South Carolina Code of Regulations
Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL
Subchapter 61-64 - X-Rays (Title B)
Part IV - USE OF X-RAYS IN THE HEALTH PROFESSIONS
Section 61-64.IV.RHB 4.2 - General Safety Provisions
Universal Citation: SC Code Regs 61-64.IV.RHB 4.2
Current through Register Vol. 48, No. 9, September 27, 2024
4.2.1 An x-ray system which does not meet the provisions of this regulation shall not be operated for diagnostic or therapeutic purposes if so directed by the Department.
4.2.2 The registrant shall assure that all x-ray machines under his or her control are operated only by a radiologic technologist possessing a current, valid certificate from the South Carolina Radiation Quality Standards Association, or a licensed practitioner. For the purpose of this Part, a radiologic technologist is defined as a person who is a limited practice radiographer, radiographer, podiatric limited practice radiographer, or limited chest radiographer certified by the American Registry of Radiologic Technologists, or who is certified by the South Carolina Radiation Quality Standards Association or who has obtained a certificate acceptable to the South Carolina Radiation Quality Standards Association. A person who applies ionizing radiation to humans or performs x-ray exam setups, including, but not limited to, patient positioning and technique selection shall be considered a radiologic technologist.
4.2.2.1 No person other than a licensed
practitioner or a radiologic technologist possessing a current, valid
certificate from the South Carolina Radiation Quality Standards Association
shall use equipment emitting ionizing radiation on humans for diagnostic
purposes.
4.2.2.2 No person shall
employ or designate as a radiologic technologist a person who does not hold a
current, valid certificate issued by the South Carolina Radiation Quality
Standards Association.
4.2.2.3 No
person holding a certificate issued by the South Carolina Radiation Quality
Standards Association shall use equipment emitting ionizing radiation on humans
for diagnostic purposes unless under the direction and supervision of a
licensed practitioner and unless so directed by prescription of a licensed
practitioner.
4.2.2.4 No person who
is not certified by the South Carolina Radiation Quality Standards Association
shall take, use, or exhibit the title of "limited practice radiographer,"
"podiatric limited practice radiographer," "limited chest radiographer," or
"radiographer" or any other title, sign, display, or declaration that tends to
lead the public to believe that the person is authorized to apply ionizing
radiation on humans for diagnostic purposes.
4.2.2.5 A student enrolled in and attending a
school or college of medicine, osteopathy, chiropractic, podiatry, radiologic
technology, or a curriculum approved by the South Carolina Radiation Quality
Standards Association, or a resident in an approved graduate education program
of medicine, osteopathy, chiropractic, or podiatry may apply ionizing radiation
to humans without a certificate from the South Carolina Radiation Quality
Standards Association, as long as the student or resident is under the direct
supervision of a licensed practitioner or direct supervision of a certified
radiologic technologist appropriately trained to supervise the specific
procedure.
4.2.2.6 The registrant
shall display each operator's current South Carolina Radiation Quality
Standards Association certificate or the registrant may post a notice to the
public that these certificates are available for review upon request. The
certificate or posting shall be displayed in public view, not obstructed by any
barrier, equipment, or other object.
4.2.2.7 The registrant shall ensure that each
operator has received facility specific training to include the equipment and
operating conditions. Documentation of this training for each operator shall be
made available for Departmental review.
4.2.2.8 Dentists and their auxiliaries who
meet the requirements of the South Carolina Dental Practice Act are exempt from
the requirements of
RHB 4.2.2.1 through
4.2.2.6.
4.2.3 The operator shall be able to demonstrate familiarity and competence with the facility's operating conditions.
4.2.4 X-ray producing machines and associated equipment shall be maintained in such a condition to ensure that the patient and staff are not exposed to radiation unnecessarily.
4.2.5 If an x-ray system is identified as not being in compliance with the provisions of this regulation and cannot meet the regulation, or if the registrant is unwilling to make corrections, and if that system is accessible for use, it shall be rendered inoperable (i.e., dismantle the x-ray source from the source support assembly) if so ordered by the Department.
