THE WELCH COMPANY
440 Davis Court #1602
San Francisco, CA 94111-2496
415 781 5700
rodwelch@pacbell.net
S U M M A R Y
DIARY: July 24, 2008 09:00 AM Thursday;
Rod Welch
Millie 1st treatment 6th cycle cetuximab Carboplatin 4th relapse IBC.
1...Summary/Objective
...Taxotere Capecitabine 2nd Relapse IBC Treatment After Mastectomy
...Cetuxiab Alone Clinical Study
...Cetuxiab with Carboplatin Clinical Study 2nd Arm
2...Schedule Weekly Treatments Continue on Thursdays
3...Access Power Port Blood Draw Required 1 Minute Worked Beautifully
4...Huber Needle Product Specification for CT Test Contrast Injections
5...Labs Blood Test
6...CA 15-3 71 Slight Decrease Past 4 Weeks Cycle 5
7...NEUTS Decrease Neupogen 2 Treatments Per Week Continue for New Cycle
8...Coagulation Control INR Missing from Blood Test Today Notify UCSF
9...Coagulation Control INR 2.4 Normal Stable PT 26.2 High
10...Cetuximab Chemotherapy Orders Not Submitted
11...Carboplatin Chemotherapy Orders
....Antimetics:
....Chemotherapy (plan to treat weekly for 3 out of 4 weeks).
....Carboplatin Dose Reduced May Aid Blood Counts Maintain Treatments
....Laboratory Work:
....Neupogen Prescribed in Chemotherapy Orders
12...Power Port Surgery Certification Required Kaiser Submit to UCSF
..............
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CONTACTS
SUBJECTS
Cetuximab 12th Cycle 3rd Treatment 18th Total Treatment Chemotherapy
0403 -
0403 - ..
0404 - Summary/Objective
0405 -
040501 - Follow up ref SDS C6 0000. ref SDS C0 0000.
040502 -
040503 -
040504 -
040505 -
040506 -
040507 -
040509 - ..
0406 -
0407 -
0408 - Progress
0409 -
040901 - Background on Millie's treatment in the clinical study is reported on
040902 - 080508. ref SDS 96 TZ8I
040904 - ..
040905 - Taxotere Capecitabine 2nd Relapse IBC Treatment After Mastectomy
040906 -
040907 - Follow up ref SDS C6 X33O, ref SDS C0 X33O.
040908 -
040909 - Millie had left mastectomy on 051021. Biopsy at that time reported
040910 - no findings of cancer. Approximately 8 months later on 060707 the
040911 - doctor diagnosed IBC relapse and prescribed treatment. ref SDS 4
040912 - PF3O
040913 -
040914 - 1. Cycle 09 and 01 ................... 060721, ref SDS 5 407N
040915 - 2. Cycle 10 and 02 ................... 060814, ref SDS 7 LY6O
040916 - 3. Cycle 11 and 03 ................... 060908, ref SDS 7 407N
040917 - 4. Cycle 12 and 04 ................... 060929, ref SDS 7 407N
040918 - 5. Cycle 13 and 05 ................... 061020, ref SDS 8 407N
040919 - 6. Cycle 14 and 06 ................... 061110, ref SDS 9 407N
040920 - 7. Cycle 15 and 07 ................... 061201, ref SDS 10 407N
040922 - ..
040923 - Cetuxiab Alone Clinical Study
040924 -
040925 - Follow up ref SDS C6 356I, ref SDS C0 356I.
040926 -
040927 - Total Cetuximab
040928 - 8. Cycle 01 and 08 and 01 01.......... 070201, ref SDS 12 SG8I
040929 - 9. Cycle 01 and 08 and 02 02.......... 070208, ref SDS 13 SG8I
040930 - 10. Cycle 01 and 08 and 03 03.......... 070215, ref SDS 14 SG8I
040931 - 11. Cycle 01 and 08 and 04 04.......... 070222, ref SDS 15 SG8I
040932 - 12. Cycle 02 and 09 and 01 05.......... 070301, ref SDS 17 SG8I
040933 - 13. Cycle 02 and 09 and 02 06.......... 070308, ref SDS 19 7T3H
040934 - 14. Cycle 02 and 09 and 03 07.......... 070315, ref SDS 20 7T3H
040935 - 15. Cycle 02 and 09 and 04 08.......... 070322, ref SDS 21 7T3H
040936 - 16. Cycle 03 and 10 and 01 09.......... 070329, ref SDS 22 7T3H
040937 - 17. Cycle 03 and 10 and 02 10.......... 070405, ref SDS 23 7T3H
040938 - 18. Cycle 03 and 10 and 03 11.......... 070412, ref SDS 24 7T3H
040939 - 19. Cycle 03 and 10 and 04 12.......... 070419, ref SDS 25 7T3H
040940 - 20. Cycle 04 and 11 and 01 13.......... 070426, ref SDS 26 7T3H
040941 - 21. Cycle 04 and 11 and 02 14.......... 070503, ref SDS 27 7T3H
040942 - 22. Cycle 04 and 11 and 03 15.......... 070510, ref SDS 28 7T3H
040943 - 23. Cycle 04 and 11 and 04 16.......... 070517, ref SDS 29 7T3H
040944 - 24. Cycle 05 and 12 and 01 17.......... 070524, ref SDS 30 7T3H
040945 - 25. Cycle 05 and 12 and 02 18.......... 070531, ref SDS 31 7T3H
040946 - 26. Cycle 05 and 12 and 03 19.......... 070607, ref SDS 32 7T3H
040947 - 27. Cycle 05 and 12 and 04 20.......... 070614, ref SDS 33 0001
040948 - 28. Cycle 06 and 13 and 01 21.......... 070621, ref SDS 34 0001
040949 - 29. Cycle 06 and 13 and 02 22.......... 070628, ref SDS 35 0001
040950 - 30. Cycle 06 and 13 and 03 23.......... 070705, ref SDS 36 0001
040951 - 31. Cycle 06 and 13 and 04 24.......... 070712, ref SDS 36 0001
040952 - 32. Cycle 07 and 14 and 01 25.......... 070719, ref SDS 37 0001
040953 - 33. Cycle 07 and 14 and 02 26.......... 070726, ref SDS 35 0001
040954 - 34. Cycle 07 and 14 and 03 27.......... 070802, ref SDS 36 0001
040955 - 35. Cycle 07 and 14 and 04 28.......... 070809, ref SDS 38 0001
040956 - 36. Cycle 08 and 15 and 01 29.......... 070816, ref SDS 39 0001
040957 - 37. Cycle 08 and 15 and 02 30.......... 070823, ref SDS 40 0001
040958 - 38. Cycle 08 and 15 and 03 31.......... 070830, ref SDS 40 0001
040959 - 39. Cycle 08 and 15 and 04 32.......... 070906, ref SDS 41 0001
040960 - 40. Cycle 09 and 16 and 01 33.......... 070920, ref SDS 42 0001
040961 - 41. Cycle 09 and 16 and 02 34.......... 070927, ref SDS 43 0001
040962 - 42. Cycle 09 and 16 and 03 35.......... 071004, ref SDS 44 0001
040963 - 43. Cycle 09 and 16 and 04 36.......... 071011, ref SDS 45 0001
040964 - 44. Cycle 10 and 17 and 01 37.......... 071018, ref SDS 46 0001
040965 - 45. Cycle 10 and 17 and 02 38.......... 071025, ref SDS 47 0001
040966 - 46. Cycle 10 and 17 and 03 39.......... 071101, ref SDS 33 0001
040967 - 47. Cycle 10 and 17 and 04 40.......... 071108, ref SDS 48 0001
040968 - 48. Cycle 11 and 18 and 01 41.......... 071115, ref SDS 49 0001
040969 - 49. Cycle 11 and 18 and 02 42.......... 071122, ref SDS 35 0001
040970 - 50. Cycle 11 and 18 and 03 43.......... 071129, ref SDS 51 0001
040971 - 51. Cycle 11 and 18 and 04 44.......... 071206, ref SDS 52 0001
040972 - 52. Cycle 12 and 19 and 01 45.......... 071213, ref SDS 55 0001
040973 - 53. Cycle 12 and 19 and 02 46.......... 071220, ref SDS 58 0001
040974 - 54. Cycle 12 and 19 and 03 47.......... 071227, ref SDS 59 0001
040975 - 55. Cycle 12 and 19 and 04 48.......... 080103, ref SDS 60 0001
040976 - 56. Cycle 13 and 20 and 01 49.......... 080110, ref SDS 63 0001
040977 - 57. Cycle 13 and 20 and 02 50.......... 080117, ref SDS 64 0001
040978 - 58. Cycle 13 and 20 and 03 51.......... 080124, ref SDS 65 0001
040979 - 59. Cycle 13 and 20 and 04 52.......... 080131, ref SDS 67 0001
040980 - 60. Cycle 14 and 21 and 01 53.......... 080207, ref SDS 71 0001
040981 - 61. Cycle 14 and 21 and 02 54.......... 080214, ref SDS 72 0001
040982 - 62. Cycle 14 and 21 and 03 55.......... 080221, ref SDS 36 0001
040983 - 63. Cycle 14 and 21 and 04 56.......... 080228, ref SDS 77 0001
040984 - 64. Cycle 15 and 22 and 01 57 01 00... 080306, ref SDS 80 TZ8I
040986 - ..
