[Federal Register Volume 59, Number 231 (Friday, December 2, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-29573]


[[Page Unknown]]

[Federal Register: December 2, 1994]


_______________________________________________________________________

Part IV





Environmental Protection Agency





_______________________________________________________________________




National Environmental Laboratory Accreditation Conference (NELAC); 
Notice
ENVIRONMENTAL PROTECTION AGENCY

[FRL-5115-5]

 
National Environmental Laboratory Accreditation Conference 
(NELAC)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of Conference and Availability of Standards.

-----------------------------------------------------------------------

SUMMARY: The Environmental Protection Agency will hold a conference on 
national environmental laboratory accreditation, to discuss all aspects 
of accreditation for laboratories performing analyses to demonstrate 
compliance with EPA regulations. The conference is open to the public. 
The constitution and the draft standards are being published to allow 
time for review before the conference.

DATES: The conference will be held on February 14-16, 1995. All 
meetings will convene at 9:00 am and adjourn at 5:00 pm, except 
Thursday, February 16 when the meeting will adjourn at 3:00 pm.

ADDRESSES: The meeting will be held at the Hyatt Regency, 2799 
Jefferson Davis Highway, Arlington, VA 22202.

FOR FURTHER INFORMATION CONTACT: Conference arrangements are being 
coordinated by TLI Systems. For information on registration, hotel 
rates, transportation, and reservations call Dan Dozier of TLI Systems 
at 301/718-2270 to receive a brochure. If you have technical questions 
regarding the conference program please contact one of the following 
individuals: Jeanne Hankins Mourrain; EPA; Office of Research and 
Development; Atmospheric Research and Exposure Assessment Laboratory 
(MD-77B); Research Triangle Park, NC 27711; telephone 919/541-1120; fax 
919/541-7953, or Gary Bennett; EPA Region IV; Environmental Services 
Division; Athens, GA 30605-2720; telephone 706/546-3287; fax 706/546-
3375 or Kenneth Jackson, Marge Prevost, and Matt Caruso; State of New 
York; Department of Health; PO Box 509; Albany, NY 12201-0509; 
telephone 518/474-8519; fax 518/474-6184.

SUPPLEMENTARY INFORMATION: Laboratories, the regulated community, 
laboratory clients and the regulatory agencies have experienced 
difficulty under the current system of laboratory accreditation. In 
response to complaints received in 1990, EPA has been working in a 
cooperative venture with the states and the public to develop a system 
which would surmount many of the existing problems.
    In 1991, the Committee on National Accreditation of Environmental 
Laboratories (CNAEL) was chartered at the request of EPA's Deputy 
Administrator. The CNAEL was charged with determining the need and 
advisability of a national environmental laboratory accreditation 
program, alternatives to such a program, and the role of EPA in any 
program. CNAEL was composed of members from the laboratory and 
regulated industry communities, academia, other federal agencies, the 
states, public environmental interest groups, and private accrediting 
bodies.
    CNAEL identified and prioritized numerous issues which were of 
concern to each of the affected parties and reached agreement on an 
overall problem statement: to achieve data of needed quality in a cost 
effective manner. Fifteen alternative solutions were proposed and 
evaluated in relation to the problem statement. Multiple options for 
operation of a program were identified and ranked. In addition, the 
scope of a program was defined in terms of environmental regulations, 
which laboratories should be included, and which activities/tests would 
be included. Finally CNAEL identified the elements of a national 
environmental laboratory accreditation program for purposes of clarity. 
At the conclusion of its deliberations CNAEL recommended that a 
national program for accreditation of environmental laboratories, which 
includes the key elements of on-site audits, performance evaluation 
testing, and data audits, be implemented by enlisting states and/or 
third parties to perform the accrediting function with oversight of the 
accrediting bodies by a federal agency.
    In order to act upon the recommendations of CNAEL, EPA convened the 
State/EPA Focus Group, which is composed of ten states (California, 
Colorado, Florida, Maryland, Michigan, New Jersey, New Mexico, New 
York, South Carolina, Texas) and eight EPA Offices (Office of Air and 
Radiation, Office of Enforcement and Compliance Assurance, Office of 
Prevention, Pesticides and Toxic Substances, Office of Research and 
Development, Office of Regional Operations and State/Local Relations, 
Office of Solid Waste and Emergency Response, Office of Water, Region 
4). The Focus Group has developed a set of draft standards based on the 
ISO 25 Guidelines, as proposed by CNAEL, and a constitution for 
operation of the National Environmental Laboratory Accreditation 
Conference (NELAC). This set of standards and the constitution will 
form the basis for the discussions at the NELAC as discussed below.
    The NELAC is a key step in implementing the solution proposed by 
CNAEL and has the potential to influence the entire environmental 
laboratory community. States and federal agencies will function as the 
decision making (voting) members of the conference. The proposed 
process is to modify and refine the set of draft standards. Additions 
and modifications are expected to be made during the NELAC committee 
meetings where the comments and suggestions of all sectors of the 
laboratory community will be solicited to ensure that the standards are 
responsive to the needs of the public, are practical to implement, are 
scientifically sound, and are as cost efficient as possible. For those 
unable to participate directly in the NELAC, written comments can be 
submitted to Jeanne Mourrain.
    Once agreement is reached on the standards, the states may 
voluntarily adopt the standards and would have responsibility for 
ensuring conformance with the standards. Any laboratory which performs 
analyses to demonstrate compliance with federal environmental 
regulations in a participating state would be required to be accredited 
under the state regulations and would be deemed accredited in all other 
participating states. EPA would provide oversight of state 
accreditation programs and inspections of state and federal 
laboratories. In most cases the states would accredit laboratories only 
within their own state. However, laboratories located in states which 
do not participate in the national program could seek accreditation 
from another state which has adopted the national standards.
    The goal of the program is to accredit all laboratories which 
perform environmental analyses for compliance with regulations. The 
information and status of these laboratories would be readily available 
to regulators, clients, and the general public. Reciprocity would be 
easily obtained and would be granted on a state-by-state basis. 
Reciprocity would eliminate duplicate on-site inspections and 
performance evaluation sample testing. Some states may have 
supplemental requirements required by state law which exceed the 
national standards, e.g. some states have regulated additional 
compounds for drinking water, which might require analysis of 
additional performance evaluation samples.
    A fully operational national environmental laboratory accreditation 
program would enable a laboratory to conduct business in any of the 
states or territories, with minimal disruption of operations and lower 
costs. International acceptance of national accreditation should be 
greatly facilitated. The capacity of laboratories for all types of 
environmental analyses would be included in the scope of a national 
program, enabling clients of laboratories to readily identify the 
laboratories which could perform the needed analyses.
    The NELAC will provide the opportunity for the entire laboratory 
community to voice their concerns, provide advice based on their 
professional experience and effect positive changes in the current 
accreditation process. Among those who are encouraged to attend are 
state and federal accrediting and laboratory agencies, private sector 
laboratories, the regulated industry, environmental interest groups, 
accrediting bodies, academia, and the general public.
Ramona Trovato,
Director, Water Enforcement Division, Office of Enforcement and 
Compliance Assurance.

National Environmental Laboratory Accreditation Conference

Draft

Constitution and Bylaws
November 1994.
Prepared by the State/EPA Focus Group

Table of Contents

Constitution

Article I--General
Article II--Objectives
    A. Forum
    B. Mechanism
    C. Consensus
    D. Uniformity
    E. Cooperation
Article III--Membership
Article IV--Officers
    Section 1--Ex Officio Officers
    A. Director
    B. Executive Secretary
    Section 2--Elective Officers
     A. Eligibility
    B. Nominations and Elections
Article V--Appointive Officials
    Section 1--Officials, Specific
    A. Appointment
    B. Assumption of Office
Article VI--Meetings of the Conference
    A. Annual Meeting
    B. Interim Meeting
    C. Special Meetings
    D. Rules of Order
Article VII--Fees and Dues
Article VIII--Amendments to the Constitution
Article IX--Bylaws
    Section 1--Supplementation of Constitution
    Section 2--Amendments and Repeals of the Bylaws
    Section 3--Renumbering

BYLAWS

Article I--Application for Membership
    Section 1--Form of Application
Article II--Fees, Membership Records
    Section 1--Fees
    Section 2--Membership Year
    Section 3--Billing
    Section 4--Evidence of Membership or Contributorship
Article III--Use of the Insignia
Article IV--Board of Directors
    Section 1--Membership
    Section 2--Duties
Article V--Duties of the Officers
    Section 1--Chair
    Section 2--Chair-Elect
    Section 3--Past Chair
    Section 4--Executive Secretary
    Section 5--Treasurer
    Section 6--Assistant Treasurer
    Section 7--Parliamentarian
Article VI--Committees
    Section 1--General
    Section 2--Administrative Committees
    A. Terms
    B. Duties
    Section 3--Standing Committees
    A. General
    B. Duties
    Section 4--Special Committees, Task Forces and Study groups
    Section 5--Subcommittees
Article VII--Voting System
Section 1--House of Representatives
A. Official Designation
B. Composition
C. Method of Designation
    Section 2--House of Delegates
    A. Designation
    B. Requirements
    Section 3--Voting Rules
    A. Proxy Votes
    B. Method
    C. Timing
    D. Recording
    E. Applicability
    Section 4--Committee Reports
    Section 5--Floor Amendments
    A. Amendments
    B. Changes
    Section 6--Seating
    A. Arrangement
    B. Supervision
    Section 7--Voting
    A. Minimum Votes
    B. Motion Accepted
    C. Motion Rejected
    D. Split or Tie Vote
    Section 8--Procedures
    Section 9--Changes in Organization and Procedure

Figure 1. Seating Arrangement

Constitution

Article I--General

    This Association shall be known as ``The National Environmental 
Laboratory Accreditation Conference'' (NELAC) and is sponsored by the 
United States Environmental Protection Agency (U.S. EPA) as a voluntary 
association of State and Federal Officials for the purpose of 
establishing standards to consolidate and make more uniform the 
laboratory accreditation process.

Article II--Objectives

    The objectives of the National Environmental Laboratory 
Accreditation Conference are:
A. Forum
    To provide a national forum for the discussion of all questions 
related to standards for environmental laboratory accreditation by 
officials of the Federal Government and regulatory officials of the 
States, Commonwealths, Territories and Possessions of the United 
States, their political subdivisions, and the District of Columbia.
B. Mechanism
    To provide a mechanism to establish policy and coordinate 
activities within the Conference on matters of national and 
international significance pertaining to environmental laboratory 
accreditation standards.
C. Consensus
    To develop a consensus on uniform standards, laws, regulations and 
specifications for laboratory inspections, procedures, criteria, 
personnel qualification, testing, administrative procedures and 
enforcement.
D. Uniformity
    To encourage and promote uniformity of requirements and methods 
among jurisdictions.
E. Cooperation
    To foster cooperation among regulatory officers and between them 
and the manufacturing, industrial, business, academic, consumer, and 
other interests affected by their official activities.

Article III--Membership

    Membership consists of two classes:
    Active Membership Active membership is limited to officials 
actively engaged in accreditation of environmental laboratories or 
environmental program officials who are in the employ of the Government 
of the United States, the States, the Commonwealths, the Territories, 
or the Possessions of the United States, or the District of Columbia.
    Contributors Contributors comprise representatives of laboratories, 
manufacturers, industry, business, consumers, academia, laboratory 
associations, industrial associations, laboratory accreditation 
associations, and other persons who are interested in the objectives 
and activities of the Conference.

Article IV--Officers

Section 1--Ex Officio Officers
    A. Director. The Director of the Environmental Protection Agency 
National Environmental Laboratory Accreditation Program is the ex 
officio Director of the Conference.
    B. Executive secretary. The Director of the Environmental 
Protection Agency National Environmental Laboratory Accreditation 
Program designates a senior member of the Environmental Protection 
Agency who is thoroughly conversant with laboratory accreditation to 
serve the National Conference as its Executive Secretary.
Section 2--Elective Officers
    The Elective officers of the Conference shall be:

Chair,
Chair-Elect,
Past-Chair,
Treasurer, and 6 members-at-large to serve on the NELAC Board of 
Directors.

    The consecutive reelection of a Chair-Elect is prohibited; the 
Chair-Elect shall not serve on any committee other than the Board of 
Directors. Should the Chair-Elect for any reason be unable or unwilling 
to be installed as Chair, his/her successor shall be elected in the 
manner prescribed. In this event, the newly elected Chair-Elect shall 
be installed as Chair.
    A. Eligibility. 1. Any Active Member in good standing shall be 
eligible to hold any office provided that the individual meets the 
other requirements set forth in the Constitution and Bylaws.
    2. The Chair-Elect will be elected at the Annual Meeting one year 
prior to the term of service as Conference Chair. After serving one 
year as Chair-Elect, the incumbent will succeed to the office of 
Conference Chair. Only a state official is eligible for election to 
Chair-Elect.
    B. Nominations and elections. 1. Nominating committee. The Chair 
shall appoint a Nominating Committee consisting of the most recent 
active Past Chair as Committee Chair and six (6) active members, to be 
geographically representative insofar as possible.
    2. Nominations. a. The Nominating Committee shall submit one name 
for each elective office and present its recommendation as a slate to 
the Conference.
    b. Additional nominations for officers may be made from the floor 
at the Annual Meeting provided that prior consent of the nominee has 
been obtained in writing and presented to the presiding officer at the 
time of the nomination.
    3. Elections. Officers shall be elected during a designated session 
of the Annual Meeting by a formal recorded vote of the members in 
attendance and eligible to vote on Conference motions.
    4. Terms of office. a. The Chair, Chair-Elect, and Past Chair, 
shall serve for a term of one year or until their successors are 
respectively qualified and elected or appointed.
    b. The Treasurer will serve a term of three years.
    c. The six Board of Directors members-at-large shall serve for 3-
year terms; two elected each year.
    d. All officers shall take office immediately following the close 
of the Annual Meeting at which they were elected.
    5. Filling vacancies. In case of a vacancy in any of the elective 
offices, the Board of Directors shall fill the office by appointment.

Article V--Appointive Officials

Section 1--Officials, Specific
    The Conference Chair with the approval of the Board of Directors 
will appoint the following officials:

Parliamentarian
Assistant Treasurer

    A. Appointment. The Conference Chair shall appoint other officials 
to conduct Conference activities. See Bylaws, Article V--Duties of the 
Officers and Article VI--Committees.
    B. Assumption of office. All appointive officials shall take office 
immediately following appointment and will serve through the subsequent 
Annual Meeting of the Conference unless otherwise specified by the 
Conference Chair, Constitution or Bylaws.

Article VI--Meetings of the Conference

A. Annual Meeting
    The Annual Meeting of members shall be held each year. The agenda 
for this meeting shall include the election of officers, reports from 
the various committees, task forces, study groups, and the Treasurer, 
other items pertinent to the Conference, and presentation to the 
Membership of pending issues requiring action by vote.
    The Annual Meeting may include the presentation of technical 
papers, discussions, displays, or other events at the discretion of the 
Board of Directors.
B. Interim Meeting
    The Interim Meeting of the Board of Directors and those Standing 
Committees designated by the Chair shall be held annually, 
approximately six months prior to the Annual Meeting to develop the 
agenda and committee recommendations for presentation to and action by 
the membership at the Annual Meeting. Draft resolutions and standards 
regarding environmental laboratory accreditation which have been 
published in the Federal Register and commented upon are discussed and 
modified as appropriate in the Interim Meeting.
C. Special Meetings
    1. The Conference Chair is authorized to order a meeting of the 
Board of Directors at any time deemed necessary by the Chair to be in 
the best interest of the Conference.
    2. Other Committees of the Conference are authorized to hold 
meetings at times other than the Annual Meeting or Interim Meeting 
provided that:
    a. such meeting or meetings have been funded in the Conference 
budget approved by the Board of Directors, or
    b. such meeting or meetings are approved by the Chair and funding 
is available within the approved budget or can be made available.
    3. A quorum shall consist of a majority of the eligible voters.
D. Rules of Order
    The rules contained in Robert's Rules of Order (Revised) shall 
govern the Conference in all cases to which they are applicable, and in 
which they are not inconsistent with the Constitution or Bylaws or the 
special rules of the Conference.

Article VII--Fees and Dues

    The annual Membership fees and the registration fees for the Annual 
Meeting are recommended by the Conference Management and Funding 
Committee and shall be approved (and may be revised) by a majority vote 
of the Board of Directors at any official meeting of that Committee.

Article VIII--Amendments to the Constitution

    This Constitution may be amended, added to, or repealed at any 
Annual Meeting of the Membership under normal Conference procedures. 
Proposed changes must be included in the agenda of the Board of 
Directors for the Interim Meeting, published in the Recommendations of 
the Board of Directors in its Tentative Report, and discussed at the 
general session of the Board of Directors at the Annual Meeting at 
which said changes will be voted upon. Amendments to the Constitution 
must be approved by a minimum of a two-thirds vote in both the House of 
Representatives and the House of Delegates.

Article IX--Bylaws

Section 1--Supplementation of Constitution
    This Constitution shall be supplemented by Bylaws which shall 
detail the methods of operation of the Conference. Such Bylaws shall 
not be inconsistent with the provisions of the Constitution.
Section 2--Amendments and Repeals of the Bylaws
    The Bylaws may be amended or repealed in the same manner as 
prescribed for the Constitution (See Article VIII).
Section 3--Renumbering
    The Executive Secretary is authorized to renumber the Articles and 
Sections of the Constitution or Bylaws to accommodate any changes made.

Bylaws

Article I--Application for Membership

Section 1--Form of Application
    Each application for membership or contributorship shall be 
submitted to the Executive Secretary. The application shall be 
accompanied by the Membership or Contributor fee. The successful 
applicant's name will be added to the Conference mailing list. 
Confirmation of Member or Contributor status will be mailed.

Article II--Fees, Membership Records

Section 1--Fees
    The fees for annual Membership, Contributorship, as well as the 
registration fee for the Annual Meeting, are established by the 
Conference Management and Funding Committee and are subject to approval 
and revision by the Board of Directors.
Section 2--Membership Year
    Annual membership fees shall be payable by July 1 of each year and 
will cover the period July 1 to June 30 of the following year.
Section 3--Billing
    The Executive Secretary shall bill each Member and Contributor for 
yearly dues 2 months prior to the expiration of the current membership 
year.
Section 4--Evidence of Membership or Contributorship
    Membership certificates and cards of suitable design, bearing the 
insignia of the Conference shall be issued to the Members. Contributor 
certificates of a noticeably differing design shall be issued to the 
Contributors. The Executive Secretary shall advise the Treasurer of the 
count of new Members and Contributors and will forward the membership 
monies for deposit in the Conference Account.

Article III--Use of the Insignia

    The insignia of the Conference may be used or displayed only by 
members of the Conference unless expressly authorized in writing by the 
Conference.

Article IV--Board of Directors

Section 1--Membership
    A. The Board of Directors consists of the Director, Executive 
Secretary, Chair of the Conference, Chair-Elect, the most recent still 
active Past Chair of the Conference, the Treasurer, and the six at-
large members.
    B. The Nominating Committee in recommending candidates for the 
Board of Directors shall consider regional representation.
    C. The term of the Board of Directors runs from the adjournment of 
the Annual Meeting at which its members are elected (or appointed) 
through the succeeding Annual Meeting of the Conference.
Section 2--Duties
    A. The Board of Directors has leadership responsibility for the 
conference and is charged with guiding the Conference in its primary 
mission of establishing standards for the accreditation of 
environmental laboratories.
    B. It generates the constitution and bylaws of the Conference, 
presents amendments, proposes changes in organizational structure, and 
defines roles and responsibilities as appropriate, for approval of the 
membership.
    C. It establishes administrative procedures and policy on internal 
matters and serves as the policy and coordinating body in matters of 
national and international significance.
    D. It holds accountable, reviews, and approves actions of all 
Committees.
    E. It utilizes the Standing Committees to resolve technical 
criteria issues regarding laboratory accreditation.
    F. It acts for the Conference in all routine or emergency 
situations.
    G. It authorizes interim meetings of Conference Committees as 
necessary.
    H. It fills any vacancy in any elective office of the Conference 
caused by death, resignation or retirement from active official 
service.
    I. It brings recommendations to the Conference for consideration 
and action as appropriate.

Article V--Duties of the Officers

Section 1--Chair
    The Conference Chair is the principal presiding officer at the 
meetings of the Conference and of the Board of Directors, makes 
appointments to the several standing and administrative committees, and 
appoints other Conference officials to serve during his or her term of 
office. All appointments will be made with the consent of the Board of 
Directors.
Section 2--Chair-Elect
    The Chair-Elect will:
    A. serve as acting Chair of the Conference and the Board of 
Directors in the event that the Chair is unable to carry out the duties 
of that office;
    B. perform other duties assigned by the Conference Chair, including 
presiding over sessions of the meetings of the Conference as assigned 
by the Conference Chair and assisting the Chair in the discharge of his 
or her duties; and
    C. serve on the Board of Directors.
Section 3--Past Chair
    The most recent still-active Past Chair will serve on the Board of 
Directors and as Chair of the Nominating Committee and perform such 
duties as may be assigned by the Board of Directors. The Conference 
Past Chair may preside over sessions of the meetings of the Conference 
as assigned by the Conference Chair and assist the Chair in the 
discharge of his or her duties.
Section 4--Executive Secretary
    The Executive Secretary acts as the executive officer of the 
Conference, the secretary and executive officer of the Board of 
Directors, and the non-voting secretary to each standing committee; 
keeps the records of the proceedings of the meetings and manages the 
conference administration as prescribed in its administrative 
procedures.
Section 5--Treasurer
    The Treasurer receives and accounts for all monies collected and 
pays all Conference bills certified by the Conference Management and 
Funding Committee as correct. The Treasurer is an ex officio member of 
the Conference Management and Funding Committee.
Section 6--Assistant Treasurer
    The Assistant Treasurer shall assist the Treasurer in the discharge 
of his or her duties.
Section 7--Parliamentarian
    The Parliamentarian shall assist in assuring meetings of the 
Conference are conducted according to Robert's Rules of Order and any 
special rules adopted by the Conference.

