THE WELCH COMPANY
440 Davis Court #1602
San Francisco, CA 94111-2496
415 781 5700
S U M M A R Y
DIARY: October 31, 2008 04:04 PM Friday;
Glenna calls on UCSF work plan for Millie to start treatment sunitinib clinical study.
2...Status Change Biopsy Test Not Required Sunitinib Clinical Study
Click here to comment!
Default Null Subject Account for Blank Record
0403 - ..
0404 - Summary/Objective
040501 - Follow up ref SDS 24 0000, ref SDS 22 0000.
040507 - ..
0408 - Progress
040901 - Glenna returned the call from an hour ago. ref SDS 24 XD4O
040903 - Glenna received Millie's letter this morning, ref SDS 24 UM8M, with a
040904 - link to the work plan on 081029 for UCSF starting treatment for Millie
040905 - in the sunitinib clinical trial. ref SDS 22 LH4O
040907 - ..
040908 - Glenna noted that the UCSF work plan on 081029 is comprehensive,
040909 - covering all pending tasks required for Millie to start timely
040910 - treatment.
040912 - [...in another record today on 081031 Glenna reported that UCSF
040913 - confirms plans to start Millie's treatment in the sunitinib
040914 - clinical study on 081113. ref SDS 27 SJ3W
040916 - ..
040917 - [On 081107 Glenna reported the UCSF work plan on 081029 has
040918 - been effective organizing the work required for Millie to start
040919 - treatment on schedule. ref SDS 34 C35J
040921 - ..
040922 - Glenna related during the call this afternoon that late this morning
040923 - she called Millie's primary care physician at Kaiser. The doctor
040924 - advised Glenna that he ordered treatment for Millie with the sunitinib
040925 - metronomic protocol at UCSF, and that he submitted authorization for
040926 - Kaiser to pay for Millie's continued treatment on referral at UCSF, as
040927 - called out in the work plan on 081029. ref SDS 22 NQ7L
040929 - [...in another record today on 081031 Glenna reports plans to
040930 - follow up with Kaiser to obtain payment authorization for
040931 - Millie's treatment on referral to UCSF in the sunitinib
040932 - clinical trial. ref SDS 27 458L
040934 - ..
040935 - [On 081112 Glenna reported Kaiser has not issued authorization
040936 - for payment which the doctor submitted for Millie's treatment
040937 - at Kaiser. ref SDS 36 ZX8F
040939 - ..
040940 - [On 081112 Paula McPhail reported that Kaiser's records show on
040941 - 081103 Millie's doctor ordered her treatment on referral to
040942 - UCSF. ref SDS 36 UV4O
040944 - ..
040945 - [On 081112 Michelle in Expedited Claims Department advised that
040946 - the doctor is in charge of ordering treatment for the patient,
040947 - and Kaiser must implement the doctor's orders. ref SDS 36 P28U
040949 - ..
040950 - [On 081112 Doctor Johnson reported ordering on 081103
040951 - authorization for payment of Millie's treatment on referral at
040952 - UCSF in the sunitinib clinical study, and Kaiser management
040953 - sent a denial to him on 081110. ref SDS 36 TH49
040955 - ..
040956 - Glenna's report on discussion with the doctor today aligns with the
040957 - meeting at Kaiser on 080829. At that time, on 080829 the primary care
040958 - physician found progression of disease in the left supraclavicular,
040959 - which signals requirement to change Millie's treatment. ref SDS 6 RP8T
040960 - The doctor told Millie to notify Doctor Rugo that Kaiser's referral on
040961 - 070105 for Millie's treatment at UCSF, and citing Kaiser's letter to
040962 - UCSF on 061230, authorizing payment for Millie's care at UCSF, would
040963 - be continued and that arrangements for changing treatment should begin
040964 - immediately. These instructions were confirmed in a letter to the
040965 - medical team on 080829. ref SDS 6 RP9W Urgency starting new treatment
040966 - was reported on 081016 when Doctor Rugo palpated the lump in the left
040967 - supraclavicular, ref SDS 9 J34X, found earlier by the primary care
040968 - physician at Kaiser on 080829. Doctor Rugo ordered a biopsy on
040969 - 081022. ref SDS 12 NZ5N The next day on 081023 Doctor Rugo determined
040970 - that pathology on the biopsy established progression of disease and so
040971 - stopped prior treatment with cetuximab and Carboplatin. ref SDS 15
040972 - D65G
040974 - ..
