Appendix_E2_-_DQRS2015_Stats.xls
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Appendix E Detailed Weekly Reports - file 2 of 3
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| 16-223-SOL-00101_Q A_2.pdf | ||
| Attachment_C_pgs_20-21rev.pdf | ||
| 16-223-SOL-00101_QA.pdf | ||
| Appendix_A_-_facility.pdf | ||
| Appendix_E1_-_FAERSWeeklyStats2015_11_17.xls | XLS spreadsheet | |
| Appendix_B_-_ZIP-Approved_SOPs_033115.zip | ZIP file | |
| Appendix_C_-_courier_route_2016.docx | DOCX document | |
| Appendix_E3_-_SOP_Weekly_Reports.docx | DOCX document | |
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| 16-223-SOL-00101_rev.pdf | ||
| Appendix_D_-_Final_DSI_May_2015_6_Month_Review_050615.pdf | ||
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| Attachment_G.pdf | ||
| Attachment_C.pdf | ||
| Attachment_E_-_Pricing_Worksheets.xls | XLS spreadsheet | |
| Attachment_J_WD_15-4281_(Rev.-3).pdf | ||
| Attachment_I_Form_FDA_3398_(10-10).pdf | ||
| Attachment_F.pdf | ||
| 16-223-SOL-00101.pdf | ||
| Attachment_A.pdf | ||
| Attachment_H.docx | DOCX document |
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DQRS 2015 Stats
| ONLY ENTER DATA INTO YELLOW CELLS | |||||||||||||||||||||||||||||||||||||||||||||||||
| Year-2015 | 2-Jan | 9-Jan | 16-Jan | 23-Jan | 30-Jan | 9-Jan | 13-Feb | 20-Feb | 28-Feb | 16-Jan | 14-Mar | 21-Mar | 28-Mar | 23-Jan | 11-Apr | 18-Apr | 25-Apr | 7-Jan | 14-Jan | 21-Jan | 28-Jan | 4-Feb | 11-Feb | 18-Feb | 25-Feb | 4-Mar | 11-Mar | 18-Mar | 25-Mar | 1-Apr | 8-Apr | 15-Apr | 22-Apr | 29-Apr | 6-May | 13-May | 20-May | 27-May | 3-Jun | 10-Jun | 17-Jun | 24-Jun | 1-Jul | 8-Jul | 15-Jul | 22-Jul | 29-Jul | 5-Aug | 12-Aug |
| DQRS Reports Sent from MedWatch CTU (Landover) | 65 | 96 | 188 | 152 | 170 | 118 | 144 | 175 | 142 | 101 | 135 | 125 | 140 | 213 | 117 | 107 | 135 | 138 | 87 | 76 | 76 | 80 | 52 | 84 | 126 | 78 | 65 | 103 | 120 | 93 | 116 | 72 | 124 | 86 | 77 | 89 | 86 | 110 | 87 | 111 | 70 | 65 | 73 | 77 | 75 | 74 | 92 | 73 | |
| DQRS Report Backlog | 0 | 0 | 9 | 16 | 25 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 72 | 0 | 32 | 0 | 0 | 66 | 67 | 81 | 30 | 7 | 0 | 21 | 0 | 162 | 106 | 43 | 28 | 3 | 0 | 35 | 1 | 51 | 24 | ||||||||||||||
| Incoming DQRS Reports | 71 | 107 | 101 | 235 | 69 | 26 | 89 | 86 | 69 | 29 | 85 | 176 | 39 | 83 | 81 | 64 | 189 | 64 | 127 | 52 | 65 | 28 | 76 | 73 | 227 | 75 | 30 | 59 | 45 | 110 | 89 | 32 | 137 | 52 | 54 | ||||||||||||||
| DQRS reports being reviewed by Compliance staff | 7 | 14 | 0 | 4 | 0 | 0 | 7 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 4 | 4 | 1 | 0 | 4 | 0 | 3 | 0 | 0 | 1 | 1 | 2 | 3 | 1 | 4 | 3 | 1 | 2 | 1 | 0 | ||||||||||||||
| Non DQRS Reports (e.g., Zicam, e-Cigs, etc.) | 15 | 10 | 4 | 107 | 4 | 0 | 1 | 7 | 3 | 0 | 0 | 3 | 1 | 4 | 3 | 3 | 1 | 3 | 5 | 5 | 9 | 0 | 8 | 4 | 2 | 5 | 1 | 3 | 4 | 6 | 1 | 3 | 3 | 3 | 2 | ||||||||||||||
