Current through Register Vol. 49, No. 13, September 23, 2024
A. Analytical
results must be reported accurately, legibly, unambiguously, objectively, and
according to any specific instructions in the laboratory's standard operating
procedure or quality assurance manual.
B. Laboratories that are operated by a
facility and whose sole function is to provide data to the facility management
for compliance purposes must have all applicable information specified in item
C readily available for review by the state agency administering the permit,
program, or rule. Formal reports detailing the information are not required if:
(1) the laboratory is itself responsible for
preparing the regulatory reports; or
(2) the laboratory provides information to
another individual within the organization for preparation of regulatory
reports.
C. The test
report must include:
(1) a title, such as
"Test Report" or "Laboratory Results";
(2) the name, address, and
commissioner-designated identification number of the laboratory;
(3) the telephone number and name of a
contact person;
(4) the information
in subitem (2) for the subcontracted laboratory and the phrase "This report
contains data that were produced by a subcontracted laboratory certified for
the fields of testing performed," if data were produced by a laboratory other
than the laboratory reporting the results;
(5) a unique identification of the test
report, such as a serial number, an identification on each page to ensure that
the page is recognized as a part of the test report, and a clear identification
of the end of the test report;
(6)
the name of the client and project name, if applicable;
(7) identification of the approved method
used;
(8) a description of, the
condition of, and unambiguous identification of the sample, including the
client's identification code;
(9)
date and time of sample collection;
(10) the date of receipt of the sample when
critical to the validity and application of the results;
(11) time of sample preparation and time of
sample analysis when critical to the validity of the sample result;
(12) date of analysis of the environmental
test;
(13) the test results with,
when appropriate, the units of measurement; whether data are calculated on a
dry weight or an "as received" basis; the reporting or detection limit for each
sample with appropriate units of measurement; and the counting error for each
radiochemistry sample;
(14) the
name, function, and signature or equivalent electronic identification of the
person authorizing the test report and the date of issue;
(15) a statement to the effect that the
results relate only to the samples;
(16) a statement that the report must not be
reproduced, except in full, without the written approval of the
laboratory;
(17) deviations from
the standard operating procedure, such as failed quality control, additions to,
or exclusions from the test method and information on specific test conditions,
such as environmental conditions and any nonstandard conditions that may have
affected the quality of results, including the use and definitions of data
qualifiers; and
(18) test results
that do not meet the requirement, or for which the laboratory is not certified,
must be documented with the reason why the result does not meet the
requirements and justification as to why the result was reported.
D. When the laboratory analyzes
samples by a procedure other than as written, the laboratory record must
include:
(1) the sample identification
traceable to client;
(2) the
modification to the procedure;
(3)
the reason for the modification; and
(4) the client's authorization or
acknowledgment of the modification.
