A person proposing to conduct a healing arts screening program must not implement the program without prior approval of the commissioner. An applicant must meet the requirements in this chapter. In addition:
an applicant must be registered with the commissioner before application for screening is initiated; and
the applicant must submit the information in this part on an application form provided by the commissioner or an equivalent form.
In the application for screening, the applicant must provide:
the name and address of the applicant;
each location of the proposed screening and the name and telephone number of a contact person at each location;
the purpose of the proposed screening program planned. This purpose must include the diseases or conditions for which the x-ray examinations are to be used in diagnoses;
a detailed description of the x-ray examination proposed in the screening program;
a description of the population to be examined in the screening program, for example, age, sex, physical condition, and other appropriate information;
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;
an evaluation by a diagnostic radiological physicist of the x-ray systems to be used in the screening program. The evaluation must show that the system satisfies all requirements of these regulations;
a measurement of patient exposures from the x-ray examination to be performed during the screening;
a description of the diagnostic x-ray quality assurance program;
a copy of the technique chart for the x-ray examination procedures to be used;
a list of the qualifications of each individual who will be operating the x-ray system;
the qualifications of the individual who will be supervising the operators of the x-ray system. The extent of supervision and the method of work performance evaluation must be specified;
a list of the name(s), business address(es), and qualifications of the individual(s) who will interpret the radiographs;
the procedures for informing the individuals screened and their private practitioners of the healing arts of the results of the screening procedure and any further medical needs indicated;
the procedures for the retention or disposition of the radiographs and other records pertaining to the x-ray examinations;
the frequency of screening; and
the duration of the entire screening program if less than the one year authorization period.
The applicant must be notified in writing of the commissioner's decision.
The applicant is responsible for informing the commissioner of any changes in the screening program described in the application. The applicant must obtain commissioner approval of the changes before the implementation.
The applicant may appeal the denial or refusal to approve an application or renewal application by requesting a contested case hearing under the provisions of the Administrative Procedure Act, Minnesota Statutes, chapter 14. The applicant must submit, within 15 days of the receipt of the department's decision, a written request for a hearing. The request for a hearing must set forth in detail the reasons why the applicant contends that the decision of the department should be reversed or modified.
Any request for the renewal of a screening program application must be submitted in writing 30 days before its expiration date. Renewal requests must contain the information specified in subpart 2.
MS s 144.12
December 10, 2007
Copyright © 2007 by the Revisor of Statutes, State of Minnesota. All rights reserved.