United States
Environmental Protection
Agency
Office of Research
and Development
Washington, DC 20460
EPA 600/R-97/139 -
July 1997
v°/EPA National Environmental
Laboratory Accreditation
Conference
Constitution, Bylaws, and Standards
Approved July 1997
Internet Address (URL) • http://www.epa.gov
Recycled/Recyclable • Printed with Vegetable Oil Based Inks on Recycled Paper (20% Postconsumer)
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NELAC
Constitution and Bylaws
Revision 7
July 31,1997
Page i of Hi
TABLE OF CONTENTS
Constitution and Bylaws
CONSTITUTION 1
ARTICLEI - GENERAL 1
ARTICLE!! - OBJECTIVES 1
A. Forum 1
B. Mechanism 1
C. Consensus 1
D. Uniformity 2
E. Cooperation 2
ARTICLE ffl - PARTICIPATION 2
ARTICLE IV - OFFICERS 2
SECTION 1 -EXOFFICIO OFFICERS 2
A. Director 2
B. Executive Secretary 3
SECTION 2 - ELECTIVE OFFICERS 3
A. Eligibility 3
B. Nominations and Elections 3
ARTICLE V- APPOINTIVE OFFICIALS 4
SECTION 1 - OFFICIALS, SPECIFIC 4
A. Appointment 4
B. Assumption of Office 4
ARTICLE VI - MEETINGS OF NELAC 5
A. Annual Meeting 5
B. Interim Meeting 5
C. Special Meetings 5
D. Rules of Order 5
ARTICLE VH - AMENDMENTS TO THE CONSTITUTION 5
ARTICLE Vni - BYLAWS 6
SECTION 1 - SUPPLEMENTATION OF CONSTITUTION 6
SECTION 2 - AMENDMENTS AND REPEALS OF THE BYLAWS 6
SECTION 3 - RENUMBERING 6
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BYLAWS 7
ARTICLE I - APPLICATION FOR PARTICIPATION 7
SECTION 1 - FORM OF APPLICATION 7
ARTICLE E - PARTICIPANTS' RECORDS 7
SECTION 1 - TERM OF PARTICIPATION 7
SECTION 2 - EVIDENCE OF VOTING MEMBERSHIP 7
ARTICLE III - USE OF THE INSIGNIA 7
ARTICLEIV-BOARD OFDIRECTORS 7
SECTION 1 - MEMBERSHIP 7
SECTION 2 - DUTIES 8
ARTICLE V - DUTIES OF THE OFFICERS 8
SECTION 1 - CHAIR 8
SECTION 2 - CHAIR-ELECT 8
SECTIONS -PAST CHAIR 9
SECTION 4 - DIRECTOR 9
SECTION 5 - EXECUTIVE SECRETARY 9
SECTION 6 - PARLIAMENTARIAN 9
ARTICLE VI - COMMITTEES 10
SECTION 1 - GENERAL 10
SECTION 2 - ADMINISTRATIVE COMMITTEES 10
A. Terms 10
B. Duties 10
SECTION 3 - STANDING COMMITTEES 11
A. Terms 11
B. Duties 11
SECTION 4 - SPECIAL COMMITTEES, TASK FORCES AND STUDY GROUPS
12
SECTION 5 - SUBCOMMITTEES 13
ARTICLE VH - VOTING SYSTEM 13
SECTION 1 - HOUSE OF REPRESENTATIVES 13
A. Official Designation 13
B. Composition 13
C. Method of Designation 14
SECTION 2 - HOUSE OF DELEGATES 14
A. Designation 14
B. Requirements 14
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SECTION 3 - VOTING RULES 15
A. Applicability 15
B. Quorum 15
C. Voting 15
D. Committee Report Voting 16
SECTION4 -FLOOR AMENDMENTS 17
A. Procedure 17
B. Editorial Changes 17
SECTION 5 - SEATING 17
A. Arrangement 17
B. Supervision 17
SECTION 6 - PROCEDURES 17
SECTION 7 - CHANGES IN ORGANIZATION AND PROCEDURE 18
Figure 1. Seating Arrangement 19
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CONSTITUTION
ARTICLE I - GENERAL
This organization shall be known as "The National Environmental
Laboratory Accreditation Conference" (NELAC) and is sponsored
by the United States Environmental Protection Agency (EPA) as a
voluntary association of State and federal Officials. The
purpose of the organization is to foster the generation of
environmental laboratory data of known and documented quality
through the development of national performance standards for
environmental laboratories, to be implemented by state and
federal accrediting authorities in a consistent fashion.1
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, Territories and Possessions of the United
States, and their political subdivisions, and the District of
Columbia, members and representatives of the regulated
community, the public, and other interested parties.
B. Mechanism
To provide a mechanism to establish policy and coordinate
activities within NELAC on matters of national and
international significance pertaining to environmental
laboratory accreditation standards.
C. Consensus
To develop a consensus on uniform standards for laboratory
accreditation and implementation of those standards by the
accrediting authorities.
1 The Constitution and Bylaws will be reviewed at a later date to accommodate the unique characteristics of the GLP
program, taking into consideration the recommendations of the Environmental Laboratory Advisory Board."
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D. Uniformity
To encourage and promote uniform standards of quality for
assessment and accreditation requirements among the various
accrediting authorities.
E. Cooperation
To foster cooperation among environmental laboratory
accrediting authorities and regulatory officials, and between
them and the manufacturing, industrial, business, academic,
consumer, and other interests affected by their official
activities.
ARTICLE III - PARTICIPATION
Participants consist of two categories:
Voting Membership is limited to officials who are in the employ
of the Government of the United States, and the States, the
Territories, the Possessions of the United States, or the
District of Columbia and who are actively engaged in
environmental regulatory programs or accreditation of
environmental laboratories.
Contributors include representatives of laboratories,
manufacturers, industry, business, consumers, academia,
laboratory associations, industrial associations, laboratory
accreditation associations, counties, municipalities, and other
political subdivisions of States, Territories and Possessions of
the United States, other federal officials not engaged in
environmental activities, and other persons who are interested in
the objectives and activities of NELAC.
ARTICLE IV - OFFICERS
SECTION 1 - EX OFFICIO OFFICERS
A. Director
The Director of the EPA National Environmental Laboratory
Accreditation Program is the ex officio Director of NELAC.
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B. Executive Secretary
The Executive Secretary is an employee of EPA who is conversant
with laboratory accreditation. She/he serves NELAC and its Board
of Directors.
SECTION 2 - ELECTIVE OFFICERS
The Elective officers of NELAC shall be:
Chair,
Chair - Elect,
Immediate Past-Chair, 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 below. In this event, the newly
elected Chair-Elect shall be installed as Chair.
A. Eligibility
1. Any Voting 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. 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, four (4)
Voting Members, to be geographically representative insofar as
possible, and five (5) Contributors.
2. Nominations
a. The Nominating Committee shall submit one name for each
elective office and present its recommendation to NELAC.
b. Additional nominations for officers may be made from the
floor by any Voting Member at the Annual Meeting provided
that prior consent of the nominee has been obtained in
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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 Voting Members
in attendance and eligible to vote on NELAC 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. After
serving one year as Chair-Elect, the incumbent will
succeed to the office of NELAC Chair.
b. The six Board of Directors members-at-large shall serve
for 3-year terms; two elected each year.
c. 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.
The term of this appointment shall be until the date of the
next Annual Meeting , at which time the Voting Members vote to
confirm the appointment or elect a candidate to fill the
remaining time in the initial term that was vacated.
ARTICLE V - APPOINTIVE OFFICIALS
SECTION 1 - OFFICIALS, SPECIFIC
A. Appointment
The NELAC Chair shall appoint the Parliamentarian and other
officials to conduct NELAC activities.
B. Assumption of Office
All appointive officials shall take office immediately following
appointment and will serve through the subsequent Annual Meeting
of NELAC unless otherwise requested by the NELAC Chair, or
specified in the Constitution or Bylaws.
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ARTICLE VI - MEETINGS OF NELAC
A. Annual Meeting
An Annual Meeting shall be held. The agenda for this meeting
shall include the election of officers, reports from the various
committees, task forces, and study groups, other items pertinent
to NELAC, and presentation to the Voting 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 and
action at the Annual Meeting. Draft resolutions and standards
regarding environmental laboratory accreditation shall be
discussed and modified as appropriate in the Interim Meeting.
C. Special Meetings
1. The NELAC Chair is authorized to call a meeting of the Board
of Directors at any time deemed necessary by the Chair to
be in the best interest of NELAC.
2. Committees of NELAC are authorized to hold meetings at times
other than the Annual Meeting or Interim Meeting.
D. Rules of Order
The rules contained in the latest version of Robert's Rules of
Order shall govern NELAC in all cases to which they are
applicable, and in which they are not inconsistent with the
Constitution or Bylaws or special rules of NELAC.
ARTICLE VII - AMENDMENTS TO THE CONSTITUTION
This Constitution may be amended, added to, or repealed at any
Annual Meeting under normal NELAC procedures. However, proposed
changes must be included in the agenda of the Board of Directors
for the preceding Interim Meeting, published in the
Recommendations of the Board of Directors in its report, and
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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 of the Voting Members in attendance at the
Annual Meeting in both the House of Representatives and the House
of Delegates.
ARTICLE VIII - BYLAWS
SECTION 1 - SUPPLEMENTATION OF CONSTITUTION
This Constitution shall be supplemented by Bylaws which shall
detail the methods of operation of NELAC. 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, added to, or repealed at any Annual
Meeting under normal NELAC procedures. However, 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 Bylaws must be approved by a majority vote of
the Voting Members in attendance at the Annual Meeting in both
the House of Representatives and the House of Delegates.
SECTION 3 - RENUMBERING
The Executive Secretary is authorized to renumber the Articles
and Sections of the Constitution or Bylaws to accommodate any
changes made.
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BYLAWS
ARTICLE I - APPLICATION FOR PARTICIPATION
SECTION 1 - FORM OF APPLICATION
A completed registration form for the Annual Meeting of the
National Environmental Laboratory Accreditation Conference
(NELAC) shall serve as the application for participation in
NELAC.
ARTICLE II - PARTICIPANTS' RECORDS
SECTION 1 - TERM OF PARTICIPATION
Registration for NELAC participation shall be prior to the
Annual Meeting each year and will cover the period from the
beginning of one Annual Meeting to the beginning of the next
Annual Meeting.
SECTION 2 - EVIDENCE OF VOTING MEMBERSHIP
Reserved.
ARTICLE III - USE OF THE INSIGNIA
The insignia of NELAC may be used or displayed only for official
publications, announcements, and documents of NELAC unless
expressly authorized in writing by the Board of Directors of
NELAC.
ARTICLE IV - BOARD OF DIRECTORS
SECTION 1 - MEMBERSHIP
A. The Board of Directors consists of the Director, Executive
Secretary, Chair of NELAC, Chair-Elect, the most recent
still active Past Chair of NELAC, and the six at-large-
members.
B. The Nominating Committee in recommending candidates for the
Board of Directors shall consider geographic representation.
C. The term of the Board of Directors begins with the
adjournment of the Annual Meeting at which its members are
elected or appointed. Six of the Board of Directors are
members-at-large with three-year terms.
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SECTION 2 - DUTIES
A. The Board of Directors has leadership responsibility for
NELAC and is charged with guiding NELAC in its primary
mission of establishing standards for the accreditation of
environmental laboratories.
B. It establishes administrative procedures and policy on
internal matters and serves as the policy and coordinating
body in matters of national and international significance.
C. It holds accountable, reviews, and approves actions of all
Committees.
D. It utilizes the Standing Committees to resolve technical
criteria issues regarding laboratory accreditation.
E. It acts for NELAC in all routine or emergency situations.
F. It authorizes interim meetings of NELAC Committees as
necessary.
G. It fills any vacancy in any elective office of NELAC
occurring during the term of office.
H. It brings recommendations to NELAC for consideration and
action as appropriate.
ARTICLE V - DUTIES OF THE OFFICERS
SECTION 1 - CHAIR
The NELAC Chair is the presiding officer at the meetings of NELAC
and of the Board of Directors, makes appointments to the several
Standing and Administrative Committees, and appoints other NELAC
officials to serve during his or her term of office.
SECTION 2 - CHAIR-ELECT
The Chair-Elect will:
A. serve as acting Chair of NELAC 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 NELAC Chair, including
presiding over sessions of the meetings of NELAC as assigned
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by the NELAC 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, serve as Chair of the Nominating Committee, and
perform such duties as may be assigned by the NELAC Chair. The
NELAC Past Chair may preside over sessions of the meetings of
NELAC as assigned by the NELAC Chair and assist the Chair in the
discharge of his or her duties.
SECTION 4 - DIRECTOR
The Director coordinates all laboratory accreditation activities
within EPA for purposes of establishing a single uniform
environmental laboratory accreditation system. The Director
serves as the link with EPA and other federal agency policy
makers, those responsible for implementation of the National
Environmental Laboratory Accreditation Program, the NELAC Board
of Directors, the Environmental Laboratory Advisory Board, and
the Accreditation Authority Review Board. The Director serves
on the Board of Directors as an ex officio member and is
responsible for the appointment and support of an Executive
Secretary to the Board of Directors.
SECTION 5 - EXECUTIVE SECRETARY
The Executive Secretary acts as the executive officer of NELAC,
as an ex officio member, secretary and executive officer of the
Board of Directors, and the non-voting secretary to each standing
committee; certifies eligible voters and records the vote of
NELAC; keeps the records of the proceedings of the meetings, and
manages NELAC administration as prescribed in its administrative
procedures.
SECTION 6 - PARLIAMENTARIAN
The Parliamentarian shall, when requested by the Chair, help in
resolving procedural matters at meetings of NELAC. The
parliamentarian shall use the latest edition of Robert's Rules
of Order and any special rules adopted by NELAC.
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ARTICLE VI - COMMITTEES
SECTION 1 - GENERAL
Except as otherwise provided, each Administrative and Standing
Committee will consist of ten participants, five Voting Members
and five Contributors who may not vote. All participants are
appointed by the Chair of NELAC to serve staggered terms on a
rotating basis or until a successor is appointed.
Except for the Nominating Committee, each committee annually
selects one of its Voting Members to serve as its chair, who may
succeed himself or herself.
When necessary, an appointment will be made to any of the
standing or administrative committees to fill any vacancy for the
unexpired portion of the participant's term.
SECTION 2 - ADMINISTRATIVE COMMITTEES
A. Terms
1. Conference Management Committee. The term of service shall
be three years; two Voting Members and two Contributors will
be appointed each of two years and one Voting Member and one
Contributor the third year.
2. Nominating Committee. The chair is the NELAC Past Chair.
Four Voting Members and five Contributors shall be appointed
annually to serve one year.
3. Membership and Outreach Committee. The term of service will
be three years. Two Voting Members and two Contributors will
be appointed in each of two years and one Voting Member and
one Contributor will be appointed in the third year.
B. Duties
1. Conference Management Committee. This committee recommends
to the Board of Directors the places and dates of each
Annual and Interim Meeting of NELAC; and advises and assists
the Executive Secretary with the logistic details of the
Interim and Annual meetings and with preparing publications
for the Annual and Interim Meetings.
2. Nominating Committee. This committee presents a slate of
nominees for all elective offices at the Annual Meeting.
The names and qualifications of these nominees shall appear
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in the report of the Nominating Committee and be published
in the Annual Meeting announcement.
3. Membership and Outreach Committee. This committee:
a. initiates Voting Member invitations for membership in the
House of Representatives and maintains an active roster,
publicizes NELAC to prospective participants, coordinates
and resolves participants' concerns and establishes
criteria for and reviews the credentials of Voting
Members.
b. solicits and develops informational materials to promote
understanding and appreciation of the importance of
consistent standards for environmental sampling and
analysis in fostering quality data on which to base
responsible public and environmental health decisions.
c. promotes a spirit of cooperation and timely dialogue
among NELAC, other organizations, the private sector and
federal agencies.
SECTION 3 - STANDING COMMITTEES
A. Terms
Standing Committee participants serve staggered five year terms,
one Voting Member and one Contributor being appointed annually.
B. Duties
1. Program Policy and Structure Committee. This committee
generates the Constitution and Bylaws of NELAC, and
interprets the intent and meaning of the Constitution and
Bylaws, presents amendments, proposes changes in
organizational structure, and defines roles and
responsibilities as appropriate, for approval of the
participants. This committee develops modifications to the
scope, structure, and requirements to the tiers and fields
of testing.
2. The Accrediting Authority Committee. This committee
develops the standards for use by EPA to oversee compliance
by State and federal accrediting authorities with NELAC
standards. This committee considers matters concerning
reciprocity of accreditation.
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3. Quality Systems Committee. This committee develops and
keeps current uniform standards for quality systems in
testing operations. The elements of the quality system
include organizational structure, responsibilities,
procedures, processes and resources (e.g., facilities,
staff, equipment) for implementing quality management in
testing operations.
4. Proficiency Testing Committee. This committee develops
standards for the proficiency testing samples, develops
criteria for selection of the providers of the samples, and
develops and updates protocols for the use of proficiency
test samples and data in the accreditation of laboratories.
5. On-Site Assessment Committee. This committee generates
procedures for the on-site assessments, and publishes
standard check lists based on these procedures. This
committee also establishes the frequency of inspection, and
the minimum education, experience, and training requirements
of the assessors.
6. Accreditation Process Committee. This committee generates
and develops procedures for the administrative aspects of
the accreditation process of environmental laboratories, for
use by the accrediting authorities, including the
requirements for accreditation, procedures for changes in
accreditation status, roles and responsibilities of
laboratories, and appeal processes.
7. Implementation Committee. This committee provides the
Standing Committees with current information on regulations
and laws that impact laboratory testing and accreditation.
The Implementation Committee is also responsible for the
development of model State legislation and regulations that
reflect the findings and actions of NELAC.
SECTION 4 - SPECIAL COMMITTEES, TASK FORCES AND STUDY GROUPS
Special committees, task forces, and study groups may be
established by the NELAC Chair as the need arises or as requested
by NELAC. Participants will be appointed for as long as deemed
appropriate. Upon completion of their assigned tasks, such
bodies shall be dissolved by the Chair of NELAC.
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SECTION 5 - SUBCOMMITTEES
Upon request of any committee, the NELAC Chair may appoint a
subcommittee(s) to assist that committee in fulfilling its
responsibilities. The NELAC Chair may appoint Voting Members or
Contributors in any combination, as the need arises or NELAC
requests. The Chair and participants of the subcommittees are
required to operate under the same rules and procedures as the
parent committee.
ARTICLE VII - VOTING SYSTEM
All questions before a meeting of NELAC that are to be decided
by a formal recorded vote of the Voting 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, Territory, Possession of the United States, and
the District of Columbia, is authorized one official to
serve as its representative in the House of Representatives
at the NELAC Annual Meeting. The representative shall be
named by the respective Governor or the Mayor for the
District of Columbia, and shall remain as the named
representative of that State, Territory, Possession of the
United States, or the District of Columbia, until such time
as the Governor or Mayor appoints someone else, or the
individual is no longer an employee of the State.
2. Each of eight EPA Assistant/Associate Administrators (Office
of Air and Radiation; Office of Enforcement and Compliance
Assurance; Office of Policy, Planning and Evaluation; Office
of Prevention, Pesticides, and Toxic Substances; Office of
Regional Operations and State/Local Relations; Office of
Research and Development; Office of Solid Waste and
Emergency Response; and Office of Water) and each of the ten
Regional Administrators, or his or her designee, may appoint
one Voting Member.
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3. Each cabinet level federal department (Department of
Agriculture, Department of Commerce, Department of Defense,
Department of Energy, Department of Interior, and Department
of Health and Human Services) with environmental laboratory
accreditation, certification or evaluation activities may
appoint one official to the House of Representatives as
determined by the Department Secretary.
4. The Nuclear Regulatory Commission may appoint one
representative to the House of Representatives.
5. At the discretion of the respective Governor or Mayor, EPA
Assistant/Associate Administrator, cabinet level federal
department, or the Nuclear Regulatory Commission, an
alternate to the House of Representatives may be named to
serve when the principal is unable to attend a national
meeting of NELAC. In the absence of the principal, the
alternate will be provided all of the rights and privileges
of the principal in the House of Representatives, provided
that he or she has met all other requirements for Voting
Membership. If the respective Governor or Mayor, EPA
Assistant/Associate Administrator, cabinet level federal
department, or the Nuclear Regulatory Commission has not
appointed a representative to the House of Representatives
then the Voting Members of that State, office, department
or commission in the House of Delegates shall elect one of
its Voting Members to vote in the House of Representatives.
C. Method of Designation
Prior to the NELAC Annual Meeting, the Executive Secretary shall
certify to the Board of Directors the names of the Voting Members
and their alternates in the House of Representatives.
SECTION 2 - HOUSE OF DELEGATES
A. Designation
All other environmental officials of the States, Territories,
Possessions of the United States, the District of Columbia and
the federal government (those not sitting in the House of
Representatives) are grouped as a body known as the "House of
Delegates".
B. Requirements
No other special requirements apply. The number of potential
Voting Members is not limited.
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SECTION 3 - VOTING RULES
A. Applicability
These rules apply only to the Annual Meetings of NELAC. However,
only Voting Members are permitted to vote in committee or other
meetings.
B. Quorum
A quorum of the House of Representatives is required for official
voting. This quorum consists of representatives from fifty
percent of the States, Territories and Possessions of the United
States, and the District of Columbia, and fifty percent of
federal representatives.
No quorum is required for a vote in the House of Delegates.
C. Voting
At the conclusion of debate on a motion, there shall be a call
for the vote, and the vote on the motion will be taken in
accordance with the following method.
1. Minimum Votes
a. House of Representatives. A majority of the eligible
and present participating representatives must cast their
votes in favor of an issue for the motion to be passed.
b. House of Delegates. A majority of those eligible and
present delegates must cast their votes in favor of an
issue for the motion to be passed.
Note that any vote on amendments to the Constitution must be
approved by a minimum of a two-thirds vote of the Voting
Members in attendance at the voting session of the Annual
Meeting in both the House of Representatives and the House of
Delegates.
2. Motion Accepted
The motion is accepted if it passes in both Houses.
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3. Disposition of Failed Motions
a. If the original motion fails, or if an amended motion
fails, the original or amended motion is returned to the
proposing committee for further consideration.
b. The Chair may consider a new motion on the same subject
prior to returning the issue to committee, if the
conditions regarding floor amendments (Article VII,
Section 4 of the Bylaws)have been met.
c. The proposing committee may drop the motion or reconsider
it for submission the following year.
4. 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.
5. Method of Indicating Vote
a. Voting is by show of hands, standing vote or machine
(electronic). There shall be no voice voting.
b. Voting by both Houses is simultaneous.
6. Recording
a. The Executive Secretary is responsible for the
establishment of a means for recording the vote of NELAC
on any matter, as well as providing a means for the
certification of eligible voters at any time a vote is
called.
b. House of Representatives. The votes of the
Representatives are recorded and published on a state-by-
state or agency-by-agency basis.
c. House of Delegates. The vote of the Delegates are
recorded as the total number of votes , and are not
tabulated on a state-by-state or agency-by-agency basis.
D. Committee Report Voting
The specific recommendations from each committee report shall be
subject to the approval of the Voting Membership at the Annual
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Meeting as expressed by a vote on each individual recommendation.
Alternatives that may be used in voting on the reports are to
vote on the entire report, to vote on grouped items or sections
or to vote on individual items. A Voting Member with the support
of 10 other Voting Members may request that the vote be on
individual items.
SECTION 4 - FLOOR AMENDMENTS
A. Procedure
1. A Voting Member can offer an amendment from the floor to the
motion under consideration.
2. A two-thirds majority favorable vote of each House on the
amendment is required for passage.
B. Editorial Changes
Following completion of voting on a Committee's report, the
Committee Chair may make a motion to extend editorial privileges
to the Executive Secretary to make editorial changes in the final
report.
SECTION 5 - SEATING
A. Arrangement
The seating arrangement for voting sessions is shown in Figure
1.
B. Supervision
The Board of Directors will control placement and movement of
delegates. The Executive Secretary will count votes.
SECTION 6 - PROCEDURES
The NELAC officers and committees are to observe the principles
of due process; specifically, to give reasonable advance notice
of contemplated committee studies, items to be considered for
committee action, and tentative or definite recommendations for
NELAC action, and to provide that all interested parties have an
opportunity to be heard by committees and by NELAC.
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SECTION 7 - CHANGES IN ORGANIZATION AND PROCEDURE
Proposals for changes in organization or procedure of NELAC are
not acted upon until the Annual Meeting of NELAC following the
Annual Meeting at which such proposals are made.
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-, OF,
PIRBCTQRS
HOtfSE OF
IUBSSESEHIATIVES
State
Federal
Designated
HOUSE OF
Federal -"
Officials *
Figure 1. Seating Arrangement
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Program Policy and Structure
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TABLE OF CONTENTS
Program Policy and Structure
1.0 PROGRAM POLICY AND STRUCTURE 1
1.1 INTRODUCTION 1
1.1.1 Overview of NELAC 1
1.1.2 History 1
1.1.3 Summary of the NELAC standards 2
1.1.4 General application of NELAC standards ... 3
1.1.5 Application of NELAC standards to small
laboratory operations 3
1.2 OBJECTIVES 3
1.3 ELEMENTS 4
1.4 PURPOSE AND SCOPE OF NELAC 5
1.4.1 Purpose 5
1.4.2 Scope 5
1.5 NELAC PARTICIPANTS 6
1.6 ROLES AND RESPONSIBILITIES OF THE FEDERAL
GOVERNMENT, THE STATES, AND OTHER PARTIES ... 6
1.6.1 EPA 6
1.6.1.1 National Environmental Laboratory
Accreditation Program 6
1.6.2 States and Federal Agencies as Accrediting
Authorities 7
1.6.2.1 Federal agencies 7
1.6.2.2 States 7
1.6.2.3 Accrediting authorities 8
1.6.2.3.1 Responsibilities of primary accrediting
authorities 8
1.6.2.3.2 Responsibilities of secondary
accrediting authorities 9
1.6.2.3.3 Accreditation fees 9
1.6.3 Reciprocity 9
1.6.4 Joint Federal and State Roles 10
1.6.5 Assessor Bodies 10
1.6.6 Other Parties 10
1.7 STRUCTURE OF NELAC 11
1.7.1 The Board of Directors 11
1.7.2 The Environmental Laboratory Advisory Board
12
1.7.3 The Accrediting Authority Review Board . . 12
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1.7.4 The Participants 12
1.7.4.1 Participation of the Voting Members and
Contributors 13
1.7.5 The Committees 14
1.7.5.1 The Standing Committees 14
1.7.5.1.1 Program Policy and Structure Committee
14
1.7.5.1.2 Accrediting Authority Committee ... 15
1.7.5.1.3 Quality Systems Committee 15
1.7.5.1.4 Proficiency Testing Committee .... 15
1.7.5.1.5 On-Site Assessment Committee .... 15
1.7.5.1.6 Accreditation Process Committee ... 15
1.7.5.1.7 Implementation Committee 16
1.7.5.2 The Administrative Committees 16
1.7.5.2.1 Conference Management Committee ... 16
1.7.5.2.2 Nominating Committee 16
1.7.5.2.3 Membership and Outreach Committee . .16
1.8 CONDUCT OF CONFERENCE BUSINESS 17
1.8.1 The Generation of Standards 17
1.8.2 Meetings 17
1.8.2.1 Annual Meeting 17
1.8.2.2 Interim Meeting 19
1.8.2.3 Special Meetings 19
1.8.2.4 Committee Meetings 19
1.9 ORGANIZATION OF THE ACCREDITATION REQUIREMENTS
19
1.9.1 Scope of Accreditation 19
1.9.2 Supplemental Accreditation Requirements . . 21
1.9.3 General Laboratory Requirements 21
1.9.4 General Field Sampling Requirements .... 22
1.9.5 Chemistry Requirements 22
1.9.6 Whole Effluent Toxicity Requirements .... 22
1.9.7 Microbiology Requirements 22
1.9.8 Radiochemistry Requirements 23
1.9.9 Microscopy Requirements 23
1.9.10 Field Measurement Requirements .23
Figure 1-1. NELAC Structure 24
Figure 1-2. Flowchart for Standards Development and
Implementation 25
Figure 1-3. NELAC Tiered Scope of Accreditation ... 26
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1.0 PROGRAM POLICY AND STRUCTURE
Chapter One provides an overview of the history, purpose and
objectives of the National Environmental Laboratory
Accreditation Conference (NELAC). The organizational
structure and function of NELAC, and the roles of the
various participants, form the major portion of this
chapter. In addition, the Constitution and Bylaws, and the
content of the five chapters which follow are briefly
described. Together, these six chapters and related
appendices constitute the NELAC standards.
1.1 INTRODUCTION
1.1.1 Overview of NELAC
This association shall be known as the "National
Environmental Laboratory Accreditation Conference" (NELAC)
and is sponsored by the United States Environmental Protec-
tion Agency (EPA) as a voluntary association of state and
federal officials. The purpose of the organization is to
foster the generation of environmental laboratory data of
known quality in a cost-effective manner through the
development of nationally accepted standards for
environmental laboratory accreditation. NELAC encompasses
all fields of testing associated with compliance with EPA
regulations. The program will be administered by state and
federal accrediting authorities in a uniform, consistent
fashion nationwide.
1.1.2 History
NELAC is the result of a joint effort by EPA, other federal
agencies, the states, and the private sector that began in
1990 when EPA's Environmental Monitoring Management Council
(EMMC) established an internal work group to consider the
feasibility and advisability of a national environmental
laboratory accreditation program. The work group concluded
that EPA should consult with representatives of all
stakeholders, by establishing a federal advisory committee.
As a result, the Committee on National Accreditation of
Environmental Laboratories (CNAEL) was chartered in 1991
under the Federal Advisory Committee Act. In its final
report to EMMC, CNAEL recommended that a national program
for environmental laboratory accreditation be established.
In response to the CNAEL recommendations, EPA and state
representatives formed the State/EPA Focus Group that
developed a proposed framework for NELAC, modeled after the
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National Conference on Weights and Measures. The Focus
Group prepared a draft Constitution, Bylaws and standards,
which were published in the Federal Register in December
1994. NELAC was established on February 16, 1995 by state
and federal officials with the adoption of an interim
Constitution and Bylaws.
NELAC was established as a standards-setting body, only, to
support a National Environmental Laboratory Accreditation
Program (NELAP). The goal of NELAP is to foster cooperation
with the current accreditation activities of different
states or other governmental agencies, through the adoption
of NELAC standards, thereby reducing the number of on-site
inspections, proficiency tests and related requirements with
which the accredited laboratories must comply. It is
intended that NELAP function in a manner which will not
compromise existing standards of the states and federal
agencies and will require minimum outlay of state and
federal funds to implement.
1.1.3 Summary of the NELAC standards
The NELAC uniform standards are contained in this chapter
and the following five chapters and related appendices.
Chapter 2 contains the criteria for the proficiency testing
(PT) program. Laboratory participation in PT programs
fulfills one part of the quality assessment requirements of
NELAC. The PT programs in which a laboratory must
participate to become accredited are defined as well as the
criteria for samples, PT providers, and acceptance limits.
Chapter 3 describes the essential elements that are to be
included in an on-site assessment and the requirements for
an accrediting authority conducting on-site assessments.
The qualifications and requirements for assessors are
described as well as the program elements to ensure uniform
and consistent implementation of the NELAC standards.
Chapter 4 describes the accreditation process the laboratory
must follow to be recognized as a NELAC laboratory. The
chapter defines the period of accreditation, and the process
for maintaining, awarding and revoking accreditation.
Chapter 5 and the related appendices contain the elements of
the laboratory quality system. The section provides detail
concerning quality assurance/quality control requirements so
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that all accrediting authorities will evaluate laboratories
consistently and uniformly.
Chapter 6 defines the process and operating requirements
established by NELAC for an accrediting authority to become
nationally recognized. It provides the policies and
criteria that an accrediting authority must meet to apply
for and maintain recognition.
1.1.4 General application of NELAC standards
These standards are for use by accrediting authorities and
others concerned with the competence of environmental
laboratories. Note that any reference to NELAP approval or
NELAP accreditation means that the accrediting authority or
laboratory meets the requirements in the NELAC standards/
and is not endorsement by EPA.
1.1.5 Application of NELAC standards to small laboratory
operations
All laboratory operations subject to NELAC standards are
expected to generate data of known quality and maintain the
quality systems required to generate quality data. However,
NELAP recognizes that some laboratory operations have some
unique characteristics that differentiate them from other
operations. The NELAC standards have addressed these issues
by allowing some flexibility in meeting the requirements for
personnel (Section 5.4.2, Section 5.6) and their credentials
(Section 4.1.1).
1.2 OBJECTIVES
The objectives of NELAC, as specified in Article II of the
Constitution, are: to provide a national forum for the
discussion of all questions related to standards for
environmental laboratory accreditation; to provide a
mechanism to establish policy and coordinate activities
within NELAC; to develop a consensus on uniform standards
for laboratory accreditation, and encourage and promote
uniform standards of quality for assessment and
accreditation; and to foster cooperation among environmental
laboratory accrediting authorities and regulatory officials.
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1.3 ELEMENTS
Functional elements of the objectives are:
a) To develop and improve the standards for qualifying as
an accredited laboratory, for qualifying as an
accrediting authority, and for uniformly implementing
the national accreditation program. The standards
address the accreditation process; on-site laboratory
assessments to review the quality systems; assessor
training; proficiency testing; and oversight of
accrediting authorities for uniform interpretation of
the standards.
b) To designate the States, Territories and Possessions of
the United States (hereinafter referred to as States)
and federal agencies as the accrediting authorities.
These authorities may be the assessor bodies, or may
use third parties as assessor bodies to carry out in
part or in whole the assessment functions. As
accrediting authorities, the States and the federal
agencies shall grant accreditation and ensure
compliance with NELAC laboratory standards and
criteria.
c) To provide for reciprocity among the States and the
federal agencies by assuring the consistent application
of the national standards. Oversight by NELAP assures
uniformity among the various accrediting authorities.
The Accrediting Authority Review Board (AARB) provides
a balanced review of the program.
d) To develop model language for legislation and
regulations which can be adopted by the State
legislatures and accrediting authorities.
e) To incorporate, to the extent applicable, ISO 25, ISO
43, and ISO 58. NOTE: A review by the Environmental
Laboratory Advisory Board (ELAB), a federal advisory
committee, is currently underway on whether to include
within NELAC, laboratories complying with Good
Laboratory Practices (GLP). GLPs are mandated by EPA
under the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA) and the Toxic Substances
Control Act (TSCA) . If GLP laboratories are included
in NELAC, the EPA GLP programs and the Organization for
Economic and Cooperative Development (OECD) GLP
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Principle Technical Standards will be incorporated, to
the extent applicable.
1.4 PURPOSE AND SCOPE OF NELAC
1.4.1 Purpose
NELAC shall be a standards-setting body. NELAC shall/
through the process described in the Constitution and
Bylaws, develop, adopt and publish uniform consensus
performance standards on which the national accreditation
program shall be based. These standards will be adopted by
NELAC at its annual meeting. These uniform standards shall
include, but are not limited to, quality systems,
proficiency testing, 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 assessor body,
oversee or approve assessor bodies, or administer any of the
main elements of the accreditation program, other than the
development and adoption of standards.
1.4.2 Scope
The scope of NELAC shall encompass the necessary scientific
testing to serve the needs of the States, United States
Environmental Protection Agency (EPA), and other federal
agencies involved in the generation and use of environmental
data, where such generation or use is mandated by EPA
statutes and pursuant regulations. Laboratories are
encouraged to use the NELAC standards for all other tests.
Applicable EPA statutes include the Clean Air Act (CAA); the
Comprehensive Environmental Response Compensation and
Liability Act (CERCLA); the Federal Insecticide, Fungicide
and Rodenticide Act (FIFRA); the Federal Water Pollution
Control Act (Clean Water Act; CWA); the Resource
Conservation and Recovery Act (RCRA); the Safe Drinking
Water Act (SDWA); and the Toxic Substances Control Act
(TSCA) . The standards shall also include provisions to
permit special requirements or fields of testing promulgated
by any of the accrediting authorities.
The standards 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
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the investigation, subject only to the bounds of sound
scientific practice. The standards shall not apply to
governmental laboratories engaged solely in the analysis of
forensic evidence.
1.5 NELAC PARTICIPANTS
The participants of NELAC shall be from the States and
federal agencies, the organizations subject to accreditation
under the standards of NELAC and other interested groups
(see Section 1.7.4).
1.6 ROLES AND RESPONSIBILITIES OF THE FEDERAL GOVERNMENT,
THE STATES, AND OTHER PARTIES
1.6.1 EPA
EPA shall provide staff support to NELAC as provided for in
the Bylaws and agreed to by EPA. EPA shall assist NELAC by
providing all proposed and final standards and publishing
final standards on the NELAC electronic bulletin board.
EPA also participates in joint activities with other federal
and State agencies, as described below.
1.6.1.1 National Environmental Laboratory Accreditation
Program
EPA shall establish and administer the National
Environmental Laboratory Accreditation Program (NELAP), and
shall staff an office to oversee the implementation of NELAC
standards. The purpose of this oversight is to ensure a
high degree of standardization and coordination among the
different accrediting authorities.
NELAP performs the following functions in support of NELAC:
a) evaluating and approving the implementation of NELAC
standards by accrediting authorities;
b) establishing and maintaining a national database on
environmental laboratories which contains information
on the status of accrediting authorities, current
status of NELAC accredited laboratories, and status of
providers of proficiency test samples;
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c) where conflict of interest may occur in an accrediting
authority, accrediting that authority's principal
laboratories;
d) accrediting EPA laboratories;
e) reporting to NELAC on the evaluation of the conformance
of State and federal accreditation program activities
to NELAC standards;
f) reporting to NELAC on results of evaluations of
proficiency testing sample providers and assessor
training programs; and
g) approving supplemental accreditation requirements
proposed by accrediting authorities (see Section
1.9.2).
1.6.2 States and Federal Agencies as Accrediting
Authorities
In order to be considered a NELAP approved accrediting
authority, the individual State or federal program must
adopt the NELAC standards, utilize assessors trained
according to the requirements of NELAC, and be evaluated by
the EPA oversight office as being an agency whose
accreditation and assessment program meet all of the
requirements of NELAC. Failure in any one of these areas
would preclude a State or federal program from being
recognized by NELAP.
1.6.2.1 Federal agencies
To operate as accrediting authorities, or to obtain NELAC
accreditation for their environmental monitoring
laboratories, federal agencies shall conform to the NELAC
standards.
1.6.2.2 States
The authority of the States to adopt the NELAC standards is
manifest in the authority granted to their administrative
agencies by State legislatures. State governments shall be
the principal accrediting authorities.
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1.6.2.3 Accrediting authorities
An accrediting authority can be either a) any federal agency
with responsibility for operating mandated environmental
monitoring programs which require laboratory testing, or b)
any State which requires laboratory testing in conformance
with at least one of the EPA programs listed within the
scope of NELAC (see Section 1.4.2). If a State chooses not
to participate in the NELAC program, laboratories in that
State may obtain accreditation from any other accrediting
authority.
A primary accrediting authority is one which ensures
directly that the laboratory is in conformance with the
NELAC standards. A secondary accrediting authority is one
which, through reciprocity, recognizes the accreditation of
a primary accrediting authority.
1.6.2.3.1 Responsibilities of primary accrediting
authorities
Once a State or federal agency has been approved by NELAP as
being an entity whose accreditation and assessment program
meets all of the requirements of NELAC, it will be a primary
accrediting authority, and it will have full responsibility
for:
a) using the NELAC standards as the basis for assessing
the qualifications of laboratories applying for initial
or continuing NELAC accreditation;
b) ensuring conformance by the laboratories it accredits
with the national standards established by NELAC;
c) accrediting applicant laboratory organizations through
the review and approval of applications, performance of
on-site assessments, evaluation of results on
proficiency testing samples, and enforcement of all
applicable laws and rules relating to accreditation;
and
d) submitting the names and appropriate accreditation
material to EPA for inclusion in the national
laboratory database.
Federal laboratories within a State may be accredited by the
State accrediting authority or by a federal accrediting
authority. A State accrediting authority is the primary
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accrediting authority for all non-federal NELAP accredited
laboratories in that State. However, if the State
accrediting authority does not grant NELAP accreditation for
testing in conformance with a particular field of testing
(see section 1.9), laboratories may obtain primary
accreditation for that particular field of testing from any
other accrediting authority.
In addition, a primary accrediting authority may delegate
assessment activities to a third party body (assessor body).
If any of these assessment activities are delegated to a
third party, the accrediting authority maintains
responsibility for ensuring compliance with the standards
established by NELAC.
1.6.2.3.2 Responsibilities of secondary accrediting
authorities
A secondary accrediting authority must be approved by NELAP
as being an entity whose accreditation and assessment
.program meets all of the requirements of NELAC for a
secondary accrediting authority.
A secondary accrediting authority may require laboratories
to submit an application, may issue certificates of
accreditation, and will exercise its legal authority for
enforcement of all applicable laws and rules. However, it
must recognize the laboratory accreditations through
reciprocity, and must not replicate any of the assessment
functions, of a primary accrediting authority.
1.6.2.3.3 Accreditation fees
Accrediting authorities may adopt and impose laboratory
accreditation fees.
1.6.3 Reciproci ty
Reciprocity means that an accrediting authority will
recognize and accept the accreditation status of a
laboratory issued by another NELAP accrediting authority.
This principle of reciprocity is an element of the national
accreditation standard to which all accrediting authorities
are held. In recognizing the accreditation status of a
laboratory through reciprocity, the accrediting authority
assumes the responsibilities of a secondary accrediting
authority as stated in Section 1.6.2.3.2. However, a
decision arising from a legal action within the jurisdiction
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of a secondary accrediting authority may prevent recognition
and acceptance of the primary accreditation.
Reciprocity among the environmental laboratory accreditation
authorities is necessary to the success of a national
program. The essential ingredient of reciprocity is
uniformity from one accrediting authority to another. The
mechanisms to assure this uniformity (e.g., uniform national
performance standards, thorough and consistent inspections,
and comparable decisions on accreditation status when
deficiencies are uncovered) are necessary to ensure that
reciprocity is equitable.
1.6.4 Joint Federal and State Roles
NELAC shall be the joint responsibility of EPA, the States,
and the other federal agencies. As provided in the
following section on the structure of NELAC and in the NELAC
Bylaws, EPA, the States, and the other federal agencies
share responsibilities of governance, analysis and
establishment of policy and NELAC technical standards.
1.6.5 Assessor Bodies
An assessor body, operating under written agreement with an
accrediting authority, may perform specified functions of
the assessment process. These functions may include: the
review of the laboratories' documentation regarding
facilities, personnel, use of approved methods, and quality
assurance procedures; and conduct of on-site assessments,
including review of performance in the analysis of
proficiency test samples. The assessor body reports
directly to the accrediting authority under which it is
operating. The assessor body will provide full
documentation to the accrediting authority. Only the
accrediting authority may determine if a laboratory has met
the NELAC standards, may issue certificates of
accreditation, may make any decisions on the granting and
withdrawal of a laboratory's accreditation status, and may
take responsibility for the accreditation process.
1.6.6 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, private
industry, third party assessors, ,and the general public, may
participate in NELAC. In this role, these other parties may
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bring technical and policy issues to the attention of NELAC,
its Board of Directors, or its committees and subcommittees.
It is anticipated that these issues shall be brought to
NELAC in the form of reports, presentations, discussion
material, or other forms of documentation for presentation
at the NELAC annual, interim , or committee/subcommittee
meetings.
1.7 STRUCTURE OF NELAC
The structure of NELAC is shown in Figure 1-1. NELAC is
composed of a Board of Directors, a House of
Representatives, a House of Delegates, Contributors, and a
number of committees. There are nine elected officials of
NELAC: the Chair; the Chair-Elect; the immediate Past
Chair; and six members at large. The Standing Committees
and Administrative Committees are appointed by the Chair.
The activities of the Standing and Administrative Committees
are overseen by the Board of Directors.
NELAC will meet twice a year: an annual meeting at which
final action is taken on all issues, and an interim meeting
about six months prior to the annual meeting at which time
committees meet to receive, consider and deliberate on
issues, propose and draft standards or policies for adoption
at the annual meeting.
