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HomeMy WebLinkAbout#5502_2022_0302_TLH_FINALNC 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 May 4, 2022 5502 Mr. Ryan Swain Town of Creswell P.O. Box 68 Creswell, NC 27928 Subject: North Carolina Wastewater/Groundwater Laboratory Certification Branch (NC WW/GW LCB) Maintenance Inspection Dear Mr. Swain: Enclosed is a report for the inspection performed on March 3, 2022 by Thomas Halvosa. 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 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: Todd Crawford, Thomas Halvosa, #5502 On-Site Inspection Report LABORATORY NAME: Town of Creswell NPDES PERMIT #: NC0027600 ADDRESS: 110 Palmetto Street Creswell, NC 27928 CERTIFICATE #: 5502 DATE OF INSPECTION: March 2, 2022 TYPE OF INSPECTION: Field Municipal Maintenance AUDITOR: Tom Halvosa LOCAL PERSON CONTACTED: Ryan Swain 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 has all the equipment necessary to perform the analyses but the Creswell Water Treatment Plant (WTP) laboratory was not neat or well organized. Contract laboratory client reports were scattered around the facility and were not well organized, which made them difficult to retrieve. During the inspection it was discovered that there is another permit associated with this Certification (Creswell Wastewater Treatment Plant, NC0048861). This inspection did not include the Wastewater Treatment Plant. The Findings and Comments in this report deal only with the Water Treatment Plant. However, all requirements listed in this report would also apply to the Wastewater Treatment Plant. 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 did not have Quality Assurance (QA) and/or Standard Operating Procedure (SOP) document(s) in place for all currently certified parameters. These documents must be submitted for review as specified in Finding I. 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, Page 2 # 5502 Town of Creswell 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. 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”. 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: General Laboratory A. Finding: Equipment and counter tops in the Water Treatment Laboratory were dirty and cluttered to the point where sample contamination could become an issue. Requirement: Each facility shall have glassware, chemicals, supplies, equipment, and a source of water that meets the criteria of the approved methodologies. Samples shall be analyzed in such a manner that contamination or error will not be introduced. Ref: 15A NCAC 02H .0805 (g) (6). Comment: See photo at the end of this report. Documentation B. Finding: The laboratory benchsheet for Total Residual Chlorine (TRC), Dissolved Oxygen (DO), pH and Temperature is lacking required documentation: the method or Standard Operating Procedure reference, the instrument identification, the sample collector, the signature or initials of the analyst, the proper units of measure, the quality control assessments and the true values of the TRC Daily Check Standard, and calibration and check standard buffers for pH. 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 instrument identification, the sample collector, the signature or initials of the analyst, 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), (C), (D), (E), (L), and (O). Requirement: The following must be documented in indelible ink whenever sample analysis is performed: True value of the Daily Check Standard. Ref: NC WW/GW LCB Approved Procedure for the Analysis of Total Residual Chlorine (DPD Colorimetric by SM 4500 Cl G- 2011). Requirement: The following must be documented in indelible ink whenever sample analysis is performed: True values of buffers used for calibration and true value for the check standard buffer. Ref: NC WW/GW LCB Approved Procedure for the Analysis of pH. Page 3 # 5502 Town of Creswell Comment: The laboratory benchsheet consists of a small spiral notebook that lacks method descriptions, instrument identifications and analyst signature or initials for all parameters. The DO, pH and Temperature parameters lack proper units. The TRC parameter is lacking documentation of the Daily Check Standard and the acceptance criterion. The pH parameter is lacking documentation of the calibration buffers and check standard buffer as well as acceptance criterion. The laboratory was provided with acceptable benchsheets the day after the inspection. C. Finding: The laboratory is not documenting the salinity, barometric pressure or temperature used in the DO meter calibration 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: 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 Hach HQ40D multimeter has an internal barometer that can be programmed to display the barometric pressure. Instructions on how to program the meter to display the barometric pressure were given to the laboratory after the inspection. If the Salinities for all sampling locations are less than 9 ppt, then the laboratory can note that on their benchsheet and not record Salinity every analysis. Refer to Finding O for additional information regarding salinity values. D. Finding: All original records are not being maintained for five years. 