THE WELCH COMPANY
440 Davis Court #1602
San Francisco, CA 94111-2496
415 781 5700
rodwelch@pacbell.net


S U M M A R Y


DIARY: November 2, 2006 00:28 AM Thursday; Rod Welch

Received coagulapathy report on hypercoagulable state affecting Millie.

1...Summary/Objective
2...Family Member Coagulapathy Report Hypercoabulable State Work Up
3...Background Hypercoagulable State Work Up for Millie Pulmonary Embolism
4...Factor V and Prothrombin G20210A Mutations Negative
5...Coagulapathy Lab Family Member May Indicate Genetic Risk for PE
6...Lupus and Cardiolipin AB IGM Positive Genetic Risk Pulmonary Embolism
7...Documents Received PDF Image of Poor Quaity Fax Difficult to Read
8...Hypecoagulable State Millie Family Member Diagnosed Pulmonary Embolism
9...Quest Diagnostics DNA Testing Report Coagulapathy Millie Family Member
10...1st Page Coagulapathy Report Seems to Say...
........Factor V (Leiden) Mutation Negative
11...2nd Page Coagulapathy Report Seems to Say...
........R506Q (Factor V Leiden) Mutation Negative
........Prothrombin/Factor II G20210A Mutation Negative
12...3rd Page Coagulapathy Report Seems to Say...
13...4th Page Coagulapathy Report Seems to Say...
........Test Specimens Lost Quest Laboratory Requests Replacements
........Lupus Anticoagulant Test Evidently Positive
14...5th Page Coagulapathy Report Seems to Say...
........Cardiolipin AB IGM 23 Circled Indicating Positive Test Finding


