Ohio Administrative Code › Title 3796:4 - Testing Laboratories › Chapter 3796:4-2 - Operations › Section 3796:4-2-01 - Testing laboratory operations

Current through all regulations passed and filed through July 1, 2024
(A)
								A testing
			 laboratory shall establish, maintain, and comply with the policies and
			 procedures contained in the operations plan submitted by the testing laboratory
			 as part of the application that was approved by the department. The operations
			 plan shall include policies and procedures for the analysis, storage, sample
			 inventory tracking, and transportation of plant material, medical marijuana
			 extract, and medical marijuana products. At a minimum, a facility's operations
			 plan shall accomplish the following:
(1)
									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;
(2)
									Implement policies and procedures that provide best
			 practices for safe, secure, and proper testing of medical
			 marijuana;
(3)
									Establish training and safety policies and procedures
			 to ensure that any person involved in analytical testing of medical
			 marijuana:
(a)
										
			 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;
(b)
										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;
(c)
										Has direct access
			 to applicable safety data sheets and labels; and
(d)
										Has been fully
			 trained regarding compliance with Chapter 3796. of the Revised Code and the
			 rules promulgated in accordance with Chapter 3796. of the Revised
			 Code.
(4)
									Document the chain of custody for all medical marijuana
			 in the inventory tracking system;
(5)
									Establish a
			 standard for the facility to be maintained in a clean and orderly condition,
			 which includes free from infestation by rodents, insects, birds, and other
			 animals of any kind; and
(6)
									Maintain a facility with adequate lighting,
			 ventilation, temperature, sanitation, equipment, and security for the testing
			 of medical marijuana, including the following:
(a)
										A testing
			 laboratory shall keep all floors and benches free of debris, dust, and any
			 other potential contaminants;
(b)
										A testing
			 laboratory shall use chemicals, cleaning solutions, and other sanitizing agents
			 generally accepted for laboratory use, and shall store them in a manner that
			 protects against contamination;
(c)
										A testing
			 laboratory shall keep its equipment in a clean, professional environment and
			 maintain a cleaning and equipment maintenance log at the facility, including
			 preventive and routine maintenance plans and corresponding records, whether the
			 preventive or routine maintenance is performed by laboratory staff or by
			 service contract with third-parties or the original equipment
			 manufacturer;
(d)
										A testing laboratory shall have its scales, balances,
			 or other weight and/or mass measuring devices routinely calibrated using
			 "National Institute of Standards and Technology" (NIST)-traceable reference
			 weights, at least once each calendar year; and
(e)
										A testing
			 laboratory shall 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.