Jim o'Dell. ord Thomas Semkow. NYSDOH Alicia P Ordona VA DCLS Jody Shoemaker, ORD Pavin Parekh. NYSDOH Sandra Spence, Region 8 Virgina Palomo, OR Mary e T. Stancavage, MD HMH Oscar Pancorbo MA DEP David Stockton, Region 6 Bahman Parsa. NJDHSS Miguel R. Suarez, Region 5 Gary Perryman, Region 8 Marilyn Thornton, Region 4 Barry Pharoah, ID Lisa touet MA DEP Max Phillips, TCEQ Laura traas. WDOTCP Sandra radwin ID Timothy Troup, AR DOH Sara Rairick. AK ayne Turnbull, Region 4 Robert rieck, Region 10 Debra waller. NJDEP J. Jane Roll. AR DOH Ted Witten, OK DEQ Irene Ronning, OR PHL Bruce wo Jack Ruckman, NV BLC Kenneth Wunschel, RI DOH David Russell, Region 3 Yue Zhang, TDH Eileen Sanders. VA DCLS Tim Sanders, Region 6 Editing Philip schlossberg, CT DPH Patricia R. Louis FSMD. ORD Richard Shibley, PA DEP
iv Jim O’Dell, ORD Alicia P. Ordona, VA DCLS Pavin Parekh, NYSDOH Virgina Palomo, OR Oscar Pancorbo, MA DEP Bahman Parsa, NJDHSS Gary Perryman, Region 8 Barry Pharoah, ID Max Phillips, TCEQ Sandra Radwin, ID Sara Rairick, AK Robert Rieck, Region 10 J.Jane Roll, AR DOH Irene Ronning, OR PHL Jack Ruckman, NV BLC David Russell, Region 3 Eileen Sanders, VA DCLS Tim Sanders, Region 6 Philip Schlossberg, CT DPH Richard Sheibley, PA DEP Thomas Semkow, NYSDOH Jody Shoemaker,ORD Sandra Spence, Region 8 Mary E. T. Stancavage, MD HMH David Stockton, Region 6 Miguel R. Suarez, Region 5 Marilyn Thornton, Region 4 Lisa Touet, MA DEP Laura Traas, WDOTCP Timothy Troup, AR DOH Wayne Turnbull, Region 4 Debra Waller, NJDEP Ted Witten, OK DEQ Bruce Woods, Region 10 Kenneth Wunschel, RI DOH Yue Zhang, TDH Editing Patricia R. Louis, FSMD, ORD
Preface Since 1978, the U.S. Environmental Protection Agency(EPA)has implemented a certification program for laboratories performing drinking water analyses for compliance with regulations issued pursuant to the Safe Drinking Water Act. These laboratories include EPA Regional laboratories, certain Federal laboratories, Tribal Nation laboratories, principa State laboratories in primacy States, and drinking water laboratories in non-primacy States. This manual describes criteria and procedures that EPa uses in evaluating laboratories for certification. EPA has concluded that laboratories that adopt the approaches discussed in this manual will generate reliable analytical data. Consequently, EPA recommends that States follow these procedures and criteria in their certification decisions This document is the fifth edition of the manual, describing the programs implementation procedures and technical criteria. It supersedes the Manual for the Certification of Laboratories Analyzing Drinking Water, EPA-815-B-97-001 March 1997) The manual was revised to address: 1 )the recently promulgated drinking water regulations and methods; and 2)Agency policy (office of Ground water and Drinking water memo, October 1, 2002)(see Appendix F)that, at the discretion of each state's Certification Authority(CA), allows National Environmental Laboratory Accreditation Program (NELAP) accreditation to be accepted in lieu of drinking water certification in terms of producing data for compliance monitoring A committee chaired by the EPA's office of Ground Water and Drinking Water (oGwDw) with participation of the National Exposure Research Laboratories in Cincinnati (NERL-Ci) and representatives from the EPa regions and the States prepared this document. Its goal is to improve implementation of the SDWa in light of newly approved methodology and additional experience with the program Like previous editions, this edition is in loose-leaf format which will allow the EPa to update it more easily. Holders of this manual should check with the Epa region or the State Certification Officers to make sure their manual is current. Additional copies of this manual may be obtained from the epa, oGWDw, 26 W m. King Dr, Cincinnati, OH 45268, fax number 513 569-7191, or by calling the Safe Drinking Water Hotline at 800 426-4791. The manual is also postedontheInternetatwww.epa.gov/safewater/certlab/labindex.html To ensure uniformity in its program in all the regions, EPa uses the certification criteria in this manual for evaluating all drinking water laboratories that it certifies. The Agency also uses this manual to determine the adequacy of State certification programs for drinking water laboratories. States are encouraged to use the criteria in this manual to evaluate all laboratories that they certify Generally the term"must"in this manual refers to elements that are required by the national Primary Drinking Water Regulations or the approved drinking water methods. This manual uses the term"should"to describe criteria and procedures that in OWs judgement are necessary for laboratories to produce data that are scientifically valid and defensible, and are of known and acceptable precision and accuracy
