reglab/statecodes huggingface dataset:
Wisconsin Administrative Code › Department of Natural Resources › NR 100-199 - Environmental Protection General › Chapter NR 149 - Laboratory Accreditation › Subchapter II - Program Administration › Section NR 149.08 - Acceptance of other accreditations, licenses, or approvals

Current through June 24, 2024
(1) AGRICULTURE,
				  TRADE, AND CONSUMER PROTECTION AGREEMENT. The department shall accept the
				  accreditation, licensure, or approval by the department of agriculture, trade,
				  and consumer protection for microbiological testing performed by a laboratory
				  submitting or generating data for a covered program.
(2) LABORATORIES ACCREDITED, LICENSED, OR
				  APPROVED BY OTHER GOVERNMENTS.
(a) The
				  department may negotiate with and attempt to enter into agreements with federal
				  agencies and agencies of other states to reciprocally accept accreditations of
				  laboratories under this chapter.
(b) The department may accept the
				  accreditation, licensure, or approval of a laboratory by another state or an
				  agency of the federal government if the standards used for the qualification of
				  a laboratory are substantially equivalent to those established in this
				  chapter.
(c) The department may not
				  accept the accreditation, licen-sure, or approval of a laboratory by another
				  state or an agency of the federal government, unless that state or federal
				  agency accepts laboratories accredited under this chapter.
Wisconsin Administrative Code › Department of Natural Resources › NR 100-199 - Environmental Protection General › Chapter NR 149 - Laboratory Accreditation › Subchapter II - Program Administration › Section NR 149.09 - Certification standards review council

Current through June 24, 2024
(1) The council
				  shall advise the department on the standards used to certify, register,
				  suspend, and revoke laboratories.
(2) The council shall advise the department
				  on training and outreach activities that the department may offer or sponsor to
				  facilitate compliance of laboratories with this chapter.
(3) The council shall advise the department
				  on the frequency and scope of evaluations necessary to determine compliance of
				  laboratories with this chapter.
(4)
				  The department shall seek the advice of the council before requiring the
				  analysis of additional PT samples and approving PT sample providers.
(5) The department shall seek the advice of
				  the council before implementing changes in the fees assessed to
				  laboratories.
(6) The department
				  shall seek the advice of the council in granting variances.
(7) The department shall prepare annually the
				  following for review by the council:
(a) A
				  summary of laboratory evaluations performed.
(b) A list of required PT samples and
				  available PT sample providers.
(c)
				  A summary of fees scheduled to be assessed to laboratories.
(d) A summary of variances issued.
Wisconsin Administrative Code › Department of Natural Resources › NR 100-199 - Environmental Protection General › Chapter NR 149 - Laboratory Accreditation › Subchapter II - Program Administration › Section NR 149.10 - Enforcement

Current through June 24, 2024
(1) ADMINISTRATIVE PROCEDURES. A laboratory's
				  accreditation is valid until it expires, is suspended, or is revoked. If, after
				  opportunity for a contested case hearing, the department finds that an
				  accredited laboratory materially and consistently failed to comply with the
				  provisions of this chapter, the department may suspend or revoke a laboratory's
				  accreditation in whole or in part by matrix, analytical technology, method,
				  analyte, or analyte group. Contested case hearings for out-of-state
				  laboratories regulated under this chapter shall be held in Madison, Wisconsin.
(2) SUSPENSION OR REVOCATION OF
				  CERTIFIED LABORATORIES.
(a) Causes for
				  suspension of certification include any of the following:
1. Material and consistent failure to comply
				  with the requirements of this chapter.
2. Reporting data to the department after a
				  laboratory is deemed temporarily incapable of performing analysis in any
				  matrix, analytical technology, method, analyte, or analyte group.
3. Suspension of certification,
				  accreditation, license, or approval by another state or agency of the federal
				  government for which the laboratory holds certification if the grounds for
				  suspension are substantially equivalent to any of those listed in this
				  paragraph.
Wisconsin Administrative Code › Department of Natural Resources › NR 100-199 - Environmental Protection General › Chapter NR 149 - Laboratory Accreditation › Subchapter II - Program Administration › Section NR 149.11 - Discretionary acceptance

