Del. Admin. Code tit. 16, Department of Health and Social Services, Division of Public Health, Health Systems Protection (HSP), 4465, pt. F, app A
Persons requesting that the Agency approve a healing arts screening program shall submit the following information for evaluation and approval:
a. Name and address of the applicant and, where applicable, the names and addresses of agents within this State;
b. Diseases or conditions for which the x ray examinations are to be used in diagnoses;
c. A description of the x ray examinations proposed in the screening program i.e., type and number of views;
d. Description of the population to be examined in the screening program, i.e., age range, sex, physical condition, and other appropriate information;
e. An evaluation of any known alternate methods not involving ionizing radiation that could achieve the goals of the screening program and why these methods are not used instead of the x ray examinations;
f. An evaluation by a QMP (QE) of the x ray system(s) to be used in the screening program. The evaluation shall include the following:
1. Documentation that such system(s) satisfy all applicable requirements of these regulations;
2. Measurement of appropriate patient exposures from the x-ray examinations to be performed;
g. A description of the x-ray quality control program;
h. A copy of the protocol information for the x ray examination procedures to be used;
i. The qualifications of each individual who will be operating the x ray system(s);
j. The qualifications of the individual who will be supervising the operators of the x ray system(s). The extent of supervision and the method of work performance evaluation shall be specified;
k. The name and address of the practitioner licensed in the state who will interpret the radiograph(s);
l. Procedures to be used in advising the individuals screened and their practitioner of the healing arts or health care provider of the results of the screening procedure and any further medical needs indicated;
m. Procedures for the retention or disposition of the radiographs and other records pertaining to the x ray examinations;
n. Frequency of screening of individuals; and
o. The duration of the screening program.
Del. Admin. Code tit. 16, Department of Health and Social Services, Division of Public Health, Health Systems Protection (HSP), 4465, pt. F, app A
22 DE Reg. 401( 11/1/2018) (Final)