NELAC shall also consider advice and comment provided by the
Environmental Laboratory Advisory Board (ELAB) chartered
under the Federal Advisory Committee Act and the Accrediting
Authority Review Board (AARB).
1.7.1 The Board of Directors
The Board of Directors consists of the NELAC Chair, the
Chair-Elect, immediate Past Chair, six members elected at
large from the active membership (to serve 3-year staggered
terms), a NELAC Director, and an Executive Secretary. The
NELAP Director is the ex officio Director of NELAC. The
Executive Secretary is an EPA employee.
The Board of Directors serves as a policy and coordinating
body in matters of national and international significance
and makes interim policy decisions when necessary between
annual meetings. The Board of Directors has the overall
responsibility and authority for the supervisory,
administrative and procedural duties associated with NELAC.
The Board of Directors will charge the committees with
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issues they must address and may suggest other issues for
committee consideration. Comments on the standards should
be directed to the committees through the chairs.
1.7.2 The Environmental Laboratory Advisory Board
The Environmental Laboratory Advisory Board (ELAB),
chartered under the Federal Advisory Committee Act, consists
of members appointed by EPA and composed of a balance of
non-State, non-federal representatives, from the
environmental laboratory community, and co-chaired by an
ELAB member and an EPA representative. The ELAB advises EPA
and NELAC on matters affecting the interests of the
regulated laboratories and other interested parties. The
recommendations of the ELAB shall be presented to the Chairs
of the standing committees, the Board of Directors and to
EPA.
1.7.3 The Accrediting Authority Review Board
The Accrediting Authority Review Board (AARB) is composed of
five representatives from EPA, other federal agencies, and
the States. The AARB shall include one member from EPA and
at least two members from the States. The AARB annually
selects one of its members to serve as its chair. All
members are appointed by the NELAC Director following
consultation with the Board of Directors. Each member shall
serve five years with one member appointed annually. The
AARB has the responsibility to monitor EPA to assure that
EPA is following the NELAC standards for approving the
accrediting authorities, and to serve as an appeal board for
accrediting authorities that have been denied NELAP
recognition or have had such recognition revoked (see
Chapter 6). In all cases, the final decision remains with
the NELAP Director. The AARB will report on its activities
to the Board of Directors at each annual meeting.
1.7.4 The Participants
The participants consist of two groups, i.e., Voting Members
and Contributors.
Membership is limited to officials who are in the employ of
the Government of the United States and the States, and who
are actively engaged in environmental programs or
accreditation of environmental laboratories. State and
federal participants being compensated by the private sector
to inspect environmental laboratories or as consultants are
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considered to have a conflict of interest and are ineligible
for Voting Membership but may participate as Contributors.
The Voting Member may vote and is eligible to serve on all
committees and the Board of Directors. At the annual
meeting 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 representative from each State, one
representative from each of eight EPA Assistant/Associate
Administrators, and one representative from each EPA Region.
Each other cabinet level federal department or independent
agency (as defined in the Constitution) with environmental
laboratory accreditation, certification or evaluation
activities may appoint one official to the House of
Representatives.
The House of Delegates is composed of all other State and
federal environmental officials. The size of the House of
Delegates is not limited.
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 Voting Members. The
Contributors may not vote, but can make presentations,
comments or input at all stages of the standards and
procedures making process, and do have the ability to enter
the substantive debate on the floor of the meeting as it
occurs. Contributors are eligible to serve as non-voting
participants on all committees.
1.7.4.1 Participation of the Voting Members and
Contributors
Contributors, as well as Voting Members, have the right to
appear before the standing committees as they consider
proposed standards and procedures related to the national
accreditation program and to debate the substantive issues
before NELAC as such discussion occurs during the meeting.
Appearance before the committees will be in accordance with
procedures approved by the Board of Directors and Voting
Membership.
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1.7.5 The Commi ttees
Two types of committee are associated with NELAC: Standing
Committees and Administrative Committees. Each committee
has five Voting Members including the chair and five
Contributors who may not vote. Except for the Nominating
Committee, the Voting Members of each committee annually
select a chair from one of its Voting Members. All
committees report to NELAC through the Board of Directors.
Following each annual meeting, the Board of Directors will
make available an updated roster of the Board of Directors,
NELAC officers and committee participants and chairs.
1.7.5.1 The Standing Committees
The participants of each committee serve for five years,
with one Voting Member and one Contributor being appointed
each year. There are seven Standing Committees:
• Program Policy and Structure Committee
• Accrediting Authority Committee
• Quality Systems Committee
• Proficiency Testing Committee
• On-site Assessment Committee
• Accreditation Process Committee
• Implementation Committee
The Standing Committees shall receive input regarding
standards and test procedures, then process this input into
resolutions which shall be put before the Voting Membership
at the annual meeting. These resolutions will be made
available not less than 30 days prior to the annual meeting.
All resolutions shall be presented to the Voting Membership
at the annual meeting for discussion and ballot. The
committees may also receive input via comments and
presentations at the interim and annual meetings. The
committees shall draft resolutions which shall be made
available not later than 30 days prior to either the interim
or annual meetings. The committees shall prepare and
arrange agenda items for interim meetings and annual
meetings to be made available 30 days prior to the meeting.
1.7.5.1.1 Program Policy and Structure Committee
This committee generates the Constitution and Bylaws of
NELAC, and interprets the intent and meaning of the
Constitution and Bylaws, presents amendments, proposes
changes in organizational structure, and defines roles and
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responsibilities as appropriate, for approval of the Voting
Membership. This committee develops modifications to the
scope, structure, and requirements to the tiers and fields
of testing.
1.7.5.1.2 Accrediting Authority Committee
This committee develops the standards for use by EPA to
oversee compliance by State and federal accrediting
authorities with NELAC standards. This committee considers
matters concerning implementation of reciprocity among
accrediting authorities.
1.7.5.1.3 Quality Systems Committee
This committee develops and keeps current uniform standards
for quality systems in testing operations. The elements of
the quality system include organizational structure,
responsibilities, procedures, processes and resources (e.g.,
facilities, staff, equipment) for implementing quality
management in testing operations.
1.7.5.1.4 Proficiency Testing Committee
This committee develops standards for the proficiency
testing samples, develops criteria for selection of the
providers of the samples, and develops and updates protocols
for the use of proficiency test samples and data in the
accreditation of laboratories.
1.7.5.1.5 On-Site Assessment Committee
This committee generates procedures for the on-site
assessments, and publishes standard check lists based on
these procedures. This committee also establishes the
frequency of inspection, and the minimum education,
experience, and training requirements of the assessors.
1.7.5.1.6 Accreditation Process Committee
This committee generates and develops procedures for the
administrative aspects of the accreditation process of
environmental laboratories, for use by the accrediting
authorities, including the requirements for accreditation,
procedures for changes in accreditation status, roles and
responsibilities of laboratories, and appeal processes.
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1.7.5.1.7 Implementation Committee
This committee provides the Standing Committees with current
information on regulations and laws that impact laboratory
testing and accreditation. The Implementation Committee is
also responsible for the development of model language for
state legislation and regulations that reflect the findings
and actions of NELAC.
1.7.5.2 The Administrative Committees
Administrative Committees have varying terms. The duties
are outlined below. The term of service shall be three
years; two Voting Members and two Contributors will be
appointed each of two years and one Voting Member and one
Contributor the third year, except for the Nominating
Committee (see below).
1.7.5.2.1 Conference Management Commi ttee
This committee recommends to the Board of Directors the
places and dates of each annual and interim meeting of
NELAC/ and advises and assists the Executive Secretary with
the logistic details of the interim and annual meetings and
with preparing publications for the Annual and interim
meetings.
1.7.5.2.2 Nominating Committee
The chair is the NELAC Past Chair. Four Voting Members and
five Contributors shall be appointed annually to serve one
year. This committee presents 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 meeting announcement.
1.7.5.2.3 Membership and Outreach Committee
This committee initiates membership invitations and
maintains an active roster, publicizes NELAC to prospective
participants, coordinates and resolves participants'
concerns, and establishes criteria and verifies the
credentials of Voting Members.
This committee solicits and develops informational materials
to promote understanding and appreciation of the importance
of consistent standards for environmental sampling and
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analysis in fostering quality data on which to base
responsible public and environmental health decisions.
This committee promotes a spirit of cooperation and timely
dialogue between NELAC and other organizations and federal
agencies.
1.8 CONDUCT OF CONFERENCE BUSINESS
1.8.1 The Generation of Standards
The process for the generation and adoption of standards by
a State accrediting authority is shown in Figure 1-2. The
standards for the accreditation of laboratories begin with
recommendations made within or to the committees. Committees
shall propose standards in the form of resolutions on which
the Voting Membership shall vote. Standards proposed by the
committees are publicized on the NELAC electronic bulletin
board by EPA not later than 30 days prior to the date of the
meeting at which they will be considered.
Proposed amendments from the floor to specific standards and
proposals offered by the committee for adoption by NELAC
shall be allowed in the manner described in the Constitution
and Bylaws. Amendments to the report describing committee
activities over the year will not be allowed without the
concurrence of the chairman of the subject committee and the
concurrence of the Chair of NELAC.
EPA shall publish the final standards.
1.8.2 Meetings
1.8.2.1 Annual Meeting
An annual meeting of NELAC shall be held to conduct business
including, but not limited to, election of officers,
consideration of issues for presentation to the membership
for voting, receiving reports from committees, task groups,
or other sources, and conducting other business of NELAC.
All final action on resolutions or proposals shall take
place at the annual meeting.
The Board of Directors shall determine the place and dates
for the annual meeting, after receiving recommendations from
the Conference Management Committee, and shall publish this
information on the NELAC electronic bulletin board at least
90 days prior to the annual meeting.
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A completed registration for the annual meeting shall serve
as the application for participation as Voting Member or
Contributor. The registration form must be completed by all
potential participants, whether or not attending the annual
meeting. Prior to the annual meeting, the Executive
Secretary shall certify the names of the Voting Members and
their alternates of the House of Representatives to the
Board of Directors. The Nominating Committee shall present,
to the Board of Directors, nominees for all elective offices
for the annual meeting. The names and qualifications of the
nominees shall be published in the annual meeting
announcement.
The following deadlines will apply in preparing and
submitting material for the annual meeting:
a) Sixty days prior to the date of the annual meeting,
each of the standing committees shall present to the
Board of Directors a summary of the issues and matters
considered by the committees over the course of the
year. This report shall discuss all matters which the
committee considered since its last report, including
how the committee disposed of the issues it considered.
The report shall also contain draft standards for
consideration by NELAC.
b) Committees shall prepare and arrange agenda items and
resolutions for the annual meeting. These, and other
resolutions received by the Board of Directors will be
made available not less than 30 days prior to the
meeting.
c) Standards proposed by the committees for consideration
at the annual meeting shall be publicized on the
electronic bulletin board not less than 30 days prior
to the annual meeting.
Within 90 days following the annual meeting, the Board of
Directors shall make available an updated roster of the
Board of Directors, NELAC officers, committee members and
chairs, and minutes and findings of the meeting to the
participants. EPA shall publish the final standards within
90 days following the annual meeting. Changes in
organization and/or procedures of NELAC proposed at the
annual meeting shall not be acted upon until the annual
meeting following the annual meeting at which proposed.
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1.8.2.2 Interim Meeting
The interim meeting, at which time committees meet to
receive, consider and debate on issues, and propose and
draft standards or policies for the annual meeting, shall be
scheduled approximately six months prior to the annual
meeting.
The Board of Directors shall determine the place and dates
for the interim meeting, after receiving recommendations
from the Conference Management Committee, and shall publish
this information on the NELAC electronic bulletin board at
least 90 days prior to the interim meeting.
Committees shall prepare and arrange agenda items for the
interim meeting. The agenda shall be approved by the Board
of Directors and will be made available not less than 30
days prior to the date of the meeting.
Conclusions and findings of the interim meeting shall be
provided to the participants not later than 90 days
following the interim meeting.
1.8.2.3 Special Meetings
The NELAC Chair is authorized to call a meeting of the Board
of Directors at any time deemed necessary by the Chair to be
in the best interests of NELAC. Announcements of the
meetings and meeting summaries or reports shall be made
available to the participants.
1.8.2.4 Committee Meetings
Committees of NELAC are authorized to hold meetings at times
other than the annual or interim meeting. Announcements of
the meetings and meeting summaries or reports shall be made
available to the participants.
1.9 ORGANIZATION OF THE ACCREDITATION REQUIREMENTS
1.9.1 Scope of Accreditation
Laboratories must meet all relevant EPA program
requirements, including quality assurance/quality control,
use of specified methods, and other criteria.
The accreditation requirements shall be based on the tiered
approach shown in Figure 1-3. Laboratories must meet the
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general requirements found in Chapter 5, and the specific
quality control requirements for the type of testing being
performed, as found in Appendix D of Chapter 5.
Accreditation will then be granted for compliance with the
relevant EPA program, the methods used by the laboratory,
and for individual analytes determined by a particular
method; e.g., a laboratory determining lead in drinking
water, in compliance with the Safe Drinking water Act, by
both inductively-coupled plasma mass spectrometry and
graphite furnace atomic absorption spectrometry would be
accredited for lead by both methods. Loss of accreditation
for an analyte would not automatically result in loss of
accreditation for all other analytes accredited under the
method, provided the laboratory remained proficient in the
determination of the other analytes.
The following example shows the tiered approach applied to a
laboratory seeking accreditation in hazardous waste organic
testing under the auspices of RCRA. The laboratory must
meet all the requirements listed in general laboratory
(NELAC Chapter 5), chemistry (NELAC Chapter 5, Appendix
D.I), the RCRA regulations (40CFR261), and the method(s)
used (e.g., SW846 5030/8240). In all cases, a NELAC
accredited laboratory must be accredited for the specific
method it uses. In some cases the regulations mandate the
method to be used (e.g., 40CFR261 specifies SW846 Method
1311, TCLP). In other cases the regulations provide
guidance for the methods which can be used (e.g., 40CFR264,
Appendix IX, suggests applicable methods). Finally, in some
situations the regulations provide no guidance as to the
methods to be used (e.g., 40CFR268 lists analytes required
to be measured, with no guidance on methods). In those
cases where the test method is not mandated by regulation,
the laboratory must be accredited for the specific method
used, as documented in the laboratory's SOP (see Chapter 5).
This method must meet the relevant start-up, calibration,
and on-going validation and QC requirements specified in
Chapter 5. The tiered approach allows for the incorporation
of performance based measurement systems (PBMS) by
substituting PBMS for the specified analytical methods when
allowed under EPA regulations.
The tiered approach eliminates redundancy by allowing for
the incorporation of new methods or new instrumentation
without the laboratories repeatedly demonstrating the basic
requirements. This structure defines the scope of
accreditation for inclusion on the laboratory accreditation
certificate. The on-site assessment, proficiency testing
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evaluation, and data assessments are the processes for
assessing the capabilities of the laboratories within the
tiered structure. These processes/ defined in Chapters 2
and 3, do not necessarily evaluate all tiers within the
tiered structure; e.g., proficiency testing examines the
determination of individual analytes in specific matrix
types, and is not method-specific. However, they are
comprehensive enough to assure the accrediting authority
that a system is in place that produces data of known and
documented quality.
An accrediting authority may approve a laboratory's
application to add an analyte or method to its scope of
accreditation by performing a data review without an on-site
assessment. An addition to the scope of accreditation via a
data review of proficiency testing performance (if
available), QC performance and written SOP is at the
discretion of the accrediting authority. An addition of a
new technology or test method requiring specific equipment
may require an on-site assessment.
1.9.2 Supplemental Accreditation Requirements
In addition, a category of supplemental accreditation
requirements is designated for additional methods or
analytes required by an accrediting authority. Supplemental
accreditation requirements shall be reserved for methods or
analytes that are not required under any of the EPA programs
that are part of NELAC, and shall not be used to modify any
NELAC standards for analytes or methods. Any supplemental
accreditation requirements essential to meet the specific
needs of an accrediting authority would be added at the
method-specific or analyte level, and must be approved by
NELAP and made available to all NELAC participants.
Exceptions to this requirement may be necessary (e.g.,
national security concerns) and will be processed as waivers
by the AARB.
1.9.3 General Laboratory Requirements
The general requirements are applicable to all laboratory
applicants regardless of their size, volume of business, or
field of testing. The organizational structure, or
procedures used by applicant laboratory organizations to
meet these general requirements may differ as a function of
size or scope of testing of an organization. Under the
tiered approach the general requirements shall include the
elements outlined in Chapter 5.
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The following applicable requirements are presented in
Chapter 5 (Quality Systems): Organization and Management
(5.4); Quality System - Establishment, Audits/ Essential
Quality Controls and Data verification (5.5); Personnel
(5.6); Physical Facilities - Accommodation and Environment
(5.7); Equipment and Reference Materials (5.8); Measurement
Traceability and Calibration (5.9); Test Methods and
Standard Operating procedures (5.10); Sample Handling,
Sample Acceptance Policy and Sample Receipt (5.11); Records
(5.12); Laboratory Report Format and Contents (5.13);
Subcontracting Analytical Samples (5.14); Outside Support
Services and Supplies (5.15); and Complaints (5.16).
1.9.4 General Field Sampling Requirements
(To be developed)
1.9.5 Chemistry Requirements
The following applicable requirements are presented in
Section D.I of Appendix D of Chapter 5 (Quality Systems):
Positive and Negative Controls (D.I.I); Analytical
Variability/Reproducibility (D.I.2); Method Evaluation
(D.I.3); Sensitivity (D.I.4); Data reduction (D.I.5);
Quality of Standards and Reagents (D.I.6); Selectivity
(D.I.7); and Constant and Consistent Test Conditions
(D.I.8).
1.9.6 Whole Effluent Toxicity Requirements
The following applicable requirements are presented in
Section D.2 of Appendix D of Chapter 5 (Quality Systems):
Positive and Negative Controls (D.2.1); Variability and/or
Reproducibility (D.2.2); Accuracy (D.2.3); Test Sensitivity
(D.2.4); Selection of Appropriate Statistical Analysis
Methods (D.2.5); Selection and Use of Reagents and Standards
(D.2.6); Selectivity (D.2.7); and Constant and Consistent
Test Conditions (D.2.8).
1.9.7 Microbiology Requirements
The following applicable requirements are presented in
Section D.3 of Appendix D of Chapter 5 (Quality Systems):
Positive and Negative Controls (D.3.1); Test
Variability/Reproducibility (D.3.2); Method Evaluation
(D.3.3); Test Performance (D.3.4); Data Reduction (D.3.5);
Quality of Standards, Reagents and Media (D.3.6);
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Selectivity (D.3.7); and Constant and Consistent test
Conditions (D.3.8).
1.9.8 Radiochamistry Requirements
The following applicable requirements are presented in
Section D.4 of Appendix D of Chapter 5 (Quality Systems);
Positive and Negative Controls (D.4.1); Laboratory
Variability/Reproducibility D.4.2); Method Evaluation
(D.4.3); Sensitivity (D.4.4); Data Reduction (D.4.5);
Quality of Standards and Reagents (D.4.6); Selectivity
(D.4.7); and Constant and Consistent Test Conditions
(D.4.8).
1.9.9 Microscopy Requirements
(To be developed)
1.9.10 Field Measurement Requirements
(To be developed)
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Proficiency Testing Program
July 31,1997
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TABLE OF CONTENTS
Proficiency Testing Program
2.0 PROFICIENCY TESTING PROGRAM: INTERIM STANDARDS . 1
2.1 INTRODUCTION, SCOPE, AND APPLICABILITY 1
2.1.1 Purpose 2
2.1.2 Goals 3
2.1.3 PT fields of testing 3
2.2 MAJOR PT GROUPS AND THEIR RESPONSIBILITIES .... 4
2.2.1 NELAC and NELAP 4
2.2.2 PT Study Providers 5
2.2.3 Proficiency Testing Oversight Body (PTOB) . 5
2.2.4 Laboratories 5
2.2.5 Accrediting Authorities (AA) 5
2.3 REQUIREMENTS FOR PT PROVIDERS 6
2.3.1 On-Site Inspection of PT Providers 6
2.3.2 Sample Requirements and Design 6
2.3.2.1 Sample Analytes 6
2.3.2.2 Provider Sample Testing 6
2.3.3 PT Study Data Analysis 7
2.3.3.1 Data Set Size Requirements . . 7
2.3.3.2 Data Acceptance Criteria 7
2.3.4 Generation of Study Reports 7
2.3.5 Provider Conflict of Interest 7
2.3.6 Disapproval of PT Study Providers 7
2.3.7 PTOB Listing of PT Providers 8
2.4 LABORATORY ENROLLMENT IN PROFICIENCY TESTING
PROGRAM(S) 8
2.4.1 Required Level of Participation 8
2.4.2 Requesting Accreditation 8
2.4.3 Reporting Results 8
2.5 REQUIREMENTS FOR LABORATORY TESTING OF PT STUDY
SAMPLES 9
2.5.1 Restrictions on Exchanging Information ... 9
2.5.2 Maintenance of Records 10
2.6 EVALUATION OF PROFICIENCY TESTING RESULTS ... 10
2.6.1 Scoring of Laboratory PT Sample Results . . 10
2.7 PT CRITERIA FOR LABORATORY ACCREDITATION .... 10
2.7.1 Result Categories 11
2.7.2 Initial and Continuing Accreditation ... 11
2.7.3 Supplemental Studies 11
2.7.4 Failed Studies and Corrective Action ... 12
2.7.5 Second Failed Study 12
APPENDIX A PT PROVIDER APPROVAL CRITERIA
A. 0.0 SCOPE A-l
A. 1.0 APPROVAL PROCESS A-l
A.2.0 QUALITY SYSTEM REQUIREMENTS A-l
A. 3.0 PROVIDER FACILITIES AND PERSONNEL A-2
A. 4.0 SAMPLE DESIGN REVIEW A-2
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A. 4.1 RELEASE OF INFORMATION A-2
A. 5.0 PROVIDER CONFLICT-OF-INTEREST REQUIREMENTS . A-2
A. 5.1 BAN ON DISTRIBUTION OF SAMPLES A-3
A. 6.0 CONFIDENTIALITY OF PT STUDY DATA A-3
A. 7.0 DATA REVIEW AND EVALUATION A-4
A. 8.0 COMPLAINTS & CORRECTIVE ACTION A-4
A. 9.0 LOSS OF PROVIDER APPROVAL A-4
A. 9.1 PERIODIC REVIEW OF PT PROVIDERS A-4
A. 9.2 REVOCATION OF APPROVAL A-5
APPENDIX B PT SAMPLE DESIGN & ACCEPTANCE GUIDELINES
B.0.0 INTRODUCTION B-l
B.1.0 VERIFICATION OF TARGET VALUE B-l
B.2.0 HOMOGENEITY VERIFICATION B-2
B.3.0 STABILITY TESTING B-2
B.4.0 SAMPLE DESIGN APPROVAL B-3
B.5.0 DATA REPORTING BY PT PROVIDERS B-3
APPENDIX C PROFICIENCY TESTING ACCEPTANCE CRITERIA AND
PROFICIENCY TESTING PASS/FAIL CRITERIA
C.0.0 PURPOSE, SCOPE, AND APPLICABILITY C-l
C.1.0 ANALYTE ACCEPTANCE LIMITS C-l
C.I.I ANALYTE ACCEPTANCE LIMITS CATEGORIES .... C-l
C.2.0 "ACCEPTABLE" PT RESULTS FOR CHEMICAL
ANALYTES IN POTABLE WATER, NON-POTABLE WATER
AND HAZARDOUS WASTE PT SAMPLES C-3
C.3.0 "NOT ACCEPTABLE" PT RESULTS FOR POTABLE
WATER, NON-POTABLE WATER AND HAZARDOUS
WASTE PT SAMPLES C-3
C.4.0 ADDITIONAL REQUIREMENTS FOR PT PROVIDERS . . C-4
C.5.0 NELAC PT STUDY PASS/FAIL CRITERIA C-4
C.5.1 INTERDEPENDENT ANALYTE PT SAMPLES C-4
C.5.2 NON-INTERDEPENDENT ANALYTE PT SAMPLES .... C-5
C.5.3 PROMULGATED EPA PASS/FAIL CRITERIA C-5
C.5.4 PASS/FAIL CRITERIA FOR INTERDEPENDENT ANALYTE
PT SAMPLES C-5
C.5.5 PASS/FAIL CRITERIA FOR NON-INTERDEPENDENT ANALYTE
PT SAMPLES C-5
APPENDIX D PROFICIENCY TESTING OVERSIGHT BODY
D.0.0 PURPOSE, SCOPE, AND APPLICABILITY D-l
D.1.0 TECHNICAL AND ADMINISTRATIVE QUALIFICATIONS . D-l
D.2.0 PTOB RESPONSIBILITIES REGARDING INITIAL
ASSESSMENT OF PT PROVIDERS D-l
D.2.1 DEVELOPMENT OF STANDARD OPERATING PROCEDURES
AND FORMS D-2
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D.2.2 Initial Application Review and On-site
Inspections D-3
D.2.3 Final Report Submittal NELAP and the PT
Provider D-4
D.3.0 PTOB Responsibilities Regarding Approval of
PT Providers D-5
D.4.0 PTOB RESPONSIBILITIES FOR ONGOING OVERSIGHT
OF PT PROVIDERS D-5
D.5.0 PTOB's Annual Report on Provider Accreditation
Status D-5
D.6.0 DEVELOPMENT AND MAINTENANCE OF A COMPREHENSIVE
PT DATABASE D-6
D.7.0 COMPLAINTS AND CORRECTIVE ACTION D-6
D.8.0 LIST OF APPROVED PT PROVIDERS D-6
D.9.0 SPONSORSHIP OF ANNUAL NELAC PROFICIENCY
TESTING CAUCUS D-6
D.10.0 PTOB ETHICS D-7
D.11.0 CONFIDENTIALITY D-7
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2.0 PROFICIENCY TESTING PROGRAM: INTERIM STANDARDS
For the period beginning with adoption of these standards by
NELAC and ending September 30, 1998, all NELAP-approved
accrediting authorities shall accept data from proficiency
testing programs that meet the requirements of current EPA
or state regulations and guidance. The intent of these
interim standards is to continue the status quo until
remaining EPA and other stakeholder issues can be addressed.
This should not be construed as NELAC approval or
disapproval of any particular PT provider.
Accrediting authorities may rely on the current laboratory
performance evaluation studies conducted by EPA. These
include: the Water Supply (WS) Study, conducted twice
annually; the Water Pollution (WP) study, conducted twice
annually; and the Discharge Monitoring Report Quality
Assurance (DMRQA), conducted once annually. Alternatively,
accrediting authorities may rely on other sources for
performance evaluation studies (such as their own state-
operated programs or programs supported by commercial
vendors), provided that these programs meet current EPA
regulatory requirements.
2.1 INTRODUCTION, SCOPE, AND APPLICABILITY
This chapter and the associated appendices define the major
participating organizations and components of the NELAC
Proficiency Testing (PT) Program. In addition to complying
with the requirements of this Chapter, any person, private
party or government entity seeking to participate as a PT
Provider in the NELAC program shall also comply with the
requirements of the applicable Appendices A (PT Provider
Approval Criteria), B (PT Sample Design and Acceptance
Guidelines), C (Proficiency Testing Acceptance Criteria and
Proficiency Testing Pass/Fail Criteria) and D (Proficiency
Testing Oversight Body). The criteria set forth in this
standard are considered to be default requirements, and
shall be used in the absence of specific program criteria.
If they conflict with any documented EPA program criteria,
the program criteria shall have precedence.
Proficiency Testing (PT) is defined for the purpose of this
Chapter as a means of evaluating a laboratory's performance
under controlled conditions relative to a given set of
criteria through analysis of unknown samples provided by an
external source. PT is not the sole criterion for
determining accreditation status. Additional essential
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elements of the overall NELAC accreditation process,
including the laboratory audit, are discussed in other
chapters of the NELAC standards. The PT program is intended
to cover all types of federal and state environmental
analyses. However, the body of the PT standard applies
primarily to chemistry. Appendices (yet to be developed)
will describe necessary variations as applied to
radiochemistry, biology, and microbiology.
The major components of the NELAC PT Program include:
a) multiple PT Providers who shall meet stringent criteria
to become Approved by the Proficiency Testing Oversight
Body (PTOB), as described in Section 2.3 and Appendix
A;
b) specific requirements for the design of PT samples and
studies, to ensure that all samples provide a
consistent, fair and known challenge to laboratories
seeking NELAC Accreditation, as described in Section
2.3 and Appendix B;
c) specifically defined pass/fail criteria for evaluating
PT sample results, as described in Section 2.3 and
Appendix C;
d) initial approval and ongoing oversight of PT Providers
by the Proficiency Testing Oversight Body (PTOB),
Section 2.3 and Appendix D;
e) specific requirements for laboratories participating in
PTOB Approved PT Programs, as described in Sections
2.5, 2.6, and 2.7; and
f) oversight of all PT Program activities by the PTOB, as
described in Section 2.2.1.
2.1.1 Purpose
The PT program incorporates several practical purposes,
which include:
a) the production and supply of test samples that are
procedure-sensitive; that is, the samples challenge the
critical components of each analytical procedure,
ranging from initial sample preparation to final data
analysis;
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b) the production and supply of test samples that are as
similar to real-world samples as is reasonably
possible. It is further expected that the PT samples
will be representative of environmental regulatory
programs, agencies, and communities;
c) a program which is affordable by all participants;
d) the yielding of PT data that are technically defensible
on the basis of the type and quality of the samples
provided;
e) the preparation of samples such that the identification
and quantitation of analytes in the samples poses
equivalent difficulty and challenge regardless of the
manner in which the samples are designed and
manufactured by the PT Providers, i.e. samples prepared
for analysis by a Drinking Water or Wastewater method
would pose equal challenge whether prepared as whole
volume or concentrated ampules.
2.1.2 Goals
The PT program incorporates several practical goals, which
include:
a) the generation of data at a quality level required by
environmental and regulatory programs;
b) the generation of data that are, at a minimum,
comparable in quality to that of currently certified
and/ or accredited laboratories; and
c) the improvement of the overall performance of
laboratories over time.
2.1.3 PT fields of testing
The PT program is organized by PT fields of testing.
Laboratories may choose to participate in one or more PT
fields of testing, or portions thereof. The following
elements collectively define PT fields of testing:
a) Regulatory or environmental program
b) Matrix
c) Analyte
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2.2 MAJOR PT GROUPS AND THEIR RESPONSIBILITIES
The PT program structure incorporates five major groups with
separate and distinct roles and responsibilities. The
groups are NELAC, the Proficiency Testing Oversight Body
(PTOB), the PT Providers, the laboratories, and the
Accrediting Authorities (AA). The lines of interaction among
these groups are shown in Figure 1.
Standard-Setting
Authority
NELAC
I
Provider Oversight
Body
Accrediting
Authority
States/EPA
Providers
i
Laboratories
(Private Sector,
Non-Profits, and/
or States
Figure 2-1. NELAP Proficiency Testing
2.2.1 NELAC and NELAP
NELAP is the Standards Setting Authority (SSA) which is
responsible for administering the NELAC PT program. EPA and
the states established NELAC to develop the written
standards by which the PT program will operate and to keep
these standards current relative to the needs of regulatory
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and environmental laboratory programs. The NELAC standing
Proficiency Testing Committee determines PT fields of
testing, sample parameters/ sample concentration ranges,
frequency of testing, and PT sample acceptance criteria.
NELAC meets annually to evaluate the PT programs, collect
input from the participants, their associated groups, and
the regulated community, and revise the standards as needed.
NELAC reviews and approves the PT sample acceptance criteria
as described in Appendix C.
2.2.2 PT Study Providers
The providers shall produce and distribute PT samples,
evaluate study results against published performance
criteria, and report the results to the laboratories, the
respective Accrediting Authorities, the PTOB, and NELAP.
The PT Provider shall meet the requirements of Appendix A,
manufacture samples that meet the requirements of Appendix
B, and score sample results in accordance with the
requirements of Appendix C.
2.2.3 Proficiency Testing Oversight Body (PTOB)
The Proficiency Testing Oversight Body (PTOB) shall
establish and implement a program to accredit PT study
suppliers and to monitor accredited suppliers to ensure that
their studies and practices meet all applicable standards.
The PTOB shall meet the requirements of Appendix D.
2.2.4 Laboratories
Laboratories that seek to become accredited by NELAP shall
perform analyses of PT samples as required by this chapter.
PT samples shall be obtained from NELAP Approved PT
Providers. The laboratory shall obtain PT samples from any
NELAP Approved PT Provider. The results of the analyses
shall be submitted to the Provider for scoring.
2.2.5 Accrediting Authorities (AA)
The States or the EPA Regions which hold primary Accrediting
Authority are the Accrediting Authorities for those
laboratories located within their respective boundaries.
The accrediting authorities shall make all decisions
regarding a laboratory's accreditation status. They are
responsible for taking action to make these determinations.
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2.3 REQUIREMENTS FOR PT PROVIDERS
This section and associated Appendix A describe the criteria
that all PT providers shall meet in order to be approved by
the PTOB as PT Providers. The PTOB shall grant approval to
PT providers on a field-of-testing basis, as described in
Section 2.1.3.
2.3.1 On-Site Inspection of PT Providers
The PTOB shall conduct an on-site inspection of any
organization seeking to participate as a PT Provider in the
NELAC Program, as described in Appendix D. The PTOB shall
determine whether the Provider meets the applicable
requirements described in this chapter and Appendices A, B,
and C. Approval of a PT Provider shall be the
responsibility of the PTOB. The PTOB shall conduct ongoing
oversight of the PT Providers as necessary to ensure
conformance with all applicable standards.
2.3.2 Sample Requirements and Design
This Section and associated Appendix B describe PT sample
design and acceptance criteria. The matrices of all PT
samples shall to the extent possible, resemble the matrices
for which the laboratory seeks accreditation. Samples may
not be reused.
2.3.2.1 Sample Analytes
The PT Provider shall prepare each sample lot such that the
target concentration of each analyte in each lot is unique.
The required group of analytes in each sample covering each
field of testing shall be determined by NELAC and shall be
evaluated and updated annually, as necessary. For a given
field of testing, it is not necessary that every analyte be
present in every study. Within each study, a certain
minimum number of analytes shall be present. The group of
analytes included shall change over time so that all
analytes are eventually included over a series of sequential
studies.
2.3.2.2 Provider Sample Testing
The PT Provider shall design, manufacture, and test the
samples for homogeneity, stability, and verification of
target values as required by Appendix B. This testing shall
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verify that the quality of all samples is acceptable for use
in each field of testing PT study.
2.3.3 PT Study Data Analysis
This Section and associated Appendix C describe the criteria
to be used by PT Providers when scoring and evaluating NELAC
PT sample results.
2.3.3.1 Data Set Size Requirements
The PT Provider shall have enough participants to ensure
that at least 20 valid data points are obtained for each
analyte in each study. However, NELAP may waive this
requirement for analytes that are analyzed infrequently by
the laboratory community.
2.3.3.2 Data Acceptance Criteria
PT Providers shall use the data acceptance criteria
described in Appendix C to evaluate laboratories' PT data to
ensure a laboratory's performance will be judged fairly and
consistently.
2.3.4 Generation of Study Reports
Each PT study provider shall demonstrate that it can receive
and evaluate the data and issue a report within 21 calendar
days of the close of each study.
2.3.5 Provider Conflict of Interest
Each PT study provider shall certify that it is free of any
organizational conflict of interest. A PT sample producer
shall never split a sample lot and offer these samples for
sale as known-value check samples before the unknown samples
are used in a PT study. In addition, each provider shall
demonstrate that its security procedures are adequate to
maintain confidentiality and security of all target values
through the closing date of each study. All records shall
be retained for a period of five years or as required by the
appropriate regulatory program.
2.3.6 Disapproval of PT Study Providers
A PT Provider shall be disapproved if documented deviations
from the standard identified by the AA, the PTOB, or
participating laboratories are not resolved within 30
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calendar days after the provider is notified in writing of
the problem (Refer to Appendix A).
2.3.7 PTOB Listing of PT Providers
The PTOB shall maintain a list of Approved PT Providers.
The PTOB shall evaluate, update, and publish this list at
intervals not to exceed six months. On this same interval,
The PTOB shall also publish the list of PT fields of testing
necessary to satisfy the PT requirements.
2.4 LABORATORY ENROLLMENT IN PROFICIENCY TESTING
PROGRAM(S)
2.4.1 Required Level of Participation
To be accredited initially and to maintain accreditation,
each laboratory shall participate in a PT study provided by
a NELAP Approved PT Provider. Laboratories must request
accreditation for a field of testing, as described in
Section 2.1.4 of this Chapter. Each laboratory shall
participate in at least two PT studies per year. The PT
Provider shall design studies that require the analysis of
one test sample for each field of testing. Section 2.5
describes the time period in which a laboratory must analyze
the PT samples and report the results. Data and laboratory
evaluation criteria are discussed in Sections 2.6 and 2.7 of
this Chapter.
2.4.2 Requesting Accreditation
At the time each laboratory applies for accreditation, it
shall notify the accrediting authority which field of
testing, that it chooses to complete to meet PT
requirements. For those tests for which PT samples are not
available, the laboratory shall ensure the reliability of
its testing procedures by maintaining a total quality
management system that meets all applicable requirements of
Chapter 5 of the NELAC standards.
2.4.3 Reporting Results
Laboratories seeking accreditation may select any provider
from the list of PTOB Approved PT study providers. The
laboratories shall bear the cost of any PT study
subscription. Each laboratory shall authorize the PT study
provider to report its results and pass/fail status directly
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to the appropriate accrediting authority, NELAP and the
PTOB, in addition to the laboratory.
2.5 REQUIREMENTS FOR LABORATORY TESTING OF PT STUDY
SAMPLES
A laboratory must participate in two PTOB-approved single-
blind, single- concentration PT studies per year for each
field of testing for which it seeks or wants to maintain
accreditation. The samples shall be analyzed and the
results returned to the PT study provider no later than 30
calendar days from the date of sample receipt. The
laboratory's management and all analysts shall ensure that
all PT samples are handled (i.e., managed, analyzed, and
reported) in the same manner as real environmental samples
to the extent possible. The laboratory shall utilize the
same staff, procedures, equipment, facilities, and frequency
of analysis for PT samples as for real environmental
samples.
2.5.1 Restrictions on Exchanging Information
Laboratories shall comply with the following restrictions on
the transfer of PT samples and communication of PT sample
results prior to the time the results of the study are
released:
a) A laboratory shall not send any PT sample or a portion
of a PT sample to another laboratory for any analysis
for which it seeks accreditation;
b) A laboratory shall not knowingly receive any PT sample
or portion of a PT sample from another laboratory for
any analysis for which the sending laboratory seeks
accreditation;
c) A laboratory shall not allow management or staff to
communicate with any individual at another laboratory
(including intracompany communication) concerning the
PT sample; and
d) Laboratory management and staff shall not attempt to
obtain the target value of any PT sample from the
provider.
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2.5.2 Maintenance of Records
The laboratory shall maintain copies of all written,
printed, and electronic records, including but not limited
to bench sheets, instrument strip charts or printouts, data
calculations, and data reports, resulting from the analysis
of any PT sample for five years or for as long as is
required by the applicable regulatory program, whichever is
greater. These records shall include a copy of the PT study
report forms used by the laboratory to record PT results.
All of these laboratory records shall be made available to
the assessors of the primary accrediting authority during
on-site audits of the laboratory.
2.6 EVALUATION OF PROFICIENCY TESTING RESULTS
Program specific criteria apply where available, but in the
absence of specific criteria established by the appropriate
EPA program offices the criteria presented in this section
and associated Appendix C are considered to be NELAC
defaults that would apply.
2.6.1 Scoring of Laboratory PT Sample Results
PT study providers shall evaluate results from all PT
studies using NELAC-mandated acceptance criteria as
described in Appendix C. NELAC shall provide (and update on
an annual basis) the data acceptance criteria that all PT
study providers shall use for all PT study data. Each
result will be scored on an acceptable/not acceptable basis.
The PT study provider will provide the participant
laboratories, the accrediting authority, the PTOB, and NELAP
a report showing at least the target value, the acceptance
range, and the acceptable/not acceptable status for each
analyte for each laboratory participant. The providers
shall not disclose specific laboratory results or
evaluations to any other parties not described in this
section.
2.7 PT CRITERIA FOR LABORATORY ACCREDITATION
The criteria presented in this section are considered to be
NELAC defaults that would apply in the absence of specific
criteria established by the appropriate EPA program offices.
The various EPA program offices may choose to establish
their own program-specific criteria.
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2.7.1 Result Categories
The criteria described in this section apply individually to
each field of testing, as defined by the laboratory seeking
accreditation in its accreditation request. These criteria
apply only to the PT portion of the overall accreditation
standard, and the accrediting authority will consider PT
results along with the other elements of the NELAC standards
when determining a laboratory's accreditation status. The
accrediting authority ultimately makes all decisions
regarding the accreditation status of the laboratory. There
are two PT result categories: "acceptable" and "not
acceptable."
2.7.2 Initial and Continuing Accreditation
A laboratory which seeks accreditation shall successfully
complete two PT studies for each requested field of testing
within the most recent three rounds attempted. Successful
performance is described in Appendix C. Once a laboratory
has been granted accreditation status, it must continue to
complete PT studies and maintain a history of at least two
successful studies out of the most recent three. For either
initial or continuing accreditation, completion dates of
successive proficiency testing rounds for a given field of
study must be at least semiannual (i.e., not more than six
months apart) but must be at least 30 days apart (i.e.,
participation in a second study or a remedial study may not
occur within 30 days of the first or failed study). Failure
to meet the semiannual schedule is regarded as a failed
study.
2.7.3 Supplemental Studies
A laboratory may elect to conduct PT studies more frequently
than required by the semiannual schedule as set by the
primary accrediting authority. This may be desirable, for
example, when a laboratory first applies for accreditation
or when a laboratory fails a study and wishes to quickly re-
establish its history of successful performance. These
additional studies are not distinguished from the routinely
scheduled studies; that is, they are counted and scored the
same way. Periodic PT studies will occur at fixed times per
year (schedule to be determined). Initial and remedial
samples can be obtained at other times.
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2.7.4 Failed Studies and Corrective Action
Whenever a laboratory fails a study/ it shall determine the
cause for the failure and take any necessary corrective
action. It shall then document in its own records both the
investigation and the action taken. If a laboratory fails
two out of the three most recent studies for a given field
of testing, its performance is considered unacceptable under
the NELAC PT standard for that field.
2.7.5 Second Failed Study
The PT Provider reports laboratory PT performance results to
the accrediting authority at the same time that it reports
the results to the laboratory. If a laboratory fails a
second study, as described above, the accrediting authority
shall take action within 60 days to determine the capability
of the laboratory to meet accreditation requirements. The
accrediting authority shall review the accreditation status
of all methods related to the analyte(s) in the failed
study, and not just the method by which the failed PT was
analyzed.
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APPENDIX A
PT PROVIDER APPROVAL CRITERIA
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A. 0.0 SCOPE
This Appendix describes the responsibilities and
requirements a Proficiency Testing (PT) Provider shall meet
in order to be a Proficiency Testing Oversight Body (PTOB)
Approved PT Provider. In order for a PT Provider to
participate in the NELAC PT Program, a Provider must be
approved by the PTOB. The criteria provided below are
designated to ensure the integrity and technical excellence
of the NELAC PT Program while allowing all qualified
Providers to participate in the program.
A. 1.0 APPROVAL PROCESS
The process for approval of a PT Provider includes an annual
on-site inspection by the PTOB to ensure that the technical
criteria of this appendix are being met. At the discretion
of the PTOB, the PT Provider may be requested to confirm
their ability to perform analyses within the required limits
through participation in a proficiency testing program
operated by the PTOB, or through the analysis of unknown
samples provided by the PTOB. Providers are also required
to submit the results of PT programs operated for NELAC to
the PTOB for review and evaluation. The PT Provider agrees
to accept the findings and decisions of the PTOB as final.
