[47 Pa.B. 4085]
[Saturday, July 29, 2017]
[Continued from previous Web Page]
Subchapter D. QUALITY ASSURANCE AND QUALITY CONTROL REQUIREMENTS § 252.401. Basic requirements.
* * * * * (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.
§ 252.402. Essential quality control requirements—chemistry.
* * * * * (c) Initial calibration requirements are as follows:
(1) An environmental laboratory shall follow the initial calibration requirements of the method.
(2) The results of testing or analysis of environmental samples shall be determined from an initial calibration and may not be determined from any continuing calibration verification, unless otherwise required by regulation, method or program.
(3) The details of the initial calibration procedures including calculations, integrations, acceptance criteria and associated statistics shall be included or referenced in the laboratory's standard operating procedure.
(4) Raw data records shall be retained to permit reconstruction of the initial calibration, including identification or reference to the reagents, standards and supplies used, dates of analysis, instrument identification, results of the initial calibration, calibration criteria and analyst identification.
* * * * * (f) Calibration verification requirements are as follows:
(1) A calibration verification standard shall be analyzed at the beginning and end of each analysis day. For methods that use an internal standard, a calibration verification standard is not required at the end of the analysis day unless specified in the method, or State or Federal law or regulation.
(2) A calibration verification standard shall be analyzed after every ten samples, unless a different frequency is specified in the method.
(3) At a minimum, the laboratory shall verify the calibration curve of each analytical batch with calibration verification standards at a low and a high level.
(i) The concentration of the low calibration verification standard shall be within the lower 20% of the calibration curve and not more than five times the lowest quantitation level.
(ii) The concentration of the high calibration verification standard shall be within the upper 20% of the calibration curve.
(4) Details of the calibration verification procedure including calculations, integrations, acceptance criteria and associated statistics shall be included or referenced in the laboratory's standard operating procedure.
(5) Raw data records shall be retained to permit reconstruction of the calibration verification.
(6) Acceptance criteria for calibration verification standards in the method shall be followed. When there are no established criteria in the method, an environmental laboratory shall use the acceptance criteria described in an equivalent method for the same type of analysis. When an equivalent method is not available, the laboratory shall establish control charts in accordance with Standard Methods for the Examination of Water and Wastewater (available from the American Public Health Association, 800 I Street, NW, Washington, D.C. 20001) to determine internal criteria and document the procedure used to establish the acceptance limits.
(7) If a calibration verification standard fails the established acceptance criteria, an environmental laboratory shall initiate corrective actions. If the corrective actions fail to produce an immediate consecutive calibration verification standard within the acceptance criteria, a new calibration verification standard shall be prepared. If the freshly prepared calibration verification standard fails to produce a result within the established acceptance criteria, the environmental laboratory shall recalibrate the test or analysis according to the method or as set forth in subsection (c) and as set forth in either subsection (d) or (e).
(8) To the extent possible, and as provided by paragraph (1), environmental samples not bracketed by acceptable calibration verification standards shall be reanalyzed. If the calibration verification standard 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 calibration verification standard shall be documented and the results flagged in an unambiguous manner on the sample analysis report with the appropriate data qualifiers.
(g) Method blank requirements are as follows:
(1) A method blank must be processed along with and under the same conditions as the associated environmental samples including all steps of the analytical procedure.
(2) A method blank must be analyzed at a minimum of one per preparation batch. When no separate preparation method is used (example: volatiles in water), the batch shall be defined as no more than 20 environmental samples that are analyzed together using the same method, personnel and lots of reagents.
(3) A method blank must consist of a matrix that is similar to the associated environmental samples and is free of the analytes of interest. When a matrix that is similar to the associated environmental samples that is free of the analytes of interest is not available, reagent water or an artificial or simulated matrix may be used.
(4) A method blank is considered contaminated if one of the following applies:
(i) The concentration of a target analyte in the method blank is at or above the reporting limit established by the method, by the laboratory or by regulation.
(ii) The contamination in the method blank otherwise affects the environmental sample results as described in the method or in individual project data quality objectives.
(5) If a contaminant is detected in the method blank, the source of contamination shall be investigated and measures shall be taken to minimize or eliminate the problem.
(6) Raw data records shall be retained to permit reconstruction of the method blank.
(7) To the extent possible, any environmental samples associated with a contaminated method blank shall be reprocessed for analysis. If a contaminated method blank 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 contaminated method blank shall be documented and the results flagged in an unambiguous manner on the sample analysis report with the appropriate data qualifiers.