Article VI--Committees

Section 1--General
    Each administrative committee will consist of five Active Members 
(except the Contributors Committee) appointed by the Chair of the 
Conference to serve appropriate terms on a rotating basis or until a 
successor is appointed. All committee members will be appointed the 
initial year for appropriate staggered terms to allow for subsequent 
appointment to full terms.
    Except for the Nominating Committee, whose chair will be the 
Conference Past-Chair, each committee annually selects one of its 
members to serve as its chair, who may succeed himself or herself.
    Each standing committee will consist of five members elected from 
the Active membership of the Conference to serve 5 years with one 
member being elected each year. All committee members shall be elected 
during a designated session of the Annual Meeting by a formal recorded 
vote of the members in attendance and eligible to vote on Conference 
motions.
    When necessary, an appointment will be made to any of the standing 
committees to fill a vacancy caused by death, resignation or retirement 
from active service by a committee member. The appointment is for the 
unexpired portion of the member's term.
Section 2--Administrative Committees
    A. Terms. 1. Conference Management and Funding Committee. The term 
of service will be three years; two members to be appointed each of two 
years and one the third year.
    2. Nominating Committee. The chair shall be the Conference Past 
Chair. Four members shall be appointed annually to serve one year.
    3. Membership Committee. The term of service will be two years. Two 
members will be appointed one year and three the alternate year.
    4. Auditing Committee. The term of service will be three years. Two 
members are to be appointed in each of two years and one in the third 
year.
    5. Liaison Committee. The term of service will be three years. Two 
members are to be appointed in each of two years and one in the third 
year.
    6. Contributors's Committee. This committee will consist of five 
contributors to serve two years. Three members will be appointed one 
year and two in alternate years.
    B. Duties. 1. Conference Management and Funding Committee. This 
committee prepares the annual budget for approval by the Board of 
Directors, sets and collects annual membership fees and conference 
registration fees, selects the place and dates of each Annual and 
Interim Meeting of the Council and manages the logistic details of the 
Interim and Annual meeting, certifies to the Treasurer the correctness 
of bills submitted to the Conference for payment, and publicizes the 
Annual and Interim Meetings. The Treasurer is an ex-officio member of 
this committee.
    2. Nominating Committee. This committee presents a slate of 
nominees for all elective offices at the Annual Meeting. The names of 
these nominees shall appear in the report of the Nominating Committee 
and be published in the Conference Announcement.
    3. Membership Committee. This committee initiates membership 
invitations and publicizes the Conference to prospective members. This 
committee also provides coordination and participation of Contributors 
in all affairs of the Conference.
    4. Fiscal Auditing Committee. This committee arranges for annual 
audits of the Conference books. This committee reviews audit reports to 
the Board of Directors with recommendations as necessary to resolve 
discrepant audit findings or recommendations.
    5. Liaison Committee. This committee provides liaison with 
international organizations, federal agencies, other groups and 
organizations. This committee provides and solicits information and 
develops a spirit of cooperation between NELAC and other organizations.
    6. Contributor's Committee. This committee serves as the focal 
point for the Contributors. It solicits information from and provides 
feedback to the Contributors and acts as liaison to the Board of 
Directors on Contributor matters.
Section 3--Standing Committees
    A. General. Standing Committee members serve for five years, one 
member being appointed annually.
    B. Duties. 1. Program Structure Committee. This committee shall 
develop modifications to the scope, structure, and requirements to the 
tiers and fields of testing.
    2. The Accrediting Authority Committee. This committee provides the 
standards used by EPA to approve state authorities.
    3. Quality Systems Committee. This committee establishes and keeps 
current the key elements of QA/QC, including record keeping and 
staffing requirements. The committee also defines uniform standards for 
each of the elements of QA/QC.
    4. Performance Evaluation Testing Committee. This committee 
determines the requirements for the Performance Evaluation Program, 
generates the standards for the Performance Evaluation samples, 
provides criteria for selection of the provider of the Performance 
Evaluation samples and provides and updates the protocol for the use of 
the Performance Evaluation Program in the accreditation of 
laboratories.
    5. On-Site Assessment Committee. This committee determines the 
training and experience requirements of the assessors, establishes the 
frequency of inspection, generates the procedures for on-site visits 
and publishes these standards in a National Environmental Laboratory 
Accreditation Manual.
    6. Accreditation Process Committee. This committee generates and 
develops modifications for the accreditation process of environmental 
laboratories, including the requirements for accreditation, procedures 
for suspension, revocation and denial of accreditation, relative roles 
and responsibilities of laboratories and appeal processes. This 
committee considers matters concerning reciprocity of accreditation and 
establishes the process for the approval of state/federal accrediting 
authorities.
    7. Regulatory Committee. This committee provides the Standing 
Committees with current information on federal regulations that impact 
laboratory testing. This committee annually presents a report for 
conference action. Its scope embraces all matters regarding the 
development and interpretation of uniform laws and regulations, the 
study and analysis of bills for legislative enactment, and the 
establishment and maintenance of published guidelines and other 
effective means of encouraging uniformity of interpretation and 
application of laboratory requirements. The Regulatory Committee shall 
also provide uniform language to assist states in adopting the 
standards in state statutes.
Section 4--Special Committees, Task Forces, and Study Groups
    Special committees, task forces, and study groups may be 
established by the Conference Chair as the need arises or as requested 
by the Conference. Members will be appointed from the Active Members 
for as long as deemed appropriate. Upon completion of its assigned 
task, such bodies shall be dissolved by the Chair of the Conference.
Section 5--Subcommittees
    Upon request of a committee, the Conference Chair may appoint a 
subcommittee(s) to assist the committee in fulfilling its 
responsibilities.

Article VII--Voting System

    All questions before a meeting of the Conference that are to be 
decided by a formal recorded vote of the Active Members are voted upon 
in accordance with the following voting structures and procedures.
Section 1--House of Representatives
    A. Official Designation. This body of officials shall be known as 
the ``House of Representatives.''
    B. Composition. 1. Each State is authorized one official to serve 
as its representative at the annual meeting of National Environmental 
Laboratory Accreditation Conference. The state representative shall be 
the Director of the State Environmental Laboratory Accreditation 
Program or the highest level technically competent scientist 
knowledgeable about environmental laboratory analysis and 
accreditation, or his/her designee.
    2. Each of seven EPA Assistant/Associate Administrators (OSWER, 
OAR, ORD, OW, OPPTS, OECA, and OROSLR) or his or her designee may 
appoint two members, one from headquarters and one from an EPA region.
    3. Each other participating federal agency with responsibilities in 
the environmental laboratory field is authorized to appoint one 
official to the House of Representatives.
    C. Method of Designation. Each representative is specified annually 
to the Board of Directors 120 days before the NELAC Annual Meeting. 
Accommodation may be made for exceptions to this deadline. An alternate 
should be named prior to the Annual Meeting in case the designated 
representative cannot attend.
Section 2--House of Delegates
    A. Designation. All other State and Federal environmental officials 
(those not sitting in the House of Representatives) are grouped as a 
body known as the ``House of Delegates''. The number of potential 
members is not limited.
    B. Requirements. No other special requirements apply.
Section 3--Voting Rules
    A. Proxy votes. Proxy votes are not permitted. Since issues and 
recommendations in the committees' interim reports are often modified 
and amended at the Annual Meeting, the attendance of officials at the 
NELAC Annual Meeting and voting sessions is vital.
    B. Method. All voting is by show of hands, standing vote or machine 
(electronic). There shall be no voice voting. No abstentions are 
permitted. NELAC Annual Meeting and voting sessions are mandatory.
    C. Timing. Voting by both Houses is simultaneous.
    D. Recording. The voting system is designed to record the votes of 
the Representatives whether an electronic system, show of hands, 
standing vote or other method capable of being tallied is used.
    E. Applicability. These procedures (rules) apply only to the Annual 
Meetings of NELAC. However, only active members are permitted to vote 
in committee or other meetings.
Section 4--Committee Reports
    Alternatives that may be used in voting on the reports:

A. vote on the entire report;
B. vote on grouped items or sections; or
C. vote on individual items, according to
    1. committee discretion, or
    2. on request by a voting delegate, with the support of 10 others.
Section 5--Floor Amendments
    A. Amendments. Committee chairs are allowed to offer amendments on 
the day of voting to make editorial changes in their final reports.
    B. Changes. Substantive changes can be made at the request of House 
of Representatives or House of Delegates members and:
    1. A majority of the voting delegates of each House must vote 
favorably before a proposed amendment can be accepted for debate.
    2. A two-thirds favorable vote of each House on the amendment is 
required for passage (the requirement for the minimum number of votes 
in both Houses also applies).
Section 6--Seating
    A. Arrangement. The seating arrangement for voting sessions is 
shown in Figure 1.
    B. Supervision. The members of the Board of Directors will control 
placement and movement of delegates. The Executive Secretary will count 
votes.
Section 7--Voting
    At the conclusion of debate on a motion, there shall be a call for 
the vote by a show of hands, standing, electronic count, or other tally 
method.
    A. Minimum Votes. 1. House of Representatives. A minimum of one-
half the participating agencies must cast their votes in favor of, or 
in opposition to an issue for the vote to be considered official.
    2. House of Delegates. A minimum number of votes, equivalent to 
one-half the number of participating agencies, must be cast in favor 
of, or in opposition to an issue for the vote to be considered 
official.
    B. Motion accepted. 1. If the minimum number of members of the 
House of Representatives votes Yea; and if
    2. A majority of the members of the House of Delegates votes Yea 
(the minimum number of Yea votes required). If the minimum number of 
votes required to pass or fail an issue is not cast in the House of 
Delegates, the issue will be determined by the vote of the House of 
Representatives.
    C. Motion rejected. 1. If the minimum number of members of the 
House of Representatives votes Nay.

and if

    2. A majority of the members of the House of Delegates votes Nay 
(the minimum number of Nay votes required). Should a tie vote occur, or 
if the minimum number of votes required to pass or fail an issue is not 
cast in the House of Delegates, the issue will be determined by the 
vote of the House of Representatives.
    D. Split or tie vote. When the two Houses split on an issue or the 
minimum number of votes supporting or opposing an issue is not obtained 
in the House of Representatives, the issue is returned to the standing 
committee for further consideration.
    The committee may drop the issue or reconsider it for submission 
the following year. The issue cannot be recalled for another vote at 
the same Annual Meeting.
Section 8--Procedures
    The Conference officers and committees observe in all procedures 
the principles of due process--the protection of the rights and 
interests of affected parties; specifically, they (a) give reasonable 
advance notice of contemplated committee studies, items to be 
considered for committee action, and tentative or definite 
recommendations for Conference action, for the information of all 
parties at interest, and (b) provide that all interested parties have 
an opportunity to be heard by committees and by the Conference.
Section 9--Changes in Organization and Procedure
    Proposals for changes in organization or procedure of the 
Conference are not acted upon until the Annual Meeting of the 
Conference following the Annual Meeting at which such proposals are 
made.

BILLING CODE 6560-50-P

TN02DE94.008


BILLING CODE 6560-50-C

National Environmental Laboratory Accreditation Conference

Draft

Standards
November 1994.
Prepared by the State/EPA Focus Group

Table of Contents

1.0  Policy and Structure
1.1  Introduction
1.2  Purpose of the Conference
1.3  Structure of the Conference
    1.3.1  The Board of Directors
    1.3.2  The Environmental Laboratory Advisory Board
    1.3.3  The Committees
    1.3.3.1  The Standing Committees
    1.3.3.2  The Administrative Committees
    1.3.4  The Membership
    1.3.5  The Generation of Standards
    1.3.6  Adoption of Standards
1.4  Roles and Responsibilities of the Federal Government, the 
States, and Other Parties
    1.4.1  Federal Government (USEPA)
    1.4.2  State Governments
    1.4.3  Joint Federal and State Roles
    1.4.4  Other Parties
1.5  Scope of the Program
1.6  Structure of the Accreditation Requirements
    1.6.1  General Requirements
    1.6.1.1  Organization and management
    1.6.1.2  Quality system, audit and review
    1.6.1.3  Personnel
    1.6.1.4  Accommodation and environment
    1.6.1.5  Equipment and reference materials
    1.6.1.6  Measurement traceability and calibration
    1.6.1.7  Calibration and test methods
    1.6.1.8  Handling of calibration and test items
    1.6.1.9  Records
    1.6.1.10  Certificates and reports
    1.6.1.11  Sub-contracting of calibration or testing
    1.6.1.12  Outside support services and supplies
    1.6.1.13  Complaints
    1.6.2  Specific Requirements Linkage
    1.6.3  Discussion
1.7  Funding of the Program
    1.7.1  Self supported NELAC
    1.7.2  EPA Program Support
    1.7.3  Fee Supported State Programs
1.8 Reciprocity
    1.8.1  Fair Representation of Accrediting Authorities
    1.8.2  Scope and Essential Quality Standards
    1.8.3  Fee Structures

Figure 1-1

Figure 1-2

Figure 1-3

2.0  Performance Evaluation Testing Program
2.1  Enrollment in PE Testing Program
2.2  Approval of PE Testing Programs
2.3  Testing of Samples
2.4  Scoring
2.5  Successful Participation
3.0  On-Site Assessment
3.1  Introduction
3.2  On-Site Assessment Personnel
    3.2.1  Training
    3.2.2  Qualifications
    3.2.3  Additional qualifications
    3.2.4  Assessor Certification
3.3  Frequency of On-Site Assessments
    3.3.1  Frequency
    3.3.2  Follow-up evaluations
    3.3.3  Changes in laboratory capabilities
    3.3.4  Announced and unannounced visits
3.4  Pre-Assessment Procedures
    3.4.1  Introduction
    3.4.2  Scope of the assessment
    3.4.2.1  Laboratory evaluations
    3.4.2.2  Records review
    3.4.3  Assessment planning
    3.4.4  Reviewing NELAP/State information
    3.4.5  Providing Advance Notification
    3.4.6  Assessment Team Coordination
    3.4.7  Gathering assessment documents and equipment
    3.4.7.1  Types of documents
    3.4.7.2  Assessment equipment
    3.4.8  Confidential Business Information Considerations
3.5. Assessment Schedule/Format
    3.5.1  Length of evaluation
    3.5.2  Opening conference
    3.5.3  Records review
    3.5.4  Staff interviews
    3.5.5  Closing conference
    3.5.6  Follow-up procedures
3.6  Criteria for Assessment
    3.6.1  Assessor's Manual
    3.6.2  Assessors role
    3.6.3  Checklists
    3.6.4  Evaluation criteria
    3.6.4.1  Facility assessment
    3.6.4.2  Organization assessment
    3.6.4.3  Personnel assessment
    3.6.4.4  Sample handling assessment
    3.6.4.5  Equipment assessment
    3.6.4.6  Calibration standards assessment
    3.6.4.7  Methodology assessment
    3.6.4.8  Data audit
    3.6.4.9  QA Plan assessment
    3.6.4.10  General health and safety procedures
    3.6.4.11  Laboratory waste disposal assessment
3.7  Documentation of On-Site Assessment
    3.7.1  Checklists
    3.7.2  Report Format
    3.7.3  Distribution
    3.7.4  Report Deadline
    3.7.5  Release of Report
    3.7.6  Report Storage Time
4.0  Accreditation Process
4.1  Components of Accreditation
    4.1.1  Personnel Qualifications
    4.1.2  On-site Assessments
    4.1.3  Performance Evaluation Samples
    4.1.4  Corrective Action Reports
    4.1.5  Ethical Standards
    4.1.6  Fee Process for National Accreditation
    4.1.7  Application Process
    4.1.8  Transfer of Ownership/Change of Ownership and/or Location 
of Laboratory
    4.1.9  ``Certification of Compliance'' Statement
4.2  Period of Accreditation
4.3  Maintaining Accreditation
    4.3.1  Performance Evaluation Samples
    4.3.2  On-Site Assessments
    4.3.3  Other Accreditation Elements
    4.3.4  Notification and Reporting Requirements
    4.3.5  Record Keeping and Retention
    4.3.6  Payment of Fees
4.4  Suspension, Revocation and Denial of Accreditation
4.5  Interim Accreditation
    4.5.1  Interim Accreditation
    4.5.2  Revocation of Interim Accreditation
4.6  Awarding of Accreditation
    4.6.1  The Certificate of Accreditation
    4.6.2  Changes in Areas of Accreditation
4.7  Enforcement
    4.7.1  Role of Enforcement vs QA/QC
    4.7.2  Defining Enforceable Violations
    4.7.3  Recommendation
5.0  Quality Systems
5.1  Introduction
5.2  Quality System
    5.2.1  Quality Assurance Plan
5.3  General Quality Control Procedures
    5.3.1  Chemical Testing
    5.3.2  Bioassays
    5.3.3  Microbiology
    5.3.4  Radiochemistry
    5.3.5  Air Testing
5.4  Performance Evaluation Samples
5.5  Environmental Laboratory Staffing Requirements
    5.5.1  General requirements for laboratory staff
    5.5.2  Laboratory Staff Responsibilities and Credentials
    5.5.3  Quality Assurance Officer
5.6  Equipment
5.7  Test Methods and Standard Operating Procedures
    5.7.1  Laboratory Method Manual(s) and Standard Operating 
Procedures
    5.7.2  Method Validation/Initial Demonstration of Method 
Performance (Performance-based methods and non-approved methods)
    5.7.3  Calibration
    5.7.3.1  Documentation and Labeling
    5.7.3.2  Initial Calibrations
    5.7.3.3  Continuing Calibration Verification
5.8  Physical Facilities
    5.8.1  Environment
    5.8.2  Work Area
5.9  Sample Acceptance Policy and Sample Receipt
    5.9.1  Sample Acceptance Policy
    5.9.2  Sample Receipt Protocols
    5.9.3  Storage Conditions
5.10  Sample Tracking
5.11  Record Keeping, Data Review and Reporting
    5.11.1  Sample Custody Requirements
    5.11.1.1  Essential Documentation
    5.11.1.2  Record Keeping System and Design
    5.11.1.3  Laboratory Report Format and Contents
    5.11.1.4  Records Management and Storage
    5.11.2  Sample Custody Tracking and Data Documentation for 
Laboratory Operations
    5.11.2.1  Sample Receipt, Log In and Storage
    5.11.2.2  Intralaboratory Distribution of Samples for Analysis
    5.11.3  Legal or Evidentiary Custody Procedures
    5.11.3.1  Basic Requirements
    5.11.3.2  Required Information in Custody Records
    5.11.3.3  Controlled Access to Samples
    5.11.3.4  Transfer of Samples to Another Party
    5.11.3.5  Sample Disposal
5.12  Corrective Action Policy and Procedures

Appendix A

Appendix B

1.0  Policy and Structure

1.1  Introduction

    The Committee on National Accreditation of Environmental 
Laboratories (CNAEL) in its final report of September 1992 recommended 
the establishment of a national environmental laboratory accreditation 
program (NELAP). The States function as the primary accrediting 
authorities and may contract with a third party as the accrediting body 
for purposes of carrying out some parts of the accrediting functions, 
e.g. on-site inspections. As accrediting authorities, the states would 
maintain the authority to grant accreditation, enforce compliance, etc. 
EPA shall oversee and approve the state's compliance with all standards 
applicable to an accrediting authority. The recommended key elements 
for NELAP include on-site assessments, performance evaluation testing, 
and data audits. To achieve the stated goals of the CNAEL report, it is 
proposed to establish a National Environmental Laboratory Accreditation 
Conference (NELAC), which is modeled after the National Conference on 
Weights and Measures. NELAC membership shall be voluntary and shall be 
open to environmental laboratory accrediting authorities. The NELAC 
shall serve as the organization that shall establish and modify the 
accreditation standards. Broad participation in NELAC shall identify 
laboratories which are capable of providing reliable, uniform 
laboratory data which are acceptable to both Federal and State 
environmental programs. National accreditation standards and procedures 
shall provide a level playing field where reciprocity among the States 
in environmental laboratory accreditation shall be practicable. The 
creation of a National Environmental Laboratory Accreditation Program 
allows coordination of the current accreditation activities of 
different States or other governmental agencies, and reduces the number 
of on-site inspections, performance evaluation tests, and related 
requirements with which the accredited organizations must comply. It is 
intended that NELAP function in a manner which minimizes negative 
effects on the current accreditation operations of the States, requires 
minimum outlay of State and Federal funds to implement, and that is 
self supporting.

1.2  Purpose of the Conference

    The National Environmental Laboratory Accreditation Conference 
shall be a standards setting body. NELAC shall, through the process 
described, establish consensus uniform standards on which the national 
accreditation program shall be based. These uniform standards shall 
include, but are not limited to, quality systems, performance 
evaluation, audit programs, and other key elements as established by 
the standing committees of NELAC. It is NOT the purpose of NELAC to 
function as an accrediting body, oversee or approve accrediting bodies, 
or administer any of the main elements of the accreditation program.

1.3  Structure of the Conference

    The structure of the Conference is shown in Figure 1-1. The Board 
of Directors shall assume the overall supervisory, administrative, and 
procedural duties. The Standing Committees and Administrative 
Committees are overseen by the Board of Directors. The Standing 
Committees shall receive input regarding standards and test procedures, 
then process this input into resolutions which shall be put before the 
Membership at the Annual Conference. These resolutions shall be voted 
on by Active Members. The non-voting Contributors shall also have the 
opportunity to make presentations and comments on the resolutions 
throughout the process and at the Annual Conference. The NELAC may also 
take into consideration advice and comment provided to the 
Environmental Protection Agency through the Environmental Laboratory 
Advisory Board (ELAB) chartered under the Federal Advisory Committee 
Act (FACA). The composition and relationships of these bodies is 
described below.
1.3.1  The Board of Directors
    The Board of Directors consists of the Conference Chair, the Chair-
Elect, the most recent still active Past Chair, the Treasurer, six 
members elected at large from the active membership (to serve 3-year 
staggered terms), an EPA official to be appointed by the EPA 
Administrator as the NELAP Director (see section 1.4.1), and an 
Executive Secretary to be named by the Director. The Board of Directors 
serves as a policy and coordinating body in matters of national and 
international significance. The Board of Directors also makes interim 
policy decisions when necessary before the Voting Delegates have an 
opportunity to vote on the issues in question.
1.3.2  The Environmental Laboratory Advisory Board
    The ELAB consists of nine members composed of eight nongovernmental 
representatives and chaired by an EPA representative. The members may 
be selected from a slate of nominees prepared by the Contributors' 
Committee. This FACA board advises the EPA on matters affecting the 
interests of the contributors and other interested parties.
1.3.3  The Committees
    The committees are the Standing Committees and the Administrative 
Committees. Both are overseen by the Board of Directors.
1.3.3.1  The Standing Committees
    These committees each consist of five members elected from the 
Active Membership of the Conference. They serve five years and one new 
member is elected each year. The committee elects a chair. The 
committees shall generate standards and policies for which they have 
responsibility to be presented at the annual Conference for vote. The 
committees shall receive input via comments and presentations at the 
interim and annual conferences. The committees shall draft resolutions 
which shall be published by EPA in the Federal Register. The committees 
shall prepare and arrange timely agendas for Interim Meetings and 
Annual Conferences.
    The Program Structure Committee. This committee shall develop 
modifications to the scope, structure, and requirements to the tiers 
and fields of testing.
    The Accrediting Authority Committee. This committee provides the 
standards used by EPA to approve state authorities.
    The Quality System Committee. This committee shall establish and 
keep current the key elements of a quality system including record 
keeping and staffing requirements. The Committee shall also define 
uniform standard criteria for each of the elements of the quality 
system.
    The Performance Evaluation Program Committee. This committee shall 
determine the requirements for the Performance Evaluation Program. The 
committee shall generate the standards for the Performance Evaluation 
Samples, provide criteria for selection of the provider of the 
Performance Evaluation Samples, and provide and update the protocol for 
the use of Performance Evaluation Program in the accreditation of 
laboratories.
    The On-Site Assessment Committee. This committee shall establish 
the training and experience requirements of the assessors; establish 
the frequency of inspections; and generate the procedures for on-site 
visits.
    The Accreditation Process Committee. This committee shall establish 
and develop modifications for the accreditation process including the 
requirements for accreditation; procedural requirements for suspension, 
revocation and denial of accreditation; relative roles and 
responsibilities of laboratories; and appeal processes. The Committee 
considers matters concerning reciprocity of accreditation.
    The Regulatory Committee. This committee provides the Standing 
Committees with current information on Federal regulations which affect 
the testing that the laboratories do. The Regulatory Committee annually 
presents a report for Conference action. Its scope embraces all matters 
regarding the development and interpretation of uniform laws and 
regulations; the study and analysis of bills for legislative enactment; 
and the establishment and maintenance of published guidelines and other 
effective means of encouraging uniformity of interpretation and 
application of laboratory accreditation laws and regulations. This 
committee shall develop language which shall assist the states in the 
preparation and adoption of standardized statutes and regulations.
1.3.3.2  The Administrative Committees
    The Administrative Committees, with the exception of the 
Contributors Committee, shall consist of members appointed from the 
active membership. The functions and the responsibilities of the 
Administrative Committees are described below.
    The Nominating Committee. The Nominating Committee annually 
presents a slate of nominees for all elective offices at the national 
annual conference.
    The Conference Management and Funding Committee. This committee 
sets annual membership fees and conference registration fees, manages 
the logistical details of the interim meetings and annual conferences, 
prepares an annual budget for the Conference to be submitted for 
approval to the Board of Directors, and publicizes the interim meetings 
and annual conferences. The Treasurer shall be an ex-officio member of 
this committee.
    The Membership Committee. This committee initiates membership 
invitations and publicizes the Conference to prospective members. The 
committee also provides coordination and participation of Contributors 
in all affairs of the Conference.
    The Fiscal Auditing Committee. This committee is responsible for 
the conduct and review of the annual audit of the Conference and shall 
report such findings to the Board of Directors. It also audits the 
Treasurer's books annually.
    The Liaison Committee. This committee shall provide liaison with 
other federal agencies such as the Department of Energy and the 
Department of Defense. In addition this committee shall provide liaison 
with other national and international standard setting bodies such as 
the National Institutes of Standards and Technology (NIST) and the 
International Organization for Standardization (ISO). The function of 
this committee is to provide and solicit information and develop a 
spirit of cooperation between NELAC and outside organizations.
    The Contributors Committee. This committee is composed of five 
Contributors. Its function is to serve as a focal point for the 
Contributors. The committee shall propose a slate of candidates to the 
EPA as potential appointees to the ELAB. It solicits information from 
and provides feedback to the Contributors.
1.3.4  The Membership
    The Membership consists of two classes--Active Members and 
Contributors.
    Active Membership. Active membership is limited to State and 
Federal Officials. The Active Members may vote and serve on the 
Committees. At the annual conference the voting Members are divided 
into a House of Representatives and a House of Delegates. The House of 
Representatives is composed of one officially designated State 
Representative from each State or Territory, two representatives from 
each of seven EPA Assistant/Associate Administrators (OSWER, OAR, ORD, 
OW, OPPTS, OECA, and OROSLR), and one officially designated Federal 
Representative from each other participating federal program. The state 
representative should be the director of the state environmental 
laboratory accreditation, or a high level technically competent 
scientist who is knowledgeable about environmental laboratory analysis 
and accreditation programs, or his or her designee. The Federal 
Representative is designated by the appropriate person in charge of the 
federal program. All other State and Federal Officials are grouped as a 
body known as the House of Delegates.
    Contributors. The contributors are all other interested parties and 
groups. They include, but are not limited to, laboratory personnel, 
industry representatives, environmental groups, the general public, 
laboratory associations, industry associations, accreditation 
associations, and retired active members. The Contributors may not 
vote, but can make presentations, comments or input at all stages of 
the standards and procedures making process.
1.3.5  The Generation of Standards
    The standards for the accreditation of laboratories begin in the 
various committees (see Figure 1-2). Draft standards proposed by the 
committees are published in the Federal Register by EPA. After 
providing an appropriate time for review, an Interim Meeting is held 
and presentations, comments and other input are received. The draft 
proposals are processed and either presented at the Annual Conference 
or returned to committee for further work. These resolutions presented 
at the Annual Conference are voted upon by the Active Membership. (See 
Constitution and Bylaws for voting procedures.) If rejected, they go 
back to committee for reassessment or shelving. If approved, they are 
presented in the Federal Register in final form by EPA.
1.3.6  Adoption of Standards
    Participating States must adopt the standards to maintain status as 
a NELAP accreditor. If a State chooses not to participate in all or 
part of the accreditation program, laboratories in that State may 
obtain certification from a participating State that is approved under 
NELAP.

