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1503 -
1503 -    ..
1504 - Summary/Objective
1505 -
150501 - Follow up ref SDS 56 0000. ref SDS 54 0000.
150502 -
150503 -
150504 -
150505 -
150506 -
150508 -  ..
1506 -
1507 -
1508 - Progress
1509 -
150901 - Infusion Clinic Review Strengthen CT Test Power Port Huber Needle
150902 -
150903 - Follow up ref SDS 56 LD3H.
150904 -
150905 - Paula has reviewed the record reporting events during Millie's CT test
150906 - on 080718, ref SDS 48 0001, and which was submitted to Kaiser with
150907 - Millie's letter to Paula on 080725. ref SDS 53 6S4G
150909 -  ..
150910 - Paula seemed to say the report on Millie's CT test on 080718 has been
150911 - elevated in Kaiser management for action to support CT tests with
150912 - Power Ports, noted by Ike in the CT department on 080711. ref SDS 43
150913 - PP7O  At this time there has been no feedback on progress showing
150914 - Kaiser in Walnut Creek will be prepared to do the next test OA 080912.
150916 -  ..
150917 - Distributing the record on CT testing complements experience reported
150918 - on 080522 that reliance on the record of patient history was effective
150919 - for referral coordination between Oncology and Surgery. ref SDS 31
150920 - 635W
150922 -  ..
150923 - There seem to be three (3) work plans for Millie's next CT test needed
150924 - OA 080912...
150925 -
150926 -        1.  Kaiser upgrade support for the CT Department at Walnut
150927 -            Creek in time for the next test OA 080912, 8 weeks after
150928 -            the prior test on 080718. ref SDS 48 0001  Training and
150929 -            experience are key ingredients needed for the next test,
150930 -            reported on 080801. ref SDS 55 N58H
150932 -             ..
150933 -        2.  Arrange for test at Kaiser in Oakland, reported on 080804
150934 -            by Bard to have experience of more than a year using Power
150935 -            Ports for injecting contrast medium. ref SDS 59 5U7G
150937 -             ..
150938 -            Kaiser in Hayward, and in Santa Clara may be other options,
150939 -            according to Julie at Bard on 080804. ref SDS 59 MS9U
150940 -
150941 -                [...below commend Bard for excellent customer support
150942 -                helping to find a Kaiser facility that can use the
150943 -                Power Port for the CT test. ref SDS 0 P95U
150945 -             ..
150946 -        3.  Arrange for test at UCSF, discussed this past Thursday,
150947 -            080807. ref SDS 60 MU37
150949 -             ..
150950 -            If the work is done at UCSF there are three (3) issues to
150951 -            be resolved, listed in the recrod on 080807. ref SDS 60
150952 -            OP37
150954 -  ..
150955 - Paula asked for evidence that other Kaiser facilities can perform CT
150956 - tests with Millie's Power Port?  Explained there is only discussion
150957 - with the Bard sales department, ref SDS 0 5J4N, and this has to be
150958 - verified.
150960 -  ..
150961 - Paula indicated today that information from Bard may not be accurate
150962 - about Kaiser in Santa Clara and Kaiser in Hayward doing CT tests with
150963 - the Bard Power Port.  Paula is not convinced as well that Kaiser in
150964 - Oakland is doing CT tests with the Power Port.  If not, then option 2
150965 - is not really available. ref SDS 0 5J4N  She feels other Kaiser
150966 - facilities may have the same problem of not having qualified nurses on
150967 - staff in the CT Department that exists at Walnut Creek.
150968 -
150969 -        [...below, Sheree reports that Paula investigated and confirmed
150970 -        that Kaiser in Oakland can perform CT tests with the Power Port
150971 -        technology. ref SDS 0 L465
150973 -  ..
150974 - Paula explained there was a reorganization within Kaiser some time
150975 - ago; this resulted in the CT Department not having qualified nurses
150976 - available for CT tests using Huber needles and Power Ports, as
150977 - reported by Bella on 080617. ref SDS 34 RP6J  This may explain strong
150978 - feelings expressed on 080715 when the proposal was denied for a nurse
150979 - from the Infusion Clinic to support Millie's test by going over to the
150980 - CT Departent for a few minutes. ref SDS 45 PQ6P
150982 -  ..
