Florida Administrative Code › 62 - DEPARTMENT OF ENVIRONMENTAL PROTECTION › 62 - Departmental › Chapter 62-160 - QUALITY ASSURANCE › Part I - QUALITY ASSURANCE › Section 62-160.120 - Definitions and Standards

Current through Reg. 50, No. 138; July 16, 2024
For purposes of this chapter:
(1) "Alternative method" is a field procedure
				  or analytical laboratory method that is intended to be used in place of an
				  existing Department-approved laboratory method or field procedure that is
				  specified in a Department rule, permit, order, or contract, as further
				  discussed in Rules  62-160.220 and
				   62-160.330, F.A.C.
(2) "Audit" is a systematic review of
				  laboratory and field protocols to determine if proper procedures are being used
				  and supporting documentation is present. An audit shall consist of an on-site
				  assessment of sample collection, field sampling procedures, laboratory
				  procedures and/or a review, assessment and/or validation of data associated
				  with a Department program activity. If necessary, an audit shall include the
				  submission of performance samples (for example, blind, split and/or performance
				  check samples) to an organization for subsequent use in the evaluation of that
				  organization's technical performance associated with a specific Department
				  project or program activity.
(3)
				  "Commercial Vendor" is a retail or wholesale company whose business is to sell
				  commodities to customers and who is not a part of the process that generates
				  environmental data. These businesses do not include organizations that purchase
				  commodities with the intent of providing the commodities as a service to
				  clients.
(4) "Common Carrier" is a
				  business or agency that is available to the general public for the
				  transportation of goods over a definite route and according to a regular
				  schedule.
(5) "Data quality
				  objectives" are a set of qualitative and quantitative statements derived from a
				  systematic planning process that clarify the purpose of the study, define the
				  most appropriate type of information to collect, determine the most appropriate
				  conditions from which to collect that information, and specify tolerable levels
				  of potential decision errors.
(6)
				  "Data validation" is an evaluation of the technical usability of the verified
				  data with respect to the planned objectives or intention of a
				  project.
(7) "Data verification" is
				  a consistent, systematic process that determines whether the data have been
				  collected in accordance with project specifications with respect to compliance,
				  correctness, consistency and completeness as compared to a method standard or
				  contract specification.
(8)
				  "Department" is the Florida Department of Environmental Protection.
(9) "Department-approved method" is a field
				  procedure or laboratory analytical method specified as acceptable for use in
				  this chapter and in any other Department contract, order, permit or Title 62
				  rules.
(10) "Department of Health
				  (DOH) Environmental Laboratory Certification Program (ELCP)" is the state of
				  Florida's environmental laboratory certification program, authorized by Section
				   381.00591, F.S., and recognized
				  by the National Environmental Laboratory Accreditation Program (NELAP)
				  Acceditation Council as an authority with responsibility and accountability for
				  granting accreditation for specified fields of laboratory testing through
				  Chapter 64E-1, F.A.C.
(11)
				  "Electronic signature" means an electronic sound, symbol, or process attached
				  to or logically associated with a record and executed or adopted by a person
				  with the intent to sign the record.
(12) "Holding time" is the storage time
				  allowed between sample collection and sample preparation and/or analysis as
				  specified by regulatory requirements or by the field sample collection protocol
				  or laboratory method.
(13)
				  "Limited-use method" is an alternative or modified field or laboratory
				  procedure that is approved by the Department for the collection or testing of
				  environmental samples by a single field sampling organization or analytical
				  laboratory for purposes specified in the scope of the approval (e.g., for
				  specified analytes, facility or site locations or types, or sample matrices,
				  such as effluent, groundwater, drinking water, fresh or marine surface waters,
				  soils, sediments, or chemical wastes). A limited-use method that is validated
				  and approved by the Department for a field sampling organization or analytical
				  laboratory may not be used by another field sampling organization or analytical
				  laboratory. The criteria for the validation and approval of a limited-use
				  method are further outlined in subparts FA 2100 and FA 2200 of DEP SOP FA 1000,
				  which is incorporated by reference in subparagraph
				   62-160.800(1)(a) 
				  1., F.A.C., and outlined in DEP-QA-001/01, which is incorporated by reference
				  in subsection  62-160.800(5),
				  F.A.C. Requirements for limited-use methods are further discussed in Rules
				   62-160.220 and
				   62-160.330, F.A.C., and must be
				  met for Department approval.
