Welch Company
San Francisco, CA


S U M M A R Y


DIARY: July 11, 2008 09:30 AM Friday; Rod Welch

Millie Neupogen treatment at Kaiser update schedule Coordinate CT test

1...Summary/Objective
2...Neupogen 1st Treatment at Kaiser for 3rd Chemotherapy 5th Cycle UCSF
3...Schedule Neupogen Treatments Extended through August
4...Infusion Clinic No Planning Millie's CT Test With Power Port on 080718
5...CT Test Department Coordinate Millie's Test on 080718
6...Correspondence CT Test with Power Port Not Received CT Test Department
7...CT Test Department Correspondence CT Test with Power Port Not Received
8...Coordinating CT Test with Power Port No Communication Past 3 Months
9...CT Department Notified Patient to Get Huber Needle for Power Port
10...Knowledge CT Test with Power Port Slipped Through the Cracks
11...Department Starts Develop Protocol Power Port Not Ready Millie's Test
12...Protocol CT Test with Power Port Not Enough Time Millie's Test 080718
13...CT Tests with Power Port Identical Skills Level of Effort Using IV
14...Protocol CT Tests Power Port Patient's Doctor Not Certified
15...Training Certification Protocol Coordination All Take More Time
16...Kaiser Has 3 Doctors Certified for CT Tests with Power Port
17...Scheduling 1 of 3 Doctors for CT Test 080718 May Not Be Convenient
18...Coordinating Doctors for CT Test on 080718 Requires Mangement Time
19...Power Port Manufacturer's Instructions Implement CT Test Protocol
20...Infusion Clinic Nurse Should Remove Huber Needle in CT Department
21...Protocol CT Power Injection Needs Review Manufacturer's Instructions
22...Coordination CT Test Department and Infusion Clinic on Power Injections
23...Delay CT Test to Develop Power Port Protocol or Use Conventional IV
24...Work Plan Arrange for CT Test with Power Port on 080718
25...CT Test on 080718 with Power Port Needs Management Coordination


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CONTACTS 

SUBJECTS
Power Port Notify Medical Team Surgery Successful Follow Up Tasks Re

2503 -
2503 -    ..
2504 - Summary/Objective
2505 -
250501 - Follow up ref SDS 31 0000. ref SDS 30 0000.
250502 -
250503 - Millie got treatment with Neupogen to increase blood counts so she can
250504 - get chemotherapy treatment for cancer next week on Thursday.
250505 - ref SDS 0 IT77  The schedule for continuing Neupogen treatments was
250506 - extended through August to correlate with Millie's weekly treatments
250507 - in the clinical study at UCSF. ref SDS 0 RW3F  The Infusion Clinic
250508 - reported today that Millie's correspondence coordinating arrangements
250509 - for the CT test scheduled next Friday have not been forwarded by the
250510 - Oncology Department nor discussed with the CT Department, ref SDS 0
250511 - OC9G, and there have been no assignments nor coordination to support
250512 - the test. ref SDS 0 PP5J  The Director of the Infusion Clinic
250513 - suggested Millie visit the CT Department to verify arrangements are
250514 - set so that the test will not be delayed. ref SDS 0 RN5O  Millie went
250515 - to the CT Department. ref SDS 0 7K8I  As with the Infusion Clinic,
250516 - correspondence over the past month sent to Oncology planning the CT
250517 - test on 080718 was not forwarded to the CT Department.  They have no
250518 - record that the test requires using Millie's Power Port. ref SDS 0
250519 - PP6O  The fact that the CT Department called Millie a month ago on
250520 - 080617 to schedule the test, and notified her to make arrangement with
250521 - the Infusion Clinic to access the Power Port at 1030 in time for
250522 - injection of contrast medium half an hour later in the CT Department
250523 - at 1100, was evidently lost or otherwise forgotten until today.
250524 - ref SDS 0 PP7O  The Department has started to think about developing
250525 - training and a protocol for using Power Ports on CT tests, but this
250526 - will not be ready in time for Millie's test next Friday. ref SDS 0
250527 - JQ55  The Department feels that plans by the Oncology doctor to
250528 - support the CT test cannot be implemented because the doctor does not
250529 - have a state certificate to operate the test equipment. ref SDS 0 JQ87
250530 - Kaiser has 3 doctors with the certificate, however, notifying any of
250531 - these doctors to perform 20 minutes of work for the CT test next week
250532 - on 080718 would inconvenience their schedules.  The Department
250533 - recommended delaying the test to allow time for training and staff
250534 - certification, and to line up support activities.  UCSF feels the test
250535 - is already a month later than needed for patient care under the
250536 - clinical study protocol. ref SDS 0 JR30  Upon discussion, the CT
250537 - Department will work the issues and notify Millie by next Wednesday,
250538 - if the test can be done on Friday, 080718, as currently scheduled.
250539 - ref SDS 0 JR7Y  Review shows 10 alternative work plans that enable
250540 - doing the test on time. ref SDS 0 JR88
250542 -             ..
250543 -            [On 080712 Millie notified the doctor that proactive
250544 -            support required to accomplish objectives for CT test using
250545 -            Power Port on 080718. ref SDS 33 K13Q
250547 -             ..
250548 -            [On 080715 Arlette called and said the doctor solved
250549 -            coordination problems; CT test is good to go on 080718.
250550 -            ref SDS 34 RB4N
250552 -             ..
250553 -            [On 080716 Ike called and confirmed that Kaiser has made
250554 -            arrangements for Millie to get a CT test using her Power
250555 -            Port. ref SDS 35 PZ4L
250557 -             ..
250558 -            [On 080718 Nora with Kaiser Interventionary Radiology
250559 -            assigned to access the Power Port for Millie's CT test,
250560 -            ref SDS 36 2U8V; during procedure, Nora requests
250561 -            manufacturer's Instructions for Use on Power Injection
250562 -            procedures, ref SDS 36 NM5V, which was submitted to Kaiser
250563 -            on 080709, ref SDS 31 TR9X, review was requested on 080712,
250564 -            ref SDS 33 K13Q, and again on 080715, ref SDS 34 RB3T;
250565 -            complications occurred on power injection when contrast
250566 -            medium overflowed; CT test with Power Port failed.
250567 -            ref SDS 36 LK3R
250569 -             ..
250570 -            [On 080801 Bard asks about Huber needle used for the CT
250571 -            test today - could be defective, ref SDS 40 OV5I; Kaiser
250572 -            was trained a year earlier, but adopted policy not to use
250573 -            Power Ports for CT tests, so nobody has experience,
250574 -            ref SDS 40 OV9H, Julie offes to consult during Millie's
250575 -            next CT test. ref SDS 40 OW41
250576 -
250577 -
250578 -
250579 -
250581 -  ..
2506 -
2507 -
2508 - Progress
2509 -
250901 - Neupogen 1st Treatment at Kaiser for 3rd Chemotherapy 5th Cycle UCSF
250902 -
250903 - Follow up ref SDS 31 IT77, ref SDS 30 IT77.
250904 -
250905 - Millie went to the Infusion Clinic at Kaiser in Walnut Creek to
250906 - implement the UCSF prescription on 080626 for 2 Neupogen treatments
250907 - this cycle for each of the 3 weekly treatments with Carboplatin
250908 - chemotherapy. ref SDS 24 QJ4H  Millie followed guidance at UCSF
250909 - yesterday to get treatment today, despite very high blood counts for
250910 - the labs yesterday on 080710 that may justify cost containment by
250911 - skipping treatment today and/or tomorrow. ref SDS 32 PU6K
250913 -  ..
250914 - Florida was the nurse today providing Neupogen treatment.
250916 -  ..
250917 - Millie made arrangements with Florida to change the meeting tomorrow
250918 - scheduled for treatment at 1100, to come in at 0900, following up
250919 - Florida's discussion of flexibility on 080620, ref SDS 22 IE7L, and
250920 - subsequent scheduling adjustments on 080627. ref SDS 26 PPVW
250921 -
250922 -
250923 -
250924 -
250925 -
250926 -
2510 -

