Radiation-Emitting Products
MQSA Inspector's Questions
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
1.0 Inspection Information
1.1 Name and Address
1.2 Equipment Registration
2.0 Facility Inspection Download
3.0 Facility Inspections
3.0 Facility Inspections - List
3.0 Facility Inspections - Facility
(Certificate) Expiration Date mm/dd/yyyy
(Certificate) Displayed (y/n)
Operating with a valid* certificate? (y/n)
(Facility) Name
(Facility) ID
(Facility) CFN
(Facility) EIN
Facility Category (check one)
Non Federal
Federal (Air Force, Army, Bureau of Prisons, Indian Health Service, Navy, VA)
3.0 Facility Inspections - Address
(Number & street, city, state, & zip code)
Address changes (double click to access new screen)
3.0 Facility Inspections - Inspection
Inspector Name & ID #
Date (of inspection) mm/dd/yyyy
Accomplishing District
Inspection Time (hours)/p>
On-site (time spent at the facility)
Other (pre-and post activities)
Travel Time (hours)
Annual Inspection Type** (check one)
Basic
Joint Audit
Mentored
Accompanying Inspector (if joint or mentored is checked)
Regulation Enforcement (Interim, Final)
Software Version
3.1 Aliases
3.2 Additional Sites (name & address info, if applicable)
3.3 Contacts
3.3.1 Facility Accreditation Contact
3.3.2 Facility Inspection Contact
3.3.3 Compliance Contact
3.3.4 Billing Contact
3.3.5 Inspection Report Contact
3.4 Related Equipment
3.5 Units – List (unit number, room, status & other info)
3.5 Units - Information
(X Ray unit) Number
(X Ray unit) Room name or number
Serial Number
X-ray unit still in use? (No/Evaluate Records Only/Temporarily out of Service/Yes)*
Manufacturer
Model
AB Model
Manufacture Date - (mm/dd/yyyy)
Is the unit mobile (van, truck,..)? (y/n)
Image Receptor (IR) Type (Film-Screen/Xeromam./Digital)
If D is pre-filled, then:
Display Method (Monitor/Laser film/Other)
3.5 Units - Screen-Film
Film Manufacturer (pop-up list)
Film Type (pop-up list)
Screen Manufacturer (pop-up list)
Screen Type (pop-up list)
3.5 Units - Evaluation
X-Ray unit designed for mammography? (y/n)
Does x-ray system include the following? (y/n)
- Image Receptors for 2 sizes?
- Moving Grids for 2 sizes?
- Compression Paddles for 2 sizes?
- Post exp. display in AEC mode for focal spot?
- Post exp. display in AEC mode for target material)?
X-Ray unit accredited? (y/n/pending/x)
[in this list, “x” refers to “N/A or not applicable”]
Is this a new* unit? (y/n/x)
Mammo equipment evaluation (by m. phy.) done? (y/n/x)
3.5.1 Collimation Assessment
Source to Image Distance (SID) (cm) --.-
Source to Patient Support Distance (SPSD) (cm) --.-
X-ray field/IR misalignment
Left (cm) --.-
Right (cm) --.-
Nipple (cm) --.-
Chest wall] (cm) --.-
IR/Paddle alignment
Is paddle image on the film? (y/n)
Compression paddle/IR chest wall edge (cm) --.-
3.5.2 Dose Estimate - Technique Factors
Target/filter (Mo/Mo, Mo/Rh, Other)
Focal Spot to Patient Support (same as SPSD) (cm) --.-
Mode (Auto [mAs, kVp, or full] / Manual)
(Pre-Exposure) SETTINGS (if indicated)
kVp -- mAs ---- Time--- Density (setting) –
3.5.2 Dose Estimate – Cassette Variability*
MDH
C.ID mAs Exp. (mR) Exp. Time (ms)
Cassette#1 ---- ----- ----- ----- ----
Cassette#2 ---- ----- ----- ----- ----
Cassette#3 ---- ----- ----- ----- ----
3.5.2 Dose Estimate – Reproducibility
