Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 263 - MAINE COMPREHENSIVE AND LIMITED ENVIRONMENTAL LABORATORY ACCREDITATION RULE › Section 144-263-2 - DEFINITIONS

Current through 2024-29, July 17, 2024
A. 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.