Current through Register Vol. 30, No. 38, September 20, 2024
A. An owner
holding a laboratory registration certificate or applicant shall ensure that
the analytical data produced at the owner's or applicant's laboratory are of
known and acceptable precision and accuracy, as prescribed by the method
criteria for each analyte in
R9-17-404.03 or
R9-17-404.04, and are
scientifically valid and defensible.
B. An owner holding a laboratory registration
certificate or applicant shall establish, implement, and comply with a written
quality assurance plan that contains the following and is available at the
laboratory for Department review:
1. A title
page identifying the laboratory and date of review and including the technical
laboratory director's signature of approval;
2. A table of contents;
3. An organization chart or list of the
laboratory personnel, including names, lines of authority, and identification
of principal quality assurance personnel;
4. A copy of the current laboratory
registration certificate and a list of approved parameters;
5. A statement of quality assurance
objectives, including data quality objectives with precision and accuracy goals
and the criteria for determining the acceptability of each testing;
6. Specifications for preservation of
samples;
7. A procedure for
documenting laboratory receipt of samples and tracking of samples during
laboratory testing;
8. A procedure
for analytical instrument calibration, including frequency of calibration and
complying with the requirements for calibration in subsection (D);
9. A procedure for testing data reduction and
validation and reporting of final results, including the identification and
treatment of data outliers, the determination of the accuracy of data
transcription, and all calculations;
10. If using control limits derived by the
laboratory as a basis for determining acceptance of a testing result, a
procedure to ensure that the control limits are:
a. Statistically significant, valid, and
defensible; and
b. Updated at least
every 12 months;
11. A
statement of the frequency of all quality control checks;
12. A statement of the acceptance criteria
for all quality control checks;
13.
Preventive maintenance procedures and schedules;
14. Assessment procedures for data
acceptability, including appropriate procedures for manual integration of
chromatograms and when manual integration is inappropriate;
15. Corrective action procedures to be taken
when results from analytical quality control checks are unacceptable, including
steps to demonstrate the presence of any interference if the precision,
accuracy, or limit of quantitation of the reported testing result is affected
by the interference; and
16.
Procedures for chain-of-custody documentation, including procedures for the
documentation and reporting of any deviation from the sample handling or
preservation requirements.
C. An owner holding a laboratory registration
certificate or applicant shall ensure that a laboratory's written quality
assurance plan is a separate document available at the laboratory and includes
all of the components required in subsection (B), but an owner or applicant may
satisfy the components required in subsections (B)(3) through (16) through
incorporating by reference provisions in separate documents, such as standard
operating procedures.
D. An owner
holding a laboratory registration certificate or applicant shall:
1. Have available at the laboratory all
methods, equipment, reagents, and supplies necessary for the testing for which
the owner or applicant is approved or is requesting approval;
2. Use only reagents of a grade equal to or
greater than that required by the method criteria in
R9-17-404.03 or
R9-17-404.04, and document the use
of the reagents;
3. Maintain and
require each laboratory agent performing testing on medical marijuana or a
marijuana product to comply with a complete and current standard operating
procedure that meets the requirements for each method, as specified in
R9-17-404.03 or
R9-17-404.04, which shall include
at least:
a. A description of all procedures
to be followed, including the recording of the information required according
to R9-17-404.06(B)(1)(g) and
(k), when the method is performed;
b. A list of the concentrations for
calibration standards, check standards, and spikes;
c. Requirements for instrumental conditions
and set up;
d. A requirement for
frequency of calibration;
e. The
quantitative methods to be used to calculate the final concentration of an
analyte in samples, including any factors used in the calculations and the
calibration algorithm used; and
f.
Requirements for preventative maintenance;
4. Calibrate each instrument as required by
the standard operating procedure, as specified in
R9-17-404.03 or
R9-17-404.04, for which the
equipment is used;
5. Maintain
calibration documentation, including documentation that demonstrates the
calculations performed using each calibration model;
6. Develop, document, and maintain a current
limit of quantitation, as specified in
R9-17-404.03, for each compliance
parameter for each instrument;
7.
For each parameter and analyte tested at the laboratory use the quality control
acceptance criteria specified according to
R9-17-404.03,
R9-17-404.04, and Table
3.1;
8. Discard or segregate all
expired standards or reagents;
9.
Maintain a record showing the traceability of reagents; and
10. Ensure that a calibration model is not
used or changed to avoid necessary instrument maintenance.
E. Except as provided in subsection (F), an
owner holding a laboratory registration certificate or applicant shall ensure
that each laboratory standard operating procedure is a separate document
available at the laboratory and includes all of the components required in
subsection (D)(3).
F. An owner
holding a laboratory registration certificate or applicant may satisfy the
components required in subsections (D)(3)(e) and (f) through incorporating by
reference provisions in separate documents, such as other standard operating
procedures.
