Application for LSMS CME Accreditation.doc

Application for LSMS CME AccreditationSection 1 Organizational Information

Name of applicant organization as it should appear on accreditation certificate:1

Chief executive officer of applicant organization:2 Name: 3 Title: 4 Address:

5 Telephone number: ( ) - 6 Fax number: ( ) - 7 e-mail address:

Individual responsible for CME unit and for the material contained within this application:8 Name: 9 Title: 10 Address:

11 Telephone number: ( ) - 12 Fax number: ( ) - 13 e-mail address:

Contact person for application/site-survey:

Check here if the contact person is the same as individual responsible for CME unit.14 Name: 15 Title: 16 Address:

17 Telephone number: ( ) - 18 Fax number: ( ) - 19 e-mail address: 20 Organization Web-Site:

Application for LSMS CME Accreditation 2009

Page 1 of 15

TYPE OF ORGANIZATION

21. Please indicate what classification most accurately describes your organization by placing a check “” next to the most appropriate item.

Consortium/ Alliance Physician Member Organization (Specialty Based)

Health Care Delivery System Physician Member Organization (Non Specialty)

Insurance Company/Managed Care Voluntary Health Association

Not For Profit Foundation (501c3) Other (please specify)

Hospital; number of beds:

Please describe the size of your organization based on the number of physicians on the medical staff or the number of members of the professional organization.

Number of physicians on medical staff:

Number of members:

The CME program of the applicant organization (One Check Per Line)

22 does receive commercial support does not receive commercial support

23 does participate in Joint Sponsorship does not participate in Joint Sponsorship

24 does produce Enduring Material does not produce Enduring Material

25 does produce Journal-based CME does not produce Journal-based CME


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Section 2 Summary of Continuing Medical Education Activities

The summarized data in this table should reflect the listing of the activities requested in the box below it. This summary and the attached listing should include the activities from the following time period depending upon your status:

Accredited Providers - Any CME activities you have conducted during the current accreditation period.

Type of activity Number of

Activities Hours of instruction Physician participants Non-physician participants

JointlySponsored

Directly Sponsored

JointlySponsored

Directly Sponsored

JointlySponsored

Directly Sponsored

JointlySponsored

Directly Sponsored

Live

26-33

One Hour Activities

34-41

Multi-hour Activities

42-49

Recurring Conferences

Enduring Materials (50-57)

Journal CME (58-65)

Subtotals

Totals

66Attach a list of all activities directly or jointly sponsored you have conducted during the current accreditation period (include date, title, location, hours of instruction, and the total number of participants—physician and non-physician). Indicate which activities received commercial support and/or were jointly sponsored.

Label your documentation as Attachment 1—CME Activities

Definitions

Activities: One hour – planned on a one-by-one basis and designated for credit as a single activity (one hour lunch session, journal club).

Multi-hour - annual meeting, special symposium

Recurrent Conferences:

A series typically offered in one-hour regularly recurring sessions and designated for credit as one activity. (Count all sessions’ together-as one activity, indicating the total hours for the entire series and the total number of physician registrants for all the sessions taken together). Example: Tumor Board is one activity which meets for one hour per week (52 hours per year). Count every attendee for each session for the total number of participants. If 20 physicians attended every session there would be a total of 1040 physician participants for that one activity.

Enduring Materials: Activities that are considered enduring materials. (Examples include audio, video, monographs)

Journal CME: An activity that is published in a peer-reviewed journal which requires reading a journal article, a learner directed phase, evaluation and documentation of completion of the activity to the provider.


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Section 3 Program Information

CME PROGRAM SUMMARY

67

Please provide a brief narrative summary of your program, addressing the issues identified below. The responses to these issues will be a frame of reference for your organization’s values and vision, which will provide the basis for an accurate understanding of your CME program over the years of its operation as an accredited provider of CME activities. Your summary must not exceed this page plus three (3) additional pages.

a. Describe the vision for the CME Program. What are the expectations that you have for your CME Program?

b. How does your CME mission complement the mission of the applicant organization?

c. Have there been any major changes in your CME program in the last year? For example, have there been changes in leadership, staff, funding, size, or direction?

d. What are the strengths of your CME program? Please give examples of innovative practices that you would like us to know about.

e. What are the areas you have identified as needing improvement? What are the challenges that you see facing your CME program in the next few years?

f. Please explain what actions you have taken to address any concerns or deficiencies pointed out in your last accreditation decision.


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Section 4 Descriptive Information and Documentation

Purpose and Mission

Element 1.1 The provider must have a written statement of its CME mission, which includes the CME purpose, content areas, target audience, type of activities provided, and expected results of the program.

