WMA 2020.05: Procedure for the Approval of Analytical Methods Used by Water Mission Area (WMA) Laboratories and WMA-Funded Activities, and Implications for Data Release

Distribution:    GS-W All

From:  Donald W. Cline - Associate Director for Water

WATER MISSION AREA MEMORANDUM 2020.05 - TECHNICAL PROCEDURE

Subject: Procedure for the Approval of Analytical Methods Used by Water Mission Area (WMA) Laboratories and WMA-Funded Activities, and Implications for Data Release

Purpose: This technical procedure supports Water Mission Area Memorandum 2020.04 - Technical Policy (WMA 2020.04) [link or image removed], Approval of Analytical Methods for Use by Water Mission Area (WMA) Laboratories and WMA-Funded Activities. This procedure and the companion policy provide requirements for the validation and publication of analytical methods, which upon completion constitute method “approval.” Satisfying these requirements ensures that analytical methods used by WMA laboratories or for WMA-funded activities are validated, documented, and available to the public, so that the data produced by using those methods can be of known and documented quality. This procedure also addresses the approval of modifications to established methods and provides best practices for documenting the status of analytical methods linked to data available via the National Water Information System (NWIS).

Definitions

Analytical methods include laboratory processes that ultimately result in recorded data, including standard and non-standard methods (i.e., custom or experimental procedures).

Approved methods are processes, procedures, and analyses that have been validated and published by the USGS in accordance with FSP and Mission Area requirements, or that have been validated and published by non-USGS entities with similar or more stringent requirements, and therefore can be used to produce data of known and documented quality. The WMA recognizes two levels of approval: (1) full approval for standard methods, and (2) limited approval for non-standard methods.

Full approval for standard methods pertains to analytical methods that are widely used for WMA programs or large numbers of projects, thus affecting large numbers of results. A method with full approval from the WMA is expected to perform consistently when used in a “production” capacity across many projects. Full approval includes review and approval by the Director of the Laboratory and Analytical Services Division (LASD) (or designee).

Limited approval for non-standard methods pertains to analytical methods operated for a limited set of matrixes or projects. A method with limited approval is expected to have performed satisfactorily for its intended use (unless exceptions are noted), as described in validation documentation and publications. Limited approval is accomplished through the supervisory lines of authority for the laboratory using the method and the internal customer publishing the resulting data by verifying that (1) the method is appropriate for the intended use and (2) the method and validation data have undergone robust peer review and are published prior to, or concurrently with, the approval and public release of the resulting data.

Modifications include all changes that could potentially substantively change the performance of the method, even if subsequent testing shows that no substantive change in performance occurred (i.e., comparability across the change).

Non-Standard Method is a laboratory method that does not meet the criteria for standard methods; includes a modification of a standard method (used outside the intended scope or context) or a method published in a peer-reviewed outlet (including journal articles) that contains limited validation information pertaining to a particular use or context.

Standard Method is a laboratory method that has been published by international, regional, or national standards-writing bodies, by a reputable technical organization, or in a peer-reviewed publication accompanied by full validation information. Standard methods published after the 2009 President’s Memorandum on Transparency and Open Government [link or image removed] include full validation data documenting a range of performance characteristics.

 Background: Analytical methods are subject to policies in the Fundamental Science Practices (FSP [link or image removed]), including the Quality Management System (QMS) for USGS Laboratories (IM OSQI 2018-01 [link or image removed]). Approval of analytical methods used by WMA laboratories and WMA-funded activities is described in WMA 2020.04 [link or image removed], which can be met through this procedure. These WMA requirements are an extension of, and do not supersede, the FSP requirements. This procedure clarifies the responsibilities regarding approval of analytical methods and implications for data release. Laboratory activities that do not result in data delivered to the public are excluded from this requirement for WMA method approval (although other requirements may apply).

