Dannemiller Anesthesiology Review Course

POLICY ON CERTIFICATION OF CME ACTIVITIES

The Dannemiller Memorial Educational Foundation is accredited by the Accreditation Council for Continuing Medical Education (ACCME) as a sponsor of continuing medical education (CME) for physicians. As such, there are certain standards and rules by which the Dannemiller Foundation must operate.

General Information

All CME activities must fall within the scope and intent of the Dannemiller Foundation's Mission Statement. Jointly sponsored activities will adhere to the same stringent standards as directly sponsored activities (see Policy on Joint Sponsorship).

According to the AMA, activities that may qualify for certification of CME credit, should "serve to maintain, develop, or increase the knowledge, skills, and professional performance and relationships a physician uses to provide services for patients, the public, or the profession. CME represents that body of knowledge and skills generally recognized and accepted by the profession as within the basic medical sciences, the discipline of clinical medicine, and the provision of health care to the public."

Documentation for all CME activity planning is crucial. Special attention will be paid to the documentation associated with the following:
  • Identifying general, focused or other need for the activity
  • Development of objectives based on the identified needs
  • Ensuring that the needs and objectives are appropriate for the intended audience
  • Ensuring the educational method to be used is appropriate for the intended audience and the objectives
  • Ensuring the faculty is qualified for the undertaking
  • Ensuring the evaluation instrument will allow the Foundation to determine if the activity accomplished its purpose
Americans with Disabilities

The Dannemiller Foundation will fully comply with the legal requirements of the ADA and the rules and regulations thereof. Brochures associated with meetings will contain applicable language associated with ADA requirements.

CME Certification Procedure

The Dannemiller Foundation will not approve an activity unless there is a valid need for it. Needs may be identified through one or more of the following mechanisms:
  • Recent research from peer-reviewed publications or other literature review
  • Previous evaluation summaries from activities on a similar subject
  • Recommendations of AHRQ or other regulatory bodies
  • New techniques or protocols
  • Expert opinion (experts could be the course chair or other experts in the field)
  • Faculty perceptions
  • Applicable physician survey
  • Medical audits and reviews
  • Consensus report, i.e., roundtable, etc
  • Formal requests by members of the target audience
  • Education Committee/Medical Specialty Review Board (MSRB)
The Director, CME Department will conduct or verify the need for an activity and provide a needs assessment summary through the Executive Director, through the MSRB (if applicable) to the Education Committee. This summary will document or explain:
  • The need for the program (as it relates to the target audience)
  • That the objectives satisfy the stated need
  • That the educational method will permit the objectives to be met and is appropriate for the audience
  • That the faculty is competent in the subject matter and qualified by experience, training and/or preparation to the tasks and methods of delivery
  • That the evaluation instrument will satisfy all ACCME requirements
The MSRB will review and recommend approval/disapproval of all aspects of the needs assessment for non-anesthesia and pain management activities and forward them to the President of the Education Committee for final approval/disapproval. Ultimately, the Education Committee approves/disapproves the participation of the Foundation in the proposed activity. The decision of the Education Committee will be returned to the Director, CME Department, in writing, and include a designation of CME credit. The Executive Director or Director, CME Department may approve changes in the title, statement of need and learning objectives as long as the changes are consistent with the intent of the approved activity. The Executive Director or Director, CME Department may also approve follow-on activities or changes in the educational method, intended audience and method of distribution, as long as the methods allow the objectives to be met and the activity is appropriate for the specialty. The Director, CME Department, working with the faculty, joint sponsors (if applicable), and MSRB/Education Committee, will approve the final amount of credit to be awarded. In addition, the Director, CME Department may authorize the conduct of additional live activities beyond the original proposal if the additional presentations are consistent with the approved activity. When a faculty member is added to the activity, the MSRB Member or the Education Committee will approve him or her. In the event that the Education Committee or the MSRB cannot be consulted, for example, when a presenter at a live presentation becomes ill at the last minute, the Executive Director or Director, CME Department may approve the faculty member. In addition, in some instances, such as when a joint sponsor proposes a satellite symposium at short notice, the Executive Director or Director, CME Department may provide preliminary approval for the activity. This action will allow the activity to be advertised. In such cases, the joint sponsor will be notified that approval is contingent upon the approval of the Education Committee, which still must review and approve the application, i.e., objectives and faculty, and that any changes prescribed by the Education Committee will be complied with.