| DQRS Reports Completed | 70 | 88 | 90 | 110 | 105 | 119 | 109 | 95 | 110 | 48 | 85 | 101 | 135 | 47 | 88 | 99 | 122 | 60 | 108 | 98 | 77 | 93 | 55 | 90 | 63 | 126 | 92 | 71 | 66 | 108 | 53 | 63 | 84 | 76 | 87 | ||||||||||||||
| Currently unentered | 0 | 9 | 16 | 34 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 72 | 0 | 32 | 22 | 0 | 66 | 67 | 84 | 30 | 9 | 0 | 21 | 0 | 162 | 106 | 43 | 28 | 33 | 0 | 35 | 1 | 51 | 24 | 0 | ||||||||||||||
| Reports reviewed (e.g., need NDC#, Center) - from CTU | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | ||||||||||||||
| Reports returned complete (e.g., with NDC#) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | ||||||||||||||
| Reports returned - ADD as 001 to Comis | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | ||||||||||||||
| Pages scanned | 319 | 357 | 245 | 440 | 366 | 211 | 268 | 632 | 525 | 246 | 206 | 424 | 244 | 296 | 326 | 72 | 371 | 377 | 312 | 392 | 260 | 164 | 268 | 252 | 247 | 176 | 139 | 357 | 226 | 242 | 309 | 315 | 302 | 166 | 181 | ||||||||||||||
| FARs backlog | 7 | 2 | 3 | 0 | 42 | 25 | 0 | 112 | 140 | 66 | 55 | 22 | 29 | 25 | 40 | 0 | 0 | 19 | 8 | 32 | 17 | 0 | 29 | 45 | 81 | 23 | 0 | 0 | 0 | 0 | 20 | 0 | 28 | 7 | 7 | ||||||||||||||
| Incoming FARs Received | 63 | 76 | 56 | 90 | 75 | 30 | 140 | 95 | 56 | 70 | 62 | 128 | 79 | 81 | 80 | 37 | 84 | 122 | 92 | 52 | 91 | 88 | 140 | 111 | 79 | 85 | 148 | 118 | 90 | 104 | 180 | 122 | 109 | 78 | 102 | ||||||||||||||
| Reviewed FAR reports returned from Compliance staff | 0 | 0 | 3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | ||||||||||||||
| FAR reports being reviewed by Compliance staff | 0 | 0 | 0 | 1 | 2 | 0 | 1 | 4 | 4 | 0 | 2 | 0 | 2 | 0 | 0 | 0 | 0 | 5 | 0 | 0 | 0 | 2 | 8 | 1 | 10 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | ||||||||||||||
| FARs Completed | 68 | 75 | 62 | 81 | 92 | 162 | 28 | 67 | 130 | 81 | 95 | 121 | 82 | 66 | 113 | 41 | 65 | 133 | 68 | 70 | 119 | 59 | 132 | 74 | 137 | 109 | 172 | 127 | 106 | 84 | 200 | 93 | 130 | 92 | 106 | ||||||||||||||
| Currently not Processed | 2 | 3 | 0 | 8 | 25 | 0 | 112 | 140 | 66 | 55 | 22 | 29 | 25 | 40 | 7 | 0 | 19 | 8 | 32 | 17 | 0 | 29 | 45 | 82 | 23 | 0 | 0 | 0 | 0 | 20 | 0 | 29 | 7 | 0 | 0 | ||||||||||||||
| BPDR backlog | 0 | 1 | 1 | 0 | 0 | 1 | 0 | 0 | 2 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 2 | 6 | 2 | 2 | 2 | 3 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | ||||||||||||||
| Incoming BPDRs Received | 1 | 0 | 0 | 1 | 2 | 1 | 0 | 2 | 3 | 1 | 0 | 0 | 1 | 1 | 1 | 3 | 0 | 0 | 1 | 6 | 1 | 0 | 1 | 2 | 0 | 0 | 2 | 0 | 0 | 1 | 1 | 1 | 0 | 1 | 0 | ||||||||||||||
| Reviewed BPDR reports returned from Compliance staff | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | ||||||||||||||