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

SUBJECTS
Coagulapathy Report Genetic Disposition Blood Clots Pulmonary Emboli

1603 -
1603 -    ..
1604 - Summary/Objective
1605 -
160501 - Follow up ref SDS 17 FW8M, ref SDS 16 IM90.
160502 -
160503 - Report on hypercoagulable state work up of first-degree family member
160504 - who recently suffered recurrent pulmonary emboli indicates factor V
160505 - and prothrombin G20210A mutations are negative. ref SDS 0 4N55  Test
160506 - results are consistent with a Lupus Anticoagulant (an antiphospholipid
160507 - antibody), ref SDS 0 KJ3H,  Additionally, Cardiolipin AB IGM tested
160508 - above the target range, and is circled in handwritting, indicating
160509 - heightened interest. ref SDS 0 4N6Q  There is no analysis nor summary
160510 - explanation expressly finding increased genetic risk for thrombosis,
160511 - including pulmonary emboli. ref SDS 0 4N48  Prior research seems to
160512 - suggest these findings demonstrate genetic cause for PE in the family
160513 - member, ref SDS 0 KJ5I, and further that patients with family history
160514 - of blood clot problems together with recurrent thrombosis present as
160515 - "strongly thrombophilic" and should get extensive evaluation for
160516 - thrombophilias to guide diagnosis and treatment. ref SDS 0 KJ5I
160517 - Conflict in reporting and publication dates of test results may be
160518 - unimportant communication misunderstanding. ref SDS 0 L48K  Quality of
160519 - documentation extremely poor using PDF technology to transmit fax of
160520 - forms are typed up to facilitate review and management going forward.
160521 - ref SDS 0 6592
160522 -
160523 -            [On 061102 2-worlds problem from work today reviewed.
160524 -            ref SDS 18 6R4O
160526 -             ..
160527 -            [On 061103 coagulapathy report submitted to Kaiser.
160528 -            ref SDS 19 VR6F
160530 -             ..
160531 -            [On 061110 primary care physician received coagulapathy
160532 -            report; advised the report finds acquired rather than
160533 -            inherited genetic risk for blood clots, and in this case
160534 -            pulmonary emboli, ref SDS 20 D84N; doctor concludes the
160535 -            report signals no increased risk of blood clot problems for
160536 -            Millie, does not require hypercoaguable state work up, nor
160537 -            other measures to evaluate patient profile, and requires no
160538 -            adjustments in diagnosis and treatment. ref SDS 20 I95L
160539 -
160540 -
160541 -
160542 -
160544 -  ..
1606 -
1607 -
1608 - Progress
1609 -
160901 - Family Member Coagulapathy Report Hypercoabulable State Work Up
160902 - Background Hypercoagulable State Work Up for Millie Pulmonary Embolism
160903 -
160904 - Received ref DRT 1 0001 responding to the letter on 061031,
160905 - ref SDS 17 FW8M, asking for the coagulapathy report, ref DIP 5 0001,
160906 - as discussed with the primary care physician on 061020. ref SDS 15
160907 - ES3I  Earlier on 050922, Doctor Bailey recommended that family history
160908 - and Millie's diagnosis of pulmonary embolism on 041104 requires a
160909 - hypercoagulable state work up. ref SDS 7 XD9X  Research on 050922
160910 - showed this DNA test evaluates acquired and inherited genetics that
160911 - increase the risk for blood clots. ref SDS 7 A24T
160913 -  ..
160914 - Kaiser did not perform a hypercoagulable state work up.
160916 -  ..
160917 - On 051007 the doctor removed Millie from treatment because her
160918 - pulmonary embolism was believed to be solely a side effect of
160919 - chemotherapy treatment with Avastin drug trial, which had a documented
160920 - history of patient deaths caused by pulmonary emboli.  Additionally,
160921 - on 051007 Millie had been treated for a year without recurrence.
160922 - ref SDS 8 EQ7K  On 060722 a family memeber suffered recurrent
160923 - pulmonary embolism; hypercoagulable state work up on the family member
160924 - with DNA testing was reported to show genetic risk. ref SDS 11 3D9T
160925 - The doctor was notified on 060724 for implications that affect
160926 - Millie's treatment. ref SDS 12 NL5Q  Research on 060722 indicates
160927 - pulmonary embolism is hard to detect, ref SDS 11 LK6M, and that 45% of
160928 - patients die who suffer recurrence of PE. ref SDS 11 BI5J
160930 -  ..
160931 - This presents a significant risk that justifies careful review, called
160932 - out in POIMS. ref OF 8 2300
160934 -  ..
160935 - On 060929 Millie reported symptoms of PE. ref SDS 14 B56N  The doctor
160936 - ordered a CT test, ref SDS 14 DY5M, and requested the coagulapathy
160937 - report on the family member cited in Millie's letter on 060724.
160938 - ref SDS 14 QT6N  Millie requested this report from the family member.
160939 - During the meeting on 061020, the doctor advised that Kaiser received
160940 - a document, but not the coagulapathy report. ref SDS 15 626L  On
160941 - 061031 a follow up letter requested the report again. ref SDS 17 FW8M
160943 -  ..
160944 - Today, the coagulapathy report on the family member hypercoagulable
160945 - state work up was received attached to a letter.
160947 -  ..
160948 - The letter says in total...
160949 -
160950 -        Attached is the lab report that is in my file.
160951 -        ref DRT 1 0001
160952 -
160953 -
160955 -  ..
160956 - Factor V and Prothrombin G20210A Mutations Negative
160957 - Coagulapathy Lab Family Member May Indicate Genetic Risk for PE
160958 - Lupus and Cardiolipin AB IGM Positive Genetic Risk Pulmonary Embolism
160959 -
160960 - The attached coagulapathy report is a PDF file...
160961 -
160962 -              G:/08/02/04/60/06/11/0102A.PDF
