5 Colo. Code Regs. § 1005-2-9.1

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

Section 5 CCR 1005-2-9.1 - Personnel

9.1.1 The laboratory must have a Laboratory Director. The Laboratory Director is responsible for the overall operation and administration of the laboratory as well as for assuring compliance with these regulations and the accuracy of the results reported by the laboratory.

9.1.2 The Laboratory Director must meet one of the following qualifications: board certified in clinical pathology by the American Board of Pathology; or certified as a Diplomate by the American Board of Forensic Toxicology (ABFT); or alternatively, have a doctoral degree in one of the natural sciences and at least three years of full-time laboratory experience in forensic toxicology; or a master's degree in one of the natural sciences and at least four years of full-time experience in forensic toxicology; or a bachelor's degree in one of the natural sciences and at least five years full-time experience in forensic toxicology.

9.1.3 The Laboratory Director is ultimately responsible for the supervision of all laboratory operations and personnel and to ensure compliance with the requirements of this rule. The Laboratory Director may delegate supervisory responsibilities to a designee if those responsibilities are designated in writing.

9.1.4 The Technical Personnel must have a minimum of an associate degree in a laboratory science or, one year training in an accredited laboratory sciences program and one year documented on-the-job laboratory experience.

9.1.5 The Laboratory Director or designee must ensure policies and procedures to assess the competency of Technical Personnel engaged in testing are established, followed and documented.

9.1.6 Competency assessments must be performed and documented on all new Technical Personnel prior to reporting results; on existing Technical Personnel on an annual basis; and on all Technical Personnel when a method or instrumentation is added or modified by the laboratory prior to reporting subject results. The competency assessments and documentation must be consistent with the laboratory's written training policies and procedures.

9.1.7 The laboratory must maintain documentation of formal education, training, and experience for the Laboratory Director and Technical Personnel.

9.1.8 The laboratory must have a written job description for each position in the laboratory.

5 CCR 1005-2-9.1

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

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