Oklahoma Administrative Code › Title 442 - Oklahoma Medical Marijuana Authority › Chapter 10 - Medical Marijuana Regulations › Subchapter 8 - Laboratory Testing › Section 442:10-8-2 - General operating requirements and procedures

Current through Vol. 41, No. 20, July 1, 2024
(a)
Laboratory accreditation.
All medical marijuana testing
				laboratories shall obtain accreditation by any accrediting entity approved by
				the Authority and subscribing to the International Laboratory Accreditation
				Cooperation ("ILAC"), prior to applying for and receiving a medical marijuana
				testing laboratory license. The accreditation must be from one of these
				entities in both chemistry and biology, or cannabis and must be specific to the
				procedure used in the laboratory. Renewal of any medical marijuana testing
				laboratory license shall be contingent upon maintaining accreditation in
				accordance with these Rules.
(b)
Testing limited to scope of accreditation.
Upon accreditation, a
				testing laboratory shall only report test results on COAs for the testing of
				analytes the laboratory conducted that are within the scope of the testing
				laboratory's accreditation. Laboratories must notify the Authority of any
				change in scope of the testing laboratory's accreditation and the Authority may
				verify that the applicant can achieve analyte-specific testing thresholds
				showing applicants meet requirements stated in this section. A lab may
				outsource testing and report those results on a COA but must identify the
				testing laboratory that actually conducted the testing.
(c)
External quality control program
				testing.
The laboratory shall be subject to an external quality control
				program administered by the Authority or its designee. Frequency of external
				quality control testing is to be determined by the Authority or its designee.
(1) The laboratory shall cooperate with the
				Authority or its designee for purposes of conducting external quality control
				testing. The Authority or its designee may require submission of samples from
				the licensed laboratory for purposes of external quality control
				testing.
(2) The quality assurance
				laboratory shall obtain reserve samples from licensed laboratories for the
				purposes of external quality control testing, which shall occur at a minimum of
				three (3) times per year for regular monitoring. The Authority or the quality
				assurance laboratory may require additional external quality control tests to
				ensure correction of or investigate violations of Oklahoma law and these
				Rules.
(3) A result outside of the
				target range of any analyte in an external quality control sample event shall
				be deemed an unsatisfactory result. Each unsatisfactory result shall be
				evaluated by the licensed laboratory and corrective measure identified. The
				evaluation and completion of corrective measures shall be documented and signed
				by the laboratory director. The laboratory must then demonstrate its ability to
				achieve the target value.
(4) More
				than twenty percent (20%) unsatisfactory results in any external quality
				control testing event shall be deemed unsuccessful participation in the
				external quality control program. Unsuccessful participation in external
				quality control testing for two (2) testing events in a row, or two (2) out of
				three (3) events, may result in suspension or revocation of a laboratory
				license.
(5) Failure to participate
				in any external quality control testing shall be deemed unsuccessful
				participation in the external quality control program.
(6) If a laboratory fails its external
				quality control testing for an analyte, the batch testing results since the
				last external quality control test for that analyte must be re-evaluated. The
				laboratory director shall assess and implement necessary procedures to ensure
				risks to public safety are mitigated following failed external quality control
				testing results.