Accreditation Program FAQ
The following questions were asked by participants at the CME Planners Conference held February 16, 2001. They are provided here as an accreditation resource for intrastate providers on CME in Illinois.
ESSENTIAL AREAS, POLICIES AND ACCREDITATION APPLICATION
1. Should answers for each question fit in space provided?
No, providers can use as many pages as are necessary to respond to the questions in the application. The new application is meant to be more of a narrative, and it is expected that responses may be several paragraphs, if not pages, long.
2. Will the application be available in Microsoft Word™ ?
Yes, all accreditation documents will be available in Microsoft Word™. We will be able to provide you a diskette with the documents on them or we can e-mail them to you. They also will be available on the ISMS Web site in Accreditation Program Section.
3. Should we use tabs or numbered attachments for reference?
This is a good idea and instructions that will be sent with accreditation packets at the eighth-month notice will include instructions to use dividers for each section and to number attachments according to the checklist at the end of the application.
4. Does "departmentalized hospital or organization" refer to hospital departments or CME programming provided by individual departments?
The term "departmentalized hospital or organization" as used on page 3 of the Accreditation Application refers to CME activities provided by individual departments for physician members of that department as opposed to activities developed for and offered to the entire medical staff.
5. How should we classify computer-based learning materials – are they enduring materials or Internet materials?
Computer-based learning materials are always enduring materials. But not every computer-based activity is accessed through the Internet. It you develop an enduring material for physician CME and offer it through your organization's Web site, this could be classified as Internet materials. If you develop a CME activity that is put on CD-ROM, this would not be Internet material.
6. How do you determine the number of credit hours to award to enduring materials?
When determining the amount of credit hours one should offer for an enduring material (outside of those enduring materials which are videotaped presentations of live activities), it would be appropriate to have several potential participants complete the activity and keep track of the amount of time it took them to complete it. The average of their times would be a good indication of the number of credit hours you should offer.
7. If you are a proctor for a medical student sent by the university, e.g., LPC program, will that constitute a CME activity?
Being a proctor in itself is not a CME activity in that the proctor is not the learner and the learning activity is designed for the medical student not the proctor. However, if the physician found that acting as a proctor was educational beneficial, then the physician could claim Category 2 in the AMA's Physician Recognition Award.
8. Do past attendance records need to be kept on-site for 6 years or do they need to be readily accessible within a designated time frame? If so, what is the time frame?
There is no requirement in the Essential Areas or accreditation policies that state where records are to be kept or the time frame for ready accessibility if records are stored off site.
9. How soon before these Essentials get amended? Seems like constant change and flux in CME.
For the most part, the Essential Areas are developed by the Accreditation Council for Continuing Medical Education. State medical societies must operate under a protocol for state accreditors established by ACCME if they wish to be recognized as an accreditor. One of the criteria states: The state society has a set of Essentials and Standards as the basis for its accreditation activities. These Essentials and Standards must be compatible with the Essentials and Standards of the ACCME, but need not be identical. Each of the ACCME Essentials and Standards must be addressed. Should ACCME substantially change any of the Essential Elements, ISMS would be obligated to do the same.
10. Clarify parent organization? On page 10 of the application, if you answer "No" to question 10 that asks if the provider has a parent organization, does this mean you skip questions 11 and 12?
Page 6 of the document "Accreditation Program: Essential Areas, Glossary of terms, Accreditation Policies and Decision Making Criteria" states that "If the accredited CME unit shares money (receives budget support), staff, or Board oversight with another organization, then the other organization is defined as the parent of the CME unit." In regards to question 10 of the application, if you answer "no" it does mean that you skip question 11. However, you would still answer question 12 since the summary statement in this question refers to the whole Essential Area 1.
11. What do you think the answer to the question "your sense of compliance" will contribute to the review and decision-making?
One of the main goals of the new accreditation system is a sense of "continuous improvement" in CME. One way to stimulate providers' thinking about improvement is to ask them how well they think they are in compliance with the accreditation Essential Areas.
