Haw. Code R. § 11-850-134

Current through September, 2024
Section 11-850-134 - Minimum operating standards for laboratories certified pursuant to this subchapter
(a) Upon being certified by the department, a laboratory shall:
(1) Display a copy of the certification in a prominent location on the laboratory premises;
(2) Obtain department approval of the laboratory's employee qualifications, quality assurance plan, and standard operating procedures to analyze cannabis and manufactured cannabis products;
(3) Follow the scope for which it is accredited for analyzing cannabis and manufactured cannabis products and the requirements for laboratory standards and analysis established in this subchapter;
(4) Notify the department within one business day after receiving notice of any kind that its accreditation has been denied, suspended, or revoked;
(5) Notify the department immediately of any change or anticipated change that may affect the operations of the laboratory with regard to its ability to continue to meet the requirements of this subchapter, including, but not limited to, proficiency test results, employee changes, instrumentation, methodology, standard operating procedures, facilities, and accreditation; and
(6) Follow other conditions set forth in the certification as issued by the department.
(b) For cannabis and each manufactured cannabis product it tests, a certified laboratory shall:
(1) Be able to meet the requirements of section 11-850-135(a) and (b) for the product;
(2) Have the appropriate certifications and accreditations to perform an analytical method or methods applicable to the product matrix;
(3) Have completed validation studies for the applicable analytical method or methods and product matrix; and
(4) Have completed annual proficiency tests for the applicable analytical method or methods and product matrix.
(c) A certified laboratory shall maintain the following records for a minimum of five years and shall make all records available to the department upon request:
(1) Records documenting compliance with subsection (b), including:
(A) An attestation that the laboratory meets the requirements;
(B) Analytical results for batch samples and quality control samples; and
(C) Records of validation studies and proficiency tests;
(2) Sampling plans required by section 11-850-135(a); and
(3) Records required by section 11-850-135(f).

Haw. Code R. § 11-850-134

[Eff 12/14/15; §11-850-84; am, ren § 11-850-134, 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)
Comp 4/29/2022
Am and comp 11/17/2022
Comp 8/7/2023
Comp 4/5/2024