| BPDR reports being reviewed by Compliance staff | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | ||||||||||||||
| BPDRs Completed | 0 | 0 | 1 | 1 | 1 | 2 | 0 | 0 | 3 | 3 | 0 | 0 | 1 | 1 | 0 | 3 | 0 | 0 | 0 | 2 | 5 | 0 | 1 | 1 | 2 | 0 | 2 | 0 | 0 | 1 | 1 | 1 | 0 | 1 | 0 | ||||||||||||||
| Currently not Processed | 1 | 1 | 1 | 0 | 1 | 0 | 0 | 2 | 2 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 2 | 6 | 2 | 2 | 2 | 3 | 1 | 1 | 1 | 1 | 0 | 1 | 1 | 1 | 1 | 1 | 1 | ||||||||||||||
| Letters backlog | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 38 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | ||||||||||||||
| Letters generated | 30 | 192 | 112 | 0 | 265 | 17 | 161 | 50 | 206 | 123 | 55 | 62 | 176 | 92 | 69 | 176 | 79 | 73 | 0 | 242 | 104 | 167 | 0 | 33 | 190 | 114 | 124 | 28 | 182 | 0 | 90 | 42 | 89 | 136 | 139 | ||||||||||||||
| Letters sent out | 30 | 192 | 112 | 0 | 265 | 17 | 0 | 66 | 206 | 123 | 55 | 62 | 176 | 92 | 69 | 176 | 79 | 0 | 19 | 242 | 104 | 167 | 72 | 33 | 190 | 114 | 124 | 28 | 182 | 59 | 0 | 0 | 89 | 136 | 0 | ||||||||||||||
| Currently not sent out | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 19 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | ||||||||||||||
| FUP's backlog | 0 | 3 | 4 | 0 | 31 | 30 | 0 | 0 | 0 | 0 | 0 | 62 | 23 | 23 | 22 | 22 | 18 | 19 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 19 | 37 | 21 | ||||||||||||||
| Incoming FUPs Received | 20 | 25 | 10 | 12 | 3 | 5 | 6 | 101 | 16 | 39 | 62 | 10 | 5 | 14 | 1 | 18 | 4 | 68 | 0 | 20 | 0 | 0 | 4 | 10 | 0 | 0 | 0 | 0 | 16 | 0 | 48 | 135 | 76 | 3 | 3 | ||||||||||||||
| Reviewed FUP reports returned from Compliance staff | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | ||||||||||||||
| FUP reports being reviewed by Compliance staff | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | ||||||||||||||
| FUPs Completed | 17 | 24 | 14 | 10 | 4 | 54 | 6 | 110 | 77 | 39 | 0 | 49 | 5 | 15 | 1 | 51 | 3 | 87 | 0 | 60 | 0 | 0 | 4 | 10 | 0 | 0 | 0 | 0 | 14 | 2 | 54 | 116 | 58 | 19 | 5 | ||||||||||||||
| Currently not Processed | 3 | 4 | 0 | 2 | 30 | 0 | 0 | 0 | 0 | 0 | 62 | 23 | 23 | 22 | 22 | 0 | 19 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 19 | 37 | 21 | 19 | ||||||||||||||
| Training (Hours spent) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 24 | 27 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | ||||||||||||||
| Meetings (Hours spent) | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 1.5 | 0 | 0 | 1.4 | 2 | 0.9 | 1 | 1.5 | 0 | 2 | 1.2 | 0 | 0 | 1.5 | 4 | 2 | 2.8 | 12.1 | 1.5 | 1.5 | 0 | 0 | 2.5 | 1.5 | 1 | 1 | 0 | ||||||||||||||
| Packing | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | ||||||||||||||
| Moving | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | ||||||||||||||
| Staff location - WO unless otherwise specified (e.g.Landover) | |||||||||||||||||||||||||||||||||||||||||||||||||
