Pennsylvania Code › Title 25 - ENVIRONMENTAL PROTECTION › Part I - Department of Environmental Protection › Subpart D - Environmental Health and Safety › Article VI - General Health and Safety › Chapter 252 - ENVIRONMENTAL LABORATORY ACCREDITATION › Subchapter A - GENERAL PROVISIONS › Section 252.1 - Definitions

Current through Register Vol. 54, No. 28, July 13, 2024
The following words and terms, when used in this
						  chapter, have the following meanings, unless the context clearly indicates
						  otherwise:
Acceptance criteria
-Specified limits
						  placed on a measurement, quality control sample or process.
Accreditation
-A determination by the
						  Department that an environmental laboratory is capable of performing one or
						  more classes of testing or analysis of environmental samples in accordance with
						  the act and this chapter.
Accreditation body
-A territorial,
						  State or Federal agency having responsibility and accountability for
						  environmental laboratory accreditation and which grants accreditation.
Accreditation-by-rule
-Accreditation
						  which an environmental laboratory is deemed to have for the fields of
						  accreditation identified in §
												252.6 (relating to
						  accreditation-by-rule) upon compliance with that section.
Act
-27 Pa.C.S. §§ 4101-4113
						  (relating to environmental laboratory accreditation).
Action level
-The concentration of a
						  contaminant which, if exceeded, triggers a treatment or other requirement which
						  a water system must follow.
Analysis day
-A continuous 24-hour
						  period during which testing or analysis of environmental samples is performed.
Analyst
-An individual who performs the
						  analytical methods and associated techniques and who is responsible for
						  applying the required laboratory practices and quality controls to meet the
						  required level of quality.
Analyte
-The component, compound,
						  element or isotope to be identified or quantified using a test or analysis.
Batch
-Environmental samples that are
						  prepared or analyzed together using the same procedures, personnel, lots of
						  reagents and standards.
Batch, analytical
-A batch composed of
						  prepared environmental samples that are analyzed together as a group. An
						  analytical batch may contain samples originating from various environmental
						  matrices and can exceed 20 samples.
Batch, preparation
-A batch composed of
						  1 to 20 environmental samples of the same matrix with a maximum time between
						  the start of processing of the first and last sample in the batch to be 24
						  hours.
Calibration verification standard
-A
						  standard used to confirm the validity of a previously performed initial
						  calibration of a measurement process.
Certificate of accreditation
-A
						  document issued by the Department certifying that an environmental laboratory
						  has met standards for accreditation.
Commonwealth agency
-An agency that is
						  a Commonwealth agency as that term is defined under
						  62 Pa.C.S. §
													103
						  (relating to definitions.)
Deficiency
-A deviation from acceptable
						  procedures or practices.
Detection limit
-The lowest
						  concentration or amount of the target analyte that can be identified, measured
						  and reported with confidence that the analyte concentration is not zero.
Drinking water
-Any aqueous sample that
						  has been collected for the purposes of demonstrating compliance with the
						  Pennsylvania Safe Drinking Water Act (35 P. S. §§
													721.1-721.17) or is from a potable or
						  potential potable water source.
ECp-Effective concentration
						  percent
-The concentration that affects the test variable at p percent
						  from the control value.
Environmental laboratory
-A facility
						  engaged in the testing or analysis of environmental samples.
Environmental sample
-A solid, liquid,
						  gas or other specimen taken for the purpose of testing or analysis as required
						  by an environmental statute.
Environmental statute
-A statute
						  administered by the Department relating to the protection of the environment or
						  of public health, safety and welfare.
Facility
-A sole proprietor,
						  partnership, corporation, association, institution, cooperative enterprise,
						  municipal authority, political subdivision, Federal government or agency, state
						  institution or agency or other legal entity which is recognized by law as the
						  subject of rights and duties.
Field of accreditation
-A combination
						  of matrix; method or technology, or both; and analyte or analyte group for
						  which an environmental laboratory may be accredited. Examples are:
(i) Nonpotable water; GC/MS, US EPA Method
						625; benzo(a)pyrene.
(ii) Drinking
						water; ICP, US EPA Method 200.7; magnesium.
(iii) Drinking water; GC/MS, US EPA Method
						524.2; total trihalomethanes.
