Resources for Laboratories Seeking Accreditation for Psilocybin
Ballot Measure 109 requires laboratories performing testing of psilocybin products to be accredited by ORELAP. Interested laboratories must submit a completed application, undergo an onsite inspection, and meet other applicable requirements as determined appropriate by ORELAP by rule.
Interested in joining an ORELAP psilocybin workgroup? Email us at ORELAP.Info@dhsoha.state.or.us
to express your interest. There are four workgroups that meet on an as needed basis, they are:
- Potency Workgroup
- Speciation Workgroup
- Sampling Workgroup
- Proficiency Testing Workgroup
ORELAP held two information sessions on March 11 & 22, 2022 to provide information to laboratory stakeholders about psilocybin accreditation. Review the meeting materials below.
ORELAP accredits laboratories interested in compliance testing of psilocybin, cannabis, drinking water, or other environmental matrices. The process is similar no matter what type of testing the laboratory is considering. The process begins by registering for a username in our ORELAP Data Input and Edit (ODIE) system (a link to ODIE is located on the homepage). Once registered, the user can create an initial application for accreditation. The laboratory's application will be reviewed and invoiced in the order they are received. Once the invoice has been paid, ORELAP will arrange for an onsite assessment. The assessment will determine the laboratory's compliance to the accreditation rules and the 2016 TNI Standard. If the laboratory successfully completes and passes the onsite assessment, a certificate of accreditation will be awarded to the laboratory with an issued date and expiration date. The laboratory must renew its accreditation annually thereafter and will be subject to follow up onsite assessments every two years.
Tips for Success
Those unfamiliar with the ORELAP accreditation process will want to make sure they get up to speed now. Obtain a copy of the 2016 TNI Standard and become familiar with the requirements for accreditation. Make sure there are personnel at the laboratory who meet the educational and experience qualifications for the technical director and quality assurance officer. Assessments cannot be scheduled until invoices are paid and the laboratory has qualified personnel. Be prepared to show assessors method validation data (as described in the appropriate modules of the TNI Standard).
What Kinds of Tests?
on the best available information, ORELAP tentatively expects to accredit
testing laboratories for potency (i.e., concentration) of psilocybin
products. The analytes for potency
testing will likely include psilocybin and psilocin. According to preliminary research, high
performance liquid chromatography (HPLC) is the most common technology used to
measure psilocybin and psilocin. ORELAP
also tentatively expects to accredit testing laboratories for speciation of
psilocybin fungi. Speciation testing may
be used to identify the target species for cultivation and may also be used to
identify potentially harmful fungi.
ORELAP is investigating the use of quantitative polymerase chain
reaction (qPCR) methods for speciation testing.
This information is all subject to change as rules are finalized and
more information becomes available.
When Can I Become Accredited?
ORELAP tentatively plans to begin accepting applications for accreditation starting June 2022.