[Intl_DxMedPhys] current MQSA policy on mammo RWS MEE testing

Wed Apr 1 11:23:03 EDT 2026

Thank you all for your responses and advice.

*James A. Tomlinson, M.S., FACR*

Senior Vice President

Diagnostic Radiological Physicist, DABR

Medical Physics Consultants, Inc.

214 E. Huron St, Ann Arbor, MI 48104

734.662.3197 (w)  810.571.0319 (c)

*From:* Geiser,William R [mailto:wgeiser at mdanderson.org]
*Sent:* Wednesday, April 1, 2026 10:57 AM
*To:* Colin Paulbeck; Jim Tomlinson;
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That list that is highlighted has been superseded by a new table that can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
<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!xWJGHcI9uqRCpLvV2TKOvZrnTLYh_L46TpqLuwWyBxae3IRZ9V9xnrkmHywv_J0_sAPxYsnx7TbnaBA19P3QE9feuzNQcfaXbB-6Bsj9zjylSA$ >

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!xWJGHcI9uqRCpLvV2TKOvZrnTLYh_L46TpqLuwWyBxae3IRZ9V9xnrkmHywv_J0_sAPxYsnx7TbnaBA19P3QE9feuzNQcfaXbB-6BsirFgI9Fw$ >

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

[image: New Anderson Logo]

*From:* Intl_dxmedphys_wd_osu_list <
intl_dxmedphys_wd_osu_list-bounces at lists.osu.edu> *On Behalf Of *Colin
Paulbeck via Intl_dxmedphys_wd_osu_list
*Sent:* Wednesday, April 1, 2026 9:09 AM
*To:* Jim Tomlinson <jtomlinson at mpcphysics.com>;
intl_dxmedphys_wd_osu_list at lists.osu.edu
*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.

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> *On Behalf Of *Jim
Tomlinson via Intl_dxmedphys_wd_osu_list
*Sent:* Tuesday, March 31, 2026 6:02 PM
*To:* intl_dxmedphys_wd_osu_list at lists.osu.edu
*Subject:* [Intl_DxMedPhys] current MQSA policy on mammo RWS MEE testing

*      External Email - Use Caution      *

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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