Section 096-263-2 - DEFINITIONSA. Definitions in this rule are in addition to definitions in the statute. As used in this rule, unless the context otherwise indicates, the following terms have the following meanings. 1.Acceptance criteria means the specified limits placed on characteristics of an item, process, or service defined in requirement documents.2.Accreditation means the process by which an agency or organization evaluates and recognizes a laboratory as meeting certain predetermined qualifications or standards, thereby accrediting the laboratory.a.Primary Accreditation means the accreditation awarded by an approved accrediting body having the responsibility of assessing a laboratory's total quality system, providing on-site assessments and tracking proficiency testing (PT) performance for fields of accreditation. Under this rule, an approved accrediting body is either the Maine Laboratory Accreditation Program (MLAP) or an accrediting body deemed equivalent by MLAP.b.Secondary Accreditation means the accreditation granted to a laboratory for a field of testing based on recognition of accreditation from a primary accreditation body for the same field of accreditation.3.Accreditation officer means the person designated by the director of the Maine CDC to manage the MLAP.4.Accuracy means the degree of agreement between an observed value and an accepted reference value. Accuracy includes a combination of random error (precision) and systematic error (bias) components that are due to sampling and analytical operations; a data quality indicator.5.Analyst means the designated individual who performs the "hands-on" analytical methods and associated techniques and who is the one responsible for applying required laboratory practices and other pertinent quality controls to meet the required level of quality.6.Analytical uncertainty means a subset of measurement uncertainty that includes all laboratory activities performed as part of the analysis.7.Approved provider or approved proficiency testing provider means a provider of proficiency testing samples that the accreditation officer has determined meet the requirements of Section 10 of this rule.8.Assessment means the evaluation process used to measure or establish the performance effectiveness and conformance of an organization and/or its systems to defined criteria and standards and requirements of laboratory accreditation.9.Audit means a systematic and independent examination of facilities, equipment, personnel, training, procedures, record-keeping, data validation, data management and reporting aspects of a system to determine whether quality assurance, quality control and technical activities are being conducted as planned and whether these activities will effectively achieve quality objectives.10.Batch means the environmental samples that are prepared and/or analyzed together with the same process and personnel, using the same lot(s) of reagents. A preparation batch is composed of at least one and no more than 20 environmental sample(s) of the same quality systems matrix, meeting the above-mentioned criteria and with a maximum time between the start of processing of the first and last sample in the batch to be 24 hours. An analytical batch is composed of prepared environmental samples (extracts, digestates or concentrates) which are analyzed together as a group. An analytical batch can include prepared samples originating from various quality system matrices and can exceed 20 samples, unless the method requirements are more stringent.11.Bias means the systematic or persistent distortion of a measurement process, which causes errors in one direction (e.g., the expected sample measurement is different from the sample's true value).12.Blank means a sample that has not been exposed to the analyzed sample stream in order to monitor contamination during sampling, transport, storage or analysis. The blank is subjected to the usual analytical and measurement process to establish a zero baseline or background value and may be used to adjust or correct routine analytical results. Blanks include field blanks, instrument blanks, method blanks, and trip blanks. a.Field blank means a clean sample (e.g., distilled water) carried to the sampling site, exposed to sampling conditions, returned to the laboratory and treated as an environmental sample.b.Instrument blank means a clean sample processed through the instrumental steps of the measurement process and used to determine instrument contamination.c.Method blank means a sample of a matrix similar to the batch of associated samples when available that is free from the analytes of interest and is processed simultaneously with and under the same conditions as samples through all steps of the analytical procedures and in which no target analytes or interferences are present at concentrations that impact the analytical results for sample analyses.d.Trip blank means a clean sample of a matrix that is carried to the sampling site and transported to the laboratory for analysis without having been exposed to sampling procedures.13.Calibration means a set of operations that establish, under specified conditions, the relationship between values of quantities indicated by a measuring instrument or measuring system, or values represented by a material measure or a reference material, and the corresponding values realized by standards. In calibration of support equipment, the values realized by standards are established through the use of reference standards that are traceable to the International System of Units (SI).
In calibration according to methods, the values realized by standards are typically established through the use of reference materials that are either purchased by the laboratory with a certificate of analysis or purity, or prepared by the laboratory using support equipment that has been calibrated or verified to meet specifications.
