§ 221.13. Information to be submitted by persons requesting approval to conduct healing arts screening.
(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 If information submitted to the Department becomes invalid or outdated, the registrant shall immediately notify the Department.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 programage, 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.
(c) Mammography facilities shall comply with 21 CFR Part 900 (relating to mammography).
The provisions of this § 221.13 amended under sections 301 and 302 of the Radiation Protection Act (35 P. S. § § 7110.301 and 7110.302); and section 1920-A of The Administrative Code of 1929 (71 P. S. § 510-20); and the Radon Certification Act (63 P. S. § § 20012014).
The provisions of this § 221.13 adopted February 1, 1972, effective February 2, 1972, 2 Pa.B. 212; amended December 18, 1987, effective December 19, 1987, 17 Pa.B. 5235; amended October 2, 1998, effective October 3, 1998, 28 Pa.B. 4894; amended November 16, 2001, effective November 17, 2001, 31 Pa.B. 6282; amended July 16, 2004, effective July 17, 2004, 34 Pa.B. 3823; amended May 16, 2008, effective May 17, 2008, 38 Pa.B. 2243. Immediately preceding text appears at serial pages (304489) to (304491).
This section cited in 25 Pa. Code § 221.11 (relating to registrant responsibilities); and 25 Pa. Code § 221.35a (relating to fluoroscopic X-ray systems).
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