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 and the
department.
(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 until given approval to do so by the department.
(3)
Additional reporting
requirements. In addition to the requirements described in rule
641-154.50 (124E), the
certificate of analysis shall contain, at a minimum, the following information:
a. All requirements of ISO/IEC 17025 dated
2017;
b. Date of primary sample
collection;
c. Date the primary
sample was received by the laboratory;
d. Date of each analysis;
e. The LOQ and action level for each analyte,
as applicable;
f. Whether the
primary sample and lot passed or failed laboratory testing; and
g. A signature by the laboratory quality
officer or delegate and the date the certificate of analysis was validated as
being accurate by the laboratory quality officer or delegate.
(4)
Measurements.
a. 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.
b. 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.
c. Measurements greater
than or equal to LOD but less than LOQ shall be reported as "detected but not
quantified."
d. The number of
significant figures reported shall reflect the precision of the
analysis.
