§ 252.401. Basic requirements.
(a) An environmental laboratory shall develop and maintain a quality manual appropriate to the type, range and volume of testing and analysis of environmental samples. The quality manual shall be available to and used by environmental laboratory personnel. The quality manual must contain the following:
(1) The full name and physical address of the laboratory.
(2) The name, address (if different from paragraph (1)), and telephone number of the laboratory supervisors.
(3) A revision number and effective date.
(4) A table of contents, and applicable lists of references, glossaries and appendices.
(b) The quality manual must state the environmental laboratory’s policies, operational procedures, protocols and practices established to meet the requirements of this chapter. These policies and procedures must include:
(1) An ethics policy statement as specified in subsection (d).
(2) A document control system as specified in subsection (c).
(3) Recordkeeping as specified in § 252.706 (relating to recordkeeping).
(4) The procedures for termination of operations and transfer of records as specified in § 252.706.
(5) The procedures for detecting and permitting departures from established procedures as specified in subsections (i) and (h).
(6) The procedures for detecting and preventing improper practices as specified in § 252.304 (relating to personnel requirements).
(7) The sample handling and acceptance procedures as specified in subsections (f) and (g).
(8) The reporting of analytical results as specified in subsection (j).
(9) The monitoring of the quality of analysis as specified in subsection (l).
(c) An environmental laboratory shall have a document control system that provides procedures for control and maintenance of all documents. The document control system must ensure that standard operating procedures, methods, manuals or documents clearly indicate the time period during which the procedure or document was in force.
(d) An environmental laboratory shall develop and maintain an ethics policy statement relevant to the employee’s duties and responsibilities under the act.
(1) The laboratory shall implement procedures for educating and training personnel in their ethical and legal responsibilities under the act.
(2) The laboratory shall provide training in ethical and legal responsibilities within 2 months of employment to the laboratory and at least every 14 months thereafter for all employees.
(e) An environmental laboratory shall maintain records of the technical personnel, which include dates of employment, signatures, initials and a list of persons authorized to approve or release reports of testing or analysis of environmental samples.
(f) An environmental laboratory shall establish procedures for handling environmental samples.
(1) The environmental laboratory shall implement procedures for checking and verifying the condition of the sample. The results of these checks shall be recorded. The environmental laboratory shall check:
(i) The sample container and the sample preservation, both thermal and chemical, of each sample.
(ii) The sample pH for all samples to be analyzed for whole effluent toxicity and safe drinking water chemistry fields of accreditation, unless the sample is collected by the environmental laboratory performing the analysis.
(iii) The sample for the presence of residual chlorine when the presence of residual chlorine will compromise the validity of the test.
(2) The laboratory shall utilize a recordkeeping system that meets the requirements of § 252.706 to document receipt of all sample containers. The recordkeeping system must include the following:
(i) The client/project name.
(ii) The date, time and location of sample collection, name of sample collector and field identification code.
(iii) The date and time of laboratory receipt and identification of the individual receiving the sample at the laboratory.
(iv) Any comments resulting from inspection for sample rejection shall be linked to the laboratory ID code.
(v) A unique laboratory ID code that corresponds to the information required by this paragraph.
(vi) An identification of the person making the entries.
(g) An environmental laboratory shall have a sample acceptance policy that clearly outlines the circumstances under which environmental samples will be accepted or rejected. The environmental sample acceptance policy must include the following areas:
(1) Sample identification, location, date and time of collection, collector’s name, preservation type and sample type.
(2) Sample labeling.
(3) Use of appropriate containers and sample preservation method.
(4) Adherence to holding times specified in the regulation and when not specified by the regulation, adherence to the holding times specified by the method.
(5) Sufficient sample volume shall be available to perform the necessary testing and analysis, including any required quality control testing or analysis.
(6) Procedures to be used when samples show signs of damage, contamination or inadequate preservation.
(h) An environmental laboratory shall document the laboratory management’s processes and procedures for permitting departures from the method, quality manual, established policies and procedures or standard operating procedures.
(i) An environmental laboratory shall establish procedures for detecting when departures from the method or quality manual have occurred. These procedures must include the following:
(1) Identify the individuals responsible for assessing each quality control type.
(2) Identify the individuals responsible for initiating or recommending, or both, corrective actions.
(3) Define how the analyst shall treat the results of testing or analysis of environmental samples if the associated quality control measures fail to meet the requirements of the method.
(4) Specify how out-of-control situations and subsequent corrective actions are to be documented.
(5) Specify procedures for the laboratory supervisor to review corrective action reports.
(j) An environmental laboratory shall develop procedures for reporting results of testing or analysis of environmental samples. Each test report must include at least the following information, except as specified in subsection (k).
(1) The name and address of the laboratory.
(2) The total number of pages in the report, including any addendums, in the format of Page x of y.
(3) The name and address of the client.
(4) An identification of the test method used.
(5) An identification of the samples including the client identification code.
(6) The date and time of sample collection.
(7) The date of sample analysis.
(8) The date and time of sample preparation or analysis, or both, if the holding time requirement for either activity is less than or equal to 72 hours.
(9) The test results and units of measurement.
(10) The quantitation limit.
(11) The names, functions and signatures of the persons authorizing the test report.
(12) An identification of results reported on a basis other than as received (for example, dry weight).
(13) An identification of testing or analysis results not covered by the laboratory’s scope of accreditation.
(14) An identification of results that do not meet the requirements of this chapter.
(15) An identification of subcontracted results.
(16) A unique test report identifier code, such as a serial number or other unique code.
(17) An identification of amendments to the test report. The laboratory shall uniquely identify all amendments to a test report. The amended report shall be issued in the form of a further document, data transfer or completely new test report, which includes the statement ‘‘Amended’’ or ‘‘Revised’’ and the identification of the unique laboratory code that meets the requirements of paragraph (16).
(k) Tests performed by an environmental laboratory operated by a facility that provides results to the facility management for compliance purposes do not need to be reported under subsection (j) regarding procedures for reporting results, provided the information required by subsection (j) is maintained under § 252.706.
(l) An environmental laboratory shall implement procedures or practices to monitor the quality of the laboratory’s analytical activities. Examples of the procedures or practices are:
(1) Internal quality control procedures using statistical techniques.
(2) Participation in proficiency testing, other inter-laboratory comparisons or round robin testing.
(3) Analysis of split samples by different laboratories.
(4) Use of certified reference materials or in-house quality control using secondary reference materials, or both.
(5) Replicate testing using the same or different test methods.
(6) Retesting of retained samples.
(7) Correlation of results for different but related analysis of a sample (for example, total phosphorus should be greater than or equal to orthophosphate).
(m) To the extent possible, results of testing or analysis of environmental samples shall be reported only if all quality control, analytical testing and sample acceptance measures are acceptable. If a quality control, analytical testing or sample acceptance measure is found to be out of control and the results of the testing or analysis of environmental samples are to be reported, all environmental samples associated with the failed quality control measure shall be documented and the results flagged in an unambiguous manner on the sample analysis report with the appropriate data qualifiers.
(n) Policies, procedures, protocols and practices specified in this section must be in writing and be followed.
(o) The environmental laboratory shall clearly identify opinions and interpretations as opinions and interpretations on test reports. When test reports include opinions and interpretations, the laboratory shall include an explanation for the basis upon which the opinions and interpretations have been made.
Authority The provisions of this § 252.401 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 § 252.401 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 (348810) to (348813).
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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