Kan. Admin. Regs. § 28-15-35

Current through Register Vol. 43, No. 49, December 5, 2024

Section 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.

(dd) "These regulations" means K.A.R. 28-15-35 through 28-15-35j and K.A.R. 28-15-37.

Kan. Admin. Regs. § 28-15-35

Authorized by K.S.A. 65-1,109a; implementing K.S.A. 65-171l and 65-1,109a; effective, E-79-14, June 23, 1978; effective May 1, 1979; amended May 1, 1983; amended May 1, 1986; amended May 1, 1988; amended Jan. 24, 1994; amended May 25, 2001; amended March 26, 2004; amended June 1, 2007; amended by Kansas Register Volume 43, No. 41; effective 10/25/2024.