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HomeMy WebLinkAbout#5698_2023_1201_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 January 11, 2024 5698 Mr. Larry T. Chilton Seagrove-Ulah Metropolitan Water District PO Box 370 Seagrove, NC 27341 Subject: North Carolina Wastewater/Groundwater Laboratory Certification Branch (NC WW/GW LCB) Maintenance Inspection Dear Mr. Chilton: Enclosed is a report for the inspection performed on December 1, 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 (984) 220- 5439. Sincerely, Beth Swanson Technical Assistance & Compliance Specialist Division of Water Resources Attachment cc: Michael Cumbus, Todd Crawford, masterfile On-Site Inspection Report LABORATORY NAME: Seagrove-Ulah Metropolitan Water District WATER QUALITY PERMIT #: WQ0002648 ADDRESS: 770 Hwy 705 Seagrove, NC 27341 CERTIFICATE #: 5698 DATE OF INSPECTION: December 1, 2023 TYPE OF INSPECTION: Field Municipal Initial AUDITOR: Michael Cumbus LOCAL PERSON CONTACTED: Larry Chilton 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 very forthcoming and responded well to suggestions from the auditor. The lab recently transitioned to a new building, and improvements are still in progress. All required Proficiency Testing (PT) Samples have been analyzed for the 2023 PT Calendar Year and the graded results were 100% acceptable. The laboratory does not have Quality Assurance (QA) and/or Standard Operating Procedure (SOP) document(s) in place for all currently certified parameter methods. These documents must be submitted for review as specified in Finding A. Any time changes are made to laboratory procedures, Quality Assurance (QA) and/or Standard Operating Procedure (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 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. Revisions to the SOPs, based on the Findings, Comments and Recommendations within this report must be submitted to this office by March 31, 2024. Page 2 #5698 Seagrove-Ulah Metropolitan Water District 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 Cameron Testing Services, Inc. (Certification #654). 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 does not have QA/SOP documents for each certified parameter method, nor a documented plan for PT procedures. 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). 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. Comment: Since there are often changes in technology or options within a particular method that are not covered in published references the laboratory SOP is the prescriptive reference document that describes a laboratory’s analytical procedure in detail. This document is intended to be the reference for analysts performing the specified test procedure. Please review the SOP and update as necessary to ensure that the method is being performed as stated, references to standard methods are correct, and that the SOP is in agreement with approved practice and regulatory requirements. Comment: The laboratory must have QC/SOP documents for the PT procedures and parameter methods included on their Certified Parameter Listing (CPL) by March 31, 2024. These must be submitted for review upon completion. SOP templates have been developed and are available for download on the NC WW/GW LCB website. Comment: The laboratory’s PT procedure may be outlined in each of the applicable parameter method SOPs. The NC WW/GW LCB SOP Templates include a section for the PT procedure. B. Finding: The laboratory lacks a documented training program. Page 3 #5698 Seagrove-Ulah Metropolitan Water District 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). Comment: The laboratory’s training program may be outlined in each of the applicable parameter SOPs. The NC WW/GW LCB SOP Templates include an Employee Training section. C. Finding: The laboratory does not document 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 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). Comment: Dates received and opened were written on the pH buffer containers, as required. While this can provide a traceability link to analyses while the chemicals are still in use, that link is lost once the bottles are discarded. D. Finding: The laboratory benchsheets lack required documentation: sample collector, the date and time of sample collection and the proper units of measure. Requirement: All laboratories shall use printable laboratory benchsheets. Certified Data shall be traceable to the associated sample analyses and shall consist of: sample collector, the date and time of sample collection and the proper units of measure. 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) (D), (F) and (L). Comment: A blanket statement on the benchsheet that the analyst and sample collector are the same person would meet the requirement. E. Finding: The laboratory benchsheet for Total Residual Chlorine (TRC) lacks required documentation: the Daily Check Standard analysis time. Requirement: Laboratory procedures shall comply with Subparagraph (a)(1) of this Rule. Ref: 15A NCAC 02H .0805 (g) (4). Page 4 #5698 Seagrove-Ulah Metropolitan Water District Requirement: The following must be documented in indelible ink whenever sample analysis is performed: Daily Check Standard analysis date and time. Ref: NC WW/GW LCB Approved Procedure for the Analysis of Total Residual Chlorine (DPD Colorimetric by SM 4500 Cl G- 2011). Proficiency Testing F. Finding: PT Samples are not distributed among all analysts from year to year. Requirement: Laboratories shall also ensure that, from year to year, PT Samples are equally distributed among personnel trained and qualified for the relevant tests and instrumentation (when more than one instrument is used for routine Compliance Sample analyses), that represents the routine operation of the work group at the time the PT Sample analysis is conducted. Ref: Proficiency Testing Requirements, January 1, 2023, Revision 6, Section 3.6. G. Finding: The laboratory does not document 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. Comment: The laboratory records the results of PT Sample analyses solely on the electronic submission form, which is then printed. H. 