Sampling requirements and procedures

General requirements. (a) Samples must be collected in accordance with OAC 310:681-8-3(a)- (c). Individuals collecting samples are called "Samplers." (1) Samplers must: (A) Follow the approved sampling policies and standard operating procedures of the laboratory that will be testing the samples collected. Samplers shall have access to a copy of the laboratory’s standard operating procedures while they are collecting the samples must be trained on how to collect samples in accordance with the standard operating procedures of the laboratory(ies) that will be conducting the testing on the samples collected and shall have access to a copy of the standard operating procedures while they are collecting the samples; and (B) Follow inventory manifest requirements set forth in these Rules. (2) Samplers shall collect samples at the location of the grower or processor. (3) A licensed laboratory must either utilize a licensed commercial transporter to transport samples or obtain a commercial transporter license in order to transport samples from the grower or processor 2021.06_OSDH681_OMMARulesChapterAsAmended 82 to the laboratory. (4) All commercial transporters, growers, or processors transporting samples to a laboratory shall be prohibited from storing samples at any location other than the laboratory facility. All samples must be delivered the day of collection. (5) Samples shall only be collected from harvest batches and production batches in final form. For purpose of this Subsection, "final form" means the form medical marijuana or a medical marijuana product is in when sold or transferred. (6) The sampler shall collect both a primary sample and a reserve sample from each harvest batch and production batch. The sample shall be clearly and conspicuously labeled and the label shall include at least the following information: (A) Whether the sample is "Primary Sample" or "Reserve Sample"; (B) Name and license number of grower or processor from whom the sample was taken; and (C) The batch number of harvest batch or production batch from which the sample was taken. (7) The primary sample and reserve sample shall be stored and separately and analyzed separately. The reserve sample is used for quality control purposes only. (8) Samples shall be transported and subsequently stored at the laboratory in a manner that prevents degradation, contamination, and tampering. If the medical marijuana or medical marijuana product specifies on the label how the product shall be stored, the laboratory shall store the sample as indicated on the label. (9) The sampler shall create and use a sample field log to record the following information for each sample: (A) Laboratory's name, address, and license number; (B) Sampler's name(s) and title(s) and the names of others onsite Title and version of the laboratory’s standard operating procedure(s) followed when collecting the sample; (C) Date and time sampling started and ended Sampler's name(s) and title(s) and the names of others onsite; (D) Grower's or processor's name, address, and license number Date and time sampling started and ended; (E) Batch number of the batch from which the sample was obtained Grower's or processor's name, address, and license number; (F) Sample matrix Batch number of the batch from which the sample was obtained; (G) Total batch size, by weight or unit count Total weight or unit count; (H) Total weight or unit count of the primary sample Total batch size, by weight or unit count; (I) Total weight or unit count of the reserve sample Total weight or unit count of the primary sample; (J) The unique sample identification number for each sample Total weight or unit count of the reserve sample; (K) Name, business address, and license number of the person who transports the samples to the laboratory The unique sample identification number for each sample; (L) Requested analyses Name, business address, and license 2021.06_OSDH681_OMMARulesChapterAsAmended 83 number of the person who transports the samples to the laboratory; (M) Sampling conditions, including temperature Requested analyses; (N) Problems encountered and corrective actions taken during the sampling process, if any; and Sampling conditions, including temperature; (O) Any other observations from sampling, including major inconsistencies in the medical marijuana color, size, or smell. Problems encountered and corrective actions taken during the sampling process, if any; and (P) Any other observations from sampling, including major inconsistencies in the medical marijuana color, size, or smell. (10) The laboratory shall maintain inventory manifest documentation listed in OAC 310:681-3-6 and utilize an electronic inventory management system that meets the requirements set forth in OAC 310:681-5-6(d) for each sample that the laboratory collects, transports, and analyzes. (11) A laboratory must maintain the documentation required in these rules for at least two (2) years and must provide that information to the Department upon request Commercial licensees shall document all employee training on a testing laboratory's standard operating procedures. (12) Commercial licensees must maintain the documentation required in these rules for at least two (2) years and must provide that information to the Department upon request. (b) Sample size. (1) To obtain a representative sample of a harvest batch, a total of 0.5% of the batch is collected from different areas of the batch following the laboratory's approved protocol. The sample is then homogenized and aliquoted into a primary sample and reserve sample, which shall be equal in amounts. The primary sample and reserve sample shall be in the amounts specified in the laboratory's standard operating procedure. Any amounts left over after aliquoting may be returned to the harvest batch. (2) To obtain a representative sample of a processed batch that is well mixed or homogeneous by its nature, obtain an amount sufficient to be aliquoted into a primary sample and a reserve sample, which shall be equal in amounts. If the batch is of not homogeneous or is of unknown homogeneity, then 0.5% of the batch shall be collected from different portions of the batch following the laboratory's approved protocol. The sample is then homogenized and aliquoted into a primary sample and reserve sample, which shall be equal in amounts. The primary sample and reserve sample shall be in the amounts specified in the laboratory's standard operating procedure. Any amounts left over after aliquoting may be returned to the harvest batch. (c) Sampling standard operating procedures. (1) Samples collected must be representative of the entire batch to ensure accurate microbiological analysis and foreign material assessments. (2) Sample protocol shall be approved by the laboratory director. The laboratory shall develop and implement written sampling policies 2021.06_OSDH681_OMMARulesChapterAsAmended 84 and procedures that are appropriate for each test method and each type of matrix to be tested