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HomeMy WebLinkAbout#5222_2022_0825_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 November 7, 2022 5222 Mr. Jimmy Mesimer Town of Kure Beach WWTP 117 Settlers Lane Kure Beach, NC 28449-3943 Subject: North Carolina Wastewater/Groundwater Laboratory Certification Branch (NC WW/GW LCB) Maintenance Inspection Dear Mr. Mesimer: Enclosed is a report for the inspection performed on August 25, 2022 by Jill Puff. 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. 251. Sincerely, Anna Ostendorff Technical Assistance & Compliance Specialist Division of Water Resources Attachment cc: Todd Crawford, Jill Puff, Master File #5222 On-Site Inspection Report LABORATORY NAME: Town of Kure Beach WWTP NPDES PERMIT #: NC0025763 ADDRESS: 401 H. Ave. Kure Beach, NC 28449-3943 CERTIFICATE #: 5222 DATE OF INSPECTION: August 25, 2022 TYPE OF INSPECTION: Field Municipal Maintenance AUDITOR(S): Jill Puff LOCAL PERSON(S) CONTACTED: Bradley Easley and Shawn Whitley 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. Staff were forthcoming and responded well to suggestions from the auditor. All required Proficiency Testing (PT) Samples have been analyzed for the 2022 PT Calendar Year and the graded results were 100% acceptable. 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 March 31, 2023. 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 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 #5222 Town of Kure Beach WWTP Contracted analyses are performed by Environmental Chemists, Inc. (Certification # 94). 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 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). B. 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: On January 11, 2022 and August 23, 2022, dates were overwritten as an improper means of correction and also lacked initials and the date of change. C. Finding: The laboratory benchsheet is lacking required documentation: the method or Standard Operating Procedure reference; and the instrument 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; and the instrument identification. 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) and (C). D. Finding: The units of measure for pH (i.e., Standard Units or S.U.) are not documented on the calibration log. Requirement: All laboratories shall use printable laboratory benchsheets. Certified Data shall be traceable to the associated sample analyses and shall consist of: the proper units of measure. Each item shall be recorded each time samples are analyzed. Ref: 15A NCAC 02H .0805 (g) (2) (L). E. Finding: The laboratory does not always document instrument calibration prior to analyzing PT Samples. Page 3 #5222 Town of Kure Beach WWTP Requirement: A record of instrument calibration or calibration verification shall be documented and available for inspection upon request. Ref: 15A NCAC 02H .0805 (g) (3). 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. Comment: The calibration of the pH meter was not documented on the date of the most recent Proficiency Testing Sample analysis. F. 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 this requirement. Ref: NC WW/GW LCB Traceability Documentation Requirements for Chemicals, Reagents, Standards and Consumables Policy. Comment: A traceability log was provided to the laboratory at the time of audit. G. 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). H. Finding: Process control data is not documented as such. Requirement: Each certified Field Laboratory shall be in accordance with Paragraph (e) of this Rule. Ref: 15A NCAC 02H .0805 (g) (17). Requirement: All uncertified data shall be documented as such on the benchsheet and on the final report. Ref: 15A NCAC 02H .0805 (e) (3). Comment: The process control samples are labeled with the same sample ID as the compliance samples on the laboratory benchsheet. Proficiency Testing I. Finding: The laboratory is not documenting PT Sample analyses in the daily analysis records. Page 4 #5222 Town of Kure Beach WWTP 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 the same benchsheets used for Compliance Samples. Ref: NC WW/GW LCB Proficiency Testing Samples Analyzed and Documented Same as Compliance Samples Policy. 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) K. Finding for Immediate Response: The Compliance Temperature-Measuring Device does not have a stated accuracy of ± 0.5 °C. Requirement: Laboratory procedures shall comply with Subparagraph (a)(1) of this Rule. Ref: 15A NCAC 02H 0805(g) (4). Requirement: All compliance temperature measurements must be made with a National Institute of Standards and Technology (NIST) traceable temperature-measuring device that has a demonstrated accuracy of ± 0.5 °C and equilibrates rapidly. Acceptable temperature- measuring devices for compliance monitoring include liquid-in-glass or electronic thermometers and devices such as Conductivity, Dissolved Oxygen, pH or multi-parameter meters. Ref: NC WW/GW LCB Approved Procedure for the Analysis of Temperature. Comment: The NIST-traceable thermometer used for compliance monitoring did not meet the specifications for a Compliance Temperature-Measuring device. The NIST-traceable thermometer (H-B Model 609001600) that is used has a stated accuracy of ± 2.0 °C. Comment: A Notice of Finding for Immediate Response (NOFIR) was issued due to the impact on reported data and so the laboratory would have an acceptable Compliance Temperature Measuring Device in use more quickly than if waiting to first receive the Page 5 #5222 Town of Kure Beach WWTP inspection report to take corrective action. A response due date of September 9, 2022 was negotiated. An NIST-traceable thermometer meeting the specifications for a Compliance Temperature-Measuring device was received and put into service by the laboratory on August 30, 2022. pH - Standard Methods, 4500 H+ B-2011 (Aqueous) L. Finding: The evaluation of the check standard buffer is not being documented on the benchsheet. 