5 Colo. Code Regs. § 1005-2-9.7
Current through Register Vol. 47, No. 11, June 10, 2024
Section 5 CCR 1005-2-9.7 - Analytical Process9.7.1 General Requirements 9.7.1.1 The laboratory must document the conditions of the instruments to include the detector response, tune and validation of new chromatography columns (when applicable).9.7.1.2 The laboratory must perform and document preventative maintenance as required by the manufacturer.9.7.1.3 The maintenance records must be readily available to the Technical Personnel.9.7.1.4 The laboratory must use an internal standard for each qualitative and quantitative analysis that has similar chemical and physical properties to that of the compound identified and is isotopically labeled when available.9.7.1.5 The laboratory must document the monitoring of the response (area or peak height) of the internal standard to ensure consistency over time of the analytical system.9.7.1.6 The laboratory must monitor analyses to check for contamination and/or carryover.9.7.1.7 The laboratory must have written acceptability criteria for variance between the results when the same analyte is quantified in multiple analyses.9.7.1.8 The laboratory must evaluate the performance of the instrument after routine and preventative maintenance prior to analyzing subject samples.9.7.1.9 If the laboratory has written its own software, the laboratory must have documentation that the software's accuracy was verified.9.7.2 Head Space-Gas Chromatography with Flame Ionization Detection (HS-GC-FID) 9.7.2.1 The laboratory must have established criteria of acceptability not to exceed 10% for variances between the results of the blood ethanol analysis using different aliquots and between different columns.9.7.3 Gas Chromatography with Mass Spectometery (GC-MS) 9.7.3.1 The laboratory must document the changes of septa as specified in the SOP.9.7.3.2 The laboratory must document changes and/or replacements of liners as specified in the SOP.9.7.3.3 The laboratory must have written criteria for an acceptable tune for the mass spectrometer. When the tune is unacceptable, corrective action to include additional maintenance must be documented (if applicable).9.7.3.4 If the laboratory uses selected ion monitoring, the laboratory must compare ion ratios and retention times between calibrators, controls and samples for identification of an analyte within the same analytical run.9.7.3.5 If the laboratory uses a library match to qualitatively identify an analyte, the laboratory must compare the relative retention time and mass spectra from a known standard or control run that has been tested on the same instrument before reporting the results.9.7.4 Immunoassays9.7.4.1 If the laboratory tests specimens differently from what the manufacturer has approved for the assay, or if the laboratory has modified the test method from the manufacturer instructions, the laboratory must have documentation of the validation for the modified test method or test system.9.7.5 Liquid Chromatography with Mass Spectometry or with Tandem Mass Spectometry (LCMS, LCMS/MS) 9.7.5.1 The laboratory must maintain records of the mass spectrometer calibration.9.7.5.2 The laboratory must confirm the identity of an analyte by LC-MS/MS (screening or quantitation) with at least two transitions in addition to the laboratory's retention time criteria.9.7.5.3 If the laboratory recycles eluting solvents, it must maintain written acceptability standards for each type of eluting solvent it recycles.41 CR 04, February 25, 2018, effective 3/17/201842 CR 02, January 25, 2019, effective 2/14/2019