Section 11-850-136 - Enforcement; suspension and revocation of laboratory certification(a) A certified laboratory or a laboratory seeking certification shall provide the department access to inspect the laboratory facility, interview laboratory personnel, or review, inspect, evaluate, and audit records and documents related to the analyses of dispensary licensee samples at any time to verify compliance with this subchapter.(b) If the department finds that a certified laboratory is not in compliance with the requirements of this chapter, the department shall notify the certified laboratory in writing of the specific areas of non-compliance and the department may do one or more of the following:(1) Establish a specific timeframe for the correction of areas of non-compliance;(2) Require the certified laboratory to submit, within fifteen days of receipt of the department's notification, a written corrective action plan that addresses the areas of non-compliance and that shall be subject to approval by the department; or(3) Suspend a laboratory certification and prohibit the laboratory from handling and analyzing cannabis and manufactured cannabis products.(c) If a satisfactory corrective action plan is not submitted to the department within the required timeframe or the identified areas of non-compliance are not corrected to the satisfaction of the department within the required timeframe, the department may suspend or revoke a laboratory certification.(d) The department may summarily suspend a laboratory certification if the department finds that a certified laboratory has engaged in a deliberate and willful violation of this subchapter or that a violation presents a substantial probability that physical harm will result.(e) The department may suspend or revoke a laboratory certification for any of the following reasons: (1) Violation of any provision of this chapter;(2) Failure to maintain a current accreditation with an accreditation body whose standards are equivalent to the ISO/IEC 17025;(3) Submission of misleading, incorrect, false, or fraudulent information;(4) Failure to allow inspections by the department;(5) Failure to pass inspections by the department;(6) Knowingly permitting unauthorized persons to perform technical procedures or issue or sign reports;(7) Consistent errors in performance of laboratory procedures, based on faulty technique or controls;(8) Where immediate action is required to comply with the law or protect the health and safety of the general public; or(9) Any other reason consistent with applicable laws, or other factors that may affect the health, safety, or welfare of the public or a qualifying patient or qualifying out-of-state patient.(f) Except as allowed by subsection (d), the department shall send, by certified mail return receipt requested, written notification of suspension or revocation to the laboratory and include the specific reasons for the department's action and the process to request a reconsideration of the department's action pursuant to section 11-850-137.(g) Upon suspension of its certification, the laboratory shall: (1) Cease performing one or more of the analyses allowed by the certification as directed by the department;(2) Follow all conditions imposed on the certification by the department; and(3) Take corrective action as required under subsection (b).(h) Upon revocation of its certification, the laboratory shall: (1) Surrender its certification to the department;(2) No longer accept or analyze cannabis or manufactured cannabis products;(3) Return to the dispensary or destroy in a manner approved by the department any samples of cannabis or manufactured cannabis products in its possession at the time of revocation.(i) Notwithstanding a laboratory's failure to surrender a revoked certification to the department, the laboratory shall no longer be qualified to analyze cannabis or manufactured cannabis products.(j) A laboratory aggrieved by a decision made pursuant to this section may request a reconsideration of the action in accordance with section 11-850-137.Haw. Code R. § 11-850-136
[Eff 12/14/15; §11-850-86; am, ren § 11-850-136, and comp 2/24/2022] (Auth: HRS §§ 321-9, 329D-7, 329D-8, 329D-9, 329D-27) (Imp: HRS §§ 329D-7, 329D-8, 329D-9, 329D-18; SLH 2017, Act 170, §3)