**EPA NATIONAL LEAD LABORATORY ACCREDITATION PROGRAM**

**LABORATORY QUALITY SYSTEM REQUIREMENTS (LQSR)**

**REVISION 3.0 (August 5, 2005 draft)**

The requirements in this document apply to all lead testing laboratories
participating in the Environmental Protection Agency\'s (EPA) National
Lead Laboratory Accreditation Program (NLLAP). In addition to meeting
the Laboratory Quality System Requirements (LQSRs), the lead testing
laboratory must also successfully participate in the Environmental Lead
Proficiency Analytical Testing (ELPAT) Program.

Number range CHAPTERNLLAP was established by the EPA Office of Pollution
Prevention and Toxics (OPPT) under the legislative directive of Title X,
the Lead-Based Paint Hazard Reduction Act of 1992 Sections 405 (a) and
(b) requiring EPA to set minimum standards for laboratory analysis of
lead in paint films, soil and dust.

Concerning any future revisions to the NLLAP Laboratory Quality System
Requirements, laboratories currently participating in NLLAP will be
given a period of twelve months from the posting of the revision on the
http://epa.gov/lead/nllap.htm to conform to any new requirements stated
in the revision. For further information concerning NLLAP, please
address your request in writing to:

Oksana Pozda

U.S. Environmental Protection Agency

Ariel Rios Building (7404T)

Office of Pollution Prevention and Toxics

1200 Pennsylvania Ave., N.W.

Washington D.C. 20460

**TABLE OF CONTENTS**

**1.0 SCOPE**

**1.1 Laboratory Types**

**2.0 NORMATIVE REFERENCES**

**3.0 TERMS AND DEFINITIONS**

**4.0 MANAGEMENT REQUIREMENTS**

**4.1 [ORGANIZATION AND MANAGEMENT]{.underline}**

**4.1.1 [Technical Manager]{.underline}**

**4.1.1.1 Qualifications**

> **4.1.1.2 Responsibilities**

**4.1.2 [Quality Manager]{.underline}**

**4.1.2.1 Qualifications**

> **4.1.2.2 Responsibilities**

**4.2 [MANAGEMENT SYSTEM]{.underline}**

**4.2.1 Management System Establishment and Maintenance**

**4.2.2 Quality Policy Statement**

**4.2.3 Management System Manual**

**4.3 [DOCUMENT CONTROL]{.underline}**

**4.3.1 General**

**4.3.2 Document Approval and Issue**

**4.3.3 Document Changes**

**[4.3.4 Document Review and Revision.]{.mark}**

**4.4 [REVIEW OF REQUEST, TENDER OR CONTRACT]{.underline}**

**4.5 [SUBCONTRACTING OF TESTS]{.underline}**

**4.6 [PURCHASING SERVICES AND SUPPLIES]{.underline}**

**[4.6.1 Reagents and Standards]{.mark}**

**[4.6.1.1 [Reagent Grades Used]{.underline}]{.mark}**

**[4.6.1.2 [Reagents and Standards Tracking]{.underline}]{.mark}**

**4.7 [SERVICE TO THE CUSTOMER]{.underline}**

**4.8 [COMPLAINTS]{.underline}**

**4.9 [IMPROVEMENTS]{.underline}**

**4.10 [CONTROL OF NONCONFORMING TESTS]{.underline}**

**4.11 [CORRECTIVE ACTION]{.underline}**

**4.11.1 General**

**4.11.2 Cause Analysis**

**4.11.3 Corrective Actions**

**4.11.4 Monitoring the Corrective Actions**

**4.11.5 Special Audits**

**4.12 [PREVENTIVE ACTION]{.underline}**

**4.13 [RECORDS]{.underline}**

**4.13.1 Sample Records**

**4.13.2 Laboratory Management System and Test Records**

**4.13.3 Electronic Data obtained**

**4.14 [INTERNAL AUDITS]{.underline}**

**4.15 [MANAGEMENT REVIEWS]{.underline}**

**5.0 TECHNICAL REQUIREMENTS**

**5.1 [GENERAL]{.underline}**

**5.2 [PERSONNEL]{.underline}**

**5.2.1 [Analysts/Technicians]{.underline}**

**5.2.1.1 Minimum Qualifications and Training for Analyst/Technician
Personnel**

**5.2.1.2 Additional Requirements for Mobile and FSMO Personnel**

**5.3 [ACCOMMODATION AND ENVIRONMENTAL CONDITIONS]{.underline}**

**5.3.1 Contamination Control**

**5.3.1.1 [Laboratory Dust Wipe Checks]{.underline}**

**[5.3.1.2 [Labware Cleaning]{.underline}]{.mark}**

**5.4 [TEST AND SAMPLING METHODS]{.underline}**

**[5.4.1. Acceptable Methodology]{.mark}**

**[5.4.2 Method Validation and Performance Demonstration
Procedures]{.mark}**

**[5.4.3 Sample Preparation]{.mark} and Analysis Procedures**

**5.4.3.1 [Standard Operating Procedures]{.underline}**

**5.4.4 Method Performance Characteristics**

**[5.4.4.1]{.mark} [Method Detection Limits]{.underline}**

**5.4.4.2 [Quantitation and Reporting Limits]{.underline}**

**5.4.4.3 [Accuracy and Precision]{.underline}**

**[5.4.5 Sample Aliquots]{.mark}**

**[5.4.6 [DATA REDUCTION AND REVIEW PROCESS]{.underline}]{.mark}**

**5.5 [EQUIPMENT]{.underline}**

**[5.5.1 Instrument Calibration and Performance Quality Checks]{.mark}**

**[5.5.2 Instrument Calibration Performance Requirements]{.mark}**

**[5.5.2.1 [Initial Calibration]{.underline}]{.mark}**

**[5.5.2.2 [Independent Calibration Verification]{.underline}]{.mark}**

**[5.5.2.3 [Continuing Calibration Verification]{.underline}]{.mark}**

**[5.5.2.4 [Continuing Calibration Blank (CCB)]{.underline}]{.mark}**

**5.6 [MEASUREMENT TRACEABILITY]{.underline}**

**5.6.1 Reference Standards and/or Reference Materials**

**[5.6.2 Documentation of Reagent and Calibration Solution
Preparation]{.mark}**

**5.7 [SAMPLING]{.underline}**

**5.7**.1 **[[Sampling Media]{.underline}]{.mark}**

**5.8 [SAMPLE HANDLING]{.underline}**

**[5.8.1 Sample Control]{.mark}**

[**5.8.2 Sample Acceptance, Documentation and Tracking
Procedure**s]{.mark}

**[5.8.2.1 [Sample Acceptance Policy]{.underline}]{.mark}**

**[5.8.2.2 [Sample Receipt Logs]{.underline}]{.mark}**

**[5.8.2.3 [Documentation on Questionable Samples]{.underline}]{.mark}**

[]{.mark}

**5.8.2.4 [Sample Custody Procedures]{.underline}**

[**5.8.2.5 [Sample]{.underline}** **[Tracking]{.underline}**]{.mark}

**[5.9 [ASSURING THE QUALITY OF TEST RESULTS]{.underline}]{.mark}**

**5.9.1 Quality Control Procedures.**

**5.9.1.1 [Bias Determination]{.underline}**

**5.9.1.2 [Precision (repeatability) Determination]{.underline}**

**[5.9.2 Control Charts or Quality Control Data Base]{.mark}**

**[5.9.3 Procedures for determination of out of control
situations]{.mark}**

**5.10 [REPORTING THE RESULTS]{.underline}**

**5.10.1 General**

**5.10.2 Test Reports**

**[5.10.2.1 Reporting Results Below the Quantitation Limit]{.mark}**

**5.10.2.2 Opinions and Interpretations**

**5.10.3 [REPORT REVIEW AND APPROVAL PROCESS]{.underline}**

**[5.10.4 [TEST REPORT CORRECTION PROCESS]{.underline}]{.mark}**

**[5.10.4.1 Corrections]{.mark} and Amendments to Test Reports**

**5.10.4.2 Test Results Obtained from Subcontractors**

**5.10.4.3 Electronic Transmission of Results**

**APPENDIX I**

**Acronyms**

**Glossary**

**NATIONAL LEAD LABORATORY ACCREDITATION PROGRAM (NLLAP)**

**LABORATORY QUALITY SYSTEM REQUIREMENTS**

**[INTRODUCTION AND PURPOSE]{.underline}**

This document identifies the minimum requirements for use by
accreditation organizations when evaluating laboratories performing
environmental testing activities under NLLAP and is based on
requirements of International Organization for Standardization and
International Electrochemical Commission (ISO/IEC) Standard
[17025]{.mark}: 2005 (E) \"General requirements for the competence of
testing and calibration laboratories\". NLLAP recognizes laboratories
that perform quantitative and/or qualitative analytical testing of paint
chip (film), dust, and/or soil samples for lead analysis. NLLAP requires
recognized laboratories to employ quality assurance/quality control
systems that meet the requirements described in this document, to
monitor for potential sample matrix and environmental interferences as
well as laboratory operational deficiencies.

**1.0 SCOPE**

The requirements described within this document must be met for a
laboratory to attain recognition under the NLLAP as a lead testing
laboratory, hereafter referred to in this document as a laboratory. An
organization requesting recognition under this program shall possess a
laboratory operation capable performing sampling and lead testing, as
appropriate, and which constitutes an identifiable part of the overall
organization. A laboratory shall have distinct staffing,
instrumentation, sampling and test methods, as appropriate, and
depending upon the type laboratory may have physical facilities and may
use field test kits. Laboratory accreditation under this program shall
be based on its meeting the requirements listed in this document.

**1.1 [Laboratory Types]{.underline}**

For the purposes of NLLAP, a **laboratory** is defined as an operation
that performs sampling and/or quantitative and/or qualitative analytical
testing of paint chip (film), dust, and/or soil samples for lead
analysis regardless of the number of personnel or the extent of the
scope of testing activities.

NLLAP recognizes three types of laboratory operations: fixed-site,
mobile and field sampling and measurement organization (FSMO). These
types of laboratory operations are defined as follows:

Fixed-Site: An operation that performs analytical lead testing at a
permanent location under controlled environmental conditions.

Mobile Facility: A transportable, self contained operation that can
perform analytical lead testing under controlled environmental
conditions.

Field Sampling and Measurement

Organization (FSMO): An operation that performs sampling and lead
testing on-site that is under evaluation by using portable testing
technologies.

A laboratory may include one, two or all three of these types of
operations. In cases where a laboratory does not perform one or more of
the operations addressed above, the requirements relating to those
activities do not apply.

**2.0 NORMATIVE REFERENCES**

The following normative documents were used in the writing of this set
of requirements.

NLLAP LQSR Rev. 2.0 08/01/96.

> ISO/IEC Standard 17025: 2005 (E) \"General requirements for the
> competence of testing and calibration laboratories\".

[40 CFR Part 745 - Lead-Based Paint Activities]{.mark}.

> Performance Characteristics Sheets, available at:
> <http://www.hud.gov/utilities/intercept.cfm?/offices/lead/guidelines/hudguidelines/>[Allpcs.pdf]{.underline}

**3.0 TERMS AND DEFINITIONS**

A list of Acronyms and a Glossary of Terms used in this document is in
Appendix 1.

**4.0 MANAGEMENT REQUIREMENTS**

**4.1 [ORGANIZATION AND MANAGEMENT]{.underline}**

The laboratory management shall accept legal responsibility for its
actions and ensure that appropriate communication processes are
established within the laboratory so that communication takes place
regarding the effectiveness of the laboratory management system. In
addition, policies and procedures needed to ensure that management and
personnel are free from any conflicts of interest that might adversely
affect the quality of work performed shall be documented and
implemented. Procedures shall be implemented to ensure confidentiality
of customer information and protection of proprietary rights.

The laboratory shall have job descriptions for all positions and an
organizational chart or other means of identifying the functions of key
personnel, their responsibilities, lines of supervision, and authority.
Laboratory management shall be responsible for all personnel employed by
the laboratory [including those assigned to mobile laboratories and/or
FSMOs and for ensuring that its personnel are aware of the relevance and
importance of their activities and how they contribute to the
achievement of the objectives of the management system.]{.mark}

The laboratory shall also appoint one member of the staff to act as
quality manager. The quality manager shall have the responsibility and
authority for assuring implementation of the management system at all
times.

