Subchapter G. MISCELLANEOUS PROVISIONS
Sec.
252.701. Denial of application.
252.702. Revocation.
252.703. Suspension.
252.704. Voluntary relinquishment.
252.705. Use of accreditation.
252.706. Recordkeeping.
252.707. Subcontracting.
252.708. Reporting and notification requirements.
Cross References This subchapter cited in 25 Pa. Code § 252.5 (relating to NELAP equivalency); and 25 Pa. Code § 252.601 (relating to assessment requirements).
§ 252.701. Denial of application.
(a) The Department will deny an application for accreditation, transfer of accreditation or application for renewal of accreditation under one or more of the following circumstances:
(1) The environmental laboratory is in continuing violation of or demonstrates an inability or lack of intention to comply with this chapter or other laws administered by the Department.
(2) The Department revoked the environmental laboratory’s certificate of accreditation for all fields of accreditation for failure to correct deficiencies identified in an assessment report within the previous 6 months.
(b) The Department may deny an application for accreditation, transfer of accreditation or application for renewal of accreditation for one or more of the following reasons:
(1) Falsifying analyses.
(2) Failure to comply with the reporting and notification requirements as specified in § 252.708 (relating to reporting and notification requirements).
(3) Making misrepresentations to the Department.
(4) Engaging in unethical or fraudulent practices.
(5) Analysis of proficiency test studies by personnel other than the analysts associated with the routine analysis of environmental samples in the laboratory.
(6) Failure to submit a complete application.
(7) Failure to pay required fees.
(8) Failure of laboratory staff to meet the personnel qualifications of education, training and experience.
(9) Failure to successfully analyze and report proficiency test studies as required by this chapter.
(10) Failure to respond to an assessment report with a corrective action report within the required time frames.
(11) Failure to submit an acceptable corrective action report in response to an assessment report within the required time frames.
(12) Failure to implement the corrective actions detailed in the environmental laboratory’s corrective action report within a time frame approved by the Department.
(13) Failure to implement a quality assurance program.
(14) Denial of entry to the Department during normal business hours for an onsite assessment.
(15) Violation of a statute, this chapter or an order of the Department.
(16) Failure to meet the requirements of this chapter.
(17) Failure to maintain test instruments, equipment, supplies and reference materials that meet the specifications required to produce valid analytical results.
Authority The provisions of this § 252.701 amended under 27 Pa.C.S. § 4105(a); and section 1920-A of The Administrative Code of 1929 (71 P.S. § 510-20).
Source The provisions of this § 252.701 amended July 28, 2017, effective July 29, 2017, 47 Pa.B. 4085. Immediately preceding text appears at serial page (348843).
§ 252.702. Revocation.
(a) The Department will revoke an environmental laboratory’s accreditation for a field of accreditation when, after being suspended due to failure to participate in a required proficiency test study or due to failure to obtain an acceptable result for a proficiency test study, the laboratory’s analysis of the next proficiency test study results in a failed proficiency test study for that field of accreditation.
(b) The Department may revoke an environmental laboratory’s accreditation, in part or in total, for one or more of the following reasons:
(1) Failure to respond to an assessment report with a corrective action report within the required time frames.
(2) Failure to correct deficiencies identified during an assessment of the environmental laboratory.
(3) Failure to implement corrective action to correct violations or deficiencies found during an assessment.
(4) Failure of an environmental laboratory that has been suspended to correct all outstanding violations or deficiencies within 6 months of the effective date of the suspension.
(5) Failure to submit an acceptable corrective action report in response to an assessment report within the required time frames.
(6) Violation of a condition of accreditation.
(7) Violation of a statute, this chapter or an order of the Department.
(8) Falsifying analyses.
(9) Making misrepresentations to the Department.
(10) Engaging in unethical or fraudulent practices.
(11) Analysis of proficiency test studies by personnel, procedures, equipment, facilities, number of replicates and methods other than those associated with the routine analysis of environmental samples in the laboratory.
(12) Failure to implement a quality assurance program.
(13) Failure to participate in the proficiency test study program as required by this chapter.
(14) Denial of entry to the Department during normal business hours for an onsite assessment.
(15) Failure to comply with the reporting and notification requirements as specified in § 252.708 (relating to reporting and notification requirements).
(16) Failure to employ staff that meets the personnel qualifications for education, training and experience.
(17) Failure to meet the requirements of this chapter.
(18) Failure to maintain test instruments, equipment, supplies and reference materials that meet the specifications required to produce valid analytical results.
(c) The environmental laboratory may continue to test or analyze environmental samples for those fields of accreditation not revoked.
(d) Within 72 hours of receiving notice of the revocation of accreditation from the Department, the environmental laboratory shall notify each of its customers affected by the revocation in writing of the revocation. The Department may require the laboratory to use specific language in the written notice or require Department approval of the notice before issuance.
