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A series activity
consists of multiple meetings (in a defined time period) focused on a
single topic or discipline. The target audience is internal
(Loyola/Hines) physicians and external (local, regional, national)
physicians. However, the actual audience attending must remain the
same for each session.
Loyola University
Chicago, Stritch School of Medicine, Division of Continuing Medical
Education is accredited by the Accreditation Council for Continuing
Medical Education (ACCME) to sponsor continuing medical
education for physicians. The Division of CME has developed the
following policies to guide the planning process and ensure the
quality of each Loyola CME Category 1 educational activity.
Activity Review
All Series
activities are reviewed and approved by the CME Committee. The
committee’s responsibilities are to: (1) provide oversight for the
conduct of Loyola Stritch School of Medicine continuing medical
education activities; including review and approval of continuing
medical education courses, (2) insure that continuing medical
education courses comply with Loyola’s policies and procedures and are
supportive of the CME Mission and (3) provide recommendations to the
course directors.
Needs Assessment
Each activity must identify
the educational needs (knowledge, competence or performance) that
underlie the professional practice gaps of the learners and are the
basis for the educational activity. The needs of the learners are the
basis for developing the learning objectives of the activity. The
activity objectives are best framed using concrete and specific
language that communicates, in active rather than passive terms, the
abilities that learners should acquire as a result of the learning
activity. This in turn allows the participant to evaluate the
activity with respect to their educational needs.
Educational Methodology
The design of the educational
activity should accommodate the identified learning needs and the
stated learning objectives. The methods used should consider the
target audience, knowledge level (skill level) of the participants,
and be appropriate for the activity objectives. All clinical
recommendations must be based on evidence that provides adequate
justifications for their indications and contraindications in the care
of patients.
Activity Evaluation and/or Outcomes
An evaluation method must
be selected and conducted at the conclusion of the activity to
initially measure the success and the intended outcome of the
activity. Three-four months post-activity a second outcome analysis
will be conducted for the activity by the CME office. The purpose of
the second analysis is to establish the extent to which the activity
advanced physician competence, enhanced practice performance or
improved healthcare outcomes in patients. A summary of the results
will be provided to the activity director.
Joint Sponsorship
Joint
sponsorship refers to CME activities sponsored by Loyola University
Stritch School of Medicine (the accredited sponsor) and a
non-accredited institution. Compliance with ACCME standards, Loyola’s
policies and procedures are required. Written documentation (letter
of agreement) will be tendered by both institutions to the
responsibility of activity events. A Loyola faculty/staff member
must be director or co-director of the jointly sponsored activity and
a representative of the Division of CME must be on the activity
planning committee. Loyola Division of CME must approve all activity
announcements (i.e. brochures, journal advertising, etc.) and activity
related materials (i.e. syllabus). All printed materials must carry
the accreditation statements for jointly sponsored activities (see
Procedures – Promotional).
Co-Sponsored Activities
A co-sponsored
activity refers to a CME activity developed by 2 CME accredited
providers. Co-sponsored activities must follow the same policies as
jointly sponsored activities. Written documentation (letter of
agreement) will indicate which accredited sponsors will assume
responsibility for the activity, and this sponsor must be clearly
indicated on all the printed materials.
Accreditation from
Other Disciplines
It is
acceptable for the sponsoring department to apply to disciplines that
do not recognize CME credit (i.e. nursing, social work, podiatry,
etc.) to request accreditation from that entity for an activity. All
inquiries and applications must be done by the sponsoring department.
The Division of CME does not apply to outside organizations for
credit.
Disclosure
Any person
having control of content at sponsored CME activities must disclose to
participants the presence of financial relationships with commercial
companies whose products are discussed in their activity. This
includes course directors, planning committee members, speakers and
moderators. ACCME focuses on financial relationships occurring in the
12 months proceeding the time the individual is being requested to
assume a role in controlling content of the CME activity.
Relationships include: grants or research support; employee;
consultant; stockholder; or member of speakers bureau. Disclosure
information is presented to the audience in printed handout
material. If a speaker refuses to disclose relevant financial
relationships, the course director must disqualify them from being a
part of the CME activity.
Speakers must also
disclose if they are discussing products that are investigational or
not labeled for use under discussion. Presentations by themselves, or
in conjunction with other presentations, must give a balanced view of
the therapeutic options. Use of generic names of products contributes
to impartiality. If trade names are used, those of several companies
should be used.
Course director
must disclose any financial relationships the Loyola sponsoring
department has with commercial companies whose products are discussed
or who are supporting the educational activity.
The disclosure of
a relationship does not suggest or condone bias in any presentation.
Disclosure is to provide participants with information that might be
of potential importance to their evaluation of a presentation.
Conflict of
Interest
The ACCME
defines a conflict of interest as present when a planner, speaker or
author has BOTH a financial relationship with a commercial interest
and the opportunity to affect content relevant to products or services
of that commercial interest. The purpose for identifying and
addressing potential conflict of interest is to ensure a proper
balance, independence, objectivity and scientific rigor of the
educational activity. Any conflicts of interest identified must be
resolved in order for the individual to participate in the activity.