All NLLAP recognized laboratories shall identify a responsible
laboratory official who is authorized to release test reports on behalf
of the laboratory. In a laboratory with one person, that person will be
the responsible official for the release of the test report. That same
person may serve as both the technical manager and the quality manager.
Alternatively, the positions of technical manager and quality manager
may be contracted out, but are not required to be. See Sections 4.14,
5.4.6 and 5.10.3 below for requirements on one-person firms regarding
internal audits and the release of test reports.

The following specific personnel requirements shall apply to NLLAP
recognized laboratories. In laboratories with a limited number of
personnel, individuals may be assigned more than one duty.

**4.1.1 [Technical Manager]{.underline}**

**4.1.1.1 Qualifications**

The individual who functions as the technical manager (however named) of
the laboratory shall have appropriate education, training, and
experience, or combination thereof, to 1) be able to design and
implement the management system, and 2) enable that individual to
identify the occurrence of departures from the implemented management
system or test procedures and to initiate actions to prevent or minimize
such departures.

**4.1.1.2 Responsibilities**

The technical manager or their designee shall be responsible for all
technical operations and shall be available to address technical issues
for laboratory staff and customers concerning NLLAP related analyses.

The technical manager shall ensure and document the competence of all
who operate specific equipment, perform tests, evaluate results, and
sign test reports. The competence determination shall be based on
appropriate education, training, experience and/or demonstrated skills.

The technical manager shall ensure that adequate supervision is provided
for all laboratory technical personnel and shall be easily accessible.

The technical manager shall ensure that mobile and FSMO personnel have
the capability to communicate with their supervisor or the technical
manager while on site at a field job location.

**4.1.2 [Quality Manager]{.underline}**

**4.1.2.1 Qualifications**

The individual who functions as the quality manager (or however named)
of the laboratory shall have the education, training, and experience, or
combination thereof, to enable that individual to identify the
occurrence of departures from the implemented management system and to
initiate actions to prevent or minimize such departures. The quality
manager shall be knowledgeable of the management system and the
technical and management system procedures used.

[]{.mark}

**4.1.2.2 Responsibilities**

The quality manager shall have defined responsibility and authority to
implement and oversee the management system, implement new quality
assurance and control practices, perform periodic audits of the
management system, perform periodic review of test reports prior to
issue, and to ensure laboratory management system deficiencies are
documented and that corrective actions are implemented.

**4.2 [MANAGEMENT SYSTEM]{.underline}**

The laboratory management system shall include all the policies and
procedures required by this document and the performance of the
activities covered by its scope of accreditation. The management system
manual (MSM) shall contain all the required policies and must either
contain or cite the related quality documentation and procedures to help
ensure and document the quality of the analytical data.

The MSM and related quality documentation shall state the laboratory\'s
policies and operational procedures established in order to meet the
requirements of this document.

All items in the laboratory\'s quality system shall be available for
on-site inspection or audit by EPA NLLAP personnel and by accreditation
organizations participating in NLLAP [or, if applicable, to
federal/state/tribal program certifying officials]{.mark}.

Laboratory management shall:

a\. Provide evidence of its commitment to the development and
implementation of the quality system and continually improving the
effectiveness of the management system.

b\. Ensure the integrity of the management system is maintained when
changes to the quality system are planned and implemented.

c\. Communicate to the organization the importance of meeting customer
as well as statutory and regulatory requirements.

**4.2.1 Management System Establishment and Maintenance**

The laboratory shall establish and maintain a management system to
ensure the quality of its testing.

> a\. The elements of this system shall be documented.
>
> b\. The quality documentation shall be available for use by laboratory
> personnel.
>
> c\. The laboratory management shall ensure that these policies and
> objectives are documented in a MSM and communicated to, understood,
> and implemented by laboratory personnel.
>
> d\. The MSM shall be reviewed annually, updated as needed and
> maintained under the responsibility of the quality manager (or however
> named).

**4.2.2 Quality Policy Statement**

Laboratory management shall define and document the objectives and
policies of the management system. These policies and objectives shall
be documented in a MSM. The overall objectives shall be provided in a
quality policy statement in the MSM that denotes the standard of
performance to be obtained and maintained. The chief executive shall
issue the quality policy statement. It shall include:

a\. a statement of the standard of service the laboratory management
intends to provide;

b.  the purpose of the management system;

c.  a requirement that all personnel involved with testing activities
    within the laboratory acquaint themselves with management system
    documentation and implement the policies and procedures used in
    their work;

d.  the commitment of the laboratory to good professional laboratory
    practice and quality of service to the customer;

e.  the laboratory management's commitment to compliance with the
    requirements of this document.

    **4.2.3 Management System Manual**

    The QM shall include the defined roles and responsibilities of
    technical management and the quality manager, including their
    responsibility for ensuring compliance with the requirements of this
    document. The management system shall include an organizational
    chart identifying key personnel, responsibilities, lines of
    authority, and interrelationships of staff. The MSM shall include or
    make reference to the supporting procedures including technical
    procedures and shall outline the structure of the documentation used
    in the management system.

    The MSM and related quality documents shall include or address at
    least the following elements:

    \# Title Page

    \# Table of Contents

    \# Management requirements

\# Organization (4.1)

\# Management system (4.2)

\# Document contro l(4.3)

\# Review of requests, tenders and contracts (4.4)

\# Subcontracting of tests and calibrations (4.5)

\# Purchasing services and supplies (4.6)

\# Service to the customer (4.7)

\# Complaints (4.8)

\# Control of nonconforming testing and/or calibration work4.9

\# Improvement (4.10)

\# Corrective action (4.11)

\# Preventive action (4.12)

\# Control of records (4.13)

\# Internal audits (4.14)

\# Management reviews (4.15)

\# Technical requirements

\# General (5.1)

\# Personnel (5.2)

\# Accommodation and environmental conditions (5.3)

\# Test and calibration methods and method validation (5.4)

\# Equipment (5.5)

\# Measurement traceability (5.6)

\# Sampling (5.7)

\# Handling of test and calibration items (5.8)

\# Assuring the quality of test and calibration results (5.9)

\# Reporting the results (5.10)

The MSM shall be updated whenever necessary and reviewed and approved by
management at least annually. The MSM shall be accessible to all
laboratory personnel.

**4.3 [DOCUMENT CONTROL]{.underline}**

**4.3.1 General**

The NLLAP recognized laboratory shall establish and maintain procedures
for the control of all documents (both internal and external documents)
that form the management system. Documents included may be external,
such as standards, regulations, normative documents, test and/or
calibration methods, drawings, specifications, instructions, and
manuals. The laboratory document control system shall ensure that all
standard operating procedures, manuals, and/or documents clearly
indicate the time period during which the procedure or document was in
force.

**4.3.2 Document Approval and Issue**

All documents in the laboratory shall be reviewed and approved before
their release for use by authorized personnel. A system shall be
implemented for identification of the current revision status of quality
system documents to prevent use of invalid or obsolete documents.

Quality system documents generated by a laboratory shall be clearly
identified. Included in the identification shall be the issue date,
revision identification and the total number of pages or a clearly
marked document end.

**4.3.3 Document Changes**

Document changes shall be reviewed by the same personnel that reviewed
the original document, unless otherwise indicated. Where possible,
changes to the document shall be noted in the document or in an
attachment. Documents may be amended by hand pending reissue of the most
current version, where permitted. A revised document shall be re-issued
as soon as practicable.

A system shall be established and used to record changes made in
computerized systems.

**[4.3.4 Document Review and Revision.]{.mark}**

[]{.mark}

[The laboratory shall outline in its MSM or document control standard
operating procedure (SOP), the process used in the adoption and revision
of management system documents. This process shall address when and how
the laboratory's documents are reviewed, identify the sign off
authority, and state that the laboratory documents are reviewed at least
every two years]{.mark} and/or revised as needed.

**4.4 [REVIEW OF REQUEST, TENDER OR CONTRACT]{.underline}**

Procedures shall be established by the laboratory for the review of
requests, tenders, or contracts. The policies and procedures shall
ensure that:

a.  the requirements including the methods to be used are adequately
    defined, documented, and understood;

b.  the laboratory has the capability and resources to meet the
    requirements;

c.  the appropriate test method is selected and capable of meeting the
    customer's requirements.

    Differences between the customer's request and the contract offered
    to the customer shall be resolved before any work commences. The
    contract shall be acceptable to both the laboratory and customer.
    Changes made at the contract review shall be recorded and
    maintained. Contract review shall also cover work to be
    subcontracted by the laboratory. If the contract requires amendment
    after work has begun, the same contract review process shall be
    repeated and amendments communicated to all necessary personnel. The
    customer shall be informed of any deviations from the contract.

    **4.5 [SUBCONTRACTING OF TESTS]{.underline}**

    An NLLAP recognized laboratory shall only subcontract work when
    necessary and with approval from the customer with another NLLAP
    recognized laboratory. The laboratory shall be able to demonstrate
    that the subcontractor is accredited by an NLLAP recognized
    accrediting body for the methods in question. A list of all
    subcontractors used for tests shall be compiled along with records
    of the evaluation of the subcontractors' qualifications.

    **4.6 [PURCHASING SERVICES AND SUPPLIES]{.underline}**

    The laboratory shall implement policies and procedures for the
    selection and purchase of services and supplies that impact the
    quality of tests. Only services and supplies that satisfy and
    maintain the quality needed to produce acceptable test results shall
    be purchased. The laboratory shall have procedures for the purchase,
    receipt and storage of reagents and laboratory consumables that
    impact the quality of tests.

    Purchasing documents shall clearly describe the product ordered. The
    laboratory shall ensure that supplies purchased are not used until
    properly inspected or otherwise verified for compliance with
    standard specifications or method requirements.

    []{.mark}

    **[4.6.1 Reagents and Standards]{.mark}**

    []{.mark}

    [Requirements for reagents and standards shall be specified in the
    documented MSM and/or technical procedures.]{.mark}

    []{.mark}

    **[4.6.1.1 [Reagent Grades Used]{.underline}]{.mark}**

    []{.mark}

    [Reagents shall be at least American Chemical Society (ACS) reagent
    grade or of the quality specified by the analytical methods in use
    by the laboratory.]{.mark}

    []{.mark}

    **[4.6.1.2 [Reagents and Standards Tracking]{.underline}]{.mark}**

    []{.mark}

    [Upon receipt, purchased reagents and standards shall be inspected,
    dated and initialed or otherwise evaluated to verify the purchasing
    document specifications have been met. An expiration date shall be
    assigned to each reagent. Reagents shall not be used beyond assigned
    expiration dates nor used if damaged or contaminated or suspected to
    be damaged or contaminated.]{.mark}

    []{.mark}

    [When available, the]{.mark} [laboratory shall maintain certificates
    of analysis or other documentation on the manufacturer\'s statement
    of purity, of the origin and traceability of all reagents and
    standards.]{.mark}

    []{.mark}

    **4.7 [SERVICE TO THE CUSTOMER]{.underline}**

    The NLLAP recognized laboratory shall cooperate with the customer.
    This may include providing the customer or customer representative
    reasonable access to areas of the laboratory to witness work
    performed for that customer or providing test or sample items needed
    by that customer for purposes of verification. The laboratory should
    also maintain contact with the customer throughout the period of
    work and inform the customer of any delays and/or deviations in
    performance of the tests. Laboratories are also encouraged to seek
    feedback from the customer for improvement of the quality system.

    **4.8 [COMPLAINTS]{.underline}**

    The laboratory shall have a documented policy and procedures for the
    resolution of complaints received from customers or other parties
    about the laboratory\'s activities or results. The policy shall
    include the notice that "Any complaint about the quality of reported
    results may be referred to the accrediting authority if such
    complaints cannot be resolved directly with the customer." A record
    shall be maintained of all complaints and of the actions taken by
    the laboratory. Where a complaint, or any other circumstance, raises
    doubt concerning the laboratory\'s compliance with policies its own
    procedures, the requirements of this document, the management system
    and/or the quality of the laboratory\'s analyses, the laboratory
    shall ensure that those areas of activity are promptly
    audited[.]{.mark}

    **4.9 [IMPROVEMENTS]{.underline}**

The laboratory shall continually improve the effectiveness of its
management system through the use of its quality policy, quality
objectives, audit results, analysis of data, corrective and preventive
actions and management review.