v Preface Since 1978, the U. S. Environmental Protection Agency (EPA) has implemented a certification program for laboratories performing drinking water analyses for compliance with regulations issued pursuant to the Safe Drinking Water Act. These laboratories include EPA Regional laboratories, certain Federal laboratories, Tribal Nation laboratories, principal State laboratories in primacy States, and drinking water laboratories in non-primacy States. This manual describes criteria and procedures that EPA uses in evaluating laboratories for certification. EPA has concluded that laboratories that adopt the approaches discussed in this manual will generate reliable analytical data. Consequently, EPA recommends that States follow these procedures and criteria in their certification decisions. This document is the fifth edition of the manual, describing the program's implementation procedures and technical criteria. It supersedes the Manual for the Certification of Laboratories Analyzing Drinking Water, EPA-815-B-97-001 (March 1997). The manual was revised to address: 1)the recently promulgated drinking water regulations and methods; and 2) Agency policy (Office of Ground Water and Drinking water memo, October 1, 2002)(see Appendix F) that, at the discretion of each state’s Certification Authority (CA), allows National Environmental Laboratory Accreditation Program (NELAP) accreditation to be accepted in lieu of drinking water certification in terms of producing data for compliance monitoring purposes. A committee chaired by the EPA's Office of Ground Water and Drinking Water (OGWDW) with participation of the National Exposure Research Laboratories in Cincinnati (NERL-Ci) and representatives from the EPA Regions and the States prepared this document. Its goal is to improve implementation of the SDWA in light of newly approved methodology and additional experience with the program. Like previous editions, this edition is in loose-leaf format which will allow the EPA to update it more easily. Holders of this manual should check with the EPA Region or the State Certification Officers to make sure their manual is current. Additional copies of this manual may be obtained from the EPA, OGWDW, 26 W M.L. King Dr., Cincinnati, OH, 45268, fax number 513 569-7191, or by calling the Safe Drinking Water Hotline at 800 426-4791. The manual is also posted on the Internet at www.epa.gov/safewater/certlab/labindex.html. To ensure uniformity in its program in all the Regions, EPA uses the certification criteria in this manual for evaluating all drinking water laboratories that it certifies. The Agency also uses this manual to determine the adequacy of State certification programs for drinking water laboratories. States are encouraged to use the criteria in this manual to evaluate all laboratories that they certify. Generally the term "must" in this manual refers to elements that are required by the National Primary Drinking Water Regulations or the approved drinking water methods. This manual uses the term "should” to describe criteria and procedures that in OW’s judgement are necessary for laboratories to produce data that are scientifically valid and defensible, and are of known and acceptable precision and accuracy
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Table of contents CHAPTER I: INTRODUCTION l-1 CHAPTER II RESPONSIBILITIES I-I CHAPTER III: IMPLEMENTATION II-1 Evaluation of Certification Programs I-1 Requirements for Certification of Laboratories II-1 Individual(s)Responsible for the Certification Program I-I On-Site Laboratory Audit Team III-2 Plans for Certification of Laboratories Principal State Laboratories III-2 Certification Process Types of Certification I-3 Drinking water Laboratories II-3 Other Considerations for Laboratory Certificatio I-4 aboratory Quality Assurance Plan I-4 Chain of Custody procedures I-6 Criteria and Procedures for Downgrading/Revoking Certification Status I-7 Reciprocity I-9 Tra Alternate Test Procedures(ATPs I-9 CHAPTER IV: CRITICAL ELEMENTS FOR CHEMISTRY IV aboratory Facilities IV-1 Laboratory equipment and Instrumentation General Laboratory Practices IV-2 Analytical Sample Collection, Handling and Preservation IV-4 Records and Data Reporting Action in Response to Noncompliant Laboratory Results Tables IV-11-37 Forms for On-site Evaluation of Laboratories Iv-39-56 CHAPTER V: CRITICAL ELEMENTS FOR MICROBIOLOGY Personn Laboratory equipment and supplies General laborat V-6 Analytical Methodology
