&EPA
United States
Environmental Protection
Agency
Office of Research and
Development
Las Vegas NV 89193
EPA600/R-00/084
June 2000
www.epa.gov
NATIONAL ENVIRONMENTAL
LABORATORY ACCREDITATION
CONFERENCE
Constitution, Bylaws, and Standards
Approved June 2000
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The U.S. Environmental Protection Agency through its Office of Research
and Development partially funded and collaborated in the standards
described here, in cooperation with the states and other federal agencies.
They have been subjected to Agency review and approved for publication.
Mention of trade names or commercial products does not constitute an
endorsement or recommendation for use.
Portions of the NELAC standards are reprinted from ISO/IEC Guide
25:1990, ISO/IEC Guide 58:1993, and ISO/IEC Standard 17025:1999, with
permission of the American National Standards Institute.
ISO/IEC Guide 25:1990 has been superceded by ISO/IEC Standard 17025.
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v>EPA
NATIONAL ENVIRONMENTAL
LABORATORY ACCREDITATION
CONFERENCE
Constitution, Bylaws, and Standards
Approved June 2000
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ACKNOWLEDGMENTS
As Director of the Environmental Protection Agency's National Environmental
Laboratory Accreditation Program (NELAP), I offer my sincere appreciation to the many
individuals who worked on the 2000 revision of the NELAC standards. I would like to
give special recognition to the chairs who facilitated the seemingly endless committee
teleconferences during which all comments were considered and debated, as well as to
the chairs who were key in addressing the issues of implementing a new program,
disseminating information, tracking regulations, and facilitating the operation of the
NELAC process: Dr. Marcia Davies, Ms. Barbara Burmeister, Mr. William Ingersoll, Dr.
John Griggs, Mr. Joe Slayton, Mr. John Anderson, Mr. Dan Bivins, Dr. Charles Brokopp,
Ms. Carol Batterton, Mr. Matthew Caruso, Dr. Irene Ronning, Dr. Michael Miller, and Dr.
Kenneth Jackson. NELAP also thanks Past Chair Dr. James Pearson and his staff at
the Virginia Department of Consolidated Laboratory Services for hosting the 6th NELAC
Annual Meeting.
In addition, it is my pleasure to recognize the extensive efforts made in implementing
the NELAC standards by the NELAP Accrediting Authorities: the California
Environmental Laboratory Accreditation Program, the Florida Department of Health, the
Illinois Environmental Protection Agency, the Kansas Department of Health and
Environment, the Louisiana Department of Health and Hospitals, the New Hampshire
Environmental Laboratory Accreditation Program, the New Jersey Department of
Environmental Protection, the New York State Department of Health, the Oregon Health
Division, the Pennsylvania Bureau of Laboratories, and the Utah Department of Health.
We are all looking forward to the announcement of the NELAC accredited laboratories
scheduled for January 2001. We have reached this point only through the efforts of
everyone who has contributed to the overall process, whether by serving on a NELAC
committee or Board of Directors, providing comments to the standards, implementing
the standards, or seeking NELAC accreditation. I applaud each of you and ask you to
continue the hard work that has created a program of which we can all be proud.
Jeanne Hankins
NELAP Director
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CONSTITUTION
AND BYLAWS
June 2Q, 2000
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NELAC
Constitution and Bylaws
Revision 15
June 29, 2000
Page i of ii
TABLE OF CONTENTS
CONSTITUTION AND BYLAWS
CONSTITUTION 1
ARTICLE I - GENERAL 1
ARTICLE II - OBJECTIVES 1
A. Forum 1
B. Mechanism 1
C. Consensus 1
D. Uniformity 1
E. Cooperation 1
ARTICLE III - PARTICIPATION 1
ARTICLE IV - OFFICERS 2
SECTION 1 - EX OFFICIO OFFICERS 2
A. Director 2
B. Executive Secretary 2
SECTION 2 - ELECTIVE OFFICERS 2
A. Eligibility 2
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 4
A. Annual Meeting 4
B. Interim Meeting 4
C. Special Meetings 4
D. Rules of Order 4
ARTICLE VII - AMENDMENTS TO THE CONSTITUTION 5
ARTICLE VIII - BYLAWS 5
SECTION 1 - SUPPLEMENTATION OF CONSTITUTION 5
SECTION 2 - AMENDMENTS AND REPEALS OF THE BYLAWS 5
SECTION 3 - RENUMBERING 5
BYLAWS 7
ARTICLE I - APPLICATION FOR PARTICIPATION 7
SECTION 1 - FORM OF APPLICATION 7
ARTICLE II - PARTICIPANTS' RECORDS 7
SECTION 1 - TERM OF PARTICIPATION 7
SECTION 2 - EVIDENCE OF VOTING MEMBERSHIP 7
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ARTICLE III - USE OF THE INSIGNIA 7
ARTICLE IV - BOARD OF DIRECTORS 7
SECTION 1 - MEMBERSHIP 7
SECTION 2 - DUTIES 7
ARTICLE V - DUTIES OF THE OFFICERS 8
SECTION 1 - CHAIR 8
SECTION 2 - CHAIR-ELECT 8
SECTION 3 - PAST CHAIR 8
SECTION 4 - DIRECTOR 8
SECTION 5 - EXECUTIVE SECRETARY 9
SECTION 6 - PARLIAMENTARIAN 9
ARTICLE VI - COMMITTEES 9
SECTION 1 - GENERAL 9
SECTION 2 - ADMINISTRATIVE COMMITTEES 9
A. Terms 9
B. Duties 9
SECTION 3 - STANDING COMMITTEES 10
A. Terms 10
B. Duties 10
SECTION 4 - SPECIAL COMMITTEES, TASK FORCES AND STUDY GROUPS 11
SECTION 5 - SUBCOMMITTEES 11
ARTICLE VII - VOTING SYSTEM 11
SECTION 1 - HOUSE OF REPRESENTATIVES 11
A. Official Designation 11
B. Composition 11
C. Method of Designation 12
SECTION 2 - HOUSE OF DELEGATES 12
A. Designation 12
B. Requirements 12
SECTION 3 - VOTING RULES 12
A. Applicability 12
B. Quorum 12
C. Voting 13
D. Committee Report Voting 14
SECTION 4 - FLOOR AMENDMENTS 14
A. Procedure 14
B. Editorial Changes 14
SECTION 5 - SEATING 14
A. Arrangement 14
B. Supervision 14
SECTION 6 - PROCEDURES 14
SECTION 7 - CHANGES IN ORGANIZATION AND PROCEDURE 15
Figure 1. Seating Arrangement 16
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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 and other entities
directly involved in the environmental field measurement and sampling process.
ARTICLE II - OBJECTIVES
The objectives of the National Environmental Laboratory Accreditation Conference are:
A. Forum
To provide a national forum for the discussion of all questions related to standards for accreditation
of laboratories and other entities directly involved in the environmental field measurement and
sampling process.
B. Mechanism
To provide a mechanism to establish policy and coordinate activities within NELAC on matters of
national and international significance pertaining to standards for accreditation of environmental
laboratories and other entities directly involved in the environmental field measurement and
sampling process.
C. Consensus
To develop a consensus on uniform standards for laboratory accreditation and implementation of
those standards by the accrediting authorities.
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 other entities directly involved in the environmental field
measurement and sampling process.
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
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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 and state 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.
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.
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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 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 shall 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.
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ARTICLE V - APPOINTIVE OFFICIALS
SECTION 1 - OFFICIALS, SPECIFIC
A. Appointment
The NELAC Chair shall appoint the Parliamentarian and other officials as needed to conduct activities
not covered by elected officials.
B. Assumption of Office
All appointive officials shall take office immediately following appointment and shall serve through the
subsequent Annual Meeting of NELAC unless otherwise requested by the NELAC Chair, or specified
in the Constitution or Bylaws.
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 Cpmmittees 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.
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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 discussed at the general session of the Board of Directors at the Annual Meeting at which
said changes shall 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 shall 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 shall 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 and organizational 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.
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.
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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.
I. It annually reviews the work of committees and task forces to assure that the concerns of the
various constituencies are being addressed.
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 perform functions not covered by elected offices to serve during his or her term of
office.
SECTION 2 - CHAIR-ELECT
The Chair-Elect shall:
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 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 shall 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 department/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 Accrediting Authority Review Board. The Director
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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.
ARTICLE VI • COMMITTEES
SECTION 1 - GENERAL
Except as otherwise provided, each Administrative and Standing Committee shall 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 shall 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. Nominating Committee. The chair is the NELAC Past Chair. Four Voting Members and five
Contributors shall be appointed annually to serve one year.
2. Membership and Outreach Committee. The term of service shall be three years. Two Voting
Members and two Contributors shall be appointed in each of two years and one Voting Member
and one Contributor shall be appointed in the third year.
B. Duties
1. 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 in the report of the
Nominating Committee and be published in the Annual Meeting announcement.
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2. Membership and Outreach Committee. This committee:
a. initiates Voting Member invitations for membership in the House of Representatives, publicizes
NELAC to prospective participants, coordinates and resolves participants' concerns,
establishes credentialing criteria and resolves credentialing conflicts of Voting Members;
b. solicits and develops informational materials to promote understanding and appreciation of the
importance of the NELAC objectives; and,
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.
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 checklists 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.
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7. Regulatory Coordination Committee. This committee provides the Standing Committees with
current information on regulations and laws that impact laboratory testing and accreditation. The
Regulatory Coordination Committee is also responsible for the development of model State
legislation and regulations that reflect the findings and actions of NELAC.
8. Field Activities Committee. This committee develops and maintains uniform standards for field
measurement and sampling, and coordinates the development of these standards with other
standing committees.
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 shall be appointed for as long as deemed
appropriate. Upon completion of their assigned tasks, such bodies shall be dissolved by the Chair of
NELAC.
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.
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 applicable governmental
organization.
2 Each of the eight EPA Assistant/Associate Administrators (Office of Air and Radiation; Office of
Enforcement and Compliance Assurance; Office of Environmental Information; Off ice of Prevention,
Pesticides, and Toxic Substances; Office of Regional Operations; 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 shall 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.
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.
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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
shall 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.
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.
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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 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 shall control placement and movement of delegates. The Executive Secretary
shall 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
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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.
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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FRONT OF ROOM
BOARD OF
DIRECTORS
HOUSE OF
REPRESENTATIVES
State and Federal
Designated
Representatives
HOUSE OF
DELEGATES
State and Federal
Officials
CONTRIBUTORS
Non-Voting
Figure 1. Seating Arrangement
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PROGRAM POLICY
AND STRUCTURE
June 29, 2000
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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 1
1.1.4 General Application of NELAC Standards 2
1.1.5 Application of NELAC Standards to Small Laboratory Operations 2
1.2 OBJECTIVES 2
1.3 ELEMENTS 3
1.4 PURPOSE AND SCOPE OF NELAC 3
1.4.1 Purpose 3
1.4.2 Scope 3
1.4.2.1 Scope of NELAC 3
1.4.2.2 Applicable EPA Statutes 4
1.4.2.3 Exemptions 4
1.4.2.4 No Restriction on Legal Actions 4
1.5 ROLES AND RESPONSIBILITIES OF THE FEDERAL GOVERNMENT, THE STATES, AND
OTHER PARTIES 4
1.5.1 EPA 4
1.5.1.1 National Environmental Laboratory Accreditation Program 5
1.5.2 States and Federal Agencies as Accrediting Authorities 5
1.5.2.1 Federal Agencies 5
1.5.2.2 States 5
1.5.2.3 Accrediting Authorities 6
1.5.3 Reciprocity 7
1.5.4 Joint Federal and State Roles 7
1.5.5 Assessor Bodies 7
1.5.6 Other Parties 8
1.6 STRUCTURE OF NELAC 8
1.6.1 The Board of Directors 8
1.6.2 The Environmental Laboratory Advisory Board 8
1.6.3 The Accrediting Authority Review Board 9
1.6.4 The Participants in NELAC 10
1.6.4.1 Participation of the Voting Members and Contributors 10
1.6.5 The Committees 10
1.6.5.1 The Standing Committees 11
1.6.5.2 The Administrative Committees 12
1.7 CONDUCT OF CONFERENCE BUSINESS 13
1.7.1 The Generation of Standards 13
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1.7.2 Meetings 13
1.7.2.1 Annual Meeting 13
1.7.2.2 Interim Meeting 14
1.7.2.3 Special Meetings 14
1.7.2.4 Committee Meetings 15
1.8 ORGANIZATION OF THE ACCREDITATION REQUIREMENTS 15
1.8.1 Scope of Accreditation 15
1.8.2 Supplemental Accreditation Requirements 16
1.8.3 General Laboratory Requirements 16
1.8.4 General Field Sampling Requirements 16
1.8.5 Chemistry Requirements 16
1.8.6 Whole Effluent Toxicity Requirements 16
1.8.7 Microbiology Requirements 17
1.8.8 Radiochemistry Requirements 17
1.8.9 Microscopy Requirements 17
1.8.10 Field Activities Requirements 17
APPENDIX A - GLOSSARY A-1
LIST OF FIGURES
Figure 1-1. NELAC Structure 18
Figure 1-2. Flowchart for Standards Development and Implementation 19
Figure 1-3 NELAC Tiered Scope of Accreditation 20
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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 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 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 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 to support a National Environmental Laboratory
Accreditation Program (NELAP). The goal of NELAP is to foster cooperation among the current
accreditation activities of different States or other governmental agencies. NELAP seeks to unify the
existing State and federal agency standards, at minimum cost to the States, federal agencies and
accredited laboratories.
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
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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 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.
The Glossary, which is contained as Appendix A to Chapter 1, contains the definition of terms which
are used throughout the standards to assure the consistency of their use and interpretation.
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 and other organizations directly involved and interested in the
standardization of environmental measurements. Note that any reference to NELAP approval or
NELAC accreditation means that the accrediting authority or laboratory meets the requirements in the
NELAC standards, and is not an endorsement by EPA.
As described in more detail in Chapter 4, an accredited organization may use the NELAC logo on
general literature. It is the ethical responsibility of an accredited organization to describe its accredited
status in a manner that does not imply accreditation in areas that are outside its actual Scope of
Accreditation. When soliciting business or reporting test results, an accredited organization must
distinguish between those tests that fall within its scope of accreditation and those that do not.
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 and
documented 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
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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.
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.
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
1.4.2.1 Scope of NELAC
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
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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.
1.4.2.2 Applicable EPA Statutes
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.
1.4.2.3 Exemptions
The NELAC standards apply to all EPA-mandated testing, except as provided below:
a) laboratory analyses associated with FIFRA (40 CFR Part 160) good laboratory practices (GLP),
for testing performed for studies that support applications for research or marketing permits for
pesticide products regulated by EPA under FIFRA.
b) laboratory analyses associated with TSCA (40 CFR Part 792) good laboratory practices (GLP),
for studies relating to health effects, environmental effects and chemical fate testing as directed
under Section 4 and Section 5 of TSCA.
c) State governmental laboratories when conducting analyses such as pesticide formulation, efficacy
and residue testing to support FIFRA compliance and enforcement activities under pesticide
cooperative agreement grants.
d) governmental laboratories engaged solely in the analysis of forensic evidence.
1.4.2.4 No Restriction on Legal Actions
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 the investigation, subject only to the bounds of sound
scientific practice.
1.5 ROLES AND RESPONSIBILITIES OF THE FEDERAL GOVERNMENT, THE STATES, AND
OTHER PARTIES
1.5.1 EPA
EPA shall provide staff support to NELAC as provided for in the Bylaws and agreed to by EPA. EPA
shall assist NELAC by publishing all proposed and final standards .
EPA also participates in joint activities with other federal and State agencies, as described below.
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1.5.1.1 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;
c) where conflict of interest may occur in an accrediting authority, accrediting that authority's
principal laboratory if requested. See Chapter 6, section 6.2.2 d) and e);
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 1.8.2).
1.5.2 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.
1.5.2.1 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.
1.5.2.2 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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1.5.2.3 Accrediting Authorities
An accrediting authority can be either a) any federal department/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 adopt the NELAC standards,
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.
1.5.2.3.1 Responsibilities of Primary Accrediting Authorities
Once a State or federal department/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) granting interim and/or full accreditation to 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 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
1.8), 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
(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.
1.5.2.3.2 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.
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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.
1.5.2.3.3 Accreditation Fees
Accrediting authorities may adopt and impose laboratory accreditation fees.
1.5.3 Reciprocity
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 1.5.2.3.2. A State, in the role
of a secondary accrediting authority, which has a law or decision resulting from a legal action, the legal
effect of which precludes that State from granting any accreditation to a particular laboratory, is not
required to accept the accreditation of this laboratory.
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.
Federal accrediting authorities shall serve as the accrediting authority only for governmental
laboratories. Non-governmental laboratories shall not claim either primary or secondary accreditation
by a federal agency, even if the laboratory is performing analyses under contract to that agency.
1.5.4 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.
1.5.5 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 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.
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1.5.6 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 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.
1.6 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).
1.6.1 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. Such
policies shall have effective and expiration dates and/or shall be referred to the appropriate committee
for potential incorporation into the standards by a NELAC vote. 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 issues they must address or take
under consideration. Comments on the standards should be directed to the committees through their
respective chairs.
1.6.2 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 chaired by an ELAB member. The
ELAB advises EPA and NELAC on matters affecting the interests of the regulated laboratories and
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other interested parties. The recommendations of the ELAB shall be presented to the Chairs of the
standing committees, the Board of Directors and to the EPA.
1.6.3 The Accrediting Authority Review Board
The Accrediting Authority Review Board (AARB) shall be an independent body composed of five voting
members and one non-voting member. Each member shall be appointed for a five-year term.
a) The non-voting member shall be a representative of the USEPA and appointed by the NELAP
Director. The appointment should be rotated among the EPA Regions and EPA Headquarters.
b) The five voting members shall consist of one federal accrediting authority official and four state
accrediting authority officials, of which at least three must be from NELAP-recognized state
accrediting authorities.
1) The state accrediting authority officials should be from different EPA Regions.
2) The appointments must be made in such a manner that the correct mix of membership is
maintained at all times. Any AARB member appointed prior to July 1, 1999 will remain an
AARB member even though the correct mix of membership may not be attained until July 1,
2004.
c) Appointments to the AARB are made by the NELAP Director after consultation with the NELAC
Board of Directors. The Director will solicit nominees from the NELAC stakeholders and present
them to Board of Directors. Nominations are to be submitted to the NELAP Director at least three
months prior to the NELAC annual meeting.
d) Voting members of the AARB shall not be NELAP staff, on the NELAC Board of Directors or a
member of a NELAC standing committee. The AARB annually selects one of its members to
serve as its chair.
e) The AARB has responsibilities to:
1) monitor NELAP to assure that EPA is following the NELAC standards for recognizing
accrediting authorities;
2) serve as a review board for accrediting authorities that have been denied NELAP recognition
or have had such recognition revoked (see Chapter 6, section 10), and providing advice to the
NELAP Director, who will make the final decision;
3) report on its activities to the NELAC Board of Directors at each annual meeting;
4) conduct an annual assessment of the NELAP process for recognizing accrediting authorities
in accordance with the NELAC standards.
1. The AARB shall report its findings at the general opening session of each NELAC annual
meeting; and
2. The report of the annual assessment shall be provided for posting on the NELAC web site;
and
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5) provide advice on issues referred by the NELAP Director, which may include matters raised
by entities other than the accrediting authorities.
1.6.4 The Participants in NELAC
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 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.
1.6.4.1 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.
1.6.5 The Committees
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.
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New Standing Committees:
The Board of Directors shall establish a new standing committee if the following conditions exist: an
ad hoc group appointed by a NELAC Chair has been studying an issue which is likely to require
continuing attention by NELAC; the ad hoc group has reached a consensus and is ready to develop
standards; once the standards are implemented, they are likely to need evaluation and revision in the
future; no NELAC committee exists to deal with the issue; the topic is of broad scope and has impact
on a significant portion of the laboratory community; the Program Policy and Structure Committee has
reviewed the proposal and has recommended that the new standing committee be created; and the
NELAC Voting Members have approved the creation of the committee.
1.6.5.1 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 eight Standing Committees:
• Program Policy and Structure Committee
• Accrediting Authority Committee
• Quality Systems Committee
• Proficiency Testing Committee
• On-site Assessment Committee
• Accreditation Process Committee
* Regulatory Coordination Committee
• Field Activities 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 45 calendar 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 calendar 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 calendar days
prior to the meeting.
1.6.5.1.1 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 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.
1.6.5.1.2 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.
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1.6.5.1.3 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.
1.6.5.1.4 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.
1.6.5.1.5 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.
1.6.5.1.6 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.
1.6.5.1.7 Regulatory Coordination Committee
This committee provides the Standing Committees with current information on regulations and laws that
impact laboratory testing and accreditation. The Regulatory Coordination Committee is also
responsible for the development of model language for state legislation and regulations that reflect the
findings and actions of NELAC.
1.6.5.1.8 Field Activities Committee
This committee develops and maintains uniform standards for field measurement and sampling, and
coordinates the development of these standards with other standing committees.
1.6.5.2 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).
1.6.5.2.1 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
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meeting. The names of these nominees shall appear in the report of the Nominating Committee and
be published in the meeting announcement.
1.6.5.2.2 Membership and Outreach Committee
This committee initiates membership invitations, publicizes NELAC to prospective participants,
coordinates and resolves participants' concerns, establishes credentialing criteria and resolves
credentialing conflicts of Voting Members.
This committee solicits and develops informational materials to promote understanding and
appreciation of the importance of the NELAC objectives.
This committee promotes a spirit of cooperation and timely dialogue between NELAC and other
organizations and federal agencies.
1.7 CONDUCT OF CONFERENCE BUSINESS
1.7.1 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 45 calendar 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 chair of the subject committee and the concurrence of the Chair of NELAC.
1.7.2 Meetings
1.7.2.1 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, and shall publish
this information on the NELAC electronic bulletin board at least 90 calendar days prior to the annual
meeting.
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
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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 calendar 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 45 calendar 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 45 calendar days prior to the annual meeting.
As soon as possible, but no later than 90 calendar days after 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 revised standards as soon as possible, but no later than 90 calendar days after 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.
1.7.2.2 Interim Meeting
The interim meeting, at which time committees meet to receive, consider and debate issues, and
propose and draft standards or policies for the annual meeting, shall be scheduled at least six months
prior to the annual meeting.
The Board of Directors shall determine the place and dates for the interim meeting, and shall publish
this information on the NELAC electronic bulletin board at least 90 calendar 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 calendar 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
calendar days following the interim meeting.
1.7.2.3 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.
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1.7.2.4 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.
1.8 ORGANIZATION OF THE ACCREDITATION REQUIREMENTS
1.8.1 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 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 then will 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.1), 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 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.
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The procedure and conditions for interim accreditation are described in Chapter 4.
1.8.2 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.
1.8.3 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.
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).
1.8.4 General Field Sampling Requirements
(To be developed)
1.8.5 Chemistry Requirements
The following applicable requirements are presented in Section D.1 of Appendix D of Chapter 5 (Quality
Systems): Positive and Negative Controls (D. 1.1); Analytical Variability/Reproducibility (D.1.2); Method
Evaluation (D.1.3); Sensitivity (D.1.4); Data Reduction (D.1.5); Quality of Standards and Reagents
(D.1.6); Selectivity (D.1.7); and Constant and Consistent Test Conditions (D.1.8).
1.8.6 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).
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1.8.7 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); Selectivity (D.3.7); and Constant and Consistent Test Conditions (D.3.8).
1.8.8 Radiochemistry Requirements
The following applicable requirements are presented in Section D.4 of Appendix D of Chapter 5 (Quality
Systems); Negative Controls (D.4.1); Positive Controls (D.4.2); Test Variability/Reproducibility (0.4.3);
Other Quality Control Measures (D.4.4); Method Evaluation (0.4.5); Radiation Measurement System
Calibration (0.4.6); Method Detection Limits (0.4.7); Data Reduction (0.4.8); Quality of Standards and
Reagents (D.4.9); and Constant and Consistent Test Conditions (0.4.10).
1.8.9 Microscopy Requirements
(To be developed)
1.8.10 Field Activities Requirements
(To be developed)
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-0 ^- 71 TJ Z
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Figure 1-1. NELAC Structure
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Committee proposes Standards or
changes to Standards
Proposed Standards published by EPA
1
Interim Meeting for
input and preparation of draft Standards
Annual Meeting
Committees present Draft Standards as
Resolutions
Laboratories in State seek
accreditation from
the primary accrediting authority In
that State
Laboratories in State seek
accreditation from
any primary accrediting authority
Figure 1-2. Flowchart for Standards Development and Implementation
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General Requirements
Laboratory
I
Field Sampling
(to be
developed)
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PROGRAM POLICY AND STRUCTURE
APPENDIX A
GLOSSARY
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APPENDIX A - GLOSSARY
Acceptance 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
laboratory 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 Territorial, State, or federal agency having responsibility and
accountability for environmental laboratory accreditation and which grants accreditation
(NELAC)[1.5.2.3]
Accrediting Authority Review Board (AARB): five voting members from Federal and State
Accrediting Authorities and one non-voting member from USEPA, appointed by the NELAP
Director, in consultation with the NELAC Board of Directors, for the purposes stated in 1.6.3.e.
(NELAC) [1.6.3]
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. (QAMS)
Assessor Body: the organization that actually executes the accreditation process, i.e., receives
and reviews accreditation applications, reviews QA documents, reviews proficiency testing results,
performs on-site assessments, etc., whether EPA, the State, or contracted private party. (NELAC)
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. (NELAC)
Applicant Laboratory or Applicant: the laboratory or organization applying for NELAP
accreditation. (NELAC)
Assessment: the evaluation process used to measure or establish the performance, effectiveness,
and conformance of an organization and/or its systems to defined criteria (to the standards and
requirements of NELAC). (NELAC)
Assessment Criteria: the measures established by NELAC and applied in establishing the extent
to which an applicant is in conformance with NELAC requirements. (NELAC)
Assessment Team: the group of people authorized to perform the on-site inspection and
proficiency testing data evaluation required to establish whether an applicant meets the criteria for
NELAP accreditation. (NELAC)
Assessor: one who performs on-site assessments of accrediting authorities and laboratories'
capability and capacity for meeting NELAC requirements by examining the records and other
physical evidence for each one of the tests for which accreditation has been requested. (NELAC)
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Audit: a systematic evaluation to determine the conformance to quantitative and qualitative
specifications of some operational function or activity. (EPA-QAD)
Batch: environmental samples that 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. (NELAC Quality Systems Committee)
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. Blanks include:
Equipment Blank: a sample of analyte-free media which has been used to rinse common
sampling equipment to check effectiveness of decontamination procedures. (NELAC)
Field Blank: blank prepared in the field by filling a clean container with pure de-ionized water
and appropriate preservative, if any, for the specific sampling activity being undertaken. (EPA
OSWER)
Instrument Blank: a clean sample (e.g., distilled water) processed through the instrumental
steps of the measurement process; used to determine instrument contamination. (EPA-QAD)
Method Blank: a sample of a matrix similar to the batch of associated samples (when
available) that is free from the analytes of interest and is processed simultaneously with and
under the same conditions as samples through all steps of the analytical procedures, and in
which no target analytes or interferences are present at concentrations that impact the
analytical results for sample analyses. (NELAC)
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. (QAMS)
Blind Sample: a sub-sample 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. (NELAC)
Calibration: to determine, by measurement or comparison with a standard, the correct value of
each scale reading on a meter, instrument, or other device. The levels of the applied calibration
standard should bracket the range of planned or expected sample measurements. (NELAC)
Calibration Curve: the graphical relationship between the known values, such as concentrations,
of a series of calibration standards and their instrument response. (NELAC)
Calibration Method: a defined technical procedure for performing a calibration. (NELAC)
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Calibration Standard: a substance or reference material used to calibrate an instrument.
(QAMS)
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 Form: record that documents the possession of the samples from the time of
collection to receipt in the laboratory. This record generally includes: the number and types of
containers; the mode of collection; collector; time of collection; preservation; and requested
analyses. (NELAC)
Clean Air Act: the enabling legislation in 42 U.S.C. 7401 etseq., Public Law 91-604, 84 Stat.
1676 Pub. L. 95-95, 91 Stat., 685 and Pub. L. 95-190, 91 Stat, 1399, as amended, empowering
EPA to promulgate air quality standards, monitor and to enforce them. (NELAC)
Comprehensive Environmental Response, Compensation and Liability Act
(CERCLA/Superfund): the enabling legislation in 42 U.S.C. 9601-9675 ef seq., as amended by
the Superfund Amendments and Reauthorization Act of 1986 (SARA), 42 U.S.C. 9601 ef seq., to
eliminate the health and environmental threats posed by hazardous waste sites. (NELAC)
Confidential Business Information (CBI): information that an organization designates as having
the potential of providing a competitor with inappropriate insight into its management, operation or
products. NELAC and its representatives agree to safeguarding identified CBI and to maintain all
information identified as such in full confidentiality.
Confirmation: verification of the identity of a component through the use of an approach with a
different scientific principle from the original method. These may include, but are not limited to:
Second column confirmation
Alternate wavelength
Derivatization
Mass spectral interpretation
Alternative detectors or
Additional cleanup procedures.
(NELAC)
Conformance: an affirmative indication or judgement that a product or service has met the
requirements of the relevant specifications, contract, or regulation; also the state of meeting the
requirements. (ANSI/ASQC E4-1994)
Contributor: a participant in NELAC who is not a Voting Member. Contributors include
representatives of laboratories, manufacturers, industry, business, consumers, academia,
laboratory associations, laboratory accreditation associations, counties, municipalities, and other
political subdivisions, other federal and state officials not engaged in environmental activities, and
other persons who are interested in the objectives and activities of NELAC. (NELAC)[Art III, Const]
Corrective Action: the action taken to eliminate the causes of an existing nonconformity, defect
or other undesirable situation in order to prevent recurrence. (ISO 8402)
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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). (NELAC)
Data Reduction: the process of transforming raw data by arithmetic or statistical calculations,
standard curves, concentration factors, etc., and collation into a more useable form. (EPA-QAD)
Deficiency: an unauthorized deviation from acceptable procedures or practices, or a defect in an
item. (ASQC)
Delegate: any environmental official of the States or the Federal government not sitting in the
House of Representatives, who is eligible to vote in the House of Delegates. (NELAC)
Demonstration of Capability: a procedure to establish the ability of the analyst to generate
acceptable accuracy. (NELAC)
Denial: to refuse to accredit in total or in part a laboratory applying for initial accreditation or
resubmission of initial application. (NELAC)[4.4.1]
Detection Limit: the lowest concentration or amount of the target analyte that can be identified,
measured, and reported with confidence that the analyte concentration is not a false positive value.
See Method Detection Limit. (NELAC)
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)
Environmental Laboratory Advisory Board (ELAB): a Federal Advisory Committee, with
members appointed by EPA and composed of a balance of non-state, non-federal representatives,
from the environmental laboratory community, and chaired by an ELAB member. (NELAC)[1.6.2]
Environmental Monitoring Management Council (EMMC): an EPA Committee consisting of
EPA managers and scientists, organized into a Policy Council, a Steering Group, ad hoc Panels,
and work groups addressing specific objectives, established to address EPA-wide monitoring
issues. (NELAC)
Federal Insecticide, Fungicide and Rodenticide Act (FIFRA): the enabling legislation under
7 U.S.C. 135 et seq., as amended, that empowers the EPA to register insecticides, fungicides,
and rodenticides. (NELAC)
Federal Water Pollution Control Act (Clean Water Act, CWA): the enabling legislation under
33 U.S.C. 1251 ef seq., Public Law 92-50086 Stat. 816, that empowers EPA to set discharge
limitations, write discharge permits, monitor, and bring enforcement action for non-compliance.
(NELAC)
Field of Testing: NELAC's approach to accrediting laboratories by program, method and analyte.