**4.10 [CONTROL OF NONCONFORMING TESTS]{.underline}**

The laboratory shall have a documented policy and procedures for
handling nonconforming tests and for describing and recording actions
taken when nonconforming tests are identified. No data shall be reported
until the cause of the problem is determined and corrected, or the
laboratory demonstrates that the root cause of the nonconformance was a
random event. The laboratory shall maintain records of all nonconforming
tests or out-of-control events, the determined cause(s), and corrective
action(s) taken. Laboratory shall respond to customer complaints and
maintain records of corrective action. Once corrective action(s) have
been implemented, the laboratory shall monitor the results to make sure
the actions taken have been effective at addressing the problem(s) of
nonconformance.

**4.11 [CORRECTIVE ACTION]{.underline}**

**4.11.1 General**

A policy and procedure for corrective action shall be established and
implemented for use by appropriate laboratory authorities when
nonconforming work is identified. Required changes to the operational
procedures resulting from corrective action investigations shall be
properly documented and implemented. When reported results have been
affected by nonconforming tests all affected customers shall be
contacted and informed of the corrective action taken and the amended
results (see 5.10.4).

**4.11.2 Cause Analysis**

Corrective action procedures shall begin with an investigation to
determine the root cause(s) of the problem.

**4.11.3 Corrective Actions**

Once the root causes have been identified, the laboratory shall identify
possible corrective actions. The action(s) most likely to eliminate the
problem and prevent its recurrence shall be selected and implemented.

**4.11.4 Monitoring the Corrective Actions**

Once corrective action(s) have been implemented, the laboratory shall
monitor the results to make sure the actions taken have been effective
at addressing the problem(s) that caused the nonconformance.

**4.11.5 Special Audits**

If there is doubt that the laboratory is complying with its own policies
and procedures or those of relevant standards, then the laboratory shall
ensure that the appropriate areas of activity are audited.

**4.12 [PREVENTIVE ACTION]{.underline}**

Needed improvements and potential sources of nonconformance, either
technical or concerning the management system, shall be identified. When
improvement opportunities are identified or if preventive action is
required, action plans shall be developed, implemented and monitored to
reduce the likelihood of the occurrence of such, nonconformities and to
take advantage of the opportunities for improvement.

**4.13 [RECORDS]{.underline}**

The records for each laboratory activity shall contain sufficient
information so that it may be repeated or otherwise verified. The record
keeping system shall allow historical reconstruction of all laboratory
activities that were used to produce the associated test report. The
record keeping system shall facilitate the retrieval of all records.
Additional record keeping guidance available from ASTM: E 2239 "Standard
Practice for Record Keeping and Record Preservation for Lead Hazard
Activities".

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 customer.

b\. [All records of]{.mark} the laboratory associated with its work
activities [shall be retained for a minimum of three years. All
hardware]{.mark} and software necessary for the historical
reconstruction of data must be maintained by the laboratory. These
records shall include a history of the locations of mobile laboratory
and FSMO operations, including a specific description of where the
sampling and testing work activity was performed and these records shall
be maintained for at least three years.

c\. Access to archived records shall be controlled and shall be
protected against fire, theft, loss, environmental deterioration,
vermin, and in the case of electronic records, electronic or magnetic
sources.

d\. In the event that a laboratory goes out of business, the laboratory
shall have a plan to ensure that its records are maintained or
transferred according to the customer\'s instructions and applicable
regulations.

e\. The records shall include the identity of all personnel involved in
sampling (if known), sample preparation, calibration, analysis, final
reporting and a signature and initial record for the involved employees
shall be created and maintained.

f\. Entries in records shall not be obliterated by methods such as
erasures, overwritten files, or markings. All corrections and/or
amendments to records shall be made [with a single strike out
line]{.mark} through the error and/or the correct data or value added
alongside, as appropriate. [All handwritten data shall be recorded using
indelible ink.]{.mark} The individual making the correction shall sign
(or initial) and date the correction.

**4.13.1 Sample Records**

A record of all procedures to which sample is subjected (sampling,
preparation and testing) while in the possession of the laboratory shall
be maintained for aperiod of at least 3 years as a readily retrievable
hard copy or electronic media that can be generated without
change[.]{.mark} These records shall include, but are not limited to,
records of

a\. Sample identification, receipt, acceptance or rejection and log-in;

b\. Sample storage and tracking including shipping receipts;

c\. Sample preparation, instrument printouts, and calculations;

d\. Sample analysis logs;

e\. Standard and reagent origin, receipt, preparation, and use;

f\. Equipment and instrument operating conditions;

g\. Calibration criteria, frequency and acceptance criteria;

h\. Data and statistical calculations, review, confirmation,
interpretation, assessment, and reporting conventions;

i\. Method performance criteria;

j\. Quality control protocols and assessment;

k\. Storage and retention; and

l\. Sample disposal procedures and schedule.

**4.13.2 Laboratory Management System and Test Records**

In addition to documenting all the above mentioned activities, the
following shall be retained:

a\. All original raw data, whether hard copy or electronic, for sampling
and testing activities to include: calibrations, samples, and quality
control measurements, work sheets and data output/instrument response
readout records;

b\. A written description or reference to the specific method used which
includes a description of the specific steps in the calculation 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 work activities;

f\. All corrective action reports, audits, and audit responses;

g\. Performance evaluation results and raw data; and

h\. Data review and cross checking.

**4.13.3 Electronic Data**

Where computers or automated equipment are used for the capture,
processing, manipulation, recording, reporting, storage or retrieval of
data, the laboratory shall ensure that:

a\. Electronic computer records can satisfy the record keeping
requirement without hard copy files if hard copies can be generated
without changing the information.

b\. The computer programs are validated before they are used and
whenever the programs are changed.

c\. Computer file back up procedures are completed in accordance with a
predetermined schedule.

d\. Records that are stored or generated by computers, have a hard copy
or write-protected backup copies.

**4.14 [INTERNAL AUDITS]{.underline}**

At least annually, the laboratory shall, in accordance with a
predetermined schedule and procedure, conduct internal audits of its
activities to ensure that operations comply with the requirements of
this document and the established management system. The quality manager
shall be responsible for the planning and implementation of such audits.
Such audits shall be carried out by trained and qualified staff who are,
whenever possible, independent of the activities to be audited. All
relevant information pertaining to the audit activity shall be recorded.
In a one-person organization, the annual audits may be conducted by the
one member of the laboratory if that person follows independent
third-party guidance for conducting a quality system audit, such as ISO
19011, Guidelines for quality and/or environmental management systems
auditing or similar third party guidance published by organizations such
as ASTM [(American Society for Testing and Materials]{.mark}) or ANSI
(American National Standards Institute) and creates and maintains a
written audit report of the audit findings in its record system.
Alternatively, the one-person organization may choose to contract out
the internal audit to an independent person or firm that is competent
and has the experience and training to conduct an audit of a quality
system.

When the audit finds doubt on the correctness or validity of the
laboratory test results, timely corrective action shall be taken by the
laboratory. If the audit indicates that laboratory results may have been
affected, customers shall be notified and informed of the corrective
action taken and the amended results.

**4.15 [MANAGEMENT REVIEWS]{.underline}**

The quality system adopted to satisfy the requirements of the NLLAP LQSR
shall be reviewed at least once a year by the laboratory management to
ensure its continuing suitability and effectiveness and to introduce any
necessary changes or improvements (see Section 4.9). Such reviews shall
be carried out by the laboratory management in accordance with a
predetermined schedule and procedure. The review shall take account of:

\# the suitability of policies and procedures;

\# reports from managerial and supervisory personnel;

\# the outcome of recent internal audits;

\# corrective and preventive actions;

\# assessments by external bodies;

\# the results of interlaboratory comparisons or proficiency tests;

\# changes in the volume and type of the work;

\# customer feedback;

\# complaints;

\# recommendations for improvement

\# other relevant factors, such as quality control activities, resources
and staff training.

All relevant information pertaining to the management review shall be
recorded. The laboratory management shall ensure that necessary changes
or improvements are carried out within an appropriate and agreed
timescale.

**5.0 TECHNICAL REQUIREMENTS**

**5.1 [GENERAL]{.underline}**

Many factors contribute to the correctness and reliability of lead
measurements performed by a laboratory. These factors include
contributions from:

\# human factors (5.2)

\# accommodation and environmental conditions (5.3)

\# test and calibration methods and method validation (5.4)

\# equipment (5.5)

\# measurement traceability (5.6)

\# sampling (5.7)

\# sample handling (5.8)

These factors shall be taken into account by the laboratory in
developing test and calibration methods, in training personnel, and in
the selection of equipment used.

**5.2 [PERSONNEL]{.underline}**

Laboratory management shall ensure that all laboratory personnel
performing NLLAP recognized analyses are educated, trained, experienced,
skilled and competent in performing lead sampling and testing
activities, as appropriate. Staff assigned to operate equipment, perform
tests, evaluate results, and sign test reports shall be qualified and
authorized in writing by management to do so. When using staff in
training, adequate supervision shall be provided. A record of all
employees and their associated competence, training, skills, experience,
authorizations and professional qualifications shall be clearly defined,
documented, and maintained on file. The criteria and training
requirements for laboratory personnel shall be clearly defined,
documented, and readily available. Training records shall include a
description of training program contents, the duration of the training,
qualifications of the trainer, and evidence that the analyst/technician
has successfully demonstrated their competence, such as described in
Section 5.2.1.1.

Goals for the laboratory training program shall be formulated by
laboratory management and a training program shall be in place to
address the training needs of laboratory employees and shall be relevant
to the present and anticipated needs of the laboratory. The
effectiveness of the training shall be evaluated. The laboratory shall
maintain current job descriptions for managerial, technical, and key
support staff involved in sampling and testing activities, as
appropriate.

The NLLAP recognized laboratory shall use permanently employed staff or
those under contract to the laboratory. When additional support or
technical personnel are needed, the laboratory shall ensure that such
personnel are competent, supervised and work within the management
system.

**5.2.1 [Analysts/Technicians]{.underline}**

Personnel who function as analysts and/or technicians (however named) in
the laboratory shall have the education, training, experience and/or
demonstrated skills or combination thereof, to enable them to adhere to
the implemented quality system and to competently perform test
procedures, operate laboratory equipment, evaluate test results and sign
test reports (when authorized).

**5.2.1.1 Minimum Qualifications and Training for Analyst/Technician
Personnel**

5.2.1.1.1 NLLAP analysts and/or technicians shall have hands on
experience conducting lead sampling and testing activities, as
appropriate, before being authorized to work on NLLAP related samples.

5.2.1.1.2 Analysts and technicians shall complete an external and/or
internal training program for lead sampling and testing activities, as
appropriate, prior to performing those activities on NLLAP related
samples. Courses on sample selection, collection, preparation (when
applicable) and instrumental analysis may be taken separately or
combined. The criteria and training requirements for laboratory
personnel shall be clearly defined, documented and maintained on file. A
description of the training program content, the duration of the
training, qualifications of the trainer, and objective evidence that the
analyst /technician has successfully selected and/or collected samples
and prepared and tested, as appropriate, unknown reference samples of
the matrices of concern within the specified acceptance criteria must be
maintained by the laboratory.

5.2.1.1.3 The analyst/technician trainee shall complete a minimum of
four independent test runs of sample preparation (when applicable)
and/or instrumental analysis for each matrix. An independent run is
defined as analysis of at least five samples of known lead content, one
of which is a certified reference material or proficiency testing
material and is separated by a period of time sufficient to evaluate the
performance of any previous independent run. For sample preparation
training, the recoveries of the associated reference materials or
proficiency training samples for each run must be within
[[+]{.underline}20% of the certified value, 75% of the time. For
instrumental analysis training, the recoveries of the associated
reference materials or proficiency training samples for each run must be
within [+]{.underline}20% of the certified value, 75% of the
time.]{.mark}

> For some analytical testing technologies it may not be possible to
> separate the sample preparation techniques from instrumental analyses.
> In such cases, the training requirements shall be based upon the
> minimum requirements stated for both analysts and technicians.
>
> The reference material/proficiency test samples utilized shall: 1) be
> similar to matrices the analyst /technician will encounter during
> routine lead sample analysis, and 2) cover the sample
> mass/concentration range for which the analytical SOP has been
> validated.

