[36 Pa.B. 465]
[Continued from previous Web Page]
Subchapter E. PROFICIENCY TEST STUDY REQUIREMENTS Sec.
252.501. Proficiency test study requirements. § 252.501. Proficiency test study requirements.
(a) By February 27, 2006, the Department will publish a list in the Pennsylvania Bulletin of fields of accreditation for which proficiency test studies are available. The Department may update the list of available fields of accreditation by publishing a revised list of available proficiency test studies.
(b) An environmental laboratory shall participate in proficiency test studies, when available, as specified in subsection (a), for each field of accreditation for which the laboratory seeks to obtain or maintain accreditation.
(c) Within the 12 months prior to applying for initial accreditation under this chapter or during the approval process, an environmental laboratory shall successfully analyze at least one single blind, single concentration proficiency test study, when available, as specified in subsection (a), for each field of accreditation for which it seeks accreditation.
(d) An environmental laboratory accredited under this chapter shall successfully analyze at least one single blind, single concentration proficiency test study for each field of accreditation, when available, as specified in subsection (a), for which the laboratory is accredited at least once every 12 months.
(e) Proficiency test studies shall be purchased at the environmental laboratory's expense directly from suppliers approved by the Department as a proficiency test provider.
(f) An environmental laboratory shall ensure that all proficiency test study samples are managed, analyzed and reported in the same manner as real environmental samples and utilize the same staff, procedures, equipment, facilities, number of replicates and methods for the routine analysis of the analyte.
(g) An environmental laboratory may not send a proficiency test study, or a portion of a proficiency test study, to another laboratory for analysis for a field of accreditation for which it seeks accreditation or is accredited prior to the time the results of the study are released by the proficiency test study provider.
(h) An environmental laboratory may not knowingly analyze a proficiency test study, or a portion of a proficiency test study, for another environmental laboratory for which the sending environmental laboratory seeks accreditation or is accredited prior to the time the results of the study are released by the proficiency test study provider.
(i) An environmental laboratory may not communicate with another environmental laboratory, including other laboratories under common ownership, concerning the proficiency test study prior to the time the results of the study are released by the proficiency test study provider.
(j) An environmental laboratory may not attempt to obtain the prepared value of a proficiency test study from the proficiency test study provider prior to the time the results of the study are released by the proficiency test study provider.
(k) If an environmental laboratory fails to successfully analyze a proficiency test study for an individual field of accreditation, it shall determine the cause for the failure and take any necessary corrective action. The laboratory shall document the investigation and corrective action.
(l) An environmental laboratory shall direct the proficiency test study provider to report the proficiency test study performance results directly to the Department at the same time that the provider reports the results to the environmental laboratory.
(m) An environmental laboratory shall maintain copies of all raw data associated with proficiency test studies for at least 5 years.
Subchapter F. ONSITE ASSESSMENT REQUIREMENTS Sec.
252.601. Onsite assessment requirements. § 252.601. Onsite assessment requirements.
(a) Prior to accrediting 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) 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.
(g) Unless otherwise approved by the Department, deficiencies shall be corrected within 120 calendar days of receipt of the onsite assessment report.
(h) 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.
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. § 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 onsite 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 onsite assessment report with a corrective action report within the required timeframes.
(11) Failure to submit an acceptable corrective action report in response to an onsite assessment 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.
§ 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 onsite assessment report with a corrective action report within the required time frames.
(2) Failure to correct deficiencies identified during an onsite assessment of the environmental laboratory.
(3) Failure to implement corrective action related to violations or deficiencies found during an onsite 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 onsite assessment report within the required timeframes.
(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 other than the analysts 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.
(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 on a form approved by the Department.
§ 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 as specified in § 252.708 (relating to 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.
(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 on a form approved by the Department.
§ 252.704. Voluntary relinquishment.
(a) An environmental laboratory wishing to voluntarily relinquish its certificate of accreditation shall notify the Department in writing.
(b) An environmental laboratory that voluntarily relinquishes its certificate of accreditation shall insure 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 on a form approved by the Department.
§ 252.705. Use of accreditation.
(a) Environmental laboratories accredited by the Department shall:
(1) Post or display their most recent certificate of accreditation for all fields 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 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 certificates of accreditation to the Department within 48 hours.
(d) NELAP accredited laboratories shall accompany the Department's name or the NELAC/NELAP logo with the phrase ''NELAP accredited'' and the laboratory's accreditation number when using the Department's name or the NELAC/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 NELAC/NELAP logo to imply endorsement by the Department or NELAC.
§ 252.706. Recordkeeping.
(a) An environmental laboratory shall maintain records in a 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.
(c) All generated data, except data generated by automated data collection systems, shall be recorded promptly and legibly in permanent ink or in an electronic format. Changes to records shall be made so that the original entry remains visible. The individual making the change shall sign or initial and date the correction. These criteria also shall 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.
§ 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 subcontracted environmental laboratory shall be indicated on the final report.
§ 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 meet the reporting and notification requirements of that chapter.
(b) An environmental laboratory shall notify the Department, in writing, within 30 calendar days of a 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 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 accrediting authority.
(f) 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.
(g) The Department may require an onsite assessment under § 252.601 (relating to onsite assessment requirements) upon receipt of notification under this subsection.
[Pa.B. Doc. No. 06-171. Filed for public inspection January 27, 2006, 9:00 a.m.]
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