Even Though CME providers undergoing the Accreditation Council for CME reaccreditation process only have to document that they've complied with the updated Standards for Commercial Support since May 2005, when the new rules took effect, they say the process has changed. Surveyors are placing a bigger emphasis on the process for disclosure and management of conflicts of interest. That's not surprising, since those are the areas that underwent the biggest revisions.
“We found it interesting that even though we were not assessed under the new Standards, about 50 percent of the conversation dealt with commercial support, how we processed grants, and how we handle conflicts of interest,” says Marsha Meyer, RPh, senior vice president of clinical information with CME LLC, Irvine, Calif. When CME LLC last went through the reaccreditation process four years ago, “the discussion was more broad-based and covered more diverse topics.” While she says theassessors were very clear that the organization was being surveyed under the old measures, ”They were still very interested in what we were doing” to identify and resolve any conflicts of interest.
Out With the Old
CME LLC had already reviewed the processes that would be affected by the changes in the revised Standards and made any necessary adjustments before undergoing review under the old guidelines, Meyer says. CME LLC, which has been accredited for 25 years, shouldn't need to undergo many revisions before its next audit, scheduled for 2009. “We have detailed processes established that we looked at with the new Standards in mind, but we didn't find any need to make changes,” she says.
Meyer also says that, for organizations like hers that were among the last to be accredited under the old Standards, the ACCME sent a memo offering a voluntary service where CME providers can submit a description of the processes and policies they're using to resolve conflicts of interest. Then the ACCME will provide feedback with no strings attached. “They're acknowledging that you were surveyed under the old Standards and that you're going to have your next accreditation period with no input from them on whether or not your processes are appropriate [under the revised Standards]. They obviously want to make sure everyone's doing the best they can to comply with the updated Standards, and they want to give you input,” she says. “I think it's very helpful, and it's an opportunity we will take advantage of.”
In With the New
MEBN, a medical education company based in Londonderry, N.H., is one of the providers that went through accreditation in 2005 under the revised Standards. Says Pamela Kleinman, MEBN's director of accreditation and outcomes analysis, “It was definitely different. The self-study questions were different, and we had to demonstrate everything that was implemented with regard to identifying and resolving conflicts of interest under the new Standards.” This took a bit of preparation, she says. “Because we produce mainly enduring materials that take place six months out, and the revised Standards went into effect immediately, we had to go back through all the disclosures and document how we resolved any conflicts on programs that were already well into the planning process. We already had our disclosure form and conflict of interest policy in place, and we already had developed forms to help us identify any conflicts of interest and ways to document actions taken to resolve any conflicts,” she says. “So it really was a matter of filling out the paperwork on what we had been doing all along.”
Generally, she says, going through the accreditation survey under the revised Standards was challenging at times, but there was lots of help available. “If there's anything you don't understand, ask the ACCME. They're very responsive — they often will get back with answers the same day.”
Survey Tips for the New Standards for Commercial Support
Pamela Kleinman, director of accreditation and outcomes analysis, MEBN, Londonderry, N.H., offers these tips:
Keep up to date on the Accreditation Council for CME's frequently asked questions, posted at accme.org. “The FAQs were very useful in helping us create forms and define what kinds of documentation we need to capture in order to meet the new Standards,” she says.
Document everything as you go.
Download the Documentation Review Labels (under Materials Used to Prepare for the Accreditation Survey on the ACCME Web site). “The ACCME doesn't want every piece of paper you've ever captured for an activity, just the ones that relate to these labels. I thought they were fantastic and would highly recommend downloading them.” She also recommends downloading the Essential Areas 3 Administration Tabs.
Download the Surveyor Report Form (also available on the ACCME Web site) so you can see exactly what the surveyors are looking for when reviewing your organization.