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HomeMy WebLinkAbout#5643_2023_0125_MC_FINAL NC Department of Environmental Quality | Division of Water Resources | Laboratory Certification Branch 4405 Reedy Creek Road | 1623 Mail Service Center | Raleigh, North Carolina 27699-1623 919-733-3908 March 2, 2023 5643 Mr. R. Jeff Wyatt GeoScience & Technology PA 2050 Northpoint Drive Winston-Salem, NC 27106 Subject: North Carolina Wastewater/Groundwater Laboratory Certification Branch (NC WW/GW LCB) Maintenance Inspection Dear Mr. Wyatt: Enclosed is a report for the inspection performed on January 25, 2023 by Michael Cumbus. Where Finding(s) are cited in this report, a response is required. Within thirty days, please supply this office with a written item for item description of how these Finding(s) were corrected. Please describe the steps taken to prevent recurrence and include an implementation date for each corrective action. If the Finding(s) cited in the enclosed report are not corrected, enforcement actions may be recommended. For Certification maintenance, your laboratory must continue to carry out the requirements set forth in 15A NCAC 02H .0800. A copy of the laboratory’s Certified Parameter List at the time of the audit is attached. This list will not reflect any changes made during the audit. Copies of the checklists completed during the inspection may be requested from this office. Thank you for your cooperation during the inspection. If you have questions or need additional information, please contact me at (919) 733- 3908 Ext. 259. Sincerely, Beth Swanson Technical Assistance & Compliance Specialist Division of Water Resources Attachment cc: Michael Cumbus, Todd Crawford, File #5643 On-Site Inspection Report LABORATORY NAME: Geoscience & Technology PA WATER QUALITY PERMIT #: WQ0014756 ADDRESS: 2050 Northpoint Drive Winston Salem, NC 27106 CERTIFICATE #: 5643 DATE OF INSPECTION: January 25, 2023 TYPE OF INSPECTION: Field Commercial Maintenance AUDITOR(S): Michael Cumbus LOCAL PERSON(S) CONTACTED: R. Jeff Wyatt I. INTRODUCTION: This laboratory was inspected by a representative of the North Carolina Wastewater/Groundwater Laboratory Certification Branch (NC WW/GW LCB) to verify its compliance with the requirements of 15A NCAC 02H .0800 for the analysis of compliance monitoring samples. II. GENERAL COMMENTS: The facility is neat and well organized and has all the equipment necessary to perform the analyses. The analyst was forthcoming and responded well to suggestions from the auditor. All required Proficiency Testing (PT) Samples have been analyzed and the laboratory has fulfilled its PT requirements for the 2022 PT Calendar Year. Any time changes are made to laboratory procedures, Quality Assurance (QA)/Standard Operating Procedure (SOP) documents must be updated and relevant staff retrained. Staff must acknowledge that they have read and understand the changes as part of the documented training program. The same requirements apply when changes are made in response to Findings, Recommendations or Comments listed in this report, to ensure the methods are being performed as stated, references to methods are accurate, and the QA and/or SOP document(s) is in agreement with each approved practice, test, analysis, measurement, monitoring procedure or regulatory requirement being used in the laboratory. In some instances, the laboratory may need to create an SOP to document how new functions or policies will be implemented. Revisions to the SOPs, based on the Findings, Comments and Recommendations within this report must be submitted to this office by August 31, 2023. The laboratory is reminded that SOPs are required to be reviewed at least every two years and are intended to describe procedures exactly as they are to be performed. Use of the word “should” is not appropriate when describing requirements (e.g., Quality Control (QC) frequency, acceptance criteria, etc.). Evaluate all SOPs for the proper use of the word “should”. Page 2 #5643 Geoscience & Technology PA Contracted analyses are performed by Meritech Inc. (Certification #165), Pace Analytical Services LLC Huntersville NC (Certification #12), Pace Analytical Services LLC Asheville NC (Certification #40), and Pace Analytical Services LLC - Eden NC (Certification #633). Approved Procedure documents for the analysis of the facility’s currently certified Field Parameters were provided at the time of the inspection. III. FINDINGS, REQUIREMENTS, COMMENTS AND RECOMMENDATIONS: Documentation Comment: The laboratory currently documents the date and time of sample collection and analysis for pH. Since the analysis is performed in situ, the laboratory may include this as a footnote on the pH benchsheet and eliminate the duplicate documentation. A. Finding: Error corrections are not properly performed. Requirement: All documentation errors shall be corrected by drawing a single line through the error so that the original entry