5.2.1.1.4 Analyst/technicians authorized to perform lead testing shall
periodically demonstrate their ability to proficiently test samples for
lead by analyzing standard reference materials (SRMs), certified
reference materials, proficiency testing materials or other quality
control samples during routine sample analysis. This demonstration shall
be evaluated at least every six months.

**5.2.1.2 Additional Requirements for Mobile and FSMO Personnel**

5.2.1.2.1 All mobile laboratory and FSMO personnel involved in the
selection of samples or sampling areas as a part of a lead-based paint
risk assessment in target housing and/or child occupied facilities shall
also be certified by EPA or an authorized state or tribal program as [a
risk assessor/inspector/sampling technician]{.mark} as pursuant to
Section 402 of the Toxic Substance Control Act (TSCA) and its
implementing regulations.

5.2.1.2.2 All mobile or FSMO technicians shall be evaluated by a
competent supervisor for their first two NLLAP-related job sites.

**5.3 [ACCOMMODATION AND ENVIRONMENTAL CONDITIONS]{.underline}**

Any fixed site or mobile laboratory operation shall have, as
appropriate, the space, equipment, instruments, ventilation, utility
services, storage space, safety equipment, and documentation and
references necessary to accomplish the analyses for lead concentrations
in the matrices of concern (see 29 CFR § 1910.1450 for information).
FSMOs shall have appropriate storage facilities to maintain the
integrity of the testing equipment when not in use.

Temperature, humidity, ventilation, dust, and vibration shall be
controlled and/or monitored to meet instrument and/or sample analysis
requirements. Tests shall be terminated when environmental conditions
jeopardize the results of the test.

Incompatible activities in the laboratory shall be separated to prevent
cross-contamination. Access to areas affecting the quality of test
and/or calibrations shall be controlled. The integrity of the laboratory
shall be maintained with good housekeeping practices. For laboratories
operating portable testing technologies, sample collection and field
testing shall be conducted so as to minimize the chance of
cross-contamination. Site access shall be controlled to the extent
possible while sampling and testing are taking place. Activities at the
site shall be conducted to minimize the possibility of creating a hazard
during or after testing, or contaminating the site from sampling and
testing.

**5.3.1 Contamination Control**

**5.3.1.1 [Laboratory Dust Wipe Checks]{.underline}**

For fixed-site and mobile laboratory facilities, wipe sampling of sample
preparation and testing area surfaces shall be conducted at least
quarterly to determine surface concentration levels of lead. Sample
preparation and analysis is not to proceed until surface contamination
is below the specified maximum allowable concentration of [50 percent of
the lowest regulatory limit for dust wipe samples. For FSMO, appropriate
contamination control blank samples shall be run in order to monitor
potential lead contamination.]{.mark}

[]{.mark}

**[5.3.1.2 [Labware Cleaning]{.underline}]{.mark}**

[]{.mark}

[Cleaning procedures for labware shall be specified by the]{.mark}
[laboratory in a written SOP. The procedure shall include, where
applicable, a specified frequency for monitoring of lead concentrations
in cleaning baths, the monitoring of glassware contamination during the
analysis of reagent or other blanks, and periodic monitoring of
disposable labware contamination by analyzing of reagent or other
blanks.]{.mark}

**5.4 [TEST AND SAMPLING METHODS]{.underline}**

[]{.mark}

**[5.4.1. Acceptable Methodology]{.mark}**

[]{.mark}

The test methods or written SOPs, dated and approved by the appropriate
authority, shall be available for use where work activities are
performed. The laboratory shall have demonstrated that the test and/or
sampling methods used are suited for the intended use. In addition the
laboratory shall have records of method performance demonstration and
validation for laboratory developed or modified procedures. This
includes MDL, Bias and Precision.

[]{.mark}

[a. Methods shall not be used for sample analysis until the laboratory
has confirmed and documented their validity. Accuracy shall be
demonstrated over the lead concentration and sample mass ranges for each
matrix stated by the method, as appropriate.]{.mark}

[]{.mark}

[b. Where sample preparation and analysis methods are not specified by
regulatory programs, the laboratory shall, whenever possible, use
validated procedures published by federal agencies such as EPA, HUD or
NIOSH, state agencies, or nationally or internationally recognized
consensus standards organizations such as ASTM International. For
methods under consideration for analytical testing the laboratory shall
demonstrate it can achieve a quantitation limit equal to or less than 20
percent of the lowest relevant action level or regulatory limit of
interest for paint and soil and 50 percent of the lowest action level
for dust wipe samples]{.mark}. Laboratory SOPs for sample analysis may
require additional QC procedures to those stated in the published
methods in order to meet requirements of this document.

[Acceptable sampling methods are cited: 40 CFR Part 745 - Lead-Based
Paint Activities.]{.mark}

[]{.mark}

[c. New, alternative or modified analytical methods and/or new testing
technologies may be used by a]{.mark} l[aboratory if they have been
validated by the laboratory or a third party, and shown to meet the
minimum performance requirements stated in 5.4.1(b). The method
validation must be documented by the laboratory or qualified third
party. In the case where validation is done by a party other than the
laboratory, the laboratory shall confirm its competency utilizing the
method as described above in Section 5.4.1(a).]{.mark}

[]{.mark}

[]{.mark}Acceptable operating characteristics for non-numerical or
pass-fail technologies (positive or negative screen technologies) shall
be appropriate to the associated regulatory limits (e. g., the measured
value including its 95% uncertainty of measurement must be less than the
associated regulatory limit).

[]{.mark}

[d.]{.mark} When a laboratory offers analyses of composite dust wipe
samples, the laboratory analytical method for composite dust wipe
samples shall address increase of sample mass. Laboratory shall meet the
minimum performance requirements stated in 5.4.1(b) and demonstrate its
competency utilizing the method as described above in Section 5.4.1(a).

**[5.4.2 Method Validation and Performance Demonstration
Procedures]{.mark}**

[]{.mark}

A list of guidance documents that should be helpful in dealing with
method validation and performance demonstration that include good
professional laboratory principles and practices are listed below:

[]{.mark}

> \# [AOAC International operates method validation programs.
> Information on these programs is available at:]{.mark}
> <http://www.aoac.org/vmeth/page1.htm>
>
> []{.mark}

[]{.mark}\# [U.S. EPA Office of Solid Waste "Guidance for Method
Development and Method Validation for the RCRA Program, June 1995."
at:]{.mark}
[www.epa.gov/SW-846/methdev.htm](http://www.epa.gov/SW-846/methdev.htm)

[]{.mark}

[]{.mark}\# ["Guidelines for Collaborative Study Procedure to Validate
Characteristics of a Method of Analysis," *J. Assoc. Off. Chem*., Vol.
72, No.4, 1989, p. 694]{.mark}

[]{.mark}

[]{.mark}\# []{.mark}\"Meeting the Traceability requirements of ISO
17025-An Analyst\'s Guide,\" 2nd Edition, at:
[www.vam.org.uk/](http://www.vam.org.uk/)

[]{.mark}

[]{.mark}\# []{.mark}"Preparation of Calibration Curves-A Guide to Best
Practice," September 2003, LGC/VAM/2003/032, at:
[www.vam.org.uk/](http://www.vam.org.uk/)

[]{.mark}

[]{.mark}\# []{.mark}"New Eurachem/CITAC guidance on traceability of
chemical measurements: A paradigm for practical traceability," April
2003, LGC/VAM/2003/016, at: [www.vam.org.uk/](http://www.vam.org.uk/)

[]{.mark}

[]{.mark}\# []{.mark}"Quantifying Uncertainty in Analytical Measurement,
2nd Edition," QUAM2000-1, 2000, at:
[www.vam.org.uk/](http://www.vam.org.uk/)

[]{.mark}

> \# []{.mark}"EURACHEM/CITAC Guide: Traceability in Chemical
> Measurement-A Guide to Achieving Comparable Chemical Measurement,"
> 2003, at: [www.vam.org.uk/](http://www.vam.org.uk/)

[]{.mark}

[]{.mark}\# []{.mark}"In-house method validation: A guide for chemical
laboratories," 2003, at: [www.vam.org.uk/](http://www.vam.org.uk/)

[]{.mark}

[]{.mark}\# ["A Practical Guide to Analytical Method Validation",
Analytical Chemistry 1996, (68) 305A-309A, published at:
<http://pubs.acs.org/hotartcl/ac/96/may/may.html>]{.mark}

[]{.mark}

[]{.mark}\# ["The Fitness for Purpose of Analytical Methods-A laboratory
Guide to Method Validation and Related Topics," EURACHEM Guide 1998, at:
[www.eurachem.ul.pt/](http://www.eurachem.ul.pt/)]{.mark}

[]{.mark}

[]{.mark}\# ["Standard Practice for Determining the Precision of ASTM
Methods for Analysis and Testing of Industrial and Specialty Chemicals"
ASTM International Practice Designation E 180, at:]{.mark}
[www.astm.org]{.underline}

[]{.mark}

[]{.mark}\# ["Standard Practice for Conducting an Interlaboratory Study
to Determine the Precision of a Test Method," ASTM International
Practice Designation E 691, at:]{.mark} [www.astm.org]{.underline}

[]{.mark}

[]{.mark}\# ["Standard Guide for Demonstrating and Assessing Whether a
Chemical Analytical Measurement system Provides Analytical Results
Consistent with Their Intended Use," ASTM International Guide
Designation D 6956-03, at:]{.mark} [www.astm.org]{.underline}

[]{.mark}

[]{.mark}\# ["Standard Guide for Conducting Ruggedness Tests," ASTM
International Guide Designation E 1169, at:]{.mark}
[www.astm.org]{.underline}

[]{.mark}

[]{.mark}\# ["Standard Guide for Evaluating Laboratory Measurement
Practices and the Statistical Analysis of the Resulting Data" ASTM
International Guide Designation E 1323, at:]{.mark}
[www.astm.org]{.underline}

[]{.mark}

[]{.mark}\# ["Standard Guide for Statistical Procedures to Use in
Developing and Applying Test Methods," ASTM International Guide
Designation E 1488, at:]{.mark} [www.astm.org]{.underline}

[]{.mark}

**[5.4.3 Sample Preparation]{.mark} and Analysis Procedures**

**5.4.3.1 [Standard Operating Procedures]{.underline}**

All method SOPs shall be available to all personnel at the locations
where work activities are performed and shall include information
addressing the following areas, as appropriate:

\# method detection limit

\# scope and application

\# summary of the method

\# definitions

\# applicable matrix or matrices

\# applicable lead concentration range

\# applicable sample mass range

[\# method performance (accuracy and precision)]{.mark}

[\# interferences]{.mark}

[\# safety considerations]{.mark}

[\# reagents and standards]{.mark}

[\# equipment and supplies]{.mark}

[\# sample collection (where applicable)]{.mark}

[\# sample preservation and storage (where applicable)]{.mark}

[\# sample preparation including grinding, homogenization, and
subsampling (where applicable)]{.mark}

[\# instrument calibration/verification]{.mark}

[\# quality control procedures]{.mark}

[\# detailed step-by-step procedures]{.mark}

[\# calculations]{.mark}

[\# data acceptance criteria]{.mark}

[\# corrective actions for out-of-control data]{.mark}

[\# contingencies for handling out of control data]{.mark}

[\# references]{.mark}

[]{.mark}

[]{.mark}Laboratory SOPs which do not address all of the areas stated
above shall be amended in accordance with the laboratory\'s SOP on
document control, revision /change, which may permit the use of
attachments in order to meet this requirement or reference other quality
system documents as appropriate. [All operating procedures relevant to
the work being conducted shall be available for use where the work
activities are performed]{.mark}.

**5.4.4 Method Performance Characteristics**

The acceptable minimum method performance characteristics provided in
Tables 3 and 4 of this document shall be replaced by t[he]{.mark}
[laboratory's own statistically determined performance]{.mark}
characteristics [and shall not be greater than values stated in Tables 3
and 4]{.mark}.

**5.4.4.1 [Method Detection Limits]{.underline}**

Method detection limits (MDLs) shall be established, statistically
verified and monitored, as needed for each method and matrix of concern.
For methods with stated MDLs, demonstration of ability to achieve such
MDLs is required and shall be documented. MDLs shall be determined using
a documented SOP that is based on procedures published or recognized by
nationally or internationally acknowledged technical authorities, e.g.,
40 CFR Part 136 Appendix B.