040975 - The following day on 081024 Millie met at Kaiser with the primary care
040976 - physician. The doctor made an examination, and reviewed patient
040977 - history, including pathology findings from the biopsy on 081022. The
040978 - doctor entered in the medical chart approval for Millie's treatment
040979 - with sunitinib metronomic treatment in a clinical study under Doctor
040980 - Rugo's care at UCSF, as ordered previosuly by the primary care
040981 - physcian on 080829. During the meeting at Kaiser on 081024, the
040982 - doctor implemented Kaiser's referral by ordering baseline tests at
040983 - Kaiser on 081107 - 081110, ref SDS 17 XZ8W, in time for Millie to
040984 - continue her regular treatment schedule at UCSF for the past 2 years,
040985 - and starting on Thursday, 081113.
040987 - ..
040988 - On 070119 Jackie reported similar discussions about Millie starting
040989 - the cetuximab Carboplatin clinical study. ref SDS 3 AS96 About 10
040990 - months later the matter was resolved.
040992 - ..
040993 - Glenna has made calls about the cost of drugs which Millie will have
040994 - to pay for getting treatment in the sinitinib clinical study, work
040995 - plan task #10, listed on 081029. ref SDS 22 SS7L She has not received
040996 - feedback on this issue yet. This is expected to be fairly nominal,
040997 - because they are older drugs, but need to see the numbers.
040999 - ..
041000 - Glenna was not familiar with patient history on challenge of
041001 - processing payment authorization for Millie's clinical trial, reported
041002 - on 061230, ref SDS 2 3X6K, and as a result the primary care physician
041003 - at Kaiser needs to follow up to verify submission of referral
041004 - authorization is processed, rather than held up for financial
041005 - engineering, as occurred on 070823. ref SDS 2 1V3K
041007 - [...in another record today on 081031 Glenna reports plans to
041008 - follow up with Kaiser to obtain payment authorization for
041009 - Millie's treatment on referral to UCSF in the sunitinib
041010 - clinical trial. ref SDS 27 458L
041012 - ..
041013 - Glenna had received Millie's letter today showing Kaiser has scheduled
041014 - Millie's brain MRI, reported in Millie's letter to Glenna this
041015 - morning, ref SDS 24 NN4W Glenna has talked to Arlette, and
041016 - understands Arlette will call later today about
041018 - ..
041019 - UCSF has scheduled Millie to start treatment on 081113, and beginning
041020 - with...
041022 - ..
041023 - Meeting Doctor Rugo 081113 0830.
041025 - [...in another record today on 081031 Millie received a letter
041026 - from Glenna confirming understandings from Glenna's call
041027 - explaining that UCSF has scheduled Millie to begin treatment in
041028 - the sunitinib clinical study on 081113.
041030 - ..
041031 - [...in another record today on 081031 Millie received Glenna's
041032 - letter, ref SDS 27 5G5H, confirming that UCSF has scheduled
041033 - Millie's treatment in the sunitinib clinical study to start on
041034 - 081113. ref SDS 27 SJ3W
041036 - ..
041037 - [...in another record today on 081031 Millie commended Kaiser
041038 - and UCSF for timely transition to the new treatment with
041039 - sunitinib, ref SDS 28 0R3I,
041041 - ..
041042 - [On 081101 Millie's letter while traveling on vacation asks
041043 - about status to start treatment. ref SDS 30 TS5H
041045 - ..
041046 - [On 081102 submitted response to Millie traveling on vacation
041047 - everything is set up to start treatment on 081113. ref SDS 31
041048 - 4P84
041050 - ..
041051 - This is excellent work maintaining continuity of Millie's treatment,
041052 - and also meeting the doctor. Aligns with Doctor Rugo's planning on
041053 - 081016 saying to keep Millie's schedule at UCSF. ref SDS 9 N99W
041055 - ..
041056 - Glenna advised that UCSF requires Millie to do another lab for blood
041057 - tests, as called out in the work plan on 081029. ref SDS 22 1H5G, and
041058 - also requires urinalysis prior to starting the sunitinib clinical
041059 - trial on 081113, as further called out in the work plan on 081029.
041060 - ref SDS 22 SE6W
041062 - ..