150983 - Paula feels that finding a way to do Millie's next CT test at Kaiser
150984 - under options 1 and 2, ref SDS 0 CW3O, is better than doing the test
150985 - at UCSF, option 3, ref SDS 0 6W4M, because then Kaiser will have
150986 - results online in the computer system, which aids review by medical
150987 - professionals, notably, the primary care physician.  Did not discuss
150988 - today that the primary review in this case is performed at UCSF, and
150989 - there were delays at Kaiser getting the last CT test read and
150990 - published in time for Millie's examination at UCSF on 080724.
150991 - ref SDS 52 VE8O
150993 -  ..
150994 - Paula will coordinate with Doctor Johnson today on this matter.
150996 -  ..
150997 - If the doctor approves, she will contact the CT Department at Kaiser
150998 - in Oakland to confirm they are using the Bard Power Port for CT tests.
150999 - If so, then she can schedule Millie's next CT test in Oakland, per
151000 - option 2. ref SDS 0 CW3O
151001 -
151002 -
151004 -  ..
1511 -
1512 -
1513 - 1354
1514 -
151401 - Sheree called back from Kaiser following up for Paula, per above.
151402 - ref SDS 0 DE8S  She was the nurse who facilitated Millie's care on
151403 - 080719 to recover from difficulties doing the CT test the day before
151404 - on 080718. ref SDS 49 SR3J
151406 -  ..
151407 - Sheree indicated that Paula has contacted Kaiser in Oakland and is now
151408 - satisfied that Kaiser's Oakland CT Department can perform tests using
151409 - Millie's Power Port, per planning discussed with Paula above.
151410 - ref SDS 0 DE67  She explained that Paula's research disclosed today
151411 - that the Oakland CT Department refers patients to the Infusion Clinic
151412 - to access the port, and then the patient goes to the CT Department
151413 - where power injection of contrast medium is performed, and then the CT
151414 - scan.
151416 -             ..
151417 -            [...below, Millie notified UCSF that Kaiser has scheduled
151418 -            Millie's next CT test on 080912, applying an 8 week
151419 -            schedule. ref SDS 0 P95P
151421 -             ..
151422 -            [...below, Doctor Rugo says okay to schedule CT tests on 8
151423 -            week schedule, which puts the next test OA 080912.
151424 -            ref SDS 0 4T4N
151426 -             ..
151427 -            [On 080822 Arlette reported the Kaiser computer does not
151428 -            show Millie scheduled for the CT test at Kaiser Oakland,
151429 -            ref SDS 62 034E; Arlette called later and advised the test
151430 -            has been scheduled. ref SDS 62 N66E
151432 -             ..
151433 -            [On 080826 Kaiser CT Department in Walnut Creek called and
151434 -            advised that the Kaiser CT Department in Oakland sent
151435 -            Millie's case back to the CT Department at Kaiser in Walnut
151436 -            Creek. ref SDS 63 VG6N
151438 -  ..
151439 - We reviewed planning on 080617 when Cal in the the Kaiser Walnut Creek
151440 - CT Department called and scheduled Millie's CT test for 080718 1100.
151441 - ref SDS 34 DF55  At that time, on 080617, Cal advised Millie to follow
151442 - the same procedure, which Sheree presents today, of going first to the
151443 - Infusion Clinic for an experienced nurse to access the Power Port.
151444 - ref SDS 34 DF6Y  Bella in the Infusion Clinic scheduled Millie to have
151445 - the port accessed at 1030. ref SDS 34 OQ61  However, weeks later on
151446 - 080716 the CT Department called and said Millie's meeting with the
151447 - Infusion Clinic 080718 1030 was cancelled, and that she should instead
151448 - come directly to the CT Department. ref SDS 46 RA9H  This last minute
151449 - change in procedure, from following the practice found effective for
151450 - Kaiser in Oakland, led to problems with Millie's CT test in Walnut
151451 - Creek on 080718. ref SDS 48 LK3R
151453 -  ..
