United Stales
Environmental Protection
Agency
Prevention, Pesticides,
And Toxic Substances
(TS-798)
EPA 747-R-92-001
March 1992
x>EPA
Laboratory Accreditation
Program Guidelines:
Measurement Of Lead
In Paint, Dust, And Soil
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LABORATORY ACCREDITATION PROGRAM GUIDELINES:
MEASUREMENT OF LEAD IN PAINT, DUST, AND SOIL
Final Report
Prepared by the
Task Group on
Methods and Standards
of the
Federal Interagency Lead-Based Paint Task Force
Distributed By
U.S. Environmental Protection Agency
Exposure Evaluation Division, TS-798
Office of Pollution Prevention and Toxics
401 M Street, SW
Washington, D.C 20460
March
1992
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NOTICE
In 1989, the U.S. Environmental Protection Agency (EPA) and the Department of
Housing and Urban Development (HUD) formed an Interagency Task Force to evaluate
issues related to the reduction of lead-based paint exposure to children. This eighteen
member Interagency Task Force operates to exchange information, coordinate activities, and
conduct joint projects aimed at reducing childhood poisoning from exposure to lead-based
paint. One effort of the Task Force is aimed at improving the measurement of lead in a
variety of media including blood, paint, dust, and soil Specific activities include improving
the accuracy and precision of analytical methods for the laboratory, the development of
standard reference materials for lead in environmental media, and establishing the evaluation
components of a laboratory proficiency testing and accreditation program. This report
presents the guideline recommendations of the Interagency Task Force for the establishment
of a national laboratory accreditation program for the analysis of Pb in paint, dust, and soil
samples. These recommendations, as well as others provided by the scientific community, are
being considered by EPA in an effort to develop a national laboratory accreditation program
for the analysis of Pb in paint, dust, and soil samples.
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Special Committee on Laboratory Accreditation
Chairman, James R. DeVoe
Members
Abel, Ray, Supervisory Chemist, Branch 1 Inorganic Division,
Occupational Safety and Health Agency, 1781 South 300
West, Salt Lake City, UT, 84165
Telephone: 8-588-4270 FAX: 801-524-4081
Ashley, Kevin, Research Chemist, National Institute for Occupational Safety &
Health, 4676 Columbia Parkway, Cincinnati, OH 45226
Telephone: 513-841-4402 FAX: 513-841-4500
Beard, Michael, AREAL/MRDD/APMB, MD-77, Environmental
Protection Agency, Research Triangle Park, NC, 27711
Telephone: 8-629-2623 FAX: 919-541-4609
Breen, Joseph, OTS/EED, TS-798, Environmental Protection Agency,
401 M Street, SW., Washington, D.C. 20460
Telephone: 202-260-3569 FAX: 202-260-0001
DeVoe, James, R., Chief, IARD, National Institute of Standards and
Technology, Chemistry Building, Room A349, Gaithersburg, MD
20899
Telephone: 301-975-4144 FAX: 301-926-6182
Galowin, Larry, NVLAP, National Institute of Standards and Technology,
TRF, Building, Room A130, Gaithersburg, MD 20899
Telephone: 301-975-4016 FAX: 301-975-3839
Harper, Sharon, AREAL/QATSD/AMSB, MD-78, Environmental Protection
Agency, Research Triangle Park, NC, 27711
Telephone: 8-629-2443 FAX: 919-541-3527
Huang, Miau, Consumer Product Safety Commission, 9620 Medical
Center, Suite 310, Rockville, MD, 20850
Telephone: 301-443-9420 FAX: 301-492-5402
Lim, Ben, TS-798, OTS/EED/FSB, Environmental Protection Agency,
401 M Street, SW., Washington, D.C. 20460
Telephone: 202-260-1509 FAX: 202-260-0001
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McKnight, Mary, BMD, National Institute of Standards and Technology,
BR Building, Room B348, Gaithersburg, MD, 20899
Telephone: 301-975-6714 FAX: 301-975-4032
Morony, Ron, Housing and Urban Development, 451 7th Street,
SW., Washington, D.C. 20410
Telephone: 202-755-1805 FAX: 202-755-1000
Scalera, John, TS-798, OTS/EED/FSB, Environmental Protection Agency,
401 M Street, SW., Washington, D.C. 20460
Telephone: 202-260-3569 FAX: 202-260-0001
Schlecht, Paul, Quality Assurance Activities, National Institute of Occupational
Safety and Health, 4676 Columbia Parkway, Cincinnati, OH 45226
Telephone: 513-841-4266 FAX: 513-841-4500
Tholen, Albert, Laboratory Accreditation, National Institute of Standards
and Technology, TRF Building, Room A146, Gaithersburg, MD 20899
Telephone: 301-975-4017 FAX: 301-975-3839