040987 - Cetuxiab with Carboplatin Clinical Study 2nd Arm
040988 -
040989 - Follow up ref SDS C6 5B6J, ref SDS C0 5B6J.
040990 -
040991 - On 080207 doctor reports IBC may be spreading. ref SDS 70 GH5H
040992 - Follow up examination on 080219 Doctor Rugo diagnosed progression of
040993 - disease. ref SDS 90 3J4I Photographs show spread of IBC rash,
040994 -
040995 - 2nd
040996 - Arm Cetuximab Carboplatin
040997 - 65. Cycle 01 15 and 22 and 02 58 02 01... 080313, ref SDS 81 TZ8I
040998 - 66. Cycle 01 15 and 22 and 03 59 03 01... 080320, ref SDS 82 TZ8I
040999 - 67. Cycle 01 15 and 22 and 04 60 04 01... 080327, ref SDS 83 TZ8I
041000 - 68. Cycle 02 16 and 23 and 01 61 05 02... 080403, ref SDS 84 TZ8I
041001 - 69. Cycle 02 16 and 23 and 02 62 06 03... 080410, ref SDS 87 TZ8I
041002 - 70. Cycle 02 16 and 23 and 03 63 07 03... 080417, ref SDS 89 TZ8I
041003 - 71. Cycle 02 16 and 23 and 04 64 08 03... 080424, ref SDS 91 TZ8I
041004 - 72. Cycle 03 17 and 24 and 01 65 09 04... 080501, ref SDS 94 5B6J
041005 - 73. Cycle 03 17 and 24 and 02 66 10 05... 080508, ref SDS 96 5B6J
041006 - 74. Cycle 03 17 and 24 and 03 67 11 05... 080515, ref SDS 97 5B6J
041007 - 75. Cycle 03 17 and 24 and 04 68 12 05... 080522, ref SDS 98 5B6J
041008 - 76. Cycle 04 18 and 25 and 01 69 13 06... 080529, ref SDS A1 5B6J
041009 - 77. Cycle 04 18 and 25 and 02 70 14 07... 080605, ref SDS A2 5B6J
041010 - 78. Cycle 04 18 and 25 and 03 71 15 08... 080612, ref SDS A5 5B6J
041011 - 79. Cycle 04 18 and 25 and 04 72 16 08... 080619, ref SDS A8 5B6J
041012 - 80. Cycle 05 19 and 26 and 01 73 17 09... 080626, ref SDS B3 5B6J
041013 - 81. Cycle 05 19 and 26 and 02 74 18 10... 080703, ref SDS B7 5B6J
041014 - 82. Cycle 05 19 and 26 and 03 75 19 11... 080710, ref SDS C0 5B6J
041015 - 83. Cycle 05 19 and 26 and 04 76 20 11... 080717, ref SDS C6 5B6J
041016 - 84. Cycle 06 20 and 27 and 01 77 21 12... 080724, ref SDS 0 5B6J
041018 - ..
041019 - Today is the 1st treatment of the 6th cycle with cetuximab and
041020 - Carboplatin together. This is the 21th treatment overall with
041021 - cetuximab on the 2nd arm of the clinical study, but is only the 12th
041022 - treatment with Carboplatin due to low blood counts.
041023 -
041024 -
041025 -
041026 -
0411 -
SUBJECTS
Default Null Subject Account for Blank Record
0903 -
090401 - ..
090402 - Schedule Weekly Treatments Continue on Thursdays
090403 -
090404 - Follow up ref SDS B3 IK7H, ref SDS A1 IK7H.
090405 -
090406 - Nola submitted UCSF schedule for Millie's care over the next few
090407 - months, updating the schedule received on 080626, ref SDS B3 IK7H, and
090408 - implementing the schedule Brigid submitted this morning meeting with
090409 - the medical team. ref SDS D0 HT6N
090410 -
090412 - ..
090413 - Date Time Staff Sta Type Dept Loc Dur Number Cycl/Trmnt
090414 - -----------------------------------------------------------------
090415 - 080731 0800 Catherine PEN AC4 CCINF INF 20 14736666 06 02
090416 - 080731 0800 Catherine PEN AC4 CCINF INF 60 14587616 06 02
090417 - 080807 0820 Catherine PEN AC1 CCINF INF 20 14587572 06 03
090418 - 080807 0900 Catherine PEN AC4 CCINF INF 60 14587582 06 03
090419 - 080814 0800 Catherine PEN AC1 CCINF INF 20 14587586 06 04
090420 - 080814 0900 Catherine PEN AC4 CCINF INF 60 14587609 06 04
090421 - 080821 0800 Catherine PEN AC1 CCINF INF 20 14587612 07 01
090422 - 080821 0830 Rugo PEN CHF BCC Z4F 30 14348712 07 01
090423 - Brigid
090424 - Jackie
090425 - 080821 0900 Catherine PEN AC4 CCINF INF 60 14587616 07 01
090426 - 080828 0800 Catherine PEN AC1 CCINF INF 20 14587621 07 02
090427 - 080828 0900 Catherine PEN AC4 CCINF INF 60 14587630 07 02
090428 - 080904 0800 Catherine PEN AC1 CCINF INF 20 14647227 07 03
090429 - 080904 0900 Catherine PEN AC4 CCINF INF 60 14647245 07 03
090430 - 080911 0820 Catherine PEN AC1 CCINF INF 20 14821159 07 04
090431 - 080911 0900 Catherine PEN AC4 CCINF INF 60 14821156 07 04
090432 - ..