and that are consistent with these regulations. Sampling procedures must describe the laboratory's method for collection, preparation, packaging, labeling, documentation, and transport of samples from each matrix type the laboratory tests. (3) The sampling standard operating procedures (SOP) shall include at least the following information: (A) A step-by-step guide for obtaining samples from each matrix type the laboratory samples; (B) Protocols for ensuring that contaminants are not introduced during sampling, including protocols relating to the sanitizing of equipment and tools, protective garb, and sampling containers; (C) Accepted test sample types; (D) Minimum test sample size; (E) Recommended test sample containers; (F) Test sample labeling; (G) Transport and storage conditions, such as refrigeration, as appropriate to protect the physical and chemical integrity of the sample; (H) Other requirements, such as use of preservatives, inert gas, or other measures designed to protect sample integrity; and (I) Chain-of-custody documentation for each sample in accordance with OAC 310:681-5-6. (4) The sampling SOP shall be signed and dated by the medical laboratory director and shall include any revision dates and authors. The laboratory director's signature denotes approval of the plan. (5) The laboratory shall retain a controlled copy of the sampling SOP on the laboratory premises and ensure that the sampling SOP is accessible to the sampler in the field during sampling. (d) Sample handling, storage and disposal. A laboratory shall establish sample handling procedures for the tracking of test samples through the analytical process (by weight, volume, number, or other appropriate measure) to prevent diversion. (1) The laboratory shall store each test sample under the appropriate conditions appropriate to protect the physical and chemical integrity of the sample. (2) Analyzed test samples consisting of medical marijuana or medical marijuana products shall be held in a controlled access area pending destruction or other disposal. (3) Any portion of a medical marijuana product test sample that is not destroyed during analysis shall be: Reserve samples shall be maintained and properly stored by the laboratory for at least thirty (30) days. (4) After the required thirty (30) day storage period, any portion of a medical marijuana or medical marijuana product test sample that is not destroyed during analysis shall be: (A) Returned to the licensed individual or entity that provided the sample after the required retention period for reserve samples; (B) Transported to a state or local law enforcement office; or (C) Disposed of in accordance with OAC 310:681-5-10 (relating to 2021.06_OSDH681_OMMARulesChapterAsAmended 85 medical marijuana waste disposal). (e) Data reporting. (1) The laboratory shall generate a certificate of analysis (COA) for each primary sample that the laboratory analyzes. (2) The laboratory shall issue the COA to the requester within two (2) business days after technical and administrative review of analysis has been completed. A laboratory shall not withhold a COA reporting a failed test from the requester for any reason. (3) The COA All COAs, whether in paper or electronic form, shall contain, at minimum, the following information: (A) The name, address, license number, and contact information of the laboratory that conducted the analysis; (B) If the laboratory sends a sample to another laboratory for testing, the reference laboratory must be identified as having performed that test; (C) The name, address, and license number of the requester; (D) The description of the type or form of the test sample (leaf, flower, powder, oil, specific edible product, etc.) and its total primary sample weight in grams, reported to the nearest gram; (E) The unique sample identifier; (F) Batch number of the batch from which the sample was obtained; (G) Sample history, including the date collected, the date received by the laboratory, and the date(s) of sample analyses and corresponding testing results, including units of measure where applicable; (H) The analytical methods used, including at a minimum identification of the type of analytical equipment used (e.g., GC, HPLC, UV, etc.); (I) The reporting limit for each analyte tested; (J) Any compounds detected during the analyses of the sample that are not among the targeted analytes and are unknown, unidentified, tentatively identified or known and injurious to human health if consumed, if any; (K) The identity of the supervisory or management personnel who reviewed and verified the data and results and ensured that data quality, calibration, and other applicable requirements were met.; and (L) Definitions of any abbreviated terms. (4) The laboratory shall report test results for each primary sample on the COA as follows: (A) When reporting quantitative results for each analyte, the laboratory shall use the appropriate units of measurement as required under this chapter and indicate "pass" or "fail"; (B) When reporting qualitative results for each analyte, the laboratory shall indicate "pass" or "fail"; (C) When reporting results for any analytes that were detected below the analytical method limit of quantitation (LOQ), indicate "Pass" and "Fail" must be clear, conspicuous, and easily identifiable in a font size no less than the size of 12 pt font in Times New Roman and shall not be in fine print or footnotes; (D) Indicate "NT" for not tested for any test that the 2021.06_OSDH681_OMMARulesChapterAsAmended 86 laboratory did not perform. When reporting results for any analytes that were detected below the analytical method limit of quantitation (LOQ), indicate "<LOQ" and list the results for analytes that were detected above the LOQ but below the allowable limit; and (E) Indicate "NT" for not tested for any test that the laboratory did not perform. (5) Upon detection of any compounds during the analyses of the sample that are not among the targeted analytes and are unknown, unidentified, tentatively identified, or known and injurious to human health if consumed, laboratories shall notify the Department immediately and shall submit to the Department a copy of the COA containing those compounds as required in OAC 310:681-8- 3(e)(3)(I). The Department may require a processor or grower to submit samples for additional testing, including testing for analytes that are not required by these Rules, at the licensee's expense. (6) When a laboratory determines that a harvest batch or production batch has failed any required testing, the laboratory shall immediately notify the Department in the manner and form prescribed by the Department on its website and shall submit a copy of the COA to the Department within two (2) business days. Submission of this information to the Department through the seed- to-sale tracking system established by the Department or a seed- to-sale tracking system that integrates with the Department- established system shall be sufficient to satisfy this reporting requirement.