4.2.6 For general radiographic systems not equipped with an operational anatomic programming option, techniques shall be documented and readily available to the operator. At a minimum, this shall include:
4.2.6.1 Patient's body part and
anatomical size, or body part thickness or age (for pediatrics), versus
technique factors to be used;
4.2.6.2 Source to image receptor distance
(SID) to be used (except for dental intra-oral radiography);
4.2.6.3 If an automatic exposure control
(AEC) system is operated in a manual mode, the technique chart shall specify
the requirements of
RHB 4.2.6.1 and 4.2.6.2;
and
4.2.6.4 The technique chart
shall accurately reflect techniques currently in use at the facility.
4.2.7 A sign shall be posted so as to be easily seen by the patient to the effect that if there is a pregnancy or the possibility of a pregnancy, the physician shall be notified.
4.2.8 The effectiveness of protective equipment and apparel shall not be impaired. Protective aprons and gloves shall be checked at least annually for cracks and holes that could compromise the radiation protection it provides. These checks shall be documented and records shall be kept for two (2) years, or until the next Department inspection, whichever is later.
4.2.9 Except for patients who cannot be moved out of the room, only the staff and ancillary personnel required for the medical procedure or training shall be in the room during the radiographic exposure other than the patient being examined.
4.2.9.1 All individuals shall be positioned
such that no part of the body will be struck by the useful beam, unless
protected by not less than 0.5 mm lead equivalent material.
4.2.9.2 The x-ray operator, other staff, and
ancillary persons shall be protected from the direct scattered radiation by
protective aprons or whole body protective barriers of not less than 0.25 mm
lead equivalent material. Temporary placement of the physician's and/or
assistant's hands in the primary beam during procedures that require sterility
and increased dexterity are exempt from
RHB 4.2.9.2.
4.2.9.3 Persons who cannot be removed from
the room shall be protected from the direct scattered radiation by whole body
protective barriers of 0.25 mm lead equivalent and when feasible shall be so
positioned that the nearest portion of the body is at least two meters (2 m)
from both the tube head and the nearest edge of the image receptor.
4.2.9.4 When a portion of the body of any
staff or ancillary personnel is potentially subjected to stray radiation which
could result in that individual receiving one quarter of the maximum
permissible dose as defined in
RHB 3.4 of this regulation,
additional protective devices may be required by the Department.
4.2.10 The useful x-ray beam shall be limited to the area of clinical interest.
4.2.11 Individuals shall not be exposed to the useful beam of electronically produced ionizing radiation except for healing arts purposes, and unless such exposure has been authorized by a licensed practitioner. This provision specifically prohibits deliberate exposure for the following purposes:
4.2.11.1
Exposure of an individual for training, demonstration or other purposes unless
there are also healing arts requirements and proper prescription has been
provided. Demonstrations or training on new x-ray equipment must be performed
with proper protection of the observers and operator(s). Phantoms, not humans,
must be used for demonstrations and training.
4.2.11.2 Healing arts screening. Any person
proposing to conduct a healing arts screening program shall not initiate such a
program without prior approval of the Department. When requesting such
approval, that person shall submit the information outlined in Appendix A of
this Part. If any information submitted to the Department becomes invalid or
outdated, the Department shall be notified within fifteen (15) calendar days.
Approval to conduct a healing arts screening program shall be renewed on an
annual basis if deemed necessary by the Department.
4.2.12 When a patient or film must be provided with auxiliary support during a radiation exposure:
4.2.12.1 Mechanical holding devices shall be
used when the technique permits.
4.2.12.2 The facility shall indicate the
requirements for selecting a holder, and the procedure the holder shall
follow.
4.2.12.3 The human holder
shall be instructed in personal radiation safety and shall be protected as
required by 4.2.9.
4.2.12.4 No
person shall be used routinely to hold patients or film.
4.2.12.5 In those cases where the patient
must hold the film, except during intraoral examinations, any portion of the
body other than the area of clinical interest struck by the useful beam shall
be protected by not less than 0.5 mm lead equivalent material.
4.2.12.6 When practical, a pregnant female
shall not be used to hold film or patients.