Laboratories requesting accreditation for a program-method-analyte combination or for an
up-dated/improved method are required to submit only that portion of the accreditation process not
previously addressed (see NELAC, section 1.8 ff). (NELAC)
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Finding: an assessment conclusion that identifies a condition having a significant effect on an
item or activity. An assessment finding is normally a deficiency and is normally accompanied by
specific examples of the observed condition. (NELAC)
Governmental Laboratory: as used in these standards, a laboratory owned by a Federal, state,
or tribal government; includes government-owned contractor-operated laboratories. (NELAC).
Holding Times (Maximum Allowable Holding Times): the maximum times that samples may
be held prior to analysis and still be considered valid or not compromised. (40 CFR Part 136)
Inspection: an activity such as measuring, examining, testing, or gauging one or more
characteristics of an entity and comparing the results with specified requirements in order to
establish whether conformance is achieved for each characteristic. (ANSI/ASQC E4-1994)
Interim Accreditation: temporary accreditation status for a laboratory that has met all
accreditation criteria except for a pending on-site assessment which has been delayed for reasons
beyond the control of the laboratory. (NELAC)
Internal Standard: a known amount of standard added to a test portion of a sample as a
reference for evaluating and controlling the precision and bias of the applied analytical method.
(NELAC)
Laboratory: a body that calibrates and/or tests. (ISO 25)
Laboratory Control Sample (however named, such as laboratory fortified blank, spiked
blank, or QC check sample): a sample matrix, free from the analytes of interest, spiked with
verified known amounts of analytes or a material containing known and verified amounts of
analytes. 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. (NELAC)
Laboratory Duplicate: aliquots of a sample taken from the same container under laboratory
conditions and processed and analyzed independently. (NELAC)
Legal Chain of Custody Protocols: procedures employed to record the possession of samples
from the time of sampling until analysis and are performed at the special request of the client.
These protocols include the use of a Chain of Custody Form that documents the collection,
transport, and receipt of compliance samples by the laboratory. In addition, these protocols
document all handling of the samples within the laboratory. (NELAC)
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. (NELAC)
Matrix: the component or substrate that contains the analyte of interest. For purposes of batch
and QC requirement determinations, the following matrix distinctions shall be used:
Aqueous: any aqueous sample excluded from the definition of Drinking Water matrix or
Saline/Estuarine source. Includes surface water, groundwater, effluents, and TCLP or other
extracts.
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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 an industrial process that results in a matrix not
previously defined.
Air: whole gas or vapor samples including those contained in flexible or rigid wall containers
and the extracted concentrated analytes of interest from a gas or vapor that are collected with
a sorbent tube, impinger solution, filter, or other device. (NELAC)
Matrix Spike (spiked sample or fortified sample): a 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. (QAMS)
Matrix Spike Duplicate (spiked sample or fortified sample duplicate): a second replicate
matrix spike prepared in the laboratory and analyzed to obtain a measure of the precision of the
recovery for each analyte. (QAMS)
May: denotes permitted action, but not required action. (NELAC)
Method 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)
National Accreditation Database: the publicly accessible database listing the accreditation
status of all laboratories participating in NELAP. (NELAC)
National Institute of Standards and Technology (NIST): an agency of the US Department of
Commerce's Technology Administration that is working with EPA, States, NELAC, and other public
and commercial entities to establish a system under which private sector companies and
interested States can be accredited by NIST to provide NIST-traceable proficiency testing (PT) to
those laboratories testing drinking water and wastewater. (NIST)
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National Environmental Laboratory Accreditation Conference (NELAC): 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)
National Environmental Laboratory Accreditation Program (NELAP): the overall National
Environmental Laboratory Accreditation Program of which NELAC is a part. (NELAC)
National Voluntary Laboratory Accreditation Program (NVLAP): a program administered by
NIST that is used by providers of proficiency testing to gain accreditation for all
compounds/matrices for which NVLAP accreditation is available, and for which the provider intends
to provide NELAP PT samples. (NELAC)
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)
NELAC Standards: the plan of procedures for consistently evaluating and documenting the ability
of laboratories performing environmental measurements to meet nationally defined standards
established by the National Environmental Laboratory Accreditation Conference. (NELAC)
NELAP Recognition: the determination by the NELAP Director that an accrediting authority
meets the requirements of the NELAP and is authorized to grant NELAP accreditation to
laboratories. (NELAC)
Non-governmental Laboratory: any laboratory not meeting the definition of the governmental
laboratory. (NELAC)
Performance Audit: the routine comparison of independently obtained qualitative and quantitative
measurement system data with routinely obtained data in order to evaluate the proficiency of an
analyst or laboratory. (NELAC)
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 test methods to meet those needs in a cost-effective manner. (NELAC)
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. (NELAC)
Precision: the degree to which a set of observations or measurements of the same property,
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.
(NELAC)
Preservation: refrigeration and/or reagents added at the time of sample collection (or later) to
maintain the chemical and/or biological integrity of the sample. (NELAC)
Primary Accrediting Authority: the agency or department designated at the Territory, State or
Federal level as the recognized authority with responsibility and accountability for granting NELAC
accreditation for a specified field of testing. (NELAC)[1.5.2.3]
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PT Fields of Testing: NELAC's approach to offering proficiency testing by regulatory or
environmental program, matrix type, and analyte. (NELAC)
Proficiency Testing: 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. (NELAC)[2.1]
Proficiency Testing Oversight Body/Proficiency Testing Provider Accreditor (PTOB/PTPA):
an organization with technical expertise, administrative capacity and financial resources sufficient
to implement and operate a national program of PT provider evaluation and oversight that meets the
responsibilities and requirements established by NELAC standards. (NELAC)
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 and the collective demographics and results summary of all participating laboratories.
(NELAC)
Proficiency Testing Study Provider: any person, private party, or government entity that meets
stringent criteria to produce and distribute NELAC PT samples, evaluate study results against
published performance criteria and report the results to the laboratories, primary accrediting
authorities, PTOB/PTPA, and NELAP. (NELAC)
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 acceptance criteria. (QAMS)
Protocol: a detailed written procedure for field and/or laboratory operation (e.g., sampling,
analysis) which must be strictly followed. (EPA-QAD)
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. (QAMS)
Quality Assurance [Project] Plan (QAPP): a formal document describing the detailed quality
control procedures by which the quality requirements defined for the data and decisions pertaining
to a specific project are to be achieved. (EPA-QAD)
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. (QAMS)
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. (EPA-QAD)
Quality Manual: a document stating the management policies, objectives, principles,
organizational structure and authority, responsibilities, accountability, and implementation of an
agency, organization, or laboratory, to ensure the quality of its product and the utility of its product
to its users. (NELAC)
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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)
Quantitation Limits: levels, concentrations, or quantities of a target variable (e.g., target analyte)
that can be reported at a specified degree of confidence . (NELAC)
Range: the difference between the minimum and the maximum of a set of values. (EPA-QAD)
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. (EPA-QAD)
Reciprocity: the mutual agreement of two or more parties (i.e., States) to accept each other's
findings regarding the ability of environmental testing laboratories in meeting NELAC standards.
(NELAC)[1.5.3]
Recognition: the determination that an accrediting authority meets the requirements of the
NELAP and is authorized to grant NELAP accreditation to laboratories. (NELAC)
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 Method: a method of known and documented accuracy and precision issued by an
organization recognized as competent to do so. (NELAQ
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)
Reference Toxicant: the toxicant used in performing toxicity tests to indicate the sensitivity of a
test organism and to demonstrate the laboratory's ability to perform the test correctly and obtain
consistent results (see Chapter 5, Appendix D, section 2.1f). (NELAC)
Replicate Analyses: the measurements of the variable of interest performed identically on two or
more sub-samples of the same sample within a short time interval. (NELAC)
Requirement: denotes a mandatory specification; often designated by the term "shall". (NELAC)
Resource Conservation and Recovery Act (RCRA): the enabling legislation under 42 USC 321
et seq. (1976), that gives EPA the authority to control hazardous waste from the "cradle-to-grave",
including its generation, transportation, treatment, storage, and disposal. (NELAC)
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Revocation: the total or partial withdrawal of a laboratory's accreditation by the accrediting
authority. (NELAC)[4.4.3]
Safe Drinking Water Act (SDWA): the enabling legislation, 42 USC 300f ef seq. (1974), (Public
Law 93-523), that requires the EPA to protect the quality of drinking water in the U.S. by setting
maximum allowable contaminant levels, monitoring, and enforcing violations. (NELAC)
Sample Tracking: procedures employed to record the possession of the samples from the time
of sampling until analysis, reporting, and archiving. These procedures include the use of a Chain of
Custody Form that documents the collection, transport, and receipt of compliance samples to the
laboratory. In addition, access to the laboratory is limited and controlled to protect the integrity of
the samples. (NELAC)
Secondary Accrediting Authority: the Territorial, State or federal agency that grants NELAC
accreditation to laboratories, based upon their accreditation by a NELAP-recognized Primary
Accrediting Authority. See also Reciprocity and Primary Accrediting Authority.
(NELAC)[1.5.2.3]
Selectivity: (Analytical chemistry) the capability of a test method or instrument to respond to a
target substance or constituent in the presence of non-target substances. (EPA-QAD)
Sensitivity: the capability of a method or instrument to discriminate between measurement
responses representing different levels (e.g., concentrations) of a variable of interest. (NELAC)
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.
(ANSI)
Should: denotes a guideline or recommendation whenever noncompliance with the specification is
permissible. (ANSI)
Spike: a known mass of target analyte added to a blank sample or sub-sample; used to determine
recovery efficiency or for other quality control purposes. (NELAC)
Standard: the document describing the elements of laboratory accreditation that has been
developed and established within the consensus principles of NELAC and meets the approval
requirements of NELAC procedures and policies. (ASQC)
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. (QAMS)
Standardized Reference Material (SRM): a certified reference material produced by the U.S.
National Institute of Standards and Technology or other equivalent organization and characterized
for absolute content, independent of analytical method. (EPA-QAD)
Statistical Minimum Significant Difference (SMSD): the minimum difference between the
control and a test concentration that is statistically significant; a measure of test sensitivity or
power. The power of a test depends in part on the number of replicates per concentration, the
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significance level selected, e.g., 0.05, and the type of statistical analysis. If the variability remains
constant, the sensitivity of the test increases as the number of replicates is increased. (NELAC)
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. (NELAC)
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. (QAMS)
Suspension: temporary removal of a laboratory's accreditation for a defined period of time, which
shall not exceed six months, to allow the laboratory time to correct deficiencies or area of non-
compliance with the NELAC standards. (NELAC)[4.4.2]
Technical Director: individual(s) who has overall responsibility for the technical operation of the
environmental testing laboratory. (NELAC)
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. 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: an adoption of a scientific technique for a specific measurement problem, as
documented in a laboratory SOP. (NELAC)
Testing Laboratory: a laboratory that performs tests. (ISO/IEC Guide 2-12.4)
Test Sensitivity/Power: the minimum significant difference (MSD) between the control and test
concentration that is statistically significant. It is dependent on the number of replicates per
concentration, the selected significance level, and the type of statistical analysis (see Chapter 5,
Appendix D, section 2.4.a). (NELAC)
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) (applies
to radiobioassay laboratories). (ANSI)
Toxic Substances Control Act (TSCA): the enabling legislation in 15 USC 2601 et seq., (1976),
that provides for testing, regulating, and screening all chemicals produced or imported into the
United States for possible toxic effects prior to commercial manufacture. (NELAC)
Traceability: the properly 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)
United States Environmental Protection Agency (EPA): the federal governmental agency with
responsibility for protecting public health and safeguarding and improving the natural environment
(i.e., the air, water, and land) upon which human life depends. (US-EPA)
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Validation: the process of substantiating specified performance criteria. (EPA-QAD)
Verification: confirmation by examination and provision of evidence that specified requirements
have been met. (NELAC)
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 adjustment,
to repair, 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.
Voting Member: officials 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. (NELAC)
Work Cell: a well-defined group of analysts that together perform the method analysis. The
members of the group and their specific functions within the work cell must be fully documented.
(NELAC)
Sources:
40CFR Part 136
American Society for Quality Control (ASQC), Definitions of Environmental Quality Assurance
Terms, 1996
American National Standards Institute (ANSI), Style Manual for Preparation of Proposed American
National Standards, Eighth Edition, March 1991
ANSI/ASQC E4, 1994
ANSI N42.23-1995, Measurement and Associated Instrument Quality Assurance for Radiobioassay
Laboratories
International Standards Organization (ISO) Guides 2, 30, 8402
International Vocabulary of Basic and General Terms in Metrology (VIM): 1984 Issued by BIPM
IEC, ISO and OIML
National Institute of Standards and Technology (NIST)
National Environmental Laboratory Accreditation Conference (NELAC), July 1998 Standards
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Random House College Dictionary
US EPA Quality Assurance Management Section (QAMS), Glossary of Terms of Quality
Assurance Terms, 8/31/92 and 12/6/95
US EPA Quality Assurance Division (QAD)
Webster's New World Dictionary of the American Language
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TABLE OF CONTENTS
PROFICIENCY TESTING
2.0 PROFICIENCY TESTING PROGRAM: INTERIM STANDARDS 1
2.1 INTRODUCTION, SCOPE, AND APPLICABILITY 1
2.1.1 Purpose 2
2.1.2 Goals 2
2.1.3 PT Fields of Testing 2
2.2 MAJOR PT GROUPS AND THEIR RESPONSIBILITIES 3
2.2.1 Proficiency Testing Study Providers . . . 4
2.2.2 Proficiency Testing Oversight Body (PTOB)/Proficiency Test Provider Accreditor
(PTPA) 4
2.2.3 Laboratories 4
2.2.4 Accrediting Authorities (AA) 4
2.3 REQUIREMENTS FOR PT PROVIDERS 4
2.3.1 PT Provider Accreditation 4
2.3.2 On-site Inspection of PT Providers 5
2.3.3 Sample Requirements and Design 5
2.3.3.1 Sample Analytes 5
2.3.3.2 PT Provider Sample Testing 5
2.3.4 PT Study Data Analysis 5
2.3.4.1 Data Acceptance Criteria 5
2.3.5 Generation of Study Reports 5
2.3.6 Provider Conflict of Interest 6
2.3.7 Disapproval of PT Providers 6
2.3.8 PTOB/PTPA Listing of PT Providers 6
2.4 LABORATORY ENROLLMENT IN PROFICIENCY TESTING PROGRAM(S) 6
2.4.1 Required Level of Participation 6
2.4.2 Requesting Accreditation 6
2.4.3 Reporting Results 6
2.5 REQUIREMENTS FOR LABORATORY TESTING OF PT STUDY SAMPLES 6
2.5.1 Restrictions on Exchanging Information 7
2.5.2 Maintenance of Records 7
2.6 EVALUATION OF PROFICIENCY TESTING RESULTS 7
2.7 PT CRITERIA FOR LABORATORY ACCREDITATION 7
2.7.1 Result Categories 7
2.7.2 Initial and Continuing Accreditation 8
2.7.3 Supplemental Studies 8
2.7.4 Failed Studies and Corrective Action 8
2.7.5 Second Failed Study 8
2.7.6 Scheduling of PT Studies 8
2.7.7 Withdrawal from PT Studies 9
2.7.8 Process for Handling Questionable PT Samples 9
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Appendix A - PT PROVIDER APPROVAL CRITERIA A-1
A.O SCOPE A'1
A.1 APPROVAL PROCESS A'1
A.2 QUALITY SYSTEM REQUIREMENTS A-1
A.3 PROVIDER FACILITIES AND PERSONNEL A-1
A.4 SAMPLE FORMULATION REVIEW A-2
A.4.1 Release of Information A-2
A.5 PROVIDER CONFLICT-OF-INTEREST REQUIREMENTS A-2
A.5.1 Ban on Distribution of Samples A-2
A.6 CONFIDENTIALITY OF PT STUDY DATA A-3
A.7 DATA REVIEW AND EVALUATION A-3
A.8 COMPLAINTS & CORRECTIVE ACTION A-3
A.9 LOSS OF PROVIDER APPROVAL A-3
A.9.1 Periodic Review of PT Providers A-3
A.9.2 Revocation of Approval A-3
A.10 NOTIFICATION OF SAMPLE INTEGRITY A-4
Appendix B - PT SAMPLE DESIGN & ACCEPTANCE GUIDELINES B-1
B.O INTRODUCTION B-1
B.1 SAMPLE FORMULATION APPROVAL B-1
B.1.1 Adequacy of the Sample Formulation B-1
B.1.2 PT Sample Composition B-1
B.1.3 PT Sample Matrix B-2
B.1.4 PT Sample Composition for Solid Matrices B-2
B.2 VERIFICATION OF ASSIGNED VALUE B-2
B.2.1 Relative Standard Deviation of Verification Analysis B-2
B.2.2 Quality Control Check of the Assigned Value B-2
B.3 HOMOGENEITY TESTING B-2
B.3.1 Homogeneity Testing Procedure B-3
B.3.2 Suitable Homogeneity Testing Procedures B-3
B.4 STABILITY TESTING B-3
B.5 DATA REPORTING BY PT PROVIDERS B-3
B.5.1 Verification and Homogeneity Reports B-3
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B.5.2 Laboratory Data and Stability Reports B-4
Appendix C - PT ACCEPTANCE CRITERIA AND PT PASS/FAIL CRITERIA C-1
C.O PURPOSE, SCOPE, AND APPLICABILITY C-1
C.1 ANALYTE ACCEPTANCE LIMITS C-1
C.1.1 Analyte Acceptance Limit Categories C-1
C. 1.1.1 Drinking Water, Waste Water, and Ambient Water Analytes with USEPA
Established Acceptance Limits C-1
C.1.1.2 Analytes with Acceptance Limits Established by the NELAC Standing Committee
on Proficiency Testing C-1
C.1.1.3 Experimental Data: Analytes without Promulgated Acceptance Limits or
Established Regression Equations C-1
C.2 ACCEPTABLE PT RESULTS FOR CHEMICAL ANALYTES IN POTABLE WATER AND NON-
POTABLE WATER PT SAMPLES C-2
C.3 NOT ACCEPTABLE PT RESULTS FOR POTABLE WATER AND NON-POTABLE WATER PT
SAMPLES C-2
C.4 ADDITIONAL REQUIREMENTS FOR PT PROVIDERS C-2
C.4.1 Additional Matrix/Analyte Groups C-2
Appendix D - PROFICIENCY TESTING OVERSIGHT BODY/
PROFICIENCY TEST PROVIDER ACCREDITOR D-1
D.O PURPOSE, SCOPE, AND APPLICABILITY D-1
D.1 TECHNICAL AND ADMINISTRATIVE QUALIFICATIONS D-1
D.2 PTOB/PTPA RESPONSIBILITIES REGARDING INITIAL ASSESSMENT OF PT PROVIDERS
D-1
D.2.1 Development of Standard Operating Procedures and Forms D-2
D.2.1.1 SOP(s) for the Assessment Process D-2
D.2.1.2 Initial Application D-2
D.2.1.3 SOP(s) for On-site Inspections and Checklist(s) D-2
D.2.2 Initial Application Review and On-site Inspections D-2
D.3 PTOB/PTPA RESPONSIBILITIES REGARDING APPROVAL OF PT PROVIDERS D-3
D.4 PTOB/PTPA RESPONSIBILITIES FOR ONGOING OVERSIGHT OF PT PROVIDERS D-3
D.5 DEVELOPMENT AND MAINTENANCE OF A COMPREHENSIVE PT DATABASE D-4
D.6 COMPLAINTS AND CORRECTIVE ACTION D-4
D.7 LIST OF APPROVED PT PROVIDERS D-4
D.8 SPONSORSHIP OF ANNUAL NELAC PROFICIENCY TESTING CAUCUS D-4
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D.9 PTOB/PTPA ETHICS D-4
D.10 CONFIDENTIALITY D-5
Appendix E - MICROBIOLOGY E-1
E.O PURPOSE E-1
E.1 SAMPLES E-1
E.1.1 SDWASamples E-1
E.1.2 CWA Samples E-1
E.2 SAMPLE PREPARATION AND QUALITY CONTROL E-2
E.3 SCORING E-2
E.3.1 Qualitative Analyses, SDWA Samples E-2
E.3.2 Quantitative Analyses E-2
E.3.2.1 Requirement for Quantitative Data Set Size E-2
Appendix F - ENVIRONMENTAL TOXICOLOGY F-1
F.O PURPOSE, SCOPE, AND APPLICABILITY F-1
F.1 RATIONALE F-1
F.2 LABORATORY ENROLLMENT IN PROFICIENCY TESTING PROGRAMS F-1
F.2.1 Required Level of Participation F-1
F.2.2 Requirements for Laboratory Testing of PT Study Samples F-1
F.3 PT CRITERIA FOR LABORATORY ACCREDITATION F-1
F.3.1 Initial and Continuing Accreditation F-1
F.4 FIELDS OF TESTING F-2
F.4.1 Whole Effluent Toxicity (WET) Method Codes F-2
F.4.2 Test Conditions for Sediment Tbxiclty (Solid Phase . F-2
F.4.2.1 Sediment Toxicity PT Samples F-2
F.4.3 Test Conditions for Soil Toxicity F-3
F.4.3.1 Soil Toxicity PT Samples F-3
Appendix G - RADIOCHEMISTRY G-1
G.OPURPOSE G-1
G.1 PROFICIENCY TESTING PROVIDER LICENSING G-1
G.2SDWA SAMPLE DESIGN G-1
G.2.1 ASSIGNED VALUES ' ' G-1
G.3 SCORING G-1
G.4 STUDY TIMETABLES G-2
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Appendix H - Performance Testing Requirements for Field Air Measurement H-1
H.O INTRODUCTION: PURPOSE, SCOPE, AND APPLICABILITY H-1
H.1 Proficiency Testing for Field Air Measurement H-1
H.2 ACCEPTANCE LIMITS H-2
H.2.1 Analyte Acceptance Limit Categories H-2
H.2.1.1 Analytes with USEPA Established Acceptance Limits (Prepared ± fixed
percentage or Mean ± 2 standard deviations) H-2
H.2.1.2 Analytes with acceptance limits derived from regression equations established by
the NELAC Standing Committee on Proficiency Testing H-2
H.2.1.3 Experimental Data: Analytes without promulgated acceptance limits or established
regression equations H-3
H.3 ACCEPTABLE PT RESULTS FOR CHEMICAL ANALYTES IN FIELD AIR PT
MEASUREMENTS H-3
H.4 NOT ACCEPTABLE PT RESULTS FOR SOURCE AND AMBIENT PT SAMPLES H-3
H.5 NELAC PT STUDY PASS/FAIL CRITERIA H-3
H.5.1 Interdependent Analyte PT Samples H-4
H.5.2 Non-interdependent Analyte PT Samples H-4
H.5.3 Promulgated USEPA Pass/fail Criteria H-4
H.5.4 Pass/fail Criteria For Interdependent Analyte PT Samples H-4
H.5.5 Pass/fail Criteria For Non-Interdependent Analyte PT Samples H-4
FIGURES
Figure 2-1. NELAP Proficiency Testing 3
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2.0 PROFICIENCY TESTING PROGRAM: INTERIM STANDARDS
For fields of testing for which proficiency testing (PT) samples are not available from a NELAP
Proficiency Testing Oversight Body (PTOB)/Proficiency Test Provider Accreditor (PTPA) (e.g., National
Institute of Standards and Technology (MIST)) accredited PT Provider, a Primary Accrediting Authority
may accept PT results from non-accredited PT Providers. In these cases, the Secondary Accrediting
Authority shall accept the decision of the Primary Accrediting Authority.
2.1 INTRODUCTION, SCOPE, AND APPLICABILITY
This chapter and the associated appendices define the major participating organizations and
components of the NELAC PT Program. In addition to complying with the requirements of this chapter,
any person, private party or government entity seeking to participate as a NELAP-designated
PTOB/PTPA-approved PT Provider 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), D (Proficiency Testing Oversight Body/Proficiency Test
Provider Accreditor), E (Microbiology), and F (Environmental Toxicology). The criteria set forth in these
standards shall be used by laboratories and PT Providers for the purposes of obtaining or maintaining
NELAP accreditation or NELAP approval.
In addition to complying with the requirements of this chapter and appendices, any entity seeking to
participate as a NELAP-designated PTOB/PTPA-approved PT Provider shall also comply with all
applicable requirements of "National Standards for Water Proficiency Testing Studies, Criteria
Document", U.S. Environmental Protection Agency or other NELAC documents that define analytes,
analyte numbers, concentrations, and acceptance criteria as required in Section C.1.1.2.
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 elements of the overall NELAP accreditation process,
including the on-site assessment, 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.
The major components of the NELAC PT program include:
a) multiple PT Providers who shall meet stringent criteria to become approved by a Proficiency
Testing Oversight Body (PTOB)/Proficiency Test Provider Accreditor (PTPA), 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 accreditation from a NELAP-
approved Accrediting Authority, as described in Section 2.3 and Appendix B;
c) specifically defined acceptable/not acceptable 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 a Proficiency Testing Oversight Body
(PTOB)/Proficiency Test Provider Accreditor (PTPA), Section 2.3 and Appendix D;
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e) specific requirements for laboratories participating in PTOB/PTPA-approved PT programs, as
described in Sections 2.4, 2.5, and 2.7; and,
f) oversight of all PT program activities by the PTOB(s)/PTPA(s), as described in Section 2.2.2.
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;
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 shall be representative of materials
analyzed for 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; and,
e) the preparation of samples such that the identification and quantitation of analytes in the samples
pose equivalent difficulty and challenge regardless of the manner in which the samples are
designed and manufactured by the PT Providers, e.g., samples prepared for analysis by a drinking
water or wastewater method would pose equal challenge whether prepared as whole volume or as
a concentrate in 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, 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. The following elements collectively define PT
fields of testing:
a) regulatory or environmental program, as listed in Chapter 1,
b) matrix type (e.g., gas, aqueous liquid, nonaqueous liquid, solid), and
c) analyte.
Note: Laboratories are permitted to analyze and report multiple method specific results for the same
analytes from one PT sample.
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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 PTOB/PTPA, the PT Providers, the testing laboratories,
and the Primary Accrediting Authorities (AA). The lines of interaction among these groups are shown
in Figure 2-1.
Standard-Setting
Authority
NELAC
PTOB/PTPA
Primary Accrediting
Authority
PT Providers
Laboratories
(Private Sector,
Non-Profits, and/
or States
Figure 2-1. NELAP Proficiency Testing
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The NELAC Standing Committee on Proficiency Testing is responsible for Chapter 2 and related
appendices. This includes:
a) establishing which analytes are included in the NELAC PT program,
b) establishing the concentration ranges for each analyte,
c) establishing acceptance criteria to be used to evaluate PT results, and
d) maintaining a comprehensive list of NELAC PT fields of testing.
2.2.1 Proficiency Testing Study Providers
The PT Providers shall produce and distribute PT samples, evaluate study results against published
performance criteria, and report the results to the laboratories, the respective Primary Accrediting
Authorities, the appropriate PTOB/PTPA, 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.
2.2.2 Proficiency Testing Oversight Body (PTOB)/Proficiency Test Provider Accreditor
(PTPA)
The PTOB/PTPA establishes and implements a program to accredit PT Providers and to monitor
accredited providers to ensure that their studies and practices meet all applicable standards. The
PTOB/PTPA shall meet the requirements of Appendix D. Organizations meeting the requirements of
this standard and its appendices, as determined by any NELAP-recognized Accrediting Authority, may
be nominated by the committee to the NELAC Board of Directors to be designated as a PTOB/PTPA.
2.2.3 Laboratories
Laboratories that seek to obtain or maintain accreditation shall perform analyses of PT samples for
each PT field of testing as defined in Section 2.1.3. PT samples shall be obtained from NELAP
designated PTOB/PTPA-approved PT Providers. The laboratory shall obtain PT samples from any so
approved PT Provider. The results of the analyses shall be submitted to the PT Provider for scoring.
2.2.4 Accrediting Authorities (AA)
The Primary Accrediting Authorities shall make all decisions regarding a laboratory's accreditation
status. They are responsible for taking action to make these determinations including ensuring that
laboratories seeking or holding their accreditations have participated in the PT program. Accrediting
authorities shall accept for the purposes of initial and continuing accreditation, PT results from any
NELAP-designated PTOB/PTPA-approved PT Provider that meets the requirements of this standard.
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/PTPA as PT Providers. A PTOB/PTPA shall grant approval to PT
Providers on a field-of-testing basis, as described in Section 2.1.3.
2.3.1 PT Provider Accreditation
For all compounds/matrices for which NIST National Voluntary Laboratory Accreditation Program
(NVLAP) accreditation is available, the PT Provider must be accredited by NIST NVLAP. The
Provider's NIST NVLAP Scope of Accreditation shall cover the specific PT samples being supplied to
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the laboratories. For all other programs and compounds for which NIST/NVLAP accreditation is not
available, a provider of PT samples for NELAC accreditation must be accredited by a Proficiency
Testing Oversight Body (PTOB)/PTPA that meets the NELAC PTOB/PTPA requirements contained
in this Chapter and associated appendices. The names of PTOB/PTPA organizations that meet the
NELAC requirements are communicated to the NELAC Standing Committee on Proficiency Testing
and the NELAC Board of Directors. A listing of organizations that meet the NELAC PTOB/PTPA
requirements is available from the Chair of NELAC.
2.3.2 On-site Inspection of PT Providers
A PTOB/PTPA shall conduct an on-site inspection of any organization seeking to participate as a PT
Provider, as described in Appendix D. The PTOB/PTPA 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 a PTOB/PTPA. A PTOB/PTPA shall conduct ongoing oversight
of the PT Providers as necessary to ensure conformance with all applicable standards.
2.3.3 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 to obtain or maintain accreditation. Samples may not be reused in any subsequent NELAC PT
study.
2.3.3.1 Sample Analytes
The PT Provider shall prepare each sample lot such that the prepared concentration of each analyte
in each lot is unique. The required group of analytes covering each PT field of testing shall be
determined by the NELAC Standing Committee on Proficiency Testing and shall be evaluated and
updated, as necessary.
2.3.3.2 PT Provider Sample Testing
The PT Provider shall design, manufacture, and test the samples for homogeneity, stability, and
verification of assigned values as required by Appendix B. This testing shall verify that the quality of
all samples is acceptable for use in each PT field of testing.
2.3.4 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.
2.3.4.1 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 shall be judged fairly and consistently.
2.3.5 Generation of Study Reports
Each PT Provider shall evaluate the data and issue a report within 21 calendar days of the close of
each study.
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2.3.6 Provider Conflict of Interest
Each PT Provider shall certify that it is free of any organizational conflict of interest. A PT Provider
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 PT Provider shall follow procedures
and have systems in place that maintain confidentiality and security of all assigned values through the
closing date of each study. All records shall be retained for a period of five years.
2.3.7 Disapproval of PT Providers
A PT Provider's approval may be subjected to revocation per the procedures outlined in Appendix A,
Section A.9.2.
2.3.8 PTOB/PTPA Listing of PT Providers
PTOBs/PTPAs shall maintain a list of approved PT Providers. PTOBs/PTPAs shall evaluate, update,
and publish this list as specified in Appendix D.
2.4 LABORATORY ENROLLMENT IN PROFICIENCY TESTING PROGRAM(S)
2.4.1 Required Level of Participation
To be accredited initially and to maintain accreditation, a laboratory shall participate in two single-blind,
single-concentration PT studies, where available, per year for each PT field of testing for which it seeks
or wants to maintain accreditation. Laboratories must obtain PT samples from a PTOB/PTPA-approved
PT Provider. Each laboratory shall participate in at least two PT studies for each PT field of testing per
year unless a different frequency for a given program is defined in the appendices. Section 2.5
describes the time period in which a laboratory shall 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 Primary Accrediting Authority
which field(s) of testing it chooses to become accredited for and shall participate in the appropriate PT
studies. For all fields of testing, including those 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 Five of the NELAC standards.
2.4.3 Reporting Results
Each laboratory shall authorize the PT Provider to release all accreditation and remediation results and
acceptable/not acceptable status directly to the Primary Accrediting Authority, NELAP and the
PTOB/PTPA, in addition to the laboratory.
