In Reply Refer To:\
Mail Stop 412 November 20, 2006

**Office of Water Quality Technical Memorandum 2007.01**

Subject: Policy for the Evaluation and Approval of Analytical
Laboratories

The U.S. Geological Survey (USGS) Water Resources Discipline (WRD) has
had a long-standing policy that analytical laboratories providing
chemical, radiochemical and biological analyses to WRD shall be
evaluated, approved and regularly reviewed. The most recent process for
laboratory evaluation, documented in the Office of Water Quality (OWQ)
Technical Memoranda 98.03R, and 2002.05 are superseded by this OWQ
Technical Memorandum 2007.01. This new laboratory evaluation policy and
process was developed to address deficiencies with the implementation of
98.03R that made the previous policy ineffective.

The 98.03R policy provided for a broad national approval of laboratories
using:

\(1\) laboratory quality-assurance plans and standard operating
procedures as evidence that the reviewed laboratory had a quality
system, and (2) a small number (maximum two per year) of blind sample
results to compare performance of the laboratory under review to the
performance of other laboratories. Laboratories were approved for
specified constituents and available for use by any project requiring
those constituents, and they were re-evaluated every three years.

The new policy: (1) is project based, assessing a laboratory's
capability to meet specific project needs (as defined by project
specific data quality objectives), (2) includes a performance-based
laboratory evaluation process using samples specific to the project
design, (3) makes it the responsibility of project management to prepare
and implement a laboratory evaluation plan that includes submitting
quality-control (QC) samples to the laboratory over the life of the
project and re-evaluating performance regularly, and\
(4) makes it the responsibility of the Water Science Center (WSC)
Director or in some cases National Program managers to approve the
laboratory evaluation plan for each project and assure that it is
implemented throughout the project term. The new policy requires more
participation from the WSC project personnel than the previous policy;
however, the emphasis now is on maintaining data quality required to
achieve project objectives. This new policy requires cooperation of the
laboratory manager. To assist in this process, the Branch of Quality
Systems (BQS) will develop and maintain a database of laboratory
information and performance data, and will provide advice and assistance
in developing and implementing the laboratory evaluation plan.

The new policy pertains to all laboratories, even when the analytical
method being used by a project does not yet have an approved analytical
method report. Projects being conducted as a formal part of analytical
methods development activities are exempted from the requirement of this
policy. However, projects being conducted as a formal part of analytical
methods development activities have specific requirements for QC data to
accompany each environmental dataset as defined in OWQ Technical
Memorandum 2004.01.

The two primary deficiencies corrected by this new policy are: (1)
general national approval, which was too generic to be useful at the
project level, is now changed to a project specific approach with
defined data quality objectives establishing a scientific defensible
approach, and (2) approval authority is designated at the level of work
with the highest knowledge of project needs and the ability to
demonstrate acceptable laboratory performance.

This policy and its procedures (Attachments 1-3) will take some time to
implement fully, but they begin in fiscal year (FY) 2007. Given the
large number of laboratories used by WSCs, implementation of this policy
will occur in a phased approach through FY 2008. By the beginning of FY
2009, all laboratories should be approved under this new policy, and OWQ
review of WSCs will include examination of laboratory approval packages.
Through FY 2007, projects may choose to have a laboratory approved or
re-approved using the procedures in 98.03R; however, they will have to
pay the cost of BQS staff time as described in 98.03R.

This OWQ Technical Memorandum includes three attached documents: (1) The
Laboratory Policy described in detail with phased implementation,
exemptions from the evaluation and approval process, and BQS
responsibilities; (2) The Process Description outlining the procedure
for evaluation, the procedure to follow for a new laboratory, or to
follow for a laboratory in the BQS database; and (3) A description of
the BQS database.

> Timothy L. Miller\
> Chief, Office of Water Quality

This memorandum supersedes Office of Water Quality Technical Memoranda
98.03R, and 2002.05.

Distribution: All WRD Employees

Attachments (3)

### Attachment 1---Laboratory Evaluation Policy

Analytical laboratories that provide chemical, radiochemical, and
biological analyses to the Water Resources Discipline (WRD) must be
evaluated relative to the objectives of a project requiring analyses and
approved for use for that specific project. Performance samples provide
the basis for the initial laboratory approval and the approved
laboratory must continue to provide performance sample results during
the life of the project.

