Definition of a Single CME Activity
A single
(one-time) educational activity focused on a single topic or
discipline (e.g. echocardiography). The target audience is internal
(Loyola) physicians and external (local, regional, national)
physicians.
Loyola University
Chicago Stritch School of Medicine, Division of Continuing Medical
Education (LUSSOM-CME) 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.
POLICIES
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 LUSSOM-CME activities; including
review and approval of continuing medical education activities, (2)
insure that continuing medical education activities comply with
Loyola’s policies/procedures and are supportive of the CME Mission and
(3) provide recommendations to the activity directors.
Education 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 Planning -
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.
Educational Planning –
Content Validity
The
activity must present recommendations involving clinical medicine
based on evidence that is accepted within the profession of medicine
as adequate justification for their indications and contraindications
in the care of patients. All scientific research referred to,
reported or used in the CME activity in support or justification of a
patient care recommendation must conform to the generally accepted
standards of experimental design, data collection and analysis. CME
activities must not promote recommendations, treatment or manners of
practicing medicine that are not within the definition of CME, or are
known to have risks/dangers that outweigh the benefits or be
ineffective in the treatment of patients.
Educational Planning -
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 LUSSOM (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 program
activities. 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. LUSSOM-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). A
commercial interest cannot take the role of a joint sponsor.
Co-Sponsored
Activities
A co-sponsored activity refers to a single CME activity
developed by two CME accredited providers. Co-sponsored activities
must follow the same policies as jointly sponsored activities.
Written documentation (letter of agreement) will indicate which
accredited sponsor will assume responsibility for the activity, and
this sponsor must be clearly indicated on all the printed materials. A
commercial interest cannot take the role of a co-sponsor.
Educational Partner
An educational partner is an institution outside of LUSSOM providing
assistance in the educational planning of a CME activity accredited by
LUSSOM (i.e. communication company, associations). LUSSOM must
control the content and presentations of all CME activities.
Educational partner may assist in planning with oversight and approval
of LUSSOM-CME. A commercial interest cannot take the role of
educational partner.
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
Every individual in a position to control the content
of an educational activity (i.e. activity directors, planning
committee members, speakers, moderators, etc.) must disclose all
relevant financial relationships to LUSSOM-CME. A 'relevant'
financial relationship is any financial relationships occurring within
the past 12 months that create a conflict of interest (i.e.
presentations may include topic for with commercial interest has
products, commercial interest may be providing support for the
activity, etc.). Relationships include but are not limited to:
grants or research support; employee; consultant; stockholder; or
member of speakers bureau. Disclosure information is presented to the
audience in printed handout material. If an individual refuses to
disclose relevant financial relationships, the activity 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. 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.
Activity director
must disclose any financial relationships the Loyola sponsoring
department has with commercial interests 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 activity
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 activity
director must submit a written explanation to the CME Review Committee
when submitting the CME credit application. Honoraria payments will
be processed by LUSSOM-CME. Joint sponsor or designated educational
partner may process payments only with the approval of LUSSOM-CME.
Travel Reimbursement
It
is appropriate for individuals conducting, planning and speaking at
CME activities to be reimbursed for travel expenses incurred as a
result of their role in the activity. Reimbursement will be made
following all LUSSOM travel policies. Reimbursement will not be
processed for spouses or any individuals not directly conducting,
planning or speaking at the activity. Expenses must be submitted with
required reimbursement forms to the CME office for review and
processing. Joint sponsor or designated educational partner may
reimburse individuals only with the approval of the CME office.
Commercial Interest Support
The (ACCME)
Standards for Commercial Support must be followed ensuring
independence of CME activities from commercial interest influence in
any aspect of planning, design, and implementation. The role of the
commercial interest in supporting CME is to provide funding or
'in-kind' support (i.e. equipment, instruments, etc.) for a CME
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
LUSSOM and commercial interest personnel in conducting CME activities:
1.
Independence of Educational Activity
1.1
The
activity shall be focused on education content that is independent,
non-promotional and free from commercial influence or bias.
Information presented about commercial products shall be objective and
based on scientific methods generally accepted in the medical
community.
1.2
LUSSOM
shall maintain full control over:
v
Identification of activity needs and needs assessment;
v
Determination of educational objectives;
v
Selection and presentation of content;
v
Selection of all persons and organizations that will be in a position
to control the content of the activity;
v
Selection of educational methods;
v
Implementation and assuring scientific integrity;
v
Evaluation of activity.
1.3
Commercial interest cannot engage in scripting or targeting points for
emphasis in faculty presentations.
1.4
Commercial interest cannot take the role of non-accredited partner in
a joint sponsorship relationship.
1.5
Commercial interest cannot act as an agent of LUSSOM by providing a
CME activity to learners (e.g., distribution of self-study CME
activities, arranging electronic access to CME activities, etc.)
1.6
LUSSOM
may request assistance of commercial interest in obtaining services of
teachers, moderators or authors (i.e. speakers bureau). Commercial
interest shall not suggest teachers, moderators or authors who are or
were actively involved in promoting the company’s products or who have
been the subject of complaints regarding misleading or biased
presentations.
