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HomeMy WebLinkAbout#5601_2023_0914_TLH_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 14, 2023 5601 Mr. Kenneth Coleson Town of Columbia P.O. Box 361 Columbia, NC 27925 Mr. Coleson Subject: North Carolina Wastewater/Groundwater Laboratory Certification Branch (NC WW/GW LCB) Maintenance Inspection Dear Mr. Coleson: Enclosed is a report for the inspection performed on September 14, 2023 by Tom 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 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. 259. Sincerely, Beth Swanson Technical Assistance & Compliance Specialist Division of Water Resources Attachment cc: Todd Crawford, Tom Halvosa, #5601 On-Site Inspection Report LABORATORY NAME: Town of Columbia NPDES PERMIT #: NC0020443 and NC0007510 ADDRESS: 606 Light St Columbia, NC 27925 CERTIFICATE #: 5601 DATE OF INSPECTION: September 14, 2023 TYPE OF INSPECTION: Field Municipal Maintenance AUDITOR: Tom Halvosa LOCAL PERSON(S) CONTACTED: Kenneth Coleson and William Davenport 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 and the laboratory has fulfilled its PT requirements for the 2023 PT Calendar Year. The laboratory does not have Quality Assurance (QA) and/or Standard Operating Procedure (SOP) document(s) in place for all currently certified parameter methods. These documents must be submitted for review as specified in Finding A. 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 Waypoint Analytical - Greenville (Certification # 10). Approved Procedure documents for the analysis of the facility’s currently certified Field Parameters were provided at the time of the inspection. Page 2 #5601 Town of Columbia III. FINDINGS, REQUIREMENTS, COMMENTS AND RECOMMENDATIONS: Documentation A. Finding: The laboratory does not have QA/SOP documents for each certified parameter method nor a documented plan for PT procedures. Requirement: Laboratory Procedures. Laboratory procedures shall comply with Subparagraph (a)(1) of this Rule. A copy of each analytical method or Approved Procedure and Standard Operating Procedure shall be available to each analyst and available for review upon request by the State Laboratory. Standard Operating Procedure documentation shall state the effective date of the document and shall be reviewed every two years and updated if changes in procedures are made. Each laboratory shall have a formal process to track and document review dates and any revisions made in all Standard Operating Procedure documents. Supporting Records shall be maintained as evidence that these practices are implemented. Ref: 15A NCAC 02H .0805 (g) (4). Requirement: Laboratories must have a documented plan [this is usually detailed in the laboratory’s Quality Assurance Manual or may be a separate Standard Operating Procedure (SOP)] of how they intend to cover the applicable program requirements for Proficiency Testing per their scope of accreditation. This plan shall cover any commercially available PT Samples and any inter-laboratory organized studies, as applicable. The plan must also address the laboratory’s process for submission of PT Sample results and related Corrective Action Reports (CARs). Ref: Proficiency Testing Requirements, January 1, 2023, Revision 6, Section 3.0. Comment: These SOPs must be submitted for review upon completion with at least two submitted no later than February 1, 2024 and the rest by May 1, 2024. SOP templates have been developed and are available for download on the NC WW/GW LCB website. Comment: The laboratory’s PT procedure may be outlined in each of the applicable parameter method SOPs. The NC WW/GW LCB SOP Templates include a section for the PT procedure. B. Finding: The laboratory 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). Comment: The laboratory’s training program may be outlined in each of the applicable parameter SOPs. The NC WW/GW LCB SOP Templates include an Employee Training section. The documented training program must be submitted no later than May 1, 2024. C. Finding: All laboratory benchsheets are lacking required documentation: the method or Standard Operating Procedure reference; the laboratory identification; the instrument identification and the quality control assessments. Page 3 #5601 Town of Columbia 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; 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), (B), (C) and (O). Comment: The laboratory was provided with customized benchsheets with all the pertinent documentation requirements for both permits at the time of inspection. D. Finding: The laboratory benchsheet for temperature is lacking required documentation: 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 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) (L). E. 