1.4  Roles and Responsibilities of the Federal Government, the States, 
and Other Parties

1.4.1  Federal Government (USEPA)
    The role of the federal government, as represented by the USEPA 
(the Agency), shall be that of oversight and evaluation of the 
accrediting authorities and that of administration of NELAP program 
elements which require a high degree of standardization between 
different accrediting authorities. In addition, the USEPA shall provide 
staff support to the Conference as provided for in the Bylaws and 
agreed to by the Agency. The EPA shall assist the Conference by 
publishing in the Federal Register all proposed and final standards. 
The EPA will also evaluate state and federal laboratories to assure 
compliance with NELAC standards. The EPA Administrator will appoint a 
Director of the National Environmental Laboratory Program. The Director 
shall serve as an ex officio member of the Board of Directors. He or 
she shall select a senior member of EPA with laboratory accreditation 
experience as the Executive Secretary of the Conference (a full time 
position). The Director's Office shall establish a program which 
evaluates, approves, and reports on the accreditation programs 
implemented by the state accrediting authorities. In these reports, 
state accreditation programs shall be evaluated against the national 
standard as established by the Conference. The EPA shall evaluate, 
inspect, and approve state and federal laboratories as complying with 
NELAC standards. In addition, the Agency shall establish a five member 
board, the Accrediting Authority Review Board, composed of 
representatives from the states, EPA, and other federal agencies, to 
review the process and procedures used by EPA to approve State and 
Federal laboratories and accrediting authorities. It is recommended 
that the Agency provide administrative support to a performance 
evaluation sample program so as to ensure uniformity of sample 
composition and performance evaluation standards.
1.4.2  State Governments
    State governments shall be the primary accrediting authority. The 
state's Laboratory Accreditation Program will be audited and approved 
by the Director's Office. As the accrediting authority, states will 
have full responsibility for ensuring conformance with the national 
standard established by NELAC. States will be responsible for 
accrediting applicant organizations through approving applications, 
performing on-site assessments and maintaining performance evaluation 
sample programs. States are responsible for ensuring that on-site 
inspectors are trained in accordance with NELAP requirements. States 
shall submit the names, and appropriate accreditation material, to the 
EPA for inclusion in the National Laboratory Database. States may 
choose to contract accreditation activities to a third party (non-
government) agency. If contracted to a third party, states remain the 
accrediting authority and retain responsibility for ensuring compliance 
with the standards established by NELAC.
1.4.3  Joint Federal and State Roles
    The NELAC (Conference) shall be the joint responsibility of the 
Federal Government (Agency) and the state accrediting authorities. As 
provided in the following section on structure of the Conference and 
the Conference Bylaws, state accrediting authorities and the Agency 
share responsibilities of governance, analysis and establishment of 
policy, and analysis and establishment of technical standards as they 
apply to the NELAP.
1.4.4  Other Parties
    All other interested parties including, but not limited to, the 
laboratory industry, clients of the laboratory industry, environmental 
or other public interest groups, and the general public, shall function 
as contributors to the Conference. In this role, these other parties 
shall bring technical and policy issues to the attention of the 
Conference, its managing Board, or its subcommittees. It is anticipated 
that these issues shall be brought to the Conference in the form of 
reports, presentations, discussion material, or other forms of 
documentation for presentation at the annual Conference, committee, or 
subcommittee meetings.

1.5  Scope of the Program

    The scope of the National Environmental Laboratory Accreditation 
Program shall encompass the necessary scientific testing to serve all 
U.S. Environmental Protection Agency (EPA) monitoring, compliance or 
other functions mandated by statutes and pursuant regulations. Some of 
the statutes are the Federal Insecticide, Fungicide and Rodenticide Act 
(FIFRA); the Safe Drinking Water Act (SDWA); the Resource Conservation 
and Recovery Act (RCRA); the Comprehensive Environmental Response 
Compensation and Liability Act (CERCLA): the Federal Water Pollution 
Control Act (Clean Water Act); the Clean Air Act (CAA); and the Toxic 
Substances Control Act (TSCA). In addition, the program shall also 
include provisions to permit special requirements or fields of testing 
promulgated by any of the States and/or Territories.
    However, the program shall not be implemented or administered in a 
way which limits the ability of local, state or federal agencies to 
investigate and prosecute enforcement cases. Specifically, when engaged 
in the collection and analysis of forensic evidence to support 
litigation those agencies may use any procedure that is appropriate 
given the nature of the investigation, subject only to the bounds of 
sound scientific practice. This program shall not apply to those 
government laboratories engaged solely in the analysis of forensic 
evidence.

1.6  Structure of the Accreditation Requirements

    The structure of the NELAP shall be based on the field of testing 
(see Figure 1-3). It shall consist of a set of general requirements 
that all applicants must satisfy. Applicants for a particular field of 
testing must also meet the necessary number of additional levels of 
specific requirements or functions that are linked to the general 
requirements. The number and the degree of difficulty of the required 
additional levels shall depend on the complexity of the test procedures 
in question.
    It is proposed that the different fields of laboratory testing be 
structured into groupings based on parameter, group of parameters, or 
method. In addition, a category of supplemental accreditation will be 
designated. A ``supplemental'' accreditation means accreditation of a 
laboratory which has met additional methods or parameters required by a 
state accrediting authority.
    ``Supplemental'' accreditation shall be needed only for those few 
methods and/or parameters which are unique to a particular state. These 
supplemental requirements shall be limited in number and scope.
1.6.1  General Requirements
    The general requirements are applicable to all applicants 
regardless of their size, volume of business, or field of testing. The 
organizational structure, or procedures used by applicant organizations 
to meet these general requirements may differ as a function of size or 
scope of testing of an organization. The general requirements shall 
include all the elements outlined in General Requirements for the 
Competence of Calibration and Testing Laboratories, ISO/IEC Guide 25: 
1990 (E).
    General requirements shall include Health and Safety, and Waste 
Management Programs. Applicant organizations shall be required to be in 
compliance with all applicable federal, state, and local rules and 
regulations covering environmental, and occupational health and safety. 
Responsibility for the evaluation of compliance with these rules and 
regulations shall remain with the appropriate regulatory body.
    The relevant elements listed in the document are as follows:
1.6.1.1  Organization and Management
    The organization shall be legally identifiable; the organization 
shall have managerial staff with the authority and resources needed to 
discharge their duties; this includes technical management with overall 
responsibility for the technical operations, and quality management 
with responsibility for the quality system and its implementation.
1.6.1.2  Quality System, Audit and Review
    The organization shall establish and maintain a quality system 
appropriate to the type, range and volume of calibration and testing 
activities it undertakes; the quality manual, and related quality 
documentation, shall state the organization's policies and operational 
procedures; the organization shall arrange for audits of its activities 
at appropriate intervals to verify that its operations continue to 
comply with the requirements of the quality system.
1.6.1.3  Personnel
    The organization shall have sufficient personnel, having the 
necessary education, training, technical knowledge and experience for 
their assigned functions.
1.6.1.4  Accommodation and Environment
    Organization facilities shall have suitable space, energy sources, 
lighting, heating and ventilation for proper performance of 
calibrations or tests.
1.6.1.5  Equipment and Reference Materials
    The organization shall be furnished with all items of equipment 
(including reference materials) required for the correct performance of 
calibrations and tests.
1.6.1.6  Measurement Traceability and Calibration
    Standards used for calibration must be traceable.
1.6.1.7  Calibration and Test Methods
    The organization must document instructions on the use and 
operation of all relevant equipment.
1.6.1.8  Handling of Calibration and Test Items
    The organization must document a system used to identify the items 
to be calibrated or tested.
1.6.1.9  Records
    The organization shall maintain a record system to suit its 
particular circumstances and comply with any applicable regulations.
1.6.1.10  Certificates and Reports
    The organization certifies and reports the calibration and/or test 
results.
1.6.1.11  Sub-Contracting of Calibration or Testing
    The organization shall sub-contract work only to organizations that 
are accredited by a NELAC accrediting authority. Subcontractors must be 
clearly identified.
1.6.1.12  Outside Support Services and Supplies
    The organization must use only those outside support services and 
supplies that are of adequate quality.
1.6.1.13  Complaints
    The organization shall have documented policy and procedures for 
the resolution of complaints received from clients or other parties 
about the organization's activities with records maintained of all 
complaints and of the actions taken by the organization; where a 
complaint, or any other circumstance, raised doubt concerning the 
procedures, or other requirements or otherwise concerning the quality 
of the organization's calibrations or tests, the organization involved 
is promptly audited in accordance with pre-established procedures.
1.6.2  Specific Requirements Linkage
    Additional tiers of requirements can be linked to the general 
requirements. To illustrate the tiered approach, a schematic 
representing the accreditation scope and structure by field of testing 
is given in Figure 1-3. It indicates that all NELAP applicants must 
meet the basic requirements. Additional specific tiers of requirements 
are linked to the basic requirements for a particular test or activity. 
An organization seeking accreditation in hazardous waste organic 
testing must meet all the requirements listed in basic requirements, 
general laboratory, organic, and hazardous waste. The specific and 
detailed requirements under this scheme have not been developed at this 
time. The appropriate and necessary requirements of the various tiers 
and fields of testing will be developed by the Program Structure 
Committee.
1.6.3  Discussion
    The field of testing structure proposed for the national 
environmental laboratory accreditation program provides flexibility. 
This allows for the incorporation of new methods or new instrumentation 
without the applicants repeatedly demonstrating the basic requirements 
that the accreditation applicants have previously satisfied. Redundancy 
of qualification assessment is avoided. Avoidance of redundant reviews 
and assessments shall significantly expedite the processing of 
applications which cover different fields of testing. Such a scheme 
provides a structure whereby appropriate and specific accreditation 
requirements can be established to meet the prevailing needs of 
environmental laws and regulations. Regulators are thus provided with 
environmental sample testing results generated by laboratories 
according to specified or equivalent methods and quality assurance 
protocols.
    Additionally, the adoption of parameter, method specific and 
supplemental classifications allows for the design of accreditation to 
suit needs of individual laboratories and states. This flexibility 
shall promote reciprocity among all the participating States. The field 
of testing approach proposed shall also allow for the future 
incorporation of performance based methods (PBM) by substituting an 
approved PBM for the specified analytical methods. Any supplemental 
requirements essential to meet state needs would be added at the 
parameter or method specific level.

1.7  Funding of the Program

    Funding shall be needed to cover the costs arising from at least 
three areas: the administration and functions of NELAC; expenses 
incurred by EPA through its oversight and related administrative 
duties; and expenses incurred by the States because of accreditation 
functions including on-site visits, performance evaluation samples, 
processing applications, and other duties. Funding mechanisms for each 
of these cost areas is proposed below:
1.7.1  Self Supported NELAC
    The NELAC should be self-sustaining financially insofar as 
possible. The Interim meetings and Annual Conferences expenses should 
be financed by registration fees and annual dues for Members and 
Contributors. These dues and registration fees should be set by the 
Conference Management and Funding Committee. Other expenses of 
committee members shall be paid by their organizations.
1.7.2  EPA Program Support
    The EPA should provide support for the National Environmental 
Laboratory Accreditation Program. This program includes oversight and 
evaluation of accreditation authorities, evaluation and approval of 
state and federal laboratories, administrative support for the 
Conference, and publications in the Federal Register.
1.7.3  Fee Supported State Programs
    All costs of state accreditation programs may be covered through 
the collection of application fees from the applicant organizations. 
Such fees would cover the cost of application and processing, 
performance evaluation, site assessments, staff training, Conference 
membership and participation, and other appropriate activities, whether 
such activities were carried out directly by the state accrediting 
authority or by contract to a third party. It is recommended that a 
dual fee structure be implemented by the state authorities. A full fee 
should be charged applicants for which the state is the primary 
accreditor. A reduced fee should be charged applicants for which the 
state is the secondary accreditor. This fee structure is based on the 
principle that fees shall cover the actual cost of an accreditation. 
The primary accrediting authority shall incur the full cost of 
accreditation. The secondary accrediting authority, having accepted the 
accreditation of another authority through reciprocity, shall only 
incur the cost of registration of the accredited organization. Costs 
incurred by a secondary accrediting authority related to supplemental 
requirements, as described in section 1.8.2, should be reflected in 
supplemental fees.

1.8  Reciprocity

    All member accrediting authorities shall grant reciprocity to all 
other member accrediting authorities which have met the national 
standard. This principle of reciprocity is an element of the national 
accreditation standard, to which all member accrediting authorities are 
held.
    Reciprocity among the environmental laboratory accrediting 
authorities is essential to the success of a national program. The 
principal accrediting authorities shall be the states. The states or 
federal agencies which act as accrediting authorities, must accept 
accreditation from other accrediting authorities in order for a 
national uniform program to succeed. Three policy issues are presented 
which are key to acceptance of the reciprocity principle by accrediting 
authorities.
1.8.1  Fair Representation of Accrediting Authorities
    The accrediting authorities must have a fair and representative 
voice in the National Environmental Laboratory Accreditation 
Conference. NELAC shall establish the basic scope, structure, and 
standards of the national program. Acceptance of the national program, 
in lieu of state programs, shall be significantly enhanced by fair and 
meaningful participation of state accrediting authorities in the 
establishment of the national program.
1.8.2 Scope and Essential Quality Standards
    The national program (the national consensus standard) adopted by 
NELAC shall have a scope and essential quality standards which meet or 
exceed the requirements of the existing state accrediting authorities. 
NELAC must consider the range of scope and quality systems requirements 
of the state accrediting authorities in the adoption of a national 
program. A national program which falls significantly short of the 
existing state program requirements, shall either not be accepted by 
state authorities, or shall require such extensive state supplementary 
requirements as to make the national program irrelevant. It is 
recognized that certain state authorities shall have special 
requirements which arise from a unique statutory, economic, or 
ecological situation. Reciprocity shall be possible if state mandated 
supplementary requirements are limited in number and complementary to 
the national program.
1.8.3  Fee Structures
    NELAC shall adopt a policy which recommends that all accrediting 
authorities institute a fee structure which reflects the cost of 
operation of the accreditation program. NELAC requires that 
laboratories apply for accreditation in the state of their primary 
operation.

BILLING CODE 6560-50-P

TN02DE94.009


TN02DE94.010


TN02DE94.011


BILLING CODE 6560-50-C

2.0  Performance Evaluation Testing Program

2.1  Enrollment in PE Testing Program

    Each laboratory must enroll in a performance evaluation (PE) 
testing program that meets the criteria detailed by the National 
Environmental Laboratory Accreditation Program (NELAP). The laboratory 
must participate in an approved program or programs for each field of 
testing for which it seeks accreditation. Participation shall mean the 
analysis and reporting of all test samples. Laboratories shall 
participate in PE testing for all fields of testing at a frequency 
determined by the NELAC standards.
    The laboratory must notify the accreditation agency of the NELAP-
approved program or programs in which it chooses to participate to meet 
PE testing requirements. For those tests performed by the laboratory 
for which PE testing is not currently available, the laboratory must 
establish and maintain the accuracy and reliability of its testing 
procedures by a system of internal quality management.
    For each field of testing for which the laboratory seeks 
accreditation, it must participate in the designated, NELAP- approved 
PE testing program for at least twelve months before designating a 
different program. The laboratory must notify the primary accreditor 
before any change in designation.
    Laboratories shall bear the cost of any subscription to a PE 
testing program required by NELAP.
    Each participant must authorize the PE testing program to release 
to the primary accreditor all data required to determine the 
laboratory's compliance with the criteria. The primary accreditor shall 
make individual performance results available to all requesters.

2.2  Approval of PE Testing Programs

    In order for a PE testing program to receive approval, the program 
must be offered by a Federal or State agency, or entity acting as a 
designated agent for the Federal or State agency. A Federal or State 
program seeking approval or renewal for its PE program for the next 
calendar year must submit an application to the NELAP director 
providing the required information by July 1 of the current year. The 
program must provide technical assistance to resolve problems that the 
participants experience such as anomalies during analysis of the 
samples, lost samples, or receipt of broken sample containers, etc. In 
addition, the PE testing program must,
    (a) Assure the quality of test samples, appropriately evaluate and 
score the PE test results, and identify performance problems in a 
timely manner;
    (b) Demonstrate to the primary accreditor (or NELAP) that it has:
    (1) The technical ability required to:
    i. Either prepare samples or evaluate samples purchased from 
manufacturers, who prepare the samples in conformance with the 
appropriate good manufacturing practices; and
    ii. Distribute samples with at least two levels of analytes. 
Rigorous quality control must assure that samples mimic actual 
environmental samples when possible and that samples are homogeneous 
and remain stable over the period of testing. Stability shall be 
verified by routine testing on stored samples, within the time frame 
for analysis by PE test participants. Samples shall be maintained by 
the PE testing program to retest laboratories with unsatisfactory 
performance, or which have significant changes in accreditation status;
    (2) A scientifically defensible process for determining the correct 
result for each challenge offered by the program;
    (3) A program of sufficient challenge, with a frequency of no less 
than two times per year, to establish that a laboratory has met 
performance requirements;
    (4) The resources needed to distribute, analyze and interpret 
individual laboratory performance. The PE program will provide:
    i. Individual results to the laboratories,
    ii. Statewide and nationwide reports to regulatory agencies on 
individual laboratory performance on PE test events,
    iii. Cumulative reports and scores for each laboratory, and
    iv. Reports of specific laboratory failures using grading criteria 
acceptable to NELAP,which must be provided on a timely basis.
    (5) Provisions on each PE report form used by the laboratory to 
record PE results, an attestation statement that PE test samples were 
tested in the same manner as routine samples, with a signature block to 
be completed by the individual performing the test as well as by the 
laboratory management;
    (6) A mechanism for notifying participants of the PE shipping 
schedule and for participants to notify the PE testing program within 
three days of the expected date of receipt of the shipment that samples 
have not arrived or are unacceptable for testing. The program must have 
provisions for replacement of samples that are lost in transit or are 
received in a condition that is unacceptable for testing; and
    (7) A process to resolve technical, administrative, and scientific 
problems about program operations;
    (c) Provide and maintain the following documentation as described:
    (1) Reports of PE test results and all scores for each laboratory's 
performance (an electronic or a hard copy, or both) must be provided to 
the primary accreditor, NELAP, and the participating laboratory in the 
format required by NELAP within 60 days after the date by which the 
laboratory must report PE test results to the PE testing program;
    (2) Records of each laboratory's performance must be maintained for 
a period of five years or such time as may be necessary for any legal 
proceedings; and
    (3) An annual report must be provided to the primary accreditor and 
NELAP with, if needed, an interim report, which identifies any 
previously unrecognized sources of variability in kits, instruments, 
methods, or PE samples, which may adversely affect the ability of the 
primary accreditor or NELAP to evaluate laboratory performance.
    If a PE testing program is determined by NELAP to fail to meet any 
criteria for acceptance as an approved performance evaluation testing 
program, NELAP will notify the PE testing program and the primary 
accreditor. The PE program must notify all laboratories enrolled in 
their PE program of the nonapproval and the reasons for nonapproval, 
within 30 days of the notification.

2.3  Testing of Samples

    The laboratory must examine or test, as applicable, the PE samples 
it receives from the PE testing program in the same manner as it tests 
environmental samples, and return the results by the deadline stated in 
the sample package. The analyst testing or examining the samples and 
the laboratory management must attest to the routine integration of the 
samples into the workload using the laboratory's routine methods. The 
laboratory must test samples the same number of times that it routinely 
tests environmental samples.
    Laboratories that perform tests on PE samples must comply with the 
following restrictions and limitations on communications and sample 
transfer:
    (a) Laboratories must not engage in any interlaboratory 
communications pertaining to the results of PE sample(s) until after 
the date by which the laboratory must report the results to the PE 
program for the PE test event in which the samples were sent;
    (b) Laboratories with multiple testing sites or separate locations 
must not participate in any communications or discussions across sites/
locations concerning PE sample results until after the date by which 
the laboratory must report the PE test results to the program; and
    (c) The laboratory must not send PE samples or portions of samples 
to another laboratory for any analysis for which they seek 
accreditation.
    Any laboratory that the primary accreditor or NELAP determines 
intentionally referred its PE samples to another laboratory for 
analysis and submits the other laboratory's results as their own, will 
have its certification revoked for a minimum period of one year. Any 
laboratory that receives PE samples from another laboratory for testing 
must notify the accreditation program of the receipt of those samples. 
Laboratories not doing so may have their accreditation suspended for a 
period not to exceed one year. This policy is not intended to prevent 
interlaboratory testing designed as part of a methods development or 
evaluation study, and applies only to PE samples.
    The laboratory shall initiate chain of custody procedures upon 
receipt of all PE samples. The laboratory must maintain a copy of all 
records, including analytical worksheets, for a minimum of five years. 
This record must include a copy of the PE program report forms used by 
the laboratory to record PE results, and an attestation statement 
signed by the analyst and the laboratory management stating that PE 
samples were tested in the same manner as routine samples.