4.2.12.7 Each facility shall have leaded
aprons and gloves available in sufficient numbers to provide protection to all
personnel who are involved in x-ray operations who are not otherwise
shielded.
4.2.13 Procedures and auxiliary equipment designed to minimize patient and personnel exposure shall be used.
4.2.13.1 The speed of
the screen and film combinations used shall be the fastest speed consistent
with the diagnostic objective of the examinations. Film cassettes without
intensifying screens shall not be used for any routine diagnostic radiological
imaging. The film cassettes shall provide good contact between the intensifying
screens and the film.
4.2.13.2 The
radiation exposure to the patient shall be the minimum exposure required to
produce images of good diagnostic quality. Exposures shall not exceed limits
for the specified anatomical thicknesses listed in Appendix D.
4.2.13.3 Portable or mobile x-ray equipment
shall be used only for examinations where it is impractical to transfer the
patient(s) to a stationary x-ray installation. Portable or mobile dental
equipment shall be exempt from this regulation.
4.2.13.4 Radiologic technologists performing
fluoroscopy as a localizing procedure shall be monitored by the supervising
radiologist who is personally and immediately available.
4.2.14 Personnel Monitoring.
4.2.14.1 All persons who are associated with
the operation of an x-ray system are subject to the occupational exposure
limits and the requirements for the determination of the doses which are stated
in RHB 3.4. In
addition, the following requirements are made:
4.2.14.1.1 When protective clothing or
devices are worn on portions of the body and a personnel monitoring device(s)
is required, at least one (1) such device shall be utilized as
follows:
4.2.14.1.2 When an apron
is worn, and one (1) monitoring device is worn, the monitoring device shall be
worn at the collar outside of the apron. If more than one (1) monitoring device
is worn, the devices shall be worn in accordance with
RHB 3.12.5.
4.2.14.1.3 The dose to the whole body based
on the maximum dose attributed to any one (1) critical organ shall be recorded
in the reports required by
RHB 3.22. If more than one (1)
device is used and a record is made of the data, each dose shall be identified
with the area where the device was worn on the body.
4.2.14.2 Exposure of a personnel monitoring
device to falsely indicate a dose delivered to an individual is
prohibited.
4.2.14.3 When an
individual who has been given responsibility that involves occupational
exposure to x-rays declares that she is pregnant, the employer must, at her
request, provide her with an additional personnel monitoring device to be worn
on the trunk underneath the leaded apron, when such apron is worn.
4.2.15 X-ray Log.
4.2.15.1 Each facility (excluding dental and
veterinary facilities) shall keep an x-ray log containing the patient's name;
the type of examination, given by title as denoted on the technique chart;
identification of the operator performing the examination; and the dates the
examinations were performed.
4.2.15.2 When the examination is performed
using any type of fluoroscopy, the log shall include a record of the amount of
time that fluoroscopy was performed or the number of times that the cumulative
timer was reset. The fluoroscopy time is not required to be recorded for
radiation therapy simulation units or instrument guided radiation therapy
units.
4.2.15.3 X-ray log records
shall be maintained for two (2) years or until the next Department inspection,
whichever is later.
4.2.16 Quality Assurance.
4.2.16.1 Each registrant covered under
RHB 4.5 through
4.12 must have "Equipment
Performance Tests" performed on each x-ray unit. The registrant is required to
meet the minimum performance criteria and test frequency. Facilities utilizing
x-ray equipment for teaching or demonstration purposes only are exempt from
this Part. Appendix F provides the required minimum performance criteria that
must be tested. Equipment performance tests results must include numerical
data. Items found to be non-compliant during such testing shall be corrected
within sixty (60) calendar days of receipt of the report. Records showing the
test results and the correction of any non-compliant items found must be
retained for five (5) years or until the next Department inspection, whichever
is later. Equipment performance tests are to be performed:
4.2.16.1.1 At the time installation at all
facilities, including veterinary facilities; or
4.2.16.1.2 Within thirty (30) calendar days
of installation, provided that the manufacturer's specified testing is
performed at the time of installation and before patient use; and
4.2.16.1.3 At the following specified
intervals thereafter:
4.2.16.1.3.1 Dental
intraoral and dental extraoral units shall be tested every two (2) years.
