[Intl_DxMedPhys] [Ext] Re: current MQSA policy on mammo RWS MEE testing

Wed Apr 1 11:29:30 EDT 2026

The small entity took tje place of pm** which we referred to for cme etc

Robert John Wilson, PhD

University of Tennessee HSC

Department of Radiology

865 Jefferson Ave., Chandler Bldg

Memphis, TN 38163

(p) 901-448-4274

(f) 901-448-5352

________________________________
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 <intl_dxmedphys_wd_osu_list at lists.osu.edu>
Sent: Wednesday, April 1, 2026 10:23 AM
To: Geiser,William R <wgeiser at mdanderson.org>; Colin Paulbeck <cpaulbeck at jhu.edu>; intl_dxmedphys_wd_osu_list at lists.osu.edu <intl_dxmedphys_wd_osu_list at lists.osu.edu>
Subject: [Ext] Re: [Intl_DxMedPhys] current MQSA policy on mammo RWS MEE testing

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)

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<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<mailto: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That list that is highlighted has been superseded by a new table that can be found in the FAQ’s for the ACR DM QC manual.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$>

[cid:image004.png at 01DCC1C9.E7716D70]

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

[New Anderson Logo]

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
Sent: Wednesday, April 1, 2026 9:09 AM
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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:image006.png at 01DCC1C9.E7716D70]

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

      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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