The 2016 TNI Standard and the National Environmental Laboratory Accreditation Program OELA May 11, 2016 Plus resources to help laboratories

Current Status of 2016 TNI Standard Volume 1: Laboratory Requirements Module 1: Proficiency Testing - FINAL Module 2: Quality Systems - FINAL Module 3: Asbestos – No Changes Module 4: Chemistry - FINAL Module 5: Microbiology - FINAL Module 6: Radiochemistry - FINAL Module 7: Whole Effluent Toxicity – No Changes

Other 2016 TNI Standards Volume 4: PTPA Requirements Volume 2: AB Requirements Module 1: Accreditation Body – No Change Module 2: Proficiency Testing - FINAL Module 3: On-Site Assessment – No Change Volume 3: PT Provider Requirements Interim Standard published for vote on 3/21/16 Volume 4: PTPA Requirements

2016 TNI Standards See presentations made on Wednesday, July 1, 2015 at the 2015 NEMC http://nemc.us/meeting/2015/techprog.php Click on the Wednesday tab! Updated versions of these presentations with more detail will be made on August 11 at the 2016 NEMC Webinars likely this fall

2016 PT Standards Volume 1 New sections for WET and Protozoa Reverse some decisions made in the 2009 standard LOQ reporting Analysis date New sections for WET and Protozoa Volumes 2, 3, and 4 Many changes affecting PT Providers Clarification of role of AB in reviewing PT results

2016 Quality System Standard Revised to include all of ISO/IEC 17025 verbatim Removed Note from Section 5.6 on traceability Added back language in Sections 5.4 on method validation Revised definition for Limit of Detection Revise temperature calibration (5.5.13.1) Allow single point verification at mandated condition Other minor clarifications and revised definitions Volume 1, Module 2

Clarifications and Definitions “Parameter” was changed to “Analyte” Any Notes were either eliminated or had the “NOTE” removed – this makes them requirements Definitions Analyte (revised) Data Integrity (revised) Lot (added) Parameter (deleted) Physical parameter (added) Reference Method (revised) Volume 1, Module 2

2016 Chemistry Standard Revised Calibration Section Revised Section on LOD and LOQ Clarified confusing language on method validation in Section 1.5 Moved general language on method selection and validation to Module 2 Volume 1, Module 4

Instrument Calibration 2009 2016 1.7.1 Initial Calibration 1.7.1.1 Instrument Calibration 10 subsections 1.7.1.2 Continuing Calibration 5 subsections 1.7.1 Calibration 1.7.1.1 Initial Calibration 13 subsections 1.7.1.2 Continuing Calibration Verification 6 subsections Volume 1, Module 4

Revised Calibration Section Removal of calibration points Number of standards required Relative Error / Relative Standard Error Corrective action for CCV Many other minor changes Volume 1, Module 4

1.7.1 Calibration Clarifies that calibration of support equipment is in Module 2 Continues to allow other options in mandated methods or programs to supersede these requirements Clarifies that calibration may be performed at the instrument or method level Volume 1, Module 4

1.7.1.1 Initial Calibration Clarifies that results from most recent initial are to be used New section on removal and/or replacement of calibration standards Section on number of calibration standard completely revised New section on relative error New sections on Arochlors, sensitivity checks and upper reporting limits Other minor clarifications Volume 1, Module 4

Anscombe’s Quartet

1.7.1.2 Continuing Calibration Verification New section requires CCV to be < ½ high point Allows use a second source CCV Allows LCS to be used as CCV in limited cases Allows a second CCV to be used with justification Volume 1, Module 4

Changes to LOD New definition for the LOD (in Module 2) Renamed TNI LOD as MDL Added several new requirements Samples used to determine MDL must be prepped and analyzed over several days Evaluation of routine method blanks must be included Specifications for ongoing verification of MDL Made consistent with revised 40 CFR Part 136 MDL Volume 1, Module 4

Changes to LOQ Minimum of 7 spikes at or below LOQ Details requirements if multiple instruments will have same LOQ LOQ is the spiking level, unless < 3X MDL in which case LOQ is 3X MDL Allows determination of precision and bias at the LOQ Consistent with revised MDL, EPA MRL and EPA LLOQ Volume 1, Module 4

2016 Microbiology Standard Significant Rewrite for Clarity Clarified definition of source water Revised Method Selection and Validation Revised chlorine residual check Additional guidance and options Reinforce the concept of minimum requirements Default to the use of the data Reorganized QC section to “before” and “during” analysis, for example: Media Checks: Before Blanks: During Volume 1, Module 5

