CONTACTS 

SUBJECTS
Surgery Thin Skin Biopsies Left Breast Perimeter Evaluate Recovery o

0503 -
0503 -    ..
0504 - Summary/Objective
0505 -
050501 - Follow up ref SDS 10 0000. ref SDS 7 0000.
050502 -
050503 -
050504 -
050505 -
050507 -  ..
0506 -
0507 -
0508 - Progress
0509 -
050901 - Biopsies to Determine Complete Response to Treatment Local Disease
050902 -
050903 - The surgeon operated on Millie today.  Four (4) thin skin biopsies
050904 - were taken around the perimter of the left breast, as planned in the
050905 - meeting on 050923, ref SDS 7 SZ6M, and implementing Doctor Grissom's
050906 - 2nd opinion recommendations, received on 050920 0910. ref SDS 6 XL7P
050908 -  ..
050909 - Millie's blood thinning Coumadin treatments for pulmonary embolism
050910 - were paused on 051007 to reduce risks of hemoraging during surgical
050911 - procedures, and were resumed today, after the biopsy procedure, as
050912 - instructed on 051006 by Gloria in Kaiser's Coagulation Treatment
050913 - Clinic. ref SDS 11 5E6O
050915 -  ..
050916 - These biopsies were originally proposed in a meeting with the surgeon
050917 - on 050324, ref SDS 1 OV8L, and discussed again four (4) months later
050918 - on 050727. ref SDS 3 SZ6M  Doctor Grissom recommended biopsies in a
050919 - 2nd opinion received on 050920, ref SDS 6 XL7P, and confirming
050920 - consultations earlier on 050912. ref SDS 4 BV8I
050922 -  ..
050923 - Biopsies were proposed to...
050924 -
050925 -        1.  Determine complete response to local disease, reported on
050926 -            050324, ref SDS 1 OV8L, and per Grissom on 050920.
050927 -            ref SDS 6 XL7P
050928 -
050929 -               [On 051021 report on biopsies show negative results for
050930 -               inflammatory carcinoma, indicating complete response to
050931 -               treatment. ref SDS 15 LH6O
050933 -             ..
050934 -        2.  Provide guidelines for establishing the location for a very
050935 -            wide mastectomy to remove sufficient skin for obtaining
050936 -            clear margins, per Grissom on 050920, ref SDS 6 GT3M, and
050937 -            addressing boundary and scope of surgery issues presented
050938 -            on 050324. ref SDS 1 0347
050940 -  ..
050941 - On 050923 the surgeon indicated that favorable PET scan test results,
050942 - which were subsequently reported by the primary care physician on
050943 - 051007, together with favorable pathology report on the biopsies,
050944 - would support changing the strategy for a very wide mastectomy, to
050945 - instead perform a standard mastectomy. ref SDS 7 4G4L  The surgeon's
050946 - notes received on 050929 confirm this understanding. ref SDS 8 EU67
050947 -
050948 -
050949 -
050950 -
050951 -
050952 -
050953 -
0510 -

SUBJECTS
Due Diligence Mastectomy Surgery Time Out Risk Management Evaluate I

1303 -
130401 -  ..
130402 - Time Out Due Diligence Risk Analysis Scope Purpose of Surgery
130403 -
130404 - We need a letter to Kaiser requesting due diligence with a Time Out
130405 - for risk analysis called out in the Healthwise Handbook, reported on
130406 - 050923 in the meeting with the surgeon. ref SDS 7 UL8K
130407 -
130408 -             [On 051018 concern for refusal of health care entitlement
130409 -             restrains filing notice for Kaiser to perform requirements
130410 -             of health care entitlements. ref SDS 13 OM8H
130412 -  ..
130413 - Prepared ref DIT 1 0001 for submission to the surgeon requesting a
130414 - report on Kaiser's surgery due diligence checklist, and based on
130415 - discussions with the primary care physician on 051007. ref SDS 12 P64J
130416 -
130417 -             [On 051018 prepared revised 2nd draft. ref SDS 13 OX9N
130418 -
130419 -             [On 051019 submitted final draft and explained benefits of
130420 -             giving notice to Kaiser on performance of due diligence.
