Section 149.03. Definitions.

  In this chapter:

(1)  "Acceptance limits" means limits established by the department that are used to determine if a laboratory has analyzed a proficiency testing sample successfully.

(2)  "Accuracy" means the closeness of a measured value to an accepted reference value or standard.

(3)  "Analysis day" means the day in which a specific type of analysis is performed.

(4)  "Analyte" means the chemical substance, physical property or organism analyzed in a sample.

(5)  "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.

(6)  "Analytical balance" means a balance that is capable of measuring masses to at least 4 decimal places.

(7)  "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.

(8)  "Analytical instruments" means any test instrument used to provide analytical results that is not support equipment.

(9)  "Analytical run" means an event consisting of the uninterrupted analysis of a set of samples used to establish the frequency of continuing calibration verification.

(10)  "Analytical staff" includes, but is not limited to, laboratory directors, supervisory personnel, quality assurance personnel, technicians, chemists, biologists, personnel performing extractions and analysts.

(11)  "Authoritative source" means a publication, text or reference included in Appendix III.

(12)  "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.

(13)  "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.

(14)  "Bias" means the consistent deviation of measured values from a true value caused by systematic errors in a procedure or a measurement process.

(15)  "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 .

(a) "Calibration blank" means a sample containing insignificant or undetectable levels of target analytes used to establish the analytical zero of a calibration function.

(b) "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.

(c) "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.

(16)  "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.

(17)  "Calibration function" means the specific mathematical relationship established to relate calibration standards to instrument response.

(18)  "Certificate" means a document owned by the department and issued to a laboratory that indicates the fields of accreditation granted to a laboratory.

(19)  "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.

(20)  "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.

(21)  "Certified laboratory" means a laboratory that has been granted certification by the department directly or through reciprocal recognition under this chapter.

(22)  "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.

(23)  "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.

(24)  "Commercially for hire" means offering analyses for payment or non-monetary compensation generally available to any party requesting analytical services.

(25)  "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.

(26)  "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 .

(27)  "Control authority" means to have direct or delegated responsibility for establishing, implementing or monitoring an industrial waste pre-treatment program.

(28)  "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.

(29)  "Corrective action" means any measure taken to eliminate or prevent the recurrence of the causes of an existing nonconformity, defect or undesirable condition.

(30)  "Council" means the certification standards review council created under s. 15.107 (12) , Stats.

(31)  "Covered program" means a program defined by s. 299.11 (1) (d) , Stats., and includes any department program, project, permit, contract or site investigation that requires analytical work to be performed by a certified or registered laboratory.

(32)  "Deficiency" means a documented or verifiable deviation from the requirements of this chapter that is noted during an on-site evaluation or while reviewing analytical data produced by a laboratory.

(33)  "Department" means the department of natural resources.

(34)  "EPA" means the United States environmental protection agency.

(35)  "Field of accreditation" means a unit by which the department grants or recognizes either certification or registration to a laboratory. There are 2 types of fields of accreditation, each consisting of 3 tiers: matrix – analytical technology – analyte or analyte group, and matrix – method – analyte or analyte group.

(a) The matrix – method – analyte or analyte group field of accreditation is limited to the drinking water matrix.

(b) The matrix – analytical technology – analyte or analyte group field of accreditation is available for both aqueous and solid matrices and for either certification or registration.

(c) Registration is available only for aqueous and solid matrices.

(36)  "Inert matrix" means a quality control matrix either containing insignificant or undetectable levels of the analytes that will be analyzed in an analytical test. Typical inert matrices are distilled water, deionized water, diatomaceous earth, and Ottawa sand.

(37)  "Internal standard" means an analyte added to calibration standards, blanks, quality control and analytical samples as a reference for evaluating and controlling the precision and bias of an analytical test. Responses of internal standards are used to adjust the quantities of analytes reported in tests that employ the standards.

(38)  "Laboratory" means a facility that performs tests in connection with a program which requires data from a certified or registered laboratory. A facility consisting of a principal laboratory and annexes within 5 miles of the principal laboratory may be considered a single laboratory at the discretion of the department. When the terms laboratory or laboratories are used unmodified in this chapter, the terms include laboratories certified or registered under this chapter and those seeking certification or registration under this chapter..

(39)  "Laboratory control sample" or "LCS" means a sample of an inert matrix or a matrix with a consistent concentration of the analytes of interest, fortified with a verified known amount of the analytes of interest. The purpose of an LCS is to determine whether the methodology is in control and whether the laboratory is capable of making accurate and precise measurements.

(40)  "Laboratory equipment" means any support equipment or analytical instrument necessary to or involved in generating the results of an analysis.

(41)  "Limit of detection" or "LOD" means the lowest concentration or amount of analyte that can be identified, measured, and reported with confidence that the concentration is not a false positive value. For department purposes, the LOD approximates the MDL and is determined per the method cited in sub. (46) .