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). Comment: The laboratory is not maintaining compliance sample analysis results or PT Sample results for five years and was not aware of the requirement. E. Finding: The laboratory is not documenting traceability information for purchased materials, reagents and standards. Cited previously on February 19, 2013. 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 Policy. Comment: The laboratory does not have a traceability log. Page 4 # 5502 Town of Creswell Proficiency Testing F. Finding: The laboratory is not documenting the preparation of PT Samples. Cited previously on February 19, 2013. 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. G. Finding: The laboratory is not documenting PT Sample analyses in the same manner as routine Compliance Samples. Cited previously on February 19, 2013. 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 laboratory is not documenting PT Sample results. The analysis of PT samples is designed to evaluate the entire process used to routinely report environmental analytical results; therefore, PT samples must be analyzed and the process documented in the same manner as Compliance Samples. The policy requirement above went into effect after the inspection, on March 9, 2022. Quality Control H. Finding: Chemicals and/or reagents are used beyond the expiration date. Requirement: Chemical containers shall be dated when received and when opened. Reagent containers shall be dated, identified, and initialed when prepared. Chemicals and reagents exceeding the expiration date shall not be used. Chemicals and reagents shall be assigned expiration dates by the laboratory if not given by the manufacturer. If the laboratory is unable to determine an expiration date for a chemical or reagent, a one-year time period Page 5 # 5502 Town of Creswell from the date of receipt shall be the expiration date unless degradation is observed prior to this date. Ref: 15A NCAC 02H .0805 (g) (7). Comment: The Hach ULR Chlorine Buffer Solution and DPD Indicator Solution used for TRC analyses had an expiration date of October 2020. The Hach SINGLET™ Single-Use pH 7.00 Buffer had an expiration date of March 2018 and the pH 10.01 Buffer had an expiration date of February 2018. I. Finding: SOPs have not been developed for all the methods included on the laboratory’s Certified Parameters Listing (CPL). 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: The laboratory must have a QA/SOP document(s) for the parameters included on their CPL by October 3, 2022. These must be submitted for review upon completion. SOP templates have been developed and were provided to the laboratory prior to the inspection. A written response is required. J. 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). K. Finding: The laboratory is not calibrating the mechanical volumetric liquid-dispensing device used for critical measurements at least once every twelve 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 analyst uses an adjustable pipettor to prepare the annual TRC PT Sample. Alternatively, the laboratory could use a 1 mL Class A volumetric pipette and forgo the use of the adjustable pipettor when preparing the annual TRC PT. Chlorine, Total Residual – Standard Methods, 4500 Cl G-2011 (Aqueous) L. Finding for Immediate Response: The laboratory is not verifying the instrument’s Factory- set Calibration Curve every 12 months. Cited previously on February 19, 2013. Page 6 # 5502 Town of Creswell 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). Comment: The analyst did not have a 5-standard calibration curve verification documentation for the Hach DR 2800 meter. Because the lack of a valid calibration curve can cast serious doubt on the validity of data produced on the meter and the fact that the laboratory had been previously cited for not having performed the required 5-standard calibration curve verification, a Notice of Finding for Immediate Response (NOFIR) was issued. A response time of two weeks was given. Subsequent to the NOFIR being issued, it was determined that the TRC meter needed to be serviced by Hach. The laboratory has sent the meter to Hach for repair and is currently using a loaner TRC meter in the interim. M. Finding: The laboratory is not assigning the gel-type standard a true value every twelve months. 