**5.4.4.2 [Quantitation Limit]{.underline}**

The quantitation limit shall be "less than" ("\<") a value at least 2
times but no greater than 10 times the method detection limit as
determined in Section 5.4.4.1.

[]{.mark}

**5.4.4.3 [Accuracy and Precision]{.underline}**

Accuracy and precision shall be determined for each analytical method.
The method evaluation results shall be documented and kept on file.
Acceptable minimum method performance criteria for accuracy and
precision can be found in Tables 3 and 4 of this document.

[]{.mark}

**5.4.5 Sample Aliquots**

Where subsampling (obtaining sample aliquots from a submitted sample) is
carried out as part of the analytical method, the laboratory shall use
documented procedures and appropriate techniques to obtain
representative subsamples.

**[5.4.6 [DATA REDUCTION AND REVIEW PROCESS]{.underline}]{.mark}**

[]{.mark}

[]{.mark}The data reduction and review process shall be conducted by a
qualified person and include, but not necessarily be limited to:
comparison of quality control data against established acceptance
limits, computation verification, transcription of data, and adherence
to the procedures established in the laboratory SOPs. Where appropriate,
computations shall be verified and transcription of data double checked.
[Qualified persons can be technicians, analysts, the quality manager, or
technical manager, or the responsible person described previously in
Section]{.mark} 4.0.

[]{.mark}

[In the case of a one person]{.mark} [laboratory, or where a qualified
person is not available for the review, the following options may be
followed to complete the review.]{.mark}

[]{.mark}

[Option 1. The review process may be conducted using an SOP]{.mark} that
is part of the laboratory\'s management system[.]{.mark}

[]{.mark}

Option 2. The review process may be contracted out if the SOP above is
followed.

Option 3. The one person or available person follows the SOP referred to
above and double checks all QC samples results for correctness and
conformance to acceptance levels, double checks all results equal to or
above applicable action levels for correctness, and double checks 20% of
the remaining sample results for correctness, using a random number
generator or sample selection software to select samples independently.

The review process shall be documented and signed by the reviewer, and
shall be retained on file with a copy of the final report for a minimum
of three years[.]{.mark}

[]{.mark}

**5.5 [EQUIPMENT]{.underline}**

The laboratory shall be furnished with the proper equipment to perform
the necessary tests. Should the laboratory need to use equipment outside
its permanent control, it shall ensure that all NLLAP requirements for
equipment and instrumentation are met. All equipment used for sample
preparation or for instrumental analysis shall be maintained and
calibrated in accordance with manufacturer instructions, as well as any
specifications stated in the analytical methods. Standards used for
calibration shall be traceable to [National Institute of Standards and
Technology (NIST)]{.mark} standards (when available). Equipment is to be
used by authorized personnel only.

Each item of equipment shall be uniquely identified when possible and
records shall be maintained for each major instrument, including records
of in-house preventive maintenance and service. The
calibration/verification frequency for each instrument shall be
established and documented. The documentation shall include descriptions
of the problem or service, dates and types of repair, organization and
person performing repair, and contact phone number shall be recorded.
Instruments that are found to be out of calibration or defective shall
be taken out of service until repaired and demonstrated to be
functioning within documented acceptance limits. The record shall
identify the instrument by make, model number, serial number, and when
available, the date placed in service.

To prevent contamination or deterioration, the laboratory shall have
procedures for the safe handling, transport, storage, use, and
maintenance of measurement equipment. Equipment that has been
mishandled, operates outside expected limits, or provides suspect
results shall be removed from service and marked accordingly until it
can be repaired, recalibrated, and returned to service. Likewise,
equipment that goes outside the control of the laboratory for any period
of time must be checked and shown to provide satisfactory performance
before being returned to service.

All equipment used to collect, prepare and test samples for lead shall
have SOPs for their calibration/verification and maintenance and shall
be readily available for use where these activities are performed.

**[5.5.1 Instrument Calibration and Performance Quality Checks]{.mark}**

[]{.mark}

[Instruments that are routinely calibrated shall be calibrated daily or
prior to analyzing samples. Acceptable instrument performance shall be
demonstrated daily or prior to use. Such checks may include evaluation
of instrument sensitivity, noise levels, instrument response and
interference levels to be compared to historical performance values.
Acceptance criteria shall be determined, documented and used.]{.mark}

[]{.mark}

Number range CHAPTER[All instrument calibration/performance verification
shall be performed using matrix matched reference standard materials of
the same matrix as the samples being measured, when available. These
standard materials shall be traceable to NIST standards (when
available). In the absence of sufficient data for statistical
determination of adequate QC limits and frequency, the types of QC
samples, minimum frequencies and the required minimum acceptance limits
shown in Tables 1 and 2 shall be met, as appropriate]{.mark}.

[]{.mark}

**[5.5.2 Instrument Calibration Performance Requirements]{.mark}**

[]{.mark}

[Instruments and equipment used for testing that have a significant
effect on the accuracy]{.mark} of the result shall be calibrated prior
to use. The laboratory shall have an established system for equipment
calibration, where applicable. See "Preparation of Calibration Curves-A
Guide to Best Practice,\" September 2003, LGC/VAM/2003/032,
[www.vam.org.uk/](http://www.vam.org.uk/) for the guidance.

a\. All calibration curves shall cover (bracket) the expected sample
concentration range with the concentrations of the calibration standards
evenly distributed across the range. The calibration curves shall be
dated, labeled and include at least the following information:
applicable method, instrument identification, analysis date, lead
concentrations, instrument response, identify the personnel responsible
for the calibration.

[b. When used, the axis of the calibration curve shall be labeled. For
electronic data processing systems that automatically compute the
calibration curve, the equation for the curve and the correlation
coefficient must be recorded. The equation for the line and the
correlation coefficient shall also be recorded when the calibration
curve is prepared manually.]{.mark}

[]{.mark}

[c. A criterion for the acceptance of a calibration curve, (for example,
an acceptable correlation coefficient) shall be established and
documented.]{.mark}

[]{.mark}

[d. All initial instrument calibration shall be verified using standards
obtained from a different source than initial calibration
standards.]{.mark}

[]{.mark}

[e. The sample results shall be bracketed by calibration standards under
all circumstances.]{.mark}

[]{.mark}

[f.]{.mark} When an instrument/technology has a preferred range of
operation (e.g., the linear response range of AA), the extent of that
range shall be verified (if possible) and the calibration standards
shall be limited to that range

[]{.mark}

**[5.5.2.1 [Initial Calibration]{.underline}]{.mark}**

[]{.mark}

[A minimum of three calibration standards, which bracket the sample
concentrations, and an initial calibration blank (ICB) shall be analyzed
and used to construct a calibration curve prior to the analysis of
samples, as appropriate. Calibration acceptance criteria shall be
stated. New calibration curves shall be prepared whenever an out of
control condition is indicated and/or after new reagents are prepared.
For those technologies and software packages requiring fewer calibration
standards, follow the manufacturer's recommendations (e. g., the
instrument operations manual).]{.mark}

[]{.mark}

[When linear fit is used,]{.mark} linearity shall be evaluated by using
the calibration standards. Acceptance criteria shall be stated (See
Tables 1 and 2).

[]{.mark}

**[5.5.2.2 [Independent Calibration Verification]{.underline}]{.mark}**

[]{.mark}

[An independent calibration verification (ICV) standard shall be
analyzed daily or prior to analyzing samples.]{.mark} See Tables 1 and 2
for minimum performance [acceptance]{.mark} criteria.

[]{.mark}

[For an instrument which produces a numerical result, the ICV standard
shall be at a lead concentration in the range of customer specified lead
levels of concern or action levels such as regulatory limits.]{.mark}

[]{.mark}

[For an instrument (or equivalent) which produces a pass-fail result,
the ICV positive (ICV-P) with lead level no more than 20% above the
applicable regulatory limit (omit for positive screen technologies)
and/or negative (ICV-N) with lead level no less than 20% below the
applicable regulatory limit (omit for negative screen
technologies).]{.mark}

[]{.mark}

**[5.5.2.3 [Continuing Calibration Verification]{.underline}]{.mark}**

[]{.mark}

[Continuing calibration verification (CCV) standards shall be analyzed
in accordance with the SOP. The CCV standard may be prepared from
independent reference standards or from the same standards used to
prepare the instrument calibration curve. Acceptance criteria shall be
stated (]{.mark}See Tables 1 and 2 [for minimum performance acceptance
criteria).]{.mark}

[]{.mark}

[a. At least two standards shall be analyzed every 12 hours, or
according to instrument manufacturer\'s recommendations, or]{.mark} at a
predetermined SOP frequency [whichever is most frequent.]{.mark}

[]{.mark}

[b. For an instrument which produces a numerical result, the
concentration of these standards shall be determined by the confirmed
operating range of the instrument, regulatory limits and/or method
specified levels. At least one standard shall be at or below the
laboratory established reporting limit. To the extent possible, the
samples in each interval should be bracketed with standard
concentrations closely representing the lower and upper range of
analyzed concentrations (diluted, if necessary). If this is not
possible, the standard calibration checks should be prepared covering
the expected concentration range of the samples being tested.]{.mark}

[]{.mark}

[c. For an instrument (or equivalent) which produces a pass-fail result,
the concentration of these standards shall be determined by the
confirmed operating range of the instrument, regulatory limits and/or
method specified levels. Continuing Calibration Verification Positive
(CCV-P) with lead level no more than 20% above the applicable regulatory
limit (omit for positive screen technologies) and Continuing Calibration
Verification Negative (CCV-N) with lead level no less than 20% below the
applicable regulatory limit (omit for negative screen
technologies).]{.mark}

[]{.mark}

[d. A new calibration curve shall be established if two consecutive test
results of one continuing calibration check are outside acceptable
limits. When the continuing calibration check is confirmed to be outside
acceptable limits, the samples affected by the unacceptable check shall
be reanalyzed after a new calibration curve has been established,
evaluated, and accepted. Sample analysis shall not continue or be
restarted until a new calibration curve is established and
verified.]{.mark}

[]{.mark}

**[5.5.2.4 [Continuing Calibration Blank (CCB)]{.underline}]{.mark}**

[]{.mark}

[Continuing Calibration Blank (CCB) standards shall be analyzed in
accordance with the testing SOP.]{.mark}

**[Table]{.mark} 1 [Summary of Instrument Calibration Performance
Requirements]{.mark}** **for an instrument which produces a numerical
result**

+-------------------+-------------------------+------------------------+
| **QC SAMPLE**     | **FREQUENCY**           | **ACCEPTANCE LIMITS**  |
+-------------------+-------------------------+------------------------+
| Independent       | Once per day after      | Within ±10% of known   |
| Calibration       | calibration             | value                  |
|                   |                         |                        |
| Verification      |                         |                        |
| (ICV)             |                         |                        |
+-------------------+-------------------------+------------------------+
| Initial           | Once per run at the     | Absolute value not     |
| Calibration Blank | beginning of the run    | more than 50 percent   |
| (ICB)             |                         | of the lowest          |
|                   |                         | regulatory limit for   |
|                   |                         | the sample matrix      |
|                   |                         | analyzed or minimum    |
|                   |                         | level of concern       |
+-------------------+-------------------------+------------------------+
| Continuing        | Beginning & at the end  | Within ±10% of known   |
| Calibration       | of a sample run as well | value                  |
| Verification      | as every 12 hours, or   |                        |
| (CCV)             | according to instrument |                        |
|                   | manufacturer\'s         |                        |
|                   | recommendations, or at  |                        |
|                   | a predetermined SOP     |                        |
|                   | frequency whichever is  |                        |
|                   | most frequent           |                        |
+-------------------+-------------------------+------------------------+
| Interference      | Beginning & end of each | Within 20% of known    |
| Check Sample      | run or twice every 12   | value                  |
| (ICS) (where      | hours                   |                        |
| applicable)       |                         |                        |
+-------------------+-------------------------+------------------------+
| Continuing        | After each ICS and CCV  | Absolute value not     |
| Calibration Blank |                         | more than 50 percent   |
| (CCB)             |                         | of the lowest          |
|                   |                         | regulatory limit for   |
|                   |                         | the sample matrix      |
|                   |                         | analyzed or minimum    |
|                   |                         | level of concern       |
+-------------------+-------------------------+------------------------+