2.5 REQUIREMENTS FOR LABORATORY TESTING OF PT STUDY SAMPLES
The samples shall be analyzed and the results returned to the PT Provider no later than 45 calendar
days from the scheduled study shipment date. 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 utilizing the same staff, methods as used for routine analysis of that
analyte, procedures, equipment, facilities, and frequency of analysis.
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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, or is accredited;
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, or is accredited;
c) Laboratory management or staff shall not communicate with any individual at another laboratory
(including intracompany communication) concerning the PT sample; and
d) Laboratory management or staff shall not attempt to obtain the assigned value of any PT sample
from their PT Provider.
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
PT Providers shall evaluate results from all PT studies using NELAC-mandated acceptance criteria
described in Appendix C. The NELAC Standing Committee on Proficiency Testing shall provide, and
update as necessary, the data acceptance criteria that all PT Providers shall use for all PT studies.
Each result shall be scored on an acceptable/not acceptable basis. The PT Provider shall provide the
participant laboratories and the Primary Accrediting Authority a report showing at a minimum the
laboratory's reported value, the assigned value, the acceptance range, the acceptable/not acceptable
status, and the method for each analyte reported by the laboratory. This report shall be sent no later
than 21 calendar days from the study closing date. Upon request by either the Primary Accrediting
Authorities or laboratories, the PT Provider shall make available a report listing the total number of
participating laboratories and the number of laboratories scoring not acceptable for each analyte. The
PT Providers shall not disclose specific laboratory results or evaluations to any other parties without
the written release of the laboratory.
2.7 PT CRITERIA FOR LABORATORY ACCREDITATION
2.7.1 Result Categories
The criteria described in this section apply individually to each PT field of testing, as defined by the
laboratory seeking to obtain or maintain accreditation in its accreditation request. These criteria apply
only to the PT portion of the overall accreditation standard, and the Primary Accrediting Authority shall
consider PT results along with the other elements of the NELAC standards when determining a
laboratory's accreditation status. The Primary Accrediting Authority ultimately makes all decisions
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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 seeking to obtain or maintain accreditation shall successfully complete two PT studies
for each requested PT field of testing within the most recent three rounds attempted. For a laboratory
seeking to obtain accreditation, the most recent three rounds attempted shall have occurred within 18
months of the laboratory's application date. Successful performance is described in Appendix C.
When a laboratory has been granted accreditation status, it shall continue to complete PT studies for
each PT field of testing and maintain a history of at least two acceptable PT studies for each PT field
of testing out of the most recent three. For initial accreditation or supplemental testing, the PT studies
shall be at least 30 calendar days apart. For continuing accreditation, completion dates of successive
proficiency rounds for a given PT field of testing shall be approximately six months apart. Failure to
meet the semiannual schedule is regarded as a failed study.
2.7.3 Supplemental Studies
A laboratory may elect to participate in PT studies more frequently than required by the semiannual
schedule. 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 shall
be reported and are counted and scored the same way and shall be analyzed at least 30 calendar days
apart from the conclusion of one study to the shipment date of another study.
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 and provide to the Primary Accrediting
Authority both the investigation and the action taken. If a laboratory fails two out of the three most
recent studies for a given PT field of testing, its performance is considered unacceptable under the
NELAC PT standard for that field. The laboratory shall then meet the requirements of initial
accreditation as described in Section 2.7.2 - Initial and Continuing Accreditation.
2.7.5 Second Failed Study
The PT Provider reports laboratory PT performance results to the Primary Accrediting Authority at the
same time that it reports the results to the laboratory. If a laboratory fails a second study out of the
most recent three, as described in Section 2.7.4, the Primary Accrediting Authority shall take action,
pursuant to Chapter Four, within 60 calendar days to determine the accreditation status of all methods
for the unacceptable analyte(s) for that program and matrix.
2.7.6 Scheduling of PT Studies
A Primary Accrediting Authority may specify which months that laboratories within its authority are
required to participate in NELAC PT programs. If the Primary Accrediting Authority chooses to specify
the months, then it shall adhere to the required semiannual schedule. If the Primary Accrediting
Authority does not specify the months, then the laboratory shall determine the semiannual schedule.
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2.7.7 Withdrawal from PT Studies
A laboratory may withdraw from a PT study for an analyte(s) or for the entire study if the laboratory
notifies both the PT Provider and the Primary Accrediting Authority before the closing date of the PT
study. This does not exempt the laboratory from participating in the semiannual schedule.
2.7.8 Process for Handling Questionable PT Samples
There may be occasions in which the PT Provider has shipped one or more samples for NELAP
accreditation which do not meet the quality control requirements of Appendix B, and the provider has
not in a timely manner notified all affected laboratories or Accrediting Authorities as described in
Section A. 10 of this standard. In this case, an AA, upon review of summary data or other relevant
documentation, may choose not to use the results of the analyte(s)/matrices to support the
accreditation status of the laboratories. In order to justify not using the results, the AA shall first
contact the PT Provider and attempt to resolve the situation. If after notifying the PT Provider, the AA
still chooses to pursue a complaint against the provider, the AA shall submit a written complaint to the
Accrediting Authority Review Board (AARB). The AARB shall evaluate the complaint. If the complaint
is determined to be valid, then the AA shall submit the written complaint to the PTOB/PTPA which
initially accredited the provider for the particular analyte(s) and matrices. The AA shall follow all
procedures for filing complaints as specified by the PTOB/PTPA. The AA may determine that the
affected laboratories shall either wait until the next regularly scheduled PT testing round to analyze
another PT for that field of testing, or may require the labs to obtain and analyze a supplemental
sample, and repeat the test.
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APPENDIX A
PT PROVIDER APPROVAL CRITERIA
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Appendix A - PT PROVIDER APPROVAL CRITERIA
A.O 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) /Proficiency Test Provider Accreditor
(PTPA) Approved PT Provider. In order for a PT Provider to participate in the NELAC PT program, a
provider shall be approved by a PTOB/PTPA. 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 APPROVAL PROCESS
The process for approval of a PT Provider includes a biennial on-site inspection by a PTOB/PTPA to
ensure that the technical criteria of this appendix are being met. At the discretion of the PTOB/PTPA,
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/PTPA, or through the
analysis of unknown samples provided by the PTOB/PTPA. Providers are also required to submit the
results of PT programs operated for NELAC to the PTOB/PTPA for review and evaluation. The PT
Provider agrees to accept the findings and decisions of the PTOB/PTPA as final.
A.2 QUALITY SYSTEM REQUIREMENTS
The manufacturing quality system used by the PT Provider shall meet the requirements of both
International Organization for Standardization (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 shall 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 shall meet the requirements of both ISO Guide
25, General Requirements for the Competency of Testing and Calibration Laboratories and Chapter
Five, Quality Systems, of the NELAC standards. The ability to meet the ISO 9001 quality system
requirement may be fulfilled through registration of the PT Provider's quality system to American
National Standards Institute (ANSI) standards by a Registrar Accreditation Board (RAB)-accredited
registrar. However, a biennial on-site inspection by the PTOB/PTPA demonstrating continuing
conformance is required.
A.3 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/PTPA 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. For the purposes of this requirement "control" can
mean ownership or that the subcontracted service is performed under an agreement which specifically
ensures the ability of the provider to access and restrict the distribution of information related to these
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services. Any subcontracted services shall be assessed by a PTOB/PTPA and meet the same criteria
as the PT Provider.
A.4 SAMPLE FORMULATION REVIEW
The PT Provider shall demonstrate to the PTOB/PTPA, by the submission of appropriate data, that the
sample formulation for which the PT Provider is seeking approval shall permit participating laboratories
to generate results that fall within the sample acceptance ranges established by the NELAC Standing
Committee on Proficiency Testing and meet the criteria of the "National Standards for Water
Proficiency Testing Studies, Criteria Document" (USEPA).
A.4.1 Release of Information
In support of the requirement in Section A.4.0, PTOBs/PTPAs shall treat all sample formulation
information submitted to them for review as the proprietary information of the PT Provider submitting
the information. Such formulation information shall not be released by a PTOB/PTPA without the prior
written consent of the PT Provider.
A.5 PROVIDER CONFLICT-OF-INTEREST REQUIREMENTS
PT Providers seeking approval shall document to the satisfaction of the PTOB/PTPA that they do not
have a conflict of interest with any laboratory seeking, or having, NELAP accreditation. PT Providers
shall notify the PTOB/PTPA of any actual or potential organizational conflicts of interest, including but
not limited to:
a) Any financial interest in a laboratory seeking, or having, NELAP accreditation;
b) The sharing of personnel, facilities or instrumentation with a laboratory seeking, or having, NELAP
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/PTPA. 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/PTPA. The disclosure shall include a description of any action which the provider has taken or
proposes to take, after consultation with the PTOB/PTPA, to avoid, mitigate or neutralize the actual
or potential conflict of interest. The PTOB/PTPA 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/PTPA may be appealed to NELAP for a final determination.
A.5.1 Ban on Distribution of Samples
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 shall not sell, distribute, or provide
samples of identical formulation and concentration to those samples which it is currently using in a
NELAC study.
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A.6 CONFIDENTIALITY OF PT STUDY DATA
The PT Provider shall demonstrate to the PTOB/PTPA that it has systems in place to ensure that the
confidentiality of data associated with NELAC PT samples and programs are not compromised. PT
Providers shall not release the assigned value of any sample currently being used in a NELAC PT
study prior to the conclusion of the study.
A.7 DATA REVIEW AND EVALUATION
The NELAP designated PTOB/PTPA shall review the data from every PT Provider's studies to ensure
that acceptance limits used to evaluate laboratories are consistent with national standards as
established by NELAC. The PTOB/PTPA shall also evaluate the performance of the PT Providers by
monitoring, and reporting, to both the providers and the NELAC Standing Committee on Proficiency
Testing the pass/fail rates of all providers on all samples tested. A PTOB/PTPA is required to
investigate any PT Provider whose pass/fail rate is statistically different from the national average.
A.8 COMPLAINTS & CORRECTIVE ACTION
Written complaints received by the PT Provider regarding technical or procedural aspects of the studies
they conduct shall be submitted to the PTOB/PTPA within 30 calendar days of receiving the complaint.
The PT Provider shall resolve the complaint to the satisfaction of the PTOB/PTPA. The PTOB/PTPA
is the sole judge of the adequacy of the corrective action taken by the PT Provider. The PTOB/PTPA
shall provide NELAP with an annual summary of all PT Provider complaints received during the prior
year.
A.9 LOSS OF PROVIDER APPROVAL
PT Providers who fail to meet the requirements of these standards 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 a PTOB/PTPA as required in Appendix A, Section A.7. Similarly, PT
Providers who fail to meet the requirements of Appendix A, Sections A.2 through A.6, on a continuous
basis may lose their approval as a PTOB/PTPA-approved PT Provider for all samples.
A.9.1 Periodic Review of PT Providers
A PTOB/PTPA may at any time, review the performance of any approved PT Provider against these
standards. Based upon this review, the PTOB/PTPA may decide 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.
A.9.2 Revocation of Approval
Should a PTOB/PTPA propose to revoke or suspend a provider's approval for failure to meet the
requirements of these standards, the PTOB/PTPA shall inform the provider of the reasons for the
proposed revocation or suspension and the procedures for appeal of such a decision. The due process
rights of the provider shall be protected during any revocation or suspension proceedings. The final
decision on the revocation or suspension of a provider's approval to supply PT samples for the NELAP
accreditation resides with the Director of NELAP. If the provider loses PTOB/PTPA approval it shall
lose NELAP approval to supply samples for the NELAC PT program.
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A.10 NOTIFICATION OF SAMPLE INTEGRITY
The provider is responsible for notifying all laboratories and Primary Accrediting Authorities when a
particular analyte was determined not to meet the requirements of Appendix B or is deemed of
unacceptable quality for NELAC purposes, within 30 calendar days of the study closing date.
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APPENDIX B
PT SAMPLE DESIGN
& ACCEPTANCE GUIDELINES
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Appendix B - PT SAMPLE DESIGN & ACCEPTANCE GUIDELINES
B.O 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. To meet the goals of NELAC, the PT
samples used in the program shall also provide all laboratories with samples which offer a
consistent challenge. All PT samples shall meet all applicable specifications of these standards.
B.1 SAMPLE FORMULATION APPROVAL
The PT Provider shall demonstrate the adequacy of sample formulation to the satisfaction of the
PTOB/PTPA. The criteria for formulation adequacy are that the sample shall provide equivalent
challenge to the laboratories under test as similar samples for the same parameters as other
providers, and that the sample shall exhibit laboratory acceptance rates, measured as provider
percentage pass/fail performance, consistent with other samples used in the program for the same
parameters.
B.1.1 Adequacy of the Sample Formulation
The testing and verification protocol required to establish sample equivalency shall be agreed to by
both the PT Provider and the PTOB/PTPA on a case-by-case basis. It is the responsibility of the
PT Provider to demonstrate the adequacy of sample formulation to the satisfaction of the
PTOB/PTPA.
B.1.2 PT Sample Composition
PT Providers may choose to leave one or more specific analyte(s) out of PT samples, yet shall still
include those analyte(s) in the PT study to be counted and scored with the present analytes. The
guidelines in this section apply only to PT samples that contain the following analyte fractions:
volatiles, pesticides, herbicides, and/or base/neutral/acids (BNA). Analytes from different fractions
may not be combined when determining the minimum number of analytes that must be present in a
sample. The value assigned to these unspiked analytes would be zero. A PT Provider may
choose not to include analytes; however, a minimum number of analytes shall be present in every
PT sample. The PT Provider shall prepare samples according to the following criteria:
1) PT samples that are to be scored for one to ten analytes must include all of these analytes.
2) PT samples that are to be scored for ten to twenty analytes must include at least ten of these
analytes or 80% of the total, whichever number is greater.
3) PT samples that are to be scored for more than twenty analytes must include at least sixteen
of these analytes, or 60% of the total analytes, whichever number is greater.
4) If following (b) or (c) above and a percentage of the total number of analytes in the sample is a
fraction, the fraction shall be rounded up to the next whole number. For example: 16 analytes
* 0.80 = 12.8 = 13 analytes in sample.
5) PT Providers shall use a random selection process to determine which parameters will be
assigned zero values within any given PT sample.
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All other PT samples must contain all the analytes of interest within the concentration ranges as
required by this standard.
B.1.3 PT Sample Matrix
Refer to the NELAC Glossary for definition of matrices. Note: PT samples are not currently
available for all matrices. Refer to the NELAC PT field of testing lists for sample availability.
B.1.4 PT Sample Composition for Solid Matrices
Soil PT samples shall be well-characterized natural soil and cannot contain 100% sand.
B.2 VERIFICATION OF ASSIGNED VALUE
All PT samples used for obtaining or maintaining NELAP accreditation shall be analyzed by the PT
Provider prior to shipment to the laboratories to ensure suitability for use in the program. The
assigned value of the sample shall be used to establish acceptance criteria, and it shall be verified
by analysis. PT Providers shall verify the assigned value by direct analysis against National
Institute of Standards and Technology (NIST) Standard Reference Materials (SRM), if a suitable
NIST SRM is available for use. If a NIST SRM is not available then verification shall 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.2.1 Relative Standard Deviation of Verification Analysis
The method used by the PT Provider for verification analysis shall have a relative standard deviation
of not more than 50% of the relative standard deviation predicted at the assigned value by the
laboratory acceptance criteria being used by NELAC for each parameter. The relative standard
deviation of the provider's verification method shall be established by a method validation study, and
the suitability for use shall be approved by the NELAP designated Proficiency Testing Oversight
Body (PTOB)/Proficiency Test Provider Accreditor (PTPA).
B.2.2 Quality Control Check of the Assigned Value
The assigned value for every parameter in all PT samples shall be verified by analysis. The
assigned value of the analyte is verified if the mean of the verification analyses is within 1.5
standard deviations, as calculated as described in Sections C.1.1.1 or C.1.1.2, of either a) the
assigned value if an unbiased verification method is used or b) the mean value for the analyte as
calculated in Sections C.1.1.1 or C.1.1.2 if a biased method is used. The standard deviation of the
verification analyses also shall be less than one standard deviation as calculated in Sections
C.1.1.1 or C.1.1.2. For analytes that are evaluated using fixed percentages as defined in Section
C.1.1.1, standard deviations are calculated by assuming that the fixed percentage is equal to two
standard deviations.
B.3 HOMOGENEITY TESTING
PT sample homogeneity is essential to ensuring that all laboratories are treated fairly. Therefore,
the purpose of the homogeneity testing procedure is to establish at the 95% confidence level that
all samples distributed to the laboratories have the same assigned value for every parameter to be
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evaluated. Homogeneity testing is required on all PT samples prior to sample shipment to the
laboratories.
B.3.1 Homogeneity Testing Procedure
The homogeneity of the samples shall be established using a generally accepted statistical
procedure. The procedure selected by the PT Provider shall be capable of evaluating the relative
consistency of each analyte across the production run, and shall be performed on the final
packaged samples. The procedure shall establish at the 95% confidence level that the assigned
value is consistent across the production run. Samples, or parameters, which fail to pass the
homogeneity testing criteria cannot be used in the NELAC PT program to evaluate laboratories.
B.3.2 Suitable Homogeneity Testing Procedures
A suitable homogeneity testing procedure shall be capable of comparing the between sample to
within sample standard deviation across the PT Provider's packaging run, and shall ensure
comparability with 95% confidence. Suitable homogeneity testing procedures are available in both
ISO Guide 35 for the Certification of Reference Materials and in the ISO Reference Material
Committee (REMCO)-Association of Official Analytical Chemists (AOAC) Harmonized Protocol for
the Proficiency Testing of Analytical Laboratories. However, the homogeneity testing procedure
used by the PT Provider shall be approved for use by the PTOB/PTPA.
B.4 STABILITY TESTING
The samples used in the NELAC PT program shall be verified as stable for the period of each
study. Therefore, the stability of all samples and parameters shall 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
parameter falls within the 95% Confidence Interval calculated for the prior to shipment verification
testing used to establish the assigned value. The testing procedure used for stability testing shall
be approved for use by the PTOB/PTPA.
B.5 DATA REPORTING BY PT PROVIDERS
The results of sample assigned value verification, homogeneity, and stability testing shall be
available to the participating laboratories. All data developed by the provider in support of verification
testing, homogeneity testing, and stability analysis shall be provided to any laboratory participating
in the program upon request after the close of the study. Providers shall supply PT data to the
Primary Accrediting Authorities, as per Section 2.6, in a format acceptable to the Primary
Accrediting Authority.
B.5.1 Verification and Homogeneity Reports
The data developed by the PT Provider in support of verification and homogeneity testing shall be
supplied in summary format to the PTOB/PTPA in an electronic format to be determined by the
PTOB/PTPA. Verification and homogeneity data shall be supplied to the PTOB/PTPA prior to
sample distribution to the laboratories.
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B.5.2 Laboratory Data and Stability Reports
All summary data from the laboratories and the results of stability testing shall be provided to the
PTOB/PTPA in an electronic format to be determined by the PTOB/PTPA within 30 calendar days
of the close of the study.
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PROFICIENCY TESTING
APPENDIX C
PT ACCEPTANCE CRITERIA
AND
PT PASS/FAIL CRITERIA
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Appendix C - PT ACCEPTANCE CRITERIA AND PT PASS/FAIL CRITERIA
C.O PURPOSE, SCOPE, AND APPLICABILITY
This appendix defines the criteria to be used by any entity which seeks to participate as a NELAP-
designated PTOB/PTPA-approved Proficiency Test Provider for scoring the results obtained from
the analyses of samples in any NELAC PT study. The PT Providers shall submit all laboratories'
performance rating(s) to the Primary Accrediting Authority, as described in Chapter Two of the
NELAC standards, to be used as a tool for determining a laboratory's accreditation status. PT
acceptance limits and pass/fail criteria are established on a PT field of testing basis.
C.1 ANALYTE ACCEPTANCE LIMITS
Acceptance limits are established for each analyte as described in this appendix.
C.1.1 Analyte Acceptance Limit Categories
Acceptance limits are separated into two categories. Results for analytes with acceptance limits
determined as described in Sections C.1.1.1 and C.1.1.2 shall 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.1.1.3 shall not be used as part of the PT field of testing
acceptable/not acceptable evaluation.
C.1.1.1 Drinking Water, Waste Water, and Ambient Water Analytes with USEPA
Established Acceptance Limits
PT Providers shall utilize the proficiency test acceptance limits that have been established by _
USEPA in the "National Standards for Water Proficiency Testing, Criteria Document" where they
apply. The "National Standards for Water Proficiency Testing, Criteria Document" is incorporated
into this appendix by reference.
C.1.1.2 Analytes with Acceptance Limits Established by the NELAC Standing Committee on
Proficiency Testing
For analytes not included in the "National Standards for Water Proficiency Testing, Criteria
Document," Proficiency Test providers shall use acceptance limits established by the NELAC
Standing Committee on Proficiency Testing and shall be made available to PTOB/PTPA-approved
PT Providers by the PT Committee Chair or the Director of NELAP. Data from sources such as the
USEPA Proficiency Evaluation (PE) studies, interlaboratory results from professional organizations
such as ASTM, other Proficiency Test Providers, commercial and non-profit organizations, shall be
used to establish the evaluation criteria. All evaluation criteria shall be approved by the NELAC
Standing Committee on Proficiency Testing prior to use by a PTOB/PTPA-approved PT Provider.
C.1.1.3 Experimental Data: Analytes without Promulgated Acceptance Limits or
Established Regression Equations
For those analytes not included in categories C.1.1.1 or C.1.1.2, e.g., newly regulated analytes, or
analytes in a matrix that have not been fully evaluated in interlaboratory studies, NELAC
acceptance limits shall be established only after interlaboratory data has been collected for a
minimum of one year unless the NELAC Standing Committee on Proficiency Testing determines
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that sufficient data have been collected in less time. The data obtained during the one-year period
shall be referred to as "experimental data". The NELAC Standing Committee on Proficiency
Testing shall derive regression equations to be used to establish acceptance limits for analytes in
the experimental category after sufficient data have been collected. The laboratory shall receive a
copy of its own experimental data from the PT Provider at the conclusion of the PT study.
C.2 ACCEPTABLE PT RESULTS FOR CHEMICAL ANALYTES IN POTABLE WATER AND NON-
POTABLE WATER PT SAMPLES
A laboratory's PT analyte result is acceptable when it falls within the regulatory promulgated
acceptance limits (Section C. 1.1.1). For Section C.1.1.2 analytes, PT Providers shall use the PT
sample's verified assigned value and said regression equations to determine the mean and
standard deviation. Acceptance limits shall be set at the mean ± two standard deviations for
potable water analytes and the mean ± three standard deviations for non-potable water analytes. A
result is acceptable when it falls within these derived acceptance limits.
C.3 NOT ACCEPTABLE PT RESULTS FOR POTABLE WATER AND NON-POTABLE WATER 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 acceptance limits;
b) the laboratory reports a result for an analyte not present in the PT sample (i.e., a false
positive); or,
c) the laboratory does not withdraw from a study as described in Section 2.7.7, and fails to
submit its results to the PT Provider on or before the deadline for the PT study.
C.4 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/Proficiency Test Provider Accreditor. If bimodal or multimodal
distribution is found and acceptance criteria are calculated using robust statistical analysis, data
should be scored by method specific robust statistical analysis. All proficiency test data are to be
submitted to the PTOB/PTPA in the format specified by the PTOB/PTPA and shall be reviewed
annually by the NELAC Standing Committee for Proficiency Testing for the purpose of revising
existing and establishing new evaluation criteria.
C.4.1 Additional Matrix/Analyte Groups
Additional matrices and/or analytes may be added to the NELAC PT fields of testing at the request
of any Accrediting Authority, USEPA program office, or PTOB / PTPA-approved PT Provider. The
request for the addition of an analyte must include at a minimum ten sets of interlaboratory data on
the analyte in the particular matrix. Each data set must contain a minimum of twenty valid data
points. The NELAC Standing Committee on Proficiency Testing shall review the data and develop
an initial set of laboratory acceptance limits based upon the needs of the Accrediting Authorities,
USEPA, and the laboratories. Laboratory acceptance limits developed by the PT Committee on
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any new matrix/analyte combinations shall be reviewed annually by the PT Committee. The
purpose of this annual review is to ensure that the limits represent the actual capabilities of the
laboratories. For any additional matrix or analyte groups added to the NELAC PT field of testing by
the NELAC PT Committee, laboratories shall complete two successful PT studies within 12 months
of the date the additional groups were added.
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PROFICIENCY TESTING
APPENDIX D
PROFICIENCY TESTING OVERSIGHT
BODY/
PROFICIENCY TEST PROVIDER
ACCREDITOR
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Appendix D - PROFICIENCY TESTING OVERSIGHT BODY/
PROFICIENCY TEST PROVIDER ACCREDITOR
D.O PURPOSE, SCOPE, AND APPLICABILITY
This appendix defines the qualifications, scope of responsibilities and requirements for a NELAP
designated Proficiency Testing Oversight Body (PTOB)/Proflciency Test Provider Accreditor (PTPA)
as defined in Section 2.2.2 of the NELAC document. In addition to complying with the
requirements of this appendix, a PTOB/PTPA, 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). Organizations meeting the requirements of this standard and its
appendices, as determined by any NELAC-recognized Accrediting Authority may be nominated to
the NELAC Board of Directors to be listed as a NELAP PTOB/PTPA.
D.1 TECHNICAL AND ADMINISTRATIVE QUALIFICATIONS
An organization shall demonstrate to the NELAC Standing Committee on Proficiency Testing by
the submission of a current Statement of Qualifications 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. In the event that the organization is not a
nationally or internationally recognized authority, the NELAC Standing Committee on Proficiency
Testing reserves the right to request further documentation detailing the organization's
qualifications. The organization shall meet the following general requirements:
a) Demonstrate the capability to manage and evaluate complex environmental reference materials
in a variety of matrices;
b) Demonstrate expertise in statistical applications as related to large interlaboratory performance
evaluation programs;
c) Demonstrate the capability to conduct on-site audits of PT Providers;
d) Demonstrate the capability to conduct technical reviews of Initial Applications;
e) Demonstrate a knowledge and understanding of the ISO guides 9001, 34, 43, and Chapter Two
of the NELAC standards including Appendices A, B, and C.
D.2 PTOB/PTPA RESPONSIBILITIES REGARDING INITIAL ASSESSMENT OF PT PROVIDERS
PTOB/PTPA responsibilities are described in this section. The primary responsibility of a
PTOB/PTPA is the oversight and ongoing monitoring and evaluation of the PT Providers. The
oversight activities of a PTOB/PTPA shall be designed to ensure that the PT Provider meets the
requirements specified in Chapter Two and Appendices A, B and C. Any variations from these
requirements shall be approved by the NELAC Standing Committee on Proficiency Testing prior to
a body being approved as a NELAC PTOB/PTPA. All activities described herein shall be
conducted by a PTOB/PTPA.
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D.2.1 Development of Standard Operating Procedures and Forms
PTOBs/PTPAs 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
Two of the NELAC standards and the associated Appendices A, B, and C. The NELAC Standing
Committee on Proficiency Testing has the authority to review and approve, as necessary, the
SOPs developed by a PTOB/PTPA.
D.2.1.1 SOP(s) for the Assessment Process
The PTOB/PTPA 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 determining that a PT Provider's approval be revoked, the procedures for
appealing approval determinations, and any other procedures deemed necessary by NELAC.
D.2.1.2 Initial Application
A PTOB/PTPA shall develop the initial application process to be submitted by 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, a PTOB/PTPA 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 Two and associated appendices.
D.2.1.3 SOP(s) for On-site Inspections and Checklist(s)
A PTOB/PTPA shall develop SOP(s) for conducting consistent, effective, 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 shall be
announced or unannounced. A PTOB/PTPA shall develop standard, consistent checklist(s) to be
used during any and all inspections of PT Providers.
D.2.2 Initial Application Review and On-site Inspections
A PTOB/PTPA shall follow the procedures described in this section for the review of applications
and on-site inspections of any candidate PT Provider.
a) A PTOB/PTPA 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) A PTOB/PTPA shall review the sample designs used by the PT Provider for compliance with
Appendix B and other applicable documents.
c) A PTOB/PTPA shall review the PT analyte and sample scoring procedures used by the PT
Provider for compliance with Appendix C and other applicable documents.
d) Following the review of the Initial Application and associated documents, a PTOB/PTPA 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.
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e) Following the inspection, a PTOB/PTPA shall conduct an exit meeting with the PT Provider,
which shall include discussion of deficiencies and discrepancies found; however, a
PTOB/PTPA 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;
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 Two.
f) A PTOB/PTPA shall send a draft report to the PT Provider after the completion date of the
inspection. A PTOB/PTPA shall allow the PT Provider to review and comment on the draft if the
PT Provider finds any discrepancies and determines that revisions are necessary. A
PTOB/PTPA shall then submit a final inspection report to the PT Provider 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) A PTOB/PTPA shall allow the provider to submit their response to the report. In order for the
provider's response to be considered acceptable, a PTOB/PTPA shall require that it include a
description of corrective actions necessary to meet the criteria of Chapter Two, and
Appendices A, B, and C.
D.3 PTOB/PTPA RESPONSIBILITIES REGARDING APPROVAL OF PT PROVIDERS
A PTOB/PTPA shall utilize the appropriate final report and associated documents submitted by the
PT Provider to grant or deny approval to that provider.
D.4 PTOB/PTPA RESPONSIBILITIES FOR ONGOING OVERSIGHT OF PT PROVIDERS
A PTOB/PTPA 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
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significantly above or below historical trends. The ongoing monitoring criteria to be used by a
PTOB/PTPA shall be developed by NELAC.
c) biennial on-site inspections 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/PTPA may determine that the provider's
approval status be reevaluated.
D.5 DEVELOPMENT AND MAINTENANCE OF A COMPREHENSIVE PT DATABASE
A comprehensive PT database shall be developed and maintained by the PTOB(s)/PTPA(s) in
conjunction with NELAC.
D.6 COMPLAINTS AND CORRECTIVE ACTION
A PTOB/PTPA shall evaluate all complaints that it receives regarding either approved or candidate
PT Providers. If the PTOB/PTPA determines that a complaint warrants investigation, the
PTOB/PTPA shall notify the provider of the complaint. The PT Provider is required to resolve the
complaint to the satisfaction of the PTOB/PTPA. A PTOB/PTPA shall provide to the NELAC
Standing Committee on Proficiency Testing a summary of all PT Provider complaints received the
previous year.
D.7 LIST OF APPROVED PT PROVIDERS
A PTOB/PTPA 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 shall be readily available to
laboratories seeking NELAP accreditation, State Accrediting Authorities and other interested
parties. PT Providers shall agree to abide by the provisions of NELAC regarding the advertising and
marketing use of the designation, "NELAP-designated PTOB/PTPA Approved Proficiency Test
Provider".
D.8 SPONSORSHIP OF ANNUAL NELAC PROFICIENCY TESTING CAUCUS
The PTOB(s)/PTPA(s) 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 quality of environmental data generated by the NELAC accredited laboratories.
D.9 PTOB/PTPA ETHICS
This section describes the overall ethics and standards of conduct that shall be adhered to for a
PTOB/PTPA to implement and administer a successful PT Provider oversight program. A
PTOB/PTPA 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
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status. A PTOB/PTPA 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. A PTOB/PTPA 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/PTPA 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 Primary Accrediting Authorities, the laboratories, and the public as appropriate.
D.10 CONFIDENTIALITY
A portion of the information provided to a PTOB/PTPA by the PT Provider in the course of its
inspection and oversight activities shall be proprietary in nature. A PTOB/PTPA shall agree to
maintain the confidentiality of proprietary information provided to it by the PT Provider.
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APPENDIX E
MICROBIOLOGY
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Appendix E - MICROBIOLOGY
E.O PURPOSE
This appendix outlines the requirements for microbiological proficiency testing under the Safe Drinking
Water Act (SDWA) and the Clean Water Act (CWA). Microbiological testing for other USEPA
programs shall be added as required. Semi-annual proficiency testing is required per the schedule
contained in Section 2.4.