A.2.0 QUALITY SYSTEM REQUIREMENTS
The manufacturing quality system used by the PT Provider
must meet the requirements of both ISO 9001 for the design,
production, testing, and distribution of performance
evaluation samples and the requirements of ISO Guide 34
Quality System Guidelines for the Production of Reference
Materials. The design and operation of the PT Provider's
proficiency testing program must meet the requirements of
ISO Guide 43, Proficiency Testing by Interlaboratory
Comparisons. The testing facilities used to support the
verification, homogeneity, and stability testing required in
Appendix B of this document must meet the requirements of
.Chapter 5, Quality Systems, of the NELAC standards for the
quality of testing facilities. The ability to meet the ISO
9001 quality system requirement may be fulfilled through
registration of the PT Provider's quality system by an ANSI
accredited registrar. However, an annual on-site inspection
by the PTOB demonstrating continuing performance is
required.
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A.3.0 PROVIDER FACILITIES AND PERSONNEL
Each Provider is required to have systems in place to
produce, test, distribute, and provide data analysis and
reporting functions for any series of samples for which they
are requesting approval. Similarly, the Provider shall have
in place sufficient technical staff, instrumentation, and
computer capabilities as may be required by the PTOB to
support the production, distribution, analysis, data
collection, data analysis, and reporting functions of the
samples. No portion of the production, testing,
distribution, data collection, data analysis, nor data
reporting functions may be outside the control of the PT
Provider for any particular study, since it is essential
that the confidentiality of the samples be maintained
throughout the PT study.
A. 4.0 SAMPLE DESIGN REVIEW
The PT Provider must demonstrate to the PTOB, by the
submission of appropriate data, that the sample design for
which the PT Provider is seeking approval will permit
participating laboratories to generate results that fall
within the sample acceptance ranges established by NELAC or
the PTOB.
A.4.1 RELEASE OF INFORMATION
In support of the above requirement, the PTOB agrees to
treat all sample design information submitted to them for
review as the proprietary information of the PT Provider
submitting the information. Such design information shall
not be released by the PTOB without the prior written
consent of the PT Provider.
A.5.0 PROVIDER CONFLICT-OF-INTEREST REQUIREMENTS
PT Providers seeking approval shall document to the
satisfaction of the PTOB that they do not have a conflict-
of-interest with any laboratory seeking, or having, NELAC
accreditation. PT Providers shall notify the PTOB of any
actual or potential organizational conflicts of interest,
including but not limited to:
a) Any financial interest in a laboratory seeking, or
having, NELAC accreditation;
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b) The sharing of personnel, facilities or instrumentation
with a laboratory seeking, or having, NELAC
accreditation.
The PT Provider is also required to inform all internal and
contract personnel who perform work on NELAC PT samples of
their obligation to report personal and organizational
conflicts of interest to the PTOB. The Provider shall have
a continuing obligation to identify and report any actual or
potential conflicts of interest arising during the
performance of work in support of NELAC PT programs. If an
actual or potential organizational conflict of interest is
identified during performance of work in support of NELAC PT
programs, the PT Provider shall immediately make a full
disclosure to the PTOB. The disclosure shall include a
description of action which the Provider has taken or
proposes to take, after consultation with the PTOB, to
avoid, mitigate or neutralize the actual or potential
conflict of interest. The PTOB may reevaluate a PT
Provider's Approval status as a result of unresolved
conflict of interest situations. Any conflict of interest
disputes between the PT Provider and the PTOB may be
'appealed to NELAP for a final determination.
A. 5.1 BAN ON DISTRIBUTION OF SAMPLES
Furthermore, PT Providers shall not sell, distribute, or
provide samples used in the NELAC PT program prior to the
conclusion of the study for which they were designed.
Providers further agree not to sell, distribute, or provide
samples of identical design and concentration to those
samples which it is currently using in a NELAC study.
A.6.0 CONFIDENTIALITY OF PT STUDY DATA
The PT Provider shall demonstrate to the PTOB that is has
systems in place to ensure that the confidentiality of data
associated with NELAC PT samples and programs is not
compromised. PT Providers shall not release the Target
Value of any sample currently being used in a NELAC PT
study. The PT Provider also agrees that the acceptance
ranges provided to them by either NELAC, or the PTOB, are
the proprietary information of NELAC or the PTOB and shall
not be disclosed by the PT Provider without the written
approval of the PTOB.
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A.7.0 DATA REVIEW AND EVALUATION
The NELAP Approved PTOB will review the data from every PT
Provider study to ensure that acceptance limits used to
evaluate laboratories are consistent with national standards
as established by NELAC. The PTOB will also evaluate the
performance of the PT Providers by monitoring and reporting
to both and the Providers the pass/fail rates of all
Providers on all samples tested. The PTOB is required to
investigate any PT Provider whose pass/fail rate is
statistically different from the national average.
A. 8.0 COMPLAINTS & CORRECTIVE ACTION
Written complaints received by the PT Provider regarding
their performance in the NELAP PT program must be submitted
to the PTOB within seven days from receipt of the complaint
by the PT Provider. The PT Provider shall resolve the
complaint to the satisfaction of the PTOB within 30 days
from the date received by the PTOB. The PTOB is the sole
judge of the adequacy of the corrective action taken by the
PT Provider. It is the responsibility of the PTOB to
provide NELAP with an annual summary of all PT Provider
complaints received during the prior year.
A. 9.0 LOSS OF PROVIDER APPROVAL
PT Providers who fail to meet the requirements of this
appendix or those of Appendix B, may be subject to loss of
their approval as a NELAC PT Provider. Providers may lose
approval to provide individual sample sets based upon review
of PT study data by the PTOB as required in Appendix A
Section A.7. Similarly, PT Providers who fail to meet the
requirements of Appendix A, Sections A2 through A6, on a
continuous basis may lose their approval as a PTOB Approved
PT Provider for all samples.
A. 9.1 PERIODIC REVIEW OF PT PROVIDERS
The PTOB may at any time, review the performance of any
approved PT Provider against the terms and conditions of
both Appendix A and Appendix B. Based upon this review, the
PTOB may determine that the approval status of a PT Provider
be revoked, adjusted, limited, or otherwise changed based
upon failure to meet one or more of the specified
requirements.
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A. 9.2 REVOCATION OF APPROVAL
The PTOB may take any of the following actions in response
•to its determination that a PT Provider's approval status
should change:
a) If the PT Provider fails to meet the requirements of
Appendix B for a particular sample set or series of
sample sets, the PTOB may revoke approval of the PT
Provider to provide these sample sets for the NELAC PT
program. PT Providers may request reapproval for the
sample sets by verifying to the PTOB that the problem
has been corrected.
b) If the PT Provider fails to meet the requirements of
Appendix A Section A2 or A3, the PTOB may revoke the PT
Provider's approval to supply any samples under the
NELAC PT program until such time that the PT Provider
corrects the problem and the PTOB verifies through an
on-site inspection that the corrective action has been
effective.
c) If the PT Provider fails to meet the requirements of
Appendix A, Sections A5 through A6, the PTOB may revoke
the PT Provider's approval to supply any samples under
the NELAC PT program. In this case, the PT Provider
may not reapply for reapproval for a period of three
years from the date of revocation of approval.
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APPENDIX B
PT SAMPLE DESIGN
& ACCEPTANCE GUIDELINES
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B.0.0 INTRODUCTION
An integral element of the NELAC PT Program Standards is the
assurance of PT samples which are of high quality, well
documented, homogeneous, and stable. In order to meet the
goals of NELAC, the PT samples used in the program must also
provide all laboratories with samples which offer a
consistent challenge. All PT samples must meet all
applicable specifications by EPA and/or NELAC.
B.1.0 VERIFICATION OF TARGET VALUE
All PT samples used in the NELAC program must be analyzed by
the PT provider prior to shipment to the laboratories to
ensure suitability for use in the program. The Target Value
of the sample will be used to establish acceptance criteria,
and it must be verified by analysis. PT providers must
verify the Target Value by direct analysis against NIST
Standard Reference Materials, if a suitable NIST SRM is
available for use. If a NIST SRM is not available then
verification must be performed against an independently
prepared calibration material. An independently prepared
calibrant is one prepared from a separate raw material
source, or one prepared and documented by a source external
to the provider.
B.I.I
The method used by the PT provider for verification analysis
must have a relative standard deviation of not more than
fifty percent of relative standard deviation predicted by
the laboratory acceptance criteria being used by NELAC for
each parameter. The relative standard deviation of the
provider's verification method will be established by a
method validation study, and the suitability for use will be
approved by the NELAP designated Proficiency Testing
Oversight Body (PTOB).
B.I.2
Every parameter in all PT samples must be verified by
analysis. The Target Value of the sample is verified if the
Target Value of the sample falls within a 99% Confidence
Interval calculated from the Mean and Standard Deviation of
the data generated during the verification analysis.
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B.2.0 HOMOGENEITY VERIFICATION
PT sample homogeneity is essential to ensuring that all
laboratories are treated fairly. Therefore, the purpose of
the homogeneity testing procedure is to ensure that within a
95% Confidence Limit that all samples distributed to the
laboratories have the same Target Value for every parameter
to be evaluated. Homogeneity testing is required on all PT
samples prior to sample shipment to the laboratories.
B.2.1
The homogeneity of the samples must be established using a
generally accepted procedure. The procedure selected by the
PT provider must be capable of evaluating the relative
consistency of each analyte across the production run, and
must be performed on the final packaged samples. The
procedure must establish within a 95% Confidence Limit that
the Target Value is consistent across the production run.
Samples or parameters which fail to pass the homogeneity
testing criteria of the procedure used by the PT provider at
the 95% Confidence Interval cannot be used in the NELAC PT
program to evaluated laboratories.
B.2.2
A suitable homogeneity testing procedure will be capable of
comparing the within sample to between sample standard
deviation across the PT provider's packaging run and will
ensure comparability within a 95% Confidence Interval.
Suitable homogeneity testing procedures are available in
both ISO Guide 35 for the Certification of Reference
Materials and in the REMCO/AOAC Harmonized Protocol for the
Proficiency Testing of Analytical Laboratories. However,
the homogeneity testing procedure used by the PT provider
must be approved for use by the PTOB.
B.3.0 STABILITY TESTING
The samples used in the NELAC PT program must to verified as
stable for the period of each study. Therefore, the
stability of all samples, and parameters, must be
established by the PT provider following the close of data
submission from the laboratories. The samples are
considered stable for the period of the study if the Mean
analytical value as determined after the study for each
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parameter falls within the 99% Confidence Interval
calculated for the prior to shipment verification testing
used to verify the Target Value. The testing procedure used
for stability testing must be approved for use by the PTOB.
B.4.0 SAMPLE DESIGN APPROVAL
The sample design for each sample used in the NELAC PT
program must be evaluated, and approved for use, by the PTOB
prior to their use in the NELAC program. The criteria for
design adequacy are that the sample will provide equivalent
challenge to the laboratories as similar samples for the
same parameters as other providers, and that the sample will
exhibit laboratory acceptance rates, measured as provider
percentage pass/fail performance, consistent with other
samples used in the program for the same parameters.
B.4.1
The testing and verification protocol required to establish
sample equivalency will be agreed to by both the PT provider
and the PTOB on a case by case basis. It is the
responsibility of the PT provider to demonstrate the
adequacy of sample design to the satisfaction of the PTOB.
B.5.0 DATA REPORTING BY PT PROVIDERS
The results of sample Target Value verification,
homogeneity, and stability testing must be available to the
participating laboratories. All data developed by the
provider in support of verification testing, homogeneity
testing, and stability analysis must be provided to any
laboratory participating in the program upon request after
the close of the study.
B.5.1
The data developed by the PT provider in support of
verification, homogeneity, and stability testing will be
supplied in summary format to the PTOB in an electronic
format to be determined by the PTOB. Verification and
homogeneity data must be supplied to the PTOB prior to
sample distribution to the laboratories.
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B.5.2
All data from the laboratories and the results of stability
testing must be provided to the PTOB in an electronic format
to be determined by the PTOB within thirty days of the close
of the study.
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APPENDIX C
PROFICIENCY TESTING
ACCEPTANCE CRITERIA
AND
PROFICIENCY TESTING
PASS/FAIL CRITERIA
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C.0.0 PURPOSE, SCOPE, AND APPLICABILITY
This Appendix defines the criteria to be used by any entity
which seeks to participate as a Proficiency Test Provider in
the NELAC Program for scoring the results obtained from the
analyses of samples in any NELAC PT Study. Two distinct
sets of scoring criteria are defined: 1) whether or not an
individual analyte result is either "Acceptable" or "Not
Acceptable" and 2) whether or not a laboratory's PT
performance for a group of interdependent analytes can be
evaluated as "Pass" or "Fail". The PT Providers shall
submit all laboratories' performance rating(s) to the
Accrediting Authority, as described in Chapter 2 of the
NELAC standards, to be used as a tool for determining a
laboratory's NELAP accreditation status. PT acceptance
limits and pass/fail criteria are established according to
PT fields of testing, which are defined in Chapter 2 of the
NELAC standards.
C.1.0 ANALYTE ACCEPTANCE LIMITS
Acceptance limits are established for each individual
analyte. Whether or not a laboratory has passed or failed a
group of interdependent analytes is based on the number of
results that are determined to be acceptable.
C.I.I ANALYTE ACCEPTANCE LIMIT CATEGORIES
Acceptance limits are separated into three categories.
Results for analytes with acceptance limits determined as
described in Sections C.I.1.1 and C.I.1.2 will be used in
the determination of a laboratory's PT Field of Testing
pass/fail evaluation. Results for analytes with acceptance
limits determined as described in Section C.I.1.3 will not
be used as part of the PT Field of Testing pass/fail
evaluation.
C.I. 1.1 Analytes with EPA Promulgated Acceptance Limits
PT Providers shall utilize the proficiency test acceptance
limits that have been promulgated in regulations or
guidelines by EPA programs. The most recent EPA regulations
and/or guidelines are incorporated into this Appendix by
reference. EPA's promulgated proficiency test acceptance
limits for chemical analytes are typically expressed in the
following manner:
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• Target ± fixed percentage. Acceptance limits shall be
set at plus and minus the published fixed percentage of
the analyte's validated target value.
• Mean ± 2 standard deviations. For those analytes for
which the PTOB has established linear regression
equations relating target value to mean and target value
to standard deviation, acceptance limits shall be set
using said equations and the sample's validated target
value. Linear regression equations may only be used for
target values that fall within the range of target values
used to establish said equations. In the event that there
are no linear regression equations available for a given
analyte, that analyte will be treated as described in
Section C.I.1.3.
C.I.1.2 Analytes with acceptance limits derived from
regression equations established by the PTOB and
approved by the NELAC
When EPA Program regulation or guidance for establishing
acceptance criteria are not available Proficiency Test
providers shall set acceptance limits as follows.
Regression equations that predict the mean and standard
deviation for an analyte in a given range of concentrations
in PT samples will be derived by the PTOB. Data from
sources such as the EPA PE studies, interlaboratory results
from professional organizations such as ASTM, other
proficiency testing providers, commercial and non-profit
organizations, will be used to establish the equations. All
regression equations will be approved by the NELAC prior to
use by a PTOB Approved PT provider. For these analytes, the
PT Provider shall use the sample's validated target value
and said equations to determine the mean and standard
deviation. The regression equations shall be designed .to
be applicable across the NELAC designated PT concentration
range.
C.I.1.3 Analytes without promulgated acceptance limits or
EPA established regression equations, i.e.,
"Experimental Data"
For those analytes not included in categories C.I.1.1 or
C.I.1.2, e.g., newly regulated analytes, analytes in a
matrix that have not been fully evaluated in interlaboratory
studies, NELAC acceptance limits will be established only
after interlaboratory data has been collected for a minimum
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of one year unless the PTOB determines that sufficient data
have been collected in less time. The data obtained during
the one-year period shall be referred to as "experimental
data". NELAC with the assistance of the Proficiency Testing
Oversight Body, will derive regression equations to be used
to establish acceptance limits for analytes in the
experimental category after sufficient data have been
collected. The laboratory will receive a copy of its own
experimental data from the PT Provider at the conclusion of
the PT study.
C.2.0 «ACCEPTABLE" PT RESULTS FOR CHEMICAL ANALYTES IN
POTABLE WATER, NON-POTABLE WATER AND HAZARDOUS WASTE
PT SAMPLES
A laboratory's PT analyte result is "Acceptable" when it
falls within the EPA's promulgated acceptance limits
(Section C.I.1.1). For Section C.I.1.2 analytes, PT
Providers shall use the PT sample's validated target value
and said regression equations to determine the mean and
standard deviation. Acceptance limits shall be set at the
99% prediction interval based on the mean and standard
deviation. A result is "Acceptable" when it falls within
these derived acceptance limits.
C.3.0 "NOT ACCEPTABLE" PT RESULTS FOR POTABLE WATER, NON-
POTABLE WATER AND HAZARDOUS WASTE PT SAMPLES
A laboratory's result for any analyte is considered
unacceptable if it meets any of the following criteria:
a) The result falls outside the EPA's promulgated
acceptance limits (Section C.I.1.1) or outside the 99%
prediction interval derived from PTOB established
regression equations (Section C.I.1.2);
b) The lab reports a result for an analyte not present in
the PT sample (i.e., a false positive);
c) The lab reports a result of "Not Detected", for an
analyte present in the PT sample (i.e., a false
negative);
NOTE: False positives and false negatives will only be
scored "not acceptable" when an analyte has an EPA
promulgated required detection limit (RDL). For
example if a laboratory reports a result above the EPA
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promulgated RDL for a given analyte that is not present
in the PT sample, then the result will be classified
as a false positive and scored as "not acceptable".
Conversely, if a laboratory reports a result less then
the RDL for an analyte present in the PT sample at a
concentration within the NELAC approved PT
concentration range, the result will be classified as
a false negative and scored as "not acceptable".
d) The lab fails to submit its results to the PT Provider
on or before the deadline for the PT study.
C.4.0 ADDITIONAL REQUIREMENTS FOR PT PROVIDERS
PT Providers shall examine all data sets for bimodal
distribution and/or situations where results from a given
method have disproportionally large failure rates or
reporting anomalies to the Proficiency Testing Oversight
Body. All proficiency test data are to be submitted to the
PTOB in the format specified by the PTOB and shall be
reviewed annually by the NELAC Standing Committee for
Proficiency Testing in conjunction with the EPA for the
purpose of revising existing and establishing new linear
regression equations.
C.5.0 NELAC PT STUDY PASS/FAIL CRITERIA
NELAC PT samples are designed to meet the requirements of
Chapter 2 and associated appendices. Once data
acceptability has been determined as described in Sections
C.I through C.3 of this appendix, the laboratory's PT "Pass"
or "Fail" evaluation is determined as described in this
Section. Pass/Fail criteria are used when groups of
interdependent analytes are evaluated as a unit for the
laboratory's initial demonstration of proficiency.
C.5.1 INTERDEPENDENT ANALYTE PT SAMPLES
Interdependent analyte PT Samples are those that are
analyzed using methods in which the ability to correctly
identify and quantitate a series of analytes is indicative
of the laboratory's ability to correctly determine the
presence or absence of similar analytes. Examples of
interdependent PT Samples are those used for the following
series of analytes; volatiles, semivolatiles, pesticides,
herbicides, etc..
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C.5.2 NON-INTERDEPENDENT ANALYTE PT SAMPLES
Non-interdependent PT Samples are those that are analyzed
using methods in which the ability to correctly identify and
quantitate an analyte or a series of analytes in a sample is
not indicative of the laboratory's ability to correctly
identify and quantitate similar analytes. Non-
interdependent analyte PT samples may contain a single
analyte, e.g., pH, BOD, TSS, etc., or may contain multiple
analytes, e.g., metals, major ions, etc.
C.5.3 PROMULGATED EPA PASS/FAIL CRITERIA
In all cases, promulgated EPA pass/fail criteria, e.g.,
drinking water volatiles as listed in 40 CFR 141.61(a),
subsection (m)(1), will be used as NELAC PT pass/fail
criteria as applicable. The criteria described in the
following Sections, 5.4 and 5.5, shall be used in the
absence of promulgated EPA pass/fail guidelines.
C.5.4 PASS/FAIL CRITERIA FOR INTERDEPENDENT ANALYTE PT
SAMPLES
Proficiency Testing pass/fail evaluations for Interdependent
Analyte PT samples shall be determined as follows. To
receive a score of "Pass", a laboratory must produce
"Acceptable" results as defined in Section C.I for 80% of
the analytes in an Interdependent Analyte PT Sample.
Greater than 20% "Not Acceptable" results will result in the
laboratory receiving a score of "Fail" for that series of
analytes.. For example, a laboratory must report all
"Acceptable" results for an Interdependent Analyte PT
Sample containing 1-4 analytes, may report no more then one
"Not Acceptable" result for a Sample containing 5-9
analytes, two "Not Acceptable" results for a Sample
containing 10-14 analytes, etc... A "Not Acceptable" result
for the same analyte in two consecutive PT studies will
also result in the laboratory receiving a score of "Fail"
for that analyte.
C.5.5 PASS/FAIL CRITERIA FOR NON-INTERDEPENDENT ANALYTE PT
SAMPLES
To receive a score of "Pass", a laboratory must produce
"Acceptable" results as defined in Section C.I for all
analytes in a Non-Interdependent Analyte PT Sample. One or
more "Not Acceptable" results will result in the laboratory
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receiving a score of "Fail" for that Field of Testing
sample.
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APPENDIX D
PROFICIENCY TESTING
OVERSIGHT BODY
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D.0.0 PURPOSE, SCOPE, AND APPLICABILITY
This Appendix defines the qualifications, scope of
responsibilities and requirements for the NELAC designated
Proficiency Testing Oversight Body (PTOB) as defined in
Section 2.2.3 of the NELAC document. In addition to
complying with the requirements of this Appendix, the PTOB,
for this oversight function, shall comply with the
applicable requirements described in Chapter 2 and
associated Appendices A (PT Provider Acceptance Criteria), B
(PT Sample Design and Acceptance Guidelines), and C
(Criteria for Setting PT Data Acceptance Limits).
D.1.0 TECHNICAL AND ADMINISTRATIVE QUALIFICATIONS
The PTOB shall demonstrate to NELAP that it has the
technical expertise, administrative capacity, and financial
resources sufficient to implement and operate a national
program of PT Provider evaluation and oversight. The PTOB
shall meet the following general requirements:
a) The PTOB shall demonstrate the capability to manage and
evaluate complex environmental reference materials in a
variety of matrices;
b) The PTOB shall demonstrate expertise in statistical
applications as related to large interlaboratory
performance evaluation programs;
c) The PTOB shall demonstrate the capability to conduct
on-site audits of PT Providers;
d) The PTOB shall demonstrate the capability to conduct
technical reviews of Initial Applications;
e) The PTOB shall demonstrate a knowledge and
understanding of the ISO guides 9001, 34, 43, and
Chapter 2 of the NELAC standards including Appendices
A, B, and C.
D.2.0 PTOB RESPONSIBILITIES REGARDING INITIAL ASSESSMENT
OF PT PROVIDERS
The PTOB responsibilities are described in this section.
The primary responsibility of the PTOB is the oversight and
ongoing monitoring and evaluation of the PT Providers. The
oversight activities of the PTOB shall be designed to ensure
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that the PT Provider meets the requirements specified in
Chapter 2 and Appendices A, B and C. All activities
described herein shall be conducted by the PTOB.
D.2.1 DEVELOPMENT OF STANDARD OPERATING PROCEDURES AND
FORMS
The PTOB shall develop the Standard Operating Procedures
(SOPs) necessary to conduct the PT Provider evaluation
process. These documents shall be based upon the
requirements of Chapter 2 of the NELAC standards and the
associated Appendices A, B, and C. NELAP has the authority
to review and approve, as necessary, the SOPs developed by
the PTOB.
D.2.1.1 SOP(s) for the Assessment Process
The PTOB shall develop and implement SOP(s) including but
not limited to: the initial application submittal and review
process, on site inspection, submittal of final reports to
NELAP, the procedures for recommending that a PT Provider's
approval be revoked, the procedures for appealing approval
recommendations, and any other procedures deemed necessary
by NELAC.
D.2.1.2 Initial Application
The PTOB shall develop the initial application process to be
submitted by all PT Providers applying for approval as PT
Providers of NELAC samples. The application shall include
questions regarding the qualifications of the organization
seeking approval. In addition to completing the initial
application process, the PTOB shall require that the PT
Provider submit copies of its current ISO 9001 registration
certificate or any other documents which detail the quality
systems required by the provisions of Chapter 2 and
associated Appendices.
D.2.1.3 SOP(s) for On-Site Inspections and Checklist(s)
The PTOB shall develop a SOP for conducting consistent,
effective, annual on-site inspections of PT Providers. The
SOP shall include policies which describe the circumstances
for conducting any additional inspections, and circumstances
for determining whether on-site inspections will be
announced or unannounced. The PTOB shall develop standard,
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consistent checklist(s) to be used during any and all
inspections of PT Providers.
D.2.2 Initial Application Review and On-site Inspections
The PTOB shall follow the procedures described in this
section for the review of applications and on-site
inspections of any candidate PT Provider.
a) The PTOB shall review the initial application
documents, described in D.2.1.2, for compliance with
the PT Provider qualifications described in Appendix A
and other applicable documents.
b) The PTOB shall review the sample designs used by the PT
Provider for compliance with Appendix B and other
applicable documents.
c) The PTOB shall review the PT analyte and sample scoring
procedures used by the PT Provider for compliance with
Appendix C and other applicable documents.
d) No later than ninety (90) days after the review of the
Initial Application and associated documents, the PTOB
shall conduct an on-site inspection of the PT Provider.
The PT Provider shall be provided with checklist(s) to
be used during the inspection as part of the initial
application process. The inspection may be conducted
more than 90 days after reviewing the initial
application only if unforeseen circumstances beyond the
control of the PTOB, prevent an inspection from being
conducted within this time period. The inspection
shall be conducted following the SOP(s) and documented
on the checklist(s) described in Section D.2.1.3.
e) Following the inspection, the PTOB shall conduct an
exit meeting with the PT Provider, which shall include
discussion of deficiencies and discrepancies found;
however, the PTOB may further revise the findings after
the closing of the exit meeting, if necessary.
The inspection shall include, at a minimum:
1) Review of the quality system for adherence to the
requirements of Appendices A, B and C;
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2) Review of staff qualifications and technical
expertise necessary to produce acceptable
proficiency testing samples;
3) Review of the sample manufacturing and
verification procedures to ensure that the
requirements of Appendices A and B are met;
4) Review of the procedures in place to ensure that
all personnel are aware of and abide by standards
of conduct for PT Providers and confidentiality of
sample values; and
5) Review of data reporting systems to ensure that
the requirements of Appendix C are met within the
time periods specified in Chapter 2.
f) The PTOB shall send a draft report to the PT Provider
no later than fourteen (14) days after the completion
date of the inspection. The PTOB shall allow the PT
Provider seven (7) days to review and comment on the
draft if the PT Provider finds any discrepancies and
determines that revisions are necessary. The PTOB
shall then submit a final inspection report to the PT
Provider no later than thirty-five (35) days after the
completion of the on-site inspection. The final report
may only contain discrepancies and findings identified
during the on site inspection or discussed during the
exit briefing.
g) The PTOB shall allow the Provider no less than thirty
(30) days to submit their response to the report. In
order for the Provider's response to be considered
acceptable, the PTOB shall require that it include a
description of corrective actions necessary to meet the
criteria of Chapter 2, and Appendices A, B, and C.
D.2.3 Final Report Submittal NELAP and the PT Provider
No later than ninety (90) days after the completion date of
inspection, the PTOB shall submit to NELAP and to the
Provider a final report that includes the PTOB's final
inspection report, the Provider's response to the inspection
report, and the review of the initial application with
associated documents. The report shall also include the
PTOB's determination of whether the PT Provider is approved
to provide NELAC samples.
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D.3.0 PTOB Responsibilities Regarding Approval of PT
Providers
The PTOB shall utilize the appropriate final report and
associated documents submitted by the PT Provider to grant
or deny approval to that Provider.
D.4.0 PTOB RESPONSIBILITIES FOR ONGOING OVERSIGHT OF PT
PROVIDERS
The PTOB shall conduct ongoing oversight of all approved PT
Providers. The oversight shall include at a minimum:
a) the use of referee laboratories to verify the
concentrations of analytes in randomly selected PT
Provider samples;
b) the statistical monitoring of PT Provider's study data
to detect occurrences which indicate samples of
unacceptable quality, i.e., failure rates that exceed
expected norms, analyte standard deviations that exceed
expected intervals, and analyte mean recoveries which
are significantly above or below historical trends.
The ongoing monitoring criteria to be used by .the PTOB
will be developed by NELAC.
c) biannual on site audits of the PT provider review and
monitoring of critical operational parameters of the PT
provider, i.e., change in senior management, sale of
the company.
d) on site inspections of the PT provider for cause.
Based upon the results of its ongoing oversight, the PTOB
may determine that the Provider's approval status be
reevaluated.
D.5.0 PTOB's Annual Report on Provider Accreditation
Status
The PTOB shall submit an annual report to NELAP and all AA's
regarding the current accreditation status of PT Providers.
NELAP may request additional information regarding a
Provider including but not limited to: the PT Provider's
monitoring data as described in Section D.4, final
inspection reports and Provider responses, Initial
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Application Forms, the frequency and results of studies and
complaints received regarding a Provider.
D.6.0 DEVELOPMENT AND MAINTENANCE OF A COMPREHENSIVE PT
DATABASE
A comprehensive PT database will be developed and maintained
by the PTOB in conjunction with NELAC.
D.7.0 COMPLAINTS AND CORRECTIVE ACTION
The PTOB shall evaluate all complaints that it receives
regarding either approved or candidate PT Providers. If the
PTOB determines that a complaint warrants investigation, the
PTOB shall notify the Provider of the complaint. The PT
Provider is required to resolve the complaint to the
satisfaction of the PTOB within thirty (30) days from the
date the PTOB notifies the Provider. The PTOB shall provide
to NELAP a summary of all PT Provider complaints received
the previous year.
D.8.0 LIST OF APPROVED PT PROVIDERS
The PTOB shall maintain a list of approved PT Providers.
The list shall be maintained on a continuing basis on an
electronic bulletin board or similar means and will be
readily available to laboratories seeking NELAC
accreditation, state accrediting authorities and other
interested parties. PT Providers must agree to abide by the
provisions of NELAC regarding the advertising and marketing
use of the designation, "PTOB Approved Proficiency Test
Provider".
D.9.0 SPONSORSHIP OF ANNUAL NELAC PROFICIENCY TESTING
CAUCUS
The PTOB shall, in conjunction with NELAC, sponsor an annual
NELAC Proficiency Testing Caucus. The Caucus shall, if
possible, be held in conjunction with the annual NELAC
meeting. The purpose of the Caucus is to provide a forum
for PT Providers, Accrediting Authorities, laboratories,
federal agencies, and other interested parties to exchange
information regarding the PT study results of the previous
year. The Caucus shall include technical presentations and
open discussions on means to improve the Proficiency Testing
aspect of NELAC with a continuing goal of improving the
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quality of environmental data generated by the NELAC
accredited laboratories.
D.10.0 PTOB ETHICS
This section describes the overall ethics and standards of
conduct that must be adhered to in order for the PTOB to
implement and administer a successful PT Provider oversight
program. The PTOB shall serve as an impartial body designed
to objectively evaluate information about PT Providers and
use this information to make sound determinations regarding
Providers' approval status. The PTOB shall be able to
certify to any interested party that it is free of any
organizational or financial conflict of interest, which
would prevent it from complying with the requirements of
Appendix D. The PTOB shall remain unbiased in evaluating
information gathered and received including inspection
reports, referee sample results, complaints, and any other
information obtained regarding a PT Provider. The PTOB
shall evaluate all information gathered and received about a
Provider related to providing NELAC PT samples, and
determine which information is relevant to the approval
status of a Provider, and provide that information to NELAP,
the AAs, the laboratories, and the public as appropriate.
D.11.0 CONFIDENTIALITY
A portion of the information provided to the PTOB by the PT
Provider in the course of its inspection and oversight
activities will be proprietary in nature. The PTOB will
agree to maintain the confidentiality of proprietary
information provided to it by the PT provider.
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TABLE OF CONTENTS
ON-SITE ASSESSMENT
3.0 ON-SITE ASSESSMENT 1
3.1 INTRODUCTION . . . . ', 1
3.2 ON-SITE ASSESSMENT PERSONNEL 1
3.2.1 Training 1
3.2.2 Basic Qualifications 2
3.2.3 Additional qualifications 2
3.2.4 Assessor Qualification 3
3.3 FREQUENCY OF ON-SITE ASSESSMENTS 3
3.3.1 Frequency 3
3.3.2 Follow-Up Assessments 3
3.3.3 Changes In Laboratory Capabilities 4
3.3.4 Announced and Unannounced Visits 4
3.4 PRE-ASSESSMENT PROCEDURES 4
3.4.1 Assessment Planning 4
3.4.2 Scope of the Assessment 5
3.4.2.1 Laboratory Assessments 5
3.4.2.2 Records Review 5
3.4.3 Information Collection and Review 5
3.4.4 Assessment Documents 6
3.4.5 Confidential Business Information (CBI)
Considerations 6
3.5 ASSESSMENT SCHEDULE/FORMAT 9
3.5.1 Length of Assessment 9
3.5.2 Opening Conference 9
3.5.3 Records Review 10
3.5.4 Staff Interviews 11
3.5.5 Closing Conference 12
3.5.6 Follow-up Procedures 12
3.5.7 Assessment Closure 12
3.6 STANDARDS FOR ASSESSMENT 13
3.6.1 Assessor's Training Manual 13
3.6.2 Assessor's Role 13
3.6.3 Checklists 14
3.6.4 Assessment Standards 14
3.7 DOCUMENTATION OF ON-SITE ASSESSMENT 15
3.7.1 Checklists 15
3.7.2 Report Format 15
3.7.3 Distribution 16
3.7.4 Report Deadline 16
3.7.5 Release of Report 17
3.7.6 Record Retention Time 17
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3.0 ON-SITE ASSESSMENT
3.1 INTRODUCTION
The on-site assessment is an integral and requisite part of
a laboratory 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 and evaluate information and
make observations which will be used to judge the
laboratory's conformance with established accreditation
standards.
It is essential that the on-site assessment conducted by any
accrediting authority in the United States wishing to be
recognized by the National Environmental Laboratory
Accreditation Program be conducted in a uniform, consistent
manner. Reasons for fostering this consistency include a
need to assure the base quality of data coming from the
laboratories; to allow more confident comparison of results
generated by different laboratories; to facilitate
reciprocity; and for the laboratory community to accept the
accreditation standards.
This section describes the essential elements that are to be
included in any acceptable on-site assessment and the
qualifications and requirements for assessors.
The responsibility for promulgating and enforcing
.occupational safety and health standards rests with the U.S.
Department of Labor. While it is not within the scope of
the assessment team to evaluate all health and safety
regulations, any obviously unsafe condition(s) observed
should be described to the appropriate laboratory official
and reported to the accrediting authority. The
accreditation on-site assessment is not intended to certify
that the laboratory is in compliance with any applicable
health and safety regulations.
3.2 ON-SITE ASSESSMENT PERSONNEL
3.2.1 Training
The National Environmental Laboratory Accreditation
Conference (NELAC) specifies the minimum level of education
and training for assessors, including refresher/update
training. The NELAC also develops standards for training
requirements. The assessor training program will be
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developed and implemented by either accrediting authorities,
accrediting bodies, or other entities. All assessor
training programs, must meet the NELAC standards.
Until such time as the NELAC has developed and published
training requirements for laboratory assessors, each
accrediting authority shall approve the training and
experience requirements for each of its assessors (federal,
state and/or third party).
When the NELAC has completed the development of assessor
training program standards, accrediting authorities,
accrediting bodies, or other entities may petition the NELAP
for approval of various formal training programs which meet
the NELAC standards.
3.2.2 Basic Qualifications
A laboratory assessor may work for a Federal, State, or a
third party assessor body. An assessor must be an
experienced professional and hold at least a B.S. degree in
a basic science, or have equivalent education and experience
in laboratory assessment or related fields.
Each assessor must also have satisfactorily completed an
approved assessor training program and take periodic
update/refresher training, as specified by NELAC. Each new
candidate assessor must undergo training with a qualified
assessor during four or more actual assessments until judged
proficient by the accrediting authority. Assessors employed
by accrediting authorities (either directly or third party)
when the authority is granted NELAP recognition (see section
6.7) are exempt from the requirement to undergo training
with a qualified assessor during four or more actual on-site
assessments, provided they have previously conducted four
assessments and been judged proficient by the accrediting
authority. Assessors employed by accrediting authorities on
the date the NELAP is fully operational must meet the
education, experience and training requirements specified in
this section within five years of that date.
3.2.3 Additional qualifications
In addition, the assessors must:
a) Be familiar with the relevant legal regulations,
accreditation procedures, and accreditation
requirements;
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b) Have a thorough knowledge of the relevant assessment
methods and assessment documents;
c) Be thoroughly familiar with the various forms of
records described in Section 3.5.3 - Records Review;
d) Be thoroughly cognizant of data reporting, analysis,
and reduction techniques and procedures;
e) Be technically conversant with the specific tests or
types of tests for which the accreditation is sought
and, where relevant, with the associated sampling and
preservation procedures; and
f) Be able to communicate effectively, both orally and in
writing.
3.2.4 Assessor Qualification
Before an assessor can conduct on-site assessments, the
individual must be qualified by an accrediting authority.
Each assessor must sign a statement before conducting an
assessment certifying that no conflict of interest exists
and provide any supporting information as required .by the
accrediting authority. Failure to provide this information
will make the proposed assessor ineligible to participate in
the assessment program.
3.3 FREQUENCY OF ON-SITE ASSESSMENTS
3.3.1 Frequency
Accrediting authorities must require a comprehensive on-site
assessment of each facility that is accredited at least
every two years. Assessments may be conducted more
frequently for cause, at the option of the accrediting
authority.
3.3.2 Follow-Up Assessments
In addition to routine assessments, assessors may need to
conduct follow-up assessments at laboratories where a
deficiency was identified by the previous assessment. These
assessments may be, but are not necessarily limited to,
determining whether a laboratory has corrected its
deficiency(ies), or determining the merit of a formal appeal
from the laboratory. When deficiencies are of such severity
as to possibly warrant the downgrading of a laboratory's
accreditation status, any follow-up assessment that is
planned or conducted should be completed and reported within
forty-five days after the original assessment.
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Nothing in this section should be construed as requiring an
accrediting authority to reassess a facility prior to taking
a regulatory or administrative action affecting the status
of the facility's accreditation. Nothing in this section
should be construed as limiting in any way the accrediting
authorities ability to revoke or otherwise limit a
laboratory's accreditation upon the identification of such
deficiencies as to warrant such action.
3.3.3 Changes In Laboratory Capabilities
The accrediting authority may also deem necessary an
assessment when a major change occurs at a laboratory in
personnel, equipment, or in a laboratory's location that
might alter or impair analytical capability and quality.
3.3.4 Announced and Unannounced Visits
The accrediting authority, at its discretion, may conduct
either unannounced or announced on-site assessments. The
accrediting authority is not required to provide advance
notice of an assessment.
3.4 PRE-ASSESSMENT PROCEDURES
3.4.1 Assessment Planning
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. Planning includes
conducting a thorough review of NELAP and/or State records
pertaining to the laboratory to be inspected. This may save
time because familiarity with the operation, history, and
compliance status of the laboratory increases the efficiency
and focus of an on-site visit.
Pre-assessment activities include: deciding the scope of the
assessment; reviewing NELAP/State information; providing
advance notification of the assessment to the laboratory,
when appropriate; obtaining any security clearances which
may be necessary; coordinating the assessment team; and
gathering assessment documents. Section 3.4.5 discusses
Confidential Business Information (CBI) issues.
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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
assessment may be a general one to determine the capability
of the laboratory to perform environmental testing or a
specific examination of a certain area of testing. The
assessment must include both an appraisal of the
laboratory's operations and a review of the appropriate
records. The assessment for a field of testing must cover
all of the tests for which the laboratory seeks
accreditation.
3.4.2.1 Laboratory Assessments
A laboratory assessment must review the ability of the lab
to conduct environmental testing. The examination of the
systems/ processes and procedures of the laboratory should
give a general sense of its past and present capabilities to
perform work of known and documented quality. During a
laboratory assessment, 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 NELAC standards.
3.4.2.2 Records Review
The purpose of a records review is to determine whether the
testing laboratory has maintained necessary documentation of
data and other information to technically substantiate
reports previously issued. During a records review, the
assessment team will conduct an overall audit of data and
will compare data with submitted reports to determine
whether the data were collected, generated, and reported
following the NELAC standards.
3.4.3 Information Collection and Review
Prior to initiating an on-site assessment, the assessment
team shall make determinations as to which laboratory
records they wish to review prior to the actual site visit.
These records, from the files of the accrediting authority,
the national laboratory accreditation database, or the
laboratory itself may include, but are not limited to:
a) Copies of previous assessment reports and proficiency
testing sample results;
b) General laboratory information such as laboratory
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submitted self-assessment forms, SOPs and Quality
Assurance Plan(s);
c) Official laboratory communications and associated
records with appropriate accrediting authority staff.
d) Available documents from recipients of reports from the
laboratory;
e) The laboratory's application for accreditation;
f) The existing program regulations and special
requirements that apply to the areas for which
accreditation is sought (i.e. security clearances,
radioactive exposure protocols, etc.); and
g) The most recently approved analytical methods for the
tests for which the laboratory has requested
accreditation.
3.4.4 Assessment Documents
Documents necessary for the assessment and which may need to
be provided to the laboratory management or staff should be
assembled before the assessment, whenever possible. The
lead assessor should obtain copies of the required
assessment forms, including the NELAC-approved checklist(s).
Other types of documents that may be required include:
• Assessment Confidentiality Notice and Declaration
(Appendix B);
• Conflict of Interest Form;
• Assessor Credentials;
• Assessment Assignment(s) ;
• Assessment Notification Letter;
• Attendance Sheet(s) (opening and closing
conference); and
• Assessment Appraisal Form.
In addition, the lead assessor should be able to provide
information about how to obtain copies of documents and
materials associated with an assessment from the accrediting
authority.
3.4.5 Confidential Business Information (CBI)
Considerations
During on-site assessments, on-site assessors may come into
possession of information claimed as business confidential.
The EPA regulations for handling confidential business
information are detailed in Title 40, Code of Federal
Regulations. Part 2, Subpart B and will be followed in NELAP
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related matters. Subpart B defines a business
confidentiality claim as "a claim or allegation that
business information is entitled to confidential treatment
for reasons of business confidentiality, or a request for a
determination that such information is entitled to such
treatment."
NELAC standards must, consistent with 40CFR Part 2, protect
Confidential Business Information (CBI) from disclosure.
For this information to be adequately protected, certain
actions are required, by NELAP, on-site assessors and the
laboratory. The lead assessor must provide a NELAP
assessment confidentiality notice to the responsible
laboratory official at the beginning of the assessment.
This notice informs laboratory officials of their right to
claim any portion of the information requested during the
assessment data as CBI. NELAP personnel, assessors and
other users of said information must have CBI training. The
assessors should be familiar with the procedures for
asserting a CBI claim and handling information which contain
the information claimed as CBI. The lead assessor must take
custody of all CBI information 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, who must also treat such
information as CBI, until an official determination has been
made in accordance with federal and/or state law.
Certain actions are required of the responsible laboratory
official when claiming information as business confidential.
The laboratory representative must place on (or attach to)
the information at the time it is submitted to the assessor,
a cover sheet, stamped or typed legend, or other suitable
form of notice, employing language such as "trade secret",
"proprietary" or "company confidential". Allegedly
confidential portions of otherwise non-confidential
information should be clearly identified by the business,
and may be submitted separately to facilitate identification
and handling by the assessor. CBI may be purged of
references to client identity by the responsible laboratory
official at the time of removal from the laboratory.
However, sample identifiers may not be obscured from the
information. If the information claimed as business
confidential suggests the need for further action, the
information may be forwarded to the appropriate agency which
may take further action outside the scope of the
accreditation process, to obtain the client's identity. If
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the information claimed as business confidential suggests
the need for further enforcement action, the accrediting
authority is responsible for ensuring that all CBI issues
are handled in accordance with NELAC standards.
