CONTACTS 

SUBJECTS
CT Test 080911 Performed Kaiser Oakland Ordered Oncology Department

1203 -
1203 -    ..
1204 - Summary/Objective
1205 -
120501 - Follow up ref SDS 41 0000. ref SDS 40 0000.
120502 -
120503 -
120504 -
120505 -
120506 -
120507 -
120508 -
120509 -
120511 -  ..
1206 -
1207 -
1208 - Progress
1209 -
1210 -
121001 - CT Test Administration and Barium Sulfate Oral Contrast Medium
121002 -
121003 - Follow up ref SDS 41 2U6L, ref SDS 21 9W9I.
121004 -
121005 - Left UCSF at 1130 after Millie's treatment today and drove to Kaiser
121006 - in Oakland. ref SDS 60 O55I
121008 -  ..
121009 - While driving from UCSF to Kaiser in Oakland, Millie drank the first
121010 - bottle of Barium Sulfate contrast medium, which Arlette ordered on
121011 - 080822, ref SDS 52 6T9K, and was received from the Kaiser Pharmacy at
121012 - Park Shadelands clinic on 080825. ref SDS 53 W35I
121013 -
121014 -        [...below after the test, and through the evening new contrast
121015 -        medium may cause upset stomach. ref SDS 0 S59G
121017 -  ..
121018 - Today, we made better time than last week, by following directions
121019 - from Valerie during the call on 080903. ref SDS 57 MD5H  After
121020 - treatment we drove to Kaiser in Oakland to get familiar with the route
121021 - from UCSF.  This was planned in a letter to Vallerie on 080903.
121022 - ref SDS 57 IO5Q
121023 -
121024 -
121026 -  ..
1211 -
1212 -
1213 - 1150
1214 -
121401 - Arrived at Kaiser CT Department in Oakland using directions developed
121402 - during initial trip last week on 080904. ref SDS 58 KB6G
121404 -  ..
121405 - Checked in with Amanda at the CT Department trailer located in the
121406 - parking garage just outside the hospital and near to the Infusion
121407 - Clinic, reported last week when a test drive was performed to get
121408 - familiar with location.
121410 -  ..
121411 - Amanda had the test scheduled in the computer ordered by the primary
121412 - care physician on 080829, as noted in Millie's letter to the medical
121413 - team on 080829, ref SDS 56 RP7S, following up initial planning by
121414 - Paula on 080811. ref SDS 49 L465  CT testing on 8 week schedule is
121415 - required by protocol for treatment at UCSF through clinical study on
121416 - cetuximab and Carboplatin, noted by Doctor Rugo at UCSF in a letter on
121417 - 080811. ref SDS 49 4T4N
121419 -  ..
121420 - Amanda indicated the CT Department transaction shows the test today
121421 - will use the Power Port for injecting contrast medium.
121423 -  ..
121424 - Millie submitted $50 co-payment for the test.  She filled out some
121425 - documentation, including consent for doing the test.
121427 -  ..
121428 - Amanda asked for Millie's latest lab work showing results of blood
121429 - test for Creatinine.  This aligns with experience doing the CT test at
121430 - Kaiser in Walnut Creek on 080718. ref SDS 41 02DF
121432 -  ..
121433 - Millie submitted the report for the test this morning on 080911 at
121434 - UCSF showing Creatinine 0.41. ref SDS 60 8U4N
121436 -  ..
121437 - Amanda explained there is another location where CT tests are
121438 - performed in the main Kaiser hosptial across the street on West
121439 - MacArthur.  She noted that this CT test facility in the trailer
121440 - outside the Infusion Clinic has slightly more advanced equipment and
121441 - capabilities than the other CT facility in the main Kaiser hospital
121442 - building.
121444 -  ..
121445 - Asked Amanda about efforts to support test analysts for comprehensive
121446 - review of scans following up prior findings.
121448 -  ..
121449 - Amanda said following up prior findings is a primary goal of test
121450 - analysis, because the aim is to disover trends in time to take
121451 - effective action.
121453 -  ..
121454 - Explained prior findings in Millie's tests on....
121455 -
121456 -                                           Test      Reviewed
121457 -
121458 -        1.  Esophagitis................... 060120... 060126, ref SDS 5 DH4O
121459 -        2.  Pulmonary embolism............ 060930... 061012, ref SDS 6 294Q
121460 -        3.  Cor Pulmonale................. 060930... 061012, ref SDS 6 7E5L
121461 -        4.  Enlarged heart.................071210... 071213, ref SDS 10 SR5I
121463 -  ..
