Record Keeping.

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

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

subject identification

date, time, and reason for analysis