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: Errors are written over. Corrections are not dated or initialed. F. Finding: The laboratory is not documenting traceability information for purchased materials, reagents and standards. Cited previously on September 25, 2012. Requirement: 15A NCAC 02H .0805 (a) (7) (K) and (g) (7) requires laboratories to have a documented system of traceability for the purchase, preparation, and use of all chemicals, reagents, standards, and consumables. That system must include documentation of the following information: Date received, Date Opened (in use), Vendor, Lot Number, and Expiration Date (where specified). A system (e.g., traceable identifiers) must be in place that links standard/reagent preparation information to analytical batches in which the solutions are used. Documentation of solution preparation must include the analyst’s initials, date of preparation, the volume or weight of standard(s) used, the solvent and final volume of the solution. This information as well as the vendor and/or manufacturer, lot number, and expiration date must be retained for primary standards, chemicals, reagents, and materials used for a period of five years. Consumable materials such as pH buffers, lots of pre-made standards and/or media, solids and bacteria filters, etc. are included in this requirement. Ref: NC WW/GW LCB Traceability Documentation Requirements for Chemicals, Reagents, Standards and Consumables Policy (03/27/2020). Comment: The laboratory was provided with an example receipt log for purchased materials, reagents and standards at the time of the inspection. G. Finding: The laboratory is not documenting the variables used to calibrate the Dissolved Oxygen (DO) meter. Page 4 #5601 Town of Columbia 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). 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). H. Finding: The Total Residual Chlorine (TRC) benchsheet is lacking required documentation: Date of most recent 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). I. 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). Proficiency Testing J. Finding: The laboratory is not documenting PT Sample analyses. Cited previously on September 25, 2012. Requirement: All PT Sample analyses must be recorded in the same daily analysis records (e.g., benchsheets) as for any Compliance Sample. This serves as the permanent laboratory record. Ref: Proficiency Testing Requirements, January 1, 2023, Revision 6, Section 3.6. Requirement: The laboratory shall retain all records necessary to facilitate historical reconstruction of the analysis and reporting of analytical results for PT Samples. This means the laboratory must have available and retain for five years [pursuant to 15A NCAC 02H .0805 (a) (7) (E) and (g) (1)] all of the raw data, including benchsheets, instrument printouts and calibration data, for all PT Sample analyses and the associated QC analyses conducted by all Parameter Methods. Ref: Proficiency Testing Requirements, January 1, 2023, Revision 6, Section 4.0. Comment: The laboratory’s current practice is to record the instrument reading directly into the PT Vendor’s electronic submission form. No record of the analysis is maintained. K. Finding: The laboratory is not documenting the preparation of PT Samples. Cited previously on September 25, 2012. Page 5 #5601 Town of Columbia Requirement: PT Samples received as ampules are diluted according to the Accredited PT Sample Provider’s instructions. It is important to remember to document the preparation of PT Samples in a traceable log or other traceable format. The diluted PT Sample then becomes a routine Compliance Sample and is added to a routine sample batch for analysis. No documentation is needed for whole volume PT Samples which require no preparation, however the instructions must be maintained. Ref: Proficiency Testing Requirements, January 1, 2023, Revision 6, Section 3.6. Comment: Dating and initialing the instruction sheet for each prepared PT Sample would satisfy the documentation requirement. L. Finding: PT Samples are not being distributed among all analysts from year to year. Requirement: Laboratories shall also ensure that, from year to year, PT Samples are equally distributed among personnel trained and qualified for the relevant tests and instrumentation (when more than one instrument is used for routine Compliance Sample analyses), that represents the routine operation of the work group at the time the PT Sample analysis is conducted. Ref: Proficiency Testing Requirements, January 1, 2023, Revision 6, Section 3.6. Chlorine, Total Residual – 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. N. Finding: The laboratory failed to perform corrective action when the analysis of the Daily Check Standard was outside the recovery acceptance criterion. Requirement: If quality control results fall outside established limits or indicate an analytical problem, the laboratory shall identify the Root Cause of the failure. The problem shall be resolved through corrective action, the corrective action process documented, and any samples involved shall be reanalyzed, if possible. If the sample cannot be reanalyzed, or if the quality control results continue to fall outside established limits or indicate an analytical problem, the results shall be qualified as such. Ref: 15A NCAC 02H .0805 (g) (8). 