5 Colo. Code Regs. § 1005-5-6

Current through Register Vol. 47, No. 11, June 10, 2024

Rule 5 CCR 1005-5-6 - Hemp Testing Laboratories: Standard Operating Procedures

6.1 Standard Operating Procedures must include, but need not be limited to, procedures for:

6.1.1 Sample receiving;

6.1.2 Sample accessioning;

6.1.2.1 All hemp products must be tested as received, must not be inappropriately manipulated, and tested in a manner that ensures results are representative of sample as received.

6.1.3 Sample storage;

6.1.4 Identifying and rejecting unacceptable Samples;

6.1.5 Recording and reporting discrepancies;

6.1.6 Security and stability of Samples, aliquots and extracts and records;

6.1.7 Sample retention to assure stability of retain Samples for 90 days.

6.1.8 Validating a new or revised method prior to testing Samples to include the performance criteria as stated in Rule 7.1.5;

6.1.9 Aliquoting Samples to avoid contamination and carry-over;

6.1.10 Preparation of Samples;

6.1.11 Disposal of Samples;

6.1.12 The theory and principles behind each assay;

6.1.13 Preparation and identification of reagents, standards, calibrators and controls and ensure all standards are traceable to a certified vendor that meets the accreditation requirements of the laboratory, such as National Institute of Standards of Technology (NIST), ISO 17034, or other similar entities;

6.1.14 Special requirements and safety precautions involved in performing assays;

6.1.15 Frequency and number of control and calibration materials;

6.1.16 Recording and reporting assay results;

6.1.17 Protocol and criteria for accepting or rejecting analytical procedure to verify the accuracy of the final report;

6.1.18 Pertinent literature references for each method;

6.1.19 Current step-by-step instructions with sufficient detail to perform the assay to include equipment operation and any abbreviated versions used by a testing analyst;

6.1.20 Acceptability Criteria for the results of calibration standards and controls as well as between two aliquots, Sample duplicates, new standard lots, or columns;

6.1.21 A documented system for reviewing the results of testing calibrators, controls, standards, and Sample test results, as well as reviewing for clerical errors, analytical errors and any unusual analytical results; and

6.1.22 A documented system for issuing, implementing, and monitoring Corrective Actions, including instructions for the laboratory to contact the requesting entity, when required;

6.1.23 Policies and procedures to follow when Samples are requested for referral and testing by another certified Hemp Testing Laboratory or an approved local or state agency's laboratory;

6.1.24 Protocol and criteria for calculating and applying Measurement Uncertainty;

6.1.25 Policies and procedures including the titles and required training of individuals responsible for the transport of biohazardous materials; and

6.1.26 Procedures and/or protocols for general laboratory upkeep and cleaning, including specific procedures to eliminate or avoid cross-contamination.

5 CCR 1005-5-6

44 CR 06, March 25, 2021, effective 4/14/2021

46 CR 21, November 10, 2023, effective 12/15/2023