Psilocybin Services in Oregon: What Facilitators Need to Know about Client Forms

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At the close of 2022, the Oregon Health Authority (OHA) released final rules for Oregon Psilocybin Services (OPS), the nation’s very first state-regulated psychedelic therapy program (known as “psychedelic services” in Oregon). Representing the culmination of hard work that began even before passage of Measure 109, the 2020 voter initiative, OPS is expected to begin offering psychedelic services in Oregon later this year. For prospective facilitators, the clock is ticking as they digest the guidelines and requirements around facilitating psilocybin services in Oregon. 

If you’re struggling to digest the legal language and requirements embedded in the current rules, we believe we can help. Maya Health is a company founded on a simple principle: To empower practitioners of psychedelic medicine to chart safe and effective practices, remain in compliance with regulatory requirements, and streamline their scheduling and therapeutic processes. We offer user-friendly and intuitive tools designed to help you be the most effective and productive practitioner you can possibly be, while avoiding the risks of non-compliance with state mandates.

With that in mind, today’s post focuses on the record-keeping and data-control aspects of providing guided psychedelic services in Oregon. Some of the key points we’ll cover include:

• What forms do psilocybin service clients need to be provided with?
• What is the purpose of each form?
• When do the forms need to be shared with clients and completed?
• What other record-keeping stipulations are psychedelic service facilitators subject to?
• What data privacy concerns do facilitators need to be aware of?

Ready? Let’s dive in.

Facilitating Psilocybin Services in Oregon: An Introduction

If you’ve visited a doctor’s office within the last twenty-odd years, you’ve probably heard of the Health Insurance Portability and Accountability Act (HIPAA). For most of us, fulfilling its requirements involves a few minutes of paperwork at most. In some regards, the record-keeping requirements around guided Oregon psychedelic services aren’t vastly different, but they entail a number of client forms that must be reviewed, signed, and filed within specific timeframes.

“Not having had a great deal of experience doing [this style of paperwork] on a regular basis, it’s onerous. If you were coming into this work without a clinical background, it could feel VERY daunting. From the facilitator standpoint, keeping track of that data if you’re not a person who already has that in your profession seems like a lot.” -Sue J., Prospective Psilocybin Facilitator

To compound the potential for confusion, the current legal framework around Oregon psychedelic services classifies such work as being expressly non-medical. Per OHA rules, facilitators are prohibited from diagnosing or treating health conditions, and facilitators and service centers are forbidden from making any health-related claims. While this may seem counterintuitive, here at Maya we see it as an opportunity: People pursuing psilocybin guide training often enter the field from vectors other than healthcare, bringing a fresh and potentially expansive set of skills to the field.

On top of this, the unorthodox format of psilocybin service as defined by the State of Oregon—divided into preparation, administration, and integration sessions—creates unique demands when it comes to managing client forms and the creation and retention of records. We’ll be referring to these three phases of psilocybin services throughout this article.

Finally, a disclaimer: Today’s post focuses on a few key points as outlined in the most recent Oregon bill regarding psilocybin services, SB303. While the bill has not yet been adopted, at present we believe it’s close enough to passage to share its basic tenets. Rest assured we’re watching the bill closely, and will update pertinent information as soon as it’s available.

Facilitating Oregon Psilocybin Services: Client Forms and Their Purposes

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As with HIPAA, the aim of OPS’ data-retention regulations is to ensure that any data relating to clients who undergo psilocybin service remains secure, confidential, and accurate. As outlined in the current regulations, clients undergoing psilocybin service must be provided with four types of forms:

• Client Information Form
• Informed Consent Document
• Client Acknowledgement Form
• Client Consent/Disclosure Form

Let’s run through each to understand their most important points, as well as delineating when each one must be completed by the client.

1. Client Information Form: The purpose of this form is to identify any potential risk factors, negative drug interactions, mental health concerns or other factors which might negatively impact the administration session. Some of these factors—for instance recent use of the prescription drug Lithium—may disqualify a given client from undertaking the administration session. Finally, this form is designed to surface any special needs, such as translation services, that may be required during the administration session.

Timeline: A client must review and complete a client information form before participating in an administration session. You can find the full text of this form here.

2. Informed Consent Document: Once a client and facilitator have reviewed the client information form, the next required form is the informed consent document. Lengthier and more in-depth than the client information form, the informed consent document is designed to help provide a framework for clients to better understand the parameters of psilocybin service they’ll receive. Representative statements include:

1. ____ I have reviewed the Psilocybin Services Client Bill of Rights, my facilitator has explained it to me, and I understand my rights as a client.

2. ____ I understand that psilocybin services do not require medical diagnosis or referral and that psilocybin services are not a medical or clinical treatment.

3. ____ I understand that psilocybin has not been approved by the Food and Drug Administration and the federal government currently classifies psilocybin as a Schedule I controlled substance under the Controlled Substances Act. 

Timeline: It’s important to know that the informed consent document must be provided to the client during the preparation session or prior to it, upon the patient’s request. The facilitator must review the contents of the informed consent form with each client and receive a signed copy of the document prior to beginning an administration session. You can find the full text of this form here.

3. Client Acknowledgement Form: This form functions as something of a  “last-minute safety check,” ensuring that clients have received, reviewed, and signed the previous documents as well as understanding the Client Bill of Rights provided by law to all clients during their preparation session.

In addition, the client acknowledgement form ensures that details pertaining to the administration session—such as the potential need for a translator or other client support person, as well as the client’s post-session transportation plan—have all been established and agreed upon.

Timeline: The client acknowledgement form must be reviewed and signed by the client prior to beginning an administration session. As of this writing, the exact language contained in the form is still being determined. We’ll provide a link or the complete text as soon as it becomes available.

