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 18, 2008 10:30 AM Friday; Rod Welch

Millie CT test at Kaiser problems using Power Port resolved.

1...Summary/Objective
2...Infusion Clinic Cancel Meetings Neupogen and Access Power Port
3...CT Test Started with Technologist Who Did the Test on 080425
4...Power Port Instructions Requested for Review During CT Test
5...CT Test Failed Power Port Access Problems Contrast Medium Overflowed
6...Chest Shoulder Swelled Contrast Medium Extrvasation Port Access Failed
7...Access Power Port Failed Contrast Medium Overflowed Power Port
8...Units of Measure Variance May Have Influenced Mistake Injection Flow Rate
9...Pain During Power Injection Contrast Medium Overflowed
10...Huber Needle Popped Loose from Power Port During Injection?
11...Power Port No Evident Damage Need Review Verify Suitability for Use
12...Causation Analysis
13...Patient Recovers Quickly from Pain and Distress
14...Staff Change for Power Port Support from Interventionary Radiology
15...Power Port Accessed at UCSF Reduces Risks Doing New Procedure at Kaiser
16...CT Test 2nd Try Swelling Prevents Locating Power Port Access Point
17...UCSF Patient History Aids Work at Kaiser for CT Test Using Power Port
18...CT Test Fails Swelling Prevents Finding Power Port Causes Bleeding
19...Bleeding from Surgery Incision Halts Use of Power Port for CT Test
20...CT Test Work Plan Using Power Port May Delay Work Several Days
21...Swelling from Contrast Medium Overflow May Delay CT Test Several Days
22...CT Test Performed Conventional IV
23...Post-Procedure Instructions Following CT Test Bleeding Incident
24...Lessons Learned Post Procedure Review In Time for Next Test
25...Power Port Vendor Review Initiated by Kaiser
26...Neupogen Booster Treatment Due to Bleeding in CT Department
27...Schedule Neupogen Treatment and Physician Review
28...Letter Request Kaiser Submit CT Test Report Notify Problems Issues


..............
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CONTACTS 

SUBJECTS
Neupogen Treatment Cancel Kaiser Infusion Clinic on Advice UCSF Infu

1103 -
1103 -    ..
1104 - Summary/Objective
1105 -
110501 - Follow up ref SDS 38 TZ8I, ref SDS 37 0000.
110502 -
110503 - CT test completed successfully with conventional IV. ref SDS 0 A363
110504 - Millie given instructions to minimize bleeding from Power Port surgery
110505 - wound. ref SDS 0 NQ4Q  CT test with Power Port failed due in part to
110506 - problems accessing the port, and possibly flow rate conflicts.
110507 - ref SDS 0 LK3R  Contrast medium overflowed the Power Port causing pain
110508 - and swelling in Millie's right chest, shoulder and upper arm.
110509 - ref SDS 0 NW5M  The Huber needle may have popped loose, ref SDS 0
110510 - 4S5L, may not have been seated correctly, ref SDS 0 LK41, or could be
110511 - defective.  Millie is concerned about suitability of Power Port for
110512 - use to get treatment next week at UCSF. ref SDS 0 A281  Communication
110513 - and coordination issues may have contributed to problems today,
110514 - ref SDS 0 NM5V, including mixup that prevented using Huber needle
110515 - accessing the port at UCSF yesterday for the CT test at Kaiser today.
110516 - ref SDS 0 FL75  A 2nd attempt to access the Power Port also failed
110517 - because swelling from contrast medium prevented finding the port.
110518 - ref SDS 0 IC6F  Pressing the chest area bloated with overflowed
110519 - contrast medium to locate the Power Port beneath the skin caused
110520 - bleeding from the surgery incision made last week to implant the Power
110521 - Port. ref SDS 0 A26Y  Overall experience was painful and stressful for
110522 - everyone. ref SDS 0 A44K  Kaiser is commended for handling difficult
110523 - problems with professional skill and determination to perform critical
110524 - testing on time for patient care. ref SDS 0 NR36  Kaiser plans
110525 - post-test review for lessons learned. ref SDS 0 A39Q  At home, Millie
110526 - rested.  There was no evident bleeding from the surgical wound, based
110527 - on observing the bandage Kathi applied. ref SDS 0 A36U  Millie wants
110528 - to get a Neupogen treatment tomorrow in case events today caused blood
110529 - counts to drop.  She is worried the Power Port and surgical incision
110530 - may be compromized, and she may not get treatment next Thursday at
110531 - UCSF. ref SDS 0 A54W  Notified medical team that CT test was completed
110532 - with complications. ref SDS 0 PU7P
110533 -
110534 -            [On 080719 Neupogen treatment received, ref SDS 40 SR37,
110535 -            Power Port accessed with 1" Huber needle at Kaiser
110536 -            Oncology Infusion Clinic, blood flows well; port flushed
110537 -            per manufacturer's protocol, ref SDS 40 HY6L; surgery
110538 -            incision wound slight gap from bleeding was cleaned,
110539 -            fresh surgical tape applied. ref SDS 40 LD84
110541 -             ..
110542 -            [On 080719 Millie relieved and feeling better recovering
110543 -            from problems today, ref SDS 40 LD8J; she hiked 5.5 miles
110544 -            at Lafayette reservoir. ref SDS 40 LD4M
110546 -             ..
110547 -            [On 080721 letter commends Infusion Clinic excellent care
110548 -            recovering from CT test problems, ref SDS 41 CW8Q; remind
110549 -            Oncology to submit the CT test report in time for everyone
110550 -            to be prepared to have a productive meeting with medical
110551 -            team at UCSF on 080724. ref SDS 41 CW9R
110553 -             ..
110554 -            [On 080723 Arlette reminded doctor about submitting CT test
110555 -            report to prepare for meeting at UCSF on 080724 starting
110556 -            the next cycle, ref SDS 42 6V5I; doctor reported that CT
110557 -            Department delayed reading the CT test. ref SDS 42 R44O
110559 -             ..
110560 -            [On 080723 report on CT test received late PM; shows stable
110561 -            conditions with no evident distant metastasis, ref SDS 42
110562 -            R45G, and no growth in adenopathy. ref SDS 42 EO8F
110564 -             ..
110565 -            [On 080724 UCSF did not get the CT test report from Kaiser
110566 -            in time to prepare for the meeting. ref SDS 43 VE8O
110568 -             ..
110569 -            [On 080724 Power Port accessed at UCSF and treatment
110570 -            accomplished routinely without problems. ref SDS 44 OK5N
110572 -             ..
110573 -            [On 080801 Bard asks about Huber needle used for the CT
110574 -            test today, ref SDS 45 OV5I, Julie offes to consult during
110575 -            Millie's next CT test. ref SDS 45 OW41
110577 -             ..
110578 -            [On 080804 Bard reports that Kaiser in Oakland has
110579 -            experience performing CT tests using Power Port with Huber
110580 -            needle technology. ref SDS 46 5U7G
110582 -             ..
110583 -            [On 080811 Paula at Kaiser Infusion Clinic investigating
110584 -            solutions to support CT Department for Millie's next test
110585 -            OA 080912; issue has been elevated, but no progress from
110586 -            management reported at this time, ref SDS 47 LD3H; there
110587 -            seems to be at least three (3) solutions. ref SDS 47 CW3O
110588 -            Paula coordinating with primary care physician about
110589 -            contacting Kaiser Oakland to perform Millie's next CT test.
110590 -            ref SDS 47 DE79
110592 -             ..
110593 -            [On 080811 Kaiser reports Oakland office has experience
110594 -            doing CT tests with Power Port and Huber needle technology,
110595 -            ref SDS 47 L465; schedule Millie's next CT test on 080911
110596 -            at Kaiser in Oakland. ref SDS 47 L549
110598 -             ..
110599 -            [On 080822 Kaiser notifies Millie that CT test using Power
110600 -            Port and Huber needle technology is scheduled for Kaiser in
110601 -            Oakland on 080911. ref SDS 50 N66E
110603 -             ..
110604 -            [On 080826 Kaiser CT Department in Walnut Creek called and
110605 -            advised that the Kaiser CT Department in Oakland sent
110606 -            Millie's case back to the CT Department at Kaiser in Walnut
110607 -            Creek. ref SDS 51 VG6N
110609 -             ..
110610 -            [On 080929 Paula confirms Kaiser CT Department in Walnut
110611 -            Creek not ready to perform tests using Power Port and Huber
110612 -            needle technology, ref SDS 53 RP7S; primary care physician
110613 -            re-ordered test at Oakland CT department which has
110614 -            experience using Power Port and Huber needle devices.
110615 -            ref SDS 53 RP7V
110617 -             ..
110618 -            [On 080903 discuss with Kaiser CT Department in Oakland
110619 -            leaving Huber needle access Power Port for chemotherapy
110620 -            treatment at UCSF so the needle can be used again for CT
110621 -            test at Oakland; schedule attendant asks Millie to notify
110622 -            primary care p[hysician at Kaiser to request procedure.
110623 -            ref SDS 54 S289
110625 -             ..
110626 -            [On 080904 Catherine seemed say that nurses must select
110627 -            from a range of different Huber needles available for
110628 -            treatment in the Infusion Clinic, per Angiodynamics
110629 -            manufacturer's Lifeguard Safety needles listed on 080724,
110630 -            ref SDS 44 N79U; Catherine plans to use the needle
110631 -            specified for high pressure injections to treat Millie at
110632 -            UCSF on the day when the same needle will be used later in
110633 -            the same day at Kaiser for a CT test. ref SDS 55 V64G
110634 -
110635 -
110636 -
110637 -
110638 -
110640 -  ..
1107 -
1108 -
1109 - Progress
1110 -
111001 - Infusion Clinic Cancel Meetings Neupogen and Access Power Port
111002 -
111003 - Follow up ref SDS 19 9W9I, ref SDS 16 669L.
111004 -
111005 - Millie went to the Oncology Department to cancel meetings with the
111006 - Infusion Clinic for today and tomorrow to get Neupogen treatments,
111007 - shown in the schedule Zan submitted on 080711. ref SDS 34 PF4F
111009 -  ..
111010 - The attendant at the check-in counter said that only the doctor can
111011 - cancel treatments.
111012 -
111013 -               [On 080719 cancelled treatment reinstated; nurse advises
111014 -               that only doctors can order treatment; Infusion Clinic
111015 -               takes immediate action to redress mistakes on CT test.
111016 -               ref SDS 40 OG6F
111018 -  ..
111019 - Millie explained that she is getting treatment at UCSF in a clinical
111020 - study on referral from Kaiser.  Her doctor at UCSF was not available
111021 - yesterday on 080717.  The nurse called and left a message with the
111022 - medical team that since Millie's blood counts are high, NEUTS 2.47
111023 - (ANC 2470 at Kaiser), ref SDS 38 QY6H, and further, since Millie did
111024 - not have chemotherapy treatment, the nurse recommended Neupogen
111025 - treatment was unnecessary this week based on patient history showing
111026 - blood counts typically rise when the patient does not get chemotherapy
111027 - treatment. ref SDS 38 V46L
111029 -  ..
111030 - The attendant will notify Millie's primary care physician, and the
111031 - Infusion Clinic that Millie will not get Neupogen treatments today and
111032 - tomorrow.
111033 -
111034 -               [...below, failure using Power Port for CT test caused
111035 -               bleeding of wound from surgery for Power Port, raises
111036 -               concerns about blood counts, ref SDS 0 A370, Millie
111037 -               feels Neupogen treatment cancelled this morning, should
111038 -               be performed, ref SDS 0 A36U; Kaiser called to order
111039 -               Neupogen treatment tomorrow. ref SDS 0 4535
111041 -                ..
111042 -               [On 080719 Neupogen treatment received at Kaiser.
111043 -               ref SDS 40 SR37
111045 -  ..
111046 - Millie asked if the Infusion Clinic was notified that the CT
111047 - Department cancelled Millie's meeting today at 1030 to access the
111048 - Power Port for a CT test today at 1100, reported by Ike on 080716?
111049 - ref SDS 37 AN5I
111051 -  ..
111052 - The attendant checked the schedule and indicated Millie is still
111053 - scheduled for port access right now at 1030.
111055 -  ..
111056 - Millie explained understandings that everything for the CT test will
111057 - now be done in the CT Department. ref SDS 37 AN6G
111059 -  ..
111060 - While Millie waited at the counter, the attendant called and talked to
111061 - Bella in the Infusion Clinic.  She advised that Millie will not need
111062 - the Neupogen treatment today, and that the CT Department will access
111063 - the port, and remove the Huber needle after the test today.
111064 -
111065 -               [On 080719 Neupogen treatment received due to problems
111066 -               with CT test, ref SDS 40 SR37; Power Port accessed with
111067 -               1" Huber needle at Kaiser Oncology Infusion Clinic,
111068 -               blood flows well; port flushed per manufacturer's
111069 -               protocol. ref SDS 40 HY6L
111070 -
111071 -
111072 -
111073 -
1111 -

