5 Colo. Code Regs. § 1005-2-5.1

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

Section 5 CCR 1005-2-5.1 - Laboratory Analysis of Blood, Urine and Post Mortem Specimens

5.1.1 Laboratories must be certified by the Department to provide analysis. Participation in the Forensic Toxicology Laboratory certification program is based upon either: successful onsite annual inspection for non-accredited labs, or, ongoing accreditation status for accredited labs, in addition to successful proficiency testing performance in the category or categories the laboratory is certified in and ongoing compliance with Parts 5 through 9 of this rule.

5.1.2 Laboratories seeking certification that are accredited by a nationally or internationally recognized accreditation organization that includes the scope of forensic toxicology may elect to forgo the annual onsite inspection as long as accreditation remains active, and, the biennial inspection performed by the accrediting organization includes review of the specialty of toxicology.

5.1.3 Accredited laboratories requesting certification from the Department must provide the Department a copy of the accrediting organizations most recent and final biennial inspection report within 30-days of receipt of accreditation in the scope of forensic toxicology in addition to, any accepted plan of correction submitted to the accrediting organization by the laboratory.

5.1.4 The Department will perform an onsite inspection of an accredited laboratory in the event that the specialty of toxicology is not reviewed by the accrediting organization during the biennial inspection.

5.1.5 Laboratories certified by the Department who send samples to a reference laboratory for testing, must send those samples to a forensic toxicology laboratory certified by the Department.

5.1.6 Laboratories may be certified to perform tests for one or more of the following categories: blood alcohol, blood drug, urine drug, and postmortem testing.

5.1.7 Laboratories must meet standards of performance as established by these regulations. Standards of performance include; personnel qualifications, standard operating procedure manual, analytical process, proficiency testing, quality assurance, quality control, laboratory security, chain of custody, specimen retention, space, records, and result reporting.

5.1.8 Laboratory inspections must be performed prior to initial certification and annually thereafter by Department personnel as established by this rule. A laboratory meeting the certification requirements of these regulations will be issued a certificate. Recertification shall be required annually and will be effective each July 1.

5 CCR 1005-2-5.1

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

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