25 Pa. Code § 221.11 - Registrant responsibilities
(a)
The registrant is responsible for directing the operation of X-ray systems
under his administrative control and shall assure that the requirements of this
article are met in the operation of the X-ray systems.
(b) An individual who operates an X-ray
system shall be instructed adequately in the safe operating procedures and be
competent in the safe use of the equipment. The instructions shall include
items included in Appendix A (relating to determination of competence) and
there shall be continuing education in radiation safety, biological effects of
radiation, quality assurance and quality control.
(1) The operator or the individual who
supervises the operation of a high-risk procedure shall have additional
instruction, which may include certification or registration in the applicable
specialty by a professional organization recognized by the Department.
Continuing education for high-risk procedures shall occur, at a minimum, every
2 years.
(2) Continuing education
for all other (low-risk) procedures shall occur, at a minimum, every 4
years.
(c) Protocol
information, which specifies the techniques for examinations performed with the
system, shall be provided in the vicinity of each diagnostic X-ray system's
control panel. The protocol shall include information pertinent to the
particular examination, such as:
(1) The
patient's body part and anatomical size, or body part thickness, or age (for
pediatrics), versus technique factors to be utilized.
(2) The type and size of the image receptor
or film-screen combination.
(3) The
type of grid, if any.
(4) The type
and location of placement of patient shielding, for example, gonad, and the
like.
(5) For mammography,
indication of kVp/target/filter combination.
(6) Source to image receptor distance to be
used, except for dental intraoral radiography.
(d) Written safety procedures and rules shall
be available at a facility including restrictions of the operating technique
required for the safe operation of the particular X-ray system. The operator
shall be able to demonstrate familiarity with the rules.
(e) Except for patients who cannot be moved
out of the room, only the staff and ancillary personnel or other persons
required for the medical procedure or training shall be in the room during the
radiographic exposure. The following apply for individuals other than the
patient being examined:
(1) Individuals shall
be positioned so that no part of the body will be struck by the useful beam
unless protected by at least 0.5 millimeter lead equivalent material. The lead
equivalent of the material is to be determined at 60 kV.
(2) All persons required for the medical
procedure shall be protected from the stray radiation by protective aprons or
whole protective barriers of at least 0.25 millimeter lead equivalent or shall
be so positioned that the persons are not in the direct line of the useful beam
and the nearest portion of the body is at least 2 meters from both the tube
head and the nearest edge of the image receptor.
(3) A patient who cannot be removed from the
room shall be protected from the stray radiation by protective barriers of at
least 0.25 millimeter lead equivalent material unless the shield would
compromise the health of the individual or shall be so positioned that the
patient is not in the direct line of the useful beam and the nearest portion of
the body is at least 2 meters from both the tube head and the nearest edge of
the image receptor.
(4) No
individual, other than the patient being examined, may be in the useful beam,
unless required to conduct the procedure.
(f) During diagnostic procedures in which the
gonads are in the useful beam, gonad shielding of at least 0.5 millimeter lead
equivalent shall be used for patients except for cases in which this would
interfere with the diagnostic procedure.
(g) An individual may not be exposed to the
useful beam except for healing arts purposes or under §
221.15 (relating to use of X-rays
in research on humans). An exposure shall be authorized by a licensed
practitioner of the healing arts. This provision specifically prohibits
deliberate exposure for the following purposes:
(1) Exposure of an individual for training,
demonstration or other nonhealing arts purposes.
(2) Exposure of an individual for the purpose
of healing arts screening except as authorized by the Department. When
requesting authorization, the registrant shall submit the information outlined
in §
221.13 (relating to information to
be submitted by persons requesting approval to conduct healing arts
screening).
(h) If a
patient or image receptor requires auxiliary support during a radiation
exposure the following apply:
(1) Mechanical
holding devices shall be used when the technique permits.
(2) The human holder shall be protected as
required by subsection (e).
(3) An
individual may not be used routinely to hold image receptors or
patients.
(i) Procedures
and auxiliary equipment designed to minimize patient and personnel exposure
commensurate with the needed diagnostic information shall be
utilized.
(j) The screen and film
system used shall be spectrally compatible. Defective screens may not be used
for diagnostic radiological imaging.
(k) With the exception of intraoral dental
radiography, film may not be used without intensifying screens for routine
diagnostic radiological imaging.
(l) The registrant shall have a quality
assurance program. This quality assurance program shall be documented and be in
accordance with guidelines established by the Department or by another
appropriate organization recognized by the Department. At a minimum, the
quality assurance program shall address repeat rate, DRLs, image recording,
processing and viewing, image quality and artifacts, and maintenance and
modifications to the quality assurance program. For CT, each study shall be
checked. If an artifact is present, the registrant shall take corrective action
as appropriate. Records shall be maintained by the registrant for inspection by
the Department for 5 years. The Department's guidelines and a list of
recognized organizations will be maintained and made available on the
Department's website and on request.
(m) Neither the X-ray tube housing nor the
collimating device may be handheld during the exposure unless specifically
designed to be handheld.
(n)
Functional damage to a patient organ or a physiological system that results
from a prescribed causative procedure shall be reported to the Department as
outlined in §
219.229 (relating to diagnostic or
interventional procedure medical reports).
(o) The registrant shall maintain records
documenting the QMP's qualifications and compliance with continuing education
requirements.
Notes
The provisions of this §221.11 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).
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