CLP-Like Level 4 Data Packages and Data Validation

Many environmental projects and programs require that a laboratory provide a CLP-Like Level IV analytical data package for data reporting. A Level IV data package is a comprehensive report that allows a data validator to evaluate analytical data and determine usability, including analytical data results, quality control, and sample handling information. Level IV data packages are typically used for data validation purposes following the U.S. EPA’s National Functional Guidelines (NFG) for Data Review.  

Level IV data packages are required for a diverse range of environmental projects. A few examples where a Level IV data package may be necessary include:

• Superfund sites;
• Brownfields programs;
• State-led regulatory projects;
• Department of Defense projects; and,
• Sites where the data user requires a higher-level of confidence and review to assist them in making important decisions for determining potential liabilities and evaluating remedial alternatives.

According to the U.S. EPA, the NFGs help data validators evaluate whether the analytical data meet quality control criteria, as well as the usability and extent of bias of any data not meeting these criteria. The NFGs also provide definitive guidance in areas such as blanks, calibration standards, and instrument performance checks and aid the reviewers in making subjective judgements regarding the use of data that is affected by site conditions.

There are many components to a Level IV data package, including CLP-like forms.  Information included in the Level IV package is specific to the type of analytical testing performed for organic or inorganic methods.  A few examples of forms provided in a Level IV can include:

• Sample ID Summary
• Analytical Results
• Surrogate Recovery
• Matrix Spike (MS)/MS Duplicate Summary
• Laboratory Control Samples (LCS)/LCS Duplicate Summary
• Method Blank Summary
• QC Batch Summary
• Instrument Performance Check
• Internal Standard Area and Retention Time Summary
• Calibration Data, including Initial, Second Source, and Continuing
• Holding Time Summary
• Linear Range Standard Summary
• Interference Check Samples
• Tuning and Response Factor Summary
• Spike Sample Summary
• Serial Dilution
• Raw Data

The above is not a comprehensive list of the components that make-up a Level IV data package, but it does provide a representative overview.  Merit Laboratories routinely provides CLP-Like Level IV data packages to support environmental investigations, routine monitoring, and remediation projects.  Please contact Merit to learn more about available reporting options.