**Table 2 Summary of Instrument (or Equivalent) Performance Requirements
for an instrument (or equivalent) which produces Pass-Fail result**

  ------------------------ ------------------------- ---------------------
  **QC SAMPLE**            **FREQUENCY**             **ACCEPTANCE LIMITS**

  Independent Calibration  Once per run at the       Positive
  Verification - Positive  beginning of the run      
  (ICV-P) (sample lead                               
  level no more than 20%                             
  above the applicable                               
  regulatory                                         
  [limit]{.mark}; omit for                           
  positive screen                                    
  technologies)                                      

  Independent Calibration  Once per run at the       Negative
  Verification - Negative  beginning of the run      
  (ICV-N) (sample lead                               
  level no less than 20%                             
  below the applicable                               
  regulatory                                         
  [limit]{.mark}; omit for                           
  negative screen                                    
  technologies)                                      

  Initial Calibration      Once per run at the       Negative
  Blank (ICB)              beginning of the run      

  Continuing Calibration   At the end of a run as    Positive
  Verification Positive    well as every 12 hours,   
  (CCV-P) (sample lead     or according to the       
  level no more than 20%   manufacturer's            
  above the applicable     recommendations, or       
  regulatory               according to its          
  [limit]{.mark}; omit for Performance               
  positive screen          Characteristics Sheet, or 
  technologies)            at a predetermined SOP    
                           frequency, whichever is   
                           most frequent             

  Continuing Calibration   At the end of a run as    Negative
  Verification Negative    well as every 12 hours,   
  (CCV-N) (sample lead     or according to the       
  level no less than 20%   manufacturer's            
  below the applicable     recommendations, or       
  regulatory               according to its          
  [limit]{.mark}; omit for Performance               
  negative screen          Characteristics Sheet, or 
  technologies)            at a predetermined SOP    
                           frequency, whichever is   
                           most frequent             

  Interference Check       At the beginning and end  Result consistent
  Sample (ICS) (where      of each run or twice      with lead level
  applicable)              every 12 hours            

  Continuing Calibration   After each ICS and CCV    Negative
  Blank (CCB)                                        
  ------------------------ ------------------------- ---------------------

**5.6 [MEASUREMENT TRACEABILITY]{.underline}**

[All equipment that has a significant effect on the accuracy or validity
of the test result shall be calibrated prior to use. The]{.mark}
l[aboratory shall have an established system for selecting, using,
calibrating, checking, controlling and maintaining measurement
standards, reference materials and equipment.]{.mark}

NLLAP recognized laboratories shall establish and use a program for the
calibration of equipment to ensure traceability to the Systme
International (SI) units of measurement. Traceability of measurement
shall be ensured through the use of calibration services from
organizations demonstrating competence, traceability and measurement
capability. The laboratory shall obtain and retain in its record system
calibration certificates from these organizations showing the link to a
primary standard and containing the measurement results including
measurement uncertainty and/or a statement of compliance with an
identified metrological specification.

**5.6.1 Reference Standards and/or Reference Materials**

[]{.mark}

[Property values for reference materials shall be]{.mark} traced to SI
units [of measurement wherever possible. The reference standards and
materials values shall be certified and traceable to NIST or verified
against NIST standards (when available). Intermediate calibration checks
shall be carried out according to defined procedures and schedules. To
protect the integrity of the reference standards, the]{.mark}
l[aboratory shall have procedures in place to ensure their proper
handling, transport, storage, and use of reference materials. Reference
materials shall have an expiration date assigned.]{.mark}

[]{.mark}

[Reference materials shall not be used beyond assigned expiration dates
nor used if damaged or contaminated or suspected to be damaged or
contaminated. The]{.mark} l[aboratory shall maintain records pertaining
to all reference standards, reference materials and reagents to include
certificates of analysis, purity, their origin and traceability, as
provided by the manufacturer]{.mark}, for a period of at least three
years.

[]{.mark}

**[5.6.2 Documentation of Reagent and Calibration Solution
Preparation]{.mark}**

[]{.mark}

Documentation of intermediate and working standard and reagent solution
preparations shall be kept to provide traceability and shall include the
date of preparation, identity and concentration or purity of parent
material, assigned expiration date and preparer\'s initials. All
prepared reagents and standards shall be uniquely identified and the
contents shall be clearly identified.

**5.7 [SAMPLING]{.underline}**

When the laboratory performs sampling of dust, paint and/or soil samples
as a part of testing for lead, the sampling shall be performed in
accordance with: [40 CFR Part 745 - Lead-Based Paint Activities]{.mark}

**5.7**.1 **[[Sampling Media]{.underline}]{.mark}**

[]{.mark}

Where the laboratory is responsible for supplying sampling media, the
media shall be evaluated, as appropriate, for lead contamination. The
evaluation process shall be defined in a SOP and results of evaluations
[shall be]{.mark} recorded.

[]{.mark}

**5.8 [SAMPLE HANDLING]{.underline}**

The laboratory shall have [written]{.mark} SOPs for transportation,
receipt, handling, protection, retention, and/or disposal of the
samples, including provisions necessary to protect the integrity of the
samples.

**[5.8.1 Sample Control]{.mark}**

[]{.mark}

[Appropriate space, equipment and procedures shall be provided for
sample receipt, storage and processing.]{.mark}

[]{.mark}

[**5.8.2 Sample Acceptance, Documentation and Tracking
Procedure**s]{.mark}

[]{.mark}

[These procedures shall include a laboratory identification system that
uniquely identifies each sample and/or batch of samples received by
the]{.mark} [laboratory.]{.mark}

[]{.mark}

**[5.8.2.1 [Sample Acceptance Policy]{.underline}]{.mark}**

[]{.mark}

[The laboratory shall have a written sample acceptance policy that
clearly outlines the circumstances under which samples will be accepted
(without issuing results with a qualifier in the associated data
report). Data from any samples which do not meet the following criteria
must be clearly flagged defining the nature and substance of the
variation. This sample acceptance policy shall be made available to
sample collecting personnel and shall include, but is not limited to,
the following areas of concern:]{.mark}

[]{.mark}

[a. Proper, full, and complete documentation, which shall include sample
identification, the location, date of collection, sample matrix and any
special remarks concerning the sample;]{.mark}

[]{.mark}

[b. Proper sample labeling that includes unique field
identification.]{.mark}

[]{.mark}

[c. Use of appropriate sample containers;]{.mark}

[]{.mark}

[d. Adequate quantity of sample for analysis.]{.mark}

[]{.mark}

**[5.8.2.2 [Sample Receipt Logs]{.underline}]{.mark}**

[]{.mark}

[The laboratory shall utilize a permanent record, such as a log book or
electronic record, to document receipt of all samples. The following
information must be recorded:]{.mark}

[]{.mark}

[a. Date of laboratory receipt of sample;]{.mark}

[]{.mark}

[b. Sample collection date (if known);]{.mark}

[]{.mark}

[c. Unique laboratory ID code (]{.mark}5.8.2.5[);]{.mark}

[]{.mark}

[d. Field ID code supplied by sample submitter;]{.mark}

[]{.mark}

[e. Sample matrix;]{.mark}

[]{.mark}

[f. Requested analyses, including method number, if applicable;]{.mark}

[]{.mark}

[g. Signature or initials of sample receiver (where applicable); for
electronic sample logging systems, the identity of the sample
receiver;]{.mark}

[]{.mark}

[h. Comments resulting because of sample rejection.]{.mark}

[]{.mark}

[All associated documentation, such as memos or transmittal forms that
are transmitted to the laboratory by the sample transmitter shall be
retained.]{.mark}

[]{.mark}

**[5.8.2.3 [Documentation on Questionable Samples]{.underline}]{.mark}**

[]{.mark}

[Where there is any doubt as to the suitability of the sample]{.mark}
for testing, the sample does not conform to the description provided, or
the analysis required is not fully specified, the laboratory shall
consult the customer for further instruction before proceeding. If the
sample does not meet the sample acceptance criteria, the laboratory
shall:

\# [Retain correspondence and/or records of conversations concerning the
final disposition of rejected samples or fully document any decision to
proceed with the analysis of compromised samples.]{.mark}

[]{.mark}

\# [The condition of these samples shall, at a minimum, be noted on the
chain of custody or transmittal form and laboratory receiving
documents.]{.mark}

[]{.mark}

\# [The associated test result shall be appropriately \"qualified\" on
the final report.]{.mark}

[]{.mark}

[]{.mark}

**5.8.2.4 [Sample Custody Procedures]{.underline}**

The use of legal chain of custody (COC) protocols is strongly
recommended and may be required by customers and/or federal/state/tribal
programs (see ASTM D 4840 Standard Guide for Sample Chain of Custody
Procedures). Chain of custody records shall establish an intact,
continuous record of the physical possession, storage and disposal of
collected samples.

[**5.8.2.5 [Sample]{.underline}** **[Tracking]{.underline}**]{.mark}

[]{.mark}

[The]{.mark} [laboratory shall have a documented system for uniquely
identifying the items to be analyzed, to ensure traceability of items
and to ensure that there can be no confusion regarding the identity of
such items at any time. This system shall include identification of all
samples, subsamples, and subsequent extracts and/or digestates.
The]{.mark} [laboratory shall assign a unique identification (ID) code
to each sample container received in the laboratory. Multiple aliquots
of a sample that have been received for testing must be assigned a
different ID code (such as a prefix or suffix).]{.mark}

[]{.mark}

The laboratory sample retention and disposal policies shall be
documented and used. The policies shall include documenting the manner
and duration of sample retention. Laboratories shall comply with all
applicable federal, state and local regulations regarding environmental
contamination and waste disposal.

[]{.mark}

**[5.9 [ASSURING THE QUALITY OF TEST RESULTS]{.underline}]{.mark}**

[]{.mark}

[T]{.mark}he laboratory is responsible for ensuring the quality of the
test results through the monitoring of the testing process. Such
monitoring plans shall include:

\# internal quality control approaches using statistical techniques;

\# participation in interlaboratory comparisons or proficiency testing
programs;

\# regular use of reference materials;

\# replication of tests using the same or different methods;

\# re-testing;

[The laboratory quality control program shall include the continual
evaluation of its performance: determinations of bias and precision for
each matrix analyzed; and participation in the ELPAT Program for each
matrix analyzed. Also laboratories are encouraged to participate in
interlaboratory comparisons and/or other proficiency testing
programs.]{.mark}

[]{.mark}

[]{.mark}Laboratory system process control and system performance
monitoring shall be accomplished using statistical process control
(charts or data base) for monitoring the laboratory\'s performance with
QC sample analysis results. The statistical process control method used
shall specify warning and action limits for acceptance or rejection of
the QC data and shall be used to monitor performance trends within the
management system over time. In the absence of a statistically
sufficient data base to determine the necessary frequency for QC samples
and/or action limits for acceptance or rejection of QC data, the
laboratory shall use of the frequencies and criteria for QC samples
stated in Tables 3 and 4.

[]{.mark}

Note: *Tables 3 and 4 contain~~s~~ the required minimum performance
criteria and frequency for QC sample analysis (frequency determinations
are usually based on system process control data produced by the
laboratory for the method in question). The laboratory shall establish
its own performance criteria for QC samples (uncertainty of
measurement), which shall not be greater than stated in tables 3 and 4.*

[]{.mark}

**5.9.1 Quality Control Procedures.**

[]{.mark}

[The]{.mark} [laboratory shall have QC procedures for monitoring the
validity of lead tests undertaken. The resulting data shall be recorded
in such a way that trends are detectable and statistical techniques
shall be applied to the reviewing of the results.]{.mark} The QC
procedures shall be stated in the quality documents such as QM and/or in
each method SOP addressing, as appropriate:

\# Duplicate or \"Side-by-Side\" Field Sample Analyses

\# Spiked and Blank Sample Analyses

\# Blind Samples

\# Split/Spiked Field Sample Analyses

\# Control Charts or Equivalent

\# Calibration Standards

\# Laboratory Control Samples

\# Internal Standards

[]{.mark}

**5.9.1.1 [Bias Determination]{.underline}**

[Laboratory Control Samples (LCS).]{.underline} LCSs (External
Reference) are used to determine the degree of bias shall be of the same
matrix as the test samples, and shall be prepared and analyzed with a
minimum frequency of one per twenty field samples or batch, whichever is
most frequent. A batch is defined as a set of samples which are
processed (for example, homogenized, digested and analyzed) in one
operation.

