§ 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).
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