Holding time
-The maximum elapsed time
						  from sample collection to initiation of testing or analysis.
ICp-Inhibition concentration
						  percent
-The concentration that inhibits the test variable at p percent
						  from the control value.
Industrial wastewater treatment
						  facility
-Any facility that treats industrial waste or pollution, but
						  not sewage, as those terms are defined in The Clean Streams Law (35 P. S.
						  §§
													691.1-691.1001).
Initial calibration
-Determination by
						  measurement or comparison with a standard of known concentration the correct
						  value or response of each scale reading on a meter, instrument or other device.
						  Comparison of a measurement standard or instrument with another standard or
						  instrument to report or eliminate by adjustment any variation in the accuracy
						  of the item being compared.
Initial demonstration of capability
-A
						  procedure to establish the ability of an analyst, technical staff member or
						  work cell to generate data of acceptable accuracy and precision.
LCp-Lethal concentration percent
-The
						  concentration that is lethal to p percent of the test organisms from the
						  control organisms.
Laboratory control sample
-A sample of
						  a controlled matrix known to be free of the analyte of interest, to which a
						  known and verified concentration of analyte has been added and that is taken
						  through all preparation and analytical steps in the method.
Laboratory management
-
(i) The individuals responsible for the
						overall operation, all personnel and the physical plant of an environmental
						laboratory.
(ii) The term includes
						the laboratory supervisor.
Laboratory notebook
-A chronological
						  record of observations, results of testing or analysis, equipment maintenance
						  or calibration or other environmental laboratory data. A laboratory notebook
						  may be maintained in an electronic format.
Laboratory supervisor
-A technical
						  supervisor of an environmental laboratory who supervises laboratory procedures
						  and reporting of analytical data.
Linear range
-The range of
						  concentrations over which the instrument response is directly proportional to
						  the analyte concentration.
MCL-Maximum Contaminant Level
-The
						  maximum permissible level of a contaminant in water which is delivered to a
						  user of a public water system, and includes the primary and secondary MCLs
						  established under the Safe Drinking Water Act (42 U.S.C.A. §§
													300f-300j-10) and MCLs adopted
						  under the Pennsylvania Safe Drinking Water Act and the regulations promulgated
						  thereunder.
Matrix
or
matrices
-The media of an environmental sample that includes
						  drinking water, nonpotable water, and solid and chemical materials.
Matrix spike
-A sample prepared by
						  adding a known mass of target analyte to a specified amount of environmental
						  sample and that is taken through all preparation and analytical steps in the
						  method.
Method
-The scientific technique used
						  to perform testing or analysis on an environmental sample.
Method blank
-A sample of a known
						  matrix, similar to the associated samples, and known to be free of the analyte
						  of interest and that is taken through all preparation and analytical steps in
						  the method.
Mobile laboratory
-
(i) A portable enclosed structure within
						which testing or analysis of environmental samples occurs.
(ii) Examples include trailers, vans and skid
						mounted structures configured to house environmental testing equipment and
						personnel.
NELAC
-National Environmental
						  Laboratory Accreditation Conference.
NELAP
-National Environmental
						  Laboratory Accreditation Program.
NELAP accreditation body
-An
						  accreditation body that has been recognized as meeting the requirements of the
						  NELAC Standard or the TNI Standard and has the authority to grant NELAP
						  accreditation.
NIST
-The National Institute of
						  Standards and Technology of the United States Department of Commerce's
						  Technology Administration.
NOAEC
-No observed adverse effect
						  concentration.
NOEC
-No observed effect concentration.
Negative culture control
-An organism
						  selected to demonstrate that the medium does not support the growth of
						  nontarget organisms or does not demonstrate the typical positive reaction of
						  the target organisms.
Nonpotable water
-
(i) Any aqueous sample excluded from the
						definition of drinking water matrix.
(ii) The term includes wastewater, ambient
						water, surface water, groundwater, effluents, water treatment chemicals and
						leachates.
Positive culture control
-An organism
						  selected to demonstrate that the medium can support the growth of the target
						  organisms and that the medium produces the specified or expected reaction to
						  the target organism.
Primary accreditation
-Accreditation
						  received from the Department that is not based upon accreditation from another
						  accreditation body.
