The 2015 TNI Standard Midwest Water Analysts Association January 29, 2016

Available Standards NELAC 2003  389 pages  Administration  Laboratory  PT  AB TNI 2016  V1: Laboratory  V2: AB  V3: PTP  V4: PTPA TNI 2009  V1: Laboratory  V2: AB  V3: PTP  V4: PTPA A very good standard A much better standard Improved even more!

2003 STANDARD  One Big Document = One Standard  Constitution and Bylaws  Chapter 1: Program Policy & Structure  Chapter 2: Proficiency Testing  Chapter 3: On-Site Assessment  Chapter 4: Accreditation Process  Chapter 5: Quality Systems  Chapter 6: Accrediting Authority

The 2003 STANDARD  Uses ISO quality system approach,  Adds specificity to improve clarity and help with consistency for environmental testing,  Requires conformance to EPA mandated methods, but otherwise allows flexibility in meeting requirements,  Represents best professional practice,  Allows for multiple Accreditation Bodies to implement consistently,  Appropriate level of proficiency testing, and  Includes data integrity component missing from  2003 is a very good standard for environmental laboratories.

The 2003 STANDARD  Refers to an organization that no longer exists,  Hard to find all the laboratory requirements,  Written by chemists for chemists,  Some language could be improved,  Not a true consensus standard,  Does not incorporate ISO for Accreditation Bodies, and  Muddled and outdated version of ISO  2009 TNI Standards corrects these weaknesses

THE NEW NELAP STANDARDS  Four Small Volumes = Four Standards  Volume 1: Requirements for Laboratories  7 Modules  Volume 2: Requirements for Accreditation Bodies  3 Modules  Volume 3: Requirements for PT Providers  Volume 4: Requirements for a PT Provider Accreditor

Basis of New Standard  International Standards  ISO  ISO  ISO Guide 43  Work of NELAC from  Significant input from TNI membership during consensus voting process

Format of New Standard  Sector  Identifiable accreditation program with unique requirements, e.g., NELAP  Volume  Key elements of an accreditation program for a particular sector  Module  Specific requirements combined with other modules to create a volume

The Environmental Sector  Applies to the accreditation of the classical definition of an environmental laboratory  The Volumes are:  Requirements for laboratories  Requirements for accreditation bodies  Requirements for PT providers  Requirements for oversight of PT providers

THE 2009 TNI LABORATORY STANDARD  138 pages (versus 289 for 2003 NELAC Standard)  Uses current version of ISO  Increased clarity.  Everything in one place:  Proficiency testing,  Quality systems, and  Personnel.  Discipline specific quality control modules greatly improved.  Very few new requirements.  Greater flexibility

Quality System Requirements  Module 2 contains the General Requirements that applies to all laboratories  Much, but not all of NELAC Chapter 5  Updated to 2005 version of  language clearly identified and not modified  Personnel requirements from NELAC Chapter 4  Modules 3 though 7 are Technical Requirements for different types of labs  Method Selection, Validation and DOC  Instrument Calibration  Quality Control  Sample Handling

VOLUME 1  Everything a lab needs to know  Proficiency testing (Module 1)  Personnel requirements (Module 2)  Quality systems (Module 2)  Technical requirements (Modules 3-7)  3: Asbestos  4: Chemistry  5: Microbiology  6: Radiochemistry  7: Toxicity

Volumes 2, 3 and 4  Interesting reading, for maybe QA Manager  Volume 2: Requirements for ABs  Includes how to assess PT sample analysis  Volume 3: Requirements for PT Providers  Includes scoring of PT results  Volume 4: Requirements for PT Provider Accreditors

BENEFITS OF TNI LABORATORY STANDARD  Removal of outdated language  Incorporation of ISO  Incorporation of current version of ISO  Volume/Modular approach simplifies understanding  Improved clarity on Technical Requirements  True consensus standard!!!

So why do we need a 2016 standard?

Issues with the 2016 Standard  PT reporting not acceptable to some ABs  Other minor PT issues  All of ISO not included  Reference Materials  Method Validation  DOC language confusing and inconsistent  Chemistry module needs improving  Microbiology and Radiochemistry modules written by chemists  Other minor issues

Standards Development Process  Committee develops Working Draft Standard (WDS)  Presented to TNI Members and Public for Comment  Committee develops Voting Draft Standard (VDS)  Presented to TNI Members for Vote  Positive, Positive with Comment, Negative with Comment, Abstain  Committee must resolve all comments  Persuasive, Non-Persuasive, Hold for Next Revision Comment Period for Working Draft Standard - V1M5 (Microbiology) The EL-V1M5 (Microbiology) Working Draft Standard (WDS) was presented by webinar to those stakeholder groups who may subsequently adopt, use, or be accredited to the standard. Pursuant to SOP 2-100, any stakeholder or stakeholder group was invited to submit written comments to the Microbiology Expert Committee Chair Robin Cook Comment Period for Working Draft Standard - V1M5 (Microbiology) The EL-V1M5 (Microbiology) Working Draft Standard (WDS) was presented by webinar to those stakeholder groups who may subsequently adopt, use, or be accredited to the standard. Pursuant to SOP 2-100, any stakeholder or stakeholder group was invited to submit written comments to the Microbiology Expert Committee Chair Robin Cook