WMA 2020.04 [link or image removed] replaces Office of Water Quality Technical Memorandum 2004.01 [link or image removed] (OWQ 2004.01). Through this policy, the WMA recognizes two levels of approval: (1) full approval for standard methods, and (2) limited approval for non-standard methods. The policy and companion procedure were written to reflect the current organization of the WMA, more clearly align with FSP and QMS, and provide pathways for full approval and limited approval through publication in outlets not addressed in OWQ 2004.01 [link or image removed]. This procedure also addresses best practices for documenting the status of analytical methods used to produce data stored in NWIS.

For background, current and past policies regarding the approval of analytical methods and implications for discrete data are listed in Table 1 at the end of this document.

Procedures for Approval of Analytical Methods for use in WMA Activities: Method approval within WMA has requirements for validation and publication. USGS FSPs (SM 502.2 [link or image removed]) specify that data collection and research activities are carried out in a consistent, objective, and replicable manner that is vetted through a vigorous and open process of peer review to ensure that the best possible results are achieved (SM 502.3 [link or image removed]). Therefore, validation and publication occur within a framework of robust peer review.

1. Validation: Validation includes ensuring that the method has been tested and found appropriate for the intended use(s) and applicable matrices. Performance characteristics to be validated may include the following:

• • accuracy,
  • bias,
  • interferences,
  • limits of detection and (or) quantitation,
  • linearity,
  • precision or variability,
  • repeatability,
  • reproducibility,
  • robustness (ruggedness),
  • sensitivity,
  • selectivity (specificity),
  • reporting range,
  • stability of reagents and standards,
  • sample preservation,
  • sample storage, and
  • sample holding times.

Best practices for method validation vary depending on the type of analysis; however, general guidelines can be found in ASTM Standard E2857-11 (2016). Methods validated for the USGS National Water Quality Laboratory (NWQL) follow NWQL guidelines for method validation. Responsibilities for ensuring that the requirements for method validation have been met are shared by the laboratory offering the method and its users (i.e., customers):

Laboratory responsibilities for method validation:

User (customer) responsibilities for verifying method performance:

●  Ensure and document that the method has undergone testing for the range of concentrations, conditions, and matrices for which the method is to be offered. Methods to be used by the National Water Quality Laboratory (NWQL) are covered by the NWQL Guidelines for Method Validation. ●  If the method is experimental or validation has not been completed prior to use, inform the users of the potential risks and uncertainties, including data-quality issues. ●  Document that the method validation results have undergone appropriate peer review. At least one of the peer reviewers must be a technical expert from outside of the originating laboratory. The selection of peer reviewers is subject to approval by the management of the laboratory performing the validation. ●  Provide method documentation and results of quality-assurance testing to users (customers), to aid in their evaluations of the data. ●  Be responsive to user questions and concerns about method performance and suitability.

●  Work with the laboratory staff to evaluate the suitability of the method for the range of concentrations, conditions, and matrices in the samples to be analyzed. ●  Be aware of the risks of using methods that are experimental or for which testing has not been completed, including rejecting data that are invalid or of poor quality. ●  Verify that the analytical method has undergone appropriate peer review (e.g., have the method and its validation results been published in a reputable outlet?). ●  Request quality-assurance results and other relevant performance data necessary for evaluating the quality of the data produced by the laboratory. ●  Complete the laboratory evaluation process (LEP) described in OWQ TM 2014.01 [link or image removed] to ensure that the data are of adequate quality for the intended use(s), as defined by the user’s program needs. Contact the QSB Chief of Laboratory Evaluations or LASD Water-Quality Specialist for assistance, if needed.

2. Publication: Methods must be documented to describe the processes used and quality- assurance procedures applied (SM 502.2 [link or image removed]). When scientific reason justifies the use of alternative or experimental methods, the rationale for their use is clearly stated. Methods used for data-collection and research activities are published in information products that are easily accessed and available in a manner that enhances the scientific reputation of the Bureau and best serves the public (SM 1100.1 [link or image removed] and SM 1100.3 [link or image removed]), exclusive of information developed through Cooperative Research and Development or Technical Assistance Agreements that may be temporarily protected from dissemination (SM 500.20 [link or image removed]). If a separate method publication is not feasible, it is permissible to provide the method description and validation data within the method-user’s publication that presents the environmental data. A method may be used while it is still experimental or undergoing validation, as long as the documentation of processes used to produce the resulting data is published prior to (or concurrent with) the release of the resulting data to the public. Peer-review requirements are described in SM 502.3 [link or image removed]. Responsibilities for publication are as follows:

Laboratory responsibilities for publication:

User (customer) responsibilities for verifying publication:

●  Adhere to best practices in documenting methods, including maintaining laboratory notebooks and publishing methods in appropriate peer-reviewed outlets (e.g., reputable journals, USGS publications, or other agency reports, such as the U.S. Environmental Protection Agency [USEPA], American Society for Testing and Materials [ASTM], or American Public Health Association [APHA]). ●  If the method has not yet been published, inform users (customers) of the anticipated timing of publication so that the data are not released as “approved” before method approval. ●  Modifications to established methods can be documented by publishing the modifications and associated validation data, along with a citation of the base method, in any of the peer-reviewed outlets identified above, or in a peer-reviewed Science Base product or NWQL Technical Memorandum (for NWQL modifications). Some journals specialize in documenting modifications (e.g., MethodsX [Elsevier]). ●  If data are being provided to customers while a method is undergoing changes, ensure that the processes used and validation data for the interim data are documented and available for citation or inclusion in reports.

●  Verify that the method has been published in an appropriate peer-reviewed outlet (e.g., reputable journals, USGS publications, or other agency reports, such as the U.S. Environmental Protection Agency [USEPA], American Society for Testing and Materials [ASTM], or American Public Health Association [APHA]). ●  If the method has not yet been published, ask the laboratory about the anticipated timing of publication so that the data are not released as “approved” before the method is approved. ●  For modifications of established methods, cite the established method plus the document(s) describing the modifications and associated validation data. ●  If the laboratory has not yet published the modifications, the user can work with the laboratory to incorporate the method documentation into the user’s own publication that presents the results. The publication(s) used for release of the data should include a full description of the analytical method, the associated validation data, and appropriate crediting of the method information through co-authorship or citation.

Levels of Approval

Analytical methods used to generate data to be used for USGS studies shall undergo validation and publication; however, the extent of the validation and level of peer review for the resulting publication can be tailored to the scope, context, and intended use of the method. Laboratory analysts and users of a method are responsible for deciding which level of approval is appropriate, within a framework of robust peer review and management controls. The WMA recognizes two levels of approval, limited and full, described as follows:

Limited approval for non-standard use of a method (or modification of an established method) is accomplished upon meeting the responsibilities for validation and publication. Non-standard use implies that the method, as implemented, is unique to the context for which it was applied. Because limited approval is limited in scope to a specific context as defined by the resulting publications, it cannot be construed as approval for future projects of a different context. Subsequent non-standard uses of that method must independently meet the requirements for validation and publication. For non-standard methods (and modifications) that have been published, limited approval for subsequent uses can be established by citing the method (and modifications) and providing results of the validation and quality-control (QC) testing for the subsequent use. Repeated use of a method to the point that it is no longer non-standard warrants a fuller validation and “full approval.”

Full approval by the WMA for standard use of a method (or modification) is accomplished by meeting the responsibilities for validation and publication with two key differences: (1) the validation is performed for a wider range of matrices and operating conditions, for example, waters (or sediment or biota) from a variety of environmental settings (covering a full range of pH values, ionic strengths, particle sizes, groundwater and surface water from various depths, flow conditions, etc.), in anticipation of the range of samples to be analyzed, and (2) the method requires review and approval by the Director of the Laboratory and Analytical Services Division (LASD) or designee, typically prior to Bureau approval of the publication(s), to ensure that the method and its documentation are appropriate for WMA needs. Methods that receive full approval are to be published along with the validation data as stand-alone reports or in collections of related methods, typically as USGS Techniques and Methods or Scientific Investigations Reports, or as articles in journals that focus on analytical methods [e.g., Analytica Chimica Acta or Talanta (Elsevier), or Analyst (Royal Society of Chemistry)]. The Office of the LASD Director will maintain a list of methods that have full approval by the WMA.