SUBJECTS
Default Null Subject Account for Blank Record

2603 -
260401 -  ..
260402 - Schedule Neupogen Treatments Extended through August
260403 -
260404 - Follow up ref SDS 22 YY88.
260405 -
260406 - After getting treatment, Millie met with Zan in the Oncology
260407 - Pharmacy.
260409 -  ..
260410 - Zan extended Kaiser's schedule of 2 Neupogen treatments per week for
260411 - Millie through August.  The current schedule received on 080620 covers
260412 - only 2 more weeks. ref SDS 22 YY88  Zan asked for dates of Millie's
260413 - chemotherapy treatments in the clinical study at UCSF, listed in the
260414 - record on 080626. ref SDS 25 IK7H  He scheduled Neupogen treatments at
260415 - Kaiser on day 2 and 3 after chemotherapy at UCSF.
260416 -
260417 -            [On 080725 Neupogen treatments have not been listed in
260418 -            Millie's schedule received from Kaiser; discussion with Zan
260419 -            indicated he does not actually schedule treatment; he
260420 -            submits a note to the Infusion Clinic to enter the schedule
260421 -            in Kaiser's computer. ref SDS 38 TS7G  Paula planned to
260422 -            schedule Millie's treatment for August, but was very busy.
260423 -            ref SDS 38 XO8J
260425 -             ..
260426 -            [On 080726 Kaiser's schedule does not show Millie's
260427 -            treatments for August; Bonnie entered in Kaiser's computer
260428 -            system Millie's schedule for Neupogen treatments for
260429 -            August. ref SDS 39 9839
260431 -  ..
260432 - Zan's schedule implements UCSF Chemotherapy Orders on 080529,
260433 - presented to Zan on 080609. ref SDS 19 L16I
260434 -
260435 -                                                        UCSF Chemo
260436 -        Date    Time   Provider         Services      Cycle Treatmnt
260437 -        080711  1630   Infusion Nurse   Neupogen        5     3
260438 -        080712  1200   Infusion Nurse   Neupogen        5     3
260439 -         ..
260440 -        080718  1030   Infusion Nurse   Port access     5     4
260441 -        080718  1100   Imaging Dep      CT scan test    5     4
260442 -         ..
260443 -        080718  1300   Infusion Nurse   Neupogen        5     4
260444 -        080719  1100   Infusion Nurse   Neupogen        5     4
260445 -        080725  1300   Infusion Nurse   Neupogen        6     1
260446 -        080726  1100   Infusion Nurse   Neupogen        6     1
260447 -         ..
260448 -        080731  0900   Infusion Nurse   Neupogen        6     2
260449 -        080801  0900   Infusion Nurse   Neupogen        6     2
260450 -        080808  0900   Infusion Nurse   Neupogen        6     3
260451 -        080809  0900   Infusion Nurse   Neupogen        6     3
260452 -         ..
260453 -        080815  0900   Infusion Nurse   Neupogen        6     4
260454 -        080816  0900   Infusion Nurse   Neupogen        6     4
260455 -        080822  0900   Infusion Nurse   Neupogen        7     1
260456 -        080823  0900   Infusion Nurse   Neupogen        7     1
260457 -        080829  0900   Infusion Nurse   Neupogen        7     2
260458 -        080830  0900   Infusion Nurse   Neupogen        7     2
260459 -
260460 -           [On 080725 Kaiser planned to enter Millie's schedule for
260461 -           treatment in the computer. ref SDS 38 TS7G
260463 -            ..
260464 -           [On 080726 Bonnie entered in Kaiser's computer system
260465 -           Millie's schedule for Neupogen treatments for August.
260466 -           ref SDS 39 BS5H
260468 -            ..
260469 -           [On 080809 Donna extended Millie's schedule of Neupogen
260470 -           treatments through September. ref SDS 41 NQ4O
260471 -
260472 -
260473 -
260474 -
2605 -

