Pennsylvania Code › Title 25 - ENVIRONMENTAL PROTECTION › Part I - Department of Environmental Protection › Subpart D - Environmental Health and Safety › Article VI - General Health and Safety › Chapter 252 - ENVIRONMENTAL LABORATORY ACCREDITATION › Subchapter E - PROFICIENCY TEST STUDY REQUIREMENTS › Section 252.501 - Proficiency test study requirements

Current through Register Vol. 54, No. 28, July 13, 2024
(a) By February 27, 2006, the Department will
						publish a list in the
Pennsylvania Bulletin
of fields of
						accreditation for which proficiency test studies are available. The Department
						may update the list of available fields of accreditation by publishing a
						revised list of available proficiency test studies.
(b) An environmental laboratory shall
						participate in proficiency test studies, when available, as specified in
						subsection (a), for each field of accreditation for which the laboratory seeks
						to obtain or maintain accreditation.
(c) Within the 12 months prior to applying
						for initial accreditation under this chapter or during the approval process, an
						environmental laboratory shall successfully analyze at least one single blind,
						single concentration proficiency test study, when available, as specified in
						subsection (a), for each field of accreditation for which it seeks
						accreditation.
(d) An environmental
						laboratory accredited under this chapter shall successfully analyze at least
						one single blind, single concentration proficiency test study for each field of
						accreditation, when available, as specified in subsection (a), for which the
						laboratory is accredited at least once every 12 months.
(e) Proficiency test studies shall be
						purchased at the environmental laboratory's expense directly from suppliers
						approved by the Department as a proficiency test provider.
(f) An environmental laboratory shall ensure
						that all proficiency test study samples are managed, analyzed and reported in
						the same manner as real environmental samples and utilize the same staff,
						procedures, equipment, facilities, number of replicates and methods for the
						routine analysis of the analyte.
(g) An environmental laboratory may not send
						a proficiency test study, or a portion of a proficiency test study, to another
						laboratory for analysis for a field of accreditation for which it seeks
						accreditation or is accredited prior to the time the results of the study are
						released by the proficiency test study provider.
(h) An environmental laboratory may not
						knowingly analyze a proficiency test study, or a portion of a proficiency test
						study, for another environmental laboratory for which the sending environmental
						laboratory seeks accreditation or is accredited prior to the time the results
						of the study are released by the proficiency test study provider.
(i) An environmental laboratory may not
						communicate with another environmental laboratory, including other laboratories
						under common ownership, concerning the proficiency test study prior to the time
						the results of the study are released by the proficiency test study
						provider.
(j) An environmental
						laboratory may not attempt to obtain the prepared value of a proficiency test
						study from the proficiency test study provider prior to the time the results of
						the study are released by the proficiency test study provider.
(k) If an environmental laboratory fails to
						successfully analyze a proficiency test study for an individual field of
						accreditation, it shall determine the cause for the failure and take any
						necessary corrective action. The laboratory shall document the investigation
						and corrective action.
(l) An
						environmental laboratory shall direct the proficiency test study provider to
						report the proficiency test study performance results directly to the
						Department's Laboratory Accreditation Program at the same time that the
						provider reports the results to the environmental laboratory.
(m) An environmental laboratory shall
						maintain copies of all raw data associated with proficiency test studies for at
						least 5 years.
(n) An environmental
						laboratory seeking to obtain or maintain accreditation in the drinking water
						matrix shall participate in proficiency test studies that meet the requirements
						of 40 CFR Part 141 (relating to national primary drinking water
						regulations).
(o) An environmental
						laboratory shall evaluate and report the analytical result of each proficiency
						test study sample to the proficiency test reporting limit for each field of
						accreditation, when available, as outlined in subsection (a).
(p) The Department will invalidate a
						proficiency test study result that is not handled, managed, analyzed or
						reported in accordance with this section.
The provisions of this §
														252.501 amended under
							 27 Pa.C.S. §§
															4103(a),
							 4104 and
							 4105; and section 1920-A
							 of The Administrative Code of 1929 (71 P.S. §
															510-20).
This section cited in 25 Pa. Code §
														252.703 (relating to
							 suspension).