151454 - At this time, it is not clear why the Infusion Clinic in Oakland can
151455 - access a Power Port any better than the Infusion Clinic in the Walnut
151456 - Creek hospital.  On 080719 Julie did excellent work accessing Millie's
151457 - Power Port at the Kaiser Infusion Clinic in Walnut Creek. ref SDS 49
151458 - HY6L
151460 -  ..
151461 - Sheree asked where Millie would like to get the CT test done?
151463 -  ..
151464 - Millie prefers Kaiser Walnut Creek for convenience.
151466 -  ..
151467 - Sheree feels "things" cannot be worked out in time for Millie to get
151468 - the test at Kaiser in Walnut Creek using her Power Port.  She feels
151469 - Oakland is the closest Kaiser facility that can do the work.
151471 -  ..
151472 - Decided to do the work at Kaiser in Oakland.
151474 -  ..
151475 - Sheree asked when Millie needs the next CT test?
151477 -  ..
151478 - We reviewed the record showing CT tests are prescribed by Doctor Rugo
151479 - at UCSF according to the protocol for the clinical study.  On 080619
151480 - Thomas called from UCSF and advised that Doctor Rugo placed Millie
151481 - back on an 8 week schedule for CT tests as a result of starting the
151482 - 2nd arm of the clinical study on 080306. ref SDS 35 YV5W  This was
151483 - discussed again a week later on 080625. ref SDS 36 IU5X  The next day
151484 - on 080626 during a meeting with the medical team Brigid confirmed that
151485 - the doctor has switched back from 12 to an 8-week schedule for CT
151486 - tests. ref SDS 37 4F5S
151488 -  ..
151489 - The next CT test should therefore be performed on Friday, 080912, 8
151490 - weeks after the previous test on 080718.  Testing on 080912 provides
151491 - time for scans to be read and summarized in a report that can be
151492 - distributed the following Monday or Tuesday, so there is time for
151493 - people to make a review, shown by the record on 080723, ref SDS 51
151494 - R45G, for the test on 080718, and be prepared for a productive meeting
151495 - with the medical team to start the 8th cycle on 080918, shown by the
151496 - UCSF schedule received from UCSF on 080807. ref SDS 60 SO8F  Doing the
151497 - test on 080912 also allows time for delays reading the scans, as
151498 - occurred on 080723. ref SDS 51 R44O
151500 -  ..
151501 - Last week on 080807, UCSF was asked about planning for the next CT
151502 - test, and possibily doing the test at UCSF where there is over a year
151503 - of experience using Power Ports for power injection of contrast
151504 - medium? ref SDS 60 WW57  UCSF has not responded, possibly planning to
151505 - address scheduling for the next CT test during the meeting to start
151506 - the next cycle on 080821, shown in the record on 080807. ref SDS 60
151507 - H38G
151509 -  ..
151510 - As a result, UCSF has not yet asked for a CT test.
151511 -
151512 -        [...below, Doctor Rugo says okay to schedule CT tests on 8 week
151513 -        schedule, which puts the next test OA 080912. ref SDS 0 4T4N
151515 -  ..
151516 - Sheree said that the primary care physician will be out of the office
151517 - for several weeks, so Paula recommends scheduling the next CT test
151518 - today while the doctor is available to order the test.
151520 -  ..
151521 - This may explain why Kaiser has scheduled two (2) meetings with the
151522 - doctor on 080829 (the regular time for a review, the day after meeting
151523 - at UCSF to start the next cycle), and another on 080905.  Evidently,
151524 - the doctor expects to be out of the office on 080829, and will be
151525 - available on 080905.
151527 -  ..
151528 - Actually, the doctor is scheduled to return to the office on 080825,
151529 - and so will be available for meeting with Millie on 080829, based on
151530 - Kaiser internal email message Millie received later this evening.
151532 -  ..