### Process Overview

The decision to select and use a laboratory for analyses of
environmental samples for a project is based on the project objectives
(data quality objectives) and the performance of the laboratory relative
to those objectives. Authority and responsibility for the decision to
use a laboratory rest with the Water Science Center (WSC) Director, or a
WRD National Program Manager. The Branch of Quality Systems (BQS) can
provide assistance in gathering information and evaluating
quality-assurance (QA) data as an advisor to the project.

Project objectives should be defined minimally in terms of the analytes
of interest and the expected environmental concentration range for each
analyte. To initially select a laboratory, project data quality
objectives are compared to defined performance (detection levels and
estimated bias and variability) of the analytical methods used by the
laboratory. The initial step should ensure that the methods available
from a laboratory provide appropriate results for the project.

Performance data from a laboratory are required to demonstrate that the
laboratory can achieve the performance that has been defined for the
analytical services the project requires. Performance data are generally
the analytical results from blind samples (concentrations unknown to the
analyst). Two phases of performance data are required from the
laboratory. Initial performance data are required to show that the
laboratory can do what they have said they can do, before any
environmental samples are submitted to the laboratory. The initial data
are part of the package of information needed to support the selection
of a laboratory for a project. Ongoing performance data are required to
show that a laboratory continues to meet their performance criteria
during the life of the project.

The project chief has the responsibility for collecting the information
and data required for selection of a laboratory to provide analytical
results to the project. The selection package must be reviewed by at
least two individuals independent from the project before it is
submitted to the WSC Director (or appropriate National Program Manager)
for approval. The WSC Director will either concur or disagree with the
project chief's recommendation to use the laboratory after reviewing the
selection package and the reviewer comments. Once the WSC Director
concurs with the selection of a laboratory, then the laboratory may be
used to analyze environmental samples for the project. Following
approval by the WSC Director, the Laboratory Evaluation Package should
be kept on file in the WSC, and a copy provided to the Regional
Water-Quality Specialist. The detailed steps for preparing a laboratory
selection package and the information and data required are documented
in Attachment 2.

The goal of this process is to ensure that a laboratory provides data
that meet the project needs. It is not a laboratory approval process
that sanctions an entire laboratory for multiple uses, which is a very
different and more complicated process. Accreditation by the National
Environmental Laboratory Accreditation Program (NELAP) was accepted as a
substitute for the previous laboratory evaluation process (OWQ Technical
Memorandum 2002.05); however, NELAP accreditation cannot be a substitute
for this new process, because the NELAP accreditation does not
incorporate project specific data requirements. Selection of a
laboratory for one project does not mean that it can automatically be
selected for another separate project, although every effort should be
made to share information and data with multiple projects that use the
same laboratory. The key for laboratory use is a match between project
specific data quality objectives and laboratory performance addressing
those project objectives. A national database will be maintained by the
BQS to facilitate sharing of information and data, as well as providing
periodic reviews of the ongoing laboratory performance for each project.
The BQS database is described in more detail in Attachment 3.

### Phased Implementation

There will be a phased implementation of this policy to ensure that it
is implemented effectively. Fiscal year (FY) 2007 will be a transition
year, and all laboratories should be approved by the end of FY 2008.
Beginning in FY 2009, WSC review by the OWQ will include examination of
laboratory approval packages.

[Transition from the existing procedure to the new
procedure:]{.underline}

The procedures supporting this policy and described in the attachments
will continue to develop during FY 2007. Projects that choose to use the
new procedures can have assistance from BQS, because these first
projects will be test cases to help build the laboratory database,
software and training material. Through FY 2007, projects may choose to
have a laboratory approved or re-approved using the procedures in OWQ
Technical Memorandum 98.03R, but they will have to fund the cost of BQS
staff time as described in 98.03R.