remains legible. Entries shall not be obliterated by erasures or markings. Wite-Out®, correction tape, or similar products designed to obliterate documentation are not to be used; instead, the correction shall be written adjacent to the error. The correction shall be initialed by the responsible individual and the date of change documented. Ref: 15A NCAC 02H .0805 (g) (1). Comment: Several instances of write-overs were noted during the data review portion of the audit. Error corrections also lacked the date of the correction and initials of the responsible party. B. Finding: The laboratory is lacking a documented training program. Requirement: Each laboratory shall develop and implement a documented training program that includes the following: that staff have the education, training, experience, or demonstrated skills needed to generate quality control results within method-specified limits and that meet the requirements of these Rules; that staff have read the laboratory quality assurance manual or applicable Standard Operating Procedures; that staff have obtained acceptable results on Proficiency Testing Samples pursuant to Rule .0803(1) of this Section or other demonstrations of proficiency (e.g., side-by-side comparison with a trained analyst, acceptable results on a single-blind performance evaluation sample, an initial demonstration of capability study prescribed by the reference method). Ref: 15A NCAC 02H .0805 (g) (5). C. Finding: The laboratory is not documenting all traceability information for purchased materials, reagents and standards. Requirement: 15A NCAC 02H .0805 (a) (7) (K) and (g) (7) requires laboratories to have a documented system of traceability for the purchase, preparation, and use of all chemicals, reagents, standards, and consumables. That system must include documentation of the following information: Date received, Date Opened (in use), Vendor, Lot Number, and Expiration Date (where specified). A system (e.g., traceable identifiers) must be in place that links standard/reagent preparation information to analytical batches in which the solutions are used. Documentation of solution preparation must include the analyst’s initials, date of preparation, the volume or weight of standard(s) used, the solvent and final volume of the solution. This information as well as the vendor and/or manufacturer, lot number, and expiration date must be retained for primary standards, chemicals, reagents, and materials used for a period of five years. Consumable materials such as pH buffers, lots of pre-made Page 3 #5643 Geoscience & Technology PA standards and/or media, solids and bacteria filters, etc. are included in this requirement. Ref: NC WW/GW LCB Traceability Documentation Requirements for Chemicals, Reagents, Standards and Consumables Policy. Comment: There is a space on the laboratory benchsheet for Total Residual Chlorine (TRC) labeled “traceability” but no information was recorded on the benchsheets that were examined during the inspection. On February 6, 2023, the laboratory submitted a benchsheet with the Date In Use, lot number and expiration date documented. The submitted benchsheet was lacking the date received and the vendor. Comment: No traceability information was available for the pH buffer solutions. Comment: The distilled water purchased for preparing PT Samples is included in this requirement. D. Finding: The laboratory benchsheet is lacking required documentation: the method or Standard Operating Procedure reference; the laboratory identification; the instrument identification; the signature or initials of the analyst; sample identification; the proper units of measure and the program or calibration curve identification. Requirement: All laboratories shall use printable laboratory benchsheets. Certified Data shall be traceable to the associated sample analyses and shall consist of: the method or Standard Operating Procedure; the instrument identification; the signature or initials of the analyst; sample identification; the proper units of measure and any other data needed to reconstruct the final calculated result. Each item shall be recorded each time samples are analyzed. Analyses shall conform to methodologies found in Subparagraph (a)(1) of this Rule. Ref: 15A NCAC 02H .0805 (g) (2) (A) (C) (E) (I) (L) and (R). Comment: The laboratory benchsheets include the sampler’s initials but lack a note that the sampler and the analyst are the same person. Comment: The laboratory benchsheet for pH is lacking the parameter being analyzed. The pH benchsheet documents the sample identification as “Trinity American” but lacks the site identification listed in the permit as “001” or “effluent”. The pH benchsheet also does not consistently document the instrument identification. Comment: The laboratory benchsheet for TRC is lacking the instrument identification and sample identification. The laboratory benchsheet for TRC is also lacking the identification