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HomeMy WebLinkAbout#5246_2022_0503_JP_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 June 10, 2022 5246 Mr. Roger Sullivan Town of Stantonsburg WQ Lab P.O. Box 10 Stantonsburg, NC 27883 Subject: North Carolina Wastewater/Groundwater Laboratory Certification Branch (NC WW/GW LCB) Maintenance Inspection Dear Mr. Sullivan: Enclosed is a report for the inspection performed on May 3, 2022 by Jill Puff. 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. 251. Sincerely, Anna Ostendorff Technical Assistance & Compliance Specialist Division of Water Resources Attachment cc: Todd Crawford, Jill Puff, Master File #5246 On-Site Inspection Report LABORATORY NAME: Town of Stantonsburg WQ Lab NPDES PERMIT #: NC0057606 ADDRESS: 7655 Peacock Bridge Rd. Stantonsburg, NC 27883 CERTIFICATE #: 5246 DATE OF INSPECTION: May 3, 2022 TYPE OF INSPECTION: Field Municipal Maintenance AUDITOR(S): Jill Puff LOCAL PERSON(S) CONTACTED: Roger Sullivan 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 lab supervisor assumed the role in 2020. Since then, he has written Standard Operating Procedures and implemented a documented training program. He was forthcoming, responded well to suggestions from the auditor and has already submitted preliminary corrective measures for review. All required Proficiency Testing (PT) Samples for the 2022 PT Calendar Year have not yet been analyzed. The laboratory is reminded that results must be received by this office directly from the vendor by September 30, 2022. The laboratory is reminded that any time changes are made to laboratory procedures, QA/SOP document(s) 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 December 30, 2022. The laboratory is also 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 Page 2 #5246 Town of Stantonsburg WQ Lab appropriate when describing requirements (e.g., Quality Control (QC) frequency, acceptance criteria, etc.). Evaluate all SOPs for the proper use of the word “should”. Contracted analyses are performed by Environment 1, Inc. (Certification # 10). 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 A. Finding: The laboratory benchsheet is lacking required documentation: meter calibration time. Requirement: Laboratory procedures shall comply with Subparagraph (a)(1) of this Rule. Ref: 15A NCAC 02H .0805 (g) (4). Requirement: The following must be documented in indelible ink whenever sample analysis is performed: Meter calibration and meter calibration time(s). Ref: NC WW/GW LCB Approved Procedure for the Analysis of Dissolved Oxygen (DO). B. Finding: The laboratory benchsheet is lacking required documentation: the method or Standard Operating Procedure reference; the laboratory identification; the instrument identification; the proper units of measure and all quality control assessments. 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 laboratory identification; the instrument identification, the proper units of measure; the quality control assessments. 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), (B), (C), (L) and (O). Comment: The laboratory identification is documented on the calibration log but not on the benchsheet. Recommendation: It is recommended that the laboratory add the NC WW/GW LCB Certification number (#5246) to the benchsheet to improve the legal defensibility of the data. C. Finding: The laboratory is not documenting 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 standards and/or media, solids and bacteria filters, etc. are included in Page 3 #5246 Town of Stantonsburg WQ Lab this requirement. Ref: NC WW/GW LCB Traceability Documentation Requirements for Chemicals, Reagents, Standards and Consumables Policy. Comment: The laboratory was provided with a traceability log at the time of inspection and immediately placed it into service, entering information for Total Residual Chlorine (TRC) reagents that had been received and opened on the previous day. D. Finding: The laboratory is not documenting the temperature, barometric pressure and salinity values used to calibrate the DO meter. Requirement: Laboratory procedures shall comply with Subparagraph (a)(1) of this Rule. Ref: 15A NCAC 02H .0805 (g) (4). Requirement: The following must be documented in indelible ink whenever sample analysis is performed: Calibration variables (temperature, elevation or barometric pressure [in mmHg], and salinity). Ref: NC WW/GW LCB Approved Procedure for the Analysis of Dissolved Oxygen (DO). Comment: The calibration temperature and barometric pressure change daily and are displayed on the screen of the DO meter. A salinity value of zero is programmed into the meter and can be documented as a blanket statement on the benchsheet rather than documenting each day. E. Finding: Only one time for sample collection and analysis is documented without noting samples are analyzed in situ. Requirement: Laboratory procedures shall comply with Subparagraph (a)(1) of this Rule. Ref: 15A NCAC 02H .0805 (g) (4). Requirement: Date and time of sample