090433 - * 080918 0820 Catherine PEN AC1 CCINF INF 20 14821189 08 01
090434 - 080918 0900 Catherine PEN AC4 CCINF INF 60 14821187 08 01
090435 - * 080918 1130 Rugo PEN CHF BCC Z4F 30 08 01
090436 - Brigid
090437 - Jackie
090438 - 080925 0800 Catherine PEN AC1 CCINF INF 20 14821209 08 02
090439 - 080925 0900 Catherine PEN AC4 CCINF INF 60 14821201 08 02
090440 - 081002 0820 Catherine PEN AC1 CCINF INF 20 14821224 08 03
090441 - 081002 0900 Catherine PEN AC4 CCINF INF 60 14821217 08 03
090442 - 081009 0820 Catherine PEN AC1 CCINF INF 20 14821235 08 04
090443 - 081009 0900 Catherine PEN AC4 CCINF INF 60 14821231 08 04
090444 - ..
090445 - 081016 0800 Catherine PEN AC1 CCINF INF 20 14821257 09 01
090446 - 081016 0900 Catherine PEN AC4 CCINF INF 60 14821243 09 01
090447 - * 081016 1130 Rugo PEN CHF BCC Z4F 30 09 01
090448 - Brigid
090449 - Jackie
090450 - ...
090451 - ...
090452 - ...
090453 - 081113 0830 Rugo PEN CHF BCC Z4F 30 14820731 10 01
090454 - Brigid
090455 - Jackie
090456 - ...
090457 - ...
090458 - ...
090459 - ...
090460 - 081211 0830 Rugo PEN CHF BCC Z4F 30 14820734 11 01
090461 - Brigid
090462 - Jackie
090463 - ...
090465 - ..
090466 - * Comment on schedule gaps...
090468 - ..
090469 - The schedule for 080918 does not show a time for meeting with the
090470 - medical team. ref SDS 0 SO8F Typically this is 0800 or 0830, to
090471 - correlate with the blood draw in the Infusion Clinic at 0800, and then
090472 - treatment at 0900 after meeting with the medical team. The schedule
090473 - for some reason does not show the blood draw at 0800 on 080918. This
090474 - presents a potential conflict, because if the meeting with the medical
090475 - team is at 0800 or even at 0830, then getting the blood draw a few
090476 - minutes before 0800, in according with past practice, provides enough
090477 - time for the lab to process results in time for the doctor discuss
090478 - with patient.
090480 - ..
090481 - Similar issue for schedule meeting with the medical team on 081016, a
090482 - time should be set for 0800 or 0830 to correlate with the schedule for
090483 - blood draw at 0800 and treatment at 0900. ref SDS 0 SO8F
090484 -
090485 - [On 080807 Lena at the front desk in the Breast Care Clinic
090486 - advised that the doctor scheduled to see Millie at 1130 on
090487 - 080918 and on 081016 after Millie gets treatment at 0900,
090488 - understanding this is a change in the protocol for previous
090489 - meetings prior to Millie getting treatments. ref SDS D4 U15Y
090491 - ..
090492 - [On 080815 Millie's letter to the medical team requested
090493 - clarification of the UCSF schedule. ref SDS D5 P96Y
090494 -
090495 -
090496 -
090497 -
0905 -
SUBJECTS
Default Null Subject Account for Blank Record
1003 -
100401 - ..
100402 - Access Power Port Blood Draw Required 1 Minute Worked Beautifully
100403 -
100404 - Follow up ref SDS C6 JZ3F.
100405 -
100406 - Catherine is Millie's nurse today.
100408 - ..
100409 - On 080718 CT test using Power Port failed at Kaiser; initial analysis
100410 - indicates Huber needle may not have been correctly seated, ref SDS C7
100411 - LK41, and/or injection flow rate may been incorrect, ref SDS C7 WI7G,
100412 - Huber needle poped loose, contrast medium flows into right chest,
100413 - shoulder and arm areas, ref SDS C7 4S5L; Kaiser relied on Millie's
100414 - memory of patient history explaining procedures at UCSF accessing the
100415 - Power Port with a Huber needle. ref SDS C7 IC6F
100417 - ..
100418 - On 080719 Julie in Infusion Clinic at Kaiser in Walnut Creek accessed
100419 - port in about 1 minute, and without incident to test operability
100420 - following events the day before; she reported that blood flows
100421 - "beautifully"; port was then maintained with saline and Heprin flush.
100422 - ref SDS C8 V36O
100424 - ..
100425 - On 080719 as a result of complications from CT test on 080718 causing
100426 - bleeding throught surgical wound, Julie in Kaiser Infusion Clinic
100427 - removed the original surgical tape from the Power Port incision wound;
100428 - inspection shows healing, but possible compromise with slight gap from
100429 - the bleeding; fresh surgical tape was placed to dress the wound.
100430 - ref SDS C8 LD87
100432 - ..
100433 - Today, Azita began the blood draw at about 0750, because Millie has a
100434 - meeting with the medical team at 0800. Catherine arrived about 0755
100435 - and observed the work.
100437 - ..
100438 - The scope of the test today was not clear. The initial requirement is
100439 - CBC to get results for NEUTS that influence prescribing Carboplatin
100440 - chemotherapy beginning the next cycle of treatment. An agenda was not
100441 - submitted to UCSF for work today (as done previously, e.g., on 080625,
100442 - ref SDS B1 IT6W, and on 080528, ref SDS 99 U45H, because the medical
100443 - team received a lot of communication on case management to plan for
100444 - changing treatments on progression of disease, resolving cost
100445 - containment errors prescribing Neupogen, errors on the dose of
100446 - Carboplatin, and most recently CT test problems. The Infusion Clinic
100447 - staff have become comfortable working with Millie to accomplish
100448 - essential tasks, like early morning blood draws, that can be adjusted,
100449 - as needed, after meeting with the medical team.
100450 -
100451 - [...below, INR blood test omitted, ref SDS 0 IU8H,
100453 - ..
100454 - Azita accessed the port in about 1 minute. There were no problems and
100455 - blood flows well today, as Julia found at Kaiser on 080719,
100456 - ref SDS C8 V36O, the day after problems using the port for the CT
100457 - test. ref SDS C7 LK3R
100459 - ..
100460 - Azita advised that the Infusion Clinic was recently notified by the CT
100461 - Department that Huber needles to inject CT test contrast medium meet a
100462 - higher design standard for high pressure injection of contrast medium.
100463 - She said Huber needles for CT tests must have "high pressure tubing,"
100464 - shown by the product specification, as follows...
100465 -
100467 - ..
100468 - Huber Needle Product Specification for CT Test Contrast Injections
100469 -
100470 - Azita made a copy of product identification and description that comes
100471 - with packaging for Huber needles used in the UCSF Infusion Clinic...
100472 -
100473 - [...below Catherine later today made a copy of this
100474 - document, and left it in the medical chart for Millie to
100475 - get next week. ref SDS 0 SB5N
100477 - ..
100478 - Angiodynamics, Incorporated
100479 - One Horton Way
100480 - Manchester, GA 31816 USA
100481 - 518 798 1215 800 722 6446
100482 -
100483 - http://www.angiodynamics.com
100485 - ..
100486 - Smart Port CT
100487 - With Vortex Technology
100488 - The Intelligent Choice in Injectable Ports
100490 - ..
100491 - Lifeguard
100492 - Safety Needle
100494 - ..
100495 - The following Lifeguard Safety Infusion Set models may be used
100496 - for Power Injection of Contrast Media with the Smart Port CT
100497 - Power Injectable Ports:
100498 -
100499 - LG-19-75
100500 - LG-19-100
100501 - LG-20-50
100502 - LG-20-75
100503 - * LG-20-100
100504 - LG-20-150
100506 - ..