vii Table of Contents Page CHAPTER I: INTRODUCTION I-1 CHAPTER II: RESPONSIBILITIES II-1 CHAPTER III: IMPLEMENTATION III-1 Evaluation of Certification Programs III-1 Requirements for Certification of Laboratories III-1 Individual(s) Responsible for the Certification Program III-1 On-Site Laboratory Audit Team III-2 Plans for Certification of Laboratories III-2 Principal State Laboratories III-2 Certification Process III-2 Types of Certification III-3 Drinking Water Laboratories III-3 Other Considerations for Laboratory Certification III-4 Laboratory Quality Assurance Plan III-4 Chain of Custody Procedures III-6 Requirements for Maintaining Certification Status III-6 Criteria and Procedures for Downgrading/Revoking Certification Status III-7 Record Keeping III-9 Reciprocity III-9 Training III-9 Alternate Test Procedures (ATPs) III-9 CHAPTER IV: CRITICAL ELEMENTS FOR CHEMISTRY IV-1 Personnel IV-1 Laboratory Facilities IV-1 Laboratory Equipment and Instrumentation IV-2 General Laboratory Practices IV-2 Analytical Methods IV-3 Sample Collection, Handling and Preservation IV-3 Quality Control IV-4 Records and Data Reporting IV-9 Action in Response to Noncompliant Laboratory Results IV-10 Tables IV-11-37 Forms for On-site Evaluation of Laboratories IV-39-56 CHAPTER V: CRITICAL ELEMENTS FOR MICROBIOLOGY V-1 Personnel V-1 Laboratory Facilities V-1 Laboratory Equipment and Supplies V-2 General Laboratory Practices V-6 Analytical Methodology V-8
Page Sample Collection, Handling, and Preservation V-29 Quality Assurance V-30 Records and Data Reporting Action Response to Laboratory Results V-32 Forms for On-site Evaluation of laboratories V-34-77 CHAPTER VI: CRITICAL ELEMENTS FOR RADIOCHEMISTRY VI-1 Personnel VI-1 VI-2 General Laboratory Practices VI-6 Analytical Methods VI-6 Sample Collection, Handling, and preservation VI-7 Quality Assurance VI-7 Records and Data Reporting VI-11 Action Response to Laboratory Results VI-13 VI14-16 Sample Forms for On-site Evaluation of Laboratories VI-17-29 APPENDICES Appendix A: Chain of Custody evaluations A-1 Appendix B: Recommended Protocol for On-Site Laboratory Evaluations B-1 ppendix C: Definitions and Abbreviations Appendix D: Memorandum Regarding Third Party Auditors Appendix E: Required Analytical Capability for Principal State Laboratory Systems Appendix F: Memorandum Regarding National Environmental Laboratory Accreditation F-1 Appendix G: Analytical Methods for Microbiology TABLES Chemistry Table IV-1 Glassware Cleaning Procedures IV-11 Table IV-2 Approved Methods for Primary Inorganic Chemicals IV-13 Table Iv-3 Approved Methods for Primary Organic Chemicals Table Iv-4 Approved Methods for Disinfectant Residuals Iv-20 Table Iv-5 Recommended Methods for Secondary Drinking Water Contaminants Table IV-6 Sample Containers, Preservation and Holding Times for Regulated Parameters IV-23 Table IV-7 MCLc and Detection Limit Requirements to Composite IV-27 Table iv-8 VOC MCLs and mdls IV-28 Table Iv-9 SoC MCLs and Detection Requirements to Reduce Monitoring(mg/L) IV-29 Table Iv-10 MCL and Proficiency Performance Evaluation Sample Acceptance Criteria IV-30 Table Iv-11 Promulgated Organic Drinking Water Methods IV-35 Radiochemistry Table VI-1 Methods for Radionuclide Analysis CFR 141.25 Table v1-2 Sample Handling, Preservation, and Instrumentation VI-16
Page viii Sample Collection, Handling, and Preservation V-29 Quality Assurance V-30 Records and Data Reporting V-31 Action Response to Laboratory Results V-32 Forms for On-site Evaluation of Laboratories V-34-77 CHAPTER VI: CRITICAL ELEMENTS FOR RADIOCHEMISTRY VI-1 Personnel VI-1 Laboratory Facilities VI-2 Laboratory Equipment and Instrumentation VI-2 General Laboratory Practices VI-6 Analytical Methods VI-6 Sample Collection, Handling, and Preservation VI-7 Quality Assurance VI-7 Records and Data Reporting VI-11 Action Response to Laboratory Results VI-13 Tables VI-14-16 Sample Forms for On-site Evaluation of Laboratories VI-17-29 APPENDICES Appendix A: Chain of Custody Evaluations A-1 Appendix B: Recommended Protocol for On-Site Laboratory Evaluations B-1 Appendix C: Definitions and Abbreviations C-1 Appendix D: Memorandum Regarding Third Party Auditors D-1 Appendix E: Required Analytical Capability for Principal State Laboratory Systems E-1 Appendix F: Memorandum Regarding National Environmental Laboratory Accreditation F-1 Appendix G: Analytical Methods for Microbiology G-1 TABLES Chemistry Table IV-1 Glassware Cleaning Procedures IV-11 Table IV-2 Approved Methods for Primary Inorganic Chemicals IV-13 Table IV-3 Approved Methods for Primary Organic Chemicals IV-17 Table IV-4 Approved Methods for Disinfectant Residuals IV-20 Table IV-5 Recommended Methods for Secondary Drinking Water Contaminants IV-21 Table IV-6 Sample Containers,Preservation and Holding Times for Regulated Parameters IV-23 Table IV-7 MCLc and Detection Limit Requirements to Composite IV-27 Table IV-8 VOC MCLs and MDLs IV-28 Table IV-9 SOC MCLs and Detection Requirements to Reduce Monitoring (mg/L) IV-29 Table IV-10 MCL and Proficiency Performance Evaluation Sample Acceptance Criteria IV-30 Table IV-11 Promulgated Organic Drinking Water Methods IV-35 Radiochemistry Table VI-1 Methods for Radionuclide Analysis CFR 141.25 VI-14 Table VI-2 Sample Handling, Preservation, and Instrumentation VI-16