151533 - Sheree proposed scheduling Millie for the CT test at Kaiser in Oakland
151534 - on 080912, so that the primary care physician can approve this today,
151535 - before going on vacation, and based on long experience with Millie's
151536 - patient history.  Millie can notify UCSF of this schedule, and if UCSF
151537 - wants the test on another date, then Kaiser can adjust the schedule as
151538 - needed.  She feels another doctor can approve a change in the date
151539 - easier, after the primary care physician has ordered the test, so she
151540 - wants to get this done today.
151542 -             ..
151543 -            [...below, Millie notified UCSF that Kaiser has scheduled
151544 -            Millie's next CT test on 080912, applying an 8 week
151545 -            schedule. ref SDS 0 P95P
151547 -             ..
151548 -            [...below, Doctor Rugo says okay to schedule CT tests on 8
151549 -            week schedule, which puts the next test OA 080912.
151550 -            ref SDS 0 4T4N
151552 -             ..
151553 -            [On 080822 Arlette reported the Kaiser computer does not
151554 -            show Millie scheduled for the CT test at Kaiser Oakland,
151555 -            ref SDS 62 034E; Arlette called later and advised the test
151556 -            has been scheduled. ref SDS 62 N66E
151558 -             ..
151559 -            [On 080826 Kaiser CT Department in Walnut Creek called and
151560 -            advised that the Kaiser CT Department in Oakland sent
151561 -            Millie's case back to the CT Department at Kaiser in Walnut
151562 -            Creek. ref SDS 63 VG6N
151564 -  ..
151565 - Additional considerations doing the next CT test...
151566 -
151567 -    1.  Can the test be done the same day that Millie gets treatment at
151568 -        UCSF on 080911, rather than the next day on 080912?  Does the
151569 -        fact that 080911 is a bye week for Carboplatin chemotherapy?
151570 -        Getting treatment at Oakland at 1300 (1pm) would support goals
151571 -        for health care cost containment by stopping at Oakland on the
151572 -        way home from San Francisco rather than making a separate trip
151573 -        and expends extra fuel, and labor.
151575 -         ..
151576 -    2.  If the test is done the same day on 080911, or the next day on
151577 -        080912, as planned in discussion with Sheree above, ref SDS 0
151578 -        L543, then can Kaiser CT department use the Huber needle
151579 -        accessing the port by UCSF for treatment on 080911?  In that
151580 -        case the Kaiser Infusion Clinic staff in Oakland need merely
151581 -        remove the needle and flush the port after the CT test?  This
151582 -        was proposed by Doctor Riley-Paull, surgeon at Kaiser Walnut
151583 -        Creek on 080606. ref SDS 32 IT40  On 080708 the surgeon did
151584 -        access the port with a Huber needle after surgery to implant
151585 -        the Power Port. ref SDS 40 LI5K  The Huber needle inserted by
151586 -        Doctor Riley-Paull on 080709, was used 2 days later at UCSF on
151587 -        080710. ref SDS 42 I27G  On 080718 Kathi at Kaiser Walnut Creek
151588 -        advised that Kaiser can use a Huber needle for a CT test in the
151589 -        same manner that UCSF used a Humber needle inserted by Kaiser.
151590 -        ref SDS 48 FL71
151591 -
151592 -            [...below letter to medical team cites planning to use
151593 -            Huber needle access Power Port at UCSF for CT test at
151594 -            Kaiser in Oakland. ref SDS 0 P43Y
151596 -             ..
151597 -            [On 080827 Millie's letter to medical team proposes
151598 -            following Kathi's advice today and leaving the Huber needle
151599 -            access for Power Port in place at UCSF for CT test at
151600 -            Kaiser. ref SDS 64 513T
151602 -             ..
151603 -            [On 080903 discuss with Kaiser CT Department in Oakland
151604 -            leaving Huber needle access Power Port for chemotherapy
151605 -            treatment at UCSF so the needle can be used again for CT
151606 -            test at Oakland; schedule attendant asks Millie to notify
151607 -            primary care p[hysician at Kaiser to request procedure.
151608 -            ref SDS 65 S289
151610 -         ..