160963 -
160964 - ...evidently of a fax that is very hard to read, with faded and fuzzy
160965 - characters that could a variety of letters that convey different words
160966 - and alternate meanings.
160968 -  ..
160969 - A total of 5 pages were received consisting of 3 documents; 2 of the
160970 - documents have 2 pages each, and page 5 is rotated 90 degrees.  There
160971 - is a lot of duplication, and very little specific findings.  The
160972 - report required work and collaboration in several Quest laboratories.
160973 - ref SDS 0 Z18L
160975 -  ..
160976 - No summary nor anlaysis is presented that expressly finds genetic risk
160977 - for pulmonary emboli (PE).  Research on 060722 indicates DNA tests for
160978 - Factor V genetic mutation, and prothrombin G20210A mutation are common
160979 - criteria for tendency to form blood clots, called "thrombophilias."
160980 - ref SDS 11 MS5H
160982 -  ..
160983 - The report today indicates Factor V tested negative, ref SDS 0 TK3V,
160984 - further at ref SDS 0 ME6X, and that the prothrombin G20210A mutation,
160985 - also, tested negative. ref SDS 0 PRXX
160987 -  ..
160988 - One of the documents says in part...
160989 -
160990 -                The results reported are consistent with a Lupus
160991 -                Anticoagulant (an antiphospholipid antibody).
160992 -                ref SDS 0 6E5M
160993 -
160994 - ...and the basis of findings are presented. ref SDS 0 6E60  This
160995 - criteria was cited in research on 060722. ref SDS 11 Q16P
160997 -  ..
160998 - This finding seems to be based on test results for Cardiolipin AB IGM
160999 - that show results above the target range.  This result is circled in
161000 - handwriting, likely indicating focus on positive finding. ref SDS 0
161001 - 6F49
161003 -  ..
161004 - Nothing in the documentation directly associates these test results
161005 - with pulmonary emboli.  Research on the Internet finds indications of
161006 - association but no express, direct association.
161008 -  ..
161009 - Experts in DNA, hermatology, oncology, ect., may recognize
161010 - association.
161012 -  ..
161013 - Implications for treatment, including benefits of hypercoagulable
161014 - state work up on Millie require professional opinion, indicated by
161015 - Doctor Bailey on 050922. ref SDS 7 XD9X
161016 -
161017 -        [On 061103 coagulapathy report submitted to Kaiser.
161018 -        ref SDS 19 VR6F
161020 -         ..
161021 -        [On 061110 primary care physician submits research in an
161022 -        article on Antiphospholipid Syndrome, which describes lupus
161023 -        anticoagulant that was discussed in the coagulapathy report on
161024 -        family member, per above, ref SDS 0 KJ3H; article says that no
161025 -        clear inheritance pattern has been identified and no gene has
161026 -        been found to be the sole cause of this condition; primary care
161027 -        physician concludes Millie's patient profile for diagnosis and
161028 -        treatment is not affected by genetic risks identified in the
161029 -        coagulapathy report in the first-degree relative, and does not
161030 -        initiate tests for hypercoagulable state work up. ref SDS 20
161031 -        4T3J
161033 -  ..
161034 - Authorities seem to indicate that patients with family history of
161035 - blood clot problems together with recurrent thrombosis present as
161036 - "strongly thrombophilic" and should undergo a more extensive
161037 - evaluation for thrombophilias, reviewed on 060722. ref SDS 11 MR6M
161038 -
161039 -        [On 061110 primary care physician received the coagulapathy
161040 -        report on first-degree relative submitted today on 061103,
161041 -        ref SDS 19 VR6F; the paragraph on risks and follow up to
161042 -        treat pulmonary emboli, ref SDS 19 N18S, was highlighted in
161043 -        the doctor's printed version, ref SDS 20 N18S; the doctor
161044 -        advised that the report shows positive findings for
161045 -        acquired rather than inherited DNA genetic risk for blood
161046 -        clots, and in this case pulmonary emboli, ref SDS 20 626L;
161047 -        the doctor recommended against further measures to evaluate
161048 -        patient profile, including defer hypercoagulable state work
161049 -        up, and indicated no adjustments required in diagnosis and
161050 -        treatment. ref SDS 20 JT6N
161052 -  ..
161053 - Timing of reporting in this case presents an issue, probably verbal
161054 - communication error, described in NWO as the "telephone game."
161055 - ref OF 14 XF5H
161057 -  ..
161058 - Millie reported on 060722 a medical finding of family history with
161059 - genetic risk for pulmonary emboli. ref SDS 11 3D9T  Reports received
161060 - today indicate that test specimens (blood samples) were not received
161061 - until 060727, ref SDS 0 LG3K, and that test results were not available
161062 - until mid August. ref SDS 0 TJ65  How then could a positive result
161063 - have been reported a month earlier on 060722?
161065 -  ..
161066 - Possibly the family member was told that testing would be performed,
161067 - and then either passed along on 060722 that the test was positive, or
161068 - this was passed along in creating the record on 060722 that results
161069 - were positive. ref SDS 11 3D9T  Another possibility is that multiple
161070 - tests were performed.  Initial testing prior to 060722 indicated
161071 - genetic risk for PE, and when asked for the report, most recently on
161072 - 061031, ref SDS 17 FW8M, a secondary report that confirms original
161073 - findings was submitted.
161074 -
161075 -
161076 -
161077 -
1611 -

