þÿ<html xmlns:v="urn:schemas-microsoft-com:vml" xmlns:o="urn:schemas-microsoft-com:office:office" xmlns="http://www.w3.org/TR/REC-html40"> <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> <link rel="File-List" href="statereq_files/filelist.xml"> <style> <!-- table.MsoNormalTable {mso-style-parent:""; font-size:10.0pt; font-family:"Times New Roman"; } --> </style> <!--[if !mso]> <style> v\:* { behavior: url(#default#VML) } o\:* { behavior: url(#default#VML) } .shape { behavior: url(#default#VML) } </style> <![endif]--> <!--[if gte mso 9]> <xml><o:shapedefaults v:ext="edit" spidmax="1027"/> </xml><![endif]--> <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>&nbsp;</td> </tr> <tr> <td> <div align="center"> <table class="MsoNormalTable" border="1" cellspacing="0" cellpadding="0" style="border-collapse: collapse; border: medium none" id="table2"> <tr style="page-break-inside: avoid"> <td width="114" valign="top" style="width: 85.15pt; border-left: 1.5pt solid windowtext; border-right: 1.0pt solid windowtext; border-top: 1.5pt solid windowtext; border-bottom: 1.5pt solid windowtext; padding-left: 5.4pt; padding-right: 5.4pt; padding-top: 0in; padding-bottom: 0in"> <p class="MsoHeader" style="margin-bottom: 2.0pt"><!--[if gte vml 1]><v:shapetype id="_x0000_t75" coordsize="21600,21600" o:spt="75" o:preferrelative="t" path="m@4@5l@4@11@9@11@9@5xe" filled="f" stroked="f"> <v:stroke joinstyle="miter"/> <v:formulas> <v:f eqn="if lineDrawn pixelLineWidth 0"/> <v:f eqn="sum @0 1 0"/> <v:f eqn="sum 0 0 @1"/> <v:f eqn="prod @2 1 2"/> <v:f eqn="prod @3 21600 pixelWidth"/> <v:f eqn="prod @3 21600 pixelHeight"/> <v:f eqn="sum @0 0 1"/> <v:f eqn="prod @6 1 2"/> <v:f eqn="prod @7 21600 pixelWidth"/> <v:f eqn="sum @8 21600 0"/> <v:f eqn="prod @7 21600 pixelHeight"/> <v:f eqn="sum @10 21600 0"/> </v:formulas> <v:path o:extrusionok="f" gradientshapeok="t" o:connecttype="rect"/> <o:lock v:ext="edit" aspectratio="t"/> </v:shapetype><v:shape id="_x0000_s1025" type="#_x0000_t75" style='width:73.5pt; height:37.5pt' fillcolor="window"> <v:imagedata src="statereq_files/image001.png" o:title="RPSLogo(BW)_2"/> </v:shape><![endif]--><![if !vml]><img border=0 width=98 height=50 src="statereq_files/image002.gif" v:shapes="_x0000_s1025"><![endif]></td> <td width="600" style="width: 450.35pt; border-left: medium none; border-right: 1.5pt solid windowtext; border-top: 1.5pt solid windowtext; border-bottom: 1.5pt solid windowtext; padding-left: 5.4pt; padding-right: 5.4pt; padding-top: 0in; padding-bottom: 0in"> <p class="MsoNormal" align="center" style="text-align: center"> <b>NORTH CAROLINA&nbsp; RADIATION PROTECTION SECTION</b></p> <p class="MsoHeader" align="center" style="text-align: center; margin-bottom: 2.0pt"> <b><span style="font-size: 12.0pt">Quick Reference Guide</span></b></td> </tr> </table> </div> <p class="MsoNormal"><span style="font-size: 8.0pt">&nbsp;</span></p> <div align="center"> <table class="MsoNormalTable" border="0" cellspacing="0" cellpadding="0" style="border-collapse: collapse" id="table3"> <tr style="page-break-inside: avoid; height: 23.3pt"> <td width="720" valign="top" style="width: 7.5in; height: 23.3pt; padding-left: 5.4pt; padding-right: 5.4pt; padding-top: 0in; padding-bottom: 0in; background: #F3F3F3"> <p class="MsoNormal" align="center"> <font color="#000080"><b> <span style="font-size: 14.0pt">Types of Records Reviewed During Inspections</span></b></font></p> <p class="MsoNormal"><b><span style="font-size: 6.0pt">&nbsp;</span></b></td> </tr> <tr style="page-break-inside: avoid; height: 618.55pt"> <td width="720" valign="top" style="width: 7.5in; height: 618.55pt; padding-left: 5.4pt; padding-right: 5.4pt; padding-top: 0in; padding-bottom: 0in"> <p class="MsoNormal"><span style="font-size: 11.0pt">The <b>facility</b> shall maintain the following documentation.