Arizona Administrative Code (Last Updated: November 17, 2016) |
Title 9. HEALTH SERVICES |
Chapter 6. LICENSING OF ENVIRONMENTAL LABORATORIES |
Section R9-14-601. Definitions
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In addition to the definitions in A.R.S. § 36-495, the following defi- nitions apply in this Article, unless otherwise specified:
1. “Acceptance criteria” means the range of satisfactory test results for a parameter.
2. “ADEQ” means the Arizona Department of Environmen- tal Quality.
3. “Affiliate” means a business organization that:
a. Controls or has the power to control the business organization that owns the laboratory,
b. Is controlled by or could be controlled by the busi- ness organization that owns the laboratory, or
c. Could be controlled by a third business organization that could also control the business organization that owns the laboratory.
4. “Alternate method” means an analytical test procedure or technique that is not an approved method and for which approval is requested under R9-14-610(C).
5. “Analyst” means an individual who performs compliance testing at a laboratory.
6. “Analyte” means the substance or chemical constituent being sought or measured in an analytical procedure.
7. “Applicant” means a person or persons requesting an ini- tial or renewal license under R9-14-603, approval of an alternate method or method alteration under R9-14- 610(C), or approval of an exemption under R9-14- 615(D), and includes, as required under A.R.S. § 36- 495.03(D), the owner and, if the owner is not the labora- tory director, the laboratory director.
8. “Approved method” means an analytical test procedure or technique authorized by the Department to test for the presence of a particular contaminant or characteristic and includes an alternate method approved by the Department under R9-14-610(C) and an approved method used with a method alteration approved by the Department under R9- 14-610(C).
9. “ASTM” means American Society for Testing and Mate- rials.
10. “Blind proficiency testing” means the Department’s determination of a laboratory analyst’s ability to analyze samples correctly, accomplished by submitting samples for testing in such a manner that the laboratory analyst is not aware that the proficiency testing is occurring.
11. “Business organization” means an entity such as a sole proprietorship, an unincorporated association, a corpora- tion, a limited liability company, a partnership, or a gov- ernmental entity.
12. “Calibration curve” means a graphical display of the functional relationship between the instrument or analyti- cal device response and the analyte amount.
13. “Calibration model” means a mathematical form for a calibration curve.
14. “CCC” means calibration check compounds.
15. “CCV” means continuing calibration verification stan- dard.
16. “Client” means a person that submits a sample to a labo- ratory for compliance testing.
17. “Contaminant” means a matter, pollutant, hazardous sub- stance, or other substance for which a sample is being tested.
18. “Contiguous grounds” means real property that can be enclosed by a single unbroken boundary line that does not enclose property owned or leased by another.
19. “Critical step” means a task in the testing procedure that is required to be performed within a specified time period by regulation, method, standard operating procedure, or quality assurance plan.
20. “Current” means up-to-date and extending to the present time.
21. “Data outlier” means a test result that falls outside of acceptance criteria.
22. “Days” means calendar days, excluding the day of the act, event, or default from which a designated period of time begins to run and excluding the last day of the period if it is a Saturday, a Sunday, or a legal holiday, in which event the period runs until the end of the next day that is not a Saturday, a Sunday, or a legal holiday.
23. “DBCP” means 1,2-Dibromo-3-chloropropane.
24. “DDT” means dichloro-diphenyl-trichloroethane.
25. “DOC” means dissolved organic carbon.
26. “ECD” means electron capture detector.
27. “EDB” means 1,2-Dibromoethane.
28. “Effluent” means an outflow, as of a stream that flows out of a facility.
29. “EOX” means extractable organic halides.
30. “EP” means extraction procedure.
31. “EPA” means the United States Environmental Protection Agency.
32. “FID” means flame ionization detector.
33. “FL” means fluorescence.
34. “FT-IR” means Fourier transform infrared.
35. “GC” means gas chromatography.
36. “HEM” means n-Hexane extractable material.
37. “HPLC” means high performance liquid chromatography.
38. “HRGC” means high resolution gas chromatography.
39. “HRMS” means high resolution mass spectrometry.
40. “ICV” means initial calibration verification.
41. “IDOC” means initial demonstration of capability.
42. “Initial Demonstration of Capability” means a test per- formed by an analyst, as prescribed by a method, to docu- ment the analyst’s ability to perform the method.
43. “Investigation” means an evaluation of a licensee’s or applicant’s compliance with A.R.S. Title 36, Chapter 4.3 and this Article conducted by the Department upon its own initiative or upon receipt of a written complaint and may include a laboratory inspection.
44. “IPC” means instrument performance check.
45. “Key reference” means a document incorporated by ref- erence in R9-14-610(B).
46. “Laboratory inspection” means the Department’s assess- ment of operations at a laboratory to determine a licensee’s compliance with A.R.S. Title 36, Chapter 4.3 and this Article.
47. “LCS” means laboratory control sample.
48. “Level I license” means an approval issued by the Department authorizing compliance testing of one to nine total parameters at a laboratory.
49. “Level II license” means an approval issued by the Department authorizing compliance testing of 10 to 17 total parameters at a laboratory.
50. “Level III license” means an approval issued by the Department authorizing compliance testing of more than 17 total parameters at a laboratory.
51. “LFB” means laboratory fortified blank.
52. “LFM” means laboratory fortified sample matrix.