[Development of tools:]{.underline}

The revised Laboratory Evaluation Policy (LEP) requires training
material, a modified
[database](http://bqs.usgs.gov/lep/pdt/database_example.xls), and
software to produce useful reports for projects. The training material
needs to be available, and the database and software needs to support
the basic functionality of data entry and storage, before the new
procedure is fully capable of meeting the needs of WRD. These activities
will proceed through FY 2007 and into\
FY 2008.

[Initial sample media and analytical services:]{.underline}

Although water chemistry is the most prominent analytical work that the
LEP addresses, the procedures also fit other types of media (i.e.,
sediment, microbiological, tissue, etc.), and analyses (i.e., radchem
and taxonomy, etc.) as well. The initial implementation of the LEP
should focus on the water chemistry analytical services. Other matrices
and analytical work should be added in later implementation during\
FY 2008.

[National Water Quality Laboratory (NWQL):]{.underline}

The initial phase of the LEP does not require approval for projects
using the NWQL, because abundant QA information is available through the
BQS blind sample projects. The NWQL will need time to establish some
automated procedures for providing method information in the project
worksheets, because the National Laboratory deals with so many different
projects. When processes are in place by the end of FY 2008, projects
that use NWQL are also required to evaluate the performance of NWQL
methods relative to their project data quality objectives. Until then,
project staffs are encouraged to apply the principles of this policy to
confirm that NWQL meets their project needs. Initial and ongoing NWQL
performance data can be accomplished largely with existing blind sample
programs in BQS. The data from these BQS programs are already available
to projects in WRD and can be used to evaluate performance.

### Exemptions from the Lab Evaluation Policy

The procedures described in this policy are not appropriate for some
projects that are designed around non-routine analytical work. The most
common type of non-routine analytical work is analytical method
development. Some characteristics of method development that make these
procedures inappropriate are:

-   There are no established measurement expectations that control the
    continuation of analyses (e.g., spike recoveries or calibration
    rules).

-   The process to analyze the sample is not predefined, nor limited to
    existing procedures.

-   The processes may be adapted during the analysis to improve data
    quality\
    (e.g. adjustments for matrix specific conditions).

-   The data cannot be compared directly to other data using the same
    generic methods because the data was subject to extra, undocumented,
    or novel procedures.

-   The data require explanation.

The procedures for evaluating the results from these types of projects
will be an inherent part of the project work plan.

### Branch of Quality Systems Responsibilities

The BQS LEP database will be a resource for data and information to
projects and programs that require the use of an analytical laboratory.
Below are some of the specific tasks that the BQS is responsible for:

-   Provide streamlined forms for collecting the appropriate laboratory
    QA information and data at the start of the approval process

-   Assist project staff in evaluating the laboratory information they
    have obtained

-   Assist project staff in locating appropriate performance test
    samples

-   Provide a national repository for the project laboratory evaluation
    and performance data

-   Provide periodic summaries of the laboratory performance data
    relative to project data quality objectives

-   Provide summaries of the performance data from any laboratory
    already in use by WRD to any project that may want to use the same
    laboratory

-   Provide training material for the laboratory selection and
    evaluation procedures

### Web site for the Laboratory Evaluation Policy

<http://bqs.usgs.gov/lep/index.html>

### Attachment 2 -- Process Description

The procedures for selecting and using an analytical laboratory are
described below. There are two phases to evaluation of a laboratory, an
initial phase for selecting a laboratory and an ongoing phase for
continuing to use a laboratory.

[Initial Assessment]{.underline}

Selecting a laboratory is the first phase of the process and requires a
project compare the project analytical needs to the analytical
capabilities of the laboratory. The data and information collected as
part of this initial assessment of the laboratory needs to be documented
and reviewed and the Water Science Center (WSC) or National Program
management must approve the selection of the laboratory, before the
laboratory can be used for analysis of environmental samples.

[Ongoing Assessment]{.underline}

The continued performance of a laboratory during the life of a project
is critical to project success. A laboratory that is providing
analytical results to a project is required to provide performance data
to demonstrate that they continue to meet the project performance
criteria.

The project staff is responsible for obtaining the data and information
from a laboratory. The data and information should be entered in the
Branch of Quality Systems (BQS) database electronically (see Attachment
3).