Note: *LCS sources include but are not limited to: proficiency testing
samples from the ELPAT [Program, commercially available certified
reference materials (CRM), or materials of known concentration
determined using definitive methods. All external reference sample
materials shall be NIST traceable.]{.mark}*

For an instrument which produces a numerical result[, the lead
concentration of the LCS shall be near the level of concern or action
level and whenever possible shall not require extensive pretreatment
dilution or concentration prior to analysis.]{.mark}

[]{.mark}

[For an instrument (or equivalent) which produces a pass-fail result,
the lead concentration of the LCS shall be near the level of concern or
action level]{.mark}, but no more than 20% above the applicable
regulatory limit (omit for positive screen technologies) or no less than
20% below the applicable regulatory [limit]{.mark} (omit for negative
screen technologies) [and whenever possible shall not require extensive
pretreatment dilution or concentration prior to analysis.]{.mark}

[]{.mark}

[[Matrix Spike (Split/Spiked) Field Samples]{.underline}. In an effort
to evaluate potential matrix interference, a matrix spike sample shall
be analyzed with a minimum frequency of 5% of the samples for each
matrix type per batch of samples. If there are fewer than twenty samples
in a batch, at least one matrix spike for each matrix per batch shall be
analyzed.]{.mark}

[]{.mark}

[Matrix spike samples shall be prepared using a split field sample
(before any digestion process when possible) and the level of lead
spiked shall be enough to result in a final lead concentration of the
prepared sample of five times the sample\'s observed lead concentration,
or five times the method detection limit, whichever is greater.]{.mark}

[]{.mark}

[Matrix spike analyses shall be performed using field samples (whenever
possible) in order to monitor for potential field sample matrix
interferences. For field samples too small or difficult to homogenize
and split in order to obtain samples for matrix spike evaluation or
replicate analyses, the laboratory shall select alternative QC options.
One of these alternative options includes the analysis of duplicate
laboratory control samples, prepared with the appropriate matrix
material, for each batch.]{.mark}

[]{.mark}

[[Method Blanks]{.underline}. A method blank containing all reagents
(and in the case of dust wipes, the representative blank wipe) and
subject to all preparation steps shall be processed and analyzed along
with the samples. Method blanks shall be analyzed with a minimum
frequency of 5% of the samples for each matrix per batch of samples. If
there are fewer than twenty samples in a batch, at least one method
blank for each matrix per batch shall be analyzed. Method blanks (or
other QC results) shall not be used to correct sample results.]{.mark}

[]{.mark}

**5.9.1.2 [Precision (repeatability) Determination]{.underline}**

A split field sample (the initial sample being split into two fractions
before digestion and analysis) for precision determination shall be
analyzed with a minimum frequency of 5% of the samples for each matrix
type per batch of samples. If there are fewer than twenty samples in a
batch, at least one test sample for each matrix per batch shall be
analyzed. For analyses where there is not a sufficient amount of field
sample for splitting or the analytical technology does not allow for
split samples, the laboratory shall use alternative QC procedures in an
effort to monitor the laboratory\'s precision of analysis. One of these
options is the analysis of duplicate laboratory control samples,
prepared with the appropriate matrix material, for each batch in order
to monitor laboratory performance.

[]{.mark}

**Table 3 [Summary of QC Sample Performance Requirements]{.mark}**
**[for an instrument which produces a numerical result]{.mark}**

  ----------------------- ----------------------- -----------------------
  **QC SAMPLE**           **FREQUENCY**           **ACCEPTANCE LIMITS**

  Laboratory Control      One per 20 samples or   Within ±20% of known
  Sample                  batch (min. frequency   value
                          5%)                     

  Matrix Spike Sample     One per 20 samples or   Within ±25% of
                          batch (min. frequency   calculated value
                          5%)                     

  Duplicate Sample        One per 20 samples or   Within ±25% Relative
                          batch (min. frequency   Percent Difference
                          5%)                     (RPD)

  Method Blank            One per 20 samples or   Absolute value not more
                          batch (min. frequency   than [50 percent of the
                          5%)                     lowest regulatory limit
                                                  for the sample]{.mark}
                                                  matrix analyzed or
                                                  minimum level of
                                                  concern
  ----------------------- ----------------------- -----------------------

**Table 4 [Summary of QC Sample Performance Requirements]{.mark}**
**[for an instrument (or equivalent) which produces Pass-Fail
result]{.mark}**

  ------------------- -------------------------- -------------------------
  **QC SAMPLE**       **FREQUENCY**              **ACCEPTANCE LIMITS**

  Laboratory Control  One per 20 samples or      Positive
  Sample Positive     batch (min. frequency 5%)  
  LCS-P (sample lead                             
  level no more than                             
  20% above the                                  
  applicable                                     
  regulatory                                     
  [limit]{.mark};                                
  omit for positive                              
  screen                                         
  technologies)                                  

  Laboratory Control  One per 20 samples or      Negative
  Sample Negative     batch (min. frequency 5%)  
  LCS-N (sample lead                             
  level no less than                             
  20% below the                                  
  applicable                                     
  regulatory                                     
  [limit]{.mark};                                
  omit for negative                              
  screen                                         
  technologies)                                  

  Duplicate           One per 20 samples or      Positive or Negative,
  Laboratory Control  batch (min. frequency 5%)  depending on the choice
  Sample LCS-P or                                of lead level and the
  LCS-N                                          capability of the
                                                 technology

  Method Blank        One per 20 samples or      Negative
                      batch (min. frequency 5%)  
  ------------------- -------------------------- -------------------------

**[5.9.2 Control Charts or Quality Control Data Base]{.mark}**

[]{.mark}

[Control charts or a quality control data base shall be used to record
quality control data and track laboratory performances with respect to
the associated acceptance limits for each matrix. The performance
tracking of critical QC samples shall be done as close as possible on a
real time basis.]{.mark}

[]{.mark}

**[5.9.3 Procedures for determination of out of control
situations]{.mark}**

The laboratory shall implement general procedures to be followed to
determine when quality control data is out of control. These procedures
shall address the following :

a\. Assigning responsibility for assessing each QC data type;

b\. Assigning responsibility for initiating and/or recommending
corrective actions;

c\. Defining how the analyst should treat a data set if the associated
QC measurements are unacceptable; and

d\. Specifying how out-of control situations and subsequent corrective
actions are to be documented.

When QC sample results fall outside the acceptance limits, the affected
batch of samples shall be reanalyzed, whenever possible. The re-analysis
shall begin with the sample preparation stage, when applicable, and
shall include a new set of QC samples, when possible. When feasible, a
lead laboratory may arrange for the re-collection or re-taking of field
samples.

10. **[REPORTING THE RESULTS]{.underline}**

    **5.10.1 General**

    Results of test activities carried out by the NLLAP recognized
    laboratory shall be reported clearly and objectively. These test
    results shall be reported in a test report that includes all the
    information needed for the interpretation of the test results and
    required by the test method used, as well as any additional
    information requested by the customer.

    When tests are performed for internal customers, or by customer
    request, the results may be reported in a simplified manner upon
    written agreement with the customer. In this case, the information
    listed in [5.10.2 that]{.mark} is not reported shall be easily
    accessed in the laboratory that performed the tests.

    **5.10.2 Test Reports**

    Final test reports shall contain, at a minimum, the information
    outlined below. The customer may request additional information to
    be included in the report. Along with the final test report, the
    laboratory shall maintain a sample case file or be able to
    assimilate the sample case information described in this document
    for a period of at [least three years]{.mark} after the final test
    report is issued. It is also recommended that the document include a
    clause stating that the test report is not to be reproduced except
    in full without written approval of the laboratory.

    Each report shall include at least the following information:

    a\. title, e.g., "Test Report", or "Report of Results" or
    "Laboratory Results";

    b\. name and address of laboratory, location where the analysis was
    carried out, if different from the address of the laboratory, and
    name and phone number of contact person for questions;

    c\. unique identification of the report (such as serial number) and
    of each page, the total number of pages, and a clear identification
    of the end of the report;

    d\. name and address of customer, where appropriate, and project
    name if applicable;

    e\. description, condition, and clear identification of the analyzed
    samples;

    f\. date of receipt of the sample(s);

    g\. identification of the validated analytical method used and of
    any significant modifications made to the method;

    h\. any deviations from, additions to, or exclusions from the
    analytical method, and any other information relevant to a specific
    analytical method, such as environmental conditions including the
    use of relevant data qualifiers;

    i\. identification of the standard(s) or specification(s) relevant
    to the test (when required by customer);

    j\. where necessary, a statement of compliance/non compliance with
    requirements and/or specifications;

    k\. analytical test results, supported by tables, graphs, sketches,
    and photographs as appropriate, with units of measurement; and any
    failures identified; and identification of the quantitation limit
    and reporting units (such as mg/kg with identification of whether
    data is calculated on a dry weight or wet weight basis);

    l\. a signature and title, or an equivalent identification, of the
    person(s) accepting responsibility on behalf of the laboratory for
    the content of the report (however produced), and date of issue;

    m\. where relevant, a statement to the effect that the results
    relate only to the items analyzed;

    n\. where appropriate and needed, opinions and interpretations
    including [synopsis of analytical quality control results focusing
    on any quality control sample measurements that did not meet the
    method specified requirements;]{.mark}

    o\. reference to sampling procedure, where relevant;

    p\. statement on the estimated uncertainty of the measurement when
    the uncertainty affects reported lead result or is required by the
    customer.

    q\. the significant figures reported for each value, if values are
    reported, shall correctly represent the estimated precision of the
    measurement;

    In addition to the requirements listed above, test reports
    containing the results of sampling shall include the following, if
    available:

    a\. the date of sampling;

    b\. location(s) of sampling, including any relevant diagrams,
    sketches, or photographs;

    c\. reference to the specific sampling plan used;

    d\. detailed environmental conditions present during sampling that
    may affect the interpretation of the test results;

    e\. identification of the sampling method or procedure used;

    f\. protocols or specifications used for the sampling methods or
    procedures, as well as any deviations from, additions to, or
    exclusions from the specification concerned.

    []{.mark}

    **[5.10.2.1 Reporting Results Below the Quantitation Limit]{.mark}**

    []{.mark}

    [Report of zero concentration is not permitted. Laboratories shall
    establish a method of limiting the lower reported values to a
    positive finite lead level that is appropriate for the technology
    being used. Measured lead levels below this positive finite value
    shall be reported with a qualifier "less than" ("\<") this positive
    finite value.]{.mark}

    []{.mark}

    [For pass-fail technologies, clear statement]{.mark} of measurement
    capability with associated uncertainty [shall be reported to the
    customer.]{.mark}

    **5.10.2.2 Opinions and Interpretations**

    When opinions and interpretations are included in the test report,
    the laboratory shall be able to show that it has documented the
    basis upon which the opinions and interpretations have been made.
    Examples of opinions and interpretations that might be included in a
    test report are recommendations on how to use results, guidance for
    improvement, and conformity of results with requirements.

    **5.10.3 [REPORT REVIEW AND APPROVAL PROCESS]{.underline}**

    All final test reports shall undergo the documented data review
    process before release to the customer. If a qualified person who
    was not involved in the physical preparation or analysis of samples
    in question is available to review the final report, than that
    person shall conduct the review. Qualified persons can be
    technicians, analysts, the quality manager, or technical manager, or
    the responsible person described previously in Section 4.0.

    In the case of a one person laboratory, or where a qualified person
    is not available for the review, the following options may be
    followed to complete the review.

    Option 1. The review process may be conducted ~~under~~ using an SOP
    that is part of the laboratory\'s management system.

    Option 2. The review process may be contracted out if the SOP above
    is followed.

    The review process shall be documented and signed by the reviewer,
    and shall be retained on file with a copy of the final report for a
    minimum of three years.

    **[5.10.4 [TEST REPORT CORRECTION PROCESS]{.underline}]{.mark}**

    []{.mark}

    **[5.10.4.1 Corrections]{.mark} and Amendments to Test Reports**

    []{.mark}

    [If corrections or additions to a test report are made, they shall
    be documented and the report reissued as an amended report.]{.mark}

    []{.mark}

    Once a test report has been issued, material amendments shall be
    made only in the form of a further document or data transfer that is
    clearly identified as a supplement to the original. When issuance of
    a complete new report is warranted, it shall be uniquely identified
    and shall contain a reference to the original it replaces.

