Section 252.601. Onsite 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 onsite assessment report documenting any deficiencies found by the Department.

(e) An environmental laboratory shall submit a corrective action report to the Department within 60 calendar days from receipt of an onsite assessment report from the Department where the Department has found deficiencies. The corrective action report shall document the corrective action taken by the laboratory to correct each deficiency.

(f) An environmental laboratory seeking NELAP accreditation shall submit a corrective action report to the Department within 30 calendar days from receipt of the onsite assessment report from the Department where 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 shall 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 approved by the Department, deficiencies shall be corrected within 120 calendar days of receipt of the onsite 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.

The provisions of this § 252.601 amended April 9, 2010, effective April 10, 2010, 40 Pa.B. 1898. Immediately preceding text appears at serial pages (317299) to (317300).

Notation

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).

Cross References

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