analysis must be documented to verify the 15- minute holding time is being met. Alternatively, one time may be documented for collection and analysis with the notation that samples are measured in situ or immediately at the sampling site. Ref: NC WW/GW LCB Approved Procedure for the Analysis of Dissolved Oxygen and NC WW/GW LCB Approved Procedure for the Analysis of pH. Requirement: The following must be documented in indelible ink whenever sample analysis is performed: Date and time of sample collection; Date and time of sample analysis - Alternatively, one time may be documented for collection and analysis with the notation that samples are measured in situ or immediately at the sampling site (i.e., immediately following collection at a location as near to the collection point as possible). When this ‘one time’ option is used, state that the documented time is both collection and analysis time. Ref: NC WW/GW LCB Approved Procedure for the Analysis of Temperature. Comment: This Finding applies to DO, pH and Temperature. Quality Control F. Finding: Error corrections are not always 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 Page 4 #5246 Town of Stantonsburg WQ Lab error. The correction shall be initialed by the responsible individual and the date of change documented. Ref: 15A NCAC 02H .0805 (g) (1). Comment: On July 7, 2021, the pH, DO and Temperature reading corrections were not dated. For the week of September 20 – 23, 2021, data were corrected but not initialed or dated. On October 23, 2021, the pH value correction was not dated. On April 7, 2022, the time of analysis was corrected but not initialed or dated. G. Finding: An inconsistency was noted between the SOP and laboratory practice as follows: The instructions for preparing the annual PT Sample specifies the use of volumetric glassware. 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: A 1000 mL beaker was used to dilute the Proficiency Testing Sample for TRC. The laboratory is in possession of volumetric glassware and the analyst was instructed in the proper use during the inspection. H. Finding: The laboratory is not calibrating the mechanical volumetric liquid-dispensing device used for critical measurements at least once every 12 months. Requirement: Mechanical volumetric liquid-dispensing devices (e.g., fixed and adjustable auto-pipettors and bottle-top dispensers) shall be calibrated at least once every twelve months. Ref: 15A NCAC 02H .0805 (g) (10). Comment: The pipettor is used for the preparation of the annual PT Sample for TRC. Proficiency Testing I. Finding: The laboratory is not documenting PT Sample analyses in the daily analysis records. Requirement: All PT Sample analyses must be recorded in the daily analysis records as for any Compliance Sample. This serves as the permanent laboratory record. Ref: Proficiency Testing Requirements, February 19, 2020, Revision 5, 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, February 19, 2020, Revision 5, Section 4.0. Requirement: The analysis of Proficiency Testing (PT) Samples is designed to evaluate the entire process used to routinely analyze and report Compliance Sample results. PT Samples must be analyzed the same as Compliance Samples. Also, documentation must be made on Page 5 #5246 Town of Stantonsburg WQ Lab the same benchsheets used for Compliance Samples. Ref: NC WW/GW LCB Proficiency Testing Samples Analyzed and Documented Same as Compliance Samples Policy. Comment: The results of PT testing were written on the instructions from the vendor packet. The NC WW/GW LCB ‘Proficiency Testing Samples Analyzed and Documented Same as Compliance Samples’ Policy was updated on March 9, 2022 to include the requirement that PT Sample analysis be documented on the same benchsheet that is used for Compliance Samples. J. 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, February 19, 2020, Revision 5, Section 3.6. Comment: Dating and initialing the instruction sheet for each prepared PT Sample would satisfy the documentation requirement. Temperature – Standard Methods, 2550 B-2010 (Aqueous) Comment: Temperature is being reported to 0.1°C on the Discharge Monitoring Report (DMR). Recommendation: Unless greater precision is required by the permit or data receiving agency, it is recommended that all temperatures reported for compliance monitoring, be reported in whole numbers as recommended by the DWR’s Precision in Discharge Monitoring Reports document. K. Finding for Immediate Response: The temperature sensors on the pH and DO meters used to obtain reported temperature values have not been checked against a Reference Temperature-Measuring Device every 12 months. Requirement: Laboratory procedures shall comply with Subparagraph (a)(1) of this Rule. Ref: 15A NCAC 02H 0805 (g) (4). Requirement: All compliance temperature-measuring devices without a valid NIST certificate must be checked initially and every 12 months against an NIST traceable temperature-measuring device and the process documented. Verification documentation must