Pennsylvania Code › Title 25 - ENVIRONMENTAL PROTECTION › Part I - Department of Environmental Protection › Subpart D - Environmental Health and Safety › Article V - Radiological Health › Chapter 221 - X-RAYS IN THE HEALING ARTS › ADMINISTRATIVE CONTROLS › Section 221.13 - Information to be submitted by persons requesting approval to conduct healing arts screening

Current through Register Vol. 54, No. 28, July 13, 2024
(a) The
						Department will consider efficacy as a factor in evaluating healing arts
						screening procedures. In its review, the Department will consider National
						medical organization consensus statements as well as peer reviewed scientific
						and medical literature that addresses the efficacy of the proposed screening
						procedures. The review may also consider relevant information from appropriate
						Federal agencies. For procedures that result in an individual organ dose or
						deep dose equivalent greater than 1 mSv (100 mrem) to a screened individual the
						Department will consult with the Department of Health (DOH) for assistance in
						reviewing the efficacy of the proposed procedures but the final decision will
						remain that of the Department. The DOH will have access to all relevant
						materials when rendering its review.
(b) A person requesting that the Department
						approve a healing arts screening program other than mammography shall submit in
						writing the following information for evaluation by the Department. If
						information submitted to the Department becomes invalid or outdated, the
						registrant shall immediately notify the Department.
(1) The name and address of the applicant
						and, if applicable, the names and addresses of agents within this
						Commonwealth.
(2) The diseases or
						conditions for which the X-ray examinations are to be used.
(3) The description in detail of the X-ray
						examinations proposed in the screening program.
(4) A description of the population to be
						examined in the screening program-age, sex, physical condition and other
						appropriate information.
(5) An
						evaluation of all known alternate methods that could achieve the goals of the
						screening program and why these methods are not used in preference to the
						proposed X-ray examinations.
(6) An
						evaluation by a qualified expert of the X-ray systems to be used in the
						screening program. The evaluation must show that the systems satisfy the
						requirements of this article. The evaluation must include a measurement of
						patient entrance exposures and calculation of the maximum shallow dose, deep
						dose equivalent and organ dose from the X-ray examinations to be
						performed.
(7) A description of the
						diagnostic X-ray quality control program.
(8) A copy of the technique chart for the
						X-ray examination procedures to be used if exposure parameters are set manually
						or a description of how exposure parameters are determined.
(9) The qualifications of all individuals who
						will be operating the X-ray systems.
(10) The qualifications of the physician who
						will be supervising the operators of the X-ray systems. The extent of
						supervision and the method of work performance evaluation shall be
						specified.
(11) The name, address
						and qualifications of the individual who will interpret the screening procedure
						results.
(12) A description of the
						information and procedure for advising the individuals screened of the
						potential for false positive or negative results and the implications for the
						patient; the procedure for recording informed consent for the procedure
						following disclosure of this information; and the procedure for advising the
						individuals screened and their private practitioners of the healing arts of the
						results of the screening procedure and further medical needs
						indicated.
(13) A description of
						the procedures for the retention or disposition of the diagnostic images, data
						and other records pertaining to the X-ray examination.
(14) An approximation of the frequency of
						screening activities and duration of the entire screening program.