(exposure) # 1
mAs (post exp) ----
Exposure (mR) ----
Pulse duration (millisec) ----
(Program will ask for above data entries for 3 or 9 additional times)
3.5.2 Dose Estimate – Beam Quality (HVL)
Settings
kVp (copied from the Technique Factors screen)
mAs ----
Exposure Values (mR)
0.0 mmAl ----
0.1 mmAl ----
0.2 mmAl ----
0.3 mmAl ----
0.4 mmAl ----
0.5 mmAl ----
3.5.2 Dose Estimate – Summary Results
ESE ----
COV ----
Beam Quality (HVL) ----
Mean Glandular Dose (MGD)
3.5.3 Phantom Image Quality Evaluations
Image #1 Image #2
Background density (0-4.00) ---- ----
# of Fibers (x.x) ---- ----
# of Fiber Artifacts (0 or 1) ---- ----
# of Speck Groups (integer) ---- ----
# of Specks in last group (integer) ---- ----
# of Speck Artifacts (integer from 0 to 6)---- ----
# of Masses (x.x) ---- ----
# of Mass Artifacts (0 or 1) ---- ----
Net Scores Compliance
0.0 0.0 Fibers p/f
0.0 0.0 Specks p/f
0.0 0.0 Masses p/f
3.6 Processors - List (status, number, room, site, model)
3.6 Processors – Information
Status (Evaluate all, Hold, Evaluate records only)
Number ------
Room name or number-------
Site (if applicable, select from list)
Type (Primary, Back-up)
Manufacturer (pop-up list)
Model (pop-up list)
Manufacturer (pop-up list)
Type (pop-up list)
Processing Cycle (Standard, Extended) [check one]
3.6 Processors – Evaluation
3.6 Processors – STEP Test
Ref. Step # xx.y
Base+Fog y.zz
Strip 1 (entries below repeated for strips 2, 3, & 4)
Lower step number (integer) --
Lower step density (x.xx) ----
Higher Step number (integer) --
Higher Step density (x.xx) ---
(STEP Test Result)
Processing Speed (PS) ---- (pass/fail)
3.7 Darkrooms – List (status, room, site)
3.7 Darkrooms – Information
Status (Evaluate all, Hold, Evaluate records only)
Room name or number -------
Site Name (if applicable, or defaults to facility) ----
3.7 Darkrooms – Evaluation
Border Visible? (y/n)
Unfogged Area O.D. y.zz
Fogged Area O.D. y.zz
Fog Density (FD)(calculated) y.zz
3.8 Quality Assurance (QA) Program
3.8 QA Program – Sites (Evaluation status & name)
3.8 QA Program – Evaluation
Do the QA records include the following? (y/n)
- QA Personnel Assigned? (y/n)
(lead I.P., QC technologist, med. physicist)
- Technique Tables/Charts? (y/n)
- Written S.O.P.’s for QC tests? (y/n)
(with acceptable limits for each)
S.O.P. for infection control?
(handling blood & other infectious materials)
S.O.P. for handling consumer complaints?
3.9 Quality Control
3.9.1 Processor Performance QC – Processor List
3.9.1 Processor Performance QC – Evaluation
Worst/Sampling Month/Yr. mm/yyyy
# days processed mammograms (in worst mo.) dd
# of processing days without recorded data dd
Calculated % for not recording
# of consecutive processing days (cd) missed
# of days/yr. operated out-of-limits(ool)
C/A (before further clinical use) Documented? (y/n/x)
3.9.1 Processor Performance QC – Evaluation
Fixer retention QC adequate (y/n)
- Done at the required frequency? (y/n)
- C/A (30 days) Documented? (y/n/x)
3.9.2 Phantom Image QC
3.9.2 Phantom Image QC – Unit List
3.9.2 Phantom Image QC – Evaluation
(in worst consecutive 12-week period)
C/A (before further exams) documented? (y/n/x)
(for failing image score, background density or contrast)
Image taken at clinical (*1kVp) setting?