of the program or calibration curve used during analysis (see Finding L). E. Finding: Chemical containers are not dated when received and when opened. Requirement: Chemical containers shall be dated when received and when opened. Ref: 15A NCAC 02H .0805 (g) (7). Comment: The buffer solutions used to calibrate the pH meter were lacking both date received and date opened. Proficiency Testing F. Finding: The laboratory does not have a documented plan for PT procedures. Requirement: Each laboratory shall develop documentation outlining the analytical quality control practices used for the Parameter Methods included in its Certification, including Page 4 #5643 Geoscience & Technology PA Standard Operating Procedures for each certified Parameter Method. Quality assurance, quality control, and Standard Operating Procedure documentation shall indicate the effective date of the document and be reviewed every two years and updated if changes in procedures are made. Each laboratory shall have a formal process to track and document review dates and any revisions made in all quality assurance, quality control, and Standard Operating Procedure documents. Supporting Records shall be maintained as evidence that these practices are implemented. The quality assurance, quality control, and Standard Operating Procedure documents shall be available for inspection by the State Laboratory. Ref: 15A NCAC 02H .0805 (a) (7). Requirement: Laboratories must have a documented plan [this is usually detailed in the laboratory’s Quality Assurance Manual or may be a separate Standard Operating Procedure (SOP)] of how they intend to cover the applicable program requirements for Proficiency Testing per their scope of accreditation. This plan shall cover any commercially available PT Samples and any inter-laboratory organized studies, as applicable. The plan must also address the laboratory’s process for submission of PT Sample results and related Corrective Action Reports (CARs). Ref: Proficiency Testing Requirements, January 1, 2023, Revision 6, Section 3.0. G.Finding: The laboratory is not documenting the preparation of PT Samples. Requirement: PT Samples received as ampules are diluted according to the Accredited PT Sample Provider’s instructions. It is important to remember to document the preparation of PT Samples in a traceable log or other traceable format. The diluted PT Sample then becomes a routine Compliance Sample and is added to a routine sample batch for analysis. No documentation is needed for whole volume PT Samples which require no preparation, however the instructions must be maintained. Ref: Proficiency Testing Requirements, January 1, 2023, Revision 6, Section 3.6. Comment: Dating and initialing the instruction sheet for each prepared PT Sample would satisfy the documentation requirement. H.Finding: The laboratory is not documenting PT Sample analyses. Requirement: All PT Sample analyses must be recorded in the same daily analysis records (e.g., benchsheets) as for any Compliance Sample. This serves as the permanent laboratory record. Ref: Proficiency Testing Requirements, January 1, 2023, Revision 6, Section 3.6. Requirement: The laboratory shall retain all records necessary to facilitate historical reconstruction of the analysis and reporting of analytical results for PT Samples. This means the laboratory must have available and retain for five years [pursuant to 15A NCAC 02H .0805 (a) (7) (E) and (g) (1)] all of the raw data, including benchsheets, instrument printouts and calibration data, for all PT Sample analyses and the associated QC analyses conducted by all Parameter Methods. Ref: Proficiency Testing Requirements, January 1, 2023, Revision 6, Section 4.0. I.Finding: The laboratory does not document QC assessments. Requirement: All laboratories shall use printable laboratory benchsheets. Certified Data shall be traceable to the associated sample analyses and shall consist of: the quality control assessments. Ref: 15A NCAC 02H .0805 (g) (2) (O). Comment: The precision and accuracy of QC results must be documented and evaluated against the prescribed acceptance criteria to demonstrate that the analytical process is in Page 5 #5643 Geoscience & Technology PA control. Any samples associated with QC not meeting the criteria must be reanalyzed, if possible. If this is not possible, the data must be flagged on the non-Discharge Monitoring Reports (nDMR) as all quality control requirements not met and giving a brief description of the QC exceedance that occurred. Comment: The gel-type standard used as the daily QC check had an assigned value of 1.01 mg/L. The acceptance criterion is ± 10% of the assigned value. A checkbox on the benchsheet indicating that the acceptance criterion has been met would satisfy the requirement. Comment: The acceptance criterion for the pH check standard buffer is ± 0.1 S.U. A checkbox on the benchsheet indicating that the acceptance criterion has been met