Minnesota Administrative Rules
Agency 167 - Pollution Control Agency
Chapter 7001 - PERMITS AND CERTIFICATIONS
MAJOR FACILITY SUBSTANCE STORAGE PERMITS
Part 7001.4390 - PROFICIENCY TESTING
Universal Citation: MN Rules 7001.4390
Current through Register Vol. 48, No. 39, March 25, 2024
Subpart 1. Requirements.
A. A laboratory
must successfully complete at least one proficiency test for each parameter or
method for which it applies for certification. The laboratory must complete the
proficiency test no more than 12 months prior to submitting the application. If
no proficiency test sample is available for an analyte, the laboratory is
exempted from the requirements of this part only for that analyte.
B. Proficiency tests results must be included
with the initial or revised certification application required under part
7001.4360.
C. Proficiency test
samples that are analyzed as a part of a discharge monitoring report-quality
assurance study required under federal regulations must meet the requirements
of item A.
Subp. 2. Laboratory testing of proficiency test study samples.
To ensure valid proficiency test results, the laboratory must:
A. obtain all proficiency test
study samples as unknowns from a nationally recognized accreditation program
approved vendor;
B. manage,
analyze, report, and otherwise handle all proficiency test samples in the same
manner as routine samples, including the same staff, procedures, equipment, and
facilities used for routine analysis for the tested parameter or
method;
C. employ the same
calibration, quality control, acceptance criteria, sequence of analytical
steps, number of replicates, and other standard operating procedures for
proficiency test samples as used when analyzing routine samples; and
D. follow sample preparation steps for the
proficiency test sample as instructed by the proficiency test sample
provider.
Subp. 3. Reporting results.
A. A
laboratory must submit the results of all proficiency tests to the agency no
later than 30 days after the laboratory receives the results from the
proficiency test sample provider.
B. A laboratory conducting proficiency
testing as part of an initial or revised application must submit the results of
proficiency testing as part of the application.
C. A laboratory must either provide a copy of
the original results to the agency or authorize the proficiency test sample
provider to provide all results directly to the agency.
D. Proficiency testing samples analyzed or
reported to the proficiency test sample provider after the provider's study
closing date are not valid for compliance with the proficiency testing
requirements under this part.
Subp. 4. Restrictions on exchanging information.
Prior to the time the results of the proficiency test are submitted to the agency:
A. a
laboratory must not communicate proficiency test results to another laboratory,
including intercompany communication; and
B. a laboratory must not attempt to obtain
the assigned value of any proficiency test sample from a proficiency test
sample provider or another laboratory.
Subp. 5. Evaluation of results.
A. A laboratory must demonstrate passing
performance to the agency, as determined by the proficiency test sample
provider, for each parameter or method reported.
B. A laboratory may use one proficiency test
sample for multiple methods.
C. A
laboratory must not request a revised report from the proficiency test sample
provider when the requested revisions are the result of error on the part of
the laboratory.
Subp. 6. Repeat proficiency tests.
A. A
laboratory may repeat proficiency tests after obtaining unacceptable results as
follows:
(1) if the first proficiency test
result is unacceptable, the laboratory must resolve the suspected cause and
complete a second proficiency test within 30 days of receiving the unacceptable
result;
(2) if the second
proficiency test result is unacceptable, the laboratory must:
(a) resolve the suspected cause and submit a
corrective action report to the agency within 30 days of receiving the second
unacceptable result; and
(b) order
and complete a third proficiency test within 30 days of receiving the
unacceptable result of the second proficiency test;
(3) if the third proficiency test result is
unacceptable, the laboratory may not provide analytical results for compliance
reporting or any agency program for the parameters and methods for which the
laboratory failed to demonstrate acceptable proficiency test results. The
laboratory may resume providing analytical results when the laboratory passes
two proficiency tests in a row. These proficiency tests must be conducted at
least 15 days apart. The laboratory must submit a corrective action report to
the agency within 30 days of passing the second of the two proficiency
tests.
B. The Laboratory
Certification Program Manual, incorporated by reference in part 7001.4340,
subpart
4, governs when a portion of
a multiple analyte group proficiency test is unacceptable.
C. The agency may request additional
information necessary to validate sample results generated during the testing
period covered under this subpart.
Disclaimer: These regulations may not be the most recent version. Minnesota may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
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