Checklist for DOELAP Service Laboratory Independent Assessments

DOE-STD-1112-98

CHECKLIST FOR DOELAP SERVICE LABORATORY INDEPENDENT ASSESSMENTS

RADIOBIOASSAY LABORATORY:

GENERAL

1. 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 radiobioassay and direct radiobioassay measurements. The

procedures include:

Sample preparation and radiochemical analyses,

Data reduction, and

Data reporting.

2. The facility/program implements an appropriate, documented QC program.

3. The facility/program has designated a person responsible for reviewing QC data.

4. Responsibility for review of all direct and indirect radiobioassay data rests with the individual who has technical responsibility

for the program.

PERSONNEL

1. The functional organization is consistent with the current organizational chart for the radiobioassay laboratory.

2. The qualifications of the individual who has technical responsibility for the radiobioassay program is consistent with the

position description.

3. The individual who has technical responsibility exhibits adequate technical knowledge and management control for the program.

4. The responsibility for maintaining and revising the QA manual or QA Plan is clearly assigned.

5. The qualifications of the individual who has responsibility for the radiobioassay QA Program are consistent with the position

description.

6. Assigned responsibilities for the technical areas addressed in the training program are appropriate for the assigned positions..

7. All radiobioassay program staff are familiar with and can implement the documented QC program.

8. The responsibility for major equipment maintenance and measurement system calibrations is clearly assigned.

9. Specialized skills required to conduct all protocols are documented annually and are included in the training program for

individuals who conduct the protocols. The training includes:

a period of close supervision until competency is demonstrated,

a mechanism for evaluating and informing staff members of the adequacy of their performance in conducting assigned

protocols, and

a mechanism for retraining on a periodic basis and for correcting any deficiencies in performance between retraining.

10. Staff have adequate training and experience with the measurement systems and specific analyses they are assigned to perform.

11. A record of training courses completed by each staff member is available for review.

12. A record of the dates and findings of competency reviews is available for review under program management supervision.

A-3