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Quick Reference Guide


Types of Records Reviewed During Inspections


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 (    ). 

v      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 

v      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) 

v      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) 

v      Posting of Signs

Notice to Employees (.1002)

Radiation Caution Signs   (.1623 & .1624)  Click here for posting information 

v      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) 

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