1 Colo. Code Regs. § 213-1-7-7020

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

Section 1 CCR 213-1-7-7020 - Standard Operating Procedures

Basis and Purpose - 7020

The statutory authority for this rule includes but is not limited to sections 25-2.5-120, 44-50-202(1)(b), 44-50-203(1)(b), 44-50-203(1)(f), 44-50-203(1)(g), 44-50-203(1)(j), 44-50-203(2)(a), 44-50-203(2)(p), and 44-50-404(2), C.R.S. The purpose of this rule is to establish minimum requirements for standard operating procedures that a Natural Medicine Testing Facility must develop and maintain.

A. A Natural Medicine Testing Facility must have Standard Operating Procedures. A Standard operating procedure manual must include, but is not limited to, procedures for:

1. Sample receiving;

2. Sample accessioning;

3. Sample storage;

4. Identifying, rejecting, and reporting unacceptable Samples;

5. Recording and reporting discrepancies during Sample receiving and accessioning;

6. Security of Samples, aliquots and extracts and records;

7. Validating a new or revised method prior to testing of Samples to include: accuracy, precision, analytical sensitivity, analytical specificity (interferences), LOD, LOQ, and verification of the reportable range;

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

9. Sample archive retention to assure stability, as follows:

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

10. Disposal of Samples;

11. The theory and principles behind each assay;

12. Preparation and identification of reagents, standards, calibrators and controls and ensure all standards are traceable to National Institute of Standards of Technology ("NIST");

13. Special requirements and safety precautions involved in performing assays;

14. Frequency and number of control and calibration materials;

15. Recording and reporting assay results;

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

17. Pertinent literature references for each method;

18. 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;

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

20. A documented system for reviewing the results of testing calibrators, controls, standards, and Sample results, as well as reviewing for clerical errors, analytical errors and any unusual analytical results and are corrective actions implemented and documented, and does the laboratory contact the requesting entity;

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

22. Investigating and documenting existing or potential Nonconformances and implementing corrective actions and/or preventive actions;

23. Contacting the requesting entity about existing Nonconformances; and

24. Retesting or additional analyses of Samples, including but not be 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).

1 CCR 213-1-7-7020

47 CR 17, September 10, 2024, effective 10/1/2024