5 Colo. Code Regs. § 1005-2-9.4

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

Section 5 CCR 1005-2-9.4 - Quality Assurance and Quality Control

9.4.1 The laboratory must check and document the accuracy of automatic and/or adjustable pipettes and other measuring devices when placed into service and annually thereafter.

9.4.2 The laboratory must clean, maintain, and calibrate, as needed, the analytical balances and in addition, verify the performance of the balance annually using certified weights to include three or more weights bracketing the ranges of measurements used by the laboratory.

9.4.3 The laboratory must annually verify and document the accuracy of thermometers using a reference thermometer.

9.4.4 The laboratory must record temperatures on all equipment when in use where temperature control is specified in SOP's, such as water baths, heating blocks, incubators, ovens, refrigerators, and freezers.

9.4.5 The laboratory must properly label reagents as to the identity, the concentration, date of preparation, storage conditions, lot number tracking, expiration date, and the identity of the preparer (when applicable).

9.4.6 The laboratory must avoid mixing different lots of reagents in the same analytical run.

9.4.7 For quantitative analysis, the laboratory must perform and document a calibration curve that has a correlation coefficient of 0.99 or greater using, at a minimum, four calibrators that encompass the reportable range.

9.4.8 If the laboratory uses historical calibration data for an assay, control materials must be included with each batch of specimens tested to verify the validity of the calibration including at or close to the reporting limits. Laboratories may use historical calibration curves only if they have demonstrated and documented the linearity and precision of the curve over time. Calibration must be validated by using control materials with each batch of specimens tested to cover the entire range of the calibration curve.

9.4.9 For qualitative analyses, the laboratory must analyze, at minimum, a negative control and a positive control with each analytical run of samples analyzed.

9.4.10 For quantitative analyses, the laboratory must analyze, at minimum, a negative control and two levels of positive controls that challenge the entire calibration curve.

9.4.11 The laboratory must use control material(s) (when possible) that differs in source, lot number, or concentration from the calibration material used with each analytical run. In instances where the same source must be utilized, separate weighing's or solutions must be used to prepare these controls.

9.4.12 For multi-analyte assays, the laboratory must perform and document calibration curves and controls specific to each analyte, or at minimum, one with similar chemical properties as reported in the analytical run.

9.4.13 The laboratory must analyze at least one control that is made using reference material from an ISO/IEC 17034 accredited manufacturer when available. For quantitative purposes, the control must be within (10% for ethanol and 20% for blood and urine drugs) of the stated assayed value with each analytic run.

9.4.14 The laboratory must analyze an appropriate matrix matched negative and positive control with each analytical run, when available.

9.4.15 The laboratory must analyze calibrators and controls in the same manner as unknowns.

9.4.16 The laboratory must define acceptability criteria for calibration standards and controls for all assays, such that they are within 10% for ethanol and 20% for blood and urine drugs, of the target value.

Note: a slightly wider acceptable value (e.g. +/-25% or +/-30%) for calibrators and controls that approach the Limit Of Quantitation (LOQ) of the assay is permitted.

9.4.17 The laboratory must monitor and document the performance of calibrator and control materials on an ongoing basis to ensure performance does not exceed the laboratory's established criteria of acceptability.

9.4.18 The laboratory must have written criteria to follow when corrective action is required for any unacceptable calibration, control, and standard or instrument performance.

9.4.19 The laboratory must document the corrective actions taken when an unacceptable calibration, control, standard, or other reagent result exceeds the laboratory's criteria of acceptability.

9.4.20 Corrective actions must be documented and reviewed by the Laboratory Director or designee on an ongoing basis to ensure the effectiveness of the actions taken.

9.4.21 The laboratory must maintain records of validation data for any new or modified methods to include; accuracy, precision, analytical specificity (interferences), Limit Of Detection (LOD), LOQ and verification of the regression model.

9.4.22 Analytical methods must be developed by the laboratory such that screening and confirmation testing can be completed on no more than 5 ml of sample volume.

9.4.23 The analyst must follow the SOP for the tests performed.

5 CCR 1005-2-9.4

41 CR 04, February 25, 2018, effective 3/17/2018

42 CR 02, January 25, 2019, effective 2/14/2019