SUBJECTS
Default Null Subject Account for Blank Record

2703 -
270401 -  ..
270402 - Infusion Clinic No Planning Millie's CT Test With Power Port on 080718
270403 -
270404 - Millie visited with Cesi, the Charge Nurse, her assistant, Bella, and
270405 - with Paula Vannicola, Service Director in the Infusion Oncology
270406 - Clinic.
270408 -  ..
270409 - Bella had not received Millie's letter to Kaiser on Wednesday, 080709,
270410 - coordinating work to be prepared for Millie's CT test on 080718,
270411 - ref SDS 31 TR9X, and for which Bella scheduled support by the Infusion
270412 - Clinic, in the call on 080617. ref SDS 20 OQ61  At that time, 3 weeks
270413 - ago, Bella recommended coordination to line up Kaiser's protocol for
270414 - doing CT tests with the Power Port. ref SDS 20 OQ67  This issue was
270415 - presented to the primary care physician a week later during a meeting
270416 - at Kaiser on 080627.
270418 -  ..
270419 - Bella recalled today that the primary care physician visited with her
270420 - in the Infusion Clinic on 080627 to plan for Millie's CT test next
270421 - week on 080718, as noted in Millie's recent letter to Kaiser on
270422 - 080709. ref SDS 31 TR5P  After meeting with Bella, the doctor expected
270423 - a certified clinician would be assigned to assist the CT test
270424 - department, as Bella had previously said was required in the call on
270425 - 080617. ref SDS 20 OQ61
270427 -  ..
270428 - Millie asked today about progress addressing issues Bella presented on
270429 - 080617, ref SDS 20 OQ67, and discussed with the doctor on 080627?
270431 -  ..
270432 - Paula said Millie is still scheduled to have the Power Port accessed
270433 - in the Infusion Clinic on 080718 1030, as Bella set out in the call on
270434 - 080617. ref SDS 20 OQ61
270435 -
270436 -            [...below, CT Test Department has not received
270437 -            correspondence over the past 3 months coordinating Millie's
270438 -            CT test on 080718. ref SDS 0 7K8I
270440 -             ..
270441 -            [On 080712 Infusion Clinic reported not receiving
270442 -            correspondence coordinating Millie's CT test on 080718.
270443 -            ref SDS 33 RK5N
270445 -             ..
270446 -            [On 080715 Arlette called and said the doctor solved
270447 -            problems; CT test is good to go on 080718. ref SDS 34 RB4N
270449 -             ..
270450 -            [On 080716 Ike called an cancelled planning for Infusion
270451 -            Clinic to access the Power Port collaborating with the CT
270452 -            Department for Millie's CT test, and ordered that all work
270453 -            would be performed in the CT Department, despite lack of
270454 -            experience. ref SDS 35 AN5I
270456 -             ..
270457 -            [On 080718 Nora with Kaiser Interventionary Radiology
270458 -            assigned to access the Power Port for Millie's CT test,
270459 -            ref SDS 36 2U8V; during procedure, Nora requests
270460 -            manufacturer's Instructions for Use on Power Injection
270461 -            procedures, ref SDS 36 NM5V, which was submitted to Kaiser
270462 -            on 080709, ref SDS 31 TR9X, review was requested on 080712,
270463 -            ref SDS 33 K13Q, and again on 080715, ref SDS 34 RB3T;
270464 -            complications occurred on power injection when contrast
270465 -            medium overflowed; CT test with Power Port failed.
270466 -            ref SDS 36 LK3R
270468 -             ..
270469 -            [On 080801 Bard asks about Huber needle used for the CT
270470 -            test that failed on 080718 - it could be defective,
270471 -            ref SDS 40 OV5I; Kaiser was trained a year earlier, but
270472 -            adopted policy not to use Power Ports for CT tests, so
270473 -            nobody has experience, ref SDS 40 OV9H, Julie offes to
270474 -            consult during Millie's next CT test. ref SDS 40 OW41
270476 -  ..
270477 - Paula is worried that Kaiser's arrangements so far may not be
270478 - sufficient for Millie to get the CT test on 080718 using the Power
270479 - Port.
270481 -  ..
270482 - Paula noted that nobody has contacted the Infusion Clinic about
270483 - coordinating with the CT test department planning assignments and
270484 - responsbilities for Millie's CT test using the Power Port, as
270485 - requested by Bella also on 080617. ref SDS 20 OQ67
270486 -
270487 -            [...below, Ike proposes that an Infusion Clinic nurse come
270488 -            to the CT Test Department and remain during the test, to
270489 -            then remove the Huber needle from the Power Port.
270490 -            ref SDS 0 JQ98
270492 -             ..
270493 -            [...below Ike took Paula's name and number along with
270494 -            Millie's primary care physician to coordinate Millie's CT
270495 -            test next Friday, 080718. ref SDS 0 JR7Y
270497 -  ..
270498 - Paula suggested Millie check with the CT Test Department today to
270499 - verify all arrangements have been made, or that someone is working the
270500 - issue, so that work goes smoothly next Friday on 080718.  Cisi said
270501 - that Millie should have a "chit chat" with CT to make sure everything
270502 - is lined up.
270503 -
270504 -
270505 -
270506 -
2706 -

