Haw. Code R. § 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).
Notes
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