130421 -             ref SDS 14 V55K
130423 -         ..
130424 -    1.  Subject:  Time Out Mastectomy Surgery Due Diligence
130426 -         ..
130427 -        Dear Doctor ***********,
130429 -         ..
130430 -    2.  I was notified yesterday that the Surgery Department has
130431 -        scheduled mastectomy surgery to remove my left breast next week
130432 -        Friday, October 21.  Thanks very much for expediting Doctor
130433 -        *******'s request, which he asked me to file with the Surgery
130434 -        Department after I met with him on October 7th.
130436 -         ..
130437 -    3.  During our meeting on September 23rd, you seemed to indicate
130438 -        plans for ordering a retest of the biopsy on April 19, 2004,
130439 -        which diagnosed inflammatory breast cancer.  Retesting was
130440 -        recommended by Doctor Shim, in Kaiser's Oakland office, for the
130441 -        purpose of status change that might increase treatment options
130442 -        in the event of relapse.  Second opinions by Doctor's Grissom
130443 -        and Bailey concurred.  The report I received on your notes of
130444 -        our meeting makes no mention of this retest having been
130445 -        ordered.  Similarly, status change retesting was discussed with
130446 -        Doctor ******* on October 7th; however, the doctor's notes,
130447 -        also, do not mention this issue.  Please investigate, and let
130448 -        me know when retesting the biopsy was ordered for status
130449 -        change.
130450 -
130451 -            [On 051022 surgeon reported retest was ordered with no
130452 -            record in surgeon's notes received on 050927, and that
130453 -            results of retesting have not been received; doctor
130454 -            following up to obtain results. ref SDS 16 NE9J
130456 -         ..
130457 -    4.  I deeply appreciate the time you have given my case.  Doctor
130458 -        Smith and Doctor Johnson cite your strong commitment to patient
130459 -        care.  I have a few questions about the purpose, risks and
130460 -        benefits of mastectomy surgery, which can be addressed with
130461 -        Kaiser's team care practice for a Time Out to implement
130462 -        treatment guidelines followed by Kaiser and listed in the
130463 -        Healthwise Handbook listed on your website. ref DIT 1 DU6I
130465 -  ..
130466 - Doctor Smith commended the surgeon's work during a meeting on 050928,
130467 - ref SDS 9 258K, and earlier on 050329 the primary care physician
130468 - credited the surgeon as a top practitioner for breast surgery.
130469 - ref SDS 2 IE8O
130471 -  ..
130472 - Time Out for Due Diligence letter continues...
130473 -
130474 -    5.  I am writing to you, because you and Doctor Smith emphasize
130475 -        risks of surgery in my case are elevated due to secondary
130476 -        inflammatory breast cancer (IBC) Therefore, I want to be extra
130477 -        careful with this decision.  As well, I apologize for adding
130478 -        extra work to your schedule by taking a Time Out to answer
130479 -        patient questions.  Previously, in 2003 I asked about redness
130480 -        on my left breast, and did not press for answers, until you
130481 -        discovered IBC on April 19, 2004.  This letter is proactive
130482 -        support for the doctor-patient partnership so that future
130483 -        problems are avoided by carefull work-up on the proposed
130484 -        procedure. ref DIT 1 JW8I
130486 -         ..
130487 -    6.  Doctor ******* says in notes of my patient visit on October
130488 -        7th... ref DIT 1 DU72
130489 -
130490 -            The patient was seen by Plastic Surgery and the decision
130491 -            was that reconstruction would add no value to our current
130492 -            palliative strategy.
130494 -         ..
130495 -    7.  Doctor Smith's notes for the meeting on September 28th do not
130496 -        mention a "palliative strategy," so, ref DIT 1 PPUP, she may
130497 -        have discussed this separately with Doctor ******* after our
130498 -        meeting on the 28th.  Doctor Smith's notes do say in part...
130499 -
130500 -            I have recommended to postpone or delay the utilization of
130501 -            a [reconstruction] TRAM or DIEP flap in this case, as the
130502 -            patient is at extremely high risk for surgical and
130503 -            postoperative and anesthetic complications.
