The NELAC Institute

Judy Duncan, TNI Chair

APHL 2007 Annual Meeting

Origin of National Program

Drinking water certification program established in 1978State programs began to expand into other media in1980’s

EPA Contract Laboratory Program (CLP) became de facto national program in1980’s

Impetus for Change

1986 Report to CongressEPA explore feasibility of a uniform, national environmental laboratory accreditation program

1990 EMMC ReportA national program is a viable option, EPA consult with representatives of all stakeholders, andEstablish a federal advisory committee (CNAEL).

CNAEL Recommendations

National program implemented by state agencies with federal oversightKey elements of program are:

Performance evaluation testingOn-site auditsLaboratory process and quality assurance certification

Program should be self-supporting

Formation of NELAC

Organization of state and federal officials who vote on requirements.Input from others considered.Implementation a voluntary decision by individual states.National Environmental Laboratory Accreditation Conference (NELAC) created on February 16, 1995.

NELAC Programs

Develop uniform accreditation standardsAdopt standards for use in accreditation programsDevelop system for recognition of state agencies (Accrediting Authorities)

Implementation of the accreditation program done voluntary by those states who chose to participate

NELAC History1995 – 1997 Development of standards1997 – Approval of first standards1999 – First Accrediting Authorities recognizedJanuary 24, 2001 – First class of laboratories accredited2002 – Decision to become a standards adoption body onlyJune 6, 2003 –NELAC standards development committees ceased operation

Note: Goal of a self-supporting system was dropped along the way.

Maturation of Program

Institute for National Environmental Laboratory Accreditation (INELA) formed in 2002 to fill gap in standards development effortNELAC recognition of need for self-supporting programEPA provided funding support to assist in the transition

The Future: NELAC and INELA Partnership

Funding provided by EPA to explore optionsNELAC and INELA combined forces on November 6, 2006 to become The NELAC Institute (TNI)All key functions of both organizations were continued

Underlying Assumptions

Combining operations of NELAC and INELA will result in a stronger organization.Combining operations will allow NELAC to achieve self-sufficiency quicker.Combining operations is less disruptive to laboratories and other stakeholders.

The NELAC Institute501(c)3 non-profit organization with members, managed by a Board of DirectorsOrganized into Programs that focus on the mission of the organizationAdministrative services support the programs.

MissionThe 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 bodiesStates that are not recognized accreditation bodiesFederal agencies that operate accreditation programs

Accredited laboratoriesCommercial, Municipal, University, State, Federal, etc.

OthersState and federal agencies that do not operate accreditation programsData 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%

Members

Individual MembersMay voteMay serve on committees or the BoardEntitled to member discountsAccess to members area of website

Organizational MembersMay appoint individual membersAre recognizedMay not vote

2007 TNI Board

Judy Duncan, OK DEQDavid Speis, AccutestSharon Mertens, City of Milwaukee Steve Arms, FL DOHJoe Aiello, NJ DEPJack Farrell, AEXKen Jackson, NY DOH

Tom McAninch. LCSDave Mendenhall, UT DOHJudy Morgan, ESCKen Olsen, DatachemAlfredo Sotomayor, WI DNRAurora Shields, KS DHEBob Wyeth, STL

3-4 Federal officials to be appointed in May

Duties of the BoardSupervise, control and direct the business affairs:

actively pursue the mission.manage the budget. appoint agents to assist with the above activities.

Support key programs:Review and approve an annual budget for each program.Evaluate how well the program is achieving its goals.

Review policies for organizational impact.

Governing Principles

Consensus standards process used for the development of accreditation standards (Expert Committees)Implementation of the program will continue to be voluntary by statesThe concept of “balance” used where possible

BalanceNo stakeholder group will have dominance on any committee or board of TNIStakeholder groups are:

Organizations that operate accreditation programsAccredited laboratoriesOthers

One exception: NELAP Board

Programs of TNIConsensus Standards DevelopmentLaboratory Accreditation SystemNational Environmental Laboratory AccreditationProficiency TestingTechnical AssistanceForum on Laboratory AccreditationNational Environmental Monitoring Conference (NEMC)

Consensus Standards Development Program

Consensus Standards Development BoardExpert Committees

Develop standards for the accreditation of environmental laboratories.

Assist the other programs with guidance.

Expert Committees

Accreditation BodyField ActivitiesOn-site AssessmentProficiency TestingQuality Systems

TNI Accreditation StandardsEnvironmental Sector

Volume 1 Laboratory Requirements

Module 1: Proficiency TestingModule 2: Quality Systems General RequirementsModule 3: Asbestos TestingModule 4: Chemical TestingModule 5: Microbiological TestingModule 6: Radiochemical TestingModule 7: Toxicological Testing

Volume 2 Accreditation Body Requirements

Module 1 – General RequirementsModule 3 – On-Site Assessment Module 2: Proficiency Testing

Volume 3 Proficiency Testing Provider RequirementsVolume 4 Proficiency Testing Oversight

TNI Accreditation StandardsField Sampling and Measurement Organization Sector

Volume 1: General requirements for FSMOs

Volume 2: General Requirements for Accreditation Bodies Accrediting FSMOs

Laboratory Accreditation System Program

Laboratory Accreditation System CommitteeDevelop a system for the accreditation of environmental laboratories:

policies and procedures, interpretations, guidance documents, and any related tools used by ABs to implement a national environmental laboratory accreditation program.

Subcommittees:National Database CommitteeNon-NELAP accreditation bodiesSmall organizations

National Environmental Laboratory Accreditation Program (NELAP)

NELAP Board (representatives from accreditation bodies)Final authority for implementation of the program for accreditation of labs –

Review & approve Accrediting Bodies to become NELAP recognized.Review NELAP ABs to assure conformance.Recommend PT accreditor to TNI Board.Adopt acceptance limits developed by PT Board.Adopt the Laboratory Accreditation System for use in the Program.

Receive complaints & direct to proper body.Ensure consistent application of the standard by NELAP ABs.

Proficiency Testing (PT) Program

PT BoardRecommend the selection of PTOB/PTPA(s).Monitor the PTOB/PTPA(s) to assure that they are following the requirements set forth by the organization.Facilitate an annual caucus on proficiency testing.Review and evaluate PT data for the purpose of determining the appropriateness of study limits.Provide recommendations to the NELAP Board as to acceptance limits.

Technical Assistance Program

Technical Assistance CommitteeDevelop tools and templates to assist laboratories and accreditation bodies with implementing accreditation programs.Ensure that training programs relevant to the needs of the stakeholder community are provided.Ensure that laboratory assessors have a forum to discuss common issues.Develop a mentoring program to assist both laboratories and accreditation bodies with implementing accreditation programs.

National Environmental Monitoring Conference

Annual technical meeting focused on the latest innovations in environmental monitoringCo-hosted with EPA and the Independent Laboratories InstituteAugust 20-24, 2007 Cambridge, MAwww.nemc.us

Forum on Laboratory Accreditation

Semiannual meeting where TNI committees, members, and others meet to discuss common issuesAugust 20-24, 2007 Cambridge, MAJanuary 18-22, 2008, Newport Beach, CA

AdministrationAdvocacy Committee Conference Planning CommitteeFinancial Audit Committee Nominating Committee Policy CommitteeWebsite Committee

Administrative staff

SummaryThe NELAC Institute is poised to take national accreditation to the next level

Improve the accreditation requirementsApprove more states as accreditation bodiesBe responsive to stakeholder needsProvide technical assistance

We need your help!Join our organizationJoin a committee

The NELAC Institute

http://www.NELAC-Institute.org

817-598-1624

jerry.parr@nelac-institute.org