5 Colo. Code Regs. § 1005-2-5.6

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

Section 5 CCR 1005-2-5.6 - Onsite Laboratory Inspection

5.6.1 Onsite laboratory inspections must be performed prior to initial certification and annually thereafter for non-accredited labs by the Department in accordance with this rule.

5.6.2 The onsite inspection will include a review of the laboratory's practices to ensure compliance with these regulations. Laboratories must demonstrate compliance with all applicable requirements in Parts 5 through 9.

5.6.3 Laboratories will be contacted by the Department to schedule the annual onsite inspection after receipt of the application requesting certification. A letter confirming the inspection date will be sent to the laboratory.

5.6.4 The Department will evaluate compliance with the laboratory certification standards listed in Part 9 during the onsite inspection.

5.6.5 Following the onsite inspection, a written report will be prepared that will list any non-conformances identified. The report should be sent to the laboratory within 30-days of inspection.

5.6.6 Within 30-days of receipt of the inspection report, the laboratory must provide to the Department for review and approval a written plan of correction that addresses each non-conformance listed in the inspection report.

5.6.7 Any requested objective evidence must be provided to the Department within 60-days of receipt of the inspection report. Any items requiring clarification will be resolved by phone or written correspondence.

5.6.8 Identification of non-conformance practices that impact test results or, failure to provide an acceptable plan of correction or, failure to provide adequate objective evidence within the specified timelines, may result in limitation, suspension, revocation or denial of certification. Such action shall be governed by Section 24-4-104, C.R.S.

5.6.9 Upon the laboratory's successful completion of the annual inspection and certification process, the department will issue a certificate. The certificate will include the name and location of the laboratory, the categories the laboratory is certified to perform testing in and the certification period.

5.6.10 The Department will annually publish a list of certified laboratories.

5 CCR 1005-2-5.6

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

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