If a business confidentiality claim is received after the
on-site assessment by the accrediting authority, the
authority should make such efforts as are administratively
practical to associate the late claim with copies of the
previously submitted information in its files. However the
accrediting authority cannot assure that such efforts will
be effective in light of the possibility of prior disclosure
or dissemination of the information.
It is not the responsibility of the on-site assessor to make
any determination with respect to the validity of a
confidential business information claim; this responsibility
rests with the accrediting authority. The assessor must
maintain custody of CBI-claimed information collected during
the assessment until they are delivered to an authorized
official of the accrediting authority. CBI-claimed
information may be the intellectual property of the
laboratory. Therefore, all CBI-claimed information must be
held in a secure manner throughout the holding period of
assessment records and may not be reproduced or distributed
inconsistent with 40CFR Part 2. If the accrediting
authority questions the claim that certain information are
CBI, the host laboratory must be contacted and given 15
working days to:
(1) provide justification of their claim to CBI,
(2) remove the claim of CBI,
(3) resolve the issue in a manner agreeable to both
the laboratory and the accrediting authority,
(4) engage legal assistance,
(5) appeal the action to NELAP, or
(6) withdraw their NELAC accreditation application for
the field of testing associated with the CBI
information.
In no instance may the accrediting authority declassify CBI-
claimed information without notification of the laboratory.
If the responsible laboratory official does not consent to
declassification of the CBI-claimed information, the
laboratory may pursue any or all of the above stated
actions.
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3.5 ASSESSMENT SCHEDULE/FORMAT
3.5.1 Length of Assessment
The length of an on-site assessment will depend upon a
number of factors such as the number of tests for which a
laboratory desires accreditation, 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 assessor body
should assign an adequate number of assessors to complete
the assessment within a reasonable period of time.
Assessors must strike a balance between thoroughness and
practicality, but in all cases must determine to what effect
the laboratories' operations meet NELAC standards.
3.5.2 Opening Conference
Arrival at the facility should normally occur during
established working hours. The responsible laboratory
official(s) should be located as soon as the assessment team
arrives on the premises.
A laboratory's refusal to admit the assessment team for an
assessment will result in an automatic failure of the
laboratory to receive accreditation or loss of an existing
accreditation by the laboratory, unless there are
extenuating circumstances that are accepted and documented
by the accreditation authority. The team leader must notify
the accrediting authority as soon as possible after refusal
of entry.
An opening conference must be conducted and shall address
the following topics:
a) the purpose of the assessment;
b) the identification of the assessment team;
c) the tests that will be examined;
d) any pertinent records and operating procedures to be
examined during the assessment and the names of the
individuals in the laboratory responsible for providing
the assessment team with the necessary documentation;
e) the roles and responsibilities of key managers and
staff in the laboratory;
f) the procedures related to Confidential Business
Information;
g) any special safety procedures that the laboratory may
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think necessary for the protection of the assessment
team while in certain parts of the facility (under no
circumstance is an assessment team required or even
allowed to sign any waiver of responsibility on the
part of the laboratory for injuries incurred by a team
member during an inspection to gain access to the
facility);
h) the standards that will be used by the assessors in
judging the adequacy of the laboratory operation;
i) confirmation of the tentative time for the exit
conference;
j) provision of the assessment appraisal form to the
responsible laboratory official (to be submitted to
NELAP and the accrediting authority); and
k) discussion of any questions the laboratory may have
about the assessment process.
3.5.3 Records Review
Records will be reviewed by assessment team members for
accuracy, completeness and the use of proper methodology for
each test and analyte to be evaluated.
A minimum record set that must be examined as part of a '
accreditation assessment includes;
a) application for accreditation from the laboratory;
b) previous assessment results and reports including
proficiency testing results;
c) laboratory management structure and chains of
responsibility (e.g. organizational charts);
d) qualifications statements of all key staff involved in
the analysis or reporting of results for which
accreditation has been requested and a matching of the
staff qualifications with the statements submitted with
the applications;
e) quality assurance plan(s) for the laboratory;
f) standard operating procedures and methodologies for
each parameter for which accreditation is sought;
g) maintenance and calibration records of specific pieces
of laboratory equipment separate and apart from that
encompassed in analyte specific records;
h) procedures.for the make-up and calibration of stock
solutions and standard reagents;
i) origins, purities, assays and expiration dates of
primary standards, analytical reagents and standard
reference materials;
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j) records associated with method-specific QA\QC
requirements;
k) the specific records associated with the initial method
validation study in the laboratory which must be
examined in detail with the historical calibration
data;
1) records associated with the methods used to estimate
precision and accuracy in general for specific
analyses;
m) sample receipt and handling documentation;
n) proficiency testing sample receipt and handling
procedures;
o) information about the proficiency testing providers;
p) records of any internal audits conducted or corrective
actions taken by the laboratory itself; and
q) the report of the laboratory's annual management
review.
The laboratory must mark all confidential information. The
lead assessor must handle it as required by appropriate laws
and regulations. 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 noted above is confidential, the
information should be treated as confidential until a ruling
can be made by the accreditation authority.
3.5.4 Staff Interviews
As an element of the assessment process, the assessment team
should evaluate an analysis regimen by requesting that the
analyst normally conducting the procedure give a step-by-
step description of exactly what is done and what equipment
and supplies are needed to complete the regimen. Any
deficiencies shall be noted and discussed with the analyst.
The deficiencies will also be discussed in the closing
conference.
The assessment team members shall have the authority to
conduct interviews with any/all staff. Calculations, data
transfers, calibration procedures, quality control/assurance
practices, adherence to SOPs and report preparation shall
be assessed for each test with the appropriate analysts(s).
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3.5.5 Closing Conference
The assessment team must meet with representative(s) of the
laboratory following the assessment for an informal
debriefing and discussion of findings with the possible
exception of any issues of improper and/or potentially
illegal activity which may be the subject of further action.
It should be noted that the assessment team in no way limits
its ability to identify additional problem areas in the
final report should it become necessary.
In the event the laboratory disagrees with the findings of
the assessor(s), and the team leader adheres to the original
findings, the deficiencies with which the laboratory takes
exception shall be documented by the team leader and
included in the report to the accreditation authority for
consideration. The accrediting authority will make the
final determination as to the validity of the contested
elements.
The assessment team should inform the laboratory
representative(s) that an assessment report encompassing all
relevant information concerning the ability of the applicant
laboratory to comply with the accreditation requirements is
forthcoming.
3.5.6 Follow-up Procedures
The accrediting authority will issue the assessment report
to the applicant laboratory outlining any area of
deficiency. The applicant laboratory must then submit a
plan of corrective action and supporting documentation that
meet applicable NELAC standards to address all deficiencies
noted in the report not later than thirty days from when the
report is received (see Section 4.1.3.b).
3.5.7 Assessment Closure
After reviewing the assessor's report(s) and any completed
corrective action(s) reported by the laboratory, the
accrediting authority will make the determination of the
accreditation status for a laboratory.
If the deficiencies listed are substantial or numerous, an
additional on-site assessment may be conducted before a
final decision for accreditation can be made.
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3 . 6 STANDARDS FOR ASSESSMENT
3.6.1 Assessor's Training Manual
The NELAP Assessor Training Manual is presented in Appendix
A. The manual will be used when assessors take the NELAC
required basic training (Section 3.2.1) and will serve as a
reference for on-site assessment personnel.
The manual for on-site assessors includes instructions for
evaluating the following items:
a) Size, appearance, and 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) Listing/inventory, condition, and performance of
laboratory instrumentation and equipment;
f) Source, traceability and preparation of
calibration/verification standards;
g) Test methods (Including the adequacy of the
laboratory's standard operating procedures as well as
confirmation of the analyst's adherence to SOPs, and
the analyst's proficiency with the described task);
h) Data reduction procedures, including an examination of
raw data and confirmation that final reported results
are derived from raw data and original observations;
i) Quality assurance/quality control procedures, including
adherence to the laboratory's quality assurance plan
and adequacy of the plan;
3.6.2 Assessor's Role
When performing an on-site laboratory assessment, the
assessor must appraise each of the areas listed in Section
3.6.1 and perform a thorough assessment of the records for
each of the tests for which accreditation has been
requested.
The on-site assessor should use a variety of tools in the
assessment process. The experience of the assessor, his/her
observations, interviews with laboratory staff, and
examination of SOPs, raw data, and the laboratory's
documentation all play important roles in the assessment.
The accreditation of a particular laboratory will depend to
a large extent on the assessment team's findings and
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recommendations. Much of the on-site assessment will depend
upon the assessor's observations of existing conditions.
The recommendation not to accredit a laboratory, or to
change a laboratory's accreditation status, must be based on
factual information and not upon subjective evaluations.
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 in
the report of the on-site assessment.
The assessment team must use specific documentation in its
reporting of deficiencies. The assessor should discuss any
deficiencies with the laboratory's management at the exit
conference.
During the assessment, sufficient information may become
available to suspect 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 further action may be necessary.
In the event that evidence of improper and/or potentially
illegal activities have or may have occurred, the assessment
team should present such information to the accrediting
authority for appropriate action(s). These issues, at the
discretion of the accrediting authority, may or may not be
subjects or issues of the closing conference. However, the
assessor should continue to gather the information necessary
to complete the accreditation assessment.
3.6.3 Checklists
Standardized checklists must be used for the on-site
assessment. The use of checklists does not replace the need
for assessor observations and staff interviews, but is
another tool which assists in conducting a thorough and
efficient assessment. A checklist is not a substitute for
assessor training and experience.
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 test methods.
3.6.4 Assessment Standards
The areas to be evaluated in an on-site assessment shall
include:
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a) Size, appearance, and 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, and performance of laboratory
instrumentation and equipment;
f) Preparation and traceability of calibration standards;
g) Test methods (Including the adequacy of the
laboratory's standard operating procedures as well as
confirmation of the analyst(s) adherence to SOPs, and
the analyst(s) proficiency with the described task);
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(s)
and adequacy of the plan(s);
These areas should be evaluated against the standards
detailed in Section 5, Quality Systems, of the NELAC
Standards. Additional information on the process for
evaluating these areas can be found in the Assessors Manual
(Section 3.6.1).
3.7 DOCUMENTATION OF ON-SITE ASSESSMENT
3.7.1 Checklists
The checklists used by the assessors during the assessment
shall become a part of the permanent file kept by the
accrediting authority for each laboratory.
3.7.2 Report Format
The final site visit report shall be written to contain a
description of the adequacy of the laboratory as it relates
to the assessment standards in Section 3.6.4. Assessment
reports should be generated in a narrative format.
Deficiencies must be addressed at a minimum. Documentation
of existing conditions at the laboratory should be included
in each report to serve as a baseline for future contacts
with the facility.
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Assessment reports will contain:
a) Identification of the organization assessed (name
and address),
b) Date of the assessment,
c) Identification and affiliation of each assessment
team member,
d) Identification of participants in the assessment
process,
e) Statement of the objective of the assessment,
f) Summary,
g) Assessment findings (deficiencies) and
requirements, and
h) Comments and recommendations.
The Findings and Requirements Section must be referenced to
a NELAC standard so that both the finding (deficiency) is
understood and the specific requirement is outlined. The
team leader shall assure that the results within the final
report conform to established standards for the evaluated
parameters.
The Comments and Recommendations Section can be used to
convey recommendations aimed at helping the laboratory
improve.
3.7.3 Distribution
The accrediting authority shall be recognized as having the
responsibility for the distribution of the assessment
reports. The assessment team leader shall compile, edit and
submit the final report to the accrediting authority.
3.7.4 Report Deadline
No more than thirty (30) days shall elapse from the
completion of the assessment until the report is completed
by the accrediting authority and copies are transmitted to
the laboratory and the National Accreditation Database. An
exception to this deadline may be necessary in those
circumstances where an investigation or other action has
been initiated by the accrediting authority, in which case
the laboratory must be notified.
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3.7.5 Release of Report
On-site assessment reports should be released initially by
the accrediting authority only. The reports will be
released to the responsible laboratory official(s). The
assessment report shall not be released to the public until
findings of the assessment have been finalized, all
Confidential Business Information has been stricken from the
report in accordance with prescribed procedures, and the
report has been provided to the laboratory.
In accordance with the Freedom of Information requirements,
any documentation adjudged to be proprietary, financial
and/or trade information, or relevant to an ongoing
enforcement investigation, will be considered exempt from
release to the public.
3.7.6 Record Retention Time
Copies of all assessment reports, checklists, and laboratory
responses must be retained by the assessors and the
accrediting authority for a period of at least ten years,
or longer if required by specific State or Federal
regulations.
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ON-SITE ASSESSMENT
APPENDIX A
ASSESSOR TRAINING MANUAL
(Note: To be included after review by
the committee)
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ON-SITE ASSESSMENT
APPENDIX B
CBI FORMS
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1. ASSESSMENT IDENTIFICATION
Date
Assessor No.
Daily Seq. No.
3. ASSESSOR NAME
5. ASSESSOR ADDRESS
2. LABORATORY NAME
4. LABORATORY ADDRESS
6. CHIEF EXECUTIVE OFFICER NAME
TITTLE
NATIONAL ENVIRONMENTAL LABORATORY ACCREDITATION PROGRAM
ASSESSMENT CONFIDENTIALITY NOTICE
TO ASSERT A CONFIDENTIALITY BUSINESS INFORMATION CLAIM
It is possible that NELAP will receive public requests for release of the information obtained during assessment of the facility above. Such requests will be
handled by NELAP in accordance with provisions of the Freedom of Information Act (FOIA), 5 USC 552 and Section 3.0 of the NELAP guidelines.
NELAP is required to make assessment data available in response to FOIA requests unless the NELAP determines mat the data contain information entitled
to confidential treatment or may be withheld from release under other exceptions of FOIA
Any or all information collected by NELAP during the assessment may be claimed confidential if it relates to trade secrets or commercial or financial
matters mat you consider to be confidential business information. If you assert a CBI claim, NELAP will disclose the information only to the extent, and by
means of the procedures set forth in the regulations and guidelines (cited above) governing NELAP's treatment of confidential business information.
Among other things, the regulations require that NELAP notify you in advance of publicly disclosing any information you have claimed as confidential
business information.
A confidential business information (CBI) claim may be asserted at any time. You may assert a CBI claim prior to, during, or after the information is
collected. The declaration form was developed by the NELAC to assist you in asserting a CBI claim. If it is more convenient for you to assert a CBI claim
on your own stationary or by marking the individual documents or samples "NELAP confidential business information," it is not necessary for you to use
this form. The assessor will be glad to answer any questions you may have regarding the NELAP's CBI procedures.
While you may claim any collected information or sample as confidential business information, such claims are unlikely to be upheld if they are challenged
unless the information meets the following criteria:
1. Your company has taken measures to protect the confidentiality of the information, and ft intends to continue to take such measures.
2. The information is not, and has not been, reasonably obtainable without your company's consent by other persons (other than governmental bodies) by
use of legitimate means (other than discovery based on showing of special need in a judicial or quasi-judicial proceeding).
3. The information is not publicly available elsewhere.
4. Disclosure of the information would cause substantial harm to you company's competitive position.
At the completion of the assessment, you will be given a receipt for all documents, samples, and other materials collected. At that time, you may make
claims that some or all of the information is confidential business information.
If your are not authorized by your company to assert a CBI claim, this notice will be sent by certified mail, along with the receipt for documents, samples,
and other materials to the Chief Executive Officer of your firm within 2 days of this date. The Chief Executive Officer must return a statement specifying
any information which should receive confidential treatment
The statement from the Chief Executive Officer should be addressed to:
and mailed by registered, return-receipt requested mail within 7 calendar days of receipt of this Notice. Claims may be made any time after the assessment
but assessment data will not be entered into the special security system for NELAP confidential business information until an official confidentiality claim
is made. The data will be handled under the agency's routine security system unless and until a claim is made.
TO BE COMPLETED BY FACILITY OFFICIAL RECEIVING THIS
NOTICE
I have received and read this notice.
SIGNATURE
NAME
TITLE
DATE SIGNED
If there is no one on the premises of the facility who is authorized to
make business confidentiality claims for the firm, a copy of this Notice
and other assessment materials will be sent to the company's chief
executive officer. If there is another company official who should also
receive this information, please designate below.
NAME
TITLE
ADDRESS
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NATIONAL ENVIRONMENTAL LABORATORY ACCREDITATION PROGRAM
ASSESSMENT CONFIDENTIALITY NOTICE
1. ASSESSMENT IDENTIFICATION
2. LABORATORY NAME
Date
Assessor No.
Daily Seq. No.
4. LABORATORY ADDRESS
3. ASSESSOR NAME
6. CHIEF EXECUTIVE OFFICERNAME
5. ASSESSOR ADDRESS
7. TITLE
INFORMATION DESIGNATED AS CONFIDENTIAL
No.
DESCRIPTION
ACKNOWLEDGMENT BY CLAIMANT
The undersigned acknowledges that the information described above is designated as Confidential Business Information under Section 3.4.5 of the NELAC
guidelines. The undersigned further acknowledges that he/she is authorized to make such claims for his/her firm.
The undersigned understands that challenges to confidentiality claims may be made, and that claims are not likely to be upheld unless the information meets
the following guidelines: (1) The company has taken measures to protect the confidentiality of the information and it intends to continue to take such
measures; (2) The information is not, and has not been reasonably attainable without the company's consent by other persons (other than governmental
bodies) by use of legitimate means (other than discovery based on a showing of special need in a judicial or quasi-judicial proceeding); (3) The information
is not publicly available elsewhere; and (4) Disclosure of the information would cause substantial harm to the company's competitive position.
TO BE COMPLETED BY FACILITY OFFICIAL RECEIVING THIS
NOTICE
I have received and read this notice (signature):
If there is no one on the premises of the facility who is authorized to
make business confidentiality claims for the firm, a copy of this Notice
and other assessment materials will be sent to the company's chief
executive officer. If there is another company official who should also
receive this information, please designate below.
ASSESSOR'S SIGNATURE
NAME
NAME
TITLE
TITLE
DATE
ADDRESS
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Accreditation Process
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TABLE OF CONTENTS
Accreditation Process
4.0 ACCREDITATION PROCESS 1
4.1 COMPONENTS OF ACCREDITATION 1
4.1.1 Personnel Qualification 1
4.1.1.1 Definition, responsible party of record.
1
4.1.2 On-site Assessments 2
4.1.3 Corrective Action Reports In Response to On-
Site Assessment 3
4.1.4 Proficiency Testing Samples 4
4.1.5 Accountability for Analytical Standards ... 5
4.1.6 Fee Process for National Accreditation ... 6
4.1.7 Application 6
4.1.8 Change of Ownership and/or Location of
Laboratory ..... 7
4.1.9 "Certification of Compliance" Statement ... 9
4.2 PERIOD OF ACCREDITATION 10
4.3 MAINTAINING ACCREDITATION 11
4.3.1 Quality Systems 11
4.3.2 Notification and Reporting Requirements . . 11
4.3.3 Record Keeping and Retention 12
4.4 DENIAL, SUSPENSION, AND REVOCATION OF ACCREDITATION
12
4.4.1 Denial 12
4.4.2 Suspension 13
4.4.3 Revocation 14
4.4.4 Voluntary Withdrawal 16
4.5 INTERIM ACCREDITATION 16
4.5.1 Interim Accreditation 16
4.5.2 Revocation of Interim Accreditation ... 16
4.6 AWARDING OF ACCREDITATION 16
4.6.1 The Certificate of Accreditation 17
4.6.2 Changes in Fields of Testing 17
4.7 ENFORCEMENT 17
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4.0 ACCREDITATION PROCESS
(NB. MANY OF THE STANDARDS AND ELEMENTS LISTED IN THIS
CHAPTER ARE REFLECTIVE OF STANDARDS SET FORTH IN CHAPTERS
DEALING WITH DETAILED EXPLANATIONS OF THESE ELEMENTS.
THEREFORE, IT IS ANTICIPATED THAT SOME OF THE DETAILS MAY
CHANGE AS THE DISCUSSIONS AND CONCLUSIONS IN THESE CHAPTERS
CHANGE.)
4.1 COMPONENTS OF ACCREDITATION
The components of accreditation include review of personnel
qualifications, on-site assessment, proficiency testing and
quality assurance/quality control standards. These criteria
must be fulfilled for accreditation. The components and
criteria are herein described. Details of some of the
requirements described below will be found in other sections
of these Standards.
4.1.1 Personnel Qualification
A person who does not meet the education credential
requirements of 4.1.1 of the NELAC compliant standards and
is the responsible party or assistant responsible party on
the date that the laboratory becomes subject to these
regulations, may qualify as director/assistant director of
that laboratory if that laboratory can demonstrate the
ability to comply with the Accrediting Authority's
proficiency testing and quality control requirements and
possesses the requisite experience.
4.1.1.1 Definition, responsible party of record.
The responsible party of record means a full-time member of
the staff of an environmental laboratory who exercises
actual day-to-day supervision of laboratory procedures and
reporting of results. The title of such person may include
but is not limited to laboratory director, technical
director, laboratory supervisor or laboratory manager.
His/her name must appear in the national database. This
person's duties shall include, but not be limited to,
monitoring standards of performance in quality control and
quality assurance; monitoring the validity of the analyses
performed and data generated in the laboratory to assure
reliable data; ensuring that sufficient numbers of qualified
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personnel are employed to supervise and perform the work of
the laboratory; and providing educational direction to
laboratory staff. An individual may not be the responsible
party of record of more than one approved environmental
laboratory without authorization from the Accrediting
Authority. Circumstances to be considered in the decision
to grant such authorization may include, but not be limited
to, the extent to which operating hours of the laboratories
to be directed overlap, adequacy of supervision in each
laboratory, and the availability of environmental laboratory
services in the area served. A responsible party of record
who is absent for a period of time exceeding 10 consecutive
business days shall designate another full-time staff member
meeting the qualifications of responsible party of record to
temporarily perform this function. If this absence exceeds
45 consecutive business days, the authority shall be
notified in writing.
4.1.2 On-site Assessments
On-site assessments are a requirement of the Accreditation
Process and a summary of the process requirements are
described. Refer to On-Site Assessment (Chapter 3) for
additional information regarding frequency, procedures,
criteria, scheduling and documentation of on-site
assessments. On-Site assessments may be of two types:
announced and unannounced. The on-site assessment of each
accredited facility must be performed a minimum of one time
per two years. On-site assessments may be conducted more
frequently for cause or at the option of the accrediting
authority. Situations which might trigger more frequent on-
site assessments include, review of a previously deficient
on-site assessment, poor performance on a PT sample, change
in other accreditation elements, or other information
concerning the capabilities or practices of the accredited
laboratory. 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.
The responsibility and accountability for meeting the NELAC
standards are the responsibility of the primary accrediting
authority. The primary accrediting authority has the
responsibility for conducting on-site assessments for
national accreditation based on the following factors:
a) Individual sites are subject to the same application
process, fees, assessments and other requirements as
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environmental laboratories. Any remote laboratory
sites are considered separate sites and subject to
separate on-site assessments, again provided that the
analysis or any portion of the analysis take place at
that site. A location that only does sample collections
is not considered an environmental laboratory and will
not be subject to these requirements;
b) The assessment may consist of all of the fields of
testing and/or methods for which the laboratory wants
to obtain accreditation;
c) The laboratory may be required to analyze PT samples
during the on-site assessment under the observation of
an assessor;
d) The number of assessors conducting the on-site
assessment should be appropriate for the laboratory's
scope and testing, and the accrediting authority should
be sensitive to fee structure/ cost, and the number of
assessors;
e) The on-site assessment should be conducted during
normal working hours.
Laboratories will be furnished with a report documenting any
deficiencies found by the assessor. This will be known as a
Deficiency Report. It should be noted, the assessor is not
limited to these factors in reaching an evaluation and
conclusion. Other factors may be considered and must be
documented as appropriate. All such reports are public
record and any or all of the information contained therein
may be put into the National Database.
4.1.3 Corrective Action Reports In Response to On-Site
Assessment
A Corrective Action Report must be submitted by the
laboratory to the accrediting authority in response to any
Deficiency Report received by the facility after an on-site
assessment. The report will include the action that the
laboratory will implement to correct each deficiency and the
time period required to accomplish the corrective action.
a) The accrediting authority or authorized third party
must present a Deficiency Report to the laboratory
within 30 working days of the assessment.
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b) After being notified of deficiencies, the laboratory
will have 30 working days from the date of receipt of
the report to provide a Corrective Action Report to
correct deficiencies noted in the Deficiency Report.
c) The accrediting authority will respond to the action
noted in the Corrective Action Report within 30 working
days of receiving it.
d) If the corrective action report (or a portion) is
deemed unacceptable to remediate a deficiency the
laboratory will have an additional 30 working days to
submit a revised corrective action report.
e) If the corrective action report is not acceptable to
the accrediting authority after the second submittal,
the laboratory can have accreditation revoked pursuant
to Section 4.4.3 for all or any portion of its scope of
accreditation for any or all of a category or a method
within a category.
f) 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 NELAP would have access to this information
through a national database.
g) If the laboratory fails to implement corrective actions
to correct deficiencies noted within the required time
period, accreditation for categories or specific
methods within those categories will be revoked. All
such reports are public record and any or all of the
information contained therein may be put into the
National Database. Proprietary data and Confidential
Business Information will be excepted from all public
records.
4.1.4 Proficiency Testing Samples
When appropriate for the evaluation and available, a
critical component of laboratory assessments is the analysis
of proficiency testing (PT) samples. Refer to Proficiency
Testing (Chapter 2) for additional information. PT samples
are used and evaluated in the accreditation process as •
follows:
a) Each laboratory seeking accreditation must receive, and
analyze initial PT samples from a NELAP approved PT
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study provider for each field of testing (program-
mat rix-analyte) in which they are requesting
accreditation.
b) Each laboratory seeking or maintaining accreditation
shall be required to perform analyses on one PT sample
twice per year in each field of testing (program-
matrix-analyte) for which they have applied for
accreditation or for which they are currently
accredited.
c) The laboratory will be informed of their score on the
PT samples by the accrediting authority or the NELAP
approved PT provider within 21 days from the closing
date of submission. The results of all of the PT
sample tests including "pass" or "fail" will be part of
the public record. The result of passing or failing a
PT sample will apply to all accredited methods a
laboratory employs for an analyte.
d) When a laboratory initially requests accreditation, it
must successfully analyze two sets of PT samples, the
analyses to be performed are at least 30 days apart.
Each set will contain one sample for each requested
field of testing (program-matrix-analyte). Once a
laboratory has been granted accreditation status, it
must maintain a history of at least two passing results
out of the most recent three for each field of testing
(program-matrix-analyte) .
e) The results of the PT sample analyses will be
considered by the accrediting authority, along with
other information obtained from announced and
unannounced assessments in determining whether
accreditation should be granted, denied, revoked, or
suspended for a field of testing (program-matrix-
analyte) or an analyte within a field of testing
(program-matrix-analyte).
4.1.5 Accountability for Analytical 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 requires that each laboratory seeking national
accreditation have a named Quality Assurance Officer or
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a person designated as accountable for data quality.
The Quality Assurance Officer will 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 requires that each laboratory seeking national
accreditation have a Quality Assurance Manual on-site.
The accrediting authority or assessor body may request
the manual prior to the on-site assessment.
c) The accrediting authority will consider that the
accountability for negligence, the falsification of
data, records or instrument parameters will rest upon
the analyst, the laboratory management and the company.
4.1.6 Fee Process for National Accreditation
Refer to Policy and Structure, Chapter 1, specifically
funding of this program (Section 1.10)
The cost incurred in the application process for national
environmental laboratory accreditation will be called an
accreditation fee.
Where required and if applicable, accreditation fees will
be paid in accordance with existing state regulations,
levels and practices to the accrediting authority
granting the accreditation.
Where required and if applicable, the level and timing of
fee payments will be established by the primary
accrediting authority to which the laboratory is applying
for accreditation. Additional fees on the laboratory may
be levied by other secondary accrediting authorities with
which the laboratory chooses to do business.
4.1.7 Application
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.
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An accrediting authority participating in NELAC will include
in its application form the following:
a) Legal name of laboratory
b) Laboratory mailing address
c) Billing address (if different from b)
d) Name of owner
e) Address of owner
f) Location (full address) of laboratory
g) Name and phone number of responsible person of record
h) Name and phone number of Quality Assurance Officer
i) Name and phone number of laboratory contact person
j) Laboratory hours of operation
k) Primary Accrediting Authority
1) Categories for which the laboratory is requesting
accreditation
m) Methods employed
n) Description of laboratory(for example)
- Commercial
- Federal
- Hospital or health care
- State
- Academic Institutes
- Public water system
- Public wastewater system
- Industrial (an industry with discharge permits)
- Mobile
- Other (Describe)
o) Certification of compliance by laboratory management
(vide infra: 4.1.9)
p) Applicable fee enclosed
q) Description of geographical location
r) FAX number
s) Lab identification number (for renewal)
t) Quality Assurance Manual
A laboratory seeking renewal of accreditation will follow
the process outlined by the accrediting authority in which
they are currently accredited.
4.1.8 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 authority may charge a transfer fee and may
conduct an On-site assessment to verify affects of such
changes on laboratory performance.
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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 accrediting authority and entered into the
national database by the accrediting authority.
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 an On-
site assessment with the elements of the assessment
being determined by the assessor.
d) Any change in ownership must assure historical
traceability of the laboratory accreditation number(s).
e) For a change in ownership, the following conditions
must be in effect:
1) The previous (transferring) owner must agree in
writing, before the transfer of ownership takes
place, to be accountable and liable for any
analyses, data and reports generated up to the time
of legal transfer of ownership; and
2) The buyer (transferee) must agree in writing to be
accountable and liable for any analyses, data and
reports generated after the legal transfer of
ownership occurs.
3) All records and analyses performed pertaining to
accreditation must be kept for a minimum of five
years and are subject to inspection by the
accrediting authorities during this period without
prior notification to the laboratory. This
stipulation is applicable regardless of change in
ownership, accountability or liability.
4) If ownership is transferred, the transferee may not
be responsible for payment of fees to the
accrediting authorities during the remainder of the
yearly period, provided that the previous owner has
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fully paid the required fees to the accrediting
authorities.
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, or other designated
person, 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
Conference (NELAC) 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 accrediting authority may
make an announced or unannounced assessment, search, or
examination of an accredited or interim approved laboratory
whenever the accrediting authority, at its discretion,
considers such an assessment, search or examination
necessary to determine the extent of the laboratory's
compliance with the NELAC standards. Additionally, the
applicant authorizes the accrediting authority assessor to;
1) make copies of any analyses or records relevant to the
accreditation process, and 2) remove any or all such copies
from the facility for purposes of assessment or regulatory
enforcement. Any refusal to allow entry to the accrediting
authority's representatives during normal business hours or
to allow copies of records relevant to laboratory
accreditation to be made shall constitute a violation of a
condition of accreditation and grounds for denial,
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suspension, or revocation of accreditation. The applicant
hereby certifies that all accredited environmental analyses
performed are done in accordance with the NELAC standards.
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 or Name of Quality Assurance Officer
other designated responsible individual
Print Name of Applicant Laboratory Date
(Legal Name)
Signature Name
Responsible Person of Record Responsible Person of Record
4.2 PERIOD OF ACCREDITATION
For a laboratory in good standing, the period for
accreditation within categories for methods or analytes will
be 12 months and will be considered to be ongoing once a
laboratory has been accredited for that category or method
within a category. To maintain accreditation the laboratory
shall meet the requirements of Section 4.3, Maintaining
Accreditation. Failure to meet the requirements delineated
in Section 4.3 shall constitute grounds for suspension or
revocation of accreditation as specified in Section 4.4.
Additionally, failure to pay the required fees as determined
by the accrediting authority within the stipulated deadlines
or by the stipulated dates may result in revocation of
accreditation. This information may be entered into the
National Database in a timely and effective manner. The
NELAP recognizes that different accrediting authorities
operate the yearly period with different start times. The
individual laboratory being accredited is responsible for
tracking an accrediting authority's period of accreditation
and is responsible for paying the necessary fees (if
applicable) to those accrediting authorities to maintain
accreditation.
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4.3 MAINTAINING ACCREDITATION
Accreditation remains in effect until revoked by the
accrediting authority, withdrawn at the written request of
the accredited laboratory, or until expiration of the
accreditation period. To maintain accreditation, the
accredited laboratory shall complete or comply with elements
4.3.1 TO 4.3.3. Failure to complete or comply with these
elements may be cause for suspending or revoking
accreditation.
4.3.1 Quality Systems
Laboratories seeking accreditation under NELAP must assure
consistency and promote the use of quality assurance/quality
control procedures. Chapter 5, Quality Systems provides the
details concerning quality assurance and quality control
requirements for the evaluation of laboratories. The
quality assurance policies, which establish essential
quality control procedures, are applicable to all
environmental laboratories regardless of size, volume of
business and fields of testing. Failure to maintain,
revise, or replace any of these key components may be cause
for suspending or revoking a laboratory's accreditation
status.
The following applicable requirements are provided in
Chapter 5 (Quality Systems) and associated Appendix:
Organization and Management; Quality System - Establishment,
Audits, Essential Quality Controls and Data Verification;
Personnel; Physical Facilities - Accommodation and
Environment; Equipment and Reference Materials; Measurement
Traceability and Calibration; Test Methods and Standard
Operating Procedures; Sample Handling, Sample Acceptance
Policy and Sample Receipt; Records; Laboratory Report Format
and Contents; Subcontracting Analytical Samples; Outside
Support Services and Supplies; and Complaints. Appendix D -
Essential Quality Control Requirements for Chemical Testing
Whole Effluent Toxicity; Microbiology; Radioanalysis; and
Air Testing.
4.3.2 Notification and Reporting Requirements
The accredited laboratory shall notify the accrediting
authority of any changes in key accreditation criteria
within 30 calendar days including but not necessarily
limited of the laboratory ownership, location, key .
personnel, and major instrumentation. The accredited
laboratory shall also comply with any other reporting
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requirements identified in these guidelines. All such
updates are public record and any or all of the information
contained therein may be put into the national database.
4.3.3 Record Keeping and Retention
All laboratory records associated with accreditation
parameters must be easily accessible/ including raw and
processed 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 or authority. 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 authority.
4.4 DENIAL, SUSPENSION, AND REVOCATION OF ACCREDITATION
4.4.1 Denial
Denial - shall mean to refuse to accredit in total or in
part a laboratory applying for initial accreditation or
resubmission of initial application.
a) Reasons to deny an initial application may include:
1) Failure to submit a completed application.
2) Failure of laboratory staff to meet the personnel
qualifications as required by the NELAC standards.
These qualifications may include education, training
and experience requirements.
3) Failure to successfully analyze and report
proficiency testing samples as required by the NELAC
standards, Chapter 2.
4) Failure to attest that analysis are performed by
methodologies as required by the NELAC standards
Chapter 5.
5) Failure to respond to a Deficiency Report from the
On-Site assessment with a corrective action report
within the specified amount of time.
6) Failure to implement the Corrective Actions detailed
in the corrective action report within the specified
time frame as required by the NELAC standards.
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7) Failure to pay required fees.
8) Failure to pass required on-site assessment(s) as
specified in the NELAC standards, Chapter 3.
9) Misrepresentation of any material fact pertinent to
receiving or maintaining accreditation.
10) Denial of entry during normal business hours for an
on-site assessment as required by the NELAC
standards, Chapter 3.
b) A laboratory shall have two opportunities to correct
the areas of deficiencies which results in a denial of
accreditation.
c) If the laboratory is not successful in correcting the
deficiencies as required by the NELAC standards, the
laboratory must wait six months before again reapplying
for accreditation.
d) Upon reapplication, the laboratory may again be
responsible for all or part of the fees incurred as
part of the initial application for accreditation.
e) No laboratory's accreditation will be denied without
the right to due process as set forth in Section 4.7 of
this Chapter.
4.4.2 Suspension
Suspension - shall mean the temporary removal of a
laboratory's accreditation for a defined period of time
which shall not exceed six months. The purpose of
suspension is to allow a laboratory time to correct
deficiencies or area of non-compliance with the NELAC
standards.
a) A laboratory's accreditation may be suspended in total
or in part. The laboratory shall retain those areas of
accreditation where it continues to meet the
requirements of the NELAC standards.
b) Reasons for suspension may include:
1) Failure to successfully analyze and report PT
samples pursuant to the NELAC standards, Chapter 2;
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2) Failure to submit an acceptable corrective action
report, in response to a deficiency report and
failure to implement corrective action(s) related to
any deficiencies found during laboratory assessments
within the required time period as required by the
NELAC standards;
3) Failure to notify the accrediting authority of any
changes in key accreditation criteria, as set forth
in Section 4.3.4 of this Chapter;
4) Failure to perform all accredited tests in
accordance with the NELAC standards; and
5) Failure to meet all the requirements of the NELAC
standard, Chapter 5.
c) A suspended laboratory would not have to reapply for
accreditation if the cause/causes for suspension are
corrected within six months.
d) A suspended laboratory:
1) Can not continue to analyze samples for the affected
fields of testing for which it holds accreditation;
and
2) Shall remain suspended (without appeal rights) due
to unacceptable proficiency testing sample results.
e) If the laboratory is unable to correct the reason for
the suspension, the laboratory's accreditation shall be
revoked in total or in part.
f) No laboratory's accreditation will be suspended without
the right to due process as set forth in Section 4.7 of
this Chapter.
4.4.3 Revocation
Revocation - shall mean the in part or total withdrawal of a
laboratory's accreditation by the accrediting authority.
a) The accrediting authority shall revoke a laboratory' s
accreditation, in part or in total for failure to
correct the deficiencies after being suspended. The
laboratory shall retain those areas of accreditation
where it continues to meet the requirements of the
NELAC standards.
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b) Reasons for revocation in part or in total include a
laboratory's:
1) Failure to submit an acceptable corrective action
report, in response to a deficiency report and
failure to implement corrective action(s) related to
any deficiencies found during a laboratory
assessment. The laboratory may submit two
corrective actions within the time limits specified
by the accrediting authority.
2) Failure to successfully analyze and report PT
samples pursuant to the NELAC standards, Chapter 2.
c) Reasons for total revocation include a laboratory's:
1) Failure to respond with a corrective action report
within the required 30 days.
2) Failure to participate in the proficiency testing
program as required by the NELAC standards, Chapter
2.
3) Submittal of proficiency test sample results
generated by another laboratory as its own.
4) Misrepresentation of any material fact pertinent to
receiving or maintaining accreditation
5) Denial of entry during normal business hours for an
on-site assessment as required by the NELAC
standards, Chapter 3.
6) Conviction of charges for the falsification of any
report of or relating to a laboratory analysis.
7) Failure to remit the accreditation fees within the
time limit as established by the accrediting
authority may be grounds for immediate revocation.
d) After correcting the reason/cause for revocation, the
laboratory may reapply for accreditation sooner than 6
months from the official date of revocation.
e) No laboratory's accreditation will be revoked without
the right to due process as set forth in Section 4.7 of
this Chapter.
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4.4.4 Voluntary Withdrawal
If an environmental laboratory wishes to withdrawal from
NELAP, it must submit written notification to the
accrediting authority no later than 30 days before the end
of the accreditation year.
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 primary accrediting authority is unable to schedule the
assessment in a timely manner, the primary accrediting
authority may issue an interim accreditation. Interim
accreditation will allow a laboratory to perform analyses
and report results with the same status as a fully
accredited laboratory until the on-site assessment
requirements have been completed. Interim accreditation
status may not exceed twelve months. The interim
accreditation status is a matter of public record and will
be entered into the National Database.
4.5.2 Revocation of Interim Accreditation
Revocation of interim accreditation may be initiated for due
cause as described in 4.4 by order of the accrediting
authority.
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.). Addenda or attachments to the
certificate are allowed and will be considered to be
official documents. Information on the addenda or
attachments may include scope, methods, analytes, etc. The
laboratory must have a certificate for each state in which
it is accredited. Even though a parent laboratory is
accredited, the subfacilities (laboratories operating under
the same parent organization, analytical procedures, and
quality assurance system) are inspected or processed
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separately and will be issued their own Certificate of
Accreditation. Any sub-facilities or remote laboratory
sites are considered separate sites and subject to .separate
Announced and Unannounced Assessments, again provided that
the analysis or any portion of the analysis take place at
that site.
4.6.1 The Certificate of Accreditation
The certificate will be signed by a member of the
accrediting authority and will be considered an official
document. It will be transmitted as a sealed and dated
(effective date and expiration date)document containing the
NELAC Insignia. The certificate will include specific
categories, analytes, and methods for which the laboratory
or site is accredited for.
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 authority upon loss of accreditation. However,
this does not require the return of a certificate which has
simply expired (reached the expiration date).
4.6.2 Changes in Fields of Testing
If an accredited laboratory changes its scope of
accreditation, a new certificate will be issued which
details the laboratory's spectrum of accreditation.
4.7 ENFORCEMENT
The development of an enforcement component of the National
Environmental Laboratory Accreditation Program (NELAC)
should be based on explicit values, or principles, with
which all participants concur. The proposed basic
principles are:
a) The program should be equitable to all participants;
b) The rules should be well publicized;
c) The program needs of the participating agencies must be
upheld; and
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d) The due process rights of participating laboratories
must be protected.
Since NELAC is a standard setting body, it can not enforce
civil or criminal penalties but rather all enforcement
actions are taken independently by USEPA or state agencies
and communicated to all other NELAC participating agencies,
Any civil/criminal actions are taken by participating
agencies and/or accrediting authorities.
