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

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)

Facility Type (check one from pop-up list)

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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)

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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)

- 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*  

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		       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 ----

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                      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)

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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

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3.6 Processors - List  (status, number, room, site, model)

3.6 Processors – Information  

Processor

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)

Developer

Manufacturer (pop-up list)

Type (pop-up list)

Processing Cycle (Standard, Extended) [check one]

3.6 Processors – Evaluation  

Processor equip. evaluation (by medical physicist) done? (y/n/x)

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

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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)

(ead 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  

Processor QC Records

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)

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3.9.2 Phantom Image QC  

3.9.2 Phantom Image QC – Unit List  

3.9.2 Phantom Image QC – Evaluation  

Number of operating weeks missing xx

(in worst consecutive 12-week period)

C/A (before further exams) documented? (y/n/x)

(for failing image score, background density or contrast)

Other phan. QC records/test conditions adeq?(y/n)

Image taken at clinical (*1kVp) setting?

BD > or = 1.20

For mobile units (van, truck,..):

Performance verification after each move? (y/n)

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:

Monitor QC done per manufacturer’s recomm.? (y/n)

If “Laser film” or “Other” was checked for the display mode, then:

Manufacturer recommended procedures used? (y/n)

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]

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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)

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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  

Rules qualifying under (interim, final)

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)

If you selected the final rules:

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

Continuing education

CME credits adequate? (15/36 m) (y/n/x)

If “n”, then:

Number of CME’s in 36 months zzz

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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

If you checked the final rules:

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]

If you selected “Bachelors&rdquo:

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 results) adequate? (y/n)

System to provide medical reports in 30 days? (y/n)

[to referring health care providers and or self-referred patients]

System to provide lay summaries in 30 days? (y/n)

[to all patients]

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)

3.5  Units - Evaluation

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Page Last Updated: 08/04/2014
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