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A single (one-time) educational
activity focused on a single topic or discipline (e.g.
echocardiography). The target audience is internal (Loyola/Hines)
physicians and external (local, regional, national) physicians.
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 of CME Category 1
educational activities.
Activity Review
All
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 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 teaching/learning 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 single 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 single 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 sponsored by Loyola University
Chicago Stritch School of Medicine. The role of the commercial company
in supporting CME is to facilitate conduct of an activity by providing
funding or equipment to support an activity. Loyola as the accredited
sponsor is responsible for the content quality and scientific
integrity of all CME activities approved 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. speaker’s travel,
honoraria, faculty dinner, 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 conference 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.
Activity
Account
The Division
of CME administers the financial account for all single CME
activities. All income (registration fees and educational grants)
and activity expenses will be managed from this account. The
sponsoring department assumes fiscal responsibility for CME activity.
In the event income exceeds expenses, funds will be transferred to the
sponsoring department’s Research and Education account; if expenses
exceed income, sponsoring department is responsible for the deficit.
In the case of joint sponsorship, fiscal responsibility may be
negotiated between the Loyola sponsoring department and the outside
organization.
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 appropriate
“Category 1 CME Activity Application”. 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 complete application
(including all required addendum) must be signed by the course
director and department chairman and returned to the Division of CME.
Budget
Estimate
The Division of 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 the 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 “Single Category 1 CME Activity
Application” and the “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
Account
An activity
account will be opened and administered by the Division of CME. At
the conclusion of the educational activity, all income exceeding
expenses will be transferred to the sponsoring department’s Research
and Education account; if expenses exceed income, sponsoring
department is responsible for the deficit.
Educational
Grants
Commercial
companies may give restricted or unrestricted educational grants for
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, the course director, 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.
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
The Division of CME must approve all
promotional materials prior to printing. All activity
brochures/flyers must contain the accreditation statements (listed
below), course objectives, schedule, faculty list, target audience,
course location, and the registration form. 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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