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TABLE OF CONTENTS
Quality Systems
5.0 QUALITY SYSTEMS ..... 1
5.1 SCOPE 1
5.2 REFERENCES 2
5.3 DEFINITIONS 2
5.4 ORGANIZATION AND MANAGEMENT 2
5.4.1 Legal Definition of Laboratory 2
5.4.2 Organization 2
5.5 QUALITY SYSTEM - ESTABLISHMENT, AUDITS, ESSENTIAL
QUALITY CONTROLS AND DATA VERIFICATION 4
5.5.1 Establishment 4
5.5.2 Quality Manual 5
5.5.3 Audits 7
5.5.3.1 Internal Audits 7
5.5.3.2 Managerial Review 7
5.5.3.3 Audit Review 8
5.5.3.4 Performance Audits 8
5.5.3.5 Corrective Actions 8
5.5.4 Essential Quality Control Procedures 9
5.6 PERSONNEL 10
5.6.1 General requirements for laboratory staff . . 10
5.6.2 Laboratory Management Responsibilities .... 11
5.6.3 Records 12
5.7 PHYSICAL FACILITIES - ACCOMMODATION AND ENVIRONMENT 12
5.7.1 Environment 12
5.7.2 Work Areas 13
5.8 EQUIPMENT AND REFERENCE MATERIALS 13
5.9 MEASUREMENT TRACEABILITY AND CALIBRATION 14
5.9.1 General Requirements 14
5.9.2 Traceability of Calibration 15
5.9.3 Reference Standards 15
5.9.4 Calibration 16
5.9.4.1 General Requirements 16
5.9.4.2 Acceptance Criteria for Support Equipment 16
5.9.4.2.1 Analytical Support Equipment 16
5.9.4.2.2 Autoclaves 17
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5.9.4.3 Instrument Calibrations 17
5.9.4.4 Calibration Verification ..19
5.9.4.4.1 Initial Calibration Verification ... 19
5.9.4.4.2 Continuing Calibration Verification . . 19
5.10 TEST METHODS AND STANDARD OPERATING PROCEDURES ... 20
5.10.1 Methods Documentation 20
5.10.1.1 Standard Operating Procedures (SOPs) ... 20
5.10.1.2 Laboratory Method Manual(s) 21
5.10.2 Test Methods 22
5.10.2.1 Method Validation/Initial Demonstration of
Method Performance 22
5.10.3 Sample Aliquots 23
5.10.4 Data Verification 23
5.10.5 Documentation and Labeling of Standards and
Reagents 23
5.10.6 Computers and Electronic Data Related Requirements
24
5.11 SAMPLE HANDLING, SAMPLE ACCEPTANCE POLICY AND SAMPLE
RECEIPT 25
5.11.1 Sample Tracking 25
5.11.2 Sample Acceptance Policy ..26
5.11.3 Sample Receipt Protocols 26
5.11.4 Storage Conditions 28
5.11.5 Sample Disposal 29
5.12 RECORDS 29
5.12.1 Record Keeping System and Design 29
5.12.2 Records Management and Storage 30
5.12.3 Laboratory Sample Tracking 31
5.12.3.1 Sample Handling 31
5.12.3.2 Laboratory Support Activities 32
5.12.3.3 Analytical Records 33
5.12.3.4 Administrative Records 33
5.12.4 Legal or Evidentiary Custody 33
5.12.4.1 Basic Requirements 34
5.12.4.2 Required Information in Custody Records . 35
5.12.4.3 Controlled Access to Samples 35
5.12.4.4 Transfer of Samples to Another Party ... 36
5.12.4.5 Sample Disposal 36
5.13 LABORATORY REPORT FORMAT AND CONTENTS 36
5.14 SUBCONTRACTING ANALYTICAL SAMPLES 40
5.15 OUTSIDE SUPPORT SERVICES AND SUPPLIES 40
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5.16 COMPLAINTS 41
Appendix A - REFERENCES Al
Appendix B - DEFINITIONS FOR QUALITY SYSTEMS Bl
Appendix C - INITIAL DEMONSTRATION OF CAPABILITY .... Cl
C.I PROCEDURE FOR INITIAL DEMONSTRATION OF CAPABILITY Cl
C.2.0 CERTIFICATION STATEMENT C2
Appendix D - ESSENTIAL QUALITY CONTROL REQUIREMENTS . . Dl
D.1.0 CHEMICAL TESTING Dl
D.I.I Positive and Negative Controls Dl
D.I.2 Analytical Variability/Reproducibility .... D3
D.I. 3 Method Evaluation D3
D.I. 4 Method Detection Limits D3
D.I. 5 Data Reduction D4
D.I. 6 Quality of Standards and Reagents D4
D.I.7 Selectivity D4
D.I. 8 Constant and Consistent Test Conditions . . . D5
D.2.0 WHOLE EFFLUENT TOXICITY D5
D.2.1 Positive and Negative Controls D5
D.2.2 Variability and/or Reproducibility D7
D.2.3 Accuracy D7
D.2.4 Test Sensitivity D7
D.2.5 Selection of Appropriate Statistical Analysis
Methods D8
D.2.6 Selection and Use of Reagents and Standards . D8
D.2.7 Selectivity D8
D.2.8 Constant and Consistent Test Conditions . . . D8
D.3.0 MICROBIOLOGY DID
D.3.1 Positive and Negative Controls Dll
D.3.2 Test Variability/Reproducibility D12
D.3.3 Method Evaluation D12
D.3.4 Test Performance D13
D.3.5 Data Reduction D13
D.3.6 Quality of Standards, Reagents and Media . . . D13
D.3.7 Selectivity D14
D.3.8 Constant and Consistent Test Conditions . . . D15
D.4.0 RADIOANALYSIS D17
Figure D-l. USE OF REFERENCE CULTURES (BACTERIA) . . . D18
D.4.1 Method Evaluation D20
D.4.2 Radiation Measurement Systems D21
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D.4.3 Data Reduction
D.4.4 Quality of Standards and Reagents . . .
D.4.5 Constant and Consistent Test Conditions
D.5.0 AIR TESTING
D23
D23
D24
D24
Appendix E - PERFORMANCE BASED MEASUREMENT SYSTEM ... El
E.1.0 Checklist Overview El
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5.0 QUALITY SYSTEMS
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. Laboratories seeking
accreditation under NELAP must assure implementation of all
QA policies and the essential applicable QC procedures
specified in this chapter. The QA policies, which
establish essential QC procedures, are applicable to
environmental laboratories regardless of size and
complexity.
The intent of this Chapter is to provide sufficient detail
concerning QA and QC requirements so that all accrediting
authorities evaluate laboratories consistently and
uniformly.
Chapter 5 is organized according to the structure of ISO/IEC
Guide 25, 1990. Where deemed necessary, specific areas
within this Chapter may contain more information than
specified by ISO/IEC Guide 25.
All items identified in this chapter shall be available for
on-site inspection or data audit.
5.1 SCOPE
a) This Standard sets out the general requirements in
accordance with which a laboratory has to demonstrate
that it operates, if it is to be recognized as
competent to carry out specific environmental tests.
b) This standard includes additional requirements and
information for assessing competence or for determining
compliance by the organization or accrediting authority
granting the recognition (or approval).
If more stringent standards or requirements are included
in a mandated test method or by regulation, the
laboratory shall demonstrate that such requirements are
met.
c) This Standard is for use by environmental testing
laboratories in the development and implementation of
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their quality systems. It shall be used by
accreditation authorities, in assessing the competence
of environmental laboratories.
5.2 REFERENCES
See Appendix A
5.3 DEFINITIONS
The relevant definitions from ISO/IEC Guide 2, ISO 8402,
ANSI/ASQC E-4,1994, the EPA "Glossary of Quality Assurance
Terms and Acronyms", and the International vocabulary of
basic and general terms in metrology (VIM) are applicable,
the most relevant being quoted in Appendix B together with
further definitions applicable for the purposes of this
Standard.
See Appendix B
5.4 ORGANIZATION AND MANAGEMENT
5.4.1 Legal Definition of Laboratory
The laboratory shall be legally identifiable. It shall be
organized and shall operate in such a way that its
permanent, temporary and mobile facilities meet the
requirements of this Standard.
5.4.2 Organization
The laboratory shall:
a) have managerial staff with the authority and resources
needed to discharge their duties;
b) have processes to ensure that its personnel are free
from any commercial, financial and other undue
pressures which might adversely affect the quality of
their work;
c) be organized in such a way that confidence in its
independence of judgment and integrity is maintained at
all times;
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d) specify and document the responsibility, authority, and
interrelation of all personnel who manage, perform or
verify work affecting the quality of calibrations and
tests;
Such documentation shall include:
1) 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 and
2) job descriptions for all positions.
e) provide supervision by persons familiar with the
calibration or test methods and procedures, the
objective of the calibration or test and the assessment
of the results. The ratio of supervisory to non-
supervisory personnel shall be such as to ensure
adequate supervision;
f) have a technical director(s) (however named) who has
overall responsibility for the technical operation of
the environmental testing laboratory;
The technical director shall certify that personnel with
appropriate educational and/or technical background
perform all tests for which the laboratory is certified.
Such certification shall be documented.
The technical director shall meet the requirements
specified in the Accreditation Process (see 4.1.1.1).
g) have a quality assurance officer (however named) who
has responsibility for the quality system and its
implementation. The quality assurance officer shall
have direct access to the highest level of management
at which decisions are taken on laboratory policy or
resources, and to the technical director. Where
staffing is limited, the quality assurance officer may
also be the technical director or deputy technical
director;
The quality assurance officer (and/or his/her designees)
shall:
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1) serve as the focal point for QA/QC and be
responsible for the oversight and/or review of
quality control data;
2) have functions independent from laboratory
operations for which they have quality assurance
oversight;
3) be able to evaluate data objectively and perform
assessments without outside (e.g., managerial)
influence;
4) have documented training and/or experience in QA/QC
procedures and be knowledgeable in the quality
system as defined under NELAC;
5) have a general knowledge of the analytical methods
for which data review is performed; and
6) arrange for or conduct internal audits on the entire
technical operation annually.
h) where applicable/ nominate deputies in case of absence
of the technical director or quality assurance officer
and shall accomplish this by having contingency plans
in the event that either the technical director or
quality assurance officer is absent;
i) where relevant, have documented policy and procedures
to ensure the protection of clients' confidential
information and proprietary rights;
j) where appropriate, participate in inter-laboratory
comparisons and proficiency testing programs. For
purposes of qualifying for and maintaining
accreditation, each laboratory shall participate in a
proficiency test program as outlined in Chapter 2.0.
5.5 QUALITY SYSTEM - ESTABLISHMENT, AUDITS, ESSENTIAL
QUALITY CONTROLS AND DATA VERIFICATION
5.5.1 Establishment
The laboratory shall establish and maintain a quality system
appropriate to the type, range and volume of environmental
testing activities it undertakes.
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a) The elements of this system shall be documented.
b) The quality documentation shall be available for use by
the laboratory personnel.
c) The laboratory shall define and document its policies
and objectives for, and its commitment to accepted
laboratory practices and quality of testing services.
d) The laboratory management shall ensure that these
policies and objectives are documented in a quality
manual and communicated to, understood, and implemented
by all laboratory personnel concerned.
e) The quality manual shall be maintained current under
the responsibility of the quality assurance officer.
5.5.2 Quality Manual
The quality manual, and related quality documentation, shall
state the laboratory's policies and operational procedures
established in order to meet the requirements of this
Standard.
The Quality Manual shall list on the title page: a document
title; the laboratory's full name and address; the name,
address (if different from above), and telephone number of
individual(s) responsible for the laboratory; the name of
the quality assurance officer (however named); the
identification of all major organizational units which are
to be covered by this quality manual and the effective date
of the version;
The quality manual and related quality documentation shall
also contain:
a) a quality policy statement, including objectives and
commitments, by top management;
b) the organization and management structure of the
laboratory, its place in any parent organization and
relevant organizational charts;
C) the relations between management, technical operations,
support services and the quality system;
d) procedures to ensure that all records required under
this Chapter are retained, as well as procedures for
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control and maintenance of documentation through a
document control system which ensures that all standard
operating procedures, manuals/ or documents clearly
indicate the time period during which the procedure or
document was in force;
e) job descriptions of key staff and reference to the job
descriptions of other staff;
f) identification of the laboratory's approved
signatories; at a minimum, the title page must have the
signed concurrence, (with appropriate titles) of all
responsible parties including the QA officer, technical
director, and the agent who is in charge of all
laboratory activities such as the laboratory director
or laboratory manager;
g) the laboratory's procedures for achieving traceability
of measurements;
h) a list of all methods under which the laboratory
performs its accredited testing;
i) mechanisms for ensuring that the laboratory reviews all
new work to ensure that it has the appropriate
facilities and resources before commencing such work;
j) reference to the calibration and/or verification test
procedures used;
k) procedures for handling submitted samples;
1) reference to the major equipment and reference
measurement standards used as well as the facilities
and services used by the laboratory in conducting
tests;
m) reference to procedures for calibration, verification
and maintenance of equipment;
n) reference to verification practices including
interlaboratory comparisons, proficiency testing
programs, use of reference materials and internal
quality control schemes;
o) procedures to be followed for feedback and corrective
action whenever testing discrepancies are detected, or
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departures from documented policies and procedures
occur;
p) the laboratory management arrangements for
exceptionally permitting departures from documented
policies and procedures or from standard
specifications;
q) procedures for dealing with complaints;
r) procedures for protecting confidentiality and
proprietary rights;
s) procedures for audits and data review;
t) processes/procedures for establishing that personnel
are adequately experienced in the duties they are
expected to carry out and/or receive any needed
training;
u) reference to procedures for reporting analytical
results; and
v) a Table of Contents, and applicable lists of references
and glossaries, and appendices.
5.5.3 Audits
5.5.3.1 Internal Audits
The laboratory shall arrange for annual quality systems
audits of its technical activities to verify that its
operations continue to comply with the requirements of the
quality system. Such audits shall be carried out by the
quality assurance officer or designee(s) who are trained and
qualified as auditors, and who are, wherever possible,
independent of the activity to be audited. Where the audit
findings cast doubt on the correctness or validity of the
laboratory's calibrations or test results, the laboratory
shall take immediate corrective action and shall immediately
notify, in writing, any client whose work may have been
affected.
5.5.3.2 Managerial Review
The quality system adopted to satisfy the requirements of
this Standard shall be reviewed at least once a year by the
management to ensure its continuing suitability and
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effectiveness and to introduce any necessary changes or
improvements.
5.5.3.3 Audit Review
All audit and review findings and any corrective actions
that arise from them shall be documented. The quality
assurance officer shall ensure that these actions are
discharged within the agreed timescale.
5.5.3.4 Performance Audits
In addition to periodic audits, the laboratory shall ensure
the quality of results provided to clients by implementing
checks to monitor the quality of the laboratory's analytical
activities. Examples of such checks are:
a) internal quality control schemes using whenever
possible statistical techniques; (see 5.5.4 below)
b) participation in proficiency testing or other
interlaboratory comparisons (See Chapter 2.0);
c) use of certified reference materials and/or in-house
quality control using secondary reference materials as
specified in Section 5.5.4;
d) replicate testings using the same or different methods;
e) re-testing of retained samples;
f) correlation of results for different parameters of a
sample (for example, total phosphorus should be greater
than or equal to orthophosphate).
5.5.3.5 Corrective Actions
a) In addition to providing acceptance criteria and
specific protocols for corrective actions in the Method
Standard Operating Procedures (see 5.10.1.1), the
laboratory shall implement general procedures to be
followed to determine when quality control data are out
of control. These procedures shall include but are not
limited to the following:
1) identify the individual(s) responsible for assessing
each QC data type;
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2) identify the individual(s) responsible for
initiating and/or recommending corrective actions;
3) define how the analyst should treat a data set if
the associated QC measurements are unacceptable;
4) specify how out-of-control situations and subsequent
corrective actions are to be documented; and
5) specify procedures for management (including the QA
officer) to review corrective action reports.
b) To the extent possible, samples shall be reported only
if all quality control measures are acceptable. If a
quality control measure is found to be out of control,
and the data is to be reported, all samples associated
with the failed quality control measure shall be
reported with the appropriate data qualifier(s).
5.5.4 Essential Quality Control Procedures
The following general quality control principles shall
apply, where applicable, to all testing laboratories. The
manner in which they are implemented is dependent on the
types of tests performed by the laboratory (i.e., chemical,
microbiological, radiological) and are further described in
Appendix D. The standards for any given test type shall
assure that the applicable principles are addressed:
a) All laboratories shall have protocols (as required in
Section 5.10.1.1) in place to monitor the following
quality controls:
1) Adequate positive and negative controls to monitor
tests such as blanks, spikes, reference toxicants,
zero blanks;
2) Adequate tests to define the variability and/or
reproducibility of the laboratory results such as
duplicates;
3) Measures to ensure the accuracy of the test data
including sufficient calibration and/or continuing
calibrations, use of certified reference materials,
proficiency test samples, or other measures;
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4) Measures to evaluate test performance, such as
method detection limits and quantitation limits or
range of applicability such as linearity;
5) Selection of appropriate formulae to reduce raw data
to final results such as linear regression, internal
standards, or statistical packages;
6) Selection and use of reagents and standards of
appropriate quality;
7) Measures to assure the selectivity of the test for
its intended purpose; and
8) Measures to assure constant and consistent test
conditions (both instrumental and environmental)
where required by the method such as temperature,
humidity, light, or specific instrument conditions.
b) All quality control measures shall be assessed and
evaluated on an on-going basis, and quality control
acceptance limits shall be used to determine the
useability of the data (See Appendix D).
c) The laboratory shall have procedures for the
development of acceptance/rejection criteria where no
method or regulatory criteria exist.
d) The quality control protocols specified by the
laboratory's method manual (5.10.1.2) shall be
followed. The laboratory shall ensure that the
essential standards outlined in Appendix D are
incorporated into their method manuals
The essential quality control measures for testing
categories are found in Appendix D of this chapter.
5.6 PERSONNEL
5.6.1 General requirements for laboratory staff
The laboratory shall have sufficient personnel, having the
necessary education, training, technical knowledge and
experience for their assigned functions.
All personnel shall be responsible for complying with all
quality assurance/quality control requirements that pertain
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to their organizational/technical function. Each technical
staff member 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.
5.6.2 Laboratory Management Responsibilities
In addition to 5.4.2.d, the laboratory management shall be
responsible for:
a) Defining the minimal level of qualification, experience
and skills necessary for all positions in the
laboratory. In addition to education and/or
experience, basic laboratory skills such as using a
balance, colony counting, aseptic techniques or
chemically transferring reagents shall be considered;
b) Assuring that all technical laboratory staff have
demonstrated initial and ongoing proficiency in the
activities for which they are responsible. Such
demonstration shall be documented;
c) Ensuring that the training of its personnel is kept up-
to-date by the following:
1) Evidence must be on file that demonstrates all
employees are aware of and are using the latest
edition of the laboratory's in-house quality
documentation.
2) Training courses or workshops on specific equipment,
analytical techniques or laboratory procedures shall
all be documented.
3) Analyst training shall be considered up-to-date when
documentation in the files indicate acceptable
performance of a blind sample (singly blind to the
analyst) at least once per year and a certification
that technical personnel have read, understood and
agreed to perform the most recent version of the
method, the approved method (if applicable) or
standard operating procedure;
d) Documenting all analytical and operational activities
of the laboratory;
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e) Supervising all personnel employed by the laboratory;
f) Assuring that all sample acceptance criteria (Section
5.11) are verified and that samples are logged into the
sample tracking system and properly labeled and stored;
and
g) Ensuring the production and quality of all data
reported by the laboratory.
5.6.3 Records
Records on the relevant qualifications, training, skills and
experience of the technical personnel shall be maintained by
the laboratory [see 5.6.2.C}], including records on
demonstrated proficiency for each laboratory method, such as
the criteria outlined in 5.10.2.1 for chemical testing.
5.7 PHYSICAL FACILITIES - ACCOMMODATION AND ENVIRONMENT
5.7.1 Environment
a) Laboratory accommodation, test areas, energy sources,
lighting, heating and ventilation shall be such as to
facilitate proper performance of tests.
b) The environment in which these activities are
undertaken shall not invalidate the results or
adversely affect the required accuracy of measurement.
Particular care shall be taken when such activities are
undertaken at sites other than the permanent laboratory
premises.
c) The laboratory shall provide facilities for the
effective monitoring, control and recording of
environmental conditions as appropriate. Attention
shall be paid, for example, to biological sterility,
dust, electromagnetic interference, humidity, mains
voltage, temperature, and sound and vibration levels,
as appropriate to the calibrations or tests concerned.
d) In instances where monitoring or control of any of the
above mentioned items are specified in a test method or
by regulation, the laboratory shall meet and document
adherence to the laboratory facility requirements.
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NOTE - It is the laboratory's responsibility to comply with
the relevant health and safety requirements. This aspect,
however, is outside the scope of this Standard.
5.7.2 Work Areas
a) There shall be effective separation between neighboring
areas when the activities therein are incompatible
including culture handling or incubation areas and
volatile organic chemicals handling areas.
b) Access to and use of all areas affecting the quality of
these activities shall be defined and controlled.
c) Adequate measures shall be taken to ensure good
housekeeping in the laboratory and to assure that
contamination is unlikely.
d) Work spaces must be available to ensure an unencumbered
work area. Work areas include:
1) access and entryways to the laboratory;
2) sample receipt area(s);
3) sample storage area(s);
4) chemical and waste storage area(s); and
5) data handling and storage area(s).
5.8 EQUIPMENT AND REFERENCE MATERIALS
a) The laboratory shall be furnished with all items of
equipment (including reference materials) required for
the correct performance of tests for which
accreditation is sought. In those cases where the
laboratory needs to use equipment outside its permanent
control it shall ensure that the relevant requirements
of this Standard are met.
b) All equipment shall be properly maintained, inspected
and cleaned. Maintenance procedures shall be
documented.
c) Any item of the equipment which has been subjected to
overloading or mishandling, or which gives suspect
results, or has been shown by verification or otherwise
to be defective, shall be taken out of service, clearly
identified and wherever possible stored at a specified
place until it has been repaired and shown by
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calibration, verification or test to perform
satisfactorily. The laboratory shall examine the
effect of this defect on previous calibrations or
tests.
d) Each item of equipment including reference materials
shall, when appropriate, be labeled, marked or
otherwise identified to indicate its calibration
status.
e) Records shall be maintained of each major item of
equipment and all reference materials significant to
the tests performed. These records shall include
documentation on all routine and non-routine
maintenance activities and reference material
verifications.
The records shall include:
1) the name of the item of equipment;
2) the manufacturer's name, type identification, and
serial number or other unique identification;
3) date received and date placed in service;
4) current location, where appropriate;
5) condition when received (e.g. new, used,
reconditioned);
6) copy of the manufacturer's instructions, where
available;
7) dates and results of calibrations and/or
verifications and date of the next calibration
and/or verification;
8) details of maintenance carried out to date and
planned for the future; and
9) history of any damage, malfunction, modification or
repair.
5.9 MEASUREMENT TRACEABILITY AND CALIBRATION
5.9.1 General Requirements
All measuring operations and testing equipment having an
effect on the accuracy or validity of tests shall be
calibrated and/or verified before being put into service and
on a continuing basis. The laboratory shall have an
established program for the calibration and verification of
its measuring and test equipment. This includes balances,
thermometers and control standards.
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5.9.2 Traceability of Calibration
a) The overall program of calibration and/or verification
and validation of equipment shall be designed and
operated so as to ensure that, wherever applicable,
measurements made by the laboratory are traceable to
national standards of measurement where available.
b) Calibration certificates shall wherever applicable
indicate the traceability to national standards of
measurement and shall provide the measurement results
and associated uncertainty of measurement and/or a
statement of compliance with an identified metrological
specification. The laboratory shall maintain records
of all such certifications.
c) Where traceability to national standards of measurement
is not applicable, the laboratory shall provide
satisfactory evidence of correlation of results, for
example by participation in a suitable program of
interlaboratory comparisons or proficiency testing.
5.9.3 Reference Standards
a) Reference standards of measurement held by the
laboratory (such as Class S or equivalent weights or
traceable thermometers) shall be used for calibration
only and for no other purpose, unless it can be
demonstrated that their performance as reference
standards has not been invalidated. Reference
standards of measurement shall be calibrated by a body
that can provide, where possible, traceability to a
national standard of measurement.
b) There shall be a program of calibration and
verification for reference standards.
c) Where relevant, reference standards and measuring and
testing equipment shall be subjected to in-service
checks between calibrations and verifications.
Reference materials shall, where possible, be traceable
to national or international standards of measurement,
or to national or international standard reference
materials.
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5.9.4 Calibration
5.9.4.1 General Requirements
a) Each calibration shall be dated and labeled with
method, instrument, analysis date, and each analyte
name, concentration and response (or response factor).
b) When used, the axes of the calibration curve shall 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.
c) A criteria for the acceptance of a calibration curve,
for example, an acceptable correlation coefficient,
shall be established and documented. If applicable,
the method specified criteria shall be met.
5.9.4.2 Acceptance Criteria for Support Equipment
5.9.4.2.1 Analytical Support Equipment
These standards apply to all devices that may not be the
actual test instrument, but are necessary to support
laboratory operations. These include but are not limited
to: balances, ovens, refrigerators, freezers, incubators,
water baths, temperature measuring devices (including
thermometers and thermistors) and volumetric dispensing
devices (such as Repipet®, Eppendorf®, or automatic
dilutor/dispensing devices). All support equipment shall
be:
a) maintained in proper working order. The records of all
activities including service calls shall be kept.
b) calibrated annually, using NIST traceable references
when available, over the entire range in which the
equipment is used. The results of such calibration
shall be within ± the manufacturer's stated sensitivity
or:
1) The equipment shall be removed from service until
repaired; or
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2) The laboratory shall prepare a deviation curve and
correct all measurements for the deviation. All
measurements shall be recorded and maintained.
c) Prior to use on each working day, balances, ovens,
refrigerators, freezers, incubators and water baths
shall be checked with NIST traceable references (where
possible) in the expected use range. Additional
monitoring as prescribed by the method shall be
performed for any device that is used in a critical
test (such as incubators or water baths). The
acceptability for use or continued use shall be
according to manufacturer requirements if not included
in the method.
5.9.4.2.2 Autoclaves
The sterilization temperature and pressure of each run must
be documented by the use of appropriate chemical or
biological sterilization indicators. Autoclave tape may be
used to indicate that a load has been processed, but not to
demonstrate completion of an acceptable sterilization cycle.
5.9.4.3 Instrument Calibrations
a) When available, all initial calibrations shall be
verified with a standard obtained from a second or
different source. This verification standard shall be
analyzed with each initial calibration and shall be
within 15% of the true value unless the laboratory can
demonstrate through historical data that wider limits
are applicable.
b) Calibration curves shall be prepared as specified in
the method. If a method does not provide guidance in
the preparation of a calibration curve, the laboratory
shall establish the appropriate number of standards for
use in the initial calibration using the following:
1) Determine the percent relative standard deviation
(%RSD) by:
i. Taking at least seven replicate measurements of a
standard with a concentration approaching the
lowest quantitation level or;
ii. Performing a calibration linearity test (such as
response factor or calibration factor) on at least
3 standards having concentrations that cover the
expected calibration range.
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2) The minimum number of standards to be used in the
initial calibration is dependent on the resulting
%RSD:
%RSD Number of Calibration Points
0 - <2 1**
2 - <10 3
10 - <25 5
>25 7
** Assumes linearity through the origin (0.0). For
analytes for which there is no origin (such as
pH), a two point calibration curve shall be used.
3) If the resulting curve is non-linear, additional
standards shall be used.
4) The number of standards as determined from the above
table and a blank shall be used for the initial
calibration of the method.
c) In addition to the verification by second-source
standards [see a) above], the calibration curve shall
be subjected to a calibration linearity test, such as a
linear regression or percent RSD of response factors
(internal standard calibration) or calibration factors
(external standard calibration).
1) If, over the calibration range, the RSD of response
factors is less than 15 percent, or the RSD of
calibration factors is less than 30 percent,
linearity through the origin can be assumed and an
average relative response factor may be used;
otherwise, the complete calibration curve shall be
used.
2) If a linear regression is used, the correlation
coefficient (R) shall be no less than 0.995 unless
the laboratory can demonstrate that a lowered
correlation coefficient consistently produces
accurate results.
d) The sample results must be bracketed by calibration
standards under all circumstances. For calibrations
employing a single calibration point, the level in the
blank or zero (whichever is applicable) is assumed to
be the low calibration point. For those situations
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where the result will be used in a decision related to
the determination of a non-occurrence or "non-detect"
(ND) of an analyte, the standard shall be at 1 - 5
times the quantitation limit of the method.
5.9.4.4 Calibration Verification
When not included in the analytical method/ the value of the
analyte(s) in the following calibration verification
standards shall be within 15% of the true value unless the
laboratory can demonstrate through historical data that
wider limits are applicable.
5.9.4.4.1 Initial Calibration Verification
a) 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 the method defined concentration or a mid-level
concentration if not included in the method.
b) If the initial calibration verification fails, the
analysis procedure shall be stopped and evaluated. A
second standard may be analyzed and evaluated or a new
initial calibration curve may be established and
verified. In all cases, the initial calibration
verification must be acceptable before analyzing any
samples.
5.9.4.4.2 Continuing Calibration Verification
Additional standards shall be analyzed after the initial
calibration curve or the integrity of the initial
calibration curve (see 5.9.4.3.a or 5.9.4.4.1 above) has
been accepted.
a) These standards shall be analyzed at a frequency of 5%
or every 12 hours whichever is more frequent and may be
the standards used in the original calibration curve or
standards from another source. The frequency shall be
increased if the instrument consistently drifts outside
acceptable limits before the next calibration.
b) The concentration of these standards shall be
determined by the anticipated or known concentration of
the samples and/or method specified levels. At least
one standard shall be at a low level concentration. To
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the extent possible, the samples in each interval (i.e.
every 20 samples or every 12 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.
c) A new curve shall be run if two back-to-back runs of
one continuing calibration check is outside acceptable
limits. When the continuing calibration check limit is
exceeded high (i.e., high bias), and there are non-
detects for the corresponding analyte in all
environmental samples associated with the continuing
calibration check, then those non-detects may be
reported, otherwise the samples affected by the
unacceptable check shall be reanalyzed after a new
calibration curve has been established, evaluated and
accepted. Additional sample analysis shall not occur
until a new calibration curve is established and
verified.
5.10 TEST METHODS AND STANDARD OPERATING PROCEDURES
5.10.1 Methods Documentation
a) The laboratory shall have documented instructions on
the use and operation of all relevant equipment, on the
handling and preparation of samples and for calibration
and/or testing, where the absence of such instructions
could jeopardize the calibrations or tests.
b) All instructions, standards, manuals and reference data
relevant to the work of the laboratory shall be
maintained up-to-date and be readily available to the
staff.
5.10.1.1 Standard Operating Procedures (SOPs)
Laboratories shall maintain standard operating procedures
that accurately reflect all phases of current laboratory
activities such as assessing data integrity, corrective
actions, handling customer complaints, and all test methods.
a) These documents may be equipment manuals provided by
the manufacturer, or internally written documents.
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b) The test methods may be copies of published methods as
long as any changes in the methods are documented and
included in the methods manual (see 5.10.1.2).
c) Copies of all SOPs shall be accessible to all
personnel.
d) The SOPs shall be logically organized and shall have
the signature(s) of the approving authority.
e) Each SOP shall clearly indicate the effective date of
the document, and the revision number.
5.10.1.2 Laboratory Method Manual(s)
a) The laboratory shall have and maintain an in-house
methods manual(s) for each accredited analyte or test.
b) This manual may consists of copies of published or
referenced methods or standard operating procedures
that have been written by the laboratory. Each method
shall include or reference where applicable:
I) identification of the test method and where
applicable, the analyte name with 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");
2) applicable matrix or matrices;
3) method detection limit;
4) scope and application;
5) summary of the method;
6) definitions;
7) interferences;
8) safety;
9) equipment and supplies;
10) reagents and standards;
11) sample collection, preservation, shipment and
storage;
12) quality control;
13) calibration and standardization;
14) procedure;
15) calculations;
16) method performance;
17) pollution prevention;
18) data assessment and acceptance criteria for quality
control measures;
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19) corrective actions for out-of-control data;
20) contingencies for handling out-of-control or
unacceptable data;
21) waste management;
22) references; and
23) any tables, diagrams, flowcharts and validation data
c) In cases where modifications to the published method
have been made by the laboratory or where the
referenced method is ambiguous or provides insufficient
detail, these changes or clarifications shall be
clearly described as an appendix to the laboratory's
method manual.
5.10.2 Test Methods
a) The laboratory shall use appropriate methods and
procedures for all tests and related activities within
its responsibility (including sampling, handling,
transport and storage, preparation of items, estimation
of uncertainty of measurement and analysis of test
data). The method and procedures shall be consistent
with the accuracy required, and with any standard
specifications relevant to the calibrations or tests
concerned.
1) When the use of mandated methods for a sample matrix
is required, only those methods shall be used.
2) Where methods are employed that are not required, as
in the Performance Based Measurement System
approach, the methods shall be fully documented and
validated (see 5.10.2.1), and be available to the
client and other recipients of the relevant reports.
5.10.2.1 Method Validation/Initial Demonstration of Method
Performance
a) Prior to acceptance and institution of any method,
satisfactory initial demonstration of method
performance, in conformance with the relevant EPA
guidelines, is required.
1) The laboratory's use of mandated methods [see
5.10.2.a)1] or EPA reference methods, shall follow
the protocols outlined in Appendix C of this
document.
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2) All other methods (including Performance Based
Measurements Systems) shall follow the protocols
outlined in Appendix E of this document.
b) Thereafter, continuing demonstration of method
performance, in conformance with the relevant EPA
guidelines, is required.
c) In all cases, the appropriate forms such as the
Certification Statement (Appendix C) or standard
performance checklists (see Appendix E) must be
completed and retained by the laboratory to be made
available upon request. All associated supporting data
necessary to reproduce the analytical results
summarized in the checklists must be retained by the
laboratory.
d) Initial demonstration of method performance must be
completed each time there is a significant change in
instrument type, personnel or method.
5.10.3 Sample Aliquots
Where sampling (as in obtaining sample aliquots from a
submitted sample) is carried out as part of the test method,
the laboratory shall use documented procedures and
appropriate techniques to obtain representative subsamples.
5.10.4 Data Verification
Calculations and data transfers shall be subject to
appropriate checks.
a) The laboratory shall establish Standard Operating
Procedures to ensure that the reported data is free
from transcription and calculation errors.
b) The laboratory shall establish a Standard Operating
Procedures to ensure that all quality control measures
are reviewed, and evaluated before data is reported.
5.10.5 Documentation and Labeling of Standards and Reagents
Documented procedures shall exist for the purchase,
reception and storage of consumable materials used for the
technical operations of the laboratory.
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a) The laboratory shall retain records, such as
manufacturer's statement of purity, of the origin,
purity and traceability of all standards (including
balance weights and thermometers). Records for all
standards shall include the date of receipt, storage
conditions, and, if applicable, the date of opening and
an expiration date.
b) Original reagent containers shall be labeled with the
date opened and expiration date.
c) Detailed records shall be maintained on reagent and
standard preparation. These records shall indicate
traceability to purchased stocks or neat compounds, and
must include the date of preparation and preparer's
initials.
d) Where calibrations do not include the generation of a
calibration curve, such as thermometers, balances, or
titrations, records shall indicate the calibration date
and type (balance weight, thermometer serial number,
primary standard concentration) of calibration standard
that was used.
e) All prepared reagents and standards must be uniquely
identified and the contents shall be clearly identified
with preparation date, concentration(s) and preparer's
initials.
5.10.6 Computers and Electronic Data Related Requirements
Where computers or automated equipment are used for the
capture, processing, manipulation, recording, reporting,
storage or retrieval of test data, the laboratory shall
ensure that:
a) all requirements of this Standard are complied with.
Section 8.1 through 8.11 of the EPA Document "2185 -
Good Automated Laboratory Practices" (1995), shall be
adopted as the standard for all laboratories employing
microprocessors and computers.
b) computer software is documented and adequate for use;
c) procedures are established and implemented for
protecting the integrity of data; such procedures shall
include, but not be limited to, integrity of data entry
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or capture, data storage, data transmission and data
processing;
d) computer and automated equipment are maintained to
ensure proper functioning and provided with the
environmental and operating conditions necessary to
maintain the integrity of calibration and test data;
e) it establishes and implements appropriate procedures
for the maintenance of security of data including the
prevention of unauthorized access to, and the
unauthorized amendment of, computer records.
5.11 SAMPLE HANDLING, 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.
5.11.1 Sample Tracking
a) The laboratory shall have a documented system for
uniquely identifying the items to be tested, to ensure
that there can be no confusion regarding the identity
of such items at any time. This system shall include
identification for all samples, subsamples and
subsequent extracts and/or digestates. The laboratory
shall assign a unique identification (ID) code to each
sample container received in the laboratory. The use
of container shape, size or other physical
characteristic, such as amber glass, or purple top, is
not an acceptable means of identifying the sample.
b) This laboratory code shall maintain an unequivocal link
with the unique field ID code assigned each container.
c) The laboratory ID code shall be placed on the sample
container as a durable label.
d) The laboratory ID code shall be entered into the
laboratory records (see 5.11.3.d) and shall be the link
that associates the sample with related laboratory
activities such as sample preparation or calibration.
e) In cases where the sample collector and analyst are the
same individual or the laboratory preassigns numbers to
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sample containers, the laboratory ID code may be the
same as the field ID code.
5.11.2 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 sample acceptance policy shall be made
available to sample collecting personnel and shall include,
but is not limited to, the following areas of concern:
a) Proper, full, and complete documentation, which shall
include sample identification, the location, date and
time of collection, collector's name, preservation
type, sample type and any special remarks concerning
the sample;
b) 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;
c) Use of appropriate sample containers.
d) Adherence to specified holding times; and
e) Adequate sample volume. Sufficient sample volume must
be available to perform the necessary tests.
5.11.3 Sample Receipt Protocols
a) Upon receipt, the condition of the sample, including
any abnormalities or departures from standard condition
as prescribed in the relevant test method, shall be
recorded. All items specified in 5.11.2 above shall be
checked.
1) All samples which require thermal preservation shall
be considered acceptable if the arrival temperature
is either within +/-2°C of the required temperature
or the method specified range. For samples with a
specified temperature of 4°C, samples with a
temperature of 0.1 to 6°C shall be acceptable.
Samples that are hand delivered to the laboratory
immediately after collection may not meet this
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criteria. In these cases, the samples shall be
considered acceptable if there is evidence that the
chilling process has begun such as arrival on ice.
2) The laboratory shall implement procedures for
checking chemical preservation using readily
available techniques, such as pH, free chlorine or
temperature, prior to or during sample preparation
or analysis.
b) The results of all checks shall be recorded.
c) Where there is any doubt as to the item's suitability
for testing, where the sample does not conform to the
description provided, or where the test required is not
fully specified, the laboratory should consult the
client for further instruction before proceeding. The
laboratory shall establish whether the sample has
received all necessary preparation, or whether the
client requires preparation to be undertaken or
arranged by the laboratory. If the sample does not
meet the sample receipt acceptance criteria listed in
5.11.3.a, 5.11.3.b or 5.11.3.C, the laboratory shall
either:
1) Retain correspondence and/or records of
conversations concerning the final disposition of
rejected samples; or
2) Fully document any decision to proceed with the
analysis of samples not meeting acceptance criteria.
i. The condition of these samples shall, at a
minimum, be noted on the chain of custody or
transmittal form and laboratory receipt documents.
ii. The analysis data shall be appropriately
"qualified" on the final report.
d) The laboratory shall utilize a permanent, sequential
log, such as a log book or electronic record, to
document receipt of all sample containers. The
following information must be recorded in the
laboratory chronological log:
1) Date and time of laboratory receipt of sample;
2) Sample collection date;
3) Unique laboratory ID code (see 5.11.1);
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4) Field ID code supplied by sample submitter;
5) Requested analyses, including approved method
number, if applicable;
6) Signature or initials of data logger;
7) Comments resulting from inspection for sample
acceptance rejection; and
8) Sampling kit code (if applicable).
e) All documentation, such as memos or transmittal forms,
that is transmitted to the laboratory by the sample
transmitter shall be retained.
f) A complete chain of custody record (Section 5.12.4), if
utilized, shall be maintained.
5.11.4 Storage Conditions
The laboratory shall have documented procedures and
appropriate facilities to avoid deterioration or damage to
the sample, during storage, handling, preparation, and
testing; any relevant instructions provided with the item
shall be followed. Where items have to be stored or
conditioned under specific environmental conditions, these
conditions shall be maintained, monitored and recorded where
necessary.
a) Samples shall be stored according to the conditions
specified by preservation protocols:
1) Samples which require thermal preservation shall be
stored under refrigeration which is +/-2° of the
specified preservation temperature unless method
specific criteria exist. For samples with a
specified storage temperature of 4°C, storage at a
temperature of 0.1 to 6°C shall be acceptable.
2) Samples shall be stored away from all standards,
reagents, food and other potentially contaminating
sources.
b) Sample fractions, extracts, leachates and other sample
preparation products shall be stored according to
5.11.4.a above or according to specifications in the
method.
c) Where a sample or portion of the sample is to be held
secure (for example, for reasons of record, safety or
value, or to enable check calibrations or tests to be
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performed later), the laboratory shall have storage and
security arrangements that protect the condition and
integrity of the secured items or portions concerned.
5.11.5 Sample Disposal
The laboratory shall have standard operating procedures for
the disposal of samples, digestates, leachates and extracts
or other sample preparation products, including all
provisions necessary to protect the integrity of the
laboratory.
5.12 RECORDS
The laboratory shall maintain a record system to suit its
particular circumstances and comply with any applicable
regulations. The system shall produce unequivocal, accurate
records which document all laboratory activities. The
laboratory shall retain on record all original observations,
calculations and derived data, calibration records and a
copy of the test report for an appropriate period.
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 5.12.1, 5.12.2 and 5.12.3. The basic
requirements for legal chain of custody (if required or
implemented) are specified in Section 5.12.4.
5.12.1 Record Keeping System and Design
The record keeping system must allow 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.
a) The records shall include the identity of personnel
involved in sampling, preparation, calibration or
testing.
b) All information relating to the laboratory facilities
equipment, analytical methods, and related laboratory
activities, such as sample receipt, sample preparation,
or data verification shall be documented.
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c) The record keeping system shall facilitate the
retrieval of all working files and archived records for
inspection and verification purposes.
d) 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 such
as "sampled by", "prepared by", or "reviewed by").
e) All generated data except those that are generated by
automated data collection systems, shall be recorded
directly, promptly and legibly in permanent ink.
f) Entries in records shall not be obliterated by methods
such as erasures, overwritten files 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.
g) Refer to 5.10.6 for Computer and Electronic Data.
5.12.2 Records Management and Storage
a) All records (including those pertaining to calibration
and test equipment), certificates and reports shall be
safely stored, held secure and in confidence to the
client. NELAP-related records shall be available to
the accrediting authority.
b) 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 5.12.3 and 5.12.4 shall be retained. All
hardware and software necessary for the historical
reconstruction of data must be maintained by the
laboratory.
c) Records that are stored or generated by computers or
personal computers (PCS) shall have hard copy or write-
protected backup copies.
d) The laboratory shall establish a record management
system for control of laboratory notebooks; instrument
logbooks; standards logbooks; and records for data
reduction, validation storage and reporting;
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e) Access to archived information shall be documented with
an access log. These records shall be protected
against fire, theft, loss, environmental deterioration,
vermin and, in the case of electronic records,
electronic or magnetic sources.
f) In the event that a laboratory transfers ownership or
goes out of business, the laboratory shall have a plan
to ensure that the records are maintained or
transferred according to the clients' instructions (see
4.1.8.e).
5.12.3 Laboratory Sample Tracking
5.12.3.1 Sample Handling
A record of all procedures to which a sample is subjected
while in the possession of the laboratory shall be
maintained. These shall include but are not limited to all
records pertaining to:
a) Sample preservation including appropriate sample
container and compliance with holding time requirement;
b) Sample identification, receipt, acceptance or rejection
and log-in;
c) Sample storage and tracking including shipping
receipts, transmittal forms, and internal routing and
assignment records;
d) Sample preparation including cleanup and separation
protocols, ID codes, volumes, weights, instrument
printouts, meter readings, calculations, reagents;
e) Sample analysis;
f) Standard and reagent origin, receipt, preparation, and
use;
g) Equipment receipt, use, specification, operating
conditions and preventative maintenance;
h) Calibration criteria, frequency and acceptance
criteria;
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i) Data and statistical calculations, review,
confirmation, interpretation, assessment and reporting
conventions;
j) Method performance criteria including expected quality
control requirements;
k) Quality control protocols and assessment;
1) Electronic data security, software documentation and
verification, software and hardware audits, backups,
and records of any changes to automated data entries;
m) All automated sample handling systems;
n) Records storage and retention; and
o) Disposal of hazardous samples including the date of
sample or subsample disposal and name of the
responsible person.
5.12.3.2 Laboratory Support Activities
In addition to documenting all the above-mentioned
activities, the following shall be retained:
a) 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);
b) A written description or reference to the specific
method used which includes a description of the
specific computational steps used to translate
parametric observations into a reportable analytical
value;
c) Copies of final reports;
d) Archived standard operating procedures;
e) Correspondence relating to laboratory activities for a
specific project;
f) All corrective action reports, audits and audit
responses;
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g) Proficiency test results and raw data; and
h) Data review and cross checking.
5.12.3.3 Analytical Records
The essential information to be associated with analysis,
such as strip charts, tabular printouts, computer data
files, analytical notebooks, and run logs, shall include:
a) Laboratory sample ID code;
b) Date of analysis;
c) Instrumentation identification and instrument operating
conditions/parameters (or reference to such data);
d) Analysis type;
e) All calculations (automated and manual); and
f) Analyst's or operator's initials/signature.
5.12.3.4 Administrative Records
The following shall be maintained:
a) Personnel qualifications, experience and training
records;
b) Initial and continuing demonstration of proficiency for
each analyst; and
c) A log of names, initials and signatures for all
individuals who are responsible for signing or
initialing any laboratory record.
5.12.4 Legal or Evidentiary Custody
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
5.12.3 and the performance standards outlined in 5.12.1 and
5.12.2, the following protocols shall be incorporated if
legal COC is implemented by the organization.
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5.12.4.1 Basic Requirements
The legal chain of custody records shall establish an
intact, continuous 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) A sample is in someone's custody if:
1) It is in one's actual physical possession;
2) It is in one's view, after being in one's physical
possession;
3) It is in one's physical possession and then locked
up so that no one can tamper with it;
4) It is kept in a secured area, restricted to
authorized personnel only.
b) The COC records shall account for all time periods
associated with the samples.
c) The COC records shall include signatures of all
individuals who had access to individual samples.
d) In order to simplify record-keeping, the number of
people who physically handle the sample should be
minimized. A designated sample custodian, who is
responsible for receiving, storing and distributing
samples is recommended.
e) 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.
f) 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.
g) The COC forms shall remain with the samples during
transport or shipment.
