| (7) operator training in accordance with §140.521
of this title (relating to Bone Densitometry Training);
(8) gonadal shielding in accordance with subsection
(i)(13) of this section;
(9) warning labels in accordance with §289.231(z)
of this title.
(10) record requirements for authorized use locations
and authorized records locations for mobile services in accordance
with subsection (s)(1)(A) - (D), (G), (J), (R), and (s)(2) of this
section; and
(11) record requirements for mobile services in accordance
with subsection (s)(1)(A), (D), (H), and (J) of this section. These
records shall be maintained with the bone densitometer authorized
to be used for mobile services.
(h) Certified x-ray systems. In addition to the requirements
of this chapter, the registrant shall not make, nor cause to be made,
any modification of components or installations of components certified
in accordance with the United States Food and Drug Administration
(FDA) Title 21, CFR, Part 1020, "Performance Standards for Ionizing
Radiation Emitting Products," as amended, in any manner that could
cause the installations or the components to fail to meet the requirements
of the applicable parts of the standards specified in Title 21, CFR,
Part 1020, except where a variance has been granted by the Director,
Center for Devices and Radiological Health, FDA. A copy of the variance
shall be maintained by the registrant in accordance with subsection
(s)(1) of this section for inspection by the agency.
(i) General operating requirements.
(1) Technique chart. A technique chart relevant to
the particular radiation machine shall be provided or electronically
displayed in the vicinity of the control panel and used by all operators.
(2) Operating and safety procedures.
(A) Each registrant shall have and implement written
operating and safety procedures. The procedures shall include, but
are not limited to, the following as applicable:
(i) posting notices to workers in accordance with §289.203(b)
of this title;
(ii) instructions to workers in accordance with §289.203(c)
of this title;
(iii) notifications and reports to individuals in accordance
with §289.203(d) of this title;
(iv) ordering x-ray exams in accordance with §289.231(b)(1)
of this title;
(v) occupational dose requirements in accordance with §289.231(m)
of this title;
(vi) personnel monitoring requirements in accordance
with §289.231(n), (q), and (s) of this title;
(vii) posting of a radiation area in accordance with §289.231(x)
of this title;
(viii) use of a technique chart in accordance with
paragraph (1) of this subsection;
(ix) use of protective devices in accordance with paragraph
(4) of this subsection;
(x) credentialing requirements for individuals operating
radiation machines in accordance with paragraph (5) of this subsection;
(xi) exposure of individuals other than the patient
in accordance with paragraph (7) of this subsection;
(xii) holding of patients or image receptors in accordance
with the following;
(I) a list of circumstances in which mechanical holding
devices cannot be routinely utilized; and
(II) a procedure used for selecting an individual to
hold or support the patient or image receptor.
(xiii) gonadal shielding in accordance with paragraph
(13) of this subsection;
(xiv) control of scattered radiation in accordance
with subsection (m)(8) of this section; and
(xv) film processing program or digital image processing
protocols in accordance with subsections (p), (q), and (r) of this
section.
(B) The registrant shall maintain the operating and
safety procedures in accordance with subsection (s)(1) of this section
for inspection by the agency.
(C) The procedures shall be made available to each
individual operating a radiation machine, including any restrictions
of the operating technique required for the safe operation of the
particular x-ray system.
(D) The registrant shall document that each individual
operating a radiation machine has read the operating and safety procedures
at least annually and shall maintain this documentation for inspection
by the agency. The documentation shall include the following:
(i) name and signature of individual;
(ii) date individual read the operating and safety
procedures; and
(iii) initials of the RSO.
(3) Occupational dose limits and personnel monitoring.
Except as otherwise exempted, all individuals who are associated with
the operation of a radiation machine are subject to the occupational
dose limits of §289.231(m) of this title regarding dose limits
to individuals, and the personnel monitoring requirements of §289.231(n)
of this title.
(4) Protective devices. Protective devices shall be
utilized when required, as in paragraphs (8)(B) and (C), (10), and
(13) of this subsection, and subsection (m)(8) of this section.
(A) Protective devices shall be of no less than 0.25
millimeter (mm) lead equivalent material except as specified in paragraph
(13) of this subsection and subsection (m)(8)(B)(i) of this section.
(B) Protective devices, including aprons, gloves, and
shields shall be checked annually for defects such as holes, cracks,
and tears. These checks may be performed by the registrant by visual
or tactile means, or x-ray imaging. If a defect is found, protective
devices shall be replaced or removed from service until repaired.
A record of this test shall be made and maintained by the registrant
in accordance with subsection (s)(1) of this section for inspection
by the agency.
(5) Operator credentialing. Individuals who operate
radiation machines for human use shall meet the appropriate credentialing
requirements of rules issued in accordance with the Medical Radiologic
Technologist Certification Act, Texas Occupations Code, Chapter 601.
Copies of the credentialing document shall be maintained at the location(s)
where the individual is working.
(6) Practice of medical physics. Surveys, tests, or
evaluations required by this section may constitute the practice of
medical physics and, therefore, require a license from the Texas Board
of Licensure for Professional Medical Physicists in accordance with
the Medical Physics Practice Act, Texas Occupations Code, Chapter
602.
(7) Exposure of individuals other than the patient.
No individual other than a patient, operator, and ancillary personnel
shall be in the x-ray room or area while exposures are being made
unless such individual's assistance is required.
(8) Holding of patient or image receptor.
(A) When a patient or image receptor must be held in
position during radiography, mechanical supporting or restraining
devices shall be used when the exam permits.
(B) If a patient or image receptor must be held by
an individual during an exposure, that individual shall be protected
with appropriate shielding devices described in paragraph (4) of this
subsection.
(C) In those cases where the patient must hold the
image receptor, any portion of the body other than the area of clinical
interest struck by the useful beam shall be protected by not less
than 0.25 mm lead equivalent material.
(9) Viewing system and contact with patient.
(A) Windows, mirrors, closed circuit television, or
another method shall be provided to permit the operator to continuously
observe the patient during irradiation.
(B) The operator shall be able to maintain verbal,
visual, and aural contact with the patient.
(10) Operator position. The operator position during
the exposure shall be such that the operator's exposure is as low
as reasonably achievable (ALARA) and the operator is a minimum of
6 feet from the source of radiation or protected by an apron, gloves,
or other shielding having a minimum of 0.25 mm lead equivalent material.
(11) Holding of tube. In no case shall an individual
hold the tube or tube housing assembly supports during any radiographic
exposure.
(12) Patient protection. Notwithstanding the provisions
of paragraph (7) of this subsection, other patients who are in line
with the primary beam and who cannot be removed from the room shall
be protected by whole body protective barriers of a minimum of 0.25
mm lead equivalent material or so positioned that the nearest portion
of their body is at least 6 feet from both the tube head and the nearest
edge of the image receptor.
Cont'd... |