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CONTENTS
Executive Summary
Introduction
Administrative Structure 3
Lead Organization 3
Accreditor Monitor 5
Advisory Committee 5
Financial Support 5
Establishment of Quality Assurance
and Training Programs 6
Quality Assurance System 6
Training Programs 6
Performance Evaluation Materials 7
Real Materials 7
Distribution 7
Primary Reference Materials 8
Specifications 8
Financial Support 8
Method Protocols 8
Selection Strategy 8
Compendium of Methods , 9
Quality Assurance/Quality Control 9
Field Methods 10
Site Inspections 10
Assessment Requirements 11
Frequency of Inspections 11
Qualifications of Inspectors 11
Administrative Rules 12
Federal Register Notice 12
Public Notices 12
Expert Advice 12
Federal Agencies 12
Notice of Laboratory Accreditation,
Schedule, and Fees 12
Fees 13
Denial, Suspension, Revocation, and
Voluntary Termination of Accreditation 13
Termination 13
References 14
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REPORT ON GUIDELINES FOR
ESTABLISHMENT OF A
LABORATORY ACCREDITATION PROGRAM
FOR THE MEASUREMENT OF LEAD IN
PAINT AND THE ENVIRONMENT
EXECUTIVE SUMMARY
'T his report summarizes the results of meetings that were held to discuss guidelines
and recommendations for conducting an intergovernmental agency laboratory
accreditation program (LAP) for the chemical analysis of lead in paint, dust, and soil.
The main factors to consider in establishing a LAP are the administrative structure,
quality assurance policy, performance evaluation materials, method protocols, site
inspections, and administrative rules.
This report suggests guidelines for structuring a LAP for lead in paint, dust and soil. It is
recommended that existing programs be utilized as much as possible, but uniformity of
requirements between the programs is needed. This can be accomplished by establishing
an organization that monitors and coordinates the activities of the laboratory accreditors.
The development of uniform requirements will create the potential for reciprocity
between accrediting organizations in the LAP.
The implementing agency will have to establish from already existing models, concepts of
quality assurance to be expected from the accredited laboratories. Training programs to
propagate this policy will have to be established. It is also recommended that annual
symposia for representatives of the accredited laboratories and other members of the
environmental community be established for the purpose of updating methods and .
standards.
While test method protocols used by any given laboratory must be clearly identified and
detailed, it is not recommended specific methods be mandated. It is believed a
comprehensive and rigorous performance evaluation material program coupled with
laboratory site inspections can verify laboratory capabilities. It is expected the fees paid
by the laboratories participating in the LAP will cover a substantial part of the program's
cost; however, additional support from the lead agency may be necessary.
It is recommended the lead agency establish an advisory committee consisting of
representatives of the users of the accredited laboratories, the accredited laboratories, the
laboratory accreditors, accreditor monitor, and lead agency. This committee would
review specific procedures and requirements developed by the lead agency from the
guidelines established in this report.
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INTRODUCTION
l~r he Interagency Lead-Based Paint Task Force has formulated a Task Group on
Methods and Standards. At the September 1991 Interagency Task Force meeting,
the Group was asked to perform a brief study on accreditation procedures for
laboratories performing analyses of paint, dust and soil samples for lead. To that end, a
Special Committee was assembled to include representatives from the various government
agencies that have particular interest in laboratory accreditation, (See list of members at
the beginning of this report.) The Special Committee on Laboratory Accreditation
limited its consideration to the analysis of lead in paint, dust, and soil. It was decided the
best way to proceed was to discuss briefly the attributes of existing laboratory
accreditation programs and to generate functional guidelines that could be used for the
establishment of a laboratory accreditation program (LAP) for the analysis of lead in
paint, dust, and soil.