A laboratory operating outside of the LASD may request full approval of an analytical method by providing the complete method description and validation results to the LASD Director (or designee) for WMA review and approval prior to Bureau approval of the method publication (or Center approval, if a delegation authority has been permitted). Laboratories seeking full approval of a new method are encouraged to seek technical input or review during the planning and validation stages to ensure that the scope and robustness of the validation are appropriate for standard use, so that any potential deficiencies are caught and addressed prior to the publication stage.

For modifications of methods, a description of the modifications and a set of validation data sufficient to document the performance of the modified method must be documented. Although it is still permissible to document a method modification in a new publication (as previously mandated by OWQ 2004.01), WMA 2020.04 [link or image removed] permits the use of additional peer-reviewed outlets, such as a section added to an method-user’s publication that presents the data, a peer-reviewed Science Base product, a methods section or supplemental information section in a journal article, or an NWQL Technical Memorandum. Customers (method users) would cite the original method and the modifications when reporting the resulting data.

The WMA also recognizes that laboratory work at the preliminary or experimental stages—that is, prior to the generation of data for use in USGS studies—can occur before a formal analytical method has been written. Such work, including the processes used and results obtained, shall be documented in a laboratory notebook (electronic or paper) or similar manner in compliance with QMS requirements. However, if data are then generated for dissemination to the public or use in USGS studies, the steps used to produce those data (e.g., the method) and associated validation data must be documented through one of the pathways for approval prior to (or concurrent with) dissemination of the data. The pathway for limited approval is context-specific and therefore is ideal for methods in development and experimental work. The context of the approval is an important consideration when determining whether the results can/should be published in NWIS.

Implications for Sample Data in the National Water Information System (NWIS) Data collectors in the WMA and Water Science Centers, are encouraged to store and publish data in NWIS, as stated in Office of Water Quality Technical Memorandum 2008.05 [link or image removed]. Data stored in NWIS-QWDATA and served to the public via NWISWeb do not have the same level of contextual information that is available in reports that provide a full description of the laboratory methods and results of validation and QC testing. Coding strategies and metadata fields must be used in NWIS to ensure that data are of known quality and documented methods. Metadata discussed in this memorandum include DQI codes, method codes, and comment fields:

Data-quality indicator (DQI) codes:  The DQI code, described in Office of Water Quality Technical Memorandum 2016.07 [link or image removed] and Office of Water Quality Technical Memorandum 2002.15 [link or image removed], is a result-level field used to designate the review status of the result and dissemination restrictions. Results may be designated for internal-only uses or as unrestricted to publish. This code controls the inclusion of the result in the default output from NWIS to the NWISWeb interface. Commonly used DQI codes include the following:

S:  Provisional. Visible to the public via NWISWeb

U:  Unapproved method or laboratory. Not visible to the public via NWISWeb

I:   Awaiting review. Not visible to the public via NWISWeb

R:  Reviewed and accepted. Visible to the public via NWISWeb

Q:  Reviewed and rejected. Not visible to the public via NWISWeb

The DQI code of “U” is to be used for data produced using analytical methods that are unapproved; these data are not visible to the public because the analytical method cannot be documented. “S” can be used for initial entry into NWIS of data produced using an approved method by a laboratory that performs internal QC checks and data review. Results initially coded as “U” can be re-coded by the laboratory as “S” following method approval, but only for those results that were covered by the version(s) of the method that was approved. “I” can be used by a laboratory or user (customer) for results that are withheld from public release pending additional review. Data affected by method performance issues are best presented within the context of a publication that explains the methods and any performance issues; it is permissible to store such data in NWIS-QWDATA, but such data should be suppressed from public release through use of DQI codes of “U” or “Q.” For data produced using an approved method (that is, with either limited or full approval), users (customers) review results as described in Office of Water Quality Technical Memorandum 2012.03 [link or image removed], including completion of the laboratory-evaluation process in Office of Water Quality Technical Memorandum 2014.01 [link or image removed]. Results for approved methods are re-coded by users as “R” (accepted) or “Q” (rejected) following review. Data initially coded as “U” can be recoded to “R” or “Q” without first using “S” as long as the method approval (validation and publication of the method) is accomplished prior to, or concurrent with, the public release of the data produced using that method.