100507 - Flow Rate - 5 ml/sec
100508 - Maximum Pressure Setting - 300 psi
100510 - ..
100511 - PN 107070 Rev A
100513 - ..
100514 - Azita marked with a circle "LG-20-100" as the Lifeguard safety needle
100515 - UCSF uses to access the Bard Power Port for CT tests. It has a 1"
100516 - needle.
100517 -
100518 - [On 080725 Paula discussed problems with Millie's CT test
100519 - on 080718, ref SDS D1 UN7G; she advised that the Kaiser
100520 - Infusion Clinic has on hand Huber needles to perform high
100521 - pressure injection of contrast medium for CT test that
100522 - require a higher standard for pressure. ref SDS D1 FQ37
100524 - ..
100525 - [On 080821 a nurse had difficulty getting blood to flow
100526 - through the Power Port with Huber needle technology,
100527 - ref SDS D6 LO5F; Diane completed the work, ref SDS D6 A66O;
100528 - Diane seemed to advise that UCSF has standardized on all
100529 - departments using the same Huber needle used for high
100530 - powered injections of contrast medium for CT tests, so that
100531 - mistakes do not occur substituting a less rigorous needle.
100532 - ref SDS D6 N96I
100534 - ..
100535 - [On 080903 Millie submitted to Kaiser product specification
100536 - for Lifeguard Safety Infusion Set Huber needle received
100537 - from UCSF. ref SDS D7 IO6R
100539 - ..
100540 - [On 080904 Catherine seemed say that nurses must select
100541 - from a range of different Huber needles available for
100542 - treatment in the Infusion Clinic, per Angiodynamics
100543 - manufacturer's Lifeguard Safety needles listed on 080724,
100544 - ref SDS 0 N79U; Catherine plans to use the needle specified
100545 - for high pressure injections to treat Millie at UCSF on the
100546 - day when the same needle will be used later in the same day
100547 - at Kaiser for a CT test. ref SDS D8 V64G
100549 - ..
100550 - [On 081017 1415 Kaiser purchased Lifeguard Huber needles
100551 - that meet requirements using high strength steel to perform
100552 - pressure injection of contrast medium for CT tests using
100553 - Bard Power Power technology. ref SDS D9 045H
100555 - ..
100556 - Azita has entered in handwriting on the front page...
100557 -
100558 - "High presure tubing."
100560 - ..
100561 - Page 2...
100563 - ..
100564 - Note: page 2 has foreign language notations; only English is
100565 - reported in the record.
100567 - ..
100568 - Page 2 continues...
100569 -
100570 - Lifeguard
100571 - Safety Needle
100572 -
100573 - Quantity: 20
100575 - ..
100576 - Attenttion: see instructions for use
100578 - ..
100579 - Do not reuse; single use only
100581 - ..
100582 - Sterile EO sterilized using ethylene oxide non-pyrogenic
100584 - ..
100585 - Lot: lot number... 956190
100587 - ..
100588 - Use by: 2011-04
100590 - ..
100591 - Ref: Cagalogue Number... LG-20-100
100593 - ..
100594 - Caution: Federal USA law restricts this device to sale by or
100595 - on the order of a physician.
100597 - ..
100598 - Safety Needles
100600 - ..
100601 - 20 Ga x 1.0" (2.5 cm)
100602 - 7" Tubing
100603 - Priming Volume 0.21 cc
100605 - ..
100606 - 20 Ga x 2.5 cm (1.0")
100607 - Slang 7"
100608 - Vulvolume - 0.21 cc
100610 - ..
100611 - Non-Toxic, Lipid Compatible
100612 - Non-DEHP Tubing, Latex Free
100614 - ..
100615 - PN 106606 Rev E
100617 - ..
100618 - Page 3
100620 - ..
100621 - This is the label on the Huber needle plastic packing says...
100623 - ..
100624 - Page 3 continues...
100625 -
100626 - Lifeguard Safety Infusion Set
100627 - 90 degree Stainless Steel Non-coring needle
100628 - Contents: One (1) only
100630 - ..
100631 - The rest of page 3 says the same thing as page 2, execpt only in
100632 - English, as shown above. ref SDS 0 6O39
100633 -
100634 - [On 080731 Diane submitted another copy of the same 3 pages
100635 - and submitted them to help understand requirements in this
100636 - matter. ref SDS D2 QY3G
100638 - ..
100639 - [On 080903 Millie submitted to Kaiser product specification
100640 - for Lifeguard Safety Infusion Set Huber needle received
100641 - from UCSF. ref SDS D7 IO6R
100643 - ..
100644 - This could relate to issues that occurred on 080718 when the CT test
100645 - failed during injection of contrast medium for Millie's CT test at
100646 - Kaiser. ref SDS C7 LK3R The record on 080718 indicates Kaiser used
100647 - the Huber needle specified in the Power Port manufacturer's
100648 - Instructions for Use. There was not an opportunity to either observe
100649 - accessing the port with the Huber needle, nor to inspect the packaging
100650 - after the failed test. ref SDS C7 XM3K Therefore, the actual
100651 - correlation with the UCSF specification received today, nor with the
100652 - Bard specification is not known.
100654 - ..
100655 - [On 080725 Paula discussed problems with Millie's CT test
100656 - on 080718, ref SDS D1 UN7G, advised that the Kaiser
100657 - Infusion Clinic has on hand Huber needles to perform
100658 - pressure injection of contrast medium for CT test that
100659 - require a higher standard for pressure. ref SDS D1 FQ37
100660 -
100661 -
100662 -
100663 -
1007 -
SUBJECTS
Default Null Subject Account for Blank Record
1103 -
1104 - 0800
110501 - ..
110502 - Labs Blood Test
110503 -
110504 - Follow up ref SDS C6 FW5N, ref SDS C0 FW5N.
110505 -
110506 - Adding Carboplatin to the treatment protocol now requires weekly blood
110507 - tests to determine if the immune system is strong enough for safe
110508 - chemotherapy treatment, reported on 070201, ref SDS 12 XR40, and citing
110509 - the clinical study protocol received from UCSF on 070116. ref SDS 11
110510 - 5U7Z
110512 - ..
110513 - During treatment, Catherine submitted results of the test.
110514 -
110529 - ..
110530 - Log#: 080724 08:05
110531 - <----------------------- U C S F -----------------------> <------------- Kaiser -------------->
110532 - Type Results Units Normal ACRO Type Units Normal
110533 - ..
110534 - CBC with DIFF & PLT CT CBCD
110535 - ..
110536 - WBC COUNT 4.5 x10E9/L 3.4 - 10 WBC WBC x10-3 K/uL 3.4 - 10.0
110537 - RBC COUNT L 3.65 x10E12/L 4 - 5.2 RBC RBC x10-6 M/uL 3.60 - 5.70
110538 - HEMOGLOBIN 12.3 g/dL 12 - 15.5 HGB Hemoglobin g/dL 11.5 - 15.0
110539 - HEMATOCRIT 36.0 PERCENT 36 - 46 HCT Hematocrit % 34.0 - 46.0
110540 - MCV 99 fL 80 - 100 MCV MCV fL 80.0 - 100.0
110541 - MCH 33.6 pg 26 - 34 MCH
110542 - MCHC 34.0 g/dL 31 - 36 MCHC
110543 - PLATELETS 273 x10E9/L 140 - 450 PLT Plt x10-3 K/uL 140 - 400
110544 -
110545 - Performed at Mt Zion Clinic Lab, 1600 Divisadero, San
110546 - Francisco, CA 94115
110547 - ..
