NR 149.22(2)(a)(a) The department shall publish a list of required proficiency testing samples and approved proficiency testing sample providers annually. The department shall seek the advice of the certification standards review council prior to identifying required proficiency testing samples and approved sample providers.
NR 149.22(2)(b)
(b) The list shall identify matrix-specific proficiency testing samples required for submittal for renewal of accreditation, or with initial or revised applications and the specific providers approved for supplying each required sample.
NR 149.22(3)(a)(a) Laboratories performing the following analytical techniques for metals analysis in aqueous and solid matrices shall analyze quality control standards 3 times per year at evenly spaced intervals in lieu of analyzing proficiency testing samples:
NR 149.22(3)(b)
(b) Laboratories analyzing ultra-low level metals in aqueous and solid matrices shall analyze quality control standards 3 times per year at evenly spaced intervals in lieu of analyzing proficiency testing samples. Quality control standards shall be diluted to fall within the working concentration of the analytical technique.
NR 149.22 History
History: CR 06-005: cr.
Register April 2008 No. 628, eff. 9-1-08.
NR 149.23
NR 149.23
Approval of proficiency testing sample providers. When evaluating a proficiency testing sample provider for approval, the department shall consider criteria including, but not limited to, the provider's:
NR 149.23(1)
(1) Accreditation status by nationally recognized accreditation programs.
NR 149.23(3)
(3) Ability to submit results to the department in a format specified by the department, including electronic media.
NR 149.23 History
History: CR 06-005: cr.
Register April 2008 No. 628, eff. 9-1-08.
NR 149.24(1)
(1)
Applications for aqueous and solid matrices. Laboratories submitting initial or revised applications for certification or registration in aqueous and solid matrices shall analyze proficiency testing samples from an approved proficiency testing sample provider and submit acceptable results for each technique and analyte or analyte group for which the department has identified that proficiency testing samples are required.
NR 149.24(1)(a)
(a) Acceptable proficiency testing samples shall be analyzed no more than 6 months prior to the date of application.
NR 149.24(1)(b)
(b) The department may not grant a certification or registration unless the associated proficiency testing sample results meet the criteria specified in
s. NR 149.27.
NR 149.24(2)
(2) Applications for drinking water matrix. Laboratories submitting initial or revised applications for certification in the drinking water matrix shall analyze proficiency testing samples from an approved proficiency testing sample provider and submit acceptable results for each method and analyte or analyte group.
NR 149.24(2)(a)
(a) Acceptable proficiency testing samples shall be analyzed no more than 6 months prior to the date of application.
NR 149.24(2)(b)
(b) The department may not grant a certification or registration unless the associated proficiency testing sample results meet the criteria specified in
s. NR 149.27.
NR 149.24(3)
(3) Annual renewal for aqueous and solid matrices. Laboratories seeking renewal of certification or registration for aqueous or solid matrices shall analyze at least one proficiency testing sample, prepared in an aqueous matrix, from an approved proficiency testing sample provider and submit acceptable results for each technique and analyte or analyte group for which the department has identified that proficiency testing samples are required. Laboratories with 3 consecutive proficiency testing sample failures in a year for any technique and analyte or analyte group shall submit 2 consecutive acceptable proficiency testing samples from an approved proficiency testing sample provider for that technique and analyte or analyte group.
NR 149.24 Note
Note: Proficiency testing samples prepared in a solid matrix are not required at this time to obtain or renew certification or registration for analytes or analyte groups under the solid matrix tier.
NR 149.24(3)(a)
(a) For renewal of certifications or registrations, which begin on September 1 of each calendar year, acceptable proficiency testing sample results shall have been reported by an approved PT provider no sooner than January 1 or later than August 15 of the same calendar year.
NR 149.24 Note
Note: For example, to renew certification for any parameter effective for the period from September 1, 2009 to August 31, 2010, a laboratory shall have successfully analyzed a PT sample for that parameter reported between January 1 and August 15, 2009.