Authority The provisions of this § 252.702 amended under 27 Pa.C.S. § 4105(a); and section 1920-A of The Administrative Code of 1929 (71 P.S. § 510-20).
Source The provisions of this § 252.702 amended July 28, 2017, effective July 29, 2017, 47 Pa.B. 4085. Immediately preceding text appears at serial page (348844).
§ 252.703. Suspension.
(a) Denial of access to the Department during normal business hours will result in immediate suspension of accreditation for all fields of accreditation. Upon notice from the Department, the laboratory shall immediately cease testing or analysis of environmental samples.
(b) The Department will suspend an environmental laboratory’s accreditation in total or in part for one or more of the following reasons:
(1) The Department finds that protection of the environment or the public health, safety or welfare requires emergency action.
(2) The environmental laboratory fails to successfully complete a proficiency test study within the previous 12 months.
(3) The environmental laboratory fails two consecutive proficiency test studies for a field of accreditation.
(c) The Department may suspend a laboratory’s accreditation in total or in part for one or more of the following reasons:
(1) Failure to comply with the reporting and notification requirements.
(2) Failure to implement a quality assurance program.
(3) Failure to employ staff that meets the personnel qualifications for education, training and experience.
(4) Failure to submit an acceptable corrective action report in response to an assessment report within the required time frames.
(5) Failure to correct deficiencies identified during an assessment of the environmental laboratory.
(6) Failure to implement corrective action related to violations or deficiencies found during an assessment.
(7) Failure to maintain test instruments, equipment, supplies and reference materials that meet the specifications required to produce valid analytical results.
(8) Failure to analyze and report proficiency testing study results in accordance with § 252.501 (relating to proficiency test study requirements).
(d) A laboratory may continue to test or analyze environmental samples for those fields of accreditation not affected by the suspension.
(e) Within 72 hours of receiving notice of the suspension of accreditation from the Department, the environmental laboratory shall notify each of its customers affected by the suspension in writing of the suspension. The Department may require the laboratory to use specific language in the written notice or require Department approval of the notice before issuance.
Authority The provisions of this § 252.703 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 § 252.703 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 page (348845).
§ 252.704. Voluntary relinquishment.
(a) An environmental laboratory wishing to voluntarily relinquish its certificate of accreditation or accreditation for fields of accreditation shall notify the Department in writing.
(b) An environmental laboratory that voluntarily relinquishes its certificate of accreditation shall ensure records are maintained in accordance with § 252.706 (relating to recordkeeping).
(c) Within 72 hours of voluntarily relinquishing its certificate of accreditation, the laboratory shall notify each of its customers affected by the voluntary relinquishment in writing of the relinquishment. The Department may require the laboratory to use specific language in the written notice or require Department approval of the notice before issuance.
Authority The provisions of this § 252.704 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 § 252.704 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 (348845) to (348846).
§ 252.705. Use of accreditation.
(a) Environmental laboratories accredited by the Department shall:
(1) Post or display their most recent certificate of accreditation in a prominent place in the laboratory.
(2) Make accurate statements concerning their accreditation status.
(3) Not use their certificate of accreditation, accreditation status or the Department’s logo to imply endorsement by the Department.
(b) Environmental laboratories using the Department’s name, making reference to its accreditation status or using the Department’s logo in catalogs, advertising, business solicitations, proposals, quotations, laboratory analytical reports or other materials, shall:
(1) Distinguish between testing for which the laboratory is accredited and testing for which the laboratory is not accredited.
(2) Include the environmental laboratory’s accreditation number.
(c) Upon expiration, suspension, revocation or voluntary relinquishment of accreditation, a laboratory shall:
(1) Discontinue use of all catalogs, advertising, business solicitations, proposals, quotations, laboratory analytical results or other materials that contain reference to the laboratory’s past accreditation status.
(2) Discontinue use or display of the Department’s logo.
(3) Return unexpired certificates of accreditation to the Department within 48 hours.
(d) NELAP accredited laboratories shall accompany the Department’s name or the NELAP logo with the phrase ‘‘NELAP accredited’’ and the laboratory’s accreditation number when using the Department’s name or the NELAP logo on general literature such as catalogs, advertising, business solicitations, proposals, quotations, laboratory analytical reports or other materials.
(e) NELAP accredited laboratories may not use their NELAP certificate, NELAP accreditation status or NELAP logo to imply endorsement by the Department or NELAP.
Authority The provisions of this § 252.705 amended under 27 Pa.C.S. § 4105(a); and section 1920-A of The Administrative Code of 1929 (71 P.S. § 510-20).
Source The provisions of this § 252.705 amended July 28, 2017, effective July 29, 2017, 47 Pa.B. 4085. Immediately preceding text appears at serial pages (348846) and (348847).