130505 -         ..
130506 -    8.  My notes show agreement that reconstruction to reduce risks of
130507 -        relapse can be deferred until after a standard mastectomy, and
130508 -        you, as the surgeon, are fully satisfied through post-op
130509 -        biopsies that clear margins are established, as Doctor Smith
130510 -        proposed on September 28th. ref DIT 1 LJ88
130512 -         ..
130513 -    9.  Until last week, "local control" has been presented as the
130514 -        reason for mastectomy.  Recall that we discussed goals for
130515 -        local control on January 7, 2005, later on March 24th, then on
130516 -        July 27th, and recently on September 23rd.  This has been a
130517 -        consistent rationale for mastectomy considerations the past ten
130518 -        (10) months, as stated in your notes for our most recent
130519 -        meeting on September 23, 2005.  Now suddenly the primary care
130520 -        physician in the Oncology Department mentioned during a meeting
130521 -        on October 7th that the purpose of mastectomy surgery is
130522 -        palliation to relieve discomfort from symptoms in the event of
130523 -        relapse and disease cascades out of control at some time in the
130524 -        future.  On October 7th, the doctor presented risk that
130525 -        microscopic remnants of disease will eventually cause relapse,
130526 -        and so avoiding this risk is the purpose of a standard
130527 -        mastectomy.  This aligns with concerns you have cited in our
130528 -        meetings.  Doctors Bailey and Grissom have filed second
130529 -        opinions that raise risk of relapse in the breast skin, citing
130530 -        patient history, and note that systemic treatments have enabled
130531 -        me to recover; so, I wonder how surgery that removes breast
130532 -        mass, where four (4) years of testing show no evidence of
130533 -        tumor, will support palliation relative to chemotherapy?
130534 -        Shouldn't the purpose of surgery be to remove breast skin,
130535 -        where patient history shows IBC tumor existed for 2 - 3 years,
130536 -        and so is where microscopic cancer cells are most likely to
130537 -        remain? ref DIT 1 0F8N
130539 -         ..
130540 -   10.  During the meeting with Doctor ******* on October 7th, he
130541 -        submitted Doctor Smith's notes of our meeting on September
130542 -        28th.  Doctor ******* did not discuss Doctor Smith's report,
130543 -        and there was no time for review during the meeting on October
130544 -        7th.  Now, after reading Doctor Smith's report, I share her
130545 -        concern about "extremely high risk for complications" in this
130546 -        proposed mastectomy surgery.  The doctor's caution raises the
130547 -        question of what palliative benefits of mastectomy exceed high
130548 -        risks of surgery for my patient profile, i.e., secondary IBC,
130549 -        multiple relapse over four (4) years, and pulmonary emboli.
130550 -        Doctor's Grissom and Bailey have also noted that I face a
130551 -        difficult decision. ref DIT 1 0F41
130553 -         ..
130554 -   11.  Therefore, I am taking advantage of Kaiser's Time Out practice
130555 -        to make sure I know what is being done and how this will
130556 -        benefit in relation to extremely high risks for complications.
130557 -        ref DIT 1 BW5O  Please coordinate with Doctor ******* and
130558 -        submit written explanation of the proposed surgery following
130559 -        Kaiser's outline in the Healthwise Handbook that says in
130560 -        part...
130561 -
130562 -           [On 061027 Millie diagnosed lymphedema and Cellulitis caused
130563 -           by removing lymphatics during mastectomy surgery, which was
130564 -           not a risk presented by Kaiser. ref SDS 17 HZ7N
130566 -         ..
130567 -   12.  Shared Decisions About Surgery
130569 -         ..
130570 -        Every surgery has risks.  Only you can decide if the benefits
130571 -        are worth the risks.
130572 -
130573 -        a.  Learn the facts:
130574 -
130575 -            •  What is the name of the surgery?  Get a description of
130576 -               the surgery.
130578 -                ..
130579 -               Doctor ******* called for a "standard mastectomy," and
130580 -               this was submitted in a written request to the Surgery
130581 -               Department on October 7th.
