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HomeMy WebLinkAbout#5537_2021_1208_MC_FINALFebruary 8, 2022 5537 Mr. Craig Koonts Davidson Water Inc. 388 Koontz Road Lexington, NC 27295- Subject: North Carolina Wastewater/Groundwater Laboratory Certification Branch (NC WW/GW LCB) Maintenance Inspection Dear Mr. Koonts: Enclosed is a report for the inspection performed on December 8, 2021 by Michael Cumbus. 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: Michael Cumbus, Todd Crawford, #5537 On-Site Inspection Report LABORATORY NAME: Davidson Water, Inc. NC GENERAL PERMIT #: NCG590021 ADDRESS: 388 Koontz Road Lexington, NC 27295 CERTIFICATE #: 5537 DATE OF INSPECTION: December 8, 2021 TYPE OF INSPECTION: Field Maintenance AUDITOR(S): Michael Cumbus LOCAL PERSON(S) CONTACTED: Craig Koonts 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 was forthcoming and responded well to suggestions from the auditor. All required Proficiency Testing (PT) Samples have been analyzed for the 2021 PT Calendar Year and the graded results were 100% acceptable. The laboratory is reminded that any time changes are made to laboratory procedures, the laboratory must update the QA/SOP document(s) and inform relevant staff. Any changes made in response to the pre- audit review or to Findings, Recommendations or Comments listed in this report must be incorporated to ensure the method is 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. 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 Environmental Chemists, Inc. (Certification #94) and Meritech, Inc (Certification #165). Page 2 #5537 Davidson Water, Inc. Approved Procedure documents for the analysis of the facility’s currently certified Field Parameters were provided at the time of the inspection. III. FINDINGS, REQUIREMENTS, COMMENTS AND RECOMMENDATIONS: Documentation A. Finding: The laboratory is lacking a documented training program. Requirement: Each laboratory shall develop and implement a documented training program that includes the following: that staff have the education, training, experience, or demonstrated skills needed to generate quality control results within method-specified limits and that meet the requirements of these Rules; that staff have read the laboratory quality assurance manual or applicable Standard Operating Procedures; that staff have obtained acceptable results on Proficiency Testing Samples pursuant to Rule .0803(1) of this Section or other demonstrations of proficiency (e.g., side-by-side comparison with a trained analyst, acceptable results on a single-blind performance evaluation sample, an initial demonstration of capability study prescribed by the reference method). Ref: 15A NCAC 02H .0805 (g) (5). Comment: The laboratory has a generalized training program for the operators, but it does not include aspects of laboratory requirements. B. Finding: The laboratory is not documenting all traceability information for purchased reagents and standards. 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 from the date of receipt shall be the expiration date unless degradation is observed prior to this date. The laboratory shall have a documented system of traceability for all chemicals, reagents, standards, and consumables. Ref: 15A NCAC 02H .0805 (g) (7). Requirement: 15A NCAC 02H .0805 (g) (7) requires laboratories to have a documented system of traceability for the purchase 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. 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… are included in this requirement. Ref: NC WW/GW LCB Policy. Comment: The laboratory is documenting the Date Opened (in use) on the Chlorine Buffer and DPD reagent containers for Total Residual Chlorine (TRC) and pH buffer containers. While this can provide a traceability link to analyses by looking at the dates that the chemicals were in use, that link is lost once the bottles are discarded. C. Finding: The laboratory benchsheet is lacking required documentation: the method or SOP reference, laboratory identification, instrument identification, the sample collector, time of Page 3 #5537 Davidson Water, Inc. sample collection, date of sample analyses, time of sample analyses, sample identification, 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 method or Standard Operating Procedure; the laboratory identification; the instrument identification; the sample collector; the date and time of sample collection; the date of sample analyses; the time of sample analyses (when required to document a required holding time or when time-critical steps are imposed by the method, a federal regulation, or this Rule); sample 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) (A) (B) (C) (D) (F) (G) (H) (I) and (L). Comment: The laboratory benchsheet is lacking the proper units of measure for pH (S.U.). Comment: The methods for which the laboratory is currently certified may be found on the Certified Parameters Listing (CPL). D.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: An entry on the laboratory benchsheet for July 12, 2021 was lacking the date of the correction. An entry on the laboratory benchsheet for October 20, 2021 was overwritten. Proficiency Testing E.Finding: The laboratory does not have a documented plan for PT procedures. 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). 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 laboratory must also be able to explain when PT Sample analysis is not possible for certain methods and provide a description of what the laboratory is doing in lieu of Proficiency Testing. This shall be detailed in the plan. 