1. Radiation
Safety Requirements. The registrant shall be responsible for directing the
operation of the x-ray system(s) under his administrative control. The
registrant or the registrant's agent shall assure that the requirements of
these regulations are met in the operation of the x-ray system(s).
a. An x-ray system which does not meet the
provisions of these regulations shall not be operated for diagnostic purposes
(if so directed by the Agency).
b.
Individuals who will be operating the x-ray systems shall be adequately
instructed in the safe operating procedures and be competent in the safe use of
the equipment. See Appendix A for a list of subject matters pertinent to this
requirement. The Agency may use interview, observation and/or testing to
determine compliance.
c. A chart
shall be provided in the vicinity of the diagnostic x-ray system's control
panel which specifies, for all examinations performed with that system, the
following information:
i. patient's body part
and anatomical size, or body part thickness, or age (for pediatrics), versus
technique factors to be utilized;
ii. type and size of the film or screen-film
combination to be used;
iii. type
and focal distance of the grid to be used, if any;
iv. source to image receptor distance to be
used (except for dental intraoral radiography); and
v. type and location of placement of patient
shielding (i.e., gonad, etc.) to be used.
d. The registrant of a facility shall
establish and make available to x-ray operators written safety procedures,
including patient holding and any 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 these procedures.
e. Except for human 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. Other than the patient being examined:
i. 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 millimeter lead equivalent material.
ii. The x-ray operator, other staff,
ancillary personnel, and other persons required for the medical procedure shall
be protected from the direct scatter radiation by protective aprons or whole
body protective barriers of not less than 0.25 millimeter lead equivalent
material.
iii. Human patients who
cannot be removed from the room shall be protected from the direct scatter
radiation by whole body protective barriers of not less than 0.25 millimeter
lead equivalent material, or shall be so positioned that the nearest portion of
the body is at least 2 meters from both the tube head and the nearest edge of
the image receptor.
f.
Gonad shielding of not less than 0.5 millimeter lead equivalent material shall
be used for human patients, who have not passed the reproductive age, during
radiographic procedures in which the gonads are in the useful beam, except for
cases in which this would interfere with the diagnostic procedure.
g. Individuals shall not be exposed to the
useful beam except for healing arts purposes and unless such exposure has been
authorized by a licensed practitioner of the healing arts. This provision
specifically prohibits deliberate exposure for the following purposes:
i. exposure of an individual for training,
demonstration, or other non-healing-arts purposes; and
ii. exposure of an individual for the purpose
of healing arts screening except as authorized by 1.6.3(1)(k).
h. When a patient or
film must be provided with auxiliary support during a radiation exposure:
i. mechanical holding devices shall be used
when the technique permits. The written safety procedures, required by
1.6.3(1)(d), shall list individual projections where holding devices cannot be
utilized;
ii. written safety
procedures, as required by 1.6.3(1)(d), shall indicate the requirements for
selecting a holder and the procedure the holder shall follow;
iii. the human holder shall be instructed in
personal radiation safety and protected as required by 1.6.3(1)(e);
iv. no individual shall be used routinely to
hold film or patients;
v. 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 millimeter
lead equivalent material;
vi. when
an animal must be held by an individual during an exposure, that individual
shall be protected with appropriate shielding devices, such as leaded aprons
and gloves, and shall be positioned such that no part of his or her body shall
be struck by the useful beam; and
vii. each facility must have leaded aprons
and gloves available in sufficient numbers to provide protection to all
personnel who are involved with x-ray operations and who are otherwise not
shielded.
i. Procedures
and auxiliary equipment designed to minimize patient and personnel exposure
commensurate with the needed diagnostic information shall be utilized.
i. 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, with the
exception of standard film packets for intraoral use in dental
radiography.
ii. The radiation
exposure to the patient shall be the minimum exposure required to produce
images of good diagnostic quality.
iii. 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.
iv. X-ray systems subject to 1.6.6 shall not
be utilized in procedures where the source to patient distance is less than 30
centimeters except for veterinary systems.
v. If grids are used between the patient and
the image receptor to decrease scatter to the film and improve contrast the
grid shall:
vi. Be positioned
properly, i.e., tube side facing the right direction, and grid centered to the
central ray.
