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<p class="MsoNormal"><span style="font-size:11.0pt">That list that is highlighted has been superseded by a new table that can be found in the FAQ’s for the ACR DM QC manual.
<o:p></o:p></span></p>
<p class="MsoNormal"><span style="font-size:11.0pt"><o:p> </o:p></span></p>
<p class="MsoNormal"><span style="font-size:11.0pt">Link to the FAQ’s: <a href="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$">
ACR Accredita</a><o:p></o:p></span></p>
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<p class="MsoNormal"><span style="font-size:11.0pt"><o:p> </o:p></span></p>
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<p class="MsoNormal"><span style="font-size:11.0pt">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.<o:p></o:p></span></p>
<p class="MsoNormal"><span style="font-size:11.0pt"><o:p> </o:p></span></p>
<p class="MsoNormal"><b><span style="font-size:11.0pt">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?</span></b><span style="font-size:11.0pt"> <o:p></o:p></span></p>
<p class="MsoNormal"><span style="font-size:11.0pt">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<o:p></o:p></span></p>
<p class="MsoNormal"><span style="font-size:11.0pt"><o:p> </o:p></span></p>
<p class="MsoNormal"><span style="font-size:11.0pt"><a href="https://urldefense.com/v3/__https://www.fda.gov/media/181152/download__;!!KGKeukY!w-3sRAtp4FyS57Dp_-1f_yN5qXYBxcKBjsI7MIDXO7R2NBWobCTMY8k-S_gKevOvE1n7UK72MCGZ_BDR9oVS6iy19_tSHQbFh_7oN_uP7Q$">Mammography Quality Standards Act and Regulation Amendments: Small Entity Compliance Guide - Guidance for Industry and Food and Drug Administration Staff</a><o:p></o:p></span></p>
<p class="MsoNormal"><span style="font-size:11.0pt"><o:p> </o:p></span></p>
<p class="MsoNormal"><span style="font-size:11.0pt"><o:p> </o:p></span></p>
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<p class="MsoNormal"><span style="font-size:14.0pt;font-family:"Times New Roman",serif">Bill Geiser, MS DABR FAAPM FACR</span><span style="font-size:11.0pt;font-family:"Calibri",sans-serif"><o:p></o:p></span></p>
<p class="MsoNormal"><span style="font-size:11.0pt;font-family:"Calibri",sans-serif">Senior Medical Physicist<o:p></o:p></span></p>
<p class="MsoNormal"><span style="font-size:11.0pt;font-family:"Calibri",sans-serif">Dept. of Imaging Physics<o:p></o:p></span></p>
<p class="MsoNormal"><span style="font-size:11.0pt;font-family:"Calibri",sans-serif">MD Anderson Cancer Center<o:p></o:p></span></p>
<p class="MsoNormal"><span style="font-size:11.0pt;font-family:"Calibri",sans-serif">Houston, TX 77030<o:p></o:p></span></p>
<p class="MsoNormal"><span style="font-size:11.0pt;font-family:"Calibri",sans-serif">Work Cell: 832-596-3158<o:p></o:p></span></p>
<p class="MsoNormal"><span style="font-size:11.0pt;font-family:"Calibri",sans-serif"> <o:p></o:p></span></p>
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<p class="MsoNormal"><b><span style="font-size:11.0pt;font-family:"Calibri",sans-serif">From:</span></b><span style="font-size:11.0pt;font-family:"Calibri",sans-serif"> Intl_dxmedphys_wd_osu_list <intl_dxmedphys_wd_osu_list-bounces@lists.osu.edu>
<b>On Behalf Of </b>Colin Paulbeck via Intl_dxmedphys_wd_osu_list<br>
<b>Sent:</b> Wednesday, April 1, 2026 9:09 AM<br>
<b>To:</b> Jim Tomlinson <jtomlinson@mpcphysics.com>; intl_dxmedphys_wd_osu_list@lists.osu.edu<br>
<b>Subject:</b> [EXTERNAL] Re: [Intl_DxMedPhys] current MQSA policy on mammo RWS MEE testing<o:p></o:p></span></p>
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<p class="MsoNormal"><o:p> </o:p></p>
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<p class="MsoNormal" style="mso-line-height-alt:.75pt"><span style="font-size:1.0pt;color:white">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<o:p></o:p></span></p>
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<p class="MsoNormal"><span style="font-size:11.0pt;font-family:"Calibri",sans-serif;mso-ligatures:standardcontextual">Hi James,<o:p></o:p></span></p>
<p class="MsoNormal"><span style="font-size:11.0pt;font-family:"Calibri",sans-serif;mso-ligatures:standardcontextual"><o:p> </o:p></span></p>
<p class="MsoNormal"><span style="font-size:11.0pt;font-family:"Calibri",sans-serif;mso-ligatures:standardcontextual">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.
<o:p></o:p></span></p>
<p class="MsoNormal"><span style="font-size:11.0pt;font-family:"Calibri",sans-serif;mso-ligatures:standardcontextual"><o:p> </o:p></span></p>
<p class="MsoNormal"><span style="font-size:11.0pt;font-family:"Calibri",sans-serif;mso-ligatures:standardcontextual">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.