SUBJECTS
Documents Received PDF Image of Poor Quaity Fax Difficult to Read 5

1903 -
190401 -  ..
190402 - Documents Received PDF Image of Poor Quaity Fax Difficult to Read
190403 - Hypecoagulable State Millie Family Member Diagnosed Pulmonary Embolism
190404 - Quest Diagnostics DNA Testing Report Coagulapathy Millie Family Member
190405 -
190406 - The quality of the documentation is very poor, rendered as PDF file of
190407 - a fax consisting of 5 pages.  There are 3 documents and 2 of them have
190408 - 2 pages each.
190409 -
190410 -              G:/08/02/04/60/06/11/0102A.PDF
190412 -  ..
190413 - Information is barely readable even with a magnifying glass, and so
190414 - succepticle to erroneous interpretation.  Content is captured here for
190415 - consistent management and precission access going forward.  Another
190416 - record reviews investing time to obtain workable content within the
190417 - 2-worlds problem of saving time by guessing from first impression or
190418 - saving more time by constructing effective work product.  This issue
190419 - was review on 030306, ref SDS 4 594F, and citing challenges working
190420 - with PDF files. ref SDS 4 M36F
190422 -             ..
190423 -            [On 061102 2-worlds problem from work today reviewed.
190424 -            ref SDS 18 6R4O
190425 -
190427 -  ..
190428 - 1st Page Coagulapathy Report Seems to Say...
190429 -
190430 - Guessing at content of PDF fax image seems to indicate....
190431 -
190471 -
190472 -
190473 -
190474 -
1905 -

SUBJECTS
Factor V Leiden Mutation Negative Coagulapathy Report Pulmonary Embo

2303 -
230401 -         ..
230402 -        Factor V (Leiden) Mutation Negative
230403 -
230404 -        Factor V Mutation
230405 -
230406 -            Factor V (Leiden) Mutation
230407 -
230408 -            Mutation Analysis:  see below
230410 -             ..
230411 -            Result:  Negative for the R5060 (Factor V Leiden) Mutation.
230413 -             ..
230414 -            DNA testing indicates this individual is negative for the
230415 -            R506Q mutation in the Factor V gene.  This negative result
230416 -            does not rule out the presence of other mutations within
230417 -            the Factor V gene or other causes of thromophilia.
230418 -
230419 -                [...below, factor V Leiden and associating with R506Q
230420 -                mutation negative test results presented again.
230421 -                ref SDS 0 ME6X
230423 -             ..
230424 -            Laboratory results and submitted clincial information
230425 -            reviewed by Matthew J McGinniss, PhD, FACMG, CGMB.
230427 -             ..
230428 -            Factor V Leiden is one of the most common causes of
230429 -            inherited thrombophilia.  The R506Q mutation leads to
230430 -            resistance to degradation of the Factor V protein by
230431 -            activated protein C (APC).  Individuals who have one copy
230432 -            of the mutation are at a 4 - 8 fold increased risk of
230433 -            thrombosis and individuals who have two copies are at 50 -
230434 -            100 fold increased risk.
230436 -             ..
230437 -            The R506Q mutation is detected by amplification of the
230438 -            Factor V gene by polymerass chain reaction (PCR) followed
230439 -            by an oligonucleotide ligation assay (OLA).  The
230440 -            biotinylated extension products are then hybridized on
230441 -            microspheres and detected by the identity of the
230442 -            microspheres as well as the reporter fluorescence.  Since
230443 -            Genetic variation and other factors can affect the accuracy
230444 -            of direct mutation testing, these results should be
230445 -            interpreted in light of clinical and familial data.
230447 -         ..
230448 -        Shared assay components performed
230450 -         ..
230451 -        Prothrombin (Factor II Mutation)
230452 -
230453 -            Factor II Mutation
230454 -
230455 -            Sent to referral Lab. separate report to follow.
230456 -
230457 -
230458 -
230459 -
2305 -

