Current through Register Vol. 35, No. 18, September 24, 2024
A.
Receipt of
test samples: An approved laboratory may receive test samples of
cannabis or cannabis derived products from any licensed producer, qualified
patient or primary caregiver, and shall apply the testing standards of this
rule, including the testing parameters, action levels, reporting levels, and
other criteria identified in Tables 1 through 6, to determine whether a sample
passes a given test.
B.
Testing policies: An approved laboratory or laboratory applicant
shall establish and implement policies for sample preparation, documentation,
and transport, including:
(1) accepted test
sample types;
(2) minimum test
sample size;
(3) recommended test
sample container;
(4) test sample
labeling;
(5) transport and storage
conditions, such as refrigeration, as appropriate;
(6) other requirements, such as use of
preservatives, inert gas, or other measures designed to protect sample
integrity; and
(7) creation of
chain of custody documentation for each sample.
C.
Recording of samples
received: An approved laboratory shall:
(1) record the receipt of every test sample
received, the record of which shall include:
(a) the name and contact information of the
licensed producer that was the source of the sample;
(b) an appropriately specific description of
the sample;
(c) the date of receipt
of the sample;
(d) a statement of
the quantity (weight, volume, number, or other amount) of the sample;
and
(e) a batch number or code that
is associated with the product batch and that is recorded by the non-profit
producer or manufacturer in the electronic tracking system specified by the
department.
(2) inform
each licensed producer or individual who submits a test sample of the policies
established in accordance with this section.
D.
Sample handling, storage and
disposal: An approved laboratory shall establish sample handling
procedures for the tracking of test samples through the analytical process (by
weight, volume, number, or other appropriate measure) to prevent diversion.
(1) An approved laboratory shall store each
test sample under the appropriate conditions to protect the physical and
chemical integrity of the sample.
(2) Analyzed test samples consisting of
cannabis or cannabis-derived product shall be appropriately segregated,
controlled, and held in a controlled access area pending destruction or other
disposal.
(3) Any portion of a
cannabis or cannabis-derived test sample that is not destroyed during analysis
shall be:
(a) returned to the licensed
producer who provided the sample; or
(b) destroyed in accordance with the wastage
requirements of this rule.
E.
State and local laws: An
approved laboratory and a laboratory applicant shall comply with all applicable
state and local laws, including but not limited to zoning, occupancy,
licensing, and building codes.
F.
Laboratory premises: An approved laboratory and a laboratory
applicant shall maintain the premises of the laboratory in a clean and orderly
condition; shall equip the premises with such utensils and equipment as
necessary to conduct the operations of the laboratory; and shall ensure
adequate space for laboratory operations, sample storage, and document
storage.
G.
Storage:
An approved laboratory and a laboratory applicant shall be equipped with one or
more secure, controlled access areas for storage of cannabis and
cannabis-derived product test samples, cannabis-derived waste, and reference
standards. Access to such storage areas shall be limited by the laboratory to
authorized individuals.
H.
Equipment:
(1) Equipment used for the
analysis of test samples shall be adequately inspected, cleaned, and
maintained. Equipment used for the generation or measurement of data shall be
adequately tested and calibrated on an appropriate schedule, as
applicable.
(2) Laboratory
operations shall document procedures setting forth in sufficient detail the
methods and schedules to be used in the routine inspection, cleaning,
maintenance, testing, and calibration of equipment, and shall specify, as
appropriate, remedial action to be taken in the event of failure or malfunction
of equipment. The procedures shall designate the personnel responsible for the
performance of each operation.
(3)
Records shall be maintained of all inspection, maintenance, testing, and
calibrating operations. These records shall include the date of the operation,
the person who performed it, the written procedure used, and any deviations
from the written procedure. Records shall be kept of non-routine repairs
performed on equipment as a result of failure and malfunction. Such records
shall document the nature of the repair, how and when the need for the repair
was discovered, and any remedial action taken in response to the
repair.
(4) Computer systems used
for the analysis of samples, retention of data, sample tracking, calibration
scheduling, management of reference standards, or other critical laboratory
management functions shall ensure that electronic records, electronic
signatures, and handwritten signatures executed to electronic records are
trustworthy, reliable, and generally equivalent to paper records and
handwritten signatures executed on paper.
I.
Reagents, solutions, and reference
standards:
(1) An approved laboratory
is authorized to possess reagents, solutions, and reference standards. Such
items shall be:
(a) secured in accordance
with the approved laboratory's storage policies; labeled to indicate identity,
date received or prepared, and expiration or requalification date; and, where
applicable, concentration or purity, storage requirements, and date opened;
(b) stored under appropriate
conditions to minimize degradation or deterioration of the material;
and
(c) used only within the item's
expiration or requalification date.
(2) Deteriorated or outdated reagents and
solutions shall be properly destroyed.