The reason for establishing a LAP for lead is based upon the desire to obtain lead
compositional data of known and appropriate quality, so proper decisions may be made
regarding the protection of those exposed to lead in paint, soil or dust. A LAP provides
recognition of competent laboratories, and if properly implemented, improves the overall
quality of compositional measurement.
The reference list at the end of this report contains a number of documents from which
information has been obtained. The review prepared by Research Triangle Institute1 is of
particular interest. Laboratory accreditation programs2 are presently in place for the
analysis of lead in blood, air and water. The Center for Disease Control monitors the
performance of lead analysis in blood. NIOSH, through its Proficiency Analytical Testing
(PAT) Program with the American Industrial Hygiene Association (AIHA), evaluates
laboratory performance for lead in air particulates. EPA's Office of Ground Water and
Drinking Water monitors laboratory performance for the analysis of lead in drinking
water. . .
It is up to laboratories to choose under which LAP(s) they may wish to participate, and
this choice may depend in large part on the types of samples (e.g., blood, air, or water),
the laboratory needing accreditation is most concerned. In view of the anticipated
magnitude of the lead analysis program for paint, dust, and soils, it is desirable to have an
accreditation program which will be employed universally so each laboratory will respond
to the same set of requirements.
There is always a compromise that must occur between the comprehensiveness of the
LAP rules and their cost of implementation. Because the cost of accreditation is usually
paid for by the user of the analytical services, those laboratories participating in a more
comprehensive accreditation program may be at a competitive disadvantage. In addition,
many laboratories are overburdened with responses to the multi-variate regulations
required for the various LAP's. For these reasons, it is important for the various
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accreditors to normalize their rules and regulations. Several standards organizations have
provided guidelines3*4, and these can provide the impetus toward effective normalization.
It might be important to establish some organization that has the mission to assist in such
a rules leveling between LAP's. There are efforts both in the United States by the EPA
Committee on National Accreditation of Environmental Laboratories (CNAEL) and
internationally by the International Association of Environmental Testing Laboratories
(IAETL) to establish uniform laboratory requirements across all environmental testing.3
The guidelines set forth here attempt to establish some uniformity between LAP's for
lead analysis of paint, dust, and soil.
This report breaks down the LAP function into sections involving administration, training
programs, quality assurance, performance evaluation materials, method protocols, site
visits, and administrative rules. While these guidelines were explicitly developed to deal
with accreditation of laboratory based operations, it is clear these guidelines may be
implemented for all types of chemical analysis for lead whether field or laboratory based,
however, the Special Committee considered the accreditation of field based analytical
operations such as portable XRF or test kit field evaluations to be beyond the mandate
of this assignemnt. In some instances, the guidelines attempt to be quite specific, but in
other cases, it is felt some of the rules need to be established by the accreditation
advisory groups with proper representation of the affected parties.
ADMINISTRATIVE STRUCTURE
T nput for the basic administrative structure for the LAP came from guidance
provided by ISO Guide 254 and the experience of members of the Special
Committee which included representatives from HUD, NIOSH, EPA, NIST and CPSC.
Lead Organization
To establish an effective LAP for lead, it is desirable to have a clear articulation of the
authority under which such a program would operate. Congress in its appropriation bill
for FY 1991 included language directing EPA to establish a federally based laboratory
accreditation program for lead. HUD received directions to determine the need to
remove leaded paint from housing, and to decide through dust analysis, if the abatement
of lead contamination was effective. OSHA has continuing responsibility for evaluating
lead exposures and cleanup in the workplace. DHHS has at mandate to evaluate the lead
levels in human blood, especially children. It would be desirable to have normalized and
consistent rules for LAP's in all of these areas. Figure 1 depicts a straightforward mode
by which an effective LAP for lead can be implemented.
The lead organization, whether it be EPA, HUD, OSHA, or DHHS, would be
responsible for administering the program. In some instances, it might be possible if it is
within the mandate of one organization to delegate this responsibility to another. For
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ORGANIZATIONAL STRUCTURE
FOR
LABORATORY ACCREDITATION
LEAD
ORGANIZATION
ACCREDITOR
MONITOR
ACCREDITOR
ACCREDITOR
ACCREDITED
LABORATORIES
ACCREDITED
LABORATORIES
Figure 1 - Organizational Structure for Laboratory Accreditation
example, HUD may request EPA to operate a LAP from which HUD can utilize
laboratory services.