(42)  "Limit of quantitation" means the lowest concentration or amount of an analyte for which quantitative results can be obtained.

(43)  "MCL" means maximum contaminant level and is the maximum permissible level of a contaminant in water which is delivered to any user of a public water system.

(44)  "Matrix spike" or "MS" means a sample prepared by adding a known quantity of analyte to an aliquot of an environmental sample and subjecting the sample to the entire analytical procedure to determine the ability to recover the known analyte or compound. The background concentrations of the analytes in the sample matrix shall be determined in a separate aliquot and the measured values in the matrix spike corrected for background concentrations.

(45)  "Matrix spike duplicate" or "MSD" means a replicate matrix spike prepared and processed in the laboratory in the same manner as its corresponding matrix spike, and generally used to determine the precision of the recovery of an analyte.

(46)  "Method detection limit" or "MDL" means the minimum concentration of an analyte that can be measured and reported with 99% confidence that the stated concentration is greater than zero, determined from analyses of a set of samples containing the analyte in a given matrix. The method detection limit is generated according to the protocol specified in 40 CFR 136 , Appendix B.

(47)  "NIST" means the National Institute for Standards and Technology.

(48)  "Nonconformance" means a documented or verifiable deviation from the requirements of this chapter.

(49)  "On-site evaluation" means an assessment conducted by the department at a laboratory seeking or maintaining certifications or registrations to determine actual or potential compliance with the requirements of this chapter.

(50)  "Ownership" means owning or controlling, directly or indirectly, a laboratory facility through an equity interest or its equivalent of 10% or more.

(51)  "Pesticide" means a chemical substance defined in s. 94.67 (25) and (25m) , Stats., an isomer of a pesticide, or a degradation product or metabolic product of a pesticide.

(52)  "Precision" means the measure of mutual agreement among individual measurements of a sample, usually under prescribed similar conditions, usually expressed as the standards deviation, variance, or range, in either absolute or relative terms.

(53)  "Proficiency testing sample" or "PT sample" means a sample obtained from an approved provider to evaluate the ability of a laboratory to produce an analytical test result meeting the definition of acceptable performance outlined in s. NR 149.27 . The concentration of the analyte in the sample is unknown to the laboratory at the time of analysis. PT samples are used to evaluate whether the laboratory can produce analytical results within specified acceptance limits.

(54)  "Qualify" means placing a written statement accompanying or referencing test results identifying anomalies or deviations from this chapter encountered in generating the results .

(55)  "Quality assurance" means an integrated system of activities involving planning, control, assessment, reporting and improvement to ensure that a product or service meets defined standards of quality.

(56)  "Quality control" means the overall system of technical activities designed to measure and control the quality of a product or service that meets the stated needs of users.

(57)  "Quality control standard" or "QCS" means a solution or sample containing method analyte of known concentration, accompanied by specified analytical acceptance limits, and obtained from a source external to the laboratory and different from the source of calibration standards. These samples are distinguished from proficiency test samples in that the acceptance limits are provided with the sample, rather than after analysis. Quality control standards are used to check either laboratory or instrument performance.

(58)  "Quality control limit" means the acceptance criteria used to evaluate for quality control samples. Quality control limits may be those published by the department, referenced in an approved method or calculated by a laboratory.

(59)  "Quality system matrix" means a type of sample classification used for establishing quality control acceptance criteria. Quality system matrices include, but are not limited to, drinking water, wastewater influent, wastewater effluent, groundwater, leaching procedure extracts, soils, oils, chemical wastes and biosolids.

(60)  "Quality system" means a structured and documented management arrangement describing the policies, objectives, principles, organizational authority, responsibilities, accountability, and implementation plan of an organization for ensuring quality in its work processes, products and services.

(61)  "Raw data" means any original information from a measurement activity or study recorded in media that allows the reconstruction and evaluation of the activity or study. Raw data include, but are not limited to, absorbance, emission counts, area counts, peak heights, abundance and millivolts. Raw data may be stored in hard copy or electronically.

(62)  "Reagent grade water" means water which has been treated to remove any impurities that may affect the quality of an analysis.

(63)  "Received on ice" means a designation to indicate that sample containers arriving at a laboratory have been received surrounded by an ice slurry, crushed, cubed or chipped ice.

(64)  "Reference material" means a material that has one or more sufficiently well established properties that can be used for calibrating or verifying the calibration of support equipment or analytical instruments.

(65)  "Reference standard" means a standard, generally of the highest metrological quality available, from which measurements made at a laboratory are derived.

(66)  "Registration" means the specific form of accreditation extended by the department to a laboratory that submits data in connection with a covered program, that does not perform analyses for hire, and that does not perform drinking water analyses.

(67)  "Registration matrix" means a matrix type that is part of the first tier of a field of registration. Registration matrices are aqueous and solids.

