Update on the Activities of The NELAC Institute (TNI) December 6, 2013

AGENDA  Overview of TNI  Recent Program Updates  Standards Development  NELAP  NEFAP  Proficiency Testing  Training and Other Tools  January Meeting in Louisville

WHO IS TNI?  A 501(c)3 non-profit organization.  A member organization managed by a Board of Directors.  A voluntary consensus standards development organization accredited by the American National Standards Institute (ANSI).

Mission The purpose of the organization is to foster the generation of environmental data of known and documented quality through an open, inclusive and transparent process that is responsive to the needs of the community.

Who Are Our Members?  Organizations that accredit laboratories  Recognized accreditation bodies  States that are not recognized accreditation bodies  Federal agencies that operate accreditation programs  Accredited organizations  Laboratories  Field Sampling and Measurement Organizations  Others  State and federal agencies that do not operate accreditation programs  Data users, consultants, PT Providers, vendors, etc.  Anyone interested in laboratory accreditation

Member Demographics Commercial laboratories: 39% State agencies: 15% EPA: 3% Other Federal Agencies: 3% Vendors: 7% PT Providers: 4% Other: 4% Regulated industry: 3% Municipalities: 22%

WHAT DO WE PROVIDE?  Infrastructure for stakeholders  Consensus building for establishing requirements for:  Organizations that accredit  Organizations that are accredited  Proficiency testing programs  Recognition of organizations that operate accreditation programs  Assistance to members and others

WHAT DO WE NOT DO?  Accredit laboratories  Resolve disputes between laboratories and their Accreditation Bodies  Interpret questions on methods

TNI PROGRAMS  Consensus Standards Development Program  National Environmental Laboratory Accreditation Program (NELAP)  National Environmental Field Activities Program (NEFAP)  Proficiency Testing Program  Stationary Source Audit Sample Program (SSAS)  Administration and Support

Consensus Standards Development Program  Expert committees develop standards consistent with TNI’s mission, using a consensus process  Expert Committees  Chemistry  Field Activities  Laboratory Accreditation Body  Microbiology  Proficiency Testing  Radiochemistry  Quality Systems  Stationary Source Audit Sample

American National Standards  TNI laboratory standards now recognized by ANSI as American National Standards  Provides additional credibility

Changes to Standard Development Process  Another review step has been added  Interim Standard  Standards Review Council being formed  To ensure consistency between standards

Chemistry Committee  Voting Draft Standard on instrument calibration  Significant changes to current standard  Minimum number of points based on degrees of freedom  Relative error used for verification  Many other changes  Working Draft Standard on detection and quantitation under development  Proposed changes to MDL Procedure published for comment

LAB Committee  Third-party assessors  Listing  Credentials  Generic Application

PT Committee  Voting Draft Standard under development  Will contain new approach for LOQ reporting  Also changes to Volumes 3 and 4

 Revised standard finalized  Minor changes  On hold until PT standard final  Current focus is Standards Interpretations Quality System Committee

Microbiology Committee  Working Draft Standards under development  Changes may be incorporated into next version of the standard  Committee has been working with EPA to determine whether NELAP ABs might implement accreditations for cryptosporidium in their programs.  No change to the standard would be needed  Checklist and other tools may need to be developed  More discussions at the winter meeting in Louisville

Radiochemistry Committees  Working Draft Standards under development  Would revise Modules 5 and 6  Changes may be incorporated into next version of the standard

New Standard?  Consensus Standards Development Executive Committee (CSDEC) has set a target date of 2015 for the next published version of the Environmental Sector Standard.  Replaces the 2009 standard.

What will be affected?  Volume 1, (labs)  Module 1, Proficiency Testing;  Module 2, Quality Systems General Requirements (the already approved 2012 version);  Module 4, Chemical Testing (Calibration section);  Module 5, Biological Testing;  Module 6, Radiochemical Testing. 

And for ABs…  Volume 2 (ABs):  Module 2, Proficiency Testing.  Volume 3, General Requirements for Environmental Proficiency Test Providers.  Volume 4, General Requirements for an Accreditor of Environmental Proficiency Test Providers.

