SECTION 310:681-8-2. General operating requirements and procedures

(a)   Laboratory accreditation. A laboratory that submits an application to become a licensed testing laboratory prior to January 1, 2020 must have made application for accreditation to ANSI/ASQ National Accreditation Board, American Association for Laboratory Accreditation (A2LA), Perry Johnson Laboratory Accreditation (PJLA), or any other accrediting entity using the ISO/IEC Standard 17025, at the time of application. Application for accreditation must be made to one of these entities in both chemistry and biology, or cannabis. A laboratory that submits an application to become a licensed testing laboratory on or after January 1, 2020 must be accredited by ANSI/ASQ National Accreditation Board, American Association for Laboratory Accreditation (A2LA), Perry Johnson Laboratory Accreditation (PJLA), or any other accrediting entity using the ISO/IEC Standard 17025. The accreditation must be from one of these entities in both chemistry and biology, or cannabis.

(b)   Proficiency testing. The laboratory shall be subject to proficiency testing by the Department or its designee at a frequency and at times to be determined by the Department or its designee.

(1)   The laboratory shall cooperate with the Department or its designee for purposes of conducting proficiency testing. The Department or its designee may require submission of samples from the licensed laboratory for purposes of proficiency testing.

(2)   The quality assurance laboratory shall obtain reserve samples from licensed laboratories for the purposes of proficiency testing, which shall occur at a minimum of three (3) times per year for regular monitoring. The Department or the quality assurance laboratory may require additional proficiency tests to ensure correction of or investigate violations of Oklahoma law and these Rules.

(3)   If the Department determines on the basis of a proficiency testing that the laboratory has not satisfactorily identified the presence, quantity, or other relevant factor(s) pertaining to a given analyte, the Department may revoke the license, require additional tests, and/or require remedial actions to be taken by the laboratory.

(4)   If a laboratory fails its proficiency testing for an analyte, the batch testing results since the last proficiency 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 proficiency testing results.

(c)   Conflict of interest. A person who is a direct beneficial owner or an indirect 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.

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

(e)   Personnel. A licensed laboratory shall not operate unless a medical laboratory director is on site during operational hours. 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's degree and five (5) years of applicable experience.

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

(f)   Equipment.

(1)   Equipment used for analysis must have a Limit of Detection (LOD) capable of detecting the thresholds listed in OAC 310:681-8-1(h)and Appendix A.

(2)   Equipment used for the analysis of test samples shall be adequately inspected, cleaned, and maintained. Equipment used for the generation or measurement of data shall be adequately tested and calibrated on an appropriate schedule, as applicable.

(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, 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.

(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 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. 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. Any non-routine repair must be reported to and reviewed by the quality assurance laboratory.

(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.

(g)   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 two (2) 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.

(h)   Materials to be maintained on premises. The laboratory shall maintain on its premises, and shall promptly present to the Department 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, protocol, 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;

(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 staff is competent in the process; and that deviations from approved standards of practice do not occur without proper authorization;

(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 Department may require.

(i)   Department access to materials and premises. The laboratory shall promptly provide the Department or the Department'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 Department or the Department's designee to laboratory premises, and to any material or information requested by the Department, for the purpose of determining compliance with the requirements of applicable Oklahoma law and these rules.

[Source: Added at 35 Ok Reg 659, eff 8-25-18 (emergency); Reserved at 35 Ok Reg 709, eff 8-25-18 (emergency); Reserved at 36 Ok Reg 1759, eff 9-13-19; Added at 37 Ok Reg 168, eff 11-1-19 (emergency); Added at 37 Ok Reg 1491, eff 9-11-20]