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Accreditor Monitor
Either as part of the lead organization or as a recognized agent of the lead organization,
a monitor of accreditors should be established. This subunit is responsible for seeing that
there is uniformity among the accreditors in the LAP. It is recommended that this unit
be responsible for developing uniform accreditation criteria. An additional responsibility
would be the establishment of reciprocity between the accreditors. The national LAP
should take maximum advantage of existing accreditation programs both in the private
professional sector and at the public state government level; thereby, saving the cost of
establishing an entirely new program. To the extent state programs exist, attempts should
be made to establish uniformity across the state accreditation programs for lead analysis.
Advisory Committee
The lead organization should establish an advisory committee for the purpose of
formulating technical specifications for the LAP. For example, such a committee can
assist the lead organization in implementing many of the recommended technical
requirements listed in the sections of this report. This committee should contain
representation from the lead organization, accreditor monitor, accreditor(s), accredited
laboratories, and users of the laboratory' services. This committee, with the lead
organization's support, should establish a team-like environment by sponsoring at least
one meeting per year open to all parties affected by the LAP to discuss methods,
standards, and uniform requirements.
Financial Support
In general, the LAP should be financially supported from fees obtained from the
accredited laboratories. For some aspects of the LAP, it will be necessary to provide
start-up funding, and in other parts continuous funding may be necessary. For example,
initial funding will be required for the production of performance evaluation and primary
reference materials (see below), and for establishing training programs. Continuous
funding will be required for monitoring accreditor operations, as well as for activities
involving the advisory committee.
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ESTABLISHMENT OF QUALITY ASSURANCE AND TRAINING
PROGRAMS
Quality Assurance System
Quality assurance requires that the laboratory establish and maintain a quality assurance
system that is represented by the combination of good laboratory practices, proper data
processing, final result reporting procedures, and well-documented methods. Good
Laboratory Practices (GLP's) have been adopted by many countries to ensure the
scientific reliability and quality of test data for chemicals that have the potential to
adversely affect human health and the environment. Food, drug, and environmental
regulatory agencies in various countries, including the U.S. Food and Drug
Administration and the U.S. Environmental Protection Agency, have cooperated to
develop a uniform set of good laboratory practices.* In manufacturing and service
industries, a series of international guides covering quality systems from initial
design/development to final inspection and testing and servicing of products has been
developed and is in wide use.7 As a result of the development and widespread use of
these new and improved quality requirements, ISO Guide 254 which is the basis of many
national laboratory accreditation programs covering many fields of testing was revised in
1990 to take into account OECD GLP and ISO Guide 9000 requirements.
It is particularly important to recognize the need for data security since computer
processing and storage of the data are preferred.'
In addition, it is suggested that establishment of quality assurance in a laboratory be
implemented in steps. Before the accreditation procedure begins, it should be possible
for a laboratory to participate in the analysis of performance evaluation materials as part
of a routine proficiency testing procedure as implemented by a laboratory accreditor.
This would permit laboratories that are not yet certain that they can meet the necessary
qualifications for accreditation to gain important information concerning their ability to
analyze lead environmental samples.
Training Programs
It is important to provide training opportunities in quality assurance for the accredited
laboratory staff. In some instances, existing courses that are given in conjunction with
specific standards organizations can be utilized. Additional courses will be required for
site inspectors and for accreditors in order to establish the uniformity of requirements
intended via these guidelines. It is suggested that the lead agency give consideration to
the use of instructional computer generated video tapes to support the various training
programs.
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PERFORMANCE EVALUATION MATERIALS
D ecause of the importance of performance evaluation to a laboratory accreditation
program, an effective lead analysis program will make available quality
performance evaluation materials (PEM's). PEM's provide a practical test of quality
performance. Properly designed PEM's can make it possible to evaluate a wide variety of
methods including field methods and test kits, as well as laboratory based methods.
