Wisconsin Legislature: ATCP 77.14(2)(a)

(a) Adequate facilities, equipment and supplies to perform the tests which the operator is certified to perform at that laboratory.

(b) At least 5 linear feet of level bench top working space per analyst.

(d) Effective climate controls to maintain proper temperature and humidity for testing.

(2) Quality control and maintenance. The operator of a certified laboratory shall do all of the following:

(a) Maintain laboratory facilities, equipment and supplies in proper working condition.

(b) Maintain temperature-controlled equipment, including incubators, water baths, refrigerators and freezers, so that the equipment functions effectively. The operator shall measure and record equipment temperatures at least daily when the equipment is in use and the laboratory is staffed with trained personnel.

(c) Maintain autoclaves to ensure proper temperature and pressure throughout the entire sterilization cycle, and keep a record of autoclave maintenance.

(d) Calibrate each electronic test instrument as recommended by the instrument manufacturer, and record the results.

(e) Ensure that each reagent and solution is clearly labeled to show its identity, its titer or concentration, its expiration or preparation date, instructions for proper storage, and other pertinent information. An operator shall store reagents and solutions according to the manufacturer’s specifications.

(f) Ensure that glassware is free of chips, excessive scratches or cloudiness. Glassware used for measurement, including pipettes, graduated cylinders and volumetric flasks, shall have clear graduations.

(3) Notice of material changes. An operator shall notify the department whenever the operator remodels laboratory facilities or installs new equipment if the remodeling or installation materially affects the performance of tests under s. ATCP 77.02 which the operator is certified to perform at that laboratory.

History: Cr. Register, September, 1999, No. 525, eff. 10-1-99; CR 19-076: am. (2) (b) Register May 2020 No. 773, eff. 6-1-20.

ATCP 77.12 Laboratory administrator. The laboratory administrator or a designated agent of the administrator shall be present at every certified laboratory during daytime business hours. The laboratory administrator shall do all of the following on behalf of the laboratory operator:

(1) Supervise the laboratory and its compliance with this chapter.

(2) Review and approve, for submission to the department, every certification application which the operator submits for that laboratory under s. ATCP 77.04.

(3) Supervise the procurement and maintenance of laboratory facilities, equipment and supplies, and notify the department of material changes under s. ATCP 77.10 (3).

(4) Facilitate department inspections of the laboratory. At the request of the department, the administrator shall grant the department access to laboratory facilities, equipment and records, and shall arrange for analysts to demonstrate their testing proficiency.

(5) Notify the department of changes in laboratory analysts under s. ATCP 77.22 (10).

(6) Notify all laboratory customers if the department suspends or revokes all or part of the laboratory’s certification.

(7) Report test results to the appropriate regulatory agency, if required by law.

(8) Supervise laboratory recordkeeping under s. ATCP 77.16.

History: Cr. Register, September, 1999, No. 525, eff. 10-1-99.

ATCP 77.14 Inspecting a laboratory.

(1) Mandatory inspections. The department shall inspect a laboratory at all of the following times:

(a) Before certifying the operator under s. ATCP 77.03, for the first time, to perform tests at that laboratory.

(b) At least once every 2 years after the department first certifies the operator under s. ATCP 77.03 to perform tests under s. ATCP 77.02 (1) at that laboratory and at least once every 3 years after the department first certifies the operator under s. ATCP 77.03 to perform any tests under s. ATCP 77.02 (2) or (3).

(c) Before the department certifies the operator to perform a test under s. ATCP 77.02 which the department has not previously certified that operator to perform at that laboratory unless the laboratory is currently certified for a test that utilizes the same or very similar methodology.

(2) Discretionary inspections. The department may inspect a certified laboratory whenever any of the following occurs:

(a) The operator materially alters laboratory facilities or equipment.

(b) The operator assigns a new analyst to perform a test for which the operator is currently certified.

(c) The department concludes that an inspection is necessary to determine whether the operator, or the operator’s laboratory, complies with this chapter.

(3) Inspection authority. The department may exercise its authority under ss. 93.08, 93.14, 93.15, 93.16 and 97.12, Stats., in support of an inspection under this chapter. The department may suspend or revoke the certification of any operator who obstructs or fails to permit an inspection under this section.