    **5.10.4.2 Test Results Obtained from Subcontractors**

    Test results obtained from subcontractors shall be clearly
    identified in the test report. The subcontracted laboratory or
    organization must be currently NLLAP recognized for the
    subcontracted test methods in question.

    **5.10.4.3 Electronic Transmission of Results**

    When transmitting test results via telex, facsimile, telephone, or
    other electronic or electromagnetic means, the requirements in
    4.12.3 of this document must be met.

    **APPENDIX I**

    **ACRONYMS AND GLOSSARY OF TERMS**

    **ASSOCIATED WITH THE NLLAP**

    **Acronyms**

    ACS American Chemical Society

    AIHA American Industrial Hygiene Association

    ASTM American Society for Testing and Materials

    ANSI American National Standards Institute

    CCB Continuing Calibration Blank

    CCV Continuing Calibration Verification

    CDC Centers for Disease Control

    COC Chain of Custody

    ELPAT Environmental Lead Proficiency Analytical Testing (AIHA/NIOSH)

    EPA Environmental Protection Agency

    HUD Housing and Urban Development

    ICB Initial Calibration Blank

    ICV Independent Calibration Verification

    ICS Interference Check Standard

    ISO International Organization for Standardization

    ISO-IEC International Organization for Standardization and
    International Electrochemical Commission

    LCS Laboratory Control Sample

    MDL Method Detection Limit

    MOU Memorandum of Understanding

    MSM Management System Manual

    NIOSH National Institute for Occupational Safety and Health

    NIST National Institute of Standards and Technology

    NLLAP National Lead Laboratory Accreditation Program

    OPPT Office of Pollution Prevention and Toxics

    PE Performance Evaluation

    PT Proficiency Testing

    QA Quality Assurance

    QC Quality Control

    RE Relative Error

    RPD Relative Percent Difference

    SAP Sample Analysis Plan

    SI Systme International units of measurement

    SOP Standard Operating Procedure

    SRM Standard Reference Material Produced by NIST

    TSCA Toxic Substances Control Act

    **Glossary**

    Accreditation: A formal recognition that an organization (e.g.,
    laboratory) is competent to carry out specific tasks or specific
    types of analyses.

    Accredited laboratory: A laboratory that has been evaluated and
    given approval to perform a specified analysis or task, usually for
    a specific property or analyte and for a specified period of time.

    Acceptance limits: Data quality limits specified by the National
    Lead Laboratory Accreditation Program for analytical method
    performance.

    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.
    See [Precision]{.underline} and [Bias]{.underline}.

    Aliquot: See [Subsample]{.underline}.

    Batch: A quantity of material produced or processed (in example,
    homogenized, digested and analyzed) in one operation, considered to
    be a uniform, discrete unit.

    Bias: The systematic error manifested as a consistent positive or
    negative deviation from the known true value.

    Blind sample: A subsample submitted for analysis with a composition
    and identity known to the submitter but unknown to the analyst and
    used to test the analyst\'s or laboratory\'s proficiency in the
    execution of the measurement process.

    Calibrate: To determine, by measurement or comparison with a
    standard, the correct value of each scale reading on a meter or
    other device, or the correct value for each setting of a control
    knob. The levels of the calibration standards should bracket the
    range of planned measurements. See [Calibration curve]{.underline}.

    Calibration blank: See [Initial calibration blank]{.underline}.

    Calibration-check: See [Calibration verification]{.underline}.

    Calibration-check

    standard: See [Calibration verification]{.underline}.

    Calibration curve: The graphical relationship between the known
    values for a series of calibration standards and instrument
    responses.

    Calibration drift: The difference between the instrument response
    and a reference value after a period of operation without
    recalibration. See [Continuing calibration
    verification]{.underline}.

    Calibration standard: A substance or reference material used to
    calibrate an instrument.

    Calibration solution: See [Calibration standard.]{.underline}

    Calibration

    verification: See [Initial or continuing calibration
    verification]{.underline}.

    Certified Reference

    Material: A reference material that has one or more of its property
    values established by a technically valid procedure and is
    accompanied by or traceable to a certificate or other documentation
    issued by a certifying body. See [Certification]{.underline} and
    [Reference material]{.underline}.

    Chain of custody (COC): An unbroken trail of accountability that
    insures the physical security of samples, data, and records.

    Check sample: An uncontaminated sample matrix spiked with known
    amounts of analytes, usually from the same source as the calibration
    standards. It is generally used to establish the stability of the
    analytical system, but may also be used to assess the performance of
    all or a portion of the measurement system. See also [Quality
    control sample.]{.underline}

Composite sample: A sample composed as a result of collection of more
than one sample of the same medium (e.g., dust) from the same type of
surface (e.g., floor, interior window sill, or window trough) so that
multiple samples can be analyzed as a single sample.

Continuing Calibration

Blank (CCB): A standard solution which has no analyte and is used to
verify blank response and freedom from carryover. The CCB should be
analyzed after the CCV and after the Interference Check Standard (ICS).

Continuing Calibration

Verification (CCV): A standard solution (or set of solutions) used to
verify freedom of excessive instrumental drift. The concentration to be
near mid-range of linear curve. The CCV should be matrix matched to acid
content present in sample digestates. The CCV should be analyzed before
and after all sample digests.

Control chart: A graph of some measurement plotted over time or sequence
of sampling, together with control limit(s) and, usually, a central line
and warning limit(s).

Control sample: See [Laboratory control sample]{.underline}.

Corrective action: Action taken to correct a deficiency noted in a
technical systems audit. See [Deficiency]{.underline} and [Systems
audit.]{.underline}

Deficiency: A failure to fully comply with the requirements of NLLAP
usually noted during a technical systems audit. See [NLLAP]{.underline}
and [Systems audit.]{.underline}

ELPAT: Environmental Lead Proficiency Analytical Testing Program.
Successful participation in this proficiency testing program on a
semi-annual basis is required for all EPA/NLLAP recognized laboratories.
ELPAT Program is administered by AIHA in cooperation with NIOSH and EPA.

Initial calibration

blank (ICB): A standard solution that contains no analyte and is used
for initial calibration and zeroing instrument response. The ICB must be
matrix matched to acid content present in sample digestates. The ICB
should be measured during calibration and after calibration.

Independent calibration

verification (ICV): A standard solution (or set of solutions) used to
verify calibration standard levels. Concentration of analyte to be near
mid-range of the calibration curve which is made from a stock solution
having a different manufacturer or manufacturer lot identification than
the calibration standards. The ICV must be matrix matched to acid
content present in sample digestates. The ICV should be measured after
calibration and before measuring any sample digestates.

Instrument: An instrument which produces a quantitative (numerical
result) performs a measurement of lead that can be quantified
numerically or an Number range CHAPTERinstrument (or equivalent) which
produces qualitative (pass-fail) result performs a measurement that
indicates the absence or presence of lead relative to a given threshold
level.

Interference check

standard (ICS): A standard solution (or set of solutions) used to verify
accurate analyte response in the presence of possible interferences from
other analytes present in samples. The ICS must be matrix matched to the
reagent content present in sample digestates.

Internal quality

control: The routine activities and checks, such as periodic
calibrations, duplicate analyses, and spiked samples, that are included
in normal internal procedures to control the accuracy and precision of
measurements.

Internal standard: A standard added to a test portion of a sample in a
known amount and carried through the entire demonstration procedure as a
reference for calibration and controlling the precision and bias of the
applied analytical method.

Laboratory: Any operation that performs quantitative and/or qualitative
analytical testing of paint chip (film), dust, and/or soil samples for
lead analysis regardless of the number of personnel or the extent of the
scope of testing activities.

Laboratory control

sample (LCS): A matrix-based reference material with an established
concentration obtained from a source independent of the instrument
calibration and traceable to NIST or other reference materials. The LCS
is carried through the entire procedure from digestion through analysis
as a field sample. The purpose of the LCS is to evaluate bias of the
method.

Laboratory systems

audit: See [Systems audit]{.underline}.

Lot: A set of samples submitted together for laboratory analysis which
can be treated as one or more batches.

Matrix: The component or substrate which contains the analyte of
interest.

Matrix spike: See [Spiked sample]{.underline}.

Method blank: A mixture of all reagents used for the digestion of paint,
soil, or dust matrices but without the matrix. This blank, is carried
through all steps of the analysis starting with the digestion step. This
blank evaluates the process for contamination from the laboratory.

Method performance: A general term used to document the characteristics
of a method. These characteristics usually include method detection
limits, linearity, precision, accuracy and bias. The minimum acceptable
criteria for method performance characteristics are determined and/or
verified as part of method validation, method measurement uncertainty
determination and method performance demonstrations.

Method detection

limit (MDL): The minimum concentration of an analyte that, in a given
matrix and with a specific method, has a 99% probability of being
identified, qualitatively or quantitatively measured, and reported to be
greater than zero.

NLLAP: National Lead Laboratory Accreditation Program. This EPA program
recognizes laboratories which have demonstrated they are capable of
analyzing paint chip (film), dust and/or soil samples for lead.

NLLAP requirements: Requirements specified by the EPA National Lead
Laboratory Accreditation Program (NLLAP) in order to be accredited for
lead analysis in paint chip (film), dust, and/or soil matrices by an
EPA-recognized laboratory accreditation organization. (NLLAP
requirements are designed to be used for accreditation purposes and
should not be used for purpose of verification/validation of any
specific technology).

Precision (repeatability): The degree to which a set of observations or
measurements of the same property, usually obtained under similar
conditions, conform to themselves; a data quality indicator. Precision
is usually expressed as standard deviation, variance, or range, in
either absolute or relative terms.

Proficiency testing: A systematic program in which one or more
standardized samples is analyzed by one or more laboratories to
determine the capability of each participant.

Quality assurance (QA): 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 within a stated level of confidence.

Quality control (QC): 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. The aim is to provide quality that is
satisfactory, adequate, dependable, and economical.

Quality manager: The manager of the quality system. The quality manager
is independent of the analyst and reports directly to management.

Quantitation Limits: The maximum or minimum levels or quantities of a
target analyte that can be quantified to a specified accuracy.

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 assigning
values to materials.

Reference standard: See [Calibration standard]{.underline}.

Relative percent

difference: A term defined as:

where \| R~1~  R~2~ \| represents the absolute difference in two values
and R represents the average of the two values.

Run: A set of consecutive sample measurements.

Sample log: The document where sample identification, condition, etc is
noted when samples arrive at the laboratory. The log is part of the
sample tracking system. See [Sample tracking.]{.underline}

Sample tracking: A system of following a sample from receipt at the
laboratory, through sample processing and analysis, and to final
reporting. The system includes unique numbering or bar coding labels and
the use of a sample log.

Site inspection/assessment: An on-site visit to a laboratory for the
purpose of conducting a systems audit.

Spiked 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. Spiked samples
are used, for example, to determine the effect of the matrix on a
method\'s recovery efficiency.

Split samples: Two or more representative portions taken from a sample
or subsample and analyzed by different analysts or laboratories. Split
samples are used to replicate the measurement of the variable(s) of
interest.

Standard operating

procedure (SOP): A written document that 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.

Standard reference

material (SRM): A certified reference material produced by the U.S.
National Institute of Standards and Technology and characterized for
absolute content independent of analytical method.

Standardization: The process of establishing the quantitative
relationship between a known mass of target material (e.g.,
concentration) and the response variable (e.g., the measurement system
or instrument response). See [Calibrate]{.underline} and [Calibration
curve]{.underline}.

Stock solution: A concentrated solution of analyte(s) or reagent(s)
prepared and verified by prescribed procedure(s), and used for preparing
working standards or standard solutions.

Subsample: A representative portion of a sample.

Systems audit: A thorough systematic on-site, qualitative review of
facilities, equipment, personnel, training, procedures, record keeping,
data validation, data management, and reporting aspects of a total
measurement system.

Traceability: An established property of the result of a measurement, to
stated references (usually national or international standards) at a
stated level of uncertainty through an unbroken chain of comparisons.

Validation: The process of substantiating specified performance
criteria.