would satisfy the requirement. Comment: No data were examined where the QC results were not within the established acceptance criteria. Quality Assurance / Quality Control J. Finding: SOPs have not been fully developed for all of the methods included on the laboratory’s Certified Parameters Listing (CPL). Requirement: Laboratory procedures shall comply with Subparagraph (a)(1) of this Rule. A copy of each analytical method or Approved Procedure and Standard Operating Procedure shall be available to each analyst and available for review upon request by the State Laboratory. Standard Operating Procedure documentation shall state the effective date of the document and shall be reviewed every two years and updated if changes in procedures are made. Each laboratory shall have a formal process to track and document review dates and any revisions made in all Standard Operating Procedure documents. Supporting Records shall be maintained as evidence that these practices are implemented. Ref: 15A NCAC 02H .0805 (g) (4). Comment: The laboratory must have an updated QC/SOP document for the parameter methods included on their CPL by August 31, 2023. This must be submitted for review upon completion. SOP templates have been developed and are available for download on the NC WW/GW LCB website. Chlorine, Total Residual – Standard Methods, 4500 Cl G-2011 (Aqueous) K. Finding for Immediate Response: The laboratory is not using the proper reagent for Total Residual Chlorine (TRC) analyses. Requirement: To obtain total chlorine in one reading, add the full amount of KI at the start, with the specified amounts of buffer reagent and DPD indicator. Ref: Standard Methods, 4500 Cl G-2011 (4) (h). Comment: During the audit, it was noted that the DPD reagent used in TRC analyses was for Free Available Chlorine (FAC). The FAC reagent lacks the potassium iodide necessary to react with monochloramine and dichloramine that are part of the TRC analysis. It was pointed out that this could potentially yield low-bias sample results. Therefore, a Notice of Finding for Immediate Response was issued. The laboratory agreed to order and implement the proper reagent. A deadline of February 8, 2023 was negotiated with the laboratory to implement the reagent and submit a copy of the laboratory benchsheet. The laboratory submitted a benchsheet on February 6, 2023 for TRC analysis with traceability showing the proper reagent is being used. No further response is necessary for this Finding. Page 6 #5643 Geoscience & Technology PA L. Finding: The laboratory is performing analyses using the incorrect program. Requirement: The HI96711 can measure Free chlorine when range P1 is selected or Total chlorine when range P2 is selected. Ref: Hanna Instruments, HI96711C Free and Total Chlorine ISM Instrument Manual, January 2018. Comment: The laboratory has both the FAC program (P1) and TRC program (P2) verified annually. In an email dated January 31, 2023, the laboratory stated that they have been using P1. Comment: The laboratory submitted a benchsheet on February 6, 2023 with the correct instrument program in use as of February 1, 2023 and the program number documented. No further response is necessary for this Finding. M.Finding: The laboratory is not analyzing a Method Blank when using laboratory-prepared standards. Requirement: Laboratory procedures shall comply with Subparagraph (a)(1) of this Rule. Ref: 15A NCAC 02H .0805 (g) (4). Requirement: Method Blanks would be required when using laboratory-prepared standards [including Proficiency Testing (PT) Samples] and anytime sample dilutions are performed. Ref: NC WW/GW LCB Approved Procedure for the Analysis of Total Residual Chlorine (DPD Colorimetric by SM 4500 Cl G-2011). Requirement: The Method Blank is deionized or distilled water from the same source used to prepare the calibration verification standards or the PT Sample, and is analyzed like a sample (i.e., with DPD/buffer added). The concentration of the Method Blank must not exceed 50% of the reporting limit (i.e., the lowest calibration verification standard concentration) or corrective action must be taken. Ref: NC WW/GW LCB Approved Procedure for the Analysis of Total Residual Chlorine (DPD Colorimetric by SM 4500 Cl G- 2011). pH – Standard Methods, 4500 H+B-2011 (Aqueous) N.Finding: The laboratory is not using fresh aliquots of standard buffers to calibrate the pH meter each day. Requirement: Laboratory procedures shall comply with Subparagraph (a)(1) of this Rule. Ref: 15A NCAC 02H .0805 (g) (4). Requirement: A portion of the standard buffer is not to be used for more than one calibration. Discard any used buffer portions. Do not pour unused portions back into the original bottle. Ref: NC WW/GW LCB Approved Procedure for the Analysis of pH. O.Finding: Values were reported that exceed the method specified accuracy of 0.1 units. Requirement: By careful use of a laboratory pH meter with good electrodes, a precision