D.C. Mun. Regs. tit. 22, r. 22-C6407

Current through Register 71, No. 45, November 7, 2024

Rule 22-C6407 - STANDARD OPERATING PROCEDURE REQUIREMENTS

6407.1

A testing laboratory shall have a written manual of standard operating procedures, with detailed instructions for performing each testing method the testing laboratory uses and the minimum standards for each test. The written manual of standard operating procedures must be available to each employee at the testing laboratory at all times.

6407.2

A testing laboratory shall establish, maintain, implement, and comply with the policies and procedures contained in its manual of standard operating procedures. At a minimum, a facility's standard operating procedures shall include policies and procedures that:

(a) Designate areas in the facility that are compartmentalized based on function, including any areas to which access is restricted, and including areas that segregate samples awaiting analysis from those samples being analyzed or prepared for analysis, to prevent cross-contamination;

(b) Provide best practices for safe, secure, and proper testing of medical marijuana;

(c) Establish training and safety policies and procedures to ensure that any person involved in analytical testing of medical marijuana:

(1) Has been fully trained in the safe operation and maintenance of any and all instrumentation that will be used in the testing of medical marijuana, with supporting documentation of the training;

(2) Has been fully trained in the safe use, handling, and storage of any and all chemicals that will be used in the testing of medical marijuana, in accordance with OSHA protocols, with supporting documentation of the training;

(3) Has direct access to applicable safety data sheets and labels; and

(4) Has been fully trained regarding compliance with the District's laws and regulations;

(d) Ensure the chain of custody for all medical marijuana will be documented in the inventory tracking system;

(e) Ensure the facility will be maintained with adequate lighting, ventilation, temperature, sanitation, equipment, and security for the testing of medical marijuana, including requiring that the testing laboratory shall:

(1) Keep the facility free of debris, dust, rodents, insects, birds, and animals of any kind, and any other potential contaminants;

(2) Use chemicals, cleaning solutions, and other sanitizing agents generally accepted for laboratory use, and store them in a manner that protects against contamination;

(3) Maintain a cleaning and equipment maintenance log at the facility, including any preventive and routine maintenance plans and corresponding records, and whether the maintenance is performed by laboratory staff or by service contract with third-parties or the original equipment manufacturer;

(4) Routinely calibrate its scales, balances, or other weight and/or mass measuring devices using "National Institute of Standards and Technology" (NIST)-traceable reference weights, at least once each calendar year; and

(5) Standardize all analytical test instrumentation using reference materials traceable to reference material producers accredited to ISO/IEC 17034 "General Requirements for the Competence of Reference Material Producers" or the national metrology institute (NMI), where available;

(f) Address the analysis, storage, sample inventory tracking, and transportation of plant material, medical marijuana extract, and medical marijuana products; and

(g) Address the following:

(1) Sample Collection;

(2) Sample preparation for each matrix that will be tested;

(3) Reagent, solution, and reference standard preparation;

(4) Instrument setup, if applicable;

(5) Standardization of volumetric reagent solutions, if applicable;

(6) Data acquisition;

(7) Calculation of results;

(8) Identification criteria;

(9) Quality control frequency;

(10) Quality control acceptance criteria; and

(11) Corrective action protocol.

6407.3

The Laboratory Director shall approve, sign, and date each standard operating procedure and each revision to any standard operating procedure.

6407.4

A testing laboratory shall establish and maintain procedures to document a clear and unbroken chain of custody at all stages from sampling to destruction, which shall include:

(a) Documenting each person handling the original samples, a liquots, and extracts;

(b) Documenting any transfer of samples, aliquots, and extracts to another testing facility for additional testing or transfer at the request of the marijuana cultivation facility that provided the testing sample;

(c) Maintaining a current list of authorized persons and restricting entry to the marijuana testing facility to those authorized persons;

(d) Securing the marijuana testing facility during non-working hours;

(e) Using a secured area to log in and aliquot samples; and

(f) Documenting the disposal of samples, aliquots, and extracts.

6407.5

A testing laboratory shall establish and maintain sample requirement procedures that include:

(a) Issuing instructions for the minimum sample requirements and storage requirements;

(b) Documenting the condition of the external package and integrity seals utilized to prevent contamination of or tampering with the sample;

(c) Documenting the condition and amount of sample provided at the time the sample is received at the marijuana testing facility;

(d) Securing short-term and long-term storage areas when not in use; and

(e) Ensuring samples are stored appropriately.

6407.6

A testing laboratory shall document the chain of custody of each sample in the Board's medical marijuana inventory tracking system.

D.C. Mun. Regs. tit. 22, r. 22-C6407

Final Rulemaking published at 65 DCR 10217 (8/9/2019); amended by Final Rulemaking published at 71 DCR 2388 (3/8/2024)