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h) If samples are shipped, the shipping container shall be
sealed in such a manner so that tampering by
unauthorized personnel is immediately evident.
i) Mailed packages should be registered with return
receipt requested. If packages are sent by common
carrier, receipts should be retained as part of the
permanent chain-of-custody documentation.
j) If required, individual sample containers shall be
sealed in such a way to prevent tampering.
k) Once received by the laboratory, laboratory personnel
are responsible for the care and custody of the sample
and must be prepared to testify that the sample was in
their possession and view or secured in the laboratory
at all times from the moment it was received from the
custodian until the time that the analyses are
completed or the sample is disposed.
5.12.4.2 Required Information in Custody Records
In addition to the information specified in 5.11.1.a and
S.ll.l.b, 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.
5.12.4.3 Controlled Access to Samples
Access to all legal samples and subsamples shall be
controlled and documented.
a) A clean, dry, isolated room, building, and/or
refrigerated space that can be securely locked from the
outside must be designated as a custody room.
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b) Where possible, distribution of samples to the analyst
performing the analysis must be made by the
custodian(s).
c) The laboratory area must be maintained as a secured
area, restricted to authorized personnel only.
d) Once the sample analyses are completed, the unused
portion of the sample, together with all identifying
labels, must be returned to the custodian. The
returned tagged sample must be retained in the custody
room until permission to destroy the sample is received
by the custodian or other authority.
5.12.4.4 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.
5.12.4.5 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 (such as sample depleted, sample disposed
in hazardous waste facility, or sample returned to
client), and the name of the individual who performed
the task.
5.13 LABORATORY REPORT FORMAT AND CONTENTS
The results of each test, or series of tests carried out by
the laboratory shall be reported accurately, clearly,
unambiguously and objectively, in accordance with any
instructions in the test methods. The results shall
normally be reported in a test report and shall include all
the information necessary for the interpretation of the test
results and all information required by the method used.
Some regulatory reporting requirements or formats such as
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monthly operating reports, may not require all items listed
below, however, the laboratory shall provide all the
required information to their client for use in preparing
such regulatory reports.
a) Except as discussed in 5.13.b), each report to an
outside client shall include at least the following
information (those prefaced with "where relevant" are
not mandatory):
1) a title, e.g., "Test Report", or "Test Certificate",
"Certificate of Results" or "Laboratory Results";
2) name and address of laboratory, and location where
the test was carried out if different from the
address of the laboratory and phone number with name
of contact person for questions;
3) unique identification of the certificate or report
(such as serial number) and of each page, and the
total number of pages;
This requirement may be presented in several ways:
i. The total number of pages may be listed on the
first page of the report as long as the subsequent
pages are identified by the unique report
identification and consecutive numbers, or
ii. Each page is identified with the unique report
identification, the pages are identified as a
number of the total report pages (example: 3 of
10, or 1 of 20).
Other methods of identifying the pages in the report
may be acceptable as long as it is clear to the reader
that discrete pages are associated with a specific
report, and that the report contains a specified number
of pages.
4) name and address of client, where appropriate and
project name if applicable;
5) description and unambiguous identification of the
tested sample including the client identification
code;
6) where relevant, characterization and condition of
the sample;
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7) date of receipt of sample, date and time of sample
collection, date(s) of performance test, and time of
sample preparation and/or analysis if the required
holding time for either activity is less than or
equal to 48 hours;
8) identification of the test method used, or
unambiguous description of any non-standard method
used;
9) where relevant, reference to sampling procedure;
10) any deviations from, additions to or exclusions from
the test method, and any other information relevant
to a specific test, such as environmental conditions
including the use of relevant data qualifiers and
their meaning;
11) measurements, examinations and derived results,
supported by tables, graphs, sketches and
photographs as appropriate, and any failures (such
as failed quality control) identified. Where
relevant, include a description of the
transformations, calculations, or operations
performed on the data, a summary and analysis of the
data. Where applicable, identification of whether
data is calculated on a dry weight or wet weight
basis; identification of the reporting units such as
//g/1 or mg/kg and for Whole Effluent Toxicity,
identification of the statistical package used to
provide data.
12) where relevant, a statement of the estimated
uncertainty of the test result;
In situations where required by the client or
regulatory agency, this information shall be provided.
It may be required of laboratories involved in
analyses, where there is an uncertainty associated with
detection limits.
13) a signature and title, or an equivalent electronic
identification of the person(s) accepting
responsibility for the content of the certificate or
report (however produced), and date of issue;
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14) where relevant, a statement to the effect that the
results relate only to the items tested or to the
sample as received by the laboratory;
15) where relevant, a statement that the certificate or
report shall not be reproduced except in full,
without the written approval of the laboratory; and
16) where relevant, clear identification of all data
provided by outside sources, such as air temperature
or ambient water temperature.
b) Laboratories who are operated by a facility and whose
sole function is to provide data to the facility
management for compliance purposes (in-house or captive
laboratories) shall have all applicable information
specified in 1 through 16 above readily available for
review by the accrediting authority. However formal
reports detailing the information are not required if:
1) The in-house laboratory is itself responsible for
preparing the regulatory reports; or
2) The laboratory provides information to another
individual within the organization for preparation
of regulatory reports. In these cases, the
laboratory must provide items 1,3,4,5,7,8,10, and 11
from the above list to the individual responsible
for preparing regulatory reports.. The facility
management must assure that the remaining items are
added in the report to the regulatory authority if
such information is required.
c) Where the certificate or report contains results of
tests performed by sub-contractors, these results shall
be clearly identified by subcontractor name or
applicable accreditation number.
d) After issuance of the report, the laboratory report
shall remain unchanged. Material amendments to a
calibration certificate, test report or test
certificate after issue shall be made only in the form
of a further document, or data transfer including the
statement "Supplement to Test Report or Test
Certificate, serial number . . . [or as otherwise
identified]", or equivalent form of wording. Such
amendments shall meet all the relevant requirements of
this Standard.
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e) The laboratory shall notify clients promptly, in
writing, of any event such as the identification of
defective measuring or test equipment that casts doubt
on the validity of results given in any calibration
certificate, test report or test certificate or
amendment to a report or certificate.
f) The laboratory shall ensure that, where clients require
transmission of test results by telephone, telex,
facsimile or other electronic or electromagnetic means,
staff will follow documented procedures that ensure
that the requirements of this Standard are met and that
confidentiality is preserved.
g) Laboratories accredited to be in compliance with these
standards shall certify that the test results meet all
requirements of NELAC or provide reasons and/or
justification if they do not.
5.14 SUBCONTRACTING ANALYTICAL SAMPLES
a) The laboratory shall advise the client in writing of
its intention to sub-contract any portion of the
testing to another party.
b) Where a laboratory sub-contracts any part of the
testing covered under NELAP, this work shall be placed
with a laboratory accredited under NELAP for the tests
to be performed.
c) The laboratory shall retain records demonstrating that
the above requirements have been met.
5.15 OUTSIDE SUPPORT SERVICES AND SUPPLIES
a) Where the laboratory procures outside services and
supplies, other than those referred to in this
Standard, in support of tests, the laboratory shall use
only those outside support services and supplies that
are of adequate quality to sustain confidence in the
laboratory's tests.
b) Where no independent assurance of the quality of
outside support services or supplies is available, the
laboratory shall have procedures to ensure that
purchased equipment, materials and services comply .with
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specified requirements.' The laboratory should,
wherever possible, ensure that purchased equipment and
consumable materials are not used until they have been
inspected, calibrated or otherwise verified as
complying with any standard specifications relevant to
the calibrations or tests concerned.
c) The laboratory shall maintain records of all suppliers
from whom it obtains support services or supplies
required for tests.
5.16 COMPLAINTS
The laboratory shall have documented policy and procedures
for the resolution of complaints received from clients or
other parties about the laboratory's activities. Where a
complaint, or any other circumstance, raises doubt
concerning the laboratory's compliance with the laboratory's
policies or procedures, or with the requirements of this
Standard or otherwise concerning the quality of the
laboratory's calibrations or tests, the laboratory shall
ensure that those areas of activity and responsibility
involved are promptly audited in accordance with Section
5.5.3.1. Records of the complaint and subsequent actions
shall be maintained.
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Appendix A - REFERENCES
40 CFR Part 136, Appendix A, paragraphs 8.1.1 and 8.2
American Association for Laboratory Accreditation April
1996. General Requirements for Accreditation
"American National Standards Specification and Guidelines
for Quality Systems for Environmental Data Collection and
Environmental Technology Programs (ANSI/ASQC E-4)", 1994
Catalog of Bacteria, American Type Culture Collection,
Rockville, MD
EPA 2185 - Good Automated Laboratory Practices, 1995
available at www.epa.gov/docs/etsdwel/irm_galp/
"Glossary of Quality Assurance Terms and Acronyms", Quality
Assurance Division, Office of Research and Development,
USE PA
"Guidance on the Evaluation of Safe Drinking Water Act
Compliance Monitoring Results from Performance Based
Methods", September 30, 1994, Second draft.
International vocabulary of basic and general terms in
metrology (VIM): 1984. Issued by BIPM. IEC. ISO. and OIML
ISO Guide 3534-1: "Statistics, vocabulary and symbols -
Part 1: Probability and general statistical terms"
ISO Guide 7218: Microbiology - General Guidance for
Microbiological Examinations
ISO Guide 8402: 1986. Quality - Vocabulary
ISO Guide 9000: 1994 Quality management and quality
assurance standards - Guidelines for selection and use
ISO Guide 9001: 1994 Quality Systems - Model for quality
assurance in design/development, production, installation
and servicing
ISO Guide 9002: 1994 Quality systems - Model for quality
assurance in production and installation
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ISO/IEC Guide 2: 1986. General terms and their definitions
concerning standardization and related activities
ISO/IEC Guide 25: 1990. General requirements for the
competence of calibration and testing laboratories
"Laboratory Biosafety Manual", World Health Organization,
Geneva, 1983
Manual for the Certification of Laboratories Analyzing
Drinking Water EPA/570/9-90/008
Manual of Method for General Bacteriology, Philipp Gerhard
et al., American Society for Microbiology, Washington, 1981
Performance Based Measurement System, EPA EMMC Method Panel,
PBM workgroup, 1996
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Appendix B - DEFINITIONS FOR QUALITY SYSTEMS
The following definitions are used in the text of Quality
Systems. In writing this document, the following hierarchy
of definition references were used: ISO 8402, ANSI/ASQC E-4,
EPA's Quality Assurance Division Glossary of Terms, and
finally definitions developed by NELAC and/or the Quality
Assurance Standing Committee. The source of each definition
is noted.
Acceptable Criteria: specified limits placed on
characteristics of an item, process, or service defined in
requirement documents. (ASQC)
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. (NELAC)
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. (NELAC)
Assessor Body: the organization that actually executes the
accreditation process, i.e., receives and reviews
accreditation applications, reviews QA documents, reviews
proficiency testing results, surveys the site, etc., whether
EPA, the state, or contracted private party. (NELAP)
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).
Analytical Reagent (AR) Grade: designation for the high
purity of certain chemical reagents and solvents given the
American Chemical Society. (Quality Systems)
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Batch: environmental samples which are prepared and/or
analyzed together with the same process and personnel, using
the same lot(s) of reagents. A preparation batch is
composed of one to 20 environmental samples of the same
NELAC-defined matrix, meeting the above mentioned criteria
and with a maximum time between the start of processing of
the first and last sample in the batch to be 24 hours. An
analytical batch is composed of prepared environmental
samples (extracts, digestates or concentrates) which are
analyzed together as a group. An analytical batch can
include prepared samples originating from various
environmental matrices and can exceed 20 samples. (Quality
Systems)
Blank: a sample that has not been exposed to the analyzed
sample stream in order to monitor contamination during
sampling, transport, storage or analysis. The blank is
subjected to the usual analytical and measurement process to
establish a zero baseline or background value and is
sometimes used to adjust or correct routine analytical
results. (ASQC, Definitions of Environmental Quality
Assurance Terms, 1996)
Blind Sample: a subsample for analysis with a composition
known to the submitter. The analyst/laboratory may know the
identity of the sample but not its composition. It is used
to test the analyst's or laboratory's proficiency in the
execution of the measurement process.
Calibrate: to determine, by measurement or comparison with
a standard, the correct value of each scale reading on a
meter or other device, or the correct value for each setting
of a control knob. The levels of the applied calibration
standard should bracket the range of planned or expected
sample measurements.
Calibration: the set of operations which establish, under
specified conditions, the relationship between values
indicated by a measuring instrument or measuring system, or
values represented by a material measure, and the
corresponding known values of a measurand. (VIM - 6.13)
Calibration Curve: the graphical relationship between the
known values, such as concentrations, of a series of
calibration standards and their instrument response.
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Calibration Method: defined technical procedure for
performing a calibration.
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) .
Certified Reference Material (CRM): a reference material
one or more of whose property values are certified by a
technically valid procedure, accompanied by or traceable to
a certificate or other documentation which is issued by a
certifying body. (ISO Guide 30 - 2.2)
Chain of Custody: an unbroken trail of accountability that
documents the physical security of samples, data and
records.
Confirmation: verification of the presence of a component
through the use of an analytical technique that differs from
the original method. These may include:
Second column confirmation
Alternate wavelength
Derivatization
Mass spectral interpretation
Alternative detectors or
Additional cleanup procedures.
Corrective Action: action taken to eliminate the causes of
an existing nonconformity, defect or other undesirable
situation in order to prevent recurrence. (ISO 8402)
Data Audit: a qualitative and quantitative evaluation of
the documentation and procedures associated with
environmental measurements to verify that the resulting data
are of acceptable quality (i.e., that they meet specified
acceptance criteria.
Data Reduction: the process of transforming raw data by
arithmetic or statistical calculations, standard curves,
concentration factors, etc., and collation into a more
useful form.
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Document Control: the act of ensuring that documents (and
revisions thereto) are proposed, reviewed for accuracy,
approved for release by authorized personnel, distributed
properly and controlled to ensure use of the correct version
at the location where the prescribed activity is performed.
(ASQC, Definitions of Environmental Quality Assurance Terms,
1996)
Double Blind Sample: a sample submitted to evaluate
performance with concentration and identity unknown to the
analyst.
Duplicate Analyses: the analyses or measurements of the
variable of interest performed identically on two subsamples
of the same sample. The results from duplicate analyses are
used to evaluate analytical or measurement precision but not
the precision of sampling, preservation or storage internal
to the laboratory.
Environmental Detection Limit (EDL): the smallest level at
which a radionuclide in an environmental medium can be
unambiguously distinguished for a given confidence interval
using a particular combination of sampling and measurement
procedures, sample size, analytical detection limit, and
processing procedure. The EDL shall be specified for the
0.95 or greater confidence interval. The EDL shall be
established initially and verified annually for each method
and sample matrix. (Radioanalysis Subcommittee)
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 of the laboratory 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).
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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).
Internal Standard: a known amount of standard added to a
test portion of a sample and carried through the entire
measurement process as a reference for evaluating and
controlling the precision and bias of the applied analytical
method.
Laboratory: Body that calibrates and/or tests.
NOTES:
1. In cases where a laboratory forms part of an
organization that carries out other activities besides
calibration and testing, the term "laboratory" refers
only to those parts of that organization that are
involved in the calibration and testing process.
2. As used herein, the term "laboratory" refers to a
body that carries out calibration or testing
- at or from a permanent location,
- at or from a temporary facility, or
- in or from a mobile facility. (ISO 25)
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).
Laboratory Duplicate: Aliquots of a sample taken from the
same container under laboratory conditions and processed and
analyzed independently.
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).
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Manager (however named): 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: The component or substrate which contains the
analyte of interest. For purposes of batch determination,
the following matrix types shall be used:
- Aqueous: Any aqueous sample excluded from the
definition of a drinking water matrix or Saline/Estuarine
source. Includes surface water, groundwater and
effluents.
- Drinking water: Any aqueous sample that has been
designated a potable or potential potable water source.
- Saline/Estuarine: Any aqueous sample from an ocean or
estuary, or other salt water source such as the Great
Salt Lake.
- Non-aqueous liquid: Any organic liquid with <15%
settleable solids.
- Biological Tissue: Any sample of a biological origin
such as fish tissue, shellfish, or plant material. Such
samples shall be grouped according to origin.
- Solids: Includes soils, sediments, sludges and other
matrices with >15% settleable solids.
- Chemical Waste: A product or by-product of a
industrial process that results in a matrix not
previously defined.
- Air Samples: Media used to retain the analyte of
interest from an air sample such as sorbent tubes or
summa canisters. Each medium shall be considered as a
distinct matrix. (Quality Systems)
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 in
the laboratory and analyzed to obtain a measure of the
precision of the recovery for each analyte. (Glossary of
Quality Assurance Terms, QAMS, 8/31/92).
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May: permitted, but not required (TRADE)
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).
Must: denotes a requirement that must be met. (Random House
College Dictionary)
Negative Control: measures taken to ensure that a test, its
components, or the environment do not cause undesired
effects, or produce incorrect test results.
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.
(NELAC)
NELAP: the overall National Environmental Laboratory
Accreditation Program of which NELAC is a part. (NELAC)
Performance Audit: the routine comparison of independently
obtained quantitative measurement system data with routinely
obtained data in order to evaluate the proficiency of an
analyst or laboratory.
Performance Based Measurement System (PBMS): a set of
processes wherein the data quality needs, mandates or
limitations of a program or project are specified and serve
as criteria for selecting appropriate methods to meet those
needs in a cost-effective manner.
Positive Control: measures taken to ensure that a test
and/or its components are working properly and producing
correct or expected results from positive test subjects.
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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.
Proficiency Test Sample (PT): 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).
Proficiency Testing: Determination of the laboratory
calibration or testing performance by means of
interlaboratory comparisons. (ISO/IEC Guide 2 - 12.6,
amended)
i
Proficiency Testing 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.
Protocol: a detailed written procedure for field and/or
laboratory operation (e.g., sampling, analysis) which must
be strictly followed.
Pure Reagent Water: shall be ASTM Type I or Type II water
in which no target analytes or interferences are detected as
required by the analytical method.
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) .
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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 Manual: A document stating the quality policy,
quality system and quality practices of an organization.
This may be also called a Quality Assurance Plan or a
Quality Plan.
NOTE - The quality manual may call up other documentation
relating to the laboratory's quality arrangements.
Quality System: a structured and documented management
system describing the policies, objectives, principles,
organizational authority, responsibilities, accountability,
and implementation plan of an organization for ensuring
quality in its work processes, products (items), and
services. The quality system provides the framework for
planning, implementing, and assessing work performed by the
organization and for carrying out required QA and QC.
(ANSI/ASQC E-41994)
Range: the difference between the minimum and the maximum
of a set of values.
Raw Data: any original factual information from a
measurement activity or study recorded in a laboratory
notebook, worksheets, records, memoranda, notes ,or exact
copies thereof that are necessary for the reconstruction and
evaluation of the report of the activity or study. Raw data
may include photography, microfilm or microfiche copies,
computer printouts, magnetic media, including dictated
observations, and recorded data from automated instruments.
If exact copies of raw data have been prepared (e.g., tapes
which have been transcribed verbatim, data and verified
accurate by signature), the exact copy or exact transcript
may be submitted.
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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).
Reference Material: a material or substance one or more
properties of which are sufficiently well established to be
used for the calibration of an apparatus, the assessment of
a measurement method, or for assigning values to materials.
(ISO Guide 30-2.1)
Reference Standard: a standard, generally of the highest
metrological quality available at a given location, from
which measurements made at that location are derived. (VIM -
6.08)
Requirement: a translation of the needs into a set of
individual quantified or descriptive specifications for the
characteristics of an entity in order to enable its
realization and examination.
Reference Toxicant: see D.2.1.a
Replicate Analyses: the measurements of the variable of
interest performed identically on two or more subsamples of
the same sample within a short time interval.
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).
Selectivity: (Analytical chemistry) the capability of a
method or instrument to respond to a target substance or
constituent in the presence of nontarget substances.
Sensitivity: the capability of a method or instrument to
discriminate between measurement responses representing
different levels (e.g., concentrations) of a variable of
interest.
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Shall: denotes a requirement that is mandatory whenever the
criterion for conformance with the specification requires
that there be no deviation. This does not prohibit the use
of alternative approaches or methods for implementing the
specification so long as the requirement is fulfilled.
(Style Manual for Preparation of Proposed American National
Standards, American National Standards Institute, eighth
edition, March 1991).
Should: denotes a guideline or recommendation whenever
noncompliance with the specification is permissible. (Style
Manual for Preparation of Proposed American National
Standards, American National Standards Institute, eighth
edition, March 1991).
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).
Spike: a known mass of target analyte added to a blank
sample or subsample; used to determine recovery efficiency
or for other quality control purposes.
Standard Reference Material (SRM) : a certified reference
material produced by the U.S. National Institute of
Standards and Technology and characterized for absolute
content, independent of analytical method.
Supervisor (however named): the individual(s) 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).
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Systems Audit (also Technical Systems Audit): a thorough,
systematic on-site, qualitative review of the facilities,
equipment, personnel, training, procedures, record keeping,
data validation, data management/ and reporting aspects of a
total measurement system.
Technical Director: Definition needs to be developed
Technical Analyst: the designated individual who performs
the "hands-on" analytical methods and associated techniques
and who is the one responsible for applying required
laboratory practices and other pertinent Quality Controls to
meet the required level of quality.
Test: a technical operation that consists of the
determination of one or more characteristics or performance
of a given product, material, equipment, organism, physical
phenomenon, process or service according to a specified
procedure.
NOTE - The result of a test is normally recorded in a
document sometimes called a test report or a test
certificate. (ISO/IEC Guide 2 - 12.1, amended)
Test Method: defined technical procedure for performing a
test.
Testing Laboratory: laboratory that performs tests.
(ISO/IEC Guide 2 - 12.4)
Test Sensitivity/Power: D.2.4.a
Tolerance Chart: A chart in which the plotted quality
control data is assessed via a tolerance level (e.g. +/- 10%
of a mean) based on the precision level judged acceptable to
meet overall quality/data use requirements instead of a
statistical acceptance criteria (e.g. +/- 3 sigma). (ANSI
N42.23-1995, Measurement and Associated Instrument Quality
Assurance for Radioassay Laboratories)
Traceability: the property of a result of a measurement
whereby it can be related to appropriate standards,
generally international or national standards, through an
unbroken chain of comparisons. (VIM - 6.12)
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Verification: confirmation by examination and provision of
evidence that specified requirements have been met.
NOTE - In connection with the management of measuring
equipment, verification provides a means for checking
that the deviations between values indicated by a
measuring instrument and corresponding known values of a
measured quantity are consistently smaller than the
maximum allowable error defined in a standard, regulation
or specification peculiar to the management of the
measuring equipment.
The result of verification leads to a decision either to
restore in service, to perform adjustments, or to repair,
or to downgrade, or to declare obsolete. In all cases it
is required that a written trace of the verification
performed shall be kept on the measuring instrument's
individual record.
Validation: the process of substantiating specified
performance criteria.
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Appendix C - INITIAL DEMONSTRATION OF CAPABILITY
C.I PROCEDURE FOR INITIAL DEMONSTRATION OF CAPABILITY
An initial demonstration of method performance must be made
prior to using any method, and at any time there is a
significant change in instrument type, personnel or method
(see 5.10.2.1).
All initial demonstrations, continuing demonstrations and
method certification shall be documented through the use of
the forms in this appendix.
The following steps, which are adapted from the EPA methods
published in 40 CFR Part 136, Appendix A, shall be
performed:
a) A quality control sample shall be obtained from an
outside source. If not available, the QC check sample
may be prepared by the laboratory using stock standards
that are prepared independently from those used in
instrument calibration.
b) The concentrate shall be diluted in a volume of clean
matrix sufficient to prepare four aliquots at the
required method volume to a concentration approximately
10 times the method-stated or laboratory-calculated
method detection limit.
c) The four aliquots shall be prepared and analyzed
according to the method either concurrently or over a
period of days.
d) Using the four results, calculate the average recovery
(x) in the appropriate reporting units (such as /ug/L)
and the standard deviation (s) (in the same units) for
each parameter of interest.
e) For each parameter, compare s and x to the
corresponding acceptance criteria for precision and
accuracy in the method (if applicable) or in
laboratory-generated acceptance criteria (if a non-
standard method). If s and x for all parameters meet
the acceptance criteria, the analysis of actual samples
may begin. If any one of the parameters exceed the
acceptance range, the performance is unacceptable for
that parameter.
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f) When one or more of the tested parameters fail at least
one of the acceptance criteria/ the analyst must
proceed according to 1) or 2) below.
1) Locate and correct the source of the problem and
repeat the test for all parameters of interest
beginning with c) above.
2) Beginning with c) above, repeat the test for all
parameters that failed to meet criteria. Repeated
failure, however, will confirm a general problem
with the measurement system. If this occurs, locate
and correct the source of the problem and repeat the
test for all compounds of interest beginning with
c) .
C.2.0 CERTIFICATION STATEMENT
The following certification statement shall be used to
document the completion of each initial demonstration of
capability. A copy of the certification statement shall be
retained in the personnel records of each affected employee
(see 5.6.3 and 5.12.3.4.b).
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Initial Demonstration of Capability
Certification Statement
Date: Page of
Laboratory Name:
Laboratory Address:
Analyst(s) Name(s):
Matrix:
(examples: laboratory pure water, soil, air, waste solid, leachate, sludge, other)
Method number, and Analyte, or Class of Analytes or Measured Parameters
(examples: barium by 200.7, trace metals by 6010, benzene by 8021, etc.)
We, the undersigned, CERTIFY that:
1. The analysts identified above, using the cited method, which
is in use at this facility for the analyses of samples under the
National Environmental Laboratory Accreditation Program, have met the
Initial Demonstration of Capability.
2. The method was performed by the analyst(s) identified on this
certification.
3. A copy of the method and the laboratory-specific SOPs are
available for all personnel on-site.
4. The data associated with the initial demonstration capability
are true, accurate, complete and self-explanatory (1) .
5. All raw data (including a copy of this certification form)
necessary to reconstruct and validate these analyses have been
retained at the facility, and that the associated information is well
organized and available for review by authorized inspectors.
Technical Director's Name and Title Signature Date
Quality Assurance Officer's Name Signature Date
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This certification form must be completed each time an initial
demonstration of capability study is completed.
(1) True: Consistent with supporting data.
Accurate: Based on good laboratory practices consistent with
sound scientific principles/practices.
Complete: Includes the results of all supporting performance
testing.
Self-Explanatory: Data properly labeled and stored so that the
results are clear and require no additional explanation.
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Appendix D - ESSENTIAL QUALITY CONTROL REQUIREMENTS
The quality control protocols specified by the laboratory's
method manual (5.10.1.2) shall be followed. The laboratory
shall ensure that the essential standards outlined in
Appendix D are incorporated into their method manuals
All quality control measures shall be assessed and
evaluated on an on-going basis and quality control
acceptance limits shall be used to determine the validity of
the data. The laboratory shall have procedures for the
development of acceptance/rejection criteria where no method
or regulatory criteria exists.
D.1.0 CHEMICAL TESTING
D.I.I Positive and Negative Controls
a) Negative Controls
1) Method Blanks - Shall be performed at a frequency of
one per batch of samples per matrix type per sample
extraction or preparation method. The results of
this analysis shall be one of the QC measures to be
used to assess batch acceptance. If blank
contamination exceeds a concentration greater than
1/10 of the measured concentration of any sample in
the associated sample batch and 1/10 of the
regulatory limit, the analysis of all samples
associated with the blank must be stopped until the
source of the contamination is investigated and
measures are taken to correct, minimize or eliminate
the problem. Each sample in the affected batch must
be assessed against the above criteria to determine
if the sample datum is acceptable. Any sample
associated with the contaminated blank shall be
reprocessed for analysis or the results reported
with appropriate data qualifying codes.
b) Positive Controls
1) Matrix Spikes (MS) - Shall be performed at a
frequency of one in 20 samples per matrix type per
sample extraction or preparation method except for
analytes for which spiking solutions are not
available such as, total suspended solids, total
dissolved solids, total volatile solids, total
solids, pH, color, odor, temperature, dissolved
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oxygen or turbidity. The selected sample(s) shall
be rotated among client samples so that various
matrix problems may be noted and/or addressed. Poor
performance in a matrix spike may indicate a problem
with the sample composition and shall be reported to
the client whose sample was used for the spike.
2) Laboratory Control Sample - (QC Check Samples)
Shall be analyzed at a minimum of 1 per batch of 20
or less samples per matrix type per sample
extraction or preparation method except for analytes
for which spiking solutions are not available such
as total suspended solids, total dissolved solids,
total volatile solids, total solids, pH, color,
odor, temperature, dissolved oxygen or turbidity.
The results of these samples shall be used to
determine batch acceptance. NOTE: the Matrix spike
(see 1 above) may be used as a control as long as
the acceptance criteria are as stringent as the LCS.
3) Surrogates - Surrogate compounds must be added to
all samples, standards, and blanks, whenever
possible, for all organic chromatography methods.
4) If the method does not specify the spiking
compounds, the laboratory shall spike all reportable
components in the Laboratory Control Sample and
Matrix Spike. However, in cases where the
components interfere with accurate assessment (such
as simultaneously spiking chlordane, toxaphene and
PCBs in Method 608), the method has an extremely
long list of components (such as Method 8270 or
6010) or components are incompatible, a
representative number (10%) of the listed components
may be used to control the method. The selected
components of each spiking mix shall represent all
chemistries, elution patterns and masses and shall
include permit specified analytes and other client
requested components. The laboratory shall ensure,
however, that all reported components are used in
the spike mixture within a two-year time period, and
that no one component or components dominate the
spike mixture.
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D.I.2 Analytical Variability/Reproducibility
Matrix Spike Duplicates (MSDs) or Laboratory Duplicates -
Shall be analyzed at a minimum of 1 in 20 samples per matrix
type per sample extraction or preparation method. The
laboratory shall document their procedure to select the use
of appropriate type of duplicate. The selected sample(s)
shall be rotated among client samples so that various matrix
problems may be noted and/or addressed. Poor performance in
the duplicates may indicate a problem with the sample
composition and shall be reported to the client whose sample
was used for the duplicate.
D. 1.3 Method Evaluation
In order to ensure the accuracy of the reported result, the
following procedures shall be in place:
a) Initial Demonstration of Analytical Capability —
(Section 5.10.2.1) shall be performed initially (prior
to the analysis of any samples) and with a significant
change in instrument type, personnel or method.
b) Calibration - Calibration protocols specified in
Section 5.9.4 shall be followed.
c) Proficiency Test Samples - The results of such analyses
(5.4.2.J or 5.5.3.4) shall be used by the laboratory to
evaluate the ability of the laboratory to produce
accurate data.
D.I.4 Method Detection Limits
Method detection limits (MDL) shall be determined by 40
CFR Part 136, Appendix B unless included in a method or
program.
a) An MDL study is not required for any component for
which spiking solutions are not available such as
total suspended solids, total dissolved solids,
total volatile solids, total solids, pH, color,
odor, temperature dissolved oxygen or turbidity.
b) The detection limit shall be initially determined
for the compounds of interest in each method in a
clean matrix appropriate to the test method (such as
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laboratory pure water or Ottawa sand) or the matrix
of interest (see definition of matrix).
c) The laboratory must verify that the MDL is at least
three (3) times less than the laboratory reporting
limit.
d) The MDL shall be verified annually by the
preparation and analysis of at least one clean
matrix sample spiked at the current reported MDL.
If the established MDL cannot be verified, the above
study must be repeated to establish a new MDL.
e) All procedures used must be documented including the
matrix type.
D.I.5 Data Reduction
The procedures for data reduction, such as use of linear
regression, shall be documented.
D.I.6 Quality of Standards and Reagents
a) The source of standards shall comply with 5.9.2.
b) Reagent Quality. Water Quality and Checks:
1) Reagents - In methods where the purity of reagents
is not specified, analytical reagent grade shall be
used. Reagents of lesser purity than those
specified by the method shall not be used. The
labels on the container should be checked to verify
that the purity of the reagents meets the
requirements of the particular method. Such
information shall be documented.
2) Water - The quality of water sources shall be
monitored and documented and shall meet method
specified requirements.
D.I. 7 Selectivity
a) Absolute retention time and relative retention time aid
in the identification of components in chromatographic
analyses and to evaluate the effectiveness of a column
to separate constituents. The laboratory shall develop
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and document acceptance criteria for retention time
windows.
b) A confirmation shall be performed to verify the
compound identification when positive results are
detected on a sample from a location that has not been
previously tested by the laboratory. Such
confirmations shall be performed on organic tests such
as pesticides, herbicides, or acid extractable or when
recommended by the analytical method except when the
analysis involves the use of a mass spectrometer.
Confirmation is required unless stipulated in writing
by the client. All confirmation shall be documented.
c) The laboratory shall develop and document acceptance
criteria for mass spectral tuning.
D.I.8 Constant and Consistent Test Conditions
a) The laboratory shall assure that the test instruments
consistently operate within the specifications of the
test methods and equipment manufacturer.
b) Glassware Cleaning - Glassware shall be cleaned to meet
the sensitivity of method.
Any cleaning and storage procedures that are not
specified by the method shall be documented in laboratory
records and SOPs.
D.2.0 WHOLE EFFLUENT TOXICITY
D.2.1 Positive and Negative Controls
a) Positive Control - Reference Toxicants - Reference
toxicant tests indicate the sensitivity of the test
organisms being used and demonstrate a laboratory's
ability to obtain consistent results with the method.
1) The laboratory must demonstrate its ability to
obtain consistent results with reference toxicants
before it performs toxicity tests with effluents for
permit compliance purposes.
i. An intralaboratory coefficient of variation (%CV)
is not established for each test method. However,
a testing laboratory shall maintain control charts
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for the control performance and reference toxicant
statistical endpoint (such as NOEC or ECp) and
shall evaluate the intralaboratory variability
with a specific reference toxicant for each
method. In addition, a laboratory must produce
test results that meet test acceptability criteria
(such as greater than 80% survival in the
control) as specified in the specific test method.
ii. Intra-laboratory precision on an ongoing basis
must be determined through the use of reference
toxicant tests and plotted in quality control
charts. As specified in the test methods, the
control charts shall be plotted as point estimate
values, such as EC25 for chronic tests and LC 50
for acute tests, over time within a laboratory.
2) The frequency of reference toxicant testing shall
comply with the EPA or state permitting authority
requirements.
3) The USEPA test methods for EPA/600/4-91-002,
EPA/600/4-91-003 and EPA/600/4-90-027F do not
currently specify a particular reference toxicant
and dilution series, however, if the state or
permitting authority identifies a reference toxicant
or dilution series for a particular test, the
laboratory shall follow the specified requirements.
4) Test Acceptability Criteria (TAG) - The test
acceptability criteria (for example, the chronic
Ceriodaphnia test, requires 80% or greater survival
and an average 15 young per female in the controls)
as specified in the test method must be achieved for
both the reference toxicant and effluent test. The
criteria shall be calculated and shall meet the
method specified requirements for performing
toxicity:
i,. The control population of Ceriodaphnia shall
contain no more than 20% males.
ii. An individual test may be conditionally acceptable
if temperature, dissolved oxygen, pH and other
specified conditions fall outside specifications,
depending on the degree of the departure and the
objectives of the tests (see test conditions and
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test acceptability criteria specified for each
test method). The acceptability of the test shall
depend on the experience and professional judgment
of the technical employee and the permitting
authority.
b) Negative Control - Control, Brine Control or Dilution
Water - The standards for the use, type and frequency
of testing are specified by the methods and by permit
and shall be followed.
D.2.2 Variability and/or Reproducibility
Intra-laboratory precision shall be determined on an ongoing
basis through the use of further reference toxicant tests
and related control charts as described in item D.2.1.a
above.
D. 2 .3 Accuracy
This principle is not applicable to Whole Effluent Toxicity.
D.2.4 Test Sensitivity
a) Test sensitivity (or test power) of the tests will
depend in part on the number of replicates per
concentration, the significance level selected (0.05),
and the type of statistical analysis. If the
variability remains constant, the sensitivity of the
test will increase as the number of replicates is
Increased. Test sensitivity is the minimum significant
difference (MSD) between the control and test
concentration that is statistically significant. If
the Dunnett's procedure is used, the MSD shall be
calculated according to the formula specified by the
EPA method and reported with the test results.
b) For non-normal distribution and or heterogenous
variances the MSD can be estimated, but is not
required.
c) Point estimates: (LCp, ICp, or ECp) - Confidence
intervals shall be reported as a measure of the
precision around the point estimate value.
d) The MSD shall be calculated and reported for only
chronic endpoints. In addition, the calculated
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endpoint is typically a lethal concentration of 50% (LC
50), therefore, confidence intervals shall be reported
as a measure of the precision around the point estimate
value. In order to have sufficient replicates to
perform a reliable MSD, such tests shall have a minimum
of four replicates per treatment so that either
parametric or non parametric tests can be conducted.
D.2.5 Selection of Appropriate Statistical Analysis
Methods
a) The methods of data analysis and endpoints will be
specified by language in the permit or, if not present
in the permit, by the EPA methods manuals for Whole
Effluent Toxicity.
b) Dose Response Curves - When required, the data shall be
plotted in the form of a curve relating the dose of the
chemical to cumulative percentage of test organisms
demonstrating a response such as death.
D.2.6 Selection and Use of Reagents and Standards
a) The grade of all reagents used in Whole Effluent
Toxicity tests is specified in the method except the
reference standard. All reference standards shall be
prepared from chemicals which are analytical reagent
grade or better. The preparation of all standards and
reference toxicants shall be documented.
b) All standards and reagents associated with chemical
measurements, such as dissolved oxygen, pH or specific
conductance, shall comply with the standards outlined
in Appendix D.1 above.
D.2.7 Selectivity
This principle is not applicable. The selectivity of the
test is specified by permit.
D.2.8 Constant and Consistent Test Conditions
a) If closed refrigerator-sized incubators are used,
culturing and testing of organisms shall be separated
to avoid loss of cultures due to cross-contamination.
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b) The laboratory or a contracted outside expert shall
positively identify test organisms to species on an
annual basis. The taxonomic reference (citation and
page(s))and the names(s) of the taxonomic expert (s)
must be kept on file at,the laboratory.
c) Instruments used for routine measurements of chemical
and physical parameters such as pH, DO, conductivity,
salinity, alkalinity, hardness, chlorine, and weight
shall be calibrated, and/or standardized per
manufacturer's instructions and Section D.I.
Temperature shall be calibrated per section 5.9.4.2.1
All measurements and calibrations shall be documented.
d) Test temperature shall be maintained as specified in
the methods manuals. The average daily temperature of
the test solutions must be maintained within 1°C of the
selected test temperature, for the duration of the
test. The minimum frequency of measurement shall be
once per 24 hour period. The test temperature for
continuous flow toxicity tests shall be recorded and
monitored continuously.
e) Water used for culturing and testing shall be analyzed
for toxic metals and organics annually or whenever the
minimum acceptability criteria for control survival,
growth or reproduction are not met and no other cause,
such as contaminated glassware or poor stock, can be
identified. The method specified analytes and
concentration levels shall be followed.
f) New batches of food used for culturing and testing
shall be analyzed for toxic organics and metals. If
food combinations or recipes are used, analyses shall
be performed on the final product upon the use of new
lot of any ingredient. If the concentration of total
organic chlorine exceeds 0.15 //g/g wet weight, or the
total concentration of organochlorine pesticides plus
PCBs exceeds 0.30 /J.g/g wet weight, or toxic metals
exceeds 20 ju-g/g wet weight, the food must not be used.
g) Test chamber size and test solution volume shall be as
specified in the methods manuals.
h) Test organisms shall be fed the quantity and type food
specified in the methods manuals. They shall also be
fed at the intervals specified in the methods.
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i) Light intensity shall be maintained as specified in the
methods manuals. Measurements shall be made and
recorded on a yearly basis. Photoperiod shall be
maintained as specified in the methods and shall be
documented at least quarterly. For algal tests/ the
light intensity shall be measured and recorded at the
start of each test.
j) At a minimum, during chronic testing DO and pH shall be
measured daily in at least one replicate of each
concentration. DO may be measured in new solutions
prior to organism transfer, in old solutions after
organisms transfer, or both.
k) All cultures used for testing shall be maintained as
specified in the methods manuals.
1) Age and the age range of the test organisms must be as
specified in the manuals.
m) The maximum holding time (lapsed time from sample
collection to first use in a test) shall not exceed 36
hours without the permission of the permitting
authority.
n) All samples shall be chilled to 4°C during or
immediately after collection. They shall be maintained
at 0.1 to 6°C and the arrival temperature shall be no
greater than 6°C. Samples that are hand delivered to
the laboratory immediately after collection (i.e.,
within 1 hour) may not meet the laboratory temperature
acceptance criteria. In these cases, the laboratory
may accept the samples if there is evidence (such as
arrival on ice) that the chilling process has begun.
o) Organisms obtained from an outside source must be from
the same batch.
D. 3. 0 MICROBIOLOGY
These standards apply to laboratories undertaking the
examination of materials, products and substances involving
microbiological analysis, recovery or testing. The
procedures involve the culture media, the test sample and
the microbial species being isolated, tested or enumerated.
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a) Microbiological testing refers to and includes the
detection, isolation, enumeration and identification of
microorganisms and their metabolites, as well as
sterility testing. It includes assays using
microorganisms as part of a detection system and their
use for ecological testing.
b) These standards are concerned with the quality of test
results and not specifically with health and safety
measures. In the performance of microbiological
testing, safety and health matters must always be
considered and conform with regulatory and national
policies in this area.
c) Clothing appropriate to the type of testing being
performed should be worn, and often includes protection
for hair, beard, hands and shoes. Protective clothing
worn in the microbiological laboratory should be
removed before leaving the area.
D.3.1 Positive and Negative Controls
a) Negative Controls
The laboratory shall demonstrate that the cultured
samples have not been contaminated through sampling
handling/preparation or environmental exposure. These
controls shall include sterility checks of media and
blanks such as filtration blanks.
1) All blanks and uninoculated controls specified by
the method shall be prepared and analyzed at the
frequency stated in the method.
2) A minimum of one uninoculated control shall be
prepared and analyzed unless the same equipment is
used to prepare samples for incubation (such as a
filtration unit). In such cases, the laboratory
shall prepared a series of blanks using the
equipment. At least one beginning and ending
control shall be prepared, with additional controls
inserted after every 10 samples.
b) Positive Controls
Positive controls demonstrate that the medium can support
the growth of the test organism, and that the medium
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produces the specified or expected reaction to the test
organism.
On a monthly basis each lot of media shall be tested with
at least one pure culture of a known positive reaction
and shall be included with the sample test batch.
D.3.2 Test Variability/Reproducibility
a) Duplicates - At least 5% of the suspected positive
samples shall be duplicated. In laboratories with more
than one analyst, each shall make parallel analyses on
at least one positive sample per month.
b) Where possible, participation in, or organization of
collaborative trails, proficiency testing, or
interlaboratory comparisons, either formal or informal,
must be done.
D.3.3 Method Evaluation
a) In order to demonstrate the suitability of a method for
specified purpose, an intended purpose, the laboratory
shall establish, through method validation, a set of
acceptance criteria for the performance characteristics
of the method unless such criteria are specified by the
method. These criteria must demonstrate that the
method provides a correct/expected result with respect
to specified limits of detection, selectivity,
repeatability, sensitivity and reproductivity.
1) Accepted (official) methods or commercialized test
kits For official methods, or methods from
recognized national or international standard
organizations, may not require a full validation-.
Laboratories are required, however, to demonstrate
proficiency with the method prior to first use.
2) Qualitative microbiological test methods in which
the response is expressed in terms of
presence/absence, shall be validated by estimating,
if possible, the specificity/ relative trueness,
positive deviation, negative deviation,
repeatability, reproducibility and the limit of
determination within a defined variability. The
differences due to the matrices must be taken into
account when testing different sample types.
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3) The validation of microbiological test methods shall
be performed under the same conditions as those of a
real assay. This can be achieved by using a
combination of naturally contaminated products and
spiked products.