Current through June 24, 2024
(1) Except for
				  results of tests required under ch. NR 809 the department may accept, on a
				  case-by-case basis, the results of tests originating in a laboratory not
				  accredited as required by a covered program if the results meet all other
				  requirements of this chapter.
(2)
				  The requirements of this chapter may be waived by the department when there is
				  a multi-agency response to a hazardous substance discharged in boundary areas
				  of the state.
(3) The requirements
				  of this chapter may be waived by the department when the environmental
				  protection agency national enforcement investigations center laboratory is
				  utilized for EPA or department led enforcement cases.
(4) The department may not accept the results
				  of tests originating in a laboratory not accredited, unless the results are
				  generated in accordance with requirements substantially equivalent to those
				  outlined in this chapter.
Note:
Refer to s.
					 NR
					 149.42 for additional information on the use of
					 alternative methods.
(5)
				  The department may charge a fee under s.
				  299.11(5)
				  (d), Stats., if it is necessary to verify the
				  results of tests for which a laboratory requests discretionary
				  acceptance.
Wisconsin Administrative Code › Department of Natural Resources › NR 100-199 - Environmental Protection General › Chapter NR 149 - Laboratory Accreditation › Subchapter II - Program Administration › Section NR 149.12 - Variances

Current through June 24, 2024
(1) GENERAL. The department may approve
				  variances from non-statutory requirements of this chapter when the department
				  determines that the variances have no effect on the department's objectives.
				  Before granting variances, the department shall consider factors such as good
				  cause, circumstances beyond the control of the laboratory, and financial
				  hardship.
(2) REQUEST FOR VARIANCE.
				  Requests for variances shall be submitted to the department. Each variance
				  request shall contain all the following:
(a)
				  The name of the applicant or laboratory.
(b) The section of this chapter from which a
				  variance is sought.
(c) A
				  description of the circumstances under which the variance will be exercised,
				  including any pertinent background information relevant to making a
				  justification.
Wisconsin Administrative Code › Department of Natural Resources › NR 100-199 - Environmental Protection General › Chapter NR 149 - Laboratory Accreditation › Subchapter IV - Accreditation Process › Section NR 149.14 - Application for accreditation

Current through June 24, 2024
(1) GENERAL
				  REQUIREMENTS.
(a)  Laboratories are required
				  to do all the following:
1. Submit
				  applications to seek, revise, or transfer accreditations.
2. Declare the fields of accreditation being
				  sought, revised, or transferred in corresponding applications.
3. For drinking water, declare the methods of
				  analysis for ana-lytes and analyte groups in the fields of accreditation being
				  sought, revised, or transferred.
4.
				  Submit a current analytical instrument list.
5. Submit acceptable results for PT samples
				  when the department requires the PT sample analysis.
6. For laboratories that are not physically
				  located in Wisconsin, submit a statement of intent to perform analyses for
				  regulatory samples originating in Wisconsin. Intent to perform analyses for
				  regulatory samples originating in Wisconsin can be manifested by any of the
				  following:
a. Referencing the affiliation of
				  the applicant laboratory with a plant, office, laboratory, or engineering firm
				  physically located in the state of Wisconsin.
b. Submitting a letter from a potential
				  client requesting the applicant to perform analyses to determine compliance
				  with a covered program.
7. Submit any information identified in an
				  application or upon request of the department such as standard operating
				  procedures or analytical data.
8.
				  When the department determines that an evaluation is necessary to determine
				  potential or actual compliance with this chapter, allow the department to
				  perform an on-site evaluation.
9.
				  Remit any necessary fees required under this chapter.
Note:
Fee information is contained in s.
					 NR
					 149.21 Tables 1, 2, and 3.
10. Agree to comply with this chapter by
				  signing the application.
Wisconsin Administrative Code › Department of Natural Resources › NR 100-199 - Environmental Protection General › Chapter NR 149 - Laboratory Accreditation › Subchapter IV - Accreditation Process › Section NR 149.15 - Period, renewal, and expiration of accreditation

Current through June 24, 2024
(1) ACCREDITATION
				  PERIOD.
(a) The accreditation period shall
				  commence on September 1 and end on August 31 of the following year for all
				  laboratories accredited by the department.
(b) The department shall renew the
				  accreditations of laboratories that meet the requirements of this section prior
				  to September 1 of each year.
Wisconsin Administrative Code › Department of Natural Resources › NR 100-199 - Environmental Protection General › Chapter NR 149 - Laboratory Accreditation › Subchapter IV - Accreditation Process › Section NR 149.155 - Required notifications

Current through June 24, 2024
(1) LABORATORY NAME
				  CHANGE. A laboratory that changes its name without changing ownership shall
				  notify the department, in writing, within 30 days of the effective date of the
				  name change. The department may not charge a fee for any processing resulting
				  solely from a name change.
(2)
				  LABORATORY OWNERSHIP CHANGE. A laboratory that changes its ownership shall
				  notify the department, in writing, within 30 days of the effective date of the
				  ownership change. Notification shall be in the form of a completed application
				  for transfer of ownership.
(3)
				  LABORATORY RELOCATION. A laboratory relocating shall notify the department, in
				  writing, at least 30 days prior to the relocation. Notification shall include
				  the new address and any changes in contact information.
(4) KEY PERSONNEL CHANGES. A laboratory
				  making changes to key personnel, including lab director, lab manager, quality
				  assurance manager, or whole effluent toxicity technical expert, shall notify
				  the department within 30 days of these changes.
Wisconsin Administrative Code › Department of Natural Resources › NR 100-199 - Environmental Protection General › Chapter NR 149 - Laboratory Accreditation › Subchapter IV - Accreditation Process › Section NR 149.16 - Notification of relocation

