Appendix A. Information Submitted to the Agency According to R12-1-604(A)(3)(c)

A.      Name and address of the applicant and, if applicable, the name and address of any person within this state that is authorized to act on behalf of the applicant;

B.       Disease or conditions to be diagnosed using the proposed x- ray examination;

C.      A detailed description of each x-ray examination that will be used in the diagnosis;

D.      A description of the population to be examined in the screen- ing program, using characteristics such as age, sex, physical condition, and other descriptive information;

E.       An evaluation of any known alternative diagnostic modalities not involving ionizing radiation that could achieve the same diagnosis as a screening program and why these modalities have not been chosen;

F.       An evaluation by a qualified expert of the x-ray equipment used in the screening program, which demonstrates that the x- ray equipment satisfies the requirements of this Article.

G.      A description of the quality control program;

H.      A copy of the technique chart for the planned x-ray examina- tion;

I.        The qualifications of each individual who will be operating the x-ray equipment;

J.        The qualifications of the individual who will be supervising each operator of the x-ray equipment;

K.      The name and address of the individual who will interpret each radiographic image;

L.       A description of the planned procedures for advising a screened individual and the screened individual’s physician of the screening procedure results, and the need for further medi- cal care, and

M.     A description of the procedures for retention or disposition of the radiographic images and other records pertaining to the x- ray examination.

Historical Note

Adopted effective January 2, 1996 (Supp. 96-1).

Amended by final rulemaking at 9 A.A.R. 4302, effective November 14, 2003 (Supp. 03-3).