Laboratory quality assurance and quality control

(a) Laboratory Quality Assurance (LQA) program. The medical laboratory director shall develop and implement an LQA program to ensure the reliability and validity of the analytical data produced by the laboratory. (1) The LQA program shall, at minimum, include a written LQA manual that addresses the following: (A) Quality control procedures, including remedial actions; (B) Laboratory organization and employee training and responsibilities; (C) LQA criteria for acceptable performance; (D) Traceability of data and analytical results; (E) Instrument maintenance, calibration procedures, and frequency; (F) Performance and system audits; (G) Steps to change processes when necessary; (H) Record retention; (I) Test procedure standardization; and (J) Method validation. (2) The laboratory director shall annually review, amend if necessary, and approve the LQA program and manual when: 2021.11.23_OSDH681_OMMARulesChapterAsAmended 99 (A) The LQA program and manual are created; and (B) There is a change in methods, laboratory equipment, or the supervisory or management laboratory employee overseeing the LQA program. (b) Laboratory quality control samples. (1) The laboratory shall use laboratory quality control (LQC) samples in the performance of each analysis according to the specifications in this section. (2) The laboratory shall analyze LQC samples in the same manner as the laboratory analyzes samples of medical marijuana and medical marijuana products. (3) The laboratory shall use negative and positive controls for microbial testing. (4) The following quality control samples must be run every 20 samples in an analytic run: (A) Method blank; (B) Continuing calibration verification (CCV); (C) Laboratory replicate sample; and (D) Matrix spike sample or matrix spike duplicate sample. (5) If the result of the analyses is outside the specified acceptance criteria in Appendix B, the laboratory shall determine the cause and take steps to remedy the problem until the result is within the specified acceptance criteria. Samples after the last acceptable run must be re-tested. (6) The laboratory shall generate a LQC sample report for each analytical run that includes LQC parameters, measurements, analysis date, and matrix. The results must fall within the criteria set forth in Appendix B. (c) Reagents, solutions, and reference standards. (1) Reagents, solutions, and reference standards shall be: (A) Secured in accordance with the laboratory's storage policies; labeled to indicate identity, date received or prepared, and expiration or requalification date; and, where applicable, concentration or purity, storage requirements, and date opened; (B) Stored under appropriate conditions to minimize degradation or deterioration of the material; and (C) Used only within the item's expiration or requalification date. (2) Deteriorated or outdated reagents and solutions shall be properly disposed, in compliance with all federal, state and local regulations. (3) The laboratory may acquire commercial reference standards for cannabinoids and other chemicals or contaminants, for the exclusive purpose of conducting testing for which the laboratory is approved. The laboratory may elect to produce reference standards in-house (internally). When internally produced, the laboratory shall utilize standard analytical techniques to document the purity and concentration of the internally produced reference standards. The laboratory is authorized to obtain marijuana or marijuana-derived product from a licensed non-profit producer for this purpose. (4) The laboratory shall obtain or, for internally-produced 2021.11.23_OSDH681_OMMARulesChapterAsAmended 100 standards, shall create a certificate of analysis (COA) for each lot of reference standard. Each COA shall be kept on-file and the lot number of the reference standard used shall be recorded in the documentation for each analysis, as applicable.