement written by a commercial Supporter? Yes. As long as the content is the same as in the USF OCPD’s Commercial Support Letter of Agreement and includes The terms, conditions and purposes of the commercial Support grant.

31. Frequently Asked Questions about Commercial Support Who is authorized to sign the Commercial Support Letter of Agreement? Dr. Deborah Sutherland, Ph.D. Only the Associate VP/Associate Dean of the College of Medicine OCPD is authorized to sign. Without authorized signatures from both parties, The agreement is not considered valid.

32. Frequently Asked Questions about Commercial Support If a speaker presents more than once during the year, Is he/she required to complete Disclosure Information Each time? Yes. The speaker will need to attest to the fact that There has been no change in the last year. This is Typically best done by obtaining a new disclosure form.

33. Frequently Asked Questions about Commercial Support If my activity is not receiving commercial support, Do I have anything to disclose to the learners? Yes. The Standards for Commercial Support Require that the faculty and provider disclose any Relationship that they night have with products or Services that are discussed during the presentations. If there is nothing to disclose, they must say that there Is nothing to disclose

34. Frequently Asked Questions about Commercial Support What are the two parts to disclosure? • Speaker Disclosure • Faculty Disclosure Form that you send to them and they return to you in advance. 2) Disclosure To the Audience Even if it indicates NO relationship at all

35. What do I do when I get back to work? Janine Hartfield, CME Coordinator assigned to Regularly Scheduled Conferences (Grand Rounds) (813) 974-7420 Jahartfi@health.usf.edu Merchal Martin, Program Assistant assigned to Regularly Scheduled Conferences (Grand Rounds) (813) 974-9805 martinM@health.usf.edu USF OCPD Grand Rounds website http://www.cme.hsc.usf.edu/grandrounds Accrediting Council for Continuing Medical Education www.accme.org AMA Resources for CME http://www.ama-assn.org/ama/pub/category/2922.html

37. Please complete an Evaluation • USF OCPD Grand Rounds Training • Date:___9/29/06______________ Speaker:____JANINE HARTFIELD_____________________________ • Presentation Title:__GRAND ROUNDS COMPLIANCE: SO MANY FORMS – SO LITTLE TIME – • WHAT DOES IT ALL MEAN? • EVALUATION • Objectives At the conclusion of this activity, the participant will be able to: • Understand and utilize the required forms for Grand Rounds, in accordance with the ACCME standards. • Discuss and Implement the rules for commercial support • Implement the procedures set forth by the Office of Continuing Professional Development, to help them monitor compliance • Identify resources to help you achieve these objectives once you return back to your office • 1. Degree to which presentation met the above objectives • [ ] Poor [ ] Fair [ ] Good [ ] Very Good [ ] Excellent • Activity Rating: • Please evaluate the PHYSICAL FACILITIES • [ ] Poor [ ] Fair [ ] Good [ ] Very Good [ ] Excellent • 3. Please evaluate the USEFULNESS OF INFORMATION TO YOUR JOB • [ ] Poor [ ] Fair [ ] Good [ ] Very Good [ ] Excellent • 4. Please evaluate the CATERING • [ ] Poor [ ] Fair [ ] Good [ ] Very Good [ ] Excellent • 5. Was commercial support provided? • [ ] Yes X No • 6. If yes, indicate supporting company: N/A • Speaker Rating: • 7. Knowledge of Subject • [ ] Poor [ ] Fair [ ] Good [ ] Very Good [ ] Excellent • 8. Overall Presentation • [ ] Poor [ ] Fair [ ] Good [ ] Very Good [ ] Excellent • 9. Responsiveness to questions • [ ] Poor [ ] Fair [ ] Good [ ] Very Good [ ] Excellent • 10. Use of audiovisual aids • [ ] Poor [ ] Fair [ ] Good [ ] Very Good [ ] Excellent • 11. Presentation was free of commercial bias • [ ] Poor [ ] Fair [ ] Good [ ] Very Good [ ] Excellent • Needs Assessment: Suggestions for future presentations

38. THANK YOU!