Dental computed tomography and dental handheld units shall be tested
annually.
4.2.16.1.3.2 All medical
x-ray equipment, including fluoroscopic, computed tomography, and radiation
therapy simulators, shall be tested annually. Self-calibrating bone
densitometry systems are exempt from this requirement. Mammography units shall
meet the requirements of Part V.
4.2.16.1.3.3 Veterinary facilities are
required to have equipment performance tests performed at the time of
installation, every five (5) years, and at any time the Department deems
necessary.
4.2.16.1.4 On
any unit expected to remain at a facility for more than thirty (30) calendar
days. If a unit is expected to remain at a facility for less than thirty (30)
calendar days, the manufacturer's specified testing must be performed, at a
minimum, prior to patient use. Mammography units shall meet the requirements of
Part V.
4.2.16.2 The
darkroom shall be light tight to the dark-adapted eye and use proper
safelighting such that a film exposed to x-radiation sufficient to produce an
optical density from 1 to 2 when processed shall not suffer an increase in
density greater than 0.1 when exposed in the darkroom for two (2) minutes with
all safelights on. If used, daylight film handling boxes shall preclude fogging
of the film.
4.2.16.3 If grids are
used between the patient and the image receptor to decrease scatter to the film
and improve contrast the grid shall:
4.2.16.3.1 Be positioned properly (i.e., tube
side facing the right direction, and grid centered to the central
ray).
4.2.16.3.2 If of the focused
type, be of the proper focal distance for the source-to-image receptor distance
(SIDs) being used.
4.2.16.4 Repeat Analysis.
4.2.16.4.1 Each registrant shall establish a
repeat analysis program. An analysis of repeats shall include, at a minimum,
the overall repeat rate and the causes for the repeats.
4.2.16.4.2 The repeat analysis shall be done
at least quarterly. Records shall be maintained for two (2) years or until the
next Department inspection, whichever is later.
4.2.16.4.3 Facilities with a single operator
may document reasons for repeats on the patient log in lieu of a repeat
analysis rate.
4.2.16.4.4
Registrants possessing dental or veterinary x-ray equipment are exempt from
this requirement.
4.2.17 X-ray Film Processing. Each installation using a radiographic x-ray system and using analog imaging systems (radiographic film) shall have available suitable equipment for handling and processing radiographic film in accordance with the following provisions:
4.2.17.1 Manual Film Processing Systems.
4.2.17.1.1 Processing tanks shall be
constructed of mechanically rigid, corrosion resistant material.
4.2.17.1.2 A dedicated darkroom thermometer
shall be used. The thermometer shall be used to adjust the film processing time
according to solution temperature.
4.2.17.1.3 A dedicated darkroom timer with an
adjustable preset function shall be used. The timer shall be used to adjust
film processing time according to solution temperature.
4.2.17.1.4 Documentation shall be kept of the
frequency at which film processing chemicals are changed. At a minimum, the
interval as recommended by the chemical manufacturer shall be used.
4.2.17.1.5 Safelight. If a safelight is used,
it shall be adequate for the film speed(s) used to prevent fogging of
unprocessed film.
4.2.17.1.6 The
temperature of solutions in the tanks shall be maintained within the range of
60°F to 80°F (16°C to 27°C). Film shall be developed in
accordance with the time-temperature relationships recommended by the film
manufacturer, or, in the absence of such recommendations, with the following
time-temperature chart:
TIME TEMPERATURE CHART
|
Thermometer Reading (Degrees) |
Minimum Developing Time (Minutes) |
|
|
°C |
oF |
|
|
26.7 |
80 |
2 |
|
26.1 |
79 |
2 |
|
25.6 |
78 |
2 1/2 |
|
25.0 |
77 |
2 1/2 |
|
24.4 |
76 |
3 |
|
23.9 |
75 |
3 |
|
23.3 |
74 |
3 1/2 |
|
22.8 |
73 |
3 1/2 |
|
22.2 |
72 |
4 |
|
21.7 |
71 |
4 |
|
21.1 |
70 |
4 1/2 |
|
20.6 |
69 |
4 1/2 |
|
20.0 |
68 |
5 |
|
19.4 |
67 |
5 |
|
18.9 |
66 |
5 1/2 |
|
18.3 |
65 |
6 |
|
17.8 |
64 |
6 1/2 |
|
17.2 |
63 |
7 |
|
16.7 |
62 |
8 |
|
16.1 |
61 |
8 1/2 |
|
15.6 |
60 |
9 1/2 |
4.2.17.1.7 Radiographs shall not be "sight
developed." 4.2.17.2 Automated Processors and Other Closed Processing
Systems.