110548 - (posted 080731, ref SDS D2 LX3M)
110549 - CA 15-3 H* 71 U/mL < 33 CA153 CA 15-3 < 39
110550 -
110551 - Note new reference range [<33 changed from <31] and change in
110552 - methodology effective March 1, 2008. Performed using the
110553 - Siemens Centaur Chemiluminesence method. CA 15-3 result using
110554 - the Roche Elecsys assay is 75 U/mL. Ref range <31 U/mL. This
110555 - rebaseline value provided at no additional charge.
110557 - ..
110558 - This new note updates explanation of tests prior to 080301,
110559 - e.g., on 080207. ref SDS 73 A16M
110560 - ..
110561 - (NEUTS x 1000 = ANC for Kaiser)
110562 - NEUTS L 2.32 x10E9/L 1.8 - 6.8 N-A ANC 1500
110563 - Neutrophils Not Reported Neutrophils % 50 - 70
110565 - ..
110566 - LYMPHS 1.51 x10E9/L 0.9 - 2.9 L-A Lymphocytes % 20 - 50
110567 - MONOS 0.43 x10E9/L 0.1 - 0.6 M-A Monocyte % 0 - 11
110568 - EOS 0.19 x10E9/L 0 - 0.4 E-A Esoinophils % 1 - 5
110569 - BASOS 0.08 x10E9/L 0 - 0.1 B-A Basophil % 0 - 2
110571 - ..
110572 - <----------------------- U C S F -----------------------> <------------- Kaiser -------------->
110573 - Type Results Units Normal ACRO Type Units Normal
110574 - PT H 26.2 s 12.0 - 14.1 PT PT, patient sec 8.9 - 11.1
110575 - INL NRM Ratio H 2.4 0.9 - 1.1 INR INR 2.0 - 3.0
110576 -
110577 - Performed at Mt Zion Clinic Lab, 1600 Divisadero, San
110578 - Francisco, CA 94115
110579 -
110580 - [...below, Catherine added INR to the test later, and
110581 - sbmitted results in a letter to Millie at the end of the
110582 - day. ref SDS 0 K66J
110584 - ..
110585 - PARTIAL
110586 - THROMBOPLASTIN H 33.6 s 22.2 - 34.2 INR PTT
110587 -
110588 - Performed at Mt Zion Clinic Lab, 1600 Divisadero, San
110589 - Francisco, CA 94115
110591 - ..
110592 - <----------------------- U C S F -----------------------> <------------- Kaiser -------------->
110593 - Type Results Units Normal ACRO Type Units Normal
110594 - ELECTROLYTE PANEL LYTE
110595 - SODIUM 136 mmol/L 134 - 143 NA Sodium mEq/L 137 - 145
110596 - POTASSIUM 4.1 mmol/L 3.4 - 4.9 K Potassium mEq/L 3.5 - 5.3
110597 - CHLORIDE 103 mmol/L 98 - 107 CL
110598 - CARBON DIOX TOTAL L 22 mmol/L 23 - 32 CO2
110599 - ANION GAP 11 3 - 14 ANGA
110600 - ..
110601 - UREA NITROGEN 12 mg/dL 8 - 23 BUN BUN mg/dL 7 - 17
110602 - * GLUCOSE mg/dL 70 - 199 GLU Glucose mg/dL ? - ?
110603 - AST 41 U/L 16 - 41 AST AST (SGOT) U/L 14 - 36
110604 - ALT 23 U/L 11 - 54 ALT ALT (SGPT) U/L 11 - 66
110605 - BILIRUBIN, TOTAL 0.8 mg/dL 0.3 - 1.3 BILT Bili Total mg/dL 0.2 - 1.3
110606 - ALKALINE PHOSPHATASE 79 U/L 29 - 111 ALKP Alkaline Ph U/L 38 - 126
110607 - ..
110608 - PROTEIN, TOTAL **** In Lab g/dL 5.8 - 8.0 TP Protine Total g/dL 6.3 - 8.2
110609 - * ALBUMIN g/dL 3.4 - 4.7 ALB Albumin g/dL 3.4 - 4.8
110610 - CALCIUM 8.7 mg/dL 8.7 - 10.1 CA Calcium mg/dL 8.4 - 10.2
110611 - ..
110612 - MAGNESIUM 1.8 mg/dL 1.8 - 2.3 MG Magnesium mg/dL 1.6 - 2.3
110614 - ..
110615 - CREAT with eGFR
110616 - CREATININE 0.54 mg/dL 0.42 - 1.06 CR Creatinine mg/dL 0.6 - 1.2
110617 -
110618 - Note: Creatinine assay changed to IDMS standardization on
110619 - February 4, 2008 causing decrease in results of approximately
110620 - 0.09 mg/dL
110622 - ..
110623 - eGFR if Caucasian >60 mL/min GFRC
110624 - eGFR if African Amer >60 mL/min GFRA
110625 -
110626 - eGFR corrected for 1.73 sq meters of body surface area
110627 - Note: eGFR is only an estimation. Please see online Lab Manual
110628 - for potential limitations.
110629 - Performed at Mt Zion Clin Lab, 1600 Divisadero, San Francisco,
110630 - CA 94115
110632 - ..
110633 - * Labs today omit following test...
110634 -
110635 - GLUCOSE.............................. ref SDS 0 SE9J
110636 - ALBUMIN.............................. ref SDS 0 GT9I
110638 - ..
110639 - Labs on 080626 omitted following tests...
110640 -
110641 - GLUCOSE.............................. ref SDS B3 HS7I
110642 - PROTEIN, TOTAL
110643 - ALBUMIN
110644 - CALCIUM
110646 - ..
110647 - Review on 080703 seemed to indicate that blood tests missing from
110648 - laboratory work on 080626 are not specified in Chemotherapy Orders.
110649 - ref SDS B7 TW3O Since Protein Total (In Lab) and Calcium, were added
110650 - to the lab for today, ref SDS 0 GT9I, and Glucose and Albumin are
110651 - omitted, how does this correlate to the Chemotherapy Order? Do the
110652 - labs not necessarily track Chemotherapy Order; is there another source
110653 - that determines the scope of labs?
110654 -
110655 -
110657 - ..
110658 - CA 15-3 71 Slight Decrease Past 4 Weeks Cycle 5
110659 -
110660 - Follow up ref SDS B3 PW7I. ref SDS B8 L74K.
110661 -
110662 - Millie received results of lab today for CA 15-3 71, ref SDS 0 A16M,
110663 - cancer marker a week later on 080731, ref SDS D2 LX3M, and seems to
110664 - reflect stable to improving condition with decrease from CA 15-3 72
110665 - for the previous cycle on 080626. ref SDS B3 PW7I
110667 - ..
110668 - Drop in cancer marker today, though slight and essentially flat,
110669 - brightens emotional feelings about long term prospects, because
110670 - testing for surgery at Kaiser on 080708 reported CA 15-3 141, which is
110671 - 40% higher than any previous lab for the cancer marker during Millie's
110672 - patient history the over past 7 years. ref SDS B8 L74K This was 100%
110673 - greater than prior labs just 2 weeks earlier at UCSF, as noted on
110674 - 080626, ref SDS B3 PW7I, and so, if correct, could suggest progression
110675 - of disease, absent contextual factors.
110677 - ..
110678 - There is a variance of 6 points or so between the cancer marker at
110679 - UCSF and Kaiser due to calibration differences. Kaiser sets the bench
110680 - mark at 39, ref SDS B8 05YW, while UCSF uses 33. ref SDS 0 A16M This
110681 - adjustment might correlate CA 15-3 141 at Kaiser as only 135 at UCSF,
110682 - which would still be a significant increase based on patient history.