SUBJECTS
Default Null Subject Account for Blank Record

2803 -
280401 -  ..
280402 - CT Test Department Coordinate Millie's Test on 080718
280403 - Correspondence CT Test with Power Port Not Received CT Test Department
280404 - CT Test Department Correspondence CT Test with Power Port Not Received
280405 - Coordinating CT Test with Power Port No Communication Past 3 Months
280406 -
280407 - Millie talked to Ike Wardle, CT Technologist.
280408 -
280409 -                      925 295 6878
280411 -  ..
280412 - Millie related discussions a few minutes ago with the Infusion Clinic,
280413 - and the suggestion to coordinate today in order to get the CT test
280414 - next Friday using the Power Port. ref SDS 0 PP5J
280416 -  ..
280417 - Ike does CT tests.  He checked Kaiser's files and found Millie is
280418 - scheduled for a CT test next week on 080718.  Ike asked about the
280419 - scope of the test, and whether Millie has scheduled a blood test for
280420 - Creatinine?
280422 -  ..
280423 - Millie explained the test will cover from her neck to the pelvis, like
280424 - all of her previous tests every 8 weeks over the past 4 years.  Kaiser
280425 - did labs on 080708 for Power Port surgery. ref SDS 30 MF4K  Creatinine
280426 - 0.39 was reported, ref SDS 30 8U4N; there is a comment that...
280427 -
280428 -        Specimen grossly hemolyzed.  Results may be affected
280430 -  ..
280431 - UCSF will do another blood test for Millie's chemotherapy treatment on
280432 - 080717, the day before the CT test on 080718.  Millie asked if she
280433 - should bring a copy of the labs at UCSF on Thursday to Kaiser for the
280434 - CT test on Friday?
280436 -  ..
280437 - Ike indicated that the Department will check the lab on file at Kaiser
280438 - for 080708, and notify Millie on whether to bring results of the UCSF
280439 - blood test to Kaiser for the CT test on 080718.
280441 -  ..
280442 - Millie asked if Ike received correspondence sent to Oncology over the
280443 - past 3 months coordinating work for the CT test using the Power Port?
280445 -  ..
280446 - Ike asked what has been sent to Kaiser on this matter?
280448 -  ..
280449 - Millie has submitted following letters notifying Kaiser on plans to
280450 - use Power Port with Huber needle for next CT test...
280451 -
280452 -    1.  Kaiser primary care physician investigating
280453 -        using Huber needle for next CT test
280454 -        presented in agenda for meeting at
280455 -        UCSF.................................. 080430, ref SDS 8 W64T
280456 -                                               YYMMDD = April 30, 2008
280458 -         ..
280459 -    2.  CT test in mid-July planned to use
280460 -        Power Port, citing 2 - 3 months
280461 -        for people to be
280462 -        prepared.............................. 080502, ref SDS 11 GN8P
280463 -                                               YYMMDD = May 2, 2008
280464 -         ..
280465 -    3.  Requests meeting with Image Department
280466 -        on planning required to be prepared
280467 -        for doing the next CT test with a
280468 -        Power Port............................ 080520, ref SDS 12 TV4S
280470 -         ..
280471 -    4.  Millie's letter to the medical team cites
280472 -        8 weeks for CT Test Department to prepare
280473 -        for using the Power Port on Millie's
280474 -        next CT test.......................... 080528, ref SDS 13 IK4Q
280476 -         ..
280477 -    5.  Millie's letter to the surgeon coordinated
280478 -        accessing the Power Port with a Huber
280479 -        needle to enable CT
280480 -        testing............................... 080608, ref SDS 17 XS4S
280482 -         ..
280483 -    6.  Kaiser Surgery Department notified that
280484 -        requirements for coordination of Power
280485 -        Port surgery in time for the next CT
280486 -        test were presented to the Schedule
280487 -        Department............................ 080609, ref SDS 18 MG5I
280489 -         ..
280490 -    7.  CT test scheduled at Kaiser on 080718 1100
280491 -        using Power Port and Infusion Clinic
280492 -        will access the Power Port with
280493 -        Huber needle.......................... 080619, ref SDS 21 YU6X
280494 -        Kaiser notified to address protocol
280495 -        certification issue................... 080619, ref SDS 21 YV4R
280497 -         ..
280498 -    8.  Millie's letter to medical team confirms
280499 -        planning for CT test to use the Power
280500 -        Port for saving time and money that
280501 -        meets requirements for cost
280502 -        containment........................... 080625, ref SDS 23 IU7R
280504 -         ..
280505 -    9.  Millie's letter to medical team confirms
280506 -        that on 080627 the primary care physician
280507 -        coordinated support by the Infusion Clinic
280508 -        to access the Power Port on 080718 in time
280509 -        for CT test at 1100; and further initiated
280510 -        planning that, if no one else is assigned,
280511 -        the primary care physician will personally
280512 -        press the button for the CT test using
280513 -        the Power Port on
280514 -        080718................................. 080702, ref SDS 28 EQ3T
280516 -         ..
280517 -   10.  Millie's letter to the medical team confirms
280518 -        planning for surgery on 080708, when the
280519 -        doctor will access the new Power Port
280520 -        with a Huber needle.................... 080707, ref SDS 29 RT9I
280522 -         ..
280523 -   11.  Millie's letter to medical team confirms
280524 -        successful surgery implanting Power
280525 -        Port for CT tests...................... 080709, ref SDS 31 TR7P
280526 -        Power Port Patient Packet has a lot of
280527 -        instructions for CT test Power Injection
280528 -        which should be reviewed by CT Test
280529 -        Department............................. 080709, ref SDS 31 TR9X
280531 -  ..
280532 - Ike seemed not aware that the CT Test Department has received any
280533 - coordination on doing a CT test with Millie's Power Port.
280534 -
280535 -            [On 080712 Infusion Clinic reported not receiving
280536 -            correspondence coordinating Millie's CT test on 080718.
280537 -            ref SDS 33 RK5N
280539 -  ..
280540 - Ike had not received a copy of Millie's letter to Kaiser on 080709
280541 - reporting successful surgery implanting a Power Port, ref SDS 31 FK6F,
280542 - and coordinating the CT test on 080718 with the Infusion Clinic and
280543 - using the new Power Port. ref SDS 31 TR5P  He indicated there is
280544 - nothing in Millie's file showing the CT test on 080718 will use a
280545 - Power Port.
280546 -
280547 -            [On 080715 Arlette called and said the doctor solved
280548 -            coordination problems; CT test is good to go on 080718.
280549 -            ref SDS 34 RB4N
280551 -             ..
280552 -            [On 080718 Nora assigned by Interventionary Radiology to
280553 -            support Power Port requirements for Millie's CT test did
280554 -            not receive communications transmitting manufacturer's
280555 -            Instructions for Use. ref SDS 36 2U51
280556 -
280557 -
280558 -
280559 -
2806 -

