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HomeMy WebLinkAbout#5091_2023_1211_JMS_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 February 23, 2024 5091 Mr. Robert Lipscomb United World Mission P.O. Box 250 Union Mills, NC 28167 Subject: North Carolina Wastewater/Groundwater Laboratory Certification Branch (NC WW/GW LCB) Maintenance Inspection Dear Mr. Lipscomb: Enclosed is a report for the inspection performed on December 11, 2023, by Jason Smith. 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) 745- 4368. Sincerely, Anna Ostendorff Technical Assistance & Compliance Specialist Division of Water Resources Attachment cc: Todd Crawford, Jason Smith, Master File #5091 On-Site Inspection Report LABORATORY NAME: United World Mission NPDES PERMIT #: NC0032174 ADDRESS: 6494 Hudlow Rd Union Mills, NC 28167 CERTIFICATE #: 5091 DATE OF INSPECTION: December 11, 2023 TYPE OF INSPECTION: Field Maintenance AUDITOR(S): Jason Smith LOCAL PERSON(S) CONTACTED: Robert Lipscomb and Donald Raisch 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 analysts were forthcoming and responded well to suggestions from the auditor. The laboratory has all the equipment necessary to perform the analyses. All required Proficiency Testing (PT) Samples have been analyzed for the 2023 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 June 1, 2024. The laboratory is reminded that SOPs 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 Earth Environmental Services (Certification #352). Page 2 #5091 United World Mission III. FINDINGS, REQUIREMENTS, COMMENTS AND RECOMMENDATIONS: Documentation A. Finding: Error corrections are not dated. 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). B. Finding: The laboratory benchsheet is lacking required documentation: the method or Standard Operating Procedure reference, the instrument identification, the time of sample analyses 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 method or Standard Operating Procedure, the instrument identification, 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), 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), (H) and (O). Comment: The instrument identification is documented for the pH and Dissolved Oxygen meters, but it’s not clear which one is used for compliance Temperature analyses. Comment: The benchsheet indicates that samples are analyzed immediately upon collection. However, the samples are collected and analyzed a few minutes later at the truck so both collection and analysis times must be documented. The “time” documented on the benchsheet is the collection time and the analysis time is not being documented. Comment: For this laboratory’s certified parameters, the only quality control assessment is for the pH check standard buffer which must be within 0.1 S.U. of the true value. C. Finding: The laboratory is not documenting the temperature value 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). D. 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 Page 3 #5091 United World Mission 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. Comment: Details of the training program must be submitted with updated SOPs by April 30, 2024. Documentation of employee training must be submitted by May 31, 2024. Proficiency Testing E. Finding: The laboratory is not documenting PT Sample analyses in the same manner as routine Compliance Samples. 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 results are only documented on the PT vendor reporting form. F. 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. Page 4 #5091 United World Mission 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 Recommendation: The laboratory SOPs describe calibration and sample analysis, but more detail is needed to be considered adequate. It is recommended that the laboratory download and complete the SOP templates from the NC WW/GW LCB website. G. Finding: SOPs are not reviewed every two years. 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: Since there are often changes in technology or options within a particular method that are not covered in published references, the laboratory SOP is the prescriptive reference document that describes a laboratory’s analytical procedure in detail. This document is intended to be the reference for analysts performing the specified test procedure. Please review the SOP and update as necessary to ensure that the method is being performed as stated, references to approved methods are correct, and the SOP is in agreement with the approved method, laboratory practice and regulatory requirements. H. Finding: The temperature of the sample storage refrigerator is not checked and documented. This is considered pertinent information. Requirement: All analytical records, including original observations and information necessary to facilitate historical reconstruction of the calculated results, shall be maintained for five years. All analytical data and records pertinent to each certified analysis shall be available for inspection upon request. Ref: 15A NCAC 02H .0805 (g) (1). Requirement: Aqueous samples must be preserved at ≤6 °C, and should not be frozen unless data demonstrating that sample freezing does not adversely impact sample integrity is maintained on file and accepted as valid by the regulatory authority. Also, for purposes of NPDES monitoring, the specification of ‘‘≤ °C’’ is used in place of the ‘‘4 °C’’ and ‘‘<4 °C’’ sample temperature requirements listed in some methods. It is not necessary to measure the sample temperature to three significant figures (1/100th of 1 degree); rather, three significant figures are specified so that rounding down to 6 °C may not be used to meet the ≤6 °C requirement. The preservation temperature does not apply to samples that are analyzed immediately (less than 15 minutes). Ref: Code of Federal Regulations, Title 40, Part 136; Federal Register Vol. 86, No. 95, May 19, 2021; Table II, Footnote 18. Comment: The temperature measuring device used in the refrigerator must meet the requirements in the NC WW/GW LCB Temperature-Measuring Devices used for Laboratory Operations Policy. It is only required to read and document the refrigerator temperature when samples are stored. Page 5 #5091 United World Mission Temperature – Standard Methods, 2550 B-2010 (Aqueous) I. Finding: The compliance temperature-measuring device is not checked at two temperatures that bracket the range of observed sample temperatures. 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 be ≤ 0.5ºC. If they are 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 meter used for compliance Temperature monitoring was verified at room temperature. IV. CONCLUSIONS: Correcting the above-cited Findings and implementing the Recommendation 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: Jason Smith Date: December 22, 2023 Report reviewed by: Tom Halvosa Date: January 8, 2024 Certificate Number:5091 Effective Date:1/1/2023 Expiration Date:12/31/2023 Lab Name:United World Mission Address:6494 Hudlow Rd Union Mills, NC 28167- North Carolina Wastewater/Groundwater Laboratory Certification Certified Parameters Listing Date of Last Amendment:10/27/2021 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 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.