130583 -                ..
130584 -               Will surgery include axillary node dissection proposed
130585 -               by Doctor Shim in her 2nd opinion consultation on
130586 -               September 8, 2005?  Why or why not?
130587 -
130588 -                   [On 051021 surgeon evidently related to Millie that
130589 -                   another axillary lymph node dissection was not
130590 -                   performed during surgery in order to reduce risk of
130591 -                   lymphadema. ref SDS 15 QU5I
130593 -                ..
130594 -               Four biopsies on the left breast were taken today for
130595 -               the purpose of assessing recovery from IBC by
130596 -               complementing clinical examination, and PET scan
130597 -               testing.  These biopsies were proposed by Doctor Grissom
130598 -               in a 2nd opinion letter on September 20, 2005 to
130599 -               identify uninfected skin, as a guide to remove a wide
130600 -               area of previously infected skin so that the risk of IBC
130601 -               relapse is reduced.  Positioning of the biopsies today
130602 -               was based on memory of observations during examination
130603 -               in the Surgery Department on March 24th, when at that
130604 -               time IBC inflammation had spread toward the neck.  At
130605 -               that time, on March 24, 2005 Surgery reported that a
130606 -               mastectomy could not be performed, because there was not
130607 -               enough healthy skin to close the surgical wound.  This
130608 -               record indicates that leaving unhealthy skin in place
130609 -               presents post-operative risks cited by Doctor Smith and
130610 -               by Doctor Johnson explaining the problem of microscopic
130611 -               disease.
130613 -                ..
130614 -               On September 28th, Doctor Smith showed photographs which
130615 -               she described as a "standard mastectomy."  There was a
130616 -               single line of incision, slightly angled, and
130617 -               approximately 2" - 3" long.  The nipple was removed and
130618 -               the skin was flat against the chest signifying loss of
130619 -               underlying breast mass.  The impression was that minimal
130620 -               breast skin was removed in the photograph presented as a
130621 -               "standard mastectomy."
130623 -                ..
130624 -               This scope therefore does not contemplate using the four
130625 -               (4) biopsies performed today to guide removal of
130626 -               previously infected skin, and in fact most of the
130627 -               original skin, where microscopic cancer cells may
130628 -               remain, will remain in place under a "standard
130629 -               mastectomy" scheme?
130631 -                ..
130632 -               Please provide any additional explanation to clarify the
130633 -               planned procedure for a "standard mastectomy" in
130634 -               relation to a secondary IBC patient with pulmonary
130635 -               emboli.
130637 -                ..
130638 -            •  Why does your physician think you need the surgery?
130639 -
130640 -               On October 7th, Doctor Johnson recommended a "standard
130641 -               mastectomy" for the purpose of a "palliation strategy"
130642 -               needed for future relapse, which will be caused by
130643 -               microscopic remnants of IBC disease not currently
130644 -               detected by tests.  In previous meetings the purpose of
130645 -               mastectomy was presented to maintain "local control,"
130646 -               which seems closely related to reducing the risk of
130647 -               relapse in the left breast.
130649 -                ..
130650 -               Is "palliation" the same as "local control," or are
130651 -               these strategies related in that local control avoids
130652 -               relapse so that palliation measures are not required?
130654 -                ..
130655 -               How will a "standard mastectomy" that leaves most of the
130656 -               previously infected left breast skin in place, and which
130657 -               contains microscopic remnants of disease, warned by
130658 -               Doctor *******, support the "palliation strategy" to
130659 -               maintain "local control"?
130661 -                ..
130662 -               Will a "standard mastectomy" remove breast mass with
130663 -               possible remnants of microscopic disease, and thus help
130664 -               prevent relapse?  Is this the rationale for palliation
130665 -               or for cure or both?  Is the idea that all of the
130666 -               previously infected skin cannot be removed because that
130667 -               risks failure of closure, but removing the breast mass
130668 -               still has some residual palliative potential that
130669 -               justifies high risks of surgery in this case?
130671 -                ..
