Current through November, 2024
Section 11-850-133 - Procedures for laboratory certification(a) To apply for a laboratory certification to analyze cannabis and manufactured cannabis products, a laboratory shall submit to the department on forms and in a manner prescribed by the department:(2) All information and documents required by the department, including but not limited to: (A) Laboratory employee qualifications;(B) Standard operating procedures;(C) Quality assurance plan;(E) Annual proficiency tests;(F) A copy of the laboratory's most recent assessment by the laboratory's accreditation body, the laboratory's responses to any findings of non-compliance with standards or recommendations, and the corrective actions taken by the laboratory to address the findings or recommendations; and(G) A copy of the laboratory's accreditation in Hawaii or another jurisdiction, accompanied by the scope of accreditation; and(3) An annual certification fee in the amount of $3,000.(b) As part of its review conducted prior to issuing certification to a laboratory, the department: (1) Shall conduct an on-site evaluation of a laboratory seeking initial certification or a laboratory seeking to meet the requirements of section 11-850-132(b) after a period of provisional certification; and(2) May conduct an on-site evaluation of a laboratory seeking renewal of certification.(c) The department may issue a certification to a laboratory that meets the applicable requirements set forth in this chapter, including the requirements of section 11-850-132(b).(d) The department may issue a provisional certification to a laboratory that meets the applicable requirements set forth in this chapter, including the requirements of section 11-850-132(c).(e) The department shall deny certification to any laboratory that does not meet the requirements set forth in this subchapter.(f) A laboratory certification pursuant to this subchapter shall expire one year after the date it is issued by the department.(g) To apply for renewal of a laboratory certification, a laboratory shall submit the application, information, documents, and fee required in subsection (a) no later than two months prior to expiration of its certification.Haw. Code R. § 11-850-133
[Eff 12/14/15; §11-850-83; am, ren § 11-850-133, 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; SLH 2017, Act 170, §3)