Furthermore, PEM's can serve as suitable comparator materials for the development of
new methods. In the following paragraphs, key attributes of a system for the preparation
of PEM's are presented along with recommendations for the lead LAP.
Real Materials
Most PEM's that are used for laboratory accreditation are not similar to the routine
samples that are measured. For example, some accreditation systems provide reference
materials of water solutions containing the elements of interest at concentration levels
that approximate those of routine samples after chemical processing. This procedure
does not test the quality of the sample preparation. It is recommended that the PEM be
a real world material, and made as close as possible to those materials that are routinely
analyzed. The PEM's are to be prepared in small lot quantities, with each lot containing
lead at different levels. The level of lead in each lot is quantitated prior to distribution
by submitting representative samples to laboratories known to provide reliable
measurements (reference laboratories). The quality assurance of the laboratory preparing
the PEM's should be carefully and continually evaluated. It is important that the
laboratory accreditor work closely with the PEM producer to assure that the best possible
materials are provided for the program.
Distribution
The mode and frequency of distribution of the PEM's is very important. The PEM's can
be delivered to the laboratory to be tested in single or double-blind mode. Submission of
PEM's is usually done single blind where the laboratory is aware that the samples are
PEM's, but is unaware of the concentration of the analyte(s). In this case, laboratories
usually analyze these samples more carefully than routine samples. In the case of the
double-blind mode, the laboratory is unaware of either which sample is the PEM or the
concentration levels of the analyte(s). This mode ensures that the PEM's are analyzed
with approximately the same care as routine samples, thereby giving a truer estimate of
the measurement quality. Distribution of PEM's in this mode is somewhat more costly
than single blind. The routine mode for distribution of PEM's should be single blind.
Even though the cost of distributing double-blind materials is higher than for single blind,
it is suggested that occasionally, selected materials be distributed in the double blind
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mode to a small representative sample of the accredited laboratories, with appropriate
followup if problems arise.
Primary Reference Materials
It is important to establish primary reference materials (PRM's) for the most frequently
analyzed PEM's. The accuracy of the measurement of lead content should be greater
than for the PEM's. The PRM serves as a benchmark whose certified concentration is
well known, and therefore provides a different function than that of a PEM. The PEM
producers and the accredited laboratories as well, will use these materials to reduce
systematic errors in their measurements.
Specifications
It is necessary in some instances to design a PEM for a specific method of chemical
analysis. This means that special design criteria must be established. For example, if
lead in dust is to be measured by X-ray fluorescence, then the PEM must be made
homogeneous to at least the target accuracy of the method for a sample size of a few tens
of milligrams. These and other specifications along with a large number of production-
oriented criteria need to be established on a case-by-case basis.
Financial Support
The cost of fulfilling the above requirements will be significant, but compromising the
quality of the reference materials defeats the core function of the LAP. It will be
necessary for the lead agency to support prototype production of reference materials, and
to provide support for production PEM's if necessary.
METHOD PROTOCOLS
A crucial component in a laboratory accreditation program is the choice of the
methods which are to be used to analyze for lead in environmental samples.
Choice of method will depend on a large number of criteria: composition of sample
matrix, concentration range, amount of necessary sample preparation, detection limit,
dynamic range, precision, potential interferences, ease of use, cost, etc. Based on these
considerations, some general guidelines on the choice of methods for the lead analysis
program are proposed.
Selection Strategy
The primary concern will be the analysis of three types of environmental sources: paint,
dust, and soil. It is recommended that the choice of method for lead analysis be left up
to the laboratory seeking accreditation, since a number of methods have been shown to
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perform well. Methods that are able to handle all three sample matrices are strongly
encouraged to help reduce costs and improve data quality. This is especially important
when conquering digestion procedures. A strategy for the selection of suitable methods
for these matrices should be guided by (at a minimum) the following considerations:
1. Target extraction efficiency and precision (95 percent confidence limit) should be
quantitative with total uncertainties for standard reference materials (SRM's), 10
percent relative; for real-world samples, sieved only, 25 percent (NOTE:
EPA/CLP program allows 15 percent), sieved and ground, 10 percent.
2. Target working range (using NIOSH model, for example) is for the detection limit:
0.1 x action concentration (or level of concern), and for the upper Limit: 10 x
action concentration (or level of concern). NOTE: Action concentration should
be based on health effects data. Unfortunately, these data are not available for
any of the three materials.