130672 -               If all of the skin with remnants of disease is not
130673 -               removed by a "standard mastectomy," does this risk
130674 -               another surgical wound that fails to heal for a year, as
130675 -               occurred with the punch biopsy?  What strategy is
130676 -               planned to meet this contingency?  Patient history in
130677 -               this case shows that chemotherapy treatment with
130678 -               Taxotere and capecitabine (Xeloda) provided palliation
130679 -               that healed the punch biopsy wound.
130681 -                ..
130682 -               How will the proposed surgery accomplish palliation
130683 -               and/or local control better than chemotherapy, and
130684 -               sufficient to accept extremely high risks of surgery
130685 -               complications cited by Doctor Smith on September 28?
130687 -                ..
130688 -               Previous relapse in December 2004 spread inflammation
130689 -               from IBC disease, and cancer blisters began popping out
130690 -               on the skin of the left breast.  How will mastectomy
130691 -               surgery of the left breast prevent or otherwise palliate
130692 -               this problem, when skin with microscopic cancer cells
130693 -               are left in place?  Will this be treated with
130694 -               chemotherapy for palliation?
130696 -                ..
130697 -               On September 28th, Doctor Smith proposed a step-by-step
130698 -               strategy to begin with a "standard mastectomy," and
130699 -               after clear margins are achieved, then review options
130700 -               for removing previously infected skin and reconstruction
130701 -               with non-infected skin to reduce the risk of relapse
130702 -               from remnants of microscopic cancer cells cited by
130703 -               Doctor *******.  How does this step-by-step strategy
130704 -               align with palliation objectives for handling relapse?
130706 -                ..
130707 -               Is standard mastectomy surgery in a case of secondary
130708 -               IBC expected to prolong disease-free survival, such that
130709 -               chemotherapy can be paused.  If so, how long might this
130710 -               pause last, before chemotherapy must be restarted?  Are
130711 -               we talking weeks, months, hopefully a year or so?  Or,
130712 -               is it expected that chemotherapy will be required
130713 -               immediately following surgery, as in the case of primary
130714 -               IBC? ref DIT 1 SK34
130716 -                ..
130717 -               Please provide other helpful guidance on the "palliative
130718 -               strategy" to indicate expected results for post-op
130719 -               assessment. ref DIT 1 8D4J
130721 -                ..
130722 -               What criteria will be used to determine the scope and
130723 -               degree of tissue removal?  If more tissue is removed
130724 -               will this increase palliative benefits? ref DIT 1 SK42
130726 -                ..
130727 -            •  Is this surgery the most common one for this problem?
130728 -               Are there other types of surgery? ref DIT 1 4I4F
130730 -                ..
130731 -               What assessment has been made of performing a "very wide
130732 -               mastectomy" discussed with the surgeon on September 23
130733 -               for the purpose of reducing the risk of relapse?
130735 -             ..
130736 -        b.  Consider the risks and benefits:
130737 -
130738 -            •  How many similar surgeries has the surgeon performed
130739 -               where the patient is extremely high risk for surgical,
130740 -               postoperative and anesthetic complications, while
130741 -               recovering from secondary IBC, and diagnosed with
130742 -               pulmonary emboli, noted by Doctor Smith?
130744 -                ..
130745 -               How many surgeries like this are done at this hospital
130746 -               on patients with secondary IBC and diagnosed with
130747 -               pulmonary emboli?
130749 -                ..
130750 -            •  What can go wrong?
130751 -
130752 -               What complications of mastectomy surgery are increased
130753 -               for a patient with secondary IBC, noted in Doctor
130754 -               Smith's report?  What solutions are proposed to avoid
130755 -               these complications?
130756 -
130757 -                  [On 061027 Millie diagnosed lymphedema and Cellulitis
130758 -                  caused by removing lymphatics during mastectomy
130759 -                  surgery, which was not a risk presented by Kaiser.
130760 -                  ref SDS 17 HZ7N
130762 -                ..
130763 -               If previously IBC infected skin is not removed, and if
130764 -               there is no tumor within the breast to remove, shown by
130765 -               PET tests, then what will prevent IBC from relapsing in
130766 -               previously infected skin left in tact by standard
130767 -               mastectomy?