(3) An approved laboratory may acquire
commercial reference standards for cannabinoids and other chemicals or
contaminants, for the exclusive purpose of conducting testing for which the
laboratory is approved. An approved laboratory may elect to internally produce
reference standards. When internally produced, an approved laboratory shall
utilize standard analytical techniques to document the purity and concentration
of the internally produced reference standards. An approved laboratory is
authorized to obtain cannabis or cannabis-derived product from a licensed
non-profit producer for this purpose.
(4) An approved laboratory shall obtain or,
for internally-produced standards, shall create a certificate of analysis (COA)
for each lot of reference standard. Each COA shall be kept on file and the lot
number of the reference standard used shall be recorded in the documentation
for each analysis, as applicable.
J.
Analysis: An approved
laboratory shall:
(1) utilize analytical
methods that are appropriate for the purpose of testing cannabis and
cannabis-derived products;
(2)
require analysts to demonstrate proficiency in the performance of the
analytical methods used;
(3)
maintain written procedures for the analytical method used for the analysis of
each test sample, including:
(a) sample
preparation;
(b) reagent, solution,
and reference standard preparation;
(c) instrument setup, as
applicable;
(d) standardization of
volumetric reagent solutions, as applicable;
(e) data acquisition; and
(f) calculation of results.
(4) specify, as applicable to each
analytical method used, requirements for accuracy, precision, linearity,
specificity, limit of detection, limit of quantitation, and other data quality
parameters;
(5) ensure that no
deviations from approved protocols or standard operating procedures are made
during any analytical process without proper authorization and documentation;
and
(6) use only primary standards
or secondary standards for quantitative analyses.
K.
Recording of analytical data:
(1) An approved laboratory shall
ensure that all data generated during the testing of a test sample, except data
generated by automated data collection systems, is recorded directly, promptly,
and legibly in ink. All data shall be annotated with the date of entry and
signed or initialed by the person recording the data. Any change in entries
shall be made so as not to obscure the original entry, shall indicate the
reason for such change, and shall be dated and signed or initialed at the time
of the change.
(2) In automated
data collection systems, the individual responsible for direct data input shall
be identified at the time of data input. Any change in an entry shall be made
so as not to obscure the original entry, shall indicate the reason for such
change, and shall be dated and signed or initialed at the time of the change. A
corrective action report (CAR) shall accompany such change and shall be made
available to the department, a non-profit producer, and a manufacturer upon
their request for up to two years after the analysis is completed.
(3) For each final result reported, an
approved laboratory shall verify that:
(a) any
calculations or other data processing steps were performed correctly;
(b) the data meet any data quality
requirements such as for accuracy, precision, linearity, etc.;
(c) any reference standards used were of the
appropriate purity and within their expiration or requalification
dates;
(d) any volumetric solutions
were properly standardized before use; and
(e) any test or measuring equipment used has
been properly tested, verified, and calibrated, and is within its verification
or calibration period.
L.
Data storage:
(1) An approved laboratory shall ensure that
all raw data, documentation, protocols, and final reports associated with
analysis of a test sample are retained for two years from the date of the
completion of analysis.
(2) An
approved laboratory shall maintain the records identified in this section. Such
records must be maintained:
(a) in a manner
that allows retrieval as needed;
(b) under conditions of storage that minimize
deterioration throughout the retention period; and
(c) in a manner that prevents unauthorized
alteration.
M.
Records maintenance and
access: An approved laboratory or laboratory applicant shall designate
an individual as responsible for records maintenance. Only authorized personnel
may access the maintained records.
N.
Data reporting:
(1)
Contents of report: A
laboratory report of a test conducted at the request of a licensed producer or
qualified patient shall contain the following information:
(a) the date of receipt of the test
sample;
(b) the description of the
type or form of the test sample (leaf, flower, powder, oil, specific edible
product, etc.);
(c) the batch
number or code that is associated with the product batch and that is recorded
in the electronic tracking system specified by the department;
(d) information on whether sampling was
performed by the laboratory operation, by the compliant business or individual
which submitted the test sample, or by a third-party;
(e) date on which analysis
occurred;
(f) the analytical method
used, including at a minimum identification of the type of analytical equipment
used (e.g., GC, HPLC, UV, etc.);
(g) the analytical results, including units
of measure where applicable;
(h)
the identity of the supervisory or management personnel who reviewed and
verified the data and results and ensured that data quality, calibration, and
other applicable requirements were met; and
(i) the name, address, and contact
information of the approved laboratory that conducted the test.
(2) The laboratory report shall
state that reported analytical results apply only to the test sample
received.
O.
Department access to materials and premises: An approved
laboratory shall promptly provide the department or the department's designee
access to a report of a test, and any underlying data, that is conducted on a
sample at the request of a licensed producer or qualified patient. An approved
laboratory shall also provide access to the department or the department's
designee to laboratory premises, and to any material or information requested
by the department, for the purpose of determining compliance with the
requirements of this rule.
P.
Drugs and alcohol: A laboratory shall prohibit its employees and
contractors from being under the influence of drugs or alcohol in the
workplace.
Q.
Failures to
meet testing requirements: Repeated failures by a laboratory to comply
with the testing requirements of department rule may result in disciplinary
action against the laboratory.