(h) Laboratory control sample requirements are as follows:
(1) A laboratory control sample must be processed along with and under the same conditions as the associated environmental samples, including all steps of the preparation and analytical procedure.
(2) A laboratory control sample must consist of a matrix that is similar to the associated environmental samples and is free of the analytes of interest. When a matrix that is similar to the associated environmental samples that is free of the analytes of interest is not available, reagent water or an artificial or simulated matrix may be used.
(3) An environmental laboratory shall analyze a laboratory control sample at a minimum of one per preparation batch. When no separate preparation method is used, for example volatiles in water, the batch shall be defined as no more than 20 environmental samples that are analyzed together with the same method, personnel and lots of reagents.
(4) All analyte concentrations in the laboratory control sample must be within the calibration range of the method and at or below the maximum contaminant level.
(5) The components to be spiked into the laboratory control sample must be as specified by the method or other regulatory requirement. In the absence of specified components, the environmental laboratory shall use the following:
(i) For those components that interfere with an accurate assessment, such as spiking simultaneously with technical chlordane, toxaphene and PCBs, the laboratory control sample must represent the chemistries and elution patterns of the components to be reported.
(ii) For methods with more than ten analytes, a representative number may be chosen. The analytes selected shall be representative of all chemistries and analytes reported and shall be chosen using the following criteria:
(A) Targeted components shall be included in the laboratory control sample over a 2-year period.
(B) For methods that include one to ten components, the laboratory control sample must contain all components.
(C) For methods that include 11—20 components, the laboratory control sample must contain at least 10 components or 80%, whichever is greater.
(D) For methods with more than 20 components, the laboratory control samples must contain at least 16 components.
(6) Each individual laboratory control sample shall be compared to the acceptance criteria in the method. When there are no established criteria in the method, an environmental laboratory shall use the acceptance criteria described in an equivalent method for the same type of analysis. When an equivalent method is not available, the laboratory shall establish control charts in accordance with Standard Methods for the Examination of Water and Wastewater (available from the American Public Health Association, 800 I Street, NW, Washington, D.C. 20001) to determine internal criteria and document the procedure used to establish the limits.
(7) Raw data records shall be retained to permit reconstruction of the laboratory control sample.
(8) Environmental samples associated with an out of control laboratory control sample shall be reprocessed and reanalyzed from the beginning of the method or the results reported with the appropriate data qualifiers.
(i) Sample duplicate requirements are as follows:
(1) A sample duplicate or matrix spike duplicate must be processed along with and under the same conditions as the associated environmental samples, including all steps of the preparation and analytical procedure.
(2) A sample duplicate or matrix spike duplicate shall be analyzed at a minimum of one per preparation batch. When no separate preparation method is used, for example volatiles in water, the batch shall be defined as no more than 20 environmental samples that are analyzed together using the same method, personnel and lots of reagents.
(3) An environmental laboratory shall document the calculations used for determining the relative percent difference or other statistical method for evaluation of the duplicate pairs.
(4) Each duplicate relative percent difference shall be compared to the acceptance criteria in the method. When there are no established criteria in the method, an environmental laboratory shall use the acceptance criteria described in an equivalent method for the same type of analysis. When an equivalent method is not available, the laboratory shall establish control charts in accordance with Standard Methods for the Examination of Water and Wastewater (available from the American Public Health Association, 800 I Street, NW, Washington, D.C. 20001) to determine internal criteria and document the procedure used to establish the acceptance limits.
(5) For duplicate results outside established criteria, corrective action shall be documented and the data reported with appropriate data qualifiers.
(j) Surrogate spike requirements are as follows:
(1) Surrogate compounds, when commercially available, shall be added to all samples, standards and blanks for all organic chromatography test methods.
(2) Surrogate compounds shall be chosen to represent the various chemistries of the target analytes in the method.
(3) The results of the surrogate spike shall be compared to the acceptance criteria published in the method. When there are no established acceptance criteria for surrogate recovery in the method, the environmental laboratory shall use the acceptance criteria described in an equivalent method for the same type of analysis. When an equivalent method is not available, the laboratory shall establish control charts in accordance with Standard Methods for the Examination of Water and Wastewater (available from the American Public Health Association, 800 I Street, NW, Washington, D.C. 20001) to establish internal criteria and document the method used to establish the acceptance limits.