Facilitating Psychedelic Services in Oregon: Client Confidentiality

The topic of data collection has been a point of contention amidst the launch of Oregon’s psilocybin service centers. Here at Maya Health, we’re committed first and foremost to helping newly licensed facilitators adhere to the letter of the law as it pertains to privileged data. 

Maya Health was created in order to bring accountability, transparency, and rigor to a field in which these attributes have often been absent. We envision a world in which such psychedelic therapy yields the most consistent, predictable, and transformative experiences possible. And for that to happen, it’s imperative that researchers have access to valid, authoritative, lawfully collected client data. That’s why HIPAA compliance, bank-level encryption, and a commitment to ethical data guardianship are built into our model.

4. Client Consent / Disclosure Form: This form is designed to explain the data-collection and privacy protections built into Oregon law, and it’s worth examining the language of the document in full. In essence, it ensures that clients know the nature and extent of the data that can be shared with third parties, as well as underscoring their right to keep that data private. 

(1) A service center or facilitator may not disclose any information that may be used to identify a client, or disclose any communication made by a client related to psilocybin services or selling psilocybin products to a client, except with client’s consent or otherwise as allowed by ORS 475A.450.

(2) A service center or facilitator must have a completed client consent form to disclose identifiable client information that contains the following:

(a) A specific description of the client’s identifiable information to be used or disclosed.

(b) The name or specific identification of the person(s) or class of person(s) the client’s information will be disclosed to. 

(c) The specific purpose for which the information will be used or disclosed.

(d) The date and signature of the patient.

(e) An expiration date when the consent to use or disclose is withdrawn.

(3) A service center or facilitator must use the client written consent form provided by the Authority to meet the requirements of section (2) of this rule. The consent form is available on the Authority’s website. 

(4) The client consent form described in section (2) of this rule must be completed at least 24 hours prior to the client’s administration session or at least 24 hours after the conclusion of the client’s administration session. 

(5) A service center or facilitator must provide a client with a disclosure form during or prior to a preparation session if the facilitator or service center intends to share de-identified data related to the client’s receipt of psilocybin product or services. The disclosure form must contain:

(a) The name of the person or organization that will receive de-identified data. 

(b) The specific purpose for which the de-identified data will be used or disclosed. 

(c) The date the form was provided to the client and client signature acknowledging receipt. 

(d) An option that allows the client to opt out of having their de-identified data disclosed to third parties. 

(6) A service center or facilitator must use the disclosure form provided by the Authority to meet the requirements of section (5) of this rule. The disclosure form is available on the Authority’s website.

(7) A service center or facilitator may not condition the provision of psilocybin services on whether a client consents to the use or disclosure of their information. 

Timeline: A client must review and complete a client consent form either 24 hours before participating in an administration session or 24 hours after its completion. You can find the full text of this form here.

Facilitating Oregon Psilocybin Services: Facilitator and Service Center Record Keeping and Confidentiality

Once these four crucial forms have been completed and collected, there exist a number of requirements as to how those records will be stored. While each service center will operate under their own guidelines, current law stipulates the following:

(1) A facilitator shall create and retain the following records for every client to whom they provide psilocybin services. A copy of these records must be also stored at the service center where the client received services:

(a) Completed information form.

(b) Completed informed consent document.

(c) Transportation plan.

(d) Client acknowledgement form.

(e) The date, start time and end time, for every preparation, administration and integration session. 

(f) The psilocybin products, including unique identification number, consumed by each client, including the amount of product consumed and whether it was consumed in a single dose or multiple doses. 

(g) Any deviation from the client’s transportation plan. 

(h) Any adverse reactions that required medical attention or emergency services. 

(2) If applicable and as required by these rules, a facilitator shall create the following records, and these records must be stored at the service center where the client received services:

(a) Consent for any applicable circumstances.

(b) Support person plans.

(c) Safety and support plans.

(3) Records required by this rule must be provided to the client upon request.

(4) Records required by this rule must identify the client receiving services. 

(5) Facilitators and service centers shall not share or disclose any records required by this rule unless permitted or required.  

Note that while licensees must retain required records for five years, they are permitted to retain them for longer unless a client requests they be destroyed after the five-year period has elapsed.

(1) Licensees shall store, maintain and destroy records, including client records, in a manner that prevents unauthorized access and protects client confidentiality. 

(2) Unless otherwise specified in these rules, licensees must retain required records for a period of five years. For example, licensees must retain security video required by OAR 333-333-4650 for a period of 30 calendar days. 

(3) Licensed facilitators and service centers must allow current and former clients to access and examine client records and request corrections to those records. Following the retention period described in section (2) of this rule a facilitator or service center must destroy client records upon the client’s request.

Facilitating Psilocybin Service in Oregon: In Conclusion

In this post we have shared a large amount of information, much of which can easily feel overwhelming to the emerging community of facilitators and service center operators.  However, if you’re considering psilocybin service training and state certification, it’s important to know which documents require client and facilitator review, as well as when each one needs to be completed. How do you fulfill these stringent compliance and reporting requirements while staying focused, productive, and on task?

Maya Health can help. Our tools designed for psychedelic practitioners offer a streamlined and intuitive way to capture and quantify client wellness throughout the preparation, therapeutic journey, and integration stages while complying with all applicable compliance requirements. The Maya Platform will allow you to personalize and optimize your services while offering a more seamless, engaging, and ultimately impactful client experience. And the bank-level encryption of our HIPAA-compliant data collection helps legitimize your work, contribute your findings to psychedelic research, and participate in academic studies. Interested in learning more? We’d love to share a demo with you.

We hope today’s post has provided clarity around the complex and fast-changing topic of Oregon psilocybin services training and implementation. If you have further questions, don’t hesitate to reach out. We’re here to help!