Method codes:  Method codes are used to uniquely identify an analytical method in NWIS and provide a means to trace the method to its documentation. The FSPs [link or image removed] require that methods used for USGS projects be known and documented; therefore, method codes requested for new methods must be updated upon publication to include the reference citation(s) for the method. For laboratories external to the USGS that use proprietary methods, the laboratory must provide the method documentation for the user’s internal files as part of the USGS project records. Requests for new method codes or updates to existing codes can be emailed to GS-W NWIS Reference List Requests at gs-w_nwis_reference@usgs.gov [link or image removed].

Comment fields:  The sample-level laboratory comment database field and result-level laboratory comment database field can be accessed by the public via NWISWeb by selecting the “expanded attributes” and “one result per row” output options. Comments can be used to provide information not covered by the other metadata fields, including non-standard modifications to analytical methods when a permanent revision to the method code is not warranted. For example, a laboratory comment of “Analytical method modified as described in <<insert publication link or number>>” could be used to document modifications to an established method (one that has a method code) and corresponding validation data described in the publication. The use of citable references (publications, digital object identifiers, web links, etc.) in comment fields is encouraged. Data from methods that have been modified from established methods can be released to the public via NWISWeb if comment fields are used to document the modifications in this manner.

Applying this Procedure in WMA Laboratories: Table 2 (at the end of this document) provides a workflow for applying this procedure in WMA laboratories. The workflow varies depending on whether the activity is non-standard or standard and on whether the activity leads to the creation of a new method vs. the modification of an established method. These factors affect the preferred approaches for validation and publication, and the level of approval (limited vs. full). For questions or comments regarding this procedure, please contact the LASD Leadership team at gs-w_lasd_leadership@usgs.gov [link or image removed].

References

ASTM International, 2016, Standard Guide for Validating Analytical Methods: ASTM Standard E2857 - 11 (2016), West Conshohocken, PA, DOI: 10.1520/E2857-11R16. http://www.astm.org [link or image removed].

Office of Water Quality Technical Memorandum 2004.01, Revised Policy for the Approval of U.S. Geological Survey (USGS) Water-Quality Analytical Methods, accessed January 27, 2020, at https://water.usgs.gov/admin/memo/QW/qw04.01.html [link or image removed].

 

Attached resources:

• Table 1. Current and past policies on approval of analytical methods and implications for discrete data.
• Table 2. Workflow for applying the policy in Water Mission Area Laboratories for approval of non-standard and standard analytical methods or modifications of methods

Table 1.  Policies relevant to the approval of analytical methods and implications for discrete data. [Changes noted in red font. WMA, Water Mission Area; TM, technical memorandum; OGW, Office of Groundwater; OSW, Office of Surface Water; OWQ, Office of Water Quality]