041063 - Discussed Glenna's letter to Millie on 081027 calling out urinalysis
041064 - testing. ref SDS 20 309F
041066 - ..
041067 - Glenna seemed to indicate during the call today that there is no
041068 - requirement for a urinalysis screening test in the Consent documents
041069 - for the suntinib clinical study, similar to...
041071 - a. Status change FNA biopsy test ordered in UCSF work plan on
041072 - 081016, ref SDS 9 J36R; Millie's letter to UCSF asks where
041073 - the requirement for status change test is specified in the
041074 - Consent document. ref SDS 9 J44R On 081017 the doctor
041075 - responds that "it is not a study for triple negative
041076 - alone." ref SDS 10 6J3T On 081031 Glenna advised in a call
041077 - that the sunitinib study does not require biopsy for status
041078 - change. ref SDS 26 T27H
041080 - ..
041081 - b. Brain MRI test ordered in work plan on 081029, ref SDS 22
041082 - SE5Q, implementng guidance in the letter from UCSF on
041083 - 081027. ref SDS 20 ML8R
041085 - ..
041086 - The doctor ordred the test for comprehensive care based on
041087 - Millie's long patient history being treatment for cancer.
041089 - [...in another record today on 081031 1604 Glenna confirmed
041090 - requirement for urinalysis. ref SDS 27 SI4X
041092 - ..
041093 - [On 081107 urinalysis performed at UCSF. ref SDS 35 BP4J
041095 - ..
041096 - Glenna discussed with the primary care physician in her call this
041097 - morning doing labs, including urinalysis, at Kaiser, which are called
041098 - out in the work plan on 081029. ref SDS 22 1H5G Doctor Johnson agreed
041099 - in the call with Glenna to schedule the work at Kaiser.
041101 - ..
041102 - Glenna proposed in this call that, since Millie's doctor at Kaiser
041103 - will schedule lab work required for Millie to start the sunitinib
041104 - clinical trial at Kaiser, the meeting planned for 081107 0800 in the
041105 - work plan on 081029, ref SDS 22 LL6Q, can be avoided to save Millie a
041106 - trip to San Francisco.
041108 - ..
041109 - Glenna proposed using modern technology to transmit a computer file
041110 - attached to an email and with the signature page of the consent
041111 - document which Millie received from Glenna during treatment in the
041112 - Infusion Clinic on 081016. ref SDS 8 5S5K Glenna explained Millie can
041113 - print the signature page, and then mail it to UCSF. This is good
041114 - progress. On 081016 Millie requested the computer file for the
041115 - Consent document. ref SDS 9 J39T UCSF reported difficulty sending the
041116 - computer file to expedite review. As a result, Millie spent 4.5 hours
041117 - typing the document, rather than hiking. ref SDS 11 DJ7N
041119 - ..
041120 - Reviewed patient history showing the UCSF medical team is very
041121 - effective with timely access to patient history stored on the UCSF
041122 - computer system, similar to Kaiser. Medical professionals everywhere
041123 - have become dependent on the computer to review patient history. As a
041124 - result, when labs are not on the computer, people get confused. Work
041125 - is delayed, shown today at Kaiser in another record scheduling the MRI
041126 - brain test. ref SDS 25 IO97 On 080724, Brigid was frustrated at UCSF
041127 - because results of the CT test at Kaiser on 080718 was not in the
041128 - medical chart for starting a new cycle. ref SDS 5 VE8O Another
041129 - example of health care impacted because labs are not posted to the
041130 - computer occurred when Millie was treated on 080409 in the Kaiser
041131 - Emergency Department. ref SDS 4 439L People have become addicted to
041132 - the computer, because tasks like lab work are fast and easy to
041133 - accomplish with the computer.
041135 - ..
041136 - A very big problem doing lab work is recovering from mistakes. Blood
041137 - tests are omitted, or the sample is corrupted, and so test have to be
041138 - done over. Patient condition observed by the doctor during
041139 - examination or by the nurse during treatment shows that additional
041140 - tests are needed. Sometimes tests are redone to verify the patient
041141 - can or cannot get treatment. Doing the lab work at the site where
041142 - decisions are made enables cost effective care. The patient cannot
041143 - jump in the care and drive 30 miles to Walnut Creek to correct a
041144 - mistake, then drive 30 miles back to San Franciso with the result.
041146 - ..