2.4  Scoring

    Option I: Pre-established pass/fail range set by calculating 95% 
confidence interval determined by previous studies.
    Option II: Statistical evaluation of data from all participants in 
the current study. Calculation of 95% and 99% confidence intervals to 
set marginal and unsatisfactory performance.
    Option III: Pre-established pass/fail intervals as established in 
40 CFR 136, appendix B.
    Option IV: The following scoring protocol applies to: All chemical 
analytes; bacteriology samples that require quantitation (total and 
fecal coliform in non-potable water); fibers in air determined by phase 
contrast microscopy; asbestos in friable solid material by polarized 
light microscopy; and asbestos in air and potable water by transmission 
electron microscopy.
    The true values may be established through robust statistical 
analysis of the results reported by all laboratories, in order to 
reject gross outliers and establish a mean result and standard 
deviation, or through results obtained by a panel of 12 reference 
laboratories (this is done for asbestos in friable material). A 
laboratory's result on a given sample is then assessed as:
    Good if it is within the 95% confidence interval about the mean, or 
reported as ``less than'' the method detection limit if the sample is a 
blank;
    Marginal if it is outside the 95% confidence interval, but within 
the 99% confidence interval about the mean, or reported as ``less 
than'' twice the method detection limit; or
    Unsatisfactory if it is any other result.
    For each test, a laboratory receives 2 PE samples for each 
certified analyte. On two consecutive tests, a laboratory must obtain a 
passing score of at least 75% on the 4 samples analyzed, calculated by 
applying the following formula.

TN02DE94.012

    Hence, the laboratory must obtain at least two good results plus 
two marginal results, or three good results plus one unsatisfactory 
result, over two consecutive tests.
    In response to the accreditation program guidelines, certain 
chemistry analytes are scored by taking fixed intervals about the known 
target value, where good performance is defined as a result within 
those fixed target intervals, and unsatisfactory performance is any 
other result.
    For the potable water total coliforms, where qualitative analysis 
is required (i.e., presence/absence), a laboratory is required to 
maintain an average passing score of 90% on two consecutive tests.
    Laboratories being tested for the determination of radon in air are 
required to submit 5 sampling devices to the PE testing program. Four 
of these are exposed to a known concentration in a standard atmosphere 
exposure chamber, and the remaining device is left unexposed as a 
``blank''. The devices are then returned to the laboratories for 
analysis, and they are required to report results within 25% of the 
target value on at least 4 of the 5 devices.

2.5  Successful Participation

    Each laboratory must successfully participate in a PE testing 
program approved by NELAP for each field of testing in which the 
laboratory is accredited. If a laboratory's accreditation is suspended 
or revoked because it fails to participate in PE testing for one or 
more fields of testing, or voluntarily withdraws its accreditation for 
the failed field of testing, the laboratory must then demonstrate 
satisfactory performance on two consecutive PE test events, one of 
which may be onsite, before the primary accreditor will consider it for 
reinstatement.
    Laboratories shall agree to test additional samples at the option 
of the primary accreditor for the following situations:
    (a) A major change in ownership or supervision of the laboratory;
    (b) Complaints by users or employees;
    (c) Unsatisfactory performance on most recent PE test event; or
    (d) Request by the laboratory to be reinstated in a field of 
testing.
    Failure to participate in a PE test event shall result in an 
automatic rating of unsuccessful performance and results in a score of 
zero for the PE test event. Consideration may be given to those 
laboratories failing to participate in a PE test event only if:
    (a) Routine testing was suspended during the time frame allotted 
for testing and reporting PE test results; and
    (b) The laboratory notifies the primary accreditor and the PE 
testing program within the time frame for submitting PE test results of 
the suspension of routine testing and the circumstances associated with 
failure to perform tests on PE samples.
    Failure to return PE test results to the PE program within the time 
frame specified by the program is unsuccessful performance and results 
in a score of zero for the PE test event. The PE testing program will 
specify the conditions and procedures for late submissions, e.g., lost 
or broken samples. For those late submission categories, the 
participant will be allowed to test the samples on an alternate 
schedule.
    For any unsatisfactory PE test event for reasons other than a 
failure to participate, the laboratory must undertake appropriate 
training and employ the technical assistance necessary to correct 
problems associated with a PE test failure.
    Remedial action must be taken and documented, and the documentation 
must be maintained by the laboratory for five years from the date of 
participation in the PE test event. Failure to achieve an overall PE 
test event passing score for two consecutive PE test events or two out 
of three consecutive PE test events is unsuccessful performance.

3.0 On-Site Assessment

3.1  Introduction

    The on-site assessment is an integral part of a lab accreditation 
program and will be one of the primary means of determining a 
laboratory's capabilities and qualifications. During the on-site 
assessment, the assessment team will collect information and make 
observations which will be used to evaluate the laboratory's 
conformance with established accreditation criteria. It is essential 
that the on-site assessment be conducted in a uniform, consistent 
manner throughout the nation to facilitate reciprocity among States, 
and for the laboratory community to accept the accreditation process. 
This section contains proposals and recommendations for conducting on-
site assessments.

3.2  On-Site Assessment Personnel

3.2.1  Training
    The National Environmental Laboratory Accreditation Conference 
(NELAC) will specify the minimum level of education and training for 
assessors, including refresher/update training. The NELAC will also 
develop criteria for training requirements. The assessor training 
course will be developed and implemented by EPA, NIST, or a non-Federal 
entity with oversight by EPA. A state may develop and implement it's 
own assessor training program, subject to EPA oversight, if the state 
program can meet the NELAC standards.
3.2.2 Qualifications
    A laboratory assessor may work for a Federal, State, or a third 
party accrediting body. An assessor, including each member of an 
inspection team, must be an experienced professional and hold at least 
a B.S. degree, or equivalent education and experience, in the specific 
discipline being evaluated. Each assessor must also have satisfactorily 
completed a laboratory accreditation training course and a health and 
safety training course, and take periodic update/refresher training, as 
specified by NELAC. Each new candidate assessor must undergo on-the-job 
training during one or more inspections until judged proficient.
3.2.3  Additional Qualifications
    In addition, the assessors must:
    (a) Be familiar with the relevant legal regulations, accreditation 
procedures, and accreditation requirements;
    (b) Have a thorough knowledge of the relevant assessment methods 
and assessment documents;
    (c) Be technically conversant with the specific tests or types of 
tests for which the accreditation is sought and, where relevant, with 
the associated sampling procedures;
    (d) Be able to communicate effectively, both orally and in writing; 
and
    (e) Be free of any commercial interest that might cause the 
assessor to act in other than an impartial or nondiscriminatory manner.
3.2.4  Assessor Certification
    Before an assessor can conduct on-site inspections, the individual 
must be certified to do so, in writing, by either the NELAP or State in 
which the individual will assess laboratories. For each laboratory 
inspection performed by a state-designated third party assessor (i.e. 
non-EPA, non-State), the assessor must sign a statement before the 
inspection, certifying that no conflict of interest exists.

3.3  Frequency of On-Site Assessments

3.3.1  Frequency
    Accreditors should perform a routine on-site assessment at least 
annually. Assessments may be more frequent at laboratories where a 
problem exists, including complaints about laboratory quality, 
questions of fraud, or recurring failure on performance evaluation 
samples.
3.3.2  Follow-Up Evaluations
    In addition to routine evaluations, assessors may need to conduct 
one-time follow-up evaluations at laboratories where a significant 
deficiency was identified by the previous evaluation. These evaluations 
may be limited to determining whether a laboratory has corrected its 
deficiency(ies), or determining the merit of a formal appeal from the 
laboratory. When deficiencies may result in downgrading of 
accreditation status, follow-up evaluations should occur as soon as 
possible but no later than 60 days after the original evaluation.
3.3.3  Changes in Laboratory Capabilities
    The accrediting authority may also deem necessary a limited one-
time evaluation when a major change occurs at a laboratory in 
personnel, equipment, or a laboratory location that might impair 
analytical/biological capability and quality. A major change in 
personnel is defined as the loss or replacement of the laboratory 
management staff, or loss of a trained and experienced individual who 
performs a particular test for which accreditation has been granted.
3.3.4  Announced and Unannounced Visits
    The accrediting authority is not required to provide advance notice 
of an assessment. However, the policy is to provide such notification, 
based on the circumstances of the particular assessment and laboratory. 
Since these highly technical assessments may involve sensitive 
information and because there is a need to ensure that appropriate 
personnel and records are available for assessment, the testing 
laboratory usually is notified in advance of a planned assessment. The 
accrediting authority, at its discretion, may conduct unannounced 
evaluations for cause (e.g., questions of fraud, tips, complaints, or 
problems with performance evaluation samples) or as part of a routine 
practice.

3.4  Pre-Assessment Procedures

3.4.1  Introduction
    A good assessment begins with planning, which should commence well 
before the assessment team visits the laboratory.
    Planning is the means by which the lead assessor identifies all the 
required activities to be completed during the assessment process. 
These activities include obtaining records before the assessment, 
conducting the assessment, writing reports and following up.
    Pre-assessment activities include: deciding the scope of the 
assessment (Section 3.4.2); assessment planning (Section 3.4.3); 
reviewing NELAP/State information (Section 3.4.4); providing advance 
notification of the assessment to the laboratory (Section 3.4.5); 
coordinating the assessment team (Section 3.4.6); and gathering 
assessment documents and equipment (Section 3.4.7). Section 3.4.8 
discusses Confidential Business Information issues.
3.4.2  Scope of the Assessment
    The first step in the assessment planning process is deciding what 
type of assessment will be conducted. The assessments usually include a 
laboratory evaluation and a records review.
3.4.2.1  Laboratory Evaluations
    A laboratory assessment obtains a ``snapshot in time'' at a testing 
laboratory by evaluating what activities are being conducted when the 
assessment takes place. During a laboratory evaluation, the assessment 
team may identify a number of samples or a recently completed or on-
going project and evaluate to what extent the tests are being conducted 
according to NELAP or client requirements.
3.4.2.2  Records Review
    The purpose of a records review is to learn if the testing 
laboratory has maintained data and other information necessary to 
support reports previously issued. During a records review, team 
members will conduct an overall audit of data, and will compare data 
with submitted reports to determine whether the data were generated or 
collected following the proper procedures in the NELAP/State, EPA, or 
client requirements.
3.4.3  Assessment Planning
    Planning includes conducting a thorough review, prior to the 
assessment, of NELAP and/or State records pertaining to the laboratory 
to be inspected. This will save time because familiarity with the 
operation, history, and compliance status of the laboratory increases 
the efficiency and focus of an on-site visit. Planning also promotes a 
better relationship with the laboratory community because the lead 
assessor will be better able to answer questions concerning the 
application of NELAP/State requirements to a particular laboratory. It 
also enhances the laboratory's confidence in the lead assessor and aids 
in establishing good relationships with laboratory representatives.
    Another important benefit of planning is to enhance the lead 
assessor's ability to identify and document potential problems and plan 
to collect necessary information to assist the accrediting authority in 
their subsequent decisions concerning the laboratory. Planning an 
assessment will result in an efficient and productive assessment 
overall.
3.4.4  Reviewing NELAP/State Information
    The lead assessor's responsibilities start with receipt of the 
Assessment Assignment. For a records review, copies of all appropriate 
documents related to the laboratory will be forwarded by the 
accrediting authority to the lead assessor or directly to a team 
member, if appropriate, ideally at least six weeks prior to the start 
of the assessment. The lead assessor should request any other 
information that will be useful in preparing for the assessment. Such 
information may include:
    (a) Copies of previous assessment reports and PE sample results;
    (b) General laboratory information such as laboratory submitted 
self-assessment forms, SOPs and Quality Assurance plan;
    (c) Correspondence with laboratory personnel;
    (d) Discussion with appropriate NELAP/State staff;
    (e) Available documents from recipients of reports from the 
laboratory; and
    (f) Relevant program documents such as NELAP/State guidelines or 
SOPs.
3.4.5  Providing Advance Notification
    No fewer than two weeks prior to an announced assessment, the 
accrediting body will contact the responsible management official at 
the laboratory to schedule the assessment. The initial telephone 
notification will be confirmed by a notification letter. A copy of the 
notification letter also will be given to the lead assessor. An 
assessment assignment that gives the name and telephone number of the 
laboratory contact person and of each assessment team member, as well 
as other available information necessary to the planning and conduct of 
the assessment will also be provided to the lead assessor.
    Once the laboratory has been notified by the accrediting authority 
that an assessment will be conducted, the primary responsibility for 
the conduct of the assessment passes to the lead assessor. Any further 
communications with the laboratory personnel should be made by the lead 
assessor. The lead assessor should keep his/her supervisory personnel 
informed of the status of the assessment, and should consult with them 
on any substantive problems that may arise or changes that may be 
required.
    There are several items to be addressed in the advanced 
notification. The lead assessor should make note of when and to whom 
advance notification was provided. Written advance notification should 
do the following:
    (a) Introduce the lead assessor and team members to the laboratory;
    (b) Schedule the assessment, including establishing time of 
arrival;
    (c) Obtain verbal agreement for entry;
    (d) Confirm the appropriate address for the assessment, including 
identifying the location of necessary records, as specified in the 
assessment plan;
    (e) Ensure that laboratory personnel are available to accompany 
assessors during the assessment;
    (f) Encourage the laboratory to transfer all records to the 
assessment site before the assessment;
    (g) Obtain directions to the laboratory; and
    (h) Allow discussion of problems, concerns, or questions about the 
assessment or any other issues.
    Especially when the laboratory has not previously been assessed by 
the accrediting authority, the lead assessor should be certain that 
laboratory personnel are aware of what an assessment involves, what 
data and records should be made available and what personnel should be 
present. If the laboratory representative does not cooperate, the lead 
assessor's supervisor and the accrediting authority management should 
be consulted for instructions on how to proceed.
3.4.6  Assessment Team Coordination
    When the identity of the assessment team is known, the lead 
assessor should contact each person and begin planning the conduct of 
the assessment. As early as possible the lead assessor should:
    (a) Coordinate travel plans, including the hotel and transportation 
arrangements;
    (b) Notify each team member of the dates of the assessment and pre-
assessment team meeting;
    (c) Ensure that each team member has been briefed on specific 
procedures for the assessment;
    (d) Define the time allotted for the assessment. The lead assessor 
should be careful not to underestimate the time needed to conduct the 
assessment; and
    (e) Confirm for those individuals who will be conducting the 
records review, their familiarity with the records to be reviewed. Each 
member of the assessment team should be aware of their responsibilities 
during the assessment.
    The lead assessor should also arrange to provide copies of 
applicable NELAP/State standard operating procedures (SOPs) to team 
members who do not already possess these documents. In addition, the 
lead assessor may need to assure that the assessment team is aware of 
proper procedures for receipt and handling of confidential business 
information (CBI). The lead assessor should determine the level of 
experience of each team member in conducting laboratory evaluations or 
records reviews under NELAP/State requirements. The lead assessor may 
need to guide less experienced team members, both prior to and during 
the assessment as well as with report preparation. The lead assessor 
should assemble the team just prior to the assessment to attend to last 
minute details.
3.4.7  Gathering Assessment Documents and Equipment
    Besides preparing the assessment plan and reviewing accrediting 
body records and laboratory submissions prior to conducting the 
assessment, the lead assessor should gather and prepare the necessary 
documents and equipment to be used during the assessment. No single 
list of documents and equipment can be appropriate for all assessments. 
The lead assessor's experience in the field and information obtained 
during pre-assessment planning should assist in preparing lists 
tailored to specific assessment sites and needs. Specific needs will be 
determined by the requirements of the assessment, the availability of 
equipment, conditions at the laboratory, NELAP/State policies, and 
whether advance notification of an assessment is given.
3.4.7.1  Types of Documents
    Documents necessary for the assessment should be prepared before 
the assessment, whenever possible. The lead assessor should obtain 
copies of the required assessment forms. Several spare copies of each 
form should always be carried. Assessments may require:

--Notice of assessment;
--Assessment confidentiality notice;
--Conflict of interest form;
--Assessor credentials;
--Assessment assignment;
--Assessment notification letter;
--Attendance sheet, opening and closing conference; and
--assessment appraisal form.

    In addition, the lead assessor should be certain to take the 
following documents and materials on an assessment:
    (a) Copies of NELAP/State requirements. Lead assessors should have 
copies of the applicable NELAP/State requirements available upon 
request. Having such data available can help improve the relationship 
between NELAP/State and the laboratory community, which can foster 
better laboratory compliance;
    (b) NELAP/State checklists for evaluations;
    (c) NELAP/State outreach materials. Lead assessors should provide 
current, relevant educational, and/or guidance information to 
laboratory officials upon request or as deemed appropriate by the lead 
assessor; and
    (d) Administrative information. Travel authorizations and telephone 
numbers of travel and procurement personnel who may need to be 
contacted should be taken by the lead assessor when on travel.
3.4.7.2  Assessment Equipment
    The types of equipment that a lead assessor takes to an assessment 
site will vary from assessment to assessment, depending upon the nature 
and extent of the assessment and the type of testing laboratory to be 
inspected. Therefore, prior to each assessment, the lead assessor 
should check the equipment to make sure that it is in good working 
condition. Since each assessment is unique, no single list of equipment 
or forms can be devised that will fit every assessment situation.
3.4.8  Confidential Business Information Considerations
    NELAP/State SOPs protect Confidential Business Information (CBI) 
from disclosure. CBI includes trade secrets (including process, 
formulation, or production data) and certain financial information, the 
uncontrolled disclosure of which could cause damage to a laboratory's 
competitive position. In general, disclosure of CBI is prohibited, 
except in certain limited situations.
    The lead assessor should keep in mind that information obtained 
from a laboratory during an assessment can, for the most part, be 
disclosed in response to a request from the public, or other requesting 
party, under Federal or State Freedom of Information requirements. 
However, if the data has been properly claimed as CBI, it may not 
generally be disclosed under these requirements.
    A lead assessor must present notice to laboratory representatives 
of their right to claim data at the laboratory as CBI and such claims 
are frequently made. Because the lead assessor is very likely to 
require access to CBI before (i.e., while preparing for an assessment), 
during, and after an assessment, the lead assessor must be 
knowledgeable of NELAP/State procedures governing access to, handling 
of, and disclosure of CBI. The lead assessor and others who may use the 
information must have CBI access authorization, since only authorized 
individuals may have access to CBI. A CBI-cleared lead assessor may 
obtain access to CBI documents from the accrediting authority by 
requesting access to the information from the appropriate official.
    Whether or not it is anticipated that CBI documents will be 
collected during an assessment, the lead assessor must provide a NELAP/
State assessment confidentiality notice to the responsible laboratory 
official at the beginning of the assessment. This notice informs 
laboratory officials of their right to claim part of the assessment 
data as CBI. The lead assessor should be familiar with the procedures 
for asserting a CBI claim, and the criteria that the claimed 
information must meet.
    The lead assessor must take custody of all CBI documents before 
leaving the laboratory, and must maintain them in custody, using all 
proper procedures and safeguards, until they can be received by the 
accrediting authority.

3.5.  Assessment Schedule/Format

3.5.1  Length of Evaluation
    The length of an on-site assessment will depend upon a number of 
factors, such as the number of tests evaluated, the number of assessors 
available, the size of the laboratory, the number of problems 
encountered during the assessment, and the cooperativeness of the 
laboratory staff. The accrediting body should assign an adequate number 
of assessors to complete the evaluation within a reasonable period of 
time. Assessors must strike a balance between thoroughness and 
practicality, assuring that the assessment covers all aspects of the 
laboratory operation.
3.5.2  Opening Conference
    Arrival at the facility should occur during normal working hours. 
The facility representative should be located as soon as the assessment 
team arrives on the premises. A laboratory's refusal to admit the 
assessment team for an evaluation may result in an automatic failure or 
loss of accreditation on the part of the laboratory, unless there are 
extenuating circumstances that are accepted by the accreditation body. 
The team leader should notify the accrediting body as soon as possible 
after refusal of entry.
    When the appropriate official has been located, the team leader 
should introduce the team and should present credentials. Many 
companies require that the assessment team sign a visitor's sheet that 
contains the name, time, reason for visit, organization, etc., which 
should be signed. However, any request for any assessment team member 
to sign a ``visitor's release'' or ``waiver'' that would relieve the 
company of responsibility for injury or that would limit the rights of 
the accrediting body to use the data obtained should not be signed. If 
such a waiver or release is presented, the team leader should politely 
explain that they cannot sign and request a blank sign-in sheet. The 
assessment team leader should brief the appropriate responsible 
official(s) of the facility to introduce team members, explain areas to 
be evaluated and verify application information.
    The assessment team leader should request relevant documents for 
review that were not part of the application materials, such as 
standard operating procedures, chain-of-custody forms, report forms, 
etc.
    The assessment appraisal form should be presented to the 
appropriate laboratory official with a request that the form be 
completed and returned to the accrediting authority after the 
assessment. This form will allow feedback from the laboratory on the 
manner in which the assessment was conducted.
3.5.3  Records Review
    The records requested during the opening conference will be 
reviewed by assessment team members for accuracy, completeness and 
proper methodology for each area to be evaluated.
    Trade secrets and confidential business information are protected 
from public disclosure. The type of information that may be considered 
confidential business information is defined in Title 40, Code of 
Federal Regulation, Part 2. All financial and trade information should 
be kept confidential, if so requested by the laboratory. All other 
information for all aspects of application, assessment and 
accreditation of laboratories is considered public information. If the 
laboratory requests that information other than that noted above is 
confidential, the information should be treated as confidential until a 
ruling can be made by the accreditation body.
    The team leader must mark all confidential information received and 
handle it as required by appropriate laws and regulations.
3.5.4  Staff Interviews
    The assessment team will evaluate a test by having the individual 
that normally conducts the specific procedure walk through the 
procedure, including a step-by-step description of exactly what is done 
and what equipment and supplies are employed. The assessor will note 
and record the procedure on the standardized checklists for that 
particular test and application. Any deficiencies shall also be noted 
and discussed with the individual.
    The assessment team members shall have the authority to conduct 
interviews with any/all staff and, if necessary, conduct private 
interviews. Calculations, data transfers, calibration procedures, 
quality control/assurance practices and adherence to SOP's shall be 
assessed for each test.
    During the evaluation, sufficient information may become available 
to indicate that a particular person has violated an environmental law 
or regulation, such as knowingly making a false statement on a report. 
This information should be carefully documented, since it may be used 
in a legal action. When the possibility of additional legal 
investigation exists, the assessor should not discuss the legal 
implications of the suspected violation with the individual or any 
laboratory representative. However, the assessor should continue to 
gather the information necessary to complete the accreditation 
assessment.
3.5.5  Closing Conference
    The assessment team should meet with representatives following the 
evaluation of the laboratory for an informal debriefing and discussion 
of findings.
    In the event the laboratory disagrees with the findings of the 
assessor(s), and the team leader adheres to the original findings, the 
area(s) protested shall be documented by the team leader and included 
in the report to the accreditation body for consideration. The 
accrediting authority will make the final determination.
    The assessment team should provide the accreditation body with an 
assessment report encompassing all relevant information concerning the 
ability of the applicant laboratory to comply with the accreditation 
requirements. If data is available from performance evaluation testing, 
this should be included in the final report.
3.5.6  Follow-Up Procedures
    The accrediting authority will issue the assessment to the 
applicant laboratory that outlines any areas of deficiencies. The 
applicant laboratory should then submit a plan of corrective action, if 
necessary, and provide any missing documentation required within 45 
days from the date of report receipt.
    After reviewing documentation and corrective actions, the 
accrediting authority will make the decision to pass, fail or provide 
interim accreditation for a laboratory. If the deficiencies listed are 
substantial or numerous, an additional assessment (possibly 
unannounced) may be conducted before a final decision for accreditation 
can be made.

