CONTACTS 

SUBJECTS
Due Diligence Mastectomy Surgery Time Out Risk Management Evaluate I

1103 -
1103 -    ..
1104 - Summary/Objective
1105 -
110501 - Follow up ref SDS 15 6D4F.
110502 -
110503 -
110504 -
110505 -
110507 -  ..
1106 -
1107 -
1108 - Progress
1109 -
110901 - On 051012 a draft letter, ref DIP 5 0001, was prepared for notifying
110902 - Kaiser to perform requirements for due diligence, ref SDS 15 6D4F,
110903 - generally called a Time Out in Kaiser procedures, and as shown in
110904 - Kaiser's Healthwise Handbook on shared decisions surgery, cited on
110905 - 051012, ref SDS 15 6D4F, and based on the meeting with the surgeon on
110906 - 050923. ref SDS 9 UL8K
110908 -  ..
110909 - There are several reasons why patients are uncomfortable filing notice
110910 - for Kaiser to take a Time Out and perform due diligence requirements
110911 - that verify accuracy of the work...
110912 -
110913 -              [On 051021 patient asks about purpose of surgery while on
110914 -              the gurney in the operating room when there is no time
110915 -              for planning to influence the scope of work. ref SDS 17
110916 -              QE4N
110918 -             ..
110919 -        1.  Filing written demand for Kaiser to perform it's own
110920 -            requirements for due diligence risks conflict with the
110921 -            primary care physician, who expressly objected to due
110922 -            diligence with documentation on 041130. ref SDS 2 YR8F
110923 -            Desire to avoid conflict with the doctor restrains giving
110924 -            notice.  This is a common problem at all levels of
110925 -            management in every setting.  There is fear that demanding
110926 -            performance of some duties could cause refusal to perform
110927 -            other duties owed to for health insurance.  People give up
110928 -            performance of critial duties in order to avoid a perceived
110929 -            threat to entitlement of all duties.  This was illustrated
110930 -            by Gloria's request on 051006 for the patient to notify the
110931 -            primary care physician of medical requirements on treating
110932 -            pulmonary emboli, in order that medical staff does not
110933 -            incur reprisal for correcting a doctor's prescription.
110934 -            ref SDS 13 5F62
110936 -             ..
110937 -        2.  There is hope that somehow risks of mastectomy surgery for
110938 -            the patient profile cited by the surgeon, the plastic
110939 -            surgeon, 2nd opinion and published guidance will not occur,
110940 -            and that surgery will somehow improve patient health,
110941 -            despite removing tissue with no evidence of tumor, and
110942 -            which may be needed for blood supply to treat relapse; yet,
110943 -            not removing the breast skin with 2 years of evidence
110944 -            showing tumor.
110946 -             ..
110947 -        3.  Cancer treatment is a highly complex part of a highly
110948 -            complex craft practicing medical treatment.  This comlexity
110949 -            presents many risks that impact decisions, which cannot be
110950 -            considered entirely in the mind, due to limited span of
110951 -            attention, reviewed on 990303. ref SDS 1 HE4N  The burden
110952 -            of cognitive overhead performing due diligence makes good
110953 -            management seem like unnecessary overkill that drives
110954 -            simplification by avoiding consideration of all factors
110955 -            that impact decisions. (see NWO, ref OF 13 PQ4M)  Focusing
110956 -            on only one or two of components in an array of many
110957 -            factors simplifies the decision process. ref OF 13 TF5M
110958 -
110960 -  ..
110961 - Submitted ref DIT 1 0001 a 2nd draft to the surgeon requesting a
110962 - report on Kaiser's due diligence surgery checklist for a Time Out, and
110963 - revising the prior version on 041012, ref SDS 15 6Q9N, that follows up
110964 - meeting on 051007 with the primary care physician, ref SDS 14 P64J,
110965 - and adding reference to published guidance for surgery on IBC
110966 - patients, which is not met in Millie's case. ref SDS 14 KE9N
110968 -  ..
110969 - The revised draft letter says...