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: Adding a column on the calibration log to document whether or not the check standard buffer met the acceptance criterion would satisfy this requirement. Comment: All the check buffer values were acceptable in the data reviewed. Total Residual Chlorine – Standard Methods, 4500 Cl G-2011 (Aqueous) M. Finding: Values less than the established reporting limit are being reported on the Discharge Monitoring Report (DMR). 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 LCB Approved Procedure for the Analysis of Total Residual Chlorine (DPD Colorimetric by SM 4500 Cl G-2011). Comment: The lowest standard concentration analyzed in the most recent calibration curve verification was 10 µg/L. Samples with concentrations less than that must be reported as < 10 µg/L on the DMR. Comment: On January 18, 2022, the TRC of the effluent was reported as 5 µg/L. On February 15, 2022, the TRC of the effluent was reported as 2 µg/L. N. Finding: The laboratory benchsheet is lacking required documentation: Date of most recent TRC calibration curve verification. 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: Date of most recent calibration curve generation or calibration curve verification. Ref: NC WW/GW LCB Approved Procedure for the Analysis of Total Residual Chlorine (DPD Colorimetric by SM 4500 Cl G-2011). Page 6 #5222 Town of Kure Beach WWTP O. Finding: The laboratory did not assign a true value to the gel-type standard prior to initial use. 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). Requirement: To assign a true value to the gel-type or sealed liquid standard: 1. Zero the instrument with the calibration blank. 2. Read and record gel standard value. 3. Repeat steps 1 and 2 at least two more times. 4. Assign the average value as the true value. 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. Comment: The HACH gel standards, Lot #A2096, were received by the laboratory on August 8, 2022 and have an expiration date of April 2024. P. Finding: The laboratory is not performing a daily check of the calibration curve used to analyze compliance samples. 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). The value obtained for the Daily Check Standard must read within ±10% of the true value of the Daily Check Standard for standards ≥50 µg/L and within ±25% of its true value for standards <50 µg/L. If the obtained value is outside of the acceptance limits, 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). Comment: The gel standard is measured on the regular level curve (program) prior to the process control samples that are collected before dechlorination. The standard is not measured on the program with the low-level curve used when analyzing compliance monitoring samples. Reporting Q. 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). Page 7 #5222 Town of Kure Beach WWTP Comment: The samples analyzed by Environmental Chemists, Inc. on January 25, 2022, were lacking the following qualifications on the DMR: BOD – Sample estimated. Did not meet quality control requirements: Blank = 0.245 mg/L, above acceptable limit of 0.2 mg/L. The samples analyzed by Environmental Chemists, Inc. on February 1, 2022, were lacking the following qualifications on the DMR: BOD – Sample estimated. Did not meet quality control requirements: The blank result of 0.76 mg/L was above the acceptable limit of 0.20 mg/L and GGA of 119% was above the acceptable limit range of 85-115%. The samples analyzed by Environmental Chemists, Inc. on February 8, 2022, were lacking the following qualifications on the DMR: BOD – Sample estimated. Did not meet quality control requirements: Blank = 0.52 mg/L, above acceptable limit of 0.2 mg/L. The samples analyzed by Environmental Chemists, Inc. on February 15, 2022, were lacking the following qualifications on the DMR: BOD – Sample estimated. Did not meet quality control requirements: The GGA of 73% was below the acceptable limit range of 85-115%. 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 Town of Kure Beach WWTP (NPDES permit # NC0025763) for January 2022, February 2022 and March 2022. The following error was noted: Date Parameter Location Value on Benchsheet Value on DMR 2/7/2022 Temperature Effluent 10 °C 11 °C 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. V. 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. Report prepared by: Jill Puff Date: August 31, 2022 Report reviewed by: Michael Cumbus Date: August 31, 2022 Certificate Number:5222 Effective Date:1/1/2022 Expiration Date:12/31/2022 Lab Name:Town of Kure Beach WWTP Address:401 H Ave. Kure Beach, NC 28449 North Carolina Wastewater/Groundwater Laboratory Certification Certified Parameters Listing Date of Last Amendment: 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) 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.