BD > or = 1.20
3.9.3 Compression QC
3.9.3 Compression QC – Unit List
3.9.3 Compression QC – Evaluation
Compression QC adequate? (y/n
- Done at the required frequency? (y/n)
- C/A (before further exams) Documented? (y/n/x))
3.9.4 Repeat Analysis QC
3.9.4 Repeat Analysis QC – Site List
3.9.4 Repeat Analysis QC - Evaluation
Repeat Analysis QC adequate? (y/n)
- Done at the required frequency?
- Evaluation done (y/n)
(cause of repeats determined for changes> +- 2%)
- C/A (30 days) Documented? (y/n/x)
3.9.5 Screen-Film Contact QC
3.9.5 Screen-Film Contact QC – Site List
3.9.5 Screen-Film Contact QC - Evaluation
Screen-Film Contact QC adequate? (y/n)
- Done at the required frequency? (y/n)
- All mammography cassettes in use tested? (y/n)
- 40 Mesh copper test tool used? (y/n)
- C/A (before further exams) Documented? (y/n/x)
3.9.6 Darkroom Fog QC – Darkroom/Site List
3.9.6 Darkroom Fog QC - Evaluation
Darkroom Fog QC adequate? (y/n)
- Done at the required frequency?
- Background Density > or = 1.20? (y/n/x)
- C/A (before further exams) Documented? (y/n/x)
3.9.7 Digital Mammography QC – Unit List
3.9.7 Digital Mammography QC - Evaluation
Manufacturer recommended QC procedures followed? (y/n)
If “Monitor” only was checked for display mode:
3.10 Survey Report – Unit List
3.10 Survey Report - Information
Survey report available? (y/n/x)
Date of previous survey (mm/dd/yyyy)
Date of current survey (mm/dd/yyyy)
Survey conducted or supervised by -----
Dose value (mrad) reported ----
C/A taken before resuming clinical use? (y/n)
Action Taken (if called for in Report)?(y/n/x)
Rules conducted under (Interim/Final)
Survey Complete (y/n): [determined by program]
3.10.1 Survey Report Part 1 - Results
Overall Survey Complete: [determined by program]
Part 1 Complete: [determined by program]
3.10.1 Survey Report Part 1 - Evaluation
Focal Spot Size/Resolution Measurement (y/n)
- Done for all clinically used focal spots?
- Numerical results given?
AEC Performance
- Reproducibility (mAs) (y/n)
- Numerical results given?
- Performance Capability (y/n)
- Done for 2, 4, and 6 cm at typical kVp(s)?
- Numerical results given?
Dose (including entrance air kerma reprod.)(y/n)
- Exposure & HVL at same clinical kVp?(y/n/u)
- RMI156 or equivalent phantom? (y/n/u)
- Numerical results given?
Phantom Image (y/n)
- Done at the kVp normally used clinically?
- RMI156/equivalent phantom? (y/n/u)
- 3 object scores given?
Artifact Evaluation (y/n)
QC Tests - New Modality (if applicable) (y/n/x)
3.10.2 Survey Report Part 2 - Results
Overall Survey Complete: [determined by program]
Part 2 Complete: [determined by program]
3.10.2 Survey Report Part 2 – Evaluation
Pass/fail list (y/n)
Recommendations for failed items (y/n/x)
Physicist's Evaluation of Tech's QC Tests (y/n)
- Processor QC? [for each processor]
- Phantom image? [for each x-ray unit]
- Repeat analysis?
- Analysis of fixer retention? [for each processor]
- Darkroom fog? [for each darkroom]
- Screen film contact? [for all cassettes]
- Compression? [for each x-ray unit]
Collimation (y/n)
- X Ray Field Light Field (y/n/x)
- X Ray Field Image Receptor Alignment
- Compression Device Edge Alignment
kVp Accuracy (y/n)
- Done at these 3 clinical kVps?
- Numerical results given?
kVp Reproducibility (y/n)
- Done at the kVp most commonly used clinically?
- Numerical results given?
Beam Quality (HVL) Measurement (y/n)
- Done at the kVp most commonly used clinically?
- Numerical results given?
Uniformity of Screen Speed (y/n)
- Numerical results given?
