Section 406.30  Certification Procedures

a)         A radiochemistry laboratory that meets or exceeds the minimum criteria for certification may receive certification from the Department for any radiological parameter for which a methodology has been specified in this Part, or for which an alternative methodology has been approved in accordance with the provisions of this Part.

b)         The operational aspects of a radiochemistry laboratory that will be evaluated in considering a request for certification are:

1)         laboratory facilities;

2)         personnel;

3)         methodology and instrumentation;

4)         data handling; and

5)         quality assurance program.

c)         In seeking certification, the petitioning radiochemistry laboratory shall:

1)         Submit a formal request for certification to the Department;

2)         File with the Department, on the applicable administrative questionnaires furnished by the Department, if available, or otherwise in a form approved by the Department, complete information on the five categories listed in subsection (b) of this Section;

3)         Analyze all performance evaluation samples required in accordance with Section 406.100 and Section 406.260(c) and (d) of this Part and report the results of such analyses to the Department; and

4)         Permit and cooperate in an on-site visit by Department authorized certification officers.  Certification officers shall provide the radiochemistry laboratory with official identification and credentials.  The initial visit will be arranged at the mutual convenience of both parties.  The Department reserves the right to make subsequent visits without prior notice during regular working hours.

d)         Approval or denial of certification may be made only after the procedure described in subsection (c) of this Section has been completed.  Denial of certification shall be in the form of a narrative, giving information as to how deficiencies may be corrected, along with a completed survey form on which all deficiencies are clearly identified.

e)         Radiochemistry laboratories in jurisdictions not having reciprocal agreements with the Department under Section 406.140 of this Part may receive certification from the Department under this Part and shall pay all of the expenses to be incurred by the Department, including travel expenses, prior to evaluation.