Kan. Admin. Regs. § 28-15-35 - Definitions
Each of the following terms, as used in K.A.R. 28-15-35 through K.A.R. 28-15-37, shall have the meaning specified in this regulation:
(a) "Accreditation"
means the process by which the department certifies laboratories.
(b) "Accrediting body" means a territorial,
state, federal, or international governmental agency that has responsibility
and accountability for laboratory certification and that grants primary
certification equivalent to standards specified in these regulations and
K.A.R.
28-15-36.
(c) "Analyst" means an individual who
performs the analytical methods and associated techniques at a laboratory and
who is responsible for applying required laboratory practices and other
pertinent quality controls.
(d)
"Assessment" means an evaluation of a laboratory conducted by an assessor to
determine compliance with
K.A.R.
28-15-36 or
28-15-36a, as applicable. Except
as otherwise provided in these regulations, an assessor may conduct an
assessment on-site, virtually, or any combination of multiple approaches as the
department determines necessary.
(e) "Assessor" means any individual approved
by the department to conduct assessments of laboratories and to evaluate the
laboratory's ability to obtain data of known and documented quality. This term
shall include laboratory certification officers, subject matter experts, or
members of a third-party assessment team.
(f) "Certification" means the issuance of a
certificate by the secretary that a firms a laboratory meets the minimum
requirements specified in these regulations.
(1) "Primary certification" means the
certification granted by an accrediting body to a laboratory compliant with the
requirements in these regulations and
K.A.R.
28-15-36 as determined by the
secretary.
(2) "Secondary
certification" means the certification granted by the secretary through
reciprocity to a laboratory located outside the state of Kansas based on
primary certification granted by an accrediting body other than the state of
Kansas.
(3) "Field laboratory
certification" means the certification granted to a laboratory or organization
within the state of Kansas based on a review of the laboratory by the
department for compliance with the requirements of these regulations and
K.A.R.
28-15-36a.
(4) "Interim certification" means the
temporary certification granted to a laboratory by the secretary to perform
analyses for a field of accreditation for which the laboratory has not been
granted certification after submission of documents specified in
K.A.R.
28-15-36a.
(g) "Certified laboratory" and "certified
field laboratory" mean any laboratory operating pursuant to a valid, current
certificate granted by the secretary pursuant to these regulations and
K.A.R.
28-15-36 or
K.A.R.
28-15-36a, as applicable.
(h) "Clean water act" and "CWA" mean the
federal water pollution control act,
33 U.S.C.
1251 et seq., and amendments
thereto.
(i) "Department" means
Kansas department of health and environment.
(j) "Environmental laboratory improvement
program office" and "ELIPO" mean the program authorized by the secretary to
implement Kansas laboratory accreditation.
(k) "EPA" means U.S. environmental protection
agency.
(l) "Field of
accreditation" means the combination of the following:
(1) The matrix;
(2) the technology or method, or both;
and
(3) the analyte or analyte
group, or both.
(m)
"Field laboratory" means any laboratory or organization located in the state of
Kansas that performs compliance analyses limited to approved methodologies for
one or more of the fields of accreditation specified in
K.A.R.
28-15-36a.
(n) "Laboratory" means a legally identifiable
facility performing environmental analyses in a controlled and scientific
manner. This term shall include mobile laboratories and field laboratories
unless otherwise provided in these regulations.
(o) "Laboratory certification officer" means
any individual determined by the secretary to have adequate credentials to
evaluate laboratories supplemented by successful completion of the EPA drinking
water laboratory certification officers' training course, nationally approved
assessor training courses, and refresher training courses.
(p) "Laboratory management" means any person
or persons who own a laboratory or any person or persons responsible for the
operation of a laboratory. Laboratory management shall include any laboratory
technical directors.
(q)
"Laboratory technical director" means an individual whose functions are to
direct technical personnel and evaluate the quality of test procedures
performed in the laboratory.
(r)
"Matrix" means the substrate of a sample, including any of the following:
(1) Drinking water;
(2) non-potable water, including all aqueous
samples that are not drinking water;
(3) solid and chemical materials, including
soils, sediments, other solids, chemical waste, and non-aqueous
liquids;
(4) air and emissions,
including ambient air and stack emissions; and
(5) biological tissue.
(s) "Mobile laboratory" means a legally
identifiable, unique, portable enclosed structure that performs the functions
of a laboratory in conformance with these regulations.
(t) "Proficiency testing sample" and "PT
sample" mean a matrix with a composition unknown to the laboratory and used to
determine if the laboratory can produce analytical results within specific
performance limits.
(u)
"Proficiency testing study" means analysis of a PT sample or samples by a
laboratory as required to obtain or retain certification.
(v) "Reciprocity" means the recognition of
the validity of the certification granted from another accrediting body by the
secretary in order to issue secondary certification based upon the evaluation
conducted by the accrediting body.
(w) "Resource conservation and recovery act"
and "RCRA" mean 42 U.S.C.
6901 et seq., and amendments
thereto.
(x) "Safe drinking water
act" and "SDWA" mean 42
U.S.C. §
300f et seq., and amendments
thereto.
(y) "Scope of
accreditation" means all fields of accreditation applied for in an application
for certification or maintained by a laboratory's existing
certification.
(z) "Secretary"
means secretary of the Kansas department of health and environment.
(aa) "Supplemental parameters" means the
fields of accreditation that EPA has not approved under SDWA or CWA as
regulated fields of accreditation, are not contained within an approved SDWA,
CWA, or RCRA method as a measurable analyte, or are not required for testing by
the state of Kansas.
(bb)
"Technology" means a specific arrangement of analytical instruments, detection
systems, or preparation techniques, or any combination of these.
(cc) "The NELAC institute" and "TNI" mean the
standards development organization that produces consensus standards of
practice, including standards for environmental testing.
Notes
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