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. Comment: The laboratory had verified the Daily Check Gel Standard at some time in the past and assigned it a true value of 205 µg/L. However, the laboratory could not provide any documentation of when or how the true value was assigned. Dissolved Oxygen – Hach 10360-2011, Rev. 1.2 (Aqueous) N. Finding: The laboratory is not calibrating the meter prior to sample analysis at each sample site or performing a Post-Analysis Calibration Verification when analyses are performed at multiple sample sites. 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 Page 7 # 5502 Town of Creswell time. Ref: NC WW/GW LCB Approved Procedure for the Analysis of Dissolved Oxygen (DO). O. Finding: The laboratory is using the default salinity value of zero without determining whether it is ≤ 9ppt. Requirement: Laboratory procedures shall comply with Subparagraph (a)(1) of this Rule. Ref: 15A NCAC 02H .0805 (g) (4). 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 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 and its sampling locations are located in an area that may contain brackish water. The Salinity of the wastewater treatment plant Effluent, Upstream and Downstream samples have not been measured to determine if they exceed 9 ppt which would prohibit the use of a default Salinity value of zero when performing analyses. pH – Standard Methods, 4500 H+ B-2011 (Aqueous) P. 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. Temperature – Standard Methods, 2550 B-2010 (Aqueous) Q. Finding for Immediate Response: Documentation could not be supplied that demonstrates the temperature sensor on the DO meter used to obtain reported temperature values has been checked against a Reference Temperature-Measuring Device every 12 months. Cited previously on February 19, 2013. 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 Page 8 # 5502 Town of Creswell 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. Requirement: To check a compliance temperature-measuring device, compare readings at two temperatures that bracket the range of compliance samples routinely analyzed against a National Institute of Standards and Technology (NIST) traceable 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 temperature compliance monitoring. Ref: NC WW/GW LCB Approved Procedure for the Analysis of Temperature. Comment: The analyst is not verifying the accuracy of the temperature-measuring device. This can cast serious doubt on the validity of data produced on the temperature-measuring device. Because of this and the fact that the laboratory had been previously cited, a Notice of Finding for Immediate Response (NOFIR) was issued. A response time of two weeks was given. A commercial laboratory performed the compliance temperature-measuring device comparison check on March 10, 2022 and the results were acceptable. The laboratory has entered into an annual contract where Environment One will notify them that maintenance is due and take the compliance temperature-measuring device in for comparison. No further response is necessary for this Finding. IV. PAPER TRAIL INVESTIGATION: The paper trail consisted of comparing original records (e.g., laboratory benchsheets, logbooks, etc.) and contract laboratory reports to Discharge Monitoring Reports (DMRs) submitted to the North Carolina Division of Water Resources. Data were reviewed for the Town of Creswell (NPDES permit # NC0027600) for June and November 2021 and January 2022. No transcription errors were observed. The facility appears to be doing a good job of accurately transcribing data. V. CONCLUSIONS: We are concerned with the Findings that were cited previously and not corrected. The number and severity of the Findings may make much of the data reported by the laboratory appear questionable to third parties. Laboratory Decertification Ref: 15A NCAC 02H .0807 (a) (1), (13) and (14): A laboratory may be decertified for any or all parameters for up to one year for any or all of the following infractions: (1) Failing to maintain the facilities, or records, personnel, equipment, or quality control program as set forth in these Rules; or (13) Failing to respond to requests for information by the date due; or (14) Failing to comply with any other terms, conditions, or requirements of this Section or of Laboratory certification. Page 9 # 5502 Town of Creswell 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 its 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: Tom Halvosa Date: March 15, 2022 Report reviewed by: Jill Puff Date: March 16, 2022 Page 10 # 5502 Town of Creswell Photo taken March 3, 2022 of Creswell WTP Laboratory Certificate Number:5502 Effective Date:1/1/2022 Expiration Date:12/31/2022 Lab Name:Town of Creswell WTP Address:110 Palmetto Street Creswell, NC 27928 North Carolina Wastewater/Groundwater Laboratory Certification Certified Parameters Listing Date of Last Amendment:11/9/2018 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.