N.M. Admin. Code § 16.8.2.47

Current through Register Vol. 35, No. 23, December 10, 2024

Section 16.8.2.47 - CANNABIS TESTING LABORATORY POLICIES AND PROCEDURES

A.Minimum policy and procedure requirements: A cannabis testing laboratory shall develop, implement, and maintain on the licensed premises, standard policies and procedures, which shall include the following:

(1) sample collection procedures, including:

(a) specifications for sampling tools and containers;

(b) use of gloves and other personal protective equipment to prevent contamination of batches;

(c) access to complete batches of cannabis products;

(d) determination of the number of sample increments required, based on batch size; and

(e) random selection of sample increments;

(2) chain of custody;

(3) data recording;

(4) sample storage and integrity, including sealing of sample containers and, if applicable, the use of preservatives, inert gas, or other measures;

(5) transportation, including protection from light, heat, and humidity;

(6) sample preparation of each matrix for each test;

(7) methodology for each test, including:

(a) sample preparation;

(b) reagent, solution, and reference standard preparation;

(c) instrument setup, as applicable;

(d) standardization of volumetric reagent solutions, as applicable;

(e) data acquisition; and

(f) calculation of results

(8) data quality parameters for each test, including:

(a) specificity;

(b) limit of detection; and

(c) limit of quantitation;

(9) reporting of results;

(10) quality assurance;

(11) employee policies and procedures, including but not limited to:

(a) adherence to state and federal laws that do not conflict with the Cannabis Regulation Act or the Lynn and Erin Compassionate Use Act;

(b) responding to an emergency, including robbery or a serious accident or incident;

(c) alcohol and drug-free workplace policies and procedures;

(d) safety and security procedures;

(e) occupational health and safety;

(f) crime prevention techniques; and

(g) if applicable, confidentiality laws, including the Health Insurance Portability and Accountability Act of 1996;

(12) equipment cleaning, maintenance, and inspection standards and schedules;

(13) standards for labeling, storage, expiration, and re-qualification dates and records relating to reagents, solutions, and reference standards;

(14) sample analysis procedures, including but not limited to procedures for the use of only primary or secondary standards for quantitative analyses;

(15) standards for data recording, review, storage, and reporting that include, but are not limited to, standards to ensure:

(a) that data is recorded in a manner consistent with this rule, and that it is reviewed to verify that applicable standards of practice, equipment calibration, and reference standards were applied before reporting;

(b) that all data, including raw data, documentation, protocols, and reports are retained in accordance with the requirements of this rule; and

(c) that reports are the property of the business or individual who provided the sample, and reports meet the requirements of this rule; and

(16) creation of chain of custody documentation for each sample.

B.Training program:

(1) Licensee shall implement a training program, approved by the division, to ensure that all personnel present at the premises are provided information and training that, at minimum, covers the following topics within 30 days of the start of employment:

(a) employee health and safety;

(b) health and safety hazards;

(c) hazard communication;

(d) security procedures; and

(e) record keeping/track and trace.

(2) A cannabis testing laboratory must provide and document training on the following subjects before permitting any authorized person to independently collect samples of cannabis products:

(a) an overview of the process and standard operating procedures of the laboratory;

(b) quality control procedures, including sterile collection of samples and storage;

(c) chain of custody, recordkeeping, and tracking requirements;

(d) calibration, use, and maintenance of measuring devices;

(e) transportation procedures; and

(f) any additional information reasonably related to sample collection.

(3) A cannabis testing laboratory must provide and document training on the following subjects before an agent or employee independently performs any cannabis testing process:

(a) an overview of the process and standard operating procedure(s);

(b) quality control procedures;

(c) chain of custody and tracking requirements;

(d) proper and safe usage of equipment or machinery;

(e) safe work practices applicable to an employee's job tasks, including appropriate use of any necessary safety or sanitary equipment;

(f) cleaning and maintenance requirements;

(g) emergency operations, including shutdown; and

(h) any additional information reasonably related to an employee's job duties.

C.Training documentation:

(1) Licensee shall ensure that all personnel receive annual refresher training to cover, at minimum, the topics listed in this section. The licensee shall maintain a record which contains at minimum:

(a) a list of all personnel at the premises, including at minimum, name and job duties of each;

(b) documentation of training topics and dates of training completion for all personnel;

(c) dates of refresher training completion for all personnel; and

(d) the signature of each employee verifying receipt and understanding of each training or refresher training completed.

(2) Licensee may assign responsibility for ensuring compliance by individual personnel with the requirements of this section to supervisory personnel.

(3) Licensees shall maintain documentation of an employee's training for a period of two years for current employees and at least six months after the termination of an employee's employment.

D.Materials to be maintained on premises: A cannabis testing laboratory shall maintain on its premises, and shall promptly present to the department upon request:

(1) all results of laboratory tests conducted on cannabis or cannabis derived products for a period of at least two years;

(2) operating manuals and other documentation for each piece of equipment;

(3) records of required inspection, calibration, and maintenance for each piece of equipment, including:

(a) the date of the operation;

(b) the person who performed it;

(c) the written procedure used; and

(d) any deviations from the written procedure;

(4) records of non-routine repairs performed on equipment as a result of failure and malfunction, including:

(a) the nature of the repair;

(b) how and when the need for the repair was discovered; and

(c) any remedial action taken in response to the repair;

(5) the certificate of analysis for all reference standards, whether acquired or internally produced.

(6) current material safety data sheets for all chemicals used;

(7) documentation of proficiency training.

N.M. Admin. Code § 16.8.2.47

Adopted by New Mexico Register, Volume XXXII, Issue 01, January 11, 2022, eff. 1/11/2022