68

Attach the most recently approved CME mission statement. Please format your CME mission statement using the following subtitles:

Purpose, Content Areas, Target Audience, Types of Activities and Services Provided, and Expected Results

a. Describe the purposes of the overall CME program,

b. Indicate the content areas of the CME effort,

c. Outline the target audience,

d. Describe the general types of activities and services provided, and

e. State the expected results of the program described in terms of changes in competence, OR performance, OR patient outcomes.

Label your CME mission statement as Attachment 2—Mission Statement

69Identify the name of the body/committee within the applicant organization that has the responsibility for approving the mission statement of the CME program.

70When was the mission statement last reviewed and approved? Please attach minutes or other documentation of the governing body meetings at which the CME mission statement was reviewed and approved.

Label your documentation as Attachment 3—Minutes

71 Describe any changes made in your mission statement during the last accreditation period. Why were they made?


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Educational Planning

Element 2.1 The provider uses a planning process(es) that links identified educational needs with a desired result in its provision of all CME activities.

Element 2.2 The provider uses needs assessment data to plan CME activities.

Element 2.3 The provider communicates the purpose or objectives of the activity so the learner is informed before participating in the activity.

Element 3.3 The provider presents CME activities in compliance with ACCME’s policies for commercial support.

72How do you incorporate educational needs that are:

a. based on the professional practice gaps of your learners

b. defined in terms of knowledge, competence, or performance into your educational activities?

73How are your activities or educational interventions designed to change either physician competence, or performance or patient outcomes? How will these changes relate to your CME Mission?

74Attach one sample of the planning process used to develop a CME activity. Show how and where this planning process links identified needs with the desired results of the activity.

Label this documentation as Attachment 4—Planning Process

75Attach a copy of any planning worksheets used.

Label this documentation as Attachment 5—Planning Worksheet

76Attach an example of each source of needs assessment with identified needs used for planning your CME activities. Include emails, memos, etc. if appropriate.

Label this document as Attachment 6—Needs Assessment Data

77Attach a list of the activities that have been presented in the last 6 months and the source of the identified need for each.

Label this documentation as Attachment 7—Activities

78Attach a list of the activities that are planned for the next 6 months and the source of the identified need for each.

Label this documentation as Attachment 8—Activities

79Attach and example of each method you use to communicate the purpose and/or objectives to the learner for each type of activity (i.e. single activity, recurring conference, enduring material, etc.). Please highlight the purpose and/or objectives.

Label this documentation as Attachment 9—Communication of Purpose and/or Objectives

80Attach copies of all correspondence sent to a speaker prior to an activity.

Label this documentation as Attachment 10—Correspondence With Speaker


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81Describe the practices that you have in place that demonstrate your organization’s CME planning process is independent or free of the control of a commercial interest.

82 Describe the mechanism that has been implemented to identify conflict of interest prior to delivery of the educational activity.

83Describe the mechanism that has been implemented to resolve conflict of interest prior to delivery of the educational activity.

84Describe the information that you plan to provide to the LSMS during the accreditation process as your verification that learners have been provided with complete disclosure information (i.e. relevant financial relationships of anyone in a position to control the content of your CME or that there is nothing to disclose.)

85Describe the process you use to ensure that commercial support for the CME activity is disclosed to learners.

86Attach one sample that shows how you transmitted information about any relevant financial relationships to learners.

Label this documentation as Attachment 11—How Relevant Financial Relationships are Transmitted to Learners

87Attach one sample that shows how you have disclosed the commercial support for the CME activity to learners in practice.

Label this documentation as Attachment 12—Example of Disclosure of Commercial Support to Learners

88Attach one completed Letter of Agreement that demonstrates appropriate management of commercial support (if applicable).

Label this documentation as Attachment 13—Letter of Agreement


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Evaluation and Improvement

Element 2.4 The provider must evaluate the effectiveness of its CME activities in meting identified educational needs.

Element 2.5 The provider must evaluate the effectiveness of its overall CME program and make improvements to the program.

89

Describe what evaluation process(es) you use to analyze the changes in your learner’s competence, OR performance, OR patient outcomes related to your program’s activities or educational interventions? What criteria do you use when choosing evaluation method(s) for your activities, how do you ensure that the method(s) is/are appropriate and consistent in scope (i.e., complexity) with the educational activity?

90Explain how the evaluation results are used.

91Describe the improvements that have been made in the evaluation process during the last accreditation cycle.

92Attach a copy of an evaluation instrument for each type of activity (i.e. single activity, recurring conference, enduring material, etc.)

