ATCP 77.10(2)(c) (c) Maintain autoclaves to ensure proper temperature and pressure throughout the entire sterilization cycle, and keep a record of autoclave maintenance.

ATCP 77.10(2)(d) (d) Calibrate each electronic test instrument as recommended by the instrument manufacturer, and record the results.

ATCP 77.10(2)(e) (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.

ATCP 77.10(2)(f) (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.

ATCP 77.10(3) (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.

ATCP 77.10 History 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 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:

ATCP 77.12(1) (1) Supervise the laboratory and its compliance with this chapter.

ATCP 77.12(2) (2) Review and approve, for submission to the department, every certification application which the operator submits for that laboratory under s. ATCP 77.04.

ATCP 77.12(3) (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).

ATCP 77.12(4) (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.

ATCP 77.12(5) (5) Notify the department of changes in laboratory analysts under s. ATCP 77.22 (10).

ATCP 77.12(6) (6) Notify all laboratory customers if the department suspends or revokes all or part of the laboratory’s certification.

ATCP 77.12(7) (7) Report test results to the appropriate regulatory agency, if required by law.

ATCP 77.12(8) (8) Supervise laboratory recordkeeping under s. ATCP 77.16.

ATCP 77.12 History History: Cr. Register, September, 1999, No. 525, eff. 10-1-99.

ATCP 77.14 ATCP 77.14 Inspecting a laboratory.

ATCP 77.14(1) (1) Mandatory inspections. The department shall inspect a laboratory at all of the following times:

ATCP 77.14(1)(a) (a) Before certifying the operator under s. ATCP 77.03, for the first time, to perform tests at that laboratory.

ATCP 77.14(1)(b) (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).

ATCP 77.14(1)(c) (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.

ATCP 77.14(2) (2) Discretionary inspections. The department may inspect a certified laboratory whenever any of the following occurs:

ATCP 77.14(2)(a) (a) The operator materially alters laboratory facilities or equipment.

ATCP 77.14(2)(b) (b) The operator assigns a new analyst to perform a test for which the operator is currently certified.

ATCP 77.14(2)(c) (c) The department concludes that an inspection is necessary to determine whether the operator, or the operator’s laboratory, complies with this chapter.

ATCP 77.14(3) (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.

ATCP 77.14 Note 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.

ATCP 77.14 History 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 ATCP 77.16 Laboratory records.