5 Colo. Code Regs. § 1005-7-6

Current through Register Vol. 47, No. 24, December 25, 2024

Rule 5 CCR 1005-7-6 - [Effective 1/14/2025] Natural Medicine Testing Facilities: Standard Operating Procedures

6.1 Standard Operating Procedures must include, but need not be limited to, procedures for:

6.1.1 Sample receiving;

6.1.2 Sample accessioning;

6.1.3 Sample storage;

6.1.4 Identifying, rejecting, and reporting unacceptable Samples;

6.1.5 Recording and reporting discrepancies during Sample receiving and accessioning;

6.1.6 Security and stability of Samples, aliquots and extracts and records;

6.1.7 Sample archive retention to assure stability, as follows:

6.1.7.1 For Samples submitted for testing, Sample archive retention for 14 days;

6.1.8 Validating a new or revised method prior to testing Samples to include the performance criteria as stated in Rule 7.1.5;

6.1.9 Sample preparation, including but not limited to, sub-sampling for testing, homogenization, and aliquoting Samples to avoid contamination and carry-over;

6.1.10 Disposal of Samples;

6.1.11 The theory and principles behind each assay;

6.1.12 Preparation and identification of reagents, standards, calibrators and controls and ensure all standards are traceable to a certified vendor that meets the accreditation requirements of the laboratory, such as National Institute of Standards of Technology (NIST), ISO 17034, or other similar entities;

6.1.13 Preparation and verification of internally developed Reference Materials, in the event that a suitable traceable CRM is not available;

6.1.14 Special requirements and safety precautions involved in performing assays;

6.1.15 Frequency and number of control and calibration materials;

6.1.16 Recording and reporting assay results;

6.1.17 Protocol and criteria for accepting or rejecting analytical procedure to verify the accuracy of the final report;

6.1.18 Pertinent literature references for each method;

6.1.19 Current step-by-step instructions with sufficient detail to perform the assay to include equipment operation and any abbreviated versions used by a testing analyst;

6.1.20 Acceptability Criteria for the results of calibration standards and controls as well as between two aliquots, Sample duplicates, new standard lots, or columns;

6.1.21 A documented system for reviewing the results of testing calibrators, controls, standards, and Sample test results, as well as reviewing for clerical errors, analytical errors and any unusual analytical results; and

6.1.22 A documented system for investigating existing or potential Nonconformances and implementing, and monitoring Corrective Actions and/or Preventative Actions, including instructions for the Natural Medicine Testing Facility to contact the requesting entity, when required;

6.1.23 Policies and procedures to follow when Samples are requested for referral and testing by another certified Natural Medicine Testing Facility or an approved local or state agency's laboratory;

6.1.24 Protocol and criteria for calculating and applying Measurement Uncertainty;

6.1.25 Policies and procedures including the titles and required training of individuals responsible for the transport of biohazardous materials;

6.1.26 Procedures and/or protocols for general laboratory upkeep and cleaning, including specific procedures to eliminate or avoid cross-contamination;

6.1.27 Retesting or additional analyses of Samples, including but not limited to, when it is appropriate to retest or perform an additional analysis of the Sample, when it is appropriate for the requesting entity to request retesting (e.g., after failing microbial contaminant testing on Regulated Natural Medicine); and

6.1.28 Policies to follow for internal audits, including the frequency of internal audits and the documentation of the results of audits. Audit reports must include, but need not be limited to: audit title, scope, name(s) of personnel and auditors, audit date, introduction, problems noted, findings, observations/opportunities noted, date issued.

5 CCR 1005-7-6

47 CR 24, December 25, 2024, effective 1/14/2025