E.1 SAMPLES
E.1.1 SDWA Samples
PT Providers shall present samples either as full volume samples or preparations easily reconstituted
to full volume samples. For the SDWA, there shall be ten 100+ ml. samples (as presented or after
reconstitution) for the qualitative determination (Presence/Absence) of total coliform and fecal coliform
(or E. co//). Sample sets which are provided to the laboratories shall contain bacteria that produce the
following:
• Verification as total and fecal coliforms (E. coli).
• Verification as total coliforms, but not as fecal coliforms.
• Bacterial contaminates which shall not verify as total or fecal coliforms.
Furthermore, each set shall contain the following samples:
• One to four samples containing an aerogenic strain of Escherichia coli for total and fecal coliform
positive results using all USEPA approved methods.
• One to four samples containing Enterobacter sp. or other microorganisms ensuring a total coliform
positive and fecal coliform negative result using all USEPA approved methods.
• One to four samples containing Pseudomonas sp. or other microorganisms ensuring a total and
fecal coliform negative result using all USEPA approved methods.
• One to four blank samples.
• Optionally, one sample for the quantitative determination of Heterotrophic Plate Count.
Sample sets for qualitative analysis shall be randomly composed of samples that are Total coliform
absent, Total coliform only present and Fecal coliform (E. coli) present.
E.1.2 CWA Samples
For the CWA, one sample shall be provided for the quantitative determination of Total coliform or Fecal
coliform. Providers may require laboratories to analyze samples during a fixed time period after sample
shipment or at any time during the testing period which shall not exceed the time limit set in Chapter
Two.
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E.2 SAMPLE PREPARATION AND QUALITY CONTROL
Proficiency test sample providers shall select bacterial strains and holding media that produce the
appropriate biochemical reactions for all approved analytical methods. This shall be documented by
analyses performed by the provider prior to sample shipment. The provider shall also demonstrate that
the samples are stable by analysis of a randomly selected set either after the study closing date or
in the case of a study with a fixed testing period, on the last working day of the testing period.
E.3 SCORING
E.3.1 Qualitative Analyses, SDWA Samples
Participating laboratory results shall be considered Acceptable or Unacceptable when compared to the
known presence or absence of total coliform or fecal coliform (or E. coli) bacteria. Passing shall be
considered as nine out of ten samples having acceptable results, and no false negatives reported.
E.3.2 Quantitative Analyses
Quantitative result data sets shall be evaluated by analytical method using standard statistical analysis
with outlier rejection. Most Probable Number data shall be transformed to logs prior to statistical
analysis. Acceptable results are those that are within the interval defined by the mean plus or minus
two standard deviations for SDWA analytes or within the 99% confidence limits as set by the mean,
standard deviation and set size (n) for their respective data set for all other analytes.
E.3.2.1 Requirement for Quantitative Data Set Size
Each PT Provider's microbiological data set shall be comprised of at least 20 valid data points for each
method evaluated. Sample sets of less than 20 data points may be used only with the approval of the
PTOB/PTPA.
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PROFICIENCY TESTING
APPENDIX F
ENVIRONMENTAL TOXICOLOGY
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Appendix F - ENVIRONMENTAL TOXICOLOGY
F.O PURPOSE, SCOPE, AND APPLICABILITY
This appendix defines the criteria applying the proficiency testing (PT) program to the following
environmental toxicology programs: 1) whole effluent toxicity, 2) sediment toxicity, and 3) soils
toxicity.
F.1 RATIONALE
Accreditation for environmental toxicology testing laboratories shall be based on Proficiency
Testing and on-site audits, the latter including but not limited to an evaluation of personnel
qualifications, facility acceptability, quality system and standard operating procedures, status of
data/reports generated and routine standard toxicant testing, Proficiency Testing provides a
snapshot of the laboratory's capability; however, due to the number of variables inherent to
environmental toxicology testing it cannot carry the same weight as PT samples for chemical
analytes. PT samples shall be comprised of unknown concentrations of EPA's historical reference
toxicant materials. Every effort shall be made by the PTOB/PTPA working together with the
providers to reduce the number of variables in each method (i.e., organism age, etc.) while following
the routine language of the EPA protocols.
F.2 LABORATORY ENROLLMENT IN PROFICIENCY TESTING PROGRAMS
F.2.1 Required Level of Participation
Laboratories seeking accreditation for environmental toxicology shall participate in at least one PT
study per year for each method code as designated (method code includes matrix, organism,
exposure system, and endpoint).
F.2.2 Requirements for Laboratory Testing of PT Study Samples
a) Analyze within 30 calendar days of sample receipt; report results within 30 calendar days of
completion.
b) Samples shall be analyzed in the same manner as routine samples within the limits of the
method code - as close to "real world" testing as possible.
F.3 PT CRITERIA FOR LABORATORY ACCREDITATION
F.3.1 Initial and Continuing Accreditation
Laboratories which seek to obtain or maintain accreditation for environmental toxicology shall
successfully complete at least one PT sample per year for a given field of testing (i.e., not more
than 12 months apart) and at least 30 calendar days apart (i.e., participation in a second round or
remedial study may not occur within 30 calendar days of the first or failed study). Failure to meet
the annual schedule shall be regarded as a failed study. Results other than acceptable/not
acceptable may apply.
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F.4 FIELDS OF TESTING
The environmental toxicology PT program shall be organized by fields of testing based on method
[including matrix, test organism, and exposure system and endpoint(s)]. Laboratories may choose
to participate in one or more PT fields of testing, or portions thereof.
F.4.1 Whole Effluent Toxicity (WET) Method Codes
Prior to NIST accreditation of PT Providers for Environmental Toxicology methods, laboratories
seeking WET accreditation shall be assessed through on-site audit and evaluation of EPA
Discharge Monitoring Report - Quality Assurance (DMR-QA) test results. During this interim
period, a failed DMR-QA endpoint shall require: 1) a formal response to the Accrediting Authority
(AA) with an explanation of probable cause for the endpoint failure and description of corrective
actions to be taken (where appropriate) and 2) a decision by the AA to accept the response or
require additional on-site audits. There shall be no loss of accreditation based solely on PT results
during this interim period.
If a laboratory fails a WET PT endpoint, the laboratory is required to successfully complete a
remedial study. A remedial study must be conducted, at least 30 calendar days from the previous
PT study, until two acceptable results are obtained. The AA may conduct additional onsite audits
as necessary. The default for the WET PT program is accreditation without PT samples.
Interim method codes shall reflect the EPA DMR-QA study codes for the current study year.
F.4.2 Test Conditions for Sediment Toxicity (Solid Phase)
The following table describes the test conditions to be followed for sediment toxicity testing:
Test Organism
Freshwater amphipod
Midge larvae
Saltwater amphipod
Polychaete worm
Test Conditions
10-d, static, renewal, synthetic MHW
10-d, static, renewal, synthetic MHW
10-d, static, non-renewal, synthetic SW @ 20 %o
10-d, static, non-renewal, synthetic SW @ 28 %o
Method Code
TBS1
TBS
TBS
TBS
1 TBS = To Be Specified
F.4.2.1 Sediment Toxicity PT Samples
Accreditation for whole sediment toxicity methods shall be based solely on the on-site audit until
further notice.
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F.4.3 Test Conditions for Soil Toxicity
The following table describes the test conditions to be followed for soil toxicity testing:
Test Organism
Eisenia foetida survival test
Lettuce (Lactuca sativa) seed
germination test
Lettuce (Lactuca sativa) root
elongation test
Test Conditions
14-d static, non-renewal, 24L:OD
120-h static, non-renewal, 16L:8D
120-h static, non-renewal, OL:24D
Method Code
TBS1
TBS
TBS
11 TBS = to be specified
F.4.3.1 Soil Toxicity PT Samples
Accreditation for soil toxicity methods shall be based solely on the on-site audit until further notice.
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APPENDIX G
RADIOCHEMISTRY
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Appendix G - RADIOCHEMISTRY
G.O PURPOSE
This appendix contains the NELAC requirements for radiochemical proficiency testing under the
Safe Drinking Water Act (SDWA). The appendix supplements the requirements of Chapter 2 and
Appendices A, B, and C with requirements specific for NELAC radiochemical proficiency testing
studies.
Radiochemical proficiency testing for other USEPA Programs shall be added as the necessary
resources, proficiency testing objectives and supporting data are available.
Other pertinent information concerning the SDWA radiochemical proficiency testing samples are
available from the NELAC PT Committee Chair or the Executive Director of NELAP.
G.1 PROFICIENCY TESTING PROVIDER LICENSING
Possession, transfer and use of many radioactive materials is regulated by the Nuclear Regulatory
Commission (NRC) or State radiological departments. The PT Provider shall ensure that they are
licensed not only for the possession and use of radioactive materials in their facility but also for the
explicit distribution of these materials in commerce.
G.2 SDWA SAMPLE DESIGN
The PT Provider must ensure that the sample design used for the SDWA radiochemical PT
samples meets the applicable criteria contained in the USEPA's "National Standards for Water
Proficiency Testing Studies, Criteria Document".
G.2.1 ASSIGNED VALUES
Assigned values must be within the ranges established by the USEPA in the "National Standards
for Water Proficiency Testing Studies, Criteria Document", where they apply. Assigned values are
selected such that the concentration of each analyte will vary over time throughout the
concentration range. The PT Provider must also ensure that the method for selecting an assigned
value meets the applicable criteria contained in the EPA's "National Standards for Water
Proficiency Testing Studies, Criteria Document". The assigned value is determined based on the
mass of standard added to the volume of water as follows:
Assigned value (pCi/L) = pCi activity added + volume preserved water * dilution factor.
G.3 SCORING
Each result from a participating laboratory is classified as "Acceptable" or "Not Acceptable"
following the procedures contained in Chapter 2, Appendix C. The acceptance limits are equal to ±2
"single determination" standard deviations (USEPA's "National Standards for Water Proficiency
Testing Studies, Criteria Document") and are centered on the assigned values.
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G.4STUDY TIMETABLES
Semi-annual proficiency testing is required per the schedule contained in Section 2.4. The
samples shall be analyzed and the results returned to the PT Provider within the applicable time
frames specified in the USEPA's "National Standards for Water Proficiency Testing Studies,
Criteria Document."
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APPENDIX H
PERFORMANCE TESTING
REQUIREMENTS FOR FIELD AIR
MEASUREMENT
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Appendix H - Performance Testing Requirements for Field Air Measurement
H.O INTRODUCTION: PURPOSE, SCOPE, AND APPLICABILITY
This Appendix defines the criteria to be used by any entity which seeks to participate as a
Proficiency Test Provider and score the results obtained from the analyses of samples in an air
measurement NELAC PT Study. This appendix specifically covers performance testing (PT)
requirements for Source and Ambient air field measurement conducted for regulatory compliance.
There are two categories of performance testing performed for compliance related air sample field
measurement: 1) calibration-based performance testing conducted for field instruments for which
delivery of a representative, quality controlled PT sample is not practical, and 2) performance
testing for field instruments for which delivery of a representative, quality controlled PT sample is
possible. For example, EPA Method 5 is used to collect (on a batch, time-integrated basis)
particulate matter from stationary emission sources. The equipment metering box and probe are
calibrated per the method prior to and then upon its return from the field after sampling is
completed. During its use in the field there is no practical means of introducing a controlled PT
sample (category 1 example). In contrast, continuous emission monitors (CEMs) for both ambient
air and source emission monitoring can be challenged with a PT gas in a cylinder to determine
performance of that instrument during its operation in the field (category 2 example).
In category 1 for field measurements in which the delivery of acceptable and appropriate PT
samples is not possible, calibration and maintenance requirements outlined in Chapter 5 Quality
Systems or Chapter 7 Field Activities will be used to assure the quality and representativeness for
field measurement data.
This standard is being developed only for the category 2 performance testing of field measurements
where delivery of a standard PT sample is possible. Calibration-based performance testing will be a
subset of either the NELAC Quality Systems or Field Activities Chapters, as appropriate.
For field measurements that fall under this standard, 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 initial PT performance for a group of interdependent analytes can be
evaluated as "Pass" or "Fail." The PT Providers will submit all field measurement performance
rating(s) to the Primary Accrediting Authority, as described in Chapter 2 of the NELAC standards,
to be used as a tool for determining a laboratory's accreditation status. PT acceptance limits and
pass/fail criteria are established on a PT field of testing basis.
H.1 Proficiency Testing for Field Air Measurement
Field air measurements refer to measurements taken in the field for regulatory compliance.
Examples include continuous emission monitors (CEM) used to obtain real-time measurements of
emissions from industrial point source discharges or from ambient air monitoring. Also included
are gaseous organic emissions by gas chromatography (GC) and Fourier transform infrared (FTIR)
spectroscopy real-time monitors used to monitor criteria pollutants at a Superfund site fence line..
NELAC intends to develop PT criteria for relevant field measurements. The criteria will be
developed to mirror PT criteria for laboratory sample analysis; however, for many field
measurements, delivery of representative, quality controlled PT samples will be problematic. The
standard will be developed to address those field measurements for which PT sample delivery is
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possible. For field measurements in which delivery of acceptable PT samples is not possible,
calibration and maintenance requirements outlined in Ch. 5 Quality Systems will be used to assure
the quality and representativeness of field measurement data.
H.2 ACCEPTANCE LIMITS
Acceptance limits are established for each 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.
H.2.1 Analyte Acceptance Limit Categories
Acceptance limits are separated into two categories. Results for analytes with acceptance limits
determined as described in Sections H.2.1.1 and H.2.1.2 shall 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 H.2.1.3 shall not be used as part of the PT field of testing
pass/fail evaluation.
H.2.1.1 Analytes with USEPA Established Acceptance Limits (Prepared ± fixed
percentage or Mean ± 2 standard deviations)
PT Providers shall utilize the proficiency test acceptance limits that have been established by
USEPA in the National Standards for air proficiency testing studies where they apply. The
National Standards are incorporated into this Appendix by reference. EPA's established proficiency
test acceptance limits for chemical analytes are typically expressed in the following manner:
Prepared ± fixed percentage. Acceptance limits shall be set at plus and minus the published
fixed percentage of the analyte's verified prepared value.
Mean ± 2 standard deviations. The NELAC Standing Committee on Proficiency Testing has a
process for establishing linear regression equations relating a PT samples prepared value to mean
and prepared value to standard deviation, acceptance limits shall be set using said equations and
the sample's verified prepared value. Linear regression equations may only be used for prepared
values that fall within the range of prepared values used to establish said equations. In the event
that there are no linear regression equations available for a given analyte, that analyte shall be
treated as described in Section H.2.1.3.
H.2.1.2 Analytes with acceptance limits derived from regression equations established
by the NELAC Standing Committee on Proficiency Testing
When USEPA Program regulations for establishing acceptance criteria are not available Proficiency
Test providers shall set acceptance limits using regression equations that predict the mean and
standard deviation for an analyte in a given range of concentrations. Regression equations shall be
derived by the NELAC Standing Committee on Proficiency Testing and shall be made available to
PTPA-approved PT Providers by the PT Committee Chair or the Executive Director of NELAP. Data
from sources such as the USEPA PE studies, interlaboratory results from professional
organizations such as ASTM, other proficiency testing providers, commercial and non-profit
organizations, shall be used to establish the equations. All regression equations shall be approved
by the NELAC Standing Committee on Proficiency Testing prior to use by a PTPA-approved PT
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Provider. For these analytes, the PT Provider shall use the sample's verified prepared value and
said equations to determine the mean and standard deviation.
H.2.1.3 Experimental Data: Analytes without promulgated acceptance limits or
established regression equations
For those analytes not included in categories H.2.1.1 or H.2.1.2, e.g., newly regulated analytes, or
analytes in a matrix that have not been fully evaluated in interlaboratory studies, NELAC
acceptance limits shall be established only after interlaboratory data has been collected for a
minimum of one year unless the NELAC Standing Committee on Proficiency Testing 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". The NELAC Standing Committee on Proficiency Testing
shall derive regression equations to be used to establish acceptance limits for analytes in the
experimental category after sufficient data have been collected. The laboratory shall receive a copy
of its own experimental data from the PT Provider at the conclusion of the PT study.
H.3 ACCEPTABLE PT RESULTS FOR CHEMICAL ANALYTES IN FIELD AIR PT
MEASUREMENTS
Criteria for acceptable results for will be dependent on the precision and accuracy of the accepted
field measurement method. A laboratory's PT analyte result is acceptable when it falls within the
regulatory promulgated acceptance limits (Section H.2.1.1). For Section H.2.1.2 analytes, PT
Providers shall use the PT sample's verified prepared value and said regression equations to
determine the mean and standard deviation. Acceptance limits shall be set at the mean ± two
standard deviations for ambient air or source sample analytes. A result is acceptable when it falls
within these derived acceptance limits.
H.4 NOT ACCEPTABLE PT RESULTS FOR SOURCE AND AMBIENT PT SAMPLES
Criteria for acceptable results for will be dependent on the precision and accuracy of the accepted
field measurement method. A laboratory's result for any analyte is considered unacceptable if it
meets any of the following criteria:
a) The result falls outside the USEPA's promulgated acceptance limits (Section H.2.1.1) or
outside prediction interval derived from established regression equations;
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", (or similar indication of no detection), for an
analyte present in the PT sample (i.e., a false negative);
NOTE: If a laboratory reports a result less then the lowest concentration contained in the
NELAC-approved PT concentration range for an analyte present in the PT sample at
a concentration within the NELAC-approved PT concentration range, the result shall
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.
H.5 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 H.1 through
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H.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.
H.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.
An example of interdependent PT analytes includes GC monitoring of a suite of VOC analytes
using EPA Method 18.
H.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, or may contain multiple analytes. Currently,
non-interdependent analytes are not expected to apply to the air matrix.
H.5.3 Promulgated USEPA Pass/fail Criteria
In all cases, promulgated USEPA pass/fail criteria, e.g., drinking water volatiles as listed in 40 CFR
141.61(a), subsection (m)(1), shall be used as NELAC PT pass/fail criteria as applicable. The
criteria described in Section 5.4 shall be used in the absence of promulgated USEPA pass/fail
guidelines.
H.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
for XX% of the analytes in an Interdependent Analyte PT Sample. Greater than 100-XX% "Not
Acceptable" results shall 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. A "Not Acceptable" result for the same analyte in two consecutive PT studies shall also
result in the laboratory receiving a score of "Fail" for that analyte.
H.5.5 Pass/fail Criteria For Non-Interdependent Analyte PT Samples
For non-interdependent analytes one unacceptable result would be failing for laboratory analysis.
Currently, non-interdependent analytes are not expected to apply to the air matrix.
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03 ?
CD
ON-SITE
ASSESSMENT
June 29, 2000
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TABLE OF CONTENTS
3.0 ON-SITE ASSESSMENT 1
3.1 INTRODUCTION 1
3.2 ON-SITE ASSESSMENT PERSONNEL 1
3.2.1 Basic Qualifications 1
3.2.2 Assessor Qualification 2
3.2.3 Training 2
3.3 FREQUENCY AND TYPES OF ON-SITE ASSESSMENTS 5
3.3.1 Frequency 5
3.3.2 Follow-up On-site Assessments 5
3.3.3 Changes in Laboratory Capabilities 6
3.3.4 Announced and Unannounced Visits 6
3.4 PRE-ASSESSMENT PROCEDURES 6
3.4.1 Assessment Planning 6
3.4.1.1 Assessment Team 6
3.4.1.2 Technical Support Personnel 7
3.4.2 Scope of the Assessment 7
3.4.2.1 Laboratory Assessments 7
3.4.2.2 Records Review 7
3.4.3 Information Collection and Review 7
3.4.4 Assessment Documents 8
3.4.5 Confidential Business Information (CBI) Considerations 8
3.4.6 National Security Considerations 10
3.5 ASSESSMENT PROCEDURES 10
3.5.1 Length of Assessment 10
3.5.2 Opening Conference 10
3.5.3 On-site Laboratory Records Review and Collection 11
3.5.4 Staff Interviews 11
3.5.5 Closing Conference 11
3.5.6 Reporting Procedures 12
3.5.7 Assessment Closure 12
3.6 STANDARDS FOR ASSESSMENT 12
3.6.1 Areas of Assessment 12
3.6.2 Assessor's Role 13
3.6.3 Use of Checklists 13
3.6.4 Standards of Professional Conduct for Assessors 13
3.7 DOCUMENTATION OF ON-SITE ASSESSMENT 14
3.7-1 Checklists/Records 14
3.7.2 Report Format 15
3.7.3 Distribution 15
3.7.4 Release of On-site Assessment Report 15
3.7.5 Record Retention Time 16
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3.0 ON-SITE ASSESSMENT
3.1 INTRODUCTION
The on-site assessment is an integral and requisite part of the NELAC laboratory accreditation program
and is one of the primary means of determining a laboratory's capabilities and qualifications. During
the on-site assessment, the assessment team collects and evaluates information and makes
observations which are used to judge the laboratory's conformance with established accreditation
standards.
It is essential that the on-site assessments conducted by all accrediting authorities recognized by the
National Environmental Laboratory Accreditation Program be conducted in a uniform, consistent
manner.
This section describes the essential elements that must 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 Basic Qualifications
An assessor must be an experienced professional and hold at least a Bachelor's degree in a scientific
discipline or have equivalent experience in environmental laboratory assessment.
Each assessor must satisfactorily complete a training program approved by the accrediting authority
responsible for on-site assessments. This program shall include training on the NELAC standards;
on how to conduct a laboratory assessment; on the technology and requirements appropriate for each
particular field of testing for which they are conducting laboratory on-site assessments; and
participation in at least four actual NELAC on-site assessments under the supervision of a qualified
assessor. Training in the NELAC standards and on how to conduct a laboratory assessment can be
satisfied by successful completion of NELAC Basic Assessor Training. Assessors must take annual
refresher/update training as defined in Section 3.2.3. Assessors employed by an accrediting authority
(either directly or as a third party) when the accrediting authority is granted NELAP recognition (See
Section 6.7) are exempt from the requirement to undergo training with a qualified assessor, provided
they have previously conducted four assessments and been judged proficient by the accrediting
authority.
All assessors must complete NELAC Basic Assessor Training within two years of becoming an
assessor. Assessors must complete the applicable technical training requirements within four years
after the NELAC-specified technical training is offered.
Each new candidate assessor must undergo training with a qualified assessor during four or more
actual assessments until judged proficient by the accrediting authority.
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In addition, the assessors must:
a) Be familiar with the relevant legal regulations, accreditation procedures, and accreditation
requirements;
b) Have a thorough knowledge of the relevant assessment methods and assessment documents;
c) Be 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) Have a working knowledge and be 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.
3.2.2 Assessor Qualification
Before an assessor can conduct on-site assessments, an accrediting authority must qualify the
individual. 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 makes the proposed assessor ineligible to participate in
the assessment program.
3.2.3 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 is implemented by either
accrediting authorities, assessor bodies, or other entities. All assessor training programs, must meet
the standards defined in the Chapter.
The purpose of the basic assessor training is to familiarize the assessor with the NELAC standards
and the skills and techniques associated with the laboratory assessment. The basic assessor training
program is defined as follows:
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NELAC Basic Assessor Training
DAY1
Basic Laboratory Assessment Techniques and Skills
DAY 2
- NELAC Overview (Chapter 1 NELAC Standards)
Accrediting Authority (Chapter 6)
Accreditation Process (Chapter 4)
Proficiency Testing (Chapter 2)
DAY 3
Quality Systems (Chapter 5)
DAY 4
On-site Assessment (Chapter 3)
DAYS
Summary
Written Examination
NOTE: Until such time as the NELAC has developed the training program for laboratory assessors,
each accrediting authority shall approve the training for each of its assessors (federal, State and/or
third party).
When the NELAC has approved the assessor training program standards defined in this section,
accrediting authorities, assessor bodies, or other entities may petition for approval of various formal
training programs that address laboratory assessment skills which may meet the NELAC standards.
It is the intent of this chapter to allow those assessors that produce evidence of successful completion
of approved alternative training concerning assessment to be exempt from the analogous NELAC
training. The specific training associated with the NELAC standards is required and must be
successfully completed. All assessor candidates must pass the written examination.
In addition to the basic NELAC assessor training, each assessor must successfully complete training
in at least one technical discipline.
The purpose of the technical training is to ensure consistency of knowledge and techniques among
the NELAC assessors. The technical training assumes a level of basic knowledge of the subject and
concentrates on the elements of the technology or methods that are key to properly assure laboratory
competency to deliver data of known and documented quality. The technical training program consists
of the following :
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NELAC Technical Training for Assessors
TECHNICAL DISCIPLINES
1. Microbiology (2.5 davs^
Bacteriology
Viruses/Parasites
Microscopic Particulate Analysis (MPA)
2. Biological (2.5 davsl
- Aquatic Toxicity Testing
Freshwater/Marine/Estuarine Fish
Freshwater/Marine/Estuarine
- Icthyoplankton
- Macrophytes
Periphyton
Phytoplankton
Zooplankton
Biomass
Chlorophyll a (Spectrophotometric and Fluorometric)
3. Inorganic - Nonmetals/MIsc (2.5 days)
Spectrophotometric
Titrimetrlc
Potentiometric
- Colorimetric
- TOC/TOX
- Residue/Solids
- COD/BOD
- IR
- 1C
4. Inorganic - Metals (2.5 days)
- FAA
- GFAA
- ICP
- ICP/MS
- Sample Preparation (Digestion/TCLP/etc.)
5. Organics (5 days)
- Sample Preparation
- HPLC
- GC
- GC/MS
- Instrument Software
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6. Asbestos (2.5 days)
- Bulk
- Air
- Water/TEM (Day 1. Assessors not requiring TEM could begin training on second day)
7. Radiochemistry (2.5 days)
8. Field Activities (tbd days)
- Source/Ambient Testing (CAA, RCRA, TSCA)
E.q. Air Source Testing
Basic Principles of Manual Methods
Basic Principles of Instrumental Methods
- Soil/Groundwater (SARA, RCRA, TSCA, FIFRA)
- Surface Water (CWA, RCRA, TSCA, FIFRA)
- Drinking Water (SDWA)
Multi-media (mix of above)
Biological
The purpose for requiring refresher/update training for all assessors is to ensure that the assessors are
aware of changes to the standards and/or approved analytical methodology as they occur and to
enhance and improve skills associated with assessment. Assessors are expected to maintain
proficiency on an on-going basis. Assessors must complete refresher/update training annually.
Initially, the refresher/update training is conceptualized as follows:
NELAC Refresher/Update Training for Assessors
Day 1
- Changes to the NELAC Standards and the Resulting Checklist Changes
Technical Changes Associated with Approved Methodology and the Resulting Checklist
Changes
- Assessment Skills and Techniques
Current Developments
3.3 FREQUENCY AND TYPES OF ON-SITE ASSESSMENTS
3.3.1 Frequency
The accrediting authority must conduct a comprehensive on-site assessment of each laboratory prior
to granting accreditation, except as allowed by interim accreditation (see Section 4.5.1). In addition,
an on-site assessment of each accredited laboratory must be completed at least every two years.
Assessments for cause are conducted more frequently, at the option of the accrediting authority.
3.3.2 Follow-up On-site Assessments
If directed by an accrediting authority, assessors must 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
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as to possibly warrant the downgrading of a laboratory's accreditation status, any follow-up
assessment that is planned or conducted must be completed and reported within thirty (30) calendar
days after the receipt of the laboratory's plan of corrective action.
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 authority's 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
When a change occurs in a laboratory's ownership, location, key personnel, or major instrumentation,
notification of the accrediting authority is required within 30 days (see Section 4.3.2). The accrediting
authority must evaluate the significance of a change that might alter or impair the laboratory's capability
and quality, and indicate to the laboratory the results of their evaluation in writing. The accrediting
authority must retain records to indicate that such an evaluation was conducted.
3.3.4 Announced and Unannounced Visits
The accrediting authority, at its discretion, conducts either unannounced or announced on-site
assessments. The accrediting authority is not required to provide advance notice of an assessment.
To the maximum extent practical, accrediting authorities shall, when necessary, work with Federal
departments/agencies/contractors to obtain government security clearances for their assessors as far
in advance as possible. Federal departments/agencies/contractors shall facilitate expeditious
attainment of the necessary clearances.
3.4 PRE-ASSESSMENT PROCEDURES
3.4.1 Assessment Planning
A good assessment begins with planning, which starts 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 saves 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: determining 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.
3.4.1.1 Assessment Team
It is encouraged that teams directed by a lead assessor perform assessments. A single assessor
knowledgeable in the discipline, methods, and regulations applicable to the laboratories he or she
assesses can competently perform some on-site assessments.
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The accrediting authority determines the number and expertise of the assessors and support personnel
that are required to conduct the on-site assessment based on the type of assessment and the scope
of accreditation of the accredited or applicant laboratory.
3.4.1.2 Technical Support Personnel
An assessment team may include technical support personnel approved by the primary accrediting
authority as capable of providing assistance to the assessors. These individuals need not be formally
qualified by the accrediting authority as assessors (see Section 3.2.2). If not so qualified, these
individuals must still meet the requirements of the standards concerning conflicts of interest and
professional conduct. Members of the assessment team who provide technical assistance but are not
qualified as assessors are not eligible to conduct interviews in the absence of the assessor nor to cite
deficiencies.
3.4.2 Scope of the Assessment
The first step in the assessment planning process is deciding the extent of the assessment. 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 the complete scope of
accreditation for which the laboratory seeks or maintains accreditation within the specific field of testing
as authorized by the accrediting authority.
3.4.2.1 Laboratory Assessments
A laboratory assessment must review the ability of the laboratory 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 must 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
the 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, the quality system, and other information to technically substantiate
reports previously issued. During a records review, the assessment team conducts an overall
assessment of data and compares the data with submitted reports to determine whether the data
collected, generated, and reported follow 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 include,
but are not limited to:
a) Copies of previous assessment reports and proficiency testing sample results;
b) General laboratory information such as laboratory submitted self-assessment forms, SOPs and
Quality Assurance Plan(s);
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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.);
g) The most recently approved or in use laboratory methods for the tests for which the laboratory has
requested or maintains accreditation, and
h) The laboratory's Quality Manual.
3.4.4 Assessment Documents
Documents necessary for the assessment must be provided to the laboratory management or staff and
assembled before the assessment, whenever possible. The lead assessor must obtain copies of all
forms required for the assessment, including the appropriate checklist(s). Other types of documents
include:
Assessment Confidentiality Notice;
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 must provide information to the laboratory on how to obtain assessment
information from the accrediting authority.
3.4.5 Confidential Business Information (CBI) Considerations
During assessments, if assessors come into possession of information claimed as business
confidential, the following procedures must be implemented. The EPA regulations for handling
confidential business information are detailed in Title 40. Code of Federal Regulations. Part 2. Subpart
B and must be followed in NELAP-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."
Consistent with 40 CFR Part 2, NELAC standards must protect Confidential Business Information (CBI)
from disclosure. For this information to be adequately protected, NELAP requires certain actions of
assessors and the laboratory. The lead assessor must provide a NELAP assessment confidentiality
notice to the responsible laboratory official at the beginnirig 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 that contain the information claimed as CBI. The lead assessor must take custody of all
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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
State laws.
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 that may take further action outside the scope of the
accreditation process, to obtain the client's identity. If 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 40 CFR Part 2. If the accrediting authority questions the claim that certain
information is CBI, the host laboratory must be contacted and given twenty-one (21) calendar 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 shall 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 has the option to pursue any or all of the above stated actions.
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3.4.6 National Security Considerations
Assessors performing assessments at laboratories owned and/or operated by Federal
departments/agencies/contractors must review the need for security clearances, appropriate badging,
and/or a security briefing before proceeding with the on-site assessment. The laboratory must inform
the assessors in writing of any information, including data, that is controlled for national security
reasons and cannot be released to the public.
NELAP assessment teams performing an on-site assessment of a Federal agency may need security
clearances, appropriate badging, and/or a security briefing before proceeding with the on-site
assessment. Assessors shall be informed in writing of any information that is controlled for national
security reasons and cannot be released to the public.