53. “Licensee” means a person or persons to whom the Department issues a license to operate a laboratory and includes, as required under A.R.S. § 36-495.03(D), the owner and, if the owner is not the laboratory director, the laboratory director.
54. “Limit of detection” means an analyte- and matrix-spe- cific estimate of the minimum amount of a substance that an analytical process can reliably detect, which may be laboratory dependent and is developed according to R9- 14-615(C)(7).
55. “Limit of quantitation” means the minimum levels, con- centrations, or quantities of a target variable such as an analyte that can be reported with a specific degree of con- fidence.
56. “LOQ” means limit of quantitation.
57. “LRMS” means low resolution mass spectrometry.
58. “Method” means an analytical test procedure or tech- nique.
59. “Method alteration” means a change to an established method.
60. “Method reporting limit” means the minimum concentra- tion of a contaminant reported after analyzing a sample in
a given parameter, determined after corrections have been made for sample dilution and sample weight.
61. “Mobile laboratory” means a non-stationary facility where compliance testing is performed.
62. “MPN” means most probable number.
63. “MRL” means minimum reporting level.
64. “MS” means mass spectrometry.
65. “MSE” means microscale solvent extraction.
66. “NPD” means nitrogen phosphorous detector.
67. “NPDES” means national pollutant discharge elimination system.
68. “NTU” means nephelometric turbidity units.
69. “ONPG-MUG” means ortho-nitrophenyl-ß-D-galactopy- ranoside-4-methylumbelliferyl-ß-D-glucuronide.
70. “Owner” means a person that has controlling legal or equitable interest in and authority over a laboratory’s operations.
71. “PAH” means polynuclear aromatic hydrocarbon.
72. “Parameter” means the combination of a particular type of sample with a particular approved method by which the sample will be analyzed for a particular analyte or characteristic.
73. “PB” means particle beam.
74. “PCB” means polychlorinated biphenyls.
75. “PCDD” means polychlorinated dibenzodioxins.
76. “PCDF” means polychlorinated dibenzofurans.
77. “PDA” means photodiode array.
78. “PID” means photoionization detection.
79. “POX” means purgeable organic halides.
80. “Precision” means repeatability of measurement data, specifically the similarity of successive independent mea- surements of a single magnitude generated by repeated applications of a process under specified conditions.
81. “Proficiency testing” means a proficiency testing ser- vice’s determination of a laboratory analyst’s ability to analyze samples correctly, accomplished by submitting samples to the laboratory for testing and then analyzing the acceptability of the results.
82. “Proficiency testing service” means an independent ser- vice acceptable to the EPA or, if the EPA has not indi- cated acceptance of a proficiency testing service for a parameter, acceptable to the Department based on recog- nition from a national organization such as the National Environmental Laboratory Accreditation Program.
83. “Qualified” means explained in documentation.
84. “Quality assurance plan” means documentation that meets the requirements of R9-14-615(B).
85. “Quality control checks” means the steps taken by labora- tory analysts to monitor the accuracy and precision of sample analysis.
86. “QCS” means quality control sample.
87. “RDX” means Hexahydro-1,3,5-trinitro-1,3,5-triazine.
88. “Records” means all written, recorded, and electronic documentation necessary to reconstruct all laboratory activities that produce data and includes all information relating to the laboratory’s equipment, analytical test methods, and related activities.
89. “RPD” means relative percent difference.
90. “Ruggedness” means the ability of a method to withstand changes in environmental factors and produce repeatable results.
91. “Sample” means a specimen that is a representative part of a whole or a single item from a group.
92. “Single laboratory” means an individual laboratory facil- ity or multiple laboratory facilities located on contiguous grounds and having the same owner.
93. “Small business” means a business organization, includ- ing its affiliates, that is independently owned and oper- ated, that is not dominant in its field, and that employs fewer than 100 full-time employees or had gross annual receipts of less than $4 million in its last fiscal year.
94. “SOUR” means specific oxygen uptake rate.
95. “SPE” means solid-phase extraction.
96. “SPLP” means synthetic precipitation leaching proce- dure.
97. “Standard operating procedure” means a documented process for carrying on business, analysis, or action, with instructions for performing routine or repetitive tasks.
98. “Statistical outlier” means an individual data point that has a value far from those of the other data points in a set and that has been determined through statistical analysis to have derived from a different population than the other data points.
99. “TCLP” means toxicity characteristics leaching proce- dure.
100. “TDS” means total dissolved solids.
101. “TE” means thermal extraction.
102. “TNT” means trinitrotoluene.
103. “TOC” means total organic carbon.
104. “TOX” means total organic halides.
105. “Traceability” means the establishment of an unbroken chain of comparisons to the reference of origin.
106. “TS” means thermospray.
107. “TSS” means total suspended solids.
108. “UV” means ultraviolet.
109. “Valid” means that a license, certificate, or other form of authorization is in full force and effect and not suspended.
110. “VOC” means volatile organic compound.
111. “VOST” means volatile organic sampling train.
Historical Note
Adopted effective August 16, 1985 (Supp. 85-4). Former Section R9-14-601 repealed, new Section R9-14-601 adopted effective December 20, 1991 (Supp. 91-4).
Amended effective June 20, 1997 (Supp. 97-2). Amended by final rulemaking at 7 A.A.R. 184, effective December 15, 2000 (Supp. 00-4). Amended by final rulemaking at
12 A.A.R. 4798, effective December 5, 2006
(Supp. 06-4).