SUBJECTS
Default Null Subject Account for Blank Record

2903 -
290401 -  ..
290402 - CT Department Notified Patient to Get Huber Needle for Power Port
290403 - Knowledge CT Test with Power Port Slipped Through the Cracks
290404 - Department Starts Develop Protocol Power Port Not Ready Millie's Test
290405 - Protocol CT Test with Power Port Not Enough Time Millie's Test 080718
290406 -
290407 - Millie related the impression from Cal who called representing the CT
290408 - Test Department on 080617.  At that time on 080617, Cal asked Millie
290409 - to schedule a meeting with the Infusion Clinic for accessing the Power
290410 - Port at least 30 minutes prior to the time for the CT test on 080718.
290411 - ref SDS 20 DF55  That sounded like the CT Test Department was ready to
290412 - go doing the CT test with Millie's Power Port.
290414 -  ..
290415 - Ike explained that sometimes things fall through the cracks.
290416 -
290417 -            [On 081219 1140 things "fell through the cracks" again when
290418 -            someone changed the doctor's order for Millie's CT test on
290419 -            081230. ref SDS 46 V76L
290420 -
290421 -            [On 090205 1318 Doctor Johnson wants better communication
290422 -            for coordinating treatment at UCSF of Millie's 6th IBC
290423 -            relapse, so that critical details do "fall through the
290424 -            cracks." ref SDS 48 256K
290426 -  ..
290427 - Problems from "things falling through the cracks" was reported at UCSF
290428 - on 080605 when Millie did not get the Chemotherapy Orders and took the
290429 - wrong dose of Neupogen. ref SDS 15 JO4V
290431 -  ..
290432 - Ike advised today that his boss, the Director of the CT Test
290433 - Department, began discussing this morning plans for training staff to
290434 - get certifications that support Power Port technology.  He noted that
290435 - more customers are beginning to get Power Ports, so the Director feels
290436 - Kaiser's CT testing should provide support.
290437 -
290438 -            [On 080801 Bard asks about Huber needle used for the CT
290439 -            test that failed on 080718 - it could be defective,
290440 -            ref SDS 40 OV5I; Kaiser was trained a year earlier, but
290441 -            adopted policy not to use Power Ports for CT tests, so
290442 -            nobody has experience, ref SDS 40 OV9H, Julie offes to
290443 -            consult during Millie's next CT test. ref SDS 40 OW41
290445 -             ..
290446 -            [On 080822 Arlette reported the Kaiser computer does not
290447 -            show Millie scheduled for the CT test at Kaiser Oakland,
290448 -            ref SDS 43 034E; Arlette called later and advised the test
290449 -            has been scheduled. ref SDS 43 N66E
290451 -             ..
290452 -            [On 080825 Kaiser cancelled Millie's test at Oakland CT
290453 -            Department where personnel are experienced using Power Port
290454 -            and Huber needle technology required for Millie's test, and
290455 -            referred the case back to the CT Department in Walnut Creek
290456 -            where personnel are not trained nor experienced to do this
290457 -            work, ref SDS 44 XF64, and where attempts on 080718 to do
290458 -            the CT test failed. ref SDS 36 LK3R
290460 -  ..
290461 - The initial plan is to contact the HR department to arrange for
290462 - training.  After the training, people have to be tested and certified
290463 - by a State Agency as qualified for performing port access and CT
290464 - testing with a Power Port.
290466 -  ..
290467 - Ike feels there may be delays getting all this done in time for
290468 - Millie's CT test on 080718.
290469 -
290470 -            [On 080715 Arlette called and said the doctor solved
290471 -            coordination problems; CT test is good to go on 080718.
290472 -            ref SDS 34 RB4N
290474 -             ..
290475 -            [On 080718 Kaiser had difficulty accessing the Power Port
290476 -            causing CT test to fail with complications. ref SDS 36 LK3R
290478 -             ..
290479 -            [On 080724 UCSF disclosed that Huber needles injecting
290480 -            contrast medium under high pressure for CT tests have a
290481 -            higher standard of construction and safety than Huber
290482 -            needles used for blood draws and chemotherapy in the
290483 -            Oncology Infusion Clinic, ref SDS 37 OK63, this could mean
290484 -            that, if Millie's port was accessed in the Kaiser Oncology
290485 -            Infusion Clinic, and if the needle for high pressure
290486 -            injection, cited in manufacturer's Instructions for Use on
290487 -            Power Injection Procedures, reported 080708, ref SDS 30
290488 -            JE7N, was not used, then problems doing the CT test on
290489 -            080718 may not have been avoided simply by accessing the
290490 -            port in the Infusion Clinic. as scheduled on 080617 by Cal
290491 -            in the CT Department. ref SDS 20 DF6Y
290493 -  ..
290494 - Millie explained planning by her primary care physician in the
290495 - Oncology Department.
290497 -  ..
290498 - The doctor arranged for a nurse in the Infusion Clinic to access the
290499 - Power Port.  Millie can then walk from the 2nd floor down to the CT
290500 - test department in the basement, where Ike and his colleagues can
290501 - perform the test.  The doctor expects the CT Department will assign a
290502 - qualified person to perform the injection for contrast medium and
290503 - press the button to start the test, monitor the work, and then send
290504 - Millie back to the Infusion Clinic for removal of the Huber needle, as
290505 - related in Millie's letter to Kaiser on 080709. ref SDS 31 TR5P  The
290506 - doctor has further agreed to come down personally and press the button
290507 - for the CT test, if no one else is available.
290508 -
290509 -
290510 -
2906 -