Current through June 24, 2024
(1) Laboratories
				  relocating shall notify the department in writing, at least 30 days prior to
				  the relocation, of their change of address and any changes in their contact
				  information.
(2) The department
				  shall issue a revised certificate to a relocating laboratory within 30 days of
				  receiving the notification or the effective date of the relocation, whichever
				  is later.
(3) Laboratories
				  undergoing a change of ownership, needing to add certifications or
				  registrations, modifying their certification or registration status, changing
				  the entity by or through which they obtained certifications or registrations as
				  a result of a relocation shall comply with the requirements of s.
				  NR
				  149.14.
(4) The department may perform an on-site
				  evaluation of the relocating laboratory at its new location to determine the
				  laboratory's continued ability to comply with the requirements of this
				  chapter.
Wisconsin Administrative Code › Department of Natural Resources › NR 100-199 - Environmental Protection General › Chapter NR 149 - Laboratory Accreditation › Subchapter IV - Accreditation Process › Section NR 149.17 - Laboratory name change

Current through June 24, 2024
(1) Laboratories that change names without
				  changing ownership shall notify the department in writing within 30 days of the
				  effective date of the name change.
(2) The department shall issue a revised
				  certificate to a laboratory changing its name without changing ownership and
				  not seeking additional certifications or registrations within 30 days of
				  receiving notification from the laboratory.
(3) The department may not charge a fee for
				  processing laboratory name changes or for issuing a revised certificate
				  resulting solely from a name change.
Wisconsin Administrative Code › Department of Natural Resources › NR 100-199 - Environmental Protection General › Chapter NR 149 - Laboratory Accreditation › Subchapter IV - Accreditation Process › Section NR 149.18 - Subcontracting

Current through June 24, 2024
(1) Subcontracting samples shall be to a
				  laboratory that holds valid certifications corresponding to the matrix,
				  technology or method, and analyte requested.
(2) A laboratory accepting samples under a
				  subcontract from another laboratory shall maintain any analytical records
				  needed to determine compliance with this chapter. The records shall be made
				  available to the laboratory providing the samples.
Wisconsin Administrative Code › Department of Natural Resources › NR 100-199 - Environmental Protection General › Chapter NR 149 - Laboratory Accreditation › Subchapter IV - Accreditation Process › Section NR 149.19 - Requirements for certification in the drinking water matrix

Current through June 24, 2024
(1) APPLICABILITY.
				  This section contains additional requirements that apply to laboratories
				  analyzing drinking water for compliance under ch. NR 809.
(2) GENERAL REQUIREMENTS.
(a) The minimum criteria and procedures for
				  certification in the drinking water matrix are specified in the following
				  documents:
1. As updated, the "Manual for the
				  Certification of Laboratories Analyzing Drinking Water," EPA 815-R-05-004,
				  fifth edition, EPA, Office of Ground Water and Drinking Water, January
				  2005.
2. As updated, the
				  "Supplement 1 to the Fifth Edition of the Manual for the Certification of
				  Laboratories Analyzing Drinking Water," EPA 815-F-08-006 EPA, Office of Ground
				  Water and Drinking Water, June 2008.
Note:
The documents above can be found on the
					 Wisconsin department of natural resources laboratory accreditation program
					 website and are available for inspection at the offices of the department and
					 the legislative reference bureau.
Wisconsin Administrative Code › Department of Natural Resources › NR 100-199 - Environmental Protection General › Chapter NR 149 - Laboratory Accreditation › Subchapter IV - Accreditation Process › Section NR 149.20 - Requirements for whole effluent toxicity testing

Current through June 24, 2024
All the following apply to laboratories accredited to
					 perform whole effluent toxicity testing:
(1) ACUTE AND CHRONIC WHOLE EFFLUENT TOXICITY
				  TESTING BY SPECIES. Laboratories analyzing whole effluents for acute and
				  chronic toxicity for a given species shall follow the quality control
				  requirements referenced in the "State of Wisconsin Aquatic Life Toxicity
				  Testing Methods Manual," as updated.
Note:
Links to the "State of Wisconsin Aquatic
					 Life Toxicity Testing Methods Manual," can be found on the Wisconsin department
					 of natural resources laboratory accreditation program website and are available
					 for inspection at the offices of the department and the legislative reference
					 bureau.
(2) ACCREDITATION
				  REQUIREMENTS FOR CHEMICAL TESTING IN SUPPORT OF WHOLE EFFLUENT TOXICITY
				  TESTING. Water chemistry testing performed in support of whole effluent
				  toxicity testing for ammonia, alkalinity, hardness, pH, dissolved oxygen,
				  conductivity, and total residual chlorine do not require separate accreditation
				  under this chapter.
Wisconsin Administrative Code › Department of Natural Resources › NR 100-199 - Environmental Protection General › Chapter NR 149 - Laboratory Accreditation › Subchapter V - Proficiency Testing › Section NR 149.22 - Required proficiency testing samples and frequency of analysis

