New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter D - Laboratories › Part 55 - APPROVAL OF LABORATORIES › Subpart 55-2 - APPROVAL OF LABORATORIES PERFORMING ENVIRONMENTAL ANALYSIS › Section 55-2.1 - Definitions

Current through Register Vol. 46, No. 28, July 10, 2024
For purposes of this Subpart, unless the context
						indicates otherwise, the following terms shall have the following
						meanings:
(a) Environmental laboratory
					 means any facility that examines, or is available for the examination of,
					 samples or specimens including, but not limited to: air, stack emissions,
					 water, wastewater, surface water, ground water, recreational waters, swimming
					 pools, leachate, land runoff, solid waste, hazardous waste, soil, sediments and
					 vegetation, as well as any substance that could contribute to the pollution of
					 or that could be contaminated by material contained in such samples or
					 specimens. Such examinations shall be limited to qualitative or quantitative
					 determinations of the biological, chemical, radiochemical or physical
					 characteristics of such samples or specimens for the purposes of public or
					 personal health protection, or the protection of the environment or natural
					 resources. Environmental laboratories shall not include facilities or entities
					 that perform non-laboratory chemical testing associated with residential water
					 softeners and residential swimming pools. Environmental laboratories shall
					 include mobile laboratories, as defined in subdivision (c) of this
					 section.
(b) Approved laboratory
					 means an environmental laboratory that has demonstrated to the New York State
					 Commissioner of Health that it has met the on-site assessment, technical
					 direction and proficiency testing requirements of this Subpart, and therefore
					 has been issued a certificate of approval. For purposes of this Subpart,
					 accredited shall have the same meaning as approved.
(c) Mobile laboratory means a separate,
					 self-contained mobile facility for the examination of environmental samples or
					 specimens as described in subdivision (a) of this section. A mobile laboratory
					 shall have a fixed address, provided to the department with each application
					 for approval, to which proficiency test samples and other correspondence may be
					 sent, and shall be managed by a responsible person authorized to receive
					 service of process.
(d) Technical
					 director means the individual responsible for the technical and scientific
					 operation of an environmental laboratory, and who meets the minimum
					 qualifications in section
					 55-2.10 
					 of this Subpart. If an environmental laboratory employs more than one technical
					 director, the laboratory owner(s) shall designate one such individual as the
					 lead technical director.
(e)
					 Approved method means an analytical method, including sample preparation, of
					 proven reliability, which has been approved, or given similar recognition by
					 the United States Environmental Protection Agency (EPA) or a New York State
					 regulatory program in environmental or public health protection, for the
					 specific purpose for which the method is to be used. Methods approved by the
					 department pursuant to section
					 55-2.5 
					 of this Subpart shall be deemed approved methods. The department shall make
					 available a list of approved methods to approved laboratories.
(f) Quality system means a structured
					 laboratory management system that meets the standards for a quality system as
					 set forth in the department's Environmental Laboratory Approval Program Quality
					 System Standards 2002, July 1, 2002 revision, which is hereby incorporated by
					 reference, with the same force and effect as if fully set forth herein. These
					 standards are available for public inspection and copying at the New York State
					 Department of Health, Records Access Office, Corning Tower, Empire State Plaza,
					 Albany, NY 12237.
(g) Analyte means
					 a chemical and/or physical property, element, compound, group of compounds,
					 organism, or group of organisms, to be determined in samples examined. Sample
					 and specimen are synonymous terms, and are used interchangeably in this
					 Subpart.
(h) Statistical mean means
					 the arithmetic average of a data set after outlier rejection, or, if
					 transformation is used, the central point of data set distribution after
					 outlier rejection.
(i) Method
					 detection limit means the minimum concentration of an analyte that can be
					 measured and reported with 99-percent confidence that the analyte concentration
					 is greater than zero, as defined or stated in the least sensitive approved
					 method.
(j) Assigned value means
					 the nominal concentration of an analyte, based on sample preparation.
(k) Relative standard deviation means the
					 standard deviation of a data set divided by the statistical mean, expressed as
					 a percentage. Predictive standard deviation means the standard deviation
					 derived from a linear regression equation based on historical data.
(l) Synthetic blank means an artificial
					 sample with contents of known purity and without added analytes.
(m) Natural blank means a sample derived from
					 the environment, for which the concentration of a given analyte or analytes,
					 after repeated analyses, has been determined to be below the method detection
					 limit.
(n) Spiked sample means a
					 sample to which a known amount of an analyte has been added.
(o) Natural sample means a sample collected
					 from the environment, to which no analytes have been added.
(p) Contract laboratory protocol (CLP) means
					 a protocol, issued by the New York State Department of Environmental
					 Conservation, for performance of environmental analyses in accordance with
					 specifications describing: the types of samples to be analyzed (such as soil or
					 water); internal sample-handling procedures (such as chain-of-custody or
					 holding times); instrumentation and method of analysis to be used for each
					 analyte; calibration procedures to be implemented (such as numbers of
					 standards, their concentrations and acceptance criteria); quality control
					 samples to be analyzed and the frequency of such analysis; the organization and
					 content of reports to be issued on analytical results obtained.
(q) CLP data package means a collection of
					 documentation whose organization and content are specified by CLPs. A CLP data
					 package shall consist of analytical reports, including, but not limited to, a
					 narrative description of how the analysis was performed, any problems
					 encountered, analytical results for all samples, results for all quality
					 control samples analyzed, copies of instrument printouts, and all logbook pages
					 and laboratory bench sheets.
(r)
					 Department means the New York State Department of Health.
(s) Denial means the department's refusal to
					 approve, in total or in part, an environmental laboratory's application for
					 approval, including resubmission of an initial or renewal
					 application.
(t) Suspension means
					 the department's temporary removal, in total or in part, of an environmental
					 laboratory's approval for a defined period of time not exceeding six months, to
					 allow such laboratory time to correct deficiencies or areas of
					 noncompliance.
(u) Revocation means
					 the department's withdrawal, in total or in part, of an environmental
					 laboratory's approval.