SUBJECTS
Default Null Subject Account for Blank Record

3003 -
300401 -  ..
300402 - CT Tests with Power Port Identical Skills Level of Effort Using IV
300403 - Protocol CT Tests Power Port Patient's Doctor Not Certified
300404 - Training Certification Protocol Coordination All Take More Time
300405 -
300406 - Ike said he feels that Millie's primary care physician cannot provide
300407 - support for Millie's CT test on 080718, as planned in the meeting on
300408 - 080627, ref SDS 27 YX5N, because he is not certified.
300409 -
300410 -            [On 080811 Paula at Kaiser Infusion Clinic investigating
300411 -            solutions to support CT Department for Millie's next test
300412 -            OA 080912; issue has been elevated, but no progress from
300413 -            management reported at this time, ref SDS 42 LD3H; there
300414 -            seems to be at least three (3) solutions. ref SDS 42 CW3O
300415 -            Paula coordinating with primary care physician about
300416 -            contacting Kaiser Oakland to perform Millie's next CT test.
300417 -            ref SDS 42 DE79
300419 -  ..
300420 - Ike explained that people need certification both as a doctor, who can
300421 - treat a central artery, and access the port with a Huber needle, and
300422 - connect the cable from the test equipment to the Huber needle, and can
300423 - also run the CT test equipment.  Ike feels he and his fellow CT
300424 - technologists can run the test equipment.  All they need is someone
300425 - with a certificate to press the button that starts the test.  He feels
300426 - getting training, and then certification from a state agency will take
300427 - time.
300429 -             ..
300430 -            [On 080715 Arlette called and said the doctor solved
300431 -            coordination problems; CT test is good to go on 080718.
300432 -            ref SDS 34 RB4N
300434 -             ..
300435 -            [On 080718 Kaiser had difficulty accessing the Power Port
300436 -            causing CT test to fail with complications. ref SDS 36 LK3R
300438 -             ..
300439 -            [On 080801 Bard asks about Huber needle used for the CT
300440 -            test that failed on 080718 - it could be defective,
300441 -            ref SDS 40 OV5I; Kaiser was trained a year earlier, but
300442 -            adopted policy not to use Power Ports for CT tests, so
300443 -            nobody has experience, ref SDS 40 OV9H, Julie offes to
300444 -            consult during Millie's next CT test. ref SDS 40 OW41
300446 -             ..
300447 -            [On 080905 Paula discussed planning for a nurse with
300448 -            special training (and certification?) for accessing a
300449 -            central artery needs to be present for the CT test using
300450 -            Power Port accessed with a Huber needle, but the actual
300451 -            access is performed by nurses in the Infusion Clinic.
300452 -            ref SDS 45 MK9H
300454 -  ..
300455 - Millie noted Catherine mentioned yesterday at UCSF that CT
300456 - technologists have been using Power Port technology for over a year,
300457 - noted by Brigid during the meeting starting cycle 3 on 080501.
300458 - ref SDS 9 TQ6F  Understandings from this research at UCSF indicates
300459 - that procedures using a Power Port are identical to using a
300460 - conventional IV.
300462 -  ..
300463 - Ike seemed to say that this is true.  After a nurse in the Infusion
300464 - Clinic accesses the Power Port with a Huber needle the CT Technologist
300465 - merely connects the cable for injecting the contrast medium to the
300466 - Huber needle, which is identical to an IV connection, and then press
300467 - the button on the CT test equipment.  These are the same, routine
300468 - tasks that CT test Technologists, like Ike, do many times every day.
300470 -  ..
300471 - Ike cited his background working at Stanford Medical Center.  He
300472 - believes from prior work at Stanford that research institutions, like
300473 - Stanford and UCSF, get special dispensation from the State regulatory
300474 - boards.  Their CT Test Technologists do not have to pass any tests for
300475 - certification.  Kaiser, however, requires the certification process.
300477 -  ..
300478 - So far, the work to be performed appears to be identical to the
300479 - training and experience of Kaiser's CT Technologists and Infusion
300480 - Clinic nurses for handling Huber needle tasks.  The problem at hand
300481 - seems administrative, not a matter of skills, training, and
300482 - experience, though a protocol should be developed to formalize
300483 - processes and assignments.
300484 -
300485 -        [On 081230 Helen in Interventional Services connected CT
300486 -        pressure injection equipment to the Huber needle for Millie's
300487 -        test; identical procedure connecting to IV for CT test pressure
300488 -        injection. ref SDS 47 FF74
300489 -
300490 -
300492 -  ..
300493 - Kaiser Has 3 Doctors Certified for CT Tests with Power Port
300494 - Scheduling 1 of 3 Doctors for CT Test 080718 May Not Be Convenient
300495 - Coordinating Doctors for CT Test on 080718 Requires Mangement Time
300496 -
300497 - Ike related that Kaiser has three doctor's at the Walnut Creek
300498 - hospital who are qualified for this work.  He is concerned there may
300499 - not be enough time to schedule any of these three (3) doctors in time
300500 - for Millie's test on 090718.  Asking one of these three doctors to
300501 - support Millie's test next Friday could inconvenience a doctor's
300502 - schedule.
300503 -
300504 -            [On 080715 Arlette called and said the doctor solved
300505 -            coordination problems; CT test is good to go on 080718.
300506 -            ref SDS 34 RB4N
300507 -
300508 -
300509 -
3006 -

SUBJECTS
Default Null Subject Account for Blank Record

3103 -
310401 -  ..
310402 - Power Port Manufacturer's Instructions Implement CT Test Protocol
310403 - Infusion Clinic Nurse Should Remove Huber Needle in CT Department
310404 - Protocol CT Power Injection Needs Review Manufacturer's Instructions
310405 - Coordination CT Test Department and Infusion Clinic on Power Injections
310406 -
310407 - Ike is also concerned that the Infusion Clinic nurse should come to
310408 - the CT test department and remain for the 20 mintues required to
310409 - accomplish the CT scan, and who can then remove the Huber needle and
310410 - flush the port, as required by manufacturer's instructions (see 080708
310411 - "Power Injection Procedures" steps 10 - 14, ref SDS 30 ML6G), rather
310412 - than the patient return for this work to be done in the Infusion
310413 - Clinic.  He feels timeliness may be a factor flushing the port and
310414 - removing the Huber needle.
310416 -             ..
310417 -            [On 080715 Infusion Clinic says absolutely cannot send
310418 -            anyone to support CT test ordered by Oncology Department
310419 -            because of short-staffing there is not enough time to spare
310420 -            anyone. ref SDS 34 PQ6P
310422 -             ..
310423 -            [On 080801 Bard field service represetative reports efforts
310424 -            to train Kaiser on using Huber needles to access Power
310425 -            Ports for high pressure injection of contrast medium
310426 -            performing CT tests. problem is how to cross-train CT
310427 -            technologists while they gain skill from experience.
310428 -            ref SDS 40 N58H
310430 -  ..
310431 - Millie asked if the CT Test Department has reviewed Power Port
310432 - "Instructions for Use" to perform "Power Injections" with a Huber
310433 - needle," which were submitted to Kaiser with the letter on 080709,
310434 - ref SDS 31 TR9X, citing the report on surgery performed 080708?
310435 - ref SDS 30 JE7N
310436 -
310437 -            [On 080801 Bard field representative volunteered to attend
310438 -            Millie's next CT test for training and consultation that
310439 -            avoids problems using Huber needle for injection contrast
310440 -            medium. ref SDS 40 OW6U
310442 -  ..
310443 - Ike feels review should yield a protocol that includes coordination
310444 - with the Infusion Clinic, if necessary.  This takes collaboration and
310445 - someone with authority to make assignments.
310446 -
310447 -            [On 080712 Millie notified the doctor that proactive
310448 -            support required to accoplish objectives for CT test using
310449 -            Power Port on 080718. ref SDS 33 K13Q
310451 -             ..
310452 -            [On 080715 Arlette called and said the doctor solved
310453 -            coordination problems; CT test is good to go on 080718.
310454 -            ref SDS 34 RB4N
310456 -             ..
310457 -            [On 080718 Nora with Kaiser Interventionary Radiology
310458 -            assigned to access the Power Port for Millie's CT test,
310459 -            ref SDS 36 2U8V; during procedure, Nora requests
310460 -            manufacturer's Instructions for Use on Power Injection
310461 -            procedures, ref SDS 36 NM5V, which was submitted to Kaiser
310462 -            on 080709, ref SDS 31 TR9X, review was requested on 080712,
310463 -            ref SDS 33 K13Q, and again on 080715, ref SDS 34 RB3T;
310464 -            complications occurred on power injection when contrast
310465 -            medium overflowed; CT test with Power Port failed.
310466 -            ref SDS 36 LK3R
310468 -             ..
310469 -            [On 080724 UCSF disclosed that Huber needles injecting
310470 -            contrast medium under high pressure for CT tests have a
310471 -            higher standard of construction and safety than Huber
310472 -            needles used for blood draws and chemotherapy in the
310473 -            Oncology Infusion Clinic, ref SDS 37 OK63, this could mean
310474 -            that, if Millie's port was accessed in the Kaiser Oncology
310475 -            Infusion Clinic, and if the needle for high pressure
310476 -            injection, cited in manufacturer's Instructions for Use on
310477 -            Power Injection Procedures, reported 080708, ref SDS 30
310478 -            JE7N, was not used, then problems doing the CT test on
310479 -            080718 may not have been avoided simply by accessing the
310480 -            port in the Infusion Clinic. as scheduled on 080617 by Cal
310481 -            in the CT Department. ref SDS 20 DF6Y
310483 -  ..
310484 - Millie cited discussion earlier this morning with the Infusion Clinic
310485 - staff.  Currently, Millie is scheduled to have a nurse access the
310486 - Power Port with a Huber needle on 080718 1030, half an hour prior to
310487 - the time of the CT test at 1100. ref SDS 0 PP5J  This was done at the
310488 - express direction of the CT Test Department on 080617 scheduling the
310489 - CT test on 080718. ref SDS 20 DF55  While no one in the Infusion
310490 - Clinic has been assigned to actually support the test by coming to the
310491 - CT Department, as Ike discusses today, Kaiser has had a month to make
310492 - any supplemental arrangements needed to perform the test scheduled for
310493 - next Friday, 080718 1100.
310494 -
310495 -
310496 -
3105 -