SUBJECTS
CT Test 080718 Evaluate Diagnosis IBC Progression Disease 4th Relaps

4503 -
4504 - 1045
450501 -  ..
450502 - CT Test Started with Technologist Who Did the Test on 080425
450503 -
450504 - Follow up ref SDS 19 9W9I, ref SDS 16 669L.
450505 -
450506 - Before leaving for the hospital this morning, Millie drank
450507 - Gastrografin contrast medium required to complement contrast medium
450508 - that will be pressure injected by the CT equipment through the Power
450509 - Port for the CT test.  Gastrografin was ordered by the CT Department
450510 - when the test today was scheduled on 080607. ref SDS 29 DF64
450512 -         ..
450513 -        [On 080822 Barium Sulfate suspension replaces Gastrografin for
450514 -        oral contrast medium to support CT tests. ref SDS 50 VY6J
450516 -         ..
450517 -        [On 080911 after the CT test, and through the evening new
450518 -        contrast medium may cause upset stomach. ref SDS 56 S59G
450520 -         ..
450521 -        [On 081230 Barium Sulfate suspension contrast medium for CT
450522 -        test in combination with sunitinib treatment for cancer has
450523 -        severe side effects, ref SDS 62 FF4K; Millie considers changing
450524 -        back to Gastrografin. ref SDS 62 N66M
450526 -  ..
450527 - Checked in at the CT Department for the test ordered by the primary
450528 - care physician on 080627, and required by protocol for treatment at
450529 - UCSF through clinical study on cetuximab and Carboplatin.
450531 -  ..
450532 - This CT test will use the Power Port for injecting contrast medium.
450533 - The port was implanted by surgery on 080708. ref SDS 31 0001  On
450534 - 080617 Kaiser scheduled surgery for the Power Port. ref SDS 29 MG5I
450535 - Later that day, the CT Department scheduled the test today to follow
450536 - surgery on 080708 so that the Power Port can be used for the CT test.
450537 - ref SDS 29 DF55  The CT Department planned for the patient to go to
450538 - the Infusion Clinic in the Oncology Department which has trained
450539 - personnel for accessing the port. ref SDS 29 DF6Y
450541 -  ..
450542 - Millie submitted $50 co-payment for the test.  She filled out some
450543 - documentation, including consent for doing the test.
450544 -
450546 -  ..
4506 -
4507 -
4508 - 1058
4509 -
450901 - Dennis, the CT Technologist took Millie into the test room.
450902 -
450903 - Millie submitted the report on blood work for Creatinine 0.42 from
450904 - labs performed at UCSF yesterday for Millie's cancer treatment.
450905 - ref SDS 38 8U4N
450907 -  ..
450908 - On 080711, Ike planned to do Millie's CT test today. ref SDS 34 JR53
450909 - Two days ago on 080716, Ike seemed to say he would see Millie today.
450910 - ref SDS 37 LI5G  Evidently, something came up, and so Dennis is the
450911 - Technologist for Millie's CT test today.
450913 -  ..
450914 - Millie recalled that Dennis did the CT test on 080425. ref SDS 19 FP6F
450915 - He feels things will go better today.
450916 -
450917 -              [...below, Millie thanks Dennis for good work supporting
450918 -              the test today. ref SDS 0 NR36
450919 -
450920 -
4510 -

SUBJECTS
Power Port Failure Manufacturer's Instructions Flow Rate Flush Salin

7503 -
7504 - 1114
750501 -  ..
750502 - Power Port Instructions Requested for Review During CT Test
750503 -
750504 - Nora came into the waiting area.  She works in the Interventional
750505 - Radiology Department, and is doing port access for Millie's CT test
750506 - today, as reported by Arlette on 080715, ref SDS 36 RB6P, and also by
750507 - Ike the next day on 080716. ref SDS 37 PZ4L
750509 -  ..
750510 - Nora advised that she has a Master's degree in the medical field,
750511 - perhaps nursing.  She is an educator with many years experience, who
750512 - trains and supervises complex procedures, like today.  She explained
750513 - that Power Ports, while new to the CT Department, are common and
750514 - familiar to her practice in the Interventionary Radiology Department
750515 - at Kaiser.
750516 -
750517 -        [On 090413 1500 Nora assisted in Millie's CT test again,
750518 -        representing the IS Department. ref SDS 64 QO4L
750520 -  ..
750521 - Nora reported that the Huber needle has been inserted to access the
750522 - Power Port, and she connected the cable on CT scan equipment to the
750523 - Huber needle, ready to begin power injection, and then launch the
750524 - scan.
750526 -  ..
750527 - Nora asked for Millie's "Power Port ID card."  It came with the
750528 - manufacturer's "Power Port Patient Packet" which Millie received after
750529 - surgery to implant the new port on 080708.  ref SDS 31 DZ5O  Nora
750530 - needs instructions printed on the ID card that specify injection flow
750531 - rates, and also requirements on flushing the port after the test
750532 -
750533 -        [...below, there was discussion in the test room during the
750534 -        procedure on converting units of measure to determine injection
750535 -        flow rates. ref SDS 0 7M6F
750537 -         ..
750538 -        [On 080911 Angela at CT Department with Kaiser in Oakland asked
750539 -        for Millie's Power Port ID card; after learning Millie has the
750540 -        Bard Power Port, she advised that training by Bard personnel a
750541 -        day or so earlier resolved issues, ref SDS 56 JX60; and so did
750542 -        not need the Power Port ID card to check flow rates and
750543 -        flushing instructions, and did not need to change settings on
750544 -        CT test equipment; this resulted in successful CT test using
750545 -        Bard Power Port. ref SDS 56 LK3R
750547 -  ..
750548 - Bard "Instructions for Use" were submitted to the Oncology Department
750549 - at Kaiser on 080709 for coordinating work on the CT test. ref SDS 32
750550 - TR9X   The manufacturer's instructions list "Power Injection
750551 - Procedures" from the record on 080708. ref SDS 31 JE7N  Millie met
750552 - with the CT Department on 080711, and requested review of Bard
750553 - requirements and procedures in time for the test today. ref SDS 34
750554 - JR6T  Millie's letter the next day on 080712 requested proactive
750555 - support for the CT Department on reviewing this section to prepare for
750556 - the work today. ref SDS 35 K13Q
750558 -         ..
750559 -        Injection "flow rates" are listed in step 7 of the
750560 -        manufacture's Instructions for Use received on 080708.
750561 -        ref SDS 31 M53H
750562 -
750563 -            Attach the power injection device to the PowerLoc* Safety
750564 -            Infusion Set (SIS) ensuring connection is secure.  Check
750565 -            indicated flow rate of safety infusion set and confirm CT
750566 -            settings.
750568 -             ..
750569 -            Warning:  Do not exceed a 300 psi pressure limit setting,
750570 -            or the maximum flow rate setting shown below, on the power
750571 -            injection machine if power injecting through the PowerPort*
750572 -            device:, ref SDS 31 M54F
750574 -             ..
750575 -            Powerloc SIS Guage   Size      19 Ga    20 Ga    22 Ga
750576 -            Powerloc SIS Wing    Color     Cream    Yellow   Black
750577 -            Maximum Flow Rate    Setting   5 ml/s   5 ml/s   2 ml/s
750579 -         ..
750580 -        Flushing requirements for the Power Port after the CT test are
750581 -        set out in steps 11 - 14. ref SDS 31 XJ6S  Instructions are
750582 -        shown calculating the amount of Heprin to use. ref SDS 31 XJ4H
750584 -  ..
750585 - On 080715, Millie drove to Kaiser and hand-delivered the Power Port
750586 - Patient Packet with Instructions for Use to the Oncology Department,
750587 - who had ordered the CT test, ref SDS 36 RB4G, and for the purpose of
750588 - distribution within Kaiser to the CT Department, as a backup to
750589 - letters on 080709, ref SDS 32 TR9X, and on 080712, submitted to
750590 - support the work today. ref SDS 35 K13Q
750592 -  ..
750593 - Nora said she did not get Millie's letters on 080709 nor on 080712,
750594 - similar to Ike's report on 080711 that the CT Department did not get
750595 - copies of correspondence sent to Oncology on coordinating the work
750596 - today. ref SDS 34 7K8I  Nora evidently did not get the Power Port
750597 - Patient Packet submitted to Kaiser on 080715.  Her department has
750598 - worked with Power Ports, so she is familiar with manufacturer's
750599 - instructions.  She said the patient ID card has specific data needed
750600 - for the test today, per above. ref SDS 0 4R5L  The patient ID card is
750601 - listed in the record on 080708, ref SDS 31 QQRZ, which was part of the
750602 - record sent to Kaiser with Millie's letter on 080709.
750604 -  ..
750605 - Looking through Millie's purse, we could not find the Power Port
750606 - Patient ID card.  Offered to go to the Oncology Department and ask for
750607 - the Power Port Patient Packet, or we could get it from the Internet.
750609 -  ..
750610 - Nora feels there is not enough time to get help.
750612 -  ..
750613 - Suggested she take Millie's purse into the CT test room, so Millie can
750614 - find the Patient ID card.  Nora took Millie's purse.  Turned out the
750615 - Patient ID card was behind another credit card, which Millie uses for
750616 - the Kaiser account.
750617 -
750618 -
750619 -
750620 -
7507 -