Current through June 24, 2024
(1)
				  REQUIREMENTS.
(a) A laboratory shall
				  participate in at least one PT sample study per accreditation period as
				  specified in sub. (2), subject to all the following:
1. For aqueous and non-aqueous matrices, a
				  laboratory shall analyze aqueous matrix PT samples for each combination of
				  technology and analyte or analyte group in its fields of
				  accreditation.
2. For the drinking
				  water matrix, a laboratory shall analyze PT samples for each combination of
				  method and analyte or ana-lyte group in its fields of certification. Acceptance
				  criteria for these samples are set in s.
				  NR
				  149.27.
Wisconsin Administrative Code › Department of Natural Resources › NR 100-199 - Environmental Protection General › Chapter NR 149 - Laboratory Accreditation › Subchapter V - Proficiency Testing › Section NR 149.23 - Approval of proficiency testing sample providers

Current through June 24, 2024
(1) CRITERIA FOR
				  APPROVAL. When evaluating a PT sample provider for approval, the department
				  shall consider criteria including all the following:
(a) The PT sample provider accreditation
				  status by national accreditation programs.
(b) The PT sample provider use of techniques
				  for calculating acceptance limits as specified in s.
				  NR
				  149.27.
Wisconsin Administrative Code › Department of Natural Resources › NR 100-199 - Environmental Protection General › Chapter NR 149 - Laboratory Accreditation › Subchapter V - Proficiency Testing › Section NR 149.24 - Proficiency testing samples for applications and accreditation renewal

Current through June 24, 2024
(1) PT SAMPLE ACCEPTANCE CRITERIA. The
				  department may not grant or renew an accreditation unless the associated PT
				  sample results meet the criteria specified in s.
				  NR
				  149.27.
(2) PT SAMPLE STUDY CLOSE DATE. Acceptable PT
				  samples shall have a PT sample study close date no more than six months prior
				  to the date of application.
(3) PT
				  SAMPLE DUE DATE FOR RENEWAL. For renewal of accreditations, which begin on
				  September 1 of each calendar year, acceptable PT sample results shall have been
				  reported electronically to the department by an approved PT sample provider no
				  sooner than January 1 or later than August 31 of the same calendar
				  year
.
Preliminary reports from approved PT sample providers may
				  not be used for renewal of accreditation.
Note:
For example, to renew accreditation for
					 any analyte effective for the period from September 1, 2009 to August 31, 2010,
					 a laboratory shall have successfully analyzed a PT sample for that analyte
					 reported between January 1 and August 31, 2009.
(4) PT SAMPLES FOR APPLICATIONS. A laboratory
				  submitting initial or revised applications for accreditation shall analyze PT
				  samples from an approved PT sample provider and submit acceptable results for
				  any of the following:
(a) For aqueous and
				  non-aqueous matrices, acceptable PT sample results are required for each
				  combination of technology and analyte or analyte group for which the department
				  has identified that PT samples are required.
(b) For the drinking water matrix, acceptable
				  PT sample results, from a water supply study, are required for each combination
				  of method and analyte or analyte group.
Wisconsin Administrative Code › Department of Natural Resources › NR 100-199 - Environmental Protection General › Chapter NR 149 - Laboratory Accreditation › Subchapter V - Proficiency Testing › Section NR 149.25 - Treatment of proficiency testing samples

Current through June 24, 2024
(1) PT samples
				  shall be subjected to any preparatory steps undergone by analytical samples of
				  that matrix, unless the preparation instructions submitted by a PT sample
				  provider specifically instruct omitting a preparatory step.
Note:
Preparatory steps include digestions,
					 distillations, extractions, concentrations, and dilutions.
(2) A laboratory may report multiple results
				  for a single PT sample when the laboratory maintains accreditations for
				  multiple technologies for any analyte or analyte group in aqueous and
				  non-aqueous matrices.
(3) A
				  laboratory may report multiple results of a single PT sample when the
				  laboratory maintains certifications for multiple methods for any analyte or
				  analyte group in the drinking water matrix.
(4) Prior to submitting PT sample results to
				  a PT sample provider, all the following apply:
(a) A laboratory may not send a PT sample, or
				  portion of a PT sample, to another laboratory for analysis.
(b) A laboratory may not knowingly analyze a
				  PT sample, or a portion of a PT sample, from another laboratory.
(c) Until a PT sample study has been closed,
				  a laboratory may not share results of a PT sample from that study to any party
				  other than the PT sample provider or regulatory agency.
Wisconsin Administrative Code › Department of Natural Resources › NR 100-199 - Environmental Protection General › Chapter NR 149 - Laboratory Accreditation › Subchapter V - Proficiency Testing › Section NR 149.26 - Reporting proficiency testing sample results

