5 Colo. Code Regs. § 1005-5-5

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

Rule 5 CCR 1005-5-5 - Hemp Testing Laboratories: Personnel

5.1Laboratory Director. The laboratory director is ultimately responsible for the overall analytical operation and quality of the results reported by the Hemp Testing Laboratory, including the employment and supervision of personnel who are competent to perform test procedures and record and report test results promptly, accurately, and proficiently, and for assuring compliance with the standards set forth in this Rule.

5.1.1 The laboratory director may also serve as a supervisory analyst or testing analyst, or both, for a Hemp Testing Laboratory.

5.1.2 The laboratory director for a Hemp Testing Laboratory must meet one of the following qualification requirements:

5.1.2.1 Be a Medical Doctor (M.D.) licensed to practice medicine and have at least three years of full-time laboratory experience in a regulated laboratory environment performing analytical scientific testing in which the testing methods were recognized by an accrediting body; OR

5.1.2.2 Hold a doctoral degree in one of the natural sciences and have at least three years of full-time laboratory experience in a regulated laboratory environment performing analytical scientific testing in which the testing methods were recognized by an accrediting body; OR

5.1.2.3 Hold a master's degree in one of the natural sciences and have at least five years of full-time laboratory experience in a regulated laboratory environment performing analytical scientific testing in which the testing methods were recognized by an accrediting body; OR

5.1.2.4 Hold a bachelor's degree in one of the natural sciences and have at least seven years of full-time laboratory experience in a regulated laboratory environment performing analytical scientific testing in which the testing methods were recognized by an accrediting body.

5.2What the Laboratory Director May Delegate. The laboratory director may delegate the responsibilities assigned under this Rule to a qualified supervisory analyst, provided that such delegation is made in writing and a record of the delegation is maintained. See Rule 13 -Business Records Required. Despite the designation of a responsibility, the laboratory director remains responsible for ensuring that all duties are properly performed.

5.3Responsibilities of the Laboratory Director. The laboratory director must:

5.3.1 Ensure that the Hemp Testing Laboratory has adequate space, equipment, materials, and controls available to perform the tests reported;

5.3.2 Establish and ensure adherence to written Standard Operating Procedures used to perform the tests reported;

5.3.3 Ensure that testing systems developed and used for each of the tests performed in the laboratory provide quality laboratory services for all aspects of test performance, which includes the preanalytic, analytic, and postanalytic phases of testing;

5.3.4 Ensure that the physical location and environmental conditions of the laboratory are appropriate for the testing performed and provide a safe environment in which employees are protected from physical, chemical, and biological hazards;

5.3.5 Ensure that the test methodologies selected are fit-for-purpose and appropriate to ensure the quality of results required for the level of testing the laboratory is certified to perform;

5.3.6 Ensure that validation and verification test methods used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method;

5.3.7 Ensure that testing analysts perform the test methods as required for accurate and reliable results;

5.3.8 Ensure that the laboratory is enrolled in and successfully participates in a Department approved Proficiency Testing program;

5.3.9 Ensure that the Quality Control and quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur;

5.3.10 Ensure the establishment and maintenance of acceptable levels of analytical performance for each test system;

5.3.11 Ensure that all necessary remedial actions are taken and documented whenever significant deviations from the laboratory's established performance specifications are identified, and that test results are reported only when the system is functioning properly;

5.3.12 Ensure that reports of test results include pertinent information required for interpretation;

5.3.13 Ensure that consultation is available to the laboratory's clients on matters relating to the quality of the test results reported and their interpretation of said results;

5.3.14 Employ a sufficient number of laboratory personnel who meet the qualification requirements and provide appropriate consultation, properly supervise, and ensure accurate performance of tests and reporting of test results;

5.3.15 Ensure that prior to testing any Samples, all testing analysts receive the appropriate training for the type and complexity of tests performed, and have demonstrated and documented that they can perform all testing operations reliably to provide and report accurate results;

5.3.16 Ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency to process Samples, perform test procedures and report test results promptly and proficiently, avoid actual and apparent conflicts of interests, and whenever necessary, identify needs for remedial training or continuing education to improve skills;

5.3.17 Ensure that an approved Standard Operating Procedure manual is available to all personnel responsible for any aspect of the testing process; and

5.3.18 Specify, in writing, the responsibilities and duties of each person engaged in the performance of the preanalytic, analytic, and postanalytic phases of testing, that identifies which examinations and procedures each individual is authorized to perform, whether supervision is required for Sample processing, test performance or results reporting, and whether consultant or laboratory director review is required prior to reporting test results.

5.4Change in Laboratory Director. In the event that the laboratory director leaves employment at the Hemp Testing Laboratory, the Hemp Testing Laboratory shall:

5.4.1 Provide written notice to the Department within seven days of the laboratory director's departure; and

5.4.2 Designate an interim laboratory director within seven days of the laboratory director's departure. At a minimum, the interim laboratory director must meet the qualifications of a supervisory analyst.

5.4.3 The Hemp Testing Laboratory must hire a permanent laboratory director within 60 days from the date of the previous laboratory director's departure.

5.4.4 Notwithstanding the requirement of subparagraph 5.4.3, the Hemp Testing Laboratory may submit a waiver request to the Department to receive an additional 60 days to hire a permanent laboratory director provided that the Hemp Testing Laboratory submits a detailed oversight plan along with the waiver request.

5.5.Supervisory Analyst. Supervisory analysts must meet one of the qualifications for a laboratory director or have at least a bachelor's degree in one of the natural sciences and two years of fulltime laboratory experience in a regulated laboratory environment performing analytical scientific testing in which the testing methods were recognized by an accrediting body. A combination of education and experience may substitute for the two years of full-time laboratory experience.

5.6.Laboratory Testing Analyst.

5.6.1Educational Requirements. An individual designated as a testing analyst must meet one of the qualifications for a laboratory director or supervisory analyst; OR

5.6.1.1 Have at least a bachelor's degree in one of the natural sciences; OR

5.6.1.2 Have earned an associate degree in a laboratory science from an accredited institution; OR

5.6.1.3 Have education and training equivalent to that specified in 5.6.1.2 of this section that includes at least 60 semester hours, or equivalent, from an accredited institution that, at a minimum, include:

a. 24 semester hours of science courses that include:

1. Six semester hours of chemistry;

2. Six semester hours of biology; AND

3. Twelve semester hours of chemistry, biology, or cannabis laboratory sciences in any combination; AND

b. Have laboratory training that includes at least 3 months documented laboratory training in each testing category in which the individual performs testing; OR

5.6.1.4 Have at least 5 years of full time experience in laboratory testing and have laboratory training that includes at least 3 months documented laboratory training in each testing category in which the individual performs testing.

5.6.2Responsibilities. In order to independently perform any test for a Hemp Testing Laboratory, an individual must at least meet the educational requirements for a testing analyst.

5 CCR 1005-5-5

44 CR 06, March 25, 2021, effective 4/14/2021

46 CR 21, November 10, 2023, effective 12/15/2023