NR 149.28(1)(a)(a) If a laboratory does not meet the acceptance limits for an analyte or analyte group and the laboratory does not have acceptable results on a previous sample analyzed during the same accreditation period, the laboratory shall analyze a second PT sample for that analyte or analyte group.

NR 149.28(1)(b)(b) If the results of a second PT sample do not meet the acceptance limits, the department may initiate an assessment of the laboratory’s quality control records if this action is necessary to validate data generated by the laboratory. If two consecutive PT samples do not meet acceptance limits, the laboratory shall do all the following:

NR 149.28(1)(b)1.1. Prepare a corrective action report and initiate an action plan to correct the problems within 30 days of the date of notification of the second failure. This action plan shall include a timetable for correcting the problems and obtaining a third PT sample.

NR 149.28(1)(b)2.2. Analyze a third PT sample within 60 days of the date of notification of the second failure. If the results of the third PT sample do not meet the acceptance limits, the laboratory shall analyze two subsequent and consecutive acceptable PT samples.

NR 149.28(1)(c)(c) The department may not renew accreditation of those analytes or analyte groups for which a laboratory has failed three consecutive PT samples and has not successfully analyzed two subsequent and consecutive PT samples for those analytes or analyte groups prior to September 1.

NR 149.28(1)(d)(d) When applying to have an analyte or analyte group reinstated after non-renewal for failing three consecutive PT samples, the laboratory shall provide acceptable results on two subsequent and consecutive PT sample studies for that analyte or analyte group. The consecutive PT samples shall be two unique studies received by the laboratory at least ten business days apart. The laboratory may not prepare or analyze the two PT samples in the same batch.

NR 149.28(2)(2) Drinking water. If a certified laboratory does not meet the acceptance limits that have been established by the department, the department shall require the laboratory to analyze a second PT sample and may require the laboratory to submit a corrective action report. If the results of the second sample do not meet the acceptance limits, the department may not renew the laboratory’s certification and may revoke the laboratory’s certification as specified in s. NR 149.10. To reinstate the certification for the affected method-analyte or analyte group, the laboratory shall submit a revised application, pay the revised application fee, and provide acceptable results on two subsequent and consecutive PT sample studies for that method-analyte or analyte group. The consecutive PT samples shall be two unique studies received by the laboratory at least ten business days apart. The laboratory may not prepare or analyze the two PT samples in the same batch.

NR 149.29(1)(1) The department shall perform on-site evaluations to determine a laboratory’s potential, actual, or continued ability to comply with the provisions of this chapter.

NR 149.29(2)(2) The department shall conduct announced on-site evaluations of laboratories once every three years and when any of the following occurs:

NR 149.29(2)(a)(a) A laboratory applies to become certified or registered in any field of accreditation unless the department waives the requirement to perform an on-site evaluation. When the department does not waive an evaluation, the evaluation shall be performed within 90 days after the department determines that a received application is complete.

NR 149.29(2)(b)(b) A laboratory changes its location, ownership or key personnel, unless the department waives the requirement to perform an on-site evaluation. When the department does not waive an evaluation, the evaluation shall be performed within 90 days after the department receives notification of these changes.

NR 149.29(2)(c)(c) The department determines that an on-site evaluation is necessary to verify corrective action implemented by a laboratory to address deficiencies identified in a previous on-site evaluation.

NR 149.29(3)(3) The department may conduct unannounced on-site evaluations of a laboratory to verify compliance with this chapter after a notice of violation has been issued to a laboratory.

NR 149.30(1)(1) The department shall perform on-site evaluations of laboratories to evaluate systems, practices, procedures, and documentation in a laboratory and to identify deficiencies according to documented procedures that promote consistency in determining a laboratory’s potential, actual, or continued ability to comply with this chapter.

NR 149.30(2)(2) If, in performing an on-site evaluation, the department finds that the laboratory is implementing a procedure that is neither allowed nor disallowed by method or this chapter, the department will assess the scientific validity of the procedure. The department may seek the advice of the council in making determinations under this subsection.