NATIONAL ENVIRONMENTAL LABORATORY ACCREDITATION PROGRAM  Accredits over 1600 laboratories  49 states and territories  9 countries

The National Program Today NELAP Accreditation Body Working on Application Accept NELAP Incorporate NELAP elements State program with significant differences Drinking water only

Non-Governmental ABs  NGABs would be recognized to grant NELAP accreditations  NELAP ABs may or may not accept these accreditations  Primary focus is on out-of-state labs  Policies and SOPs in development  Draft program was presented in August with implementation expected in 2014

NEFAP  Consensus standards that are voluntarily adopted by state agencies or third parties approved as Accreditation Bodies (ABs)  AB grants accreditation, which is unconditionally recognized by other participating ABs  Program applies to Field Sampling and Measurement Organizations (FSMOs)

PT Program  Recognize organizations to be PT Provider Accreditors  Establish Fields of Proficiency Testing  Drinking Water  Non-potable water  Solid & Chemical Materials  Whole effluent toxicity

PT Program News & Plans  Recently expanded to include  Stationary source audit samples  Field lead testing  Update the WET table  Plan to implement a Protozoa FoPT table (Cryptosporidium)

Training and Other Tools  Comprehensive Training Curriculum being developed  Technical training  QA Manager training  Assessor training  Goal is to move most training on-line  Will begin awarding CEUs  Other tools to assist labs

Educational Delivery System  New EDS/training pages on TNI website  Educational opportunities  Application to provide training  Needs survey  Training developed by TNI and others  “Live” training courses  Webinars  Webcasts

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…

On-Demand Training: TitlePresented By Brown Bag 1: Corrective Action Process and Root Cause Analysis Jack Farrell Brown Bag 10: Records and Record KeepingJack Farrell Brown Bag 2: Theoretical and Practical Consideration for Establishing Sensitivity of Measurements Jack Farrell and Jerry Parr Brown Bag 3: Internal Audits and Management ReviewJack Farrell Brown Bag 4: Ethics Training for the Environmental Professional Jack Farrell Brown Bag 5: Establishing a Data Integrity PlanJack Farrell Brown Bag 6: Defining Organizational ResponsibilitiesJack Farrell Brown Bag 7: Method Selection and ValidationJack Farrell and Jerry Parr Brown Bag 8: Developing the Quality Manual as a Useful Management Tool Jack Farrell and Ilona Taunton Brown Bag 9: Document and Document ControlJack Farrell NEFAP as seen through the FOG - Quality for Field Operations Marlene Moore NEFAP Assessor Training TNI FSMO Standard Volume 1Marlene Moore The 2012 EPA Method Update RuleJerry Parr On-Demand Training:

Other Tools  Small Laboratory Advocacy Group  Small Laboratory Handbook  Quality Manual Template  SOP Templates  Audit Process (in development)  Accreditation Profiles

Small Laboratory Advocacy Group (SLAG)  Open to TNI members and non-members   Elizabeth Turner, NTMWD   Seeks input from small laboratories and provides advice to TNI  Raises concerns of small laboratories to high visibility in TNI

Accreditation / Certification Profiles  New web site area   Profiles for all 50 states  Summary information  Scope of program  Summary of fees  Contact information  Links

MEETINGS  TNI holds two conferences each year  Winter Conference  Forum on Laboratory Accreditation  Summer Conference  Environmental Measurement Symposium

Why go to a TNI Conference?  Opportunity to contribute to development of standards.  Participate on TNI Committees.  Annual mentor sessions and technical assistance for labs and lab accreditors (how do others do this?)  “Talk to the other side”  Learn new things; and

Forum on Laboratory Accreditation January 27-30, 2014 Hyatt Regency Louisville Louisville, KY

2014 and Beyond  Implement the adopted NELAP standards  Implement the FSMO accreditation program  Implement a Stationary Source Audit Sample Program  Develop and refine a comprehensive training program  Implement a national database of accredited laboratories  Continue to develop consensus standards that meet the needs of the community

Contact TNI Jerry Parr, Executive Director   