Over the last several years, changes in national CME accreditation requirements have required changes in educational planning, assessment, and documentation for all CME activities. This document will assist you in the educational planning required for a live CME activity by helping you through the SMCS CME credit request process. In order for the Education Team to consider a program for Category I CME credits, the application documents must be complete and returned to Medical Staff/CME Services no later than ninety (90) days before the activity. PLEASE NOTE THAT YOU CANNOT ADVERTISE THE PROGRAM AS RECEIVING CME CREDIT WITHOUT APPROVAL BY THE NOR CAN YOU INDICATE THAT APPROVAL OF CME CREDITS IS PENDING. NOTE: JUST BECAUSE PHYSICIANS ARE ATTENDING DOES NOT MAKE YOUR PROGRAM ELIGIBLE FOR CATEGORY I CME CREDITS. YOUR ACTIVITY NEEDS TO DEMONSTRATE THAT IT WILL IMPROVE PHYSICIAN COMPETENCY AND/OR, PERFORMANCE AS WELL AS PATIENT OUTCOMES. Planning Tips The Education Team should be involved from the start of the planning process. While the CME planner should play an intimate role in completion of the application, the Activity Planning Chair should be particularly involved in completing the sections on Practice Gaps, Needs Assessment, Desired Outcomes and Objectives. Application Documents CME Activity Request Form (http://www.suttermedicalcenter.org/forourphysicians/cme/files/smcscme-activity-request-form.doc) Disclosure Statement By All Speakers, Moderators, and CME Planners (http://www.suttermedicalcenter.org/forourphysicians/cme/files/disclosure-form.doc) If the speaker indicates they have a relevant financial relationship with any commercial company, a copy of the speaker s presentation must be included. The Education Team or designee must determine that the program will be unbiased despite the financial relationship. Depending on the requesting department/entity, the Program Planner at the requesting department may be responsible for assuring the Education Team Chair that all conflicts due to a speaker s relevant financial relationship has been resolved prior to the program. The Content Validation Record Form will be used to confirm there is no conflict. (http://www.suttermedicalcenter.org/forourphysicians/cme/files/content-validation-record.doc) Copy of Flyer/Announcement/Brochure Flyer must include the following information (http://www.suttermedicalcenter.org/forourphysicians/cme/files/flyer-for-smcs.doc): Target audience Course objectives Required wording indicating program has been approved for CME credits Name of company that provided an unrestricted education grant if applicable Speakers, moderators, planning committee and Education Team s disclosure even if they have no disclosures Page 1 of 7
Preliminary budget form Evaluation Form (). The evaluation form must ask the following questions. (Templates located at this website: http://www.suttermedicalcenter.org/forourphysicians/cme/) Commercial support documentation, if applicable Copy of letter/email requesting unrestricted educational grant Copy of letter/email from commercial supporting approving unrestricted educational grant Signed Agreement Honorarium Documentation, if applicable Education Chair approval if honorarium for non-local/regional speaker Independent Contractor Check List Speaker Contractor Agreement W-9 Form The program planner s designated liaison will review the application for completeness. Upon completion, the Education Team Chair will evaluate the application and approve or disallow if the information or content of the program does not meet the standards for Category I CME as set forth by the Institute for Medical Quality/California Medical Association. Completing the Request for CME Describing the Practice Gap(s): What practice needs to be improved? (What problem are we trying to solve?) This is the professional practice gap, defined as the difference between 1) currently observed health care performance/outcomes and 2) those potentially achievable on the basis of current professional knowledge and standards of care. Example: o Description of current practice: Despite the fact that prophylactic mechanical and pharmacological interventions have been shown to decrease the rate of VTE (venous thromboembolism) only one-third of all patients at risk for VTE who are appropriate candidates receive such therapy. o Description of desired or achievable practice: All eligible patients should receive prophylaxis o The Practice Gap is the two-thirds of eligible patients who don t receive inhospital VTE prophylaxis, but should Reference: National Quality Forum: National Voluntary Consensus Standards for Prevention and Care of Venous Thromboembolism: Policy, Prfererred Practices, and Initial Performance Measures. http://www.premierinc.com/safety/topics/venous- Thromboembolism/downloads/5_NQF-VTE-Vote-draft22707b.pdf. Accessed 8/29/11. While practice gaps may seem unavailable for many activities, there are actually a surprising number that are available that can direct planning. Page 2 of 7