041147 - Glenna said that coordination on referral patients presents difficult
041148 - challenges for medical professionals, because people like to access
041149 - lab work on the computer. Papers get lost, faxed to the wrong
041150 - location; have fuzzy characters that are hard to read, and use
041151 - different units of measure that cause mistakes for people working with
041152 - limited time, shown by comparing Millie's blood work on 081023 at UCSF
041153 - compared with Kaiser. ref SDS 13 075H
041155 - ..
041156 - Decided therefore to sign the Consent documents at UCSF on 081107
041157 - 0800, as shown in the UCSF work plan updated on 081029. ref SDS 22
041158 - LL6Q Glenna suggested meeting in the lobby of the Breast Care clinic
041159 - on the 2nd floor.
041161 - [...in another record today on 081031 Glenna's letter to Millie
041162 - confirms plans to meet at UCSF on 081107 0800. ref SDS 27 SI4X
041164 - ..
041165 - [...in another record today on 081031 Millie commended Kaiser
041166 - and UCSF for timely transition to the new treatment with
041167 - sunitinib. ref SDS 28 0R3I
041169 - ..
041170 - [On 081103 Millie notified Catherine and Diane in the Infusion
041171 - Clinic about blood draw on 081007. ref SDS 33 5U6U
041173 - ..
041174 - Decided to do the labs at UCSF on 081107 0800 prior to meeting with
041175 - Glenna to sign consent documents, called out in the work plan on
041176 - 081029. ref SDS 22 LL6Q
041178 - ..
041179 - Glenna will schedule labs for Millie in the Infusion Clinic on the 2nd
041180 - floor at UCSF prior to the meeting, including urinalysis.
041182 - ..
041183 - This plan uses the schedule for Millie's labs in the Infusion Clinic
041184 - shown in the record on 080918. ref SDS 7 YB5H
041186 - [...in another record today on 081031 Glenna's letter to Millie
041187 - confirms plans to order labs when Millie meets to sign Consent
041188 - documents at UCSF on 081107 0800, and to perform requirements
041189 - for Millie to start treatment in the sunitinib clinical trial.
041190 - ref SDS 27 SI4X
041192 - ..
041193 - On 081016 the doctor ordered an FNA biopsy to test for cancer and
041194 - status change. ref SDS 9 J36R The biopsy was performed at Kaiser on
041195 - 081022. ref SDS 12 NZ5N The next day on 081023 Doctor Daamen reported
041196 - in a letter to the medical team that pathology on the biopsy was
041197 - positive for cancer. This established progression of disease that
041198 - signals need to change treatments.
041200 - ..
041201 - The FNA biopsy did not yield enough tissue to test for status change.
041202 - ref SDS 14 4Q9Q
041204 - ..
041205 - Doctor Daamen explained that Kaiser's Lab requires a core biopsy to
041206 - test for status change. The doctor asked if this is "necessary,"
041207 - which raises a flag of caution about safety of core biopsy, because
041208 - the question of "necessity" was not raised until the procedure was
041209 - changed from FNA ordered by UCSR to a core biopsy because the Kaiser
041210 - lab cannot check status with an FNA biopsy. ref SDS 14 4Q5V
041212 - ..
041213 - On 050909 Doctor Shim at Kaiser in Oakland issued an opinion
041214 - recommending Kaiser test for status change because this would have a
041215 - "huge" impact on Millie's traetments. ref SDS 1 JX9P "Huge impact"
041216 - conveys justification to test within the bounds of safety, such that
041217 - core biopsy does not threaten greater harm than benefits. The
041218 - solution is to do the FNA procedure ordered by UCSF, which has not
041219 - been cited for causing increased risks.
041221 - ..
041222 - Later that day on 081023, Kaiser scheduled Millie for a core biopsy to
041223 - test for status change on 081024. ref SDS 14 667F Later in the
041224 - evening on 081023 Doctor Rugo advised that UCSF uses FNA biopsies to
041225 - test for status change. ref SDS 15 4Q52 During the meeting at Kaiser
041226 - on 081024, Doctor Wong explained increased risks of core biopsy
041227 - compared to less invasive FNA biopsy, and recommended Millie defer the
041228 - core biopsy to test for status until after returning from vacation on
041229 - 081107. ref SDS 16 6N5L The following Monday, on 081027 Kaiser called
041230 - and further deferred the core biopsy to test for status change until
041231 - 081117. ref SDS 18 G15K
041233 - ..