3.6  Criteria for Assessment

3.6.1  Assessor's Manual
    The NELAC will develop a manual(s) for on-site assessors to assure 
that on-site assessments are performed in a uniform, consistent manner. 
The manual(s) will be provided when assessors take the NELAC required 
training (section 3.2.1) and will serve as guidance for on-site 
assessment personnel.
    The manual(s) provided to on-site assessors should include 
instructions for evaluating the following items:
    (a) Size, appearance, adequacy of the laboratory facility;
    (b) Organization and management of the laboratory;
    (c) Qualifications and experience of laboratory personnel;
    (d) Receipt, tracking and handling of samples;
    (e) Quantity, condition, performance of laboratory instrumentation 
and equipment;
    (f) Preparation and traceability of calibration standards;
    (g) Analytical and biological methodology (including the 
laboratory's standard operating procedures as well as confirmation of 
individuals' adherence to SOPs, and the individual's proficiency with 
the methodology);
    (h) Data reduction procedures, including an examination of raw data 
and confirmation that final reported results can be traced to the raw 
data/original observations;
    (i) Quality assurance/quality control procedures, including 
adherence to the laboratory's quality assurance plan and adequacy of 
the plan;
    (j) General health and safety procedures as they relate to good 
scientific practices;
    (k) Laboratory waste disposal procedures;
    (l) Environmental and toxicological test methods and SOPs; and
    (m) Care, use, and maintenance of test organisms.
3.6.2  Assessors Role
    When performing an on-site laboratory evaluation, the assessor must 
appraise each of the areas listed in section 3.6.1. The on-site 
assessor should use a variety of tools in the evaluation process. The 
experience of the assessor, his/her observations, interviews with 
laboratory staff, and examination of SOPs, raw data, and the 
laboratory's documentation will all play an important role in the 
assessment. The role of the on-site assessor is a critical one in the 
entire laboratory accreditation process. The accreditation of a 
particular laboratory will depend to a large extent on the assessor's 
recommendation. While much of the on-site assessment will depend upon 
the assessor's judgement, the recommendation not to accredit a 
laboratory must be based on factual information, not on opinions or 
suppositions. Therefore it is crucial that the on-site assessor have a 
clear understanding of the laboratory's procedures and policies, and 
that the assessor document any deficiencies. Also the assessor should 
discuss any deficiencies with the laboratory's management in order to 
allow them to provide additional information which might affect the 
assessor's recommendations.
3.6.3  Checklists
    Standardized checklists for the on-site assessment must be used. 
The use of checklists does not discourage the need for additional 
observations and staff interviews, but is merely another tool in the 
assessor's inventory which assists in conducting a thorough and 
efficient evaluation. Using a checklist as a substitute for assessor 
training and experience must not occur.

    Note: It is anticipated that standardized checklists will be 
developed or adopted by NELAC's On-Site Assessment Committee for the 
assessor's review of analytical and biological methodology.
3.6.4  Evaluation Criteria
    The following considerations should be taken into account by on-
site assessors when evaluating the areas listed in section 3.6.1:
3.6.4.1  Facility Assessment
    The assessor(s) should tour the laboratory facility with the 
laboratory management representative. Usually the tour will occur 
during the initial phase of the on-site visit, perhaps after the 
opening conference. During the tour, the assessor should visually 
inspect the facility with respect to general housekeeping, cleanliness, 
lighting, bench space and continuous temperature monitoring (if 
required). The assessor should note whether the appropriate laboratory 
services (e.g., vacuum system, compressed air, gases, etc.) are 
available. It may be necessary to have the laboratory representative 
demonstrate that certain pieces of equipment are working properly, for 
example, a fume hood may be turned on to assure that it does indeed 
exhaust air from the laboratory. This type of demonstration is not 
intended to certify that the hood meets design specifications or safety 
requirements, but merely that it is operational. During the tour, the 
assessor(s) should determine if sample storage areas are sufficient and 
whether there are problems with laboratory operations which would 
affect data quality. For example, an extraction operation located in 
the same room where volatile organic analyses are performed could 
contribute contamination to the volatile organic analyses.
    Any problems or deficiencies with the laboratory facility should be 
brought to the attention of the laboratory management at the time of 
the tour and reinforced at the closing conference. If discrepancies are 
noted between statements made by the laboratory representative and 
visual observations, it may be necessary to interview other laboratory 
personnel to obtain an explanation of the situation. As with all areas 
of the on-site assessment, the experience and training of the on-site 
assessor are critical to the success of the facilities evaluation.
3.6.4.2  Organization Assessment
    The assessor should review laboratory QA plans, SOPs, 
organizational charts and/or other documentation to determine the 
laboratory's operational structure. If a documented organizational plan 
exists, the assessor should ascertain during subsequent interviews with 
laboratory personnel if the laboratory operation follows the documented 
plan. The assessor should interview laboratory management to determine 
the roles of management and how laboratory policy is created. The 
absence of a documented organizational structure, clearly defined 
functional responsibilities, and lines of communication, should be 
considered a deficiency.
3.6.4.3  Personnel Assessment
    The assessor should review the laboratory's written qualification 
requirements for each position, and the qualifications of those persons 
currently holding the positions. Key personnel, e.g., laboratory 
management staff, quality assurance coordinator, section managers, 
chief analysts, etc., should be interviewed to verify their 
qualifications for their positions. These interviews may be conducted 
concurrently with interviews on analytical and biological procedures, 
quality control requirements, etc., in order to expedite the process. 
The assessor should be cautious when making judgments on personnel 
qualifications, and must be aware that experience may be an acceptable 
substitute for formal education. When in doubt concerning personnel 
qualifications, the assessor should conduct an in-depth interview with 
the individual to determine his/her expertise in a given area.

    Note: Section 5, Quality Systems, contains details on personnel 
qualifications.
3.6.4.4  Sample Handling Assessment
    The assessor should review the laboratory's SOP for sample receipt 
to assure that all appropriate elements (e.g., proper sample 
containers, preservatives, chain of custody, sample storage, sample 
rejection policy, etc.) are included. Any omissions should be brought 
to the attention of the laboratory management and appropriate 
laboratory staff person. Absence of a written sample receipt SOP should 
be considered a serious deficiency. The assessor should inspect the 
sample storage areas to insure that the facilities are adequate and 
secured. Cold storage facilities should be checked for maintenance of 
proper temperatures, proper monitoring devices (thermometers, etc.) and 
appropriate documentation. Sample receipt personnel should be 
interviewed to determine their adherence to the SOP. Sample receipt 
documentation and chain-of-custody records should be reviewed to 
determine if documentation is adequate. Failure to follow SOPs may be 
considered a serious deficiency, depending on the degree of deviation. 
Failure to keep sample receipt and chain-of-custody documentation 
should be considered a serious deficiency.
3.6.4.5  Equipment Assessment
    The assessor should determine if the laboratory has all equipment 
and instrumentation necessary to perform the analyses for which 
certification is requested. This determination should be performed by 
visual inspection of the laboratory. The assessor should determine if 
the equipment is in reasonable working condition. An actual 
demonstration of equipment performance is not necessary in all 
circumstances, but should be required if the assessor has doubts about 
the condition of certain pieces of equipment. The absence of a required 
piece of equipment or instrument for a particular test should be 
considered a serious deficiency. The assessor should determine if the 
laboratory has written records of equipment repairs, maintenance, 
testing and calibration.
3.6.4.6  Calibration Standards Assessment
    The assessor shall ascertain whether the laboratory has the 
necessary stock calibration standards and should spot check calibration 
standards to see if they are within expiration dates. The assessor 
should determine if stock standards are properly stored, e.g., volatile 
organic standards are stored in sealed vials in a freezer. The assessor 
should examine the laboratory's records for stock standards and the 
preparation of working standards to determine if the records are 
complete.
3.6.4.7  Methodology Assessment
    The assessor should determine whether the laboratory has standard 
operating procedures for all test methods used by the laboratory. The 
standard operating procedures should be reviewed to determine if they 
adequately address all aspects of the analytical and biological 
procedures, e.g., sample preparation, calibration standard preparation, 
instrument calibration, etc. The analysts should be interviewed to 
verify that they have access to and are following the standard 
operating procedures for all methods. The lack of analytical and 
biological standard operating procedures or significant deviations from 
the standard operating procedures should be considered as serious 
deficiencies.
    While the ideal on-site assessment would consist, in part, of 
observing each individual perform his/her assigned work, time 
considerations will not permit this approach in a laboratory which 
conducts a wide variety of analytical or biological procedures. 
Consequently, the on-site assessor will need to rely more heavily on 
interviews with laboratory personnel, observations, and review of 
records to determine proficiency with, and knowledge of, the analytical 
or biological methodology. The assessor's experience and training will 
play a key role in this process.
    The assessor should be familiar with the performance of a test, so 
that the appropriate technical questions may be asked of the 
laboratory's analysts. The assessor should pose questions to the 
laboratory's staff in such a way as to not lead the individual into the 
correct response. The individual's responses should be cross-checked 
with the laboratory's documentation. During interviews with the 
individuals, it may be unclear as to how the analytical and biological 
procedures are being performed. If this occurs, then the assessor 
should ask the individual to demonstrate the procedure.
3.6.4.8  Data Audit
    The assessor should perform a data audit on an appropriate number 
of sample sets which contain all the tests for which the laboratory is 
seeking accreditation. It may be necessary to audit multiple sample 
sets in order to cover all tests. The assessor should verify that the 
required sample receipt documentation and chain-of-custody records are 
on file and that they contain all necessary information. The assessor 
should obtain final data reports for the sample set being audited. The 
assessor should verify that the final reports contain the following 
information:

--Sample receipt date;
--Sample analysis date;
--Sample identification;
--Method used for analysis;
--Quantitation units, e.g., mg/L, mg/Kg, g/m3, etc.;
--If sample is a solid, whether results are calculated on a wet weight 
or dry weight basis, and if on a dry weight basis, the percent moisture 
or percent solids;
--The sample result (if the result is none detected, the method 
detection limit should also be reported); and
--Method of statistical determination of test result, if applicable.

    The assessor should assure that all information needed to verify 
the final result is on file, including reasons for invalidating testing 
results if this has occurred. The information may include sample 
preparation data, instrument output (chromatograms, mass spectra, strip 
charts), instrument calibration records, and records of dilutions. Once 
the information is located, the assessor should recreate the 
calculation in order to verify the final reported result. The absence 
of the required information needed to verify the final result should be 
considered a serious deficiency. If the assessor is unable to recreate 
a calculation, the problem should be discussed with laboratory 
personnel in an attempt to resolve the issue. If any calculations/final 
results are determined to be incorrect, the assessor should examine 
approximately ten percent of the data for the test in question over a 
selected time period to see if a systematic error has occurred.
    In addition to auditing results from routine sample analyses, 
assessors must also audit results of performance evaluation (PE) 
samples analyzed by the laboratory for the NELAP. Assessors should 
verify that the sample(s) were analyzed using the criteria set forth by 
NELAP. The data generated during the analysis of PE samples should be 
examined and compared with final results reported to the NELAP.
3.6.4.9  QA Plan Assessment
    The assessor should examine the laboratory's written QA Plan to 
determine if it conforms to the Quality Systems requirements in Section 
5.0. The assessor should examine the laboratory's raw data to ascertain 
if the required QC checks have been documented. If QC criteria were 
exceeded, the assessor must determine if corrective action was 
initiated. Laboratory personnel should be interviewed to determine if 
they understand and follow the requirements of the QA Plan. Laboratory 
management should be interviewed to determine their commitment to the 
QA program. The absence of a QA Plan, or an incomplete QA Plan, should 
be considered a major deficiency. The lack of appropriate corrective 
action or documentation of corrective action should be considered a 
serious deficiency.
3.6.4.10  General Health and Safety Procedures
    The responsibility for promulgating and enforcing occupational 
safety and health standards rests with the U.S. Department of Labor.\1\ 
While it is not within the scope of the assessment team to evaluate all 
health and safety regulations, any obviously unsafe condition(s) should 
be described to the appropriate laboratory official, and reported to 
the appropriate state or federal agency. The accreditation on-site 
assessment is not intended to certify that the laboratory is in 
compliance with all applicable health and safety regulations.
---------------------------------------------------------------------------

    \1\Handbook for Analytical Quality Control in Water and 
Wastewater Laboratories, EPA-600/4-70-019, March 1979.
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3.6.4.11  Laboratory Waste Disposal Assessment
    The assessor(s) should ask if adequate facilities are available for 
the collection, storage and/or treatment (if applicable) of all 
laboratory wastes. The waste disposal system(s) should be operated in 
such a manner to protect the air, water, and land by minimizing and 
controlling all releases from fume hoods and bench operations. 
Compliance is also required with any wastewater discharge permits and 
regulations. It is the laboratory's responsibility to comply with all 
federal, state, and local regulations governing waste management, 
particularly the hazardous waste regulations. The accreditation on-site 
assessment is not intended to certify that the laboratory is in 
compliance with all applicable waste disposal regulations.

3.7  Documentation of On-Site Assessment

3.7.1  Checklists
    The checklists used by the assessors during the assessment should 
become a part of the permanent file kept by the NELAP/State on each 
laboratory.
3.7.2  Report Format
    Evaluation reports should be generated in a narrative format, 
allowing for differences in style and technique between accrediting 
authorities. Deficiencies must be addressed at a minimum, however, 
documentation of positive aspects should be included. Documentation of 
existing conditions at the laboratory should be included in each report 
to serve as a baseline for future contacts with the facility.
3.7.3  Distribution
    The accrediting authority should be recognized as having the 
responsibility for the content of the evaluation reports. The team 
leader should compile, edit and submit the final report to the 
accrediting authority. The team leader must assure that the results 
within the final report conform to established criteria for the 
evaluated parameters.
3.7.4  Report Deadline
    No longer than thirty (30) days should elapse from the last day of 
an on-site evaluation until the report is submitted to the accrediting 
authority for review and final decision.
3.7.5  Release of Report
    On-site evaluation reports should be released by the accrediting 
authority only. The reports will be released to the management of the 
affected laboratory and to those persons nominated by the laboratory to 
receive a copy of the report. The assessment report shall not be 
released until the assessment and all other appropriate action has been 
completed. In accordance with the Freedom of Information requirements, 
any documentation adjudged to be proprietary, financial and/or trade 
information will be considered exempt from release to the public.
3.7.6  Report Storage Time
    At a minimum, copies of all evaluation reports must be retained by 
the evaluators and the accrediting authority for a period of five 
years, or longer if required by regulation.

4.0  Accreditation Process

4.1  Components of Accreditation

    These criteria must be fulfilled for accreditation. The components 
and criteria are herein described.
4.1.1  Personnel Qualifications
    This component ensures that the managerial and supervisory 
personnel in the environmental laboratory meet a minimum set of 
qualifications that address the elements of education, training and 
experience. It should be recognized that some of these elements are 
interconnectable, i.e. a greater magnitude of training and/or 
experience may substitute for lesser degrees of formal education. Refer 
to Quality Systems for a detailed review of supervisors and managers, 
and the criteria to be maintained by the supervisors and managers for 
awarding accreditation.
4.1.2  On-Site Assessments
    On-site assessments and evaluations may be of two types: announced 
and unannounced. The assessment ensures that the environmental 
laboratory is capable of performing analyses to the level, precision 
and accuracy required by the specific method or performance based 
method. Announced assessments test these methods and evaluate the 
results against the criteria under the best circumstances in a 
controlled environment. The unannounced assessment measures the 
abilities of the laboratory to meet these standards for methods on an 
average day under normal working conditions and in a normal working 
environment. Each type of assessment has limitations and advantages, 
but the information obtained from both will provide a higher degree of 
confidence in the ability of the laboratory to attain a required level 
of competence in the quality of data produced for regulatory and 
compliance purposes. Refer to on-site assessment for additional 
information regarding frequency, procedures, criteria, scheduling and 
documentation of on-site assessments.
    Announced Assessments--The elements present in and criteria for 
announced assessments for national accreditation are:
    (a) The assessment must be performed a minimum of one time per year 
and be conducted on-site; i.e., the site at which the actual analyses 
take place;
    (b) The assessment may consist of any or all of the categories for 
which the laboratory wants to obtain accreditation;
    (c) The inspector must have access to all information and data 
requested both for analyses completed and laboratory personnel;
    (d) The results of the assessment and the Performance Evaluation 
sample analyses indicating satisfactory or unsatisfactory performance 
will be sent to the National Database on environmental laboratories; 
and
    (e) At least two performance evaluation (PE) samples, twice per 
year, for each method or field of testing, must be successfully 
analyzed according to the standards established for quality assurance/
quality control, precision and accuracy. It may not be required to 
analyze PE samples during the on-site assessment. Marginal performance 
on any previous PE samples can be grounds for requiring that a 
subsequent PE sample analysis be performed under the observation of an 
inspector.
    Unannounced Assessments--The elements and criteria for the 
unannounced assessments for the purpose of the national accreditation 
program are:
    (a) The inspector may not be denied immediate access to the 
laboratory facility;
    (b) Elements (a) through (d) under announced assessments are also 
applicable to unannounced assessments;
    (c) Performance evaluation samples may be distributed and analyses 
run in the categories and for the methods that are determined by and 
prescribed by the inspector; and
    (d) All performance evaluation samples and other analyses required 
by the inspector are to be done as directed by the inspector. These 
include parameters such as: specified equipment, analysts and times, 
but are not limited to these factors.
    Factors Examined in Announced and Unannounced Laboratory 
Assessments.--Refer to On-site Assessments for assessment criteria 
required to be satisfied for accreditation. It should be noted, the 
inspector is not limited to these factors in reaching an evaluation and 
conclusion. Other factors may be considered and documented as 
appropriate.
    Laboratories will be furnished with an inspection report 
documenting any deficiencies found in the factors listed above or any 
others considered by the inspector. It shall also include whether a 
specific method passed or failed based on the Performance Evaluation 
sample. All such reports are public record and any or all of the 
information contained therein may be put into the National Database. 
Proprietary data will be excepted from all public records.
    The laboratory will have no more than 45 days from the date of 
receipt of the report to correct deficiencies noted in the inspection 
report. At that time, if no remedial action has been taken to correct 
the noted deficiencies, accreditation for categories or specific 
methods within those categories will be immediately revoked.
4.1.3  Performance Evaluation Samples
    A critical component of laboratory assessments is the analysis of 
the Performance Evaluation Samples. Refer to Performance Evaluation 
Testing, specifically Testing of Samples, for additional information 
regarding separate treatment of Performance Evaluation samples, 
discussion of issues of availability, and purity and distribution. 
Performance Evaluation samples would be used and evaluated in the 
accreditation process in the following manner:
    (a) All laboratories seeking National Accreditation must receive, 
examine and analyze initial performance evaluation sample(s) for each 
category (e.g., drinking water, hazardous waste, etc.) in which they 
are requesting accreditation. The analysis must be completed and the 
results reported to the performance evaluation testing organization or 
the Inspector within 45 days of the receipt of the sample.
    (b) Each laboratory seeking national accreditation shall also be 
required to perform analyses on at least two performance evaluation 
samples, two concentrations, two times per year in each category for 
which they have applied for accreditation or for which the laboratory 
is currently accredited.
    (c) The laboratory will be informed of the results of the 
performance evaluation sample analysis within 60 days of receipt by the 
state agency or authorized third party contractor. The results of all 
of the performance evaluation sample tests indicating satisfactory or 
unsatisfactory compliance will be public record and will be recorded on 
the national database.
    (d) The results of the performance evaluation sample analysis will 
be considered, along with other information obtained from announced 
and/or unannounced assessments in determining whether accreditation 
should be granted, denied or modified for a category, or whether the 
laboratory should lose accreditation for a category or method within a 
category.
4.1.4  Corrective Action Reports
    The purpose of the corrective action report is to have a written 
record of response to deficiencies that are noted in the laboratory 
assessment procedure.
    (a) After being notified of deficiencies from the laboratory 
inspection, the laboratory has 45 days from the date of receipt of the 
deficiency report to submit a corrective action report.
    (b) The state authority or authorized third party contractor will 
respond to the action noted in the corrective action report within 30 
days of receiving it. The report must address each of the deficiencies 
noted on the deficiency report.
    (c) A laboratory can lose accreditation in a category or a method 
within a category by any or all of the following items:
    i. Failing to respond to corrective action two times;
    ii. Failing to submit a corrective action report;
    iii. Failing to address each item noted as a deficiency in the 
corrective action report;
    iv. Failing the same performance evaluation sample analysis two 
consecutive times for the same analyte; or
    v. Failing to achieve an overall testing event passing score for 
two consecutive testing events or two out of three consecutive testing 
events.
    (d) All information included and documented in a deficiency report 
and the corrective action report are considered to be public 
information. Other states participating in the National Environmental 
Laboratory Accreditation Program would have access to this information 
through a national database. At a minimum, the database would include 
the following information:
    i. Name and location of laboratory;
    ii. Number and dates of assessments performed and whether they were 
announced or unannounced;
    iii. Performance evaluation samples and analyses done, the date 
completed and the status (in process; passed, failed);
    iv. Categories and methods for which the laboratory is currently 
accredited and date of accreditation; and/or
    v. Categories and method for which the laboratory has lost 
accreditation and the date of loss of accreditation.
4.1.5 Ethical Standards
    Elements in a national program that ensure consistency and promote 
the use of quality assurance/quality control procedures to generate 
quality data for regulatory purposes are
    (a) NELAC strongly recommends requires that each laboratory seeking 
national accreditation have a named Quality Assurance Officer. NELAC 
strongly recommends that the Quality Assurance Officer be a person 
other than any supervisor of laboratory analysts, who reports directly 
to the laboratory management and not to the laboratory supervisor in 
matters related to quality assurance and quality control of analyses, 
methods relating to these analyses, and instrumentation.
    (b) NELAC will consider that responsibility for falsification of 
data, records or instrument parameters will rest upon the Quality 
Assurance Officer (named in 4.1.4a above), the laboratory management 
and the company.
    (c) The National Environmental Laboratory Accreditation Program 
shall establish a ``Laboratory Fraud Hotline'' telephone number. 
Alleged cases of data, record or analytical fraud reported via this 
hotline will be referred to the relevant state authority for 
investigation. The fact that a federal or state has taken regulatory, 
legal, or contractual action against a laboratory will be made 
available on the national database.
4.1.6  Fee Process for National Accreditation
    Refer to Policy and Structure, specifically funding of the program 
1.7.3, regarding the funding of state accreditation programs, including 
a fee structure covering the actual cost of an accreditation.
    (a) The cost incurred in the application process for national 
environmental laboratory accreditation will be called an accreditation 
fee.
    (b) Where required, accreditation fees will be paid to the state(s) 
which grants accreditation to the laboratory. These fees must be paid 
in accordance with existing state regulations, levels and practices.
    (c) Failure to remit the accreditation fee within the time limit as 
established by the individual state authority will be grounds for 
immediate loss of accreditation in that state. The loss of 
accreditation will immediately be entered in the national database.
4.1.7  Application Process
    The National Environmental Laboratory Accreditation Program 
encompasses a standardized set of elements in each application for 
accreditation that will be reported to and recorded in the national 
database. The application package includes any specific state 
regulatory requirements that are essential for accreditation within an 
individual state.
    The application form for national environmental laboratory 
accreditation shall include:
    (a) Legal name of laboratory
    (b) Laboratory mailing address
    (c) Name of owner
    (d) Location (full address) of laboratory
    (e) Name and phone number of laboratory contact person
    (f) Name and phone number of Quality Assurance Officer
    (g) Name and phone number of laboratory management representative
    (h) Laboratory hours of operation
    (i) States for which the laboratory is requesting accreditation
    (j) Categories for which the laboratory is requesting accreditation
    (k) Description of laboratory type

--Commercial
--Federal
--Hospital or health care
--State
--University
--Public water system
--Public wastewater system
--Industrial (an industry with discharge permits)
--Other (Describe)____________

    (1) Certification of compliance by laboratory management (vide 
infra: 4.1.9)
4.1.8  Transfer of Ownership/Change of Ownership and/or Location of 
Laboratory
    Accreditation may be transferred when the legal status or ownership 
of an accredited laboratory changes without affecting its staff, 
equipment, and organization. The accrediting agency may charge a 
transfer fee and shall conduct an on-site assessment to verify affects 
of such changes on laboratory performance.
    The following conditions apply to the change in ownership and/or 
the change in location of a laboratory that has national accreditation.
    (a) Any change in ownership and/or location of an accredited 
laboratory must be reported in writing to the primary state(s) and the 
National Environmental Laboratory Accreditation Program within twenty 
business days of such a change taking effect.
    (b) Such a change in ownership and/or location will not necessarily 
require reaccreditation or reapplication in any or all of the 
categories in which the laboratory is currently accredited.
    (c) Change in ownership and/or location may require a mandatory on-
site assessment with the elements of the assessment being determined by 
the inspector.
    (d) Any change in ownership must assure historical traceability of 
the laboratory accreditation number(s).
    (e) For a change in ownership, one of the following conditions must 
be in effect:
    i. The previous (transferring) owner must agree in writing, before 
the transfer of ownership takes place, to be responsible for any 
analyses, data and reports generated up to the time of legal transfer 
of ownership; or
    ii. The buyer (transferee) must agree in writing to be responsible 
for any analyses, data and reports generated before the legal transfer 
of ownership occurs.
4.1.9  ``Certification of Compliance'' Statement
    The following ``Certification of Compliance'' statement must 
accompany the application for laboratory accreditation. It must be 
signed and dated by both the laboratory management and the quality 
assurance officer for that laboratory.