SUBJECTS
CT Test Failed Access Power Port Contrast Medium Extrvasation Overfl

A303 -
A304 - 1144
A30501 -  ..
A30502 - CT Test Failed Power Port Access Problems Contrast Medium Overflowed
A30503 - Chest Shoulder Swelled Contrast Medium Extrvasation Port Access Failed
A30504 - Access Power Port Failed Contrast Medium Overflowed Power Port
A30505 - Units of Measure Variance May Have Influenced Mistake Injection Flow Rate
A30506 -
A30507 - Nora comes into the waiting room.  There have been complications.
A30509 -  ..
A30510 - The CT test failed on the power injection process.
A30512 -  ..
A30513 - Millie was brought into a holding area with a bandage on the port
A30514 - access site.
A30516 -  ..
A30517 - Several patients are on gurneys waiting to get CT tests.  One of the
A30518 - patients is taken into the test room.
A30520 -  ..
A30521 - Nora explained an "operator" mistake occurred of some kind.  She feels
A30522 - the Huber needle was inserted at the correct location, but may not
A30523 - have been fully seated, required by step 1 in the manufacturer's
A30524 - Instructions for Use on "Power Injection Procedures," reported on
A30525 - 080708. ref SDS 31 JE7N
A30526 -
A30527 -        [On 080821 difficulties drawing blood at UCSF Infusion Clinic
A30528 -        with Huber needle and Power Port, was resolved by another more
A30529 -        experienced nurse; indicates regular use of this procedure
A30530 -        essential to maintain skills for mission critical tasks like
A30531 -        blood draws, and injecting contract medium for CT test.
A30532 -        ref SDS 49 04GH
A30534 -  ..
A30535 - Great care was taken on accessing the port, which may have taken 5
A30536 - minutes or so performing similar steps that take about 1 minute at
A30537 - UCSF Infusion Clinic, reviewed the day before on 080717. ref SDS 38
A30538 - TZ8I
A30540 -  ..
A30541 - Length of the Huber needle may relate to the issue Nora describes, and
A30542 - was noted on 080708 reviewing manufacturer's Instructions for Use on
A30543 - Power Injection Procedures step 1, ref SDS 31 JE7N, citing prior
A30544 - problems with needle length on 080409, when Kaiser discovered that a
A30545 - 1" needle was effective. ref SDS 17 6R8O
A30547 -  ..
A30548 - The Huber needle used for the failed CT test, including product
A30549 - identification packaging, was on a small table next to Millie in the
A30550 - holding area; it had markings that appeared be for the Bard Power
A30551 - Port, including the color purple on the Bard Power Port Patient
A30552 - Packet.
A30554 -  ..
A30555 - Bard Power Port Instructions for Use show "Power Injection Procedures"
A30556 - reported on 080708, which says in part...
A30558 -             ..
A30559 -        1.  Access the port with a PowerLoc* Safety Infusion Set.  Make
A30560 -            certain that needle is long enough to be inserted fully
A30561 -            within the port and that needle tip has made contact with
A30562 -            the bottom of the port reservoir.  Warning:  The PowerPort*
A30563 -            system is only power injectable when accessed with a
A30564 -            PowerLoc* Safety Infusion Set.  Note:  Follow institutional
A30565 -            protocol to verify correct catheter tip position prior to
A30566 -            power injection. ref SDS 31 JE7N
A30568 -  ..
A30569 - If Kaiser used the device specified in instruction #1 for Power
A30570 - Injection Procedures, then injection overflow should not have occured
A30571 - due to using the wrong needle for power injection.
A30572 -
A30573 -        [On 080719 Kaiser Infusion Clinic used 1" needle to access the
A30574 -        port verifying operability, and performing flush requirements.
A30575 -        ref SDS 40 OH5H
A30577 -  ..
A30578 - Yesterday on 080717 at UCSF, Catherine mentioned inserting the Huber
A30579 - needle to the bottom of the Power Port for Millie's chemotherapy
A30580 - treatment. ref SDS 38 TZ8I  At that time, UCSF decided not to contact
A30581 - Kaiser about leaving the Huber needle in place, so that "accessing the
A30582 - port" would not be necessary for the CT test today. ref SDS 38 E68N
A30583 -
A30584 -        [On 080724 UCSF disclosed that Huber needle for power injection
A30585 -        of contrast medium doing CT tests requires a higher standard
A30586 -        for high injection pressures; may suggest Kaiser used the wrong
A30587 -        needle today, 080718; it could, also, mean that, if the Huber
A30588 -        needle in the port used for treatment at UCSF on 080717, was
A30589 -        left in place for the CT test on 080718, and, if it was not the
A30590 -        needle that supports high pressures, per above, ref SDS 0 RQ4I,
A30591 -        problems that occurred today at Kaiser, may not have been
A30592 -        avoided by using the Huber needle for the test that was used
A30593 -        the day before at UCSF. ref SDS 44 OK63
A30595 -         ..
A30596 -        [On 080821 nurse had difficulty getting blood to flow through
A30597 -        the Power Port with Huber needle, ref SDS 49 LO5F; Diane
A30598 -        completed the work, ref SDS 49 A66O; indicates regular use of
A30599 -        procedure is essential to maintain skills for mission critical
A30600 -        tasks like blood draws, and injecting contrast medium for CT
A30601 -        tests. ref SDS 49 04GH
A30603 -         ..
A30604 -        [On 080821 Diane seemed to advise that UCSF has standardized on
A30605 -        all departments using the same Huber needle used for high
A30606 -        powered injections of contrast medium for CT tests, so that
A30607 -        mistakes do not occur substituting a less rigorous needle.
A30608 -        ref SDS 49 N96I
A30610 -         ..
A30611 -        [On 080904 Catherine seemed say that nurses must select from a
A30612 -        range of different Huber needles available for treatment in the
A30613 -        Infusion Clinic, per Angiodynamics manufacturer's Lifeguard
A30614 -        Safety needles listed on 080724, ref SDS 44 N79U; Catherine
A30615 -        plans to use the needle specified for high pressure injections
A30616 -        to treat Millie at UCSF on the day when the same needle will be
A30617 -        used later in the same day at Kaiser for a CT test. ref SDS 55
A30618 -        V64G
A30620 -  ..
A30621 - Millie's right chest, shoulder, and arm noticably bloated due to
A30622 - contrast extravasation.
A30623 -
A30624 -        [On 080523 report on CT test today describes contrast
A30625 -        extravasation. ref SDS 42 EO8F
A30627 -  ..
A30628 - At this time, no actual CT scan has been done, and contrast medium has
A30629 - not been fully charged throughout the body needed for the scan to be
A30630 - performed.
A30632 -  ..
A30633 - Nora feels the contrast medium overflowed the Power Port, suggesting
A30634 - a failure of some kind.
A30636 -  ..
A30637 - Millie recalled discussions during test setup between Nora and Dennis
A30638 - about flow rates.  Nora noted the Power Port design capabity is 600
A30639 - psi, so 300 psi is well within design tolerance.  This discussion in
A30640 - the test room seems to align with manufacturer's guidance, per above.
A30641 - ref SDS 0 SF7I  It further correlates with Nora briefly leaving the
A30642 - test room and going into the waiting room to request manufacturer's
A30643 - guidance on flow rates and flushing criteria, per above. ref SDS 0
A30644 - NM5V
A30646 -  ..
A30647 - In the test room, someone said something about units of measure being
A30648 - changed from "cc" which can sometimes be mistaken for "00," to what
A30649 - sounded like "mls."  This may indicate efforts to translate figures
A30650 - for injection flow rates listed in manufacturer's documentation, which
A30651 - is presented in ml/s, per above. ref SDS 0 SF7I
A30653 -  ..
A30654 - Confusion from variance in units of measure between organizations has
A30655 - presented problems previously in Millie's patient history, discussed
A30656 - at UCSF on 070830. ref SDS 5 L94G  Even small mistakes can quickly
A30657 - escalate into major loss illustrated by NASA mixing up units of
A30658 - measure on the Mars probe that failed on 991001. ref SDS 1 0001
A30659 -
A30660 -        [On 080911 Angela at CT Department with Kaiser in Oakland asked
A30661 -        for Millie's Power Port ID card; after learning Millie has the
A30662 -        Bard Power Port, she advised that training by Bard personnel a
A30663 -        day or so earlier resolved issues, ref SDS 56 JX60; and so did
A30664 -        not need the Power Port ID card to check flow rates and
A30665 -        flushing instructions, and did not need to change settings on
A30666 -        CT test equipment; this resulted in successful CT test using
A30667 -        Bard Power Port. ref SDS 56 LK3R
A30668 -
A30669 -
A30670 -
A30671 -
A307 -

SUBJECTS
Pain Power Injection CT Test Contrast Medium Overflowed Extravasion

AX03 -
AX0401 -  ..
AX0402 - Pain During Power Injection Contrast Medium Overflowed
AX0403 - Huber Needle Popped Loose from Power Port During Injection?
AX0404 - Power Port No Evident Damage Need Review Verify Suitability for Use
AX0405 -
AX0406 - Nora believes the Power Port and connections to the catheter and to
AX0407 - the artery have not been damaged, and so can still be used for the
AX0408 - test.
AX0410 -  ..
AX0411 - Millie recalled that during power injection, she had the sensation
AX0412 - that the Huber needle seemed to "pop loose" from the Power Port.  She
AX0413 - felt severe pain from rising pressure in her right chest and shoulder.
AX0414 - She was about to raise her hand to comment, when Dennis, and Nora came
AX0415 - into the CT test room from the control room, and said something was
AX0416 - wrong.  Power injection of contrast medium for the CT test was
AX0417 - stopped.
AX0419 -  ..
AX0420 - Manufacturere's "Instructions for Use" under step 9 for "Power
AX0421 - Injection Procedures" present a warning...
AX0422 -
AX0423 -            W a r n i n g
AX0424 -
AX0425 -            Inject warmed contrast, taking care not to exceed the flow
AX0426 -            rate limits.  Warning:  If local pain, swelling or signs of
AX0427 -            extravasation are noted, the injection should be stopped
AX0428 -            immediately.  Warning:  Exceeding the maximum flow rate may
AX0429 -            result in port system failure and/or catheter tip
AX0430 -            displacement. ref SDS 31 XJ5S
AX0431 -
AX0432 -
AX0433 -
AX05 -