SUBJECTS
Default Null Subject Account for Blank Record

3203 -
320401 -  ..
320402 - Delay CT Test to Develop Power Port Protocol or Use Conventional IV
320403 -
320404 - Ike explained that since this just came up today, Millie should
320405 - consider delaying the test a week or so, to give the department time
320406 - for rolling out a new set of procedures.
320408 -  ..
320409 - Millie explained that UCSF has already objected to delaying the test
320410 - until after the Power Port surgery this past Tuesday.  The test was
320411 - actually needed the week of 080618, 4 weeks earlier.  The blood test
320412 - on 080708 for surgery shows the cancer marker, CA 15-3 has increased
320413 - to significant highs in patient history, ref SDS 30 05YW, adding
320414 - urgency to correlate with CT test results for guiding treatment
320415 - decisions starting the next cycle on 080724.
320417 -  ..
320418 - Ike proposed that rather than inconvenience the CT Department to
320419 - expedite arrangements for Millie's CT test using the Power Port on
320420 - 080718, instead, Millie could have the CT test with a conventional IV
320421 - that damages her arm, reported on 080425. ref SDS 7 FP6F  The CT
320422 - Department has enough time to cancel arrangements requested by the CT
320423 - Department a month ago, for the Infusion Clinic to access Millie's
320424 - Power Port on 080718, but not enough time to arrange for the CT test
320425 - to use the Power Port.
320426 -
320427 -        [On 080715 Kaiser working on lining up staff to support
320428 -        Millie's CT test. ref SDS 34 RB8S
320430 -  ..
320431 - Millie began to cry trying to explain the doctor's finding of damage
320432 - to her arm on 080502, ref SDS 10 WX6I, caused by the last CT test on
320433 - 080425. ref SDS 7 FP6F  At that time on 080502, the doctor prescribed
320434 - the Power Port to solve the problem in time for the next CT test.
320435 - ref SDS 10 AA8L  After months of planning, per above, ref SDS 0 7K8I,
320436 - suddenly there are more delays unless the patient undergoes a painful,
320437 - damaging procedure which everything was designed to avoid?
320439 -  ..
320440 - Ike opened a door to the hallway and suggested stepping outside the
320441 - work area away from other patients and staff to continue the
320442 - discussion.  He noted that Kaiser is aware of difficulties patients
320443 - experience with needle punctures for CT tests.  He offered to
320444 - personally set up the IV for Millie to inject contrast medium.  Ike
320445 - related his 24 years experience that ensures minimal inconvenience
320446 - from discomfort to the patient.
320448 -  ..
320449 - We reviewed procedures the anesthesiologist used this past Tuesday,
320450 - 080708, providing a local anesthetic for an IV, so the patient was not
320451 - inconvenienced while drawing blood for a test needed to perform
320452 - surgery, for the purpose of enabling the CT test department to use the
320453 - Power Port on 080718.  For that procedure, the doctor had to use a
320454 - hand pump because blood flowed too slowly through the vein.
320455 - ref SDS 30 ME85
320457 -  ..
320458 - Ike noted that injecting CT contrast medium requires finding a vein
320459 - where flow is normal to optimal.  Millie related experience on 080425
320460 - when the CT test Department Technologist was unable to find a vein in
320461 - Millie's arm.  He had to call in someone else, and that person
320462 - required several more tries.  Like Ike, all of these professionals
320463 - were extremely competent.  The problem is with the arm, not the skill
320464 - of the practitioner, nor convenience of the patient. ref SDS 7 FP6F
320465 -
320466 -
320467 -
3205 -

