Administrative Rules of Montana › Department 37 - PUBLIC HEALTH AND HUMAN SERVICES › Chapter 37.12 - LABORATORIES › Subchapter 37.12.3 - Licensure of Laboratories Conducting Analyses of Public Water Supplies › Rule 37.12.301 - DEFINITIONS

Current through Register Vol. 13, July 5, 2024
For the purpose of this subchapter:
(1) "Accuracy" means the degree of agreement
				between an observed value and an accepted reference value.
(2) "Analyte" means the substance or thing
				for which a water sample is analyzed to determine its presence or quantity.
(3) "Bachelor degree or
				equivalent" means a college degree with the equivalent of 30 semester hours in
				a biological or physical science program or at least four years of experience
				in a specific related scientific discipline.
(4) "Certification officer" means a
				representative of the department who conducts assessments of laboratories to
				determine if they should be approved for licensure. The representative may be a
				third party contractor who acts under the authority of the department.
(5) "Chemical hygiene plan" means
				a document written by a laboratory that describes the procedures used to store,
				handle, and dispose of chemicals in the laboratory.
(6) "Conditional licensure" refers to a
				laboratory applying for a license for the first time that is in compliance with
				most requirements for licensure but has not yet met all of the requirements of
				this subchapter, but whose deficiencies do not affect the capability of the
				laboratory to perform valid analyses.
(7) "Contaminated" means exceeding a maximum
				contaminant level established in ARM Title 17, chapter 38, subchapter 2.
(8) "Department" means the
				Department of Public Health and Human Services.
(9) "Environmental laboratory" means the
				environmental laboratory of the Department of Public Health and Human Services
				that is responsible for the licensing of laboratories performing drinking water
				analyses in Montana.
(10)
				"Environmental Protection Agency (EPA)" means the United States Environmental
				Protection Agency.
(11) "EPA
				laboratory certification manual" means the EPA publication entitled "Manual for
				the Certification of Laboratories Analyzing Drinking Water," January 2005, 5th
				edition (EPA 815-R-05-004).
(12)
				"Holding time" means the maximum time that a sample may be held prior to
				preparation or analysis.
(13)
				"Initial demonstration of analytical capability" means the procedure described
				in the method cited in 40 CFR part 136 , appendix A, as amended August 28,
				2017, for chemistry analysis, used to determine a laboratory's accuracy and
				precision in applying an analytical method.
(14) "Interdependent analyte group" means a
				group of analytes, as determined by the department, for which the ability to
				correctly identify and quantify a single analyte in the group indicates the
				ability to correctly identify and quantify other analytes in the
				group.
(15) "Interim licensure"
				refers to a status that may be granted by the certifying agency to a fully
				licensed laboratory without an on-site inspection for a particular analyte or
				interdependent analyte group if the certifying agency determines with
				appropriate documentation that the laboratory has the appropriate
				instrumentation, is using a previously approved method, has adequately trained
				personnel to perform the analyses, and has satisfactorily analyzed PT samples,
				if available for the analytes in question.
(16) "Key personnel" means a laboratory's
				director, supervisor, and quality assurance officer, all of whom meet the
				requirements of the EPA laboratory certification manual.
(17) "Method detection limit" means the
				minimum concentration of a substance that can be measured and reported with 99%
				confidence that the analyte concentration is greater than zero as determined
				from analysis of a sample containing the analyte in a given matrix as described
				in 40 CFR part 136 , appendix B, as amended August 28, 2017.
(18) "Performance evaluation (PE) sample"
				means a sample obtained through a source approved by the environmental
				laboratory whose composition is unknown to the laboratory performing the
				analysis and which is used to evaluate the ability of the laboratory to produce
				precise and accurate results.
(19)
				"Precision" means the degree to which a set of observations or measurements of
				the same property, usually obtained under similar conditions, conform to
				themselves. Precision is usually expressed as standard deviation, variance or
				range, in either absolute or relative terms.
(20) "Proficiency testing (PT)" refers to
				testing an unknown sample to evaluate the ability of the laboratory to produce
				precise and accurate results and is used interchangeably with performance
				evaluation (PE).
(21) "Provisional
				licensure" refers to the downgraded status of a laboratory previously holding
				full certification due to noted deficiencies, but in the opinion of the
				certifying agency the laboratory can still demonstrate their ability to
				consistently produce valid data.
(22) "Quality assurance plan" means a
				document written by a laboratory that describes the procedures used to ensure
				that routinely generated analytical data are scientifically valid and that
				their precision and accuracy are within defined limits.
(23) "Safe Drinking Water Act" means the
				federal law set out in 42
				USC 300f through
				300j-11, governing drinking water
				programs.
(24) "Standard operating
				procedures (SOPs)" means a laboratory's written document which details the
				steps of an operation, analysis, or action whose techniques and procedures are
				thoroughly prescribed and is accepted by the laboratory as the procedure for
				performing certain routine or repetitive tasks.
(25) "Variance" means written approval from
				the environmental laboratory allowing a laboratory to use a method, procedure,
				or equipment other than that required by these rules that meets the purpose and
				intent of these rules and that has been shown to have no adverse material
				effects on the accuracy of analyses.
(26) "Waiver" means written approval from the
				environmental laboratory exempting a laboratory from a requirement of these
				rules if the environmental laboratory finds that the requirement is
				inapplicable to the particular practice of that laboratory.
AUTH:
					 50-1-202, MCA; IMP:
					 50-1-202,
					 75-6-106,
					 MCA