Label this documentation as Attachment 14—Evaluation Forms

93Provide the corresponding summarized data set for each type of activity offered.

Label this documentation as Attachment 15—Summarized Data

94Describe the process used by the CME Program to evaluate its effectiveness in meeting its mission. How frequently does this evaluation occur? When did your last evaluation occur?

95Did you make improvements in your CME Program as a result of the overall evaluation? If yes, please provide a short description of your improvements.

96Describe the improvements you have made in the evaluation process during the last accreditation cycle.


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If your organization produces Recurring Conferences (daily, weekly or monthly CME activities that are primarily planned by and presented to the provider’s professional staff), then please answer the following questions as part of your overall program evaluation.

97 Element 2.5Describe the system used to monitor and evaluate Recurring Conferences.

98 Element 2.5Describe any improvements made as a result of using this system.

99 Element 3.3, Criteria 8Describe the mechanism used for disclosing commercial relationships of speakers with commercial entities, products discussed in the presentation, and off-label uses of FDA regulated products.

100 Element 2.5Provide a summary of your most recent CME Program Evaluation and evidence of improvements made as a result of the program evaluation.

Label this documentation as Attachment 16—Evidence of Improvements

Note: The evaluation of the overall CME Program reviews the extent to which the organization is fulfilling its mission. The fact that you have evaluated each individual CME activity does not mean that you have evaluated the overall CME Program.


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Section 5 Administration

Administrative Policies

Element 3.1 The provider must have an organizational framework for the CME unit that provides the necessary resources to support its mission including support by the parent organization, if a parent organization exists.

Element 3.2 The provider must operate the business and management policies and procedures of its CME program (as they relate to human resources, financial affairs and legal obligations), so that its obligations and commitments are met.

101Attach a copy of an organizational chart that depicts the internal structure of your CME unit (including names, titles and responsibilities), the relationship of the CME unit to other operating units within the application and organization, if applicable, and its relationship to the governing body.

Label this documentation as Attachment 17—Organizational Chart

102 Attach a list of your CME Committee members, including their specialty and term dates.

Label this documentation as Attachment 18—CME Committee Members

103Describe all resources available to the CME Program. Explain the type of support that is provided for the CME Program including support from the parent organization, if one exists.

104Did you make any changes in the organizational structure and support during the last accreditation period? If yes, please provide a short description of the changes and how this improved your CME Program.

105Describe how you have organized the implementation and monitoring of the business and management components of your CME Program. Describe the processes and the structure through which this implementation occurs.

106What criteria do you use to determine that your CME Program’s business and management practices meet the human resource, fiscal and legal obligations and commitments that the CME Program has set for itself?

107Please attach the following:

a. The most recent annual income and expense report for the Program. Include the sources of revenues.

b. A copy of a budget and income and expense summary for one activity.

c. A copy of the policies on honoraria and expense reimbursement.

d. A copy of the table of contents of your Organization’s Policy and Procedure Manual and/or related documents for human resources, financial and legal affairs.

e. A copy of the table of contents of your CME Policy and Procedure Manual.

f. A written attestation to your organization’s compliance with business management/policies.

Label your documents as Attachment 19—Administrative Documentation


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Section 6 Policies

LSMS Policies for Commercial Support

Element 3.3 The Provider must present CME activities in compliance with LSMS’s policies for disclosure and commercial support

Element 3.3a The Provider discloses required information and relationships.

Element 3.3b The Provider maintains control of the educational content of the activity.

Element 3.3c The provider ensures that promotion and education are separate.

Element 3.3d The provider demonstrates appropriate management of funds from commercial supporters.

108Describe your method(s) of disclosure of provider and faculty relationships with commercial supporters to the learner prior to the activity.

109Describe methods of identifying and resolving conflicts of interest prior to the start of an educational activity.

110How do you document that disclosure (including verbal disclosure) has, in fact, occurred?

111Explain your practice concerning identifying products, reporting industry-based scientific research and discussing unlabeled uses of products, including how information is made known to participants.

112What mechanism do you use to inform faculty of the requirement to disclose off-label uses to the participants?

113Describe the mechanism in place that your CME Program uses to record and, when authorized, verify participation of participating physicians.

114Describe your procedure for ensuring that faculty who refuse to disclose relevant relationships do not have control over the educational content of the activity.

115How do you ensure what decisions and individuals involved with the educational content are not governed by the commercial interest?

116Describe the practices you use to ensure that the quality and scientific integrity of the content of all activities is assured.


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117How do you ensure that proprietary company representatives do not engage in sales activity where the educational activity occurs?