Faculty

Faculty approved to serve as faculty for Dannemiller sponsored activities should be experts in the field. As a general rule, the proposed faculty should possess the following criteria:
  1. Physicians - physicians train physicians unless the topic is such that a PharmD or PhD would be better able to present the material. Physicians are preferred because they will have knowledge of the educational needs of the audience, as well as an understanding of practice issues and problems related to the subject matter.
  2. Academic and/or research background - a proposed faculty should know the difference between evidence based and anecdotal information. A person with an academic or research background will understand this concept. Moreover, academic physicians will possess an understanding of adult learning concepts.
  3. Published in the area - proposed faculty should be well versed on the topic and being published in the area will demonstrate their competence.
  4. In accordance with the Dannemiller Foundation's firewall policy, no employee of an FDA regulated company may serve as faculty for a Dannemiller sponsored activity.
Completion of the Commercial Support Agreement

The Dannemiller Foundation is responsible for all decisions regarding funding arrangements. Accordingly, the Dannemiller Foundation requires that a formal, written agreement be entered into between the Dannemiller Foundation and the source(s) of funding for the activity provided by a commercial supporter. In the case of jointly sponsored activities, the non-accredited sponsor may solicit funds with the direction of the Dannemiller Foundation, but may not make any representations or commitments to funding sources as to content, choice of speakers, or anything else not allowed by the Standards for Commercial Support. The commercial supporter must be acknowledged in the activity's materials.

Financial Disclosure Statements

All moderators, course directors, faculty and others involved in the CME activity (content) must complete the Dannemiller Foundation's Financial Disclosure Form, or similar form, which must be submitted to the Dannemiller Foundation prior to the commencement of the CME activity (see Policy on Disclosure). The reported faculty disclosure information will be provided to all participants - preferably in writing. If necessary, a Dannemiller/Joint Sponsor representative may obtain faculty disclosure verbally from the faculty member. In this situation, a written record will be made of the communication, the representative will sign it, and it will be filed in the activity folder. In the event a faculty member does not provide disclosure, a statement will be provided to participants of the activity indicating that disclosure by the faculty was requested but that he/she did not provide the disclosure.

Development of Activity Materials

In order to comply with ACCME Essential Areas and policies, activity materials WILL be reviewed by the Dannemiller staff for compliance with the Checklist for Review of Brochure/Invitation; Checklist for Review of Enduring Materials; and Checklist for Review of Live Activity Materials, as appropriate (see Checklists).

Content

In accordance with ACCME policy:
  1. Recommendations involving clinical medicine in a CME activity must be based on evidence that is accepted within the profession of medicine as adequate justification for their indications and contraindications in the care of patients.
  2. All scientific research referred to, reported or used in CME in support or justification of a patient care recommendation must conform to the generally accepted standards of experimental design, data collection and analysis.
Accordingly, content for all CME activities will be developed around clinical guidelines published by authoritative organizations such as Cochrane Review, AHRQ, AAP, AAFP, etc., or material that has been peer-reviewed. If however, new and important information becomes available, it may be inserted into the CME activity, provided it meets some specific criteria. Specifically:
  1. It must be consistent with the peer-reviewed information already available. New information that hasn't been peer-reviewed will not be used to refute peer-reviewed information.
  2. It must be a minor part of the information being presented. An activity will not be developed around new information.
  3. The faculty must be familiar with the information being presented and able to attest that the science involved meets the "generally accepted standards of experimental design, data collection and analysis."
Review of Content

As the ACCME holds the Dannemiller Foundation responsible for the content, quality and scientific integrity of every activity, the Foundation will endeavor to have the content for each activity, especially joint sponsorship projects, reviewed by an expert in the appropriate field (see Content Review Policy).

Activity Participant On-Site Registration, Verification of Participation and Evaluation Mechanisms
  • A record of attendance at each activity must be maintained. Accordingly, attendance at meetings/symposia must be documented. Documentation will normally be accomplished by requiring the participant to complete either a CME Registration/Evaluation Form for short duration meetings or a Verification of Participation Form for meetings of considerable length, i.e., review courses. CME certificates will be issued based on the amount of time the participant spent in the educational offering. A record of participation will be maintained for six (6) years.
  • The receipt of an activity evaluation of an enduring material will serve as verification of participation. In addition, it is the policy of the Dannemiller Foundation that all enduring materials provide for physician interaction. This is normally accomplished by a post-test. The Director, CME Department, however, may waive the post-test requirement for individual enduring materials, provided the enduring material allows for some type of participant interaction. A roster of all participants of each enduring material will be maintained for six (6) years following the expiration date of the activity.
  • Participants of the journals published by the Dannemiller Foundation must complete a post-test for each issue of the journal in order to receive credit for that issue. Certificates will be issued annually. A roster of all participants of each journal will be maintained for six (6) years following the expiration date of the activity.
  • The record of attendance at an audio program, i.e., teleconference should be accomplished through electronic means or by the CME Registration/Evaluation Form. The roster of attendees must be provided to the Dannemiller Foundation, where it will be maintained for six (6) years.
  • Certificates will be mailed to participants no later than four (4) weeks after the conclusion of the activity or receipt of appropriate documentation associated with participation.
Faculty Correspondence