1.7
Materials that are a part of the activity (i.e. brochures, slides,
abstracts, handouts, syllabi, etc.) cannot contain any commercial
interest advertising, logos, trade names or product-group messages.
2.
Disclosure of Commercial Support
2.1
All
commercial interests supporting an activity will be disclosed to the
learners by LUSSOM prior to the beginning of the educational
activity. When commercial support is 'in-kind', the nature of the
'in-kind' support will be disclosed to learners. Disclosure shall not
include the use of trade names, logos or product-group messages.
2.2
LUSSOM
and commercial interest must follow all ACCME Standards for Commercial
Support with regard to disclosure, conflict of interest resolution and
content/format without commercial bias for all individuals in control
of the educational content of this activity.
3.
Management of Associated Commercial Promotion and Conduct of
Commercial Interest
3.1
LUSSOM/LUMC decisions to buy products and/or services from commercial
interests are not contingent upon the commercial interest's support of
educational activity.
3.2
Commercial interest cannot require LUSSOM to accept advice or services
concerning teachers, authors or participants or any other educational
matters, including content, from a commercial interest as conditions
of providing an educational grant or 'in-kind' support.
3.3
Financial support of educational activity is not to be exchanged for
any LUSSOM/LUMC business.
Specific to
activities held at Loyola University Medical Center Campus
3.4
Commercial exhibits are not allowed at the educational activity.
3.5
No
commercial promotional materials shall be displayed or distributed at
the educational activity.
3.6
Commercial interest representatives cannot attend the educational
activity as a representative of the commercial interest.
Specific to
activities held off site of Loyola University Medical Center
Campus
3.7
Arrangements for commercial exhibits or advertisements cannot
influence planning or interfere with the presentation, nor can they be
a condition of the provision of commercial support for CME activities.
3.8
Product-promotion material or product-specific advertisement of any
type is prohibited in or during CME activities. The juxtaposition of
editorial and advertising material on the same products or subjects
must be avoided. Live (staffed exhibits, presentations) or enduring
(printed or electronic advertisements) promotional activities must be
kept separate from the CME activity.
3.9
Advertisements and promotional materials cannot be displayed or
distributed in the educational space immediately before, during or
after a CME activity.
3.10
Commercial interest representative must wear name tags identifying
them as representative of the commercial interest.
3.11
Commercial interest representatives cannot engage in sales or
promotional activities while in the space or place of the CME
activity.
Specific to computer based activities
3.12
Advertisements and promotional materials cannot be visible on the
screen at the same time as the CME content and not interleafed between
computer 'windows' or screens of the CME content.
Specific to audio and video recording
3.13
Advertisement and promotional materials cannot be included within the
activity. There will be no 'commercial breaks.'
4.
Structure of Educational Grant and Use of Commercial Support
4.1
LUSSOM
must have full knowledge and approve all support received for the
activity.
4.2
Commercial support must be in the form of an educational grant to
LUSSOM (payable to: Loyola University Chicago, Division of CME) or
with the approval of LUSSOM, to the joint sponsor or designated
educational partner.
4.3
LUSSOM
will make all decisions regarding the disposition and disbursement of
commercial support. Payment of all activity expenses will be made by
LUSSOM, or with the approval of LUSSOM, by the joint sponsor or
designated educational partner.
4.4
The
commercial interest shall make no other payments to the activity
director, planning committee members, teachers/authors, joint sponsor
or any others involved with or aspects of the supported activity.
4.5
The
honoraria amount will be decided by the activity director in
accordance with LUSSOM policies.
4.6
All
reimbursements for travel, lodging and personal expenses of teachers
will be paid in accordance with LUSSOM policies.
4.7
Funds
cannot be used to pay travel, lodging, registration fee, honoraria, or
personal expenses for non-teacher or non-author participants of the
activity. LUSSOM may use commercial support to pay these expenses for
bona fide employees and volunteers of LUSSOM, or with the approval of
LUSSOM, the joint sponsor or the educational partner.
5.
Social
Events
5.1
Social
events must not compete with or take precedence over the educational
activity. The appropriateness of the social event is at the sole
discretion of LUSSOM. LUSSOM shall have final authority in approving
and scheduling the production of the social event.
6.
Regulatory Authority
6.1
LUSSOM
and commercial interest agree to abide by all requirements of the
ACCME Standards for Commercial Support, the FDA Final Guidance on
Industry-Supported Scientific and Educational Activities, the AMA
regulations regarding the Physician’s Recognition Award, the AMA
Opinion 8:061: Gifts to Physicians from industry and the AMA Opinion
9.011: Continuing Medical Education, Loyola University Medical Center
Administrative Policies and LUSSOM-CME policies.
Activity Account
The Division of CME administers the financial accounts
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 joint sponsor.
Non-Compliance
LUSSOM 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, joint sponsor or educational partner being
ineligible for accreditation of future activities.
Activity Application
All educational
activities applying for Category 1 CME Credit must complete the
appropriate application for CME credit. 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 activity
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 activity director and the department
chair 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 credit application
and the budget estimate for each activity. The Division of CME must
receive the application including all addendum (i.e. schedule, speaker
list, disclosure forms, etc) and signed budget estimate by the 1st
of the month for review at that month's review meeting.