041234 - Millie notified Doctor Rugo in a letter on 081027 of additional delay
041235 - performing the biopsy for status change, and asked if this will delay
041236 - the UCSF work plan to start treatment for cancer in the sunitinib
041237 - clinical study. ref SDS 19 R79W Glenna called later in the afternoon
041238 - on 081027 and planned to ask Doctor Rugo about the effect of delaying
041239 - Millie's treatment until the status change test is accomplished.
041240 - ref SDS 21 934O On 081029 Millie's letter to UCSF discusses doing FNA
041241 - biopsy for status check at UCSF to avoid risks of core biopsy at
041242 - Kaiser. ref SDS 22 C49U
041244 - ..
041245 - Millie's letter earlier this morning to UCSF with copy to Kaiser asks
041246 - again about doing FNA biopsy at UCSF. ref SDS 24 NN5S
041249 - ..
041250 - Status Change Biopsy Test Not Required Sunitinib Clinical Study
041252 - Glenna explained during her call this afternoon that core biopsy to
041253 - test status change is not required for Millie to start treatment in
041254 - the sunitinib clinical trial. UCSF issued an order for medical
041255 - services to perform an FNA biopsy which is item 2 in the work plan on
041256 - 081029, ref SDS 22 SF3P, implementing Doctor Rugo's instructions on
041257 - 081016. ref SDS 9 J36R She therefore did not investigate scheduling
041258 - the work at UCSF presented in Millie's letter on 081029, ref SDS 22
041259 - C49U, and again in Millie's letter today, ref SDS 24 NN5S Glenna
041260 - indicated this is now a controversy, and so does not require her
041261 - support for coordination clinical studies.
041263 - ..
041264 - Controversy centers on increased risks of core biopsy, and that Kaiser
041265 - requires this method to test for status change, while UCSF can test
041266 - status change with less risky FNA procedures. The fact that Kaiser
041267 - has deferred the work 3 times suggest reluctance that signals high
041268 - risks using core biopsy to test for status change with Millie's
041269 - patient history, reviewed on 081027. ref SDS 18 UE6N Huge benefits of
041270 - expanding treatments for Millie makes testing status change highly
041271 - desirable clinical solution, cited in the letter from Doctor Shim at
041272 - Kaiser in Oakland on 050909. ref SDS 1 JX9P
041274 - ..
041275 - Glenna suggested that Millie contact Doctor Johnson at Kaiser and
041276 - Doctor Rugo about implementing the UCSF order on 081016 for an FNA
041277 - biopsy to test for status change. ref SDS 9 J36R
041279 - ..
041280 - [...in another record today on 081031 Millie asks about doing
041281 - the FNA biopsy ordered by UCSF on 081016 at UCSF. ref SDS 28
041282 - 0R3I,
041284 - ..
041285 - [On 081101 Doctor Rugo says the biopsy to check for status
041286 - change is not part of the sunitinib clinical study. ref SDS 29
041287 - 5G5H
041289 - ..
041290 - [On 081102 Millie's letter to Doctor Rugo with copy to primary
041291 - care physician at Kaiser asks how much the FNA biopsy to test
041292 - for status change will cost at UCSF, and notes this should be
041293 - less expensive than doing the core biopsy at Kaiser.
041294 - ref SDS 32 AD3F
041296 - ..
041297 - Glenna will submit a letter confirming understandings from the call
041298 - this afternoon on Millie starting treatment in the sunitinib clinical
041299 - study on 081113.
041301 - [...in another record today on 081031 Millie received a letter
041302 - from Glenna confirming understandings from Glenna's call
041303 - explaining that UCSF has scheduled Millie to begin treatment in
041304 - the sunitinib clinical study on 081113. ref SDS 27 5G5H
041311 - ..
0416 - 1656
041701 - Arlette called for Doctor Johnson.
041703 - She offered to assist scheduling Millie's brain MRI, ordered by the
041704 - doctor yesterday on 081030. ref SDS 23 FR5H
041706 - ..
041707 - This call reflects the call earlier today from Glenna at UCSF, per
041708 - above. ref SDS 0 XJ84
041710 - ..
041711 - Explained that earlier this morning Laura in the Kaiser Radiology
041712 - Department scheduled the brain MRI on 081108 1045. ref SDS 25 UJ68