5 Colo. Code Regs. § 1005-2-9.2

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

Section 5 CCR 1005-2-9.2 - Standard operating procedure manual

9.2.1 The laboratory must have a written procedure manual for the performance of all methods of analytes it reports available for Technical Personnel to follow at all times.

9.2.2 The current Laboratory Director or designee must approve, sign and date each procedure.

9.2.3 The Laboratory Director or designee must approve, initial, and date each change or revision to the procedure.

9.2.4 The laboratory must maintain copies of previous standard operating procedures with effective dates of use for a minimum of 5-years from the date last used.

9.2.5 The Standard Operating Procedure (SOP) manual must include the following criteria and processes for laboratory personnel to follow.

9.2.5.1 Specimen receiving

9.2.5.2 Specimen accessioning

9.2.5.3 Specimen storage

9.2.5.4 Identifying and rejecting unacceptable specimens

9.2.5.5 Recording and reporting discrepancies

9.2.5.6 Security of specimens, aliquots and/or extracts and records

9.2.5.7 Validation of a new or revised method prior to testing specimens to include: accuracy, precision, analytical sensitivity, analytical specificity (interferences), Limit Of Detection (LOD), Limit Of Quantitation (LOQ) and verification of the reportable range

9.2.5.8 Aliquoting specimens to avoid contamination and/or carry-over

9.2.5.9 Sample retention to assure stability for one year

9.2.5.10 Disposal of specimens

9.2.5.11 The theory and principles behind each assay

9.2.5.12 Preparation and identification of reagents, standards, calibrators and controls

9.2.5.13 Special requirements and safety precautions involved in performing assays

9.2.5.14 Frequency and number of control and calibration materials

9.2.5.15 Recording and reporting assay results

9.2.5.16 Protocol and criteria for accepting or rejecting analytical data

9.2.5.17 Procedure to verify the accuracy of the final report

9.2.5.18 Pertinent literature references for each method

9.2.5.19 Current step-by-step instructions with sufficient detail to perform the assay to include equipment operation and any abbreviated versions used by the Technical Personnel.

9.2.5.20 Acceptability criteria for the results of calibration standards and controls as well as for the comparison between two aliquots or columns.

9.2.5.21 A documented system for reviewing the results of testing calibrators, controls, standards, and subject tests results, as well as reviewing for clerical errors, analytical errors and any unusual analytical results.

9.2.5.22 A documented system for the review, notification and implementation of corrective actions to include, when applicable, contacting the requesting agency.

9.2.5.23 Policies and procedures to follow when specimens are requested for referral and testing by another certified laboratory.

5 CCR 1005-2-9.2

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

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