Subchapter F. ASSESSMENT REQUIREMENTS
Sec.
252.601. Assessment requirements.
Cross References This subchapter cited in 25 Pa. Code § 252.5 (relating to NELAP equivalency).
§ 252.601. Assessment requirements.
(a) Prior to granting primary accreditation to an environmental laboratory, the Department will perform an onsite assessment of the laboratory.
(b) Prior to granting accreditation for an additional field of accreditation to an environmental laboratory, the Department may perform an onsite assessment of the laboratory.
(c) The Department may conduct announced or unannounced onsite assessments of an environmental laboratory to ensure compliance with the conditions of accreditation, this chapter or orders issued by the Department.
(d) The Department will provide the environmental laboratory with an assessment report documenting any deficiencies found by the Department. The Department may deny, suspend or revoke an environmental laboratory’s accreditation in accordance with Subchapter G (relating to miscellaneous provisions) before issuing the assessment report or during the corrective action process.
(e) An environmental laboratory shall submit a corrective action report to the Department within 60 calendar days from receipt of an assessment report from the Department when the Department has found deficiencies. The corrective action report must:
(1) Document the corrective action taken by the laboratory to correct each deficiency and the time frame for completion.
(2) Include documentation demonstrating correction of the deficiencies as requested by the Department.
(f) An environmental laboratory seeking NELAP accreditation shall submit a corrective action report to the Department within 30 calendar days from receipt of the assessment report from the Department when the Department has found deficiencies. If TNI establishes a different time for submitting corrective action reports, the laboratory shall follow the time established by TNI. The corrective action report must document the corrective action taken by the laboratory to correct each deficiency.
(g) If any portion of the corrective action report is not acceptable, an environmental laboratory shall submit a revised written corrective action report within 30 calendar days from receipt of the Department’s response. If the second corrective action report is not acceptable, the Department may revoke accreditation.
(h) Unless otherwise required or approved by the Department, deficiencies shall be corrected within 120 calendar days of receipt of the assessment report.
(i) The Department may extend the period of implementing corrective actions, for specific deficiencies, for a maximum of 30 calendar days upon receipt of the laboratory’s written petition and corrective action report, when the laboratory must take one or more of the following actions:
(1) Purchase new equipment.
(2) Revise the quality manual.
(3) Replace significant laboratory personnel.
Authority The provisions of this § 252.601 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 § 252.601 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 (348841) to (348842).
Cross References This section cited in 25 Pa. Code § 252.708 (relating to reporting and notification requirements).
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