3.5 ASSESSMENT PROCEDURES
3.5.1 Length of Assessment
The length of an on-site assessment depends 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 accrediting authority must 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 extent the laboratories'
operations meet NELAC standards.
3.5.2 Opening Conference
Arrival at the facility for routine NELAC assessments occurs during established working hours unless
special arrangements are made with the laboratory.
A laboratory's refusal to admit the assessment team for assessment results 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 assessment 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;
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g) any special safety procedures that the laboratory may 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) the confirmation of the tentative time for the exit conference;
j) the presentation of the assessment appraisal form to the responsible laboratory official for
submittal to the accrediting authority; and
k) the discussion of any questions the laboratory may have about the assessment process.
3.5.3 On-site Laboratory Records Review and Collection
Assessment team members must review laboratory records for accuracy, completeness and the use
of proper methodology. NELAC Chapter 5, Section 5.12 lists the records required for review during the
assessment. The assessor must document the required elements of the records review on the NELAC
assessment checklists.
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 is confidential, the information must be treated as confidential until a ruling can be made
by the accrediting authority.
3.5.4 Staff Interviews
As an element of the assessment process, the assessment team evaluates the analysis process by
requesting that the analyst(s) normally conducting the test(s) give a step-by-step description of exactly
what is done and what equipment and supplies are needed to complete the analysis. Any deficiencies
shall be noted and discussed with the analyst. The deficiencies must be discussed again 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 the complete scope of accreditation with the
appropriate analyst(s).
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. 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. The assessors must describe all deficiencies identified-to-date during the closing
conference with the possible exception of any issues of improper and/or potentially illegal actiivity,
which may be the subject of further action.
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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 makes a determination as to the validity of the contested elements.
The assessment team must 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 Reporting Procedures
The accrediting authority or its authorized third party must present an assessment report to the
laboratory within thirty (30) calendar days of the assessment. The laboratory has thirty (30) calendar
days from the date of receipt of the report to provide a plan of corrective action to the accrediting
authority (see Section 4.1.3). An exception to these deadlines is in those circumstances where a
possible enforcement investigation or other action has been initiated.
3.5.7 Assessment Closure
After reviewing the assessment report and any completed corrective action(s) reported by the
laboratory, the accrediting authority makes the determination of the accreditation status for a
laboratory.
If the deficiencies listed in the initial assessment report are substantial or numerous, additional on-site
assessment may be conducted before a final decision for accreditation following the procedures of the
accrediting authorities.
3.6 STANDARDS FOR ASSESSMENT
3.6.1 Areas of Assessment
The areas to be evaluated during an on-site assessment to determine the competence of an
environmental laboratory shall include:
a) Organization and Management
b) Quality System - Establishment, Assessments, Essential Quality Controls and Data Verification
c) Personnel
d) Physical Facilities - Accommodation and Environment
e) Equipment and Reference Materials
f) Measurement Traceability and Calibration
g) Test Methods and Standard Operating Procedures
h) Sample Handling, Sample Acceptance Policy and Sample Receipt
I) Records
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j) Laboratory Report Format and Contents
k) Subcontracting of Analytical Samples
I) Outside Support Services and Supplies
m) Complaints
These areas must be evaluated against the standards detailed in Chapter 5, Quality Systems, Chapter
2, Proficiency Testing and Chapter 4, Accreditation Process of the NELAC Standards and the
appropriate method references. Sufficient detail is provided in Chapter Five (5) and/or the method
reference(s) cited to enable accrediting authorities to evaluate laboratories consistently and uniformly.
3.6.2 Assessor's Role
The on-site assessor uses 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 depends primarily upon the assessment team's findings. Much of the on-site
assessment depends upon the assessor's observations of existing conditions (i.e. observing operations
and processes). 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 assessment report
of the on-site assessment. The assessment team must use specific documentation in its reporting of
deficiencies.
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 must 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 must 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 must continue to gather the information necessary to
complete the accreditation assessment.
3.6.3 Use of 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 that assists in
conducting a thorough and efficient assessment. A checklist is not a substitute for assessor training
and experience.
3.6.4 Standards of Professional Conduct for Assessors
Professional standards apply to every NELAC assessor, whether a government employee or an
employee of a third party organization conducting assessments under an agreement with a NELAP
accrediting authority. Assessors that knowingly engage in unprofessional activity may be liable for
punitive actions as initiated by the affected accrediting authority.
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The Standards for Professional Conduct, as outlined in this section, are based upon 5 CFR 2635,
"Standards of Ethical Conduct for Employees of the Executive Branch" and will be followed in NELAP
related matters. NELAC assessors shall:
a) have no interest at play other than that of the accrediting authority and NELAC during the entire
accreditation process;
b) act impartially and not give preferential treatment to any organization or individual;
c) provide equal treatment to all persons and organizations regardless of race, color, religion, sex,
national origin, age, and/or disability;
d) not use their position for private gain;
e) not solicit or accept any gift or other item of monetary value from any laboratory, laboratory
representative, or any other affected individual or organization doing business with, or affected by,
the actions of the assessor's employer or accrediting authority;
f) not hold financial interests that conflict with the conscientious performance of their duties;
g) not engage in financial transactions using information gained through their positions as assessors
to further any private interest;
h) not engage in employment activities (seeking or negotiating for employment) or attempt to arrange
contractual agreements with a laboratory that would conflict with their duties and responsibilities
as an assessor;
i) not knowingly make unauthorized commitments or promises of any kind purporting to bind the
affected accrediting authority and,
j) attempt to avoid any actions that could create even the appearance that they are violating any of
the standards of professional conduct outlined in this section.
Assessors are reminded that it is their responsibility to report to the affected accrediting authority any
personal issues or activities that constitute a conflict of interest before an assessment occurs. It is up
to the affected accrediting authority to determine if the reported issues and activities regarding a
specific assessor constitute, or be construed as, a conflict of interest. Appeals of decisions made by
accrediting authorities regarding such matters must be directed to the Executive Director of the
NELAC, who shall make the final decision as to the merit of such appeals.
3.7 DOCUMENTATION OF ON-SITE ASSESSMENT
3.7.1 Checklists/Records
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. The assessor shall specify the laboratory
records, documents, equipment, procedures, or staff evaluated and the observations that contributed
to the evaluation of "No" for each assessment checklist item. This information must be documented
in the comments section or referenced on the checklist. The assessment report must contain
sufficient evidence to support all assessment findings and the overall evaluation of the laboratory.
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3.7.2 Report Format
The final assessment report shall be written to contain a description of the adequacy of the laboratory
as it relates to the assessment standards in Section 3.6.1. Assessment reports must be generated
in a narrative format. Documentation of existing conditions at the laboratory must be included in each
report to serve as a baseline for future contacts with the facility.
Assessment reports must 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 observations, findings (deficiencies) and requirements, and,
h) Comments and recommendations.
The Findings and Requirements section must be referenced to the NELAC standards 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 assessment 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 Release of On-site Assessment Report
On-site assessment reports must 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 National Accreditation Database and the public until findings of the assessment and the
corrective actions have been finalized, all Confidential Business Information and information related to
national security has been stricken from the report in accordance with prescribed procedures, and the
report has been provided to the laboratory (see Section 4.1.3).
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, must
be considered exempt from release to the public.
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3.7.5 Record Retention Time
Copies of all assessment reports, checklists, and laboratory responses must be retained by the
accrediting authority for a period of at least five (5) years, or longer if required by specific State or
Federal regulations (see Sections 4.3.3 & 5.12.2(b)).
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TABLE OF CONTENTS
ACCREDITATION PROCESS
4.0 ACCREDITATION PROCESS 1
4.1 COMPONENTS OF ACCREDITATION 1
4.1.1 Personnel Qualifications 1
4.1.1.1 Definition, Technical Director(s) 1
4.1.1.2 Personnel Qualification Clarifications and Exceptions 3
4.1.2 On-site Assessments 3
4.1.3 Corrective Action Reports In Response to On-Site Assessment 4
4.1.4 Proficiency Testing Samples 4
4.1.5 Accountability for Analytical Standards 5
4.1.6 Fee Process for National Accreditation 5
4.1.7 Application 6
4.1.7.1 Primary Application Package 6
4.1.7.2 Secondary Accreditation Package 6
4.1.8 Change of Ownership and/or Location of Laboratory 7
4.1.9 "Certification of Compliance" Statement 7
4.2 PERIOD OF ACCREDITATION 8
4.3 MAINTAINING ACCREDITATION 8
4.3.1 Quality Systems 8
4.3.2 Notification and Reporting Requirements 9
4.3.3 Record Keeping and Retention 9
4.4 DENIAL, SUSPENSION, AND REVOCATION OF ACCREDITATION 9
4.4.1 Denial 9
4.4.2 Suspension 10
4.4.3 Revocation 11
4.4.4 Voluntary Withdrawal 11
4.5 INTERIM ACCREDITATION 12
4.5.1 Interim Accreditation 12
4.5.2 Revocation of Interim Accreditation 12
4.6 AWARDING OF ACCREDITATION 12
4.6.1 Use of NELAC Accreditation by Accredited Laboratories 12
4.6.2 Changes in Fields of Testing 12
4.7 DUE PROCESS 13
4.8 ENFORCEMENT 13
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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.)
Laboratories applying for accreditation may be fixed-base or mobile.
a) An individual fixed-base laboratory requires a separate accreditation. The primary accrediting
authority shall determine what constitutes an individual fixed-base laboratory when noncontiguous
laboratory facilities operate under the same ownership, technical directorship, and quality system
as the parent laboratory.
b) The primary accrediting authority shall determine if a separate accreditation is required for a
mobile laboratory that is owned by an accredited fixed-base laboratory, operates under the same
quality system as the fixed-based laboratory, performs a subset of the analyses for which the
fixed-base laboratory is accredited, and operates exclusively within the state in which the parent
fixed-base laboratory is located.
c) Separate accreditation by the primary accrediting authority is required for a mobile laboratory that
is owned by an accredited fixed-base laboratory, operates under the same a quality system as the
fixed-based laboratory, performs a subset of the analyses for which the fixed-base laboratory is
accredited, and operates outside of the state In which the parent fixed-base laboratory is located.
d) Separate accreditation by the primary accrediting authority is required for a mobile laboratory that
is owned by a fixed-base laboratory but operates under a different quality system or performs
analyses for which the parent fixed-base laboratory is not accredited.
e) Separate accreditation by the primary accrediting authority is required for a mobile laboratory that
is not owned and operated by a fixed-base laboratory.
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 Qualifications
Persons who do not meet the education credential requirements but possess the requisite experience
of Section 4.1.1.1 of the NELAC standards and are the technical director(s) on the date that the
laboratory becomes subject to these NELAC Standards and obtains accreditation shall qualify as
technical directors) for the same field(s) of testing of that laboratory or any other NELAC-accredited
laboratory.
4.1.1.1 Definition, Technical Director(s)
The technical director(s) means a full-time member of the staff of an environmental laboratory who
exercises actual day-to-day supervision of laboratory operations for the appropriate fields of testing 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. A laboratory may appoint one or more
technical directors for the appropriate fields of testing for which they are seeking accreditation. His/her
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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. An individual
shall not be the technical directors) of more than one accredited environmental laboratory without
authorization from the primary Accrediting Authority. Circumstances to be considered in the decision
to grant such authorization shall 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. The technical director(s) who is absent for a
period of time exceeding 15 consecutive calendar days shall designate another full-time staff member
meeting the qualifications of the technical director(s) to temporarily perform this function. If this
absence exceeds 65 consecutive calendar days, the primary accrediting authority shall be notified in
writing.
Qualifications of the technical director(s).
a) Any technical director of an accredited environmental laboratory engaged in chemical analysis
shall be a person with a bachelors degree in the chemical, environmental, biological sciences,
physical sciences or engineering, with at least 24 college semester credit hours in chemistry and
at least two years of experience in the environmental analysis of representative inorganic and
organic analytes for which the laboratory seeks or maintains accreditation. A masters or doctoral
degree in one of the above disciplines may be substituted for one year of experience.
b) Any technical director of an accredited environmental laboratory limited to inorganic chemical
analysis, other than metals analysis, shall be a person with at least an earned associate's degree
in the chemical, physical or environmental sciences, or two years of equivalent and successful
college education, with a minimum of 16 college semester credit hours in chemistry. In addition,
such a person shall have at least two years of experience performing such analysis.
c) Any technical director of an accredited environmental laboratory engaged in microbiological or
biological analysis shall be a person with a bachelors degree in microbiology, biology, chemistry,
environmental sciences, physical sciences or engineering with a minimum of 16 college semester
credit hours in general microbiology and biology and at least two years of experience in the
environmental analysis of representative analytes for which the laboratory seeks or maintains
accreditation. A masters or doctoral degree in one of the above disciplines may be substituted
for one year of experience.
A person with an associate's degree in an appropriate field of the sciences or applied sciences,
with a minimum of four college semester credit hours in general microbiology may be the technical
directors) of a laboratory engaged in microbiological analysis limited to fecal coliform, total
coliform and standard plate count. Two years of equivalent and successful college education,
including the microbiology requirement, may be substituted for the associate's degree. In addition,
each person shall have one year of experience in environmental analysis.
d) Any technical director of an accredited environmental laboratory engaged in radiological analysis
shall be a person with a bachelor's degree in chemistry, physics or engineering with 24 college
semester credit hours of chemistry with two or more years of experience in the radiological
analysis of environmental samples. A masters or doctoral degree in one of the above disciplines
may be substituted for one year experience.
e) The technical director(s) of an accredited environmental laboratory engaged in microscopic
examination of asbestos and/or airborne fibers shall meet the following requirements:
i) For procedures requiring the use of a transmission electron microscope, a bachelor's
degree, successful completion of courses in the use of the instrument, and one year of
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experience, under supervision, in the use of the instrument. Such experience shall include
the identification of minerals.
ii) For procedures requiring the use of a polarized light microscope, an associate's degree
or two years of college study, successful completion of formal coursework in polarized
light microscopy, and one year of experience, under supervision, in the use of the
instrument. Such experience shall include the Identification of minerals.
iii) For procedures requiring the use of a phase contrast microscope, as in the determination
of airborne fibers, an associate's degree or two years of college study, documentation of
successful completion of formal coursework in phase contrast microscopy, and one year
of experience, under supervision, in the use of the instrument.
f) Any technical director of an accredited environmental laboratory engaged in the examination of
radon in air shall have at least an associate's degree or two years of college and one year of
experience in radiation measurements, including at least one year of experience in the
measurement of radon and/or radon progeny.
4.1.1.2 Personnel Qualification Clarifications and Exceptions
a) Notwithstanding any other provision of this section, a full-time employee of a drinking water or
sewage treatment facility who holds a valid treatment plant operator's certificate appropriate to the
nature and size of such facility shall be deemed to meet the educational and experience
requirements serving as the director of the accredited laboratory devoted exclusively to the
examination of environmental samples taken within such facility system. Such accreditation for
a water treatment facility and/or a sewage treatment facility shall be limited to the scope of that
facility's regulatory permit, and when the facility's laboratory is analyzing water treatment/sewage
treatment samples collected within the state where the laboratory is situated, the scope of
accreditation shall be determined by the accrediting authority.
b) A full-time employee of an industrial waste treatment facility with a minimum of one year of
experience under supervision in environmental analysis shall be deemed to meet the requirements
for serving as the director of an accredited laboratory devoted exclusively to the examination of
environmental samples taken within such facility for the scope of that facility's regulatory permit.
Such accreditation for a industrial waste treatment facility shall be limited to laboratories analyzing
industrial waste treatment samples collected within the state where the laboratory is situated, and
the scope of accreditation shall be determined by the state accrediting authority.
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 shall be of two types: announced and unannounced. The on-site assessment of
each accredited laboratory 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 primary accrediting
authority. Situations which might trigger more frequent on-site assessments include, review of a
previously deficient on-site assessment, poor performance on a proficiency testing (PT) sample,
change in other accreditation elements, or other information concerning the capabilities or practices
of the accredited laboratory. The on-site assessment ensures that the environmental laboratory is in
compliance with NELAC standards.
The primary accrediting authority has the responsibility for conducting on-site assessments for national
accreditation based on the following factors:
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a) The assessment may consist of all of the fields of testing and/or methods for which the laboratory
wants to obtain accreditation.
b) The number of assessors conducting the on-site assessment should be appropriate for the
laboratory's scope and testing.
c) The on-site assessment should be conducted during normal working hours.
Laboratories shall be furnished with a report documenting any deficiencies found by the assessor. This
report shall be known as an assessment report.
4.1.3 Corrective Action Reports In Response to On-Site Assessment
A corrective action report must be submitted by the laboratory to the primary accrediting authority in
response to any assessment report received by the laboratory after an on-site assessment. The
corrective action report shall include the action that the laboratory shall implement to correct each
deficiency and the time period required to accomplish the corrective action.
a) The primary accrediting authority shall present an assessment report to the laboratory within 30
calendar days of the on-site assessment.
b) After being notified of deficiencies, the laboratory shall have 30 calendar days from the date of
receipt of the assessment report to provide a corrective action report.
c) The primary accrediting authority shall respond to the action noted in the corrective action report
within 30 calendar days of receipt.
d) If the corrective action report (or a portion) is deemed unacceptable to remediate a deficiency, the
laboratory shall have an additional 30 calendar days to submit a revised corrective action report.
e) If the corrective action report is not acceptable to the primary accrediting authority after the second
submittal, the laboratory shall 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 field of testing, a method, or analyte within
a field of testing.
f) All information included and documented in an assessment report and the corrective action report
are considered to be public information and are to be released pursuant to Chapter 3, Section
3.7.4.
g) If the laboratory fails to implement the corrective actions as stated in their corrective action report,
accreditation for fields of testing, specific methods, or analytes within those fields of testing shall
be revoked.
h) Proprietary data, Confidential Business Information and classified national security information will
be excluded from all public records.
4.1.4 Proficiency Testing Samples
A critical component of laboratory assessments is the analysis of PT samples. Refer to Proficiency
Testing (Chapter 2) for additional information. PT samples are used and evaluated in the accreditation
process as follows:
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a) Each laboratory seeking accreditation must receive, and analyze initial PT samples from a NELAP
approved PT study provider for each field of testing (program-matrix-analyte) in which it is
requesting accreditation.
b) Unless otherwise specified by the proficiency testing standard, each laboratory seeking or
maintaining accreditation shall be required to perform analysis of one PT sample twice per year
in each field of testing (program-matrix-analyte) for which it has applied for accreditation or for
which it is currently accredited,
c) The laboratory shall be informed of its score on the PT samples by the primary accrediting
authority or the NELAP approved PT provider within 21 calendar days from the closing date of
submission. The results of all of the PT sample tests including acceptable or not acceptable shall
be part of the public record. PT sample results shall apply to all accredited methods for an analyte
in a particular matrix.
d) When a laboratory initially requests accreditation, it must successfully analyze two sets of PT
samples, the analyses to be performed 30 calendar days apart. Each set shall contain one
sample for each requested field of testing (program-matrix-analyte). When 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 shall be considered by the primary accrediting authority,
in determining whether accreditation should be granted, denied, revoked, or suspended pursuant
to this Chapter, for a field of testing (program-matrix-analyte) or an analyte within a field of testing
(program-method-analyte).
4.1.5 Accountability for Analytical Standards
Elements in NELAP that shall ensure consistency and promote the use of quality assurance/quality
control procedures to generate quality data for regulatory purposes are:
a) In accordance with Chapter 5, each laboratory seeking or maintaining NELAP accreditation shall
have a named quality assurance officer or a person designated as accountable for data quality.
b) NELAC requires that each laboratory seeking or maintaining NELAP accreditation have a
developed and maintained Quality Assurance Manual on-site, as required in Chapter 5.
c) The primary accrediting authority shall consider that the accountability for negligence and the
falsification of data shall 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, for specific information on funding of this program (Section
1.5.2.3.3).
Where required, and if applicable, the level and timing of fee payments shall be established by the
primary accrediting authority (ies) 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 seek accreditation.
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4.1.7 Application
The NELAP encompasses a standardized set of elements in each application for accreditation that
shall 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.
4.1.7.1 Primary Application Package
A laboratory seeking accreditation shall complete and submit an application package to the primary
accrediting authority(ies). An accrediting authority participating in NELAP shall 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 technical director(s),however named, and the lead technical director
(if applicable),
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,
I) Fields of Testing for which the laboratory is requesting accreditation,
m) Methods employed including analytes,
n) Description of laboratory type (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) Fee enclosed (if applicable),
q) Description of geographical location,
r) FAX number,
s) Lab identification number, and,
t) Quality Manual enclosed (if required with application)
A laboratory seeking renewal of accreditation shall follow the process outlined by the accrediting
authority by which they are currently accredited.
4.1.7.2 Secondary Accreditation Package
A laboratory seeking accreditation from a secondary accrediting authority (ies) shall complete and
submit a secondary application package as required by the secondary accrediting authority. Refer to
Section 4.2 for the assessment of fees (if applicable) and Section 4.4.1 (1) and (2) for the reasons to
deny a secondary application package.
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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 primary accrediting authority may
charge a transfer fee and may conduct an on-site assessment to verify affects of such changes on
laboratory performance.
The following conditions apply to the change in ownership and/or the change in location of a laboratory
that has national accreditation.
a) Any change in ownership and/or location of an accredited laboratory must be reported in writing
to the primary accrediting authority within 30 calendar days and entered into the national database
by the primary accrediting authority. Required notification for change in location shall apply only
to fixed-based laboratories.
b) Such a change in ownership and/or location shall 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 primary accrediting authority.
d) Any change in ownership must assure historical traceability of the laboratory accreditation
number(s).
e) When there is a change in ownership all records and analyses performed pertaining to
accreditation must be kept for a minimum of 5 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.
4.1.9 "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 (insert the name of the primary accrediting authority) standards and is subject to
the enforcement and penalty provisions of that accrediting authority.
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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 Name of Quality Assurance Officer
or other designated individual
Print Name of Applicant Laboratory Date
(Legal Name)
Signature Name
Technical Director(s) Technical Directors)
4.2 PERIOD OF ACCREDITATION
For a laboratory in good standing, the period for accreditation within fields of testing for methods or
analytes shall be 12 months and will be considered to be ongoing once a laboratory has been
accredited for that field of testing method or analyte within a field of testing. 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 to the primary
accrediting authority (ies) within the stipulated deadlines or by the stipulated dates shall result in
revocation of accreditation by all the accrediting authorities (primary and secondary) with which the
laboratory maintains accreditation. Failure to pay required fees to a secondary accrediting authority
shall result in revocation of accreditation by that secondary accrediting authority. 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.
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 Section/elements 4.3.1 to 4.3.3.
Failure to complete or comply with these elements shall be cause for suspending or revoking
accreditation as specified in Section 4.4 of this Chapter.
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, as specified in Section 4.4 of this Chapter.
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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 of the change. This written notification includes but is not limited to
changes in the laboratory ownership, location, key personnel, and major instrumentation. All such
updates are public record, and any or all of the information contained therein may be placed in the
national database.
4.3.3 Record Keeping and Retention
All laboratory records associated with accreditation parameters shall meet the requirements of Chapter
5, Section 5.12 and 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 shall include:
1) Failure to submit a completed application;
2) Failure to pay required fees;
3) Failure of laboratory staff to meet the personnel qualifications of education, training, and
experience as required by the NELAC standards;
4) Failure to successfully analyze and report proficiency testing samples as required by the
NELAC standards, Chapter 2;
5) Failure to respond to an assessment report from the on-site assessment with a corrective
action report within the required 30 calendar days after receipt of the assessment report;
6) Failure to implement the corrective actions detailed in the corrective action report within the
time frame as specified by the primary accrediting authority;
7) Failure to implement a quality system as defined in Chapter 5;
8) Failure to pass required on-site assessment(s) as specified in the NELAC standards, Chapter
3.
9) Misrepresentation of any 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) 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.
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c) Upon reapplication, the laboratory may again be responsible for all or part of the fees as applicable
incurred as part of the initial application for accreditation.
d) No laboratory's accreditation shall be denied without the right to due process.
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 an area of non-compliance with the NELAC standards.
a) A laboratory's accreditation shall be suspended in total or in part. The laboratory shall retain
accreditation for the field of testings, methods and analytes where it continues to meet the
requirements of the NELAC standards.
b) Reasons for suspension shall include:
1) If the primary accrediting authority finds during the on-site assessment that the public interest,
safety or welfare imperatively requires emergency action;
2) Failure to complete proficiency testing studies and maintain a history of at least two
successful proficiency testing studies for each affected accredited field of testing out of the
three most recent proficiency testing studies as defined in NELAC, Chapter 2; or,
3) Failure to notify the primary accrediting authority of any changes in key accreditation criteria,
as set forth in Section 4.3.2 of this Chapter.
4) Failure to maintain a Quality System as defined in Chapter 5.
5) Failure of laboratory to employ staff that to meet the personnel qualifications for education,
training and experience as required by the NELAC standards.
c) A suspended laboratory cannot continue to analyze samples for the affected fields of testing for
which it holds accreditation.
d) The laboratory's suspended accreditation status will change to accredited when the laboratory
demonstrates to the primary accrediting authority that the laboratory complies with the NELAC
standards.
e) A suspended laboratory would not have to reapply for accreditation if the cause/causes for
suspension are corrected within six months.
f) If the laboratory fails to correct the causes of suspension within six months after the effective date
of the suspension, the primary accrediting authority shall revoke in total or part the laboratory's
accreditation.
g) No laboratory's accreditation shall be suspended without the right to due process as set forth by
the primary accrediting authority.
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4.4.3 Revocation
Revocation - shall mean the in part or total withdrawal of a laboratory's accreditation by the accrediting
authority. After correcting the reason/cause for revocation and satisfying any legal remedies, the
laboratory may reapply for accreditation.
a) The accrediting authority shall revoke a laboratory's accreditation, in part or in total for failure to
correct the deficiencies as set forth in Section 4.1.3 (e) of this Chapter and for failure to correct the
reasons for being suspended. The laboratory shall retain accreditation for the fields of testing,
methods and analytes where it continues to meet the requirements of the NELAC standards.
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 an assessment report
and failure to implement corrective action(s) related to any deficiencies found during a
laboratory assessment. The laboratory may submit two corrective action reports within the
time limits specified in Section 4.1.3.
2) After being suspended due to failure of proficiency testing samples, if the laboratory's analysis
of the next proficiency testing study results in three consecutively failed proficiency testing
studies, the laboratory shall be revoked for each affected accredited field of testing as defined
in NELAC Chapter 2.
c) Reasons for total revocation include a laboratory's:
1) Failure to respond with a corrective action report within the required 30 calendar 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 and 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 relating to the falsification of any report relating to a laboratory analysis;
or,
7) Failure to remit the accreditation fees, if applicable, within the time limit as established by the
accrediting authority.
d) No laboratory's accreditation shall be revoked without the right to due process.
4.4.4 Voluntary Withdrawal
If an environmental laboratory wishes to withdraw from NELAP, in total or in part, it must notify the
primary accrediting authority in writing no later than 30 calendar days before the end of the
accreditation year.
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4.5 INTERIM ACCREDITATION
4.5.1 Interim Accreditation
If a laboratory completes all of the requirements for accreditation except that of an on-site assessment
because the accrediting authority is unable to schedule the assessment, the accrediting authority may
issue an interim accreditation. Interim accreditation shall allow a laboratory to perform analyses and
report results with the same status as an accredited laboratory until the on-site assessment
requirements have been completed. Interim accreditation status shall not exceed twelve months. The
interim accreditation status is a matter of public record and shall 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 Section 4.4.3 by
order of the primary accrediting authority.
4.6 AWARDING OF ACCREDITATION
When a participating laboratory has met the requirements specified for receiving accreditation, the
laboratory shall receive a certificate awarded on behalf of the accrediting authority. The certificate
shall be signed by a member of the accrediting authority and shall be considered an official document.
It will be transmitted as a sealed and dated (effective date and expiration date) document containing
the NELAP insignia. The certificate shall include:
a) name of laboratory,
b) address of the laboratory,
c) fields of testing (program, method, analyte), and,
d) addenda or attachments (these shall be considered to be official documents).
The laboratory must have a certificate for each State or federal department/agency for which it is
accredited. The certificate shall explain that continued accredited status depends on successful
ongoing participation in the program. The certificate shall 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). If an accredited laboratory changes
its scope of accreditation, a new certificate shall be issued which details the laboratory's
accreditation(s).
4.6.1 Use of NELAC Accreditation by Accredited Laboratories
An accredited laboratory shall not misrepresent its NELAP accredited fields of testing, methods,
analytes, or its NELAP accreditation status on any document. This includes laboratory reports,
catalogs, advertising, business solicitations, proposals, quotations or other materials (pursuant to
NELAC Chapter 6, Section 8).
4.6.2 Changes in Fields of Testing
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), quality control
performance, and written standard operating procedure is at the discretion of the accrediting authority.
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An addition of a new technology or test method requiring specific equipment may require an on-site
assessment.
4.7 DUE PROCESS
Regardless of the language in this chapter concerning actions such as denial, suspension and
revocation of accreditation, a laboratory is always entitled to the right of due process. Due process
rights are delineated in the appropriate state laws and regulations of the accrediting authorities. Since
these laws and regulations may vary from state to state, laboratories seeking accreditation are
encouraged to become familiar with the specific laws and regulations governing due process for each
of the accrediting authorities of interest.
4.8 ENFORCEMENT
Since NELAC is a standard setting body, it cannot enforce civil or criminal penalties but rather all
enforcement actions are taken independently by the accrediting authorities.
The enforcement component of the accrediting authorities 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.
d) The due process rights of participating laboratories must be protected.
