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
 

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.
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
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
CONTENTS

Executive Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

Introduction ................................................. 2

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
T

REPORT ON GUIDELINES FOR 

ESTABLISHMENT OF A

LABORATORY ACCREDITATION PROGRAM

FOR THE MEASUREMENT OF LEAD IN

PAINT AND THE ENVIRONMENT

EXECUTIVE SUMMARY

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. 
T

2

INTRODUCTION

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 Institute is of 1

particular interest. Laboratory accreditation programs are presently in place for the analysis of 2

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 accreditors to normalize their rules and 


5

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. 

ESTABLISHMENT OF QUALITY ASSURANCE AND TRAINING

PROGRAMS
B

6

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 6

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. As a result of the 7

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. 8

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.

PERFORMANCE EVALUATION MATERIALS

ecause of the importance of performance evaluation to a laboratory accreditation program,

an effective lead analysis program will make available quality performance evaluation
7

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 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
A

8

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

 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 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 considering 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.
* It is the intent of the Task Group on Methods and Standards to provide such a compendium of

methods and standards. 

** This reference material is often referred to as a secondary reference material whose

concentration is established from and is traceable to a PRM.

9

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 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. 
A

10

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

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 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
E

11

should follow the general requirements of appropriate international guides for laboratory

accreditation programs such as ISO Guides 54 and 55. This will provide a common base from 10,11

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

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/IEC Guide

54.10

ADMINISTRATIVE RULES

xamples of rules for accreditation are listed below. Some items are from NIST 4493 that 12

reflect NVLAP operating requirements. Selection of specific rules should be the
12

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 seeking status as

accrediting organizations and for individual laboratories seeking status as accredited laboratories.

Fees

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. 
13

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. 
14

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.]

11. ISO/IEC Guide 55: 1988, "Testing Laboratory Accreditation Systems-General

Recommendations for Operation." [Currently under revision.]
15

12. National Voluntary Laboratory Accreditation Program Procedures, NISTIR 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).
16

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: 513-841-4402 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, MD

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
17