§ 252.307. Methodology.
(a) An environmental laboratory shall follow the requirements for testing or analysis, sample collection, sample preservation and holding times specified in this section.
(b) An environmental laboratory shall select an analytical method for a specific test or analysis that meets the following criteria:
(1) The method is appropriate for the analyte and sample matrix.
(2) The method is required by, or considered appropriate for use under, applicable State or Federal regulations, a permit, an order, or is an approved alternate method under subsection (c).
(3) The method enables the laboratory to quantitate at required levels.
(c) When a method meeting the requirements of subsection (b) is not available, an environmental laboratory may apply to the Department to use alternate or experimental procedures.
(1) The Department will approve the use of alternate methodologies if the EPA has approved their use. An environmental laboratory shall submit a copy of the EPA’s written approval for the use of the alternate method to the Department.
(2) The Department may allow alternate methods that use new or innovative technologies on a case-by-case basis.
(3) An environmental laboratory shall submit a request for use of new or innovative technology in writing to the Department. The request must include the reasons for proposing the method and the potential scope of use for the method.
(4) The Department will establish criteria for validating the method that are based upon the analyte to be tested.
(5) Upon receipt of the method validation data that meets the established criteria, the Department will approve or deny the request within 90 days and inform the laboratory of the basis of its decision in writing. The evaluation for approval will include consideration of the demonstrated need for the new or innovative technology, reasons for using the method, performance of the method, method validation data and applicability of the method to the matrix.
(d) An environmental laboratory shall develop and maintain written standard operating procedures for all fields of accreditation.
(1) The environmental laboratory’s standard operating procedures must accurately reflect all aspects of the testing or analysis for the fields of accreditation, including the following:
(i) Identification of the method.
(ii) Effective date.
(iii) Scope, including applicable matrix or matrices, quantitation range, and for drinking water testing MCLs or action levels as appropriate.
(iv) Equipment and supplies.
(v) Reagents and standards.
(vi) Quality control.
(vii) Calibration and standardization.
(viii) Analytical procedure.
(ix) Calculations.
(x) Corrective actions or contingencies for handling out-of-control or unacceptable quality control data.
(xi) Reporting of results.
(2) The standard operating procedures may consist of copies of published or referenced test methods or standard operating procedures that have been written by the environmental laboratory. When modifications to the published or referenced method have been made by the laboratory or when the published or referenced method is ambiguous or provides insufficient detail, the changes or clarifications shall be clearly described.
(e) An environmental laboratory shall make copies of the standard operating procedures, the promulgated method, Department regulations and Department guidance pertaining to testing or analysis of environmental samples available to the technical staff.
(f) When an environmental laboratory collects a sample to be analyzed, the sample collection method required by applicable State and Federal laws, regulations or permit conditions shall be followed.
(g) An environmental laboratory shall follow the sample container, preservation procedures and holding times required by State and Federal regulations. If the sample container, preservation procedures and holding times are not required by State or Federal regulations, an environmental laboratory shall follow the sample container, sample preservation procedures and holding time established in the method.
(h) The range of quantitation and detection limit shall be determined for each analyte reported by an environmental laboratory in accordance with a method specified by the Department.
(i) When a method specifies a validation procedure, the validation procedure shall be completed before environmental samples may be analyzed and reported. The results of this validation procedure shall be documented and kept on file for the duration of use of the method and for at least 5 years after the method is no longer in use.
(j) An environmental laboratory shall maintain instructions for sample collection and preservation that meet the requirements of subsections (f) and (g).
(1) The environmental laboratory’s instructions must accurately reflect all aspects of the sample collection and preservation requirements for the particular analyses, including the following:
(i) Container type, size and number of containers or bottles.
(ii) Sample collection method, amount of sample required and explanation of other specific requirements for sample collection such as ‘‘zero headspace’’ and ‘‘first draw.’’
(iii) Chemical preservation, including type of preservation and the procedure used to preserve the sample.
(iv) Thermal preservation, including the temperature requirements and procedure used to preserve the sample.
(v) Field blank requirements.
(vi) Holding time.
(2) The environmental laboratory shall make the sample collection and preservation instructions available to all laboratory sample collection personnel and to customers and clients that collect samples.
Authority The provisions of this § 252.307 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 § 252.307 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 (348807) to (348809).
Cross References This section cited in 25 Pa. Code § 252.5 (relating to NELAP equivalency); 25 Pa. Code § 252.402 (relating to essential quality control requirements—chemistry); 25 Pa. Code § 252.403 (relating to essential quality control requirements—toxicity testing); 25 Pa. Code § 252.404 (relating to essential quality control requirement—microbiology); and 25 Pa. Code § 252.405 (relating to essential quality control requirement—radiochemistry).
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