110683 - For example, on 020603, Kaiser changed treatments when CA 15-3 reached
110684 - 117. ref SDS 1 4X5K On 070301 UCSF called emergency meeting for
110685 - 080308 to consider changing treatment with the cancer marker only at
110686 - CA 15-3 56. ref SDS 16 4140 Accordingly, CA 15-3 141 seems to
110687 - present significant progression of disease, except, the blood draw at
110688 - Kaiser was evidently compromised in important respects. ref SDS B8
110689 - MG6M
110691 - ..
110692 - The record on 080708 describes the lab for surgery at Kaiser cancelled
110693 - the entire CBC panel, ref SDS B8 075H; and other tests were
110694 - "hemolyzed," which may affect results, including CA 15-3. ref SDS B8
110695 - 05YW
110697 - ..
110698 - CA 15-3 71 results for the blood test today at UCSF indicates results
110699 - at Kaiser on 080708 were evidently significantly affected by problems
110700 - with the blood draw, or test process.
110701 -
110702 - [On 080821 cancer marker CA 15-3 96 big increase.
110703 - ref SDS D6 VK6H
110705 - ..
110706 - This presents a big relief from emotional trauma of stress and
110707 - anxiety.
110708 -
110709 -
110711 - ..
110712 - NEUTS Decrease Neupogen 2 Treatments Per Week Continue for New Cycle
110713 -
110714 - Follow up ref SDS C6 PU6K, ref SDS C0 PU6K.
110715 -
110716 - Blood counts decreased again this week, shown by the Lab report today
110717 - with NEUTS 2.32, ref SDS 0 QY6H, compared with NEUTS 2.47 last week on
110718 - 080717, ref SDS C6 QY6H Drop in blood counts despite no Carboplatin
110719 - chemotherapy treatment last week, ref SDS C8 G53G, and further despite
110720 - adding Neupogen treatment on 080719, which was not prescribed, but
110721 - added by the patient as a precaution due to problems with the CT test
110722 - on 080718, ref SDS C8 OG4M, seems conflicting with 3 consecutive weeks
110723 - when labs increased while getting 2 treatments with Neupogen at the
110724 - Kaiser Infusion Clinic, reported on 080712. ref SDS C2 IT77 This
110725 - record of blood counts falling without chemotherapy and with only 1
110726 - Neupogen treatment on 080719 supports Brigid's prescription during the
110727 - meeting on 080626 for Millie to continue with 2-weekly Neupogen
110728 - treatments. ref SDS B2 QJ4H
110730 - ..
110731 - Chemotherapy Order today extends regimen for cycle 6 prescribing 2
110732 - Neupogen treatments per week, shown below.
110734 - ..
110735 - Side effects of Neupogen reported on...
110736 -
110737 - 080628................, ref SDS B4 6Q5J
110738 - 080629................, ref SDS B6 6Q5J
110739 - 080713................, ref SDS C3 RM94
110740 - 080721................, ref SDS C9 9W9I
110741 -
110742 - ...has been less severe the past week even though Neupogen treatments
110743 - have continued at 2 per week.
110744 -
110745 -
110746 -
110747 -
1108 -
SUBJECTS
Coagulation Control INR Medical Mistakes Mssing from Labs Blood Tes
2003 -
2004 - 1508
200501 - ..
200502 - Coagulation Control INR Missing from Blood Test Today Notify UCSF
200503 -
200504 - There was a mixup this morning with the blood draw that did not
200505 - specify INR required to manage Coumadin treatments for pulmonary
200506 - embolism. The agenda typically specifies INR, CA 15-3, and other
200507 - tests which have slipped through the cracks from time to time, shown
200508 - for example on 080430. ref SDS 93 4L6G However, as noted above, an
200509 - agenda was not submitted for the work today. ref SDS 0 RT6O The blood
200510 - draw was done a few minutes earlier than usual at 0745 because the
200511 - meeting with the medical team was at 0800, and so Catherine who
200512 - normally does the blood draw had not arrived, and Diane, who treats
200513 - Millie when Catherine is not available, was on vacation this week. As
200514 - a result, Azita did the blood draw. ref SDS 0 OK5N Lack of
200515 - familiarity with Millie's patient history of including INR
200516 - understandably caused this test to be omitted from the initial labs.
200518 - ..
200519 - Catherine submitted results of the labs this morning, after Millie's
200520 - treatment was completed, and when Millie was leaving the Infusion
200521 - Clinic. Review showed that INR was missing.
200523 - ..
200524 - This omission is mitigated by having done an INR blood test out of
200525 - sequence with labs last week on 080717 to evaluate Millie's recovery
200526 - from having been off Coumadin treatment for 5 days, ref SDS C6 IL75,
200527 - required for increasing blood thickness to prepare for surgery the
200528 - week before on 080708. ref SDS B8 MF4K Results of the test on 080717
200529 - were submitted the next day on 080718 to Gloria in Kaiser's
200530 - Coagulation Control Clinic. ref SDS C7 I44R This was part of a letter
200531 - reporting problems with the CT test, and asking Kaiser to submit the
200532 - report in time for review to be prepared meeting with UCSF on 080724.
200533 - ref SDS C7 PU7P
200535 - ..
200536 - On arriving home, Millie submitted ref DIT 1 0001, a letter to
200537 - Catherine asking to add INR if convenient...
200538 -
200539 - 1. Since we did INR ahead of schedule last week at Gloria's
200540 - request to check on recovery from being off Coumadin for
200541 - surgery the week before, ref SDS C6 IL75, we can probably get
200542 - by without INR this week. ref SDS 0 J23N We were within range
200543 - last week, and for all the weeks before going back to January
200544 - of 2007. ref DIT 1 0001
200546 - ..
200547 - 2. So, if time permits, and its not too much trouble to add INR
200548 - for the labs today, please let me know. I will tell Gloria I
200549 - forget to send an agenda for today [per above, ref SDS 0 RT6O],
200550 - even Brigid was upset about not getting the CT report until
200551 - after the meeting. ref SDS D0 KV4M The PT can wait until next
200552 - week, if necessary, then get back on track for the next cycle.
200553 - ref DIT 1 OM6G
200554 -
200555 -
200556 -
200557 -
2006 -
200601 -
2007 -
SUBJECTS
Coagulation Control INR 2.4 Case Management Plmonary Embolism Couma
3503 -
3504 - 1749
350501 - ..
350502 - Coagulation Control INR 2.4 Normal Stable PT 26.2 High
350503 -
350504 -
350505 - Millie received ref DRT 1 0001 from Catherine responding to the letter
350506 - sent to UCSF earlier this afternoon, per above, ref SDS 0 RX5K, which
350507 - requested correction to labs that omitted the test for INR, also, per
350508 - above. ref SDS 0 IU8H Test results on INR are needed by Gloria at
350509 - Kaiser to manage Coumadin treatment of pulmonary emobolism.
350511 - ..
350512 - Catherine says...
350513 -
350514 - 1. I had already added on the PT/INR but results weren't back when
350515 - you left: PT 26.2; INR 2.4. ref DRT 1 0001
350517 - ..
350518 - Posted INR 2.4 and PT 26.2 to blood test report for today, per above.
350519 - ref SDS 0 PU7Y
350520 -
350521 - [On 080804 Millie submitted a letter notifying the
350522 - Coagulation Control Department at Kaiser in Martinez, CA
350523 - about results of the blood test today. ref SDS D3 BY5H
350525 - ..
