In Reply Refer To:
Mail Stop 412
November 14, 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for laboratory evaluation, documented in the Office of Water Quality (OWQ) Technical Memoranda 98.03R, and 2002.05 are superseded by this OWQ Technical Memorandum 2007.01.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 /s/
Chief, Office of Water Quality
This memorandum supersedes Office of Water Quality Technical Memoranda 98.03R, and 2002.05.
Distribution: All WRD Employees
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.
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.
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:
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:
The revised Laboratory Evaluation Policy (LEP) requires training material, a modified database, 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
Initial sample media and analytical services:
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
National Water Quality Laboratory (NWQL):
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:
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:
Web site for the Laboratory Evaluation Policy
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.
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.
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
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
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.
The general plan for the database content is:
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.
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.
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.
Timothy L. Miller, Chief, Office of Water Quality
U.S. Geological Survey
412 National Center
Reston, VA 20192