12. Does the application ask about a parent organization?
Yes, Essential Element 1.2 states the provider must "demonstrate how the CME mission is congruent with and supported by the mission of the parent organization, if a parent organization exists"; and Essential Element 3.1 states: "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 exists."
For both Essential Elements, questions are included in the application which are specific to describing how parent organizations impact on the CME unit, if a parent exists.
13. Does the parent organization's mission statement need to reflect some CME goal/mission with regard to the "congruent: concept"?
Essential Element 1.2 states that the provider must demonstrate how the CME mission is congruent with and supported by the mission of the parent organization, if a parent organization exists. The criterion for compliance with this Essential Element states that full compliance means that CME is mentioned in the parent organization mission statement and supported with financial, facility, and human resources; or a CME mission statement is reviewed and approved by the governing body of the parent organization on a regular basis.
14. If a hospital has its own Board of Trustees/Medial Executive Board, does that mean the hospital does not have a parent, even if it is part of a health care system?
In the ISMS document, Accreditation Program: Essential Areas, Glossary of Terms, Accreditation Policies and Decision Making Criteria, a parent organization is defined as follows: "If the accredited CME unit shares money (receives budget support), staff, or Board oversight with another organization, then the other organization is defined as the parent of the CME unit." Given this definition of a parent and your description of your hospital it seems as though you would not have to indicate that you have a parent organization. However, you are encouraged to contact ISMS accreditation staff to discuss your organization's particular circumstances.
15. For Essential Area 1 Summary - Barriers to Improvement, is this limited to CME only or the entire facility?
The intent of this statement is to address any barriers to your ability to meet this Essential Area. Such barriers could be specific only to your CME unit or could be related to your organization as a whole.
16. Can you use data gathered from the Iowa Foundation "Project in a Box"?
Essential Element 2.2 does not define from where needs assessment data must come. If this is a needs assessment source that provides learning needs specific to your potential participants, you should use the data.
17. Can we distribute a review article, e.g., Management of Pneumonia, and a post-test or other evaluation and provide credit to a physician for reading the article and completing the evaluation?
A learning scenario as described can be considered CME for which credit is granted, if a provider has needs assessment data that shows that management of pneumonia is a physician need, and the provider determines through the learning objectives that having physicians read an article on the management of pneumonia and then taking a comprehension exam is an appropriate learning format and evaluation strategy. As a note of warning, there may be copyright issues that the provider may have to address when using any previously published material.
18. Do you consider "knowledge" or "attitude" to be behaviorally-oriented objectives? If not, are they valid objectives? What are behaviorally-oriented objectives?
The term "behaviorally oriented" is related to whether the learning objectives are written using learner-centered, measurable language. Behaviorally oriented objectives try to answer the question, "What will the physician be able to know, or do, or feel after participating in this educational event?" In this sense, knowledge and attitude are categories of learning that can be stated using behaviorally-oriented language. An excellent reference on writing behavioral learning objectives is the book, "Continuing Medical Education", A Primer, which is published by the Alliance for Continuing Medical Education (ACME), Southcrest Building, Suite 208 1025 Montgomery Highway, Birmingham, AL, 205-824-1355.
19. For Essential Element 2.3, you don't differentiate between learner-centered (what the session participant will be able to do after the session) from teacher-centered (what the presenter will do during the educational session). I believe this is a critical distinction.
Essential Element 2.3 state that providers must communicate behaviorally oriented learning objectives of the activity so the learner is informed before participating in the activity. By using the term behaviorally oriented learning objectives, the Committee on CME Accreditation intended that the emphasis be on what the learner will be able to know, do, or feel by participating in an educational activity.
20. Regarding global objectives for a journal club — since the topic changes from month to month do global objectives apply or should objectives be specific to the topic?