Policy	Subject	Relevance to this memorandum
WMA 2020.04 [link or image removed]	Approval of Analytical Methods for Use by Water Mission Area (WMA) Laboratories and WMA-Funded Activities	The WMA policy that is supported by this procedure (WMA 2020.05 [link or image removed]) and that supersedes OWQ TM 2004.01.
USGS Instructional Memo No. OSQI 2018-01 [link or image removed]	Quality Management System for USGS Laboratories	Bureau-level policy for laboratory quality management system (QMS), supplemented by WMA 2020.04 [link or image removed].
OGW 2017.03 / OSW 2017.01 / OWQ 2017.07 [link or image removed]	Procedures for Processing, Approving, Publishing, and Auditing Time-Series Records for Water Data	WMA policy for approval of time-series (“continuous”) data, included because time-series data can have dependencies on the discrete data or overlapping workflows for approval and publication.
OWQ 2016.07 [link or image removed]	Revision of terminology for Data-Quality Indicator Codes in NWIS 5.2	WMA policy that describes new terminology for DQI codes used to indicate the quality and dissemination status of discrete results in NWIS-QWDATA.
OWQ 2014.01 [link or image removed]	Updated Policy for the Evaluation and Approval of Analytical Laboratory Performance for Water Mission Area Projects and Programs	WMA policy on user responsibilities for evaluating laboratory performance. Revised as follows: ●  Replace “Branch of Quality Systems” with “Quality Systems Branch” and replace BQS with QSB. ●  “The Water-Quality Specialist (or designee) in the WSC and a Water-Quality Specialist in the Laboratory and Analytical Services Division will review Level 2 laboratory evaluation packages…” ●  “...Level 2 evaluation packages with appropriate signatures should be maintained in the WSC files; copies should be provided to the appropriate LASD Water-Quality Specialist and the Chief of Laboratory Evaluations, QSB...”
OGW 2012.03 / OSW 2012.03 / OWQ 2012.03 [link or image removed]	Update of Policy on Review and Publication of Discrete Water Data	WMA policy for approval of discrete data. Revised as follows: “…DQI codes of “S” (data are provisional)” and “…DQI codes of “S” (released, provisional)” per OWQ TM 2016.07 [link or image removed].
OWQ 2008.05 [link or image removed]	Appropriate Data Storage in the National Water Information System (NWIS)	WMA policy that all well-defined water-resource data produced by USGS activities that represent monitoring, investigations, and research of environmental conditions at any specific place and time should be recorded in NWIS.
OWQ 2004.01 [link or image removed]	Revised Policy for the Approval of U.S. Geological Survey (USGS) Water-Quality Analytical Methods	SUPERSEDED by WMA 2020.04 [link or image removed] and OSQI 2018-01 [link or image removed].
OWQ 2002.15 [link or image removed]	Use of the new data-quality-indicator (DQI) field in NWIS 4_1	WMA policy that describes the DQI field added to NWIS-QWDATA for marking the review status and quality of water-quality results.
OWQ 98.05 [link or image removed]	Policy for the Approval of U.S. Geological Survey (USGS) Water-Quality Analytical Methods	SUPERSEDED by OWQ TM 2004.01 [link or image removed] and WMA 2020.04 [link or image removed].

Table 2.  Workflow for applying this policy for approval of new analytical methods or modifications of analytical methods for Water Mission Area laboratories and programs

	Use of a new non-standard method  or modification	Use of a new standard method or modification
Planning:	-- Analyst develops a plan for validation and sample analysis targeted to the non-standard use. -- For work done at the NWQL, a custom proposal is required. Customer accepts risks that method performance might not be adequate for the intended use.   For modifications to an established method: -- Analyst verifies that the core method has been validated and published. -- Validation focuses on aspects of performance most likely to be affected by the modification(s).	-- Analyst develops a plan for validation that covers the full range of expected sample matrices, operating conditions, and concentrations.   For modifications to an established method: -- Analyst verifies that the core method has been validated and published. -- Validation focuses on aspects of performance most likely to be affected by the modification(s).
Documentation:	-- Work is documented in a laboratory notebook. -- The analyst prepares a description of the method (or modification) as implemented for the dataset, including any variations over time. The method description and validation data are shared with the customer.   For modifications to an established method: -- The citable reference for the core method is shared with the customer.	-- Work is documented in a laboratory notebook and follows written SOPs. -- If data are delivered to a customer, the customer agrees to delay publication of the data until all steps of validation, peer review, and publication of the method are complete and can be cited. -- If the customer cannot accept this delay, the alternative is to follow the workflow for non-standard methods.
Validation:	-- Validation includes quality-control (QC) samples for characterizing the bias and variability of the method (or modification) across the range of concentrations and matrices observed in the samples. The scope can be limited to a smaller range of matrices than would typically be seen in standard applications. -- Validation includes assessing sample holding times, detection limits, bias, and precision.   For modifications to an established method: Validation includes comparison to the unmodified method.	-- Validation includes quality-control (QC) samples for characterizing the bias and variability of the method across a wider range of matrices and concentrations, reflecting anticipated samples. -- Validation shall include independent, external performance test samples, if available. -- Validation includes assessing sample holding times, detection limits, bias, and precision. -- For work performed at the NWQL, the NWQL Guidelines for Method Validation apply.   For modifications to an established method: Validation includes comparison to the unmodified method.

