Regularly Scheduled Series (RSS)

1. Regularly Scheduled Series (RSS) Required Annual Training

2. Learning Objectives: Upon completion of this activity, participants will be able to: • Plan RSS sessions that meet the needs/gaps of their learners • Implement forms/tools used to monitor each RSS session • Comply with the ACCME standards of commercial support • Identify a conflict of interest and know how to resolve it prior to each RSS session

3. Helpful Hints for Training The forms and documents that are referred to throughout this training can be downloaded at: http://www.cme.hsc.usf.edu/grandrounds/

4. Training Agenda • RSS Annual Planning Process • RSS Session Process • Disclosure of Commercial Support • Post RSS Session Process • Resources

5. RSS Annual Planning Process • There is an Annual Re-Certification, in which the following are identified for the series/year on the Annual Planning Document • Target Audience • Gap Analysis • Needs Assessment • Learning Objectives • Educational Format • Evaluation Method

6. RSS Annual Planning Process Application for CE Credit WHAT, WHERE & WHEN? WHO?

7. RSS Annual Planning Process Application for CE Credit WHY?? Target Audience & Gap Analysis

8. RSS Annual Planning ProcessApplication for CE Credit WHY?? Gap Analysis & Physician Competencies and Attributes

9. RSS Annual Planning ProcessApplication for CE Credit HOW? Learning Objectives & Educational Design

10. RSS Annual Planning ProcessGap Analysis Purpose Best Practice Current Practice The Key to RSS Annual Planning is identifying the GAPS in education or practice. Refer to Gap Analysis Worksheet!!!!

11. RSS Annual Planning ProcessGap Analysis Worksheet The following direct measurement of learners can be used to identify Current Practice (What is):  Clinical practice data  Quality assurance studies  Practice profiles  Gap(s) identified by target audience/experts  Committee findings/audits  Faculty and/or planning committee’s perception of learners’ need  Focus panels (interviews)  Opinion leader interviews  Summary of previous outcomes data Refer to Gap Analysis Worksheet!!!!

12. RSS Annual Planning ProcessGap Analysis Worksheet The following external sources can be used to identify Current Practice (What is):  Public health data  Review of peer-reviewed literature  New information, diagnostic techniques, treatment plans, etc.  Data from mainstream sources including journals and websites  National quality data sources such as The Joint Commission – www:jointcommission.org) Refer to Gap Analysis Worksheet!!!!

13. RSS Annual Planning ProcessGap Analysis Worksheet The following sources can be used to identify Best Practice (What should be):  External Sources such as Practice Guidelines and Specialty Societies  Performance mandates by various external agencies (e.g. the Joint Commission)  Specialty specific requirements as determined by departments and divisions of the medical school and/or affiliate hospitals  Institutional credentialing requirements as mandated by USF Health’s affiliate hospitals  Authoritative national or specialty society guidelines and consensus statements  Core competencies from AGME  Maintenance of Certification (MOC) Refer to Gap Analysis Worksheet!!!!

14. RSS Annual Planning ProcessGap Analysis Worksheet Compare Current and Best Practice to identify the gap(s) that exist(s). The identified gap must be linked to one (or more) of the ABMS core Competences for maintenance of certification 6 Core Competencies • Patient care • Medical knowledge • Interpersonal and communication skills • Professionalism • Systems-based practice • Practice-based learning and the five core competencies as identified by the Institute of Medicine (IOM) report on Healthcare Quality and Safety in America: • Provide patient centered care • Work in interdisciplinary teams • Employ evidence based practice • Apply quality improvement • Utilize informatics Refer to Gap Analysis Worksheet!!!!

15. RSS Annual Planning ProcessStatement of Need Every Series must have a statement of need or “Designation of Intended Result” and has to be measured. Regularly scheduled series would typically have Application of learning as intended result ( i.e. Improvement in Physician Competence), as this is the easiest measure for our audience and volume of activities. Refer to Gap Analysis Worksheet!!!!

16. RSS Annual Planning ProcessWriting Learning Objectives Learning objectives should be written in terms of being: • Measurable and • Behavioral Always Consider the following: What do we want the learners to do as a result of this activity? Do we want them to simply KNOW more? Or do we want to inspire a CHANGE in their practice?