4) All validation data shall be recorded and stored at
least as long as the method is in force, or if
withdrawn from active use, for at least 5 years past
the date of last use.
b) Laboratories shall participate in the proficiency test
program identified by NELAP (5.4.2.J or 5.5.3.4).
Further, laboratories should regularly participate in
schemes which are relevant to their scope of
accreditation. Such program provide an independent
means by which a laboratory may objectively assess and
demonstrate the reliability and trueness of results
produced by its analytical methods.
D.3.4 Test Performance
All growth and recovery media must be checked to assure that
the target organisms respond in an acceptable and
predictable manner (see D.3.b).
D.3.5 Data Reduction
a) The calculations, data reduction and statistical
interpretations specified by each method shall be
followed.
b) If the method specifies colony counts, such as membrane
filter or colony counting, then the ability of
individual analysts to count colonies shall be verified
at least once per month, by having two or more analysts
count colonies from the same plate.
D.3.6 Quality of Standards, Reagents and Media
The laboratory shall ensure that the quality of the reagents
and media used is appropriate for the test concerned.
a) Culture media may be prepared in the laboratory from
the different chemical ingredients, from commercial
dehydrated powders or may be purchased ready to use.
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b) Reagents and commercial dehydrated powders shall be
consumed within the shelf-life of the product and shall
be documented according to 5.9.4. The laboratory shall
retain all manufacturer supplied "quality
specification statements" which may contain such
information as shelf life of the product, storage
conditions, sampling regimen/rate, sterility check
including acceptability criteria, efficacy checks
including the organism used, their culture collection
reference and acceptability criteria, date of issue of
specification, or statements assuring that the relevant
product batch meets the product specifications.
c) Distilled water, deionized water or reverse osmosis
produced water free from bactericidal and inhibitory
substances shall be used in the preparation of media
solutions and buffers. Where required by the method,
the quality of the water (such as pH, chlorine
residual, specific conductance or metals) shall be
monitored at the specified frequency and evaluated
according to the stated standards. Records shall be
maintained on all activities.
d) Media, solutions and reagents shall be prepared, used
and stored according to a documented procedure
following the manufacturer's/author's instructions.
e) All laboratory media shall be checked to ensure they
support the growth of specific microbial cultures. In
addition, selective media should be checked to ensure
they suppress the growth of non-target organisms. In
preference to using the commonly used streak method, it
is better to use a quantitative procedure, where a
known (often low) number of relevant organisms are
inoculated into the medium under test and the recovery
evaluated.
f) Each lot of laboratory detergent shall be checked to
ensure that residues from the detergent do not inhibit
or promote growth of microorganisms.
D.3.7 Selectivity
a) All confirmation/verification tests specified by the
method shall be performed according to method
protocols.
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b) In order to demonstrate traceability and selectivity,
laboratories shall use reference cultures of
microorganisms obtained from a recognized national
collection or an organization recognized by the
assessor body.
1) Reference cultures may be subcultured once to
provide reference stocks. Appropriate purity and
biochemical checks shall be made and documented.
The reference stocks shall be preserved by a
technique which maintains the desired
characteristics of the strains. Examples of such
methods are freeze-drying, liquid nitrogen storage
and deep-freezing methods. Reference stocks shall
be used to prepare working stocks for routine work.
If reference stocks have been thawed, they must not
be re-frozen and re-used.
2) Bacterial working stocks shall not be sub-cultured
under normal conditions. However working stocks may
be subcultured up to a defined number of subcultures
when:
i. it is required by standard methods, or
ii. laboratories can provide documentary evidence
demonstrating that there has been no loss of
viability, no changes in biochemical activity
and/or no change in morphology.
3) Working stocks shall not be subcultured to replace
reference stocks.
4) A scheme for handling reference cultures is included
in figure D.I.
D.3.8 Constant and Consistent Test Conditions
a) The laboratory shall devise an appropriate
environmental monitoring program to indicate trends in
levels of contamination appropriate to the type of
testing being carried out. Acceptable background
counts shall be determined and there shall be a
documented procedures to deal with situations in which
these limits are exceeded.
b) Walls, floors, ceilings and work surfaces should be
non-absorbent and easy to clean and disinfect. Wooden
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surfaces of fixtures and fitting shall be adequately
sealed. Measures should be taken to avoid accumulation
of dust by the provision of sufficient storage space by
having minimal paperwork in the laboratory and by
prohibiting plants and personal possessions from the
laboratory work area.
c) Temperature measurement devices
1) Where the accuracy of temperature measurement has a
direct effect on the result of the analysis,
temperature measuring devices such as liquid-in-
glass thermometers, thermocouple, platinum
resistance thermometers used in incubators,
autoclaves and other equipment shall be the
appropriate quality to achieve the specification in
the test method. The graduation of the temperature
measuring devices must be appropriate for the
required accuracy of measurement and they shall be
calibrated to national or international standards
for temperature (see 5.9.2.1).
2) The stability of temperature, uniformity of
temperature distribution and time required to
achieve equilibrium conditions in incubators,
waterbaths, ovens and temperature controlled rooms
shall be established, for example, position, space
between and height of stacks of Petri dishes.
d) Autoclaves
1) The performance of each autoclave shall be initially
evaluated by establishing its functional properties,
for example heat distribution characteristics with
respect to typical uses. Autoclaves shall be
capable of meeting specified temperature tolerances.
Pressure cookers fitted only with a pressure gauge
are not recommended for sterilization of media or
decontamination of wastes.
2) Records of autoclave operations including
temperature and time shall be maintained. This
shall be done for every cycle. Acceptance/rejection
criteria shall be established and used to evaluate
the autoclave efficiency and effectiveness.
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e) Volumetric equipment such as automatic dispensers,
dispenser/diluters, mechanical hand pipettes and
disposal pipettes may all be used in the microbiology
laboratory. Regular checks as outlined in Section
5.9.4.2.1 shall be performed and documented.
f) Conductivity meters, oxygen meters, pH meters,
hygrometers, and other similar measurement instruments
shall be calibrated according to the method specified
requirements (see Appendix D.I). Timers shall be
checked regularly to ensure accurate timing.
D.4.0 RADIOANALYSIS
A radioanalytical laboratory shall maintain a Quality
Assurance (QA) program that assures the validity of
analytical measurements that are being made by the
laboratory. The QA activities of the laboratory shall be
described in the laboratory's Quality Manual and outlined in
the Standard Operating Procedures (SOPs). The laboratory
shall utilize both intralaboratory and interlaboratory (when
readily available) quality control (QC) samples on a routine
basis.
The measurement of QC samples is a critical element used to
verify that instrumentation is calibrated within prescribed
control limits, rules out the presence of contamination in
excess of acceptable limits, and ensures the precision and
accuracy of the analytical method meets acceptable standards
of analytical quality.
Corrective actions to be taken by the laboratory must be
documented when the analysis results are outside of the
predetermined control limits for that parameter. These
control limits, and the required frequency of use for each
type of QC sample, must be defined in either the
laboratory's QA Plan or the individual SOPs. When possible,
all QC samples should be prepared using standards purchased
from the MIST, or from commercial suppliers that participate
in NIST traceable programs as described in ANSI N42.23 and
N42.22.
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Figure D-l. USE OF REFERENCE CULTURES (BACTERIA)
Flow Chart
Reference culture from source recognized by NELAC
Culture once
Purity Checks and Biochemical Tests as Appropriate
Reference Stocks
Retained under specific Conditions:
Freeze dried, liquid nitrogen storage, deep frozen or other
storage means under specified conditions and storage times/
Purity Checks and Biochemical Tests as Appropriate
Thaw/Reconstitute
Purity Checks and Biochemical Tests as Appropriate
Working Stocks
Maintained under specific conditions and storage times
Regular/Daily Quality Controls
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a) Reagent Blank - Reagent blanks, or method blanks,
are used to monitor for contamination that may have
occurred as a result of the sample preparation
process. They can be prepared from an actual
sample, or synthetic matrix, that is known to be
free of radioactivity (at background concentrations)
for any of the analytes of interest in the
analytical process. These blanks are prepared with
the sample batch and processed identically to the
actual sample. Reagent blanks are applicable to all
radiochemical procedures where chemical separations
or other manipulations of the sample matrix is
performed. A reagent blank shall be prepared and
used for each batch of samples, regardless of batch
size.
b) Matrix Spike - Matrix spikes are used to verify that
the procedural calibration to a specific sample
matrix is accurate and ensures that an adverse trend
is not developing. While the instrument is
calibrated relative to a known quantity of
calibration standard, this calibration does not
account for systematic errors that occur during
sample preparation. Matrix spikes shall be
performed on each batch where sample preparation
includes chemical separations or other
manipulations. They are prepared by adding a known
quantity of NIST traceable standard (if available)
solution to an actual sample. Matrix spikes shall
be prepared with the sample batch and processed
identically to the actual samples. A matrix spike
sample shall be prepared and used for each batch of
samples, regardless of batch size.
c) Laboratory Control Sample - A laboratory control
sample is similar in nature to a matrix spike
sample. It is prepared by adding a known amount of
NIST traceable calibration standard to either a
clean, or synthetic sample matrix. Laboratory
control samples are used where sample preparation
includes chemical separations or other
manipulations. These samples are prepared with the
sample batch and processed identically to the actual
samples. A matrix spike, or a laboratory control
sample/ shall be prepared and used for each batch of
samples analyzed, regardless of batch size.
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d) Laboratory Duplicates/Matrix Spike Duplicates -
Laboratory duplicates/matrix spike duplicates are
used to measure the precision of the analytical
process. Duplicates are produced by separating an
additional aliquot of an existing sample and
preparing it identically to the other samples
present in the batch. Due to the relatively low
concentrations of environmental radioactivity in the
samples analyzed in most laboratories, duplicate
analysis frequently yields little data of
statistical significance to provide a true
indication of the actual precision of the analytical
process.
As an alternative to sample duplicates, a matrix
spike duplicate is sometimes used as an indicator of
the analytical precision. A matrix spike duplicate
is prepared comparably to the matrix spike.
•However, if a sufficient volume of sample isn't
available, a synthetic sample can be used. A volume
of synthetic sample is spiked with a routine spike
solution (NIST traceable) prior to the removal of
two aliquots for preparation. The two aliquots of
the samples are then drawn and processed identically
to the other samples in the batch.
Matrix spike duplicates shall not be used when the
probability of measurable concentrations of the
analyte of interest is high. Laboratory
duplicates/matrix duplicates are applicable to all
radiochemical procedures where chemical separations
or other manipulations of the sample matrix is
performed. Duplicate analysis shall constitute at
least 5% of the radiochemical analytical effort of
the laboratory.
D. 4 .1 Method Evaluation
The laboratory shall analyze traceable reference materials
to evaluate the accuracy and precision of an analytical
methodology or an analyst. Traceable reference material, as
defined by (ANSI N42.23 and ANSI N42.22 - Measurement
Quality Assurance For Radioassay Laboratories), is a NIST
prepared standard reference material (SRM) or a sample of
known concentration prepared from a NIST traceable reference
material (derived standard material) supplied by a
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commercial vendor. The material shall be analyzed
initially, and on a continuing annual frequency.
D.4.2 Radiation Measurement Systems
Quality control measures for nuclear counting
instrumentation shall at a minimum utilize the following
practices: (1) instrument calibration with reference
standards as defined in section D.4.6, (2) periodic
instrument performance checks monitored with control charts
and tolerance charts and (3) instrument background •
measurements monitored with control charts and tolerance
charts.
a) Calibration - Instrument calibration shall be performed
with reference standards as defined in section D.4.4.
The standard shall have the same general
characteristics (i.e. geometry, homogeneity, density,
etc.) as the samples. At the time of calibration, an
instrument quality control chart and tolerance chart
shall be prepared and used to monitor instrument
performance. An instrument shall be re-calibrated
whenever the response to a check source exceeds the
tolerance level on the tolerance chart. If an
instrument check source becomes damaged or changes its
characteristics or if documentation demonstrating that
all instrument performance checks are within tolerance
limits since the last calibrations are not available,
the instrument shall be re-calibrated. An instrument
control chart is used to detect statistically
significant changes in the instrument's performance
before the tolerance level is exceeded.
b) Instrument performance checks - Instrument performance
checks using appropriate check sources shall be
performed on a regular basis and monitored with control
charts and tolerance charts to ensure that the
instrument is operating properly and that the
calibration has not changed. The same check source
used in the preparation of the tolerance chart and
control chart at the time of calibration shall be used
in the performance checks of the instrument. The check
sources must provide adequate counting statistics for a
relatively short count time and the source should be
sealed or encapsulated to prevent loss of activity and
contamination of the instrument and laboratory
personnel. For alpha and gamma spectroscopy systems,
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the instrument performance checks shall include checks
on the counting efficiency and the relationship between
channel number and alpha or gamma ray energy.
1) For gamma spectroscopy systems, the performance
checks for efficiency and energy shall be
performed on a day of use basis along with
performance checks on peak resolution.
2) For alpha spectroscopy systems, the performance
check for energy shall be performed on a day of
use basis and the performance check for counting
efficiency shall be performed on at least a
monthly basis.
3) For proportional and scintillation counters, the
performance checks for counting efficiency shall
be performed on a day of use basis.
c) Background measurements - Background measurements shall
be made on a regular basis and monitored using control
charts and tolerance charts to ensure that a laboratory
maintains its capability to meet required data quality
objectives. These values are subtracted from the total
measured activity in the determination of the sample
activity.
Significant increases in background measurements are
normally due to detector contamination. Instabilities in
instrument backgrounds may indicate instrument
malfunction.
1) For gamma spectroscopy systems, background
measurements shall be performed on at least a
monthly basis.
2) For alpha spectroscopy systems, background
measurements shall be performed on at least a
monthly basis.
3) For proportional and scintillation counters,
background measurements shall be performed on a day
of use basis.
d) Environmental Detection Limit , (EDL) - the smallest
level at which a radionuclide in an environmental
medium can be unambiguously distinguished for a given
confidence interval using a particular combination of
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sampling and measurement procedures, sample size,
analytical detection limit, and processing procedure.
The EDL shall be specified for the 0.95 or greater
confidence interval. The EDL shall be established
initially and verified annually for each method and
sample matrix.
e) Analytical Detection Limit (LD) - the smallest amount
of an analyte that can be distinguished in a sample by
a given measurement procedure throughout a given (e.g.,
0.95) confidence interval. The analytical detection
limit shall be established initially and verified
annually for each method and sample matrix.
f) Method Uncertainties - the laboratory shall have the
ability to trace all sources of method uncertainties
and their propagation to reported results.
D. 4 .3 Data Reduction
Refer to Section 5.10.6, Computers and Electronic Data
Related Requirements of this document.
D.4.4 Quality of Standards and Reagents
A Radioanalysis laboratory shall have an operational
internal quality control program that ensures that all
radiation detection instruments are calibrated and
functioning.
a) The quality control program shall establish and
maintain provisions for radionuclide standards.
1) Reference standards that are used in a radio
analytical laboratory shall be obtained from
either the National Institute of Standards and
Technology (NIST), EPA, or suppliers who
participate in supplying NIST standards or NIST
traceable radionuclides. Any reference standards
purchased outside the United States shall be
traceable back to each country's national
standards laboratory.
2) Reference traceable standards shall be accompanied
with a certificate of calibration whose content is
as described in ANSI N42.22 - 1995, Section 8,
Certificates.
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3) Laboratories should consult with the supplier if
the lab's verification of the activity of the
reference traceable standard indicates a
noticeable deviation from the certified value.
The laboratory shall not use a value other than
the decay corrected certified value.
b) Calibration standards shall be as similar as
technically feasible to the sample with respect to
geometry and physical and chemical characteristics.
c) All reagents used shall be analytical reagent grade or
better.
D.4.5 Constant and Consistent Test Conditions
To prevent incorrect analysis results caused by the spread
of contamination among samples, the laboratory shall
establish and adhere to written procedures to minimize the
possibility of cross-contamination between samples.
D.5.0 AIR TESTING
Analyses for Air Toxics shall follow the essential quality
controls for chemistry outlined in Appendix D.I. For air
testing, the blank, laboratory control sample and a
desorption efficiency (such as charcoal tubes) shall be
used. Matrix spikes and duplicate samples shall be used
when feasible.
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Appendix E - PERFORMANCE BASED MEASUREMENT SYSTEM
RESERVED - The information presented here is the most recent
EMMC Workgroup draft, and is provided for information only.
E.1.0 Checklist Overview
The Checklists present consensus among EPA's programs on
performance "categories" that allow use of the same
Checklists across the Agency's various programs/projects.
The Checklists may be applied to screening and field
techniques as well as traditional laboratory procedures.
Implementation of the Checklists is intended to be program-
specific and a category that does not apply within a
specific EPA program or project will be indicated by NA
(not applicable). Criteria for a specific EPA program or
project are to be filled in under the "Performance Criteria"
column; e.g., an Office of Water Reference Method may
specify 20% RSD or a correlation coefficient of 0.995 for
the category that specifies calibration linearity, whereas
an Office of Solid Waste project may specify a Measurement
Quality Objective of 12% RSD or a correlation coefficient of
0.998 for this category.
For each EA program or project, the checklists are to be
completed for each matrix within each medium for which
performance is demonstrated.
Each completed Checklist must be retained on file at the
laboratory that uses the performance-based method (PBM) or
method modification and must be submitted to the appropriate
regulatory authority upon request to support analysis of
those samples to which the PBM or modified method was
applied.
E.1.1 Header
Each page of the checklist contains six lines of header
information, consisting of:
a) Date: enter the date that the checklist was completed
and associated samples were collected.
b) Laboratory Name & Address: If the method is being
employed by a commercial contract laboratory on behalf
of one or more applicable clients, enter the name of
the laboratory if possible followed by a listing of the
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appropriate clients from which the samples were
collected).
c) Discharge Point ID, where applicable.
d) Facility Name: enter the name of the water treatment
facility, system, or regulated facility or other
program/project specified entity where the facility
maintains an on-site analytical laboratory.
e) EPA Program & Applicable Regulation: enter the name of
the Agency program or project to whom the results will
be reported, or under the auspices of which the data
are collected, e.g., "CAA" for Clean Air Act
testing/monitoring and "SDWA" for analyses associated
with the Safe Drinking Water Act.
f) Medium: enter the type of environmental sample, e.g.,
water—NOTE a separate checklist should be prepared for
each matrix, e.g., for checklists associated with
performance-based methods for SDWA, enter Drinking
Water as the matrix type. As the evaluations of a
performance-based method will involve matrix-specific
performance measures, a separate checklist would be
prepared for each matrix. The medium is the
environmental sample type to which the performance-
based method applies, whereas the performance category
matrix, appearing in the body of the checklists refers
to the specific sample type within the Medium that was
spiked, e.g., for Medium hazardous waste, the checklist
category Matrix may be solvent waste.
g) Analyte, Class of Analytes, or Other Measured
Parameters--CAS # where available: As many methods
apply to a large number of analytes, it is not
practical to list every analyte in this field, as
indicated on the form, the class of analytes may be
listed here, i.e., volatile organics. However, if such
a classification is used, a separate list of analytes
and their respective Chemical Abstract Service Registry
Numbers (CAS #) must be attached to the checklist.
C.2.2 EPA PBMS Checklist for Initial Demonstration of
Method Performance
The Initial Demonstration of Method Performance involves
multiple spikes into a defined sample matrix (e.g.,
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wastewater, paper plant effluent), to demonstrate that the
Performance-based Method meets the Program or Project
Performance Criteria based on the performance of established
Reference Method or based on Measurement Quality Objectives
(analytical portion of the Data Quality Objectives). This
exercise is patterned after the Initial Demonstration of
Capability in C.I of this appendix.
Footnote #1 indicates that a detailed narrative description
of the initial demonstration procedure is to be provided.
Footnote #2 For multi-analyte methods, enter "see
attachment" and attach a list or table containing the
analyte-specific performance criteria from the reference
method or those needed to satisfy measurement quality
objectives. Complete only one of the two columns. For
multi-analyte methods it is suggested that the list also
contain the information for the "Results Obtained" and
Performance Specification Achieved" columns.
Footnote #3 indicates that if a reference method is the
source of the performance criteria, the reference method
should be appropriate for its intended application and the
listed criteria should be fully consistent with that
reference method. The reference method name and EPA number
(where applicable) should be delineated.
There are 34 numbered entries in the body of the checklist—
each program will indicate the performance categories which
do not pertain to the application/project, e.g., by listing
as NA ("Not Applicable") for the corresponding performance
criteria.
#1. Written Method (addressing all elements in the EMMC
format)
The details of the method used for analysis (and sampling,
where applicable) should be described in a version of the
method written in EMMC format. The EMMC method format
includes the following sections: 1.0 Scope & Application;
2.0 Summary of Method; 3.0 Definitions; 4.0 Interferences;
5.0 Safety; 6.0 Equipment & Supplies; 7.0 Reagents &
Standards; 8.0 Sample Collection, Preservation & Storage;
9.0 Quality Control; 10.0 Calibration & Standardization;
11.0 Procedure; 12.0 Data Analysis & Calculations; 13.0
Method Performance; 14.0 Pollution Prevention; 15.0 Waste
Management; 16.0 References; 17.0 Tables, Diagrams,
Flowcharts & Validation Data. While this format may differ
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from that used in standard operation procedures (SOPs) in a
given laboratory, the use of a consistent format is
essential for the efficient and effective evaluation by
inspectors, program and project managers/officers.
#2. Title, Number and date/revision of "Reference Method" if
applicable.
For example Polychlorinated Dioxins and Furans, EPA Method
1613, Revision B, October, 1994.
#3. Copy of the reference method, if applicable, maintained
at the facility.
A copy of the reference method should be available to all
laboratory personnel, however, it need not be attached to
the checklist itself.
#4. Differences between PBM and reference method attached,
if applicable.
The laboratory should summarize the differences between the
reference method and the performance-based method and attach
this summary to the checklist. This summary should focus on
significant differences in techniques (e.g., changes beyond
the flexibility allowed in the reference method), not minor
deviations such as the glassware used.
#5. Concentrations of calibration standards.
The range of the concentrations of materials used to
establish the relationship between the response of the
measurement system and analyte concentration. This range
must bracket any action, decision or regulatory limit. In
addition, this range must include the concentration range
for which sample results are measured and reported.
#6. % RSD or Slope/Correlation Coefficient of Calibration
Regression.
This performance category refers to quantitative measures
describing the relationship between the amount of material
introduced into the measurement system and the response of
the measurement system, such as an analytical instrument. A
linear response is generally expected and is typically
measured as either a linear regression (for inorganic
analytes) or as the relative standard deviation (or
coefficient of variation) of the response factors or
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calibration factors (for organic analytes). For example,
traditional performance specifications consider any
regression line with a correlation coefficient (r) of 0.995
or greater as linear. Also, for organic analytes, a
relative standard deviation (RSD) of 15% or less is often
considered linear (RCRA). The calibration relationship is
not necessarily limited to a linear relationship. However,
it should be remembered if the Program/Project Office or
Officer/Managers specifies other calibration relationships,
e.g., quadratic fit, more calibration standards are
generally necessary to establish accurately the calibration.
If applicable, a calibration curve, graphical representation
of the instrument response versus the concentration of the
calibration standards, should be attached.
#7. Performance range tested (with units).
This range must reflect the actual range of sample
concentrations that were tested and must include the
concentration units. Since the procedures may include
routine sample dilution or concentration, the performance
range may be broader than the range of the concentrations of
the calibration standards.
#8. Samples(s) used in initial demonstration have
recommended preservative, where applicable. Sample(s) used
in the initial demonstration should employ the recommended
preservative, where applicable. Answer "yes" if the
preservation in the reference method was used. If "no",
include a narrative description of the testing done to
support use of the alternate preservation technique.
#9. Samples(s) used in the initial demonstration must be
within the recommended holding times, where applicable.
Unless holding time (time from when a sample is collected
until analysis) has been specifically evaluated, this entry
should be taken directly from the reference method, where
applicable or standard table. If holding time has been
evaluated, include the study description and conclusions of
that evaluation here, with a reference to the specific study
description. The data must be attached.
#10. Interferences.
Enter information on any known or suspected interferences
with the performance-based method. Such interferences are
difficult to predict in many cases, but may be indicated by
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unacceptable spike recoveries in environmental matrices,
especially when such recovery problems were not noted in
testing a clean matrix such as reagent water. The
interferences associated with the reference method are to be
indicated, as well as, the effect of these interferences on
the performance-based method.
#11. Qualitative identification criteria used.
Enter all relevant criteria used for identification,
including such items as retention time, spectral wavelengths
and ion abundance ratios. If the instrumental techniques
for these performance-based method are similar to a
reference method, use the reference method as a guide when
specifying identification criteria. If the list of criteria
is lengthy, attach it on a separate sheet, and enter "see
attached" for this item.
#12. Performance Evaluation Studies performed for analytes
of interest, where available (last study sponsor and title
last study number:).
Several EPA programs conduct periodic performance evaluation
(PE) studies. Organizations outside of the Agency also may
conduct such studies. Where available and applicable, enter
the sponsor, title, and date of the most recent study in
which the performance-based method was applied to the matrix
of interest. A program/project may specify that a
performance-based method be fully successful, i.e., within
the PE study QC acceptance criteria. Where applicable,
provide a listing of analytes for which the PE results were
"not acceptable".
#13. Analysis of external reference material.
Enter the results of analyses on reference material from a
source different from that used to prepare calibration
standards (if available). This performance category is
especially important if Performance Evaluation Studies are
not available for the analytes of interest.
#14. Source of reference material.
Enter information, if applicable and available, for
traceability of external reference materials used to verify
the accuracy of the results, e.g., obtained from the
National Institute of Science and Technology (NIST).
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#15. Surrogates used, if applicable.
Enter the names of the surrogate compounds used. Surrogates
are often used in analysis of organic analytes. Surrogates
may be added to samples prior to preparation, as a test of
the entire analytical procedure. These compounds are
typically brominated, fluorinated or isotopically labeled,
with structural similarities to the analytes of interest.
Target analytes of the method may be used as surrogates, if
they can be demonstrated not to be present in the samples to
be analyzed.
#16. Concentrations of surrogates, if applicable.
Enter the concentration of surrogates once spiked into the
sample (i.e., final concentration).
#17. Recoveries of Surrogates appropriate to the proposed
use, if applicable.
Enter the summary of the surrogate recovery limits; attach a
detailed listing if more space is needed.
#18. Sample Preparation.
Enter preliminary procedures, e.g., digestion, distillation
and/or extraction. A detailed listing may be attached if
more space is needed.
#19. Clean-up Procedures.
Enter appropriate sample clean-up steps prior to the
determinative step (instrumental analysis), e.g., GPC,
copper, alumina treatment, etc.
#20. Method Blank Results.
A clean matrix (i.e., does not contain the analytes of
interest) that is carried through the entire analytical
procedure, including all sample handling, preparation,
extraction, digestion, cleanup and instrumental procedures.
The volume or weight of the blank should be the same as that
used for sample analyses. The method blank is used to
evaluate the concentrations of analytes that may be
introduced into the samples as a result of background
contamination in the laboratory. Enter the analyte/s and
concentration measured in the blank.
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§21. Matrix (reagent water, drinking water, sand, waste
solid, ambient air, etc.).
Refers to the specific sample type within the broader Medium
that was spiked, e.g., for Medium: Hazardous Waste an
example matrix spiked as part of the initial demonstration
of method performance might be "solvent waste".
#22. Spiking System, appropriate to the method and
application.
Enter the procedure by which a known amount of analyte/s
("spike") was added to the sample matrix. This may include
the solvent that is employed and the technique to be
employed (e.g., permeation tube, or volumetric pipet
delivery techniques spiked onto a soil sample and allowed to
equilibrate 1 day, etc.). Solid matrices and air are often
difficult to spike and considerable detailed narrative may
be necessary to delineate the procedure. For spikes into
aqueous samples generally a water miscible solvent is
needed.
#23. Spike concentrations (w/units corresponding to final
sample concentration).
Enter the amount of the analyte/s ("spike") that was added
to the sample matrix in terms of the final concentration in
the sample.
#24. Source of spiking material.
Enter the organization or vendor from which the spiking
material was obtained or how the spiking material was
prepared. This should include specific identification
information, e.g., lot#, catalogue number, etc.
#25. Number of Replicate Spikes.
The initial demonstration of method performance involves the
analyses of replicate spikes into a defined sample matrix
(category #21). Enter the number of such replicates. For
example in the NPDES and SDWA programs, at least 4
replicates should be prepared and analyzed independently.
#26. Precision (analyte by analyte) .
Precision is a measure of agreement among individual
determinations. Statistical measures of precision include
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standard deviation, relative standard deviation or percent
difference.
#27. Bias (analyte by analyte).
Bias refers to the systematic or persistent distortion of a
measurement process which causes errors in one direction.
Bias is often measured as the ratio of the measured value to
the "true" value or nominal value. Bias is often
(erroneously) used interchangeably with "accuracy", despite
the fact that the two terms are complementary, that is, high
"accuracy" implies low "bias", as well as good precision.
Enter the name of the bias measure (% recovery, difference
from true, etc.), and the numeric value with associated
units for each analyte obtained for each analyte spiked in
the initial demonstration procedure.
#28. Detection Limit (w/units; analyte by analyte), if
applicable.
A general term for the lowest concentration at which an
analyte can be detected and identified. There are various
measures of detection which include "Limit of Detection" and
'Method Detection Limit". Enter the detection measure (e.g.,
MDL) and the analytical result with units for each analyte
in the matrix (see #21).
This performance category is of importance when operating at
extremely low concentrations. If the concentrations
measured or the decisions to be made, e.g., action levels,
are several orders of magnitude above these concentrations,
the "quantitation level" should be entered.
#29. Confirmation of Detection Limit, if applicable.
In addition to spikes into the matrix of interest (see #21)
it may be beneficial to perform the detection limit
measurements in a clean matrix, e.g., laboratory pure water,
air, sand, etc. Results of the spikes in the clean matrix
are frequently available in the Agency's published methods.
Determining MDLs in a clean matrix using the performance-
based method will allow a comparison to the MDLs published
in the Agency methods.
This performance category is of importance when operating at
extremely low concentrations. If the concentrations
measured or the decisions to be made, e.g., action levels,
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are several orders of magnitude above these concentrations,
the "quantitation level" should be entered.
Also, the detection limit technique may specify specific
procedures to verify that the obtained limit is correct,
e.g., the "iterative process" detailed in the 40 CFR Part
136, Appendix B, MDL procedures.
#30. Quantitation Limit (w/ units; analyte by analyte).
The lowest concentration at which the analyte can be
reported with sufficient certainty that an unqualified
numeric value is reported. Measures of quantitation limits
include the Minimum Level (ML), Interim Minimum Level (IML),
Practical Quantitation Level (PQL), and Limit of
Quantitation (LOQ). Enter the measure of quantitation
limits, and the corresponding units for each analyte
appropriate to the intended application and a description of
how hey were determined.
#31. Qualitative Confirmation.
Enter all relevant criteria used for identification,
including such items as: retention time; use of second
chromatographic column; use of second (different) analytical
technique; spectral wavelengths, ion abundance ratios. If
the instrumental techniques for the performance-based method
are similar to those of a reference method, use the
reference method as a guide when specifying confirmation
criteria. If the list of criteria is lengthy, attach it on
a separate sheet, and enter "see attached" for this item.
#32. Frequency of performance of Initial Demonstration:
Enter the frequency that the initial demonstration needs to
be repeated.
#33-#34. Other Criteria.
Enter other necessary program/project specific method
performance categories.
Signatures:
The printed name, signature and date of each analyst
involved in the initial demonstration of method performance
is to be provided at the bottom of the checklist sheet.
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C.2.3 EPA PBMS Checklist for Continuing Demonstration of
Capability:
The process by which a laboratory documents that its
previously established performance of an analytical
procedure continues to meet performance specifications as
delineated in this checklist.
#1. Method Blank Result.
A clean matrix (i.e., does not contain the analytes of
interest) that is carried through the entire analytical
procedure, including all sample handling, preparation,
extraction, digestion, cleanup and instrumental procedures.
The volume or weight of the blank should be the same as that
used for sample analyses. The method blank is used to
evaluate the levels of analytes that may be introduced into
the samples as a result of background contamination in the
laboratory. Enter the analyte/s and concentration measured
in the blank.
#2. Concentrations of calibration standards used to verify
working range, where applicable (include units).
The range of the concentration(s) of materials used to
confirm the established relationship between the response
of the measurement system and analyte concentration. This
range should bracket any action, decision or regulatory
limit. In addition, this range must include the
concentration range for which sample results are measured
and reported (when samples are measured after sample
dilution/concentration). Enter the concentrations of the
calibration standards.
#3. Calibration Verification.
A means of confirming that the previously determined
calibration relationship still holds. This process typically
involves the analyses of two standards with concentrations
which bracket the concentration(s) measured in the sample/s.
Enter the procedure to be used to verify the calibration and
the results obtained for each analyte.
#4. Laboratory Control Sample.
An analytical standard carried through all aspects of the
analytical method, e.g., digestions, distillations and
determinative steps/instrumentation. It is generally used
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to assess the performance of all of the measurement system
independent of the challenges of the sample matrix.
#5. External QC sample (where applicable).
Enter the results of analyses for reference material (e.g.,
quality control samples/ampoules) from a source different
from that used to prepare calibration standards (where
applicable). Enter the concentration, as well as, the
source of this material. This performance category is of
particular importance if Performance Evaluation (PE) studies
are not available for the analytes of interest.
#6. Performance Evaluation Studies performed for analytes
of interest, where available (last study sponsor and title
last study number:).
Several EPA programs conduct periodic performance evaluation
(PE) studies. Organizations outside of the Agency also may
conduct such studies. Where available and applicable, enter
the sponsor, title, and date of the most recent study in
which the performance-based method was applied to the matrix
of interest. A program/project may specify that a
performance-based method be fully successful, i.e., within
the PE study QC acceptance criteria.
# 7. List of analytes for which results were "not
acceptable" in PE study where available and applicable..
#8. Surrogates used, if applicable.
Enter the names of the surrogate compounds used. Surrogates
are often used in analysis of organic analytes. Surrogates
may be added to samples prior to preparation, as a test of
the entire analytical procedure. These compounds are
typically brominated, fluorinated or isotopically labeled,
with structural similarities to the analytes of interest.
Target analytes of the method may be used as surrogates, if
they can be demonstrated not to be present in the samples to
be analyzed.
#9. Concentration of surrogates, if applicable.
Enter the concentration of surrogates once spiked into the
sample (i.e., final concentration), with units.
#10. Recoveries of Surrogates appropriate to the proposed
use (if applicable).
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Enter the summary of the surrogate recovery limits and
attached a detailed listing (each surrogate compound), if
more space is needed.
#11. Matrix (reagent water, drinking water, sand, loam,
clay, waste solid, ambient air, etc.).
Refers to the specific sample type within the broader
"Medium" that was spiked, e.g., for Medium: Waste an example
matrix, spiked as part of the initial demonstration of
method performance, might be solvent waste.
#12. Matrix Spike Compounds.
Enter the analytes spiked. In preparing a matrix spike, a
known amount of analyte is added to an aliquot of a real-
world sample matrix. This aliquot is analyzed to help
evaluate the effects of the sample matrix on the analytical
procedure. Matrix spike results are typically used to
calculate recovery of analytes as a measure of bias for that
matrix.
#13. Matrix Spike Concentrations (w/units corresponding to
final sample concentration).
Enter the amount of the analyte/s or "spike" that was added
to the sample matrix in terms of the final concentration in
the sample.
#14. Recovery of Matrix Spike (w/units).
The ratio of the standard deviation of a series of at least
three measurements to the mean of the measurements. This
value is often expressed as a percentage of the mean.
Note: Some programs/projects have utilized matrix spike
duplicates (a separate duplicate of the matrix spike) to
help verify the matrix spike result and to provide precision
data for analytes which are not found in real-world samples,
since duplicates of non-detects provides little information
concerning the precision of the method. See Item # 19.
#15. Qualitative identification criteria used.
Enter all relevant criteria used for identification,
including such items as retention times, spectral
wavelengths, and ion abundance ratios. If the instrumental
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techniques for the performance-based method are similar to a
reference method, use the reference method as a guide when
specifying identification criteria. If the list of criteria
is lengthy, attach it on a separate sheet, and enter "see
attached" for this item.
#16. Precision (analyte by analyte).
#17-18. Other category.
Enter other necessary program/project specific method
performance categories.
Signatures:
The printed name, signature and date of each analyst
involved in the initial demonstration of method performance
is to be provided at the bottom of the checklist sheet.
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EPA Performance-Based Measurement System
Certification Statement
Date: Page of
Laboratory Name & Address
Facility Name:
Discharge Point ID, where applicable:
EPA Program and Applicable Regulation:
Medium:
(i.e., water, soil, air, waste solid, leachate, sludge, other)
Analyte, Class of Analytes or Measured Parameters (CAS # where available)
(i.e , barium, trace metals, benzene, volatile organics, etc.)
We, the undersigned, CERTIFY that:
1. The methods in use at this facility for the analyses of
samples for the programs of the U.S. Environmental Protection Agency
have met the Initial and any required Continuing Demonstration of
Method Performance Criteria specified under the Performance-Based
Measurement System.
2. A copy of the Performance-Based Method, written in EMMC
format, and copies of the reference method and laboratory-specific
SOPs are available for all personnel on-site.
3. The data and checklists associated with the initial and
continuing demonstration of method performance are true, accurate,
complete and self-explanatory (1).
4. All raw data (including a copy of this certification form)
necessary to reconstruct and validate these performance related
analyses have been retained at the facility, and that the associated
information is well organized and available for review by authorized
inspectors.
Facility Manager's Name and Title Signature Date
Quality Assurance Officer's Name Signature Date
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This certification form must be completed when the
performance-based method is originally certified, each time a
continuing demonstration of method performance is documented,
and whenever a change of personnel involves the Facility
Manager or the Quality Assurance Officer.
(1) True: Consistent with supporting data.
Accurate: Based on good laboratory practices consistent
with sound scientific principles/practices.
Complete: Includes the results of all supporting
performance testing.
Self-Explanatory: Data properly labeled and stored so
that the results are clear and require no
additional explanation.
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EPA PBMS
Checklist for Initial Demonstration of Method Performance
Provide a checklist for each matrix included in the demonstration.
Date: Page of
Laboratory Name & Address:
Facility Name:
Discharge Point ID, where applicable:
EPA Program and Applicable Regulation:
Medium:
(i.e., water, soil, air, waste soiid, leachate, sludge, other)
Analyte, Class of Analytes or Other Measured Parameters (CAS #, where
available):
(i.e., barium, trace metals, benzene, volatile organics, etc.)
initial Demonstration of Method Performance (1)
Category
1. VWtten method (addressing all elements in the EMMC format)
attached
2. Title, number and date/rev, of "reference method", if applicable
fil
3. Copy of the reference method, if applicable, maintained at facility
4. Differences between PBM and reference method (if applicable)
attached
5. Concentrations of calibration standards
6. %RSO or slope/correlation coefficient of calibration regression
7. Performance range tested (with units)
8. Sample(s) used in initial demonstration have recommended
Performance
Criteria^
Based on
Measurement
Reference Quality
Method Objective
Resufts
Obtained
Perf,
Spec,
Achieved
(/)
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Initial Demonstration of Method Performance (1)
Category
9. Samplers) used in initial demonstration met recommended
holding times, where applicable
10. Interferences
11. Qualitative identification criteria used
12. Performance Evaluation studies performed for analytes of
interest, where available:
Last study sponsor and title:
Last study number.
13. Analysis of external reference material
Last study sponsor and title:
Last study number
List of analytes with "not acceptable" results:
14. Source of reference material
15. Surrogates used, If applicable
16. Concentrations of surrogates, if applicable
17. Recoveries of Surrogates appropriate to the proposed use, if
applicable
18. Sample preparation
19. Clean-up procedures
20. Method Blank Result
21. Matrix (reagent water, drinking water, sand, waste solid, ambient
air, etc.)
22. Spiking system, appropriate to method and application
23. Spike concentrations (w/ units corresponding to final sample
concentration)
Performance
Criteria (2)
Based on
Measurement
Reference Qualify
Method Objective
Results
Obtained
Pert.
Spec.
Achieved
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Initial Demonstration of Method Performance (1)
Category
24. Source of spiking material
26. Number of replicate spikes
26. Precision (analyte by analyte)
27. Bias (analyte by analyte)
28. Detection Limit (w/ units; analyte by analyte)
29. Confirmation of Detection Limit, if applicable
30. Quantitation Limit (w/ units: analyte by analyte)
31. Qualitative Confirmation
32. Frequency of performance of the Initial Demonstration
33. Other criterion (specify)
34. Other criterion (specify)
Performance
Criteria^)
Based on
Measurement
Reference Quality
Method Objective
Results
Obtained
Pert.
Spec.
Achieved
C^>
Provide a detailed narrative description of the initial demonstration.
2 For multi-analyte methods, enter "see attachment" and attach a list or table containing the
analyte-specific performance criteria from the reference method or those needed to satisfy
measurement quality objectives.
* If a reference method is the source of the performance criteria, the reference method should
be appropriate to the required application, and the listed criteria should be fully consistent
with that reference method.
Name and signature of each analyst involved in the initial demonstration of method
performance (includes all steps in the proposed method/modification):
Name
Signature
Date
Name
Signature
Date
Name Signature Date
The certification above must accompany this form each time it is submitted.
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EPA PBMS
Checklist for Continuing Demonstration of Method Performance
Date: Page of
Facility Name:
Laboratory Name & Address:
Discharge Point ID, where applicable:
EPA Program and Applicable Regulation:
Medium:
(i.e.,water, soil, air, waste solid, leachate, sludge, other)
Analyte, Class of Analytes or Measured Parameters (CAS # where available)
(i.e., barium, trace metals, benzene, volatile organics, etc.)
Continuing Demonstration of Method Perforniwe,' ,,, :*/T~~~
Category „
1 . Method blank result (taken through all steps in the procedure)
2. Concentrations of calibration standards used to verify
working range (with units), where applicable
3. Calibration verification
4. Laboratory Control Sample
6. External QC sample (where available)
6. Performance evaluation (PE) studies, if applicable
Last study sponsor and title:
Last study number.
7. List analytes for which results were "not acceptable" in PE study
8. Surrogates used, if applicable
9. Concentration of Surrogates, if applicable
10. Recovery of Surrogates (acceptance range for multianalyte
methods), if applicable
11. Matrix
12. Matrix spike compounds
13. Concentration of Matrix spike compounds
14. Recoveries of Matrix spike compounds
15. Qualitative identification criteria used
16. Precision (analyte by analyte)
17. Other category (specify)
18. Other category (specify)
Requires
f«
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EPA PBMS
Checklist for Continuing Demonstration of Method Performance
Date: Page of
Facility Name:
Discharge Point ID, where applicable:
EPA Program and Applicable Regulation:
Medium:
(i.e. water, soil, air, waste solid, leachate, sludge, other)
Analyte, Class of Analytes or Measureand (CAS # where available)
(i.e. barium, trace metals, benzene, volatile organics, etc.)
Name and signature of each analyst involved in continuing
demonstration of method performance (includes all steps in the
proposed method/modification):
Name Signature Date
Name Signature Date
Name Signature Date
The certification above must accompany this form each time it is submitted.
