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PDFWAC 16-309-090

Standard operating procedures.

(1) The laboratory must have a complete and current standard operating procedures (SOP) manual that describes in detail all laboratory operations and ensures all samples are tested in a consistent manner using the same procedures.
(2) Copies of relevant sections of the SOP must be available to all staff in their work areas.
(3) The scientific director must review and show written approval of all sections of the SOP dating when they were implemented. An itemized list of changes and versions made within the last five years must be documented on a summary of changes sheet for each section.
(4) The SOP must include a safety manual, procedure, or policy that describes specific precautionary issues throughout the lab that makes employees aware of, and know how to safely maneuver through, the issue as described in the OSHA laboratory safety guidance document.
(5) The SOP must include a procedure for decontamination and cleaning of instruments, bench space, and ventilation and microbial hoods.
(6) The SOP must include testing procedures that include pertinent information for the scope and complexity of the procedure, including:
(a) Title that identifies the activity or procedure;
(b) Scope and principle;
(c) Sample requirements;
(d) Calibration and control preparation and usage protocol;
(e) Instrumentation, equipment, materials and supplies used;
(f) Instrument settings, data acquisition, system operation, parameters and conditions for testing;
(g) Procedure for sample preparation and testing;
(h) Results review and acceptability;
(i) Additional information, notes, safety requirements, and precautions to include calculations, interferences, limitations, background corrections, and proper disposal of lab waste including biohazardous waste and cannabis waste compliant with WAC 314-55-097; and
(j) References.
(7) The SOP must include a policy for the use of personal protective equipment (PPE) when working with samples, reagents, chemicals, or potential hazards in the workplace along with a written and documented system on the competency of personnel on how to handle chemical spills and the use of chemical spill kits.
(8) The SOP must include a policy for limiting access to controlled areas of testing, storage of samples, disposal of samples, and records. Personnel must be assigned limited access according to their job responsibilities.
(9) The SOP must include a policy or procedure informing employees how to interact with law enforcement should they request information or come on-site for regulatory issues.
(10) The SOP must include a policy or procedure that informs employees and staff what tasks need to be performed and what information or documents need to be gathered prior to an audit or inspection.
(11) The SOP must include information on the proper handling and disposal of used and unused samples once testing is completed.
(12) The SOP must include information on how employees can access medical attention for chemical or other exposures, including follow-up examinations, without cost or loss of pay.
(13) The SOP must include a record or log of any deviations from the SOP detailing the reason for the deviation, the date, and approval from the scientific director.
(14) The laboratory must maintain retired procedures for at least five years beyond the retirement date and must be able to reconstruct the procedures that were in effect when a given sample was tested.
[Statutory Authority: RCW 15.150.030 and 2022 c 135. WSR 24-09-079, ยง 16-309-090, filed 4/17/24, effective 5/18/24.]