Section 691-5-4 - Required Cannabis Testing Facility Personnel, Training and SupervisionSection 4.1 - Required Personnel Certification requires a cannabis testing facility to employ a qualified facility director and sufficient cannabis testing facility analysts and staff to handle the anticipated volume of testing. The cannabis testing facility must either employ a qualified quality assurance officer (QAO) or designate the facility director to fulfill that role. The cannabis testing facility must ensure that a testing facility director or QAO meeting the requirements of this rule is onsite and available during the hours of operation indicated on the facility's operating plan.
4.1.1.General requirements.A. All management of the cannabis testing facility and performance of required testing and related activities must be performed by personnel who meet the required educational and experience requirements.B. Only degrees issued by, or courses completed at, an accredited college or university may fulfill the educational requirements of this section.C. To meet practical laboratory experience requirements, prior work experience must: (1) Have involved full-time work of 30 or more hours per week;(2) Not have been completed as part of any educational requirement, even if it did not lead to the conferring of a degree; and(3) Have taken place in a laboratory or cannabis testing facility performing analytical scientific testing in which the testing methods are or were recognized by a laboratory-accrediting body.4.1.2.Facility director.A. To be a facility director of a certified cannabis testing facility under this rule, a person must meet one of the following:(1) A doctoral degree in a related science and 1 year of practical laboratory experience;(2) A master's degree in a related science and 2 years of practical laboratory experience; or(3) A bachelor of science or bachelor of art degree in a related science and 4 years of practical laboratory experience.B. The facility director must be capable of fulfilling all the following core responsibilities:(1) Oversee and direct the scientific methods of the cannabis testing facility;(2) Ensure that the cannabis testing facility achieves and maintains quality standards of practice;(3) Supervise all personnel; and(4) Be present in the cannabis testing facility an average of 60% of hours of operation.C. The facility director may not have been convicted of an offense punishable by 1 year or more in prison and related to conduct involving dishonesty, fraud, deceit or gross negligence with the intent to substantially benefit himself, herself or another or to substantially injure another.D. The testing facility must appoint a deputy when the testing facility director is absent from the testing facility for more than 15 consecutive calendar days. (1) The deputy facility director must meet the qualifications for testing facility director or QAO.(2) Testing facility management must notify OCP and CDC in writing when the absence of the testing facility director is expected to, or in fact exceeds, 60 consecutive calendar days.E. Any requests for a waiver of any provision under this paragraph must be submitted in writing to the CDC, which reserves the right to deny such a request.4.1.3.Quality assurance officer (QAO).A. To be a QAO of a certified cannabis testing facility under this rule, a person must satisfy one of the following:(1) Meet the qualification criteria required for a facility director; or(2) Hold a bachelor's degree in one of the related sciences; or(3) Have completed at least 2 years of college coursework and at least 1 year of practical laboratory experience.B. The QAO must be capable of fulfilling all the following core responsibilities:(1) Ensure that the cannabis testing facility achieves and maintains quality standards of practice;(2) Review cannabis testing facility quality control data, conduct annual internal audits, notify management of deficiencies found in the quality system, ensure the accuracy and integrity of certificates of analysis and be free from internal and external influences, when evaluating data and conducting audits;(3) Provide documented training and/or experience in QA and QC procedures and demonstrate knowledge of the approved analytical methods and quality system requirements, as well as maintain the QA documents up to date;(4) Have direct access to cannabis testing facility management; and(5) Whenever possible, conduct functions that are independent from the cannabis testing facility operations for which they have quality assurance oversight.C. The QAO, regardless of other duties and responsibilities, must have defined responsibility and authority for ensuring that the management system related to quality and integrity of testing results is implemented and complied with at all times.D. The QAO duties and responsibilities may alternatively be carried out by the cannabis testing facility technical director.4.1.4.Cannabis Testing Facility Analyst. Any person who performs analytical tasks must meet the experience and educational requirements of an analyst and must be able to demonstrate proper performance of all analytical tasks. To be an analyst employed by a certified cannabis