&nbsp; These documents will be reviewed for compliance with the regulations at the time of inspection(s). Radiation rule reference in parenthesis (&nbsp;&nbsp;&nbsp; ).&nbsp;</span></p> <p class="MsoNormal" style="text-indent: -.25in; margin-left: .5in"> <span style="font-size: 11.0pt; font-family: Wingdings"> v<span style="font-style: normal; font-variant: normal; font-weight: normal; font-size: 7.0pt; font-family: Times New Roman">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span></span><b><span style="font-size: 11.0pt">For all X-Ray Units</span></b></p> <p class="MsoNormal" style="text-indent: .25in; margin-left: .25in"> <span style="font-size: 11.0pt">Copy of the plan review (.0603)</span><span style="font-size: 11.0pt; color: red">&nbsp;</span></p> <p class="MsoNormal" style="text-indent: .25in; margin-left: .25in"> <span style="font-size: 11.0pt">Copy of the letter of acknowledgement (.0210)&nbsp;</span></p> <p class="MsoNormal" style="text-indent: .25in; margin-left: .25in"> <span style="font-size: 11.0pt">Copy of the post installation room(s) survey (.0603)&nbsp;</span></p> <p class="MsoNormal" style="text-indent: .25in; margin-left: .25in"> <b><span style="font-size: 11.0pt">Copy of the Form FDA 2579, FDA Report of Assembly Form</span></b><span style="font-size: 11.0pt"> </span></p> <p class="MsoNormal" style="text-indent: .25in; margin-left: .5in"> <span style="font-size: 11.0pt">(.0206) and Federal Part 21 CFR Part 1020&nbsp;</span></p> <p class="MsoNormal" style="text-indent: -.25in; margin-left: .5in"> <span style="font-size: 11.0pt; font-family: Wingdings"> v<span style="font-style: normal; font-variant: normal; font-weight: normal; font-size: 7.0pt; font-family: Times New Roman">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span></span><b><span style="font-size: 11.0pt">General Documents</span></b></p> <p class="MsoNormal" style="text-indent: .25in; margin-left: .25in"> <span style="font-size: 11.0pt">Current copy of the Notice of Registration from RPS<span style="color: red"> </span>(.0203) &amp; (.0209)&nbsp;</span></p> <p class="MsoNormal" style="text-indent: .25in; margin-left: .25in"> <span style="font-size: 11.0pt">Previous inspections reports and correspondence regarding inspections with RPS (.1002)&nbsp;</span></p> <p class="MsoNormal" style="text-indent: .25in; margin-left: .25in"> <b><span style="font-size: 11.0pt">Current copy</span></b><span style="font-size: 11.0pt"> of the State Regulations (2002 latest edition) (.1002)</span><span style="font-size: 11.0pt; color: red">&nbsp;</span></p> <p class="MsoNormal" style="text-indent: .25in; margin-left: .25in"> <span style="font-size: 11.0pt">Dosimetry Records for Personnel (.1638 &amp; .1644) </span> <span style="font-size: 11.0pt; color: red">&nbsp;</span></p> <p class="MsoNormal" style="text-indent: .25in; margin-left: .25in"> <span style="font-size: 11.0pt">Technique charts posted visibly and current for all procedures.