1. On behalf of Jerry Parr, Executive Director, TNI
The 2016 TNI Standards
Presented by:
Zonetta E. English, MBA
On behalf of Jerry Parr, Executive Director, TNI

2. Current Status of 2016 TNI Laboratory Standard
Volume 1: Laboratory Requirements
Module 1: Proficiency Testing - FINAL
Module 2: Quality Systems - FINAL
Module 3: Asbestos – FINAL
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
FINAL
Volume 4: PTPA Requirements

4. 2016 TNI Laboratory 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 were made on August 11 at the 2016 TNI meeting
Webinars likely this fall

5. 2016 PT Standards Volume 1, Module 1 New sections for WET and Protozoa
Reverse some decisions made in 2009
LOQ reporting
Analysis date
New sections for WET and Protozoa
Radiochemistry now included
Volumes 2, 3, and 4
Many changes affecting PT Providers
Clarification of role of AB in reviewing PT results

6. Changes in Reporting V1M1
TNI has published Proficiency Test Reporting Limits (PTRL) for every analyte:
PTRLs are the lowest possible concentration of the analyte in the sample
Lab LOQ must be equal to or greater than the TNI PTRL
Results above LOQ should be reported without qualifiers
If the Lab LOQ > PTRL, and the analyte is present, the result will be scored unacceptable See Note in Section 4.3.7
V1M1

7. V1M1 Study Date
Opening date of second study at least 7 days after the closing date of first study.
No longer analysis dates
This reduces the waiting time for a laboratory to analyze a second PT to have accreditation reinstated
V1M1

8. Whole Effluent Toxicity PTs
Allow the use of DMR-QA to meet PT requirements.
Sets the frequency for WET to one time per year.
Defines what the corrective action is to be submitted.
V1M1

9. Radiochemistry PTs V1M1 Requirements same as Chemistry
Analyze 2 PT samples per year
Pass two of most recent three
Analytes and Acceptance limits in FoPT tables
Drinking water only
V1M1

10. V1M2 Quality Systems 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 ( )
Allow single point verification at mandated condition
Other minor clarifications and revised definitions

11. 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)
V1M2

12. Reference Method
A published method issued by an organization generally recognized as competent to do so. (When the ISO language refers to a “standard method”, that term is equivalent to reference method).
Definition important for Module 3-7, especially Module 4, Chemical Testing
V1M2

13. V1M4 Chemistry Standard V1M4 Revised Method Selection and Validation
Revised Calibration Section
Revised Section on LOD and LOQ
Moved general language on method selection and validation to Module 2
V1M4

14. 1.4 METHOD SELECTION
When adding a new analyte to a reference method, the inclusion of the analyte in the method shall meet all required calibration requirements and the QC requirements of the method to which the analyte is being added. If no QC exists in the method, the laboratory shall adhere to the requirements outlined in a reference method of the same technology (when available).
Section 1.4 in modules 3 through 6 is ISO section 5.4.4, except where ISO uses Standard Method, the TNI standard has changed this to Reference Method and provided a definition. This change is to prevent confusion with Standard Methods. ISO does not define Standard Method/
i.e., Reference Methods do not need to be “validated” for new analytes
V1M4

15. QC REQUIREMENTS V1M4 624 8260 ICAL RSD: 35% CCAL: MIN RF:
BFB Recovery:
ICAL RSD: 30%
CCAL: 20%
MIN RF: 0.1
BFB Recovery:
So, in this example, Method 624 requires a 35% RSD for the initial calibration, so that criterion must be used. Since acetone is not a 624 analyte, there are no QC limits for the continuing calibration check. So, the requirement in the “similar” method, 8260 would be used also has requirements for a minimum response factor and surrogate recovery that are not in 624.
V1M4

16. 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
V1M4

17. Revised Calibration Section
Removal of calibration points
Number of standards required
Relative Error / Relative Standard Error
Corrective action for CCV
Many other minor changes
V1M4

18. 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
V1M4

19. 1.7.1.1 Initial Calibration V1M4
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
V1M4

20. Anscombe’s Quartet

21. 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
V1M4

22. Changes to LOD V1M2 New definition for the LOD (in Module 2)
Equivalent to EPA MDL
Added several new requirements
Samples used to determine LOD must be prepped and analyzed over several days
Evaluation of routine method blanks must be included
Where appropriate use MDLB instead of MDLS
Specifications for ongoing verification of LOD
Made consistent with revised Method Detection Limit in 40 CFR Part 136
V1M2

23. Changes to LOQ V1M4 Minimum of 7 spikes at or below LOQ
Details requirements if multiple instruments will have same LOQ
LOQ is the spiking level, unless < 3X LOD in which case LOQ is 3X LOD
Allows determination of precision and bias at the LOQ
LOQ verification used for LOD determination
One set of analyses; two results
V1M4

24. V1M5 Microbiology 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

25. 2016 Radiochemistry Standard
Volume 1, Module 6 25

26. Background
The laboratory community is familiar with “stable” chemistry
Environmental testing protocols for inorganic and organic evolved separately
Some of these protocols and concepts are less applicable to radiochemistry
Volume 1, Module 6

27. Regulatory Background
Only one formalized program (EPA Laboratory Certification for Water)
Narrow and specific set of parameters for water
Methods based on 1950s -1980s EPA lab procedures
Technology has changed
Instruments and even reagents not always available
Little or no performance/validation data
Peculiar biases specific to SDWA and CWA compliance
Quality requirements sparse (to put it politely…)

28. What are Some Key Differences?
Isotopic measurements of radionuclides
Chemical separations with yield tracers
Lab-developed, performance-based methods
Measurements relative to background
Reported
“As measured” - positive, negative or zero
Not censored against IDL, MDL, RL!
The measurement uncertainty is calculated and reported together with each result

29. “MARLAP”
Cross-agency document developed and approved by eight federal agencies:
EPA, DOD, DOE, DHS, NRC, FDA, USGS, NIST
Part I for project planners / managers of radioanalytical projects
Parts II and III address technical topics
Very worthwhile !!!

30. Radiochemistry Expert Committee
Formed in 2012
Consists of 10 radiochemists
Extensive experience in operation and oversight of state, federal, and commercial laboratories
Reviewed and updated TNI Standard Module 6
The Voting Draft Standard was successfully balloted in April 2015

31. 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

32. Major Changes
Definitions for key terms were added to Section 1.3.
Requirements for method validation in Section 1.5 were refined to better address laboratory-developed/modified methods and to evaluate uncertainty and method performance at background (zero) activity.
Section 1.6 requirements for Demonstrations of Capability include analysis of blanks, once again to address method performance at background activity.
Technical requirements in Section 1.7 were reorganized to logically parallel set-up, calibration, calibration verifications, and quality control of instrumentation.
V1M6

33. Major Changes (Cont.) V1M6
Section provides requirements for mathematical calibration methods, and for several approaches to background determination, both of which are in common use but neither of which are currently permitted.
The most substantial change to method quality controls in Section 1.7.2, the Radiation Measurements Batch, was introduced to eliminate substantial confusion, and inconsistent implementation of batch quality controls for non-destructive analyses such as gamma spectrometry.
Section contains requirements for evaluating chemical yield which were not included in previous revisions. It also addresses reporting requirements for uncertainty.
V1M6

34. The 2016 TNI Standard
Changes to PT, Quality Systems, Chemistry, Microbiology and Radiochemistry
Also changes to Volumes 2, 3, and 4
Expected to be fully adopted by CSDP by October 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

35. 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

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