110970 -
110971 -    1.  I was notified today of good news on favorable results of the
110972 -        biopsies you took last week on October 12.  You found IBC with
110973 -        a biopsy on April 19, 2004, and now 18 months later, you find
110974 -        no evidence of IBC.  This is a big weight off my mind, together
110975 -        with the PET scan test on October 5 showing no evidence of
110976 -        distant, nor locoregional metastatic disease. ref DIT 1 0001
110977 -
110978 -            [On 051019 submitted another draft and explained benefits
110979 -            of giving notice to Kaiser on performance of duties for due
110980 -            diligence. ref SDS 16 V55K
110982 -         ..
110983 -    2.  At this time the Surgery Department has scheduled mastectomy to
110984 -        remove my left breast on Friday, October 21.  Thanks very much
110985 -        for expediting Doctor Johnson's request, which he asked me to
110986 -        file with the Surgery Department after I met with him on
110987 -        October 7th.
110989 -         ..
110990 -    3.  During our meeting on September 23rd, you seemed to indicate
110991 -        plans for ordering a retest of the biopsy on April 19, 2004,
110992 -        which, as noted above, diagnosed inflammatory breast cancer.
110993 -        Retesting was recommended by Doctor Shim, in Kaiser's Oakland
110994 -        office, for the purpose of status change that might increase
110995 -        treatment options in the event of relapse.  Second opinions by
110996 -        Doctor's Grissom and Bailey concurred.  The report I received
110997 -        on your notes of our meeting makes no mention of this retest
110998 -        having been ordered.  Similarly, status change retesting was
110999 -        discussed with Doctor Johnson on October 7th; however, the
111000 -        doctor's notes, also, do not mention this issue.  Please
111001 -        investigate, and let me know when retesting the biopsy was
111002 -        ordered for status change.
111004 -         ..
111005 -    4.  I deeply appreciate the time you have given my case.  Doctor
111006 -        Smith and Doctor Johnson cite your strong commitment to patient
111007 -        care.  I have a few questions about the purpose, risks and
111008 -        benefits of mastectomy surgery, which can be addressed with
111009 -        Kaiser's team care practice for a Time Out to implement
111010 -        treatment guidelines followed by Kaiser and presented in the
111011 -        Healthwise Handbook listed on your website.
111013 -  ..
111014 - Doctor Smith commended the surgeon's work during a meeting on 050928,
111015 - ref SDS 11 258K, and earlier on 050329 the primary care physician
111016 - credited the surgeon as a top practitioner for breast surgery.
111017 - ref SDS 4 IE8O
111019 -  ..
111020 - Time Out for Due Diligence letter continues...
111021 -
111022 -    5.  I am informed by you, and others, that my case is unusual and
111023 -        high risk.  Therefore, workup for this surgery requires special
111024 -        attention.  Before signing a consent for surgery, I want to
111025 -        know what is being done and how it will benefit in relation
111026 -        to risks for complications, which you and Doctor Smith mention
111027 -        in your notes.  Please coordinate with Doctor Johnson and
111028 -        submit written explanation of the proposed surgery following
111029 -        Kaiser's outline in the Healthwise Handbook that says in
111030 -        part...
111032 -         ..
111033 -    6.  Shared Decisions About Surgery
111035 -         ..
111036 -        Every surgery has risks.  Only you can decide if the benefits
111037 -        are worth the risks.
111039 -             ..
111040 -        a.  Learn the facts:
111041 -
111042 -            •  What is the name of the surgery?  Get a description of
111043 -               the surgery.
111045 -                ..
111046 -               Doctor Johnson called for a "standard mastectomy," and
111047 -               this was submitted in a written request to the Surgery
111048 -               Department on October 7th.
111050 -                ..
111051 -               Will surgery include axillary node dissection proposed
111052 -               by Doctor Shim in her 2nd opinion consultation on
111053 -               September 8, 2005?  Why or why not?
111055 -                ..