NR 149.24(3)(b)
(b) Reports from proficiency testing sample providers shall be received by the department on or before August 15 of each year.
NR 149.24(3)(c)
(c) The department may not renew a certification or registration unless the associated proficiency testing sample results meet the criteria specified in
s. NR 149.27.
NR 149.24(4)
(4) Annual renewal for drinking water matrix. Laboratories seeking renewal of certification for the drinking water matrix shall analyze at least one proficiency testing sample from an approved proficiency testing sample provider and submit acceptable results for each method and analyte or analyte group.
NR 149.24(4)(a)
(a) For renewal of certifications or registrations, which begin on September 1 of each calendar year, acceptable proficiency testing sample results shall have been reported by an approved PT provider no sooner than January 1 or later than August 15 of the same calendar year.
NR 149.24(4)(b)
(b) Reports from proficiency testing sample providers shall be received by the department on or before August 15 of each year.
NR 149.24(4)(c)
(c) The department may not renew a certification or registration unless the associated proficiency testing sample results meet the requirements specified in
s. NR 149.27.
NR 149.24 History
History: CR 06-005: cr.
Register April 2008 No. 628, eff. 9-1-08.
NR 149.25
NR 149.25
Treatment of proficiency testing samples by laboratories. NR 149.25(1)
(1) Proficiency testing samples shall be subjected to any preparatory steps undergone by analytical samples, unless the preparation instructions submitted by a provider specifically instruct omitting a preparatory step.
NR 149.25 Note
Note: Preparatory steps include digestions, distillations, extractions, concentrations and dilutions.
NR 149.25(2)
(2) Laboratories may report multiple results of multiple analyses of a single proficiency testing sample when a laboratory maintains certifications or registrations for multiple techniques for any analyte or analyte group in aqueous and solid matrices.
NR 149.25(3)
(3) Laboratories may report multiple results of a single proficiency testing sample when the laboratory maintains certifications for multiple methods for any analyte or analyte group in the drinking water matrix.
NR 149.25(4)
(4) Prior to submitting proficiency testing results to a proficiency testing sample provider:
NR 149.25(4)(a)
(a) Laboratories may not send a proficiency testing sample, or portion of a proficiency testing sample to another laboratory for analysis.
NR 149.25(4)(b)
(b) Laboratories may not knowingly analyze a proficiency testing sample, or a portion of a proficiency testing sample from another laboratory.
NR 149.25(4)(c)
(c) Laboratories may not communicate results of a proficiency testing sample with another laboratory.
NR 149.25 History
History: CR 06-005: cr.
Register April 2008 No. 628, eff. 9-1-08.
NR 149.26(1)(1) Laboratories shall submit proficiency testing sample results to providers in accordance with the dates specified by the providers.
NR 149.26(2)
(2) Proficiency testing reports may be submitted to the department directly from the provider or by the laboratory, but it is the laboratory's responsibility to ensure the department receives the necessary reports for initial and revised applications. Reports submitted by the laboratory shall be submitted in their entirety, without modification, to the department.
NR 149.26(3)
(3) Results from all proficiency testing reports issued to the department by providers shall be used to determine a laboratory's certification or registration status.
NR 149.26(4)
(4) Proficiency testing reports may be amended and reissued by the provider when errors attributable to the proficiency testing sample provider are identified. The department shall accept amended and reissued reports if they are:
NR 149.26 History
History: CR 06-005: cr.
Register April 2008 No. 628, eff. 9-1-08.
NR 149.27
NR 149.27
Proficiency testing sample acceptance limits and grading. NR 149.27(1)(1)
Acceptance limits. A laboratory's result for any analyte or analyte group is considered unacceptable if it meets any of the following conditions:
NR 149.27(1)(b)
(b) The laboratory reports a result for an analyte not present in the proficiency testing sample.
NR 149.27(1)(c)
(c) The laboratory does not report a result for an analyte present in the proficiency testing sample.
