[Intl_DxMedPhys] current MQSA policy on mammo RWS MEE testing

Wed Apr 1 11:26:04 EDT 2026

Jim,

We follow a similar approach to Colin by following the ACR FFDM manual for guidance when the display manufacturer's QC manual or the mammography system QC manual does not provide guidance on major repairs to the RWS.  As Bill indicated, we believe that using the ACR manual in this situation is valid since it is "substantially equivalent" to the manufacturer's QC program and substantially better than nothing.

However, based on a recent experience, our group has decided that any change to a mammography RWS that is not a simple relocation or software update requires an on-site evaluation.  We have frequently found that IT does not understand the QC software's function or the required settings resulting in non-compliant workstations following installation or reinstallation of the QC software.  In our group, we do not agree that these should fall under MP Oversight and require an on-site visit.  We believe that this puts our clients' best interests forward and is worth the extra workload.

Related Story:
Recently, one of our clients had their IT team replace the PC on the mammography RWS at several locations and not notify the QC tech or us that they did so.  We found out by chance while I was on site and the manager mentioned it to me.  The most recent RWS impacted was the same week the most distant was several months back.  Believing this to be a major repair on the RWS, we reached out to our state inspectors and the MQSA hotline for guidance.  Both agreed that replacing the RWS computer was a major repair and these sites were in a level 2 violation status since they were reading on them without having our report clearing them for clinical use.  MQSA hotline advised us to correct the problem and self-report the violation to the FDA.  Additionally, MQSA hotline informed me that replacing the video card was also a major repair which contradicts the ACR table.  Although, I don't know who is the ultimate authority that decides what is or is not a major repair.

Our team scrambled to get 10 or so RWS evaluated ASAP to get these workstations back into compliance.  All but one were found in compliance with the manufacturer's QC manual.  One of them did not have QA Web installed correctly, and IT was able to rectify the problem the next day.

So, what about the images read during the period of non-compliance?  Due to the time and number of sites involved, we had over a thousand exams that were read on noncompliant workstations.  The regulators advised that if we believed image quality was compromised, the images would need to be reread.  The radiologist group was in full panic mode.  Thankfully, we had QA Web data and tech QC data going back to when the computers were replaced on the compliant workstations.  Using this information, I was able to get both MQSA Hotline and our state inspectors to accept these records as proof that image quality was not compromised.  For the non-compliant workstation, we had the radiologist spot check several cases and write a letter stating they believed that image quality was not compromised.  Thankfully, for this site the RWS was only non-compliant for a little over a week.

For each site involved, we had to draft a report, gather supporting evidence, and update IT policies to make sure this wasn't going to happen again and send these reports to MQSA hotline.  The letter needed to be signed by a QMP and the lead interpreting physician (LIP) for each site.  Through my conversations with MQSA hotline and our inspectors, I was surprised to learn that neither body has the authority to require images to be reread due to non-compliance.  The decision to reread images or repeat exams resides solely with the LIP.

Our state inspectors were helpful throughout the process.  They were impressed by the response from the clients and accepted the reports as proof that the violation was discovered and "corrected before inspection" which would not result in the sites receiving a fine due to the violation.  The end result was the best possible outcome.  The sites did not have to reread or repeat any exams and no level 2 violations and accompanying citations were issued for any site.

Hope this helps,

Travis C. Greene, M.S., DABR
Senior Medical Physicist

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From: Intl_dxmedphys_wd_osu_list <intl_dxmedphys_wd_osu_list-bounces+tgreene=radser.com at lists.osu.edu> On Behalf Of Geiser, William R via Intl_dxmedphys_wd_osu_list
Sent: Wednesday, April 1, 2026 10:57 AM
To: Colin Paulbeck <cpaulbeck at jhu.edu>; Jim Tomlinson <jtomlinson at mpcphysics.com>; intl_dxmedphys_wd_osu_list at lists.osu.edu
Subject: Re: [Intl_DxMedPhys] current MQSA policy on mammo RWS MEE testing

That list that is highlighted has been superseded by a new table that can be found in the FAQ's for the ACR DM QC manual. Link to the FAQ's: ACR Accredita If you are not using the ACR DM QC manual then you must follow the QC manual
That list that is highlighted has been superseded by a new table that can be found in the FAQ's for the ACR DM QC manual.

Link to the FAQ's:  ACR Accredita<https://urldefense.com/v3/__https:/edge.sitecorecloud.io/americancoldf5f-acrorgf92a-productioncb02-3650/media/ACR/Files/Clinical/Quality-Control-Manuals/Mammography-QC-Manual-FAQs.pdf__;!!KGKeukY!w-3sRAtp4FyS57Dp_-1f_yN5qXYBxcKBjsI7MIDXO7R2NBWobCTMY8k-S_gKevOvE1n7UK72MCGZ_BDR9oVS6iy19_tSHQbFh_4mK3NOlg$>

[cid:image005.png at 01DCC1C7.5A368F50]

If you are not using the ACR DM QC manual then you must follow the QC manual requirements from the mammography unit manufacturer or the workstation manufacturer. See the FDA Small Entity Compliance Guide for more information. See Question 9 on Page 46 under Section O. Quality Control.