121464 - Additionally, there have numerous occassions when a report makes a
121465 - comparison on a prior test for which there were no findiings.
121467 -  ..
121468 - Amanda said the doctor has to specifically ask in the referral for
121469 - comparison with prior tests.
121471 -  ..
121472 - Explained over the past several years Millie's doctor has asked
121473 - numerous times for specific comparisons, and the report comes back
121474 - with nothing.
121476 -  ..
121477 - Amanda said that sometimes things fall through the cracks, because
121478 - doctor's who analyze tests have limited time.  Even though all the
121479 - test files on the computer, finding the files from prior tests, and
121480 - then going through the various images to examine specific locations is
121481 - a lot of hard work.  Therefore reporting test results can be uneven at
121482 - times.  She said that the scope and quality of test reporting and
121483 - trend analysis is a big topic for meetings in the Oakland CT test
121484 - department.
121486 -  ..
121487 - After checking in, walked across the streed at West MacArther to the
121488 - main hospital.  Found a talble in the main lobby and played dominos.
121489 -
121491 -  ..
1215 -
1216 -
1217 - 1230
1218 -
121801 - Millie drank the second bottle of Barium Sulfate contrast medium to
121802 - prepare for the CT test at 1330.
121812 -  ..
1219 -
1220 -
1221 - 1315
1222 -
122201 - Walked back to the CT Department located in the parking garage for the
122202 - Kaiser building, and with access from Piedmont street.
122203 -
122204 -
122205 -
1223 -

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

4203 -
4204 - 1355
420501 -  ..
420502 - Power Port Instructions Requested for Review During CT Test
420503 -
420504 - Follow up ref SDS 41 2U8V.
420505 -
420506 - Angela, the CT technologist, came into the waiting lounge.  She asked
420507 - how long Millie has had the Power Port?
420509 -  ..
420510 - Millie advised that surgery was done at Kaiser in Walnut Creek on
420511 - 080708. ref SDS 33 0001
420513 -  ..
420514 - Angela seemed to indicate that she is the only technologist in this CT
420515 - test facility.  During the test today, there was no nurse nor other
420516 - medical professional contributing to the CT test activity.  Seems to
420517 - be a "one-man-job" in this auxillary CT Department at Kaiser in
420518 - Oakland on West MacArthur Boulevard.
420520 -  ..
420521 - Angela advised that the only training she got for doing CT tests with
420522 - the Power Port and Huber needle technology was from a Bard
420523 - representative who visited the department and explained flow rates.
420524 - They don't need training to access the port, because that is done in
420525 - the Infuison Clinic next door.
420527 -  ..
420528 - Angela took Millie into the CT test room.
420530 -  ..
420531 - When Millie left UCSF today, Catherine gave Millie product information
420532 - for the Lifeguard Safety Infusion Set Huber needle, ref SDS 60 O65N,
420533 - which Diane used to access the port for the blood test and treatment
420534 - this morning, reported in another record. ref SDS 60 OY4J  This
420535 - specification was received from UCSF on 080724, ref SDS 46 MV7Y, and
420536 - was submitted to Kaiser previously with Millie's letter on 080903.
420537 - ref SDS 57 IO6R
420539 -  ..
420540 - In the CT test room, Millie submitted product specifications for the
420541 - Lifeguard Safety Infusion Set Huber needle to Angela.
420543 -  ..
420544 - Angela asked why Millie submitted the specs for the Huber needle?
420546 -  ..
420547 - Millie explained Huber needle specifications may relate to verifying
420548 - flow rates for injecting contrast medium to perform the CT test, and
420549 - flushing procedures for the Power Port after the test, based on
420550 - correlations with manufacturer's "Instructions for Use," received from
420551 - Kaiser on 080708. ref SDS 33 JE7N  Injection flow rates were discussed
420552 - at Kaiser for the prior test on 080718, and misunderstandings may have
420553 - caused problems. ref SDS 41 7M6F  UCSF has addressed this issue with
420554 - submission of product specification for the Lifeguard Huber needle
420555 - today. ref SDS 0 N43F
420557 -  ..
420558 - Angela was not familiar with the Lifeguard Safety Infusion Set Huber
420559 - needle.  She explained that patients come into the CT Department with
420560 - the needle already accessing the port, which is done in the Infusion
420561 - Clinic.  Raising a question about compatibility of the Lifeguard
420562 - Safety Infusion Set Huber needle with the Bard Power Port created
420563 - confusion and doubt about how to proceed.