* * * * * § 252.404. Essential quality control requirement—microbiology.
* * * * * (c) The following pieces of equipment shall be maintained according to this subsection:
(1) Autoclave.
(i) An environmental laboratory shall use autoclaves that meet specified temperature tolerances of the method. Pressure cookers may not be used.
* * * * * (9) Plastic and glassware washing procedure.
(i) Prior to the initial use of a lot of detergent or washing procedure, an environmental laboratory shall perform an inhibitory residue test utilizing the method described in the currently approved editions of Standard Methods for the Examination of Water and Wastewater (available from the American Public Health Association, 800 I Street, NW, Washington, D.C. 20001). Records of inhibitory residue tests shall be maintained and include the detergent identification, date, calculations, results and initials of responsible individual.
(ii) Washed plastic and glassware shall be tested at least once each month for possible acid or alkaline residue by testing at least one piece of plastic and glassware with a suitable pH indicator such as 0.04% bromothymol blue. Records of pH tests shall be maintained and include the date, results and identification of the responsible individual.
(10) Ultraviolet lamp. An environmental laboratory shall use a 365-nm, 6-watt ultraviolet lamp in a darkened room to view sample fluorescence.
(11) Quanti-TrayTM Sealer.
(i) An environmental laboratory shall perform a sealer check on each Quanti-Tray Sealer once a month by adding a dye to a water sample and performing the sealing procedure.
(ii) Records of the sealer check shall be maintained and include the sealer identification, date, results and initials of responsible individual. If dye is observed outside the wells, the Quanti-Tray Sealer may not be used.
(d) The requirements for reagent water are as follows:
(1) An environmental laboratory shall use reagent water in the preparation of media, solutions and buffers.
(2) An environmental laboratory shall demonstrate that reagent water meets the following criteria on a monthly basis or whenever maintenance is performed on the water treatment system or at startup after a period of nonuse longer than 1 month:
(i) Total chlorine residual must be less than 0.1 mg/L.
(ii) Conductivity must be less than 2.0 µmhos/cm or resistance greater than 0.5 megohms at 25°C.
(iii) Heterotrophic plate count must be less than 500 CFU/mL.
(3) An environmental laboratory shall demonstrate that reagent water meets the following criteria every 12 months:
(i) The individual concentration of lead, cadmium, chromium, copper, nickel and zinc must be less than 0.05 mg/L.
(ii) The total concentration of lead, cadmium, chromium, copper, nickel and zinc must be less than 0.1 mg/L.
(iii) Except as provided in subsection (d)(6), the bacteriological water quality test ratio must be between 0.8 and 3.0. The bacteriological water quality test shall be performed according to the currently approved editions of Standard Methods for the Examination of Water and Wastewater (available from the American Public Health Association, 800 I Street, NW, Washington, D.C. 20001).
(4) The metals analyses may only be performed by an environmental laboratory accredited under this chapter for those fields of accreditation.
(5) Results of the monthly and annual reagent water analysis shall be maintained and include the date, type of test, results and initials of responsible individual. Reagent water that does not meet the required criteria may not be used.
(6) The bacteriological water quality test need not be performed if the environmental laboratory can supply documentation to show that their laboratory pure water or reagent water meets the criteria, as specified in section 1080 of the currently approved editions of Standard Methods for the Examination of Water and Wastewater (available from the American Public Health Association, 800 I Street, NW, Washington, D.C. 20001), for Type I (high-quality) or Type II (medium-quality) reagent water.
(7) The heterotrophic plate count and bacteriological water quality test ratio analyses described in paragraphs (2) and (3) shall be performed by an environmental laboratory accredited under this chapter for the appropriate field of accreditation.
(e) The requirements for dilution/rinse water are as follows:
(1) Stock buffer solution or peptone water shall be prepared as specified in the currently approved editions of Standard Methods for the Examination of Water and Wastewater (available from the American Public Health Association, 800 I Street, NW, Washington, D.C. 20001).
(2) Stock buffers shall be autoclaved or filter-sterilized. Stock buffers shall be refrigerated and must be free from turbidity.
(3) Dilution/rinse water solutions shall be prepared as specified in the currently approved editions of Standard Methods for the Examination of Water and Wastewater (available from the American Public Health Association, 800 I Street, NW, Washington, D.C. 20001).
(f) The requirements for media are as follows:
(1) An environmental laboratory shall use dehydrated or commercially manufactured prepared media. Dehydrated media shall be stored in a cool, dry location. Caked or discolored dehydrated media shall be discarded.