Objectives for journal club activities can be either global or specific to the topic covered in an individual session. Global objectives usually are written for CME activities that are repetitive or serial in nature such as tumor boards or clinical-pathological conferences. Global objectives are used to describe what will happen at these types of conferences, how the activity is structured to cover the same process of reviewing case material, no matter what the topic. Global objectives are allowed when dealing with such CME activities because they are case-based and the cases may not be selected until the last minute, making it nearly impossible to put the activity through a CME approval process. This does not mean that learning objectives specific to the topics addressed by tumor boards, CPCs, journal clubs, etc. cannot be written. In fact, such objectives would be encouraged if at all possible and would be supplemental to the global objectives written for the series. Therefore, it would be appropriate to write global objectives for a journal club series, and to write learning objectives for each individual topic addressed at each session (as a supplement to global objectives) or to treat each session of a journal club as a separate CME activity and write behaviorally-oriented learning objectives for each topic addressed.
21. Where does it say global objectives are to be reviewed every 2 years?
On page 9 of the document "Accreditation Program: Essential Areas, Glossary of terms, Accreditation Policies and Decision Making Criteria," the last several lines of the final paragraph under the guideline for Element 2.3 state, "Global objectives are often written for CME series that occur over a stated period of time. At the end of that time frame, the global objectives should be reviewed for continued appropriateness. Such review should occur at least every 2 years."
22. Will ISMS be updating the "How to Write Behavioral Objectives" information that was provided in the ISMS Resource Manual which was distributed several years ago?
All documents from the old accreditation system will be reviewed and those that need revising will be. While the Organizational Guide needs to be reviewed, the information on writing behavioral objectives continues to be valid. If you would like a copy of "How to Write Behavioral Objectives," contact ISMS staff in the Division of Education and Accreditation.
23. Please help distinguish or provide a good example of what is a good overall CME program evaluation?
Overall CME program evaluation is likely to vary from provider to provider. However, one place where all accredited providers can start is a review of the CME mission statement in comparison to the CME activities conducted over a period of time. Do the activities reflect what the CME mission states is the purpose, content areas, target audience, type of activities provided, and expected results of the program? Another area for overall program evaluation is how the CME unit/committee operates when planning and/or approving activities and implementing activities. As providers are reviewed, it is expected that "best practices" will be identified and shared with all providers.
24. If we regularly evaluate each element's compliance and make appropriate adjustments, does this "count" for evaluating "overall CME effort?"
Regularly evaluating an organization's compliance with each element and making appropriate adjustments could be considered as part of the effort to evaluate the effectiveness of the overall CME program. The key would be to describe that this review of compliance was part of your mechanism for measuring the effectiveness of the program and that "appropriate adjustments" are evidence of improvements having been made. See "Accreditation Program: Essential Areas, Glossary of terms, Accreditation Policies and Decision Making Criteria," page 22 for decision making criteria for Essential Element 2.5: The sponsor must evaluate the effectiveness of its overall CME program and make improvements to the program.
25. Please cite some examples of legal obligations? Are there other specific legal obligations in addition to Americans with Disability Act (ADA)?
Essential Element 3.2 states: "...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 are met." Organizations have both state and federal laws with which they must comply. For example, on a federal level, there is the Americans with Disabilities Act, the Occupational Health And Safety Act, and laws related to anti-discrimination in hiring and firing. At the state level, there are laws related to unemployment security, compensation, harassment and discrimination. These legal obligations apply to the organization as a whole, not just the CME unit. Therefore, if you can show your organization has a policy and procedure manual by including its table of contents in the application, you will be viewed as showing your CME unit's efforts to comply with this Essential Element.
26. Do we need ADA statements on all announcements?
In those instances in which potential participants are likely to be more than your medical staff, then it would be appropriate to carry an ADA statement on your publicity materials.
27. Do you need faculty disclosure for each activity in a global activity setting (Tumor Boards, Morbidity and Mortality Conferences, etc.)?