4.2.17.2.1 The temperature
of film processing chemicals shall be appropriate for the type of film(s) being
processed at the film transport speed selected.
4.2.17.2.2 The film processing chemicals used
and their replenishing rate (if applicable) shall be appropriate for the film
transport speed selected.
4.2.17.2.3 Documentation shall be kept of the
frequency at which film processing chemicals are changed. At a minimum, the
interval recommended by the chemical manufacturer shall be used.
4.2.17.2.4 Safelight. If a safelight is used,
it shall be adequate for the film speed(s) used to prevent fogging of
unprocessed film.
4.2.17.2.5 Films
shall be developed in accordance with the time-temperature relationships
recommended by the film manufacturer, or, in the absence of such
recommendations, the film shall be developed using the following chart:
|
Developer Temperature |
Minimum Immersion Time * |
|
|
°C |
°F |
Seconds |
|
35 |
95 |
20 |
|
34 |
94 |
21 |
|
34 |
93 |
22 |
|
33 |
92 |
23 |
|
33 |
91 |
24 |
|
32 |
90 |
25 |
*Immersion time only, no crossover time included.
4.2.17.2.6 The specified developer
temperature shall be available.
4.2.17.2.7 The sensitometric performance of
an automatic processor shall be equivalent to other operating processor models
set up to meet the above developer temperature and immersion time
specifications. This is determined by processing identically exposed film
through each model and comparing the results.
4.2.17.2.8 Densitometric and sensitometric
performance testing.
4.2.17.2.8.1
Densitometric and sensitometric performance testing of the processor is
required of facilities that process more than two hundred fifty (250) films per
week.
4.2.17.2.8.2 Control limits
shall be established for each parameter monitored. Provisions for correctable
action shall be undertaken whenever the pre-established control limits are
exceeded.
4.2.17.2.8.3
Documentation of testing must be maintained for at least two (2) years or until
the next Department inspection, whichever is later.
4.2.17.2.8.4 Facilities processing more than
two hundred fifty (250) films per day are required to perform this testing on
each day that examinations are performed before any clinical films are
processed that day.
4.2.17.2.8.5
Facilities that operate twenty-four (24) hours per day must perform the
required testing once each day.
4.2.17.2.8.6 Registrants possessing dental or
veterinary x-ray equipment are exempt from this requirement.
4.2.17.2.9 Records of processor
maintenance shall be kept for at least two (2) years or until the next
Department inspection, whichever is later.
4.2.17.3 Other Requirements.
4.2.17.3.1 Film pass boxes, if provided,
shall be so constructed as to exclude light when film is placed in or removed
from the boxes, and shall incorporate adequate shielding to prevent exposure of
undeveloped film to stray radiation.
4.2.17.3.2 Film shall be stored in a cool,
dry place and shall be protected from exposure to stray radiation. Film in open
packages shall be stored in a light tight container.
4.2.17.3.3 Film cassettes and intensifying
screens shall be cleaned and replaced as necessary to best assure radiographs
of good diagnostic quality. Documentation of this periodic inspection and
cleaning must be maintained for at least two (2) years or until the next
Department inspection, whichever is later.
4.2.17.4 Outdated x-ray film shall not be
used for human diagnostic radiographs, unless the film has been stored in
accordance with the manufacturer's recommendations and a sample of the film
passes a sensitometric test for normal ranges of base fog and speed.
4.2.17.5 Film developing solutions shall be
prepared in accordance with the directions given by the manufacturer, and shall
be maintained in strength by replenishment or renewal so that full development
is accomplished within the time specified by the manufacturer.
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