OPS 2023 Summer Newsletter
Oregon Health Authority and Oregon Department of Human Services sent this bulletin at 07/07/2023 03:39 PM PDT |
Welcome to the Oregon Psilocybin Services (OPS) 2023 Summer Newsletter.
A FOCUS ON CLIENT SAFETY AS LICENSED SERVICE CENTERS OPEN THEIR DOORS
OPS has now issued licenses to six service centers and expects to issue many more licenses over the coming months. As service center doors open to clients, we want to emphasize the importance of client safety.
OPS administrative rules support client safety in many ways, including rules on facilitator conduct, client safety and support planning, transportation planning, informed consent, client bill of rights, duty to contact emergency services and other requirements. One of the most important factors in ensuring client safety is the licensed facilitator’s interaction with clients, as well as understanding their own limitations as a licensed facilitator.
Ensuring client safety begins with preparation sessions before any psilocybin products are consumed and continues through administration sessions, follow-up contact with clients within 72 hours of administration sessions, and optional integration sessions. Trained and licensed facilitators work within their scope of practice and level of expertise to identify potential safety risks and support clients. OPS rules create a container to support client safety, but it is the responsibility of all licensees to ensure practices that support the safe provision of psilocybin services in Oregon.
OPS will investigate complaints, incidents, or concerns related to safety issues or statute and rule violations that occur on licensed premises and during the provision of psilocybin services. OPS hopes that licensees enter this new space with the intention of centering client safety, and that service centers and facilitators roll out services cautiously. While OPS rules provide an important framework for client safety, the facilitator-client relationship and service center operating guidelines will ultimately be the most important factors in ensuring safe and effective psilocybin experiences.
OPS rules reflect recommendations from the Oregon Psilocybin Advisory Board and were adopted after a thorough rule making process in 2022. The process for developing board recommendations for draft rules included 19 board meetings and 110 subcommittee meetings. The rulemaking process in 2022 included 12 hours of public listening sessions offered in English, Spanish, American Sign Language (ASL), and CART captioning; 6 Rules Advisory Committees (RACs) that consisted of 62 members, 13 meetings, and over 39 hours of discussion on draft rules; 2 public comment periods for rulemaking that totaled 44 days and included hundreds of written comments; and 5 public hearings on rules offered in English, Spanish, American Sign Language (ASL), and CART Captioning for 10 hours of public testimony.
The OPS team looks forward to hearing from the regulated community, partners, and the public to identify ways to improve the administrative rules over time. In developing best practices and operational guidelines, we ask licensees to remember that OPS rules set minimum standards designed to protect public health and safety. The rules are a floor, not a ceiling, and offer flexibility for varied operational models. If licensees choose to adopt practices that exceed the minimum requirements established in rule, they are welcome and encouraged to do so.
Thank you!
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LEGISLATIVE SESSION 2023 UPDATE
The 82nd Oregon Legislative Assembly convened for the 2023 Legislative Session Tuesday, January 17th and adjourned Sunday, June 25th.
An important accomplishment from legislative session included the passage of SB 5525, the Oregon Health Authority budget bill. While the Preliminary Budget Report published on June 7, 2023, included a recommendation to fund Package 449: Oregon Psilocybin Services, The Nation’s First Regulatory Framework, OPS will better understand the details of the budget over the coming weeks and will share as more information becomes available.
Many bills were considered during 2023 Legislative Session, including SB 303, which directs OPS-licensed service centers to collect and report certain client data related to psilocybin services and directs OPS to share data with Oregon Health and Science University. OPS will convene rulemaking and begin implementation of SB 303 in 2023-24 and will provide technical support to licensees for reporting, which will begin in 2025.
There were hundreds of bills passed during the 2023 Legislative Session. For more information, please visit the Oregon Legislative Information System under 2023 Regular Session.
PLEASE JOIN US FOR PUBLIC LISTENING SESSIONS THIS MONTH
Public Listening Sessions are an opportunity to provide feedback about the ongoing administration of the Oregon Psilocybin Services Act.
