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HomeMy WebLinkAbout#5362_2023_0825_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 September 21, 2023 5362 Mr. Jeff Jarman Scientific Water Co. 112 Scientific Lane Jacksonville, NC 28540- Subject: North Carolina Wastewater/Groundwater Laboratory Certification Branch (NC WW/GW LCB) Maintenance Inspection Dear Mr. Jarman: Enclosed is a report for the inspection performed on August 25, 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 5362 On-Site Inspection Report LABORATORY NAME: Scientific Water Co. NPDES PERMIT #: NC0036226 ADDRESS: 112 Scientific Lane Jacksonville, NC 28450 CERTIFICATE #: 5362 DATE OF INSPECTION: August 25, 2023 TYPE OF INSPECTION: Field Maintenance AUDITOR(S): Jill Puff LOCAL PERSON(S) CONTACTED: Jeffrey Jarman 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 for the 2023 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, 2023. 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 A. Any time changes are made to laboratory procedures, QA and/or 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 December 31, 2023. Page 2 #5362 Scientific Water Co. 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). 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: SOPs have not been developed for all of 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: This Finding applies to Temperature. The SOP for this parameter is required to be submitted with the report response. B. Finding: The laboratory benchsheet is lacking required documentation: the method or Standard Operating Procedure reference; the laboratory identification and sample identification. 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 and sample identification. Each item shall be recorded each time samples are analyzed. Analyses shall conform to methodologies found in Subparagraph (a)(1) of this Rule. Ref: 15A NCAC 02H .0805 (g) (2) (A) (B) and (I). C. 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 Temperature. Page 3 #5362 Scientific Water Co. D. Finding: The laboratory is not documenting the variables used to calibrate the DO meter. Requirement: Laboratory procedures shall comply with Subparagraph (a)(1) of this Rule. Ref: 15A NCAC 02H .0805 (g) (4). Requirement: The 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). E. Finding: The laboratory benchsheet is lacking required documentation: Date of most recent Total Residual Chlorine (TRC) calibration curve verification. Requirement: Laboratory procedures shall comply with Subparagraph (a)(1) of this Rule. Ref: 15A NCAC 02H .0805 (g) (4). Requirement: The following must be documented in indelible ink whenever sample analysis is performed: Date of most recent calibration curve generation or calibration curve verification. Ref: NC WW/GW LCB Approved Procedure for the Analysis of Total Residual Chlorine (DPD Colorimetric by SM 4500 Cl G-2011). F. Finding: The laboratory is not documenting all traceability information for purchased materials, reagents and standards. Requirement: 15A NCAC 02H .0805 (a) (7) (K) and (g) (7) requires laboratories to have a documented system of traceability for the purchase, preparation, and use of all chemicals, reagents, standards, and consumables. That system must include documentation of the following information: Date received, Date Opened (in use), Vendor, Lot Number, and Expiration Date (where specified). A system (e.g., traceable identifiers) must be in place that links standard/reagent preparation information to analytical batches in which the solutions are used. Documentation of solution preparation must include the analyst’s initials, date of preparation, the volume or weight of standard(s) used, the solvent and final volume of the solution. This information as well as the vendor and/or manufacturer, lot number, and expiration date must be retained for primary standards, chemicals, reagents, and materials used for a period of five years. Consumable materials such as pH buffers, lots of pre-made standards and/or media, solids and bacteria filters, etc. are included in this requirement. Ref: NC WW/GW LCB Traceability Documentation Requirements for Chemicals, Reagents, Standards and Consumables Policy (03/27/2020). Comment: Dates received and opened were written on the DPD indicator and pH buffer bottles, as required. While this can provide a traceability link to analyses while the chemicals are still in use, that link is lost once the bottles are discarded. Comment: An example traceability log was provided to the laboratory during the audit. Proficiency Testing G. Finding: The laboratory is not documenting the preparation of PT Samples. Page 4 #5362 Scientific Water Co. 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 TRC. Comment: Dating and initialing the instruction sheet for each prepared PT Sample would satisfy the documentation requirement. H. Finding: The laboratory does not have 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: The laboratory’s PT procedure may be outlined in each of the applicable parameter SOPs. The NC WW/GW LCB SOP Templates include a section for the PT procedure. Quality Assurance/Quality Control I. 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). Page 5 #5362 Scientific Water Co. 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. pH - Standard Methods, 4500 H+ B-2011 (Aqueous) 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). 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: All results for the check buffer were acceptable in the data sets reviewed. Chlorine, Total Residual – Standard Methods, 4500 Cl G-2011 (Aqueous) K. Finding: The laboratory is not assigning a true value to the gel-type standard 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). Comment: When a true value is assigned every 12 months, these standards may be used after the manufacturer’s expiration date. It is only necessary to assign a true value to the gel- type or sealed liquid standard which falls within the concentration range of the calibration curve used to measure sample concentrations. For example, if you are measuring samples against a low-range calibration curve, a 200 μg/L standard would be verified, and not the 800 μg/L standard since the 800 μg/L standard would be measured using a high-range calibration curve. Comment: The gel/sealed liquid standard must be assigned a true value for each applicable calibration curve on all instruments used by the laboratory. Documentation must link the gel/sealed liquid standard identification to the meter and curve with which the assigned value was determined. Reporting L. Finding: Data qualifiers from the contract laboratory reports are not being transferred to the Discharge Monitoring Report (DMR). Requirement: Each certified Field Laboratory shall be in accordance with Paragraph (e) of this Rule. Ref: 15A NCAC 02H .0805 (g) (17). Page 6 #5362 Scientific Water Co. 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). IV. 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: Jill Puff Date: August 31, 2023 Report reviewed by: Michael Cumbus Date: September 5, 2023 Certificate Number:5362 Effective Date:1/1/2023 Expiration Date:12/31/2023 Lab Name:Scientific Water Co. Address:112 Scientific Lane Jacksonville, NC 28540- North Carolina Wastewater/Groundwater Laboratory Certification Certified Parameters Listing Date of Last Amendment:10/12/2021 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.