### Procedure for a single project using a new laboratory

1.  Collect and document the project data quality requirements and
    laboratory information in the Project Worksheet provided by the BQS
    for the Laboratory Evaluation Policy (LEP):

    a.  Project requirements for the analytical results:

-   List of the analytes

-   The range of concentrations expected for each analyte

-   The matrix and any comments to the laboratory regarding special
    handling or warnings of possible hazards.

-   The analytical method, if a specific method is required by the
    project.

    a.  Method performance information from the laboratory:

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-   The method identification number

-   The analytes included in the method

-   The lab method detection level for each analyte

-   The lab reporting level for each analyte

-   The concentration range for each analyte

-   The laboratory estimates for bias and variability for each analyte

2.  Obtain quality-control (QC) data that provides an initial
    demonstration of capability for the laboratory in order of
    decreasing information provided:

    a.  Obtaining double-blind known sample results

    b.  Obtaining single-blind known sample results

> The samples and results used for this demonstration of capability must
> be representative of the expected analytes and concentrations of the
> project.
>
> Reference material for some new or specialized methods may be
> difficult to find. BQS or the analysts running the method may be able
> to assist the projects in locating reference material. If appropriate
> reference material cannot be found, then BQS can help design a special
> case approach.

3.  Evaluate the lab capabilities in relation to project objectives: The
    information and data collected at this point should be sufficient
    for an initial assessment of how well the project objectives can be
    met by the laboratory. The information and data collected should be
    entered into the LEP database and some reports generated to identify
    any potential mismatches. If the objectives and capability match
    well, then proceed with the Laboratory Selection Package described
    in step 4 below. If the laboratory and project do not appear to be a
    good match or there are some concerns, the project should try to
    resolve the questions at this point. The project or program staff
    can seek advice about their concerns from the WSC water-quality
    specialists, other experts in an office, the Regional Water-Quality
    Specialists or the BQS. Some negotiation with the laboratory may be
    possible to resolve existing differences or concerns. If the
    laboratory and the project are not a good match and the differences
    cannot be resolved, the project should look for a different
    laboratory to provide analytical results.

4.  Prepare a Laboratory Selection Package to include:

    a.  Project information: Describe the project, the type of
        analytical services needed, including the data quality
        objectives, how frequently the samples will be submitted, when
        sample collection will begin and the expected timeframe that the
        analytical services will be needed.

    b.  Laboratory information: Name, address, contact and phone number
        of the laboratory and references to publications that describe
        the method(s) that have been selected.

    c.  Project Worksheet completed through the initial demonstration of
        capability.

    d.  Results of the Initial demonstration of capability: briefly
        describe the results of the initial demonstration of capability;
        does the capability of the laboratory meet expectations?

    e.  Plan for testing ongoing capability: define the sample types and
        frequency for the performance testing that will be conducted
        during the life of the project.

    f.  Data management plan: define how data will be obtained from the
        laboratory, and where the data from the laboratory will be
        stored. Include parameter codes that will be used and any other
        metadata or codes that will be stored with the data.

    g.  Recommendation from the project staff to use the laboratory.

5.  Submit the Laboratory Selection Package for review. The package
    should be reviewed by at least two people who are independent of the
    project. The reviewers may be a WSC water-quality specialist, a
    Regional Water-Quality Specialist, the BQS LEP support staff, a
    chemist from a different laboratory, a research chemist, or other
    selected peer reviewer that has some knowledge of the analytical
    needs of the project. The project staff will address any questions
    or concerns from the reviewers.

6.  Submit the Laboratory Selection Package to the WSC Director or
    National Program manager: The Laboratory Selection Package,
    including the reviews and responses, should be submitted for
    management approval and signature concurring with the project staff
    that the laboratory can be used for the project. The approved
    Laboratory Selection Package should be kept on file in the WSC or
    National Program office, and a copy should be sent to the
    corresponding Regional Water-Quality Specialist.