SUBJECTS
Coagulapathy Report Hypecoagulable State Millie Family Member Diagno

2403 -
240401 -  ..
240402 - 2nd Page Coagulapathy Report Seems to Say...
240403 -
240404 - Quest Diagnostics in San Jose and in San Juan Capistrano indicates
240405 - coordination between multiple laboraties to accomplish coagulapathy
240406 - report.
240407 -
240408 -    2.  Quest Diagnostics Incorporated
240409 -        13608 Ortega Highway
240410 -        San Juan Capistrano, CA  92675
240411 -        Client Services 800 553 5445
240412 -        Director: RE Raltz MD
240414 -         ..
240415 -        Sent To:
240416 -
240417 -            Quest Diagnostics San Jose
240418 -            967 Maybury
240419 -            ATTN:  Referrals
240420 -            San Jose, CA  95133
240422 -         ..
240423 -        x   Align Here
240425 -         ..
240426 -        Patient Name:
240430 -         ..
240431 -        Patient ID NO:
240435 -         ..
240436 -        Accession No.
240440 -         ..
240441 -        Age:  52
240443 -         ..
240444 -        Sex:  Male
240446 -         ..
240447 -        Sample ID No:   Not Given
240449 -         ..
240450 -        Other ID No:
240454 -  ..
240455 - Aligns with first form above. ref SDS 0 TJ62
240456 -
240458 -  ..
240459 - Quest report continues...
240460 -
240461 -        Remarks:    [blank]
240462 -
240463 -        Referring Physician:  [blank]
240465 -         ..
240466 -        Collected:  060807 1055
240467 -        Received:   060808 0734
240468 -        Reported:   060815 0913
240469 -        Status:     Duplicate
240471 -         ..
240472 -        Test:
240473 -
240474 -            Factor V (Leiden)
240476 -         ..
240477 -        Results: (* = Out of Range)
240479 -         ..
240480 -        Units   [blank]
240482 -         ..
240483 -        Reference Range   [blank]
240485 -         ..
240486 -        Mutation Analysis       See Below
240487 -
240488 -
240489 -
240490 -
2405 -

SUBJECTS
R506Q Factor V Leiden Mutation Negative Coagulapathy Report Hypecoag

2803 -
280401 -         ..
280402 -        R506Q (Factor V Leiden) Mutation Negative
280403 -
280404 -        Result:  Negative for the R506Q (Factor V Leiden) mutation.
280406 -             ..
280407 -            DNA testing indicates this individual is negative for the
280408 -            R506Q mutation in the Factor V gene.  This negative result
280409 -            does not rule out the presence of other mutations within
280410 -            the Factor V gene or other causes of thrombophilia.
280411 -
280412 -                [...above, factor V Leiden mutation initial test
280413 -                results negative. ref SDS 0 TK3V
280415 -             ..
280416 -            Laboratory results and submitted clinical information
280417 -            reviewed by Matthew J McGinniss, PhD, FACMG, CGMB.
280419 -             ..
280420 -            Factor V Leiden is one of the most common causes of
280421 -            inherited thrombophilia.  The R506Q mutation leads to
280422 -            resistance to degradation of the Factor V protein by
280423 -            activated protein C (APC).  Individuals who have one copy
280424 -            of the mutatino are at a 4 - 8 fold increased risk of
280425 -            thrombosis and individuals who have two copies are at 50 -
280426 -            100 fold increased risk.
280428 -             ..
280429 -            The R506Q mutation is detected by amplification of the
280430 -            Factor V gene by polymerass chain reaction (PCR) followed
280431 -            by an oligonucleotide ligation assay (OLA).  The
280432 -            biotinylated extension products are then hybridized on
280433 -            microspheres and detected by the identity of the
280434 -            microspheres as well as the reporter fluorescence.  Since
280435 -            Genetic variation and other factors can affect the accuracy
280436 -            of direct mutation testing, these results should be
280437 -            interpreted in light of clinical and familial data.
280439 -             ..
280440 -            This test was developed and its performance characteristics
280441 -            determined by Quest Diagnostics Nichols Institute.  It has
280442 -            not been cleared for approved by the US Food and Drug
280443 -            Administration.  The FDA has determined that such clearance
280444 -            or approval is not necessary.  Performance characteristics
280445 -            refer to the analytical performance of the test.
280447 -         ..
280448 -        --------------------------------------------------
280449 -        Shared assay components      performed
280450 -        --------------------------------------------------
280451 -
280452 -
280453 -
2805 -