<o:p></o:p></span></p>
<p class="MsoNormal"><span style="font-size:11.0pt;font-family:"Calibri",sans-serif;mso-ligatures:standardcontextual"><o:p> </o:p></span></p>
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<p class="MsoNormal"><span style="font-size:11.0pt;font-family:"Calibri",sans-serif;mso-ligatures:standardcontextual"><o:p> </o:p></span></p>
<p class="MsoNormal"><span style="font-size:11.0pt;font-family:"Calibri",sans-serif;mso-ligatures:standardcontextual">Colin<o:p></o:p></span></p>
<p class="MsoNormal"><span style="font-size:11.0pt;font-family:"Calibri",sans-serif;mso-ligatures:standardcontextual"><o:p> </o:p></span></p>
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<p class="MsoNormal"><span style="font-size:11.0pt;font-family:"Calibri",sans-serif;color:#2F5496">Colin Paulbeck, PhD, DABR<o:p></o:p></span></p>
<p class="MsoNormal"><span style="font-size:11.0pt;font-family:"Calibri",sans-serif;color:#2F5496">Diagnostic Medical Physicist<o:p></o:p></span></p>
<p class="MsoNormal"><span style="font-size:11.0pt;font-family:"Calibri",sans-serif;color:#2F5496">Johns Hopkins Medicine, Baltimore MD<o:p></o:p></span></p>
<p class="MsoNormal"><span style="font-size:11.0pt;font-family:"Calibri",sans-serif;color:#2F5496">Office: 410-955-4181<o:p></o:p></span></p>
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<p class="MsoNormal"><b><span style="font-size:11.0pt;font-family:"Calibri",sans-serif">From:</span></b><span style="font-size:11.0pt;font-family:"Calibri",sans-serif"> Intl_dxmedphys_wd_osu_list <</span><a href="mailto:intl_dxmedphys_wd_osu_list-bounces@lists.osu.edu"><span style="font-size:11.0pt;font-family:"Calibri",sans-serif">intl_dxmedphys_wd_osu_list-bounces@lists.osu.edu</span></a><span style="font-size:11.0pt;font-family:"Calibri",sans-serif">>
<b>On Behalf Of </b>Jim Tomlinson via Intl_dxmedphys_wd_osu_list<br>
<b>Sent:</b> Tuesday, March 31, 2026 6:02 PM<br>
<b>To:</b> </span><a href="mailto:intl_dxmedphys_wd_osu_list@lists.osu.edu"><span style="font-size:11.0pt;font-family:"Calibri",sans-serif">intl_dxmedphys_wd_osu_list@lists.osu.edu</span></a><span style="font-size:11.0pt;font-family:"Calibri",sans-serif"><br>
<b>Subject:</b> [Intl_DxMedPhys] current MQSA policy on mammo RWS MEE testing<o:p></o:p></span></p>
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<p class="MsoNormal"><span style="font-size:12.0pt;mso-ligatures:standardcontextual"><o:p> </o:p></span></p>
<p><b><br>
<strong><span style="font-family:"Aptos",sans-serif;color:white;background:red"> External Email - Use Caution </span></strong></b><span style="font-size:11.0pt"><o:p></o:p></span></p>
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<p class="MsoNormal" style="mso-line-height-alt:.75pt"><span style="font-size:1.0pt;color:white;mso-ligatures:standardcontextual">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<o:p></o:p></span></p>
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<p class="MsoNormal"><span style="font-size:12.0pt;mso-ligatures:standardcontextual">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.<o:p></o:p></span></p>
<p class="MsoNormal"><span style="font-size:12.0pt;mso-ligatures:standardcontextual">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?<o:p></o:p></span></p>
<p class="MsoNormal"><span style="font-size:12.0pt;mso-ligatures:standardcontextual">What policy are most of you following?<o:p></o:p></span></p>
<p class="MsoNormal"><span style="font-size:12.0pt;mso-ligatures:standardcontextual"> <o:p></o:p></span></p>
<p class="MsoNormal"><b><u><span lang="FR" style="font-size:12.0pt;color:#215E99;mso-ligatures:standardcontextual">James A. Tomlinson, M.S., FACR</span></u></b><span style="font-size:12.0pt;mso-ligatures:standardcontextual"><o:p></o:p></span></p>
<p class="MsoNormal"><span style="font-size:12.0pt;mso-ligatures:standardcontextual">Senior Vice President<o:p></o:p></span></p>
<p class="MsoNormal"><span style="font-size:12.0pt;mso-ligatures:standardcontextual">Diagnostic Radiological Physicist, DABR<o:p></o:p></span></p>
<p class="MsoNormal"><span style="font-size:12.0pt;mso-ligatures:standardcontextual">Medical Physics Consultants, Inc.<o:p></o:p></span></p>
<p class="MsoNormal"><span style="font-size:12.0pt;mso-ligatures:standardcontextual">214 E. Huron Street, Ann Arbor, MI 48104<o:p></o:p></span></p>
<p class="MsoNormal"><span style="font-size:12.0pt;mso-ligatures:standardcontextual">734.662.3197 (w) 810.571.0319 (c)
<o:p></o:p></span></p>
<p class="MsoNormal"><span style="font-size:12.0pt;mso-ligatures:standardcontextual"> <o:p></o:p></span></p>
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