Certification By Applicant

    The applicant understands and acknowledges that the laboratory is 
required to be continually in compliance with the National 
Environmental Laboratory Accreditation Program's rules and regulations 
concerning laboratory accreditation and standards and will be subject 
to the penalty provisions provided therein.
    The applicant understands and acknowledges that accreditation is 
specifically subject to unannounced assessments.
    Authorized representatives of any state in which the laboratory is 
accredited may make an announced or unannounced inspection, search, or 
examination of an accredited or interim approved laboratory whenever 
the state, at its discretion, considers such an inspection, search or 
examination necessary to determine the extent of the laboratory's 
compliance with the conditions of its accreditation and these 
regulations. Any refusal to allow entry to the state's representatives 
shall constitute a violation of a condition of accreditation and 
grounds for revocation of accreditation or loss of accreditation.
    The applicant hereby certifies that all analyses performed are done 
in accordance with applicable U.S. Environmental Protection Agency 
Guidelines.
    I hereby certify that I am authorized to sign this application on 
behalf of the applicant/owner and that there are no misrepresentations 
in my answer to the questions on this application.
----------------------------------------------------------------------
Signature Quality Assurance Officer
Officer

----------------------------------------------------------------------
Name of Quality Assurance

----------------------------------------------------------------------
Print Name of Applicant Laboratory
(Legal Name)

----------------------------------------------------------------------
Date

----------------------------------------------------------------------
Signature
Laboratory Management Representative
Representative

----------------------------------------------------------------------
Name
Laboratory Management.

4.2  Period of Accreditation

    For a laboratory in good standing, the period for accreditation 
within categories for methods or analytes will be reevaluated yearly 
and will be considered to be ongoing once a laboratory has been 
accredited for that category, method, or analyte. The loss of 
accreditation for categories, methods or analytes will occur upon not 
fulfilling any of the conditions outlined below in the sections on 
maintaining accreditation and supervision, revocation and loss of 
accreditation. Additionally, failure to pay the required fees as 
determined by the participating states within the stipulated deadlines 
or by the stipulated dates will result in loss of accreditation. This 
information will be entered into the National Database.
    There is a separate process for accreditation for new categories, 
methods and analytes (vide supra: Application Process, 4.1.7).
    Each year the National Environmental Laboratory Accreditation 
Program will provide each laboratory with a current directory with 
information on what categories, methods, and analytes for which they 
are accredited. Additionally, new categories, methods, and analytes 
will appear on the actual certificate that is reissued as these items 
are added and/or deleted during the year. All new categories will be 
included in updates to the database.

4.3  Maintaining Accreditation

    Accreditation remains in affect until revoked by the accrediting 
authority, until discontinued by the accredited laboratory, or until 
expiration of accreditation date. To maintain accreditation, the 
accredited laboratory shall complete or comply with elements 4.3.1 TO 
4.3.7. Failure to complete or comply with these elements may be cause 
for downgrading or revoking accreditation.
4.3.1  Performance Evaluation Samples
    Performance evaluation samples appropriate for the accredited 
methodology shall be acquired twice per year from a source acceptable 
to the National Environmental Laboratory Accreditation Program, 
successfully analyzed, and reported to the accrediting body within 
required deadlines. In the event of unsatisfactory performance and 
required reanalysis, repeat analysis shall also be completed and 
reported within established deadlines. Poor performance on a 
performance evaluation sample or failure to submit results within 
required deadlines may be cause for downgrading accreditation.
4.3.2  On-Site Assessments
    Announced on-site assessments shall be performed by the accrediting 
agency at a minimum frequency of one assessment every year. Unannounced 
on-site assessments or follow-up on-site assessments may be conducted 
more frequently, for cause, at the option of the accrediting agency. 
Situations which might trigger an unannounced on-site assessment or 
follow-up on-site assessment include, review of a previously deficient 
on-site assessment, poor performance on a performance evaluation 
sample, change in other accreditation elements, or other information 
concerning the capabilities or practices of the accredited laboratory. 
On-site assessments, regardless of frequency, shall be successfully 
completed to maintain accreditation. Deficiencies identified during the 
on-site assessment shall be corrected within deadlines established in 
these guidelines or according to deadlines in an approved correction 
action plan. Failure to pass an on-site assessment or to correct 
deficiencies according to the provisions of an approved corrective 
action plan may be cause for downgrading accreditation.
4.3.3  Other Accreditation Elements
    The accredited laboratory shall maintain other key accreditation 
elements which originally served as the basis for accreditation 
including the facility, organization and management, qualifications of 
key personnel, sample handling procedures, calibration standards, 
analytical methods, data reduction procedures, and laboratory quality 
assurance plan. Failure to maintain, revise, or replace any of these 
key components may be cause for downgrading accreditation status.
4.3.4  Notification and Reporting Requirements
    The accredited laboratory shall notify the accrediting body of any 
changes in key accreditation criteria including but not necessarily 
limited to the laboratory ownership, location, key personnel, and major 
instrumentation. The accredited lab shall also comply with any other 
reporting requirements identified in these guidelines.
4.3.5  Record Keeping and Retention
    All lab records associated with accreditation parameters, including 
raw data associated with each analysis, changes in method standard 
operating procedures, or the laboratory quality assurance plan, shall 
be maintained for a minimum of five years unless otherwise designated 
for a longer period in another regulation. In the case of data used in 
litigation, the laboratory is required to store such records for a 
longer period upon written notification from the accrediting agency.
4.3.6  Payment of Fees
    The accredited lab shall pay all fees associated with maintaining 
accreditation to the accrediting body within established deadlines.

4.4  Suspension, Revocation and Denial of Accreditation

    Reasons to deny an initial application or reapplication shall 
include:
    (a) Failure of laboratory staff to meet the personnel 
qualifications as required by NELAC. These qualifications include 
education, training and experience requirements.
    (b) Failure to successfully perform performance evaluation test as 
required by NELAC.
    (c) Failure to attest that analysis are performed by approved 
methodologies and/or in accordance with NELAC requirements.
    A laboratory shall have two opportunities to correct the areas of 
deficiencies which results in a denial of applications. If the 
laboratory is not successful in remedying said deficiencies, it must 
wait six months before again applying for accreditation.
    Revocation--shall mean the total withdrawal of a laboratory's 
accreditation by the accrediting authority. The laboratory cannot 
reapply for accreditation for 6 months, by which time the reason/cause 
of the revocation must be corrected.
    Reasons for revocation shall include:
    (a) Failure to participate or unsatisfactory performance in the 
performance evaluation testing program as required by the program.
    (b) Submitting performance evaluation sample results generated by 
another laboratory.
    (c) Misrepresentation of any material fact pertinent to receiving 
initial approval.
    (d) Denial of entry for laboratory inspection.
    (e) Conviction of charges of the falsification of any report of or 
relating to a laboratory analysis.
    (f) Failure to pay accreditation fees.
    No laboratory's accreditation will be revoked or a renewal denied 
without the opportunity to request a hearing.
    Suspension shall mean the temporary removal of a laboratory's 
accreditation for a defined period of time. The purpose of suspension 
is to allow a laboratory time to correct deficiencies or area of non-
compliance with program requirements as defined by regulation. A 
suspended laboratory would not have to reapply for accreditation if the 
cause/causes for suspension are corrected within six months. A 
laboratory's accreditation may be suspended in total or in part. It may 
retain those areas of accreditation where it continues to meet the 
standards and requirements of the program.
    Reasons for suspension shall include:
    (a) Failure to successfully perform performance evaluation tests 
pursuant to the requirements of the program;
    (b) Failure to submit and implement corrective action related to 
deficiencies found during laboratory inspections;
    (c) Loss of personnel with the required educational, training and 
experience qualifications; or
    (d) Failure to pay accreditation application fees.

4.5  Interim Accreditation

4.5.1  Interim Accreditation
    If a laboratory completes all of the requirements for accreditation 
except that of an on-site assessment because the accrediting authority 
is unable to schedule the assessment an interim accreditation shall be 
issued and will be in effect until the assessment requirements have 
been completed. Interim accreditation will allow a laboratory to 
perform analyses and report results of samples with the same status as 
a fully accredited laboratory until an on-site assessment has been 
completed. Accreditation will still be granted when performance 
evaluation samples are not available.
4.5.2  Revocation of Interim Accreditation
    Revocation of interim accreditation may be initiated for due cause 
as described in 4.4.0 by order of the accrediting agency, without right 
to a hearing.

4.6  Awarding of Accreditation

    When a participating laboratory has met the requirements specified 
for receiving accreditation, the laboratory will receive a single 
certificate awarded on behalf of the state accrediting authority. The 
certificate will provide the following information: the name of the 
laboratory, address of the laboratory, the specifications of the 
accreditation action (for example, the laboratory may be accredited for 
analysis of water or for use of a specific analytical methodology, 
etc.), the states in which the laboratory may operate. Even though a 
parent laboratory is accredited, the subfacilities (laboratories 
operating under the same parent organization, analytical procedures, 
and quality assurance system) are also required to become accredited. 
The subfacilities accredited will be listed on the certificate of the 
parent laboratory.
4.6.1  The Certificate of Accreditation
    The certificate of accreditation will briefly define the rules of 
obtaining and maintaining accreditation. Finally, the certificate will 
be signed by a member of the accrediting authority.
    To address the concern that an individual state may revoke a 
laboratory's accreditation for work in that state, the certificate will 
explain that continued accredited status depends on successful ongoing 
participation in the program. The certificate will urge a customer to 
verify the laboratory's current accreditation standing within a 
particular state. The certificate must be returned to the accrediting 
agency upon loss of accreditation.
4.6.2  Changes in Areas of Accreditation
    If an accredited laboratory increases its areas of accreditation, a 
new certificate will be awarded which details the spectrum of 
accreditations the laboratory has achieved.

4.7  Enforcement

    The development of an enforcement component of the National 
Environmental Laboratory Accreditation Program (NELAP) should be based 
on explicit values, or principles, with which all participants concur. 
The proposed basic principles are:
    (a) The program should be fair to all participants;
    (b) The rules should be well publicized;
    (c) The program needs of the participating agencies must be upheld; 
and
    (d) The due process rights of participating laboratories must be 
protected.
    The major components of the program shall include:
    (a) All enforcement actions are taken independently by EPA or state 
agencies and communicated to all other NELAP participating agencies.
    (b) NELAP enforcement is limited to suspension (short-to-long-term) 
from NELAP only. Any other civil/criminal actions are taken by 
participating agencies.
    (c) An effective information-sharing database used by all 
participating agencies is essential to ensure informed decision-making 
based on lab performance.
4.7.1  Role of Enforcement vs QA/QC
    Most agencies have historically conducted laboratory QA/QC programs 
designed to help laboratories identify and correct technical problems 
affecting their performance. This is basically a technical assistance 
function by government. Enforcement, on the other hand, is an oversight 
process of taking informative (``warning/information gathering 
letters'') or punitive actions to ensure the public's desired 
objectives (``reliable data'') are achieved. QA/QC and enforcement are 
different functions and need to be kept separate.
4.7.2  Defining Enforceable Violations
    The NELAP will need to specify what actions by laboratories will 
result in enforcement action. Furthermore, enforcement actions should 
be developed in increasing severity to allow laboratory correction with 
minimal enforcement effort. This could be done with tiers of 
enforcement actions, e.g. warning letter, suspension investigation 
order, suspension order, and suspension hearing.
    Enforceable violations will also need to be established to provide 
the basis for the enforcement program. Categories of enforceable 
violations could include:
    (a) Data falsification--intentional, by lab management, by 
employees, etc.;
    (b) False advertising--misinforming clients regarding their 
accreditation and capabilities; and
    (c) Continuing technical problems--lack of technical staff, failure 
to follow required SOP's, lack of equipment, etc.
4.7.3  Recommendation
    Given resource constraints, strong interest in encouraging state 
support, and the greater potential for implementation in the mid-term 
(2 to 5 years), a variation of the decentralized option is recommended. 
This approach will still require a federal-state laboratory integrated 
effort to ensure the objectives, structure, and issues are defined in 
the necessary detail.

5.0  Quality Systems

5.1  Introduction

    Quality Systems include all quality assurance (QA) policies and 
quality control (QC) procedures, which shall be delineated in a QA Plan 
to help ensure and document the quality of the analytical data. These 
shall include QA policies, which will establish essential QC procedures 
applicable to environmental laboratories regardless of size and 
complexity. The laboratory shall meet any additional or more stringent 
requirements as specified by the analytical methods, specific programs 
or Agencies.
    All items identified in this discussion shall be available for on-
site inspection or data audit.

5.2  Quality System

5.2.1  Quality Assurance Plan
    All laboratories shall prepare and have available for review a 
written description of the laboratory's quality assurance activities, 
i.e., a QA plan. The QA plan must be an independent document that may 
incorporate by reference, already available standard operating 
procedures (SOPs) or other material, e.g., methods, guidance documents, 
etc., that are approved by the laboratory management. Analysts in the 
laboratory should either have copies of the document or easy access to 
the document. The items listed below constitute essential requirements 
of a Quality System. All laboratories should be encouraged to add any 
additional items thought to improve the analytical data. The following 
items shall be included:

--General QC procedures
--Performance evaluation samples
--Staff
--Equipment
--Test methods & standard operating procedures (SOPs)
--Physical facilities
--Sample acceptance policy & sample receipt
--Sample tracking
--Record keeping, data review and reporting
--Corrective action policy and procedures
--Definition of terms
--Bibliography

5.3  General Quality Control Procedures

    The following are the essential requirements and routines to 
calculate and assess analytical precision, accuracy, and method 
detection limits. All records and related quality control procedures 
shall be documented and maintained.
    The required essential quality control shall be as specified in the 
analytical methods or as listed below, whichever is more stringent.
5.3.1  Chemical Testing
    (a) Method Reagent Blanks--A minimum of 1 per batch of 20 or less 
samples per matrix type per sample extraction or preparation.
    (b) Matrix Spikes (MS), Matrix Spike Duplicates (MSDs), and Sample 
Duplicates (SD).
    i. Matrix spikes: required frequency as per the method reagent 
blank, except for analytes for which standards are not available (BOD, 
TSS, O&G, and pH, etc.).
    ii. Matrix spike duplicates or sample duplicates shall be analyzed 
at the same frequency as the original matrix spike (MS).
    (c) Laboratory Fortified Blanks--(QC Check Samples).
    It is suggested that these be analyzed at the same frequency as the 
matrix spikes, but are mandatory if the matrix spikes are not within 
quality control acceptance limits.
    (d) Surrogates--Surrogate compounds must be added to all samples, 
standards, and blanks whenever possible for all organic chromatography 
methods. Limits must be used to determine acceptable surrogate 
recoveries on a daily basis.
    (e) Quality Control Validation Studies or Initial Demonstration of 
Analytical Capability--QC Validation Studies shall be performed on a 
one-time basis (initially and with a significant change, e.g., new 
analyst, instrument or technique).
    (f) Methods Used to Assess Precision and Accuracy--The laboratories 
shall calculate and track precision and accuracy of test measurements 
and the associated acceptance ranges using the data from the duplicate, 
MS, blank and surrogate measurements. The resulting acceptance ranges 
(and/or quality control charts) shall be used to assess data acceptance 
and shall be readily accessible in an identifiable file to all 
personnel involved with the data review/data acceptance process.
    (g) Method Detection Limits--Method detection limits shall be 
determined by an approved protocol or by a method specified by the 
accrediting authority. The detection limit is to be determined for the 
compounds of interest in each method in laboratory pure water and the 
matrix of interest. The procedure used must be documented.
    (h) Qualitative Identifications--Qualitative quality control refers 
to the identification of a specific compound. Identification of all 
analytes must be accomplished with a verified standard of the analyte.
    When analyzing a new matrix, a new analyte or where other reasons 
for doubt exists, a confirmatory analysis shall be performed. Such 
analysis shall be a technique with a different scientific principle and 
may include:

--Second column confirmation
--Alternate wavelengths
--Derivatization
--Mass spectral interpretation
--Alternate detectors
--Additional cleanup procedures

    (i) Reagent Quality, Water Quality and Checks
    i. Reagents--In methods where the purity of reagents is not 
specified, analytical reagent grade shall be used. Reagents of lesser 
purity than that specified by the method shall not be used. The labels 
on the container should be checked and the contents examined to verify 
that the purity of the reagents meets the needs of the particular 
method.
    ii. Water--Where the method does not specify the type of water 
(e.g., distilled, deionized, etc.), the water quality shall be free 
from all constituents that may potentially interfere with the sample 
preparation or analytical test. The quality of water sources shall be 
monitored and documented.
    (j) Glassware Cleaning--In the analysis of samples containing 
components in the parts per billion range, the preparation of 
scrupulously clean glassware is mandatory. Particular care must be 
taken with glassware such as Soxhlet extractors, Kuderna-Danish 
evaporative concentrators, sampling-train components, or any other 
glassware coming in contact with an extract that will be evaporated to 
a lesser volume.
    Any cleaning and storage procedures that are not specified by the 
method shall be documented in laboratory records and SOPs.
    (k) Internal Audits--The laboratory shall have a system in place 
for conducting internal audits of the methods, data, and staff employed 
at the lab. The audits shall be conducted at least twice annually and 
the results shall be documented.
5.3.2  Bioassays
    (a) Dilution Water Control--Every toxicity test or range-finding 
test shall include a dilution water control treatment consisting of the 
same dilution water, conditions, procedures, types and number of 
organisms as used in the effluent treatments, except that none of the 
effluent being tested shall be added to the dilution water.
    Whenever artificial sea salts are used in the salinity adjustment 
of either the dilution water sample or effluent sample, an additional 
control treatment shall be included. This additional control treatment 
shall consist of replicate chambers containing only artificial 
saltwater made with the same artificial sea salts used to adjust the 
samples. The artificial saltwater shall be made to the same 
standardized salinity and Ph as the other test treatments.
    (b) Distribution of Test Organisms--Test organisms must be randomly 
distributed to the test chambers either by:
    i. Adding to each chamber no more than 20% of the total number to 
be assigned to each chamber, then repeating the process until each test 
chamber contains the total number of test organisms desired; or
    ii. Randomly assigning one test organism to each test chamber, then 
randomly assigning a second test organism to each test chamber, etc., 
continuing the random assignments until the total number of test 
organisms desired has been distributed to each test chamber.
    (c) Dissolved Oxygen Requirement--The DO in the test chambers shall 
be maintained at greater than 40% of saturation but less than 100% when 
testing chronic toxicity for all species except Ceriodaphnia which must 
be adjusted only prior to test initiation or sample renewal. Acute 
tests shall assure that a minimum level of 4.0 mg/L DO is maintained.
    (d) Duplicate Requirements--When the purpose of a definitive acute 
toxicity test is to determine compliance with an LC50, or EC50 permit 
limitation, the test shall consist of one or more control treatments 
and a series of at least five effluent concentrations, in duplicate.
    i. If the toxicity of the effluent to the test organism is not 
known, then the concentration of effluent in each treatment, except for 
the highest concentration and the control(s) shall be at least 50% of 
the next higher one. The concentrations selected shall be evenly spaced 
on either a logarithmic or geometric scale.
    ii. Definitive test concentration series must, at a minimum, be 
conducted in duplicate. Additional replicate series may be necessary in 
order to achieve required test precision. Only true replicates, with no 
water connections between test chambers shall be used.
    iii. A minimum of twenty test organisms shall be exposed to each 
effluent concentration and each control treatment; this means, when 
conducting the test in duplicate, at least ten organisms per test 
chamber. The number of organisms used in each effluent concentration 
shall be equal to the number used in other effluent concentrations and 
to the number used in the control. Organism loading limits shall be 
observed.
    (e) No Measurable Acute Toxicity--When the purpose of ``no 
measurable acute toxicity (N.M.A.T.) is to determine compliance with a 
N.M.A.T. permit limitation, the effluent must be known to generally 
have an LC50 of greater than or equal to 100%, and the toxicity test 
design must comply with the following:
    i. The test series shall consist of one or more control treatments, 
a 100% effluent-by-volume concentration and a 50% effluent-by-volume 
concentration. The test shall be conducted with at least four 
replicates, and at least ten organisms per chamber. Additional 
duplicate series may be necessary in order to achieve required test 
precision. Only true duplicates, with no water connections between test 
chambers, shall be used.
    ii. Forty or more test organisms shall be exposed to each control 
treatment and each effluent treatment.
    (f) Range Finding Toxicity Test--If required by the accrediting 
agency and in the event historical aquatic toxicological data are not 
available on an effluent, the lab shall conduct a range finding 
toxicity test to ascertain the range of effluent concentrations for 
subsequent definitive tests. Range finding toxicity tests shall at a 
minimum consist of one or more control treatments, and treatments of 
100% effluent-by-volume, 50% effluent-by-volume, and 12.5% effluent-by-
volume. A single test series is adequate, although duplicates may be 
used. Five or more test organisms shall be exposed to each control 
treatment and each effluent treatment.
    (g) Species Identification
    i. For species identification, the laboratory shall maintain or 
have access to a type specimen collection.
    ii. The laboratory must, at a specified frequency, use taxonomic 
experts to corroborate species identification. In-house or outside 
experts are acceptable for taxonomic identification of test species.
    (h) Criteria for Test Types--All definitive acute toxicity tests 
and N.M.A.T definitive acute toxicity tests must be conducted as either 
static non-renewal, static-renewal, or flow-through tests. Range-
finding toxicity tests (if required) must be conducted as either static 
or flow-through.
    (i) Reference Toxicants--Reference toxicants shall be used as 
specified by method.
5.3.3  Microbiology
    (a) Blanks (Sterility Checks)
    i. Membrane Filter (MF) Analysis Blank--A membrane filter sterile 
control test of rinse water, media and supplies shall be inoculated 
with at least 10 milliliters of sterile phosphate buffered dilution 
water (dilution blank control). These shall be performed at the 
beginning and end of all processed samples and after every tenth 
sample.
    ii. Multiple Tube Fermentation (MTF) Analysis Blank--A MTF blank 
shall be performed with each MTF sample. A single tube of LTB broth 
media shall be inoculated with 10 milliliters of sterile phosphate 
buffered dilution water (dilution blank control).
    (b) Laboratory Pure (Reagent) Water Requirements
    i. Laboratory pure water shall be analyzed annually by the 
Suitability Test for bactericidal properties for distilled water.
    ii. Laboratory pure water shall be analyzed monthly for pH, 
chlorine residual, standard plate count, and conductivity.
    iii. The laboratory pure water must be analyzed annually for trace 
metals.
    (c) MPN Analysis--The MPN test for all water samples shall be 
completed on 10% of positive confirmed samples, except that gram 
staining need not be performed for drinking water samples. If no 
positive tubes result from the tested drinking water samples, the 
complete MPN test, but not gram staining, must be performed on a 
quarterly basis on at least one positive water source.
    (d) MF Analysis--5% of all positive environmental samples analyzed 
and at least 10 of the sheen colonies for drinking water by membrane 
filter shall be verified per method requirements.
    (e) Duplicates--At least 5% of the positive samples shall be 
duplicated. In laboratories with more than one analyst, have each make 
parallel analyses on at least one positive sample per month.
    (f) Positive and Negative Controls--Positive and negative control 
cultures shall be analyzed for the microorganisms under test for each 
lot of media used with each analytical procedure.
5.3.4  Radiochemistry
    (a) Instrument Blanks--Instrument blanks are blanks at the 
background levels for any of the nuclide emission of interest. 
Instrument blanks consist of a clean planchet, ampule or sealed 
canister that is placed in the instrument to duplicate sample counting 
geometry. The purpose of the instrument blank is to verify instrument 
operation and ensure that no contamination has occurred in the counting 
chamber. Instrument blanks are used for calculation of lower limits of 
detection. The frequency of instrument analysis depends on the type of 
instrument. Essential frequencies for analysis of instrument blanks on 
typical instruments are:

------------------------------------------------------------------------
                        Instrument                           Frequency  
------------------------------------------------------------------------
Gamma spectrometers......................................  Monthly.     
Low background proportional counters.....................  Daily.       
Low level liquid scintillation counters..................  Daily.       
Scintillation counters...................................  Weekly.      
Alpha spectrometers......................................  Weekly.      
Radon flask counters.....................................  Monthly.     
------------------------------------------------------------------------

    (b) Method Blanks--The required frequency for method blanks shall 
be at least once each batch or one out of every 20 samples, whichever 
is greater. These specifications are applicable to all radiochemistry 
techniques except for gamma spectroscopy where no chemical separation 
or other chemical manipulation is performed.
    (c) Laboratory Control Samples (LCS)--At least one LCS shall be 
included with each batch or one out of every 20 analytical samples, 
whichever is greater.
    (d) Matrix Spikes--Matrix spikes shall be included with each sample 
batch where chemical manipulations and separations are performed. The 
frequency for measurement of matrix spikes shall be at least one per 
batch or one out of every 20 samples, whichever is greater.
    The following criteria is recommended for spiking:
    i. Samples should be spiked at random within each batch. There 
should be adequate samples available for duplicate analysis, if 
necessary.
    ii. Spikes should be prepared in a manner to minimize alteration of 
the original matrix (i.e., minimize dilution of the sample during the 
spiking).
    iii. Spikes should be prepared at a level that is at least two 
times the concentration of the analyte of interest.
    (e) Laboratory Duplicates--Sample analysis shall be duplicated on a 
randomly selected sample (not field blanks) within every batch or one 
per 20 samples, whichever is greater.
5.3.5  Air Testing--To be added as document undergoes review.

5.4  Performance Evaluation Samples

    Each laboratory shall participate in a performance evaluation 
program as outlined in Chapter 2.0.

5.5  Environmental Laboratory Staffing Requirements

5.5.1  General Requirements for Laboratory Staff
    The testing laboratory shall have sufficient supervisory and other 
personnel, having the necessary education, training, technical 
knowledge and experience for their assigned functions.
    Job descriptions shall be available for all positions.
    The laboratory shall have available a clear description of the 
lines of responsibility in the laboratory and shall be proportioned 
such that adequate supervision is ensured. An organizational chart is 
recommended.
5.5.2  Laboratory Staff Responsibilities and Credentials
    Laboratory management shall be responsible for:
    (a) All analytical and operational activities of the laboratory, 
including those of any auxiliary or mobile laboratory facilities;
    (b) Supervision of all personnel employed by the laboratory, 
including those assigned to work in any auxiliary or mobile laboratory 
facilities, and those persons designated as principle analysts;
    (c) Assuring that all sample acceptance criteria (Section 5.9) are 
met and that samples are logged into the sample tracking system and 
properly labeled and stored; and
    (d) The production and quality of all data reported by the 
laboratory, including any auxiliary or mobile laboratory facilities.
    Each analyst and other members of the staff shall be responsible 
for complying with all QA requirements. Each laboratory position must 
have a combination of experience and education to adequately 
demonstrate a specific knowledge of their particular function and a 
general knowledge of laboratory operations, analytical methods, quality 
assurance/quality control procedures and records management.
5.5.3  Quality Assurance Officer
    A quality assurance officer shall:
    (a) Serve as the focal point for QA/QC and be responsible for 
analytical data review (sign off on data is required);
    (b) Have functions independent from laboratory management;
    (c) Be able to objectively evaluate data and perform assessments 
without outside (e.g., managerial) influence;
    (d) Have formal training and experience in QA/QC procedures and be 
knowledgeable in the quality system as defined under NELAP;
    (e) Have a general knowledge of the analytical methods for which 
data review is performed; and
    (f) Conduct internal audits on the entire operation twice annually.

5.6  Equipment

    A laboratory must have access to all equipment specified by the 
analytical procedures for which accreditation is sought. All 
maintenance activities, both routine and nonroutine, shall be 
documented. The following records shall be maintained for each piece of 
equipment:

--Name of item;
--Manufacturer's name, type identification and serial number;
--Date received and placed in service;
--Current physical location;
--Maintenance log; and
--Calibration information, if appropriate.

5.7  Test Methods and Standard Operating Procedures

    When the use of approved methods for a specific sample matrix is 
required, only those methods shall be used. In addition, where 
performance-based methods or non-legally mandated methods are 
permitted, the relevant start-up and ongoing validation procedures, and 
calibrations as specified in 5.7.2 must be followed and documented.
    The criteria listed in 5.7 must be met for all methods and SOPs.
5.7.1  Laboratory Method Manual(s) and Standard Operating Procedures
    Each certified laboratory shall have and maintain an in-house 
methods manual(s) and SOPs. The methods manual(s) and any associated 
reference works (if required) shall be available to the bench analyst.
    For each analyte certified, a method or methods to be used by the 
laboratory shall be described in the methods manual. The method 
description shall include:

--Analyte name and qualifier (the qualifier is a word, phrase or 
number that better identifies the method; e.g., ``Iron, Total'', or 
``Chloride, Automated Ferricyanide'', or ``Our Lab. Method SOP No. 
101'');
--Applicable matrix or matrices;
--Method detection limit;
--Scope and application;
--Summary of the method;
--Definitions;
--Interferences;
--Safety;
--Equipment and supplies;
--Reagents and standards;
--Sample collection, preservation, shipment and storage;
--Quality control;
--Calibration and standardization;
--Procedure;
--Data analysis and calculations;
--Method performance;
--Pollution prevention;
--Waste management;
--References; and
--Any tables, diagrams, flowcharts and validation data.
5.7.2  Method Validation/Initial Demonstration of Method Performance 
(Performance-Based Methods and Non-Approved Methods)
    Prior to acceptance and institution of any method, satisfactory 
initial demonstration of method performance, in conformance with the 
relevant EPA guidelines, is required. In the absence of method-
specified requirements, this demonstration shall follow the outlined 
protocols of Paragraph 8.1.1 and Section 8.2 in the methods published 
in 40 CFR Part 136, Appendix A. Thereafter, continuing demonstration of 
method performance, in conformance with the relevant EPA guidelines, is 
required. In both cases, the appropriate standard Performance Based 
Method System (PBMS) checklist (see Appendix B) must be completed, 
submitted to the accrediting organization, and a copy must be retained 
in the laboratory. All associated supporting data necessary to 
reproduce the analytical results summarized in the checklists must be 
retained by the laboratory. Initial demonstration of method performance 
must be completed each time there is a change in equipment, personnel 
or procedure.
5.7.3  Calibration
5.7.3.1  Documentation and Labeling
    The laboratory shall retain records (e.g., manufacturer's statement 
of purity), of the origin, purity and traceability of all standards and 
reagents (including balance weights and thermometers). These records 
shall include the date of receipt, the date of opening and an 
expiration date.
    Detailed records shall be maintained on reagent and standard 
preparation. These records shall indicate traceability to purchase 
stocks or neat compounds, and must include the date of preparation and 
preparer's initials.
    Where calibrations do not include the generation of a standard 
curve (e.g., thermometers, balances, titrations, etc.), records shall 
indicate the calibration date and type (e.g. balance weight, 
thermometer serial number, primary standard concentration, etc.) of 
calibration standard that was used.
    All prepared reagents and standards shall be clearly identified 
with preparation date, concentration(s) and preparer's initials.
    All standard curves shall be dated and labeled with method, analyte 
and standard concentrations and instrument responses.
    The axes of the calibration curve should be labeled. For electronic 
data processing systems, that automatically compute the calibration 
curve, the equation for the curve and the correlation coefficient must 
be recorded. The equation for the line and the correlation coefficient 
shall also be recorded when the calibration curve is prepared manually.
    A criteria for an acceptable correlation coefficient shall be 
established.
5.7.3.2  Initial Calibrations
    All initial calibrations shall be verified with standards of high 
quality obtained from a second or different source. These verification 
standards shall be analyzed with each initial calibration or quarterly, 
whichever is more frequent.
    Standard curves shall be prepared as specified in the method.
    The lowest standard should approach the method detection limit.
    If a method does not provide guidance in the preparation of a 
standard curve, the following guidelines shall be followed: For all 
methods, use a blank and at least three (3) standards that lie within 
the linear portion of the curve. Additional standards are required for 
non-linear calibration curves. In all cases, the sample results must be 
closely bracketed by calibration standards.
    A new curve shall be run if two successive runs of one continuing 
calibration check is outside acceptable limits.
5.7.3.3  Continuing Calibration Verification
    When an initial calibration curve is not run on the day of 
analysis, the integrity of the initial calibration curve shall be 
verified on each day of use (or 24 hour period) by initially analyzing 
a blank and a standard at a concentration equal to or near the lowest 
calibration standard (the lowest calibration standard shall be in the 
range of 4 to 8 times the calculated method detection limit).
    Additional standards shall be analyzed after the initial 
calibration curve or the integrity of the initial calibration curve 
(see previous paragraph) has been accepted.
    (a) These standards shall be analyzed at a frequency of 5% or every 
8 hours whichever is more frequent and may be standards used in the 
original calibration curve or standards from another source.
    (b) The concentration of these standards shall be determined by the 
anticipated or known concentration of the samples. To the extent 
possible, the samples in each interval (i.e. every 20 samples or every 
8 hours) should be bracketed with standard concentrations closely 
representing the lower and upper range of reported sample 
concentrations. If this is not possible, the standard calibration 
checks should vary in concentration throughout the range of the data 
being acquired.
    When not specified by the analytical method, these calibration 
verification standards shall be within 15% of the true value.

5.8  Physical Facilities

5.8.1  Environment
    The laboratory facilities shall be maintained to permit the 
production of analytical data of needed quality. In addition to 
adequate housekeeping that must be performed to assure that 
contamination is unlikely, the following elements shall be controlled:

--Temperature;
--Humidity;
--Electrical power;
--Vibration;
--Electromagnetic fields;
--Dust;
--Direct sunlight;
--Ventilation (exhaust hoods, air exchangers, etc.); and
--Lighting.
5.8.2  Work Area
    Adequate work spaces to ensure an unencumbered work area must be 
available. These include:

--Controlled access to the laboratory;
--Separation of incompatible analyses;
--Sample receipt area;
--Sample storage area;
--Chemical and waste storage area(s); and
--Data handling and storage area(s).

5.9 Sample Acceptance Policy and Sample Receipt

    Regardless of the laboratory's level of control over sampling 
activities, the following are essential to ensure sample integrity and 
valid data.
5.9.1 Sample Acceptance Policy
    The laboratory shall have a written sample acceptance policy that 
clearly outlines the circumstances under which samples will be 
accepted. Data from any samples which do not meet the following 
criteria must be flagged in an unambiguous manner clearly defining the 
nature and substance of the variation. This document should be 
circulated to sample collecting personnel with other sampling 
instructions and shall include the following areas of concern:
    (a) Submittal of field quality control samples as required by the 
accrediting agency. The samples may include trip blanks, field blanks, 
equipment blanks, duplicates or other field-submitted quality control 
measures;
    (b) Proper, full, and complete documentation, which shall include 
sample identification, the location, date and time of collection, 
collector's name, preservative added, sample type and any special 
remarks concerning the sample;
    (c) Proper sample labeling to include unique identification and a 
labeling system for the samples with requirements concerning the 
durability of the labels (water resistant) and the use of indelible 
ink;
    (d) Evidence of proper preservation and use of appropriate sample 
containers. The type of sample containers and preservatives are as 
specified by the individual programs, a Performance Based Method System 
or NELAP;
    (e) Adherence to specified holding times. The maximum allowable 
holding time prior to analyses are as specified by individual Programs, 
a Performance Based Method System or NELAP; and
    (f) Adequate sample volume. Sufficient sample volume must be 
available to perform the necessary analysis.
5.9.2 Sample Receipt Protocols
    Samples shall be checked upon receipt for thermal preservation (if 
applicable) and all other aforementioned items. Chemical preservation 
(e.g., appropriate Ph) shall be checked upon receipt or prior to sample 
preparation/analyses. The results of such checks shall be recorded. 
Data from any samples which do not meet the criteria must be flagged in 
an unambiguous manner clearly defining the nature and substance of the 
variation.
    If applicable, a complete chain of custody record (Section 5.11.3) 
shall be maintained.
5.9.3 Storage Conditions
    The samples shall be properly preserved and stored in approved 
containers specified by the individual EPA or state programs, the 
Performance Based Method System or NELAP. Samples shall be stored in a 
secure area.

5.10 Sample Tracking

    The laboratory shall design a system to unequivocally identify all 
samples, subsamples and subsequent extracts and/or digestates so that 
each aliquot is uniquely identified.
    The laboratory shall assign a unique identification (ID) code to 
each sample container received in the laboratory. Multiple aliquots of 
a sample that have been received for different analytical tests (e.g., 
nutrients, metals, VOCs, etc.) must be assigned a different ID code. 
The use of container shape, size or other physical characteristic 
(e.g., amber glass, purple top, etc.) is not an acceptable means of 
identifying the sample.
    This laboratory code shall maintain an unequivocal link with the 
unique field ID assigned each container.
    The laboratory ID number shall be placed on the sample container as 
a durable label.
    The laboratory ID number shall be entered into the laboratory 
records (see 5.11.2) and shall be the link that associates the sample 
with related laboratory activities (i.e., sample preparation, 
calibration, etc.).
    In cases where the sample collector and analyst are the same 
individual or the laboratory preassigns numbers to sample containers, 
the laboratory ID number may be the same as the field ID number.
5.11 Record Keeping, Data Review and Reporting
    The laboratory shall implement protocols that will produce 
unequivocal, accurate records which document all laboratory activities 
associated with sample receipt, preparation, analysis, review and 
reporting.
    There are two levels of record keeping: (1) Sample custody or 
tracking and (2) legal or evidentiary chain of custody. All essential 
requirements for sample custody are outlined in Sections 5.11.1.1, and 
5.11.1.2. The basic requirements for legal chain of custody (if 
required or implemented) are specified in Section 5.11.3.
5.11.1 Sample Custody Requirements

5.11.1.1 Essential Documentation

    (a) Sample Handling--Sample custody shall document all procedures 
and activities to which a sample is subjected. These activities shall 
include but are not limited to
--Sample preservation including appropriate sample container and 
compliance with holding time;
--Sample identification, receipt, acceptance or rejection and log-
in;
--Sample storage and tracking (includes shipping receipts, 
transmittal forms, and internal routing and assignment records);
--Sample preparation (includes cleanup and separation protocols, ID 
#s, volumes, weights, instrument printouts, meter readings, 
calculations, reagents, etc.);
--Sample analysis;
--Standard and reagent origin, receipt, preparation, and use;
--Equipment receipt, use, specification, operating conditions and 
preventative maintenance;
--Calibration criteria, frequency and acceptance criteria;
--Data and statistical calculations, review, confirmation, 
interpretation, assessment and reporting conventions;
--Method performance criteria including expected quality control 
requirements;
--Quality control protocols and assessment;
--Electronic data security, software documentation and verification, 
software and hardware audits, backups, and records of any changes to 
automated data entries;
--All automated sample handling systems;
--Records storage and retention; and
--Sample disposal including the date of sample or subsample disposal 
and name of the responsible person.

    (b) Laboratory Support Activities--In addition to documenting all 
the above-mentioned activities, the following shall be retained:
--All original raw data, whether hard copy or electronic, for 
calibrations, samples and quality control measures, including 
analysts work sheets and data output records (chromatograms, strip 
charts, and other instrument response readout records);
--Copies of final reports;
--Archived standard operating procedures;
--Correspondence relating to laboratory activities for a specific 
project;
--All corrective action reports, audits and audit responses;
--Performance evaluation results and raw data; and
--Data review and cross checking.

    (c) Analytical Records--The essential information to be recorded on 
all raw data associated with analysis (e.g., strip charts, tabular 
printouts, computer data files, analytical notebooks, run logs, etc.) 
shall include:

--Laboratory sample ID number;
--Date of analysis;
--Instrumentation identification and instrument operating 
conditions/parameters (or reference to such data);
--Analysis type;
--All calculations (automated and manual); and
--Analyst's or operator's initials/signature.
5.11.1.2  Record Keeping System and Design
    Each organization shall design and maintain a record keeping system 
that is succinct, self-explanatory and efficient and allows historical 
reconstruction of all laboratory activities that produced the resultant 
sample analytical data. The history of the sample must be readily 
understood through the documentation. This shall include 
interlaboratory transfers of samples and/or extracts.
    All information relating to the laboratory facilities equipment, 
analytical methods, and related laboratory activities (e.g., sample 
receipt, sample preparation, data review, etc.) shall be documented. 
All documentation shall be maintained to reflect current operating 
protocols.
    The organization should establish essential personnel 
qualifications and shall maintain records on personnel training.
    Organizations shall maintain standard operating procedures (SOPs) 
that accurately reflect all phases of current laboratory activities 
including assessing data integrity.
    (a) These documents may be specific sample preparation or 
analytical references, (e.g., analytical method numbers), equipment 
manuals (provided by the manufacturer), or internally written 
documents.
    (b) The SOPs shall also include a list of analytical methods that 
are used by the laboratory. This list shall be indexed according to 
NELAC accreditation categories (e.g., drinking water, solid waste, 
etc.).
    (c) In cases where minor modifications to accepted methods have 
been made (e.g., change in type of column, change in operating 
conditions, etc.), or where the referenced method is ambiguous or 
provides insufficient detail (e.g., reagent purity, reagent 
concentration, etc.), these changes or clarifications shall be 
documented as an appendix to the referenced method.
    Copies of the above-mentioned SOPs shall be accessible to the 
workplace.
    The record keeping system shall facilitate the retrieval of all 
working files and archived records for inspection and verification 
purposes.
    All documentation entries shall be signed or initialed by 
responsible staff. The reason for the signature or initials shall be 
clearly indicated in the records (e.g., sampled by, prepared by, 
reviewed by, etc.).
    Entries into all records shall be legibly written in indelible ink.
    Entries in records shall not be obliterated by erasures or 
markings. All corrections to record-keeping errors shall be made by one 
line marked through the error. The individual making the correction 
shall sign (or initial) and date the correction. These criteria also 
shall apply to electronically maintained records.
5.11.1.3  Laboratory Report Format and Contents
    The laboratory shall report results, accurately, clearly, 
unambiguously and objectively and in a manner that is understandable to 
the recipient. The basic information to be included in the report 
includes the following:
    (a) Report title (e.g., ``Certificate of Results'', ``Laboratory 
Results'', etc.) with the name, address and phone number of the 
laboratory (or laboratories, see subcontracted laboratories below);
    (b) Name and address of client and/or project;
    (c) Description and identification of sample (including client ID 
number);
    (d) Date of sample receipt, sample collection and sample analysis;
    (e) Time of sample preparation and/or analysis if the required 
holding time for either activity is less than or equal to 48 hours;
    (f) Test method or unambiguous description of any non-standard 
method;
    (g) Test results with any failures or deviations from methods or 
quality control criteria identified (i.e., data qualifiers);
    (h) Signature and title of individual(s) accepting responsibility 
for the content of the report and date of issue; and
    (i) Clear identification of any results that were performed by a 
subcontracted laboratory.
    If appropriate, the laboratory shall certify that the test results 
meet all requirements of NELAP or provide reasons and/or justification 
if they do not.
    Once issued, the laboratory report shall remain unchanged. Any 
corrections, additions and/or deletions from the original reports shall 
be supported by supplementary documentation, shall clearly identify its 
purpose, and shall contain all reporting requirements specified above.
5.11.1.4  Records Management and Storage
    (a) All records of an organization that are pertinent to a 
specified project shall be retained for a minimum of five years unless 
otherwise designated for a longer period of time in another regulation. 
The records specified in 5.11.1.1 and 5.11.1.2 above shall be retained.
    (b) Records that are stored or generated by computers or personal 
computers (PCs) shall have hard copy and write-protected backup copies.
    (c) When a procedure or document (e.g., initial calibration 
records, SOPs, etc.) becomes obsolete or is replaced, the records shall 
clearly indicate the time period (or sample sets, if applicable) during 
which the procedure or document was in force.
    (d) All access to archived information shall be documented.
    (e) If an organization goes out of business or changes ownership 
before the time period for records retention has expired, all 
documentation shall be transferred in whole to the archives of the 
sponsor (client) of the work or to the new owner as described in 
Section 4.1.8.
5.11.2  Sample Custody Tracking and Data Documentation for Laboratory 
Operations
5.11.2.1  Sample Receipt, Log In and Storage
    All records pertinent to sample receipt, log in and storage shall 
be maintained. In addition, the laboratory shall:
    (a) Retain all correspondence and/or official conversations 
concerning the final disposition of rejected samples;
    (b) Fully document any decision to proceed with the analysis of 
compromised samples:

--The condition of these samples shall be noted in all documentation 
associated with the sample.
--The analysis data shall be appropriately ``qualified as 
estimated'' on all internal documentation and on the final report.