Current through June 24, 2024
(1) A laboratory
				  shall submit PT sample results to PT sample providers in accordance with the
				  dates specified by the PT sample providers.
(2) PT sample reports may be submitted to the
				  department directly from the PT sample 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. The laboratory shall submit PT
				  sample reports in their entirety, without modification, to the
				  department.
(3) Results from all PT
				  sample reports issued to the department by PT sample providers shall be used to
				  determine a laboratory's accreditation status.
(4) The department may only accept amended
				  and reissued PT sample reports if the reissue is due to an error made by the PT
				  sample provider and revised reports are all the following:
(a) Clearly labeled as revised or
				  reissued.
(b) Directly submitted to
				  the department by the PT sample provider.
(c) Accompanied by an explanation of the PT
				  sample provider's error.
Wisconsin Administrative Code › Department of Natural Resources › NR 100-199 - Environmental Protection General › Chapter NR 149 - Laboratory Accreditation › Subchapter V - Proficiency Testing › Section NR 149.27 - Proficiency testing sample acceptance limits and grading

Current through June 24, 2024
(1) ACCEPTANCE
				  LIMITS. A laboratory's result for any analyte or analyte group is considered
				  unacceptable if it meets any of the following conditions:
(a) The result falls outside the acceptance
				  limits.
(b) The laboratory reports
				  a result for an analyte not present in the PT sample.
(c) The laboratory does not report a result
				  for an analyte present in the PT sample.
(d) The laboratory fails to submit its
				  results to the PT sample provider on or before the deadline for the PT sample
				  study.
(e) The laboratory reports a
				  method code for either an unap-proved method or the method code reported is not
				  appropriate for the technology-analyte or method-analyte combination.
(f) The laboratory fails to meet department
				  specified grading criteria for multi-analyte PT samples.
Note:
Department grading criteria can be found
					 on the Wisconsin department of natural resources laboratory accreditation
					 program website.
Wisconsin Administrative Code › Department of Natural Resources › NR 100-199 - Environmental Protection General › Chapter NR 149 - Laboratory Accreditation › Subchapter V - Proficiency Testing › Section NR 149.28 - Procedure for correcting unacceptable proficiency testing sample results

Current through June 24, 2024
(1)
				  AQUEOUS AND NON-AQUEOUS MATRICES.
(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.
(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:
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.
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.
(c) The department may not renew
				  accreditation of those ana-lytes 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.
(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.
Wisconsin Administrative Code › Department of Natural Resources › NR 100-199 - Environmental Protection General › Chapter NR 149 - Laboratory Accreditation › Subchapter VI - On-Site Laboratory Evaluations › Section NR 149.29 - Purpose, type, and frequency

Current through June 24, 2024
(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.
(2) The department shall
				  conduct announced on-site evaluations of laboratories once every three years
				  and when any of the following occurs:
(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.
(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.
(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.
(d) The department has reason to believe that
				  a laboratory is not in compliance with this chapter.
Wisconsin Administrative Code › Department of Natural Resources › NR 100-199 - Environmental Protection General › Chapter NR 149 - Laboratory Accreditation › Subchapter VI - On-Site Laboratory Evaluations › Section NR 149.30 - Evaluation procedures and appraisal

Current through June 24, 2024
(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.
(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.
(3) The department shall provide laboratories
				  with a survey to allow them to appraise the evaluation
				  process.
Wisconsin Administrative Code › Department of Natural Resources › NR 100-199 - Environmental Protection General › Chapter NR 149 - Laboratory Accreditation › Subchapter VI - On-Site Laboratory Evaluations › Section NR 149.31 - Evaluation reports

Current through June 24, 2024
(1) The department shall document the
				  deficiencies identified during an on-site evaluation under s.
				  NR
				  149.30 in reports issued to the evaluated
				  laboratory.
(2) The report of an
				  on-site evaluation shall be issued to a laboratory within 30 days of the
				  conclusion of the on-site visit. When the department finds it necessary to
				  issue an evaluation report at a date later than 30 days after the conclusion of
				  an on-site visit, the department shall notify the laboratory about the delay.
				  The notice shall include an expected delivery date for the report.
Wisconsin Administrative Code › Department of Natural Resources › NR 100-199 - Environmental Protection General › Chapter NR 149 - Laboratory Accreditation › Subchapter VI - On-Site Laboratory Evaluations › Section NR 149.32 - Evaluation corrective action