17. RSS Annual Planning ProcessWriting Learning Objectives Following are verbs that are preferred for Effective learning Objectives. Refer to: Blooms Taxonomy (Application-Evaluation Columns)

18. RSS Session Policies Every form that is provided is necessary to meet compliance. Every form for every session is reviewed and monitored by the RSS Coordinator to insure sessions and series are compliant. Policy: If monitoring data indicate that performance in a series or session did not meet a Criterion or Policy, then the RSS Coordinator identifies the problem, implements improvements, and measures the impact of the implemented improvements. • After notification is made by the RSS Coordinator for non- compliance and it continues after 3 additional requests for resolution in a year, it is cause for revoking credit for the RSS.

19. RSS SessionRequired Forms5 Business Days Before Activity • Planning Worksheet • Faculty Disclosure Form (s) • Speaker Letter • Disclosure to Audience • Flyer/Brochure showing accreditation statement and objectives • Disclosure of Commercial Support

20. RSS Session PlanningWorksheet • Disclosure Form for all speakers, planners and others in a position to influence the content of the RSS series • How will disclosure to audience of significant financial interest (or lack there of) take place? • Verbal Disclosure (Written documentation of Verbal Disclosure Form must be completed and submitted to CPD) • Written Disclosure Form distributed to the leaners prior to the activity. • Power Point Slide (copy of slide must be submitted to CPD office) • Letter to speaker regarding their participation in the RSS and their requirements to comply with the Standards for Commercial Support • Copy of Standards of Commercial Support sent with speaker letter • Copy of promotional materials that demonstrate the following information was communicated to the learners in advance of the CME activity/session: • Accreditation Statement and Credit Designation Statement • Global or sub-objectives for the session • Disclosure of Commercial Support (Grants or in-kind contributions) being provided for this activity • Conflict of Interest Resolution Form - completed whenever someone in a position to influence the content of the RSS series have indicated a potential conflict of interest. • Signed Commercial Support Letter of Agreement (if commercial support has been provided for this activity) • Budget Information, including: honoraria, expenses, food and beverage costs, other costs associated with the session • Evaluations • Planned improvements (if applicable). If the session or series warrants improvements, then documentation regarding the changes needed as well as the expected results must be included. • Consideration has been given to the potential barriers that could prevent changes in practice • No relevant system barriers have been identified at this time for this activity. • The following barriers have been identified and will be addressed in the educational intervention formulary restrictions insufficient time for implementation of new skills or behaviors lack of insurance reimbursement lack of organization’s support lack of resources policy issues within organization • Consideration has been given to Patient Safety issues • No patient safety issues apply to this activity. • Patient Safety issues will be addressed in the content are attached. Used as a cover sheet/checklist for every activity

21. RSS SessionFaculty 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 Everyone in a position to control the content, must complete a disclosure form

22. RSS SessionFaculty 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 Don’t forget to sign!

23. RSS SessionFaculty Disclosure Form Dear Dr. «LastName»: Thank you for agreeing to serve as a faculty member for USF Health's upcoming medical education activity “Name of Program”which will be held (Date and Place). You are scheduled as follows: (Times and Titles of Presentations) The CME planning committee for this conference formulated the following objectives for the course. Your presentation should encompass these objectives as appropriate: At the completion of this CME activity the participant will be able to: (Insert Course Objectives) If you have any questions concerning these objectives or need clarification regarding the expectations of the planning committee, please contact me. As an accredited CME sponsor, USF Health requires that its speakers comply with the ACCME Standards for Commercial Support. As our speaker you are required to disclose any significant financial interest or relationship that you may have with these companies or the manufacturer(s) of any commercial product/service that is discussed as part of your presentation. To this end, we ask that you complete the enclosed "Disclosure Statement" and return it to me by (Date). The Commercial Support Standards also require that your presentation be free of commercial bias and that any information regarding commercial products/services be based on scientific methods generally accepted by the medical community. When discussing therapeutic options, it is our preference that you use only generic names. If it is necessary to use a trade name, then those of several products must be used. Further, should your presentation include discussion of any unlabeled/investigational use of a commercial product, you are required to disclose this to the participants. Should you determine that you cannot comply with these requirements or any of the provisions of the Commercial Support Standards (see copy enclosed), please call me as soon as possible. Include Letter to speaker outlining program, objectives, accreditation

