<mxfile host="app.diagrams.net" agent="tch-process-diagram" version="24.0.0"><diagram id="fig-01-equipment-tagout-and-return-to-service" name="Figure 1 — Equipment malfunction tag-out, repair, and return-to-service verification flow"><mxGraphModel dx="1000" dy="700" grid="1" gridSize="10" guides="1" tooltips="1" connect="1" arrows="1" fold="1" page="1" pageScale="1" pageWidth="1000" pageHeight="1414" math="0" shadow="0"><root><mxCell id="0"/><mxCell id="1" parent="0"/><mxCell id="title" value="Figure 1 — Equipment malfunction tag-out, repair, and return-to-service verification flow" style="text;html=1;fontSize=20;fontStyle=1;align=left;verticalAlign=top;whiteSpace=wrap;fontFamily=Segoe UI;fontColor=#0F172A;" vertex="1" parent="1"><mxGeometry x="36" y="20" width="940" height="36" as="geometry"/></mxCell><mxCell id="lane_cmt" value="Chief Medical Technologist / Laboratory Quality Manager" 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as="geometry"/></mxCell><mxCell id="n3" value="&lt;b&gt;&lt;font color=&quot;#2E7D32&quot;&gt;5.9.2&lt;/font&gt;&lt;/b&gt;&lt;br&gt;Patient specimens tested between last satisfactory check and failure reviewed" style="rounded=1;arcSize=14;fillColor=#FFFFFF;fontColor=#1E293B;html=1;whiteSpace=wrap;fontSize=12;fontFamily=Segoe UI;shadow=1;strokeWidth=1.5;strokeColor=#2E7D32;" vertex="1" parent="lane_mt"><mxGeometry x="12" y="440" width="268" height="58" as="geometry"/></mxCell><mxCell id="n4" value="&lt;b&gt;&lt;font color=&quot;#B35C00&quot;&gt;5.10.1&lt;/font&gt;&lt;/b&gt;&lt;br&gt;Chief Medical Technologist shall notify clinical hospital units of testing delays" style="rounded=1;arcSize=14;fillColor=#FFFFFF;fontColor=#1E293B;html=1;whiteSpace=wrap;fontSize=12;fontFamily=Segoe UI;shadow=1;strokeWidth=1.5;strokeColor=#B35C00;" vertex="1" parent="lane_cmt"><mxGeometry x="12" y="552" width="268" height="58" as="geometry"/></mxCell><mxCell id="n5" value="&lt;b&gt;&lt;font color=&quot;#555555&quot;&gt;5.10.3&lt;/font&gt;&lt;/b&gt;&lt;br&gt;Downtime events and repair chronologies documented in equipment service log" style="rounded=1;arcSize=14;fillColor=#FFFFFF;fontColor=#1E293B;html=1;whiteSpace=wrap;fontSize=12;fontFamily=Segoe UI;shadow=1;strokeWidth=1.5;strokeColor=#555555;" vertex="1" parent="lane_vendor"><mxGeometry x="12" y="664" width="268" height="58" as="geometry"/></mxCell><mxCell id="n6" value="&lt;b&gt;&lt;font color=&quot;#2E7D32&quot;&gt;5.9.3a&lt;/font&gt;&lt;/b&gt;&lt;br&gt;Perform recalibration, precision checks, and routine QC testing" style="rounded=1;arcSize=14;fillColor=#FFFFFF;fontColor=#1E293B;html=1;whiteSpace=wrap;fontSize=12;fontFamily=Segoe UI;shadow=1;strokeWidth=1.5;strokeColor=#2E7D32;" vertex="1" parent="lane_mt"><mxGeometry x="12" y="776" width="268" height="58" as="geometry"/></mxCell><mxCell id="d1" value="&lt;b&gt;&lt;font color=&quot;#2E7D32&quot;&gt;5.9.3b&lt;/font&gt;&lt;/b&gt;&lt;br&gt;Does testing confirm satisfactory operational status?" style="shape=hexagon;perimeter=hexagonPerimeter2;fixedSize=1;size=18;fillColor=#E0F3E2;fontColor=#0F172A;html=1;whiteSpace=wrap;fontSize=12;fontFamily=Segoe UI;shadow=1;strokeWidth=1.5;strokeColor=#2E7D32;" vertex="1" parent="lane_mt"><mxGeometry x="7" y="888" width="278" height="60" as="geometry"/></mxCell><mxCell id="n7" value="&lt;b&gt;&lt;font color=&quot;#B35C00&quot;&gt;5.4.2a&lt;/font&gt;&lt;/b&gt;&lt;br&gt;Chief Medical Technologist authorizes return to service; attach Green IN SERVICE tag" style="rounded=1;arcSize=14;fillColor=#FFFFFF;fontColor=#1E293B;html=1;whiteSpace=wrap;fontSize=12;fontFamily=Segoe UI;shadow=1;strokeWidth=1.5;strokeColor=#B35C00;" vertex="1" parent="lane_cmt"><mxGeometry x="12" y="1002" width="268" height="74" as="geometry"/></mxCell><mxCell id="e1" value="&lt;b&gt;&lt;font color=&quot;#FFFFFF&quot;&gt;5.4.2b&lt;/font&gt;&lt;/b&gt;&lt;br&gt;Equipment authorized for clinical testing; patient testing resumed" style="rounded=1;arcSize=50;fillColor=#2E7D32;fontColor=#FFFFFF;fontStyle=1;strokeWidth=3;html=1;whiteSpace=wrap;fontSize=12;fontFamily=Segoe UI;shadow=1;strokeWidth=1.5;strokeColor=#2E7D32;" vertex="1" parent="lane_mt"><mxGeometry x="12" y="1130" width="268" height="56" as="geometry"/></mxCell><mxCell id="e2" value="&lt;b&gt;&lt;font color=&quot;#FFFFFF&quot;&gt;5.4.2c&lt;/font&gt;&lt;/b&gt;&lt;br&gt;Instrument remains Red-tagged OUT OF SERVICE; quarantined from diagnostic use" style="rounded=1;arcSize=50;fillColor=#2E7D32;fontColor=#FFFFFF;fontStyle=1;strokeWidth=3;html=1;whiteSpace=wrap;fontSize=12;fontFamily=Segoe UI;shadow=1;strokeWidth=1.5;strokeColor=#2E7D32;" vertex="1" parent="lane_mt"><mxGeometry x="12" y="1003" width="268" height="72" as="geometry"/></mxCell><mxCell id="n8" value="&lt;b&gt;&lt;font color=&quot;#2E7D32&quot;&gt;5.10&lt;/font&gt;&lt;/b&gt;&lt;br&gt;Arrange alternative testing (backup analyzer, referral laboratory, or STAT diversion) per LAB-QM-IT-002" 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