include the serial number of the device being checked. The serial number, stated accuracy and expiration date of the Reference Temperature-Measuring Device used in the comparison must also be documented. Verification data must be kept on file and be available for inspection for 5 years. Note: International Organization for Standardization (ISO) 17025 compliant vendors or other Certified laboratories may provide assistance in meeting this requirement. When an ISO compliant vendor provides this assistance, they must provide the serial number, accuracy and calibration date for the Reference Temperature-Measuring Device used for the verification. When a Certified laboratory provides this service, they must provide a copy of the NIST traceable certificate of the Reference Temperature-Measuring Device used for the verification. Ref: NC WW/GW LCB Approved Procedure for the Analysis of Temperature. Please respond with the corrective actions taken to prevent further recurrence of this Finding. Page 6 #5246 Town of Stantonsburg WQ Lab Requirement: A Reference Temperature-Measuring Device is an NIST traceable temperature-measuring device used only to verify the calibration of other temperature- measuring devices. It must have a stated accuracy of ± 0.5 °C, be able to distinguish temperature changes of 0.1 °C and equilibrate rapidly. Ref: NC WW/GW LCB Approved Procedure for the Analysis of Temperature. Requirement: To check a compliance temperature-measuring device, compare readings at two temperatures that bracket the range of compliance samples routinely analyzed against a Reference Temperature-Measuring Device and record all four readings. The readings from both devices must agree within 0.5ºC. If they do not, the device may not be used for temperature compliance monitoring. Ref: NC WW/GW LCB Approved Procedure for the Analysis of Temperature. Comment: A Notice of Finding for Immediate Response (NOFIR) was issued due to the impact on reported data and so the laboratory would have the temperature sensor verified more quickly than if waiting to first receive the inspection report to take corrective action. A new NIST thermometer to be used as the Reference Temperature-Measuring Device was ordered by the laboratory on April 19, 2022, with a targeted ship date of May 10, 2022. A response due date of May 17, 2022 was negotiated, but this deadline was missed due to supply chain issues. The laboratory made arrangements with Environment 1 to have the verifications completed by May 20, 2022, and documentation demonstrating acceptable verifications was submitted to the auditor on May 23, 2022. L. Finding: Temperature sensor check readings for devices used for compliance monitoring varied more than 0.5°C from the Reference Temperature-Measuring Device reading. Requirement: Laboratory procedures shall comply with Subparagraph (a)(1) of this Rule. Ref: 15A NCAC 02H .0805 (g) (4). Requirement: To check a compliance temperature-measuring device, compare readings at two temperatures that bracket the range of compliance samples routinely analyzed against a Reference Temperature-Measuring Device and record all four readings. The readings from both devices must agree within 0.5ºC. If they do not, the device may not be used for temperature compliance monitoring. Ref: NC WW/GW LCB Approved Procedure for the Analysis of Temperature. Comment: In April 2021, four temperature sensors were checked and the readings varied from 1.6 °C to 2.6°C from the Reference Temperature-Measuring Device. Upon examination of the Reference Temperature-Measuring Device during the audit a separation of the liquid in the column was discovered. The laboratory submitted documentation of temperature verification by Environment 1 on May 23, 2022. Three sensors had acceptable results, but a fourth did not and was taken out of service. M. Finding: The compliance temperature-measuring device is not checked at two temperatures that bracket the range of observed sample temperatures. Requirement: Laboratory procedures shall comply with Subparagraph (a)(1) of this Rule. Ref: 15A NCAC 02H .0805 (g) (4). Requirement: To check a compliance temperature-measuring device, compare readings at two temperatures that bracket the range of compliance samples routinely analyzed against a Reference Temperature-Measuring Device and record all four readings. The readings from both devices must agree within 0.5 ºC. If they do not, the device may not be used for Page 7 #5246 Town of Stantonsburg WQ Lab temperature compliance monitoring. Ref: NC WW/GW LCB Approved Procedure for the Analysis of Temperature. Comment: The probes used for compliance Temperature monitoring were only checked at a single temperature. pH – Standard Methods, 4500 H+ B-2011 (Aqueous) N. 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). Comment: The laboratory is reporting pH to two decimal places on the DMR. 