MQSA Inspection Preparation and EQUIP Assistance – Pre-Consultation Questions

Facility Information

This form must be filled out prior to your consultation. Please email Jen Neely if you have any questions: jen@mammographyeducators.com

Facility or Hospital (where the training will be held)*

Does your facility have multiple sites/locations?*

Yes
No

Equipment Information

What is the mammography equipment manufacturer and model?*

Does your facility follow the ACR Digital QC Manual or the manufacturer's QC manual?*

ACR Digital QC Manual
Manufacturer's QC Manual

Has your facility had any software upgrades on your machine in the last 12 months/since the last inspection.*

Yes
No

Exam Information

Does your facility perform screening and diagnostic mammography exams?*

Yes
No

Does your facility perform procedures? (I.e. stereotactic, localizations, CEM)*

Yes
No

If yes, what type of procedures?*

Does your state have requirements for breast density in addition to the FDA's requirements?*

Yes
No

Does your facility provide lay letters in another language other than English?*

Yes
No

If yes, please provide other languages:*

Radiologist Information

Does your facility have radiologists who interpret exams off-site?*

Yes
No

If so, how many off-site locations/monitors are there?*

Personnel Information

Who does the QC testing at your facility (list name, credentials & how long the individual has been performing mammography QC)?*

Please confirm that the following necessary items will be completed and available when the consultant arrives on-site:

Printed sample of reports and lay letters for each BIRADS category (or provide templates)*

Yes
No

If no, please explain:*

All QA binders are out and available for review: personnel (Medical Physicist, Radiologists, Technologists), P&P, EQUIP, QC, Medical Outcomes Audit, and equipment*

Yes
No

If no, please explain:*

Equipment service reports are filed and will be available.*

Yes
No

If no, please explain:*

A copy of the monitor QC manual is included/accessible.*

Yes
No

If no, please explain:*

All QC for all rad monitors are available for review from the previous inspection to the present.*

Yes
No

If no, please explain:*

All Medical Physicist reports for all rad monitors are available for review from the previous inspection to the present.*

Yes
No

If no, please explain:*

Provide a copy of your current FDA certificate and ensure it is posted.*

Yes
No

If no, please explain:*

Proper documentation is available for review of any corrective action.*

Yes
No

If no, please explain:*

A review of your P&P manual to ensure that you have the necessary P&Ps written and in place will be completed.*

Yes
No

A list of P&Ps can be found on the checklist and the FDA website: https://www.fda.gov/radiation-emitting-products/mammography-quality-standards-act-mqsa-and-mqsa-program

If no, please explain:*

Additional Information

Any additional information/details we should know?

CAPTCHA

Pre-Consultation Questions

MQSA Inspection Preparation and EQUIP Assistance Training

Facility Information

Equipment Information

Exam Information

Radiologist Information

Personnel Information

Please confirm that the following necessary items will be completed and available when the consultant arrives on-site:

Additional Information