420564 -
420565 -            [On 081017 1415 Kaiser has purchased Lifeguard Huber
420566 -            needles that meet requirements using high strength
420567 -            steel to perform pressure injection of contrast medium
420568 -            for CT tests using Bard Power Power technology.
420569 -            ref SDS 63 045H
420571 -  ..
420572 - Angela and Millie both returned to the CT Department waiting room.
420574 -  ..
420575 - Angela asked for Millie's "Power Port ID card," which was in Millie's
420576 - purse.
420578 -  ..
420579 - Angela's request today at Kaiser in Oakland was similar to Nora's
420580 - request during Millie's last CT test at Kaiser in Walnut Creek on
420581 - 080718. ref SDS 41 NM5V  The ID card came with the manufacturer's
420582 - "Power Port Patient Packet," which Millie received after surgery to
420583 - implant the new port on 080708. ref SDS 33 DZ5O  Angela needs
420584 - instructions printed on the ID card that specify injection flow rates,
420585 - and also requirements on flushing the port after the test
420587 -  ..
420588 - Bard "Instructions for Use" were submitted to the Oncology Department
420589 - at Kaiser on 080709, ref SDS 34 TR9X, for coordinating work on the CT
420590 - test scheduled for 080718.  Manufacturer's instructions list "Power
420591 - Injection Procedures" from the record on 080708. ref SDS 33 JE7N
420592 - Millie met with the CT Department on 080711, and requested review of
420593 - Bard requirements and procedures. ref SDS 36 JR6T  Millie's letter the
420594 - next day on 080712 requested proactive support for the CT Department
420595 - to review Bard instructions, ref SDS 37 K13Q, in order to prepare for
420596 - the test on 080718.
420598 -         ..
420599 -        Injection "flow rates" are listed in step 7 of the
420600 -        manufacturer's Instructions for Use received on 080708.
420601 -        ref SDS 33 M53H
420602 -
420603 -            Attach the power injection device to the PowerLoc* Safety
420604 -            Infusion Set (SIS) ensuring connection is secure.  Check
420605 -            indicated flow rate of safety infusion set and confirm CT
420606 -            settings.
420608 -             ..
420609 -            Warning:  Do not exceed a 300 psi pressure limit setting,
420610 -            or the maximum flow rate setting shown below, on the power
420611 -            injection machine if power injecting through the PowerPort*
420612 -            device:, ref SDS 33 M54F
420614 -             ..
420615 -            Powerloc SIS Guage   Size      19 Ga    20 Ga    22 Ga
420616 -            Powerloc SIS Wing    Color     Cream    Yellow   Black
420617 -            Maximum Flow Rate    Setting   5 ml/s   5 ml/s   2 ml/s
420619 -         ..
420620 -        Flushing requirements for the Power Port after the CT test are
420621 -        set out in steps 11 - 14. ref SDS 33 XJ6S  Instructions are
420622 -        shown calculating the amount of Heprin to use. ref SDS 33 XJ4H
420624 -  ..
420625 - On 080715, Millie drove to Kaiser and hand-delivered the Power Port
420626 - Patient Packet with Instructions for Use to the Oncology Department,
420627 - who had ordered the CT test, ref SDS 38 RB4G, and for the purpose of
420628 - distribution within Kaiser to the CT Department, as a backup to
420629 - letters on 080709, ref SDS 34 TR9X, and on 080712, ref SDS 37 K13Q
420630 - submitted to support the CT test on 080718.
420632 -  ..
420633 - At that time on 080718, the people doing the work disclosed that they
420634 - never received communication on reviewing the Power Port Patient
420635 - Packet with Instructions for Use. ref SDS 41 2U51
420637 -  ..
420638 - During the test preparation process on 080718, Millie recalled
420639 - discussion in the test room on converting units of measure in the
420640 - manufacturer's instructions to determine injection flow rates for
420641 - setting the injection equipment. ref SDS 41 7M6F
420643 -  ..
420644 - Subsequently, the test on 080718 failed. ref SDS 41 LK3R  Nora
420645 - speculated failure occurred because the Huber needle was not fully
420646 - seated. ref SDS 41 LK41  Review of causation shows other factors may
420647 - have been involved. ref SDS 41 WI7G
420649 -  ..