14.Calibration curve means the mathematical relationship between the known values, such as concentrations, of a series of calibration standards and their instrument response.15.Calibration standard means a substance or reference material used for calibration.16.Certified reference material (CRM) means reference material, accompanied by a certificate, having a value, measurement of uncertainty and stated metrological traceability chain to a national metrology institute.17.Chain-of-custody form means a record, either paper-based or electronic, that documents the possession of the samples from the time of collection to receipt in the laboratory in accordance with chain-of-custody protocol. This record, at a minimum, must include the sample location, the number and types of containers, the mode of collection, the collector, the date and time of collection, preservation, and requested analyses. See also Legal chain-of-custody protocols.18.Corrective action means an action taken by the laboratory to eliminate or correct the causes of an existing nonconformance to prevent the recurrence of the nonconformance.19.Corrective action plan means a report, including specific corrective actions and a specific date of completion, generated by a laboratory in response to deficiencies.20.Data reduction means the process of transforming the number of data items by arithmetic or statistical calculation, standard curves and concentration factors, and collating them into a more useful form.21.Deficiency or deviation means the finding of noncompliance that is a failure of the laboratory to meet any of the requirements in this rule.22.Demonstration of capability means a procedure to establish the ability of the analyst to generate analytical results of acceptable accuracy and precision.23.Director means the director of Maine CDC or the director's designee.24.Duplicate means aliquots of a sample taken from the same container under laboratory conditions and processed and analyzed independently.25.Field of testing (FOT) means those programs, matrices, methods or analyte combinations for which accreditation is offered.26.Field duplicate means an additional sample taken in the field from the same location as the initial sample to ascertain sampling precision.27.Internal standard means a known amount of standard added to a test portion of a sample as a reference for evaluating and controlling the precision and bias of the applied analytical method.28.Laboratory control sample (LCS) means a sample matrix, free from the analytes of interest, spiked with verified known amounts of analytes or a material containing known and verified amounts of analytes and taken through all sample preparation and analytical steps of the procedure unless otherwise noted in a reference method. It may be used to establish intra-laboratory or analyst-specific precision and bias or to assess the performance of all or a portion of the measurement system, however named, such as laboratory fortified blank, spiked blank or quality control (QC) check sample.29.Legal chain-of-custody protocols means the procedures developed and employed by the laboratory to record the possession of samples from the time of sampling through the retention time specified by the client or program. These procedures are performed at the special request of the client and include the use of a chain of custody form that documents the collection, transport and receipt of compliance samples by the laboratory. In addition, these protocols document all handling of the samples within the laboratory.30.Limit(s) of detection (LOD) means an estimate of the minimum amount of an analyte in a given matrix that an analytical process can reliably detect in the laboratory.31.Limit(s) of quantitation (LOQ) means the minimum levels, concentrations or quantities of a target variable (e.g., target analyte) that can be reported with a specified degree of confidence.32.Limited laboratory accreditation means a laboratory with limited accreditation that reports no more than a total of five analytes for no more than two methods.33.Managing agent means the person legally authorized to direct the activities of a laboratory and commit the appropriate resources to comply with this rule.34.Matrix or matrices means the substrate of a test sample.35.Matrix duplicate means a replicate matrix prepared in the laboratory and analyzed to obtain a measure of precision.36.Matrix spike means a sample prepared by adding a known quantity of analyte and subjecting the sample to the entire analytical procedure to determine the ability to recover the known analyte or compound.37.Measurement system means a method, as implemented at a particular laboratory, which includes the equipment used to perform the test and the name(s) of the analyst(s).38.Method means a body of procedures and techniques for performing an activity (e.g., sampling, chemical analysis or quantification), systematically presented in the order in which they are to be executed.39.Method analyte table (MAT) means the table used to identify methods, analytes, programs and matrices available for accreditation.40.Method detection limit (MDL) means the minimum measured concentration of a substance that can be reported with 99 percent confidence that the measured analyte is distinguishable from method blank results.41.Mobile laboratory means a portable, enclosed structure with necessary and appropriate accommodations and environmental conditions for a laboratory, within which testing is performed. Examples include, but are not limited to the following: trailers, vans and skidmounted structures configured to house testing equipment and personnel.42.National Institute of Standards and Technology (NIST) means a federal agency of the United States Department of Commerce's Technology Administration that is designated as the National Metrology Institute (NMI).43.Nonconformance or noncompliance means a failure of a laboratory to meet any requirement in this rule.44.Owner means a person who is a sole proprietor of a laboratory; holds a partnership interest in a laboratory; or owns five percent or more of the shares in a corporation that owns a laboratory.45.Precision means the degree to which a set of observations or measurements of the same property, obtained under similar conditions, conform to themselves. Precision serves as a data quality indicator. Precision is usually expressed as standard deviation, variance or range, in either absolute or relative terms.46.Preservation means any conditions under which a sample must be kept in order to maintain chemical and/or biological integrity prior to analysis.47.Proficiency testing (PT) means a means of evaluating a laboratory's performance under controlled conditions relative to a given set of criteria through analysis