Faculty disclosure must be made for every CME activity certified for AMA PRA credit, whether or not commercial support is provided, whether or not the faculty person has any significant relationship to disclose, or whether the faculty is "inside" or "outside" the organization. For reoccurring activities, where the faculty is likely to be the same throughout the series, it is possible to get faculty disclosure from this faculty once a year and keep it on file in the CME office, with the proviso that should a significant relationship develop or cease to exist for any faculty member, he or she would notify the CME office as soon as possible.
28. What is the difference between restricted and unrestricted educational grants and how the money is used in each case?
A restricted educational grant means that there is agreement between the accredited provider and the commercial supporter that grant monies will be used for a specific purpose, such as to provide a meal service or to rent audio-visual equipment or provide a specified honorarium for a speaker. An unrestricted educational grant means that the accredited provider can use grant monies to support the CME activity (or activities) in ways that are completely at the discretion of the provider.
29. If there is no handout, can disclosure be stated verbally without anything written and not get penalized?
Accredited providers have the option of verbally making faculty disclosure, principally for regularly scheduled CME activities. Where providers have the most trouble is that they do not document in activity files that verbal disclosure was made.
30. What if the speaker never returns the disclosure form?
It should be noted that there is no requirement in the Standards for Commercial Support or Essential Element 3.3 that accredited providers must use forms to get disclosure from faculty. Many providers use a disclosure form because it is a convenient way to obtain information about faculty relationships and to document that disclosure was obtained. However, there is a difference between a faculty person failing to return a disclosure form and refusing to disclose. Therefore, if a faculty person does not return a form, the provider is still obligated to obtain that faculty's disclosure. This might be done by means of a phone call or an e-mail or even verbally just before the faculty person gives the presentation. The provider must document what information was obtained and that it was disclosed to the participants. If the faculty person is fully award of the requirement to disclose significant relationships but refuses to do so, then the provider must inform participants that the faculty person has refused to disclose.
31. What happens when a presenter uses slides that are from the pharmaceutical company and have a logo on every slide (even though the presenter signed a disclosure and the supporter signed a letter of agreement)?
Even when we make every effort to comply with the Standards for Commercial Support, an occasion may arise, like the one you describe, that is clearly outside compliance. The main concern of the surveyors and the Committee on CME Accreditation is that this is an exceptional situation not typical practice. In such an occurrence, the site surveyors would expect to see in the activity file that this issue was addressed with the presenter and the commercial supporter, and that you have reviewed your procedures to see if you need to make changes to ensure that such a situation does not happen again.
32. Can a speaker use slides from a drug company with disclosure?
In the Standards for Commercial Support, standard 1b(1) Assistance with Preparation of Educational Materials states: "The content of slides and reference materials must remain the ultimate responsibility of the faculty selected by the accredited sponsor. A commercial supporter may be asked to help with the preparation of conference related educational materials, but these materials shall not, by their content or format, advance the specific proprietary interests of the commercial supporter."
33. A pharmaceutical Company brings a request for a satellite broadcast that has CME credit issued by another accredited provider. Would this need to be considered co-sponsorship?
This scenario does not need to be considered co-sponsorship since your organization was not involved in any way in the design of the activity. In this case, your organization is just considered a broadcast site, the same as a hotel or restaurant would be.
34. Do you have to have control and input into content in order for it to be Category 1 or can you agree with the activity as is?
If an accredited provider is approached to provide credit for a CME activity that is already produced, the ISMS Committee on CME Accreditation would expect that the activity file for this CME educational event would clearly show how the need for this activity for this provider's medical staff was derived and that the provider's CME authority reviewed and approved learning objectives, design and evaluation based on the provider's needs assessment. If commercial support was provided for such an activity, the Committee on CME Accreditation would want to be assured that accepting the CME activity "as is" was not a condition for receiving the educational grant.
35. How can a CME committee grant credit to a CME activity that is an in-service training session for physicians on new equipment that has been purchased by your institution?