24. RSS SessionFlyer/Brochure {Title of Activity} Date/Time Location 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 Required on Flyer: Learning Objectives, USF Health logo & Accreditation Statement (verbatim)

25. RSS SessionAccreditation Statement & Designation of Credit Accrediation: USF Health is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. USF Health designates this educational activity for a maximum of 1.0 AMA PRA Category 1 Credit(s)™.  Physicians should claim only the 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} Verbatim includes: Italicized font for AMA PRA Category 1 Credit and trademark symbol

26. RSS SessionAudience Disclosure The speakers (Dr Name) have each signed a disclosure form and indicated they have no significant financial interest or relationship with companies of the manufacturer(s) of any commercial product/service that will be discussed as part of the presentation. Include a speaker disclosure to the Audience addressing any significant financial relation. It can be in the form of Power Point, Written or Verbal – a copy of any verbal is to be included in the packet.

27. RSS SessionDisclosure of Commercial Support PROGRAM NAME Disclosure of Relevant Financial Relationships with Commercial Interests USF Health endorses the standards of the ACCME and ANCC that requires everyone in a position to control the content of a CME activity to disclose all financial relationships with commercial interests that are related to the content of the CME activity. CME activities must be balanced, independent of commercial bias and promote improvements or quality in healthcare. All recommendations involving clinical medicine must be based on evidence accepted within the medical profession. A conflict of interest is created when individuals in a position to control the content of CME have a relevant financial relationship with a commercial interest which therefore may bias his/her opinion and teaching. This may include receiving a salary, royalty, intellectual property rights, consulting fee, honoraria, stocks or other financial benefits. USF Health will identify, review and resolve all conflicts of interest that speakers, authors or planners disclose prior to an educational activity being delivered to learners. Disclosure of a relationship is not intended to suggest or condone bias in any presentation but is made to provide participants with information that might be of potential importance to their evaluation of a presentation. USF Health does not endorse any products or services. Relevant financial relationships exist between the following individuals and commercial interests: SPEAKER AFFILIATION COMPANY RELATIONSHIP It is a must for the speaker to disclose, if they have (or do not have) any Conflict of Interest.

28. RSS SessionConflict of Interest Resolution When your speaker has identified a relationship with a commercial interest (on the disclosure form), a potential conflict of interest exists. This potential COI must be resolved prior to the activity taking place. Submit Conflict of Interest Resolution form with every session packet where a COI has been identified. A Peer Review Form is also to be included for resolving conflict of interest

29. RSS SessionCommercial 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 When commercial support (pharmaceutical or device company) is received, a letter of agreement must be executed

30. RSS SessionCommercial Support Letter of Agreement (pg. 2) 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: Dr. Sutherland is the only authorized signatory on the Commercial Support Letter of Agreement

31. RSS SessionPeer Review Form to Resolve Conflict • Office of Continuing Professional Development • Title of Activity: • Program Number: • Presentation Title: • Were the educational objectives of this presentation accomplished? □ Yes □ No • 2. Have new scientific developments occurred which will alter the present content? • □ Yes □ No If yes, please explain: • Signed: Date: • Printed Name: • Reviewer: Please attach your CV to this form. Thank you! For Any Conflict of Interest a Peer Review Form has to be SIGNED and submitted!!

32. RSS SessionRequired Forms5 business days after the Activity • Original Sign-in sheets • Physician Info Forms • Evaluations • Speaker’s W9/signed T&E form (if applicable)

33. RSS SessionSign-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.

34. RSS SessionMaintaining 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 • USF CPD 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.

35. RSS SessionEvaluations • 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 We are evaluating whether the topic specific objectives Have been met for this session! Don’t forget to change with each session

36. RSS SessionW9, 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

37. ACCME Standards for Commercial Support STANDARD #1 INDEPENDENCE You must ensure that decisions were made free of the control of a commercial interest. • Including, but not limited to, the following: • 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

38. ACCME Standards for Commercial Support STANDARD #2 Resolution of Personal Conflicts of Interest You 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

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

40. ACCME Standards for Commercial Support • STANDARD #3 • Appropriate Use of Commercial Support • Expenditures • USF CPD 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

41. Additional Resources Marsha Moyer, CPD Coordinator assigned to Regularly Scheduled Conferences (813) 974-5984 mmoyer1i@health.usf.edu USF OCPD 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