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TABLE OF CONTENTS
QUALITY SYSTEMS
5.0 QUALITY SYSTEMS 1
5.1 SCOPE 1
5.2 REFERENCES 1
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 3
5.5.1 Establishment 3
5.5.2 Quality Manual 4
5.5.3 Audits, Reviews and Corrective Actions 5
5.5.3.1 Internal Audits 5
5.5.3.2 Managerial Review 6
5.5.3.3 Audit Review 6
5.5.3.4 Performance Audits 6
5.5.3.5 Corrective Actions 6
5.5.4 Essential Quality Control Procedures 7
5.6 PERSONNEL 8
5.6.1 General Requirements for Laboratory Staff 8
5.6.2 Laboratory Management Responsibilities 8
5.6.3 Records 9
5.7 PHYSICAL FACILITIES - ACCOMMODATION AND ENVIRONMENT 9
5.7.1 Environment 9
5.7.2 Work Areas 10
5.8 EQUIPMENT AND REFERENCE MATERIALS 10
5.9 MEASUREMENT TRACEABILITY AND CALIBRATION 11
5.9.1 General Requirements 11
5.9.2 Traceability of Calibration 11
5.9.3 Reference Standards 11
5.9.4 Calibration 12
5.9.4.1 Support Equipment 12
5.9.4.2 Instrument Calibration 13
5.10 TEST METHODS AND STANDARD OPERATING PROCEDURES 15
5.10.1 Methods Documentation 15
5.10.1.1 Standard Operating Procedures (SOPs) 15
5.10.1.2Laboratory Method Manual(s) 15
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5.10.2 Test Methods 16
5.10.2.1 Demonstration of Capability 16
5.10.3 Sample Aliquots 17
5.10.4 Data Verification 17
5.10.5 Documentation and Labeling of Standards and Reagents 18
5.10.6 Computers and Electronic Data Related Requirements 18
5.11 SAMPLE HANDLING, SAMPLE ACCEPTANCE POLICY AND SAMPLE RECEIPT 18
5.11.1 Sample Tracking 19
5.11.2 Sample Acceptance Policy 19
5.11.3 Sample Receipt Protocols 20
5.11.4 Storage Conditions 21
5.11.5 Sample Disposal 22
5.12 RECORDS 22
5.12.1 Record Keeping System and Design 22
5.12.2 Records Management and Storage 23
5.12.3 Laboratory Sample Tracking 23
5.12.3.1 Sample Handling 23
5.12.3.2Laboratory Support Activities 23
5.12.3.3Analytical Records 24
5.12.3.4Administrative Records 25
5.13 LABORATORY REPORT FORMAT AND CONTENTS 25
5.14 SUBCONTRACTING ANALYTICAL SAMPLES 27
5.15 OUTSIDE SUPPORT SERVICES AND SUPPLIES 27
5.16 COMPLAINTS 28
Appendix A - REFERENCES A-1
Appendix B - (Reserved)
Appendix C - DEMONSTRATION OF CAPABILITY C-1
C.1 PROCEDURE FOR DEMONSTRATION OF CAPABILITY C-1
C.2 CERTIFICATION STATEMENT C-2
Appendix D - ESSENTIAL QUALITY CONTROL REQUIREMENTS D-1
D.1 CHEMICAL TESTING D-1
D.1.1 Positive and Negative Controls D-1
D.1.2 Analytical Variability/Reproducibility D-2
D.1.3 Method Evaluation D-2
D.1.4 Detection Limits D-2
D.1.5 Data Reduction D-3
D.1.6 Quality of Standards and Reagents D-3
D.1.7 Selectivity D-3
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D.1.8 Constant and Consistent Test Conditions D-4
D.2 TOXICITY TESTING D^
D.2.1 Positive and Negative Controls D-4
D.2.2 Variability and/or Reproducibility D-6
D.2.3 Accuracy D-7
D.2.4 Test Sensitivity D-7
D.2.5 Selection of Appropriate Statistical Analysis Methods D-7
D.2.6 Selection and Use of Reagents and Standards D-7
D.2.7 Selectivity D-7
D.2.8 Constant and Consistent Test Conditions D-7
D.3 MICROBIOLOGY TESTING D-10
D.3.1 Positive and Negative Controls D-10
D.3.2 Test Variability/Reproducibility D-11
D.3.3 Method Evaluation D-11
D.3.4 Test Performance D-12
D.3.5 Data Reduction D-12
D.3.6 Quality of Standards, Reagents and Media D-12
D.3.7 Selectivity D-13
Figure D.1 Use of Reference Cultures (Bacteria) D-14
D.3.8 Constant and Consistent Test Conditions D-14
D.4 RADIOCHEMICAL TESTING D-16
D.4.1 Negative and Positive Controls D-16
D.4.2 Analytical Variability/Reproducibility D-18
D.4.3 Method Evaluation D-18
D.4.4 Radiation Measurement System Calibration D-18
0.4.5 Detection Limits D-20
D.4.6 Data Reduction D-20
D.4.7 Quality of Standards and Reagents D-20
0.4.8 Constant and Consistent Test Conditions D-21
D.5 AIR TESTING 0-21
D.5.1 Negative and Positive Controls D-21
D.5.2 Analytical Variability/Reproducibility 0-22
D.5.3 Method Evaluation D-22
D.5.4 Detection Limits D-22
D.5.5 Data Reduction D-23
D.5.6 Quality of Standards and Reagents 0-23
D.5.7 Selectivity D-23
D.5.8 Constant and Consistent Test Conditions D-23
Appendix E - ADDITIONAL SOURCES OF INFORMATION E-1
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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 Quality Manual and followed to 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 quality system requirements so that
all accrediting authorities evaluate laboratories consistently and uniformly.
NELAC is committed to the use of Performance-based Measurement Systems (PBMS) in
environmental testing and provides the foundation for PBMS implementation in these standards. While
this standard may not currently satisfy all the anticipated needs of PBMS, NELAC will address future
needs within the context of State statutory and regulatory requirements and the finalized EPA
implementation plans for PBMS.
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 that a laboratory has to successfully demonstrate
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. If it is not clear which
requirements are more stringent, the standard from the method or regulation is to be followed.
(See the supplemental accreditation requirements in Section 1.9.2.)
c) This Standard is for use by environmental testing laboratories in the development and
implementation of their quality systems. It shall be used by accrediting authorities, in assessing
the competence of environmental laboratories.
5.2 REFERENCES
See Appendix A.
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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 A, Glossary, of
Chapter 1 together with further definitions applicable for the purposes of this Standard.
See Appendix A, Glossary, of Chapter 1.
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 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;
d) specify and document the responsibility, authority, and interrelationship 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 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 to ensure adherence to laboratory procedures and accepted techniques.
f) have a technical directors) (however named) who has overall responsibility for the technical
operation of the environmental testing laboratory;
The technical director(s) shall certify that personnel with appropriate educational and/or technical
background perform all tests for which the laboratory is accredited. Such certification shall be
documented.
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The technical director(s) 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:
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 test methods for which data review is performed;
6) arrange for or conduct internal audits as per 5.5.3 annually; and,
7) notify laboratory management of deficiencies in the quality system and monitor corrective
action.
h) nominate deputies in case of absence of the technical director(s) and/or quality assurance officer;
i) have documented policy and procedures to ensure the protection of clients' confidential information
and proprietary rights (this may not apply to in-house laboratories);
j) for purposes of qualifying for and maintaining accreditation, each laboratory shall participate in a
proficiency test program as outlined in Chapter 2.
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 based on the required elements contained
in this chapter and appropriate to the type, range and volume of environmental testing activities it
undertakes.
a) The elements of this quality system shall be documented in the organization's quality manual.
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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 relationship 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 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 of the Quality
Manual must have the signed and dated concurrence, (with appropriate titles) of all responsible
parties including the QA officer(s), technical director(s), 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 test 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;
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j) reference to the calibration and/or verification test procedures used;
k) procedures for handling submitted samples;
I) 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 which may include 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 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 (including national security concerns), 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 are receiving any needed training;
u) ethics policy statement developed by the laboratory and processes/procedures for educating and
training personnel in their ethical and legal responsibilities including the potential punishments and
penalties for improper, unethical or illegal actions;
v) reference to procedures for reporting analytical results; and,
w) a Table of Contents, and applicable lists of references and glossaries, and appendices.
5.5.3 Audits, Reviews and Corrective Actions
5.5.3.1 Internal Audits
The laboratory shall arrange for annual internal audits to verify that its operations continue to comply
with the requirements of the laboratory's quality system. It is the responsibility of the quality
assurance officer to plan and organize audits as required by a predetermined schedule and requested
by management. Such audits shall be carried out by trained and qualified personnel who are, wherever
resources permit, independent of the activity to be audited. Personnel shall not audit their own
activities except when it can be demonstrated that an effective audit will be carried out. 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 was involved.
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5.5.3.2 Managerial Review
The laboratory management shall conduct a review, at least annually, of its quality system and its
testing and calibration activities to ensure its continuing suitability and effectiveness and to introduce
any necessary changes or improvements in the quality system and laboratory operations. The review
shall take account of reports from managerial and supervisory personnel, the outcome of recent internal
audits, assessments by external bodies, the results of interlaboratory comparisons or proficiency
tests, any changes in the volume and type of work undertaken, feedback from clients, corrective
actions and other relevant factors. The laboratory shall have a procedure for review by management
and maintain records of review findings and actions.
5.5.3.3 Audit Review
All audit and review findings and any corrective actions that arise from them shall be documented. The
laboratory management shall ensure that these actions are discharged within the agreed time frame
as indicated in the quality manual and/or SOPs.
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 procedures using statistical techniques; (see 5.5.4 below)
b) participation in proficiency testing or other interlaboratory comparisons (See Chapter 2);
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 test methods;
e) re-testing of retained samples;
f) correlation of results for different but related analysis 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 departures from documented policies, procedures
and quality control have occurred. These procedures shall include but are not limited to the
following:
1) identify the individual(s) responsible for assessing each QC data type;
2) identify the individual(s) responsible for initiating and/or recommending corrective actions;
3) define how the analyst shall treat a data set if the associated QC measurements are
unacceptable;
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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 qualifiers).
5.5.4 Essential Quality Control Procedures
These 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, whole effluent toxicity, microbiological, radiological, air) 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 detailed written protocols in place to monitor the following quality
controls:
1) Positive and negative controls to monitor tests such as blanks, spikes, reference toxicants;
2) Tests to define the variability and/or repeatability of the laboratory results such as replicates;
3) Measures to assure the accuracy of the test method including calibration and/or continuing
calibrations, use of certified reference materials, proficiency test samples, or other measures;
4) Measures to evaluate test method capability, such as 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 regression
analysis, comparison to internal/external standard calculations, and statistical analyses;
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 test 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 criteria shall be used to determine the usability 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. (See 5.11.2, Sample Acceptance Policy.)
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, or
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mandated methods or regulations (whichever are more stringent) are incorporated into their method
manuals. When it is not apparent which is more stringent the QC in the mandated method or
regulations is to be followed.
The essential quality control measures for testing 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 with 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 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, test 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 or quantitative techniques shall be considered;
b) Ensuring that all technical laboratory staff have demonstrated capability in the activities for which
they are responsible. Such demonstration shall be documented. (See Appendix C);
Note: In laboratories with specialized "work cells" (a well defined group of analysts that together
perform the method analysis), the group as a unit must meet the above criteria and this demonstration
must be fully documented.
c) Ensuring that the training of each member of the technical staff is kept up-to-date (on-going) by
the following:
1) Evidence must be on file that demonstrates that each employee has read, understood, and
is using the latest version of the laboratory's in-house quality documentation, which relates to
his/her job responsibilities.
2) Training courses or workshops on specific equipment, analytical techniques or laboratory
procedures shall all be documented.
3) Training courses in ethical and legal responsibilities including the potential punishments and
penalties for improper, unethical or illegal actions. Evidence must also be on file which
demonstrates that each employee has read, acknowledged and understood their personal
ethical and legal responsibilities including the potential punishments and penalities for
improper, unethical or illegal actions.
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4) Analyst training shall be considered up to date if an employee training file contains a
certification that technical personnel have read, understood and agreed to perform the most
recent version of the test method (the approved method or standard operating procedure as
defined by the laboratory document control system, 5.5.2.d) and documentation of continued
proficiency by at least one of the following once per year:
i. Acceptable performance of a blind sample (single blind to the analyst);
ii. Another demonstration of capability;
iii. Successful analysis of a blind performance sample on a similar test method using the
same technology (e.g., GC/MS volatiles by purge and trap for Methods 524.2, 624 or
5035/8260) would only require documentation for one of the test methods;
iv. At least four consecutive laboratory control samples with acceptable levels of precision
and accuracy;
v. If i-iv cannot be performed, analysis of authentic samples with results statistically
indistinguishable from those obtained by another trained analyst.
d) Documenting all analytical and operational activities of the laboratory;
e) Supervising all personnel employed by the laboratory;
f) Ensuring 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;
g) Documenting the quality of all data reported by the laboratory; and
h) Developing a proactive program for prevention and detection of improper, unethical or illegal
actions. Components of this program could include: internal proficiency testing (single and double
blind); post-analysis, electronic data and magnetic tape audits; effective reward program to improve
employee vigilance and co-monitoring; and separate SOPs identifying appropriate and
inappropriate laboratory and instrument manipulation practices.
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 test 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.
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c) The laboratory shall provide for the effective monitoring, control and recording of environmental
conditions as appropriate. Such environmental conditions may include biological sterility, dust,
electromagnetic interference, humidity, mains voltage, temperature, and sound and vibration levels.
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.
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 ensure
that any contamination does not adversely affect data quality.
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 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 be labeled, marked or otherwise
identified to indicate its calibration status.
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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 (if available);
4) current location, where appropriate;
5) if available, 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.
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 measurements made by the laboratory are traceable to national
standards of measurement.
b) Calibration certificates shall 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, proficiency testing, or independent analysis.
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 have not been
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invalidated. Reference standards of measurement shall be calibrated by a body that can provide
traceability. Where possible, this traceability shall be 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 be traceable.
Where possible, traceability shall be to national or international standards of measurement, or to
national or international standard reference materials.
5.9.4 Calibration
Calibration requirements are divided into two parts: (1) requirements for analytical support equipment,
and 2) requirements for instrument calibration. In addition, the requirements for instrument calibration
are divided into initial instrument calibration and continuing instrument calibration verification.
5.9.4.1 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), thermal/pressure sample preparation devices and volumetric dispensing devices (such
as Eppendorf®, or automatic dilutor/dispensing devices) if quantitative results are dependent on their
accuracy, as in standard preparation and dispensing or dilution into a specified volume.
a) All support equipment shall be maintained in proper working order. The records of all repair and
maintenance activities including service calls, shall be kept.
b) All support equipment shall be calibrated or verified at least annually, using NIST traceable
references when available, over the entire range of use. The results of such calibration shall be
within the specifications required of the application for which this equipment is used or:
1) The equipment shall be removed from service until repaired; or
2) The laboratory shall maintain records of established correction factors to correct all
measurements.
c) Raw data records shall be retained to document equipment performance.
d) Prior to use on each working day, balances, ovens, refrigerators, freezers, and water baths shall
be checked in the expected use range, with NIST traceable references where available. The
acceptability for use or continued use shall be according to the needs of the analysis or application
for which the equipment is being used.
e) Mechanical volumetric dispensing devices including burettes (except Class A glassware) shall be
checked for accuracy on at least a quarterly use basis. Glass microliter syringes are to be
considered in the same manner as Class A glassware, but must come with a certificate attesting
to established accuracy or the accuracy must be initially demonstrated and documented by the
laboratory.
f) For chemical tests the temperature, cycle time, and pressure of each run of autoclaves must be
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documented by the use of appropriate chemical indicators or temperature recorders and pressure
gauges.
g) For biological tests that employ autoclave sterilization see section D.3.8.
5.9.4.2 Instrument Calibration:
This standard specifies the essential elements that shall define the procedures and documentation for
initial instrument calibration and continuing instrument calibration verification to ensure that the data
must be of known quality and be appropriate for a given regulation or decision. This standard does not
specify detailed procedural steps ("how to") for calibration, but establishes the essential elements for
selection of the appropriate technique(s). This approach allows flexibility and permits the employment
of a wide variety of analytical procedures and statistical approaches currently applicable for calibration.
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. If it is not apparent which standard
is more stringent, then the requirements of the regulation or mandated test method are to be followed.
Note: In the following sections, initial instrument calibration is directly used for quantitation
and continuing instrument calibration verification is used to confirm the continued validity
of the initial calibration.
5.9.4.2.1 Initial Instrument Calibration:
The following items are essential elements of initial instrument calibration:
a) The details of the initial instrument calibration procedures including calculations, integrations,
acceptance criteria and associated statistics must be included or referenced in the test method
SOP. When initial instrument calibration procedures are referenced in the test method, then the
referenced material must be retained by the laboratory and be available for review.
b) Sufficient raw data records must be retained to permit reconstruction of the initial instrument
calibration, e.g., calibration date, test method, instrument, analysis date, each analyte name,
analyst's initials or signature; concentration and response, calibration curve or response factor;
or unique equation or coefficient used to reduce instrument responses to concentration.
c) Sample results must be quantitated from the initial instrument calibration and may not be
quantitated from any continuing instrument calibration verification.
d) All initial instrument calibrations must be verified with a standard obtained from a second
manufacturer or lot. Traceability shall be to a national standard, when available.
e) Criteria for the acceptance of an initial instrument calibration must be established, e.g., correlation
coefficient or relative percent difference. The criteria used must be appropriate to the calibration
technique employed.
f) Results of samples not bracketed by initial instrument calibration standards (within calibration
range) must be reported as having less certainty, e.g., defined qualifiers or flags or explained in
the case narrative. The lowest calibration standard must be above the detection limit.
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g) If the initial instrument calibration results are outside established acceptance criteria, corrective
actions must be performed. Data associated with an unacceptable initial instrument calibration
shall not be reported.
h) Calibration standards must include concentrations at or below the regulatory limit/decision level,
if these limits/levels are known by the laboratory, unless these concentrations are below the
laboratory's demonstrated detection limits (See D.1.4 Detection Limits)
i) If a reference or mandated method does not specify the number of calibration standards, the
minimum number is two, not including blanks or a zero standard. The laboratory must have a
standard operating procedure for determining the number of points for establishing the initial
instrument calibration.
5.9.4.2.2 Continuing Instrument Calibration Verification
When an initial instrument calibration is not performed on the day of analysis, the validity of the initial
calibration shall be verified prior to sample analyses by a continuing instrument calibration verification
with each analytical batch. The following items are essential elements of continuing instrument
calibration verification:
a) The details of the continuing instrument calibration procedure, calculations and associated
statistics must be included or referenced in the test method SOP.
b) A continuing instrument calibration verification must be repeated at the beginning and end of each
analytical batch. The concentrations of the calibration verification shall be varied within the
established calibration range. If an internal standard is used, only one continuing instrument
calibration verification must be analyzed per analytical batch.
c) Sufficient raw data records must be retained to permit reconstruction of the continuing instrument
calibration verification, e.g., test method, instrument, analysis date, each analyte name,
concentration and response, calibration curve or response factor, or unique equations or
coefficients used to convert instrument responses into concentrations. Continuing calibration
verification records must explicitly connect the continuing verification data to the initial instrument
calibration.
d) Criteria for the acceptance of a continuing instrument calibration verification must be established,
e.g., relative percent difference.
e) If the continuing instrument calibration verification results obtained are outside established
acceptance criteria, corrective actions must be performed. If routine corrective action procedures
fail to produce a second consecutive (immediate) calibration verification within acceptance criteria,
then either the laboratory has to demonstrate performance after corrective action with two
consecutive successful calibration verifications, or a new initial instrument calibration must be
performed. If the laboratory has not demonstrated acceptable performance, sample analyses shall
not occur until a new initial calibration curve is established and verified. However, sample data
associated with an unacceptable calibration verification may be reported as qualified data under
the following special conditions:
i. When the acceptance criteria for the continuing calibration verification are exceeded
high, i.e., high bias, and there are associated samples that are non-detects, then those
non-detects may be reported. Otherwise the samples affected by the unacceptable
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calibration verification shall be reanalyzed after a new calibration curve has been
established, evaluated and accepted.
ii. When the acceptance criteria for the continuing calibration verification are exceeded low,
i.e., low bias, those sample results may be reported if they exceed a maximum regulatory
limit/decision level. Otherwise the samples affected by the unacceptable verification shall
be reanalyzed after a new calibration curve has been established, evaluated and accepted.
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, for example, may be equipment manuals provided by the manufacturer, or
internally written documents.
b) The test methods may be copies of published methods as long as any changes or selected
options 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 organized .
e) Each SOP shall clearly indicate the effective date of the document, the revision number and the
signature(s) of the approving authority.
5.10.1.2Laboratory Method Manual(s)
a) The laboratory shall have and maintain an in-house methods manual(s) for each accredited analyte
or test method.
b) This manual may consist of copies of published or referenced test methods or standard operating
procedures that have been written by the laboratory. In cases where modifications to the published
method have been made by the laboratory or where the referenced test method is ambiguous or
provides insufficient detail, these changes or clarifications shall be clearly described. Each test
method shall include or reference where applicable:
1) identification of the test method;
2) applicable matrix or matrices;
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3) detection limit;
4) scope and application, including components to be analyzed;
5) summary of the test 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;
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.
5.10.2 Test Methods
The laboratory shall use appropriate test methods and procedures for all tests and related activities
within its responsibility (including sample collection, sample handling, transport and storage, sample
preparation and sample analysis). The method and procedures shall be consistent with the accuracy
required, and with any standard specifications relevant to the calibrations or tests concerned.
a) When the use of reference test methods for a sample analysis are mandated or requested, only
those methods shall be used.
b) Where test 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 Appendix C), and be available to the client and other recipients of the relevant reports.
5.10.2.1 Demonstration of Capability
a) Prior to acceptance and institution of any test method, satisfactory demonstration of method
capability is required. (See Appendix C and 5.6.2.b.) In general, this demonstration does not test
the performance of the method in real world samples, but in the applicable and available clean
matrix sample of a matrix in which no target analytes or interferences are present at
concentrations that impact the results of a specific test method), e.g., water, solids, biological
tissue and air. In addition, for analytes which do not lend themselves to spiking, the demonstration
of capability may be performed using quality control samples.
b) Thereafter, continuing demonstration of method performance, as per the quality control
requirements in Appendix D (such as laboratory control samples) is required.
c) In cases where a laboratory analyzes samples using a test method that has been in use by the
laboratory before July 1999, and there have been no significant changes in instrument type,
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personnel or test method, the continuing demonstration of method performance and the analyst's
documentation of continued proficiency shall be acceptable. The laboratory shall have records on
file to demonstrate that an initial demonstration of capability is not required.
d) In all cases, the appropriate forms such as the Certification Statement (Appendix C) 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 Certification
Statement must be retained by the laboratory. (See Appendix C for Certification Statement.)
e) A demonstration of capability must be completed each time there is a change in instrument type,
personnel, or test method.
f) In laboratories with a specialized "work cell(s)" (a group consisting of analysts with specifically
defined tasks that together perform the test method), the group as a unit must meet the above
criteria and this demonstration of capability must be fully documented.
g) When a work cell(s) is employed, and the members of the cell change, the new employee(s) must
work with experienced analyst(s) in that area of the workcell where they are employed. This new
work cell must demonstrate acceptable performance through acceptable continuing performance
checks (appropriate sections of Appendix D, such as laboratory control samples). Such
performance must be documented and the four preparation batches following the change in
personnel must not result in the failure of any batch acceptance criteria, e.g., method blank and
laboratory control sample, or the demonstration of capability must be repeated. In addition, if the
entire work cell is changed/replaced, the work cell must perform the demonstration of capability
(Appendix C).
h) When a work cell(s) is employed the performance of the group must be linked to the training record
of the individual members of the work cell (see section 5.6.2).
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 Procedure to ensure that the reported data are
free from transcription and calculation errors.
b) The laboratory shall establish Standard Operating Procedures to ensure that all quality control
measures are reviewed, and evaluated before data are reported.
c) The laboratory shall establish Standard Operating Procedures addressing manual calculations
including manual integrations.
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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.
a) The laboratory shall retain records for all standards, reagents and media including the
manufacturer/vendor, the manufacturer's Certificate of Analysis or purity (if supplied), the date of
receipt, recommended storage conditions, and an expiration date after which the material shall not
be used unless its reliability is verified by the laboratory.
b) Original containers (such as provided by the manufacturer or vendor) shall be labeled with an
expiration date.
c) Records shall be maintained on reagent and standard preparation. These records shall indicate
traceability to purchased stocks or neat compounds, reference to the method of preparation, date
of preparation, expiration date and preparer's initials.
d) All containers of prepared reagents and standards must bear a unique identifier and expiration date
and be linked to the documentation requirements in 5.10.5.C above.
5.10.6 Computers and Electronic Data Related Requirements
Where computers, automated equipment, or microprocesors, are used for the capture, processing,
manipulation, recording, storage or retrieval of test data, the laboratory shall ensure that:
a) all requirements of this Standard (i.e. Chapter 5) are met;
b) computer software is tested and documented to be adequate for use, e.g., internal audits,
personnel training, focus point of QA and QC;
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 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; and,
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
While the laboratory may not have control of field sampling activities, the following are essential to
ensure the validity of the laboratory's data.
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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 sample containers, the laboratory ID code may be the same as the field
ID code.
5.11.2 Sample Acceptance Policy
The laboratory must have a written sample acceptance policy that clearly outlines the circumstances
under which samples shall be accepted or rejected. 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 collection 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;
e) Adequate sample volume. Sufficient sample volume must be available to perform the necessary
tests; and
f) Procedures to be used when samples show signs of damage, contamination or inadequate
preservation.
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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 ranging from
just above the freezing temperature of water to 6°C shall be acceptable. Samples that are
hand delivered to the laboratory immediately after collection may not meet this 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 or free chlorine, 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
shall attempt to 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 this standard , 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 chronological record such as a log book or electronic
database to document receipt of all sample containers.
1) This sample receipt log shall record the following:
i. Client/Project Name,
ii. Date and time of laboratory receipt,
iii. Unique laboratory ID code (see 5.11.1), and,
iv. Signature or initials of the person making the entries.
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2) During the log-in process, the following information must be unequivocally linked to the log
record or included as a part of the log. If such information is recorded/documented elsewhere,
the records shall be part of the laboratory's permanent records, easily retrievable upon request
and readily available to individuals who will process the sample. Note: the placement of the
laboratory ID number on the sample container is not considered a permanent record.
i. The field ID code which identifies each container must be linked to the laboratory ID code
in the sample receipt log.
ii. The date and time of sample collection must be linked to the sample container and to the
date and time of receipt in the laboratory.
Hi. The requested analyses (including applicable approved test method numbers) must be
linked to the laboratory ID code.
iv. Any comments resulting from inspection for sample rejection shall be linked to the
laboratory ID code.
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 form (Sections 5.12.3 and Appendix E), if utilized, shall be
maintained.
5.11.4 Storage Conditions
The laboratory shall have documented procedures and appropriate facilities to avoid deterioration,
contamination, 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.
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 +1-2°
of the specified preservation temperature unless method specific criteria exist. For samples
with a specified storage temperature of 4°C, storage at a temperature above the freezing point
of water to 6°C shall be acceptable.
2) Samples shall be stored away from all standards, reagents, food and other potentially
contaminating sources. Samples shall be stored in such a manner to prevent cross
contamination.
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 test 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 performed later), the laboratory shall
have storage and security arrangements that protect the condition and integrity of the secured
items or portions concerned.
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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.
5.12 RECORDS
The laboratory shall maintain a record system to suit its particular circumstances and complies with
any applicable regulations. The system shall produce unequivocal, accurate records which document
all laboratory activities. The laboratory shall retain all original observations, calculations and derived
data, calibration records and a copy of the test report for a minimum of five years.
There are two levels of sample handling: 1) sample tracking and 2) legal chain of custody protocols,
which are used for evidentiary or legal purposes. All essential requirements for sample tracking (e.g.,
chain of custody form) are outlined in Sections 5.12.1, 5.12.2 and 5.12.3. If a client specifies that a
sample will be used for evidentiary purposes, then a laboratory shall have a written SOP for how that
laboratory will carry out legal chain of custody for example, ASTM D 4840-95 and Manual for the
Certification of Laboratories Analyzing Drinking Water, March 1997, Appendix A.
5.12.1 Record Keeping System and Design
The record keeping system must allow historical reconstruction of all laboratory activities that produced
the 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, sample receipt,
preparation, calibration or testing.
b) All information relating to the laboratory facilities equipment, analytical test methods, and related
laboratory activities, such as sample receipt, sample preparation, or data verification shall be
documented.
c) The record keeping system shall facilitate the retrieval of all working files and archived records for
inspection and verification purposes.,e.g., set format for naming electronic files.
d) All changes to records 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.
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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, including those specified in 5.12.3 shall be retained for a minimum of five years from
generation of the last entry in the records. All information necessary for the historical
reconstruction of data must be maintained by the laboratory. Records which are stored only on
electronic media must be supported by the hardware and software necessary for their retrieval.
c) Records that are stored or generated by computers or personal computers 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.
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) 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) in the event that a laboratory transfers ownership or goes
out of business. In addition, in cases of bankruptcy, appropriate regulatory and state legal
requirements concerning laboratory records must be followed.
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 appropriateness of 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, sample transmittal forms, (chain of
custody form); and
d) The laboratory shall have documented procedures for the receipt and retention of test items,
including all provisions necessary to protect the integrity of samples.
5.12.3.2Laboratory Support Activities
In addition to documenting all the above-mentioned activities, the following shall be retained:
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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 test 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;
g) Proficiency test results and raw data; and,
h) Results of data review, verification, and cross-checking procedures.
5.12.3.3Analytical 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 and time of analysis is required if the holding time is 72 hours or less or when
time critical steps are included in the analysis, e.g., extractions, and incubations;
c) Instrumentation identification and instrument operating conditions/parameters (or reference to such
data);
d) Analysis type;
e) All manual calculations, e.g., manual integrations; and,
f) Analyst's or operator's initials/signature;
g) Sample preparation including cleanup, separation protocols, incubation periods or subculture, ID
codes, volumes, weights, instrument printouts, meter readings, calculations, reagents;
h) Sample analysis;
i) Standard and reagent origin, receipt, preparation, and use;
j) Calibration criteria, frequency and acceptance criteria;
k) Data and statistical calculations, review, confirmation, interpretation, assessment and reporting
conventions;
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I) Quality control protocols and assessment;
m) Electronic data security, software documentation and verification, software and hardware audits,
backups, and records of any changes to automated data entries;
n) Method performance criteria including expected quality control requirements.
5.12.3.4Administrative Records
The following shall be maintained:
a) Personnel qualifications, experience and training records;
b) Records of demonstration of capability 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.
5.13 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. 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 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.
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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) identification of test results derived from any sample that did not meet NELAC sample
acceptance requirements such as improper container, holding time, or temperature;
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 72 hours;
8) identification of the test method used, or unambiguous description of any non-standard method
used;
9) if the laboratory collected the sample, reference to sampling procedure;
10) any deviations from (such as failed quality control), additions to or exclusions from the test
method (such as environmental conditions), and any non-standard conditions that may have
affected the quality of results, and including the use and definitions of data qualifiers;
11) measurements, examinations and derived results, supported by tables, graphs, sketches and
photographs as appropriate, and any failures identified; identify whether data are calculated
on a dry weight or wet weight basis; identify the reporting units such as Fg/l or mg/kg; and for
Whole Effluent Toxicity, identify the statistical package used to provide data;
12) when required, a statement of the estimated uncertainty of the test result;
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;
14) at the laboratory's discretion, a statement to the effect that the results relate only to the items
tested or to the sample as received by the laboratory;
15) at the laboratory's discretion, a statement that the certificate or report shall not be reproduced
except in full, without the written approval of the laboratory;
16) clear identification of all test data provided by outside sources, such as subcontracted
laboratories, clients, etc; and,
17) clear identification of numerical results with values outside of quantitation limits
b) Laboratories that 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 17 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
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2) The laboratory provides information to another individual within the organization for preparation
of regulatory reports. The facility management must ensure that the appropriate report items
are in the report to the regulatory authority if such information is required.
c) Where the certificate or report contains results of tests performed by subcontractors, 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.
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, where clients require transmission of test results by telephone, telex,
facsimile or other electronic or electromagnetic means, 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 subcontract any portion of the
testing to another party.
b) Where a laboratory subcontracts 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 specified requirements. The laboratory shall, 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.
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5.16 COMPLAINTS
i
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
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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/etsdwe1/irm_galp/
"Glossary of Quality Assurance Terms and Acronyms", Quality Assurance Division, Office of
Research and Development, USEPA
"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
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 Revision 4, EPA 815-B-97-001
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Manual of Method for General Bacteriology, Philipp Gerhard et al., American Society for
Microbiology, Washington, 1981
Performance Based Measurement System, EPA EMMC Method Panel, PBMS Workgroup, 1996
EPA/600/4-90/027F Methods for Measuring the Acute Toxicity of Effluents and Receiving Waters to
Freshwater and Marine Organisms, 4th Ed., Office of Research and Development, Washington, DC,
1993.
EPA/600/4-91/002 Short-term Methods for Estimating the Chronic Toxicity of Effluents and
Receiving Waters to Freshwater Organisms, 3rd Ed., Office of Research and Development,
Washington, DC, 1994.
EPA/600/4-91/003 Short-term Methods for Estimating the Chronic Toxicity of Effluents and
Receiving Water to Marine and Estuarine Organisms, 2nd Ed., Office of Research and
Development, Washington, DC, 1994.
EPA/600/4-90/031 Manual for Evaluation of Laboratories Performing Aquatic Toxicity Tests., Office
of Research and Development, Washington, DC, 1991.
EPA/600/R-94/025 Methods for Assessing the Toxicity of Sediment-associated Contaminants with
Estuarine and Marine Amphipods, Office of Research and Development, Washington, DC, 1994.
EPA/600/R-94/024 Methods for Measuring the Toxicity and Bioaccumulation of Sediment-
associated Contaminants with Freshwater Invertebrates, Office of Research and Development,
Washington, DC, 1994.
EPA/823/B-98/004 Evaluation of Dredged Material Proposed for Discharge in Waters of the U.S. -
Inland Testing Manual. Office of Water, Washington, DC, 1994.
