Radiation-Emitting Products

MQSA Inspector's Questions

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Following are the questions that MQSA inspectors will address during the course of the annual inspection.

Mammography Quality Standards Act (MQSA)

Inspection Questions under the Final Regulations

 

Facility
           
Inspection Information                       
Inspector ID # & Inspector Name
Date (of inspection) (mm/dd/yyyy)
Accomplishing District
Annual Inspection Type (Select one) - Basic, Joint Audit, or Mentored
Accompanying Inspector (if Joint Audit or Mentored inspection type is selected)
Inspection Time (Hours)          
On-site (time spent at the facility)        
                     Other (pre- and post activities)
                     Total    Auto-calculated value from On-site and Other time entered
                      Travel Time (Hours)                
Software Version                     
Remarks (Text field for additional comments (printable and non-printable))
 
Facility Information                
Facility ID       
            Facility Name
            Facility) EIN  
            (Facility) FEI   
            Facility Type   
            Facility Category (Non-Federal or Federal)
           
Certificate       
Continuously operating with a valid certificate (y/n)
Displayed         (y/n)
Expiration Date (mm/dd/yyyy)
Remarks           (Text field for additional comments (printable and non-printable))
 
Additional Sites (If additional site is applicable)
Additional Site Name  
Mailing Address           
Line 1,
Line 2,
Line 3,
City, State, and Zip
           
Remarks (Text field for additional comments (printable and non-printable))
 
Contacts                     
Facility Accreditation Contact
First Name, MI, Last Name,
Title    
Contact Methods         
Phone, Ext,
Fax,
E-mail 
Mailing Address
Line 1,
Line 2,
Line 3,
City, State, and Zip      
                       
Facility Inspection Contact     
First Name, MI, Last Name
Title    
Contact Methods
Phone  
Ext
Fax
E-mail 
Mailing Address           
Line 1,
Line 2,
Line 3,
City, State, and Zip      
                       
Most Responsible Individual   
First Name, MI, Last Name      
Title    
Contact Methods         
Phone
Ext 
Fax      
Mailing Address           
Line 1,
Line 2,
Line 3,
City, State, and Zip      
 
Billing Contact
First Name, MI, Last Name 
Title 
Billing Company Name
Contact Methods         
Phone
Ext 
Fax      
Mailing Address           
Line 1,
Line 2,
Line 3,
City, State, and Zip      
 
 Inspection Report Contact
First Name, MI, Last Name 
Title 
Contact Methods         
Phone  
Ext      
                         Fax      
Mailing Address           
Line 1,
Line 2,
Line 3,
City, State, and Zip      
Remarks          (Text field for additional comments (printable and non-printable))
 
Image Output QC                   
Processor Performance QC     
Processor QC records: 
* Done on all days films processed        (y/n)
* C/A (before further exams) documented         (y/n/NA)
Laser Printer QC        
Laser Printer QC records:         
* Done at least weekly when hardcopy printed   (NA)
* C/A (before further images) documented        (NA)
RWS Monitor QC       
RWS Monitor QC records:       
* Done at frequency specified by output device manufacturer when clinical images are interpreted   (y/n/NA)
* C/A (before further images) documented        (y/n/NA)
Remarks          (Text field for additional comments (printable and non-printable))
 
Medical Records                     
Site Information         
Site Name        (selected site)
Evaluate           (y/n)
Evaluation       
System (to communicate results) adequate:       (y/n) 
                                                * System to provide medical reports within 30 days       (y/n)
                                                * System to provide lay summaries within 30 days         (y/n)
                                                * System to communicate serious cases ASAP   (y/n)
Random written reports:          
                                                * Number of random written reports reviewed ---          
                                                * Number with assessment categories ---
                                                * Number with qualified interpreting physician identification ---
Remarks           (Text field for additional comments (printable and non-printable))
 
Medical Audit and Outcome Analysis             
Site Information         
Site Name        (selected site)
Evaluate           (y/n)
Evaluation       
All positive mammograms entered in system     (y/n/NA)
Biopsy results present (or attempt to get)           (y/n/NA)
An audit (reviewing) interpreting physician is designated            (y/n/NA)
Analysis done annually (y/n/NA)
Done separately for each individual       (y/n/NA)
Done for the facility as a whole (y/n/NA)
 
Remarks          (Text field for additional comments (printable and non-printable))
 
Quality Assurance                  
Site Information
Site Name        (selected site)
Evaluate           (y/n)
Evaluation       
*QA personnel assigned            (y/n)
*Written S.O.P.s for QC tests    (y/n)
S.O.P. for infection control       (y/n)
S.O.P. for handling consumer complaints          (y/n)
Remarks          (Text field for additional comments (printable and non-printable))
 
Repeat Analysis QC                
Site Information         
Site Name        (selected site)
                                    Evaluate           (y/n)
                                    Evaluation       
Repeat analysis QC is adequate: (y/n) 
* Done at least quarterly           (y/n)
* Evaluation done         (y/n)
* C/A documented        (y/n)
 