&nbsp; Chart should include patient s anatomical size versus technique factors at a given source to image distance (SID). (.0603(a)(1)(C)&nbsp;</span></p> <p class="MsoNormal" style="text-indent: -.25in; margin-left: .5in"> <span style="font-size: 11.0pt; font-family: Wingdings"> v<span style="font-style: normal; font-variant: normal; font-weight: normal; font-size: 7.0pt; font-family: Times New Roman">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span></span><b><span style="font-size: 11.0pt"> Radiation Safety Program</span></b></p> <p class="MsoNormal" style="margin-left: .5in"> <span style="font-size: 11.0pt">Current copy of the radiation safety program (.1603 and .1636)</span><span style="font-size: 11.0pt; color: red">&nbsp;<a target="_self" href="radprotprog.htm">Click here for guidance</a></span></p> <p class="MsoNormal" style="text-indent: .25in; margin-left: .25in"> <span style="font-size: 11.0pt">Reviewed annually by the RSO and signed (.1603)&nbsp;</span></p> <p class="MsoNormal" style="text-indent: .25in; margin-left: .25in"> <span style="font-size: 11.0pt">Reviewed annually and when changes occur <b>by all operators and signed</b> (.1603)&nbsp;</span></p> <p class="MsoNormal" style="text-indent: -.25in; margin-left: .5in"> <span style="font-size: 11.0pt; font-family: Wingdings"> v<span style="font-style: normal; font-variant: normal; font-weight: normal; font-size: 7.0pt; font-family: Times New Roman">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span></span><b><span style="font-size: 11.0pt">Posting of Signs</span></b></p> <p class="MsoNormal" style="margin-left: .5in"> <span style="font-size: 11.0pt">Notice to Employees (.1002)</span></p> <p class="MsoNormal" style="margin-left: .5in"> <span style="font-size: 11.0pt">Radiation Caution Signs&nbsp;&nbsp; (.1623 &amp; .1624)&nbsp; <a target="_self" href="../xray/documents/signs_posting.doc">Click here for posting information</a>&nbsp;</span></p> <p class="MsoNormal" style="text-indent: -.25in; margin-left: .5in"> <span style="font-size: 11.0pt; font-family: Wingdings"> v<span style="font-style: normal; font-variant: normal; font-weight: normal; font-size: 7.0pt; font-family: Times New Roman">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span></span><b><span style="font-size: 11.0pt">Other Items of Interest</span></b></p> <p class="MsoNormal" style="margin-left: .5in"> <span style="font-size: 11.0pt">Brand, type and emitting color of film</span></p> <p class="MsoNormal" style="margin-left: .5in"> <span style="font-size: 11.0pt">Brand, type and emitting color of screens</span></p> <p class="MsoNormal" style="margin-left: .5in"> <span style="font-size: 11.0pt">Film/Screen combination speed</span></p> <p class="MsoNormal" style="margin-left: .5in"> <span style="font-size: 11.0pt">Type of processor chemicals (MSDS sheets for chemistry)</span></p> <p class="MsoNormal" style="margin-left: .5in"> <span style="font-size: 11.0pt">Type and wattage of safelight in darkroom</span></p> <p class="MsoNormal" style="margin-left: .5in"> <span style="font-size: 11.0pt">Type of filter on safelight in darkroom and date last changed</span></p> <p class="MsoNormal" style="margin-left: .5in"> <span style="font-size: 11.0pt">Film storage procedures and policy</span></p> <p class="MsoNormal" style="text-indent: .25in; margin-left: .25in"> <span style="font-size: 11.0pt">Shielding devices and procedures (lead aprons)</span><span style="color: red">&nbsp;</span></td> </tr> </table> </div> </td> </tr> <tr> <td height="99"> <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>