You’re invited to three upcoming virtual Public Listening Sessions:
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Tuesday, July 18, 6:00 – 8:00 p.m. Pacific Time https://www.zoomgov.com/j/1612722135?pwd=U1Fpakt4YmpmaDhjRTFES042dG1wQT09 Call in: 1-669-254-5252 (US) Meeting ID: 161 272 2135 Passcode: 657256
Wednesday, July 19, Noon – 2:00 p.m. Pacific Time https://www.zoomgov.com/j/1619547163?pwd=K21NcVRVaUtuWldnRTZrd1Q0a2pXZz09 Call in: 1-669-254-5252 (US) Meeting ID: 161 954 7163 Passcode: 517846
Thursday, July 20, 11:00 a.m. – 1:00 p.m. Pacific Time https://www.zoomgov.com/j/1607961742?pwd=TWVGS3hacDFmZUt2N0RUa3gzWXkrQT09 Call in: 1-669-254-5252 (US) Meeting ID: 160 796 1742 Passcode: 807126
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We want to clarify that this is not a forum to receive feedback on the statutory language of the Oregon Psilocybin Services Act, which is already set in law and would require legislative action to amend.
Everyone is invited to participate in these open forums. Real-time captioning (CART), and simultaneous interpretation in Spanish and American Sign Language (ASL) will be provided. If you have other accommodation requests, please get in touch and let us know how we can help: OHA.Psilocybin@odhsoha.state.or.us / 971-341-1713, 711 TTY.
OPS IS NOW ACCEPTING APPLICATIONS TO SERVE ON 2023 RULES ADVISORY COMMITTEES
OPS is currently accepting applications to serve on 2023 Rules Advisory Committees (RACs). One RAC will focus on adjustments and technical fixes to existing OPS administrative rules. The other RAC will focus on rules required to implement Senate Bill 303 passed during the 2023 legislative session, which directs psilocybin service centers to collect and submit aggregated client data to OHA beginning in 2025.
RACs are comprised of individuals who have subject matter expertise, lived experience, and who are likely to be affected by the proposed rules. The RAC process is designed to include a diversity of opinions and viewpoints. In addition to providing recommendations, RACs evaluate fiscal and racial impact of the proposed rules. Draft rules are updated based on RAC input, and the next version of proposed rules will then be made available for public comment in November 2023.
If you are interested in serving on a RAC, please submit a RAC Application by Friday, July 28, 2023. More information on how to apply can be found on the OPS Administrative Rules page.
RAC meetings are public virtual meetings and will be held in September 2023. Meeting dates and materials, including draft rules, will be posted on the OPS Administrative Rules page once meetings are scheduled.
Please note that OPS will not consider recommendations for big policy changes until 2024. The Oregon Psilocybin Advisory Board (OPAB) and subcommittees will be working to develop more significant policy recommendations for the 2024 rulemaking process. OPAB and subcommittee meetings are open to the public and include opportunities for public comment. Meeting information, including dates, zoom links, and meeting agendas can be found on the OPAB and subcommittees webpage. Additional public listening sessions and opportunities to participate in RACs for significant policy changes will be announced in 2024.
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PRODUCT TRACKING SYSTEM UPDATE
OPS is finishing development of the psilocybin product tracking system, which will be accessed through the Training Program, Licensing and Compliance (TLC) system. TLC is the online portal for applying for psilocybin licenses.
The new product tracking system, TLC-PTS, is on schedule to be released in the summer of 2023. OPS will keep using the interim product tracking system while TLC-PTS is in final stages of development. OPS will provide training to all licensed psilocybin businesses and provide ongoing technical support.
LICENSING UPDATE
With each week that passes, OPS is issuing new licenses to a growing network of licensees. The OPS Licensee Directory includes a list of licensees who wish to have their contact information publicly listed.
At the time of sending this newsletter, OPS has licensed: 2 laboratories, 3 manufacturers, 6 service centers, and 30 facilitators. You can find the latest stats by going to our Weekly Report on Applications for Licenses and Worker Permits.
We welcome your feedback.
Please do not hesitate to reach out with comments or questions.
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