118If you have exhibits in conjunction with any activities, how do you ensure that promotional activity is kept separate from the educational activity?


a. A copy of your disclosure policy and an example of a completed disclosure form.

b. An example of correspondence with faculty communicating your disclosure policies.

c. An example of how disclosure is documented.

Attach your documentation as Attachment 20—Disclosure Policy

Check here if you DO NOT accept commercial support and proceed to question 126. If you DO accept commercial support, answer questions 120-125.

120Describe the methods you use to manage the budge and funds for an educational activity that receives commercial support.

121Explain how you oversee commercial activities during educational events.

122Describe how you assure that commercial support is not used to benefit individual participants in educational activities rather than all participants.

123Describe how you prevent commercially supported social events from competing with/taking precedence over educational activities.

124What improvements or changes in your disclosure and commercial support practices were made during the last accreditation period?

125Please attach an example from one activity that illustrates how commercial support is managed (Include your correspondence, agreements, methods of disclosure, commercial support acknowledgment, minutes of the planning meeting and an income & expense summary for the activity).

Attach your documentation as Attachment 21—Management of Commercial Support


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LSMS Policies

126How do you ensure that the CME Program utilizes the appropriate statements on its publications?

127Describe the mechanism in place that your CME Program uses to record and, when authorized, verify participation of participating physicians.

128If the CME Program offers enduring materials, describe how the Program consistently communicates all of the following to participants prior to the beginning of the educational activities?

a. Principal faculty and their credentials

b. Medium or combination media used

c. Method of physician participation in the learning process

d. Estimated time to complete the educational activity (same as the number of credit hours designated)

e. Dates of original release and the most recent review of update

129How is commercial support acknowledged at the beginning of the enduring material?

130How do you ensure that product specific advertising of any type is not in any enduring materials?

131If the CME Program offers Journal CME, describe how it meets the following requirements:

a. The reading of an article(s)

b. A provider stipulate/learner directed phase, and

c. The completion by the learner of a predetermined set of questions or tasks relating to the content of the material as part of the learning process.


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132If the CME Program currently jointly-sponsors activities or plans to joint-sponsor during the next accreditation cycle describe how it meets the following requirements:

a. Determines if the missions of the organizations are congruent;

b. Determines needs;

c. Designs purpose or objectives;

d. Chooses appropriate faculty;

e. Evaluates the activities;

f. Determines that the legal and financial obligations are met;

g. Monitors commercial support to assure that the Stands for Commercial Support are met;

h. Determines that all policies of the LSMS are adhered to.


a. Two copies of examples of all accreditation and designation statements used (copies of brochures, flyers, etc., including directly sponsored and jointly sponsored statements).

b. Two copies of each type of enduring material produced, if appropriate.

c. Two copies of a journal CME activity, if appropriate.

d. Joint-sponsorship policies, planning forms, or any other documentation used.

e. A copy of a yearly transcript provide to a physician (if available).

Label these documents as Attachment 22—Examples


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Section 7 AttestationBefore the LSMS will move forward with the accreditation process of your organization, your intentions, understanding, and commitment to abide by LSMS’s expectations must be confirmed.

Please read carefully each of the following confirmation statements and use and ‘X’ as your attestation.

We understand and attest that our organization must plan, implement, and evaluate at least two CME activities within the 24-months period prior to the initial LSMS accreditation survey interview.

We understand and attest that our organization’s activities adhere to ACCME definition of CME found at www.accme.org.

We understand and attest that by virtue of submitting an application for accreditation and paying the accreditation fee to the LSMS our organization agrees to follow all LSMS policies and procedures as specified by the LSMS.

We understand and attest that LSMS policies and procedures prohibit the provider from submitting to the LSMS, either

with the completed application or in any other material, any individually identifiable health information.

We attest that all the materials submitted to the LSMS in any format will not contain any untrue statements, will not omit any necessary material facts, will not be misleading, will fairly present the organization, and are the property of the organization applying for accreditation.

You have completed the Application for LSMS CME Accreditation

Sign and submit this application to the LSMS along with the non-refundable fee of $2,500. Check that all sections are completed and all attachments provided. Applications will not be processed unless the fee is attached and all materials and information are provided. Applications will not be returned. Your organization will be notified that the submission was successful, incomplete or unsuccessful. The fee will not be returned if the Application is incomplete or unsuccessful.

Name of Organization:

Name of CEO:

Signature of CEO: ______________________________________ Date: ______________________

Name of CME Contact:

Signature of CME Contact: ______________________________________ Date: ______________________


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http://www.accme.org/

Documents

Application for LSMS CME Accreditation.doc