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. Quality Assurance/Quality Control I. Finding: The laboratory is not diluting TRC samples that exceed the verified range of the instrument. Page 5 #5698 Seagrove-Ulah Metropolitan Water District 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. Ref: NC WW/GW LCB Approved Procedure for the Analysis of Total Residual Chlorine (DPD Colorimetric by SM 4500 Cl G- 2011). Comment: The colorimeter used for sample analyses has been verified up to 2.0 mg/L. Analytical results are occasionally close to or above this value. Undiluted results from October 27, 2023 were 2.1 mg/L as entered into the Non-Discharge Monitoring Report (NDMR). Comment: The laboratory is reminded that a Method Blank must be analyzed and evaluated whenever dilutions are performed. The Method Blank consists of the reagent water used to prepare dilutions, and is analyzed like a compliance sample (e.g., with DPD reagent). Chlorine, Total Residual – Standard Methods, 4500 Cl G-2011 (Aqueous) J. Finding: The meter is not being zeroed with a Calibration Blank each day samples are analyzed. Requirement: Laboratory procedures shall comply with Subparagraph (a)(1) of this Rule. Ref: 15A NCAC 02H .0805 (g) (4). Requirement: When an annual five-standard Factory-set Calibration Curve verification is used, the laboratory must check the calibration curve each analysis day. To do this, the laboratory must zero the instrument with a Calibration Blank and analyze a Daily Check Standard (gel-type standards are most widely used for these purposes). Ref: NC WW/GW LCB Approved Procedure for the Analysis of Total Residual Chlorine (DPD Colorimetric by SM 4500 Cl G-2011). Comment: Current laboratory practice is to zero the instrument with a portion of the sample prior to sample analysis to eliminate bias due to sample color (known as “sample blanking”). While this is an acceptable practice, the instrument must first be zeroed with a Calibration Blank (such as the gel-type Blank) and the Daily Check Standard analyzed, prior to sample blanking. K. Finding for Immediate Response: The laboratory is not verifying the instrument’s Factory- set Calibration Curve or assigning a true value to the Daily Check Standard every 12 months. 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: 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 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). Page 6 #5698 Seagrove-Ulah Metropolitan Water District 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). Comment: During the inspection, the analyst was unable to provide a copy of the most recent calibration curve verification and the assignment of a True Value to the Daily Check Standard. When asked if previous years were available, the analyst was unable to produce those either. A Notice of Finding for Immediate Response was issued with a negotiated deadline of December 15, 2023 for the laboratory to have the manufacturer’s calibration curve verified and a new True Value assigned to the Daily Check Standard. The analyst informed the auditor on December 11, 2023 that this had been completed by the contract laboratory. A copy of the verification report was provided to the auditor on December 13, 2023 with a passing calibration curve verification and a new True Value of 0.99 mg/L assigned to the Daily Check Standard. No Further Response is necessary for this Finding. pH – Standard Methods, 4500 H+ B-2011 (Aqueous) L. Finding: Samples are not being properly stirred during analysis. Requirement: Establish equilibrium between electrodes and sample by stirring sample to ensure homogeneity; stir gently to minimize carbon dioxide entrainment. Ref: Standard Methods, 4500 H+ B-2011. (4) (b). Comment: The analyst was following the manufacturer’s directions to stir and allow the reading to stabilize. The analyst interpreted this to mean that stirring should cease while the reading stabilized. The analyst was informed at the time of the inspection that stirring must continue until the reading stabilized. M. Finding: The laboratory is not analyzing a check standard buffer after calibration and prior to sample analysis. Requirement: Laboratory procedures shall comply with Subparagraph (a)(1) of this Rule. Ref: 15A NCAC 02H .0805 (g) (4). Requirement: Instruments are to be calibrated according to the manufacturer’s calibration procedure prior to analysis of samples each day compliance monitoring is performed. Calibration must include at least two buffers. The meter calibration must be verified with a third standard buffer solution (i.e., check buffer) prior to sample analysis. Ref: NC WW/GW LCB Approved Procedure for the Analysis of pH. Comment: The laboratory calibrates with three standard buffers. The analyst was informed that only two standard buffers were required for calibration and the third may be used for calibration verification. IV. CONCLUSIONS: Correcting the above-cited Findings 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. Page 7 #5698 Seagrove-Ulah Metropolitan Water District Report prepared by: Michael Cumbus Date: December 15, 2023 Report reviewed by: Tonja Springer Date: December 18, 2023 Certificate Number:5698 Effective Date:1/1/2023 Expiration Date:12/31/2023 Lab Name:Seagrove-Ulah Metropolitan Water District Address:770 Hwy 705 Seagrove, NC 27341 North Carolina Wastewater/Groundwater Laboratory Certification Certified Parameters Listing Date of Last Amendment:10/26/2017 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.