Note: The department conducts its inspections during laboratory business hours. The department ordinarily pre-arranges inspection dates and times that are acceptable to laboratory operators, but is not required to do so. A person who obstructs or interferes with an inspection may also be subject to penalties under s. 93.21 (2) or (4) or s. 97.12 (4), Stats.

History: Cr. Register, September, 1999, No. 525, eff. 10-1-99; CR 19-076: am. (1) (b), (c) Register May 2020 No. 773, eff. 6-1-20.

ATCP 77.16 Laboratory records.

(1) Records required. An operator shall make complete records related to all of the following:

(a) The training, experience and proficiency testing of every analyst who performs tests for which the laboratory is certified.

(b) Laboratory evaluations required under this chapter.

(d) Laboratory facilities, equipment and supplies, including records related to procurement, calibration, testing and maintenance.

(e) Quality control procedures and monitoring.

(f) Tests performed at the laboratory, including records related to the nature of the test, the person for whom the test is performed, the assigned analysts, the test methods used, the date and time of testing, and the test results obtained.

(g) Test reports filed with the department and other government agencies.

Note: For example, see reporting requirements under chs. ATCP 65 and 70 and chs. NR 809 and 812.

(2) Record retention; availability.

(a) The operator of a milk or food laboratory shall retain all records under sub. (1) for at least 2 years. The operator of a water laboratory shall retain all records under sub. (1) for at least 5 years.

(b) An operator shall make records under sub. (1) available to the department for inspection and copying upon request.

(c) An operator may keep records under sub. (1) in hard copy or electronic form, or both, provided that the department can obtain ready access to the records.

(d) An operator shall take reasonable security measures to prevent record loss, damage or tampering.

(3) Falsifying records. No operator may falsify any laboratory records.

History: Cr. Register, September, 1999, No. 525, eff. 10-1-99.

Subchapter II — Milk and Food Laboratories

ATCP 77.20 Milk and food laboratories; procedures.

(1) Test methods. An operator who performs any test listed under s. ATCP 77.02 (1) and (2) shall perform that test according to methods specified in applicable reference materials under sub. (2), or according to methods which the department approves in writing.

(2) Reference materials.

(a) General. An operator who performs any test listed under s. ATCP 77.02 (1) or (2) shall keep, at the certified laboratory, the manufacturer’s complete operating and maintenance instructions for equipment used to perform that test.

(b) Milk tests. An operator who performs any test listed under s. ATCP 77.02 (1) shall keep the following reference materials at the certified laboratory:

1. The FDA 2400 series laboratory evaluation forms for that test.

2. The “Standard Methods for the Examination of Dairy Products,” 17th edition, published by the American Public Health Association.

(c) Food tests. An operator who performs any test listed under s. ATCP 77.02 (2) shall keep or have online access to all of the following reference materials at the certified laboratory:

1. The authoritative reference manual, if any, that applies to each type of food testing for which the laboratory is certified.

2. The “Compendium of Methods for the Microbiological Examination of Foods,” 4th edition, published by the American Public Health Association.

3. The FDA “Bacteriological Analytical Manual,” current on-line edition, if the operator performs a microbiological test on food.

Note: Copies of “Standard Methods for the Examination of Dairy Products” and “Compendium of Methods for the Microbiological Examination of Foods” are on file with the department and the legislative reference bureau and may be obtained from the “APHA Bookstore” at http://secure.apha.org/iMIS/APHA/Store .

Copies of the “Bacteriological Analytical Manual” are on file with the department and the legislative reference bureau and may be viewed online at http://www.fda.gov/Food/FoodScienceResearch/LaboratoryMethods/ucm2006949.htm.

(3) Culture media. Culture media used for any test listed under s. ATCP 77.02 (1) or (2) shall be effectively sterilized before they are used. Culture media shall be autoclaved for the total cycle time and sterilization time specified by the media manufacturer or by the applicable test method under this section.

History: Cr. Register, September, 1999, No. 525, eff. 10-1-99; CR 07-006: am. (2) (b) 2. and (c) 2. and 3., Register January 2008 No. 625, eff. 2-1-08; CR 19-076: am. (2) (c) (intro.), (3) Register May 2020 No. 773, eff. 6-1-20.

ATCP 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 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.

(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.