The AMA definition of CME states, in part, that, " CME consists of educational activities that serve to maintain, develop, or increase the knowledge, skills, and professional performance and relationships a physician uses to provide services for the patient, the public or the profession." If the provider can show that there is a need for medical staff of an organization to know the capabilities of new equipment, when it is appropriate to use or to prescribe its use, etc., then it would meet the definition of CME and the activity can be considered for credit.
36. In hands-on workshops that feature new products that are supported (financially) by the company producing/manufacturing them, how do you prevent violating commercial support essentials?
In workshops that feature new products, whether or not there is commercial support for the activity, there should be several comparable products discussed or available for use. If there are several treatment options, and the new product is one of these options, as many options as is appropriate should be featured. If this is a singular product, then it is probable that it cannot be considered CME. That is not to say that you cannot have an educational activity to talk about this product, it means that you should not call the educational event CME and you should not provide AMA PRA Category 1 credit. A corollary to this would be if an organization purchases a piece or equipment on which physicians must be educated, such as a fiber optic endoscope to be used in gastroenterology. In this case, while this is a single product, it has already been purchased, so the activity is not to promote a particular product but to educate physicians on its use, etc.
37. Commercial supporter offers funding and a speaker. Is this acceptable?
A commercial supporter may not offer funding and make it contingent upon the use of a particular faculty person. You should be able to see a list of speakers from which you may choose or if no faculty on that list is acceptable, you should be able to select a faculty person of your own choosing.
DOCUMENTATION REVIEW FORM
38. What is the expectation of file and documentation compliance with the new system and format?
File review has been used in the "old" system of accreditation as a way to verify what was written in the application. Documentation review will continue to play an important role in verifying what is described in the application. However, under the new system, site surveyors now will complete a documentation review form for each activity file that is reviewed. These completed forms will be returned to the Committee on CME Accreditation along with the Surveyors Report. Providers should use this documentation review form as a guide as to what should be kept in activity files.
39. Is a specific CME program reviewed in detail?
It is assumed that specific CME program means a single CME activity. In the new application, providers are not limited to describing how they use the Essential Elements as they relate to only one activity. Providers are encouraged to use as many examples as they wish. One new aspect of the survey process, however, is that surveyors will review activity files and complete a documentation review form for each activity. This form is quite specific as to what is expected to be in the activity files as supporting documentation for what is described in the application.
40. Does any deviation from the checklist have to be explained and described at the bottom of the Documentation Review form?
It is expected that if the answer on a form is not "Yes" there must be an explanation as to why the surveyors responded with a "questions mark" or a "No" under the new system, it is anticipated that "best practices" will be identified and shared with all providers.
41. Please tell us how to manage our programs with shrinking hospital budgets and rapidly expanding CME requirements with respect to documenting everything and every step of every program?
As in every system of accreditation, documentation is a requirement. It allows for the accrediting body to validate an organization's adherence to requirements and to look across all accredited organizations for balance and consistency. The new form " Documentation Review" can be used by providers as a checklist as to what documentation is required for a CME activity file.
42. Do we need to record our conversations with MDs, etc., for proper documentation?
Informal discussion that are used as needs assessment or as part of a planning process should be documented in activity files. These can be hand-written notes on small sheets of paper, as long as these capture the essence of the conversation.
43. Please discuss the importance of activity files during the site visit.
Activity files will play an increasingly important role in the new accreditation system, because the application is less structured and more of a narrative. The activity files will be the validation of what is described in the application and site surveyors will complete a Documentation Review form for each activity file reviewed on site during the survey. The activity files will, therefore, need to contain the documentation necessary to demonstrate compliance with Essential Elements. The Documentation Review form can be used by providers as a guide to ensure that necessary documents are included.
SURVEYORS REPORT FORM
44. On the Surveyors Report, how do we indicate that an item is "not applicable?" For example, for # 6 under Essential Element 2.4, if there are no objectives related to attitudinal change (and that is appropriate for the CME activity) does the surveyor mark "yes," "?," or "no"? The proper answer would be NA (not applicable), but that is not a choice.
