The Benefits of National Accreditation

1. The Benefits of National Accreditation Steve Arms The NELAC Institute TNI

2. The NELAC Institute’s Mission 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

3. The NELAC Institute’sVision for the Future A true national accreditation program, whereby all entities involved in the generation of environmental measurement data within the United States are accredited to one uniform, rigorous, and robust program that has been implemented consistently nationwide and focuses on the technical competence of the entity pursuing accreditation

4. TNI’s Accreditation Programs • Designed to ensured competency • Intended to ensure environmental data of known and documented quality An objective way of showing clients, the community and the government that an organization has the demonstrated capability to conduct the services they provide.

5. National Environmental Laboratory Accreditation Program (NELAP) To establish and implement a program for the accreditation of environmental laboratories Program components: • The recognition of accreditation bodies • The adoption of acceptance limits for proficiency testing • The adoption of consensus standards for use in the program • The adoption of the laboratory accreditation system

6. National Environmental Field Accreditation Program (NEFAP) To establish and implement a program for the accreditation of field sampling and measurement organizations (FSMOs) Program components: • The recognition of accreditation bodies • The development and adoption of the accreditation system TNI is also pursuing the development of standards for assuring the competency of organizations involved in stationary source air emissions testing.

7. NELAP AccreditationUnique • Based on an internationally recognized standard expanded to focus on unique aspects of environmental testing • Performed with respect to a specific scope of accreditation conducted by qualified assessors • Involves review of results of periodic proficiency testing performed by the laboratory

8. NELAP AccreditationExtensive • Over 1500 accredited laboratories • Over 2000 accreditations • 48 states and 1 territory • 8 foreign countries

9. Laboratory Accreditation System Program • Develops a system for the accreditation of environmental laboratories: • Policies and procedures, interpretations, guidance documents, and related tools for use by Accreditation Bodies to implement a national environmental laboratory accreditation program. • Reviews standards for suitability • Subcommittee: • National Database Committee

10. Our Heritage . . . SDWA Certification Program Explore Self Sufficiency CLP De-facto National Program NELAC Restructure November 6, 2006 1995 2001 2003 2006 1978 1980’s 1999 2002 2004 Explore Self Sufficiency State Programs expand into other media 2003 NELAC Standard

11. Uses ISO 17025 quality system approach Adds specificity to improve clarity and help with consistency for environmental testing Allows flexibility in meeting requirements Represents best professional practice Allows for multiple Accreditation Bodies to implement consistently The 2003 NELAC StandardStrengths

12. The 2003 NELAC StandardWeaknesses • 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 17011 for Accreditation Bodies • Muddled and outdated version of ISO 17025

13. A New Approach • Start with the purpose of an accreditation program • Ensure key elements are retained • Consider the following goals: • Easy to use and understand • Easy to grow and expand • Easy to revise and implement • Applicable to all laboratories

14. Basis of the New Standard • International Standards • ISO 17025 • ISO 17011 • ISO Guide 43 • Work of NELAC from 1994 - 2003 • Significant input from TNI membership during consensus voting process

15. Benefits of New Laboratory Standards • Removal of outdated NELAC language • Incorporation of ISO 17011 • Incorporation of current version of ISO 17025 • Volume/Modular approach simplifies understanding • Improved clarity of Technical Requirements • Increased flexibility • Very few new requirements • True consensus standard!!!

16. Format of the 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

17. Volume 1 Laboratory Requirements Module 1: Proficiency Testing Module 2: Quality Systems General Requirements Module 3: Asbestos Testing Module 4: Chemical Testing Module 5: Microbiological Testing Module 6: Radiochemical Testing Module 7: Toxicity Testing Volume 2 Accreditation Body Requirements Module 1 – General Requirements Module 3 – On-Site Assessment Module 2: Proficiency Testing Volume 3 Proficiency Test Provider Requirements Volume 4 Proficiency Testing Oversight 2008 TNI Standards

18. Benefits for the PublicConfidence • Health and environment are being protected using reliable, authentic data • A recognized concept • Hospitals • Universities • Forensic laboratories

19. Benefits for Data UsersConsumer Protection • Assurance that the laboratory has been evaluated and has met established standards • Reduces risks associated with unreliable data • Expensive re-testing • Legal or financial liability • Regulatory acceptance of data

20. Benefits for the ProfessionAdvances the Field • Uniform standards of practice • A venue to share knowledge • Professional interaction in consensus • Forum for improvement

21. Benefits for AgenciesAssurance that data is adequate for use • Dependable environmental decisions based on data that is: • Accurate • Traceable • Reproducible • Reduced uncertainty • Increased public confidence in governmental management of the environment

22. Benefits for AgenciesEfficient allocation of resources • A single set of standards to manage • Cost effective • Data can be used by multiple stakeholders • Redundant assessments by QA oversight bodies can be reduced

23. Benefits for AgenciesEfficient allocation of resources • Reduced direct costs due to “problems” • Less re-testing • Less re-sampling • Less lost time • Fewer false positives and negatives • Reduced effort needed to define project expectations and requirements • More constant baseline expectations for environmental projects • More efficient communications regarding Data Quality Objectives and project deliverables

24. Benefits for the OrganizationSelf-evaluation • Improved training program and communication • Improved processes and procedures • Improved internal consistency • Reduction in QC incidents, rejections and complaints

25. Benefits for the OrganizationSelf-evaluation • Promotes continuous improvement attitude • Effective system for accountability • Reputation benchmark for maintaining competence • Improved employee quality awareness • A Better Quality System!

26. Benefits for the Organization and for Accreditation BodiesA Nationally Consistent Standard • An industry hindered by political boundaries • Opportunities for reciprocity and recognition • Removal of barriers • Reduced time and expense caused by redundancy

27. The Florida Experience • All environmental testing laboratories are held to the same standard • Assessment consistency has improved • Marginal labs have become acceptable • Environmental decisions are now clearly traceable to documented data • Benefits of mutual recognition realized

28. A Self-Nourishing ConceptOpportunities for Quality Improvements • The TNI standards development process encourages pooling of expertise from multiple governmental agencies and private sector groups. • A larger scope of expertise strengthens the quality concepts and practices upon which the standards are based. • Having additional requirements for laboratory assessments facilitates the expansion of the scope of accreditation programs and improves the abilities of the assessors. • Result: better assessments and ultimately better laboratories and data!

29. Thank You!