3. Interferences (and their remedies) will depend on the sample matrix, digestion
procedure, and instrumentation employed for analysis. The type of sample matrix
should be reported to the laboratory performing the analysis. Recommendations
can be made on digestion procedures based on the type of sample matrix.
4. Cost per sample. Due to the large volume of samples expected, this will be very
important information to provide to the users of the proposed accreditation
program. Cost considerations will be a result of such factors as; equipment and
materials costs, training required (skill level) and the availability of trained
personnel, through-put rate (usually Limited by rate of sample digestion), ease of
use of the methodology, special precautions required, and disposal of wastes.
Compendium of Methods
As a starting point, a compendium of method protocols from such organizations as EPA,
NIOSH, ASTM, RTI, and others should be assembled. The performance of a number of
candidate methods is currently being evaluated by many investigators. Protocols for
methods which are found to perform well should be made available to user/consumers.'
Quality Assurance/Quality Control
There should be a strong quality assurance/quality control (QA/QC) component in the
lead analysis accreditation program. It is emphasized that realistic sample matrices
should be used for QA/QC samples. Recommended minimal considerations to ensure
* It is the intent of the Task Group on Methods and Standards to provide such a
compendium of methods and standards.
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good laboratory practice are that 5 percent of the samples should be blanks, both reagent
and field types where possible; 5 percent-duplicates which are independently prepared
samples run as "blinds"; one reference material per batch"; and 5 percent are
instrument check solutions which are a known spiked solution or spiked sample matrix.
The spike must be prepared from a standard stock which is different from the calibration
standard stock, and should have a lead concentration that is within the range of the
samples to be run.
It is noted that both the PRM and the check solution should have "real-time evaluation"
with quantitative lead recovery within 10 percent relative. Control charts are also
recommended.
Field Methods
Field collection techniques are not specified here because field collection methodologies
are rapidly changing and improving due to identification of problems in ongoing studies.
As results from further research become available, we will be in a better position to
recommend more specific sampling protocols for field analysis.
The choice of laboratory technique (consisting of digestion and instrumental analysis) will
depend on the sample matrix. Also, field analysis techniques are not addressed here as
they will probably fall under 'Training" or "Certification of Abatement Personnel."
Decisions on what technique is to be used, be it a field technique or laboratory method,-
will depend on the purpose of the sampling (e.g., screening vs. quantitative). For any
field analytical method, which is to be used for quantitative purposes, the performance
criteria that the field method satisfies should be the same as those criteria recommended
above for laboratory methods. The issue of sample collection in the field is extremely
important, but at present remains in its formative stages. It is too early in the process of
method development to address this issue, and it is recommended that the field sampling
protocols outlined in the HUD guidelines be followed.9
SITE INSPECTIONS
A ssessment of a laboratory to be accredited by a skilled and knowledgeable person
is considered to be mandatory. Most of the existing LAP's use site inspections.
There are a number of advantages to having a well-trained inspector visit the laboratory.
The quality of the facilities, equipment, written procedures, and personnel can be
perceived in ways that are impossible by other means. A properly conducted site
inspection can result in improvement in performance of the laboratory, because the
** This reference material is often referred to as a secondary reference material whose
concentration is established from and is traceable to a PRM.
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inspector can suggest improvements in procedure. In addition to the obvious factor that
the inspector determines the existence of specific methods and equipment, it is possible to
verify from laboratory records that PEM's have been rotated among analysts and
instruments, and that special precautions have not been taken in the analysis of these
samples. The fact that the assessor can witness all or part of the analysis using a PEM,
provides added assurance that performance evaluation results are representative of typical
analytical performance. The assessor can provide important feedback to various groups
within the government that are conducting analytical research on any problems that the
accredited laboratories are having in using the analytical methods.