    (c) Utilize a permanent, chronological log to document receipt of 
all sample containers. The following information must be recorded in 
the laboratory sequential log:

--Date of laboratory receipt of sample;
--Sample collection date;
--Unique laboratory ID code (see 5.10 above);
--Field ID code supplied by sample submitter;
--Requested analyses, including approved method number, if 
applicable;
--Signature or initials of data logger;
--Comments resulting from inspection for sample acceptance 
rejection; and
--Sampling kit code (if applicable).

    (d) All documentation that is transmitted to the laboratory by the 
sample transmitter shall be retained (e.g., memos, transmittal forms, 
etc.).
5.11.2.2  Intralaboratory Distribution of Samples for Analysis
    (a) The laboratory shall utilize a proactive procedure to ensure 
that all samples and subsamples are analyzed within allowed maximum 
allowable holding times.
    (b) All distribution of samples and subsamples for preparation and 
analysis shall be documented as to task assignment and analysis date 
deadline.
5.11.3  Legal or Evidentiary Custody Procedures
    The use of legal chain of custody (COC) protocols is strongly 
recommended and may be required by some state or federal programs. In 
addition to the records listed in 5.11.1.1 and 5.11.1.2, the following 
protocols shall be incorporated if legal COC is implemented by the 
organization.
5.11.3.1  Basic Requirements
    The chain of custody records shall establish an intact, contiguous 
record of the physical possession, storage and disposal of sample 
containers, collected samples, sample aliquots, and sample extracts or 
digestates. For ease of discussion, the above-mentioned items shall be 
referred to as samples:
    (a) The COC records shall account for all time periods associated 
with the samples.
    (b) The COC records shall include signatures of all individuals who 
were involved with physically handling the samples.
    (c) In order to simplify record-keeping, the number of people who 
physically handle the sample should be minimized.
    (d) The COC records are not limited to a single form or document. 
However, organizations should attempt to limit the number of documents 
that would be required to establish COC.
    (e) Legal chain of custody shall begin at the point established by 
the federal or state oversight program. This may begin at the point 
that cleaned sample containers are provided by the laboratory or the 
time sample collection occurs.
    (f) The COC forms shall remain with the samples during transport or 
shipment.
5.11.3.2  Required Information in Custody Records
    In addition to the information specified in 5.11.1.1 and 5.11.1.2, 
tracking records shall include, by direct entry or linkage to other 
records:
    (a) Time of day and calendar date of each transfer or handling 
procedure;
    (b) Signatures of all personnel who physically handle the 
sample(s);
    (c) All information necessary to produce unequivocal, accurate 
records that document the laboratory activities associated with sample 
receipt, preparation, analysis and reporting; and
    (d) Common carrier documents.
5.11.3.3  Controlled Access to Samples
    Access to all legal samples and subsamples shall be controlled and 
documented.
5.11.3.4  Transfer of Samples to Another Party
    Transfer of samples, subsamples, digestates or extracts to another 
party are subject to all of the requirements for legal chain of 
custody.
5.11.3.5  Sample Disposal
    (a) If the sample is part of litigation, disposal of the physical 
sample shall occur only with the concurrence of the affected legal 
authority, sample data user and/or submitter of the sample.
    (b) All conditions of disposal and all correspondence between all 
parties concerning the final disposition of the physical sample shall 
be recorded and retained.
    (c) Records shall indicate the date of disposal, the nature of 
disposal (i.e. sample depleted, sample disposed in hazardous waste 
facility, sample returned to client, etc.), and the name of the 
individual who performed the task.

5.12  Corrective Action Policy and Procedures

    The laboratory shall develop contingencies for unacceptable quality 
control results. These policies shall be specified in written SOPs and 
shall include the following:
    (a) Identification of such problems, and the anticipated and/or 
recommended corrective actions to correct and/or eliminate future 
occurrences;
    (b) Requirement for written records that document the problem, the 
corrective measures, and the final outcome; and
    (c) An established policy requiring that a laboratory does not 
accept samples on a routine basis without the capability of meeting the 
maximum holding times.

Appendix A

Definitions

    Accreditation: The process by which an agency or organization 
evaluates and recognizes a program of study or an institution as 
meeting certain predetermined qualifications or standards, thereby 
accrediting the laboratory. In the context of the National 
Environmental Laboratory Accreditation Program (NELAP), this process 
is a voluntary one.
    Accreditation Authority Review Board: A five member group 
appointed by EPA from the states, EPA, and other federal agencies to 
review the process and procedures used by EPA to approve state and 
federal laboratories and accreditation authorities.
    Accrediting Authority: The agency having responsibility and 
accountability for environmental laboratory accreditation and who 
grants accreditation. For the purposes of NELAC, this is EPA, other 
federal agencies, or the state.
    Accrediting Body: The organization that actually executes the 
accreditation process, i.e., receives and reviews accreditation 
applications, reviews QA documents, reviews performance evaluation 
testing results, surveys the site, etc., whether EPA, the state, or 
contracted private party.
    Accuracy: The degree of agreement between an observed value and 
an accepted reference value. Accuracy includes a combination of 
random error (precision) and systematic error (bias) components 
which are due to sampling and analytical operations; a data quality 
indicator. (Glossary of Quality Assurance Terms, QAMS, 8/31/92).
    Administrative Committee: A committee of the National 
Environmental Laboratory Accreditation Conference involved with the 
internal business affairs of the conference. Currently, these are 
the Conference Management and Funding, Nominating, Membership, 
Auditing, Liaison, and Contributor Committee.
    Applicant: Any environmental laboratory seeking accreditation.
    Assessment: The physical process of inspecting, testing and 
documenting results from a laboratory for purposes of accreditation.
    Assessment Team: An individual or group of individuals who 
perform the on-site assessment of a laboratory.
    Board of Directors: The guiding body of NELAC composed of the 
Director, Executive Secretary, Chair, Chair-elect, Past Chair, 
Treasurer, and six at-large members.
    Calibration Standard: A solution prepared from the primary 
dilution standard solution or stock standard solutions and the 
internal standards and surrogate analytes. The Calibration solutions 
are used to calibrate the instrument response with respect to 
analyte concentration. (Glossary of Quality Assurance Terms, QAMS, 
8/31/92).
    CNAEL: The Committee on National Accreditation of Environmental 
Laboratories chartered by EPA in 1991 to assess the need, 
feasibility, and practicability of a national environmental 
laboratory accreditation program. Dissolved after its report to EPA 
in September 1992.
    Compromised Samples: Those samples which were improperly 
sampled, or with insufficient documentation (chain of custody and 
other sample records and/or labels), improper preservation and/or 
containers were used, or the holding time has been exceeded. Under 
normal conditions compromised samples are not analyzed. If emergency 
situations require analysis, the results must be appropriately 
qualified.
    Contracted Organization: A private accrediting body meeting the 
standards for accreditation of environmental laboratories and 
employed by an accrediting authority to perform certain accrediting 
functions, e.g. on-site audits.
    Contributors: Any person or group having an interest in 
environmental laboratory accreditation other than a state or federal 
official involved in environmental laboratory affairs, who may 
participate in the deliberations of the conference by presenting 
papers, debating issues, etc. but without vote or formal membership 
on a committee.
    Deficiency Report: A report generated by the Inspector who is a 
state employee or authorized agent of the state in response to 
deficiencies noted in the course of a laboratory assessment, 
inspection or performance evaluation sample analysis result.
    Denial: The refusal to grant approval to all or part of a 
laboratory's initial or subsequent application for certification by 
the National Environmental Laboratory Accreditation Program.
    Environmental Laboratory Advisory Board: The name of the Federal 
Advisory Committee Act body chartered by EPA and composed of special 
interest groups or persons to interact with the Board of Directors.
    Equipment Blank (Sample Equipment Blank): A clean sample (e.g., 
distilled water) that is collected in a sample container with the 
sample-collection device and returned to the laboratory as a sample. 
Sampling equipment blanks are used to check the cleanliness of 
sampling devices. (Glossary of Quality Assurance Terms, QAMS, 8/31/
92).
    Failure: Failing one or more of the criteria outlined in factors 
examined in announced and unannounced laboratory assessments which 
include: competence of staff, qualifications of staff and 
supervisors, working conditions, equipment, supplies, supervision, 
methods used, quality assurance/quality control procedures, 
recordkeeping, and compliance with good laboratory practices.
    Field Blank: A clean sample (e.g., distilled water), carried to 
the sampling site, exposed to sampling conditions (e.g., bottle caps 
removed, preservatives added) and returned to the laboratory and 
treated as an environmental sample. Field blanks are used to check 
for analytical artifacts and/or background introduces by sampling 
and analytical procedures. (Glossary of Quality Assurance Terms, 
QAMS, 8/31/92).
    Holding Times (Maximum Allowable Holding Times): The maximum 
times that samples may be held prior to analysis and still be 
considered valid. (40 CFR Part 136).
    Initial Demonstration of Analytical Capability: Procedure to 
establish the ability to generate acceptable accuracy and precision 
which is included in many of the EPA's analytical methods. In 
general the procedure includes the addition of a specified 
concentration of each analyte (using a QC check sample) in each of 
four separate aliquots of laboratory pure water. These are carried 
through the entire analytical procedure and the percentage recovery 
and the standard deviation are determined and compared to specified 
limits. (40 CFR Part 136).
    Inspection Report: The written results listing specific 
deficiencies and levels of performance that result from a laboratory 
assessment. This is a public record document prepared by the 
inspector.
    Inspector: The authorized representative of the appropriate 
department within a state who directly conducts the laboratory 
assessment of inspection. This representative may be a third party 
contractor to the state who inspects and acts under the authority of 
the state. All actions and requests made by such a third party are 
made under the regulatory authority of the state.
    Instrument Blank: A clean sample (e.g., distilled water) 
processed through the instrumental steps of the measurement process; 
used to determine instrument contamination. (Glossary of Quality 
Assurance Terms, QAMS, 8/31/92).
    Laboratory: A facility engaged in the collection or analysis and 
reporting of environmental samples, whether fixed or mobile.
    Laboratory Control Sample (quality control sample): An 
uncontaminated sample matrix spiked with known amounts of analytes 
from a source independent of the calibration standards. It is 
generally used to establish intra-laboratory or analyst specific 
precision and bias or to assess the performance of all or a portion 
of the measurement system. (Glossary of Quality Assurance Terms, 
QAMS, 8/31/92).
    Legal Chain of Custody (COC): An unbroken trail of 
accountability that ensures the physical security of samples, data 
and records. (Glossary of Quality Assurance Terms, QAMS, 8/31/92).
    Local: An individual state.
    Manager: The individual designated as being responsible for the 
overall operation, all personnel, and the physical plant of the 
environmental laboratory. A supervisor may report to the manager. In 
some cases, the supervisor and the manager may be the same 
individual.
    Matrix Spike (spiked sample, fortified sample): Prepared by 
adding a known mass of target analyte to a specified amount of 
matrix sample for which an independent estimate of target analyte 
concentration is available. Matrix spikes are used, for example, to 
determine the effect of the matrix on a method's recovery 
efficiency. (Glossary of Quality Assurance Terms, QAMS, 8/31/92).
    Matrix Spike Duplicate (spiked sample/fortified sample 
duplicate): A second replicate matrix spike is prepared and analyzed 
to obtain a measure of the precision of the recovery for each 
analyte. (Glossary of Quality Assurance Terms, QAMS, 8/31/92).
    Member (or active member): A state or federal official engaged 
in setting regulatory standards or accreditation of environmental 
laboratories, eligible for committee assignment and having voting 
privileges in the NELAC.
    Method Blank: A clean sample processed simultaneously with and 
under the same conditions as samples containing an analyte of 
interest through all steps of the analytical procedures. (Glossary 
of Quality Assurance Terms, QAMS, 8/31/92).
    Method Detection Limit (Analytical Detection Limit): The minimum 
concentration of a substance (an analyte) that can be measured and 
reported with 99% confidence that the analyte concentration is 
greater than zero and is determined from analysis of a sample in a 
given matrix containing the analyte. (40 CFR Part 136 Appendix B).
    National Database: A database run by the Federal Government or 
its authorized agent that has public information readily available 
to the states participating in the NELAP program. It would include 
information regarding the current accreditation and accreditation 
process and status on a laboratory by laboratory basis.
    NELAC: National Environmental Laboratory Accreditation 
Conference. A voluntary organization of state and federal 
environmental officials and interest groups purposed primarily to 
establish mutually acceptable standards for accrediting 
environmental laboratories. A subset of NELAP.
    NELAP: The overall National Environmental Laboratory 
Accreditation Program of which NELAC is a part.
    On-site: The laboratory facility, whether fixed or mobile, in 
the context of actually visiting the facility for evaluation or 
review of its program.
    Reagent Blank (method reagent blank): A sample consisting of 
reagent(s), without the target analyte or sample matrix, introduced 
into the analytical procedure at the appropriate point and carried 
through all subsequent steps to determine the contribution of the 
reagents and of the involved analytical steps. (Glossary of Quality 
Assurance Terms, QAMS, 8/31/92).
    PBM: Performance Based Methods.
    Participating Member: A state or federal agency identified by 
EPA as having met all the standards for an accrediting authority to 
accredit environmental laboratories.
    Performance Evaluation Program: The aggregate of providing 
rigorously controlled and standardized environmental samples to a 
laboratory for analysis, reporting of results, statistical 
evaluation of the results in comparison to peer laboratories and the 
collective demographics and results summary of all participating 
laboratories.
    Performance Evaluation Sample (PE): A sample, the composition of 
which is unknown to the analyst and is provided to test whether the 
analyst/laboratory can produce analytical results within specified 
performance limits. (Glossary of Quality Assurance Terms, QAMS, 8/
31/92).
    Precision: The degree to which a set of observations or 
measurements of the same property, usually obtained under similar 
conditions, conform to themselves; a data quality indicator. 
Precision is usually expressed as standard deviation, variance or 
range, in either absolute or relative terms. (Glossary of Quality 
Assurance Terms, QAMS, 8/31/92).
    Preservation: Refrigeration and/or reagents added at the time of 
sample collection to maintain the chemical and/or biological 
integrity of the sample.
    Pure Reagent Water: Water in which an interferant is not 
observed at the MDL of the parameters of interest. (40 CFR Part 136)
    Quality Assurance Plan: A written description of the 
laboratory's quality assurance activities.
    Quality Assurance: An integrated system of activities involving 
planning, quality control, quality assessment, reporting and quality 
improvement to ensure that a product or service meets defined 
standards of quality with a stated level of confidence. (Glossary of 
Quality Assurance Terms, QAMS, 8/31/92).
    Quality Control: The overall system of technical activities 
whose purpose is to measure and control the quality of a product or 
service so that it meets the needs of users. (Glossary of Quality 
Assurance Terms, QAMS, 8/31/92).
    Quality Control Sample: An uncontaminated sample matrix spiked 
with known amounts of analytes from a source independent from the 
calibration standards. It is generally used to establish intra-
laboratory or analyst specific precision and bias or to assess the 
performance of all or a portion of the measurement system. (Glossary 
of Quality Assurance Terms, QAMS, 8/31/92).
    Quality Control Validation Studies: The formal study of a 
sampling and/or analytical method, conducted with replicate, 
representative matrix samples, following a specific study protocol 
and utilizing a specific written method, by a minimum of seven 
laboratories, for the purpose of estimating inter-laboratory 
precision, bias and analytical interferences. (Glossary of Quality 
Assurance Terms, QAMS, 8/31/92).
    Sample Container: The specific requirements for sample 
containers are to assure a representative samples and sample 
integrity, e.g., septa vials, glass or plastic.
    Sample Duplicate: Two samples taken from and representative of 
the same population and carried through all steps of the sampling 
and analytical procedures in an identical manner. Duplicate samples 
are used to assess variance of the total method including sampling 
and analysis. (Glossary of Quality Assurance Terms, QAMS, 8/31/92).
    Standard Operating Procedures (SOPs): A written document which 
details the method of an operation, analysis or action whose 
techniques and procedures are thoroughly prescribed and which is 
accepted as the method for performing certain routine or repetitive 
tasks. (Glossary of Quality Assurance Terms, QAMS, 8/31/92).
    Standing Committee: A committee of NELAC involved with 
establishing the technical standards for accreditation of 
environmental laboratories. Currently, these are the Quality 
Systems, Performance Evaluation Testing, On-site Assessment, 
Accreditation Process, Regulatory, Accrediting Authority, and 
Program Structure Committees.
    Supervisor: The individual designated as being responsible for a 
particular area or category of scientific analysis. This 
responsibility includes direct day-to-day supervision of technical 
employees, supply and instrument adequacy and upkeep, quality 
assurance/quality control duties and ascertaining that technical 
employees have the required balance of education, training and 
experience to perform the required analyses.
    Surrogate: A substance with properties that mimic the analyte of 
interest. It is unlikely to be found in environment samples and is 
added to them for quality control purposes. (Glossary of Quality 
Assurance Terms, QAMS, 8/31/92).
    Technical Employee: The designated individual who performs the 
``hands-on'' analytical methods and associated techniques and who is 
the one responsible for applying required Good Laboratory Practice 
notices and other pertinent Quality Controls to meet the required 
level of quality.
    Trip Blank: A clean sample of matrix that is carried to the 
sampling site and transported to the laboratory for analysis without 
having been exposed to sampling procedures. (Glossary of Quality 
Assurance Terms, QAMS, 8/31/92).

Appendix B

Bibliography

References for Water, Sediments, Soils, Sludges, Hazardous Wastes and 
Biological Analyses

    These methods or methods specified by the accreditation 
authority shall be used when analyzing samples.

Drinking Water

    (1) 40 CFR Part 141, National Primary Drinking Water 
Regulations, July 1, 1992, Subpart C and Subpart I.
    (2) ``Methods for the Determination of Organic Compounds in 
Drinking Water,'' EPA 600/4-88-039, December 1988.
    (3) ``Methods for Chemical Analysis of Water and Wastes,'' EPA 
600/4-79-020, revised March 1983.
    (4) ``Manual for Certification of Laboratories Analyzing 
Drinking Water, Criteria and Standards Quality Assurance'' EPA 570/
9-90-008, April 1990 and the first update (Change I) EPA 570/9-90-
008a, October 1991.
    (5) 40 CFR Part 136, Guidelines Establishing Test Procedures for 
the Analysis of Pollutants Under the Clean Water Act, July 1, 1991, 
Appendix A.
    (6) Standard Methods for the Examination of Water and 
Wastewater, APHA-AWWA-WPCF, 18th Edition, 1992.
    (7) ``Guidance on the Evaluation of Safe Drinking Water Act 
Compliance Monitoring Results from Performance Based Methods'', 
September 30, 1994, Second draft.

Surface Water, Groundwater, and Wastewater Municipal/Industrial 
Effluents

    (1) 40 CFR Part 136, Guidelines Establishing Test Procedures for 
the Analysis of Pollutants Under the Clean Water Act, Tables IA, IB, 
IC, ID and IE, as published in the Federal Register, Vol. 65, No. 
165, pp. 50758-50770, October 8, 1991.
    (2) Methods for Chemical Analysis of Water and Wastes, EPA 600/
4-79-020, revised March 1983.
    (3) Test Methods for Evaluating Solid Waste, Physical/Chemical 
Methods, (SW-846), Third edition, 1986, as amended by Updates 1 and 
IIA, August 31, 1993.
    (4) 40 CFR Part 261, Identification and Listing of Hazardous 
Waste, July, 1991, Appendix III (Chemical Analysis Test Methods)
    (5) Standard Methods for the Examination of Water and 
Wastewater, APHA-AWWA-WPCF, 17th Edition, 1989.

    Notes:
    (1) Laboratories analyzing samples in support of NPDES Permits 
are limited to methods specified in Reference 1 above or those 
specifically approved for use by EPA.

Soils and Sediments, Municipal and Industrial Sludges (Residuals) and 
Solid and Hazardous Wastes

    (1) ``Test Methods for Evaluation of Solid Waste, Physical and 
Chemical Methods'', Third Edition (EPA SW-846), 1986 as amended by 
Final Updates I and II, November, 1990 and 1991.
    (2) ``Procedures for Handling and Chemical Analysis of Sediments 
and Water Samples'' EPA/Corps of Engineers, EPA/CE-81-1, 1981.
    (3) *USEPA Contract Laboratory Statement of Work for 
Inorganic Analysis'', ILMO 2.1 (September 1991).
    (4) *USEPA Contract Laboratory Program Statement of Work 
for Organic Analysis'', ILMO 2.0 (July 1990) and ILMO 2.1 (September 
1991).
---------------------------------------------------------------------------

    \*\Methods from these references shall be used by laboratories 
participating in the EPA Contract Laboratory Program to perform 
analyses for Superfund (CERCLA) site investigations.
---------------------------------------------------------------------------

    (5) ``POTW Sludge Sampling and Analysis Guidance Document'' 
USEPA Permits Division, August 1989.

Air

    To be added as document goes through review.

Biological

    Microbiological. (1) Drinking Water Analyses--40 CFR Part 141, 
Subpart C (Monitoring and Analytical Requirements, section 141.21) 
July 1, 1991.
    (2) Water and Wastewater Analyses--40 CFR Part 136, Table IA as 
published in the Federal Register, Vol. 65, No. 165, pp. 50758-
50770, October 8, 1991.
    (3) ``Microbiological Methods for Monitoring the Environment'' 
EPA-600/8-78-017, 1978.
    (4) Standard Methods for the Examination of Water and 
Wastewater, APHP-AWWA-WPCF, 17th Edition, 1989.
    Bioassay. (1) ``Methods for Measuring the Acute Toxicity of 
Effluents and Receiving Waters to Freshwater and Marine Organisms 
(Fourth Edition)'' EPA 600/4-90-027, September, 1991.
    (2) ``Short-Term Methods for Estimating the Chronic Toxicity of 
Effluents and Receiving Waters to Freshwater Organisms (Third 
Edition)'' EPA 600/4-91-002, 1991.
    (3) ``Short-Term Methods for Estimating the Chronic Toxicity of 
Effluents and Receiving Waters to Marine and Estuarine Organisms 
(Second Edition)'' EPA 600/4-91/003, 1991.
    Macrobenthic identification and enumeration. (1) 
``Macroinvertebrate Field and Laboratory Methods for Evaluating the 
Biological Integrity of Surface Waters'', ORD, Washington, D.C., 
November, 1990.
    (2) Standard Methods for the Examination of Water and 
Wastewater, Part 10500, 17th Edition, APHA, 1989.

Radiochemistry

    (1) 40 CFR Part 141.25, ``Analytical Methods for 
Radioactivity'', July 1, 1992 edition.
    (2) Analytical Methods for Radiochemistry Analyses, EPA 600/4-
80-032 and EPA 600/5-84-006.

[FR Doc. 94-29573 Filed 12-1-94; 8:45 am]
BILLING CODE 6560-50-P