Current through June 24, 2024
(1) A laboratory
				  shall take corrective action to address all deficiencies discovered during an
				  on-site evaluation under s.
				  NR
				  149.30 and contained in an evaluation report under s.
				  NR
				  149.31.
(2) A laboratory shall submit to the
				  department, within 30 days from the evaluation report's date, a plan of
				  corrective action to address all the deficiencies noted in the report. When a
				  laboratory finds it necessary to submit a corrective action plan at a date
				  later than 30 days after the evaluation report's date, the laboratory shall
				  notify the department about the delay and provide an expected delivery date in
				  consultation with the department.
(3) The department shall review the
				  corrective action plan submitted by a laboratory under sub. (2) and inform the
				  laboratory whether the submitted plan addresses satisfactorily all noted
				  deficiencies, or whether additional action or documentation is necessary to
				  determine the laboratory's ability to comply with this chapter, subject to all
				  the following:
(a) When the department
				  determines that the submitted corrective action plan addresses all noted
				  deficiencies satisfactorily, the department shall inform the laboratory in
				  writing within 30 days that the plan is acceptable.
(b) When the department determines that
				  additional action or documentation is needed to evaluate compliance with this
				  chapter, the department, in consultation with the laboratory, shall set a date
				  for the laboratory to submit a second corrective action plan.
1. If the department determines that the
				  second corrective action plan submitted under sub. (3) (b) addresses all noted
				  deficiencies satisfactorily, the department shall inform the laboratory in
				  writing that the evaluation process has concluded.
2. If the department determines that the
				  second corrective action plan submitted under sub. (3) (b) does not address all
				  the noted deficiencies satisfactorily, the department may schedule another
				  on-site evaluation to determine the laboratory's compliance with this chapter,
				  terminate any outstanding application that led to the original on-site
				  evaluation, or direct enforcement to the laboratory.
3. If a second on-site evaluation is
				  scheduled as a follow-up to a second corrective action plan submitted under
				  sub. (3) (b), the department shall establish deadlines that resolve any
				  remaining unresolved deficiencies expeditiously, but no later than 90 days
				  after the conclusion of the follow-up visit.
Wisconsin Administrative Code › Department of Natural Resources › NR 100-199 - Environmental Protection General › Chapter NR 149 - Laboratory Accreditation › Subchapter VI - On-Site Laboratory Evaluations › Section NR 149.33 - Conflicts of interest

Current through June 24, 2024
(1) The department shall establish procedures
				  to ensure and document that laboratory evaluators under its employment are free
				  of any conflicts that would render the laboratory evaluator incapable of
				  performing an objective and unbiased evaluation of a laboratory.
				  <hr>
(2) A laboratory may
				  request information and documents used by the department to establish that any
				  evaluator assigned to perform the laboratory's evaluation is free of any
				  conflicts of interest.
Wisconsin Administrative Code › Department of Natural Resources › NR 100-199 - Environmental Protection General › Chapter NR 149 - Laboratory Accreditation › Subchapter VI - On-Site Laboratory Evaluations › Section NR 149.34 - Evaluator qualifications

Current through June 24, 2024
(1) The department
				  shall develop procedures to establish and evaluate the education, experience,
				  and credentials of the laboratory evaluators under its employment.
(2) A laboratory may request information and
				  documents used by the department to establish that any evaluator assigned to
				  perform the laboratory's evaluation has the necessary education, experience, or
				  credentials to perform evaluations competently.
Wisconsin Administrative Code › Department of Natural Resources › NR 100-199 - Environmental Protection General › Chapter NR 149 - Laboratory Accreditation › Subchapter VII - Quality Systems › Section NR 149.35 - General requirements

Current through June 24, 2024
(1) SCOPE. This subchapter establishes
				  personnel, quality assurance, quality control, method selection, sample
				  handling, and documentation requirements for laboratories.
(2) RESPONSIBILITY FOR QUALITY SYSTEM. A
				  laboratory shall conduct analytical activities under a quality system that
				  incorporates the provisions of this subchapter. At least one individual within
				  a laboratory's organization or under the laboratory's employment shall be
				  identified to the department as responsible for establishing, implementing,
				  assessing, and revising, as needed, a laboratory's quality system.
Wisconsin Administrative Code › Department of Natural Resources › NR 100-199 - Environmental Protection General › Chapter NR 149 - Laboratory Accreditation › Subchapter VII - Quality Systems › Section NR 149.36 - Laboratory personnel