The Dannemiller Foundation will provide each faculty member/author appropriate administrative information regarding the activity.
The faculty letter should contain the following information:
  • The title of the activity, date, and location
  • Overall program objectives
  • The specific title of the faculty's presentation
  • Type of activity (live, enduring material)
  • Anticipated amount of credit to be awarded
  • Intended audience
  • Honoraria (if any) and policies on expense reimbursement
  • The name(s) of commercial supporters (if any)
  • Financial disclosure policies and attached disclosure form
  • Policy on disclosure of discussions of unlabeled, unapproved uses
  • Other ACCME Commercial Support requirements
  • Fair balance requirements
  • Audio-visual and other logistical information and forms to complete regarding the faculty's presentation
In addition, faculty will be informed of the ACCME policy on evidence-based medicine:
  1. All the recommendations involving clinical medicine in a CME activity must be based on evidence that is accepted within the profession of medicine as adequate justification for their indications and contraindications in the care of patients.
  2. All scientific research referred to, reported or used in CME in support or justification of a patient care recommendation must conform to the generally accepted standards of experimental design, data, collection and analysis.
Furthermore, faculty will be required to sign a faculty requirements form which outlines their responsibilities and emphasizes/requires a fair balanced presentation.

For jointly sponsored activities, some of this information may be provided by the joint sponsor.

Distribution of CME Materials

The Dannemiller Foundation may permit CME activities to be disseminated by commercial entities, including commercial supporters. This permission will be in writing (see Policy on the Distribution of CME Activities).

Delineation of Joint Sponsor Responsibilities

For jointly sponsored activities, the joint sponsor must agree to follow the Dannemiller Foundation's policies and procedures and sign the Acknowledgment of Responsibilities of Joint Sponsorship form (see Acknowledgment of Responsibilities of Joint Sponsorship form).

Outcomes

The ACCME and the Foundation are focused on outcome (see Policy on Program Evaluation). The Dannemiller Foundation will contact some participants of selected activities regarding their perception of the activity attended and its impact on their practice. This survey will be in addition to the evaluation form that will accompany each activity. Moreover, faculty and administrative staff at each activity may be asked to critique the educational offering from their perspective. Questions asked in outcome surveys will be tailored to each activity and will be used by the Foundation to evaluate the effectiveness of the educational activity, as well as the effectiveness of the overall educational program. The survey will also be used to help identify educational needs.

Firewall Policy

There must be no employees of a commercial supporter involved in the development of CME activities sponsored by the Dannemiller Foundation. This provision is to ensure that CME sponsored by the Foundation is independent of the commercial interests of the supporter.

Copyright

Appropriate copyright release must be obtained for all CME activities.

Compliance Policy

The Dannemiller Memorial Educational Foundation is committed to full compliance with all applicable regulations and guidelines, including:
  1. ACCME's Essentioal Areas and Policies, as well as the ACCME's Standards for Commercial Support of Continuing Medical Education.
  2. The Office of Inspector General: Compliance Program Guidance for Pharmaceutical Manufacturers.
  3. PhRMA Code on Interactions with Healthcare Professionals.
  4. FDA: Guidance for Industry Supported Scientific and Educational Activities.
  5. AMA: Guidelines on Gifts to Physicians from Industry.
Disclamer

The following statement should be included in all CME activities:
The content and views presented in this educational activity are those of the authors and do not necessarily reflect those of the Dannemiller Memorial Educational Foundation, <commercial supporter>, or <joint sponsor>. This material is prepared based upon a review of multiple sources of information, but it is not exhaustive of the subject matter. Therefore, healthcare professionals and other individuals should review and consider other publications and materials on the subject matter before relying solely upon the information contained within this educational activity.

Summary

As they become available, the following materials must be placed in the Dannemiller Foundation's activity file:
  • Completed financial disclosure forms
  • Completed faculty responsibility forms
  • Completed commercial grant agreement
  • All planning materials and notes regarding the needs assessment and other aspects of activity planning, including hand-written notes regarding conversations with faculty, moderators, and course directors
  • Copies of all moderator and faculty curriculum vitae/biography, if available
  • Copies of all promotional materials, advertisements, and handout materials (syllabus)
  • Copies of all enduring materials
  • Evaluation summary/analysis; and copies of correspondence to faculty, moderators, and course directors providing them with evaluation summary feedback at the conclusion of the activity.
 
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