151611 -        If this is acceptable to use port access at UCSF for the CT
151612 -        test at Oakland on the way home, or the next day on 080912,
151613 -        then Millie should be examined in the Infusion Clinic at
151614 -        Oakland to verify that the Huber needle inserted at UCSF is
151615 -        still in good working order, including standard of care for
151616 -        flush and blood draw.
151618 -         ..
151619 -    3.  Millie's Power Port has demonstrated numerous successful
151620 -        specified uses for blood draws and infusion of chemotherapy
151621 -        drip treatments before and after the CT test failed using the
151622 -        Power Port on 080718.  Is this record of effective use other
151623 -        than for CT tests sufficient to conclude that the Power Port is
151624 -        adequate for power injection of contrast medium, either that
151625 -        the device does not have difficult to recognize product defect,
151626 -        or that the surgery does not have some minor issue, or further
151627 -        that extravasation which occurred on 080718 causing the CT test
151628 -        to fail have not damaged anything, or for any other reason that
151629 -        increases risks of another failure, as considered on 080804?
151630 -        ref SDS 59 MS4T
151632 -         ..
151633 -        On 080804 Bard disclosed the company has a protocol for
151634 -        investigating failed CT tests to verify suitability of the
151635 -        Power Port and Huber needle devices for future CT tests.
151636 -        ref SDS 59 4R40
151638 -         ..
151639 -        In light of problems on 080718, what precautions should be
151640 -        taken to recover in the event of further problems for reasons
151641 -        that may not be evident at this time, and until there is a test
151642 -        showing evidence of successful use for design and intended use
151643 -        to power inject CT contrast medium?
151645 -         ..
151646 -        Kaiser should submit affirmative notice that this issue has
151647 -        been considered, and plans for taking appropriate action,
151648 -        including request for comment from the manufacturer.
151649 -
151650 -            [...below, letter to medical team asks about verifying
151651 -            suitability of Power Port for doing the next CT test.
151652 -            ref SDS 0 P44W
151654 -             ..
151655 -            [On 080826 Kaiser CT Department in Walnut Creek called and
151656 -            advised that the Kaiser CT Department in Oakland sent
151657 -            Millie's case back to the CT Department at Kaiser in Walnut
151658 -            Creek. ref SDS 63 VG6N
151659 -
151660 -
151661 -
151663 -  ..
1517 -
1518 -
1519 - 1814
1520 -
152001 - Millie submitted a letter to Doctor Rugo with copies to the medical
152002 - team saying...
152003 -
152004 -    1.  Subject: CT Test Schedule 080912 Prepare for Meeting 080918 Start Cycle 8 Clinical Study
152005 -        Date: Mon, 11 Aug 2008 18:28:38 -0700
152010 -         ..
152011 -    2.  Dear Doctor Rugo,
152013 -         ..
152014 -    3.  Sheree at Kaiser called today about scheduling my next CT test.
152015 -        [Sheree advised that the primary care physician] will be out of
152016 -        the office for several weeks beginning tomorrow. ref SDS 0
152017 -        P68J].  She feels we should get the doctor's approval today for
152018 -        the next CT test, rather than wait to the last minute when he
152019 -        returns to the office. ref SDS 0 L543
152021 -         ..
152022 -    4.  Since the last test was on 080718, Kaiser has scheduled the
152023 -        next test 8 weeks later on 080912 (Sep 12).  Sheree indicated
152024 -        that this can be adjusted, if UCSF needs a different test date,
152025 -        as further set out in the record. ref SDS 0 L56Y
152026 -
152027 -            [On 080822 Arlette reported the Kaiser computer does not
152028 -            show Millie scheduled for the CT test at Kaiser Oakland,
152029 -            ref SDS 62 034E; Arlette called later and advised the test
152030 -            has been scheduled for 080911. ref SDS 62 N66E
152032 -         ..
152033 -    5.  By copy to Kaiser, I am thanking Paula Vannicola, Service
152034 -        Director for the Infusion Clinic at Kaiser in Walnut Creek for
152035 -        finding the CT Department in Oakland that has experience using
152036 -        Power Ports. ref SDS 0 L465  I cannot emphasize enough relief
152037 -        to have this matter resolved.  My thanks, as well, to Steve and
152038 -        Julie at Bard for excellent customer support. ref SDS 0 5J4N
152040 -         ..