§ 252.706. Recordkeeping.
(a) An environmental laboratory shall maintain records in an organized manner accessible by the Department.
(b) An environmental laboratory shall maintain records, including original handwritten data, that allow reconstruction of all laboratory activities associated with the testing or analysis of environmental samples, proficiency test studies, initial demonstration of capability or demonstration of continued proficiency. These records include the following:
(1) Start and end dates and times of incubations, drying cycles, digestion, distillations, and the like, when a minimum or maximum time is specified by method, regulation or permit.
(2) Unequivocal link between the laboratory’s sample identification number to the results of all associated quality control.
(3) Instrument identification.
(4) Identification of, or reference to, the standards, reagents, media, supplies, and the like, used during sample preparation or analysis, or both.
(5) The results of chemical or thermal preservation verifications or adjustments, or both.
(6) Date of sample preparation or analysis, or both.
(7) Time of sample preparation or analysis, or both, if the holding time for either activity is less than or equal to 72 hours.
(8) Manual calculations.
(9) Test results.
(c) All records, except records generated by automated collection systems, shall be recorded promptly and legibly in permanent ink or in an electronic format.
(1) The individual generating the record must be identified by initials or name and the individual making the observation must be identified by initials or name if different from the individual generating the record.
(2) Changes to records shall be made so that the original entry remains visible. The individual making the change shall be identified by name or initials, date the correction and include the reason for the change unless correcting a typographical error. These criteria also apply to electronically maintained records.
(d) Records required under this chapter shall be maintained for a minimum of 5 years unless otherwise specified.
(e) An environmental laboratory shall have a written plan that specifies how records will be maintained or transferred if the laboratory transfers ownership or terminates operations.
Authority The provisions of this § 252.706 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 § 252.706 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 page (348847).
Cross References This section cited 25 Pa. Code § 252.6 (relating to accreditation-by-rule); 25 Pa. Code § 252.401 (relating to basic requirements); and 25 Pa. Code § 252.704 (relating to voluntary relinquishment).
§ 252.707. Subcontracting.
(a) An environmental laboratory may not subcontract testing or analysis covered under this chapter to an environmental laboratory that is not accredited and in compliance with this chapter.
(b) The accreditation number of the subcontracted environmental laboratory shall be indicated on the final report.
Authority The provisions of this § 252.707 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 § 252.707 amended April 9, 2010, effective April 10, 2010, 40 Pa.B. 1898. Immediately preceding text appears at serial page (317304).
§ 252.708. Reporting and notification requirements.
(a) An environmental laboratory conducting testing or analysis of drinking water under Chapter 109 (relating to safe drinking water) shall:
(1) Meet the reporting and notification requirements of that chapter.
(2) Review all sample analysis data within 24 hours of acquisition of the initial sample results for inorganic nonmetals and trace metals analyses. The 24-hour deadline may be extended to a maximum of 72 hours to accommodate a holiday or weekend when the laboratory is closed for business.
(3) For organic and radiochemical analyses, review all sample analysis data within 7 days of acquisition of the initial sample results for organic analysis.
(4) For microbiological results, read all sample results within 30 minutes of the end of the incubation period.
(5) Analyze the laboratory control sample at a concentration at or below the maximum contaminant level.
(6) Report to the Drinking Water Environmental Lab Reporting system only those analytical test results that meet the method, regulatory and permit requirements for sample collection, preservation, holding time, sample analysis and quality control performance, unless the Department has specifically approved that the result may be reported.
(b) An environmental laboratory shall notify the Department, in writing, within 20 calendar days of a permanent change in laboratory supervisor.
(c) An environmental laboratory shall notify the Department, in writing, within 30 calendar days of a change in the legal name of the laboratory.
(d) An environmental laboratory shall notify the Department, in writing, within 30 calendar days of a change in any item contained on the application for accreditation.
(e) An environmental laboratory shall notify the Department, in writing, if a change in the laboratory’s capability to produce valid analytical results persists for more than 90 calendar days for any field of accreditation listed on the laboratory’s scope of accreditation.
(f) An out-of-State environmental laboratory with either primary or secondary accreditation from the Department shall notify, in writing, the Department within 48 hours of any changes in the laboratory’s accreditation status from any other primary accreditation body.
(g) The Department may require additional information or proof of continued capability to perform the testing or analysis for affected fields of accreditation upon receipt of notification under this subsection.
(h) The Department may require an onsite assessment under § 252.601 (relating to assessment requirements) upon receipt of notification under this subsection.
Authority The provisions of this § 252.708 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 § 252.708 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 (348848) and (354387).
Cross References This section cited in 25 Pa. Code § 252.301 (relating to laboratory supervisor); 25 Pa. Code § 252.701 (relating to denial of application); and 25 Pa. Code § 252.702 (relating to revocation).
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