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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,</div>
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<p class="MsoNormal"><span style="font-size:12.0pt">Jim,<o:p></o:p></span></p>
<p class="MsoNormal"><span style="font-size:12.0pt"><o:p> </o:p></span></p>
<p class="MsoNormal"><span style="font-size:12.0pt">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.<o:p></o:p></span></p>
<p class="MsoNormal"><span style="font-size:12.0pt"><o:p> </o:p></span></p>
<p class="MsoNormal"><span style="font-size:12.0pt">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.<o:p></o:p></span></p>
<p class="MsoNormal"><span style="font-size:12.0pt"><o:p> </o:p></span></p>
<p class="MsoNormal"><span style="font-size:12.0pt"><o:p> </o:p></span></p>
<p class="MsoNormal"><span style="font-size:12.0pt">Related Story:<o:p></o:p></span></p>
<p class="MsoNormal"><span style="font-size:12.0pt">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.<o:p></o:p></span></p>
<p class="MsoNormal"><span style="font-size:12.0pt"><o:p> </o:p></span></p>
<p class="MsoNormal"><span style="font-size:12.0pt">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. <o:p>
</o:p></span></p>
<p class="MsoNormal"><span style="font-size:12.0pt"><o:p> </o:p></span></p>
<p class="MsoNormal"><span style="font-size:12.0pt">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.
<o:p></o:p></span></p>
<p class="MsoNormal"><span style="font-size:12.0pt"><o:p> </o:p></span></p>
<p class="MsoNormal"><span style="font-size:12.0pt">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.<o:p></o:p></span></p>
<p class="MsoNormal"><span style="font-size:12.0pt"><o:p> </o:p></span></p>
<p class="MsoNormal"><span style="font-size:12.0pt">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.<o:p></o:p></span></p>
<p class="MsoNormal"><span style="font-size:12.0pt"><o:p> </o:p></span></p>
<p class="MsoNormal"><span style="font-size:12.0pt">Hope this helps</span><span style="font-size:11.0pt;font-family:"Arial",sans-serif;mso-ligatures:standardcontextual">,<o:p></o:p></span></p>
<p class="MsoNormal"><span style="font-size:11.0pt;font-family:"Arial",sans-serif;mso-ligatures:standardcontextual"><o:p> </o:p></span></p>
<p class="MsoNormal"><span style="font-size:11.0pt;font-family:"Arial",sans-serif;mso-ligatures:standardcontextual">Travis C. Greene, M.S., DABR<o:p></o:p></span></p>
<p class="MsoNormal"><span style="font-size:11.0pt;font-family:"Arial",sans-serif;mso-ligatures:standardcontextual">Senior Medical Physicist<o:p></o:p></span></p>
<p class="MsoNormal"><span style="font-size:11.0pt;font-family:"Arial",sans-serif;mso-ligatures:standardcontextual"><o:p> </o:p></span></p>
<p class="MsoNormal"><span style="font-size:11.0pt;font-family:"Arial",sans-serif"><img width="340" height="58" style="width:3.5458in;height:.6041in" id="Picture_x0020_714191430" src="cid:image004.jpg@01DCC1C7.5A368F50"><span style="mso-ligatures:standardcontextual"><o:p></o:p></span></span></p>
<p class="MsoNormal"><span style="font-size:11.0pt;font-family:"Arial",sans-serif;mso-ligatures:standardcontextual">9320 McIntosh Road, Dover, Florida 33527-3712<o:p></o:p></span></p>
<p class="MsoNormal"><span style="font-size:11.0pt;font-family:"Arial",sans-serif;mso-ligatures:standardcontextual">Office: 813-685-3796 | FAX 813-685-2448 | Direct: 813-893-3428<o:p></o:p></span></p>
<p class="MsoNormal"><b><span style="font-size:11.0pt;font-family:"Arial",sans-serif;mso-ligatures:standardcontextual"><a href="https://urldefense.com/v3/__https://radser.com/satisfaction-survey/__;!!KGKeukY!0KBhouZPay8o-s7r779noCM5U0Na6dvhPs607BsUl4eyL91pCbdIcHAtE5pWoy3z6Gk2s7zFxcr3KjQGUoJUOGqW8rmfv2WycWos2A$"><span style="color:blue">Tell us how we’re doing! </span></a><u><span style="color:blue"><o:p></o:p></span></u></span></b></p>
<p class="MsoNormal"><span style="font-size:12.0pt;mso-ligatures:standardcontextual"><a href="https://urldefense.com/v3/__http://www.radser.com/__;!!KGKeukY!0KBhouZPay8o-s7r779noCM5U0Na6dvhPs607BsUl4eyL91pCbdIcHAtE5pWoy3z6Gk2s7zFxcr3KjQGUoJUOGqW8rmfv2WjeWJjaA$"><span style="color:blue">www.radser.com</span></a></span><span style="font-size:12.0pt;mso-ligatures:standardcontextual"><o:p></o:p></span></p>
<p class="MsoNormal"><span style="font-size:12.0pt"><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+tgreene=radser.com@lists.osu.edu>
<b>On Behalf Of </b>Geiser, William R via Intl_dxmedphys_wd_osu_list<br>
<b>Sent:</b> Wednesday, April 1, 2026 10:57 AM<br>
<b>To:</b> Colin Paulbeck <cpaulbeck@jhu.edu>; Jim Tomlinson <jtomlinson@mpcphysics.com>; intl_dxmedphys_wd_osu_list@lists.osu.edu<br>
<b>Subject:</b> Re: [Intl_DxMedPhys] current MQSA policy on mammo RWS MEE testing<o:p></o:p></span></p>
</div>
<p class="MsoNormal"><o:p> </o:p></p>
<div>
<p class="MsoNormal" style="mso-line-height-alt:.75pt"><span style="font-size:1.0pt;color:white">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<o:p></o:p></span></p>
</div>
<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>
<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>
<p class="MsoNormal"><span style="font-size:11.0pt"><img border="0" width="700" height="453" style="width:7.2958in;height:4.7208in" id="Picture_x0020_4" src="cid:image005.png@01DCC1C7.5A368F50"></span><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>
<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>
<div>
<div>
<div>
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<div>
<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>
<p class="MsoNormal"><span style="font-size:11.0pt;font-family:"Calibri",sans-serif"><img border="0" width="157" height="78" style="width:1.6333in;height:.8125in" id="_x0000_i1027" src="cid:image006.png@01DCC1C7.5A368F50" alt="New Anderson Logo"></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:12.0pt;mso-ligatures:standardcontextual"> <o:p></o:p></span></p>
</div>
</div>
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<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>
<p class="MsoNormal"><span style="font-size:11.0pt"><o:p> </o:p></span></p>
<div style="border:none;border-top:solid #E1E1E1 1.0pt;padding:3.0pt 0in 0in 0in">
<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 <<a href="mailto:intl_dxmedphys_wd_osu_list-bounces@lists.osu.edu">intl_dxmedphys_wd_osu_list-bounces@lists.osu.edu</a>>
<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 <<a href="mailto:jtomlinson@mpcphysics.com">jtomlinson@mpcphysics.com</a>>;
<a href="mailto:intl_dxmedphys_wd_osu_list@lists.osu.edu">intl_dxmedphys_wd_osu_list@lists.osu.edu</a><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" 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>
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<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>
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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>
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<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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