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="931" align="left" valign="top"> <p align="center"> <img border="0" src="images/mammobanner.jpg" width="845" height="155"></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;&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;&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;&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;&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"><b><font color="#000080" size="6">How Do I Respond to Violations?</font></b></td> </tr> <tr> <td> <p align="center">&nbsp;</p> <p align="left"><b><font size="5" color="#0000FF">Did you know there are two inspections going on simultaneously during your annual inspection?</font></b></p> <p align="left"><b><font size="5" color="#0000FF">Are you able to keep the State and FDA inspections separate?</font></b></p> <p align="left"><font size="4">Knowing the difference is especially helpful when responding to violations.&nbsp; The FDA is only interested in clearing MQSA violations and has no need for any response to state violations.</font></p> <p align="left">&nbsp;</p> <p align="left"><u><b><font size="5" color="#3333FF">State Responses</font></b></u></p> <p align="left"><b>The inspector will be looking for the following State Inspection Requirements:</b></p> <ul> <li> <p align="left"><b>Shielding Design/Plan review</b></li> <li> <p align="left"><b>Letter of Acknowledgement</b></li> <li> <p align="left"><b>Report of Assembly (pink copy)</b></li> <li> <p align="left"><b>Post Installation Area Radiation Survey</b></li> <li> <p align="left"><b>Notice of Registration</b></li> <li> <p align="left"><b>Notice to Employees</b></li> <li> <p align="left"><b>State Regulations</b></li> <li> <p align="left"><b>Film Badge Records</b></li> <li> <p align="left"><b>Radiation Protection Program</b></li> <li> <p align="left"><b>Annual Review of Radiation Safety Program</b></li> <li> <p align="left"><b>Protective Aprons</b></li> <li> <p align="left"><b>Technique Chart</b></li> <li> <p align="left"><b>Self Referral Policy</b></li> <li> <p align="left"><b>Dissolution Policy</b></li> </ul> <p align="left"><b>A deficiencies in any of these areas will generate state violations.</b></p> <p class="MsoNormal"><b>State Violation/Response Levels are as follows:</b></p> <dir> <li> <p class="MsoNormal"><b>All items in compliance:&nbsp; &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; No response necessary</b></li> <li> <p class="MsoNormal"><b>Level IA Violation:&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; &nbsp;&nbsp;&nbsp;&nbsp;&nbsp; 15 days to respond</b></li> <li> <p class="MsoNormal"><b>Level 1, II, III, IV, or V Violation(s):&nbsp;&nbsp; 30 days to respond</b></li> </dir> <p align="left"><font size="4">Responses are determined by the facility to reflect an acceptable attempt at correcting the violation.&nbsp; Your inspector will not clear the violation until the response is deemed acceptable.&nbsp; </font> <font color="#FF0000"><i><b>Do not respond to MQSA violations in your response to Radiation Protection for State violations.&nbsp; </b></i></font><font size="4">State responses are to be mailed to the attention of your inspector to the following address:</font></p> <address align="center"> <span style="font-style: normal"><b>NC Radiation Protection&nbsp;&nbsp; <br> 3825 Barrett Drive&nbsp; Raleigh, NC&nbsp; 27609</b></span></address> <address align="center"> <span style="font-style: normal"><b>Phone:&nbsp; (919)571-4141&nbsp;&nbsp; Fax:&nbsp; (919)571-4148</b></span></address> <p align="left">&nbsp;</p> <p>&nbsp;</td> </tr> <tr> <td><u><b><font size="5" color="#3333FF">MQSA Responses</font></b></u><p> <b>The most efficient way to familiarize yourself with citable deficiencies is to review the inspection questions in the FDA inspection software.&nbsp; If any question is answered &quot;No&quot; the inspection software will issue a violation.&nbsp; Inspection software questions can be found in the Policy Guidance Help System.&nbsp; Click here for a copy in <font color="#000000"> <span style="text-decoration: none">Word&nbsp; </span></font> <a target="_self" href="documents/inspsoftwquest.doc"> <img border="0" src="images/word.gif" width="24" height="23"></a>&nbsp;</b></p> <p><b>Response Levels are as follows (lowest to most severe):</b></p> <dir> <li> <p class="MsoNormal"><b>All items in compliance:&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; No response necessary</b></li> <li> <p class="MsoNormal"><b>Level III:&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; &nbsp;&nbsp;&nbsp;&nbsp; No response necessary</b></li> <li> <p class="MsoNormal"><b>Repeat Level III (same as Level II):&nbsp; &nbsp;&nbsp;30 days to respond</b></li> <li> <p class="MsoNormal"><b>Level II:&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; &nbsp;&nbsp;&nbsp;30 days to respond</b></li> <li> <p class="MsoNormal"><b>Repeat Level II (same as a level I):&nbsp; &nbsp; &nbsp;&nbsp;15 days to respond</b></li> <li> <span style="font-family: Times New Roman; font-weight: 700"> Level I:&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; &nbsp;&nbsp; &nbsp;&nbsp;&nbsp;15 days to respond</span></li> </dir> <p><span style="font-family: Times New Roman; font-weight: 700"> Responses are determined by the facility to reflect an acceptable attempt at correcting the violation.&nbsp; Your inspector will not clear the violation until the response is deemed acceptable.&nbsp; </span><font color="#FF0000"><i><b>Do not respond to State violations in your response to the FDA for MQSA violations</b></i></font><b>.&nbsp; You will need to send your response to the following address:</b></p> <address style="text-indent: .25in; line-height: 95%" align="center"> <span style="font-style: normal"><b>Food and Drug Administration</b></span></address> <address style="text-indent: .25in; line-height: 95%" align="center"> <span style="font-style: normal"><b>Abraham Maekele</b></span></address> <address style="text-indent: .25in; line-height: 95%" align="center"> <span style="font-style: normal"><b>300 Fayetteville Street Mall, Suite 422</b></span></address> <address style="text-indent: .25in; line-height: 95%" align="center"> <span style="font-style: normal"><b>Raleigh, NC 27601-1749&nbsp;</b></span></address> <p style="line-height: 95%"><b>The FDA will not clear violations until your inspector clears your violations.&nbsp; Therefore it is important that you send a copy of your response to:</b></p> <address style="text-indent: .25in; line-height: 95%" align="center"> <span style="font-style: normal"><b>NC Radiation Protection Section</b></span></address> <address style="text-indent: .25in; line-height: 95%" align="center"> <span style="font-style: normal"><b>(to the attention of your inspector)</b></span></address> <address style="text-indent: .25in; line-height: 95%" align="center"> <span style="font-style: normal"><b>3825 Barrett Drive </b> </span> </address> <address style="text-indent: .25in; line-height: 95%" align="center"> <span style="font-style: normal"><b>Raleigh, NC 27609-7221</b></span></address> <p>&nbsp;</p> <p>&nbsp;</td> </tr> <tr> <td><b><font color="#FF0000" size="4">S<i>o remember, don&#39;t include State violations in your MQSA response </i></font><font size="5">&nbsp;NOR</font><font color="#FF0000" size="4">&nbsp; <i>MQSA violations in your State response.</i></font></b></td> </tr> <tr> <td> <p align="center">&nbsp;</p> <p align="center"><font size="4" color="#0000FF"><b> <a target="_self" href="index.htm">Mammography Home</a></b></font></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>