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HomeMy WebLinkAbout#5158_2023_0112_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 February 16, 2023 5158 Mr. Darrell J. Covington Topsail Greens Subdivision P.O. Box 70 Hampstead, NC 28443 Subject: North Carolina Wastewater/Groundwater Laboratory Certification Branch (NC WW/GW LCB) Maintenance Inspection Dear Mr. Covington: Enclosed is a report for the inspection performed on January 12, 2023 by Jill Puff. 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 #5158 On-Site Inspection Report LABORATORY NAME: Topsail Greens Subdivision COUNTY SUBSURFACE PERMIT #: Pender County #487797 ADDRESS: Topsail Greens Subdivision CERTIFICATE #: 5158 DATE OF INSPECTION: January 12, 2023 TYPE OF INSPECTION: Field Maintenance AUDITOR(S): Jill Puff LOCAL PERSON(S) CONTACTED: Darrell Covington 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. The analyst was 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, 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/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 July 31, 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”. Contracted analyses are performed by Environmental Chemists, Inc. (Certification # 94). Page 2 # 5158 Topsail Greens Subdivision 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. 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. 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. Finding: The laboratory benchsheet is lacking required documentation: 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 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) (C). Comment: This Finding applies to pH and Temperature. C. 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). D. 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: This Finding applies to pH. Page 3 # 5158 Topsail Greens Subdivision E. 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). F. Finding: All analytical records are not consistently 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 benchsheets for July and October 2022 were not available for review. The laboratory recently had an abrupt change in staff and those benchsheets were not returned to the current operator. Recommendation: It is recommended that the laboratory designate a specific location for records storage and document that in the laboratory SOPs. Proficiency Testing G. Finding: The laboratory is not documenting 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. 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: This Finding applies to Settleable Residue. Comment: Dating and initialing the instruction sheet for each prepared PT Sample would satisfy the documentation requirement. pH - Standard Methods, 4500 H+ B-2011 (Aqueous) I. Finding: Values were reported that exceed the method specified accuracy of 0.1 units. Page 4 # 5158 Topsail Greens Subdivision 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 to Pender County. J. 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: There were no instances observed where there were unacceptable results for the check buffer. K. 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) L. Finding for Immediate Response: Temperature sensor check readings for devices used for compliance monitoring varied more than 0.5°C from the Reference Temperature- Measuring Device reading. Requirement: Laboratory procedures shall comply with Subparagraph (a)(1) of this Rule. Ref: 15A NCAC 02H .0805 (g) (4). Requirement: To check a compliance temperature-measuring device, compare readings at two temperatures that bracket the range of compliance samples routinely analyzed against a Reference Temperature-Measuring Device and record all four readings. The readings from both devices must agree within 0.5ºC. If they do not, the device may not be used for temperature compliance monitoring. Ref: NC WW/GW LCB Approved Procedure for the Analysis of Temperature. Page 5 # 5158 Topsail Greens Subdivision Comment: The laboratory currently uses a Baxter Scientific Glass Thermometer (Serial #T-2010-1) for compliance measurements. The laboratory contracted with Environmental Chemists, Inc. (Cert #94) to have the annual temperature verification performed on 3 devices on December 21, 2022. The readings on the Baxter Scientific thermometer and the 20i DO Meter varied by more than 0.5°C. from the Reference Temperature-Measuring