Section 77.24. Milk and food analysts; proficiency evaluation.

 

(1)   Annual proficiency evaluation required. Except as provided in sub. (4) , the department may not renew an analyst's certification to perform any test listed under s. ATCP 77.02 (1) or (2) unless, within the year immediately preceding that renewal, the analyst passes a proficiency evaluation for that test. The proficiency evaluation shall comply with this section.

(2)   Form of evaluation. In a proficiency evaluation under sub. (1) , an analyst shall examine samples prepared by an approved evaluator under sub. (3) . The contents of the samples shall be known only to the evaluator. The evaluator shall rate the analyst's proficiency by comparing the analyst's results to the known contents of the samples, and shall report those results and ratings to the department. The reported results and ratings are rebuttably presumed to be valid for purposes of s. ATCP 77.22 and this section.

(3)   Approved evaluator. The department, or another evaluator approved by the department in writing, shall serve as a proficiency evaluator under sub. (2) .

(4)   Evaluation procedure; general. A proficiency evaluation under sub. (1) shall be conducted according to a standard evaluation procedure which the department approves in writing. An analyst is not required to complete a proficiency evaluation for any test unless the department has approved a standard evaluation procedure for that test. A standard evaluation procedure shall comply with applicable requirements under sub. (5) , and shall include standards for all of the following:

(a) The evaluator's preparation of proficiency evaluation samples.

(b) The analyst's examination of proficiency evaluation samples.

(c) Deadlines for examining proficiency evaluation samples and reporting test results.

(d) The evaluator's review and rating of the analyst's proficiency.

(5)   Milk tests; evaluation standards.

(a) Proficiency evaluations for the following tests under s. ATCP 77.02 (1) shall test include at least the following number of samples:

1. At least six but not more than 20 samples for standard plate count, petrifilm aerobic count, plate loop count, or phosphatase tests.

2. At least eight but not more than 20 samples for direct microscopic somatic cell counts, electronic somatic cell counts, drug residue tests, or coliform tests

(b) To pass a proficiency evaluation under par. (a) which involves 6 to 10 samples, an analyst shall obtain no more than one unacceptable sample result. To pass a proficiency evaluation under par. (a) which involves 11 to 20 samples, an analyst shall obtain no more than 2 unacceptable sample results.

(c) In a proficiency evaluation for any of the following tests, a sample result is unacceptable if it falls outside the statistical limits established in FDA's "Evaluation of Milk Laboratories," 1995 edition.

1. Standard plate count.

2. Petrifilm aerobic count.

3. Plate loop count.

4. Direct microscopic somatic cell count.

5. Electronic somatic cell count.

(d) In a proficiency evaluation for a test, such as a drug residue or phosphatase test, in which sample test results are reportable as positive or negative, a sample result is unacceptable if the analyst fails to report the correct positive or negative result.

(e) In a proficiency evaluation for a coliform test, a sample result is unacceptable if the analyst fails to report the correct result.

History: Cr. Register, September, 1999, No. 525 , eff. 10-1-99; CR 07-006 : am. (2) and (5) (e), Register January 2008 No. 625 , eff. 2-1-08.

Note

The department will approve an evaluator under sub. (3) if FDA approves that evaluator for the same purpose. Microsoft Windows NT 6.1.7601 Service Pack 1