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The
facility shall maintain the following
documentation. These documents will be reviewed for
compliance with the regulations at the time of
inspection(s). Radiation rule reference in parenthesis
( ).
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For all
X-Ray Units
Copy of the plan review
(.0603)
Copy of the letter of
acknowledgement (.0210)
Copy of the post
installation room(s) survey (.0603)
Copy of the Form FDA
2579, FDA Report of Assembly Form
(.0206) and Federal Part
21 CFR Part 1020
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General
Documents
Current copy of the
Notice of Registration from RPS
(.0203) & (.0209)
Previous inspections
reports and correspondence regarding inspections with
RPS (.1002)
Current copy
of the State Regulations (2002 latest edition) (.1002)
Dosimetry Records for
Personnel (.1638 & .1644)
Technique charts posted
visibly and current for all procedures. Chart should
include patient’s anatomical size versus technique
factors at a given source to image distance (SID).
(.0603(a)(1)(C)
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Radiation Safety Program
Current copy of the
radiation safety program (.1603 and .1636) Click
here for guidance
Reviewed annually by the
RSO and signed (.1603)
Reviewed annually and
when changes occur by all operators and signed
(.1603)
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Posting
of Signs
Notice to Employees
(.1002)
Radiation Caution
Signs (.1623 & .1624)
Click here
for posting information
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Other
Items of Interest
Brand, type and emitting
color of film
Brand, type and emitting
color of screens
Film/Screen combination
speed
Type of processor
chemicals (MSDS sheets for chemistry)
Type and wattage of
safelight in darkroom
Type of filter on
safelight in darkroom and date last changed
Film storage procedures
and policy
Shielding devices and
procedures (lead aprons) |
