Example 4.7. Example of Performance Specifications for a Bioassay Laboratory

DOE-STD-1121-98

Example 4.7. Example of Performance Specifications for a Bioassay Laboratory

The radiobioassay laboratory shall meet the contractual minimum detectable amounts, as defined in

HPS N13.30-1996, as listed in [DOE site to provide specific list].

Control sample results shall, as a minimum, meet the criteria concerning relative bias statistics within

-0.25 to +0.50 and the relative precision statistic shall be less than or equal to 0.4. At the levels to be

used in spikes, the bias and precision should normally be smaller than the limits in HPS N13.30-

1996. The radiobioassay laboratory shall verify that these limits are met.

The radiobioassay laboratory (if required by 10 CFR 835) shall participate in the DOELAP for

Radiobioassay. The radiobioassay laboratory shall achieve satisfactory results for all appropriate test

categories. In addition, the radiobioassay laboratory should participate in traceability-testing for

bioassay sample matrices offered through NIST's Radiochemistry Intercomparison Program (NRIP).

(Note: non-bioassay matrices are not good indicators of bioassay laboratory performance) The

radiobioassay laboratory shall furnish the DOE site with all intercomparison data annually and/or

upon request.

The radiobioassay laboratory shall furnish the DOE site with all internal quality assurance and

quality control (QA/QC) data upon request.

The radiobioassay laboratory's quality assurance program shall be implemented through an

established documented plan. The QA program must also satisfy HPS N13.30-1996.

The radiobioassay laboratory will prepare and analyze reagent blanks and spiked urine and fecal

samples for internal quality control. The number of QC spiked samples shall be at least 5% of the

total samples analyzed and a reagent blank shall be analyzed with each set of samples. The reagent

blanks will be used by the radiobioassay laboratory and the DOE Site, during audits and review of

bioassay reports, to verify that all detection levels comply with the Contractual Detection Levels

specified above. (The correct equation for verification of detection level is documented in

HPS N13.30-1996.)

The radiobioassay laboratory must satisfy initially and on a continuing basis certain quality control

factors specified below concerning yields, resolution, contamination and control standards or a "stop

work order" may be enforced until the problem(s) is resolved. The radiobioassay laboratory will

report internal quality control results to the DOE Site Procurement Manager when requested.

The DOE site may send, from time to time, blind spiked and/or blank samples to the radiobioassay

laboratory. These sample results will be compared to the in vitro performance criteria documented

in HPS N13.30-1996 and will be used in conjunction with the radiobiossay laboratory's in-house

quality control results to determine if the radiobioassay laboratory is meeting the Contractual

Detection Levels. (Note: A limited number of blanks are not a good indicator of the true MDA. It is

better to use the lab's QC results).

(continued)