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16-309-030  <<  16-309-040 >>   16-309-050

PDFWAC 16-309-040

Laboratory personnel.

(1) The laboratory must have a training and retraining program for all personnel that is kept current and is documented and maintained with personnel records.
(2) The laboratory must maintain personnel files on all employees detailing their qualifications and duties for all positions that include:
(a) Resume of training and experience.
(b) Job description of current position.
(c) Copies of certificates.
(d) Copies of diploma(s).
(e) Training checklists which include what training was performed, who did the training, and when it was performed.
(f) Documentation of continuing education, if any.
(g) Documentation of demonstrated abilities and competencies.
(3) The laboratory must document the technical staff's competency for each method performed on a yearly basis demonstrating their abilities to perform their specific job functions. Completion must be signed and dated by the scientific director.
(a) Demonstration of competencies include performing instrument setup or maintenance, sample handling, extractions, testing on each instrument used, quality control acceptance, and reporting of results.
(b) Testing personnel must demonstrate acceptable performance on precision, accuracy, selectivity, reportable ranges, blanks, and unknown challenges through the use of proficiency samples or internally generated quality controls. Completion must be signed and dated by the scientific director.
(4) The laboratory must have a personnel organization chart showing the chain of command and responsibilities approved, initialed, and dated by the scientific director.
(5) The scientific director may delegate some responsibilities in their absence or for other management staff. The delegation must be in writing, indicating what functions are being delegated (i.e., quality control data review, assessment of competency, or review of proficiency testing performance), and the delegate must be qualified and approved by the scientific director.
(6) If the laboratory performs microbiological testing, at least one member of the laboratory staff must have a bachelor's degree in a biological or clinical laboratory science or medical technology from an accredited institution, or associate degree in a biological or clinical laboratory science or medical laboratory technology from an accredited institution. The scientific director may satisfy this requirement if they hold a biological or clinical laboratory science degree or medical technology from an accredited institution, as described in WAC 16-309-050.
(7) All staff must be properly trained and evaluated for proper test performance prior to starting sample testing and reporting results.
(8) The accrediting authority may waive the academic requirements listed in WAC 16-309-050 through 16-309-070, on a case-by-case basis, for highly experienced analysts. The accrediting authority may also waive the need for the specified training, on a case-by-case basis, for supervisors of laboratories associated with testing of cannabis and cannabis products.
(9) Laboratory testing personnel must be supervised by persons familiar with test methods and procedures.
(10) Supervisors of testing personnel must meet one of the qualifications for a scientific director or have at least a bachelor's degree in one of the natural sciences and three years of full-time laboratory experience in a regulated laboratory environment performing analytical scientific testing. A combination of education and experience may substitute for the three years of full-time laboratory experience.
(11) The laboratory must designate a quality assurance manager or officer with defined responsibilities for ensuring the quality system is implemented and followed. The QA manager must be a separate person from the scientific director.
(12) The laboratory must report to the accrediting authority any change in the status of the scientific director. A laboratory cannot be without a scientific director for more than 30 days.
[Statutory Authority: RCW 15.150.030 and 2022 c 135. WSR 24-09-079, ยง 16-309-040, filed 4/17/24, effective 5/18/24.]
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