Okla. Admin. Code § 442:10-8-6.2

Current through Vol. 41, No. 24, September 3, 2024

Section 442:10-8-6.2 - [Effective until 9/14/2024] Laboratory standardization recommendations for general operating requirements and procedures

(a)Laboratory standardization recommendations. Beginning June 1, 2024, medical marijuana testing laboratories renewing their medical marijuana business license shall be subject to and comply with the following rules relating to the testing of medical marijuana, medical marijuana concentrate, and medical marijuana products. The refusal or failure of a medical marijuana testing laboratory licensee to comply with these rules relating to laboratory standards and testing procedures shall result in the permanent revocation of the medical marijuana testing laboratory license.

(b)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.

(c)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. A lab may outsource testing and report those results on a COA but must identify the testing laboratory that actually conducted the testing.

(d)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.

(e)Conflict of interest. A person who is a direct beneficial owner of a licensed dispensary, commercial grower, or processor shall not be an owner of a licensed laboratory. A licensed testing laboratory shall establish policies to prevent the existence of or appearance of undue commercial, financial, or other influences that may diminish the competency, impartiality, and integrity of the testing processes or results of the laboratory. At a minimum, employees, owners, or agents of a licensed laboratory who participate in any aspect of the analysis and results of a sample are prohibited from improperly influencing the testing process, improperly manipulating data, or improperly benefiting from any ongoing financial, employment, personal, or business relationship with the medical marijuana business licensee that provided the sample. A medical marijuana testing laboratory shall not test samples for any medical marijuana business in which an owner, employee or agent of the medical marijuana testing laboratory has any form of ownership or financial interest in the medical marijuana business.

(f)Safety standards. Licensed laboratories must comply with Occupational Safety and Health Administration (OSHA) Standard 29 CFR § 1910.1450.

(g)Personnel. A licensed laboratory shall not operate unless a medical laboratory director is on site during operational hours; in his or her absence, the medical laboratory director may delegate in writing the duties and responsibilities to a qualified designee that meets all requirements of a laboratory director required by applicable Oklahoma law and these rules. Personnel of a licensed laboratory shall meet the following minimum requirements:

(1) A medical laboratory director must possess a bachelor's degree in the chemical, environmental, biological sciences, physical sciences or engineering, with at least twenty-four (24) college semester credit hours in chemistry and at least two (2) years of experience in the environmental analysis of representative inorganic and organic analytes for which the laboratory will be performing. A master's degree or doctoral degree in one of the above disciplines may be substituted for one (1) year of experience. The medical laboratory director shall be responsible for the development of and adherence to all pre-analytic, analytic, and post-analytic procedures, and the implementation of a quality system that assures reliable test results and regulatory compliance.

(2) Analysts must possess a bachelor's degree applicable to a laboratory testing environment, with a minimum of two (2) years of experience, or an associate degree and five (5) years of applicable experience.

(3) Ancillary personnel must possess a high school diploma or equivalent.

(4) A licensed laboratory shall notify the Authority within seven (7) business days after any change of the laboratory's director occurs.

(h)Equipment.

(1) Equipment used for analysis must have an in sample Limit of Quantification (LOQ) capable of detecting quantities at or below fifty percent (50%) of the thresholds listed in OAC 442:10-8-1(i).

(2) Equipment used for the analysis of test samples shall be adequately inspected, cleaned, and maintained. Preventive maintenance shall be carried out in accordance with the requirements and recommendations of the manufacturer. Equipment used for the generation or measurement of data shall be adequately tested and calibrated on an appropriate schedule, as applicable. Any modification or repair of an instrument shall undergo verification that it can meet the quality control requirements of these Rules.

(3) Laboratory operations shall document procedures setting forth in sufficient detail the methods and schedules to be used in the routine inspection, cleaning, maintenance, testing, and calibration of equipment used in preparation or analysis of laboratory samples, storage of samples, reagents, calibrators and controls and shall specify, as appropriate, remedial action to be taken in the event of failure or malfunction of equipment. The procedures shall designate the personnel responsible for the performance of each operation and shall be readily accessible to all personnel who operate the equipment.

(4) Records shall be maintained of all inspection, maintenance, testing, and calibrating operations. These records shall include the date of the operation, the person who performed it, the written procedure used, and any deviations from the written procedure. All deviations must be reviewed and approved in writing by the medical laboratory director. Records shall be kept of non-routine repairs performed on equipment. Such records shall document the nature of the repair, how and when the need for the repair was discovered, and any remedial action taken in response to the repair to bring the instrument into compliance with the quality control requirements of these Rules. A written assessment of the validity of the results obtained previous to the failure must be made. Documentation of any repeat testing performed must also be maintained.

(5) Computer systems used for the analysis of samples, retention of data, sample tracking, calibration scheduling, management of reference standards, or other critical laboratory management functions shall ensure that electronic records, electronic signatures, and handwritten signatures executed to electronic records are trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed on paper.

(i)Data storage.

(1) The laboratory shall ensure that all raw data, documentation, protocols, and final reports associated with analysis of a test sample are retained for at least seven (7) years from the date of completion of analysis.

