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HomeMy WebLinkAbout#5318_2022_1011_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 December 16, 2022 5318 Mr. Bernie Hall Newport WWTP Lab P.O. Box 1869 Newport, NC 28570 Subject: North Carolina Wastewater/Groundwater Laboratory Certification Branch (NC WW/GW LCB) Maintenance Inspection Dear Mr. Hall: Enclosed is a report for the inspection performed on October 11, 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 #5318 On-Site Inspection Report LABORATORY NAME: Newport WWTP Lab NPDES PERMIT #: NC0021555 ADDRESS: 136 Kirby Lane Newport, NC 28570 CERTIFICATE #: 5318 DATE OF INSPECTION: October 11, 2022 TYPE OF INSPECTION: Field Municipal Maintenance AUDITOR(S): Jill Puff LOCAL PERSON(S) CONTACTED: Bernie Hall and John Simmons 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. 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 May 15, 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 #5318 Newport WWTP Lab 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: the method or Standard Operating Procedure reference, the laboratory identification, the instrument identification, the date of sample collection and the date of sample analysis. 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. 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) (F) and (G). Comment: The laboratory revised the benchsheet prior to the audit but had not yet put it into use. B. Finding: The laboratory calibration log is lacking required documentation: The laboratory identification; the instrument identification; 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: the laboratory identification; the instrument identification; 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) (B) (C) and (L). Comment: This Finding applies to pH and to Dissolved Oxygen (DO). 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 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: This Finding applies to pH and Total Residual Chlorine (TRC). Page 3 #5318 Newport WWTP Lab Comment: The traceability log for the laboratory was created prior to the audit and after current consumables were put into service. The dates received and opened were not able to be documented for the consumables currently in use (See Finding D) but the log has a space dedicated for this purpose D. 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). E. 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 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 August 15, 2022, the correction for the pH entry was not dated. F. Finding: The laboratory’s annual Factory-Set calibration verification for the chlorine meter could not be produced for years prior to 2021. Requirement: All analytical records, including original observations and information necessary to facilitate historical reconstruction of the calculated results, shall be maintained for five years. All analytical data and records pertinent to each certified analysis shall be available for inspection upon request. All analytical data and records shall be legible to all parties and safeguarded against unauthorized amendment, obliteration, erasures, overwriting and corruption. Records that are stored only on electronic media shall be maintained throughout the five-year retention period and supported in the laboratory by all hardware and software necessary for data retrieval and review. Ref: 15A NCAC 02H .0805 (g) (1). Comment: The calibration curve verification dated December 20, 2021 was the only dataset available for review. The laboratory recently had an abrupt change in staff and it is not always clear where the previous analyst stored records. G. Finding: The laboratory’s annual verification of the gel-type chlorine standard could not be produced for years prior to 2021. Requirement: All analytical records, including original observations and information necessary to facilitate historical reconstruction of the calculated results, shall be maintained for five years. All analytical data and records pertinent to each certified analysis shall be available for inspection upon request. All analytical data and records shall be legible to all parties and safeguarded against unauthorized amendment, obliteration, erasures, overwriting and corruption. Records that are stored only on electronic media shall be maintained throughout the five-year retention period and supported in the laboratory by all hardware and software necessary for data retrieval and review. Ref: 15A NCAC 02H .0805 (g) (1). 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 Page 4 #5318 Newport WWTP Lab every 12 months thereafter. Ref: NC WW/GW LCB Approved Procedure for the Analysis of Total Residual Chlorine (DPD Colorimetric by Hach 10014 ULR). Comment: The gel standard verification dated December 20, 2021 was the only dataset available for review. H. 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 Hach 10014 ULR). I. Finding: The laboratory’s annual verification of the compliance temperature-measuring device could not be produced for years prior to 2022. Requirement: All analytical records, including original observations and information necessary to facilitate historical reconstruction of the calculated results, shall be maintained for five years. All analytical data and records pertinent to each certified analysis shall be available for inspection upon request. All analytical data and records shall be legible to all parties and safeguarded against unauthorized amendment, obliteration, erasures, overwriting and corruption. Records that are stored only on electronic media shall be maintained throughout the five-year retention period and supported in the laboratory by all hardware and software necessary for data retrieval and review. 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 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: Annual verification of the compliance temperature-measuring device was performed by Environment 1, Inc. on September 14, 2022. That was the only dataset available for review. Page 5 #5318 Newport WWTP Lab Proficiency Testing J. Finding: The laboratory is not documenting PT Sample analyses in the same manner as routine Compliance Samples. 