420650 - CT tests with Power Port involve many issues...
420651 -
420652 -        1.  Flow rate set incorrectly.
420653 -
420654 -               possibly Kaiser CT Dep WC...... 080718, ref SDS 41 7M6F
420656 -             ..
420657 -        2.  Huber needle not long enough
420658 -
420659 -               Bard protocol.................. 080708, ref SDS 33 JE7N
420660 -               possibly Kaiser CT Dep WC...... 080718, ref SDS 41 LK41
420661 -               possibly Kaiser Infusion Clin.. 080719, ref SDS 42 OH5H
420663 -             ..
420664 -        3.  Huber needle not fully seated.
420665 -
420666 -               Bard protocol.................. 080708, ref SDS 33 JE7N
420667 -               possibly Kaiser CT Dep WC...... 080718, ref SDS 41 LK41
420668 -               possibly UCSF Infusion Clin.... 080821, ref SDS 51 04GH
420670 -             ..
420671 -        4.  Huber needle not designed for high pressure injection.
420672 -
420673 -               investigated at UCSF........... 080724, ref SDS 46 MV7Y
420674 -               investigated at Kaiser......... 080903, ref SDS 57 IO6R
420675 -               investigated at Bard........... 080905, ref SDS 59 Y83V
420677 -             ..
420678 -        5.  Huber needle access not tested for adequate flow.
420679 -
420680 -              Bard protocol requires aspirate for
420681 -              blood flow, and flush with
420682 -              saline.......................... 080708, ref SDS 33 JE56
420684 -               ..
420685 -              Specified flow rate can still be
420686 -              cause over pressurization when
420687 -              occluded catheter occurs, reported
420688 -              by Bard Instructions for Use
420689 -              on High Pressure Injection
420690 -              Procedures...................... 080708. ref SDS 33 EE4S
420692 -               ..
420693 -              Julia explains Bard training protocol
420694 -              requires flushing port with saline
420695 -              drawing blood to verify
420696 -              flow............................ 080801, ref SDS 47 OW43
420698 -  ..
420699 - Of these 5 issues, today Angela was only concerned with flow rate.
420700 - Since the Huber needle access to the port was performed at UCSF, other
420701 - health care professionals took responsibility for issues 2 - 5.
420702 - (below, Angela flushed the port with saline, but may not have drawn
420703 - blood. ref SDS 0 WF4K)
420705 -  ..
420706 - Today, Angela asked about the manufacturer of the Power Port?
420708 -  ..
420709 - Millie said she has the Bard Power Port.
420711 -  ..
420712 - Angela advised that a Bard representative visited the Kaiser Oakland
420713 - CT Department a few days ago to review procedures.  She feels this
420714 - review was effective clarifying use of the Power Port for power
420715 - injection of contrast medium.  Angela decided that since Millie has a
420716 - Bard Power Port it was not necessary to examine the Power Port ID
420717 - card.  She seemed to indicate that settings for power injection of
420718 - contrast medium for the Bard Power Port are the same as for
420719 - conventional IV injection.  This simplified the work, reducing chances
420720 - of mistakes, illustrated by experience at Kaiser in Walnut Creek on
420721 - 080718. ref SDS 41 2U8V
420723 -  ..
420724 - Bard training of Kaiser staff near to the time of the test today
420725 - implements proposal by Julie on 080801 offering to consult on site
420726 - during the test to help avoid problems using the Bard Power Port.
420727 - ref SDS 47 OW41
420728 -
420729 -        [On 080912 Steve, District Manager for Bard, disclosed that he
420730 -        sent a representative to the Kaiser CT Department in Oakland a
420731 -        few days before Millie's test to provide training and
420732 -        orientation. ref SDS 61 C65I
420734 -         ..
420735 -        [On 081017 Kaiser in Walnut Creek investigating how Kaiser in
420736 -        Oakland handled laws about accessing a central venous artery
420737 -        with CT test equipment using a Power Port, ref SDS 63 8Y4N, and
420738 -        seemed to indicate that if legal issues are resolved, and the
420739 -        Power Port is accessed by qualified nurses in the Infusion
420740 -        Clinic, then support from the Power Port manufacturer is not
420741 -        needed. ref SDS 63 035K
420743 -  ..