Standards Development Process  Committee develops Interim Standard (IS)  Presented to TNI Members and Public for Comment  Response to Comments document also published  Committee works with stakeholder groups to resolve any remaining comments and pass a Final Standard Comment Period for Interim Standard - V1M4 (Calibration) The EL-V1M4 (Calibration) Voting Draft Standard (VDS), dated March 2013, was approved by the membership. Pursuant to SOP 2-100, changes were made to the standard as a result of persuasive comments received from voters. On June 18, 2014 it was presented by webinar as an Interim Standard (IS) to those stakeholder groups who may subsequently adopt, use, or be accredited to the standard. Comments that were submitted were used to create the final version. Comment Period for Interim Standard - V1M4 (Calibration) The EL-V1M4 (Calibration) Voting Draft Standard (VDS), dated March 2013, was approved by the membership. Pursuant to SOP 2-100, changes were made to the standard as a result of persuasive comments received from voters. On June 18, 2014 it was presented by webinar as an Interim Standard (IS) to those stakeholder groups who may subsequently adopt, use, or be accredited to the standard. Comments that were submitted were used to create the final version.

Changes to PT Standards  Reverse some decisions made in the 2009 standard  LOQ reporting  Analysis date  5-7 months  No QC check sample for chemistry  New sections for WET  Many changes affecting PT Providers  Clarification of role of AB in reviewing PT results

PTRL Reporting  Result = or > PTRL—report result  PTRL< LOQ  Report result without qualification  If lab LOQ > PTRL and is reported it will be scored “Not Acceptable”  Result <PTRL  Report a result of “<“ PTRL  Result between LOQ & PTRL  Report result of “<“ PTRL, or  Report result when LOQ < PTRL

 Opening date of second study at least 7 days after the closing date of first study.  This reduces the time waiting time for a laboratory to analyze a second PT to regain their accreditation. Closing Dates

 New PT requirements have been added for WET  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. Whole Effluent Toxicity

2012 Quality System Standard  Revised to include all of ISO/IEC verbatim  Clarified confusing language on method validation in Modules 3-7  Moved general language on method selection and validation to Module 2  New definition for LOD to be consistent with MDL  Other minor clarifications

2016 Standard  2009 becomes 2016  Quality Systems Committee subdivided  Each Module becomes a Committee  No more Chemists writing Microbiology!

Clarification Revisions to the 2009 TNI Standard were almost exclusively clarification Chemistry Committee has done a great deal of work on LOD and Calibration – those are more than clarifications

Clarification Global Changes  “Parameter” was changed to “Analyte”  Any Notes were either eliminated or had the “NOTE” removed – this makes them requirements  ISO Notes, also not enforceable, were reviewed to see if they needed to become requirements

Clarification  Change ISO citation from ISO/IEC 17025:2005(E) to ISO/IEC 17025:2005  Definitions  Analyte (revised)  Data Integrity (revised)  Parameter (deleted)  Physical parameter (added)  Reference Method (revised)

Clarification Module 2  Non Standard Methods – added ISO Text  Validation of Methods – added ISO Text  (TNI additional requirements) – revised for clarity)  V1M2: Section (ISO update)

Clarification  Revise support equipment requirements ( )  Allow single point verification  Address single use materials  Clarify glassware requirements  Add a definition for “lot”

Clarification Modules 3-7  1.4 Method Selection – deleted majority of text and referred to Module 2  1.5 Method Validation – deleted majority of text and referred to Module 2  Added clarifying language to indicate that DOCs are related to individual competency.  Revised for clarity – on-going DOC are meant to be continuous rather than singular events.

Chemistry: Module 4  Revise calibration section  Revise section on LOD and LOQ

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

Changes to LOD  Renamed TNI LOD as MDL  Added several requirements  Samples used to determine MDL must be prepped and analyzed over several days  Evaluation of routine method blanks must be included  Added details for MDLV  Specifications for ongoing verification of MDL Made consistent with revised 40 CFR Part 136 MDL

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

Microbiology: Module 5  Clarified definition of source water  Revised Method Selection and Validation  Revised chlorine residual check  QC Section reorganized into “before” and “during” activities  Many other minor clarifications

Radiochemistry: Module 6  Many new terms  Major rewrite  Training course on 1/28/16  TNI meeting in Tulsa  Simulcast webinar

The 2016 Standard  Changes to PT, Quality Systems, Chemistry, Microbiology and Radiochemistry  Also changes to Volumes 2, 3, and 4  Expected to be adopted by CSDP in May  Will need review by LASEC for suitability  Will need adoption by NELAP for implementation NELAP implementation will be for a specific date, likely 2017

Implementation of 2016 Standard  2-3 year process  Extensive training will be provided to labs and lab assessors  New checklists will be developed  Quality Manual template will likely be revised

Questions/Contact TNI Jerry Parr, Executive Director    Paul Junio, Quality Systems Chair  Northern Lake Service  