Identifying the Practice Gap SUTTER MEDICAL CENTER, SACRAMENTO QA (quality assurance), QI (quality improvement), or PI (performance improvement) data/initiatives from your own department. This is an ideal source for education activities. Never Events: The 2006 NQF report reflects consensus on a list of unambiguous, serious, preventable adverse events. The events on the list are identifiable and measurable, and the risk of occurrence of these events is significantly influenced by the policies and procedures of the healthcare organization. Society Guidelines, Clinical Policies, and Practice Recommendations: These describe optimal or potentially achievable health care performance. While they do not necessarily define practice gaps, they often include descriptions of current practice or practice gaps. Identify the Educational Need(s) What improvement is needed to close the gap? (Why does this gap exist?) Examples: o Knowledge improvements may be needed to close the gap, such as the fact that VTE is a reported quality measure and prophylaxis decreases VTE events, or a description of organizational approaches that are associated with improved compliance. o Competence improvements (the application of knowledge) may be needed to close the gap, such as the ability to select the appropriate medication for individual patients, skills to implement prophylaxis in different clinical settings, the ability to counsel patients, or the ability to work in teams and advocate for organizational change. o Performance improvements may be needed to close the gap, such as system changes to elicit desired behaviors (electronic reminders, preprinted orders, etc.). Identify the Desired Outcome(s) The desired outcome is what you will actually measure after your activity. These should link directly to your Practice Gap. At a minimum, the goal of your activity should be improved competence. Note that while improved knowledge can be an educational need utilized to close the gap, improved knowledge is not considered by the current accreditation system to be a sufficient outcome. Only include the type of outcome that you plan to actually monitor. Examples of desired CME activity outcomes: o Competence: Such as the ability to identify patients eligible for prophylasxis, the ability to counsel patients, or ways to advocate for organizational change This can be measured at the end of the course by intent to change surveys or testing using clinical scenarios o Performance: Such as an increase in the number of eligible patients receiving prophylaxis through implementation of changes such as reminders, or preprinted order sets This can be measured subsequent to the course by a follow up performance survey Page 3 of 7
o Patient Outcomes: Such as decreased rates of VTE or death This is measured subsequent to the course with follow up reporting of changes in patient data, for example with chart audits, or department or hospital performance improvement data Objectives Describe the objectives for each presentation. Remember, these need to be linked to your identified practice gaps when appropriate and written to reflect the desired outcomes in competence, performance, or patient outcomes. Examples: o Describe and implement current guidelines for VTE prophylaxis o Perform an effective problem-focused history and physical examination for evaluation of eligibility for VTE prophylaxis o Describe and implement systems which have been shown to increase selection accuracy and improve rates of implementation for VTE prophylaxis Graphic Example: 1) Practice Gap Ideal Practice Current Practice =100% VTE prophylaxis =33% VTE prophylasxis Practice Gap =66% of eligible pts do not received VTE prophylaxis 2) Educational Need Knowledge Unaware of benefits or methods of prophylaxis Competence Unable to distinguish who is eligible vs ineligible for prophylaxis Performance Does not have prewritten order sets to facilitate implementation 3) Desired Outcomes Competence Identify eligible vs ineligible pts for prophylaxis Performance Prewritten orders sets for prophylaxis are implemented Patient Outcomes Decreased rates of VTE are documented Page 4 of 7
Requirement at Time of Activity Sutter Medical Center, Sacramento has implemented a process where everyone who is in a position to control the content of an education activity has disclosed to the audience all relevant financial relationships with any commercial interest. IF the speaker s or moderator s disclosures were not provided to the audience in writing before the education program, then the speaker s or moderator s disclosure must be verbalized to the audience prior to the program. This can be done as part of the speaker s or moderator s introduction. The CME file in Medical Staff Services must contain proof that disclosures were provided to the audience. Therefore, an affidavit indicating verbal disclosure was provided must be completed by a member of the planning committee or designee who attended the activity and returned to Medical Staff Services along with the sign-in sheet and evaluation summary (example is available upon request). The sign-in sheet must contain the printed name of the attendee, their degree (MD/DO or other), the number of hours the attendee plans to report, as well as their signature, facility name, title of the education