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R9 Laboratory SOP 885
INITIAL AND CONTINUING DEMONSTRATION OF BIOLOGICAL LABORATORY CAPABILITY AND ANALYST PROFICIENCY
Summary
The procedures described in this SOP apply to all the specified biological analytical procedures conducted at the EPA Region 9 Laboratory. 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 and the successful ongoing maintenance of method performance criteria. 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 and successful ongoing method quality control.
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. For toxicity testing analyses, the capability of the laboratory to perform at the level required in the SOP and associated reference methods is demonstrated through adequate performance of controls, the analysis of 5 reference toxicant tests within the method precision and accuracy requirements, and the analysis of a single blind performance evaluation sample. Laboratory capability is demonstrated on a continuing basis by adequate control performance, concurrent or monthly reference toxicant analyses, and annual analysis of a performance evaluation sample. Any time the use of a different exposure period, organism, or endpoint (larval development vs reproduction) is planned, the capability must be demonstrated.
For BOD, 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, and the analysis of a single-blind performance evaluation sample. Laboratory capability is demonstrated on a continuing basis through ongoing calibration, method blank analysis, annual precision and accuracy study, and annual analysis of a performance evaluation sample. Any time an analytical system is significantly altered its capability must be demonstrated once again.
For microbiology, 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, positive, negative and control media evaluations, and the analysis of five (5) or more blind performance evaluation samples. Laboratory capability is demonstrated on a continuing basis through ongoing calibration, method blank and media analyses, and annual analysis of performance evaluation 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. For many toxicity tests, individual analysts demonstration of capability is not appropriate. The tests, because of their duration (up to 10 days), will not be performed by a single analyst. The individual demonstration of proficiency for the principal analysts should include: reading and following the SOP, calibration of meters, and participation in the laboratory demonstration of capability. Since we use student volunteers to assist with the procedures, their demonstration of proficiency should include reading and following the SOP, calibration of meters, and participation in the performance of a reference toxicant test which meets the performance criteria of the method. Continuing demonstration of proficiency should be covered by those procedures outlined for laboratory capability.
For BOD, 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, and analyzing a single-blind performance evaluation sample. Continuing proficiency is demonstrated through ongoing calibration, method blank analysis, annual precision and accuracy study and annual analysis of a performance evaluation sample.
For microbiology, the individual demonstration of proficiency includes reading and following the SOP, calibrating the instrumentation, and analyzing five (5) or more blind performance evaluation samples. Continuing proficiency is demonstrated through ongoing calibration, method blank and media analysis, and annual analysis of performance evaluation samples. The laboratory documents all the above activity and maintains a schedule to assure that each requirement is fulfilled annually.