5 Colo. Code Regs. § 1005-2-9.6

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

Section 5 CCR 1005-2-9.6 - Records and Reporting

9.6.1 All instrumentation and analysis records maintained by the testing laboratory must be retained for a period of not less than 5-years.

9.6.2 Prior to reporting results, all specimens that have been identified as positive on an initial screening drug test must be confirmed using a second analytical procedure using a different chemical principle from the initial screening test when available or as applicable.

9.6.3 The laboratory must confirm the identity of an analyte using a different extract of the same specimen than was used for the screening test.

9.6.4 Prior to reporting results, all blood ethanol results must be confirmed using a second GC column where the results from the second column had a significant difference in retention time and a change in elution order of some of the common volatiles from the column utilized in the initial column.

9.6.5 When blood samples are screened for ethanol by head space gas chromatography with flame ionization detection (if applicable), a separate aliquot from the original specimen must be used for confirmation. (e.g. two separate aliquots should be tested for blood alcohol).

9.6.6 For postmortem testing (if applicable), the laboratory must confirm the identity of a drug analyte or alcohol concentration using a second column and a different extract from the same sample, or use a different sample matrix from the same subject when possible.

9.6.7 The laboratory must only report quantitative results that are within the calibration curve.

9.6.8 The laboratory must verify results that are outside the calibration curve in a manner consistent with the laboratory's SOPs.

9.6.9 The laboratory must qualitatively report results below the lowest concentration of calibrator or standard and above the Limit Of Detection (LOD) as a semi-quantitative result. (e.g. less than or greater than X mg/L).

9.6.10 The laboratory must maintain records of testing for at least 5-years to include: accession numbers, specimen type, raw data from the analytical run, controls, subject results, final and/or amended reports, acceptable reference range parameters, identification of Technical Personnel who performed the testing, and date of analysis.

9.6.11 The laboratory's final report must contain the name and location of the laboratory where the testing was performed, name and unique identifier of subject, submitting agency, sample received date, date of report, type of specimen tested, test result, units of measure, and any other information or qualifiers needed for interpretation when applicable to the test method and results being reported, to include any identified and documented discrepancies.

9.6.12 The laboratory must develop an adequate discovery packet that meets the requirements specified in Part 1.5 of these rules and regulations.

5 CCR 1005-2-9.6

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

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