SUBJECTS
CT Test Failure Extravasion Contrast Medium Overflowed Power Port Pr

BO03 -
BO0401 -  ..
BO0402 - Causation Analysis
BO0403 -
BO0404 - Problems today seem to align with the Bard "warning" in step 7 of
BO0405 - manufacturer's instructions for use on exceeding injection flow rates,
BO0406 - reported in the record on 080708. ref SDS 31 M54F  This was expressly
BO0407 - discussed with Nora during the procedure, noted above. ref SDS 0 NM56
BO0409 -  ..
BO0410 - The Huber needle, in this case "Powerloc Safety Infusion Set," cited
BO0411 - in manufacturer's instructions, ref SDS 0 RQ4G, may not have been long
BO0412 - enough, or was not fully seated, and/or the needle may not have met
BO0413 - specifications for high pressure injections, discussed above.
BO0414 - ref SDS 0 LK41
BO0416 -  ..
BO0417 - There may have been an error setting injection flow rate, possibly
BO0418 - from converting units of measure, per above, ref SDS 0 NM5V, and
BO0419 - citing discussions during the test procedure. ref SDS 0 A26L
BO0420 -
BO0421 -        [On 080724 UCSF disclosed that a Huber needle for CT tests
BO0422 -        requires a higher standard for pressure injection of contrast
BO0423 -        medium; this may suggest that Kaiser used the wrong needle
BO0424 -        today, 080718; it could, also, mean that, if the Huber needle
BO0425 -        in the port used for treatment at UCSF on 080717, was left in
BO0426 -        place for the CT test on 080718, then if it was not the needle
BO0427 -        that supports high pressures, problems that occurred today at
BO0428 -        Kaiser, may not have been avoided by using the Huber needle for
BO0429 -        the test that was used for chemotherapy treatment the day
BO0430 -        before at UCSF. ref SDS 44 OK63
BO0432 -         ..
BO0433 -        [On 080821 difficulties drawing blood at UCSF Infusion Clinic
BO0434 -        with Huber needle and Power Port, was resolved by another more
BO0435 -        experienced nurse; indicates regular use of this procedure
BO0436 -        essential to maintain skills for mission critical tasks like
BO0437 -        blood draws, and injecting contract medium for CT tests.
BO0438 -        ref SDS 49 04GH
BO0440 -         ..
BO0441 -        [On 080821 Diane seemed to advise that UCSF has standardized on
BO0442 -        all departments using the same Huber needle used for high
BO0443 -        powered injections of contrast medium for CT tests, so that
BO0444 -        mistakes do not occur substituting a less rigorous needle.
BO0445 -        ref SDS 49 N96I
BO0447 -         ..
BO0448 -        [On 080904 Catherine seemed say that UCSF nurses must select
BO0449 -        from a range of different Huber needles available for treatment
BO0450 -        in the Infusion Clinic, per Angiodynamics manufacturer's
BO0451 -        Lifeguard Safety needles listed on 080724, ref SDS 44 N79U;
BO0452 -        Catherine plans to use the needle specified for high pressure
BO0453 -        injections to treat Millie at UCSF on the day when the same
BO0454 -        needle will be used later in the same day at Kaiser for a CT
BO0455 -        test. ref SDS 55 V64G
BO0457 -         ..
BO0458 -        [On 080911 Angela at CT Department with Kaiser in Oakland asked
BO0459 -        for Millie's Power Port ID card; after learning Millie has the
BO0460 -        Bard Power Port, she advised that training by Bard personnel a
BO0461 -        day or so earlier resolved issues, ref SDS 56 JX60; and so did
BO0462 -        not need the Power Port ID card to check flow rates and
BO0463 -        flushing instructions, and did not need to change settings on
BO0464 -        CT test equipment; this resulted in successful CT test using
BO0465 -        Bard Power Port. ref SDS 56 LK3R
BO0467 -  ..
BO0468 - Bard "Instructions for Use" warn about problems of over pressurization
BO0469 - due to an "occuluded catheter," reviewed on 080708. ref SDS 31 EE4S
BO0470 -
BO0471 -        [On 080801 Bard representative lists factors that cause failure
BO0472 -        of power injection using the Power Port. ref SDS 45 OW43
BO0474 -  ..
BO0475 - There could also be product defect issues with the Power Port, or even
BO0476 - a surgery issue.  Xray showed the Power Port correctly implanted on
BO0477 - 080708. ref SDS 31 UY3I
BO0478 -
BO0479 -        [...below manufacturer review for product defects, and support
BO0480 -        implementing Instructions for Use. ref SDS 0 WO9J
BO0482 -         ..
BO0483 -        [On 080801 Bard asks about Huber needle used for the CT test
BO0484 -        today - could be defective, ref SDS 45 OV5I; Kaiser was trained
BO0485 -        a year earlier, but adopted policy not to use Power Ports for
BO0486 -        CT tests, so nobody has experience, ref SDS 45 OV9H, Julie
BO0487 -        offes to consult during Millie's next CT test. ref SDS 45 OW41
BO0489 -  ..
BO0490 - Additionally, was the Power Port damaged in some way by improper use
BO0491 - today that prevents future use?  Even if it can be used for blood
BO0492 - draws and chemotherapy treatments, might it have been damaged in a way
BO0493 - that prevents power injection of contrast medium?  How is this
BO0494 - investigated?
BO0495 -
BO0496 -        [...below, Kathi indicated that Kaiser Interventionary
BO0497 -        Radiology plas case review for lessons learned on problems
BO0498 -        today. ref SDS 0 A44K
BO0500 -         ..
BO0501 -        [On 080811 Paula at Kaiser Infusion Clinic investigating
BO0502 -        solutions to support CT Department for Millie's next test
BO0503 -        OA 080912; issue has been elevated, but no progress from
BO0504 -        management reported at this time, ref SDS 47 LD3H; there
BO0505 -        seems to be at least three (3) solutions. ref SDS 47 CW3O
BO0506 -        Paula coordinating with primary care physician about
BO0507 -        contacting Kaiser Oakland to perform Millie's next CT test.
BO0508 -        ref SDS 47 DE79
BO0510 -         ..
BO0511 -        [On 080811 Kaiser reports Oakland office has experience doing
BO0512 -        CT tests with Power Port and Huber needle technology,
BO0513 -        ref SDS 47 L465; schedule Millie's next CT test on 080911 at
BO0514 -        Kaiser in Oakland. ref SDS 47 L549
BO0516 -         ..
BO0517 -        [On 080822 Kaiser notifies Millie that CT test using Power Port
BO0518 -        and Huber needle technology is scheduled for Kaiser in Oakland
BO0519 -        on 080911. ref SDS 50 N66E
BO0521 -         ..
BO0522 -        [On 080826 Kaiser CT Department in Walnut Creek called and
BO0523 -        advised that the Kaiser CT Department in Oakland sent Millie's
BO0524 -        case back to the CT Department at Kaiser in Walnut Creek.
BO0525 -        ref SDS 51 VG6N
BO0526 -
BO0527 -
BO0529 -  ..
BO0530 - Patient Recovers Quickly from Pain and Distress
BO0531 -
BO0532 - Nora asked if Millie still feels pain or distress?
BO0534 -  ..
BO0535 - Millie said no.  There was discomfort during the power injection, but
BO0536 - now she feels "okay." ref SDS 0 4S5L
BO0538 -  ..
BO0539 - Nora felt Millie's foreheand.  There was no evident temperature.
BO0540 - Millie seemed comfortable, and calm, as usual.
BO0541 -
BO0542 -
BO0543 -
BO06 -

SUBJECTS
CT Test Failed Personnel Changed from Interventionary Radiology Debr

CG03 -
CG0401 -  ..
CG0402 - Staff Change for Power Port Support from Interventionary Radiology
CG0403 -
CG0404 - Nora left the CT Department and went back to the Interventionary
CG0405 - Radiology Department.  She will consult with a colleague for
CG0406 - assistance on Millie's test.
CG0407 -
CG0409 -  ..
CG05 -
CG06 -
CG07 - 1231
CG08 -
CG0801 - Kathi Fotinos arrived in the CT Department.
CG0802 -
CG0803 - She reported having a lot of experience working with Power Ports.  The
CG0804 - Interventionary Radiology Department has been implanting Power Ports
CG0805 - for some time, because this technology has become the default
CG0806 - procedure, rather than port catheters.
CG0808 -  ..
CG0809 - Kathi feels she can complete port access to perform the CT test today.
CG0810 - She is concerned about swelling from the contrast medium overflow.
CG0812 -  ..
CG0813 - Millie has to wait while another patient gets a CT test.  Kathi uses
CG0814 - the time to gently massage the swelling attempting to get the contrast
CG0815 - medium to disperse inside Millie's body.
CG0816 -
CG0817 -
CG0818 -
CG09 -

