Required analyses of proficiency testing samples.
Approval of proficiency testing sample providers.
Schedule of analysis.
Treatment of proficiency testing samples by laboratories.
Proficiency testing sample acceptance limits and grading.
Procedure for correcting unacceptable proficiency testing sample results.
Subchapter VI — On-Site Laboratory Evaluations
Purpose, type and frequency.
Evaluation procedures and appraisal.
Evaluation corrective action.
Conflicts of interest.
Subchapter VII — Quality Systems
Corrective action for quality system and quality control samples.
Records and documents.
Standard operating procedures.
Handling of samples.
Laboratory test reports.
Quality control requirements for chemical testing.
Quality control requirements for whole effluent toxicity testing.
Ch. NR 149 Note
Chapter NR 149 as it existed on April 30, 2008, was repealed and a new chapter NR 149 was created, Register April 2008 No. 628
, effective September 1, 2008.
NR 149.01 Purpose.
The purpose of this chapter is to establish a program for the certification and registration of laboratories performing testing under s. 299.11
NR 149.01 History
History: CR 06-005
: cr. Register April 2008 No. 628
, eff. 9-1-08.
This chapter specifies requirements for the administration of the laboratory certification and registration program by the department.
Unless otherwise exempted in this section, this chapter applies to laboratories:
Submitting data to the department for a covered program.
Generating data that is necessary for the department to determine compliance with a covered program.
NR 149.02 Note
Administrative codes and programs requiring analyses to be performed by a certified or registered laboratory are chs. NR 110
– Sewerage Systems, 113 – Servicing Septic Systems, 123 – Well Compensation Program, 131 – Metallic Mineral Prospecting, 132 – Metallic Mineral Mining, 140 – Groundwater Quality, 145 – Private Wells, 150 – Environmental Analysis and Review Procedures, 157 – Management of PCBs, 158 – Hazardous Substance Discharge Notification, 182 – Metallic Mining Waste, 206 – Land Disposal of Municipal and Domestic Wastewaters, 210 – Sewage Treatment Works, 211 – General Pretreatment Requirements, 212 – Wasteload Allocated Effluent Limits, 214 – Land Treatment of Industrial Liquid Wastes, 216 – Stormwater Management, 219 – Analytical Test Methods and Procedures, 347 – Sediment Sampling and Analysis, 507 – Environmental Monitoring for Landfills, 528 - Management of Accumulated Sediment from Storm Water Management Structures, 661 – Hazardous Waste Identification and Listing, 662 – Hazardous Waste Generator Standards, 664 – Hazardous Waste Treatment, Storage and Disposal Facility Standards, 665 – Interim License Hazardous Waste Treatment, Storage and Disposal Facility Standards, 700 – General Requirements for Investigation and Remediation of Environmental Contamination, 712 – Environmental Response Actions, 716 –Site Investigations, 809 – Safe Drinking Water, 811 – Design of Community Water Supplies, 845 – County Administration of NR 812 (Private Wells), and DCF 251 – Group Day Care Centers for Children.
The requirements for the certification of laboratories performing analyses for the safe drinking water program covered by ch. NR 809
are specified in s. NR 149.19
NR 149.02 Note
Note: Laboratories performing analyses for the safe drinking water program covered by ch. NR 809 must be certified even if they do not perform or intend to perform tests commercially for hire. Registration is not available for these analyses.
The requirements for the certification and registration of laboratories performing whole effluent toxicity testing are specified in ss. NR 149.20
This chapter applies to laboratories analyzing industrial pre-treatment samples when the department is the control authority of a pre-treatment ordinance, or when another control authority requires it.
Laboratories required to perform bacteriological testing for a covered program shall be certified or approved under ch. ATCP 77
by the department of agriculture, trade, and consumer protection.
Laboratories required to perform radiological testing for a covered program shall be certified or approved by EPA.
This chapter establishes requirements that shall be followed, at a minimum, by all laboratories.
Laboratories are also responsible for following any requirements pertaining to analyses and analytical operations contained in mandated test methods or regulations when those requirements are more stringent than the ones specified in this chapter, unless this chapter grants explicit, alternative allowances.
When it is not apparent whether the minimum requirements of this chapter or those specified in mandated test methods or regulations are more stringent, laboratories shall follow the requirements in mandated test methods or regulations.
The department shall retain the authority to make a decision on the stringency of a laboratory requirement when the applicability of a requirement is disputed.
NR 149.02 Note
Note: The order of precedence for the authority of a requirement is statute, code, and method. The order of applicability of a requirement is generally method, code, and statute, whenever each succeeding source contains more general or less stringent requirements that are not in conflict.
NR 149.02 History
History: CR 06-005
: cr. Register April 2008 No. 628
, eff. 9-1-08.
NR 149.03 Definitions.
In this chapter:
“Acceptance limits" means limits established by the department that are used to determine if a laboratory has analyzed a proficiency testing sample successfully.
“Accuracy" means the closeness of a measured value to an accepted reference value or standard.
“Analysis day" means the day in which a specific type of analysis is performed.
“Analyte" means the chemical substance, physical property or organism analyzed in a sample.