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, February 19, 2020, Revision 5, Section 3.0. Page 4 #5537 Davidson Water, Inc. Requirement: SOPs must address situations where the instructions from the Accredited PT Provider for the preparation, analysis or result calculations would constitute a deviation from the laboratory’s routine procedure. Examples of this may include how low-level PT Samples will be analyzed, including concentration of the sample or adjustment of the normality of a titrant. These instructions shall be followed when the concentration of a PT Sample is below the range of their routine analytical method. Instructions shall also be included in the laboratory’s SOP for how high-level PT Samples will be analyzed, including preparation of multiple dilutions of the sample. These instructions will be followed when the concentration of a PT Sample is above the range of their routine analytical method. Ref: Proficiency Testing Requirements, February 19, 2020, Revision 5, Section 3.0. F. Finding: The laboratory is not documenting the preparation of PT Samples. Requirement: PT Samples received as ampules are diluted according to the Accredited PT Sample Provider’s instructions. It is important to remember to document the preparation of PT Samples in a traceable log or other traceable format. The diluted PT Sample then becomes a routine Compliance Sample and is added to a routine sample batch for analysis. No documentation is needed for whole volume PT Samples which require no preparation, however the instructions must be maintained. Ref: Proficiency Testing Requirements, February 19, 2020, Revision 5, Section 3.6. Comment: Dating and initialing the instruction sheet for each prepared PT Sample would satisfy the documentation requirement. G.Finding: Additional QC beyond what is routine for Compliance Samples is being analyzed with PT 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 laboratory confirmed during the audit that additional QC was being performed in the form of a known value standard that is not routinely analyzed with compliance samples. Supporting documentation could not be found for this additional QC (see Finding H), Standards that are provided with the true values in a sealed envelope, are not considered PT Samples and do not meet the PT requirements outlined in 15A NCAC 02H .0800. Laboratories must not analyze additional standards with known concentrations along with PT Samples with unknown concentrations, as this is not the routine testing protocol for Compliance Samples. This is not to say that they cannot be used for troubleshooting purposes before analyzing a remedial PT Sample. This would be considered part of the corrective action plan. Page 5 #5537 Davidson Water, Inc. H.Finding: PT Samples are not being documented 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. Comment: The PT Sample data is currently recorded on the forms provided by the PT provider but is not recorded on the analytical benchsheet. QA/QC I.Finding: SOPs have not been fully developed for all of the methods included on the laboratory’s 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). The laboratory must have an updated QC/SOP document for the parameters included on their CPL by June 30, 2022. This must be submitted for review upon completion. SOP templates have been developed and are available for download on the NC WW/GW LCB website. A written response is required. Comment: An SOP describes the method in such detail that an experienced analyst unfamiliar with the method can obtain acceptable results and meet documentation requirements. SOPs must be developed which describe in detail how the methods are performed in that particular laboratory. Comment: The SOP document provided prior to inspection for TRC is a copy of the analytical method. The SOP document provided prior to inspection for pH included only the analytical procedure steps but no other information. J. Finding: The laboratory is not calibrating mechanical volumetric liquid-dispensing devices used for critical measurements at least once every 12 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). Page 6 #5537 Davidson Water, Inc. Comment: The laboratory is using an automatic pipettor to prepare the TRC PT Sample, which is considered a critical measurement. Alternatively, a Class-A volumetric pipet may be used. Reporting K.Finding: The laboratory does not report all characteristics of the pollutants analyzed from permitted locations. Requirement: The results of all tests on the characteristics of the effluent, including but not limited to NPDES permit monitoring requirements, shall be reported on the monthly report forms. Ref: 15A NCAC 2B .0506 (b) (3) (J). Comment: An effluent sample collected on July 12, 2021 was sent to Environmental Chemists, Inc. for analysis of Turbidity and Hardness. The sample was analyzed out of holding time for Turbidity as noted in the qualified Contract Lab Report. The results were not reported and another sample was collected and analyzed. Once analytical results have been obtained (qualified or not), the data must be reported on the DMR. Chlorine, Total Residual – Standard Methods, 4500 Cl G-2011 (Aqueous) Comment: During pre-inspection information gathering, it was discovered that the laboratory was having the instrument serviced by Hach annually but was not verifying the factory pre-set calibration curve. The laboratory was informed that verification of the curve, with standards bracketing the permitted discharge limit concentration, the range of sample concentrations to be analyzed and anticipated PT Sample concentrations, was required. An acceptable calibration curve verification was performed on November 29, 2021 by Meritech, Inc. The lowest standard concentration analyzed was 15 µg/L, which establishes the lower reporting limit as 15 µg/L. Compliance Sample results less than that must be reported as <15 µg/L on the DMR. L. Finding: The meter's Factory-set Calibration Curve Verification was not verified prior to initial use. 