Rhode Island Code of Regulations
Title 216 - Department of health
Chapter 60 - Laboratories and Medical Examiner
Subchapter 05 - State Laboratory
Part 6 - Licensing Analytical Laboratories for Sampling and Testing Cannabis
Section 216-RICR-60-05-6.12 - Cannabis Proficiency Testing (PT) and Demonstration of Capability
Current through September 18, 2024
A. The quality assurance plan must include standard procedure for determining the capability of its analysts before they can begin conducting quantitative analysis of cannabis products.
B. RIDOH must be notified when significant changes are made to the standard analytical procedure such as changes to extraction technique or the instrumentation used.
C. Each analyst is required to perform initial demonstration of capability prior to implementing routine analyses.
D. Each laboratory must participate in a proficiency testing program approved by RIDOH for each analyte (or group of analytes), matrix and method for which the laboratory is certified or is requesting certification. Proficiency testing samples must be procured from a proficiency testing provider approved by RIDOH. RIDOH may require that the proficiency testing program include "round robin" proficiency testing whereby samples from the same batch are tested by more than one licensed analytical laboratory for comparison of results.
E. If proficiency test samples are not commercially available, analytical laboratories must submit a plan to define and develop in-house quality control samples it will use to demonstrate its proficiency for each analyte, matrix, and method of analysis. The plan must include:
F. The laboratory must participate in a PT sample annually for each analyte, matrix and method and receive an acceptable evaluation for each of the following:
G. Proficiency test results must be submitted by the accredited provider directly to the RIDOH licensing office by October thirty-first (31st) of each year. Analytical laboratories must designate RIDOH as a recipient of the provider's proficiency test results report. Analytical laboratories must not communicate or receive proficiency test results to or from other analytical laboratories before the accredited provider makes them available.
H. When a laboratory receives an unacceptable evaluation for an analyte in a study, it must determine the cause for the failure, take corrective action, and participate in another PT study for the failed analyte. Documentation of the investigation and corrective action must be maintained and a copy provided to RIDOH before the next proficiency testing study.
I. Failure to complete PT studies annually or failure to make-up an unacceptable PT result for any analyte annually will result in loss of licensing for the analyte until two (2) consecutive PT studies resulting in acceptable evaluations have been completed. There must be an interval of at least thirty (30) days between the two studies.
J. All proficiency test samples must be analyzed in the same manner and frequency as real cannabis products and samples using the same staff, procedures, and equipment.
K. Laboratories must not send a PT sample, or a portion thereof, to another laboratory for any analysis for which it is certified or seeks certification.
L. A laboratory must not knowingly receive any PT sample, or a portion thereof, from another laboratory for any analysis for which the sending laboratory is licensed or seeks licensing.
M. Laboratory management or staff must not communicate with any individual at another laboratory concerning a PT sample or attempt to obtain the assigned value from their PT provider.
N. All raw data obtained in analyzing PT samples must be retained and be available for review for a minimum of five (5) years.