“Analyte group" means a set of analytes that can be determined using the same method or technology and that constitute a unit, acknowledged by the department, of the third tier of certification or registration.
“Analytical balance" means a balance that is capable of measuring masses to at least 4 decimal places.
“Analytical class" means a set of analytes or analyte groups of similar behavior or composition, or a set of analytes or analyte groups regulated under the same provisions of the federal safe drinking water act, that is used to organize the third tier of certification or registration.
“Analytical instruments" means any test instrument used to provide analytical results that is not support equipment.
“Analytical run" means an event consisting of the uninterrupted analysis of a set of samples used to establish the frequency of continuing calibration verification.
“Analytical staff" includes, but is not limited to, laboratory directors, supervisory personnel, quality assurance personnel, technicians, chemists, biologists, personnel performing extractions and analysts.
“Authoritative source" means a publication, text or reference included in Appendix III.
“Aqueous" means a certification or registration matrix designating any aqueous sample that is not a drinking water, and samples with no more than 15% settleable solids.
NR 149.03 Note
Note: Samples with more than 10% settleable solids may also be classified as solid.
“Batch" means a set of samples prepared or analyzed together under the same process, instrumentation, personnel, and lots of reagents. An analytical batch refers to a set of any number of prepared samples, such as extracts, digestates or concentrates or samples requiring no preparatory steps analyzed together as a group in an uninterrupted sequence, and may consist of samples of various quality system matrices. A preparation batch refers to a batch of samples, excluding quality control samples, of the same quality system matrix which can be processed simultaneously using the same equipment, reagents and staff. Preparation batch processing shall be completed in a 24-hour period from the start of the processing of the first sample to the start of the processing of the last sample. For laboratories that do not analyze more than 7 samples for a given test and quality system matrix per week, a preparation batch may consist of up to 7 samples, excluding quality control samples, processed during the course of no more than a week.
“Bias" means the consistent deviation of measured values from a true value caused by systematic errors in a procedure or a measurement process.
“Blank" refers to a type of quality control sample optimally containing no detectable levels of the analyte or analyte group of interest, typically used to zero an analytical instrument and ensure that any reagents used do not contribute to overall measurements
“Calibration blank" means a sample containing insignificant or undetectable levels of target analytes used to establish the analytical zero of a calibration function.
“Method blank" means a sample of a matrix devoid of or having a consistent concentration or amount of the analytes of interest processed simultaneously with and under the same conditions, preparatory and analyses steps as the associated samples.
“Temperature blank" means a sample container, of at least 40 ml. capacity, filled with water and transported with each shipment of collected samples to determine the temperature of other samples in the shipment on arrival at a laboratory.
“Calibration" means the process used to establish an observed relationship between the response of an analytical instrument and a known amount of analyte, or the process used to determine, by measuring or comparison with a reference standard, the correct value of each scale reading in an instrument, meter or measuring device.
“Calibration function" means the specific mathematical relationship established to relate calibration standards to instrument response.
“Certificate" means a document owned by the department and issued to a laboratory that indicates the fields of accreditation granted to a laboratory.
“Certification" means the specific form of accreditation extended by the department to laboratories that perform analyses for hire in connection with a covered program, or to laboratories that perform drinking water analyses.
“Certification matrix" means a matrix type that is part of the first tier of a field of certification. Certification matrices are drinking water, aqueous and solids.
“Certified laboratory" means a laboratory that has been granted certification by the department directly or through reciprocal recognition under this chapter.
“Chain of custody" means the procedures and records that document the possession and handling of samples from collection through disposal.
A chain-of-custody form is used to document, with a signature, date and time, transfer of the sample from collector to transport/delivery service and then to the laboratory staff receiving the samples. “Evidentiary chain-of-custody" refers to more stringent sample transfer documentation in which samples are stored in secure storage areas. In addition, a chronological written record shall be maintained of all individuals who have possession of the sample from its initial acquisition until its final disposition.
“Coefficient of determination" means a quantity that measures the degree of agreement between the points in a calibration curve and the quadratic function derived to connect them.
“Commercially for hire" means offering analyses for payment or non-monetary compensation generally available to any party requesting analytical services.
“Confirm" means to verify the identity of a compound by an alternative procedure, column, detector, wavelength, or by a technique that bases detection on a different scientific principle from the one originally identifying the compound.
“Control" means to possess, directly or indirectly, the power to direct or cause the direction of the management and policies of an entity, whether that power is exercised through one or more intermediary entities, or alone, or in conjunction with, or by an agreement with, any other entity, and whether that power is established through a majority or minority ownership or voting of securities, common directors, officers, stockholders, voting trusts, holding trusts, affiliated companies, or documented agreements between government entities, whether statewide, countywide, citywide or any combination thereof.
“Control authority" means to have direct or delegated responsibility for establishing, implementing or monitoring an industrial waste pre-treatment program.
“Correlation coefficient" means a quantity that measures the degree of agreement between the points in a calibration curve and the linear function derived to connect them.
“Corrective action" means any measure taken to eliminate or prevent the recurrence of the causes of an existing nonconformity, defect or undesirable condition.