Current through Register Vol. 54, No. 44, November 2, 2024
(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.
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).
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).
