Section 77.22. Milk and food laboratories; certified analysts.

 

(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 department conducts the next biennial inspection of the laboratory under s. ATCP 77.14 (1) .

(b) 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 or electronic somatic cell counts, the department shall check the analyst's ability to perform the 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. 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. If a provisionally certified 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. If a provisionally certified analyst fails a proficiency evaluation on a new set of proficiency samples, 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) .

History: Cr. Register, September, 1999, No. 525 , eff. 10-1-99; r. (2) (b) and renum. (2) (c) to be (2) (b), Register, December, 1999, No. 528 , eff. 1-1-00; emerg. r. and recr. (1), eff. 11-15-01; CR 01-124 : r. and recr. (1) Register December 2002 No. 564 , eff. 1-1-03.