June 15, 2018
11 EDT/10 CDT/9 MDT/8 PDT
Attending: Francis Kwakwa, Chair; Doris Auth, Caitlyn Briggs, Leslie Christy, Jackie Goldstein, Shelly Harris, Ilana Hardesty, Cynthia Kear, Ed Kennedy, Linda Kitlinski, Joanna Krause, Jack Kues, Suzanne McLeod, Rahul Natarajan, Kate Regnier, Sheila Robertson, Valerie Smothers, Marsha Stanton, Dimitra Travlos, Mark Tyrrell, and Marcus?
The minutes were accepted as submitted. Valerie provided a brief summary. The group discussed the draft activity report specification used for conveying data about learner activity. Edits made included data about REMS participation at the learner level. The ACGME shared their experiences to prevent duplication of data using activity identifiers.
2 Review of message regarding collection of data for ER/LA Opioid REMS and Opioid REMS
Valerie mentioned the group discussed the switch over from ER/LA Opioid REMS to Opioid REMS, and several people expressed concerns. The label allows you to distinguish to which REMS the data relates. A new label is needed for Opioid REMS. The labels will make it possible for providers creating new content in support of Opioid REMS to report on that content. Cynthia agreed this was a great plan, but problems rise in the transition period. CORE has not started using the new REMS. She requested advice on handling that. Valerie noted new content and data requirements need to be met for activities to be considered Opioid REMS activities. There are documents from the FDA specifying questions they want answered.
Cynthia noted they have not changed any questions yet on targeting Jan 1, 2019. When they start tracking the new data, they will move over to Opioid REMS. Illana suggested the FDA specify that everybody convert by March 1, 2019. Valerie noted there does not need to be a specific date; anyone can switch over as soon as they are ready. It is difficult to move when final REMS is not completed. Doris added everyone should be able to collect the data. Valerie noted the standard itself provides flexibility. Mark revealed they are releasing an RFA for content based on the new blueprint with data capture based on learner level data previously defined. They have not made a decision on ER/LA Opioid Activities. Cynthia supported using a modified blueprint.
A Should we include a free text field for profession for those that select other?
Valerie brought forward a question from the RPC: Should we include a free text field for profession for those that select other? Francis questioned why this was required. Valerie commented to learn more about professions not represented. Doris added they opened up education requirements to all providers. Mark agreed they wanted a broad range of professions. Cynthia expressed concern about the physical logistics. Valerie mentioned people might choose other when they could be included in other fields. Doris commented it would be helpful but not necessary. Marsha added free text areas can be problematic. Ilana suggested further clarifying the definition of “other”. Jack mentioned the cost and time, and suggested opting out of a free text field. Mark added the RPC would support whatever decision made. Mark suggested beginning with “other” without a text field and reassessing in a year.
B Should we include vets in the list of healthcare professionals?
Valerie noted that the RPC also asked about including veterinarians in the list of healthcare professionals. Marsha supported including veterinarians, and Mark agreed. There was consensus on adding veterinarians to the list.
4 Definitions of individual registration and institutional registration
Implementation guidelines for Activity Report provides guidance on how to convey information related to practice type and what profession best describes them. Valerie referenced section 3.4. on page 13, which lists demographic information collected about the learner. Veterinarians will be added to the list of professions. She will update the definitions on the website so they are available.
The Polaris colleagues provided information on their current process and discussed upgrades to the system to streamline the process. Marcus mentioned the updates would follow the MedBiquitous REMS requirements. Valerie suggested anyone with questions regarding the change for CE providers and accreditors should reach out with questions. Marsha thanked the CE providers and accreditors.
Cynthia suggested having a meeting with the providers. She will send an email to Marcus.
- There will be no free text field for Profession for those answering other. We can revisit this decision in a year.
- We will add veterinarians to the list of professions in the guidelines and website.