North Carolina Administrative Code
Title 10A - HEALTH AND HUMAN SERVICES
Chapter 15 - RADIATION PROTECTION
Section .0600 - X RAYS IN THE HEALING ARTS
Section 15 .0603 - GENERAL REQUIREMENTS
Universal Citation: 10A NC Admin Code 15 .0603
Current through Register Vol. 39, No. 6, September 16, 2024
(a) Administrative controls
(1) The registrant shall be
responsible for directing the operation of the x-ray machines which he has
registered with the agency. He or his agent shall assure that the following
provisions are met in the operation of the x-ray machine(s):
(A) An x-ray machine which does not meet the
provisions of these Rules shall not be operated for diagnostic or therapeutic
purposes, if so ordered by the agency in accordance with Rules.0109 and.0110 of
this Chapter.
(B) Individuals who
will be operating the x-ray equipment shall be instructed in the safe operating
procedures and use of the equipment and demonstrate an understanding thereof to
the registrant.
(C) In the vicinity
of each diagnostic x-ray system's control panel, a chart shall be provided,
which specifies for all usual examinations and associated projections which are
performed by that system, a listing of information including patient's
anatomical size versus technique factors to be utilized at a given source to
image receptor distance. The chart shall also provide:
(i) type and size of the film or film-screen
combination to be used,
(ii) type
and ratio of grid to be used, if any, and focal spot to film
distance,
(iii) type and placement
of gonad shielding to be used.
(D) Written safety procedures and rules shall
be established and made available to each individual operating x-ray equipment
under his control. The operator shall be familiar with these rules.
(E) Only the professional staff and ancillary
personnel required for the medical procedure or for training shall be in the
room during the radiographic exposure. Other than the patient being examined:
(i) All individuals shall be positioned such
that no part of the body including the extremities which is not protected by
0.5 mm lead equivalent will be exposed to the useful beam.
(ii) Professional staff and ancillary
personnel shall be protected from the direct scatter radiation by protective
aprons or whole body protective barriers of not less than 0.25 mm lead
equivalent.
(iii) Patients who
cannot be removed from the room shall be protected from the direct scatter
radiation by whole body protective barriers of 0.25 mm lead equivalent or shall
be so positioned that the nearest portion of the body is at least six feet from
both the tube head and the nearest edge of the image receptor.
(iv) When a portion of the body of a non-
occupationally exposed professional staff or ancillary personnel is potentially
subjected to stray radiation which would result in that individual receiving
one-fourth of the maximum permissible dose as defined in Rule.1604 of this
Chapter, additional protective measures shall be employed.
(v) Upon written application to the agency,
the agency may waive the requirements in Subparts (a)(1)(E)(ii) and
(a)(1)(E)(iii) of this Rule if the registrant demonstrates that such waiver is
necessary for best management of patients and will not result in violation of
the public and occupational dose limits established in the rules in this
Chapter.
(F) Gonad
shielding of not less than 0.5 mm lead equivalent shall be used for potentially
procreative patients during radiographic procedures in which the gonads are in
the direct, or useful beam, except for cases in which this would interfere with
the diagnostic procedures.
(G)
Individuals shall not be exposed to the useful beam except for healing arts
purposes. Such exposures shall have been authorized by a licensed practitioner
of the healing arts. This provision specifically prohibits deliberate exposure
of an individual for training, demonstration or other nonhealing arts
purposes.
(H) When a patient or
film must be provided with auxiliary support during a radiographic exposure:
(i) Mechanical holding devices shall be used
whenever medical circumstances permit. Written safety procedures, as required
in Part (a)(1)(D) of this Rule shall indicate the requirements for selecting a
holder;
(ii) If a human holder is
required, written safety procedures as required in Part (a)(1)(D) of this Rule,
shall indicate the instructions provided to the holder;
(iii) The human holder shall be protected as
required in Part (a)(1)(E) of this Rule;
(iv) No individual shall be used routinely to
hold patients or film.
(I) Procedures and auxiliary equipment
designed to minimize patient and personnel exposure commensurate with the
needed diagnostic information shall be utilized. This includes, but is not
limited to, the following requirements:
(i)
The speed of film or screen and film combinations shall be the fastest speed
consistent with the diagnostic objective of the examinations.
(ii) The radiation exposure to the patient
shall be the minimum exposure required to produce images of good diagnostic
quality.
(iii) Portable or mobile
equipment shall be used only for examinations where it is impractical for
medical reasons to transfer the patient to a stationary radiographic
installation.
(J) All
persons who are associated with the operation of an x-ray system are subject to
the occupational exposure limits as defined in Rules.1604 and.1638 of this
Chapter, and personnel monitoring procedures in Rule.1614 of this Chapter. In
addition, when protective clothing or equipment is worn on portions of the body
and a monitoring device(s) is required, at least one such monitoring device
shall be utilized as follows:
(i) When an
apron is worn the monitoring device shall be worn at the collar outside the
apron.
(ii) The dose to the whole
body shall be recorded in the reports required in Rule.1640 of this Chapter. If
more than one device is used, each dose shall be identified with the area where
the device was worn on the body.
(2) The registrant shall maintain at least
the following information for each x-ray machine:
(A) current registration information and
other correspondence with the agency regarding that machine;
(B) records of surveys and
calibrations;
(C) records of
maintenance or modifications which affect the useful beam after the effective
date of these Rules, along with the names of persons who performed the
service.
(b) Plans Review. Prior to construction or structural modification, the floor plans and equipment arrangement of all installations utilizing x-rays for diagnostic or therapeutic purposes shall be reviewed by a qualified expert. The registrant shall submit recommendations of the expert to the agency.
(c) Radiation Survey
(1) For installations of x-ray equipment
after the effective date of this Rule, an area radiation survey shall be
performed within 30 days following initial operation of each radiation machine
to show compliance with Rule.0604(b) of this Section. This survey shall
include:
(A) a drawing of the room in which a
stationary x-ray system is located and radiation levels in adjacent areas;
and
(B) the name of the person
approved by the agency performing the survey and the date the survey was
performed.
(2) Any
modification to the x-ray room or adjacent areas which could increase the
radiation dosage to any individual shall require a new survey.
(3) Records of this survey shall be
maintained in accordance with Subparagraph (a)(2) of this Rule.
Authority
G.S.
104E-7;
104E-12(a);
Eff. February 1, 1980;
Amended Eff. January 1, 1994; October 1,
1980;
Transferred and Recodified from
15A NCAC
11.0603 Eff. February 1,
2015.
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