þÿ<html> <head> <meta http-equiv="Content-Language" content="en-us"> <meta http-equiv="Content-Type" content="text/html; charset=unicodeFFFE"> <title>Section Home&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Program O</title> <meta name="Microsoft Border" content="b, default"> </head> <body background="images/ribbon.gif" style="background-attachment: fixed"><!--msnavigation--><table dir="ltr" border="0" cellpadding="0" cellspacing="0" width="100%"><tr><!--msnavigation--><td valign="top"> <div align="center"> <table border="0" width="800" cellspacing="0" cellpadding="0" id="table1"> <tr> <td height="20"> &nbsp;</td> </tr> <tr> <td height="139" width="800" align="left" valign="top"> <p align="center"> <img border="0" src="images/mammobanner.jpg" width="796" height="141"></td> </tr> <tr> <td height="41" align="center"> <div> <p align="center"><b><a target="_self" href="http://ncradiation.net/"> <font color="#3333FF">Section Home</font></a><font color="#3333FF">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; &nbsp;&nbsp; </font> <a target="_self" href="progoverview.htm"> <font color="#3333FF">Program Overview</font></a><font color="#3333FF">&nbsp;&nbsp;&nbsp;&nbsp; &nbsp;&nbsp; &nbsp;&nbsp; </font> <a target="_self" href="mammcontacts.htm"><font color="#3333FF">Mammography Contacts</font></a><font color="#3333FF">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; &nbsp; </font> <a target="_self" href="documents/ncac.rules.pdf"> <font color="#3333FF">NC Regulations</font></a><font color="#3333FF">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; &nbsp; &nbsp;&nbsp; </font> <a target="_self" href="http://www.fda.gov/Radiation-EmittingProducts/MammographyQualityStandardsActandProgram/default.htm"> <font color="#3333FF">MQSA Regulations</font></a></b></div> </td> </tr> <tr> <td> <p align="center">&nbsp;</p> <p align="center"><u><b><font size="5" color="#000080">The Digital Inspection</font></b></u></td> </tr> <tr> <td>&nbsp;<p>The inspector will be looking at the following items for the MQSA portion of the inspection.&nbsp; State requirements are the same as for screen/film.</p> <ul> <li> <p class="MsoNormal">Manufacturer&#39;s QC Manuals - Both printer and unit.&nbsp;In general, we expect the facility to use the latest version of the QC manual issued to it by the manufacturer. If the manufacturer has sent the facility more than one version since the previous inspection, the facility would likely use the first version for a period of time and the updated version(s) afterwards. </li> <li>Equipment Evaluation by Medical Physicist</li> </ul> <blockquote> <ol> <li>Unit - Same <a target="_self" href="physinvolv.htm"> requirements</a> as screen film units</li> <li><span style="color:black">Printer - The physicists tests are dependent upon manufacturer recommendations in the printer manual. </span>&nbsp;<span style="color:black">For example, there may be a requirement that the physicist</span> <span style="color:black">only</span> <span style="color:black">evaluate the printer annually.&nbsp; The facility is expected to have the QC manuals for all their system components, and should be advised that having the manual will assure that all the required QC tests are performed correctly and</span> <span style="color:black">at the appropriate time.&nbsp; </span></li> </ol> </blockquote> <ul> <li>Phantom Image Scored at RWS - We will need a hard copy of your phantom if possible</li> <li>Display Method - Soft copy or hard copy</li> <li>Survey Report - We will be checking dose, corrective action for failures and/or recommendations and that your survey has not exceeded the 14 month time frame.</li> <li> <p ALIGN="LEFT">Manufacturer recommended QC procedures followed?</li> </ul> <blockquote> <ol> <li> <p ALIGN="LEFT">Conducted all the QC tests listed in the manual provided by the manufacturer of the unit in question, and </li> <li> <p ALIGN="LEFT">Took (and documented) timely corrective action(s) for the tests that failed. </li> </ol> </blockquote> <ul> <li> <p ALIGN="LEFT">Monitor QC done per manufacturer s recommendation? </li> <li> <p ALIGN="LEFT">Manufacturer recommended procedures [for Laser Film or Other] used? </li> </ul> <p>&nbsp;</td> </tr> <tr> <td> <p align="center"><b><font color="#000080" size="4"> <a target="_self" href="index.htm">Mammography Home</a></font></b></td> </tr> </table> </div> <!--msnavigation--></td></tr><!--msnavigation--></table><!--msnavigation--><table border="0" cellpadding="0" cellspacing="0" width="100%"><tr><td> <p>&nbsp;</p> <p>&nbsp;</p> </td></tr><!--msnavigation--></table></body> </html>