152041 -    6.  I am also asking Kaiser to submit the report on the next CT
152042 -        test NLT 080916, if possible, which is a Tuesday.  This will
152043 -        allow time for review to prepare for meeting with you and the
152044 -        medical team at UCSF on Thursday, 080918.
152045 -
152046 -           [On 080912 Kaiser submitted the CT test report the day
152047 -           after the test on 080911, providing ample time for review
152048 -           to prepare for meeting at UCSF on 080918. ref SDS 67 6V5I
152050 -         ..
152051 -    7.  Please note consideration in the record on getting the CT test
152052 -        done the same day as my treatment at UCSF on 080911 rather than
152053 -        080912 discussed with Sheree today. ref SDS 0 486F
152055 -         ..
152056 -    8.  If there is no medical constraint on doing the CT test the same
152057 -        day as infusion treatment, doing the test on Thursday 080911
152058 -        (Sep 11) would be convenient for me stopping at Oakland on the
152059 -        way home from UCSF, rather than driving back the next day on
152060 -        080912, as Sheree discussed today.  In that case, I will ask
152061 -        Kaiser to schedule the test for 1pm, after my treatment at
152062 -        UCSF, which typically completes at 1130, since I will not get
152063 -        Carboplatin, because 080911 is the 4th week in the cycle.
152064 -
152065 -            [On 080822 Arlette reported the Kaiser computer does not
152066 -            show Millie scheduled for the CT test at Kaiser Oakland,
152067 -            ref SDS 62 034E; Arlette called later and advised the test
152068 -            has been scheduled for 080911. ref SDS 62 N66E
152070 -             ..
152071 -            [On 080826 Kaiser CT Department in Walnut Creek called and
152072 -            advised that the Kaiser CT Department in Oakland sent
152073 -            Millie's case back to the CT Department at Kaiser in Walnut
152074 -            Creek. ref SDS 63 VG6N
152076 -         ..
152077 -    9.  I am further confirming that UCSF has scheduled my meeting with
152078 -        you to start cycle 8 on 080918 1130, and similarly, starting
152079 -        cycle 9 on 081016 1130, reported last week on 080807.
152080 -        ref SDS 60 SO8F
152082 -         ..
152083 -   10.  Typically, meetings with you occur OA 0800 or 0830 after
152084 -        getting a blood draw in the Infusion clinic and before getting
152085 -        treatment at 0900.  These two (2) meetings, however, are
152086 -        scheduled at 1130 after treatment.  This was confirmed by Lena
152087 -        in your office indicating the schedule reflects examination on
152088 -        080724 showing response to treatment, with falling CA 15-3, and
152089 -        stable CT tests.  Yeah...  I'm for it!!! ref SDS 60 U15Y
152090 -
152091 -            [...below, the doctor responds proposing to "figure out
152092 -            timing" later, but the referent is unclear. ref SDS 0 4T4N
152094 -             ..
152095 -            [On 080821 during meeting with medical team the current
152096 -            schedule was not clarified nor changed and so seems to
152097 -            stand confirmed. ref SDS 61 HT6N
152099 -         ..
152100 -   11.  Another consideration only for the Kaiser Oakland Infusion
152101 -        Clinic and CT Department is whether we can use the Huber needle
152102 -        inserted for my cetuximab treatment at UCSF on 080911, for the
152103 -        CT test later that day or the next day at Oakland.  This
152104 -        procedure was followed with Kaiser accessing the port on
152105 -        080708, and UCSF using the same access on 080710.  It was
152106 -        discussed by Kathi at Kaiser in Walnut Creek for the CT test on
152107 -        080718, as further set out in patient history in the record
152108 -        today. ref SDS 0 4931
152110 -             ..
152111 -            [On 080827 Millie's letter to medical team proposes
152112 -            following Kathi's advice today and leaving the Huber needle
152113 -            access for Power Port in place at UCSF for CT test at
152114 -            Kaiser. ref SDS 64 513T
152116 -             ..