350526 - UCSF letter from Catherine continues...
350527 -
350528 - 2. Also, I have the Power Port needle info for you - it's in the
350529 - chart for your nurse to give you next week. ref DRT 1 Q85N
350531 - ..
350532 - This refers to the product specification Azita submitted earlier this
350533 - morning, per above. ref SDS 0 MV7Y
350534 -
350535 - [On 080731 Diane submitted the 2nd copy of specifications
350536 - for the Huber needle for CT tests. ref SDS D2 QY3G
350537 -
350538 - [On 080903 Millie submitted to Kaiser product specification
350539 - for Lifeguard Safety Infusion Set Huber needle received
350540 - from UCSF. ref SDS D7 IO6R
350541 -
350542 -
350543 -
350544 -
3506 -
SUBJECTS
Default Null Subject Account for Blank Record
3603 -
360401 - ..
360402 - Cetuximab Chemotherapy Orders Not Submitted
360403 -
360404 - Follow up ref SDS B3 MM6N. ref SDS 94 MM6N.
360405 -
360406 - Chemotherapy Orders for cetuximab were not submitted today. This
360407 - conflicts with the practice last cycle on 080626, ref SDS B3 MM6N, and
360408 - aligns with the prior cycle on 080529 when a Chemo Order for cetuximab
360409 - was not submitted. ref SDS A1 I66I
360410 -
360411 -
360412 -
360413 -
3605 -
SUBJECTS
Default Null Subject Account for Blank Record
3703 -
370401 - ..
370402 - Carboplatin Chemotherapy Orders
370403 -
370404 - Follow up ref SDS B3 N54I, ref SDS A1 I66I.
370406 - ..
370407 - No evident difference between chemotherapy orders today and for last
370408 - month starting cycle 5 on 080629, except the order for cycle 6 today
370409 - includes the prescription for Neupogen, which was given verbally
370410 - during the meeting on 080626 with medical team, per below. ref SDS 0
370411 - PWSY
370413 - ..
370419 - Auth# Stor BCC LOC
370420 - Visit: 14348723 DOS 20080724
370422 - ..
370423 - Date: 20080724
370425 - ..
370426 - Study Order for CC#05752: Phase II Trial of Cetuximab alone and
370427 - in combination with Carboplatin in ER-negative, PR-negative,
370428 - HER2-negative Nonoverexpressing Metastatic Breast Cancers.
370430 - ..
370431 - Arm: 2 - Cetuximab + Carboplatin
370433 - ..
370434 - Dates to be given: 20080724
370436 - ..
370437 - Allergies: NKDA
370439 - ..
370440 - Height: 62 inches
370442 - ..
370443 - Weight: 138 pounds
370445 - ..
370446 - Diagnosis: Metastatic breast cancer (IBC)
370448 - ..
370449 - ICD-9 codes: 174.9/198.5/196.2
370451 - ..
370452 - This ICD-9 codes section conflicts with assignments in Chemotherapy
370453 - Order for 080626. ref SDS B3 PVSS
370455 - ..
370456 - Chemotherapy Order Carboplatin continues...
370457 -
370458 - Cycle: 4
370460 - ..
370461 - Days: 1, 8, 15 (arm 2)
370462 -
370464 - ..
370465 - Antimetics:
370466 -
370467 - Follow up ref SDS B3 PVTT, ref SDS A1 PVTT.
370468 -
370469 - x Dexamethasone 10 mg IV (Decadron)
370470 - x Ondansetron 8 mg IV (Zofran)
370471 -
370473 - ..
370474 - Chemotherapy (plan to treat weekly for 3 out of 4 weeks).
370475 - Carboplatin Dose Reduced May Aid Blood Counts Maintain Treatments
370476 -
370477 - Follow up ref SDS B3 PVUQ, ref SDS A1 PVUQ.
370478 -
370479 - May administer Carboplatin if vital signs are unremarkable one
370480 - hour after cetuximab infusion..
370481 -
370482 - ** Please note start and stop times **
370484 - ..
370485 - Carboplatin (commercial supply) AUC 1.5 = 175 mg in D5W 250 ml
370487 - ..
370488 - Chemo orders today seem to show the same dose specified for cycle (4)
370489 - started on 080529 and marked "error," ref SDS A1 PVUQ, reviewed on
370490 - 080626. ref SDS B2 2X5L At that time, the medical chart was
370491 - confusing, because Brigid could not find the Chemotherapy Order for
370492 - 080529 marked "error." ref SDS B2 RF4J Brigid planned to investigate
370493 - the error in the Chemotherapy Order. ref SDS B2 RF53
370495 - ..
370496 - Chemotherapy Orders continue...
370497 -
370498 - IV over 30 minutes weekly x 3 doses followed by 1 week rest.
370500 - ..
370501 - [hand writting...]
370502 -
370503 - Carbo dose to remain the same unless CR > 1.3
370505 - ..
370506 - [...where CR = "Creatinine"]
370507 -
370508 - Carboplatin dose in mg = (desired AUC)(GFR+25)
370509 -
370510 - GFR (estimated) =
370511 -
370512 - (140-age in years)(weight in kg)(for females x 0.85)
370513 - ----------------------------------------------------
370514 - (Cr in mg/dL)(72)
370516 - ..
370517 - Unlike previous Chemotherapy Orders issued on 080403 which showed
370518 - handwritten values in the dosage formula, ref SDS 84 NV9H, there is
370519 - no similar handwriting on the Chemotherapy Orders received today from
370520 - UCSF.
370522 - ..
370523 - Chemotherapy Orders continues...
370525 - ..
370526 - Laboratory Work:
370527 -
370528 - Follow up ref SDS B3 PWPW, ref SDS A1 PWPW.
370529 -
370530 - x CBC with differential and platelets
370531 - x Creatinine, magnesium every 4 weeks
370532 - x BUN, AST, Alk phos, Alt, Total bilirubin, eletrolytes every 8 weeks
370534 - ..
370535 - Before meeting with the medical team this morning, Millie got a blood
370536 - draw at 0745 in the Infusion Clinic for labs that show blood counts
370537 - needed for the meeting at 0800. Unlike prior cycles, there was no
370538 - agenda showing the scope of work required today, see for example
370539 - Millie's letter to UCSF on 080625 planning scope for the previous
370540 - cycle. ref SDS B2 IU3Y
370542 - ..
370543 - There was another a mixup today. The nurse got the order and vials
370544 - for the blood draw from the study coordinator, but for some reason
370545 - INR was not included with the blood test.
370547 - ..
370548 - Millie noted this problem after the report was submitted about 1030
370549 - this morning. She sent a letter to UCSF requesting INR for pulmonary
370550 - embolism case management by the Coagulation Control Clinic at Kaiser.
370552 - ..
370553 - Catherine submitted a revised scope to the lab, and the report for INR
370554 - was received from Catherine after Millie arrived home from treatment
370555 - today. ref SDS 0 PU7Y
370557 - ..
370558 - Chemotherapy Orders continues...
370559 -
370560 - If ANC >= 1.5 x 1000/L, platelets >= 75 x 1000/L give 100% of dose
370562 - ..
370563 - If ANC < 1.5 x 1000/L, platelets < 75 x 1000/L....
370564 -
370567 - ..
370568 - x See cetuximab orders.
370570 - ..
370571 - The section checked to see cetuximab orders conflicts with not getting
370572 - Chemotherapy Order for cetuximab, per above. ref SDS 0 MM6N There may
370573 - have been a Chemotherapy Order for cetuximab that was not submitted to
370574 - Millie today.