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. Comment: The only documentation of PT Sample analysis available was the printed vendor report for the current year. Comment: Meter calibration data for the date of PT Sample analysis is documented on the benchsheet and the pH calibration log. K. Finding: PT Samples are not being analyzed in the same manner as routine Compliance Samples. Requirement: Laboratories are required to analyze an appropriate PT Sample by each parameter method on the laboratory’s CPL. The same PT Sample may be analyzed by one or more methods. Laboratories shall conduct the analyses in accordance with their routine testing, calibration and reporting procedures, unless otherwise specified in the instructions supplied by the Accredited PT Sample Provider. This means that they are to be logged in and analyzed using the same staff, sample tracking systems, standard operating procedures including the same equipment, reagents, calibration techniques, analytical methods, preparatory techniques (e.g., digestions, distillations and extractions) and the same quality control acceptance criteria. PT Samples shall not be analyzed with additional quality control. They are not to be replicated beyond what is routine for Compliance Sample analysis. Although, it may be routine to spike Compliance Samples, it is neither required, nor recommended, for PT Samples. PT sample results from multiple analyses (when this is the routine procedure) must be calculated in the same manner as routine Compliance Samples. Ref: Proficiency Testing Requirements, February 19, 2020, Revision 5, Section 3.6. Comment: The analyst stated that the PT Sample for TRC was analyzed in duplicate and the average was reported, which is not how routine Compliance Samples are analyzed. L. Finding: The laboratory is not documenting the preparation of PT Samples. Page 6 #5318 Newport WWTP Lab 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. Dissolved Oxygen – Standard Methods, 4500 O G-2016 (Aqueous) M. Finding: The laboratory is producing Uncertified Data without reporting it as such. Requirement: “Uncertified Data" means any analytical result, including the Supporting Records, obtained using a method or procedure that is not acceptable to the State Laboratory pursuant to these Rules; analytical results produced by a laboratory for an analysis not within the scope of the rules of this Section; or analytical results produced by a laboratory without proper Certification. Ref: 15A NCAC 02H .0803 (35). 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: At the time of the inspection, the laboratory was not properly certified for the parameter method in use. They were certified for SM 4500 O G-2016, which is a membrane sensor technology. In practice, they were using a luminescence sensor technology, which is a separate parameter method (i.e., SM 4500 O H-2016). An Amendment Application was submitted on October 6, 2022 requesting the addition of the SM 4500 O H-2016 method. The laboratory gained certification effective October 19, 2022. Comment: The laboratory was instructed to report all compliance data for DO as uncertified until certification was granted for the correct method. N. 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 laboratory must document each time that a calibration is performed. Calibration documentation must include the instrument identification as well as the temperature, the elevation or barometric pressure (in mmHg), and the salinity of the sample to be analyzed. After calibration, record the final DO reading in mg/L or % saturation. Ref: NC WW/GW LCB Approved Procedure for the Analysis of Dissolved Oxygen (DO). Comment: The YSI ProSwap meter used for DO compliance measurement has the ability to store the calibration variables including barometric pressure and salinity. However, these variables must also be documented on the benchsheet or calibration log. O. Finding: When 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. Page 7 #5318 Newport WWTP Lab 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). pH – Standard Methods, 4500 H+ B-2011 (Aqueous) P. 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: 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 DMR. Q. Finding: The laboratory benchsheet does not clearly label which buffer is used to check the meter calibration. 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: True value for the check standard buffer. Ref: NC WW/GW LCB Approved Procedure for the Analysis of pH. R. Finding: The acceptance criterion for the check standard buffer is not being assessed. 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 laboratory is documenting the check standard buffer in whole numbers. NC WW/GW LCB requires the Check standard buffers to read within ±0.1 S.U. of the true value to be acceptable. An assessment of this requirement is not possible unless the result is documented to at least 0.1 S.U. Page 8 #5318 Newport WWTP Lab Total Residual Chlorine – Hach 10014 ULR (Aqueous) Recommendation: The laboratory currently reports TRC results as less than 20 µg/L. The lowest value on the annual curve verification is 10 µg/L, so it is recommended to report down to that level on the DMR. S. Finding: The laboratory is not subtracting the value of the Reagent Blank from sample results. Requirement: Laboratory procedures shall comply with Subparagraph (a)(1) of this Rule. Ref: 15A NCAC 02H .0805 (g) (4). Requirement: Analyze a Reagent Blank (Subtract that value from the Daily Check Standard, Method Blank and samples). Ref: NC WW/GW LCB Approved Procedure for the Analysis of Total Residual Chlorine (DPD Colorimetric by Hach 10014 ULR). Comment: The laboratory is analyzing a Reagent Blank daily but not documenting the measured value nor subtracting the measured value from sample results. Temperature – Standard Methods, 2550 B-2010 (Aqueous) Comment: Temperature is being reported to 0.1°C on the 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 Precision in Discharge Monitoring Reports document. Reporting T. 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 June 9, 2022 were lacking the following qualifications on the DMR: BOD – All Quality Control requirements were not met: (b) The dilution water blank was >0.20 mg/l. The samples analyzed by Environment 1, Inc. on June 14, 2022 were lacking the following qualifications on the DMR: BOD – All Quality Control requirements were not met: (b) The dilution water blank was >0.20 mg/l, and (g) the GGA check standard was not 198 ± 30.5 mg/l. Comment: 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 #5318 Newport WWTP Lab 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 Newport WWTP (NPDES permit # NC0021555) for June, July and August 2022. The following errors were noted: The Atmospheric temperature was reported on the DMR instead of the Effluent temperature in all instances for the months reviewed. The readings are adjacent on the daily logs. The laboratory was advised to contact the regional office to determine whether amended DMRs would be required. V. CONCLUSIONS: Correcting the above-cited Findings and implementing the Recommendation(s) 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: October 19, 2022 Report reviewed by: Jason Smith Date: October 24, 2022 Certificate Number:5318 Effective Date:1/1/2021 Expiration Date:12/31/2021 Lab Name:Newport WWTP Lab Address:136 Kirby Lane Newport, NC 28570 North Carolina Wastewater/Groundwater Laboratory Certification Certified Parameters Listing Date of Last Amendment:8/5/2021 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 CHLORINE, TOTAL RESIDUAL Hach 10014 ULR (Aqueous) DISSOLVED OXYGEN SM 4500 O G-2016 (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.