of ±0.02 unit and an accuracy of ±0.05 unit can be achieved. However, ± 0.1 pH unit represents the limit of accuracy under normal conditions, especially for measurement of water and poorly buffered solutions. For this reason, report pH values to the nearest 0.1 pH unit. Ref: Standard Methods, 4500 H+ B-2011. (6). Page 7 #5643 Geoscience & Technology PA Comment: Per PT Vendor instructions, the PT Sample results should be reported to two decimal places, which is an exception to the requirement for Compliance Samples. Recommendation: The laboratory currently reports pH sample results to two decimal places. It is recommended that the laboratory continue to measure and document sample results on the benchsheet to two decimal places, and to round to the nearest 0.1 S.U. when reporting results on the nDMR. Reporting P.Finding: Values less than the established reporting limit are being reported on the nDMR. Requirement: Laboratory procedures shall comply with Subparagraph (a)(1) of this Rule. Ref: 15A NCAC 02H .0805 (g) (4). Requirement: For all calibration options, the range of standard concentrations must bracket the permitted discharge limit concentration, the range of sample concentrations to be analyzed and anticipated PT Sample concentrations. One of the standards must have a concentration less than the permitted Daily Maximum Limit. The lower reporting limit concentration is equal to the lowest standard concentration. Sample concentrations that are less than the lower reporting limit must be reported as a less-than value. Ref: NC WW/GW LC Approved Procedure for the Analysis of Total Residual Chlorine (DPD Colorimetric by SM 4500 Cl G- 2011). Comment: The laboratory established a lower reporting limit of 0.1 mg/L by verifying that concentration against the factory-set calibration curve. Values with concentrations less than that must be reported as < 0.1 mg/L on the nDMR. Q.Finding: Data qualifiers from the contract laboratory reports are not being transferred to the nDMR. Requirement: Each certified Field Laboratory shall be in accordance with Paragraph (e) of this Rule. Ref: 15A NCAC 02H .0805 (g) (17). Requirement: Reported data associated with quality control failures, improper sample collection, holding time exceedances, or improper preservation shall be qualified as such. Ref: 15A NCAC 02H .0805 (e) (5). Comment: The pH sample collected on July 27, 2022 was qualified by the contract laboratory for being analyzed outside of the 15 minute hold time, and the qualifier was not documented on the nDMR. IV.PAPER TRAIL INVESTIGATION: The paper trail consisted of comparing original records (e.g., laboratory benchsheets, logbooks, etc.) and contract laboratory reports to nDMRs submitted to the North Carolina Division of Water Resources. Data were reviewed for Trinity American Corporation (Non-Discharge permit # WQ0014756) for January 2022 through November 2022. The contract lab listed on the nDMR for July 2022 does not list the correct Certification number. The nDMR notes the certification number as #165, but the correct Certification number is #633. The following errors were noted: Page 8 #5643 Geoscience & Technology PA Date Parameter Location Value on Benchsheet *Contract Lab Data Value on nDMR 07/27/2022 TSS 001 *10.6 mg/L 106 mg/L 09/22/2022 Chlorine, Total Residual 001 0.06 mg/L 0.11 mg/L To avoid questions of legality, it is recommended that you contact the appropriate Regional Office for guidance as to whether amended nDMRs will be required. A copy of this report will be made available to the Regional Office. V.CONCLUSIONS: Correcting the above-cited Findings and implementing the Recommendations will help this laboratory to produce quality data and meet Certification requirements. The inspector would like to thank the staff for their assistance during the inspection and data review process. Please respond to all Findings and include supporting documentation, implementation dates and steps taken to prevent recurrence for each corrective action. Report prepared by: Michael Cumbus Date: February 9, 2023 Report reviewed by: Jill Puff Date: February 14, 2023 Certificate Number:5643 Effective Date:1/1/2022 Expiration Date:12/31/2022 Lab Name:GeoScience & Technology PA Address:2050 North Point Drive Winston-Salem, NC 27106- North Carolina Wastewater/Groundwater Laboratory Certification Certified Parameters Listing Date of Last Amendment:5/1/2018 The above named laboratory, having duly met the requirements of 15A NCAC 2H.0800, is hereby certified for the measurement of the parameters listed below. CERTIFIED PARAMETERS INORGANIC CHLORINE, TOTAL RESIDUAL SM 4500 Cl G-2011 (Aqueous) pH SM 4500 H+B-2011 (Aqueous) This certification requires maintance of an acceptable quality assurance program, use of approved methodology, and satisfactory performance on evaluation samples. Laboratories are subject to civil penalties and/or decertification for infractions as set forth in 15A NCAC 2H.0807.