Code of Colorado Regulations
1000 - Department of Public Health and Environment
1005 - Division of Disease Dontrol and Public Health Response
5 CCR 1005-5 - HEMP TESTING LABORATORY CERTIFICATION
8 - Hemp Testing Laboratories: Proficiency Testing

Universal Citation: 5 CO Code Regs 1005-5 ยง 8

Current through Register Vol. 47, No. 5, March 10, 2024

8.1 Proficiency Testing Required. A Hemp Testing Laboratory must participate in a Proficiency Testing program for each approved category in which it seeks certification under Rule 4 - Hemp Testing Laboratories: Certification Requirements.

8.2. Participation in Designated Proficiency Testing Event. If required by the Department as part of certification, the Hemp Testing Laboratory must have successfully participated in Proficiency Testing in the category for which it seeks certification, within the preceding 12 months.

8.2.1 The laboratory shall request the proficiency testing provider to send results concurrently to the Department, if available, or the laboratory shall provide the proficiency testing results to the Department within 3 business days after the laboratory receives notification of their results.

8.2.2. The department may designate proficiency testing providers which meet, at minimum, the following criteria:
8.2.2.1 Be a ISO 17043 accredited organization or be a government agency (state or federal),

8.2.2.2 Offer proficiency testing in cannabis matrices, offer proficiency testing which includes the analytes for which the laboratory is certified, and

8.2.2.3 offer proficiency testing which challenges the analytical method.

8.3 Continued Certification. To maintain continued certification, a Hemp Testing Laboratory 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.

8.4 Analyzing Proficiency Testing Samples. A Hemp Testing Laboratory 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.

8.5 Proficiency Testing Attestation. The laboratory director and all testing analysts who participated in Proficiency Testing must sign corresponding attestation statements.

8.6 Laboratory Director Must Review Results. The laboratory director must review and evaluate all Proficiency Testing results after receiving them from the proficiency testing provider.

8.7 Remedial Action. A Hemp Testing Laboratory 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.

8.8 Unsatisfactory Participation in a Proficiency Testing Event. Unless the Hemp Testing Laboratory 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 negative or false positive result reported will be considered unsatisfactory participation in the Proficiency Testing event.

8.9 Consequence of Unsatisfactory Participation in Proficiency Testing Event. Unsatisfactory participation in a Proficiency Testing event may result in limitation, suspension or revocation of certification. A Hemp Testing Laboratory'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 or successful completion of corrective actions. 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 laboratory may be eligible to reapply for certification. Any limitation, suspension or revocation of certification must be disclosed to clients.

Disclaimer: These regulations may not be the most recent version. Colorado may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
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