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HomeMy WebLinkAbout#5665_2023_1003_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 December 1, 2023 5665 Mr. Tim Collins Town of Boonville P.O. Box 326 Boonville, NC 27011 Subject: North Carolina Wastewater/Groundwater Laboratory Certification Branch (NC WW/GW LCB) Maintenance Inspection Dear Mr. Collins: Enclosed is a report for the inspection performed on October 3, 2023 by Michael Cumbus. I apologize for the delay in getting this report to you. 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, #5665 On-Site Inspection Report LABORATORY NAME: Town of Boonville NPDES PERMIT #: NC0020931 ADDRESS: 456 Lon Ave. Boonville, NC CERTIFICATE #: 5665 DATE OF INSPECTION: October 3, 2023 TYPE OF INSPECTION: Field Municipal Initial AUDITOR(S): Michael Cumbus LOCAL PERSON(S) CONTACTED: Tim Collins 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 has all the equipment necessary to perform the analyses. The analyst was forthcoming and responded well to suggestions from the auditor. Any time changes are made to laboratory procedures, Quality Assurance (QA) and/or 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 SOP documents are 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. Drafts of the SOPs must be submitted to this office by February 29, 2024. 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”. Contracted analyses are performed by Statesville Analytical Holdings LLC (Certification #440). Approved Procedure documents for the analysis of the facility’s currently certified Field Parameters were provided at the time of the inspection. Page 2 #5665 Town of Boonville III. FINDINGS, REQUIREMENTS, COMMENTS AND RECOMMENDATIONS: Documentation Recommendation: It is recommended that the laboratory utilize the WWTP Operations Log as the first place data is recorded in order to facilitate data retrieval and review. Currently, data for Dissolved Oxygen (DO) is recorded solely in a bound notebook, while pH and Temperature data is recorded in the WWTP Operations Log. 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). B. Finding: The laboratory is not using indelible ink for all documentation purposes. Requirement: All manual data and log entries shall be written in indelible ink. Ref: 15A NCAC 02H .0805 (g) (1). Comment: The laboratory uses pencil to record data and log entries for pH and Temperature analyses. C. Finding: The laboratory lacks 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). D. Finding: The Temperature Measuring Devices (TMDs) used for compliance temperature analyses are not verified at the required frequency. Requirement: All analytical records, including original observations and information necessary to facilitate historical reconstruction of the calculated results, shall be maintained for five years. Ref: 15A NCAC 02H .0805 (g) (1). 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 an NIST traceable certificate, or with an expired NIST traceable certificate, must be verified against a Reference Temperature-Measuring Device and the process documented initially and every 12 months. 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 Page 3 #5665 Town of Boonville 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. Comment: At the time of the inspection, the analyst was not able to provide any records from the last five years documenting the annual verification of the TMDs used for compliance temperature monitoring. The contract laboratory emailed copies of the TMD verifications, performed on February 14, 2023 and February 16, 2023, to the auditor on November 17, 2023. E. Finding: The laboratory benchsheet for Dissolved Oxygen (DO) is lacking required documentation: the method or SOP reference; the laboratory identification; the instrument identification; the sample collector; the signature or initials of the analyst; the time of sample collection; the date and time of sample analysis; the proper units of measure; and the final value to be reported. 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 sample collector; the signature or initials of the analyst; the time of sample collection; the date of sample analyses; the time of sample analyses (when required to document a required holding time or when time-critical steps are imposed by the method, a federal regulation, or this Rule); the proper units of measure and the final value to be reported. 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), (D), (E), (F), (G), (H), (L) and (Q). Comment: When samples are analyzed immediately or in-situ, this may be noted and only one time may be recorded. Comment: When the sample collector and analyst are the same person, this may be noted and only one signature or initials may be recorded. Comment: The laboratory notebook does not clearly indicate which recorded numbers are the DO results to be reported. F. Finding: The laboratory benchsheet for DO is lacking required documentation: the meter calibration time and the Salinity value 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) and meter calibration and/or verification date and time(s). Ref: NC WW/GW LCB Approved Procedure for the Analysis of Dissolved Oxygen (DO). Requirement: Per NC WW/GW LC Branch policy, facilities may use the Salinity default value of zero when calibrating the DO meter unless it is known or suspected that the Salinity value Page 4 #5665 Town of Boonville of the samples being analyzed is > 9 ppt. In those situations, actual Salinity values must be used. Regardless of which value is used, it must be documented. Ref: NC WW/GW LCB Approved Procedure for the Analysis of Dissolved Oxygen (DO). Comment: The laboratory is using the Salinity default value of zero, but this is not documented. G. Finding: Calibration variables for the DO meter are not clearly identified as such. Requirement: All laboratories shall use printable benchsheets. Certified Data shall be traceable to the associated sample analyses and shall consist of: 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) (R). Comment: Numerical values for temperature, barometric pressure and percent saturation are recorded in the laboratory notebook, but these values lack labels that identify what variables the values represent. H. Finding: The laboratory is not documenting traceability information for purchased pH buffers. 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). 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 this requirement. Ref: NC WW/GW LCB Traceability Documentation Requirements for Chemicals, Reagents, Standards and Consumables Policy (03/27/2020). Quality Assurance/Quality Control I. Finding: SOPs are not available to each analyst and were not available for review upon request. 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: Staff informed the auditor during the inspection that they thought there were SOPs, but due to multiple personnel changes recently they were unable to locate the SOPs. Recommendation: It is recommended that the laboratory develop a dedicated system for document storage and note this in the SOPs or the laboratory operations manual. Page 5 #5665 Town of Boonville Dissolved Oxygen – ASTM D 888-12 C (Aqueous) J. Finding: When DO analyses are performed at multiple sample sites, the laboratory is not calibrating prior to sample analysis at each sample site or performing a Post-Analysis Calibration Verification. 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, the meter must be calibrated at each sample site prior to analysis or a post-analysis calibration verification must be performed at the end of the run, regardless of meter type. The calculated theoretical DO value must verify the meter reading within ±0.5 mg/L. If the meter verification does not read within ±0.5 mg/L of the theoretical DO, corrective action must be taken. If the meter is not calibrated at each sample site, it is recommended that a mid-day calibration be performed when samples are extended over an extended period of time. Ref: NC WW/GW LCB Approved Procedure for the Analysis of Dissolved Oxygen (DO). Temperature – Standard Methods, 2550 B-2010 (Aqueous) K. Finding: The compliance temperature-measuring devices are 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 0.5ºC. 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: The temperatures used during the TMD verifications did not exceed 22°C. Temperature readings in August 2023 regularly exceeded 22°C, with several instances of compliance temperatures exceeding 26°C noted. Recommendation: It is recommended that the laboratory review the last 12 months of Discharge Monitoring Reports (DMRs) to determine what temperatures must be used for future TMD verifications. pH – Standard Methods, 4500 H+ B-2011 (Aqueous) L. Finding: Values for pH 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: 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. Page 6 #5665 Town of Boonville 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 DMR. IV. 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: October 18, 2023 Report reviewed by: Jason Smith Date: October 19, 2023 Certificate Number:5665 Effective Date:1/1/2023 Expiration Date:12/31/2023 Lab Name:Town of Boonville Address:456 Lon Ave Boonville, NC 27011 North Carolina Wastewater/Groundwater Laboratory Certification Certified Parameters Listing Date of Last Amendment:9/9/2021 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 DISSOLVED OXYGEN ASTM D 888-12 C (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.