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 laboratory recently purchased a second Hach DR6000 spectrophotometer. If the second instrument will be used for TRC analyses, the factory-set calibration curve must be verified prior to sample analysis and the gel-type standards assigned a True Value for each instrument. M.Finding: The meter is not being zeroed with a Calibration Blank each day samples are analyzed. Page 7 #5537 Davidson Water, Inc. Requirement: Laboratory procedures shall comply with Subparagraph (a)(1) of this Rule. Ref: 15A NCAC 02H .0805 (g) (4). Requirement: When an annual five-standard Factory-set Calibration Curve verification is used, the laboratory must check the calibration curve each analysis day. To do this, the laboratory must zero the instrument with a Calibration Blank and analyze a Daily Check Standard (gel-type standards are most widely used for these purposes). Ref: NC WW/GW LCB Approved Procedure for the Analysis of Total Residual Chlorine (DPD Colorimetric by SM 4500 Cl G-2011). Comment: Current laboratory practice is to zero the instrument with a portion of sample that has not had reagents added to it. Zeroing the instrument with a portion of sample is optional but must be performed after zeroing the instrument with a Calibration Blank (the gel-type blank is sufficient for this purpose) and the analysis of a Daily Check Standard. N.Finding: The Factory-set Calibration Curve is not checked with a Daily Check Standard each day that samples are analyzed. Requirement: Laboratory procedures shall comply with Subparagraph (a)(1) of this Rule. Ref: 15A NCAC 02H .0805 (g) (4). Requirement: When an annual five-standard Factory-set Calibration Curve verification is used, the laboratory must check the calibration curve each analysis day. To do this, the laboratory must zero the instrument with a Calibration Blank and analyze a Daily Check Standard (gel-type standards are most widely used for these purposes). The value obtained for the Daily Check Standard must read within ±10% of the true value of the Daily Check Standard for standards ≥50 μg/L and within ±25% of its true value for standards <50 μg/L. If the obtained value is outside of the acceptance limits, corrective action must be taken. Ref: NC WW/GW LCB Approved Procedure for the Analysis of Total Residual Chlorine (DPD Colorimetric by SM 4500 Cl G-2011). O.Finding: The laboratory is not analyzing a Method Blank when applicable. Requirement: Laboratory procedures shall comply with Subparagraph (a)(1) of this Rule. Ref: 15A NCAC 02H .0805 (g) (4). Requirement: Method Blanks would be required when using laboratory-prepared standards [including Proficiency Testing (PT) Samples] and anytime sample dilutions are performed. Ref: NC WW/GW LCB Approved Procedure for the Analysis of Total Residual Chlorine (DPD Colorimetric by SM 4500 Cl G-2011). pH – Standard Methods, 4500 H+B-2011 (Aqueous) P.Finding: The laboratory benchsheet is lacking required documentation: value obtained for the check standard buffer, and the quality control assessments. 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. 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) (O). Requirement: Laboratory procedures shall comply with Subparagraph (a)(1) of this Rule. Ref: 15A NCAC 02H .0805 (g) (4). Page 8 #5537 Davidson Water, Inc. 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. Requirement: The following must be documented in indelible ink whenever sample analysis is performed: value obtained for the check standard buffer. Ref: NC WW/GW LCB Approved Procedure for the Analysis of pH. Comment: The calibration log for the pH meter did not list the result for the check standard buffer or the acceptance criterion of the check standard buffer. Q.Finding: The laboratory is not documenting the true value of the check standard buffer or buffers used for 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 values of buffers used for calibration; true value for the check standard buffer. Ref: NC WW/GW LCB Approved Procedure for the Analysis of pH. 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 Davidson Water, Inc. (NPDES permit # NCG590021) for June, July and November 2021. The following errors were noted: Date Parameter Location Value on Benchsheet *Contract Laboratory Data Value on DMR June 30, 2021 pH Effluent 6.5 S.U. No Value Reported July 12, 2021 Hardness, Total Effluent 40 mg/L* No Value Reported July 12, 2021 Turbidity Effluent 3.0 NTU* No Value Reported July 12, 2021 Chlorine, Total Residual Effluent 16.0 µg/L 0.16 µg/L July 22, 2021 pH Effluent 6.9 S.U. No Value Reported July 22, 2021 Chlorine, Total Residual Effluent 19.0 µg/L 0.19 µg/L To avoid questions of legality and possible monitoring frequency violations, it is recommended that you contact the appropriate Regional Office for guidance as to whether an amended DMR(s) will be required. A copy of this report will be made available to the Regional Office. V. CONCLUSIONS: Correcting the above-cited Findings will help this laboratory to produce quality data and meet Certification requirements. The inspector would like to thank the staff for their assistance during the inspection and data review process. Please respond to all Findings and include supporting documentation, implementation dates and steps taken to prevent recurrence for each corrective action. Report prepared by: Michael Cumbus Date: December 14, 2021 Report reviewed by: Tom Halvosa Date: December 17, 2021 Certificate Number:5537 Effective Date:1/1/2021 Expiration Date:12/31/2021 Lab Name:Davidson Water Inc. Address:388 Koontz Road Lexington, NC 27295- North Carolina Wastewater/Groundwater Laboratory Certification Certified Parameters Listing Date of Last Amendment: The above named laboratory, having duly met the requirements of 15A NCAC 2H.0800, is hereby certified for the measurement of the parameters listed below. CERTIFIED PARAMETERS INORGANIC CHLORINE, TOTAL RESIDUAL SM 4500 Cl G-2011 (Aqueous) pH SM 4500 H+B-2011 (Aqueous) 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.