Device. The readings on the Oakton pH Meter were acceptable. Comment: A Notice of Finding for Immediate Response (NOFIR) was issued due to the impact on reported data and so the laboratory would utilize an acceptable temperature monitoring device more quickly than if waiting to first receive the inspection report to take corrective action. The laboratory was instructed to submit verification that an acceptable temperature measuring device was being used A response date of January 27, 2023 was negotiated. The laboratory submitted a Corrective Action Plan on January 27, 2023 stating that the Oakton pH meter would be used for compliance measurements of temperature. No further response is required for this Finding. Reporting M. Finding: The laboratory does not report results of all tests on the characteristics of the effluent. Requirement: The results of all analyses for each sample shall be reported by the certified wastewater laboratory directly to the ORC and simultaneously to the health department and the state. 15A NCAC 18A .1970 (n) (5). Comment: The laboratory analyzes Settleable Residue on the effluent for operational process control but does not report the results on the DMR. 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 Pender County Health Department. Data were reviewed for Topsail Greens Subdivision WWTP (Pender County Subsurface permit # 487797) for August, September, and November 2022. There were numerous discrepancies between reported pH values and the DMR on the August and September reports. The current analyst assumed the responsibility of preparing the DMR beginning in November 2022 and there were no errors on that report. The laboratory was advised to contact the Pender County Health Department to determine whether amended DMRs would be required. Date Parameter Location Value on Benchsheet Value on DMR 8/1/2022 pH Effluent 8.09 S.U. 8.27 S.U. 8/3/2022 pH Effluent 8.41 S.U. 8.25 S.U. 8/4/2022 pH Effluent 8.64 S.U. 8.64 S.U. 8/15/2022 pH Effluent 7.29 S.U. 8.55 S.U. 8/17/2022 pH Effluent 7.56 S.U. 8.14 S.U. 8/18/2022 pH Effluent 7.56 S.U. 8.01 S.U. 8/20/2022 pH Effluent 7.52 S.U. 7.95 S.U. Page 6 # 5158 Topsail Greens Subdivision 8/21/2022 pH Effluent 7.54 S.U. 8.37 S.U. 8/22/2022 pH Effluent 7.63 S.U. 8.49 S.U. 8/24/2022 pH Effluent 7.54 S.U. 7.71 S.U. 8/25/2022 pH Effluent 7.73 S.U. 7.61 S.U. 8/28/2022 pH Effluent 7.62 S.U. 8.22 S.U. 8/29/2022 pH Effluent 7.60 S.U. 8.33 S.U. 8/31/2022 pH Effluent 7.62 S.U. 8.27 S.U. 9/1/2022 pH Effluent 7.64 S.U. 8.27 S.U. 9/3/2022 pH Effluent 7.36 S.U. 8.25 S.U. 9/4/2022 pH Effluent 7.59 S.U. 8.64 S.U. 9/6/2022 pH Effluent 7.55 S.U. 8.26 S.U. 9/7/2022 pH Effluent 7.80 S.U. 8.32 S.U. 9/8/2022 pH Effluent 7.69 S.U. 8.39 S.U. 9/10/2022 pH Effluent 7.75 S.U. 8.37 S.U. 9/11/2022 pH Effluent 7.53 S.U. 8.17 S.U. 9/12/2022 pH Effluent 7.51 S.U. 8.57 S.U. 9/14/2022 pH Effluent 6.97 S.U. 8.55 S.U. 9/17/2022 pH Effluent 7.31 S.U. 8.14 S.U. 9/18/2022 pH Effluent 7.37 S.U. 8.01 S.U. 9/20/2022 pH Effluent 7.36 S.U. 7.95 S.U. 9/21/2022 pH Effluent 7.31 S.U. 8.37 S.U. 9/23/2022 pH Effluent 7.19 S.U. 8.49 S.U. 9/24/2022 pH Effluent 7.36 S.U. 7.71 S.U. 9/25/2022 pH Effluent 7.20 S.U. 7.61 S.U. 9/27/2022 pH Effluent 7.20 S.U. 8.22 S.U. 9/29/2022 pH Effluent 7.24 S.U. 8.33 S.U. 9/30/2022 pH Effluent 7.30 S.U. 8.27 S.U. Page 7 # 5158 Topsail Greens Subdivision V. CONCLUSIONS: Correcting the above-cited Findings and implementing the Recommendations will help this laboratory to produce quality data and meet Certification requirements. The inspector would like to thank the staff for their assistance during the inspection and data review process. Please respond to all Findings and include supporting documentation, implementation dates and steps taken to prevent recurrence for each corrective action. Report prepared by: Jill Puff Date: January 25, 2023 Report reviewed by: Tom Halvosa Date: January 30, 2023 Certificate Number:5158 Effective Date:1/1/2023 Expiration Date:12/31/2023 Lab Name:Topsail Greens Subdivision Address:505 Topsail Plantation Dr Hampstead, NC 28443 North Carolina Wastewater/Groundwater Laboratory Certification Certified Parameters Listing Date of Last Amendment:9/1/2021 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 pH SM 4500 H+B-2011 (Aqueous) SW-846 9045 D (Non-Aqueous) RESIDUE, SETTLEABLE SM 2540 F-2015 (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.