130769 -                ..
130770 -               If the left breast mass is removed through a standard
130771 -               mastectomy how will loss of blood vessels that normally
130772 -               service the skin limit ability of the patient to recover
130773 -               in the event of relapse?  Does loss of blood vessels to
130774 -               the remaining breast skin from mastectomy surgery risk
130775 -               losing local control for a patient with secondary IBC,
130776 -               in the same way Doctor Smith explained that prior
130777 -               surgery in the lower stomach area during the late 1960s
130778 -               prevents harvesting this tissue for reconstruction due
130779 -               to loss of blood vessels?
130781 -                ..
130782 -               On November 4, 2004 I was notified by Doctor Kaufman,
130783 -               substituting for Doctor Johnson, that I was diagnosed
130784 -               with pulmonary emboli based on a CT scan test performed
130785 -               the day before on November 3, 2004, and that I would
130786 -               therefore require treatment with anticoagulants
130787 -               (Coumadin) for the rest of my life.  Subsequent
130788 -               discussion over ensuing months with Doctor *******
130789 -               confirmed this prescription.  A few weeks ago, on
130790 -               September 28, 2005, Doctor Smith cited pulmonary emboli
130791 -               requiring Coumadin treatment as one of the factors in my
130792 -               patient profile that makes me very high risk for
130793 -               complications from undergoing mastectomy surgery.  Last
130794 -               week, on October 7th Doctor ******* related that
130795 -               Kaiser's standard practice for pulmonary emboli is
130796 -               treatment for one (1) year, and that chemotherapy
130797 -               patients are treated for life, as related previously by
130798 -               Doctor Kaufman.  Also, on the 7th Doctor ******* ended
130799 -               my treatment for pulmonary emboli, perhaps reflecting
130800 -               successful treatment with chemotherapy, as shown by the
130801 -               PET scan test performed last week on October 5th, and
130802 -               presented by the doctor on the 7th.  Does this patient
130803 -               history eliminate pulmonary emboli as a high risk for
130804 -               complications in mastectomy surgery?  If not, what are
130805 -               Kaiser's plans for addressing this risk during and after
130806 -               surgery?
130808 -                ..
130809 -            •  How long will it be before you're fully recovered?
130810 -
130811 -               How many days in the hospital for close observation of
130812 -               complications cited by Doctor Smith?
130814 -                ..
130815 -               You mentioned today, while performing the minor biopsy
130816 -               surgery, that Kaiser plans a one (1) day hospital stay
130817 -               for my patient profile.  How does this address Doctor
130818 -               Smith's report of high risk post-operative
130819 -               complications?  Does Kaiser have experience showing that
130820 -               one (1) is sufficient for evaluation of post-op
130821 -               complications on a secondary IBC patient?  What signals
130822 -               will the medical team be checking to establish that one
130823 -               (1) is sufficient observation in this case?
130825 -                ..
130826 -            •  How can you best prepare for the surgery and the
130827 -               recovery period?
130829 -                ..
130830 -               What should I expect for recovery complications as a
130831 -               secondary IBC patient, that are different from other
130832 -               patients who have mastectomy surgery?  How will Kaiser
130833 -               handle these uncommon risks?
130834 -
130835 -
130837 -         ..
130838 -   13.  I would like to get a draft of your report on the above issues
130839 -        by Wednesday of next week, so there is time for review and
130840 -        finalization.  You can submit draft language via email to
130841 -        expedite the process (millie************.net).  After we agree
130842 -        on the language, I will then attach your signed report to the
130843 -        consent form I sign for the mastectomy operation on Friday,
130844 -        October 21.  A copy of this letter to Doctor *******
130845 -        facilitates collaboration on Time Out review.
130847 -         ..
130848 -   14.  Thanks again for your excellent work in my case, and please
130849 -        extend to Doctor Smith my deep appreciation for her clear and
130850 -        informative presentation on September 28.
130851 -
130852 -
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130854 -
130855 -
130856 -
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130859 -
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130861 -
130862 -
130863 -
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130869 -
130870 -
130871 -
130872 -
1309 -