Assessment Requirements
On-site assessments, the appointment of assessors, the training and qualifications of
assessors, and the laboratory accreditation program's quality assurance program for on-
site assessments should follow the general requirements of appropriate international
guides for laboratory accreditation programs such as ISO Guides 54 and 55.1041 This will
provide a common base from which cooperation among various accreditation programs in
closely related areas could occur. This is important because some laboratories that
perform environmental lead analyses also operate in other fields of testing and are
subjected to multiple laboratory accreditations. This would facilitate the use of a single
assessor with training and experience in multiple fields to conduct simultaneous site visits
for more than one laboratory accreditation program at considerable cost savings to the
laboratory.
Frequency of Inspections
The frequencies of site assessments for similar laboratory accreditation programs range
from once every two years to once every three years with the option of more frequent site
visits if other information indicates that problems exist. It is recommended that on-site
assessments be performed at least once every three (3) years.
Qualifications of Inspectors
Similar laboratory accreditation programs require assessors to have experience in the
field and in laboratory quality assurance techniques. It is recommended that assessors
have a bachelors degree in chemistry, at least five (5) years' analytical chemistry
experience with senior position responsibilities, and at least two (2) years' specific
knowledge of laboratory quality assurance and inorganic environmental analyses. Masters
or Ph.D. degrees in chemistry or closely related fields may reduce the number of required
years of experience in analytical chemistry. The assessor should also complete a short
course on laboratory quality assurance, accreditation program procedures, and lead
analytical requirements which includes an examination of competence. The assessor
should also accompany an experienced assessor on at least one site visit before being
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qualified. Experienced assessors may initially be drawn from lists of assessors that are
currently performing assessments and have taken the required training course.
Other laboratory accreditation programs have schemes to rate the effectiveness of
assessors. The accreditation program should have a scheme to either rate assessor
reports or to obtain feedback from participating laboratories on the usefulness and
completeness of assessor laboratory evaluations and recommendations. This should be
part of the laboratory accreditation program's own quality assurance system that conforms
to the requirements of Section 8 of ISO/EEC Guide 54."
ADMINISTRATIVE RULES
E1 xamples of rules for accreditation are listed below. Some items are from MIST
449312 that reflect NVLAP operating requirements. Selection of specific rules
should be the responsibility of the lead agency with advice from the advisory group
described above. There are a number of pertinent references.13-14
Federal Register Notice
Conclusions related to the lead agency's decisions associated with the lead LAP
(including lists of accredited laboratories) should be published in the Federal Register.
Public Notices
Means should be available for disseminating widely adequate and impartial LAP
information to the private sector.
Expert Advice
Input based on specialist's skills and knowledge shall be utilized in the development of
technical requirements. The use of an advisory group as described above, and public
workshops or reviews is an important consideration.
Federal Agencies
Coordination, consultation, and communication with appropriate department components
shall be maintained.
Notice of Laboratory Accreditation, Schedule, and Fees
Details of Lead Laboratory Accreditation Program shall be announced in the Federal
Register. FR Notice would include processes to be implemented both for organizations
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seeking status as accrediting organizations and for individual laboratories seeking status
as accredited laboratories.
A fully reimbursable fee structure for all services performed by the accreditation entity
should be the objective of the programs once operational. It is envisioned some measure
of federal funding may be required to support the initial stages of implementing the
program. This could include initial funding for the development of performance
evaluation materials (PEM's); proficiency testing of federal laboratories; the use of
federal agency staff in monitoring accreditor operations and in serving on the technical
advisory committee.
Denial. Suspension. Revocation, and Voluntary Termination of Accreditation
Conditions need to be stipulated in an unequivocal manner and formulated with a
suitable appeals procedure for fairness and objectivity.
Termination
When determination of the need for accreditation no longer exists, a public notice and
period for commentary shall be provided prior to the evaluation and decision for
termination.
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REFERENCES
1. Estes, E. D., E. E. Williams and W. F. Gutknecht, "Options for a Lead Analysis
Laboratory Accreditation Program," EPA Contract 68-02-4550, RTI Project 91U-
4699-037, Research Triangle Institute, Research Triangle Park, NC 27709, January
1991.
2. NIST Special Publication 808, "Directory of Federal Government Laboratory
Accreditation/Designation Programs," Maureen Breitenberg, Ed., February 1991.
3. ASTM E548 (1990), "Standard Practice for Preparation of Criteria for Use in the
Evaluation of Testing Laboratories and Inspection Bodies." (This document is
currently under revision to incorporate appropriate information contained in
reference 4.)
