25 Pa. Code § 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.
Notes
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).
This section cited in 25 Pa. Code § 252.708 (relating to reporting and notification requirements).
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