The easiest way to indicate that an item is not applicable is to state that an item is not applicable and the reason for that determination in the "Comments" section for the appropriate Essential Element. For items 4 through 9 under Essential Element 2.4, surveyors are asked to look across the whole of the CME program to determine if the provider attempted to influence physician attitudes in any CME activities. If the surveyors determine this to be the case, then they are to assess whether the provider used an evaluation technique that would measure the effectiveness of the CME activity in achieving this change in attitude.
45. Should any response on the Surveyors Report under the "?" heading be accompanied by a clarifying statement under "Surveyors Comments?"
Whenever site surveyors indicate a response other that "Yes," the Committee on CME Accreditation expects to see a clarifying statement under the "Comments" section for the Essential Element.
46. In the Surveyors Report on page 9 for Essential Element 2.4, it seems that items 6 and 7 have significant overlap and could be combined.
In the Surveyors Report on page 9 for Essential Element 2.4, items 4 through 8 are stated the same way, the major difference is that each item deals with a different category of learning outcome that a sponsor could identify. Combine any or all into one statement would make it difficult for the Committee on CME Accreditation to determine which of the outcomes the sponsor was appropriately evaluating.
47. Does the phrase "evaluation strategies" imply test and measurement?
The phrase does not imply test but it does mean measurement. For example, if the identified need of an educational activity was to change a physician practice, an evaluation strategy would be to determine if practice has changed. This means some type of measurement would occur and this measurement would be an evaluation of the effectiveness of the CME activity.
48. In the Surveyors Report, Essential Element 3.2, item 4 (on page 12) the word "continuity" (I believe) means in terms of CME leadership, but that is not specified and could be misinterpreted.
Continuity applies to CME physician leadership, staff, or CME committee ( if one exists).
ON-SITE CME ACTIVITY REVIEW FORM
49. Item 12 of the On-Site CME Activity Review asks "Does the provider demonstrate acceptable practices concerning identifying products, reporting on research, and discussing off-labeled uses of products?" Other than the letter of agreement, how would a provider demonstrate acceptable practices?
When observing a CME activity during the site survey, surveyors would be expected to observe if specific products are identified during a presentation or if several brand names or only generic names are used. If research is being reported, then surveyors would be asked to determine if the research conformed to generally accepted standards of experimental design, data collection and analysis. If a presenter discusses off-label used of products, the surveyors would be expected to observe that the presenter disclosed that the product was not labeled for the use under discussion or that the product was still investigational. If these practices are not observed during the CME activity, surveyors should also look in faculty correspondence to determine if the provider indicates to faculty that the practices indicated above are expected.
50. Item 5 on the On-Site Activity Review form asks for Element 2.4 Evaluate Effectiveness of Activity: What was the mechanism? What were the parameters that were evaluated? If a surveyor attaches an evaluation form to the review, does this satisfy item 5?
Attaching an evaluation form to the On-Site Activity Review form satisfies item 5.
COMMITTEE DECISION FORM
51. Who makes decisions concerning "consistency?"
It is the role of the Committee on CME Accreditation to determine the level of compliance for each Essential Element. The Committee bases its decision by reviewing the accreditation application, the Surveyors Report, the Documentation Review forms and the On-Site Activity review form.
52. Who determines commendations, concerns, etc. The survey team or Committee on CME Accreditation?
The site surveyors may indicate areas of concerns, possible commendations, etc, in the Surveyors Report because they are on site and are seeing the program first-hand. The Committee on CME Accreditation reviews the Surveyors Report and determines if it accepts the site surveyors recommendations, commendations, etc. The Committee also may indicate that it believes that a practice is commendable or is a deficiency, etc. based on whether it has reviewed similar situations in other Survey Reports. The ultimate decision maker is the Committee on CME Accreditation.
53. Can suggestions be either followed or ignored by the provider?
Suggestion is defined as "Changes that may enhance or improve compliance." Since it is considered optional by the Committee on CME Accreditation, providers are not obligated to comply with a suggestion.