Radiochemistry Standard 1.1 Introduction 1.2 Scope 1.3 Terms and Definitions 1.3.1 Additional Terms and Definitions 1.3.2 Exclusions and Exceptions 1.4 Method Selection 1.5 Method Validation 1.5.1 Validation of Methods 1.5.2 Detection Capability 1.5.3 Evaluation of Precision and Bias 1.5.4 Measurement Uncertainty 1.5.5 Evaluation of Selectivity 1.6 Demonstration of Capability 1.6.1 General 1.6.2 Initial DOC 1.6.3 Ongoing DOC 1.7 Technical Requirements 1.7.1 Instrument Set-up, Calibration, Performance Checks, and Background Measurements 1.7.2 Quality Control for Radiochemistry 1.7.3 Data Evaluation and Reporting 1.7.4 Sample Handling Volume 1, Module 6

The 2016 TNI Standard Changes to PT, Quality Systems, Chemistry, Microbiology and Radiochemistry Also changes to Volumes 2, 3, and 4 Expected to be adopted by CSDP by August 2016. Will need review by LASEC for suitability Will need adoption by NELAP for implementation NELAP implementation will be for a specific date, likely 2018

Implementation of 2016 TNI Standard 2-3 year process Extensive training will be provided to labs and lab assessors New checklists and guidance will be developed Quality Manual template will likely be revised Full day session planned for August 11 in conjunction with TNI’s summer meeting

TNI Resources Course 2-1013: Implementing the 2009 TNI Standard The objective of this course is to help laboratory management understand the requirements of the 2009 TNI Standard. The material will "demystify" terminology, provide assistance in understanding the requirements, and provide guidance on how to incorporate the requirements of the Standard into laboratory operations without disrupting current practices.

Technical Assistance Small Laboratory Handbook Quality Manual Template Tips and Hints for implementing the standard Quality Manual Template Fill in the blank template TNI Standard webcast 16- hour comprehensive training on the TNI Standard TNI Quality Systems webcast lectures A series of 10 lectures on various topics (e.g., data integrity, corrective actions, LOD/LOQ)

Technical Assistance Listing of consultants to help laboratories How to get accredited flow chart Quality Systems checklist Standards Interpretations Small Laboratory Advocacy Group bulletin board Assessment Forum and Mentor Sessions Fields of Proficiency Testing Tables LAMS

Assessment Forum and Mentor Sessions Making Internal Audits Effective Internal Audits for Small Municipal Laboratories Practicing Root Cause and Corrective Action Microbiology QA/QC Requirements Meeting TNI Standard Requirements for Microbiology Writing Findings What a QA Officer Really Does… Following the Yellow Brick Road to Managing Quality Top 10 Suggestions on Being a Better QA Officer …and many more http://www.nelac-institute.org/content/tnidocs.php

Laboratory Accreditation Management System (LAMS) Searchable database of accredited laboratories Method Table 4116 methods Includes approvals in 136 and 141 Includes links to methods Analyte Table 3219 analytes

Downloadable Webcasts Corrective Action Process and Root Cause Analysis Theoretical and Practical Consideration for Establishing Sensitivity of Measurements Internal Audits and Management Review Ethics Training for the Environmental Professional Establishing a Data Integrity Plan Defining Organizational Responsibilities Method Selection and Validation Etc…

Webinars Planned for 2016 The TNI Radiochemistry Standard 2016 TNI Standard How to Select Instrumentation ???? Send us your suggestions for training Send us a proposal to provide training

Member Benefits Access the TNI Methods Compendium, an on-line portal to copies of over 3,000 environmental testing methods. No charge to use the TNI Generic Laboratory Application. Access the Stationary Source Audit Sample Statistics for no charge. Free webcasts and webinars (Sponsor and Patron)

Future Meetings Summer Meeting Winter Meeting Orange County, CA August 8-12, 2016 Washington, DC August 2017 January 23-26, 2017 Houston, TX

Summer Meeting In conjunction with National Environmental Monitoring Conference Orange County, CA www.nemc.us

NEMC Sessions Academic Research Topics Advances in Sample Preparation and Clean-up Air Methods & Monitoring Applications of qPCR Methods for Microbiological Contaminants Best Practices for Reference Materials California Efforts in Revitalizing the Environmental Laboratory Accreditation Program Changing the Paradigm for Water Pollution Monitoring Citizen Science Collaborative Efforts to Improve Environmental Monitoring Contaminated Sediments Current Trends in LIMS Data Quality, Management and Validation Forensic Chemistry HPLC in Environmental Monitoring Metals and Metals Speciation Non Targeted Compound Screening Operational and Advocacy Issues Overcoming Legacy Obstacles Review of Data for Chlorinated Dioxins Citizen Science and Innovation Sensors and Field Analytical Chemistry Topics in Drinking Water Topics in Shale Gas Use of Continuous Monitoring

Contact TNI Jerry Parr, Executive Director www.nelac-institute.org jerry.parr@nelac-institute.org 817-598-1624