SUBJECTS
Debrief CT Test Failure Access Port Problems Communication Breakdown

DD03 -
DD0401 -  ..
DD0402 - Power Port Accessed at UCSF Reduces Risks Doing New Procedure at Kaiser
DD0403 -
DD0404 - Kathi asked about background on the Power Port?
DD0406 -  ..
DD0407 - Millie explains surgery was done here at Kaiser in Walnut Creek in the
DD0408 - Surgery Department 10 days ago on 080708. ref SDS 31 0001
DD0410 -  ..
DD0411 - Kathi commented that Interventionary Radiology does Power Port
DD0412 - surgery, because the work does not require a general anesthetic.
DD0414 -  ..
DD0415 - Kathi said she assumes the work implanting Millie's Power Port was
DD0416 - tested, and that blood was drawn after surgery was completed?
DD0418 -  ..
DD0419 - Millie advised that the surgeon did an xray, ref SDS 31 O67N, which is
DD0420 - on file at Kaiser. ref SDS 31 UY3I  The doctor drew blood for a lab
DD0421 - test. ref SDS 31 6F4I  The doctor submitted a letter certifying the
DD0422 - port was working correctly. ref SDS 31 BF4K
DD0424 -  ..
DD0425 - Kathi asked if the Power Port has been used since surgery on 080708?
DD0427 -  ..
DD0428 - Millie reported that the surgeon left a Huber needle inserted in the
DD0429 - port on 080708, as explained in Kaiser's letter. ref SDS 31 BF4K  It
DD0430 - was used 2 days later at UCSF on 080710 where Millie received
DD0431 - treatment with blood draws and chemotherapy. ref SDS 33 TZ6H
DD0433 -  ..
DD0434 - Yesterday on 080717 Millie received weekly chemotherapy treatment
DD0435 - again at UCSF using the Power Port without incident. ref SDS 38 TZ8I
DD0437 -  ..
DD0438 - Kathi asked why UCSF didn't leave the Huber needle configured in the
DD0439 - Power Port for work today at Kaiser, like Kaiser did for UCSF a week
DD0440 - earlier on 080708?
DD0442 -  ..
DD0443 - Millie recalled that Kaiser rejected this work plan on 080716, citing
DD0444 - risks of quality control. ref SDS 37 053S
DD0446 -  ..
DD0447 - Kathi feels there may have been a communication mixup on this issue.
DD0448 - Possibly people were extra cautious because this is the first time
DD0449 - using Power Port technology in the CT Department.  Since the port was
DD0450 - in place at UCSF and demonstrated operability for both blood draw and
DD0451 - infusion, this reduced the range of mistakes that could be made at
DD0452 - Kaiser for Power Injection, discussed with Kaiser a few days ago on
DD0453 - 080716. ref SDS 37 K140
DD0455 -  ..
DD0456 - Kathi's review today following initial procedure difficulties, fits
DD0457 - the model of pre-test planning and preparation required for rolling
DD0458 - out a new technology and protocol, cited in letters on 080709,
DD0459 - ref SDS 32 TR9X, and on 080712, ref SDS 35 KZ5X, which presented
DD0460 - planning scope from the meeting with the CT Department the day before
DD0461 - on 080711, asking Kaiser to develop a protocol for CT testing with the
DD0462 - Power Port. ref SDS 34 JS46
DD0463 -
DD0464 -      [On 080811 planning for next CT test reviews doing the work at
DD0465 -      Kaiser in Oakland, and setting schedule on 080911 after Millie
DD0466 -      gets treatment at UCSF so that Huber needle access Power Port for
DD0467 -      chemotherapy at UCSF can be used for the CT test at Kaiser in
DD0468 -      Oakland. ref SDS 47 4931
DD0470 -       ..
DD0471 -      [On 080811 letter to medical team cites planning to use Huber
DD0472 -      needle access Power Port at UCSF for CT test at Kaiser in
DD0473 -      Oakland. ref SDS 47 P43Y
DD0475 -       ..
DD0476 -      [On 080827 Millie's letter to medical team proposes following
DD0477 -      Kathi's advice today and leaving the Huber needle access for
DD0478 -      Power Port in place at UCSF for CT test at Kaiser. ref SDS 52
DD0479 -      513T
DD0481 -       ..
DD0482 -      [On 080903 discuss with Kaiser CT Department in Oakland leaving
DD0483 -      Huber needle access Power Port for chemotherapy treatment at UCSF
DD0484 -      so the needle can be used again for CT test at Oakland; schedule
DD0485 -      attendant asks Millie to notify primary care p[hysician at Kaiser
DD0486 -      to request procedure. ref SDS 54 S289
DD0487 -
DD0488 -
DD0489 -
DD05 -

SUBJECTS
CT Test 2nd Attempt Access Port PowerLoc Safety Infusion Set Huber N

DS03 -
DS04 - 1254
DS0501 -  ..
DS0502 - CT Test 2nd Try Swelling Prevents Locating Power Port Access Point
DS0503 - UCSF Patient History Aids Work at Kaiser for CT Test Using Power Port
DS0504 -
DS0505 - The door to the CT test room opens, and a patient is wheeled out on a
DS0506 - gurney.
DS0507 -
DS0508 - Millie goes into CT test room again.
DS0510 -  ..
DS0511 - Dennis had gone to lunch, and had not yet returned, so a woman CT
DS0512 - Technologist, Pat, assists Kathi.
DS0514 -  ..
DS0515 - Pat positions Millie on the test panel horizontally, and makes her
DS0516 - comfortable with support for her head and knees.
DS0517 -
DS0518 -        [On 081024 Pat recalled assisting Dennis, Nora, and and Kathi
DS0519 -        with Millie's CT test today; that there were problems using the
DS0520 -        Power Port, and so for Millie's next CT test on 081107 Millie
DS0521 -        should arrange to get the Power Port accessed in the Infusion
DS0522 -        Clinic before coming to the CT Department for the test.
DS0523 -        ref SDS 57 208W
DS0525 -         ..
DS0526 -        [On 081107 Pat assisted Cassandra with Millie's next CT test at
DS0527 -        Kaiser in Walnut Creek and did not remember working on Millie's
DS0528 -        first CT test nor schduling Millie's next CT test using the
DS0529 -        Bard Power Port. ref SDS 59 2D60
DS0531 -  ..
DS0532 - There is no discussion of certificates, presented as essential on
DS0533 - 080711, ref SDS 34 JQ87, and no evident review of Power Port
DS0534 - manufacturer's User Instructions for Power Injections, submitted to
DS0535 - Kaiser on 080709, ref SDS 32 TR9X, and again on 080715. ref SDS 36
DS0536 - RB4G
DS0537 -
DS0538 -
DS0539 -
DS0540 -
DS0541 -
DS06 -

SUBJECTS
CT Test 2nd Attempt Failed Access Power Port Cannot Find Beneath Ski

EC03 -
EC0401 -  ..
EC0402 - CT Test Fails Swelling Prevents Finding Power Port Causes Bleeding
EC0403 - Bleeding from Surgery Incision Halts Use of Power Port for CT Test
EC0405 -  ..
EC0406 - Kathi asks how Millie's port is accessed at UCSF?
EC0408 -  ..
EC0409 - Reviewed the record of Millie's care in the Infusion Clinic at UCSF,
EC0410 - reported yesterday on 080717. ref SDS 38 TZ6H
EC0412 -  ..
EC0413 - Millie is typically sitting up in a chemotherapy chair, rather than
EC0414 - lying down, as on the CT test table now.
EC0416 -  ..
EC0417 - Pat, the CT Technologist, assists Kathi changing Millie's position to
EC0418 - sitting up somewhat on the CT table, rather than laying down fully
EC0419 - prone.  Kathi indicated this presents a better angle for work with the
EC0420 - Power Port, although at UCSF the nurse is sitting on a lower chair and
EC0421 - so is below the patient and pressing slightly up and forward on the
EC0422 - patient's chest.
EC0424 -  ..
EC0425 - Kathi says she cannot feel the Power Port beneath Millie's skin.
EC0427 -  ..
EC0428 - Quickly related work yesterday on 080717...
EC0430 -  ..
EC0431 - The UCSF nurse, Catherine, accessing the Power Port explained that
EC0432 - feeling the Power Port 3 palpation points beneath the skin is
EC0433 - difficult.  Catherine seems to press firmly on the skin, about .5" or
EC0434 - so below the surgeon's incision to locate the perimeter of the Power
EC0435 - Port. ref SDS 38 E668  This position was pointed out during the
EC0436 - procedure today, evident by a bruise on the skin from surgery
EC0437 - performed 080708. ref SDS 31 WD49
EC0439 -  ..
EC0440 - Catherine then grips the perimeter of the port causing the device to
EC0441 - protrude slightly pushing the skin above the plane of the chest.  This
EC0442 - presents a visible target for the needle, which is centered by eye,
EC0443 - and then pressed into the port until hitting the bottom.  Depth of
EC0444 - penetration is recognized by sudden resistance of the metal floor that
EC0445 - prevents pushing the needle any further. ref SDS 38 JG9F  This
EC0446 - accomplishes Bard manufacturer's "Instructions for Use" on "Power
EC0447 - Injection Procedures" shown in the record on 080708. ref SDS 31 JE7N
EC0449 -  ..
EC0450 - Pat commented that assistance with Millie's patient history
EC0451 - facilitates work on the CT test.
EC0452 -
EC0453 -        [On 081107 CT test team denied patient assistance for accurate
EC0454 -        medical history to support the 2nd attempt using Bard Power
EC0455 -        Port for Millie's next CT test at Kaiser in Walnut Creek,
EC0456 -        ref SDS 59 AN6H; Pat does not recall supporting Millie's CT
EC0457 -        test on 080718; does not recall having difficulties using the
EC0458 -        Power Port, and does not recall getting assistance from the
EC0459 -        patient assistant during the first CT test using the Power Port
EC0460 -        to understand relevant patient history. ref SDS 59 9J9M
EC0462 -  ..
EC0463 - Kathi pressed firmly on Millie's skin, and reported feeling an edge of
EC0464 - the Power Port.  She could not feel the other two edges, in the manner
EC0465 - Catherine used yesterday at UCSF to cause the Power Port to protrude
EC0466 - slightly for locating a needle insertion point. ref SDS 38 E668  There
EC0467 - was too much contrast medium swelling this location.
EC0469 -  ..
EC0470 - Continued pressing with both hands to locate the Power Port access
EC0471 - point, suddently caused blood flow through stitches from the incision
EC0472 - for surgery last week on 080708.  The incision tape was still in
EC0473 - place, so blood flowed through the tape.  The tape then came loose, as
EC0474 - blood flowed faster.
EC0475 -
EC0476 -        [On 080719 next day swelling from contrast medium significantly
EC0477 -        subsided, ref SDS 40 OG6F; Julie in the Oncology Infusion
EC0478 -        Clinic accessed the port to flush with saline and Heprin per
EC0479 -        manufacturer's protocol. ref SDS 40 1E4L
EC0481 -  ..
EC0482 - Kathi asked the Technologist for gause (used another name).  She
EC0483 - pressed this onto the wound.  Blood flow increased.  Several changes
EC0484 - were made of the gause dressing, with Milling holding her finger on
EC0485 - the gause while Kathi applied tape prepared by the Technologist.  This
EC0486 - was a rapidly evolving situation for a few minutes, and was handled
EC0487 - with expert professionalism by Kathi and the CT Technologist.
EC0489 -  ..
EC0490 - Millie was concerned because Kathi seemed very concerned, though at
EC0491 - all times calm and purposeful taking immediate action to resolve
EC0492 - expanding problems.
EC0494 -  ..
EC0495 - Kathi seemed to describe the bleeding as not "Frank," and said the
EC0496 - seepage appears to be a combination of blood and contrast medium.
EC0497 - Relieving the contrast medium is an objective, but not bleeding.
EC0498 -
EC0499 -        [On 080719 as a result of complications from CT test causing
EC0500 -        bleeding throught surgical wound, Julie in Kaiser Infusion
EC0501 -        Clinic removed the original surgical tape from the Power Port
EC0502 -        incision wound; inspection shows healing, but possible
EC0503 -        compromise with slight gap from the bleeding; fresh surgical
EC0504 -        tape was placed to dress the wound. ref SDS 40 LD87
EC0506 -  ..
EC0507 - Millie is worried bleeding during the procedure today, ref SDS 0 A26Y,
EC0508 - will cause blood counts to drop, and thereby prevent chemotherapy
EC0509 - treatment next week on Thursday, 080724, at UCSF, since earlier today,
EC0510 - Neupogen treatments were cancelled for today and tomorrow, per
EC0511 - above. ref SDS 0 9W9I
EC0512 -
EC0513 -        [...below, Millie proposes getting Neupogen treatment tomorrow
EC0514 -        at Kaiser Infusion Clinic. ref SDS 0 A54W; Kaiser called to
EC0515 -        order Neupogen treatment tomorrow. ref SDS 0 4535
EC0517 -         ..
EC0518 -        [On 080719 Neupogen treatment received at Kaiser.
EC0519 -        ref SDS 40 SR37
EC0521 -         ..
EC0522 -        [On 080721 UCSF reports Neupogen treatment not needed on
EC0523 -        080719, because blood counts in this case are not affected by
EC0524 -        bleeding incident, ref SDS 41 YU7N, that occurred during the CT
EC0525 -        test at Kaiser on 089718. ref SDS 0 A370
EC0527 -         ..
EC0528 -        [On 080814 UCSF says Neupogen was ordered on the Power Port
EC0529 -        issue, ref SDS 48 4Q5O; but Nuepogen not needed with labs
EC0530 -        showing blood counts NEUTS 1.37 below safe level for
EC0531 -        chemotherapy treatment because the medical team expects the
EC0532 -        body will replace needed blood in time for treatment the
EC0533 -        following week on 080821. ref SDS 48 UK3K
EC0535 -  ..
EC0536 - Kathi explained the first problem is to stop the bleeding from the
EC0537 - surgery incision wound.
EC0539 -  ..
EC0540 - Millie comments that inability to access the Power Port prevents
EC0541 - maintenance flushing with saline and Heperin, required by
EC0542 - manufacturer's Instructions for Use steps 11 - 14 on "Power Injection
EC0543 - Procedures" discussed with Nora earlier this morning, per above.
EC0544 - ref SDS 0 4R6F  The port will get clogged, and may not be usable for
EC0545 - treatments and blood draws next Thursday.
EC0546 -
EC0547 -        [...Kaiser contacted about treatment at Infusion Clinic
EC0548 -        tomorrow for Neupogen and to maintain the port. ref SDS 0 4535
EC0550 -         ..
EC0551 -        [On 080719 Power Port accessed with 1" Huber needle at Kaiser
EC0552 -        Oncology Infusion Clinic, blood flows well; port flushed per
EC0553 -        manufacturer's protocol. ref SDS 40 HY6L
EC0554 -
EC0555 -
EC0556 -
EC06 -

