5 Colo. Code Regs. § 1005-7-5

Current through Register Vol. 47, No. 24, December 25, 2024

Rule 5 CCR 1005-7-5 - [Effective 1/14/2025] Natural Medicine Testing Facilities: Personnel

5.1Natural Medicine Testing Facility Director. The laboratory director is ultimately responsible for the overall analytical operation and quality of the results reported by the Natural Medicine Testing Facility, 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 Natural Medicine Testing Facility director may also serve as a supervisory analyst, quality assurance manager, or testing analyst, or a combination of these roles for a Natural Medicine Testing Facility. If the laboratory director is serving as a combination of roles, a secondary review of data and quality documentation must be performed by qualified personnel that did not generate the data, report, or quality documentation.

5.1.2 The Natural Medicine Testing Facility director for a Natural Medicine Testing Facility must meet one of the following qualification requirements:

5.1.2.1 Be a Medical Doctor (M.D.) licensed to practice medicine in Colorado 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;

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;

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 Natural Medicine Testing Facility Director May Delegate. The Natural Medicine Testing Facility director may delegate the responsibilities assigned under this Rule to a qualified supervisory analyst or quality assurance manager, 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 Natural Medicine Testing Facility director remains responsible for ensuring that all duties are properly performed.

5.3Responsibilities of the Natural Medicine Testing Facility Director. The Natural Medicine Testing Facility director must:

5.3.1 Ensure that the Natural Medicine Testing Facility 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 Natural Medicine Testing Facility 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 Natural Medicine Testing Facility 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 Natural Medicine Testing Facility 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 Natural Medicine Testing Facility 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 Natural Medicine Testing Facility'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 Natural Medicine Testing Facility'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 Natural Medicine Testing Facility 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 Natural Medicine Testing Facility director review is required prior to reporting test results.

5.3.19 Ensure internal and vendor audits are completed regularly at a frequency established by the Natural Medicine Testing Facility; and

5.3.20 Ensure that quality anomalies and Nonconformances are regularly reviewed and documented as open or completed. Open Nonconformances should be reviewed at least annually, and high impact Nonconformances must be reviewed at least monthly.

5.4Change in Natural Medicine Testing Facility Director. In the event that the Natural Medicine Testing Facility director leaves employment at the Natural Medicine Testing Facility, the Natural Medicine Testing Facility shall:

5.4.1 Provide written notice to the Department within seven days of the Natural Medicine Testing Facility's director's departure;

5.4.2 Designate an interim Natural Medicine Testing Facility director within seven days of the Natural Medicine Testing Facility director's departure. At a minimum, the interim Natural Medicine Testing Facility director must meet the qualifications of a supervisory analyst; and

5.4.3 Hire a permanent Natural Medicine Testing Facility director within 60 days from the date of the previous Natural Medicine Testing Facility director's departure.

5.4.3.1 The Natural Medicine Testing Facility may submit a waiver request to the Department to receive an additional 60 days to hire a permanent Natural Medicine Testing Facility director provided that the Natural Medicine Testing Facility submits a detailed oversight plan along with the waiver request.

5.5.Supervisory Analyst. Supervisory analysts must meet one of the qualifications for a Natural Medicine Testing Facility director or have at least a bachelor's degree in one of the natural sciences and two 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. A combination of education and experience may substitute for the two years of full-time laboratory experience.

5.6Quality Assurance Manager. Quality Assurance Managers must meet one of the qualifications for Natural Medicine Testing Facility director or have at least a bachelor's degree in one of the natural sciences and two 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. A combination of education and experience may substitute for the two years of full-time laboratory experience.

5.7.Natural Medicine Testing Facility Testing Analyst.

5.7.1 Educational Requirements. An individual designated as a testing analyst must meet one of the qualifications for a Natural Medicine Testing Facility director or supervisory analyst; OR

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

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

5.7.1.3 Have education and training equivalent to that specified in 5.7.1.2 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 or biology 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

5.7.1.4 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.

5.7.2 Responsibilities. In order to independently perform any test for a Natural Medicine Testing Facility, an individual must at least meet the educational requirements for a testing analyst.

5 CCR 1005-7-5

47 CR 24, December 25, 2024, effective 1/14/2025