activity and date. The program planner or designee is required to summarize all evaluations. The evaluation summary must indicate the number of people who responded to each question (templates available on this website: http://www.suttermedicalcenter.org/forourphysicians/cme/). Important Note: For regular scheduled series ( RSS ) standing education activities, a disclosure statement must be completed by the moderator/expert. The moderator/expert s and planning committee s disclosures must be included on all written announcements. If the disclosures were not provided to the audience in writing before the education program, then the disclosure must be verbalized to the audience prior to the program. The CME file in Medical Staff Services must contain proof that disclosures were provided to the audience. Therefore, a member of the planning committee or designee who attended the program must complete an affidavit, indicating verbal disclosure was provided. Certificate of Attendance Notification of Category 1 CME approval will be sent via email to the CME planner. Attached to the notification will be two CME certificates that are to be distributed to the attendees at the conclusion of the activity. We recommend that you distribute the certificates upon receiving the evaluation form. One certificate is for physicians who are not members of the SMCS medical staff and the other certificate is for non-physician healthcare professionals. The certificate is proof of attendance; no other affidavit of attendance will be supplied. Attendance for SMCS medical staff members will be tracked by Medical Staff Services and a transcript will be mailed out each January. Page 5 of 7
Regularly Scheduled Series Monitoring The CME planner for Regularly Scheduled Series (RSS) will be responsible for monitoring each session of the RSS. The RSS Monitoring Form will be utilized to track compliance with the Standards for each session. Once the CME is approved the planner will initial Criteria 2-7. Then for each session, the planner will write the session date at the top of the column and initial each element present. The RSS Monitoring Form will be turned into Medical Staff Services on a quarterly basis. The Monitoring Form will then be reviewed by the Education Team. If Criteria are not being met an action plan will be developed to improve compliance. Commercial Support IMPORTANT INFORMATION If you are receiving an educational grant from a pharmaceutical or Device Company, a letter of agreement, signed by the commercial company and your organization, is required. The pharmaceutical or device company IS NOT PERMITTED to pay any of the expenses of the program, e.g. honorariums, travel, catering. The facility is allowed to receive an unrestricted education grant and in turn pay all the bills associated with the activity. Any money not used for the CME activity must be paid back to the commercial supporter. "Accredited sponsors are responsible for the content, quality and scientific integrity of all CME activities certified for credit. Identification of continuing medical education needs, determination of educational objectives, and selection of content, educational methods and materials is the responsibility of the accredited sponsor." IT IS YOUR DEPARTMENT'S RESPONSIBILITY TO DETERMINE THE COURSE OBJECTIVES, NOT THE PHARAMCEUTICAL OR DEVICE COMPANY OR IT'S REPRESENTATIVE! "No commercial promotional materials shall be displayed or distributed in the same room immediately before, during, or immediately after an educational activity certified for credit. Representatives of commercial supporters may attend an educational activity, but may not engage in sales activities while in the room where the activity takes place." "Commercial support must be acknowledged in printed announcements and brochures. However, reference must not be made to specific products." Page 6 of 7
Cultural and Linguistic Competency In 2004, the State of California passed Assembly Bill (AB 1195), which mandates the incorporation of activities that address Cultural and Linguistic Competency into all Continuing Medical Education curricula for physicians in the state. All California CME Providers are required to adhere to this law. Your CME activity MUST document and clearly establish how you are going to incorporate cultural and/or linguistic competency into your program. Cultural and/or linguistic competencies can include but are not limited to religion, gender, age, ethnicity and/or language. An example of cultural competency in a CME activity would be an education program regarding diabetes. There is clinical evidence that certain ethnicities are at higher risk for diabetes. To meet this requirement, you will need to describe what type of cultural or linguistic competencies you plan to incorporate in your activity. Ways to meet this requirement is to have the speaker include the competency in his/her lecture or maybe distribution of pertinent literature. Applications without a description on how your activity will incorporate cultural and linguistic competency will be considered incomplete. Revised: 10/08; 8/11 Education Team Approval: 9/2/11 Page 7 of 7