Approval
Status
The
activity director will receive written correspondence regarding the
activity’s credit approval or denial, as well as, any concerns the
committee may have identified.
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.
Commercial
Interest Support
Commercial interests may provide support to CME activities in the form
of educational grants or 'in-kind' support. LUSSOM-CME will manage
all support and maintain all ACCME standards for commercial support,
as well as, LUMC administrative policies and LUSSOM-CME policies. The
Division of CME will tender a written agreement to be signed by the
commercial interest representative and LUSSOM-CME representative.
Agreement must be tendered between and signed by LUSSOM and the
commercial interest even if support is given directly to the joint
sponsor or educational partner. Agreement must be tendered, signed
and received by the CME office prior to the date of the activity.
Disclosure
Activity director is responsible for obtaining a completed disclosure
response form from every individual (activity director, speakers,
moderators, planning committee members, etc) participating in the
educational activity. Activity director must complete a disclosure
response form for him/herself. The disclosure information will be
presented to the audience in printed handout material. The activity
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 activity director. Activity director must review disclosure
response forms of every individual participating in the education
activity 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 activity 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 activity director, the
department chair must review the disclosure information and identify
any potential conflicts of interest. If a potential conflict is
identified, department chair must take steps to resolve the conflict
before the individual can continue in their capacity as activity
director. If the conflict is not able to be resolved, the department
chair must replace the activity director or postpone conference until
another activity 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 activity 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
activity 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 activity director. If the conflict is not able to be
resolved, the activity 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 activity 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 activity
director and submitted to the CME coordinator.
Accreditation Statement / Promotional
Materials
The Division of CME must approve all promotional
materials prior to printing. All activity brochures/flyers must
contain the accreditation statements (listed below), activity
objectives, schedule, faculty list, target audience, activity
location, and the registration form.
Accreditation
statements must be used only after CME credit has been assigned by
LUSSOM-CME and must be used exactly as printed and in their entirety
in all printed materials. References to "credit applied for" or
"submitted for approval" cannot be made.
ACCREDITATION
STATEMENT (Loyola sponsored activities only)
The Loyola University
Chicago, Stritch School of Medicine is accredited by the Accreditation
Council for Continuing Medical Education 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
Upon completion of activity a Certificates of
Participation are mailed to all participants 2-4 weeks following the
activity. In the case of a joint sponsor or educational partner
involvement in the activity planning, Certificates of Participation
will not be mailed until all policy and procedure elements have been
satisfied.
CME MISSION STATEMENT
Context
The
Division of Continuing Medical Education at Loyola University Chicago
– Stritch School of Medicine serves a Jesuit tradition of academic
excellence in education, research and clinical care that embraces
social responsibility, service to those in need, and respect for
diversity of thought, opinion, and belief.
Vision
At
Stritch School of Medicine, the CME program seeks to see beyond the
traditional administrative and crediting functions of medical
education, and challenges itself to become a catalyst, advocate for,
and a provider of education that promotes change, development and
improvement. We recognize that as a CME program and provider we must
model behaviors that place a premium on quality improvement if we are
to successfully communicate this message and practice to our educators
and learners.
Purpose
We
believe that CME facilitates and promotes the process of lifelong
learning – a process that should help healthcare professionals at all
stages of their professional development acquire the knowledge,
attitude and skills necessary for contemporary medical practice.
Our CME program sees
its purpose as providing high-quality, evidence-based educational
opportunities that are designed to advance physician competence,
enhance practice performance, promote patient safety, and, where
possible, improve patient outcomes in the populations served by the
healthcare providers we educate.
Target
Audience
We
seek to serve not only the educational needs of healthcare
professionals (physicians, allied health personnel, basic scientists,
and researchers) within our institution but the needs of local,
regional, and national healthcare providers and colleagues as well.
Types of Activities
Provided
As a
CME provider at an academic tertiary-care medical center, our
educational activities include department-specific, interdepartmental
and specialty-specific conferences, symposia and seminars. These
events take the form of live courses, live regularly scheduled series,
and live internet activities. The educational design, instructional
method and learning format for each event is chosen to best serve the
educational needs and learning objectives of the planned educational
activity.
Content
Our
activities offer a broad array of educational content targeted to the
needs of the learners. Included among our educational offerings are
updates in clinical medicine and basic science research, reviews of
current or best practice recommendations for clinical care, learning
modules in quality improvement, procedural and communication skill
development exercises, as well as professional development in
bioethics, leadership and patient safety.
Expected
Results
Following an
educational activity, we expect that learners, when surveyed, will
report expanded or reinforced knowledge. We expect that they will
report greater confidence in their approach to clinical problems or
express their intent to change their behavior and apply newly acquired
strategies in their practice. We expect that when observed our
learners will demonstrate competence and an effective use of targeted
skills. Finally, if evaluated within the setting of clinical
practice, we expect performance parameters to show improvement or a
favorable impact on targeted patient outcomes to be demonstrated.
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