(2) The laboratory shall designate an individual as responsible for records maintenance. Only authorized personnel may access the maintained records.

(3) The laboratory shall maintain the records identified in this section:

(A) In a manner that allows retrieval, as needed;

(B) Under conditions of storage that minimize deterioration throughout the retention period; and

(C) In a manner that prevents unauthorized alteration.

(j)Materials to be maintained on premises. The laboratory shall maintain on its premises, and shall promptly present to the Authority upon request:

(1) Personnel documentation including, but not limited to employment records, job descriptions, education, and training requirements of the laboratory, and documentation of education and training provided to staff for the purpose of performance of assigned functions;

(2) Policies concerning laboratory operations, business licensing, and security procedures;

(3) Any policies, protocols, or procedures for receipt, handling, and disposition of samples of usable marijuana;

(4) Equipment information detailing the type of equipment used, inspection policies and practices, testing and calibration schedules and records, and standards for cleaning and maintenance of equipment;

(5) Reagents, solutions, and reference policies including, but not limited to standards for labeling, storage, expiration, and re-qualification dates and records including traceability from current container to original container; all reagents must be traceable from current container to original container.

(6) Reference standards, acquired or internally produced, including the certificate of analysis;

(7) Sample analysis procedures including, but not limited to procedures for the use of only primary or secondary standards for quantitative analyses;

(8) Documentation demonstrating that the analytical methods used by the laboratory are appropriate for their intended purpose; that deviations from approved standards of practice do not occur without documented authorization in writing; method performance is verified each time a new analyst performs the test, and that staff is competent in the process; including but not limited to:

(A) Direct observations of routine test performance, including sample preparation, handling, processing and testing as appropriate;

(B) Monitoring recording and reporting of test results;

(C) Review of intermediate test results or worksheets, quality control records, proficiency testing results and preventive maintenance records;

(D) Direct observation of instrument maintenance and function checks;

(E) Test performance using previously analyzed specimens, blind sample testing, and external proficiency testing results;

(F) Assessment of problem-solving skills;

(G) Initial assessment within the first six (6) months of employment, with annual assessments thereafter unless a change in methodology occurs; and

(H) Documentation must be complete before reporting results.

(9) Policies for data recording, review, storage, and reporting that include, but are not limited to standards to ensure that:

(A) Data are recorded in a manner consistent with applicable Oklahoma law and these Rules, and are reviewed to verify that applicable standards of practice, equipment calibration, and reference standards were applied before reporting;

(B) All data, including raw data, documentation, protocols, and reports are retained in accordance with applicable Oklahoma law and these rules; and

(C) Reports are the property of the business or individual who provided the sample, and reports meet the requirements of this rule.

(10) Documentation showing the laboratory complies with OSHA Standard 29 CFR § 1910.1450; and

(11) Such other materials as the Authority may require.

(k)Authority access to materials and premises. The laboratory shall promptly provide the Authority or the Authority's designee access to a report of a test, and any underlying data, that is conducted on a sample. The laboratory shall also provide access to the Authority or the Authority's designee to laboratory premises, and to any material or information requested by the Authority, for the purpose of determining compliance with the requirements of applicable Oklahoma law and these rules.

(l)Reporting of accreditation and proficiency testing results. The laboratory must submit to the Authority, within thirty (30) days of an accrediting entity's assessment, the results of any proficiency testing or an accrediting entity's audit, including the findings and any corrective action required following the assessment.

(m)Licensed premises standards. The laboratory must be constructed, arranged and maintained in a way that ensures the laboratory premises, ventilation and utilities are sufficient for conducting all phases of the testing process:

(1) Work area shall be arranged to minimize problems in specimen handling, examination and testing, and reporting of test results. Workbench space must be sufficient for the performance of testing, including, but not limited to, adequate lighting, water, gas, vacuum, and electrical outlets. Instruments, equipment, and computer systems shall be placed in locations where their operation is not affected adversely by physical or chemical factors, such as heat, humidity, direct sunlight, vibrations, power fluctuations, or fumes from acid or alkaline solutions. Equipment tops shall not be used as a workbench space;

(2) Lighting or backgrounds as appropriate for visual interpretation of test results;

(3) There is a system in place which ensures that the ventilation system properly removes vapors, fumes, and excessive heat as appropriate for the type of testing done in the laboratory;

(4) There is an adequate, stable electrical source maintained at each testing location that meets the power requirements for each piece of equipment;

(5) The Laboratory is designed to minimize contamination of samples, equipment, instruments, reagents and supplies. Laboratories performing molecular amplification procedures must have a mechanism to detect cross-contamination of specimens; and

(6) Reagents must be prepared in an area that is separate, as applicable, from where specimens are processed, prepared, amplified, and detected to prevent contamination.

Okla. Admin. Code § 442:10-8-6.2

Adopted by Oklahoma Register, Volume 41, Issue 3, October 16, 2023, eff. 9/11/2023, exp. 9/14/2024 (Emergency)