of unknown samples provided by an external source.48.Proficiency test sample or PT sample means a sample, the composition of which is unknown to the laboratory, provided to test whether the laboratory can produce analytical results within the specified acceptance criteria.49.Protocol means the detailed written procedure for field and/or laboratory operation (e.g., sampling, analysis) which must be strictly followed.50.Quality assurance (QA) means an integrated system of management activities involving planning, implementation, assessment, reporting and quality improvement to ensure that a process, item or service is of the type and quality needed and expected by the client.51.Quality control (QC) means the overall system of technical activities that measures the attributes and performance of a process, item or service against defined standards to verify that they meet the stated requirements established by the client; operational techniques and activities that are used to fulfill requirements for quality; also the system of activities and checks used to ensure that measurement systems are maintained within prescribed limits, providing protection against "out of control" conditions and ensuring that the results are of acceptable quality.52.Quality control sample means a sample used to assess the performance of all or a portion of the measurement system. One of any number of samples, such as certified reference materials, a quality system matrix fortified by spiking, or actual samples fortified by spiking, intended to demonstrate that a measurement system or activity is in control.53.Quality manual means a document stating the management policies, objectives, principles, organizational structure and authority, responsibilities, accountability and implementation of an agency, organization or laboratory, to ensure the quality of its product and the utility of its product to its users.54.Quality system means a structured and documented management system describing the policies, objectives, principles, organizational authority, responsibilities, accountability and implementation plan of an organization for ensuring quality in its work processes, products (items) and services. The quality system provides the framework for planning, implementing and assessing work performed by the organization and for carrying out required QA and QC activities.55.Quantitate means to undertake the arithmetic process of determining the amount of analyte in a sample.56.Raw data means the documentation generated during sampling and analysis. This documentation includes, but is not limited to, field notes, electronic data, magnetic tapes, untabulated sample results, QC sample results, chromatograms, instrument outputs and handwritten records.57.Reagent water for chemical analysis means water with no detectable concentration of the analyte to be analyzed at the detection limit of the analysis.58.Reference material means a material or substance, one or more of which the property values are sufficiently homogeneous and well established to be used for the calibration of an apparatus, the assessment of a measurement method, or for assigning values to materials.59.Replicate means two or more substantially equal aliquots analyzed independently for the same parameter.60.Reporting limit (RL) means the lowest level of an analyte that can be accurately recovered from the matrix of interest (e.g., the level of quantitation).61.Revocation means a determination by the accreditation officer to invalidate in part, or in total, a laboratory's accreditation.62.Sampling date means the date that a sample was taken in the field, which will be reported as such when reporting the sample results to laboratory clients or regulatory programs.63.Scope of accreditation means the sum of all fields of testing for which a laboratory has been granted accreditation by the accreditation officer.64.Second source means a different vendor or manufacturer, or different lots from the same vendor or manufacturer, usually in reference to standards.65.Selectivity means the ability to analyze, distinguish and determine a specific analyte or parameter from another component that may be a potential interferent or that may behave similarly to the target analyte or parameter within the measurement system.66.Sensitivity means the capability of a method or instrument to discriminate between measurement responses representing different levels (e.g., concentrations) of a variable of interest.67.Solid means a matrix that includes: soils, sediments, solid waste and sludges.68.Standard means the certified reference materials produced by NIST or other equivalent organization and characterized for absolute content, independent of analytical method or the dilutions made from these certified reference materials for the purposes of calibration or determining accuracy of a test method.69.Standard operating procedure (SOP) means a written document that details the method for an operation, analysis or action, with thoroughly prescribed techniques and steps. SOPs are officially approved by the laboratory's senior management as the methods for performing certain routine or repetitive tasks.70.Surrogate standard means a non-target analyte that has similar chemical properties to the analyte of interest. The surrogate standard is added to the sample in a known amount and used to evaluate the response of the analyte to preparation and analysis procedures.71.Suspension means the temporary invalidation, in part or in total, of a laboratory's accreditation for a defined period of time according to Section 7(E), to allow a laboratory time to correct deficiencies or areas of noncompliance to comply with this rule.72.Target or target analyte means an analyte or list of analytes within a test method that may be analyzed and for which the laboratory has obtained accreditation from the accreditation officer to test as part of a field of testing.73.Technology means a specific arrangement of analytical instruments, detection systems and/or preparation techniques.74.Traceability means the ability to trace the history, application or location of an entity by means of recorded identifications. In a calibration sense, traceability relates measuring equipment to national or international standards, primary standards, basic physical constants or properties or reference materials. In a data collection sense, it relates calculations and data generated throughout the project back to the requirements for the quality of the project.75.Verification means the confirmation by examination of and provision of objective evidence that specified requirements have been fulfilled. Verification is the process of examining a result of a given activity to determine conformance with this rule.06-096 C.M.R. ch. 263, § 2