Subpart
1.
Use of approved providers.
A laboratory must obtain proficiency testing samples from an
approved provider meeting the requirements under part 4740.2075.
Subp. 2. [Repealed, 44 SR
371]
Subp. 3. [Repealed,
]
Subp. 4.
Laboratory testing
of PT study samples.
A. A laboratory's
management and all analysts must ensure that all PT samples are managed,
analyzed, reported, and otherwise handled in the same manner as routine
samples, including utilizing the same staff, procedures, equipment, facilities,
and frequency of analysis as used for routine analysis for that field of
testing.
B. When analyzing a PT
sample, a laboratory must employ the same calibration, quality control,
acceptance criteria, sequence of analytical steps, number of replicates, and
other standard operating procedures as used when analyzing routine samples. The
laboratory must follow sample preparation steps for the PT sample as instructed
by the approved PT provider for which the PT sample was obtained.
Subp. 5. [Repealed, ]
Subp. 6. [Repealed, ]
Subp. 7.
Evaluation of results.
A laboratory may not request from the PT provider a revised
report when the revisions to the report are due to any error on the part of the
laboratory.
Subp. 8.
[Repealed, ]
Subp. 9.
Corrective actions for unacceptable results.
When an approved provider notifies a laboratory that a PT
sample result for any reported field of testing is unacceptable, the laboratory
must:
A. within 30 days after
receiving the notification of unacceptable results from the approved provider,
submit written documentation to the commissioner indicating corrective actions
planned and taken;
B. within 30
days after receiving the notification of unacceptable results from the approved
provider, submit written documentation to the commissioner indicating the
laboratory's request to purchase a PT sample from an approved provider;
and
C. within 30 days after
receiving the results of the PT sample under item B, supply a copy of the
results to the commissioner.
Subp.
10. [Repealed, ]
Subp.
11.
Additional samples for compliance.
The commissioner may require certified laboratories to test
additional PT samples at any time to determine compliance with parts 4740.2010
to 4740.2120.