152117 -            [On 080903 discuss with Kaiser CT Department in Oakland
152118 -            leaving Huber needle access Power Port for chemotherapy
152119 -            treatment at UCSF so the needle can be used again for CT
152120 -            test at Oakland; schedule attendant asks Millie to notify
152121 -            primary care p[hysician at Kaiser to request procedure.
152122 -            ref SDS 65 S289
152124 -         ..
152125 -   12.  I appreciate that until we get a successful test, we should
152126 -        closely adhere to protocol.  Just asking...
152128 -         ..
152129 -   13.  What action, if any, is required to evaluate suitability of the
152130 -        Power Port for power injection of contrast medium, following
152131 -        events on 080718, as further presented in the record today.
152132 -        ref SDS 0 4956
152134 -  ..
152135 - Bard has a protocol to investigate failed CT tests to verify Power
152136 - Port has no manufacture defects, reported on 080804. ref SDS 59 4R40
152137 -
152138 -            [On 080905 Millie notified Bard Kaiser will perform another
152139 -            CT test using the same Bard Power Port device which failed
152140 -            for the test on 080718, and asking if Bard is satisfied the
152141 -            record presents no product defect risks for Millie.
152142 -            ref SDS 66 Y76X
152144 -  ..
152145 - Letter to medical team continues...
152146 -
152147 -   14.  Until there is a successful CT test, should any standby
152148 -        precautions be taken?  By copy to the manufacturer Field
152149 -        Service department, giving Bard an opportunity to comment.
152151 -         ..
152152 -   15.  Thanks very much again to everyone for timely coordination, and
152153 -        quality care.
152154 -
152161 -
152162 -
152164 -  ..
1522 -
1523 -
1524 - 2131
1525 -
152501 - Millie received a response from Doctor Rugo saying...
152502 -
152503 -    1.  Subject:  CT Test Schedule 080912 Prepare for Meeting 080918 Start Cycle 8 Clinical Study
152504 -        Date: Mon, 11 Aug 2008 19:38:59 -0700
152509 -         ..
152510 -    2.  Ok, thanks.  We will figure the timing out but go with 8 weeks
152511 -        for now.
152513 -  ..
152514 - The doctor's reference to timeing is not clear; may relate to Millie's
152515 - question about scheduling meetings with the medical team to evaluate
152516 - being ready for treatment before getting treatment, per above.
152517 - ref SDS 0 P96Y
152518 -
152519 -            [On 080821 meeting with medical team the current schedule
152520 -            was not clarified nor changed and so seems to stand
152521 -            confirmed. ref SDS 61 HT6N
152523 -  ..
152524 - Cursory communications occur when people are very busy, like
152525 - battlefield medical care.
152527 -  ..
152528 - UCSF letter concludes...
152529 -
152538 -  ..
152539 - The doctor copied...
152540 -
152542 -
152543 - ...who is a new name in the cast of characters.
152544 -
152546 -  ..
1526 -
1527 -
1528 - 2137
1529 -
152901 - Millie submitted a response to Doctor Rugo saying...
152902 -
152903 -    1.  Subject: CT Test Schedule 080912 Prepare for Meeting 080918 Start Cycle 8 Clinical Study
152904 -        Date: Mon, 11 Aug 2008 21:40:44 -0700
152909 -         ..
152910 -    2.  Dear Doctor Rugo,
152912 -         ..
152913 -    3.  Thank you for confirming in a letter this evening that the next
152914 -        CT test should be on an 8 week schedule from the last test on
152915 -        Jul 18th.
152917 -         ..
152918 -    4.  Since Doctor Johnson has approved getting the test done in
152919 -        Oakland, which has experience using Power Ports, we have time
152920 -        to discuss details, e.g., doing the test on Sep 11th after
152921 -        treatment at UCSF.
152922 -
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152929 -
152930 -
152931 -
152932 -
152933 -
152934 -
152935 -
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152937 -
152938 -
1530 -