(68)  "Registered laboratory" means a laboratory that has been granted registration by the department directly or through reciprocal recognition under this chapter. A registered laboratory may be a captive industrial laboratory that performs tests solely on its own behalf or that of a subsidiary under common ownership or control, a municipal laboratory owned by a single municipality, or a municipal laboratory owned by more than one municipality that only performs tests for the owning municipalities.

(69)  "Relocation" means a move by a laboratory resulting in a change in the laboratory's facility identification number.

(70)  "Replicate" means 2 or more substantially equal aliquots analyzed independently for the same parameter.

(71)  "Reporting limit" means a concentration or amount of analyte required by the department or client above which numerical results must be reported. Reporting limits may be limits of detection, limits of quantitation, practical quantitation limits or other concentrations, and may be specific to a project or investigation.

(72)  "Revocation" means cancellation of a laboratory's certification or registration.

(73)  "Results" means the quantitative or qualitative output of an analysis, including, but not limited to, measurements, determinations and information obtained or derived from tests.

(74)  "Sample standard deviation" means the standard deviation calculated for a set of samples belonging to a larger population. The sample standard deviation formula contains the quantity "n - 1" in the denominator inside the radical, where n equals the number of samples.

(75)  "Second source standard" means a standard procured from a supplier or manufacturer different from the supplier or manufacturer of a laboratory's calibration standards, or a standard obtained from the same supplier or manufacturer of a laboratory's calibration standards from a lot verifiably different from the lot of the calibration standards.

(76)  "Sensitivity" means the capability of a method or instrument to discriminate between measurement responses representing different levels of analyte, or the capability of a method or instrument to detect an analyte at or above a stated quantity.

(77)  "Signature" means the name of a person written by that person, or a distinctive mark or characteristic indicating the identity of that person. Signatures can be provided in hard copy or electronically.

(78)  "Solid" means a certification or registration matrix designating samples such as soils, sediments, sludges, organic liquids, oils or aqueous products and by-products of industrial processes, and aqueous samples with more than 10% settleable solids.

(79)  "Subcontract" means the act of sending a sample or a portion of a sample by a certified laboratory to another certified laboratory.

(80)  "Support equipment" means devices that may not be analytical instruments, but that are necessary to support laboratory tests and operations. These devices include, but are not limited to, autoclaves, balances, ovens, refrigerators, freezers, incubators, water baths, temperature measuring devices, sample preparation devices and volumetric dispensing devices when quantitative results depend on the accuracy of the support equipment.

(81)  "Surrogate" means a substance unlikely to be found in environmental samples, with properties similar to those of analytes of interest, which is used to evaluate the bias of an analysis in the fortified sample.

(82)  "Suspension" means a temporary cancellation of a laboratory's certification which may not require an on-site evaluation for reinstatement.

(83)  "Test" means any chemical, biological, physical, radiological or microscopic assay, examination or analysis conducted by a laboratory on water, wastewater, groundwater, biosolid, waste material, hazardous substance or any other matrix analyzed to determine compliance with a covered program.

(84)  "Traceability of measurement" means the ability of relating a result or measurement to appropriate state, national or international standards through an unbroken chain of documented comparisons.

(85)  "Unfamiliar sample" means a sample for which a laboratory has either no information or questionable information from previous characterizations of samples from the same source. The term unfamiliar also describes a sample for which there is no information about the process generating it .

(86)  "Ultra-low level metals" means concentrations of metals at sub-microgram per liter or sub-microgram per kilogram concentrations and those required to be determined in clean room environments.

(87)  "Waste characteristic extractions" means extractions, such as the toxicity characteristic leaching procedure, performed on any solid or waste to establish whether it exhibits a defined regulatory characteristic.

(88)  "Waste characterization assays" means determinative tests, such as Pensky-Martens closed cup ignitability, corrosivity of liquids and polychlorinated biphenyls screening of organic liquids, performed on any solid or waste to evaluate whether it exhibits a defined regulatory characteristic.

History: CR 06-005 : cr. Register April 2008 No. 628 , eff. 9-1-08.

Note

Samples with more than 10% settleable solids may also be classified as solid. Microsoft Windows NT 6.1.7601 Service Pack 1 Consult the note in s. NR 149.02 (2) (d) for a list of department administrative rules of programs requiring certification or registration under this chapter. Microsoft Windows NT 6.1.7601 Service Pack 1 In many EPA methods, the term "lab-fortified blank" is substantially equivalent to a laboratory control sample. Microsoft Windows NT 6.1.7601 Service Pack 1 In many EPA methods, the term "lab-fortified matrix" is substantially equivalent to a matrix spike. Microsoft Windows NT 6.1.7601 Service Pack 1 Proficiency testing samples are also known as performance evaluation samples or reference samples. Microsoft Windows NT 6.1.7601 Service Pack 1 Samples containing more than 10% but less than 15% settleable solids may also be classified as aqueous. Microsoft Windows NT 6.1.7601 Service Pack 1