SUBJECTS
CT Test Work Plan Power Port Delay Test Several Days Until Swelling

EU03 -
EU0401 -  ..
EU0402 - CT Test Work Plan Using Power Port May Delay Work Several Days
EU0403 - Swelling from Contrast Medium Overflow May Delay CT Test Several Days
EU0404 -
EU0405 - Kathi feels that the Power Port cannot be used until the contrast
EU0406 - medium that swells Millie's chest, shoulder and arm, dissipates, so
EU0407 - that the port can be located by feel.  This may take a day or so.
EU0409 -  ..
EU0410 - Considered doing the CT test tomorrow, Sunday, or Monday.
EU0412 -  ..
EU0413 - Pat, the CT Technologist, indicated concerns about doing the test with
EU0414 - the Power Port on Saturday and Sunday, because nurses, who can access
EU0415 - the port, like Kathi and Nora, do not work on weekends.
EU0416 -
EU0417 -
EU0419 -  ..
EU0420 - CT Test Performed Conventional IV
EU0421 -
EU0422 - Kathi proposed trying a conventional IV in the right arm.
EU0424 -  ..
EU0425 - She suggested making one try, and if that fails then she would commit
EU0426 - to getting the work done with the Power Port NLT Monday, after the
EU0427 - swelling goes down, and in time for Millie's meeting at UCSF to start
EU0428 - the next cycle of treatment on Thursday, 080724.
EU0430 -  ..
EU0431 - Millie agreed.  She recalled her doctor at UCSF was anxious to get the
EU0432 - CT test for compliance with clinical trial protocol, reported on
EU0433 - 080625. ref SDS 30 IU6U
EU0435 -  ..
EU0436 - Kathi used a tourniquet to identify a good spot for the IV.
EU0438 -  ..
EU0439 - Millie cited patient history on 080425.  After several tries, the IV
EU0440 - was successful for the last CT test using an area just below the elbow
EU0441 - on the inner arm.  She pointed to a spot. ref SDS 19 N076
EU0443 -  ..
EU0444 - Kathi said that normally, this would not be a first choice.  She said
EU0445 - that the tourniquet she applied supports Millie's suggestion, and
EU0446 - agreed to try the IV at that location.
EU0448 -  ..
EU0449 - This was succesful.  Everyone was relieved.
EU0451 -  ..
EU0452 - Dennis returned from lunch.  Pat explained problems using the Power
EU0453 - Port, and that Millie approved trying an IV, which Kathi was able to
EU0454 - accomplish on the first try today.
EU0456 -  ..
EU0457 - With the IV in place, the CT test was completed without further
EU0458 - incident.
EU0459 -
EU0460 -
EU0462 -  ..
EU0463 - Post-Procedure Instructions Following CT Test Bleeding Incident
EU0464 -
EU0465 - Kathi recommended that Millie stay vertical for 3 - 4 hours to give
EU0466 - the blood a chance to clot. ref SDS 0 A26Y  This aligns with Millie's
EU0467 - treatment for pulmonary embolism with Coumadin.
EU0469 -  ..
EU0470 - Dennis told Millie to drink lots of water after the test, 3 - 12 ounce
EU0471 - glasses.
EU0472 -
EU0473 -        [...below post procedure instructions implemented. ref SDS 0
EU0474 -        A36U
EU0476 -  ..
EU0477 - The work today took about 3 hours.  This was 1 hour less than the CT
EU0478 - test on 080425. ref SDS 19 FP6F
EU0479 -
EU0480 -
EU0481 -
EU0482 -
EU0483 -
EU0484 -
EU05 -

SUBJECTS
CT Test 8 Weeks Lessons Learned CT Test Failure Solutions Be Prepare

FO03 -
FO0401 -  ..
FO0402 - Lessons Learned Post Procedure Review In Time for Next Test
FO0403 -
FO0404 - Dennis confirmed understandings from 080711, that Millie is the first
FO0405 - patient for the CT Department at Kaiser in Walnut Creek to use the
FO0406 - Power Port protocol for injecting contrast medium. ref SDS 34 JQ55
FO0407 - The CT Department learned a lot about Power Port issues working with
FO0408 - the Interventionary Radiology nurses today, including ways to solve
FO0409 - difficult IV problems, shown by Kathi's work listening to the patient.
FO0410 - ref SDS 0 RL74
FO0412 -  ..
FO0413 - Communication can be a component of quality care, discussed with the
FO0414 - CT Department last week on 080711. ref SDS 34 7K8I  Investing time to
FO0415 - review manufacturer's "Instructions for Use" prior to procedures can
FO0416 - be time well spent, requested by the patient on 080709, ref SDS 32
FO0417 - TR9X, again on 080712, ref SDS 35 K13Q, and on 080715. ref SDS 36 RB4G
FO0418 -
FO0419 -        [On 081107 Dennis, the supervisor of CT tests at Kaiser in
FO0420 -        Walnut Creek, was not available to support the CT test usig
FO0421 -        new technology for the 2nd time, ref SDS 59 VR4L; Pat who
FO0422 -        had worked on Millie's prior test using the Power Port for
FO0423 -        the 1st time, and had scheduled the current test, did not
FO0424 -        remember Millie nor that the test would use Bard Power Port
FO0425 -        technology, ref SDS 59 MX4L, Steve, District Manager for
FO0426 -        Bard, who had talked to Dennis and said Kaiser was ready to
FO0427 -        do the CT test with the Power Port, and Julie, who had
FO0428 -        offered to support the test on-site, did not have time to
FO0429 -        visit Kaiser to support the 2nd attempt to prform a CT test
FO0430 -        using Bard equipment which had previously failed on the 1st
FO0431 -        attempt, ref SDS 59 2F6S; communication to collaborate on
FO0432 -        coordinating the work failed by relying on memory of very
FO0433 -        talented, dedicated people under stress with limited time.
FO0434 -        ref SDS 59 2F32
FO0436 -  ..
FO0437 - Dennis apologized for the way things turned out today, noting Millie
FO0438 - really went through a lot for this first try using Power Port
FO0439 - technology at Kaiser in Walnut Creek.  He agreed with Jake's analysis
FO0440 - on 080711 explaining that sometimes small details just slip through
FO0441 - the cracks, ref SDS 34 PP7O, but feels that events today crossed the
FO0442 - line to affect quality care. ref SDS 0 LK3R  Dennis credited Millie's
FO0443 - fortitude being a trooper, and never once crying out nor complaining
FO0444 - while suffering pain and trauma worrying what would go wrong next.
FO0445 -
FO0446 -        [On 081219 1140 things "fell through the cracks" again when
FO0447 -        someone changed the doctor's order for Millie's CT test on
FO0448 -        081230. ref SDS 61 V76L
FO0450 -         ..
FO0451 -        [On 090205 1318 Doctor Johnson wants better communication for
FO0452 -        coordinating treatment at UCSF of Millie's 6th IBC relapse,
FO0453 -        so that critical details do "fall through the cracks."
FO0454 -        ref SDS 63 256K
FO0456 -         ..
FO0457 -        [On 090919 0742 poor coordination again caused trauma for CT
FO0458 -        Department staff and Millie because Kaiser has not had time to
FO0459 -        prepare a protocol on using Lifeguard Huber needles with Bard
FO0460 -        Power Ports. ref SDS 65 HK4F
FO0462 -         ..
FO0463 -        [On 091223 0639 Paula disclosed that Kaiser has written a
FO0464 -        protocol for using Bard Power Ports with Lifeguard and Bard
FO0465 -        Huber needles; it is filed in Kaiser's system under a heading
FO0466 -        of some kind that begins wth "Nursing." ref SDS 66 057K
FO0468 -  ..
FO0469 - Millie thanked Dennis and the Kaiser CT team seeing a difficult,
FO0470 - stressful job through to completion that is critical for her care.
FO0471 - It's easy to quit.  Overcoming problems in time to be effective takes
FO0472 - courage and professionalism.  Kaiser can build on this experience to
FO0473 - do better next time. cited in Millie's letter to the medical team on
FO0474 - 080709. ref SDS 32 VK5I
FO0475 -
FO0476 -        [On 080801 Bard asks about Huber needle used for the CT test
FO0477 -        today, ref SDS 45 OV5I, Julie offes to consult during Millie's
FO0478 -        next CT test. ref SDS 45 OW41
FO0480 -         ..
FO0481 -        [On 080811 Kaiser reports Oakland office has experience
FO0482 -        doing CT tests with Power Port and Huber needle technology,
FO0483 -        ref SDS 47 L465; schedule Millie's next CT test on 080911
FO0484 -        at Kaiser in Oakland. ref SDS 47 L549
FO0486 -         ..
FO0487 -        [On 080822 Kaiser notifies Millie that CT test using Power
FO0488 -        Port and Huber needle technology is scheduled for Kaiser in
FO0489 -        Oakland on 080911. ref SDS 50 N66E
FO0491 -         ..
FO0492 -        [On 080826 Kaiser CT Department in Walnut Creek called and
FO0493 -        advised that the Kaiser CT Department in Oakland sent
FO0494 -        Millie's case back to the CT Department at Kaiser in Walnut
FO0495 -        Creek. ref SDS 51 VG6N
FO0497 -         ..
FO0498 -        [On 081117 after reviewing the record of difficulties Kaiser
FO0499 -        had with Millie's CT test on 081107, Steve recalled that Dennis
FO0500 -        the supervisor seemed more receptive, ref SDS 60 PQ3P, to
FO0501 -        offers of help on 081030, ref SDS 58 UF5H, possibly reflecting
FO0502 -        difficulties Dennis had recognized occurred doing Millie's
FO0503 -        first CT test using the Power Port on 080718, ref SDS 0 FM74;
FO0504 -        Steve plans to offer again to assist Kaiser in Walnut Creek
FO0505 -        develop a protocol with instructions on using the Bard Power
FO0506 -        Port for CT tests in time for Millie's next test in 6 weeks.
FO0507 -        ref SDS 60 JH3N
FO0508 -
FO0509 -
FO0510 -
FO0512 -  ..
FO06 -
FO07 -
FO08 - 1338
FO09 -
FO0901 - Kathi came into the waiting room.
FO0903 -  ..
FO0904 - Kathi feels important issues were identified today for developing a
FO0905 - protocol and training to use Power Ports for injecting CT test
FO0906 - contrast medium.  She will write a report on work today for lessons
FO0907 - learned.  Millie can contact her doctor for a copy of the report, and
FO0908 - can submit her own understandings to support Kaiser's review through
FO0909 - the doctor as well.
FO0910 -
FO0911 -        [On 080721 Millie's letter requests copy of Kaiser's internal
FO0912 -        review of review for lessons learned on Millie's CT test using
FO0913 -        Power Port. ref SDS 41 CW9U
FO0915 -         ..
FO0916 -        [On 081107 Heather suggested that lessons learned from the 1st
FO0917 -        attempt using the Bard Power Port Millie's CT test can be
FO0918 -        supplemented with experience on the 2nd attempt to write up a
FO0919 -        protocol that improves the work with less stress and worry.
FO0920 -        ref SDS 59 2F32
FO0922 -  ..
FO0923 - Thanked Kathi for doing great work on short notice, and under exigent
FO0924 - conditions.  She will emphasize to Nora that Millie was pleased with
FO0925 - results today, having expected initial issues from being the first
FO0926 - patient to use the Power Port for CT tests, noted in Millie's letter
FO0927 - to the medical team on 080709. ref SDS 32 VK5I  Carefully, detailed
FO0928 - post-op report may provide guidance to formalize the protocol on using
FO0929 - Power Ports in time for Millie's next CT test in 8 weeks.
FO0930 -
FO0931 -        [On 080811 Paula at Kaiser Infusion Clinic investigating
FO0932 -        solutions to support CT Department for Millie's next test
FO0933 -        OA 080912; issue has been elevated, but no progress from
FO0934 -        management reported at this time, ref SDS 47 LD3H; there
FO0935 -        seems to be at least three (3) solutions. ref SDS 47 CW3O
FO0936 -        Paula coordinating with primary care physician about
FO0937 -        contacting Kaiser Oakland to perform Millie's next CT test.
FO0938 -        ref SDS 47 DE79
FO0940 -         ..
FO0941 -        [On 090919 0742 poor coordination again caused trauma for CT
FO0942 -        Department staff and Millie because Kaiser has not had time to
FO0943 -        prepare a protocol on using Lifeguard Huber needles with Bard
FO0944 -        Power Ports. ref SDS 65 HK4F
FO0946 -         ..
FO0947 -        [On 091223 0639 Paula disclosed that Kaiser has written a
FO0948 -        protocol for using Bard Power Ports with Lifeguard and Bard
FO0949 -        Huber needles; it is filed in Kaiser's system under a heading
FO0950 -        of some kind that begins wth "Nursing." ref SDS 66 057K
FO0951 -
FO0952 -
FO0954 -  ..
FO0955 - Power Port Vendor Review Initiated by Kaiser
FO0956 -
FO0957 - Since Millie had the sensation that the Huber needle "poped loose"
FO0958 - during power injection, ref SDS 0 4S5L, the needle should be saved to
FO0959 - review for defects, along with the Power Port, also, noted above on
FO0960 - causation. ref SDS 0 WI7G
FO0961 -
FO0962 -        [On 080801 Bard asks about Huber needle used for the CT test
FO0963 -        today - could be defective, ref SDS 45 OV5I; Kaiser was trained
FO0964 -        a year earlier, but adopted policy not to use Power Ports for
FO0965 -        CT tests, so nobody has experience, ref SDS 45 OV9H, Julie
FO0966 -        offes to consult during Millie's next CT test. ref SDS 45 OW41
FO0967 -
FO0968 -
FO0969 -
FO0970 -
FO0971 -
FO0972 -
FO10 -

