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R9 Laboratory SOP 880
Initial and Continuing Demonstration of Laboratory Capability and Analyst Proficiency
Summary
The procedures described in this SOP apply to all analytical chemistry procedures conducted at the EPA Region 9 Laboratory. (Proficiency and capability requirements for biological procedures (toxicity, etc.) are detailed in SOP 885.) Prior to laboratory analysis using a particular methodology, the Region 9 Laboratory will demonstrate the capability of laboratory instrumentation and analysts to perform as specified in the reference method or performance criteria and document this demonstration. Continuing capability will be monitored through analysis of performance evaluation samples, calibrations, and method detection limit studies. In addition, each analyst must individually demonstrate their proficiency with a particular laboratory technique through an initial demonstration of proficiency prior to the analyst conducting the analysis on laboratory samples. Analysts must also demonstrate continuing proficiency through the analysis of performance evaluation samples, calibrations, and method detection limit studies.
Initial and continuing demonstrations of laboratory capability are performed to verify and document that Region 9 laboratory procedures are capable of meeting performance criteria as outlined in the methods or other guidance documents. The initial demonstration of capability includes the standardization of the procedure as specified in a standard operating procedure (SOP) which must be approved as part of the method development process. The capability of laboratory instrumentation and analysts to perform at the level required in the SOP and associated reference methods is demonstrated through instrument calibration, method blank evaluation, the analysis of four (4) mid-level standards within method precision and accuracy requirements, the completion of a method detection limit (MDL) study, and the analysis of a single-blind performance evaluation sample containing at least 10 percent of the method analytes. Laboratory capability is demonstrated on a continuing basis through ongoing calibration, method blank analysis, annual MDL study, annual precision and accuracy study, and annual analysis of a performance evaluation sample. Additionally, upon acquiring new instrumentation such as an additional gas chromatograph to be used for an existing procedure, the initial demonstration of capability must be completed to demonstrate that the new instrument is capable of generating acceptable data prior to its use for the analysis of environmental samples. Any time an analytical system is significantly altered its capability must be demonstrated once again.
In addition to demonstration of laboratory capability, individual analysts must demonstrate proficiency with each analytical technique prior to generating data for environmental samples. Analytical techniques are defined by the technology employed. For example, extraction of aqueous samples for pesticide analysis might be performed using either solid phase extraction or continuous liquid-liquid extraction. As these are grossly different extraction techniques the analyst would complete two initial demonstrations of proficiency prior to extracting samples using either of the two techniques. However, extraction of aqueous samples for semi-volatile GCMS analysis using continuous liquid-liquid extraction employs the same techniques as used for pesticides so an additional demonstration of proficiency would not be required.
Instrumentation techniques are separated based on the entire instrument system used. For instance, a GC with dual electron capture detectors is a different technology than a GC with photo ionization detectors and flame ionization detectors so an analyst would demonstrate proficiency with all the detector technology employed.
The individual demonstration of proficiency includes reading and following the SOP, calibrating the instrumentation, analyzing a method blank, analyzing four (4) mid-level standards within method precision and accuracy requirements, completing a method detection limit (MDL) study, and analyzing a single-blind performance evaluation sample containing at least 10 percent of the method analytes. Continuing proficiency is demonstrated through ongoing calibration, method blank analysis, annual MDL study, annual precision and accuracy study and annual analysis of a performance evaluation sample.
The laboratory documents all the above activity and maintains a schedule to assure that each requirement is fulfilled annually.