| Drexel Lyles | 32.0 | 16.0 | 32.0 | 40.0 | 32.0 | 37.1 | 23.7 | 40.0 | 40.0 | 40.0 | 32.0 | 40.0 | 40 | 40 | 40 | 40 | 40 | 40 | 40 | 40 | 16 | 36.6 | 40 | 32 | 40 | 40 | 40 | 40 | 32 | 40 | 40 | 40 | 40 | 40 | 40 | ||||||||||||||
| Daaiyah Rashada | 32.2 | 39.8 | 32.0 | 24.0 | 16.0 | 40.0 | 32.0 | 40.0 | 40.0 | 40.0 | 32.0 | 40.0 | 40 | 40 | 40 | 40 | 40 | 40 | 40 | 40 | 40 | 40 | 40 | 32 | 40.2 | 39.8 | 40 | 40 | 32 | 40 | 40 | 40 | 40 | 40 | 40 | ||||||||||||||
| Debra Rollins | 8.0 | 0.0 | 16.0 | 8.0 | 32.0 | 8.0 | 0.0 | 8.0 | 0.0 | 8.0 | 8.0 | 8.0 | 8 | 8 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | ||||||||||||||
| NOTES: |
DQRS LOE-Workload Data
| Month | 2006 | FTEs | 2007 | FTEs | 2008 | FTEs | 2009 | FTEs | 2010 | FTEs | 2011 | FTEs | 2012 | FTEs | 2013 | FTEs |
| Jan | 227 | 1.0 | 259 | 1.0 | 410 | 1.0 | 550 | 1.6 | 850 | 2.5 | 576 | 1.9 | 616 | 2.20 | 377 | 2 |
| Feb | 190 | 1.0 | 268 | 1.0 | 580 | 1.0 | 696 | 1.8 | 368 | 2.4 | 583 | 2.3 | 441 | 2.10 | 342 | 2 |
| Mar | 234 | 1.0 | 342 | 1.0 | 515 | 1.1 | 730 | 1.8 | 622 | 2.6 | 541 | 2.3 | 321 | 2.10 | ||
| Apr | 171 | 1.0 | 300 | 1.0 | 480 | 1.1 | 620 | 2.0 | 515 | 2.4 | 489 | 2.1 | 409 | 2.00 | ||
| May | 172 | 1.0 | 351 | 1.0 | 1168 | 1.3 | 610 | 2.8 | 773 | 2.7 | 565 | 2.2 | 324 | 2.10 | ||
| Jun | 187 | 1.0 | 224 | 1.0 | 477 | 1.8 | 759 | 2.8 | 483 | 2.3 | 397 | 2.1 | 351 | 2.10 | ||
| Jul | 154 | 1.0 | 293 | 1.0 | 659 | 1.8 | 603 | 2.1 | 448 | 2.1 | 437 | 1.8 | 413 | 2.10 | ||
| Aug | 242 | 1.0 | 328 | 1.0 | 495 | 1.9 | 519 | 2.2 | 429 | 2.2 | 493 | 2.0 | 349 | 2.00 | ||
| Sep | 209 | 1.0 | 394 | 1.0 | 493 | 1.9 | 551 | 2.8 | 526 | 2.4 | 362 | 2.0 | 338 | 2.00 | ||
| Oct | 236 | 1.0 | 404 | 1.0 | 535 | 1.9 | 519 | 1.9 | 523 | 1.5 | 468 | 2.1 | 788 | 2.10 | ||
| Nov | 365 | 1.0 | 337 | 1.0 | 525 | 1.4 | 425 | 1.9 | 630 | 2.6 | 340 | 2.1 | 427 | 2.00 | ||
| Dec | 234 | 1.0 | 280 | 1.0 | 736 | 1.2 | 419 | 2.0 | 325 | 2.1 | 311 | 2.0 | 403 | 2.00 | ||
| CY total | 2,621 | 3,780 | 7,073 | 7,001 | 6,492 | 5,562 | 0 | 5,108 | ||||||||
| Daily Average | 10 | 15 | 28 | 28 | 26 | 21 | 20 | |||||||||
| Weekly Average | 50 | 73 | 136 | 135 | 125 | 107 | 100 | |||||||||
| FTE Monthly Avg. | 1.0 | 1.0 | 1.5 | 2.1 | 2.3 | 2.1 | 98 | 2.10 | ||||||||
| NOTE: | ||||||||||||||||
| 1. LOE data reflects entire DQRS process (includes DE, Imaging, Follow-up letters, FARs, etc.). | ||||||||||||||||
| 2. Spike in May 2008 due mainly to Heparin crisis. | ||||||||||||||||
| 3. Some Zicam reports were sent to Office of Compliance in Jun (469)/Jul (154) Aug/Sep (286) 2009 per special request | ||||||||||||||||
| but were NOT processed into the DQRS database due to DQRS business rules/special requirements. Totals | ||||||||||||||||
| above reflect only processed reports. |
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