SUBJECTS
Power Port Access Failure Recovery Surgery Incision Bleeding Extrava

GC03 -
GC0401 -  ..
GC0402 - Neupogen Booster Treatment Due to Bleeding in CT Department
GC0403 -
GC0404 - On leaving the hospital, stopped at the Oncology Department to report
GC0405 - results, and ask about taking Neupogen tomorrow in light of trauma
GC0406 - from the CT test, which might effect WBC. ref SDS 0 A26Y
GC0408 -  ..
GC0409 - The doctor was not available (may have left the building), and Arlette
GC0410 - was still at lunch.
GC0411 -
GC0412 -               [On 080719 Neupogen treatment received, ref SDS 40 SR37,
GC0413 -               Power Port accessed with 1" Huber needle at Kaiser
GC0414 -               Oncology Infusion Clinic, blood flows well; port flushed
GC0415 -               per manufacturer's protocol. ref SDS 40 HY6L
GC0416 -
GC0417 -
GC0419 -  ..
GC05 -
GC06 -
GC07 - 1422
GC08 -
GC0801 - Millie arrives home.  Has a hot dog for lunch, and drinks water, per
GC0802 - Dennis' instructions. ref SDS 0 E73N
GC0804 -  ..
GC0805 - Examination shows no further bleeding from observing the bandage
GC0806 - Kathi used earlier today.
GC0808 -  ..
GC0809 - Becomes emotional about events of the day.
GC0811 -  ..
GC0812 - She is worried about blood counts falling due to bleeding during the
GC0813 - CT test, ref SDS 0 A370, and that the Power Port could not be acessed
GC0814 - to flush with saline and Heprine according to protocol, because
GC0815 - swelling from overflowing contrast medium prevented finding the Power
GC0816 - Port beneath the skin. ref SDS 0 4S5M
GC0817 -
GC0818 -            [On 080721 UCSF reports Neupogen treatment not needed on
GC0819 -            080719, because blood counts in this case are not affected
GC0820 -            by bleeding incident, ref SDS 41 YU7N, that occurred during
GC0821 -            the CT test at Kaiser on 089718. ref SDS 0 A370
GC0823 -             ..
GC0824 -            [On 080721 UCSF advises that Neupogen treatment was not
GC0825 -            needed to recover blood counts, ref SDS 41 YU4J, from the
GC0826 -            bleeding incident today on 080718, per above, ref SDS 0
GC0827 -            IC6F, and in order to get chemotherapy next Thursday at
GC0828 -            UCSF.
GC0830 -  ..
GC0831 - Millie slept for a few hours in a big chair with a foot rest, but
GC0832 - remained mostly verticle, per Kathi's instructions. ref SDS 0 A39Q
GC0834 -  ..
GC0835 - She went to dinner with a friend.
GC0836 -
GC0838 -  ..
GC09 -
GC10 -
GC11 - 1708
GC12 -
GC1201 - Schedule Neupogen Treatment and Physician Review
GC1202 -
GC1203 - Called Kaiser to investigate follow up requested by Millie.
GC1204 - ref SDS 0 CE5O
GC1205 -
GC1206 - Oncology voice mail says the department is closed.
GC1208 -  ..
GC1209 - Called a "hot line" number for Kaiser after-hours support.
GC1211 -  ..
GC1212 - Talked to Didi at Kaiser in Sacramento.
GC1214 -  ..
GC1215 - Presented Millie's concerns and request for follow up care tomorrow at
GC1216 - Kaiser Infusion Clinic to maintain blood counts with Neupogen,
GC1217 - ref SDS 0 5P5F, per above, ref SDS 0 A370, and flush the Power Port.
GC1218 - ref SDS 0 4S5M
GC1220 -  ..
GC1221 - Didi feels Millie should get the Power Port flushed.  She proposes
GC1222 - Millie first have labs for a CBC tomorrow at Kaiser in Walnut Creek to
GC1223 - check blood counts in light of trauma of bleeding from the surgery
GC1224 - wound during the CT test today. ref SDS 0 A370  If the counts are low,
GC1225 - then Millie should get Neupogen in the Infusion Clinic in order to get
GC1226 - chemotherapy treatment on 080724 to start the next cycle at UCSF.
GC1227 -
GC1228 -        [On 080719 Millie does not receive call from Kaiser; goes to
GC1229 -        Kaiser Infusion Clinic, Sharee approves Neupogen treatment, and
GC1230 -        flushing the Power Port; defers CBC labs to UCSF on Thursday.
GC1231 -        ref SDS 40 ZG6F
GC1233 -         ..
GC1234 -        [On 080721 UCSF advises that Neupogen treatment was not needed
GC1235 -        to recover blood counts, ref SDS 41 YU4J, from the bleeding
GC1236 -        incident today on 080718, per above, ref SDS 0 IC6F, and in
GC1237 -        order to get chemotherapy next Thursday at UCSF.
GC1239 -  ..
GC1240 - Didi is worried about complexity of Millie's problem, noting that
GC1241 - doctors get mad if they have to read explanations of context conveying
GC1242 - critical nuance.  She asks for assistance summarizing the story and
GC1243 - objectives for Millie's care tomorrow that makes sense of patient
GC1244 - history today.
GC1246 -  ..
GC1247 - Didi crafts a letter.  Collaborated on editing the narrative to Didi's
GC1248 - satisfaction.  She sends the letter for distirubtion to after-hours
GC1249 - Oncology Department support, explaining Millie needs treatment in the
GC1250 - Infusio Clinic tomorrow.
GC1252 -  ..
GC1253 - Didi says someone will call Millie before 0900 tomorrow.
GC1254 -
GC1255 -        [On 080719 Millie does not receive call from Kaiser; goes to
GC1256 -        Kaiser Infusion Clinic, Sharee approves Neupogen treatment, and
GC1257 -        flushing the Power Port; defers CBC labs to UCSF on Thursday.
GC1258 -        ref SDS 40 ZG6F
GC1260 -         ..
GC1261 -        [On 080719 Kaiser calls at 1115; work has been completed.
GC1262 -        ref SDS 40 PRXW
GC1264 -         ..
GC1265 -        [On 080721 UCSF advises that Neupogen treatment was not needed
GC1266 -        to recover blood counts, ref SDS 41 YU4J, from the bleeding
GC1267 -        incident today on 080718, per above, ref SDS 0 IC6F, and in
GC1268 -        order to get chemotherapy next Thursday at UCSF.
GC1269 -
GC1270 -
GC1272 -  ..
GC13 -
GC14 -
GC15 - 1839
GC16 -
GC1601 - Millie home from dinner.
GC1602 -
GC1603 - She is crying suddenly overwhelmed from worry she cannot get a blood
GC1604 - draw tomorrow because the port might be damaged, or unusable for the
GC1605 - same reason Kathi could not use the port today, because swelling from
GC1606 - the contrast medium does not subside enough for the nurse to find the
GC1607 - port. ref SDS 0 A26Y
GC1609 -  ..
GC1610 - Millie feels doubt about having enough personal will to work through
GC1611 - complexities of biology with so many things going wrong in her health
GC1612 - care, coupled with so many people resisting collaboration, shown by
GC1613 - discussions with the CT Department last week on Friday, 080711.
GC1614 - ref SDS 34 7K8I  Nora, Dennis, Kathi, and everyone worked well
GC1615 - together today as events unfolded.  But nobody listens to be prepared
GC1616 - by coordinating to avoid problems.  Communicating with so many people
GC1617 - to get things done is very stressful.  She feels this is why cancer
GC1618 - patients give up.  On 080403, Doctor Rugo explained resistance to
GC1619 - coordination that makes case management very difficult for everybody,
GC1620 - because nobody has authority to direct work outside their department.
GC1621 - and nobody has precision access to understand patient history.
GC1622 - ref SDS 16 SG7I
GC1623 -
GC1624 -            [On 080719 Power Port accessed with 1" Huber needle at
GC1625 -            Kaiser Oncology Infusion Clinic, blood flows well; port
GC1626 -            flushed per manufacturer's protocol, ref SDS 40 HY6L;
GC1627 -            surgical wound cleaned and fresh dressing. ref SDS 40 LD84
GC1629 -             ..
GC1630 -            [On 080719 Millie relieved and feeling better recovering
GC1631 -            from problems today, ref SDS 40 LD8J; she hiked 5.5 miles
GC1632 -            at Lafayette reservoir. ref SDS 40 LD4M
GC1634 -             ..
GC1635 -            [On 080811 Paula at Kaiser Infusion Clinic investigating
GC1636 -            solutions to support CT Department for Millie's next test
GC1637 -            OA 080912; issue has been elevated, but no progress from
GC1638 -            management reported at this time, ref SDS 47 LD3H; there
GC1639 -            seems to be at least three (3) solutions. ref SDS 47 CW3O
GC1640 -            Paula coordinating with primary care physician about
GC1641 -            contacting Kaiser Oakland to perform Millie's next CT test.
GC1642 -            ref SDS 47 DE79
GC1644 -  ..
GC1645 - Millie wants to get Neupogen treatment tomorrow without a CBC
GC1646 - suggested by Didi, ref SDS 0 A535, and as a precaution to ensure blood
GC1647 - counts are high enough for treatment next Thursday; and, she wants to
GC1648 - have the Power Port maintained, since this was not done in the CT
GC1649 - Department today due to inability to access the port, per above.
GC1650 - ref SDS 0 4535   She feels it was a mistake for Didi to order a CBC,
GC1651 - since they may not be able to access the port, and will problems
GC1652 - drawing blood with an IV.  She wants to avoid problems.
GC1653 -
GC1654 -               [On 080719 Millie gets Neupogen treatment without CBC
GC1655 -               blood draw, as requested. ref SDS 40 SR37
GC1657 -                ..
GC1658 -               [On 080721 UCSF advises that Neupogen treatment was not
GC1659 -               needed to recover blood counts, ref SDS 41 YU4J, from
GC1660 -               the bleeding incident today on 080718, per above,
GC1661 -               ref SDS 0 IC6F, and in order to get chemotherapy next
GC1662 -               Thursday at UCSF.
GC1664 -  ..
GC1665 - Decided to wait for Kaiser's call tomorrow at 0900, and then go to the
GC1666 - Kaiser Infusion Clinic and work through the issues to get a solution
GC1667 - that fits Millie's objectives and requirements.
GC1668 -
GC1669 -               [...below, letter to medical team conveys Millie's
GC1670 -               objective to get Neupogen without blood test, and to
GC1671 -               access the port for maintenance. ref SDS 0 I45R
GC1673 -  ..
GC1674 - Examination shows no further bleeding from observing the bandage Kathi
GC1675 - used earlier today.
GC1676 -
GC1677 -
GC1678 -
GC17 -
GC18 -
GC1801 -
GC19 -