Current through June 24, 2024
(1) MANAGEMENT AND ANALYTICAL STAFF. The
				  laboratory shall have personnel with education, training, or experience that
				  allows the laboratory to comply with the requirements of this chapter.
				  Contractors, external to the laboratory, may serve in key laboratory roles.
				  When external contractors serve in essential laboratory roles, the contracts
				  shall be available to the department to ensure that contractual specifications
				  satisfy the requirements of this chapter.
Note:
For requirements regarding changes in
					 key personnel see s. NR 149.155.
(2) DEMONSTRATION OF CAPABILITY.
(a) When a laboratory references a method
				  that contains procedures for demonstrating initial capability, continuing
				  capability or both, personnel performing analyses using these methods shall
				  perform the procedures, meet any associated evaluation criteria, and document
				  the results. When initial demonstrations of capability include the analysis of
				  samples, the samples shall be prepared from a clean matrix and processed
				  through all method preparation steps.
(b) When a laboratory references a method
				  that does not contain procedures for demonstrating initial capability, the
				  laboratory shall establish initial demonstration of capability criteria for
				  determining that each person who performs testing on compliance samples using
				  the method has demonstrated the necessary skills and expertise required to
				  generate quality analytical results. The laboratory shall retain documentation
				  that each person performing a given test on compliance samples has satisfied
				  the demonstration of capability criteria established by the
				  laboratory.
Wisconsin Administrative Code › Department of Natural Resources › NR 100-199 - Environmental Protection General › Chapter NR 149 - Laboratory Accreditation › Subchapter VII - Quality Systems › Section NR 149.365 - Laboratory ethics

Current through June 24, 2024
All the following practices are prohibited and may result
					 in enforcement action under s.
					 NR
					 149.10:
(1)
				  Fabrication, falsification, or misrepresentation of data.
(2) Improper instrument clock setting, termed
				  time traveling, or improper recording of date or time.
(3) Unwarranted manipulation of samples,
				  software, peak integration, or analytical conditions.
(4) Concealing or failing to report a known
				  improper or unethical behavior or action associated with sample
				  analysis.
Wisconsin Administrative Code › Department of Natural Resources › NR 100-199 - Environmental Protection General › Chapter NR 149 - Laboratory Accreditation › Subchapter VII - Quality Systems › Section NR 149.37 - Quality manual

Current through June 24, 2024
(1) PURPOSE AND GENERAL PROVISIONS. Each
				  laboratory shall define its quality system in a quality manual. All policies
				  and procedures governing the laboratory's quality system shall be documented or
				  referenced in the quality manual. All laboratory personnel shall follow the
				  policies and procedures established by the quality manual.
(2) FORMAT. The quality manual shall have a
				  format that addresses the content elements specified in this section. Content
				  elements may be presented in narrative, tabular, schematic, or graphical form.
				  The manual shall be a document in hard copy or electronic format traceable to
				  the laboratory.
(3) CONTENT. Unless
				  included in other standard operating procedures maintained under s.
				  NR
				  149.40, the quality manual shall include, address, or
				  refer to all the following elements:
(a)
				  Procedures for retention, control, and maintenance of documents used in or
				  associated with analysis.
(b)
				  Procedures for achieving traceability of standards, reagents, and reference
				  materials used to derive any results or measurements.
(c) Procedures for handling
				  samples.
(d) Procedures for
				  calibration, verification, and maintenance of support equipment.
(e) Procedures for evaluating quality control
				  samples.
(f) Procedures for
				  initiating, following up on, and documenting corrective action, addressing
				  quality assurance and quality control failures, and any discrepancies or
				  nonconformances.
Wisconsin Administrative Code › Department of Natural Resources › NR 100-199 - Environmental Protection General › Chapter NR 149 - Laboratory Accreditation › Subchapter VII - Quality Systems › Section NR 149.38 - Corrective action

Current through June 24, 2024
(1) The laboratory shall take corrective
				  action in response to any nonconformances including all the following:
(a) Departures from established procedures in
				  the quality system are identified.
(b) Quality control samples fail, unless
				  immediate reanalysis of the affected sample resolves the issue.
Wisconsin Administrative Code › Department of Natural Resources › NR 100-199 - Environmental Protection General › Chapter NR 149 - Laboratory Accreditation › Subchapter VII - Quality Systems › Section NR 149.39 - Records and documents

