Direct Radiobioassay Criteria

DOE-STD-1112-98

CHECKLIST FOR DOELAP SERVICE LABORATORY INDEPENDENT ASSESSMENTS

13. Documented, signed, approved, and controlled procedures are established for each step in the activities used to determine

radioactivity concentrations or total radioactivity results for indirect and direct radiobioassay measurements. The procedures

include:

Sample preparation and radiochemical analyses

Data reduction

Data reporting.

14. The facility participates in a recognized, documented QC program.

15. The facility has designated a person responsible for reviewing QC data.

DIRECT RADIOBIOASSAY CRITERIA

1. The bias and precision criteria of the DOE Technical Standard and the customer's Minimum Detectable Amount (MDA)

requirements are met by the Direct radiobioassay measurement systems (detectors, electronics support, and shielding). The Lc

and MDA are calculated by techniques as described in the DOE Technical Standard and the draft ANSI N13.30 standard (ANSI

1996)

2. Personnel shower facilities are in close proximity to the direct radiobioassay laboratory.

3. Measurement chambers are designed to mitigate claustrophobia (may include two-way communications, remote viewing, fail-

safe doors, etc.).

4. Measurement chambers have adequate ventilation. (The use of O2 monitors is recommended)

5. Contamination-free clothing is used or available while the subject is counted.

6. The laboratory is located at an appropriate distance from areas where radioactive materials are processed, stored, or transported.

7. Periodic evaluations of chamber background measurements and Minimum Detectable Amounts (MDAs) are made.

8. Prior to the initial radiobioassay, an orientation briefing on the measurement process are explained to the subject.

9. The laboratory staff recognize the potential for external contamination and are able to describe appropriate investigative

techniques to confirm the type of the contamination (i.e., internal or external).

10. The direct radiobioassay program is designed to minimize measurement uncertainties and biases.

11. An estimate of the total propagated uncertainties for the important radionuclides at the facility has been generated and

documented.

12. Direct radiobioassay spectra and associated data are retained in a retrievable format.

INDIRECT RADIOBIOASSAY CRITERIA

1. Practices for receiving, handling, and storing samples are consistent with provisions in the QA plan.

2. A system is in use for identifying and tracking all samples within the laboratory.

3. Sufficient information is included with the samples to analyze and track the sample.

4. The number of quality control samples is at least 5 percent of the total number of samples analyzed.

5. Specific procedures to analyze biological samples from human subjects for assessment of excretion rates are validated and

documented before being used.

6. The laboratory uses appropriate techniques to ensure proper identification and quantification of specific radionuclide(s), and are

capable of separating interferences or resolving a mixture of radionuclides.

7. The laboratory determines analytical results and propagated standard errors in appropriate units. The results include appropriate

volume, recovery, and decay correction. The standard error of each result is calculated and includes propagation of the

estimated measurement uncertainties (e.g., calibration counting, measurement of volume or weight, losses from chemical

separations, transfer, operations, and impurities).

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