Preparation of an In Vivo radiobioassay program for accreditation

Abstract

The Nevada Test Site was operated by the Department of Energy's Nevada Operations Office (DOE/NV), through 1992, as a test facility for nuclear weapons. This resulted in an environment with many unique hazards, including areas that when disturbed, could lead to intakes of radioactive material. DOE/NV Maintenance and Operations Contractor, Bechtel Nevada, operates the In Vivo Service Laboratory (IVSL) to monitor personnel for some of these intakes. To establish a standard of quality for such laboratories, the DOE has proposed the Department of Energy Laboratory Accreditation Program, or DOELAP. This program uses a new national standard on radiobioassay performance as its technical basis (HPS 1996). This standard, and the DOELAP handbook, encompass all aspects of the radiobioassay program including requirements for staffing, training, infrastructure, data handling, backup provisions, reporting, records management, document control, self assessment, performance evaluation, calibration, background and blank counting, calibration and quality control checks, personnel counting, and many other issues associated with program quality assurance. The objectives of this thesis were to perform a well-documented assessment of the IVSL, with respect to guidance documents bearing directly upon the DOELAP process, and then to implement corrective actions to bring the lung counting protocol into compliance. This work identified that while the IVSL maintained counting and quality practices generally consistent with the proposed guidelines (and within the scope of any current requirements), the program documentation was inadequate in most cases. A procedures manual was developed, in response to this finding, that included general programmatic sections as well as those specific to lung counting. A close-out assessment identified that, by generating these procedures from the known regulatory drivers, all pertinent requirements were included therein.