420744 - Talking to Malisa in the Interventional Radiology Department, she said
420745 - that doing CT tests with Power Ports is still fairly rare.  Past
420746 - history of failures doing CT tests with the older port catheters makes
420747 - CT technologists risk averse to using Power Ports now designed to
420748 - support high pressure injections.  As a result, most patients with
420749 - Power Ports still have contrast medium injected with conventional IV
420750 - for CT tests.  This has the effect of making everyone a bit nervous
420751 - when the Power Port has to be used, because nobody ever gets
420752 - confidence from routine experience using it.
420754 -  ..
420755 - Worry about mechanical steps is a natural part of technology transfer,
420756 - shown by Angela's reaction today, when Millie presented specifications
420757 - for the Huber needle, per above. ref SDS 0 UE6L
420759 -  ..
420760 - Angela's confidence today appeared to come from orientation by the
420761 - Bard representative the day before. ref SDS 0 JG43
420763 -  ..
420764 - Until using Power Port technology become routine for CT tests, support
420765 - by the manufacturer for near-term orientation seems an important,
420766 - prudent part of facilitating this wonderous new technology.
420767 -
420768 -
420769 -
420770 -
420771 -
420772 -
4208 -

SUBJECTS
CT Test Failed Access Power Port Contrast Medium Extrvasation Overfl

7003 -
7004 - 1414
700501 -  ..
700502 - CT Test Successful Using Bard Power Port Lifeguard Huber Needle
700503 -
700504 - Follow up ref SDS 41 LK3R.
700505 -
700506 - Millie came into the CT Department waiting room.  The test was
700507 - successful.  She felt no pain; there were no problems of any kind.
700509 -  ..
700510 - Millie recalled that Angela made no changes to the injection CT
700511 - equipment.  She flushed the Huber needle which had been configured to
700512 - access the Power Port at UCSF, per above, ref SDS 0 UE6L, with saline,
700513 - per Bard protocol in Instructions for Use, reported on 080708,
700514 - ref SDS 33 EE75, then connected the power injection equipment, and
700515 - then pressed the button to do the test (after first doing a standard
700516 - test run to verify the scan equipment was operating correctly for
700517 - Millie's patient profile).
700519 -  ..
700520 - The entire process took about 30 minutes, including an extra 10
700521 - minutes to discuss the Huber needle issue, per above. ref SDS 0 UE6L
700523 -  ..
700524 - Successful use of Power Port for the CT test today accomplishes
700525 - planning by the primary care physician at Kaiser on 080502,
700526 - ref SDS 26 WX6I, to solve problems of excessive needle punctures with
700527 - prior CT test reported by Millie on 080425. ref SDS 21 FP6F  Success
700528 - today demonstrates "proof of concept" resolving training and
700529 - certification issues for Power Port technology presented at Kaiser in
700530 - Walnut Creek on 080711. ref SDS 36 JQ55  Further demonstrates that
700531 - using Infuson Clinic staff, who have daily experience accessing Power
700532 - Ports with Huber needles, helps solve problems that occurred on
700533 - 080718. ref SDS 41 LK3R
700534 -
700535 -        [On 080912 Millie reported in a letter to the primary care
700536 -        physician at Kaiser in Walnut Creek CA success today using the
700537 -        Power Port for the CT test, and asked about upgrading service
700538 -        to perform follow up tests at the Kaiser CT Department in
700539 -        Walnut Creek. ref SDS 62 LO4W
700540 -
700541 -
700543 -  ..
7006 -
7007 -
7008 - 1415
7009 -
700901 - After the test, walked next door to the Infusion Clinic for steps 11 -
700902 - 14 of Bard protocol.
700904 -  ..
700905 - Ann flushed the port with saline, and applied Heprin required by
700906 - protocol for post-test procedures, listed in Bard Instructions for
700907 - Use, shown on 080708. ref SDS 33 XJ6S
700908 -
700909 -        [On 081107 similar work at the Kaiser Infusion Clininc in
700910 -        Walnut Creek CA. ref SDS 64 W8DG
700912 -  ..
700913 - Ann examined the Lifeguard Safety Infusion Set Huber needle.  She
700914 - noted it is slightly different from the Bard Powerloc Safety Infusion
700915 - Set Huber needle that Kaiser uses for CT tests, and which is specified
700916 - in the Bard Patient Packet for the Power Port received from Kaiser on
700917 - 080708. ref SDS 33 JE7N
700919 -  ..
700920 - It presents no evident performance nor application issues.
700921 -
700922 -
710911 -
710912 -
710913 -
710914 -
710915 -
7110 -