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

2. 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

3. 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

4. 2016 TNI Standards
See presentations made on Wednesday, July 1, 2015 at the 2015 NEMC
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

5. 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

6. 2016 Quality System Standard
Revised to include all of ISO/IEC 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 ( )
Allow single point verification at mandated condition
Other minor clarifications and revised definitions
Volume 1, Module 2

7. 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

8. 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

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

10. 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

11. 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

12. 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

13. Anscombe’s Quartet

14. 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

15. 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

16. 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

17. 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

18. 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

19. 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

20. 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

22. 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.

23. 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)

24. 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

25. 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

26. 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

27. 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…

28. 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

29. 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)

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

31. Summer Meeting
In conjunction with National Environmental Monitoring Conference
Orange County, CA

32. 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

33. Contact TNI Jerry Parr, Executive Director www.nelac-institute.org