4. ISO/IEC Guide 25: (1990), "General Requirements for the Technical Competence
of Testing Laboratories."
5. Report to the Administrator EPA, Committee on National Accreditation of
Environmental Laboratories (CNAEL) to be published in 1992.
6. OECD (Organization for Economic Cooperation and Development), Code of
Good Laboratory Practice (GLP).
7. ISO 9000:1987, Quality Management and Quality Assurance Standards-Guidelines
for Selection and Use. ISO 9001:1987, Quality Systems- Model for Quality
Assurance in Design/Development, Production, Installation, and Servicing. ISO
9002:1987, Quality Systems-Model for Quality Assurance in Production and
Installation. ISO 9003:1987, Quality Systems-Model for Quality Assurance in Final
Inspection and Test. ISO 9004:1987, Quality Management and Quality System
Elements-Guidelines.
8. EPA Report "Good Automated Laboratory Practices," Scientific Systems Staff,
Office of Information Resources Management, U.S. EPA. Research Triangle Park,
NC 27711, December 28, 1990, Final Draft.
9. Lead-Based Paint, Interim Guideline for Hazard Identification for Lead
Abatement in Public and Indian Housing, September 1990, Office of Public and
Indian Housing, Department of Housing and Urban Development, 451 7th Street,
SW., Washington, D.C
10. ISO/IEC Guide 54: 1988, "Testing Laboratory Accreditation Systems-General
Recommendations for the Acceptance of Accreditation Bodies." [Currently under
revision.]
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11. ISO/IEC Guide 55: 1988, Testing Laboratory Accreditation Systems-General
Recommendations for Operation." [Currently under revision.]
12. National Voluntary Laboratory Accreditation Program Procedures, N1STTR 4493,
November 1990.
13. American Association for Laboratory Accreditation, "General Requirements for
Accreditation", 656 Quince Orchard Road, #704, Gaithersburg, MD 20878, March
1991.
14. American Industrial Hygiene Association: "Quality Assurance Programs for
Success. AIHA Laboratory Programs: Your Benchmark of Quality," 475 Wolf
Ledges Parkway, Akron, OH, 44311 (1990).
Mr-tennis Belong To:
O.-'PT Library
40.1 i'-.I Htivci 'AV v V':.--V.'3)
Washington, DJ 20-ioU
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Task Group on
Methods and Standards
Chairman, James R. DeVoe
Members
Ashley, Kevin, Research Chemist, National Institute for Occupational Safety &
Health, 4676 Columbia Parkway, Cincinnati, OH 45226
Telephone: 513-841^402 FAX: 513-841-4500
Breen, Joseph, OTS/EED, TS-798, Environmental Protection Agency,
401 M Street, SW., Washington, D.C. 20460
Telephone: 202-260-3569 FAX: 202-260-1724
DeVoe, James, R., Chief, IARD, National Institute of Standards and
Technology, Chemistry Building, Room A349, Gaithersburg, ME)
20899
Telephone: 301-975-4144 FAX: 301-926-6182
Harper, Sharon, AREAL/QATSD/AMSB, MD-78, Environmental Protection
Agency, Research Triangle Park, NC, 27711
Telephone: 8-629-2443 FAX: 919-541-3527
Huang, Miau, Consumer Product Safety Commission, 9620 Medical
Center, Suite 310, Rockville, MD, 20850
Telephone: 301-443-9420 FAX: 301-492-5402
McKnight, Mary, BMD, National Institute of Standards and Technology,
BR Building, Room B348, Gaithersburg, MD, 20899
Telephone: 301-975-6714 FAX: 301-975-4032
Paschal, Dan, CHAM. 17/2810, F18, Centers for Disease Control, 1600
Clifton Road, NE., Atlanta, GA 30333
Telephone: 8-236-4026 FAX: 404-488-4609
Simpson, James, Childhood Lead Program, Center for Environmental
Health, 1600 Clifton Road, Atlanta, GA 30338
Telephone: 404-488-4788 FAX: 404-488-4308
Weitz, Steve, Housing and Urban Development, 451 7th Street,
SW., Washington, D.C. 20410
Telephone: 202-755-1810 FAX: 202-755-1000
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