5 Colo. Code Regs. § 1005-7-8

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

Rule 5 CCR 1005-7-8 - [Effective 1/14/2025] Natural Medicine Testing Facilities: Proficiency Testing

8.1.Participation in Proficiency Testing. If required by the Department as part of certification, the Natural Medicine Testing Facility must have successfully participated in Proficiency Testing in the category for which it seeks certification, within the preceding 12 months.

8.1.1 The Natural Medicine Testing Facility shall request the proficiency testing provider to send results concurrently to the Department, if available, or the Natural Medicine Testing Facility shall provide the proficiency testing results to the Department within 3 business days after the Natural Medicine Testing Facility receives notification of their results.

8.1.2 The Department may designate proficiency testing providers which meet, at minimum, the following criteria:

8.1.2.1 are ISO 17043 accredited organizations or state or federal government agencies,

8.1.2.2 offer proficiency testing in relevant matrices and which includes the Analytes for which the Natural Medicine Testing Facility is certified, and

8.1.2.3 offer proficiency testing which challenges the analytical method.

8.2Continued Certification. To maintain continued certification, a Natural Medicine Testing Facility must participate twice per calendar year in a designated Proficiency Testing program with continued satisfactory performance as determined by the Department as part of certification. The Department may designate a local agency, state agency, or independent third-party to provide Proficiency Testing.

8.3Analyzing Proficiency Testing Samples. A Natural Medicine Testing Facility must analyze Proficiency Test Samples using the same procedures with the same number of replicate analyses, standards, testing analysts, equipment, and data review processes as used in its Standard Operating Procedures.

8.4Proficiency Testing Attestation. The Natural Medicine Testing Facility director and all testing analysts who participated in Proficiency Testing must sign corresponding attestation statements.

8.5Natural Medicine Testing Facility Director Must Review Results. The Natural Medicine Testing Facility director must review and evaluate all Proficiency Testing results after receiving them from the proficiency testing provider.

8.6Remedial Action. A Natural Medicine Testing Facility must take and document remedial action when a score of less than 100% is achieved on any test during Proficiency Testing. Remedial action documentation must include a review of Samples tested and results reported since the last successful Proficiency Testing event. A requirement to take remedial action does not necessarily indicate unsatisfactory participation in a Proficiency Testing event.

8.7Unsatisfactory Participation in a Proficiency Testing Event. Unless the Natural Medicine Testing Facility positively identifies at least 80% of the target Analytes tested, participation in the Proficiency Testing event will be considered unsatisfactory. A positive identification must include accurate quantitative and qualitative results as applicable. Any false positive result reported will be considered unsatisfactory participation in the Proficiency Testing event.

8.8Consequence of Unsatisfactory Participation in Proficiency Testing Event. Unsatisfactory participation in a Proficiency Testing event may result in limitation, suspension or revocation of certification. A Natural Medicine Testing Facility's certification will be suspended for the relevant testing category if two consecutive unsatisfactory Proficiency Testing events occur, or if two out of three consecutive unsatisfactory Proficiency Testing events occur. Certification may be reinstated after successful participation in the next Proficiency Testing event. Failure to achieve a satisfactory score in the next test event will result in the revocation of the certification and will require two successful consecutive Proficiency Testing events before the Natural Medicine Testing Facility may be eligible to reapply for certification. Any limitation, suspension or revocation of certification must be disclosed to clients.

5 CCR 1005-7-8

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