vii. If of the focused
type, be of the proper focal distance for the SIDs being
used.
j. All individuals
who are associated with the operation of an x-ray system are subject to the
requirements of 1.4.5 and 1.4.7 of these regulations. In addition:
i. When protective clothing or devices are
worn on portions of the body and a personnel 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 of the apron.
ii. The dose to the whole body based on the
maximum dose attributed to the most critical organ shall be recorded in the
reports required by 1.4.6 of these regulations. If more than one 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.
ii. Exposure of a personnel monitoring device
to deceptively indicate a dose delivered to an individual is
prohibited.
k. Healing
Arts Screening. Any person proposing to conduct a healing arts screening
program shall not initiate such a program without prior approval of the Agency.
When requesting such approval, that person shall submit the information
outlined in Appendix B of this Subchapter. If any information submitted to the
Agency becomes invalid or outdated, the Agency shall be immediately
notified.
l. Information and
Maintenance Record and Associated Information. The registrant shall maintain
the following information for each x-ray system for inspection by the Agency:
i. model and serial numbers of all major
components, and user's manuals for those components;
ii. tube rating charts and cooling
curves;
iii. records of surveys,
calibrations, maintenance, and modifications performed on the x-ray system(s);
and
iv. a copy of all
correspondence with this Agency regarding that x-ray system.
m. X-Ray Log. Each facility shall
maintain an x-ray log containing the patient's name, the type of examinations,
and the dates the examinations were performed. When the patient or film must be
provided with human auxiliary support, the name of the human holder shall be
recorded.
n. A sign shall be posted
in a conspicuous area 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 should
be notified. Prescription of x-ray examinations of pregnant or possibly
pregnant patients shall assure that medical consideration has been given to
possible fetal exposure and appropriate protective measures are taken.
2 X-ray Film Processing Facilities and
Practices. Each installation using a radiographic x-ray system and using
analog image receptors (radiographic film) shall have available suitable
equipment for handling and processing radiographic film in accordance with the
following provisions:
a. Manually
developed film:
i. Processing tanks shall be
constructed of mechanically rigid, corrosion resistant material; and
ii. 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 time-temperature chart below:
Time-Temperature Chart |
Thermometer Reading (Degrees) |
Minimum Developing Time (Minutes) |
°C |
°F |
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 1/2 |
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 |
iii. Devices shall be utilized which will:
i. Indicate the actual temperature of the
developer; and
ii. Signal the
passage of a preset time appropriate to the developing time required.
b. Automatic Processors
and Other Closed Processing Systems:
i. Films
shall be developed in accordance with the time-temperature relationships
recommended by the film manufacturer; in the absence of such recommendations,
the film shall be developed using the chart below:
Developer Temperature (Degrees) |
Minimum Immersion Time:* (Seconds) |
°C |
°F |
35.5 |
96 |
19 |
35 |
95 |
20 |
34.5 |
94 |
21 |
34 |
93 |
22 |
33.5 |
92 |
23 |
33 |
91 |
24 |
32 |
90 |
25 |
31.5 |
89 |
26 |
31 |
88 |
27 |
30.5 |
87 |
28 |
30 |
86 |
29 |
29.5 |
85 |
30 |
*Immersion time only, no crossover time included.
ii. The specified developer
temperature and immersion time shall be posted in the darkroom or on the
automatic processor.
c.
Other Requirements
i. Pass boxes, if
provided, shall be so constructed as to exclude light from the darkroom when
cassettes are placed in or removed from the boxes, and shall incorporate
adequate shielding from stray radiation to prevent exposure of undeveloped
film.
ii. The darkroom shall be
light tight and use proper safelighting such that any film type in use exposed
in a cassette 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 (0.02
for mammography) when exposed in the darkroom for 2 minutes with all safelights
on. If used, daylight film handling boxes shall preclude fogging of the
film.
iii. Darkrooms typically used
by more than one individual shall be provided a positive method to prevent
accidental entry while undeveloped films are being handled or
processed.
iv. 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.
i. Film cassettes and intensifying screens
shall be inspected periodically and shall be cleaned and replaced as necessary
to best assure radiographs of good diagnostic quality.
ii. 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 plus fog and speed.
iii. 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.
Miss. Code Ann.
§
45-14-11