(14)
				  "Matrix" is the predominant material in which an analyte of interest is
				  contained. For example, soil, groundwater and drinking water are three
				  environmental matrices.
(15)
				  "Method-defined analyte" is defined by the U.S. Environmental Protection Agency
				  as an analyte whose result is totally dependent on how the measurement is made.
				  Any changes or modifications in the preparation or determinative techniques of
				  these methods have the potential of changing the result, and are not approved
				  by the Department, as indicated in paragraph
				   62-160.330(2)(a),
				  F.A.C. Examples are: Carbonaceous Biological Oxygen Demand, Oil and Grease, and
				  Toxicity Characteristic Leaching Procedure (TCLP).
(16) "Method detection limit (MDL)" is an
				  estimate of the minimum amount of a substance that an analytical process can
				  reliably detect, the minimum measured concentration of a substance that can be
				  reported with 99% confidence that the measured concentration is distinguishable
				  from method blank results, or the minimum result that can be reliably
				  discriminated from a blank with a predetermined confidence level (Limit of
				  Detection [LOD] as defined in the 2016 TNI Standards, which are incorporated by
				  reference in paragraph
				   62-160.800(3)(b),
				  F.A.C.). The Department accepts any of the preceding definitions of the MDL. An
				  MDL is analyte-specific and matrix-specific and is laboratory-dependent. The
				  MDL for an analyte is determined from the preparation and analysis of a sample
				  in a given matrix containing the analyte. MDLs shall be determined for each
				  matrix/analytical technology/analyte combination reported by the laboratory,
				  except for those tests where determination of the MDL is not appropriate for
				  the analytical technique, such as biochemical oxygen demand, chlorophyll or
				  microbiological tests. When required according to Department rules, MDLs shall
				  be calculated following the procedure specified in those rules. If not
				  specified in Department rules, MDLs may be determined and verified by any
				  technically justifiable and scientifically sound method appropriate for the
				  test. For the purposes of data usability evaluation, the DEP-defined MDL is
				  equivalent to the Limit of Detection (LOD) as defined in the 2016 TNI
				  Standards, which are incorporated by reference in paragraph
				   62-160.800(3)(b),
				  F.A.C.
(17) "Method modification"
				  is any change that alters the scope, applicability, specifications, steps,
				  performance criteria, or any other requirements described in a published field
				  procedure or laboratory analytical method, as further specified in subsections
				   62-160.220(3) 
				  and  62-160.330(3),
				  F.A.C. The resultant method is defined by the Department as a "modified
				  method."
(18) "Field of
				  Accreditation Matrix" is defined in the Glossary of the 2003 NELAC Standards,
				  which is incorporated by reference in paragraph
				   62-160.800(3)(a),
				  F.A.C., and shall be used to determine matrices under which a laboratory must
				  be certified by the DOH ELCP for reporting data to be used by the Department:
(a) Drinking Water: any aqueous sample that
				  has been collected from a water source designated by the Department as a
				  potable or potential potable water source.
(b) Non-potable Water: any aqueous sample
				  excluded from the definition of drinking water matrix including surface water,
				  groundwater, effluents, water treatment chemicals, or samples derived from
				  synthetic precipitation leaching procedures (SPLP), toxicity characteristic
				  leaching procedures (TCLP) or other extracts. To be considered as non-potable
				  water, water treatment chemicals must be in an aqueous solution. If the
				  laboratory receives the original environmental sample as a solid or chemical
				  material for SPLP or TCLP extraction, the laboratory must be certified for the
				  SPLP or TCLP extraction in the Solid and Chemical Material matrix. For the
				  analytical tests to be performed on the SPLP or TCLP extract, the laboratory
				  must be certified in the non-potable water matrix for at least one method for
				  each analytical technology/analyte combination for each reported
				  analyte.
(c) Solid and Chemical
				  Materials: includes soils, sediments, sludges, products and by-products of an
				  industrial process that results in a matrix not previously defined. For
				  purposes of accreditation, biosolids are considered a solid, unless the sample
				  matrix comprises liquid biosolids as defined in Chapter 62-640, F.A.C. All
				  other sample matrices not previously defined and comprising <= 15%
				  settleable solids are liquids, and may require laboratory certification for
				  analysis using techniques for non-potable water or liquid chemical
				  materials.
(d) Biological Tissue:
				  any sample of a biological origin, such as fish, shellfish, macroinvertebrates,
				  algae, or plant material.