Section 16-309-050 - Scientific director(1) Each laboratory must employ a scientific director to ensure the achievement and maintenance of quality standards of practice who meets the following minimum qualifications:(a) Must possess a doctorate in the chemical or microbiological sciences from a college or university accredited by a national or regional certifying authority with a minimum of two years post-degree laboratory experience; or(b) A master's degree in the chemical or microbiological sciences from a college or university accredited by a national or regional certifying authority with a minimum of four years of post-degree laboratory experience; or(c) A bachelor's degree in the chemical or microbiological sciences from a college or university accredited by a national or regional certifying authority with a minimum of six years of post-education laboratory experience.(2) The scientific director must have supervisory authority over all personnel involved with the accessioning, testing and storage of samples, and the reporting of results.(3) The scientific director is not required to have direct supervisory authority over client service or IT personnel. However, they are responsible for ensuring laboratory compliance with chapters 314-55 and 246-70 WAC and this chapter, even if functions are performed by staff outside the cannabis laboratory (e.g., another department, off-site staff, corporate staff) ensuring that the confidentiality of reported results is maintained.(4) The scientific director's responsibilities include, but are not limited to: (a) Engaging in and responsible for the daily management of the laboratory;(b) Establishing a training program for personnel;(c) Ensuring that personnel are sufficiently trained;(d) Ensuring that all personnel have demonstrated proficiency in assigned duties prior to working independently on customer cannabis samples;(e) Ensuring that the standard operating procedures (SOP) manual is complete, current, available, signed, and followed by all personnel;(f) Reviewing and approving any requests to modify analytical methods and documentation;(g) Ensuring that all personnel are properly informed, and training documented when changes occur in the SOP;(h) Ensuring that analytical methods are properly validated;(i) Establishing a quality assurance program sufficient to legally and scientifically support results;(j) Establishing acceptable performance limits for calibrators and controls;(k) Ensuring that corrective action is taken in response to unacceptable QC performance or when other errors occur;(l) Ensuring that results are not reported until after corrective actions have been taken and that the results provided are accurate and reliable;(m) Fully understanding the function of the laboratory information management systems (LIMS) and other laboratory computer systems in sample receiving, accessioning, chain of custody, testing, and the review and reporting of results;(n) Ensuring that the LIMS software and other software in the laboratory have been properly validated; (o) Fully understanding the role of any external service providers and the functions of external information systems and computer systems in the laboratory's activities associated with cannabis testing;(p) Ensuring that external information systems and software used by the laboratory have been properly validated;(q) Ensuring that corrective actions are taken in response to issues identified in the inspection and proficiency testing (PT) phases of the program;(r) Demonstrating knowledge of the cannabis regulatory documents and the cannabis laboratory analysis standards program.Wash. Admin. Code § 16-309-050
Adopted by WSR 24-09-079, Filed 4/17/2024, effective 5/18/2024