111056 -               Four biopsies on the left breast were taken on October
111057 -               12th for the purpose of assessing recovery from IBC by
111058 -               complementing clinical examination, and PET scan
111059 -               testing.  These biopsies were proposed by Doctor
111060 -               Grissom in a 2nd opinion letter on September 20, 2005
111061 -               as a guide to remove a wide area of previously infected
111062 -               skin so that the risk of IBC relapse in the left breast
111063 -               is reduced.  Positioning of the biopsies was based on
111064 -               memory of observations during examination in the
111065 -               Surgery Department on March 24th, when at that time IBC
111066 -               inflammation had spread toward the neck.  At that time,
111067 -               on March 24, 2005, Surgery reported that a mastectomy
111068 -               could not be performed, because there was not enough
111069 -               healthy skin to close the surgical wound.  This record
111070 -               indicates that leaving unhealthy skin in place presents
111071 -               post-operative risks cited by Doctor Smith and by
111072 -               Doctor Johnson explaining the problem of microscopic
111073 -               disease which can cause relapse.
111075 -                ..
111076 -               On September 28th, Doctor Smith showed photographs
111077 -               which she described as a "standard mastectomy."  There
111078 -               was a single line of incision, slightly angled, and
111079 -               approximately 2" - 3" long.  The nipple was removed and
111080 -               the skin was flat against the chest signifying loss of
111081 -               underlying breast mass.  The impression was that
111082 -               minimal breast skin was removed in the photograph
111083 -               presented as a "standard mastectomy."
111085 -                ..
111086 -               This scope therefore does not contemplate using the
111087 -               four (4) biopsies performed on October 12th to guide
111088 -               removal of previously infected skin, and in fact most
111089 -               of the original skin, where microscopic cancer cells
111090 -               may remain, will remain in place under a "standard
111091 -               mastectomy" scheme?
111093 -                ..
111094 -               Please provide any additional explanation to clarify
111095 -               the planned procedure for a "standard mastectomy" to
111096 -               treat a patient profile of secondary IBC, multiple
111097 -               relapse, and pulmonary emboli.
111098 -
111100 -                ..
111101 -            •  Why does your physician think you need the surgery?
111102 -
111103 -               On October 7th, Doctor Johnson recommended a "standard
111104 -               mastectomy" for the purpose of a "palliation strategy"
111105 -               needed for future relapse, which may be caused by
111106 -               microscopic remnants of IBC disease not currently
111107 -               detected by tests.  In previous meetings the purpose of
111108 -               mastectomy was presented to maintain "local control,"
111109 -               which seems closely related to reducing the risk of
111110 -               relapse in the left breast.
111112 -                ..
111113 -               Is "palliation" the same as "local control," or are
111114 -               these strategies related in that local control avoids
111115 -               relapse so that palliation measures are not required?
111117 -                ..
111118 -               How will a "standard mastectomy" that leaves most of the
111119 -               previously infected left breast skin in place, and which
111120 -               may contain microscopic remnants of disease, warned by
111121 -               Doctor Johnson, support "palliation" to maintain "local
111122 -               control," when removing the breast mass also removes
111123 -               blood vessels that bring treatment and nutrients to the
111124 -               breast skin? ref DIT 1 HB8S
111126 -                ..
111127 -               If all of the skin with remnants of disease is not
111128 -               removed by a "standard mastectomy," does this risk
111129 -               another surgical wound that fails to heal for a year,
111130 -               as occurred with the punch biopsy?  What strategy is
111131 -               planned to meet this contingency?  Patient history in
111132 -               this case shows that chemotherapy treatment with
111133 -               Taxotere and capecitabine (Xeloda) provided palliation
111134 -               that healed the punch biopsy wound.  Is this the plan
111135 -               for healing the mastectomy surgical wound?  What other
111136 -               measures are planned for this contingency.
111138 -                ..
111139 -               On May 17, 2004, I received from the primary care
111140 -               physician the report on the biopsy you took that
111141 -               discovered IBC.  At that time, research was performed
111142 -               and cites published guidance for primary IBC that says
111143 -               in part...
111144 -
111145 -                  If the inflammatory cancer has not spread beyond the
111146 -                  breast, a mastectomy (removal of the entire breast)
111147 -                  may be performed to remove the tumor.  However,
111148 -                  because inflammatory breast cancer involves lymphatic
111149 -                  vessels of the skin, mastectomy can increase the
111150 -                  chances for the cancer to recur (since the skin is
111151 -                  stitched together after mastectomy).