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. O. Finding: The laboratory is not analyzing a post-analysis check standard buffer when analyses are performed at multiple sample sites in a single day. Requirement: Laboratory procedures shall comply with Subparagraph (a)(1) of this Rule. Ref: 15A NCAC 02H .0805 (g) (4). Requirement: When performing analyses at multiple sample sites, a post-analysis calibration verification using the check standard buffer must be analyzed at the end of the run. It is recommended that a mid-day check standard buffer be analyzed when samples are analyzed over an extended period of time. The post-analysis check standard buffer(s) must read within ±0.1 S.U. or corrective actions must be taken. If recalibration is necessary, all samples analyzed since the last acceptable calibration verification must be reanalyzed, if possible. If samples cannot be reanalyzed, the data must be qualified. Ref: NC WW/GW LCB Approved Procedure for the Analysis of pH. Comment: The laboratory is not analyzing a post-analysis check standard buffer on dates when analyses are performed at the upstream and downstream sites. Total Residual Chlorine – Standard Methods, 4500 Cl G-2011 (Aqueous) Comment: The facility utilizes UV disinfection and did not have compliance data available for review. Proficiency Testing data was evaluated for this parameter. P. Finding: The laboratory is not verifying the instrument’s Factory-set Calibration Curve every 12 months. Requirement: Laboratory procedures shall comply with Subparagraph (a)(1) of this Rule. Ref: 15A NCAC 02H .0805 (g) (4). Requirement: Annual Factory-set Calibration Curve Verification: This type of calibration curve verification must be performed initially, at least every 12 months and any time the instrument optics are serviced. Zero the instrument with a Calibration Blank and then analyze a Method Blank and a series of five standards (do not use gel or sealed liquid Page 8 #5246 Town of Stantonsburg WQ Lab standards for this purpose). The calibration standard values obtained must not vary by more than ±10% from the known value for standard concentrations greater than or equal to 50 μg/L and must not vary by more than ±25% from the known value for standard concentrations less than 50 μg/L. Ref: NC WW/GW LCB Approved Procedure for the Analysis of Total Residual Chlorine (DPD Colorimetric by SM 4500 Cl G-2011). Comment: The factory-set calibration curve was last verified by Environment 1, Inc. on June 10, 2020. Q. Finding: The laboratory has not assigned the gel-type standard a true value. Requirement: Laboratory procedures shall comply with Subparagraph (a)(1) of this Rule. Ref: 15A NCAC 02H .0805 (g) (4). Requirement: Purchased “gel-type” or sealed liquid standards may be used only for daily calibration curve verifications. These standards must have a true value assigned initially and every 12 months thereafter. Ref: NC WW/GW LCB Approved Procedure for the Analysis of Total Residual Chlorine (DPD Colorimetric by SM 4500 Cl G-2011). Please submit a copy of the gel verification with the report reply. Reporting R. Finding: Data qualifiers from the contract laboratory reports are not being transferred to the DMR. 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 samples analyzed by Environment 1, Inc. on September 29, 2021, February 9, 2022, February 16, 2022 and February 22, 2022 were lacking the following qualifications on the DMR: BOD – b. The Dilution water blank was >0.20 mg/L. The samples analyzed by Environment 1, Inc on February 12, 2022, February 22, 2022 and February 23, 2022 were lacking the following qualifications on the DMR: BOD – g. The GGA check standard was not 198 ± 30.5 mg/L. IV. PAPER TRAIL INVESTIGATION: The paper trail consisted of comparing original records (e.g., laboratory benchsheets, logbooks, etc.) and contract laboratory reports to DMRs submitted to the North Carolina Division of Water Resources. Data were reviewed for Stantonsburg WWTP (NPDES permit # NC0057606) for June 2021, September 2021 and December 2021. No transcription errors were observed. The facility appears to be doing a good job of accurately transcribing data. However, as stated in Finding R, data qualifiers were not transferred from the contract laboratory report. To avoid questions of legality, it is recommended that you contact the appropriate Regional Office for guidance as to whether an amended DMR(s) will be required. A copy of this report will be made available to the Regional Office. Page 9 #5246 Town of Stantonsburg WQ Lab 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: Jill Puff Date: May 10, 2022 Report reviewed by: Jason Smith Date: May 11, 2022 Certificate Number:5246 Effective Date:1/1/2022 Expiration Date:12/31/2022 Lab Name:Town of Stantonsburg WQ Lab Address:7655 Peacock Bridge Rd Stantonsburg, NC 27883 North Carolina Wastewater/Groundwater Laboratory Certification Certified Parameters Listing Date of Last Amendment:7/17/2020 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) DISSOLVED OXYGEN Hach 10360-2011, Rev. 1.2 (Aqueous) pH SM 4500 H+B-2011 (Aqueous) TEMPERATURE SM 2550 B-2010 (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.