Proficiency test reporting limit
-The
						  value that corresponds to the lowest acceptable result that could be obtained
						  from the lowest spike level for each analyte in a proficiency test sample.
Proficiency test study
-A sample or
						  group of samples, the composition of which is unknown to the environmental
						  laboratory and the analyst.
Promulgated method
-A protocol for
						  testing or analysis of a specific analyte that is approved for use by a State
						  or Federal regulation.
Quality manual
-A document stating, or
						  making reference to, the policies, objectives, principles, responsibilities,
						  accountability, implementation plans, methods, operating procedures or other
						  documents of an environmental laboratory for ensuring the quality of its
						  testing and analysis.
Quantitation limit
-The minimum
						  concentration or activity of the component, compound, element or isotope that
						  can be reported with a specified degree of confidence. Typically it is the
						  concentration that produces a signal ten standard deviations above the reagent
						  water blank signal.
Range of quantitation
-The
						  concentration range between which an environmental laboratory reports results
						  quantitatively which is defined by a low concentration standard and a high
						  concentration standard.
Reagent water
-Water with no detectable
						  concentration of the component, compound, element or isotope to be analyzed and
						  that is free of substances that interfere with the method. Reagent water may be
						  prepared by distillation, ion exchange, adsorption, reverse osmosis or a
						  combination thereof.
Revocation
-Removal by the Department
						  of one or more fields of accreditation from an environmental laboratory.
Sample duplicate
-Replicate aliquots of
						  the same sample taken through the entire analytical procedure.
Secondary accreditation
-Accreditation
						  received from the Department based upon the accreditation status granted by
						  another accreditation body.
Solid and chemical materials
-Soils,
						  sediments, sludges, solid waste, drill cuttings, overburden, minerals, coal
						  ash, and products and by-products of an industrial process that result in a
						  matrix that is not otherwise defined.
Solid waste
-Any waste, including, but
						  not limited to, municipal, residual or hazardous wastes, including solid,
						  liquid, semisolid or contained gaseous materials as that term is defined in the
						  Solid Waste Management Act (35 P. S. §§
													6018.101-6018.1003).
Spike
-A known and verified mass or
						  activity of the target analyte of interest added to reagent water or
						  environmental sample to determine recovery efficiency or for other quality
						  control purposes.
Standard operating procedure
-A written
						  document that provides detailed instructions for the performance of all aspects
						  of test, analysis, operation or action.
Surrogate
-A substance with properties
						  similar to the analyte of interest. A surrogate is unlikely to be found in an
						  environmental sample. A surrogate is added to an environmental sample prior to
						  all preparation and analytical steps in the method for quality control
						  purposes.
Suspension
-The temporary removal by
						  the Department of one or more fields of accreditation from an environmental
						  laboratory for a period not to exceed 6 months.
Technical staff
-Employees of an
						  environmental laboratory that perform any portion of testing or analysis of
						  environmental samples, including the analysts of the environmental
						  laboratory.
Test
-A technical operation that
						  consists of the determination of one or more characteristics or performance of
						  a given product, material, equipment, organism, physical phenomenon, process or
						  service according to a specified procedure.
TNI
-The NELAC Institute or its
						  successor organization/Standard.
Wastewater
-A substance that contains
						  the waste products or excrement or other discharge from the bodies of human
						  beings or animals and noxious or deleterious substances being harmful or
						  inimical to the public health, or to animal or aquatic life, or to the use of
						  water for domestic water supply or for recreation, or which constitutes
						  pollution under The Clean Streams Law.
Wastewater facility
-A facility that
						  operates a system designed to collect, convey or treat wastewater and from
						  which effluent is discharged into waters of this Commonwealth.
Work area
-The areas in an
						  environmental laboratory necessary for testing and analysis and related
						  activities. These areas include sample receipt area, sample storage area,
						  chemical and waste storage area, data handling area and analytical
						  areas.
Work cell
-A defined group of analysts
						  that together perform testing or analysis of environmental samples.
The provisions of this § 252.1 amended under
							 27 Pa.C.S. §§
															4103(a),
							 4104 and
							 4105; and section 1920-A
							 of The Administrative Code of 1929 (71 P.S. §
															510-20).