5 Colo. Code Regs. § 1005-2-5.4

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

Section 5 CCR 1005-2-5.4 - General Requirements

5.4.1 In addition to the laboratory's application, the laboratory must provide an updated listing of all technical personnel engaged in testing to the Department. The listing will be in the form and manner required by the Department.

5.4.2 Prior to independently analyzing samples, technical personnel must demonstrate acceptable performance on precision, accuracy, specificity, reportable ranges, blanks, and unknown challenge samples (proficiency samples or internally generated quality controls). The laboratory must have a system to evaluate and document the competency of technical personnel as specified in Part 9.

5.4.3 The laboratory must notify the Department in writing within thirty days of any changes pertaining to laboratory location and/or key management.

5.4.4 The Laboratory Director is directly responsible for the accuracy of the tests performed, the accuracy of the reports issued, and adherence to the applicable requirements in this rule.

5.4.5 The laboratory must have adequate space, equipment, materials, and use reference materials from a manufacturer accredited to the International Standards Organization (ISO) requirements for certified reference materials and certified reference standards, ISO/IEC 17034 when available.

5.4.6 The laboratory must establish and adhere to written methods of analysis (Standard Operating Procedure (SOP) used to perform the tests reported. Critical elements that must be addressed in the SOP are in Part 9.

5.4.7 The laboratory must demonstrate compliance with these regulations through a successful onsite inspection conducted by Department personnel prior to certification. Certified laboratories will be inspected on an annual announced basis. Certified laboratories may be inspected on an unannounced basis to evaluate complaints.

5.4.8 The laboratory must maintain all records related to analysis for a minimum of 5 years. Records to be maintained include instrument maintenance, calibration, quality control and quality assurance documentation for all analyses performed, specimen processing, test results and test reports of analysis, dates of analysis and the identity of the person performing the analysis. Retained records must be made available for review by Department personnel.

5.4.9 The laboratory must investigate all analytical non-conformances. Whenever subject test results are impacted, further testing using the affected method(s) may not resume until the laboratory has performed a root cause analysis and corrected the non-conformance. All subject tests impacted by the non-conformance must be reviewed by the laboratory director and amended reports issued when necessary. Copies of the non-conformance, root cause analysis and corrective action plan must be provided to the Department upon request.

5 CCR 1005-2-5.4

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

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