(2) An environmental laboratory that prepares media from dehydrated stock shall follow method specifications.
(3) Media may not be reautoclaved.
(4) After preparation, media shall be stored and maintained as follows:
(i) Stored away from sources of direct light.
(ii) Prepared plates shall be stored in sealed plastic bags or containers.
(iii) Each bag, container or rack of broth or agar media shall be labeled with the date prepared or expiration date.
(iv) Fermentation media stored in a refrigerator shall be brought to room temperature before use. Media that shows growth or false positive results may not be used.
(v) Prepared liquid media shall be discarded if evaporation exceeds 10% of the original volume.
(vi) Poured agar plates and broth in tubes, bottles or flasks with loose-fitting closures shall be discarded if not used within 2 weeks of sterilization unless otherwise specified by the method.
(vii) Broth in tightly closed screw-cap tubes, bottles or flasks shall be discarded if not used within 3 months of sterilization unless otherwise specified by the method.
(g) An environmental laboratory shall demonstrate that the filtration equipment and filters, sample containers, media and reagents have not been contaminated through improper handling or preparation, inadequate sterilization or environmental exposure as follows:
(1) A sterility blank shall be analyzed for each lot of preprepared, ready-to-use medium and for each batch of medium prepared in the laboratory prior to first use of the medium. Records shall be maintained and include media identification, date and time of the start and end of incubation, results and initials of the responsible individuals. If sterility blank indicates contamination, the media may not be used.
(i) For chromogenic/fluorogenic media, add single-strength media to sterile reagent water and incubate at the appropriate temperature and time.
(ii) For all other media, incubate uninoculated, single-strength at the appropriate temperature and time.
(2) For each reusable membrane filtration unit used during a filtration series, the laboratory shall prepare at least one sterility blank at the beginning and at the end of the series. A series is considered ended when more than 30 minutes elapses between filtrations. The laboratory shall insert a sterility blank after every ten sample aliquots filtered through each membrane filtration unit or sanitize filtration units by UV light after each sample filtration in addition to the regular rinsing procedure. Records of sterility blank results shall be maintained in the same manner as the associated sample and include the date and time of the start and end of the incubation, results and initials of the responsible individuals. If sterility blanks indicate contamination, the laboratory must treat each affected sample according to program requirements.
(3) For presterilized single use filtration funnel units, a sterility check shall be performed on one funnel unit per lot.
(4) Sterility checks on sample containers shall be performed on at least one container for each lot of purchased, presterilized containers with an appropriate nonselective growth media. For containers prepared and sterilized in the laboratory, a sterility check shall be performed on one container per sterilized batch with an appropriate nonselective growth media. Results shall be maintained and include sample container identification, date and time of the start and end of incubation, results and initials of responsible individuals. If sample container sterility check indicates contamination, the affected sample container may not be used.
(5) A sterility blank shall be performed on each batch of dilution/rinse water prepared in the laboratory and on each batch of preprepared, ready-to-use dilution water with an appropriate nonselective growth media. The concentration of media shall be single strength after addition of dilution water. Results shall be maintained and include dilution/rinse water identification, date and time of the start and end of incubation, results and initials of the responsible individuals. If dilution/rinse water sterility check indicates contamination, the affected dilution water may not be used.
(6) At least one filter from each new lot of membrane filters shall be checked for sterility with an appropriate nonselective growth media. Results shall be maintained and include membrane filter identification, date and time of the start and end of incubation, results and initials of the responsible individuals. If the membrane filter sterility check indicates contamination, the affected membrane filters may not be used.
(7) Sterility checks on Quanti-Tray sample trays shall be performed on at least one sample tray for each lot of purchased presterilized sample trays with an appropriate nonselective growth media. Results shall be maintained and include sample tray identification, date and time of the start and end of incubation, results and initials of the responsible individuals. If the sample tray sterility check indicates contamination, the affected lot of sample trays may not be used.
(h) The requirements for positive and negative culture control checks are as follows:
(1) Each preprepared, ready-to-use lot of medium and each batch of medium prepared in the laboratory shall be tested by the laboratory with at least one pure culture of a known positive reaction prior to first use of the medium. Records shall be maintained and include the date and time of the start and end of incubation, media lot or batch number, type of media, positive culture control organism identification, results and initials of the responsible individuals. If positive culture control checks do not meet expected results, the affected media may not be used.