Honoraria
It is
appropriate to give individuals conducting, planning and speaking at
CME activities a reasonable honorarium. The principle for setting
guidelines for honorarium amounts is to compensate those individuals
who contribute to the content of an activity. Honoraria amounts vary
widely due to medical specialty, location of the activity, level of
participation in planning the activity, number of lectures, etc.
Therefore the honoraria amounts are to be determined by the course
director and his/her department chairman. The CME Director and CME
Review Committee will determine whether the honoraria amount is
considered reasonable. If any honorarium exceeds $3000 the course
director must submit a written explanation to the CME Review Committee
when submitting the CME Application.
Commercial Company
Support
The
Accreditation Council for Continuing Medical Education (ACCME)
Standards for Commercial Support of Continuing Medical Education must
be followed regarding commercial influence in the planning, design,
and implementation of CME activities at Loyola University Medical
Center. The role of the commercial company in supporting CME is to
facilitate conduct of an activity by providing funding to support an
activity. Loyola as the accredited sponsors are responsible for the
content quality and scientific integrity of all CME activities
certified for credit. The following policies define the actions of
Loyola and commercial company personnel in conducting CME activities:
1. Commercial
financial support may be used for a) honoraria for activity faculty
(amount decided by activity director), b) travel, lodging, meals for
activity faculty, c) meals, refreshments and receptions provided for
activity registrants and faculty, and d) activity expenses including,
facility rental, supplies, equipment. Commercial companies may not
pay directly for CME activity expenses (i.e. speakers travel,
honoraria, etc.).
2. Inducements
(other than meals or token gifts) are not permissible. This would
include excessive meals or social events for participants; substantial
gifts; or paying travel, lodging, or registration fees for any
activity attendees.
3. Commercial
promotional activities (i.e. exhibits), distribution of promotional
materials (product handouts, brochures, etc.), and attendance of
company representatives are prohibited at educational sessions, meals
or social functions.
4. Commercial
companies may supply equipment, (eg. surgical "tools" for laboratory
sessions) for participant use in an activity.
5. Commercial
company representatives do not have a role in the
following areas of a CME activity a) planning activity content, b)
selection of activity speakers, c) contacting of speakers/faculty, and
d) promotion of products during presentation.
6.
Printed activity materials (i.e. syllabus, brochures when possible)
will list all companies providing support for an activity. The course
director will also make acknowledgment at the activity in opening
remarks.
7. The Division
of CME administers all educational grants for all CME activities and
must be copied on any correspondence between the activity director and
commercial company representatives.
Third Party
Involvement
Any
institution outside of Loyola is considered a third party; these
institutions are commercial companies or communication companies.
Loyola must control the content and presentations of all CME
activities. Educational activities must be free of commercial bias
for or against any product and the activity related educational
materials including speaker's slides must not advance the specific
proprietary interests of a financial supporter or proprietary
company. If scientific research conducted by a proprietary company is
the basis for a presentation, then the research must conform to the
generally accepted standards of experimental design, data collection
and analysis.
Product promotion
must not interfere with the presentation of CME activities and not be
a condition of support for a CME activity. Product promotion may not
be offered to the learner while he/she is engaged in the educational
activity.
Non-Compliance
Loyola
University Chicago Stritch School of Medicine reserves the right to
withhold or withdraw accreditation from any CME activity that is found
to be non-compliant with any of the aforementioned policies and
procedures. Non-compliance may result in sponsoring department and/or
section being ineligible for accreditation of future activities.
Activity Application
All
educational activities applying for Category 1 CME Credit must
complete the “Application for CME Activity Approval.” The application
must be submitted six months prior to the date of the activity. The
application identifies the activity’s needs assessment, objectives,
teaching methodology, evaluation/outcomes, activity schedule, speaker
information, and budget planning form. The completed application
(including all required addendum) must be signed by the course
director and the department chairman and returned to the Division of
CME.
Budget Estimate
CME will
develop a budget estimate based on the budget planning form data from
the application. The budget estimate will be returned to the
sponsoring department for review and approval. The completed estimate
must be signed by the course director and department chairman and
returned to the Division of CME.
CME Committee Review
The CME
committee reviews all activities submitted to the Division of CME for
credit approval. The committee reviews both the "Application of CME
Activity Approval" and "Budget Estimate" for each activity. The
Division of CME must receive the application including all addendum
(i.e. documentation supporting evidence of need, schedule, speaker
list, disclosure forms, etc) and signed budget estimate by the 15th
of the month for review at the next committee meeting.
Approval Status
The course
director will receive written correspondence regarding the activity's
credit approval or denial, as well as, any concerns the committee may
have identified.
Activity Coordination
Series CME
activities are coordinated by the sponsoring department and as a
result the CME administrative fee is reduced.