111153 -                ..
111154 -               As you know, I have secondary IBC, discovered two (2)
111155 -               years after you performed surgery to remove the tumor in
111156 -               the breast.  PET tests show there is no tumor in the
111157 -               breast to remove.  On March 24, 2005 you found IBC had
111158 -               spread beyond the breast.  Does Kaiser have published
111159 -               guidance that supports standard mastectomy treatment in
111160 -               my case?  If there is no tumor to remove in the breast,
111161 -               and if previously infected breast skin is not removed to
111162 -               reduce chance of relapse, what is the purpose of
111163 -               mastectomy, given the prior spread of disease beyond the
111164 -               breast?
111166 -                ..
111167 -               How will the proposed surgery accomplish palliation
111168 -               and/or local control better than chemotherapy, and
111169 -               sufficient to justify risks of surgery complications
111170 -               cited by Doctor Smith on September 28?
111172 -                ..
111173 -               Previous relapse in December 2004 spread inflammation
111174 -               from IBC disease, and cancer blisters began popping out
111175 -               on the skin of the left breast.  How will mastectomy
111176 -               surgery of the left breast prevent or otherwise palliate
111177 -               this problem, when skin with microscopic cancer cells
111178 -               are left in place?  Will this be treated with
111179 -               chemotherapy for palliation?  How will mastectomy
111180 -               enhance palliation in this scenario?
111182 -                ..
111183 -               On September 28th, Doctor Smith proposed a step-by-step
111184 -               strategy to begin with a "standard mastectomy," and
111185 -               after clear margins are achieved, then review options
111186 -               for removing previously infected skin and
111187 -               reconstruction with non-infected skin to reduce the
111188 -               risk of relapse from remnants of microscopic cancer
111189 -               cells cited by Doctor Johnson.  How does this
111190 -               step-by-step strategy align with palliation objectives
111191 -               for handling relapse?
111193 -                ..
111194 -               Is standard mastectomy surgery in a case of secondary
111195 -               IBC expected to prolong disease-free survival, such
111196 -               that chemotherapy can be paused.  If so, how long might
111197 -               this pause last, before chemotherapy must be restarted?
111198 -               Are we talking weeks, months, hopefully a year or so?
111199 -               Or, is it expected that chemotherapy will be required
111200 -               immediately following surgery, as in the case of
111201 -               primary IBC?
111203 -                ..
111204 -               What criteria will be used to determine the scope and
111205 -               degree of tissue removal?  If more tissue is removed
111206 -               will this increase palliative benefits?
111208 -                ..
111209 -            •  Is this surgery the most common one for this problem?
111210 -               Are there other types of surgery?
111212 -                ..
111213 -               What assessment has been made of performing a "very
111214 -               wide mastectomy" discussed with the surgeon on
111215 -               September 23 for the purpose of reducing the risk of
111216 -               relapse?
111217 -
111219 -             ..
111220 -        b.  Consider the risks and benefits:
111221 -
111222 -            •  How many similar surgeries has the surgeon performed
111223 -               where the patient is extremely high risk for surgical,
111224 -               postoperative and anesthetic complications, while
111225 -               recovering from secondary IBC, and diagnosed with
111226 -               pulmonary emboli, noted by Doctor Smith?
111228 -                ..
111229 -               How many surgeries like this are done at this hospital
111230 -               on patients with secondary IBC and diagnosed with
111231 -               pulmonary emboli?
111233 -                ..
111234 -            •  What can go wrong?
111235 -
111236 -               What complications of mastectomy surgery are increased
111237 -               for a patient with secondary IBC, noted in Doctor
111238 -               Smith's report?  What solutions are proposed to avoid
111239 -               these complications?
111241 -                ..
111242 -               If previously IBC infected skin is not removed, and if
111243 -               there is no tumor within the breast to remove, shown by
111244 -               PET tests, then what will prevent IBC from relapsing in
111245 -               previously infected skin left in tact by standard
111246 -               mastectomy?
