Washington Administrative Code › Title 16 - Agriculture, Department of (See also Titles 24, 60, and 142) › SEEDS AND PLANTING STOCK CERTIFICATION › Chapter 16-309 - Cannabis laboratory accreditation standards program › Section 16-309-130 - Facilities, equipment, and maintenance

Current through Register Vol. 24-14, July 15, 2024
(1)
				Facilities where laboratory testing is performed must be designed for dealing
				with preanalytical, analytical, and postanalytical functions.
(2) The laboratory must monitor, control, and
				record environmental conditions as required by the relevant specifications,
				methods, and procedures where they influence the quality of the results. Due
				attention must be paid to biological sterility, dust, electromagnetic
				disturbances, humidity, electrical supply, temperature, and sound and vibration
				levels, as necessary to the technical activities concerned.
(3) Laboratories recycling solvents by
				roto-evaporator or similar equipment must have a procedure for evaluating
				recycled solvent performance prior to use in testing. This must be applied any
				time the laboratory recycles solvents.
(4) The laboratory must have space for the
				number of personnel and separation of work areas.
(5) The arrangement of space must allow for
				workflow, sampling, lab space, office space, and break areas.
(6) The laboratory must have eyewash
				stations, safety showers, and sinks within the laboratory in areas where
				exposure to corrosive chemicals or substances may occur. Eyewash facilities
				must be no greater than 10 seconds unobstructed travel distance from the area
				in the laboratory where hazardous chemicals are present.
(7) The laboratory must have chemical spill
				kits on-site and placed in locations that are well-labeled and easily available
				to personnel.
(8) The laboratory
				must have adequate electrical outlets, unobstructed, single-use, multiplug
				adaptors with surge control; single-use extension cords; ground fault circuit
				interrupters near wet areas.
(9)
				The laboratory must have sufficient numbers and types of safety equipment to
				minimize personnel exposure to biological hazards and toxic materials. There
				must be vacuum traps, ventilation for fume hoods and around solvent use or
				storage of solvents or waste. There must be storage cabinets for flammable
				solvent, acids, and bases. There must be vented hoods for any microbiological
				analysis (i.e., Class II Type A biosafety cabinets as applicable).
(10) The laboratory must assign a unique
				identifier to distinguish the individual test instrument and software version
				used. Each test result must be traceable back to the instrument used at the
				time of testing.
(11) The
				laboratory must comply with the scheduled maintenance and function checks
				recommended by the manufacturer at minimum and perform preventive maintenance
				and check critical operating characteristics of each instrument used in the
				testing process. Records must be retained for all instruments and
				equipment.
(12) For automated
				liquid handling equipment performing quantitative aliquoting, the laboratory
				must check the accuracy and precision of each system, perform a contamination
				check, and monitor and detect system issues or failures (e.g., drips or leaks,
				short sampling, bubbles, or air gaps in reagent dispensing lines) on a regular
				basis.
(13) The laboratory must
				verify the accuracy and precision of each pipette or pipetting device prior to
				placing it into service. Each device must be rechecked at least every six
				months. If the pipette or pipetting device is used to make measurements at
				different volumes, accuracy and precision must be checked at each volume used.
				Devices that do not meet stated precision and accuracy criteria must be removed
				from service.
(14) The laboratory
				must check and record temperatures on temperature sensitive devices (e.g.,
				water baths, heating blocks, incubators, ovens, refrigerators, freezers, and
				refrigerated centrifuges) on a daily or when used basis. The laboratory must
				establish acceptance ranges to ensure proper storage conditions for samples,
				calibrator and control materials, test materials, and to ensure correct
				analytical conditions according to manufacturer and procedure requirements.
				Temperature records must be complete and clearly document the date and
				individual performing the check, and the laboratory must document corrective
				actions taken to address unacceptable temperature readings.
(15) Analytical balances must be mounted in
				accordance with manufacturer's instructions. They must be serviced and checked
				periodically over the relevant weight range using ANSI/ASTM Classes 1-3 or
				equivalent weights.
(16) The
				laboratory must verify instrument and equipment performance prior to initial
				use, after major maintenance or service, and after relocation to ensure that
				they run within defined tolerance limits and according to
				expectations.
(17) Instrument
				maintenance records and function check documents must be reviewed by technical
				supervisory staff or the scientific director at least monthly.
(18) Instruments that do not meet performance
				specifications must be placed out of service and labeled as "Not in Use" until
				it has been repaired and shown by verification that it will perform
				correctly.
(19) Laboratories must
				demonstrate, when possible, that calibrations of critical equipment and hence
				the measurement results generated by that equipment, relevant to their scope of
				accreditation, are traceable to the SI through an unbroken chain of
				calibrations.
(20) Laboratories
				must have breakrooms separate from the laboratory and ensure that food is not
				kept in refrigerators that have specimens, chemicals, or other laboratory
				related materials.