5 Colo. Code Regs. § 1005-5-9

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

Rule 5 CCR 1005-5-9 - Hemp Testing Laboratories: Quality Assurance and Quality Control

9.1Quality Assurance Program Required. A Hemp Testing Laboratory must establish, monitor, and document the ongoing review of a quality assurance program that is sufficient to identify problems in the laboratory preanalytic, analytic and postanalytic systems when they occur and must include, but is not limited to:

9.1.1 Review of instrument preventive maintenance, repair, and troubleshooting;

9.1.2 Documentation of Nonconformances and implementation of Corrective Actions and Preventive Actions when necessary;

9.1.3 Review of quality assurance documentation must be performed by the laboratory director or designated supervisory analyst on an ongoing basis to ensure the effectiveness of actions taken over time;

9.1.4 Review by the laboratory director or designated supervisory analyst of all ongoing quality assurance; and

9.1.5 Review of the performance of validated methods used by the Hemp Testing Laboratory to include calibration standards, controls and the Standard Operating Procedures used for analysis on an ongoing basis to ensure quality improvements are made when problems are identified or as needed.

9.2Quality Control Measures Required. A Hemp Testing Laboratory must establish, monitor and document on an ongoing basis the Quality Control measures taken by the laboratory to ensure the proper functioning of equipment, validity of Standard Operating Procedures and accuracy of results reported. The laboratory must ensure that appropriate quality assurance and Quality Control measures are performed and documented as necessary for the specific methodology. Such Quality Control measures must include, but shall not be limited to:

9.2.1 Documentation of instrument preventive maintenance, repair, troubleshooting and Corrective Actions taken when performance does not meet established levels of quality;

9.2.2 Review and documentation of the accuracy of automatic and adjustable pipettes and other measuring devices when placed into service and annually thereafter;

9.2.3 Cleaning, maintaining, verifying, and calibrating as needed the analytical balances and in addition, verifying the performance of the balance annually using certified weights to include three or more weights bracketing the ranges of measurement used by the laboratory;

9.2.4 Annually verifying working thermometers against a certified reference thermometer. Certified reference thermometers shall be calibrated traceable to the SI (International System of Units) through NIST, or equivalent by an ISO/IEC 17025 accredited calibration laboratory with a listed certification date;

9.2.5 Recording temperatures on all equipment when in use where temperature control is specified in the Standard Operating Procedures, such as water baths, heating blocks, incubators, ovens, refrigerators, and freezers;

9.2.6 Properly labeling reagents as to the identity, the concentration, date of preparation, storage conditions, lot number tracking, expiration date and the identity of the preparer;

9.2.7 Avoiding mixing different lots of reagents in the same analytical run;

9.2.8 Performing and documenting a calibration curve with each analysis using at minimum five calibrators throughout the reporting range;

9.2.8.1 The laboratory shall not remove data points from within a calibration range while still retaining the extreme ends of the calibration range. if a calibration point fails, the laboratory must re-prepare and re-analyze the calibration standard.

9.2.9 For qualitative analyses, analyzing, at minimum, a negative and a positive control with each batch of Samples analyzed;

9.2.10 For quantitative analyses, analyzing, at minimum, a negative and two levels of controls that challenge the linearity of the entire curve;

9.2.11 Using a control material or materials that differ in either source or, lot number, or concentration from the calibration material used with each analytical run;

9.2.12 For multi-Analyte assays, performing and documenting calibration curves and controls specific to each Analyte, or at minimum, one with similar chemical properties as reported in the analytical run;

9.2.13 Analyzing an appropriate Matrix blank and control with each analytical run, when available;

9.2.14 Analyzing calibrators and controls in the same manner as unknowns;

9.2.15 Documenting the performance of calibration standards and controls for each analytical run to ensure the Acceptability Criteria as defined in the Standard Operating Procedure is met;

9.2.16 Documenting all Corrective Actions taken when unacceptable calibration, control, and standard or instrument performance does not meet Acceptability Criteria as defined in the Standard Operating Procedure;

9.2.17 Maintaining records of validation data for any new or modified methods to include; accuracy, precision, analytical specificity (interferences), LOD, LOQ, and verification of the linear range; and

9.2.18 Performing testing that follows the current Standard Operating Procedures for the test or tests to be performed.

5 CCR 1005-5-9

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

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