Activity Account
The Division
of CME administers an activity account for all Series CME activities.
All educational grants from commercial companies will be managed in
this account and a CME accounting fee will be charged. If activity
has no income from commercial company educational grants, the CME
accounting fee is waived.
A per registrant
processing fee is accessed for processing credit records.
Educational Grants
Commercial
companies may give restricted or unrestricted educational grants for
Series CME activities. The Division of CME will manage these grants.
A letter of agreement will be tendered and signed by the commercial
company representative, the course director, and the Division of
CME.
Disclosure
Course
director is responsible for obtaining a completed disclosure response
form from each individual (course director, speakers, moderators,
planning committee members, etc) participating in the educational
activity. Course director must complete a disclosure response form
for him/herself. The disclosure information will be presented to the
audience in printed handout material. The course director must
disqualify any individual refusing to disclose from being a part of
the CME activity.
Conflict of
Interest
Identifying
and resolving conflicts of interest is the responsibility of the
course director. Course director is responsible for obtaining a
completed disclosure response form from each individual (course
director, speakers, moderators, planning committee members, etc.)
participating in the educational activity. Course director must
review each disclosure response form and identify any potential
conflicts of interest. If a potential conflict is identified, steps
must be taken to resolve the conflict before the individual's
participation is secured. If the conflict is not able to be resolved,
the course director must disqualify the individual from participating
in the CME activity.
Methods to resolve
a conflict include but are not limited to:
·
Replace topic to be presented by the individual to one in which a
conflict does not exist;
·
Limit individual's presentation to include areas of the topic that do
not create a conflict;
·
Change focus of topic so content is not about products or services of
the commercial interest that are the basis of the conflict;
·
Limit individual's presentation to data and results of research
allowing another speaker to address implications and recommendations
for clinical care.
In the case of the
disclosure response form completed by the course director, the
department chair must review the disclosure information and identify
any potential conflicts of interest. If a potential conflict is
identified, dept. must take steps to resolve the conflict before the
individual can continue in their capacity as course director. If the
conflict is not able to be resolved, the department chair must replace
the course director or postpone conference until another course
director can be identified.
The CME committee
will examine the disclosure response forms as part of the review
process to grant credit to the activity. Any questions or concerns
identified during the review process regarding conflict of interest
will be referred back to the course director and must be addressed and
resolved before CME credit will be granted for the activity.
If a speaker is
added to the educational activity after CME credit has been granted
the course director must follow the same procedure of obtaining,
reviewing and resolving a conflict of interest. Form is then
forwarded to CME coordinator who will review with the CME director.
Any questions or concerns identified must be immediately addressed and
resolved by the course director. If the conflict is not able to be
resolved, the course director must disqualify the individual from
participating in the CME activity.
In the event a
substitute speaker is appointed the day of the activity, the speaker
must complete a disclosure information form and verbally disclose in
the opening remarks of their presentation. This is the only instance
in which a verbal disclosure is permissible. The course director is
responsible for verifying the speaker does not have any conflict of
interest and that the speaker verbally discloses to the audience.
Documentation of verbal disclosure must be completed by the course
director and submitted to the CME coordinator.
Promotional
All activity fliers must
contain the accreditation statements and acknowledge any unrestricted
or restricted educational grants supporting the activity. It is
permissible to include these statements only after CME credit has been
assigned by the Division of CME. References to "credit having been
applied for" may not be made.
ACCREDITATION
STATEMENT (Jointly sponsored activities only)
This
activity has been planned and implemented in accordance with the
Essentials Areas and Policies of the Accreditation Council for
Continuing Medical Education (ACCME) through the joint sponsorship of
Loyola University Chicago Stritch School of Medicine and
<the non-accredited institution>.
The Loyola University Chicago Stritch School of Medicine is accredited
by the ACCME to provide continuing medical education for physicians
and takes responsibility for the content, quality, and scientific
integrity of this CME activity.|
The
Loyola University Chicago, Stritch School of Medicine designates this
educational activity for a maximum of [number of credits] AMA PRA
Category 1 Credit(s)™. Physicians should only claim credit
commensurate with the extent of their participation in the activity.
ACCREDITATION
STATEMENT (Co-sponsored activities only)
This activity has been planned and implemented in accordance with the
Essential Areas and Policies of the Accreditation Council for
Continuing Medical Education (ACCME) by
<the accredited provider 1>
and <the accredited provider 2>.
The <the names of both accredited
providers> are accredited by the ACCME to provide continuing
medical education for physicians. The
<the accredited provider 1>
takes responsibility for the content, quality, and scientific
integrity of this CME activity.
The
Loyola University Chicago, Stritch School of Medicine designates this
educational activity for a maximum of [number of credits] AMA PRA
Category 1 Credit(s)™. Physicians should only claim credit
commensurate with the extent of their participation in the activity.
Issuing of Category 1 Credit
Upon
completion of activity a Certificate of Participation is mailed to all
participants 2-4 weeks following the activity.
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