Remarks          (Text field for additional comments (printable and non-printable))
 
Units               
 
Unit Evaluation    (selected unit)
 
Information    
Unit Number    Pre-filled - AB data
Mobile Checkbox
Room Name or Number           
Serial Number 
X-ray Unit still in Use   (No / Evaluate Records Only / Temporarily out of
Service /Yes)
Removed from Service Date      (mm/dd/yyyy)
Unit Type         (Screen-Film, Full-Field Digital, Computed Radiography, Digital Tomosynthesis)
Manufacturer   
Model  
AB Model        
Manufacture Date         (mm/dd/yyyy)
                       
Evaluation      
The x-ray system includes the following:          
* Appropriately sized compression paddle(s)      (y/n)
* Post-exp. display in AEC mode for focal spot (y/n/NA)
* Post-exp. display in AEC mode for target material       (y/n/NA)
This unit is accredited   (y/n/pending/NA)
This unit is new            (y/n/NA)
Mammo equip. evaluation (by medical physicist) done    (y/n/NA)
 
 Remarks          (Text field for additional comments (printable and non-printable))        
 
Phantom Image Quality Evaluation                
            Phantom image display method (inspector)        (AWS / RWS / Hardcopy)
            Phantom image display method (facility)           (AWS / RWS / Hardcopy)
            Phantom used   "RMI156" displayed
                       
Evaluation       Image 1 
* # of fibers 
* # of fiber artifacts 
* # of speck groups  
* # of specks in last group 
* # of specks artifacts
* # of masses 
* # of mass artifacts
 
Image 2
* # of fibers     
* # of fiber artifacts      
* # of speck groups      
* # of specks in last group                    
* # of specks artifacts   
* # of masses                                                   
* # of mass artifacts     
                       
Scores Image 1 calculations:  
 
* Fibers score 
* Fibers pass/fail 
* Specks score
* Specks pass/fail 
* Masses score 
* Masses pass/fail
           
Scores Image 2 calculations:   
 
* Fibers score   
* Fibers pass/fail          
* Specks score 
* Specks pass/fail         
* Masses score 
* Masses pass/fail         
                       
Remarks          (Text field for additional comments (printable and non-printable))
 
Quality Control                      
 
Phantom Image QC    
Number of operating weeks missing in which test not done at least once           
Image taken at clinical (+/-1 kVp) or manufacturer recommended setting (y/n)
C/A (before further exams) documented            (y/n/NA)
For mobile units (van, truck, ....)          
 * Performance verification after each move        (y/n/NA)
 
Compression Force QC           
Compression QC adequate:       (y/n)
                                    * Done at least semiannually     (y/n)
                                    * C/A (before further exams) documented         (y/n/NA)
SNR/CNR QC 
CNR QC          
                                    * Done at frequency specified by unit manufacturer       (y/n)
                                    * C/A (before further exams) documented         (y/n/NA)
                                   
SNR QC          
                                    * Done at frequency specified by unit manufacturer       (y/n)
                                    * C/A (before further exams) documented         (y/n/NA)
 
Remarks          (Text field for additional comments (printable and non-printable))
 
Survey Report            
 
Information    
Survey report available (y/n/NA)          
Date of previous survey (mm/dd/yyyy)
Date of current survey (mm/dd/yyyy)
                       
Dose value measured by physicist          (y/n)
* Dose value (mGy) reported     (x.xx);                        
* C/A taken before resuming clinical use (y/n)
Survey conducted or supervised by       
Action taken     (y/n/NA)
                       
Survey Report Part 1   
Resolution measurement   (y/n)
AEC performance – reproducibility (mAs)   (y/n/NA)
AEC performance capability   (y/n/NA)
Phantom image (y/n)
CNR   (y/n/NA)
SNR   (y/n/NA)
Artifact evaluation   (y/n)
                       
Survey Report Part 2 
                        Pass/fail list   (y/n)
                                    Recommendations for failed items   (y/n/NA)
                                    Physicist’s evaluation of technologist’s QC tests:   (y/n)
                                    * Processor QC   (y/n/NA)
                                    * Laser printer QC   (NA)
                                    * RWS QC   (y/n/NA)
                                    * Phantom image   (y/n)
                                    * CNR   (y/n/NA)
                                    * SNR   (y/n/NA)
                                    * Repeat analysis   (y/n)
                                    * Analysis of fixer retention   (y/n/NA)
                                    * Darkroom fog   (y/n/NA)
                                    * Screen-Film contact   (y/n/NA)
                                    * Compression   (y/n)
                                    Collimation:     (y/n) 
* X-ray field – light field   (y/n/NA)
* X-ray field – image receptor alignment   (y/n/NA)
* Compression device edge alignment   (y/n/NA)
kVp accuracy   (y/n)
kVp reproducibility   (y/n)
Beam quality (HVL) measurement   (y/n)
Uniformity of screen speed   (y/n/NA)
Radiation output   (y/n)
Decompression    (y/n/NA)
                       
