Subchapter E. PROFICIENCY TEST STUDY REQUIREMENTS
Sec.
252.501. Proficiency test study requirements.
Cross References This subchapter cited in 25 Pa. Code § 252.5 (relating to NELAP equivalency).
§ 252.501. Proficiency test study requirements.
(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.
Authority 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).
Source The provisions of this § 252.501 amended April 9, 2010, effective April 10, 2010, 40 Pa.B. 1898; amended July 28, 2017, effective July 29, 2017, 47 Pa.B. 4085. Immediately preceding text appears at serial pages (348839) to (348841).
Cross References This section cited in 25 Pa. Code § 252.703 (relating to suspension).
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