NR 149.27(1)(d)
(d) The laboratory fails to submit its results to the proficiency testing sample provider on or before the deadline for the proficiency testing study.
NR 149.27(2)(a)(a) Proficiency testing samples for analytes in aqueous and solid matrices shall be graded in accordance with acceptance limits established by the department considering criteria developed by EPA.
NR 149.27(2)(b)
(b) For required proficiency testing sample analytes in aqueous and solid matrices for which EPA has not developed acceptance limits, the department may develop acceptance limits based on its experience or information supplied by approved providers.
NR 149.27(2)(c)
(c) When an insufficient number of laboratories participate in a study to generate peer-based acceptance limits in a proficiency testing sample with analytes for which EPA has not established acceptance limits, the department may grade results using fixed acceptance limits.
NR 149.27(2)(e)
(e) Where certification or registration in an analyte group is based on passing a representative proficiency testing sample containing more than one analyte, the laboratory shall report acceptable results on at least 80% of the analytes to achieve acceptable results for that sample.
NR 149.27(2)(f)
(f) The department shall establish procedures for evaluating false positives and false negatives reported in analyzed proficiency testing samples.
NR 149.27 History
History: CR 06-005: cr.
Register April 2008 No. 628, eff. 9-1-08.
NR 149.28
NR 149.28
Procedure for correcting unacceptable proficiency testing sample results. NR 149.28(1)
(1)
Aqueous and solid matrices. If a laboratory does not meet the acceptance limits for a particular analyte or analyte group and the laboratory does not have acceptable results on a previous sample analyzed during the same certification or registration period, the department shall require the laboratory to analyze a second proficiency testing sample for that analyte or analyte group.
NR 149.28(1)(a)
(a) If the results of a second proficiency testing 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. After failing 2 consecutive proficiency testing samples, the laboratory shall:
NR 149.28(1)(a)1.
1. Submit 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 proficiency testing sample.
NR 149.28(1)(a)2.
2. Analyze a third proficiency testing sample within 60 days of the date of notification of the second failure. If the results of the third proficiency testing sample do not meet the acceptance limits, the laboratory shall analyze 2 subsequent and consecutive acceptable proficiency testing samples.
NR 149.28(1)(b)
(b) The department may not renew the certification or registration of those analytes or analyte groups for which a laboratory has failed 3 consecutive proficiency testing samples for those analytes or analyte groups and has not successfully analyzed 2 subsequent and consecutive proficiency testing samples for those analytes or analyte groups prior to September 1.
NR 149.28(1)(c)
(c) When applying to have an analyte or analyte group reinstated after non-renewal for failing 3 consecutive proficiency testing samples, the laboratory shall provide acceptable results on 2 subsequent and consecutive proficiency testing sample studies for that analyte or analyte group.
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 proficiency testing 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.
NR 149.28 History
History: CR 06-005: cr.
Register April 2008 No. 628, eff. 9-1-08.
NR 149.29
NR 149.29
Purpose, type and frequency. 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 3 years and:
NR 149.29(2)(a)
(a) When a laboratory submits an application to become certified or registered in any field of certification or registration, 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 and satisfactory.
NR 149.29(2)(b)
(b) When a laboratory changes its location, 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 the change in location.
NR 149.29(2)(c)
(c) When 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(2)(d)
(d) When the department has reason to believe that a laboratory is not in compliance with this chapter.
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 149.29 History
History: CR 06-005: cr.
Register April 2008 No. 628, eff. 9-1-08.
NR 149.30
NR 149.30
Evaluation procedures and appraisal. NR 149.30(1)(1) The department shall perform on-site evaluations of laboratories 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) The department shall provide forms that allow laboratories to voluntarily appraise the evaluation process.
NR 149.30 History
History: CR 06-005: cr.
Register April 2008 No. 628, eff. 9-1-08.
NR 149.31(1)(1) The department shall document the deficiencies of an on-site evaluation in reports issued to the evaluated laboratory.