Current through June 24, 2024
(1) RECORDS AND DOCUMENTS RETENTION AND
				  CONTROL.
(a) The laboratory shall establish
				  procedures to control and manage all records and documents that form part of
				  its quality system and that are required to demonstrate compliance with this
				  chapter.
(b) The procedures shall
				  ensure that documents required to perform analyses and to ensure the quality of
				  generated data are available to laboratory personnel, and that records and
				  documents are reviewed periodically for continuing suitability and, when
				  necessary, revised to facilitate compliance with the requirements of this
				  chapter.
(c) The laboratory shall
				  retain all records and documents, which are part of its quality system, and
				  that are required to demonstrate compliance with this chapter, for a minimum of
				  three years after the generation of the last entry in an associated record or
				  document. The laboratory shall retain records and documents for a longer
				  minimum period if the records and documents are necessary to reconstruct
				  analytical results generated during a three-year period.
(d) The department may require, in writing,
				  that records be retained for a longer period than that specified in par. (c) if
				  the department has initiated legal action involving test results or the
				  accreditation status of the laboratory.
(e) The laboratory shall identify to the
				  department a responsible party for retaining documents and records for the
				  required period in the event the laboratory changes ownership or ceases to be
				  accredited.
(f) Records and
				  documents shall be handled and stored in a manner that ensures permanence and
				  security for the required retention period and that facilitates retrieval to
				  demonstrate compliance with this chapter.
(g) All records shall allow for
				  reconstruction of reported results from raw data. Records and documents shall
				  be legible, and entries shall be safeguarded against obliteration, erasures,
				  overwriting, and corruption and are subject to all the following requirements:
Note:
The determination of legibility includes
					 concerns regarding the quality and permanence of records and the ability to
					 decipher numbers and letters. For example, thermal paper ages and eventually
					 becomes unreadable, so thermal paper printouts should ultimately be scanned or
					 copied to ensure permanence.
1.
				  Handwritten records shall be recorded in ink.
2. Records and documents that are stored only
				  on electronic media shall be supported by the hardware and software necessary
				  for retrieval and reproduction into hard copy.
3. Corrections or other alterations made to
				  entries in records or documents may not obscure the original entry.
4. The laboratory shall have procedures to
				  prevent unauthorized access or amendments to records and documents.
Wisconsin Administrative Code › Department of Natural Resources › NR 100-199 - Environmental Protection General › Chapter NR 149 - Laboratory Accreditation › Subchapter VII - Quality Systems › Section NR 149.40 - Standard operating procedures

Current through June 24, 2024
(1) A laboratory
				  shall maintain written standard operating procedures that document or reference
				  activities needed to maintain its quality systems and that enable performing or
				  reproducing an analysis in its entirety as performed at the laboratory. Each
				  laboratory shall develop, maintain, and keep current its standard operating
				  procedures for both sample preparation and analysis.
Note:
Sample preparation includes digestions,
					 distillations, extractions, concentrations, dilutions, and clean-up performed
					 on samples prior to the determinative analytical step.
(2) Standard operating procedures may be
				  documents written by laboratory personnel or may consist entirely of copies of
				  published documents, manuals, or procedures if the laboratory follows the
				  chosen source exactly.
(3) Standard
				  operating procedures may consist, in part, of copies of published documents,
				  manuals, or procedures if all the following conditions are met:
(a) Modifications to the published source are
				  described in writing in additional documents.
(b) Clarifications, changes, or choices are
				  completely described in additional documents, when published sources offer
				  multiple options, ambiguous directives, or insufficient detail to perform or
				  reproduce an analysis.
Wisconsin Administrative Code › Department of Natural Resources › NR 100-199 - Environmental Protection General › Chapter NR 149 - Laboratory Accreditation › Subchapter VII - Quality Systems › Section NR 149.41 - Method selection

Current through June 24, 2024
(1) The laboratory shall use methods for
				  environmental testing required by covered programs under this chapter and that
				  are suitable for the matrix, type of analyte, expected level of analyte,
				  regulatory limit, and potential interferences in the samples to be tested.
Note:
Sources, including the following as
					 updated, likely contain methods that are acceptable for testing under this
					 chapter: The EPA, the department, Standard Methods for the Examination of Water
					 and Wastewater, Test Methods for Evaluating Solid Waste, Physical/Chemical
					 Methods - SW-846, American Society for Testing and Materials, and the U.S.
					 Geological Survey Agency.
(2) When methods are not specified by covered
				  programs under this chapter or specified in permits issued by the department,
				  the laboratory shall consult with the department to select a method that meets
				  the requirements in sub. (1).
(3)
				  When using methods associated with the methods compendium document, "Test
				  Methods for Evaluating Solid Waste," the laboratory shall comply with the
				  minimum requirements of the methods as written and state which options are
				  being implemented when options exist.
Note:
The documents above can be found on the
					 Wisconsin department of natural resources laboratory accreditation program
					 website and are available for inspection at the offices of the department and
					 the legislative reference bureau.
(4) The department will assess the scientific
				  validity of method modifications to determine if the modification is within the
				  scope of a method.
A list of authoritative sources for methods and quality
						control information is provided in Appendix III to this chapter.