SUBJECTS
Prothrombin Factor II G20210A Mutation Negative Coagulapathy Report

3203 -
320401 -         ..
320402 -        Prothrombin/Factor II G20210A Mutation Negative
320403 -
320404 -        Prothrombin Gene Analysis    See Below
320406 -         ..
320407 -        Result:
320408 -
320409 -            Negative for the G20210A (Prothrombin/Factor II) mutation.
320411 -         ..
320412 -        DNA testing indicates this individual is negative for the
320413 -        G20210A mutation in the Prothrombin/Factor II gene.  This
320414 -        negative result does not rule out the presence of other
320415 -        mutations within the Promthrombin/Factor II gene or other
320416 -        causes of thrombophilia.
320422 -         ..
320423 -        [Handwritten symbol, could be an initial, looks like an S or
320424 -        an ampersand character "&"....]
320426 -         ..
320427 -        Trans Code: 06
320429 -         ..
320430 -        Client No:
320434 -         ..
320435 -        Date Printed:  060818 1406
320437 -         ..
320438 -        Patient Name:
320442 -         ..
320443 -        Page #1 cont.
320444 -
320445 -
320446 -
320447 -
3205 -

SUBJECTS
Prothrombin Factor II G20210A Mutation Explanation Coagulapathy Repo

3303 -
330401 -  ..
330402 - 3rd Page Coagulapathy Report Seems to Say...
330403 -
330404 - Another document from Ron seems a continuation of the first page of
330405 - the 2nd document; it has the same letterhead...
330406 -
330407 -    3.  Quest Diagnostics Incorporated
330408 -        13608 Ortega Highway
330409 -        San Juan Capistrano, CA  92675
330410 -        Client Services 800 553 5445
330411 -        Director: RE Raltz MD
330413 -         ..
330414 -        Sent To:
330415 -
330416 -            Quest Diagnostics San Jose
330417 -            967 Maybury
330418 -            ATTN:  Referrals
330419 -            San Jose, CA  95133
330421 -         ..
330422 -        x   Align Here
330424 -         ..
330425 -        Patient Name:
330429 -         ..
330430 -        Patient ID NO:
330434 -         ..
330435 -        Accession No.
330439 -         ..
330440 -        Age:  52
330442 -         ..
330443 -        Sex:  Male
330445 -         ..
330446 -        Sample ID No:   Not Given
330448 -         ..
330449 -        Other ID No:
330450 -
330453 -         ..
330454 -        Remarks:    [blank]
330456 -         ..
330457 -        Referring Physician:  [blank]
330458 -
330471 -         ..
330472 -        The G20210A mutation in the Prothrombin (Factor II) gene is
330473 -        the second most common inherited risk factor for thrombosis.
330474 -        Individuals who have the one copy of the mutation are at a 3 -
330475 -        6 fold increased risk for thrombosis and individuals who have
330476 -        two copies are at an even more increased risk.
330478 -         ..
330479 -        The G20210A mutation is detected by amplification of the
330480 -        Prothrombin (Factor II) gene by polymerase chain reaction (PCR)
330481 -        followed by an oligonucleotide ligation assay (OLA).  The
330482 -        biotnylated extension products are then hydridized on
330483 -        microspheres and detected by the idendtity of the microspheres
330484 -        as well as the reporter fluoresence.
330486 -         ..
330487 -        Since genetic variation and other factors can affect the
330488 -        accuracy of direct mutation testing, these testing results
330489 -        should be interpreted in light of clincial and familial data.
330491 -  ..
330492 - This sound like DNA test results for genetic disposition for
330493 - pulmonary embolism is not conclusive.
330495 -  ..
330496 - Quest report continues...
330497 -
330498 -        This test was developed and its performance characteristics
330499 -        determined by Quest Diagnostics Nochols Institute.  It has not
330500 -        been cleared or approved by the US Food and Drug
330501 -        Administration.  The FDA has determined that such clearance or
330502 -        approval is not necessary.  Performance characteristics refer
330503 -        to the analytical performance of the test.
330504 -
330505 -        --------------------------------------------------
330506 -        Shared assay components      performed
330508 -         ..
330509 -        TNP-Common procedures performed in test code ordered on same
330510 -        assession.
330512 -         ..
330513 -        Trans Code: 06
330515 -         ..
330516 -        Client No:
330520 -         ..
330521 -        Date Printed:  060818 1406
330523 -         ..
330524 -        Patient Name:
330528 -         ..
330529 -        Page #2 of 2.
330530 -
330531 -
330532 -
330533 -
3306 -