111248 -                ..
111249 -               If the left breast mass is removed through a standard
111250 -               mastectomy how will loss of blood vessels that normally
111251 -               service the skin limit ability of the patient to recover
111252 -               in the event of relapse?  Does loss of blood vessels to
111253 -               the remaining breast skin from mastectomy surgery risk
111254 -               losing local control for a patient with secondary IBC,
111255 -               in the same way Doctor Smith explained that prior
111256 -               surgery in the lower stomach area during the late 1960s
111257 -               prevents harvesting this tissue for reconstruction due
111258 -               to loss of blood vessels?
111260 -                ..
111261 -               On November 4, 2004 I was notified by Doctor Kaufman,
111262 -               substituting for Doctor Johnson, that I was diagnosed
111263 -               with pulmonary emboli based on a CT scan test performed
111264 -               the day before on November 3, 2004, and that I would
111265 -               therefore require treatments with anticoagulants
111266 -               (Coumadin) for the rest of my life.  Subsequent
111267 -               discussion over ensuing months with Doctor Johnson
111268 -               confirmed this prescription.  A few weeks ago, on
111269 -               September 28, 2005, Doctor Smith cited pulmonary emboli
111270 -               requiring Coumadin treatment as one of the factors in my
111271 -               patient profile that makes me very high risk for
111272 -               complications from undergoing mastectomy surgery.  Last
111273 -               week, on October 7th Doctor Johnson related that
111274 -               Kaiser's standard practice for pulmonary emboli is
111275 -               treatment for one (1) year, and that chemotherapy
111276 -               patients are treated for life, as related previously by
111277 -               Doctor Kaufman.  Also, on the 7th Doctor Johnson ended
111278 -               my treatment for pulmonary emboli, perhaps reflecting
111279 -               successful treatment with chemotherapy, as shown by the
111280 -               PET scan test performed last week on October 5th, and
111281 -               presented by the doctor on the 7th.  Does this patient
111282 -               history eliminate pulmonary emboli as a high risk for
111283 -               complications in mastectomy surgery?  If not, what are
111284 -               Kaiser's plans for addressing this risk during and after
111285 -               surgery?
111287 -                ..
111288 -            •  How long will it be before you're fully recovered?
111289 -
111290 -               How many days in the hospital for close observation of
111291 -               complications cited by Doctor Smith?
111293 -                ..
111294 -               On October 12th, you mentioned, while performing the
111295 -               minor biopsy surgery, that Kaiser plans a one (1) day
111296 -               hospital stay for my patient profile.  How does this
111297 -               address Doctor Smith's report of high risk
111298 -               post-operative complications?  Does Kaiser have
111299 -               experience showing that one (1) is sufficient for
111300 -               evaluation of post-op complications on a secondary IBC
111301 -               patient?  What signals will the medical team be checking
111302 -               to establish that one (1) is sufficient observation in
111303 -               this case?
111305 -                ..
111306 -            •  How can you best prepare for the surgery and the
111307 -               recovery period?
111309 -                ..
111310 -               What should I expect for recovery complications as a
111311 -               secondary IBC patient, that are different from other
111312 -               patients who have mastectomy surgery?  How will Kaiser
111313 -               handle these uncommon risks?
111315 -                ..
111316 -               What is the treatment plan going forward after surgery,
111317 -               and how will this plan be different if surgery is not
111318 -               performed?  Is there a workup showing alternate
111319 -               strategies?
111321 -         ..
111322 -    7.  I would like to get a draft of your report on the above issues
111323 -        by Thursday, so there is time for review and finalization.  You
111324 -        can submit draft language via email to expedite the process
111325 -        (m*********@*******.net).  After we agree on the language, I
111326 -        will then attach your signed report to the consent form I sign
111327 -        for the mastectomy operation on Friday, October 21.  A copy of
111328 -        this letter to Doctor Johnson facilitates collaboration on Time
111329 -        Out review.
111331 -         ..
111332 -    8.  Thanks again for your excellent work in my case, and please
111333 -        extend to Doctor Smith my deep appreciation for her clear and
111334 -        informative presentation on September 28th.
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