SUBJECTS
Default Null Subject Account for Blank Record

3303 -
330401 -  ..
330402 - Work Plan Arrange for CT Test with Power Port on 080718
330403 - CT Test on 080718 with Power Port Needs Management Coordination
330404 -
330405 - Ike said he understands requirements.  The CT test department will
330406 - work the issue to use Millie's Power Port for the test on 080718.  He
330407 - expects to notify Millie by next Wednesday on how this matter will be
330408 - handled.
330410 -  ..
330411 - Ike took down the phone number for the primary care physician, and
330412 - Paula, the director of services in the Oncology Infusion Clinic, per
330413 - above. ref SDS 0 RF6K
330414 -
330415 -            [On 080712 Millie notified the doctor that proactive
330416 -            support required to accomplish objectives for CT test using
330417 -            Power Port on 080718. ref SDS 33 K13Q
330419 -             ..
330420 -            [On 080715 Arlette called and said the doctor solved
330421 -            coordination problems; CT test is good to go on 080718.
330422 -            ref SDS 34 RB4N
330424 -             ..
330425 -            [On 080716 Ike called and confirmed that Kaiser has made
330426 -            arrangements for Millie to get a CT test using her Power
330427 -            Port. ref SDS 35 PZ4L
330429 -  ..
330430 - Several work plans were considered on 080617. ref SDS 20 4Q3K  Today,
330431 - there are roughly 10 separate work plans that enable Kaiser to meet
330432 - the schedule using Millie's Power Port for the CT test on 080718 at
330433 - 1100...
330434 -
330435 -    1.  Arrange for one of the 3 doctors certified to work with the CT
330436 -        test equipment, noted by Ike today, per above, ref SDS 0 RG9M,
330437 -        to be availabe for Millie's test on 080718 1100.
330439 -         ..
330440 -    2.  Arrange for a nurse in the Oncology Infusion Clinic to come to
330441 -        the CT Test Department for Millie's test on 080718 at 1100, and
330442 -        support the work, as suggested by Ike today, per above.
330443 -        ref SDS 0 JQ98
330445 -         ..
330446 -    3.  Same as step 1, but change the time of Millie's test on 080718
330447 -        to a time convenient for any one of the 3 doctors.
330449 -         ..
330450 -    4.  Same as step 1, but change the date of Millie's test to a day
330451 -        prior to 080718 and at a time convenient for any one of the 3
330452 -        doctors.
330454 -         ..
330455 -    5.  Arrange for a doctor at another Kaiser hospital who has been
330456 -        trained on using the CT test equipment to be available for
330457 -        Millie's CT test on or prior to 080718 and at a time convenient
330458 -        for the doctor.
330460 -         ..
330461 -    6.  Train and certify another doctor or care provider, for example
330462 -        a nurse practitioner, or nurse in the Infusion Clinic, to work
330463 -        with the CT test technologist for performing Millie's CT test
330464 -        on 080718 1100.
330466 -         ..
330467 -    7.  Perform the CT test at another Kaiser location, e.g.,
330468 -        Pleasanton, San Francisco, or at UCSF, where the protocol for
330469 -        using Power Port technology accessed with Huber needle to
330470 -        inject contrast medium has already been developed.
330472 -         ..
330473 -    8.  Train only at Kaiser Walnut Creek CT Department, and skip
330474 -        certification of another doctor or care provider, for example a
330475 -        nurse practitioner, or nurse in the Infusion Clinic, to work
330476 -        with the CT test technologist for performing Millie's CT test
330477 -        on 080718 1100.
330479 -         ..
330480 -    9.  Train and certify CT Test Technologists to perform injection
330481 -        services for contrast medium in time for Millie's CT test on
330482 -        080718 1100.
330484 -         ..
330485 -   10.  Train only, and skip certification, of CT Test Technologists to
330486 -        perform injection services for contrast medium in time for
330487 -        Millie's CT test on 080718 1100.
330489 -         ..
330490 -   11.  Millie can waive certification on showing that a doctor, nurse,
330491 -        and/or CT Test Technologist has been trained to perform the
330492 -        work.
330494 -         ..
330495 -        This includes review of Power Port Bard manufacturer's
330496 -        instructions for "power injections" in literature received from
330497 -        Kaser on 080708. ref SDS 30 JE7N
330499 -         ..
330500 -        Kaiser should generate a protocol with interdepartmental
330501 -        coordination, as needed.
330502 -
330503 -            [On 080718 CT test with Power Port failed; ref SDS 36 LK3R,
330504 -            manufacturer's "Instructions for Use" were reviewed during
330505 -            the procedure, ref SDS 36 NM5V; CT Department did not
330506 -            receive correspondence coordinating the work to be
330507 -            prepared. ref SDS 36 2U51
330509 -             ..
330510 -            [On 080724 UCSF disclosed that Huber needles injecting
330511 -            contrast medium under high pressure for CT tests have a
330512 -            higher standard of construction and safety than Huber
330513 -            needles used for blood draws and chemotherapy in the
330514 -            Oncology Infusion Clinic, ref SDS 37 OK63, this could mean
330515 -            that, if Millie's port was accessed in the Kaiser Oncology
330516 -            Infusion Clinic, and if the needle for high pressure
330517 -            injection, cited in manufacturer's Instructions for Use on
330518 -            Power Injection Procedures, reported 080708, ref SDS 30
330519 -            JE7N, was not used, then problems doing the CT test on
330520 -            080718 may not have been avoided simply by accessing the
330521 -            port in the Infusion Clinic. as scheduled on 080617 by Cal
330522 -            in the CT Department. ref SDS 20 DF6Y
330524 -         ..
330525 -        Consideration should be given to having a walk through of
330526 -        procedures the day before the actual test, to discover any
330527 -        issues that are overlooked, and can be adjusted in time for the
330528 -        actual work on 080718.
330529 -
330530 -            [On 080801 Bard asks about Huber needle used for the CT
330531 -            test that failed on 080718 - it could be defective,
330532 -            ref SDS 40 OV5I; Kaiser was trained a year earlier, but
330533 -            adopted policy not to use Power Ports for CT tests, so
330534 -            nobody has experience, ref SDS 40 OV9H, Julie offes to
330535 -            consult during Millie's next CT test. ref SDS 40 OW41
330537 -         ..
330538 -   12.  Since Millie is the first patient getting a CT test using new
330539 -        Power Port technology, Kaiser should schedule extra standby
330540 -        staff to be availabe for recovery in the event of problems,
330541 -        indicated by Millie's letter to Kaiser on 080709. ref SDS 31
330542 -        VK5I
330544 -         ..
330545 -        A list should be developed of possible problems, and plans
330546 -        written out to addess any such contingencies.
330547 -
330548 -            [On 080811 Paula at Kaiser Infusion Clinic investigating
330549 -            solutions to support CT Department for Millie's next test
330550 -            OA 080912; issue has been elevated, but no progress from
330551 -            management reported at this time, ref SDS 42 LD3H; there
330552 -            seems to be at least three (3) solutions. ref SDS 42 CW3O
330553 -            Paula coordinating with primary care physician about
330554 -            contacting Kaiser Oakland to perform Millie's next CT test.
330555 -            ref SDS 42 DE79
330556 -
330557 -
330558 -
330559 -
330560 -
330561 -
330562 -
330563 -
3306 -