EPA/503/8-91/001 Evaluation of Dredged Material Proposed for Ocean Disposal - Testing Manual.
Office of Water, Washington, DC, 1991.
EPA/600/3-88/029 Protocol for Short-term Toxicity Screening of Hazardous Wastes, Office of
Research and Development, Washington, DC, 1991.
EPA/600/3-89/013 Ecological Assessment of Hazardous Waste Sites, Office of Research and
Development, Washington, DC, 1991.
ASTM E1598-94 Conducting Early Seedling Growth Tests, American Society for Testing and
Materials, West Conshohocken, PA 1999..
ASTM E11676-97 Conducting a Laboratory Soil Toxicity Test with Lumbricid Earthworm Eisenia
foetlda, American Society for Testing and Materials, West Conshohocken, PA 1999..
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APPENDIX B
(Reserved)
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APPENDIX C
DEMONSTRATION OF CAPABILITY
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Appendix C - DEMONSTRATION OF CAPABILITY
C.1 PROCEDURE FOR DEMONSTRATION OF CAPABILITY
A demonstration of capability (DOC) must be made prior to using any test method, and at any time
there is a change in instrument type, personnel or test method (see 5.10.2.1).
Note: In laboratories with specialized "work cells" (a well defined group of analysts that together
perform the method analysis), the group as a unit must meet the above criteria and this demonstration
must be fully documented.
In general, this demonstration does not test the performance of the method in real world samples, but
in the applicable and available clean matrix (a sample of a matrix in which no target analytes or
interferences are present at concentrations that impact the results of a specific test method), e.g.,
water, solids, biological tissue and air. However, before any results are reported using this method,
actual sample spike results may be used to meet this standard, i.e.,at least four consecutive matrix
spikes within the last twelve months. In addition, for analytes which do not lend themselves to spiking,
e.g., TSS, the demonstration of capability may be performed using quality control samples.
All demonstrations shall be documented through the use of the form in this appendix.
The following steps, which are adapted from the EPA test methods published in 40 CFR Part 136,
Appendix A, shall be performed if required by mandatory test method or regulation. Note: For analytes
for which spiking is not an option and for which quality control samples are not readily available, the
40 CFR approach is one way to perform this demonstration. It is the responsibility of the laboratory
to document that other approaches to DOC are adequate, this shall be documented in the laboratory's
Quality Manual, e.g., for Whole Effluent Toxicity Testing see section D.2.1.a.1.
a) A quality control sample shall be obtained from an outside source. If not available, the QC sample
may be prepared by the laboratory using stock standards that are prepared independently from
those used in instrument calibration.
b) The analyte(s) shall be diluted in a volume of clean matrix sufficient to prepare four aliquots at the
concentration specified, or if unspecified, to a concentration approximately 10 times the method-
stated or laboratory-calculated method detection limit.
c) At least four aliquots shall be prepared and analyzed according to the test method either
concurrently or over a period of days.
d) Using all of the results, calculate the mean recovery (0) in the appropriate reporting units (such as
pg/L) and the standard deviations of the population sample (n-1) (in the same units) for each
parameter of interest. When it is not possible to determine mean and standard deviations, such
as for presence/absence and logarithmic values, the laboratory must assess performance against
established and documented criteria.
e) Compare the information from (d) above to the corresponding acceptance criteria for precision and
accuracy in the test method (if applicable) or in laboratory-generated acceptance criteria (if there
are not established mandatory criteria). If all parameters meet the acceptance criteria, the
analysis of actual samples may begin. If any one of the parameters do not meet the acceptance
criteria, 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.confirms 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 CERTIFICATION STATEMENT
The following certification statement shall be used to document the completion of each 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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Demonstration of Capability
Certification Statement
Date: Page_of_
Laboratory Name:
Laboratory Address:
Analyst(s) Name(s):
Matrix:
(examples: laboratory pure water, soil, air, solid, biological tissue)
Method number, SOP#, Rev#, 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 test method(s), which is in use at
this facility for the analyses of samples under the National Environmental Laboratory
Accreditation Program, have met the Demonstration of Capability.
2. The test method(s) was performed by the analyst(s) identified on this certification.
3. A copy of the test method(s) and the laboratory-specific SOPs are available for all
personnel on-site.
4. The data associated with the 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 assessors.
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 a 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
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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 criteria 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.
The requirements from the body of Chapter 5, e.g., 5.5.4, apply to all types of testing. The specific
manner in which they are implemented is detailed in each of the sections of this Appendix, i.e.,
chemical testing, W.E.T. testing, microbiology testing, radiochemical testing and air testing.
D.1 CHEMICAL TESTING
D.1.1 Positive and Negative Controls
a) Negative Controls
1) Method Blanks - Shall be performed at a frequency of one per preparation batch of samples
per matrix type . The results of this analysis shall be one of the QC measures to be used to
assess the batch. The source of contamination must be investigated and measures taken to
correct, minimize or eliminate the problem if
i) the blank contamination exceeds a concentration greater than 1/10 of the measured
concentration of any sample in the associated sample batch or
ii) the blank contamination exceeds the concentration present in the samples and is greater
than 1/10 of the specified regulatory limit.
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) Laboratory Control Sample (LCS) - Shall be analyzed at a minimum of 1 per preparation batch
of 20 or less samples per matrix type, 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 assess the batch . NOTE: the matrix spike (see 2 below) may be
used in place of this control as long as the acceptance criteria are as stringent as for the LCS.
2) Matrix Spikes (MS) - Shall be performed at a frequency of one out of every 20 samples per
matrix type prepared over time, 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 selected sample(s)
shall be rotated among client samples so that various matrix problems may be noted and/or
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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.
3) Surrogates - Surrogate compounds must be added to all samples, standards, and blanks, for
all organic chromatography methods except when the matrix precludes its use or when a
surrogate is not available. Poor surrogate recovery may indicate a problem with the sample
composition and shall be reported to the client whose sample produced the poor recovery.
4) If the mandated or requested test method does not specify the spiking components, the
laboratory shall spike all reportable components to be reported 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 test method has an extremely long list of components, the components coelute or
components are incompatible, a representative number (at a minimum 10%) of the listed
components may be used to control the test method. The selected components of each
spiking mix shall represent all chemistries, elution patterns and masses, permit specified
analytes and other client requested components. However, the laboratory shall ensure that
ail reported components are used in the spike mixture within a two-year time period, unless
the spiking list is specified by the reference method.
D.1.2 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) 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, matrix or
test 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.1.4 Detection Limits
The laboratory shall utilize a test method that provides a detection limit that is appropriate and relevant
for the intended use of the data. Detection limits shall be determined by the protocol in the mandated
test method or applicable regulation, e.g., Method Detection Limit (MDL). If the protocol for
determining detection limits is not specified, the selection of the procedure must reflect instrument
limitations and the intended application of the test method.
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a) A detection limit study is not required for any component for which spiking solutions or quality
control samples are not available such as temperature.
b) The detection limit shall be initially determined for the compounds of interest in each test method
in a matrix in which there are not target analytes nor interferences at a concentration that would
impact the results or the detection limit must be determined in the matrix of interest (see definition
of matrix).
c) Detection limits must be determined each time there is a change in the test method that affects
how the test is performed, or when a change in instrumentation occurs that affects the sensitivity
of the analysis.
d) All sample processing steps of the analytical method shall be included in the determination of the
detection limit.
e) All procedures used must be documented. Documentation must include the matrix type. All
supporting data must be retained.
f) The laboratory must have established procedures to relate detection limits with quantitation limits.
g) The test method's quantitation limits must be established and must be above the detection limits.
D.1.5 Data Reduction
The procedures for data reduction, such as use of linear regression, shall be documented.
D.1.6 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 test 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 test method. Such information shall be documented.
2) Water - The quality of water sources shall be monitored and documented and shall meet
method specified requirements.
3) The laboratory will verify the concentration of titrants in accordance with written laboratory
procedures.
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 and document acceptance criteria for retention time windows.
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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 test 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 document acceptance criteria for mass spectral tuning.
D.1.8 Constant and Consistent Test Conditions
a) The laboratory shall assure that the test instruments consistently operate within the specifications
required of the application for which the equipment is used.
b) Glassware Cleaning - Glassware shall be cleaned to meet the sensitivity of the test method.
Any cleaning and storage procedures that are not specified by the test method shall be
documented in laboratory records and SOPs.
D.2 TOXICITY TESTING
These standards apply to laboratories measuring the toxicity and/or bioaccumulation of contaminants
in general. They are applicable to toxicity or bioaccumulation test methods for evaluating effluents
(whole effluent toxicity or WET), receiving waters, sediments, elutriates, leachates and soils. In
addition to the essential quality control standards described below, some methods may have additional
or other requirements based on factors such as the type of matrix evaluated. Additional information
can be found in the following methods manuals (or most recent edition): EPA/600/4-91/002,
EPA/600/4-91/003, EPA/600/4-90/027F (WET testing), EPA/600/4-90/031 (general aquatic toxicity
testing), EPA/600/R-94/025, EPA/600/R-94/024, EPA/503/R-91/001, EPA/823/B-98/004 (sediments
and elutriates), EPA/600/3-88/029, EPA/600/3-89/013, ASTM E1598-94 AND ASTM 1676-97 (soils).
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
test method.
1) The laboratory must demonstrate its ability to obtain consistent results with reference
toxicants before it performs toxicity tests with effluents or other environmental samples for
regulatory compliance purposes.
i) To meet this requirement, the intra-laboratoty precision must be determined by performing
five or more acceptable reference toxicant tests for each test method and species with
different batches of organisms and appropriate negative controls (water, sediment, or soil).
ii) An intralaboratory coefficient of variation (%CV) is not established for each test method.
However, a testing laboratory shall maintain control charts 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 test method.
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2) Ongoing laboratory performance shall be demonstrated by performing regular reference
toxicant tests for each test method and species in accordance with the minimum frequency
requirements specified in D.2.1.a.3.
i) Intralaboratory precision on an ongoing basis must be determined through the use of
reference toxicant tests and plotted in quality control charts. The control charts shall be
plotted as point estimate values, such as EC25 for chronic tests and LC50 for acute tests,
or as appropriate hypothesis test values, such as the NOEC or NOAEC, over time within
a laboratory.
ii) For endpoints that are point estimates (ICp, ECp) control charts are constructed by
plotting the cumulative mean and the control limits which consist of the upper and lower
95% confidence limits (+ 2 std. dev.); these values are re-calculated with each successive
test result. For endpoints from hypothesis tests (NOEC, NOAEC) the values are plotted
directly and the control limits consist of one concentration interval above and below the
concentration representing central tendency (i.e. the mode).
iii) After 20 data points are collected for a test method and species, the control chart is
maintained using only the 20 most recent data points, i.e. each successive mean value
and control limit is calculated using only the last 20 values.
iv) Control chart limits are expected to be exceeded occasionally regardless of how well a
laboratory performs. Acceptance limits for point estimates (ICp, ECp) which are based
on 95% confidence limits should theoretically be exceeded for one in twenty tests.
Depending on the dilution factor and test sensitivity, control charts based on hypothesis
test values (NOEC, NOAEC) may be expected to be exceeded on a similar frequency.
Test results which fall outside of control chart limits at a frequency of 5% or less, or which
fall just outside control chart limits (especially in the case of highly proficient laboratories
which may develop relatively narrow acceptance limits over time), are not rejected de
facto. Such data are evaluated in comparison with control chart characteristics including
the width of the acceptance limits and the degree of departure of the value from
acceptance limits.
v) Laboratories shall develop an acceptance/rejection policy for reference toxicant data which
considers test dilution factor, test sensitivity (for hypothesis test values), testing
frequency, out-of-control test frequency, relative width of acceptance limits and degree of
difference between test results and acceptance limits.
vi) In the case of reference toxicant data which fails to meet acceptance criteria, the results
of environmental toxicity tests conducted during the affected period may be suspect and
regarded as provisional. In this case the test procedure is examined for defects and the
test repeated if necessary, using a different batch of organisms, as soon as possible or
the data is qualified.
3) The frequency of reference toxicant testing shall comply with the EPA or state permitting
authority requirements. The following minimum frequency shall be met:
i) Each batch of test organisms obtained from an outside source, field collection or from
laboratory spawning of field-collected species not amenable to routine laboratory culture
(for example, sea urchins and bivalve mollusks) must be evaluated with a reference
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toxicant test of the same type as the environmental toxicity test within the seven days
preceding the test or concurrently with the test.
ii) Test organisms obtained from in-house laboratory cultures must be tested with reference
toxicant tests at least once each month for each test method. However, if a given species
produced by in-house cultures is used only monthly, or less frequently, a reference
toxicant test of the same type must be performed with each environmental toxicity test.
iii) For test methods and species commonly used in the laboratory, but which are tested on
a seasonal basis (e.g. sea urchin fertilization tests), reference toxicant tests must be
conducted for each month the method is in use.
4) These standards 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. All reference toxicant
tests conducted for a given test method and species must use the same reference toxicant,
test concentrations, dilution water and data analysis methods. A dilution factor of 0.5x or
greater shall be used for both acute and chronic tests.
5) The reference toxicant tests shall be conducted following the same procedures as the
environmental toxicity tests for which the precision is being evaluated, unless otherwise
specified in the test method (for example, 10-day sediment tests employ 96-h water-only
reference toxicant tests). The test duration, dilution or control water, feeding, organism age,
age range and density, test volumes, renewal frequency, water quality measurements, and the
number of test concentrations, replicates and organisms per replicate shall be the same as
specified for the environmental toxicity test.
b) Negative Control - Control, Brine Control, Control Sediment, Control Soil or Dilution Water -
1) The standards for the use, type and frequency of testing of negative controls are specified by
the test methods and by permit or regulation and shall be followed. A negative control is
included with each test.
2) Appropriate additional negative controls shall be included when sample adjustments (for
example addition of sodium hydroxide for pH adjustment or thiosulfate for dechlorination) or
solvent carriers are used in the test.
3) Test Acceptability Criteria (TAG) - The test acceptability criteria (for example, the whole-
effluent 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 the effluent or environmental sample toxicity test. The criteria shall be
calculated and shall meet the method specified requirements for performing toxicity tests.
D.2.2 Variability and/or Reproducibility
Intralaboratory 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.
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D.2.3 Accuracy
This principle is not applicable to Toxicity Testing.
D.2.4 Test Sensitivity
a) If the Dunnett's procedure is used, the statistical minimum significant difference (SMSD) shall be
calculated according to the formula specified by the test method and reported with the test
results.
b) Estimate the SMSD for non-normal distribution and or heterogenous variances.
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 SMSD shall be calculated and reported for only hypothesis test values, such as the NOEC
or NOAEC.
D.2.5 Selection of Appropriate Statistical Analysis Methods
a) If required, methods of data analysis and endpoints are specified by language in the regulation,
permit or the test method.
b) Dose Response Curves - When required, the data shall be plotted in the form of a curve relating
the dose of the chemical or concentration of sample 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 toxlcity tests is specified in the test 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 Section 5.9.4 above.
c) Only reagent-grade water collected from distillation or deionization units (> 17 megohm resistivity)
is used to prepare reagents.
D.2.7 Selectivity
This principle is not applicable. The selectivity of the test is specified by permit or regulation.
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) Laboratory space must be adequate for the types and numbers of tests performed. The building
must provide adequate cooling, heating and illumination for conducting testing and culturing; hot
and cold running water must be available for cleaning equipment.
c) Air used for aeration of test solutions, dilution waters and cultures must be free of oil and fumes.
d) 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. When organisms are obtained from an
outside source the supplier must provide this same information.
e) 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 5.9.4. Temperature shall be calibrated
per section 5.9.4.2.1. All measurements and calibrations shall be documented.
f) Test temperature shall be maintained as specified for the test method. Temperature control
equipment must be adequate to maintain the required test temperature(s). 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.
g) Reagent grade water, prepared by any combination of distillation, reverse osmosis, ion exchange,
activated carbon and particle filtration, shall meet the following requirements as verified by monthly
measurement: conductivity less than or equal to 0.1 umhos or resistivity greater than or equal to
17 megohm, pH 5.5 to 7.5 S.U. and total residual chlorine non-detectable.
h) The quality of the standard dilution water used for testing or culturing must be sufficient to allow
satisfactory survival, growth and reproduction of the test species as demonstrated by routine
reference toxicant tests and negative control performance. Water used for culturing and testing
shall be analyzed for toxic metals and organics 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. It is recognized that the analyte lists of some methods
manuals may not include all potential toxicants, are based on estimates of chemical toxicity
available at the time of publication and may specify detection limits which are not achievable in all
matrices. However, for those analytes not listed, or for which the measured concentrationor
detection limit is greater than the method-specified limit, the laboratory must demonstrate that the
analyte at the measured concentration or reported detection limit does not exceed one tenth the
expected chronic value for the most sensitive species tested and/or cultured. The expected
chronic value is based on professional judgement and the best available scientific data. The
"USEPA Ambient Water Quality Criteria Documents" and the EPA AQUIRE data base provide
guidance and data on acceptability and toxicity of individual metals and organic compounds..
i) For each new batch of food used for culturing and testing.the performance of organisms fed with
the new food shall be compared with the performance of organisms with a food of known quality
in side-by-side tests. If the food is used for culturing, its suitability is determined using a short-
term chronic test that measures the effect of food quality on growth or reproduction of each of the
relevant test species in culture, using a minimum of four replicates with each food source. Where
applicable, foods used only in chronic toxicity tests are compared with a food of known quality in
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side-by-side, multi-concentration chronic tests, using the reference toxicant regularly employed
in the laboratory QA program. In the case of algae, rotifers or other cultured foods, which are
collected as a continuous batch, the quality is assessed, using side-by-side tests as described
above, each time new nutrient stocks are prepared, a new starter culture is employed or when a
significant change in culture conditions occurs. The laboratory shall have written procedures for
the statistical evaluation of food acceptance.
j) Food used to culture organisms used in bioaccumulation tests must be analyzed for the
compounds to be measured in the bioaccumulation tests.
k) Test chamber size and test solution volume shall be as specified in the test method. All test
chambers used in a test must be identical.
I) Test organisms shall be fed the quantity and type food or nutrients specified in the test method.
They shall also be fed at the intervals specified in the test methods.
m) All organisms in a test must be from the same source. Where available certified seeds are used
for soil tests.
n) All organisms used in tests, or used as broodstock to produce neonate test organisms (for
example cladocerans and larval fish), must appear healthy, show no signs of stress or disease and
exhibit acceptable survival (90% or greater) during the 24 hour period immediately preceding use
in tests.
o) All materials used for test chambers, culture tanks, tubing, etc. and coming in contact with test
samples, solutions, control water, sediment or soil or food must be non-toxic and cleaned as
described in the test methods. Materials must not reduce or add to sample toxicity. Appropriate
materials for use in toxicity testing and culturing are described in the referenced manuals.
p) 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 test
methods and shall be documented at least quarterly. For algal and plant tests, the light intensity
shall be measured and recorded at the start of each test.
q) At a minimum, during aquatic chronic testing DO and pH shall be measured daily in at least one
replicate of each concentration. In static-renewal tests DO must be measured at both the
beginning and end of each 24-h exposure period and may be measured in old and new solutions
prior to organism transfer, or after organism transfer; pH is measured at the end of each exposure
period (i.e. in old solutions).
r) All cultures used for testing shall be maintained as specified in the methods manuals. If test
organisms are obtained from an outside source, certification of culture methods and conditions
must be provided by the supplier for each lot of organisms used in tests.
s) Age and the age range of the test organisms must be as specified in the test method. Supporting
information, such as hatch dates and times, times of brood releases and metrics (for example,
chironomid head capsule width) shall be documented.
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t) The maximum holding time of effluents (elapsed time from sample collection to first use in a test)
shall not exceed 36 hours and the last use of the sample in test renewals shall not exceed 72
hours without the permission of the permitting authority.
u) All samples shall be chilled to 4EC during or immediately after collection (see requirements in
section 5.11.3). .
v) Organisms obtained from an outside source must be from the same batchw) Chronic tests shall
have a minimum of four replicates per treatment.
w) The control population of Ceriodaphnia in chronic effluent or receiving water tests shall contain no
more than 20% males.
x) Dissolved oxygen and pH in aquatic tests shall be within acceptable range at test initiation and
aeration (minimal) is provided to tests if, and only if, acceptable dissolved oxygen concentrations
cannot be otherwise maintained or if specified by the test method
y) The test soils or sediments must be within the geochemical tolerance range of the test organism
z) 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 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.
D.3 MICROBIOLOGY TESTING
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.
a) Microbiological testing refers to and includes the detection, isolation, enumeration and
identification of microorganisms and their metabolites or confirmation of the absence of growth in
materials and media. 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, laboratories must be aware of and
have SOPs that conform with local, State, and national regulatory policies for the safety and health
of personnel.
D.3.1 Positive and Negative Controls
a) Negative Controls
The laboratory shall demonstrate that the equipment, media and reagents have not been
contaminated through sample handling, preparation or environmental exposure. These controls
shall include sterility checks of media, blanks such as filtration blanks, bottle, and buffer blanks.
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1) All blanks and uninoculated controls specified by the test method shall be prepared and
analyzed at the frequency stated in the method and must include the following controls.
2) Analyze (culture) a known negative control using a non-target organism, as a procedural
control of the method for each commercial lot of selective media or batch of media prepared
in the lab.
3) Except for self-contained chromofluorogenic methods, a minimum of one uninoculated control
shall be prepared and analyzed with each batch of samples. The laboratory shall prepare 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, when the same equipment
set is used to prepare multiple samples.
b) Positive Controls
Positive culture controls demonstrate that the medium can support the growth of the test organism,
and that the medium produces the specified or expected reaction to the test organism.
1) Each lot of media shall be tested with at least one pure culture of a known positive reaction
and.except for self-contained chromofluorogenic methods, shall be included with each sample
test batch, each month that the media is used.
2) If routine maintenance culturing is not part of a laboratory's testing and pre-prepared media are
routinely used, strict control of the storage conditions and expiration date of media shall be
maintained. A positive growth control from a known positive sample shall be run with each lot
to ensure that the newly prepared media support growth.
3) If the laboratory has at least one known positive result with an appropriate target organism
during the month, a separate positive control is not required.
D.3.2 Test Variability/Reproducibility
a) The laboratory must demonstrate its ability to duplicate the results by analyzing duplicative
samples or by performing a positive control in duplicate at least once per month.
b) Participation in, collaborative trials, proficiency testing, or Intel-laboratory comparisons, either
formal or informal, must be done.
D.3.3 Method Evaluation
a) In order to demonstrate the suitability of a test method for its intended purpose, the laboratory shall
demonstrate and document that the test method meets acceptance criteria either specified by the
method or by the EPA or State program requirements. Acceptance criteria must meet or exceed
these requirements and must demonstrate that the test method provides correct/expected results
with respect to specified detection capabilities, selectivity, and reproducibility.
1) Laboratories are required to demonstrate proficiency with the test method prior to first use.
This can be achieved by simultaneous, side-by-side analysis by several analysts, or in a one
person laboratory with repetitive testing or collaborative testing with another laboratory.
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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, and
reproducibility. Differences in matrices must be taken into account when testing different
sample types.
3) The validation of microbiological test methods shall be performed under the same conditions
as those for routine sample analysis. This can be achieved by using a combination of
naturally contaminated products and spiked products with results that can be statistically
analyzed to demonstrate that the test meets its intended purpose.
4) All validation data shall be recorded and stored at least as long as the test 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 programs (interlaboratory) identified by
NELAP (5.4.2.J or 5.5.3.4).
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.3.1.b).
D.3.5 Data Reduction
a) The calculations, data reduction and statistical interpretations specified by each test method shall
be followed.
b) If the test method specifies colony counts, such as on membrane filter or plated media then the
ability of individual analysts to count colonies accurately shall be verified at least once per month,
by having two or more analysts count colonies from the same plate. In a one person laboratory,
repetitive counting of the same sample or collaborative testing in another laboratory can be used.
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.
b) Reagents, commercial dehydrated powders and media shall be used within the shelf-life of the
product and shall be documented according to 5.10.5. 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 information, including acceptability
criteria. Performance checks including the organism used, their culture collection reference a date
of issue of specification, or statements assuring that the relevant product batch meets the product
specifications must be verified.
c) Distilled water, deionized water or reverse-osmosis produced water free from bactericidal and
inhibitory substances (e.g., demonstrated with the Water Suitability test) shall be used in the
preparation of media, solutions and buffers. The quality of the water shall be monitored for chlorine
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residual, specific conductance, and heterotrophic bacteria plate count on a monthly frequency
(when used) and analyzed for metals yearly and evaluated according to the required method.
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 instructions or the test method.
e) All laboratory media shall be checked to ensure they support the growth of specific microbial
cultures. In addition, selective media shall be checked to ensure they suppress the growth of
non-target organisms. Media purchased pre-prepared from the manufacturer shall be checked
monthly except when the use and maintenance of pure cultures is not part of laboratory
procedures. Rather than the commonly used streak method, a quantitative procedure where a
known (often low) number of relevant organisms are inoculated into the medium under test and the
recovery evaluated must be used.
D.3.7 Selectivity
a) All confirmation/verification tests specified by the test method shall be performed according to
method protocols.
b) In order to ensure identity and traceability, 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 revived (if freeze-dried) or transferred from slants and subcultured
once to provide reference stocks. Appropriate purity and biochemical checks shall be made
with the reference stocks and documented. The reference stocks shall be preserved by a
technique which maintains the characteristics of the strains. Examples of such methods are
freeze-drying, liquid nitrogen storage and deep-freezing. 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) Working stocks shall not be sequentially cultured more than five times except when:
i. it is required by standard test 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.1.
5) Where used, a new reference culture must be obtained on at least an annual basis.
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Flow Chart
Reference culture from source recognized by NELAC (usually American Type Culture Collection)
Culture once
Appropriate Purity Checks and Biochemical Tests
Reference Stocks
Retained under specific Conditions:
Freeze dried, liquid nitrogen or deep frozen storage
Thaw/Reconstitute
Purity Checks and Biochemical Tests as Appropriate
Working Stocks
Maintained under specific conditions and storage times
Regular/Daily Quality Controls
Figure D.1 Use of Reference Cultures (Bacteria)
D.3.8 Constant and Consistent Test Conditions
a) The laboratory shall devise an appropriate environmental monitoring program and examine trends
in levels of contamination. Acceptable background counts shall be determined and there shall be
documented procedures to deal with situations in which these limits are exceeded.
b) Walls, floors, ceilings and work surfaces shall be non-absorbent and easy to clean and disinfect.
Wooden surfaces of fixtures and fittings shall be adequately sealed. Measures shall 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,
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platinum resistance thermometers used in incubators, autoclaves and other equipment shall
be the appropriate quality to meet specification(s) 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).
Calibration shall be done at least annually.
2) Demonstration of sterilization shall be provided by a continuous temperature recording and
through the use of appropriate biological indicators at least once each month of use except
when temperature recording is not available and then the frequency of biological indicator use
shall be once each week.
3) The stability and uniformity of temperature distribution and time after test sample addition to
re-establish equilibrium conditions in incubators, water baths, ovens and temperature
controlled rooms shall be established.
d) Autoclaves
1) The performance of each autoclave shall be initially evaluated by establishing its functional
properties and performance, for example heat distribution characteristics with respect to
typical uses. Autoclaves shall meet 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.
e) Volumetric equipment such as automatic dispensers, dispenser/diluters, mechanical hand pipettes
and disposal pipettes used in the microbiology laboratory shall be calibrated, as outlined in
Section 5.9.4.2.1 and documented. Each lot of disposable pipets requires a manufacturer's
verification of accuracy and these records shall be retained.
f) UV Instruments
1) Are to be tested quarterly for effectiveness by testing of the power output of the UV bulb in
the UV instruments.
g) Conductivity meters, oxygen meters, pH meters, hygrometers, and other similar measurement
instruments shall be calibrated according to the method specified requirements (see Section
5.9.4. Mechanical timers shall be checked regularly against electronic timing devices to ensure
accuracy.
h) Glassware
1) Glassware shall be tested for possible presence of residues which may inhibit or promote
growth of microorganisms by performing the Inhibitory Residue Test each time the lab changes
the lot of detergent, personnel, or washing procedures.
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2) Each batch of washed glassware shall be tested for possible acid or alkaline residue by
testing one piece of glassware with a suitable pH indicator such as bromthymol blue.
D.4 RADIOCHEMICAL TESTING
These standards apply to laboratories undertaking the examination of environmental samples by
radiochemical analysis. These procedures for radiochemical analysis may involve some form of
chemical separation followed by detection of the radioactive decay of analyte (or indicative daughters)
and tracer isotopes where used. For the purpose of these standards procedures for the determination
of radioactive isotopes by mass spectrometry (e.g. ICP-MS or TIMS) or optical (e.g. KPA) techniques
are not addressed herein.
D.4.1 Negative and Positive Controls
a) Negative Controls
1) Method Blank - Shall be performed at a frequency of one per preparation batch. The results
of this analysis shall be one of the quality control measures to be used to assess the batch.
The method blank result shall be assessed against the specific acceptance criteria [see
5.10.1.2.b)18] specified in the laboratory method manual [see 5.10.1.2]. When the specified
method blank acceptance criteria is not met the specified corrective action and contingencies
[see 5.10.1.2.ab) 19 and 20] shall be followed and results reported with appropriate data
qualifying codes. The occurrence of a failed method blank acceptance criteria and the actions
taken shall be noted in the laboratory report [see 5.13.a)10].
2) In the case of gamma spectrometry where the sample matrix is simply aliquoted into a
calibrated counting geometry the method blank shall be of similar counting geometry that is
empty or filled to similar volume with ASTM Type II water to partially simulate gamma
attenuation due to a sample matrix.
3) There shall be no subtraction of the required method blank [see D.4.1.a)1] result from the
sample results in the associated preparation or analytical batch unless permitted by method
or program. This does not preclude the application of any correction factor (e.g. instrument
background, analyte presence in tracer, reagent impurities, peak overlap, calibration blank,
etc.) to all analyzed samples, both program/project submitted and internal quality control
samples. However, these correction factors shall not depend on the required method blank
result in the associated analytical batch.
4) The method blank sample shall be prepared with similar aliquot size to that of the routine
samples for analysis and the method blank result and acceptance criteria [5.10.1.2.b)18] shall
be calculated in a manner that compensates for sample results based upon differing aliquot
size.
b) Positive Controls
1) Laboratory Control Samples - Shall be performed at a frequency of one per preparation batch.
The results of this analysis shall be one of the quality control measures to be used to assess
the batch. The laboratory control sample result shall be assessed against the specific
acceptance criteria [see 5.10.1.2.b)18] specified in the laboratory method manual [see
5.10.1.2]. When the specified laboratory control sample acceptance criteria is not met the
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specified corrective action and contingencies [see 5.10.1.2.b)19 and 20] shall be followed.
The occurrence of a failed laboratory control sample acceptance criteria and the actions taken
shall be noted in the laboratory report [see 5.13.a)10].
2) Matrix Spike - Shall be performed at a frequency of one per preparation batch for those
methods which do not utilize an internal standard or carrier, for which there is a chemical
separation process, and where there is sufficient sample to do so. The exceptions are gross
alpha, gross beta and tritium which shall require matrix spikes for aqueous samples. The
results of this analysis shall be one of the quality control measures to be used to assess the
batch . The matrix spike result shall be assessed against the specific acceptance criteria
[see 5.10.1.2.b)18] specified in the laboratory method manual [see 5.10.1.2]. When the
specified matrix spike acceptance criteria is not met, the specified corrective action and
contingencies [see 5.10.1.2.b)19 and 20] shall be followed. The occurrence of a failed matrix
spike acceptance criteria and the actions taken shall be noted in the laboratory report [see
5.13.a)10]. The lack of sufficient sample aliquot size to perform a matrix spike shall be noted
in the laboratory report.
3) The activity of the laboratory control sample shall: (1) be two to ten times the detection limit
or (2) at a level comparable to that of routine samples if the sample activities are expected to
exceed 10 times the detection limit.
4) The activity of the matrix spike analytes(s) shall be greater than ten times the detection limit.
