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| DOE-STD-1112-98
5.6.5 Record Keeping. The service facility shall maintain functional records on direct and indirect
radiobioassay analyses. The records should be easily accessible, in logical order, and
complete. Records covering the following items shall be required and are reviewed during the
on-site visit:
a. staff training dates and results;
b. measurement equipment calibration and maintenance;
c. system minimum detectable activities (MDAs), sample decision levels (Lc),
probabilities of Type I and Type II errors used for MDA and Lc calculations, and
the data and equations used to calculate the MDA and Lc;
d. results of internal and external equipment checks, measurement QA programs,
audits, etc.;
e. performance test data and reports; and
f.
tracking and logging systems for indirect radiobioassay samples.
5.6.5.1 Measurement equipment calibration (or verification) records should include the
following: equipment name or description; model, style, or serial number; manufacturer;
notation of all equipment variables requiring calibration or verification; the range of
calibration/verification; the resolution of the instrument and its allowable error; the calibration
frequency; the date and result of last calibration; the identity of the laboratory individual(s) or
external service responsible for calibration; and sources of the reference standards and
traceability thereof.
5.6.5.2 Tracking and logging records should trace the movement of each indirect
radiobioassay sample through the service laboratory from its receipt through all the analyses
performed to the final report.
5.6.5.3 The measurement report the service laboratory develops for the permanent record
should include or reference the location of the following information:
a. Direct Radiobioassay Information
1.
subject identification
2.
date, time, and reason for analysis
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