SUBJECTS
Test Specimens Lost Laboratory Requests Replacements Coagulapathy Re

4003 -
400401 -  ..
400402 - 4th Page Coagulapathy Report Seems to Say...
400403 -
400404 - The 4th document in the test report seems to explain disposition of
400405 - specimens, and indicates loss or damage, though received in good
400406 - order, and requests replacements. ref SDS 0 TH6V
400408 -  ..
400409 - There is no record of replacements nor of impact on the report.
400410 -
400411 -    4.  Quest Diagnostics Incorporated
400412 -
400413 -        Patient Information:
400421 -         ..
400422 -        Report Status:  Final
400424 -         ..
400425 -        Ordering Physician:
400426 -
400429 -         ..
400430 -        Client Information:
400431 -
400432 -            58794
400433 -            East Bay Med Oncology-Hematology
400434 -            2700 Grant Street, Suite 106
400435 -            Concord, CA  94520
400437 -         ..
400438 -        Specimen Information
400443 -             ..
400444 -            Collected:    060727 1538
400445 -            Received:     060728 0016
400446 -            Reported:     060808 1704
400447 -
400449 -         ..
400450 -        Test Name      In Range     Out of Range      Reference Range
400451 -
400453 -         ..
400454 -        Test Specimens Lost Quest Laboratory Requests Replacements
400455 -
400456 -        Factor V (Leiden) Mutation
400457 -
400458 -            Mutation Analysis       See note
400459 -
400460 -                Please note that although the specimen was in an
400461 -                acceptable condition when received by the laboratory, a
400462 -                problem developed during the handling of this specimen.
400463 -                Please accept or apology.
400465 -                 ..
400466 -                Please resubmit.
400468 -         ..
400469 -        Prothrombin (Factor II) Mutation
400470 -
400471 -            Factor II Mutation      See note
400472 -
400473 -                Please note that although the specimen was in an
400474 -                acceptable condition when received by the laboratory, a
400475 -                problem developed during the handling of this specimen.
400476 -                Please accept or apology.
400478 -                 ..
400479 -                Please resubmit.
400481 -  ..
400482 - There is nothing in the record showing specimens were resubmitted,
400483 - possibly because the patient has begun Coumadin treatment, and
400484 - protocol requires blood drawn prior to starting treatments.
400485 -
400486 -
400487 -
4005 -

SUBJECTS
Lupus Anticoagulant Test Positive Evidently Coagulapathy Report Hype

4403 -
440401 -         ..
440402 -        Lupus Anticoagulant Test Evidently Positive
440403 -
440404 -
440405 - Quest report continues...
440406 -
440407 -        Lupus Anticoagulant Evaluation
440408 -
440409 -            Lupus Anticoagulant         Detected        Not Detected
440410 -
440411 -                The results reported are consistent with a Lupus
440412 -                Anticoagulant (an antiphospholipid antibody).
440414 -                 ..
440415 -                This interpretation is based on the following test
440416 -                results:
440417 -
440418 -                      61 H          40 or less seconds
440419 -
440420 -                      Confirmed     Not Confirmed
440422 -                       ..
440423 -                      67 H          42 or less seconds
440425 -  ..
440426 - This part of the test report is less clear than the next section on
440427 - Cardiolipin AB IGM showing results are above target level, and has
440428 - been circled for emphasis. ref SDS 0 6F49
440430 -  ..
440431 - Quest report continues...
440432 -
440433 -            [handwritten letters that look like...
440434 -
440436 -
440437 -            ....end of handriting]
440442 -         ..
440443 -        Page 1 - Continued on page 2.
440444 -
440445 -
440446 -
440447 -
4405 -

