Current through Register Vol. 47, No. 6, September 18, 2024
(1)
Reporting test results. The laboratory shall generate a
certificate of analysis for each primary sample that it tests and make the
certificate of analysis available to the manufacturer who ordered the tests and
the department through the department's secure sales and inventory tracking
system, if available, or another laboratory information management
system.
(2)
Tentatively
identified analytes. A laboratory shall report on the certificate of
analysis any tentatively identified analytes detected during the analysis of
the primary sample. When a laboratory identifies additional analytes in a
primary sample, the laboratory shall:
a.
Notify the department of the additional analytes detected.
b. Refrain from issuing a final certificate
of analysis to a manufacturer until given approval to do so by the
department.
(3)
Additional reporting requirements.
a. In addition to the requirements described
in rule 641-154.72 (124E), the certificate of analysis shall contain, at a
minimum, the following information:
(1) All
requirements of Standard ISO/IEC 17025;
(2) Date of primary sample
collection;
(3) Date the primary
sample was received by the laboratory;
(4) Date of each analysis;
(5) The LOQ and action level for each
analyte, as applicable;
(6) Whether
the primary sample and lot passed or failed laboratory testing; and
(7) A signature by the laboratory quality
officer and the date the certificate of analysis was validated as being
accurate by the laboratory quality officer.
b. Any test result that is not covered under
the laboratory's ISO/IEC 17025 scope of accreditation shall be clearly
identified on the certificate of analysis.
c. Measurements below a method's limit of
detection shall be reported as "<" (less than) or "not detected" and
reference the reportable limit. The reporting of zero concentration is not
permitted.
d. Measurements =>
LOD but < LOQ shall be reported as "detected but not quantified."
e. The number of significant figures reported
shall reflect the precision of the analysis.