Remarks          (Text field for additional comments (printable and non-printable))
                       
Personnel
                       
Interpreting Physicians
                       
Information    
Status   (Evaluate / Hold)
First Name, MI, Last Name      
Lead Interpreting Physician (check box)
                       
Evaluation       Rules qualifying under (Final / Interim)
 
                                    (If the inspector selected the “Interim” rules):
                                    Initial qualifications under interim rules met:   (y/n)
                                    * Licensed   (y/n)
                                    * Certified or 2 months training (y/n)
                                    * 40 CME hours   (y/n)
                                    * Initial experience adequate (y/n)
                       
                                    (If the inspector selected the “Final” rules):      
                                    Initial qualifications met:   (y/n)
                                    * Licensed   (y/n)
                                    * Certified or 3 months training   (y/n)
                                    * 60 category I CME hours   (y/n)
                                    * Initial experience adequate     (y/n)
                       
Date completed initial requirements   (mm/dd/yyyy)
 
Currently licensed   (y/n)
Trained in all applicable mammographic modalities
Trained mammographic modalities (check all that apply):
 [_]S/F [_]FFDM [_]DBT"   (y/n)
                       
Continuing experience 
                                    * Continuing experience adequate   (y/n/NA)
                                    * Number of exams in 24 months         
           
Continuing education  
                                    * CME credits adequate   (y/n/NA)
                                    * Number of CMEs in 36 months         
                       
Remarks          (Text field for additional comments (printable and non-printable))
 
Technologists
                       
Information    
Status   (Evaluate / Hold)
First Name, MI, Last Name      
                       
Evaluation       Rules qualifying under (Final / Interim)
                       
If the inspector selected the “Interim” rules):   
Initial qualifications under interim rules met:   (y/n)
* Licensed or certified   (y/n)
* Training specific to mammography   (y/n)
                       
(If the inspector selected the “Final” rules):      
Initial qualifications met:  (y/n)
* Licensed or certified  (y/n)
* 40 supervised hours of training adequate    (y/n)
           
Date completed initial requirements      (mm/dd/yyyy)
 
Currently licensed or certified   (y/n)
Trained in all applicable mammographic modalities
Trained mammographic modalities (check all that apply):
                                                [_]S/F [_]FFDM [_]DBT"        (y/n)
           
Continuing experience adequate   (y/n/NA)
                       
Continuing education  
                                    * CEU credits adequate   (y/n/NA)
                                    * Number of CEUs in 36 months         
                       
Remarks          (Text field for additional comments (printable and non-printable))
 
Medical Physicists
                       
Information    
Status   (Evaluate / Hold)
First Name, MI, Last Name     
                       
Evaluation       Degree qualifying under   (Bachelor's / Master's (or Higher) / None)
 
(If the inspector selected the “Master's (or Higher)” degree):      
 Initial qualifications met:   (y/n)
* Certified or state licensed/approved   (y/n)
* Master's (or higher) degree in a physical science   (y/n)
* 20 contact hours of training in surveys   (y/n)
* Experience in conducting surveys   (y/n)
                       
(If the inspector selected the “Bachelor's” degree):        
Alternate initial qualifications met before 04/28/1999:    (y/n)
* Certified or state licensed/approved     (y/n)
* Bachelor's degree in a physical science   (y/n)
* 40 contact hours of training in surveys   (y/n)
* Experience in conducting surveys   (y/n)
                       
(If the inspector selected the “None” degree):   
* Currently certified or state licensed approved
                       
Date completed initial requirements      (mm/dd/yyyy)
 
Currently certified or state licensed/approved     (y/n/certified);  
Trained in all applicable mammographic modalities
Trained mammographic modalities (check all that apply):
                                                [_]S/F [_]FFDM [_]DBT"           (y/n)
 
Continuing experience adequate   (y/n/x)
                       
Continuing education  
* CME credits adequate   (y/n/NA)
* Number of CMEs in 36 months         
                       
Remarks          (Text field for additional comments (printable and non-printable))
 
Summary
                       
Evaluation
Required personnel documents available   (y/n/NA)      
                       
Remarks          (Text field for additional comments (printable and non-printable))
                       
Completed Inspection Submission screen
                       
Inspection Information           
Facility ID       
Facility Name  
Facility Address           
Line 1
Line 2
Line 3
City, State, and Zip
                        Inspection ID   
                        Inspection Date
                        Inspection Type           
                        Inspector ID - Inspector Name
                        Annual Inspection Type ( Basic, Joint Audit or Mentored)
                        Accompanying Inspector    Inspector ID - Inspector Name
 
Noncompliances          
A table consisting of Section, Noncompliance Statement, Level, Repeat indicator List of noncompliances
 
Report Delivery          
Delivery Method          
Date Delivered/Sent      (mm/dd/yyyy)
                       
Notes   (Text field for additional comments (will not appear as Remarks))

Page Last Updated: 09/28/2015
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