|
Definition
of a Ongoing CME Activity
A
regularly scheduled departmental activity (e.g. grand
rounds). Target audience is Loyola/Hines faculty and staff.
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 ongoing educational 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 activities comply with Loyola’s
policies and procedures and are supportive of the CME Mission
and (3) provide recommendations to the activity directors.
Educational
Planning
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 to measure the success of
the activity or to measure the intended outcome of the
activity.
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 the opening remarks. 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 (CME) 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 sponsor is
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. The
activity director is responsible for designing educational
activities to assure the following characteristics are met:
-- Free
of commercial bias for or against any product
--
Presenting
objective information about commercial products
--
Based on
scientific methods generally accepted in the medical community
2. 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. When income from educational grants is
received, expenditures (honoraria, travel, food, etc.) will be
managed from this account.
3. 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
d) activity expenses including, facility rental, supplies,
equipment. Commercial companies may
not pay directly for CME activity expenses (i.e. speakers
travel, honoraria, etc.).
4. 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.
5. 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.
6. 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
7. Printed
activity materials (i.e. syllabus, brochures when possible)
will list all companies providing support for an activity.
8. The
activity director will also acknowledge support in opening
remarks and disclose any financial relationship with any
commercial product(s) discussed in the educational
presentation.
9. Commercial
companies may supply equipment, (eg. surgical "tools" for
laboratory sessions) for participant use in an activity.
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 Credit Approval
Activity
Application
All ongoing educational activities applying for
Category 1 CME Credit must complete the “Ongoing Category 1
CME Activity Application”. The application identifies the
activity’s needs assessment, objectives, teaching methodology,
evaluation/outcomes, activity schedule, and speaker
information. The application (including all required
addendum) must be signed by the activity 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 the activity content and activity process.
The Division of CME must receive the application including all
addendum 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. Approved activities are granted credit for an
initial period of two years, with subsequent approvals
occurring biennially.
Activity Account
The Division of CME administers an activity
account for ongoing activities only if the sponsoring
department receives an educational grant in support of the
activity. When educational grants are received, expenditures
(honoraria, travel, food, etc.) must also be managed from this
account. A CME accounting fee is charge to departments
annually.
Educational Grants
Commercial companies may give restricted or
unrestricted educational grants for ongoing CME activities.
The Division of CME will manage these grants. The Division of
CME will tender a letter of agreement to be signed by the
commercial company representative and the Division of CME
representative.
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.
Completed and
signed disclosure forms must be returned to the CME department
monthly.
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.
Promotional
All activity flyers 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 granted and
the number of credit hours assigned by the Division of CME.
References to "credit having been applied for or processed"
may not be used.
ACCREDITATION
STATEMENT
Loyola University Chicago, Stritch School of
Medicine is accredited by the Accreditation Council for
Continuing Medical Education (ACCME) to sponsor continuing
medical education for physicians. The Loyola University
Chicago, Stritch School of Medicine 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
The Division of CME will track Loyola/Hines
faculty and staff at all Category 1 Ongoing activities. The
Category 1 credit reports can be generated by individual
physicians for any time period that is needed.
Departmental
Responsibilities
Department Contact
A department contact must be named for each
ongoing activity. The department contact will be responsible
for completion of department responsibilities and to serve as
CME contact for administration and monitoring of ACCME
Elements and Policies, data entry, etc. The department
contact is NOT the activity director and should be a staff
person or department manager.
Disclosure
A disclosure response form must be completed
for each activity occurrence and all submitted to CME office
monthly.
Schedules
Schedules must be submitted to CME
office quarterly for the upcoming three month period.
Evaluation
Evaluation of activity must be done quarterly
and an evaluation summary submitted to CME office
Calendar
The ongoing calendar of events will be sent to
each department contact monthly for review. Any changes must
be submitted to CME office by the date indicated on the
correspondence.
Learner Participation
Participant attendance at specific
sessions shall be recorded and maintained in the CME database.
|