testing facility pursuant to this Rule, a person must meet one of the following standards: A. Fulfill the qualification criteria required for the facility director; orB. Hold a bachelor's degree in one of the related sciences; orC. Demonstrate completion of at least 2 years of college coursework and at least 1 year of practical laboratory experience.4.1.5Cannabis Testing Facility Sample Collection. If the cannabis testing facility offers sample collection services, any person who performs sample collection for a cannabis testing facility must meet the experience and educational requirements of a sample collector contained in Section 5.1.5 of this Rule and be able to demonstrate appropriate sampling methods.Section 4.2 - Verification and Maintenance of Personnel Documentation The cannabis testing facility must verify and maintain documentation of qualifications of all employees and contracted workers. Required documentation includes the following:
A. Documentation of the employee's education: (1) The colleges and universities attended by the employee and the names and addresses of the colleges and universities, the major course of study, dates of attendance, degrees conferred and completion date;(2) Official transcripts from the registrar of the colleges and universities attended by the employee showing all courses, course credits, degrees conferred, and dates degrees were conferred; and(3) Records from credential evaluation services, including translations of transcripts from nonEnglish-language colleges and universities. For an employee who attended a college or university not located in the United States (U.S.) or its territories, the requirement that the college or university be accredited is satisfied if the educational credentials of the employee are found, by the credential evaluation service, to be equivalent to those of a person who attended an accredited U.S. college or university.B. Documentation of each employee's experience:(1) Name and address of the laboratory or cannabis testing facility where the employee received noncourse related experience, dates of employment, number of hours per week employed and a description of the testing and analytic methods performed by the person; and(2) Signed documentation of such experience from the director or equivalent of the laboratory or cannabis testing facility.C. Records of all individual identification cards including the identification number and the date of issuance and expiration for every principal office, board member and employee of the cannabis testing facility.D. Personnel plans reflecting sufficient personnel with the necessary education, training, technical knowledge and experience for their assigned functions. cannabis testing facility management must:(1) Specify and document the responsibility, authority and interrelationships of all personnel who manage, perform or verify work affecting the quality of the tests;(2) Establish job descriptions to include the minimum level of qualifications, experience and basic cannabis testing facility skills necessary for all positions in the cannabis testing facility;(3) Document authority of specific personnel to perform particular types of sampling and environmental testing, issue test reports, give opinions and interpretations and operate particular types of equipment; and(4) Document authority of specific personnel to maintain document control policies, chain of custody forms for each sample tested and control access to certificate of analysis data.E. Records of the relevant authorization(s), demonstration(s) of capability, educational and professional qualifications, training, skills and experience of all technical personnel, including contracted personnel. This information must be readily available and include the date on which authorization and/or competence is confirmed.F. Documentation of the initials and signatures of anyone analyzing or reviewing data so that the records can be traced back to the individual approving the data.Section 4.3 - Personnel Training and Supervision The cannabis testing facility management must:A. Provide adequate supervision of staff by persons familiar with methods and procedures;B. Formulate goals with respect to the education and training skills of the cannabis testing facility personnel, including:(1) Policies and procedures for identifying training needs and providing training of personnel;(2) Ensuring relevance of the training program to the present and anticipated tasks of the cannabis testing facility; and(3) Making documentation available upon request from the CDC;C. Ensure all technical cannabis testing facility staff has demonstrated capability in the activities for which they are responsible; and D. Ensure that the training of the cannabis testing facility personnel is kept up to date (on-going) by providing the following:(1) Documentation that each employee has read, understands and uses the latest version of the cannabis testing facility's quality documents and security plan;(2) Training documentation on equipment, techniques and/or procedures;(3) Training in ethical and legal responsibilities; and(4) Documentation of each analyst's continued performance at least once per year.