 

 

 

	Use of a new non-standard method  or modification (continued)	Use of a new standard method or modification (continued)
Peer review:	-- Analyst’s supervisor reviews the validation plan. -- Customer reviews laboratory performance data as described by the Laboratory Evaluation Policy (OWQ TM 2014.01) to determine whether data are of appropriate quality for the intended use. -- Method descriptions, validation data, and sample data that will be published undergo peer review by subject-matter experts, including at least one from outside of the analyst's work unit. Peer reviewers evaluate the method’s performance characteristics.	-- Analyst’s supervisor reviews the validation plan. --Customer reviews laboratory performance data as described by the Laboratory Evaluation Policy (OWQ TM 2014.01) to determine whether data are of appropriate quality for the intended use. -- The full description of the laboratory method and validation data undergo peer review, including at least one reviewer from outside of the analyst's work unit. Peer reviewers evaluate the method’s performance characteristics. -- The LASD Director or designee provides final review prior to submission for Bureau approval.
Publication:	Any environmental sample data released to the public must be presented within the context of the method description and validation testing. If the customer is the lead author, it may be appropriate for the analyst to be a coauthor.   Options for non-standard new methods: -- USGS publication (SIR, T&M, etc.) with methods section and validation data in a companion data release, -- Science Base product with methods section and validation data in a companion data release, -- Journal article with methods section and validation data (journal-hosted supplemental information files are acceptable if peer-reviewed).   Options for new non-standard modifications: -- A methods section and supporting information in a publication that serves the sample data, including outlets listed above; include a citation for the core method, description of modifications, and results of validation testing. -- For work performed at the NWQL, an NWQL Technical Memorandum is an acceptable outlet.	The complete method is published as a stand-alone publication or in a collection of related methods from the same analyst or laboratory.   Options for standard new methods: -- USGS interpretive publications (e.g., T&M or SIR) with validation data in a companion data release, -- Other agency report with comparable quality of review (e.g., ASTM, USEPA, etc.), -- Journals that focus on analytical methods and that can host the validation data.   Options for new standard modifications: -- A methods section and supporting information in a publication that serves the sample data, including outlets listed above; include a citation for the core method, description of the modifications, and results of validation testing. -- A Science Base product with a companion data release also could be used, along with a citation to the base method. -- For work performed at the NWQL, an NWQL Technical Memorandum is an acceptable outlet for publication.
Method approval:	"Limited approval" for that implementation of the method (or modification) is achieved upon publication of the method description and resulting data in an appropriate outlet.	"Full approval" is granted by the LASD Director for standard implementation of the method (or modification) upon publication of the method description and resulting data in an appropriate outlet. A list of methods with full approval will be maintained by the Office of the LASD Director.
	Use of a new non-standard method or modification (continued)	Use of a new standard method or modification (continued)
Data inclusion in NWIS:	For non-standard new methods:  Maybe. For inclusion in NWIS, the method description and validation data must be documented via method codes and comment fields, which could be difficult to manage for multiple variations.   For modifications to established methods: Yes, under limited conditions. -- The modification has been approved and the data are deemed appropriate for public release. -- Metadata include the analyzing entity and the method code for the core method. -- A laboratory comment field is used to cite the publication that documents the modifications; e.g., "Laboratory method modified as described in <<reference citation>>." -- The DQI code is set to "U" for "unapproved method" until the publication is released, upon which the DQI code can be changed by the customer to "R" for "reviewed and approved" or "Q" for "reviewed and rejected."	For all methods:  Yes, this is permitted unless the data are otherwise exempted from inclusion in NWIS.   Follow this process: -- Use appropriate metadata for NWIS, including analyzing entity and method codes, -- The DQI code is set to "U" for "unapproved method" until the publication is released, upon which the DQI code can be changed by the customer to "R" for "reviewed and approved" or "Q" for "reviewed and rejected" following customer review of the data.   For new methods: New method codes, parameter codes, etc. are requested and established in NWIS.   For modifications to established methods: Either new method codes are established (for substantial modifications) or the existing method codes are updated to include a reference to the new documentation (for minor modifications).