25 Pa. Code § 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information submitted to the Department becomes invalid or outdated, the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 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.
(c) Mammography facilities shall
comply with 21 CFR Part 900 (relating to mammography).
Notes
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. §§ 2001-2014).
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