Current through August 26, 2024
(1) CERTIFICATION
REQUIRED.
(a) Except as provided in par. (b),
no analyst may perform a test listed under s.
ATCP 77.02(1) or (2) unless the department
certifies that analyst under this section to perform that test.
(b) Paragraph (a) does not apply to an
individual who is solely engaged in performing a drug residue screening test,
provided that the department has approved that individual under s.
ATCP 77.23(2) to perform that
test.
(c) The department shall
certify the analysts employed at a laboratory when it conducts a mandatory
inspection of that laboratory under s.
ATCP 77.14(1). The department may certify
new analysts, or certify analysts to perform other tests, at other
times.
(2) TERM OF
CERTIFICATION. An analyst's certification to perform a test remains in effect
until one of the following occurs:
(a) The
laboratory administrator or designated agent requests the analyst's
certification to be withdrawn.
(b)
The certified laboratory does not pay the annual license fee for the
analyst.
(c) The department
suspends or revokes the analyst's certification.
(3) COMPETENCY EVALUATION.
(a) Before the department certifies an
analyst to perform any test listed under s.
ATCP 77.02(1) or (2), the department shall
observe and evaluate that analyst's competency to perform that test.
(b) Whenever the department performs a
mandatory inspection of a laboratory under s.
ATCP 77.14(1), the department shall
perform a competency evaluation under par. (a) of every analyst who performs a
test listed under s.
ATCP 77.02(1) or (2).
(c) The department shall use an appropriate
FDA 2400 series form or if no FDA 2400 series form applies, another standard
form to evaluate an analyst's competency under par. (a). If an analyst performs
plate loop counts, electronic bacteria counts, or electronic somatic cell
counts, the department shall check the analyst's accuracy based on any
statistical comparisons required by those tests.
(4) ANNUAL PROFICIENCY EVALUATION
. An analyst who performs a test listed under s.
ATCP 77.02(1) or (2) shall complete an
annual proficiency evaluation for that test if an annual proficiency evaluation
is required under s.
ATCP 77.24.
(5)
CONDITIONAL CERTIFICATION. If the department determines under sub. (3) that an
analyst is competent to perform a test, but the analyst has not yet completed a
proficiency evaluation under s.
ATCP 77.24 for that test, the department shall
conditionally certify the analyst. If a conditionally certified analyst fails a
proficiency evaluation under s.
ATCP 77.24, the department shall summarily suspend the
analyst's certification to perform that test.
(6) FULL CERTIFICATION. If the department
determines under sub. (3) that an analyst is competent to perform a test, and
the analyst also passes a proficiency evaluation under s.
ATCP 77.24 for that test, the department shall fully
certify that analyst to perform that test.
(7) PROVISIONAL CERTIFICATION AND RESTORATION
OF FULL CERTIFICATION.
(am) An analyst shall
be placed in provisional certification if one of the following occurs:
1. If a fully certified analyst fails a
proficiency evaluation under s.
ATCP 77.24 for any test, the department shall issue a
notice stating that the analyst is provisionally certified to perform that
test.
2. If the department conducts
a biennial inspection of a laboratory under s.
ATCP 77.14(1) and a fully certified
analyst is not present to demonstrate competence to perform the test(s) they
are certified for, the department shall issue a laboratory report stating that
the analyst is provisionally certified to perform that test.
(c) If an analyst is
provisionally certified because of failing a proficiency evaluation under s.
ATCP 77.24 and that analyst passes a proficiency evaluation
under s.
ATCP 77.24 on a new set of proficiency samples, the
department shall restore the analyst to full certification.
(d) If an analyst is provisionally certified
because they were not present to demonstrate their competence to perform the
tests they are certified for during the biennial inspection of the laboratory,
they shall remain in provisional certification status until they again
demonstrate their competence during an inspection of the laboratory.
(e) If a provisionally certified analyst
fails a proficiency evaluation on a new set of proficiency samples, or is not
present to demonstrate their competence during a biennial inspection of the
laboratory, the department shall summarily suspend the analyst's certification
to perform that test.
(8)
RESTORING CERTIFICATION. The department may restore the certification of any
analyst whose certification is summarily suspended under sub. (5) or (7) if the
analyst completes a training program approved by the department and passes a
proficiency evaluation under s.
ATCP 77.24 on a new set of proficiency samples. The
department shall restore the analyst to full certification, even if the analyst
was conditionally certified when certification was suspended.
(9) LIST OF CERTIFIED ANALYSTS. The
department shall maintain, for each certified laboratory, a list of analysts
currently certified to perform tests listed under s.
ATCP 77.02(1) and (2). The list shall
identify the tests which each analyst is certified to perform.
(10) NOTICE OF CHANGES.
(a) An operator shall notify the department
within 30 days after any of the following occurs:
1. An analyst certified under this section is
no longer employed by the laboratory.
2. There is a change in the name of any
analyst certified under this section.
(b) An operator shall notify the department
of a staffing change within 7 days after that change occurs if, as a result of
that change, the operator no longer meets applicable certification requirements
under s.
ATCP 77.08(3).