7.  Obtain QC data to assess the laboratory performance during the life
    of the project: Reference material submitted as a double-blind or
    single-blind sample will be used to provide measures of the
    laboratory's analytical performance over time for the project. The
    project staff should regularly submit QC samples, arrange for QC
    samples to be submitted, or obtain existing QC data for the
    laboratory's ongoing demonstration of capability. The performance
    samples should be representative of the project samples, cover the
    timeframe of the project and be submitted frequently enough to
    provide confidence that the laboratory continues to provide adequate
    data for the project. The data should be provided to BQS as soon as
    possible to add to the LEP national database.

8.  Review the laboratory performance at least biannually and probably
    more frequently. BQS will provide the project staff with a
    Laboratory Evaluation Package with charts and data summaries from
    data in the BQS national laboratory information database. The data
    can be compared against the initially documented laboratory limits
    and the project data requirements. An example for when the
    laboratory performance might be re-evaluated is during project
    reviews.

### Procedure for a project using a laboratory with existing data in BQS

A project that is planning to use a laboratory that other projects have
already used may be able to obtain information about the laboratory
methods and performance data from the BQS database. The information in
the database needs to be about the same method from the same laboratory
and the information needs to be relatively recent to use this source
instead of getting new information from the laboratory. The performance
data needs to be representative of the new project concentration range
to be useful. Retrieving the information from this database will shorten
the process for the project, save the laboratory significant time and
save money if the performance data can be used.

### Procedure for a national or regional program using a laboratory

A national or regional program or many projects from separate WSCs that
are seeking to use a laboratory for national or regional objectives, may
work with a single Laboratory Selection Package and the data from common
performance samples. The project data quality objectives and the
performance data need to encompass the range of analytical needs of all
the sites and environmental conditions expected.

### Attachment 3 -- Branch of Quality Systems (BQS) Data Base

### Purpose

To support a national laboratory evaluation policy, BQS maintains a
database to collect and store laboratory performance data submitted
through the BQS website. The database needs to serve two distinct
functions. First, the database houses initial and ongoing
method-specific performance data for selected laboratories and provides
laboratory performance reports to the projects. Second, the database
serves as the "yellow pages" for new projects looking for a laboratory
with specific methodology, quality features, or specific locales. In
some cases, projects may find some efficiency in choosing laboratories
already in the database because some of the data collection work is
already done. The database functionality, platform, and output will
continue to be a work in progress through, at least, FY 2007.

### Information content

The general plan for the database content is:

-   Project identification, analytes required and expected ranges

-   Laboratory identification, method identification, and expected
    analyte performance

-   Laboratory/method/analyte specific blind quality-control (QC) data.

Web based worksheets and batch file capabilities will be available for
uploading the Water Science Center project data quality objectives
(analytes, range, data needs) and the laboratory information and QC
data.

### Planned output

There are several obvious uses for the collected data. First, these data
can be used to compare laboratory-stated capability to actual
performance as part of the initial laboratory selection process. A data
summary can be provided for projects just beginning the selection
process that alerts the project when there are mismatches between
project data quality objectives and laboratory capability or
performance.

Second, selected laboratories require on-going review to assure
long-term project consistency and quality of project data. The BQS can
provide the projects with periodic data summaries of on-going
performance. The details of the report are being developed, and will
include analyte specific bias and variability analysis.

Third, existing data from selected laboratories can be reviewed by new
projects looking for laboratories with specific capabilities.

There will be a user interface, located on the BQS website, where USGS
personnel can query the database for their own interest in laboratory
performance. Links to pertinent information such as the Standard
Reference Sample data, the National Environmental Monitoring Index
(NEMI), BQS inorganic blind sample data or organic blind sample data for
the National Water Quality Laboratory for comparison, will be included.

### Phased implementation

During fiscal year 2007, the focus is on developing the database, the
web-based input forms, and assuring that the appropriate data are being
collected based on pilot project feedback.

After the basic structure is built, the focus will be on database
output. The summary reports assessing initial and ongoing performance
should be the first tasks. Feedback from projects as to what types of
reports and what kinds of data are useful will be used to develop the
BQS database output.

As the scope of laboratory selection expands into other analytical
types\
(e.g., radiochemistry or taxonomy), the database and the input /output
will be expanded and modified to accommodate the needs of different
analysis types.