9. A facility recently had a part repaired/replaced on their mammography unit (and/or display device) and is not sure if it's a major component that would require an MEE. What does FDA recommend in this situation?
Facilities with digital mammography units must follow a quality assurance program that is substantially the same as the quality assurance program recommended by the image receptor manufacturer (mammography unit), except that the maximum allowable dose shall not exceed the maximum allowable dose for screen-film systems in 21 CFR 900.12(e)(5)(vi). (21 CFR 900.12(e)(6)). If it is unclear whether an MEE is indicated under the image receptor manufacturer's recommended quality assurance program for an adjustment, change, or repair of a digital mammography unit (or display device), the FDA recommends that the facility or its medical

Mammography Quality Standards Act and Regulation Amendments: Small Entity Compliance Guide - Guidance for Industry and Food and Drug Administration Staff<https://urldefense.com/v3/__https:/www.fda.gov/media/181152/download__;!!KGKeukY!w-3sRAtp4FyS57Dp_-1f_yN5qXYBxcKBjsI7MIDXO7R2NBWobCTMY8k-S_gKevOvE1n7UK72MCGZ_BDR9oVS6iy19_tSHQbFh_7oN_uP7Q$>

Bill Geiser, MS DABR FAAPM FACR
Senior Medical Physicist
Dept. of Imaging Physics
MD Anderson Cancer Center
Houston, TX 77030
Work Cell: 832-596-3158

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From: Intl_dxmedphys_wd_osu_list <intl_dxmedphys_wd_osu_list-bounces at lists.osu.edu<mailto:intl_dxmedphys_wd_osu_list-bounces at lists.osu.edu>> On Behalf Of Colin Paulbeck via Intl_dxmedphys_wd_osu_list
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Subject: [EXTERNAL] Re: [Intl_DxMedPhys] current MQSA policy on mammo RWS MEE testing

Hi James, I just went through this as we changed our breast PACS vendor which required a change in the computer tower that all the monitors were plugged into. I treated this situation as a "new installation", and did monitor testing before the
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Hi James,

I just went through this as we changed our breast PACS vendor which required a change in the computer tower that all the monitors were plugged into. I treated this situation as a "new installation", and did monitor testing before the radiologists started viewing images on them. It turned out to be pretty valuable, as some of the monitors weren't properly set up by our IT team. It was all simple issues, like an issue with improper Windows scaling (should be 100%), or Windows not correctly identifying certain monitors. So even though you'd be reloading the same software, if it's a fresh OS install, I'd say it's best practice to treat it as a new installation. You'll also want to make sure the QA Web (or whichever auto QA program is used for that monitor) was properly installed and the QA tests are all running on their schedule.

I was following the ACR QC Manual for all this. I did look somewhat thoroughly through the MQSA documentation and couldn't find anything specifically about monitors and video cards. Here's a screenshot of the relevant section from the ACR Manual.

[cid:image007.png at 01DCC1C7.5A368F50]

Colin

________________________________
Colin Paulbeck, PhD, DABR
Diagnostic Medical Physicist
Johns Hopkins Medicine, Baltimore MD
Office: 410-955-4181

From: Intl_dxmedphys_wd_osu_list <intl_dxmedphys_wd_osu_list-bounces at lists.osu.edu<mailto:intl_dxmedphys_wd_osu_list-bounces at lists.osu.edu>> On Behalf Of Jim Tomlinson via Intl_dxmedphys_wd_osu_list
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Subject: [Intl_DxMedPhys] current MQSA policy on mammo RWS MEE testing

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It's clear to me that when a mammo RWS image display is replaced, an MEE is required before reading mammograms. But there's been differing opinions about when the other parts of the RWS are replaced, like the tower/desktop computer. What is
It's clear to me that when a mammo RWS image display is replaced, an MEE is required before reading mammograms.  But there's been differing opinions about when the other parts of the RWS are replaced, like the tower/desktop computer.
What is the current MQSA policy on this?  I don't imagine that the power supply or motherboard would affect the image quality, but are there specific features of video cards that require testing?  What if the computer is replaced and the same software is reloaded?
What policy are most of you following?

James A. Tomlinson, M.S., FACR
Senior Vice President
Diagnostic Radiological Physicist, DABR
Medical Physics Consultants, Inc.
214 E. Huron Street, Ann Arbor, MI 48104
734.662.3197 (w) 810.571.0319 (c)

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