370576 - ..
370577 - Chemotherapy Orders continue...
370578 -
370579 - x Study tubes 3 purple top, 1 cell saver
370581 - ..
370582 - Not sure about handwriting on "cell saver"
370584 - ..
370585 - Chemotherapy Orders continue...
370587 - ..
370588 - Neupogen Prescribed in Chemotherapy Orders
370589 -
370590 - Follow up ref SDS B3 PWSY, ref SDS A1 PWTR.
370591 -
370592 - During the meeting with the medical team on the 2nd floor at 0800 this
370593 - morning, Brigid advised that the doctor continues for the 6th cycle
370594 - the same prescription issued for the 4th cycle shown in the record on
370595 - 080529, ref SDS A2 PWSY The Chemotherapy Orders for today shows in
370596 - handwriting...
370597 -
370598 - Neupogen 480 mcg SQ on D2 & 3 3 carbo
370600 - ..
370601 - This seems to reflect instructions that Neupogen is only given on the
370602 - 3 days in the cycle when Millie gets Carboplatin, and so is skipped
370603 - for the 4th treatment in the cycle when Millie gets only cetuximab.
370605 - ..
370606 - On 080609 Zan in the Kaiser Oncology Pharmacy set up an account for
370607 - Millie to get Neupogen treatments in the Kaiser Infusion Clinic based
370608 - on Chemotherapy Orders showing the UCSF prescription. At that time,
370609 - Zan used the Chemotherapy Orders for 080529 which show a prescritpion
370610 - for 2 Neupogen treatments per week. ref SDS A4 L16I
370612 - ..
370613 - Chemotherapy Orders continue...
370615 - ..
370616 - x Physician has discussed risks/benefits of chemotherapy with the
370617 - patient. Consent, form obtained.
370618 -
370619 - x Yes O2 [oxygyn] by nasal cannula at 2 liters/min prn for chest pain or SOB
370621 - ..
370622 - x Yes Diphenhydramine 50 mg IV prn x 1 unticaria pruntis, SOB
370623 - (this is Benadryl)
370625 - ..
370626 - x Yes Hydrocrotisone 100 mg IV prn x 1 unticaria pruntis, SOB
370628 - ..
370629 - x Yes Aubterol inhaler 2 - 4 puffs prn SOB or chest tightness
370631 - ..
370632 - x Yes Epnephnna nhaler 2 - 4 puffs prn SOB or chest tightness
370634 - ..
370635 - Physician Signature
370636 -
370639 - Date: 080723
370641 - ..
370642 - Nurse Signature:
370643 -
370646 - Date: 080724
370648 - ..
370649 - No nurses signature is shown in the copy received from UCSF; may have
370650 - been entered and filed in UCSF records later.
370651 -
370652 -
370653 -
3707 -
SUBJECTS
Default Null Subject Account for Blank Record
3803 -
380401 - ..
380402 - Power Port Surgery Certification Required Kaiser Submit to UCSF
380403 -
380404 - Millie advised Catherine today that on 080619 Kaiser scheduled surgery
380405 - for 080708 to upgrade the port catheter to a Power Port. ref SDS A8
380406 - MG5I Catherine was very pleasd to hear Kaiser is solving problems
380407 - injecting contrast medium for CT tests by accessing the port rather
380408 - than continue using IV needle punctures in the arm, which caused
380409 - severe injury during the last CT test on 080425, ref SDS 94 FP6F, and
380410 - shown by bruising observed during treatment a week later on 080501.
380411 - ref SDS 95 DT3M
380413 - ..
380414 - Catherine asked if Kaiser will permit UCSF to access the port so soon
380415 - after surgery on 080708 for Millie's treatment on 080710?
380417 - ..
380418 - Millie explained the doctor's instruction on 080606 that the new port
380419 - cannot be accessed for 4 days after surgery. The surgeon plans to
380420 - access the port on the day of surgery, 080708, with a Huber needle so
380421 - that Catherine can use this access to the port for treatment on
380422 - 080710. ref SDS A4 IT40
380424 - ..
380425 - Catherine requested that Kaiser submit a copy of the certificate
380426 - showing the new Power Port is ready for use.
380428 - ..
380429 - Millie asked what the certificate should say. Is this a standard
380430 - medical form of some kind?
380432 - ..
380433 - Catherine clarified that UCSF needs a letter from Kaiser saying the
380434 - Power Port was successfully tested after surgery on 080708. UCSF
380435 - needs this on file to verify safe treatment on 080710. The surgeon
380436 - reported on 040419 that the original port was successfully tested
380437 - after surgery. ref SDS 3 WQ7I Millie can follow up during the meeting
380438 - at Kaiser tomorrow, so the suergon is notified that UCSF needs a copy
380439 - of the certificate.
380440 -
380441 - [On 080627 primary care physician at Kaiser sent a letter to
380442 - the surgeon requesting a certificate for UCSF that the Power
380443 - Port was successfully tested for use.
380445 - ..
380446 - [On 080702 letter to medical team confirms surgeon notified to
380447 - submit certificate that Power Port was successfully tested for
380448 - use at UCSF. ref SDS B5 EQ3W
380450 - ..
380451 - [On 080628 Laura at Kaiser requested Chemotherapy Orders
380452 - documenting UCSF prescription for Neupogen treatments at
380453 - Kaiser. ref SDS B4 QQ9I
380455 - ..
380456 - [On 080708 Power Port was implanted by surgery to replace the
380457 - port catheter, ref SDS B7 WD9J; surgeon not familiar with a
380458 - "certificate" on results of surgery nor for implanting port
380459 - catheter devices. ref SDS B7 O65F
380461 - ..
380462 - [On 080708 Kaiser submitted a letter stating the Power Port was
380463 - tested successfully, and signed by the surgeon. ref SDS B7 O14F
380465 - ..
380466 - [On 080710 Millie submitted the doctor's letter to UCSF,
380467 - ref SDS B8 EE4O, the nurse advised that UCSF actually needs the
380468 - report on the xray performed showing placement of the Power
380469 - Port, ref SDS B7 UY3I; UCSF management called Kaiser; the
380470 - Surgery department coordinated submission of the xray report to
380471 - the Infusion Clinic at UCSF. ref SDS B8 TM5J
380473 - ..
380474 - Millie asked Catherine about Bella's concern on 080617 that Kaiser
380475 - cannot use the Power Port to inject CT test contrast medium unless a
380476 - doctor or other professional with a certificate assists the technician
380477 - during the process of pressing the button the the test equipment that
380478 - injects the contrast medium through the Power Port. ref SDS A8 ER5K
380480 - ..
380481 - Catherine said this issue has never come up at UCSF. Patients
380482 - routinely get port access in the Infusion Clinic with a Huber needle
380483 - in a Power Port, and then go to the testing department where a
380484 - technician connects to the Huber needle for injecting CT contrast
380485 - medium. Catherine said that connecting to an IV for injecting
380486 - contrast medium is identical to connecting to a Huber needle accessing
380487 - a Power Port.
380488 -
380489 - [On 080708 surgery blood test shows INR 1.1 well below target
380490 - range INR 2.0 - 3.0 for pulmonary embolism case management;
380491 - doctor describes INR 1.1 adequate and normal for patients not
380492 - suffering pulmonary embolism, and within expected range when
380493 - Coumadin is paused 5 days prior to surgery. ref SDS B7 MF4K
380494 -
380495 -
380496 -
380497 -
380498 -
380499 -
380500 -
380501 -
380502 -
380503 -
380504 -
380505 -
3806 -