5) The laboratory standards used to prepare the laboratory control sample and matrix spike shall
be from a source independent of the laboratory standards used for instrument calibration.
6) The matrix spike shall be prepared by adding a known activity of target analyte. Where a
radiochemical method, other than gamma spectroscopy, has more than one reportable analyte
isotope (e.g. plutonium, Pu 238 and Pu 239, using alpha spectrometry), only one of the
analyte isotopes need be included in the laboratory control or matrix spike sample at the
indicated activity level. However, where more than one analyte isotope is present above the
specified detection limit each shall be assessed against the specified acceptance criteria.
7) Where gamma spectrometry is used to identify and quantitate more than one analyte isotope
the laboratory control sample and matrix spike shall contain isotopes that represent the low
(e.g. americium-241), medium (e.g. cesium-137) and high (e.g. cobalt-60) energy range of the
analyzed gamma spectra. As indicated by these examples the isotopes need not exactly
bracket the calibrated energy range or the range over which isotopes are identified and
quantitated.
8) The laboratory control sample shall be prepared with similar aliquot size to that of the routine
samples for analyses.
c) Other Controls
1) Tracer - For those methods that utilize a tracer (i.e. internal standard) each sample result shall
have an associated tracer recovery calculated and reported. The tracer recovery for each
sample result shall be one of the quality control measures to be used to assess the
associated sample result acceptance. The tracer recovery shall be assessed against the
specific acceptance criteria [see 5.10.1.2.b)18] specified in the laboratory method manual [see
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5.10.1.2]. When the specified tracer recovery acceptance criteria is not met the specified
corrective action and contingencies [see 5.10.1.2.b)19 and 20] shall be followed. The
occurrence of a failed tracer recovery acceptance criteria and the actions taken shall be noted
in the laboratory report [see 5.13.a)10].
2) Carrier - For those methods that utilize a carrier, each sample shall have an associated carrier
recovery calculated and reported. The carrier recovery for each sample shall be one of the
quality control measures to be used to assess the associated sample result acceptance. The
carrier recovery shall be assessed against the specific acceptance criteria [see 5.10.1.2.b)18]
specified in the laboratory method manual [see 5.10.1.2]. When the specified carrier recovery
acceptance criteria is not met the specified corrective action and contingencies [see
5.10.1.2.b)19 and 20] shall be followed. The occurrence of a failed carrier recovery acceptance
criteria and the actions taken shall be noted in the laboratory report [see 5.13.a)11].
D.4.2 Analytical Variability/Reproducibllity
a) Replicate - Shall be performed at a frequency of one per preparation batch where there is sufficient
sample to do so. The results of this analysis shall be one of the quality control measures to be
used to assess batch acceptance. The replicate result shall be assessed against the specific
acceptance criteria [see 5.10.1.2.b)18] specified in the laboratory method manual [see 5.10.1.2].
When the specified replicate acceptance criteria is not met the specified corrective action and
contingencies [see 5.10.1.2.b)19 and 20] shall be followed. The corrective action shall consider
the fact that sample inhomogeneity may be a cause of the failed replicate acceptance criteria. The
occurrence of a failed replicate acceptance criteria and the actions taken shall be noted in the
laboratory report [see 5.13.a)10].
b) For low level samples (less than approximately three times the detection limit) the laboratory may
analyze duplicate laboratory control samples or a replicate matrix spike (matrix spike and a matrix
spike duplicate) to determine reproducibility within a preparation batch.
D.4.3 Method Evaluation
In order to ensure the accuracy of the reported result, the following procedures shall be in place:
a) Initial Demonstration of Capability - (section 5.10.2.1 and Appendix C) shall be performed initially
(prior to the analysis of any samples) and with a significant change in instrument type, personnel
or method.
b) Proficiency Test Samples - The results of such analysis (5.4.2.J and 5.5.3.4) shall be used by the
laboratory to evaluate the ability of the laboratory to produce accurate data.
D.4.4 Radiation Measurement System Calibration
Because of the stability and response nature of modern radiation measurement instrumentation, it is
not typically necessary to verify calibrate of these systems each day of use. This section addresses
those practices that are necessary for proper calibration and those requirements of section 5.9.4.2
(Instrument Calibrations) that are not applicable to some types of radiation measurement
instrumentation.
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a) Initial Instrument Calibration
1) Given that activity detection efficiency is independent of sample activity at all but extreme
activity levels, the requirements of subsections f, h and i of 5.9.4.2.1 are not applicable to
radiochemical method calibrations except mass attenuation in gas-proportional counting and
sample quench in liquid scintillation countingRadiochemistry analytical instruments are
subject to calibration when purchased, when the instrument is serviced, when the instrument
is moved and when the instrument setting(s) have been changed.
2) Instrument calibration shall be performed with reference standards as defined in section
D.4.7a. The standards shall have the same general characteristics (i.e., geometry,
homogeneity, density, etc.) as the associated samples.
3) The frequency of calibration shall be addressed in the laboratory method manual [see
5.10.1.2.b)13] if not addressed in the method. A specific frequency (e.g. monthly) or
observations from the associated control or tolerance chart, as the basis for calibration shall
be specified.b) Continuing Instrument Calibration Verification
b) Continuing Instrument Calibration Verification
Calibration verification checks shall be performed using appropriate check sources and monitored
with control charts or 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 or control chart at the time of calibration shall be used in the calibration verification 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, the instrument calibration verification 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 calibration verification checks for efficiency and energy
calibration shall be performed on a day of use basis along with performance checks on peak
resolution.
2) For alpha spectroscopy systems, the calibration verification check for energy calibration shall
be performed on a weekly basis and the performance check for counting efficiency shall be
performed on at least a monthly basis.
3) For gas-proportional and liquid scintillation counters, the calibration verification check for
counting efficiency shall be performed on a day of use basis. Verification of instrument
calibration does not directly verify secondary calibrations, e.g., the mass efficiency curve or
the quench curve.
4) For scintillation counters the calibration verification for counting efficiency shall be
performed on a day of use basis.
c) Background Measurement
Background measurements shall be made on a regular basis and monitored using control charts
or tolerance charts to ensure that a laboratory maintains its capability to meet required data quality
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objectives. These values are subtracted from the total measured activity in the determination of
the sample activity.
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 gas-proportional counters background measurements shall be performed on a weekly
basis.
4) For scintillation counters, background measurements shall be performed each day of use.
D.4.5 Detection Limits
a) Must be determined prior to sample analysis and must be redetermined each time there is a
significant change in the test method or instrument type.
b) The procedures employed must be documented and consistent with mandated method or
regulation.
D.4.6 Data Reduction
a) Referto Section 5.10.6," Computers and Electronic Data Related Requirements," of this document.
b) Measurement Uncertainties - each result shall be reported with the associated measurement
uncertainty. The procedures for determining the measurement uncertainty must be documented
and be consistent with mandated method and regulation.
D.4.7 Quality of Standards and Reagents
a) The quality control program shall establish and maintain provisions for radionuclide standards.
1) Reference standards that are used in a radiochemical laboratory shall be obtained from 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. Commercial suppliers of reference standards shall conform to ANSI
N42.22 to assure the quality of their products.
2) Reference standards shall be accompanied with a certificate of calibration whose content is
as described in ANSI N42.22 -1995, Section 8, Certificates.
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) All reagents used shall be analytical reagent grade or better.
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0.4.8 Constant and Consistent Test Conditions
a) 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.
b) For gamma spectrometry systems, background check measurements shall be performed each
day of use.
c) For alpha spectrometry systems, background check measurements shall be performed except
when using the electro-plating method of sample preparation.
d) For gas-proportional counter systems, background check measurements shall be performed each
day of use.
D.5 AIR TESTING
These standards shall apply to samples that are submitted to a laboratory for the purpose of analysis.
They do not apply to field activities such as source air emission measurements or the use of
continuous analysis devices.
D.5.1 Negative and Positive Controls
a) Negative Controls
1) Method Blanks - Shall be performed at a frequency of at least one (1) per batch of twenty (20)
environmental samples or less per sample preparation method. The results of the method
blank analysis shall be used to evaluate the contribution of the laboratory provided sampling
media and analytical sample preparation procedures to the amount of analyte found in each
sample. If the method blank result is greater than the detection limit and contributes greater
than 10% of the total amount of analyte found in the sample, the source of the contamination
must be investigated and measures taken to eliminate the source of contamination. If
contamination is found, the data shall be qualified in the report.
2) Collection Efficiency- Sampling trains consisting of one or more multi-section sorbent tube,
that are received intact by the laboratory, shall be separated into "front" and "back" sections
if required by the client. Each section shall be processed and analyzed separately and the
analytical results reported separately.
b) Positive Controls
1) Laboratory Control Sample (LCS) - Shall be analyzed at a rate of at least one (1) per batch
of twenty (20) or fewer samples per sample preparation method for each analyte. If a spiking
solution is not available, a calibration solution whose concentration approximates that of the
samples, shall be including in each batch and with each lot of media. The concentration of
the LCS shall be relevant to the intended use of the data and either at a regulatory limit or
below it.
c) Surrogates - Shall be used as required by the test method.
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d) Matrix spike - Shall be used as required by the test method.
D.5.2 Analytical Variability/Reproducibility
Matrix Spike Duplicates (MSDs) or Laboratory Duplicates - Shall be analyzed at a minimum of 1 in
20 samples per sample batch. The laboratory shall document their procedure to select the use of
appropriate types of spikes and duplicates. The selected samples(s) shall be rotated among client
samples so that various matrix problems may be noted and/or addressed. Poor performance in the
spikes and duplicates may indicate a problem with the sample composition and shall be reported to
the client.
D.5.3 Method Evaluation
In order to ensure the accuracy of the reported result, the following procedures shall be in place:
a) Demonstration of Capability- (Sections 5.6.2 and 5.10.2.1) shall be performed prior to the analysis
of any samples and with a significant change in instrument type, personnel, matrix, or test
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.5.4 Detection Limits
The laboratory shall utilize a test method that provides a detection limit that is appropriate and relevant
for the intended use of the data. Detection limits shall be determined by the protocol in the mandated
test method or applicable regulation, e.g., MDL. If the protocol for determining detection limits is not
specified, the selection of the procedure must reflect instrument limitations and the intended
application of the test method.
a) A detection limit study is not required for any component for which spiking solutions are not
available such as temperature or on-line analyses.
b) The detection limit shall be initially determined for the compounds of interest in each test method
in a matrix in which there are not target analytes nor interferences at a concentration that would
impact the results or the detection limit must be determined in the matrix of interest (see definition
of matrix).
c) Detection limits must be determined each time there is a significant change in the test method
or instrument type.
d) All sample processing steps of the analytical method must be included in the determination of
the detection limit.
e) All procedures used must be documented. Documentation must include the matrix type. All
supporting data must be retained.
f) The laboratory must have established procedures to tie detection limits with quantitation limits.
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D.5.5 Data Reduction
The procedures for data reduction, such as use of linear regression, shall be documented.
D.5.6 Quality of Standards and Reagents
a) The source of standards shall comply with 5.9.2.
b) The purity of each analyte standard and each reagent shall be documented by the laboratory
through certificates of analyses from the manufacturer/vendor, manufacturer/vendor specifications,
and/or independent analysis.
c) In methods where the purity of reagents is not specified, analytical reagent grade or higher quality,
if available, shall be used.
D.5.7 Selectivity
The laboratory shall develop and document acceptance criteria for test method selectivity such as
absolute and relative retention times, wavelength assignments, mass spectral library quality of match,
and mass spectral tuning.
0.5.8 Constant and Consistent Test Conditions
a) The laboratory shall assure that the test instruments consistently operate within the
specifications required of the application for which the equipment is used.
b) The laboratory shall document that all sampling equipment, containers and media used or supplied
by the laboratory meet required test method criteria.
c) If supplied or used by the laboratory, procedures for field equipment decontamination shall be
developed and their use documented.
d) The laboratory shall have a documented program for the calibration and verification of sampling
equipment such as pumps, meter boxes, critical orifices,flow measurement devices and
continuous analyzers, if these equipment are used or supplied by the laboratory.
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APPENDIX E
ADDITIONAL SOURCES OF
INFORMATION AND ASSISTANCE
-Non-Mandatory Appendix-
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Appendix E - ADDITIONAL SOURCES OF INFORMATION
Non-Mandatory Appendix-
Additional sources of information are available to assist laboratories in the design and implementation
of a quality system. These materials may be found on the NELAC web page at www.epa.gov/ttn/nelac
under the topic "Related Information".
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TABLE OF CONTENTS
6.0 ACCREDITING AUTHORITY
6.1 INTRODUCTION [[[ 1
6.2 GENERAL PROVISIONS ................................................. 1
6.2.1 Reciprocity [[[ 2
6.2.2 Where to Apply for NELAP Accreditation ................................ 4
6.2.3 Documentation Maintained by Accrediting Authorities ....................... 5
6.3 APPLICATION FOR NELAP RECOGNITION ................................... 5
6.3.1 Written Application for NELAP Recognition .............................. 5
6.3.2 Application Completeness Review by NELAP ............................. 7
6.3.3 Application Technical Review by a NELAP Assessment Team ................. 8
6.3.3.1 Required Technical Elements of a NELAP-Recognized Accrediting Authority's
Program [[[ 9
6.3.3.1.1 Records ............................................. 11
6.3.3.1.2 Use of Contractors by an Accrediting Authority ................. 11
6.3.3.1.3 Accrediting Authority's Quality System ....................... 11
6.3.3.1.4 Mutual Assistance Agreements ............................ 12
6.3.3.2 Application Technical Review Report ............................... 12
6.3.4 Notification of Changes to An Accrediting Authority's Program ................ 14
6.4 ON-SITE ASSESSMENT OF THE ACCREDITING AUTHORITY ..................... 14
6.4.1 Scheduling the On-site Assessments ................................. 14
6.4.2 Conducting the On-site Assessment .................................. 15
6.4.3 On-site Assessment Reports ....................................... 16
6.5 ACCREDITING AUTHORITY'S REQUEST FOR EXTENSION OF TIME TO COMPLY WITH THE
NELAC STANDARDS .................................................. 18
6.6 NELAP ASSESSMENT TEAM RECOMMENDATIONS TO THE NELAP DIRECTOR ...... 18
6.7 CERTIFICATE OF RECOGNITION TO THE ACCREDITING AUTHORITY ............... 19
6.8 USE OF ACCREDITATION BY NELAP ACCREDITED LABORATORIES .............. 19
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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 6 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 6 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 6. Those ISO/IEC Guide 58 requirements not addressed in Chapter 6
are addressed in the NELAC standards, Chapters 2 through 5. Since Chapter 6 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 2 through 6, 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 6 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 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. The accrediting authority also shall
require accredited laboratories to maintain impartiality and integrity. 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
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4) conflict with any territorial, state or federal laws governing discrimination.
e) Accrediting authorities and their contractors 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."
g) Accrediting authorities, within the scope and applicability of their prevailing rules and regulations,
shall establish one or more technical committees for assistance in interpretation of requirements
and 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 relevant competent technical
support and impartiality through a balance of interests where no single interest predominates,
and
3) a mechanism for publishing interpretations and recommendations made by these committees.
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 Reciprocity
a) Except for NELAP-recognized federal accrediting authorities (see 6.2.1 (h) and (i) below),
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:
1) grant reciprocal accreditation for only the fields of testing, methods and analytes for which
the laboratory holds current primary NELAP accreditation, and
2) grant reciprocal accreditation and issue certificates, as required in NELAC, Chapter 4, to
an applicant laboratory within 30 calendar days of receipt of the laboratory's application.
c) All fees shall be paid by laboratories as required by the NELAP-recognized secondary
accrediting authority.
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d) Laboratories seeking NELAP accreditation by a NELAP-recognized secondary accrediting
authority shall not be 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 already has been granted NELAP accreditation through
reciprocity, the NELAP-recognized secondary accrediting authority shall immediately notify, in
writing, the applicable NELAP-recognized primary accrediting authority and the laboratory.
However, the laboratory is to be notified only in situations where no administrative or judicial
prosecution is contemplated. 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 initialapplication 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 6.2.1 (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 4,
Accreditation Process,
3) respond to the NELAP-recognized secondary accrediting authority, in writing, with a copy
to the NELAP Director, within 20 calendar days of receipt of the subsection 6.2.1 (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 calendar 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.
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h) Federal accrediting authorities shall serve as the accrediting authority only for governmental
laboratories.
i) County, municipal, and non-governmental laboratories shall not claim either primary or
secondary accreditation by a federal agency, even if the laboratory is performing analyses
under contract to that agency.
6.2.2 Where to Apply for NELAP Accreditation
a) All county, municipal and non-governmental 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.
b) Laboratories located in a territory or state that is not NELAP-recognized may seek NELAP
accreditation through any NELAP-recognized state or territorial accrediting authority.
c) Except as noted in subsection 6.2.2 (g) below, state governmental laboratories seeking NELAP
accreditation or renewal of NELAP accreditation may apply for such accreditation through their
home state, home territory or through a NELAP-recognized federal accrediting authority.
d) Except as noted in subsection 6.2.2 (g) below, federal governmental laboratories located in a
department or agency that is a NELAP-recognized federal accrediting authority shall follow that
department or agency's policy regarding NELAP accreditation or renewal of NELAP
accreditation.
e) Federal governmental laboratories located in a federal department or agency that is not a
NELAP-recognized accrediting authority may seek NELAP accreditation through any NELAP-
recognized federal or state accrediting authority, except where the relationship poses a conflict
of interest.
f) Laboratories that are NELAP accredited by a state accrediting authority that has lost NELAP
recognition may seek renewal of NELAP accreditation through any NELAP-recognized state
accrediting authority. The laboratory's NELAP accreditation from an accrediting authority that
has lost NELAP recognition shall remain valid throughout its current certificate of accreditation.
g) 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 shall:
1) demonstrate by organizational structure that the laboratory's Technical Director and the
environmental laboratory accreditation program manager do not report within the same
chain-of-command; and
2) demonstrate by policies and procedures that conflicts-of-interest do not exist; or
3) apply for NELAP accreditation through any other NELAP-recognized accrediting authority.
h) 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.
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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;
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 6.2.3(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 calendar days of the review.
c) The document or documents described in subsection 6.2.3(a)(1) above shall be made readily
available upon request.
d) The accrediting authority shall have arrangements, consistent with NELAC, Chapter 3, On-site
Assessment to safeguard information claimed by the laboratories as confidential.
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
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authority's environmental laboratory accreditation program. When documentation is required,
copies of the 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 telefacsimile
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, promulgating instructions 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);
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);
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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);
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 calendar 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. This notification of renewal shall indicate whether an on-site
assessment is due as set forth in subsection 6.4 (a).
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 calendar days of receiving the renewal notification.
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 20 calendar days of receipt of this notification from the
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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.
1) 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 20 calendar 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 20 calendar days of receipt of the 6.3.2(c)(2) notification.
A) The NELAP may grant extensions to the 20-day time period for up to an additional 20
calendar days if the accrediting authority requests the extension in writing.
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 seven calendar days of the date of such determination.
6.3.3 Application Technical Review by a NELAP Assessment Team
a) Within 30 calendar 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 assessment.
3) In the years when no on-site assessment 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 assessment 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 assessment cycle as set forth in Section 6.4 (a) of this chapter. New
four-year NELAP on-site assessment cycles shall start with each renewal application when
an on-site assessment 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
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accredited laboratories to meet the standards set forth by the NELAC standards, Chapter 2,
Proficiency Testing, Chapter 3, On-site Assessment, Chapter 4, Accreditation Process and
Chapter 5, 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, rights and responsibilities necessary 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 financial stability and the physical and human resources
required for the operation of an accrediting authority's laboratory accreditation program. The
accrediting authority shall have and make available on request a description of the means by which
it receives its financial support. As a benchmark, 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, who meet the education, experience and training requirements set forth in the NELAC
standards, Chapter 3, 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.
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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 3, 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.
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;
I) 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;
m) The accrediting authority shall require NELAP-accredited laboratories to participate in a proficiency
testing program meeting the requirements of the NELAC standards, Chapter 2, Proficiency
Testing, Appendix A; and
n) The accrediting authority or its contractors shall not offer consultancy or other services which may
compromise the objectivity or impartiality of its accreditation process and decisions.
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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.
d) The accrediting authority shall have a policy and procedure for updating the NELAP national
database with the NELAP-required information specific to the laboratories for which that accrediting
authority is the primary or secondary accrediting authority. These updates must occur no less
frequently than every two weeks. The schedule for the updates would include submitting a report
even if there were no changes to the database.
6.3.3.1.2 Use of Contractors by an Accrediting Authority
a) The accrediting authority shall have arrangements to ensure and require by signed contract or
other similar type of binding document 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 contracted work,
2) ensure that the contractor and their employees are competent and comply with the applicable
provisions of the NELAC standards,
3) ensure that the contractor and their employees comply with the confidentiality requirements
of the accrediting authority and NELAC, and,
4) ensure that the contractor and their employees are not directly involved with:
A) the laboratory seeking NELAP accreditation from the accrediting authority employing the
contractor; or
B) any other affiliation which would compromise impartiality in the NELAP laboratory
accreditation process.
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 and shall be made available for use by the staff. The quality manual shall include at
least the following:
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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 policies and procedures for acquiring, training, 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, including Quality System reviews, 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;
6) the procedures established to address conflict-of-interest questions arising from the NELAC
standards as set forth in subsection 6.2.2 (d)(2) and for the accrediting authority's
management and technical staff as set forth in subsection 6.3.3.1 (i);
7) the policies and procedures established to maintain document control for documents required
by the NELAC standards;
8) the policies and procedures to implement the accreditation process; and
9) the policies and procedures for dealing with appeals, complaints and disputes by laboratories.
6.3.3.1.4 Mutual Assistance Agreements
Upon mutual agreement, another NELAP-recognized accrediting authority may perform laboratory
accreditation functions on behalf of a NELAP-recognized primary accrediting authority. Such an
arrangement does not require approval by the NELAP Director.
6.3.3.2 Application Technical Review Report
a) The NELAP assessment team will accept an initial application and its supporting documentation
for continued processing 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
assessment as set forth in subsection 6.4.1 below.
b) The NELAP assessment team will accept a renewal application and its supporting documentation
for continued processing 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.
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c) Except as noted in Section 6.5, the NELAP assessment team will not accept the application for
continued processing 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:
1) 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) To proceed with the review process, the accrediting authority shall respond with written corrective
actions within 30 calendar days of receipt of the NELAP assessment team's subsection 6.3.3.2(c)
notification. The NELAP assessment team will review the corrective actions within 30 calendar
days of receipt of the accrediting authority's response. Alternately, the accrediting authority has
the option to withdraw all or part of its NELAP recognition request.
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 20 calendar 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 20 calendar 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 document those deficiencies which are
not resolved and 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 6.3.3.2(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
assessment 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, when required, an on-site assessment of the accrediting
authority's environmental laboratory accreditation program as set forth in Section 6.4 (a) and
subsection 6.4.1 (a) below.
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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, regulations and promulgating
instructions establishing and governing the accrediting authority's environmental laboratory
accreditation program,
2) the organizational structure including key personnel,
3) the rules, regulations, policies, guidance documents and standard operating procedures,
4) the mailing address and office location, telephone and telefacsimile 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 calendar 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 assessments 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 ASSESSMENT OF THE ACCREDITING AUTHORITY
a) On-site assessments of an accrediting authority's environmental laboratory accreditation program
shall be conducted on a four-year cycle as follows:
1) An initial on-site assessment shall be conducted in conjunction with an accrediting authority's
initial application process and every four years thereafter; and
2) No on-site assessment 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 assessment was conducted.
b) The NELAP assessment team will arrange on-site assessments except as stated in subsection
6.4(c) below at the mutual convenience of the parties.
c) The NELAP assessment team may make subsequent announced or unannounced on-site
assessments of an accrediting authority's environmental laboratory accreditation program
whenever such an assessment is necessary to determine the accrediting authority's compliance
with the requirements of the NELAC standards.
6.4.1 Scheduling the On-site Assessments
a) The NELAP assessment team shall contact the accrediting authority to schedule on-site
assessments as set forth in Section 6.4 (a) above within 20 calendar days of the date the NELAP
assessment team accepts an initial or renewal application.
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b) The NELAP assessment team must send to the accrediting authority written confirmation of the
logistics required to conduct the on-site assessment. The written confirmation shall include, but
is not limited to:
1) on-site assessment date and agenda or schedule of activities,
2) copies of the standardized assessment checklists,
3) the names, titles, affiliations, and on-site assessment 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 assessment.
c) All on-site assessments shall be conducted no later than 50 calendar days following approval of
the application.
6.4.2 Conducting the On-site Assessment
a) The purpose of the on-site assessment 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 documents; 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
assessment 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 assessment, 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 only have access to records of the accrediting authority's
environmental laboratory accreditation program that are necessary to determine compliance with
the NELAC standards. An accrediting authority shall not be required to give the NELAP
assessment team access to sensitive or confidential documents, or documents that are part of
the record of an ongoing legal proceeding.
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d) NELAP assessment teams performing an on-site assessment of a Federal agency may need
security clearances, appropriate badging, and/or a security briefing before proceeding with the on-
site assessment. Assessors shall be informed in writing of any information that is controlled for
national security reasons and cannot be released to the public.
e) 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.
f) The NELAP assessment team must ensure that the assessment 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 comprehensive on-site assessment of the accrediting authority's environmental laboratory
accreditation program, and
3) an exit interview to discuss all noted deficiencies.
g) The NELAP assessment team shall conduct all assessments in accordance with the NELAP
standard operating procedure for conducting on-site assessments of accrediting authorities.
6.4.3 On-site Assessment Reports
a) The NELAP assessment team will send by certified mail to the accrediting authority an on-site
assessment report within 30 calendar days of completion of the on-site assessment. 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 for which initial recognition or renewal is sought; and
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 assessment 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 assessment, the report will:
1) identify any specific deficiencies noted during the on-site assessment,
2) include references to the specific NELAC standards, and
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3) provide suggested corrective action.
d) If the on-site assessment reveals deficiencies, the accrediting authority shall submit a plan of
corrective action to the NELAP assessment team within 30 calendar days of receipt of the on-site
assessment 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 assessment.
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 assessment report.
3) Except for those deficiencies set forth in Section 6.5, the implementation of corrective actions
must take place no more than 65 calendar days from receipt of the on-site assessment report.
e) The NELAP assessment team shall recommend to the NELAP Director revocation or denial of
NELAP recognition for on-site assessment deficiencies for any accrediting authority that fails to
submit a plan of corrective action within 30 calendar days as set forth in subsection 6.4.3(d) above.
f) Within 20 calendar 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 20 calendar 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 20 calendar days of receipt of a subsection 6.4.3(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 assessment 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 assessment 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 assessment
deficiencies requires the accrediting authority to promulgate new or revised regulations, or
3) when implementation of corrective actions to correct application and/or assessment
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 assessment
deficiencies.
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 assessment review letters sent to the accrediting authority and all
corrective action response letters submitted by the accrediting authority; and
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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 with all supporting documentation to
the NELAP Director also shall be furnished to the accrediting authority.
d) Within 20 calendar 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.
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 assessment,
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;
9) a seal incorporating the NELAP insignia; and
10) a unique designator, such as date of issuance and a serial or certificate number.
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 and/or use of the
NELAC/NELAP logo. These arrangements shall include, but are not limited to requirements that:
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June 29, 2000
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1) NELAP accredited laboratories post or display their most recent NELAP accreditation
certificate or their NELAP-accredited 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 and/or the
NELAC/NELAP logo 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,
laboratory analytical reports or other materials; and
4) NELAP accredited laboratories not use their NELAP certificate, NELAP accreditation status
and/or NELAC/NELAP logo 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, making reference to its NELAP accreditation
status and/or using the NELAC/NELAP logo in any catalogs, advertising, business solicitations,
proposals, quotations, laboratory analytical reports or other materials, the NELAP accredited
laboratory shall:
1) distinguish between proposed testing forwhich 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,
laboratory analytical results or other materials that contain reference to their past NELAP
accreditation status and/or display the NELAC/NELAP logo, and,
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, misleading use of
the laboratory's NELAP accreditation status and/or unauthorized use of the NELAC/NELAP logo
is found in catalogs, advertisements, business solicitations, proposals, quotations, laboratory
analytical reports or other materials.
6.9 REQUIREMENTS OF THE NELAP
a) The NELAP assessment team shall submit all documents, letters, assessment notes, checklists,
etc. to the NELAP headquarters office within:
1) 30 calendar days of the final decision on the application by the NELAP Director, or
2) 30 calendar days after the final recommendation by the Accrediting Authority Review Board
(AARB) as set forth in Section 6.10 of this chapter.
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NELAC
Accrediting Authority
Revision 12
June 29, 2000
Page 21 of 24
b) The NELAP Director shall maintain complete and accurate records of all documents relating to the
application and on-site assessment 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 assessments.
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 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 an employee of a NELAP-recognized
accrediting authority.
d) Prior to conducting the on-site assessment of an accrediting authority's program, at least one
member of the NELAP assessment team shall complete the NELAP Accrediting Authority
Assessor Training Course.
e) The NELAP assessment team shall:
1) have at least one member of the NELAP assessment team who meets the education,
experience and training requirements for laboratory assessors specified in the NELAC
standards, Chapter 3, On-site Assessment; and
2) have at least another member with experience that includes at least one of the following:
A) certification as a management systems lead assessor (quality or environmental) from an
internationally recognized auditor certification body;
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.
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NELAC
Accrediting Authority
Revision 12
June 29, 2000
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6.10 APPEALING DECISIONS TO DENY OR REVOKE NELAP RECOGNITION
a) Within 20 calendar days of official notification of the NELAP action on an accrediting authority's
application for NELAP recognition, the accrediting authority shall notify the NELAP Director if the
accrediting authority chooses to appeal the NELAP action. If the accrediting authority does not
receive satisfactory resolution, the accrediting authority may request a review by the AARB. This
request shall be made within 20 calendar days of the Director's decision.
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 all relevant parts of the record.
d) The AARB shall conduct interviews with the accrediting authority and the NELAP Director. The
AARB also may conduct interviews with the NELAP assessment team member(s) or 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 meet jointly with the AARB shall be granted.
f) The AARB shall complete its review and render a final recommendation to the NELAP Director
within 90 calendar days following receipt of the notice of appeal. This time frame may be extended
by mutual agreement of all parties up to a maximum of 60 additional calendar days.
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 20 calendar days of receipt of the recommendation from the AARB.
h) Accrediting authorities shall be limited to one appeal for each application cycle.
f) Upon filing an appeal, the status existing prior to the decision will remain in effect pending
resolution of the appeal.
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NELAC
Accrediting Authority
Revision 12
June 29, 2000
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START
Request for Application
NELAP Sends Application
Package
National Environmental Laboratory
Accreditation Conference/
Accrediting Authority
Figure 1: Flow Chart for NELAP Recognition of An
Accrediting Authority
Review App. and prepare Technical
Report by HELAP Assmt, Team
. 3Qd to prepare 1st report
30d to review 1st resubmittal
20d to review 2nd resubmittal
Accrediting Authority Submits
Corrective Actions
1st Resubmittal-30 days
2nd Resubralttal-20 days
(Application Process \
Terminated J
NELAP Director Reviews
Team's Recommendation to
Deny or Revoke
20 days
Audit Scheduled
50 days MAX to complete
Accrediting Authority Submits
Corrective Actions
1st Resubmittal-30 days
2nd Reeubmittal-20 days
Q
0
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NELAC
Accrediting Authority
Revision 12
June 29, 2000
Page 24 of 24
/" "N
Y 1TELAP Raaognieicra
\ Dwniad oir Revokad
V, _>
Figure 1: Flow Chart for NELAP Recognition of An Accrediting Authority
* U.S. QOVOTMEMT PRINTING OTTTCE: 2000-523-355/95172
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xvEPA
United States
Environmental Protection Agency
ORD, NERL, ESD
PO Box 93478
Las Vegas, NV 89193-3478
Official Business
Penalty for Private Use
$300
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