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 Page 6 #5601 Town of Columbia 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 results of the Daily Check Standard were consistently more than 10% higher than the assigned true value going back to January 31, 2020 when the Daily Check Gel Standard was put into use. The meter’s calibration was recently verified on September 12, 2023 and the Gel standard was assigned a true value of 146 µg/L. The laboratory documented Daily Check Standard results of 194 µg/L and 195 µg/L on September 14, 2023 which is around 33% greater than the true value assigned on September 12, 2023. During the inspection, the analyst removed the cuvette housing and cleaned the optics using a can of compressed gas. Afterwards, the Daily Check Standard results averaged around 156 µg/L after several readings. It was agreed that the laboratory would contact the NC DEQ Washington Regional Office and determine if they need to qualify all compliance sample results on their DMRs where the Daily Check Standard QC failed. On September 29, 2023 they successfully performed another five-standard calibration verification and re-assigned a true value to the Gel standard of 140 µg/L. Dissolved Oxygen – Standard Methods, 4500 O G-2016 (Aqueous) O. Finding: The DO membrane was dirty, indicating the need for cleaning and required maintenance. 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). Requirement: Once the sensors have been properly installed, remember that periodic cleaning and DO membrane changes are required. If the membrane is coated with oxygen consuming (e.g., bacteria) or oxygen producing organisms (e.g., algae), erroneous readings may occur. Ref: YSI Model 556 Operators Manual, 11.1 and 11.1.1. Comment: The analyst could not recall the last time the membrane cap was changed or other maintenance was performed. pH - Standard Methods, 4500 H+ B-2011 (Aqueous) P. Finding: Corrective action is not performed when the pH calibration check standard does not read within ± 0.1 S.U. of the true value. Requirement: Laboratory procedures shall comply with Subparagraph (a)(1) of this Rule. Ref: 15A NCAC 02H .0805 (g) (4). Requirement: All check standard buffers must read within ±0.1 S.U. to be acceptable. If the meter verification does not read within ±0.1 S.U., corrective actions must be taken before any samples are analyzed. Ref: NC WW/GW LCB Approved Procedure for the Analysis of pH. Comment: If the check buffer does not read within ± 0.1 S.U., the laboratory should first try pouring a new aliquot of the check buffer and reading it again. If it still does not read within ± 0.1 S.U., the meter must be recalibrated. If, after recalibration, the check buffer does not read within ± 0.1 S.U., the meter and/or probe operation may be suspect and may require servicing. Page 7 #5601 Town of Columbia If the laboratory does not have a back-up meter/electrode, or another meter/electrode cannot be procured, the laboratory is required to report the measured pH results with a qualifier that indicates the value is estimated. Reporting Q. Finding: Qualified Data is not reported as such on 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: Data qualifiers from the contract laboratory reports are not transferred to the DMR. Comment: The laboratory did not qualify pH results on days that the Daily QC Check Buffer QC failed. It was agreed that the laboratory would contact the NC DEQ Washington Regional Office and determine if they need to amend previous DMR reports to qualify all compliance pH sample results where the Daily Check Buffer QC failed. IV. 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), (14) and (20): 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. (20) Failing to correct findings in an inspection report. 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: Tom Halvosa Date: September 28, 2023 Report reviewed by: Jason Smith Date: October 4, 2023 Certificate Number:5601 Effective Date:1/1/2023 Expiration Date:12/31/2023 Lab Name:Town of Columbia Address:606 Light St Columbia, NC 27925 North Carolina Wastewater/Groundwater Laboratory Certification Certified Parameters Listing Date of Last Amendment:11/9/2021 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 SM 4500 Cl G-2011 (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.