SUBJECTS
Notify Kaiser Coordination Referral Request  Sbmit Report CT Test OA

H403 -
H404 - 2342
H40501 -  ..
H40502 - Letter Request Kaiser Submit CT Test Report Notify Problems Issues
H40503 -
H40504 - Millie submitted ref DIT 1 0001 dated the next day 080719 0023, a
H40505 - little past midnight, and to the primary care physician who ordered
H40506 - the CT test on 080627, and with copies to the medical team,
H40507 - ref DIT 1 00W3, including Gloria in the Kaiser Coagulation Clinic, and
H40508 - to Arlette who assists the doctor with case management at Kaiser, and
H40509 - to let everybody know the CT test was performed in time for the
H40510 - meeting on 080724.
H40512 -         ..
H40513 -    1.  Please submit results of the CT test today for review on
H40514 -        Tuesday or Wednesday in time for meeting at UCSF with Doctor
H40515 -        Rugo on 080724, starting cycle 6 of the clinical study.
H40516 -        ref DIT 1 0001
H40517 -
H40518 -            [On 080721 reminder to get report on CT test in time for
H40519 -            meeting with medical team at UCSF on 080724. ref SDS 41
H40520 -            CW9R
H40522 -             ..
H40523 -            [On 080723 Arlette reminded doctor about submitting CT test
H40524 -            report to prepare for meeting at UCSF on 080724 starting
H40525 -            the next cycle, ref SDS 42 6V5I; doctor reported that CT
H40526 -            Department delayed reading the CT test, ref SDS 42 R44O;
H40527 -            report received lated PM. ref SDS 42 R45G
H40529 -             ..
H40530 -            [On 080724 UCSF did not get the CT test report from Kaiser
H40531 -            in time to prepare for the meeting. ref SDS 43 VE8O
H40533 -         ..
H40534 -    2.  Efforts using the Power Port for the first time on CT testing
H40535 -        were problematic.  Everyone did a great job preventing small
H40536 -        problems from escalating. ref SDS 0 0001, ref DIT 1 OP54
H40538 -             ..
H40539 -            [On 080811 Paula at Kaiser Infusion Clinic investigating
H40540 -            solutions to support CT Department for Millie's next test
H40541 -            OA 080912; issue has been elevated, but no progress from
H40542 -            management reported at this time, ref SDS 47 LD3H; there
H40543 -            seems to be at least three (3) solutions. ref SDS 47 CW3O
H40544 -            Paula coordinating with primary care physician about
H40545 -            contacting Kaiser Oakland to perform Millie's next CT test.
H40546 -            ref SDS 47 DE79
H40548 -         ..
H40549 -    3.  Kaiser appreciated patient history using the Power Port at
H40550 -        UCSF, and expects for the next test, leaving the Huber needle
H40551 -        in place after treatment at UCSF can reduce risks at Kaiser.
H40552 -        ref SDS 0 FL71, ref DIT 1 OP67
H40554 -         ..
H40555 -    4.  By copy to Gloria, notifying the Coagulation Control Clinic in
H40556 -        Martinez about bleeding during the procedure yesterday for the
H40557 -        CT test. ref SDS 0 A26Y, ref DIT 1 OP75
H40559 -         ..
H40560 -    5.  INR 2.4 for the blood test at UCSF on 080717, indicates
H40561 -        prescribed Coumadin treatment effective. ref SDS 38 PU7Y,
H40562 -        ref DIT 1 OP76
H40564 -         ..
H40565 -    6.  Questions...
H40566 -
H40567 -        1.  Should Power Port be inspected, xrayed, etc to verify
H40568 -            suitability for treatment next week at UCSF? ref DIT 1 OP85
H40569 -
H40570 -               [On 080719 Power Port accessed with 1" Huber needle at
H40571 -               Kaiser Oncology Infusion Clinic, blood flows well; port
H40572 -               flushed per manufacturer's protocol. ref SDS 40 HY6L
H40574 -             ..
H40575 -        2.  Should surgery incision wound be examined following up
H40576 -            events today? ref DIT 1 OP7N
H40577 -
H40578 -               [On 080719 surgery incision examined; find slight gap
H40579 -               from bleeding episode today; wound cleaned, and fresh
H40580 -               dressing applied with surgical tape. ref SDS 40 LD84
H40582 -             ..
H40583 -        3.  Since Neupogen treatment for tomorrow was canceled on
H40584 -            advice of UCSF due to high blood counts NEUTS 2.47 (ANC
H40585 -            2470), should Neupogen treatment occur tomorrow as risk
H40586 -            management to ensure counts are high enough for treatment
H40587 -            on Thursday, in light of bleeding incident today?  I would
H40588 -            like to avoid getting another blood test until next
H40589 -            Thursday, since there may still problems with the port
H40590 -            until the swelling goes down. ref SDS 0 A559, ref DIT 1
H40591 -            OP8Q
H40592 -
H40593 -               [On 080719 Millie gets Neupogen treatment without CBC
H40594 -               blood draw, as requested. ref SDS 40 SR37
H40596 -                ..
H40597 -               [On 080721 UCSF advises that Neupogen treatment was not
H40598 -               needed to recover blood counts, ref SDS 41 YU7N, from
H40599 -               the bleeding incident today on 080718, per above,
H40600 -               ref SDS 0 IC6F, and in order to get chemotherapy next
H40601 -               Thursday at UCSF.
H40603 -                ..
H40604 -               [On 080814 UCSF advises Neupogen was ordered for the
H40605 -               Power Port matter. ref SDS 48 4Q5O which seems
H40606 -               conflicting with the record on 080721. ref SDS 41 YU7N
H40608 -         ..
H40609 -    7.  After figuring out what happened today, I called a Kaiser Hot
H40610 -        Line this late afternoon on these issues. ref SDS 0 A46R  Didi
H40611 -        sent a letter to the doctor.  This letter confirms
H40612 -        understandings to the full medical team. ref SDS 0 HZ7M,
H40613 -        ref DIT 1 OP8Z
H40614 -
H40615 -
H40616 -
H40617 -
H40618 -
H40619 -
H40620 -
H407 -