(2) Each preprepared, ready-to-use lot of selective medium and each batch of selective medium prepared in the laboratory shall be tested by the laboratory with at least one pure culture of a known negative reaction prior to first use of the medium. Records shall be maintained and include the date and time of the start and end of incubation, media lot or batch number, type of media, negative culture control organism identification, results and initials of the responsible individuals. If negative culture control checks do not meet expected results, the affected media may not be used.
(3) An environmental laboratory shall use stock positive and negative culture controls that are known and traceable to a recognized National collection. Documentation of traceability shall be maintained.
(4) Stock positive and negative culture controls shall be discarded after the manufacturer's expiration date.
(5) Culture controls may be single use or cultures maintained by the laboratory using a documented procedure that maintains the purity and viability of the organisms.
(6) For cultures maintained by the laboratory, the following criteria must be met:
(i) Reference control cultures may be revived and subcultured once to provide reference stocks.
(ii) Reference stocks shall be preserved using a method which maintains the characteristics of the organism strains. If reference stocks are thawed, they may not be refrozen and reused.
(iii) Working stocks shall be prepared from reference stocks for routine laboratory work.
(iv) If the laboratory sequentially cultures working stocks, the laboratory shall prepare a second working stock. Sequential culturing may not be performed from a working stock that has been used for routine laboratory work.
(v) Working stocks may not be used for more than 30 days.
(vi) Working stocks may not be sequentially cultured more than five times and may not be subcultured to replace reference stocks.
(vii) Secondary working stocks shall be used to prepare sequential working stocks.
(7) Positive and negative controls must be processed under the same conditions and using the same equipment as routine environmental samples, including all steps of the preparation and analytical procedure.
(i) For test methods that specify colony counts, duplicate counts shall be performed monthly on one positive sample for each month that the test is performed. If the laboratory has two or more analysts, each analyst shall count typical colonies on the same plate. Counts may not differ by more than 10%. In an environmental laboratory with only one analyst, the analyst shall count the same plate twice. Counts may not differ by more than 5%.
(j) Quality control checks, including sterility checks and positive and negative controls, shall be conducted after the laboratory receives the material or supply and before or during first use. These checks shall be performed by an environmental laboratory accredited under this chapter and utilizing the same supplies, reagents and media to be used during laboratory analysis of environmental samples. Certificates of analysis from a manufacturer may not be used to demonstrate compliance with the requirements of this subsection.
(k) Records of all equipment, reference materials, reagents, media and supplies shall be maintained in accordance with § 252.306 (relating to equipment, supplies and reference materials).
Subchapter E. PROFICIENCY TEST STUDY REQUIREMENTS § 252.501. Proficiency test study requirements.
* * * * * (o) An environmental laboratory shall evaluate and report the analytical result of each proficiency test study sample to the proficiency test reporting limit for each field of accreditation, when available, as outlined in subsection (a).
(p) The Department will invalidate a proficiency test study result that is not handled, managed, analyzed or reported in accordance with this section.
Subchapter F. ASSESSMENT REQUIREMENTS § 252.601. Assessment requirements.
(a) Prior to granting primary accreditation to 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 assessment report documenting any deficiencies found by the Department. The Department may deny, suspend or revoke an environmental laboratory's accreditation in accordance with Subchapter G (relating to miscellaneous provisions) before issuing the assessment report or during the corrective action process.
(e) An environmental laboratory shall submit a corrective action report to the Department within 60 calendar days from receipt of an assessment report from the Department when the Department has found deficiencies. The corrective action report must:
(1) Document the corrective action taken by the laboratory to correct each deficiency and the time frame for completion.
(2) Include documentation demonstrating correction of the deficiencies as requested by the Department.
(f) An environmental laboratory seeking NELAP accreditation shall submit a corrective action report to the Department within 30 calendar days from receipt of the assessment report from the Department when the Department has found deficiencies. If TNI establishes a different time for submitting corrective action reports, the laboratory shall follow the time established by TNI. The corrective action report must document the corrective action taken by the laboratory to correct each deficiency.
(g) 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.
(h) Unless otherwise required or approved by the Department, deficiencies shall be corrected within 120 calendar days of receipt of the assessment report.
(i) 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 § 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.
§ 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.
§ 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.
§ 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.
§ 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.
§ 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.
§ 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.
[Pa.B. Doc. No. 17-1248. Filed for public inspection July 28, 2017, 9:00 a.m.]
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