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ACCREDITING
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TABLE OF CONTENTS
ACCREDITING AUTHORITY
6.0 ACCREDITING AUTHORITY 1
6.1 INTRODUCTION 1
6.2 GENERAL PROVISIONS 1
6.2.1 Reciprocity 3
6.2.2 Where to Apply for NELAP Accreditation 5
6.2.3 Documentation Maintained by Accrediting Authorities
6
6.3 APPLICATION FOR NELAP RECOGNITION 7
6.3.1 Written Application for NELAP Recognition .... 7
6.3.2 Application Completeness Review by NELAP .... 11
6.3.3 Application Technical Review by a NELAP Assessment
Team 12
6.3.3.1 Required Technical Elements of a NELAP-
Recognized Accrediting Authority's Program . 13
6.3.3.1.1 Records 16
6.3.3.1.2 Use of Contractors by an Accrediting
Authority 16
6.3.3.1.3 Accrediting Authority's Quality System . . 17
6.3.3.2 Application Technical Review Report . . . .18
6.3.4 Notification of Changes to An Accrediting
Authority's Program 20
6.4 ON-SITE AUDIT OF THE ACCREDITING AUTHORITY 20
6.4.1 Scheduling the On-Site Audits 21
6.4.2 Conducting the On-Site Audit 22
6.4.3 On-Site Audit Reports 23
6.5 ACCREDITING AUTHORITY'S REQUEST FOR EXTENSION OF TIME TO
COMPLY WITH THE NELAC STANDARDS 26
6.6 NELAP ASSESSMENT TEAM RECOMMENDATIONS TO THE NELAP
DIRECTOR 27
6.7 CERTIFICATE OF RECOGNITION TO THE ACCREDITING AUTHORITY
28
6.8 USE OF ACCREDITATION BY NELAP ACCREDITED LABORATORIES
28
6.9 REQUIREMENTS OF THE NELAP 30
6.9.1 NELAP Assessment Team 30
6.10 APPEALING DECISIONS TO DENY OR REVOKE NELAP RECOGNITION
31
FIGURE 1. Flow Chart for NELAP Recognition of an Accrediting
Authority 34
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6.0 ACCREDITING AUTHORITY
6.1 INTRODUCTION
The standards in this Chapter define the process and
criteria that will be used by the National Environmental
Laboratory Accreditation Program (NELAP) to determine
whether accrediting authorities applying for NELAP
recognition meet the standards required for such
recognition.
Chapter six is structured so that the requirements of the
International Organization for Standardization/the
International Electrotechnical Commission (ISO/IEC) Guide
58: Calibration and testing laboratory accreditation
systems-General requirements for operation and recognition,
1993 are incorporated into the requirements for an
accrediting authority to be NELAP-recognized.
Chapter six addresses most of the requirements of ISO/IEC
Guide 58. All NELAP-recognized accrediting authorities are
required to administer an environmental laboratory
accreditation program that meets the requirements contained
in the National Environmental Laboratory Accreditation
Conference (NELAC) standards, Chapter six. Those ISO/IEC
Guide 58 requirements not addressed in Chapter six are
addressed in the NELAC standards, Chapters two through five.
Since Chapter six requires an accrediting authority to
administer an environmental laboratory accreditation program
that requires laboratories to meet the standards set forth
in the NELAC standards, Chapters two through six, all the
requirements of ISO/IEC Guide 58 will be met by a NELAP-
recognized accrediting authority. In most cases, the
ISO/IEC requirements, contained in Chapter six or elsewhere
in the NELAC standards are not direct quotations from the
ISO/IEC guidance document.
6.2 GENERAL PROVISIONS
a) In all cases, accrediting authorities are governmental
organizations at the territory, state or federal
levels.
b) A territorial, state or federal entity shall designate
the appropriate agencies or departments as its
designated NELAP-recognized accrediting authorities for
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the fields of testing for which NELAP recognition is
being sought.
c) A NELAP-recognized accrediting authority shall not
delegate authority for granting, maintaining,
suspending or revoking a laboratory's NELAP
accreditation to an outside person or body. Portions
of the accreditation process may be contracted out
when the accrediting authority follows the provisions
of subsections 6.3.3.1.2 and 6.3.3.1.3 (b)(3); however,
the authority to grant, maintain, suspend or revoke
NELAP accreditation must remain with the accrediting
authority.
d) The procedures under which a NELAP-recognized
accrediting authority operates shall be administered in
an impartial and non-discriminatory manner. An
accrediting authority shall have no rules, regulations,
procedures or practices that:
1) restrict the size, large or small, of any laboratory
seeking accreditation;
2) require membership or participation in any
laboratory or other professional association;
3) impose any financial conditions or restrictions for
participation in the accreditation program other
than the fees authorized by territorial, state or
federal law; and
4) conflict with any territorial, state or federal laws
governing discrimination.
e) Accrediting authorities and their subcontractors shall
confine their requirements, assessments and decision
making processes for a NELAP accredited laboratory to
those matters specifically related to the fields of
testing of the NELAP accreditation being sought by a
laboratory.
f) If the NELAP insignia is used on general literature
such as brochures, letterheads and business cards, a
NELAP-recognized accrediting authority shall accompany
the display of the NELAP insignia with at least the
phrase "NELAP-recognized".
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g) Accrediting authorities are encouraged to establish one
or more technical committees for advising the
accrediting authority on the technical matters relating
to the operation of its environmental laboratory
accreditation program. When such committees are
established, the accrediting authority shall have
1) formal rules and structures for the appointment and
operation of committees involved in the
accreditation process and such committees shall be
free from any commercial, financial, and other
pressures that might influence decisions, or
2) a structure where committee members are chosen to
provide impartiality through a balance of interests
where no single interest predominates.
h) Unless the contrary is clearly indicated, all
references in this Chapter to singular nouns include
the plural noun, and all references to plural nouns
include the singular, for example, "area of
responsibility" also includes multiple "areas of
responsibility."
6.2.1 Reciproci ty
a) Except as noted in this subsection, NELAP-recognized
secondary accrediting authorities shall grant
accreditation to laboratories accredited by any other
NELAP-recognized primary accrediting authority. Such
reciprocal NELAP accreditation shall be granted on a
laboratory-by-laboratory basis. The NELAP-recognized
secondary accrediting authority shall consider only the
current certificate of accreditation issued by the
NELAP-recognized primary accrediting authority.
b) When granting reciprocal accreditation to a laboratory,
the NELAP-recognized secondary accrediting authority
shall grant reciprocal accreditation for only the
fields of testing for which the laboratory holds
current primary NELAP accreditation.
c) All fees shall be paid by laboratories as required by
the NELAP-recognized secondary accrediting authority.
d) Laboratories seeking NELAP accreditation by a NELAP-
recognized secondary accrediting authority shall not be
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required to meet any additional proficiency testing,
quality assurance, or on-site assessment requirements
for the fields of testing for which the laboratory
holds primary NELAP accreditation.
e) If a NELAP-recognized secondary accrediting authority
notes any potential nonconformance with the NELAC
standards by a laboratory during the initial
application process for reciprocal accreditation or for
a laboratory that it has already granted NELAP
accreditation through reciprocity, the NELAP-recognized
secondary accrediting authority shall immediately
notify, in writing, the applicable NELAP-recognized
primary accrediting authority. The notification must
cite the applicable sections within the NELAC standards
for which nonconformance by the laboratory has been
noted.
1) If the alleged nonconformance is noted during the
initial application process for reciprocal NELAP
accreditation, final action on the application for
reciprocal NELAP accreditation shall not be taken
until the alleged nonconformance issue has been
resolved, or
2) If the alleged nonconformance is noted after
reciprocal NELAP accreditation has been granted, the
laboratory shall maintain its current NELAP
accreditation status until the alleged
nonconformance issue has been resolved.
f) Upon receipt of the subsection (e) notification, the
NELAP-recognized primary accrediting authority shall:
1) Review and investigate the alleged nonconformance,
2) Take appropriate action on the laboratory as set
forth by the NELAC standards, including the addition
of any change of accreditation status in the
National Environmental Laboratory Accreditation
Database. All such actions shall be taken in
accordance with the laboratory's right to due
process as set forth in the NELAC standards, Chapter
four, Accreditation Process,
3) Respond to the NELAP-recognized secondary
accrediting authority, in writing, with a copy to
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the NELAP Director, within 20 days of receipt of the
subsection (e) notification providing:
A) an initial report of the findings;
B) a description of the actions to be taken; and
C) a schedule for implementation of further action on
the alleged nonconformance, if necessary.
g) If, in the opinion of the secondary accrediting
authority, the primary accrediting authority does not
take timely and appropriate action on the complaint,
the secondary accrediting authority should notify the
NELAP Director of the dispute between the two
accrediting authorities regarding proper disposition of
the complaint. Within 20 days of receipt of such
notification, the NELAP Director shall review the
alleged nonconformance and take appropriate action
according to the standards set forth in this Chapter.
6.2.2 Where to Apply for NELAP Accreditation
a) Laboratories that are NELAP accredited by an
accrediting authority that has lost NELAP recognition
may seek NELAP accreditation through any NELAP-
recognized accrediting authority. The laboratory's
NELAP accreditation shall remain valid throughout its
current certificate of accreditation.
b) Except for governmental laboratories in federal
departments or agencies holding NELAP recognition as an
accrediting authority, laboratories seeking NELAP
accreditation or renewal of NELAP accreditation must
apply for such accreditation through their home state
(the state in which the laboratory facility is located)
accrediting authority.
c) Laboratories located in a territory or state that is
not NELAP-recognized may seek NELAP accreditation
through any NELAP-recognized accrediting authority.
d) Governmental laboratories not an organizational unit
within the department or agency in which the
accrediting authority is located shall apply for NELAP
accreditation through their home-state accrediting
authority.
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e) Governmental laboratories that are organizational units
of the same department or agency in which the
accrediting authority is located or have other
institutional conflicts of interest may:
1) demonstrate by organizational structure that the
laboratory's responsible party of record and the
environmental laboratory accreditation program
manager do not report to the same individual;
2) demonstrate by policies and procedures that
conflicts-of-interest, actual or potential, do not
exist; or
3) apply for NELAP accreditation through any other
NELAP-recognized accrediting authority.
f) In order that all laboratory applications for NELAP
accreditation are treated equally, accrediting
authorities shall initiate processing applications for
NELAP accreditation in the chronological order that the
applications are received.
6.2.3 Documentation Maintained by Accrediting Authorities
a) The accrediting authority shall provide through
publication, electronic media or other means a document
or documents describing its environmental laboratory
accreditation program.
1) The document or documents shall include the
following:
A) information setting forth the authority of the
accrediting authority to grant laboratory
accreditations and whether such laboratory
accreditation is mandatory or voluntary;
B) information setting forth the accrediting
authority's requirements for an environmental
laboratory to become accredited;
C) information stating the requirements for granting,
maintaining, withdrawing, suspending or revoking
laboratory accreditation;
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D) information about the laboratory accreditation
process;
E) information on fees charged to applicants and
accredited laboratories;
F) information regarding the rights and duties of
accredited laboratories; and
G) information listing its NELAP accredited
laboratories describing the NELAP accreditation
granted.
2) The document or documents shall be reviewed
annually. A written record of this review must be
available for inspection by the NELAP assessment
team.
b) When the document or documents reviewed in subsection
(a)(2) above reveals that the accrediting authority's
environmental laboratory accreditation program has
changed or is otherwise different from the
accreditation program described in such documents, the
document or documents shall be updated within 30 days
of the review.
c) The document or documents described in subsection
(a)(1) above shall be made readily available upon
request.
6.3 APPLICATION FOR NELAP RECOGNITION
This section describes the process by which accrediting
authorities may apply for NELAP recognition and the
procedures that NELAP will use to review the applications.
6.3.1 Written Application for NELAP Recognition
a) Each accrediting authority requesting initial NELAP
recognition shall complete an application and supply
all supporting documentation. Applications can be
obtained from the Office of the NELAP Director, USEPA.
b) The application shall request information that is
essential for the NELAP to evaluate an accrediting
authority's environmental laboratory accreditation
program. When documentation is required, copies of the
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applicable statutes, rules, regulations, policy
statements, standard operating procedures, guidance
documents, etc. must be submitted along with a clear
citation of where the required information is found in
the documents. The application will request the
following information and documentation from the
accrediting authority:
1) the name, mailing address, telephone number,
electronic mail address and telefacsimilie number of
the accrediting authority;
2) the statutes and regulations establishing and
governing the accrediting authority's environmental
laboratory accreditation program as required in
subsection 6.3.3.1 (b) and (c);
3) the policies, guidance documents and standard
operating procedures governing the operation of the
accrediting authority's environmental laboratory
accreditation program as set forth in subsection
6.3.3.1 ;
4) the accrediting authority's arrangements for
liability insurance and workman's compensation
insurance coverage as required in subsection 6.3.3.1
(d);
5) the requirements governing how the accrediting
authority restricts the use of its accreditation by
accredited laboratories as required in Section 6.8;
6) the fields of testing for which the accrediting
authority is requesting NELAP recognition;
7) the name and title of the primary person responsible
for the day-to-day management of the accrediting
authority's environmental laboratory accreditation
program as required in subsection 6.3.3.1 (h) ;
8) the names, education and experience levels of the
accrediting authority's environmental laboratory
accreditation program's management and technical.
staff as required in subsection 6.3.3.1 (f), (g) and
(h);
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9) the names and contractual agreements for any
external assessment bodies used by the accrediting
authority as required in subsection 6.3.3.1.2 and
6.3.3.1.3 (b)(3);
10) the names, areas of responsibility, education and
experience levels of all technical and assessment
employees of any external assessment bodies used by
the accrediting authority as required in subsection
6.3.3.1.2 and 6.3.3.1.3 (b)(3);
11) RESERVED
12) a description of the accrediting authority's
environmental laboratory accreditation program
quality systems (e.g., a quality systems manual or a
quality assurance plan) as required in subsection
6.3.3.1.3;
13) the procedures for the selecting, training,
contracting and appointing of the accrediting
authority's laboratory assessors as required in
subsection 6.3.3.1 (f) and (g);
14) a description of the accrediting authority's
conflict-of-interest disclosure program as required
in subsection 6.3.3.1 (i);
15) a tabular listing of all laboratories applying for
accreditation in the two-year period immediately
preceding the date of the application. The table
shall set forth the date on which the laboratory's
application for accreditation was received by the
accrediting authority and the date on which final
action on the application was taken.
16) the policies and procedures used by the accrediting
authority for establishing and maintaining records
on each accredited laboratory and procedures for
record access and retention as required in
subsection 6.3.3.1.1;
17) the accrediting authority's findings, reports and
corrective actions from internal audits conducted in
the last two years as required in subsection 6.3.3.1
(j) and 6.3.3.1.3 (b) (4) ;
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18) a certification that the accrediting authority meets
the provisions of Section 6.2 of this Chapter;
19) the name and job title of the individual or
individuals authorized to sign accreditation
certificates; and
20) the standardized checklist required by subsection
6.3.2 (c)(1) is to be completed by the applicant
accrediting authority citing the location in the
application or supporting documents where the
checklist information is provided.
c) The application must be signed and dated by the highest
ranking individual within the department or agency
responsible for laboratory accreditation activities for
which NELAP recognition is being sought. By signature
on the application, this individual must attest to the
validity of the information contained within the
application and its supporting documents.
d) The accrediting authority shall submit a renewal
application to the NELAP every two years to maintain
NELAP recognition.
1) The NELAP shall send by certified mail or some other
verifiable means to the accrediting authority, no
later than 180 days prior to the expiration of the
accrediting authority's then-current NELAP
recognition an application for renewal of NELAP
recognition to the accrediting authority.
2) The accrediting authority must address each
requirement of subsection 6.3.1 (b); however, it
must submit information and documentation only of
changes from the accrediting authority's most recent
NELAP-recognized environmental laboratory
accreditation program.
3) The accrediting authority must submit the completed
renewal application and supporting documents to the
NELAP within 30 days of receiving the renewal
notification.
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6.3.2 Application Completeness Review by NELAP
a) The NELAP is required to provide notices required by
this Chapter only to those accrediting authorities who
have submitted an initial application for NELAP
recognition or who hold NELAP recognition.
b) If the NELAP does not receive a completed renewal
application as specified in subsection 6.3.1 (d) (3),
the accrediting authority shall be notified in writing.
If the accrediting authority does not submit the
completed application within 15 days of receipt of this
notification from the NELAP, the accrediting
authority's NELAP recognition will not be renewed upon
expiration of its current NELAP recognition.
c) Following receipt of an initial or a renewal
application, the NELAP must complete a review of the
application and supporting documents to determine that
information and supporting documentation required in
subsection 6.3.1 (b) is included with the submittal.
I) The completeness review of the application and
supporting documents shall be conducted using a
standardized checklist provided by the NELAP as part
of the application. The checklist shall be designed
to assist the applicant in gathering all the
information needed to complete the application and
include a place to note the date the completeness
review was completed.
2) The NELAP must notify the accrediting authority in
writing within 15 days of receiving the application
of any additional information needed to complete the
application.
3) The accrediting authority must provide any
additional information or clarification requested in
writing within ten days of receipt of the (c)(2)
notification.
A) The NELAP may grant extensions to the ten-day time
period for up to an additional ten days if the
accrediting authority requests the extension in
writing.
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B) The NELAP shall notify the accrediting authority
in writing when an extension is granted.
4) Written notification to the accrediting authority
that an application is complete shall be furnished
by the NELAP within five days of the date of such
determination.
6.3.3 Application Technical Review by a NELAP Assessment
Team
a) Within 30 days of the determination that the
application is complete, the NELAP assessment team as
established in subsection 6.9.1 will perform a
technical review of the application and its supporting
documents and respond in writing to the accrediting
authority.
1} The review shall be conducted in accordance with the
NELAP standard operating procedures for application
review; and
2) The review shall be performed by the same NELAP
assessment team assigned to conduct the on-site
audit.
3) In the years when no on-site audit is required, as
provided in subsection 6.4 (a)(2), the NELAP
Director shall endeavor to appoint the same NELAP
assessment team that conducted the application
technical review and on-site audit for the
accrediting authority's immediately preceding
application cycle.
4) The NELAP Director shall appoint a different NELAP
assessment team for each succeeding four-year NELAP
on-site audit cycle as set forth in Section 6.4 (a)
of this Chapter. New four-year NELAP on-site audit
cycles shall start with each renewal application
when an on-site audit of the accrediting authority
is required.
b) The NELAP assessment team will review the application
and supporting documents to evaluate whether the
accrediting authority's environmental laboratory
accreditation program requires its accredited
laboratories to meet the standards set forth by the
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NELAC standards, Chapter two, Proficiency Testing,
Chapter three, On-Site Assessment, Chapter four,
Accreditation Process and Chapter five, Quality
Systems.
c) Should the NELAP assessment team have questions or need
additional application information to determine the
accrediting authority's compliance with this Chapter,
the NELAP assessment team must seek additional
application information and documentation from the
accrediting authority.
6.3.3.1 Required Technical Elements of a NELAP-Recognized
Accrediting Authority's Program
a) The NELAP assessment team will review the application
and supporting documentation to ensure that the
accrediting authority's environmental laboratory
accreditation program meets the requirements of
subsection (b) through (m) below.
b) The accrediting authority shall be a legally
identifiable governmental entity;
c) The accrediting authority shall have the authority to
carry out an environmental laboratory accreditation
program;
d) The accrediting authority shall have the same
arrangements to cover liabilities and workman's
compensation claims arising from its operations and
activities as all other programs, units, divisions,
bureaus, etc. in the department or agency in which the
accrediting authority is located;
e) The accrediting authority shall have the resources
necessary to complete action on a laboratory's
application within nine months from the time a
completed application is first received from the
laboratory. This time period applies as long as all
turn-around times for responses to application review,
proficiency testing and on-site assessment issues are
carried out within the required time limits set forth
in the NELAC standards.
f) The accrediting authority shall appoint and maintain
records on assessors, including contractual assessors,
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who meet the education, experience and training
requirements set forth in the NELAC standards, Chapter
three, On-Site Assessment. Such records shall include:
1) name and address;
2) organization affiliation and position held;
3) educational qualification and professional status;
4) work experience;
5) training applicable to laboratory accreditation;
6) experience in laboratory assessment, together with
field of competence; and
7) date of most recent updating of record.
g) The accrediting authority shall have a system in place
to evaluate assessor performance that is consistent
with the organizational employee evaluation program and
demonstrates compliance with the NELAC standards,
Chapter three, On-Site Assessment;
h) The accrediting authority shall identify one individual
responsible for day-to-day management of the
accrediting authority's environmental laboratory
accreditation program. This individual must:
1) be an employee of the accrediting authority, and
2) have the technical expertise necessary to:
A) plan and manage the laboratory accreditation
program,
B) coordinate various facets of the laboratory
accreditation program with other territory, state
and federal accrediting authorities,
C) coordinate development of environmental laboratory
accreditation regulations, and
D) evaluate the technical competence and performance
of contractors or employees.
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i) The accrediting authority shall have arrangements to
ensure that the accrediting authority's management and
technical staff are free of any commercial, financial
or other pressures that influence the results of the
accreditation process and are subject to the same
conflict of interest disclosure requirements designed
to identify and eliminate potential conflict-of-
interest problems as all other programs, units,
divisions, bureaus etc. in the department or agency in
which the accrediting authority is located;
j) The accrediting authority shall have a documented
procedure in place to conduct systematic internal
audits annually of the accrediting authority's
environmental laboratory accreditation program to
verify compliance with the NELAC standards. One
element of the annual internal audit shall be to review
the effectiveness of the quality systems required in
subsection 6.3.3.1.3. When applicable, the accrediting
authority shall use the same policies and procedures
for internal audits as used by all other programs,
units, divisions, bureaus etc. in the department or
agency in which the accrediting authority is located;
k) The accrediting authority shall designate the
individual specified in subsection 6.3.3.1 (h) or an
individual who reports directly to the individual
responsible for day-to-day management of the
accrediting authority's environmental laboratory
accreditation program to take responsibility for the
quality system and maintenance of the quality
documentation required in subsection 6.3.3.1.3;
1) The accrediting authority shall have established
standard operating procedures for dealing with appeals,
complaints and disputes arising from denial, suspension
or revocation of laboratory accreditation, or from
users of the services about the NELAP accredited
laboratories or any other matters; and
m) The accrediting authority shall require a proficiency
testing program meeting the requirements of the NELAC
standards, Chapter two, Proficiency Testing.
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6.3.3.1.1 Records
a) The accrediting authority shall have arrangements to
establish and maintain records for each accredited
laboratory with respect to all aspects of the
laboratory's accreditation process.
b) The accrediting authority shall have a policy and
procedure for retaining NELAP accreditation records for
a minimum of ten years or a longer period of time if
required by contractual obligations or pertinent
territorial/ state or federal laws and regulations..
c) The accrediting authority shall have a policy and
procedures concerning access to records as prescribed
by the territorial, state or federal entity in which
the accrediting authority resides.
6.3.3.1.2 Use of Contractors by an Accrediting Authority
a) The accrediting authority shall have arrangements to
ensure that all laboratory accreditation functions
performed by a contractor on behalf of the accrediting
authority are carried out in compliance with the NELAC
standards.
b) When laboratory accreditation functions are contracted
out, the accrediting authority shall:
1) take full responsibility for such subcontracted
work,
2) ensure that the subcontractor or his employees are
competent and comply with the applicable provisions
of the NELAC standards, and
3} ensure that the subcontractor or his employees are
not directly involved with:
A) the laboratory seeking NELAP accreditation from
the accrediting authority employing the
contractor; or
B) any other affiliations which would compromise
impartiality in the NELAP laboratory accreditation
process.
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6.3.3.1.3 Accrediting Authority's Quality System
a) The accrediting authority shall have a quality system
appropriate to the type, range and volume of work
performed by the accrediting authority.
b) The quality system shall be documented in a quality
manual and associated written quality procedures. The
quality manual shall include at least the following:
1) the quality policy statement, including objectives
and commitments, signed by the manager responsible
for day-to-day management of the accrediting
authority's environmental laboratory accreditation
program;
2) the organizational structure of the accrediting
authority's environmental laboratory accreditation
program and the responsibilities of individual staff
assigned to the structure;
3) the procedures for acquiring, supervising and
evaluating the performance of contractors carrying
out any part of the accrediting authority's
laboratory accreditation program;
4) the arrangements for annual internal audits as
required in subsection 6.3.3.1 (j);
5) the system for providing feedback to personnel
responsible for the area audited and for taking
timely and appropriate corrective actions whenever
discrepancies are detected; and
6) the procedures established to address conflict-of-
interest questions arising from the NELAC standards
as set forth in subsection 6.2.2 (e)(2) and for the
accrediting authority's management and technical
staff as set forth in subsection 6.3.3.1 (i).
7) the procedures established to maintain document
control for documents required by the NELAC
standards.
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6.3.3.2 Application Technical Review Report
a) The NELAP assessment team will accept an initial
application and its supporting documentation that
contains sufficient information to determine that an
accrediting authority meets the requirements of the
NELAC standards for designation as a NELAP-recognized
accrediting authority. When the NELAP assessment team
completes its review of an initial application and
notes no deficiencies, the NELAP assessment team will
schedule the on-site audit as set forth in subsection
6.4.1 below.
b) The NELAP assessment team will accept a renewal
application and its supporting documentation that
contains sufficient information to determine that an
accrediting authority meets the requirements of the
NELAC standards for designation as a NELAP-recognized
accrediting authority. When the NELAP assessment team
completes its review of a renewal application and
denotes no deficiencies, the NELAP assessment team will
recommend to the NELAP Director that NELAP recognition
be maintained.
c) Except as noted in Section 6.5, the NELAP assessment
team will not accept the application if it notes
deficiencies. The NELAP assessment team will send by
certified mail an application technical review report
to the accrediting authority. The report will:
I) identify any specific deficiencies noted during the
application technical review,
2) include references to the specific NELAC standards,
and
3) provide suggested corrective action.
d) The accrediting authority shall respond with written
corrective actions within 30 days of receipt of the
NELAP assessment team's subsection (c) notification.
Alternately, the accrediting authority has the option
to withdraw all or part of its NELAP recognition
request. The NELAP assessment team will review the
corrective actions within 15 days of receipt of the
accrediting authority's response.
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1) If the corrective actions submitted by the
accrediting authority do not meet the requirements
of this Chapter, the NELAP assessment team will
notify the accrediting authority that it must submit
additional corrective actions within 15 days of
receipt of the NELAP assessment team's response.
The NELAP assessment team will review the
accrediting authority's second corrective action
response within 15 days of receipt.
2) If the second corrective action response submitted
by the accrediting authority does not address
satisfactorily all of the application deficiencies,
the NELAP assessment team will make no further
suggestions to the accrediting authority for
correction of application deficiencies.
3) If application deficiencies still remain after the
assessment team's second attempt to resolve those
deficiencies, the NELAP assessment team will
recommend to the NELAP Director that:
A) the accrediting authority's application for
initial NELAP recognition be denied; or
B) the accrediting authority's NELAP recognition be
revoked.
e) If the initial application as submitted contained no
deficiencies or if deficiencies were corrected as
provided in subsection (d), except those deficiencies
requiring legislative or rulemaking action as .set forth
in Section 6.5, the NELAP assessment team will schedule
the on-site audit as set forth in subsection 6.4.1
below.
f) If an accrediting authority elects to appeal denial or
revocation of NELAP recognition resulting from the
Section 6.3.3 application technical review process, an
accrediting authority must follow the procedure set
forth in Section 6.10 of this Chapter.
g) After review of the renewal NELAP-recognition
application and supporting documents, the NELAP
assessment team will schedule an on-site audit of the
accrediting authority's environmental laboratory
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accreditation program as set forth in Section 6.4 (a)
and subsection 6.4.1 (a) below.
6.3.4 Notification of Changes to An Accrediting
Authority's Program
a) For all changes in the accrediting authority's
environmental laboratory accreditation program listed
below, the NELAP Director shall be notified of changes
to:
1) the authority to accredit laboratories as stated in
the statutes and regulations establishing and
governing the accrediting authority's environmental
laboratory accreditation program,
2) the organizational structure involving either the
management or technical staff,
3) the rules, regulations, policies, guidance documents
and standard operating procedures,
4) the mailing address and office location, telephone
and telefacsimilie numbers and electronic mail
address, and
5) the contractual arrangements, including contractor's
personnel, for laboratory accreditation activities
contracted out under authority of subsection 6.2
(c) .
b) The notification to the NELAP Director shall be made
within 30 days of the change taking place in the
accrediting authority's environmental laboratory
accreditation program.
c) The NELAP Director may request further documentation or
conduct on-site audits to verify that changes in the
accrediting authority's NELAP-recognized environmental
laboratory accreditation program do not place that
program in violation of the NELAC standards.
6.4 ON-SITE AUDIT OF THE ACCREDITING AUTHORITY
a) On-site audits of an accrediting authority's
environmental laboratory accreditation program shall be
conducted on a four-year cycle as follows:
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1) An initial on-site audit shall be conducted in
conjunction with an accrediting authority's initial
application process and every four years thereafter;
and
2) No on-site audit of an accrediting authority's
environmental laboratory accreditation program is
required for the two-year renewal application
immediately following an application for NELAP
recognition where an on-site audit was conducted.
b) The NELAP assessment team will arrange on-site audits
except as stated in subsection (c) below at the mutual
convenience of the parties.
c) The NELAP assessment team may make subsequent announced
or unannounced on-site audits of an accrediting
authority's environmental laboratory accreditation
program whenever such an audit is necessary to
determine the accrediting authority's compliance with
the requirements of the NELAC standards.
6.4.1 Scheduling the On-Site Audits
a) The NELAP assessment team shall contact the accrediting
authority to schedule on-site audits as set forth in
Section 6.4 (a) above within 15 days of the date the
NELAP assessment team accepts an initial or renewal
application.
b) The NELAP assessment team must send to the accrediting
authority written confirmation of the logistics
required to conduct the on-site audit. The written
confirmation shall include, but is not limited to:
1) on-site audit date and agenda or schedule of
activities,
2) copies of the standardized audit checklists,
3) the names, titles, affiliations, and on-site audit
responsibilities of the NELAP assessment team
members, and
4) the names and titles of all accrediting authority
staff that need to be available during the on-site
audit.
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c) All on-site audits shall be conducted no later than 45
days following approval of the application.
6.4.2 Conducting the On-Site Audit
a) The purpose of the on-site audit is to verify
compliance with the requirements of the NELAC standards
including, but not limited to:
1) determining the accuracy of information contained in
the accrediting authority's application and
supporting documents;
2) determining whether the accrediting authority's
implementation of its environmental laboratory
accreditation program conforms with the information
and data contained in the application and supporting
do cument s; and
3) observing, upon recommendation of the NELAP
assessment team and the approval of the NELAP
Director, an accrediting authority's laboratory
assessor(s) conducting an on-site audit of a
laboratory seeking initial or renewal NELAP
accreditation. The NELAP assessment team members
shall not participate in the laboratory's
assessment.
b) When conducting an on-site audit, the NELAP assessment
team shall, at a minimum:
1) review the accrediting authority's record keeping
and documentation procedures;
2) conduct interviews with the accrediting authority's
management and technical staff;
3) review selected laboratory accreditation cases;
4) review records of laboratory complaints, disputes
and appeals; and
5) review quality assurance and internal audit
procedures employed by the accrediting authority.
c) The NELAP assessment team shall have access to all
records of the accrediting authority's environmental
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laboratory accreditation program to determine
compliance with the NELAC standards.
d) The NELAP assessment team shall have the opportunity to
interview privately:
1) all management and technical staff of the
accrediting authority's environmental laboratory
accreditation program; and
2) any NELAP-accredited laboratory receiving its
accreditation from the applicant accrediting
authority.
e) The NELAP assessment team must ensure that the audit is
conducted according to the schedule as set forth in
subsection 6.4.1 (b)(1) and consists of the following:
1) an opening meeting,
2) the physical audit of the accrediting authority's
environmental laboratory accreditation program, and
3) an exit interview to discuss all noted deficiencies.
f) The NELAP assessment team shall conduct all audits in
accordance with the NELAP standard operating procedure
for conducting on-site audits of accrediting
authorities.
6.4.3 On-Site Audit Reports
a) The NELAP assessment team will send by certified mail
to the accrediting authority an on-site audit report
within 30 days of completion of the on-site audit. The
report shall include, but is not limited to:
1) the date(s) of assessment;
2) the name(s) of the person(s) responsible for the
report;
3) the NELAP recognition fields of testing being
applied for; and
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4) the comments of the NELAP assessment team on the
accrediting authority's compliance with the
requirements of the NELAC standards.
b) If the on-site audit does not reveal any deficiencies,
the NELAP assessment team shall recommend to the NELAP
Director that the accrediting authority be granted or
maintain NELAP recognition.
c) If deficiencies are noted during the on-site audit, the
report will:
1) identify any specific deficiencies noted during the
on-site audit,
2) include references to the specific NELAC standards,
and
3) provide suggested corrective action.
d) If the on-site audit reveals deficiencies, the
accrediting authority shall submit a plan of corrective
action to the NELAP assessment team within 30 days of
receipt of the on-site audit report.
1) The plan of corrective action must detail those
specific actions taken or that will be taken by the
accrediting authority to correct all deficiencies
noted by the NELAP assessment team during the on-
site audit.
2) The plan of corrective action must include the
accrediting authority's projected time to complete
the corrective actions not yet complete at the time
of the accrediting authority's response to the on-
site audit report.
3) Except for those deficiencies set forth in Section
6.5, the implementation of corrective actions must
take place no more than 60 days from receipt of the
on-site audit report.
e) The NELAP assessment team shall recommend to the NELAP
Director revocation or denial of NELAP recognition for
on-site audit deficiencies for any accrediting
authority that fails to submit a plan of corrective
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action within 30 days as set forth in subsection (d)
above.
f) Within 15 days of receipt of the accrediting
authority's plan of corrective actions, the NELAP
assessment team shall review the plan and respond in
writing to the accrediting authority.
1) If the accrediting authority corrects all
deficiencies, the NELAP assessment team shall
recommend to the NELAP Director that the accrediting
authority be granted or maintain NELAP recognition.
2) If the accrediting authority's plan of corrective
actions does not address all deficiencies, the NELAP
assessment team will notify the accrediting
authority by certified mail that it must submit
another plan of corrective actions for the remaining
deficiencies not covered by Section 6.5 within 15
days of the accrediting authority's receipt of this
notification.
g) The NELAP assessment team shall review the corrective
actions for the remaining deficiencies within 15 days
of receipt of a subsection (f)(2) response from the
accrediting authority.
1) If all deficiencies are not corrected and the
remaining deficiencies affect only certain fields of
testing, the NELAP assessment team shall recommend
to the NELAP Director that the accrediting
authority's NELAP recognition be denied or revoked
for those fields of testing for which on-site audit
deficiencies remain.
2) If all deficiencies are not corrected and the
remaining deficiencies affect the entire accrediting
authority's environmental laboratory accreditation
program, the NELAP assessment team shall recommend
to the NELAP Director that the accrediting
authority's NELAP recognition be denied or revoked.
3) If the only remaining deficiencies require
legislation or rulemaking as set forth in Section
6.5, the NELAP assessment team shall recommend to
the NELAP Director that the accrediting authority be
granted or maintain NELAP recognition.
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4) If remaining deficiencies are corrected, the NELAP
assessment team shall recommend to the NELAP
Director that the accrediting authority be granted
or maintain NELAP recognition.
h) If the NELAP assessment team determines that the
accrediting authority has falsified information
included in its application and supporting documents,
the NELAP assessment team shall recommend to the NELAP
Director that the accrediting authority's NELAP
recognition be denied or revoked.
6.5 ACCREDITING AUTHORITY'S REQUEST FOR EXTENSION OF TIME
TO COMPLY WITH THE NELAC STANDARDS
a) Upon written request to the NELAP Director, through the
NELAP assessment team, an extension of time, not to
exceed two years, to correct deficiencies noted in the
accrediting authority's application and/or deficiencies
noted during the on-site audit will be granted only:
1) when an applicant accrediting authority has an
operating environmental laboratory accreditation
program for the fields of testing for which it is
seeking or renewing NELAP recognition, and
2) when implementation of corrective actions to correct
application and/or audit deficiencies requires the
accrediting authority to promulgate new or revised
regulations, or
3) when implementation of corrective actions to correct
application and/or audit deficiencies requires the
accrediting authority to seek new or revised
legislation.
b) If the deficiencies continue to exist after two years
from the date the extension was granted, the NELAP
recognition granted as set forth in subsection 6.4.3
(g)(3) above will not be renewed.
c) The accrediting authority shall include in its request
for an extension of time to comply with the NELAC
standards a projected time table for correction of the
application and/or audit deficiencies.
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6.6 NELAP ASSESSMENT TEAM RECOMMENDATIONS TO THE NELAP
DIRECTOR
a) All recommendations required by this Chapter from the
NELAP assessment team to the NELAP Director must be
made in writing.
b) All NELAP assessment team recommendations to the NELAP
Director shall include the following documentation when
applicable:
1) a recommendation to grant, maintain or revoke NELAP
recognition in full or in part;
2) a summary of the reasons supporting the
recommendation;
3) a copy of all application review letters sent to the
accrediting authority and all corrective action
response letters submitted by the accrediting
authority to the NELAP assessment team;
4) a copy of all on-site audit review letters sent to
the accrediting authority and all corrective action
response letters submitted by the accrediting
authority; and
5) a copy of the accrediting authority's requests for
extension of time to implement corrective actions if
legislative or additional rulemaking is required
pursuant to Section 6.5.
c) A copy of any NELAP assessment team's recommendation to
the NELAP Director also shall be furnished to the
accrediting authority.
d) Within 20 days of receipt of the NELAP assessment
team's recommendation, the NELAP Director shall provide
written notification to the accrediting authority of
acceptance or rejection of the NELAP assessment team's
recommendation.
e) The accrediting authority has the option to appeal a
revocation or denial decision regarding NELAP
recognition by the NELAP Director as set forth in
Section 6.10 of this Chapter.
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6.7 CERTIFICATE OF RECOGNITION TO THE ACCREDITING AUTHORITY
a) The NELAP Director will issue a certificate of NELAP
recognition dated the day on which NELAP recognition is
granted.
b) The certificate of NELAP recognition shall include the
following items:
1) the name and address of the accrediting authority,
2) the fields of testing for which the accrediting
authority is NELAP-recognized,
3) the date of the accrediting authority's most recent
on-site audit,
4) the expiration date of the accrediting authority's
NELAP recognition which shall not be more than two
years from the date of the most recent date granting
NELAP recognition,
5) the signature of the NELAP Director,
6) a statement that the accrediting authority is in
compliance with the NELAC standards,
7) a statement that the accrediting authority has been
granted the authority to accredit environmental •
laboratories for the fields of testing for which the
accrediting authority is NELAP-recognized,
8) a statement that continued NELAP recognition depends
on compliance with the NELAC standards; and
9) a seal incorporating the NELAP insignia.
6.8 USE OF ACCREDITATION BY NELAP ACCREDITED LABORATORIES
a) The accrediting authority shall have requirements for
controlling the ownership, use and display of the
accrediting authority's NELAP accreditation documents
and for controlling the manner in which an accredited
laboratory may refer to its NELAP accreditation. These
arrangements shall include, but are not limited to
requirements that:
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1) NELAP accredited laboratories post or display their
most recent NELAP accreditation certificate or their
NELAP accreditation fields of testing in a prominent
place in the laboratory facility;
2) NELAP accredited laboratories make accurate
statements concerning their NELAP accreditation
fields of testing and NELAP accreditation status;
3) NELAP accredited laboratories accompany the
accrediting authority's name with at least the
phrase "NELAP accredited" and the laboratory's
accreditation number or other identifier when the
accrediting authority's name is used on general
literature such as catalogs, advertising, business
solicitations, proposals, quotations, or other
materials; and
4) NELAP accredited laboratories not use their NELAP
certificate or NELAP accreditation status to imply
endorsement by the accrediting authority.
b) The accrediting authority shall have arrangements to
ensure that NELAP accredited laboratories choosing to
use the accrediting authority's name or making
reference to its NELAP accreditation status in any
catalogs, advertising, business solicitations,
proposals, quotations, or other materials, the NELAP
accredited laboratory shall:
1) distinguish between proposed testing for which the
NELAP-accredited laboratory is accredited and the
proposed testing for which the NELAP accredited
laboratory is not accredited;
2) include the NELAP-accredited laboratory's
accreditation number or other identifier; and
c) The accrediting authority shall have arrangements to
ensure that the NELAP-accredited laboratories upon
suspension, revocation or withdrawal of their NELAP
accreditation shall:
1) discontinue use of all catalogs, advertising,
business solicitations, proposals, quotations, or
other materials that contain reference to their past
NELAP accreditation status, and
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2) return any certificates for NELAP accreditation to
the accrediting authority.
d) The accrediting authority shall have arrangements to
take suitable actions/ including legal action, when
incorrect references to the accrediting authority's
NELAP accreditation or misleading use of the
laboratory's NELAP accreditation status is found in
catalogs, advertisements, business solicitations,
proposals, quotations, or other materials.
6.9 REQUIREMENTS OF THE NELAP
a) The NELAP assessment team shall submit all documents,
letters, audit notes, checklists, etc. to the NELAP
headquarters office within:
1) 30 days of the final decision on the application by
the NELAP Director, or
2) 30 days after the final recommendation by the
Accrediting Authority Review Board (AARB) as set
forth in Section 6.10 of this Chapter.
b) The NELAP Director shall maintain complete and accurate
records of all documents relating to the application
and on-site audit processes for each accrediting
authority for a minimum of ten years or a longer period
of time if required by contractual obligations or
pertinent federal laws and regulations.
c) The NELAP Director shall maintain an electronic
directory to display the status of all NELAP-recognized
accrediting authorities, pending applications for NELAP
recognition and currently scheduled announced on-site
audits.
6.9.1 NELAP Assessment Team
a) The NELAP Director shall appoint NELAP assessment team
members as set forth in Section 6.3.3 (a)(4) and
delegate the responsibilities required by this Chapter
to assessment teams.
b) During the time prior to the NELAP issuing the first
NELAP recognitions to accrediting authorities, the
NELAP assessment team shall consist of at least one
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member who is an employee of the USEPA and at least
one member who is an employee of another operating
territorial/ state or federal environmental laboratory
accreditation program.
c) No later than two years from the date that the first
accrediting authority recognitions are announced , the
NELAP assessment team shall consist of at least one
member who is an employee of the USEPA and at least
one member who is a employee of a NELAP-recognized
accrediting authority.
d) Each member of the NELAP assessment team shall meet the
education, experience and training requirements
specified in the NELAC standards, Chapter three, On-
Site Assessment, for laboratory assessors.
e) The NELAP assessment team shall:
1) have at least one member with three years of
experience assessing laboratories at a minimum rate
of four assessments each year;
2) have at least one member with experience that
includes at least one of the following:
A) registration as a lead assessor;
B) one year of experience implementing federal or
state laboratory accreditation rulemaking;
C) laboratory accreditation management; or
D) one year experience developing or participating in
laboratory accreditation programs.
3) All experience required by this subsection must have
been acquired within the five year period
immediately preceding appointment as a NELAP
assessment team member.
6.10 APPEALING DECISIONS TO DENY OR REVOKE NELAP RECOGNITION
a) Within 15 days of official notification of the NELAP
action on an accrediting authority's application for
NELAP recognition, the accrediting authority shall
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notify the NELAP Director and the Accrediting Authority
Review Board (AARB) (as established in the NELAC
standards, Chapter one, Policy and Structure) if the
accrediting authority chooses to appeal the NELAP
action.
b) If any AARB member is not free of financial connection
to the appealing accrediting authority, or is not free
of any other relationship that would bias their review
of the case, that AARB member shall be excluded from
participating in deliberations on that appeal.
c) The AARB shall carry out an independent review of the
entire record (all application information, checklists,
review notes, on-site audit notes, letters, reports and
any other data in the NELAP and NELAP assessment team
files) .
d) The AARB must conduct interviews with the accrediting
authority, the NELAP assessment team members and the
NELAP Director. The AARB also may conduct interviews
with other individuals deemed appropriate by the AARB.
e) If the accrediting authority so desires, an opportunity
for both the NELAP and the accrediting authority to
appear before the AARB shall be granted. Such a
meeting shall be held in the state of the appealing
accrediting authority.
f) The AARB must complete its review and render a final
recommendation to the NELAP Director within 90 calendar
days following receipt of the notice of appeal.
g) The ultimate decision to grant, maintain, deny or
revoke NELAP recognition remains with the NELAP
Director. The NELAP Director shall notify the
appealing accrediting authority of his/her decision
within 15 days of receipt of the recommendation from
the AARB.
h) Accrediting authorities shall be limited to one appeal
for each application cycle.
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Plgnz* 1: Flow Chart tax HELAP Recognition of An Aoondltlng Authority
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U.S. Environmental Protection Agency
Region 5, Library (PL-12J)
77 West Jackson Boulevard, 12th FlOOf
Chicago, IL 60604-3590
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