Radiation Output (y/n)
Decompression (y/n)
3.11 Personnel (list of status & names of all personnel)
3.11.1 Interpreting Physicians - List
3.11.1 Interpreting Physicians – Information
Status (Evaluate, Hold)
Name xxx [FIRST, M.I., LAST]
UPIN
Lead interpreting physician ( )
3.11.1 Interpreting Physicians – Evaluation
If you selected the interim rules:
Initial qualifications under interim rules met? (prior to 4/28/99) (y/n)
- Licensed?
- Certified or 2 months training?
- 40 CME hours
- Initial experience adequate? (240 exams/6 months)
Initial qualifications met? (y/n)
- Licensed?
- Certified or 3 months training?
- 60 category I CME hours?
- Initial experience adequate? (240 exams/6 months)
Date completed initial requirements mm/dd/yyyy
New modality training (8 hrs.) (if applicable) (y/n/x)
Continuing experience
Continuing experience adequate? (y/n/x)
(960 exams/24 months) If “n”, then:
Number of exams in 24 months yyy
CME credits adequate? (15/36 m) (y/n/x)
If “n”, then:
Number of CME’s in 36 months zzz
3.11.2 Technologists - List
3.11.2 Technologists - Information
Status (Evaluate, Hold)
Name yyy [FIRST, M.I., LAST]
3.11.2 Technologists - Evaluation
Rules qualifying under (interim, final)
If you selected the interim rules:
Initial qualifications under interim rules met?(y/n) [prior to 4/28/99]
- Licensed or certified
- Training specific to mammography
Initial qualifications met? (y/n)
- Licensed OR Certified? (y/n)
- 40 supervised hours of training adequate? (y/n/c) [Includes subject training &25 supervised exams]
Date completed initial requirements mm/dd/yyyy
New modality training (8 hrs.) (if applicable) (y/n/x)
Continuing experience adequate? (y/n/x)
[200 exams/24months]
Continuing education
CEU credits adequate? (15/36 months) (y/n/x)
If “n”, then :
Number of CEU’s in 36 months xxx
3.11.3 Medical Physicists - List
3.11.3 Medical Physicists - Information
Status (Evaluate, Hold)
Name yyy [FIRST, M.I., LAST]
3.11.3 Medical Physicists - Evaluation
Degree qualifying under (Masters/higher, Bachelors, None)
If you selected “Masters (or higher)”:
Initial qualifications met? (y/n)
- Certified or state licensed/approved? (y/n)
- Masters degree in a physical science? (y/n)
[w/20 semester hours in physics]
- 20 contact hours of training in surveys? (y/n)
- Experience in conducting surveys? (y/n)
[1 facility & 10 units]
Alternative initial qualif. met before 4/28/99? (y/n)
- Certified or state licensed/approved? (y/n)
- Bachelor’s degree in a physical science? (y/n)
[w/10 semester hours in physics]
- 40 contact hrs. training in surveys? (y/n)
[after Bachelors]
- Experience in conducting surveys? (y/n)
[after Bachelors, 1 facility & 20 units]
If you selected “None”, the program will answer “n” to all the questions above
Date completed initial requirements mm/dd/yyyy
New modality training (8 hrs) (if applicable) (y/n/x)
Continuing experience adequate? (y/n/x) [2 facilities & 6 units/24months)]
Continuing Education
CME Credits/year adequate? (15/36 months) (y/n/x) If “n”, then :
Number of CME’s in 36 months xxx
3.11.4 Summary - Evaluation
For all personnel categories:
Required documents available? (y/n/x)
3.12 Medical Records – Site List
3.12 Medical Records – Evaluation
System to communicate serious cases ASAP? (y/n)
[Serious: suspicious or highly suggestive cases]
Random written reports
Number of random written reports reviewed ----
Number with assessment* categories ----
Number with qualified interpreting physician identification
3.13 Medical Audit and Outcome Analysis – Site List
3.13 Medical Audit and Outcome Analysis – Evaluation
- ALL positive mammograms entered in system? (y/n/x)
- Biopsy results present (or attempt to get) (y/n/x)
- Is there a designated audit (reviewing) interpreting physician? (y/n/x)
- Analysis done annually? (y/n/x)
- Done separately for each individual? (y/n/x)
- Done for the facility as a whole? (y/n/x)