SUBJECTS
Lupus Anticoagulant Test Continue Coagulapathy Report Hypecoagulable

4503 -
450401 -  ..
450402 - 5th Page Coagulapathy Report Seems to Say...
450403 -
450404 - Final page in documents received today is rotated 90 degrees, and so
450405 - is very awkward to read, although the writing is the most clear of all
450406 - the pages received.
450407 -
450408 -    5.  Quest Diagnostics Incorporated
450409 -
450410 -        Patient Information:
450411 -
450426 -         ..
450427 -        Reported:   060808 1704
450428 -        Collected:  060727 1538
450430 -         ..
450431 -        Test Name      In Range     Out of Range      Reference Range
450433 -         ..
450434 -        Lupus Anticoagulant Evaluation (Continued)
450435 -
450436 -            Phospho Neutraliz         Not Confirmed    Not Confirmed
450437 -
450438 -                If either neutralization test is confirmed, a lupus
450439 -                anticoagulant is present.  If both neutralization tests
450440 -                are not confirmed/not indicated, a lupus anticoagulant
450441 -                is not detected.
450443 -                 ..
450444 -                Lupus anticoagulants (LA) represent a hetrogeneous mix
450445 -                of anbibodies to phospholipid binding proteins.  The
450446 -                titer and avidity of these antibodies are highly
450447 -                variable.  No single test is sensitive enough to detect
450448 -                all LA antibodies.
450450 -         ..
450451 -        Cardiolipin AB Screen W/Reflex
450452 -
450453 -            Cardiolipin AB IGG
450454 -
450455 -                            <10                  GPL U/mL
450456 -
450457 -                            Reference Range:
450458 -                            <10      Normal
450459 -                            10 - 15  Equivocal
450460 -                            >15      Positive
450461 -
450462 -
450463 -
450464 -
4505 -

SUBJECTS
Cardiolipin AB IGM 23 Circled Indicating Positive Test Finding Coagu

4903 -
490401 -         ..
490402 -        Cardiolipin AB IGM 23 Circled Indicating Positive Test Finding
490403 -
490404 -
490405 -            Cardiolipin AB IGM
490406 -
490407 -                            23 H                 MPL U/mL
490409 -                 ..
490410 -                [handwriting "23 H" is circled for emphasis...]
490411 -
490412 -                            Reference Range:
490413 -                            <10      Normal
490414 -                            10 - 15  Equivocal
490415 -                            >15      Positive
490417 -  ..
490418 - This test with the value 23 H circled, seems to be the criteria that
490419 - may show genetic disposition for pulmonary emboli, although PE is not
490420 - mentioned anywhere in the report.  The section above on the Lupus
490421 - anticoagulant test may, also, indicate positive results, but is less
490422 - clear than this part of the report. ref SDS 0 6E5M
490424 -  ..
490425 - Quest report continues...
490426 -
490427 -            Cardiolipin AB IGA
490428 -
490429 -                            <10                  APL U/mL
490430 -                            Reference Range:
490431 -                            <10      Normal
490432 -                            10 - 15  Equivocal
490433 -                            >15      Positive
490434 -
490436 -                 ..
490437 -                Additional charge for Anti-cardiolipin reflex testing.
490439 -                 ..
490440 -                On occassion, a cardiolipin screen will yield positive
490441 -                results which are not confirmed by this more specific
490442 -                individual cardiolipin isotype assays.  The screen
490443 -                technology is constructed to capture all possible
490444 -                cardiolipin positive sera.  The highly specific
490445 -                individual cardiolipin IgM, IgG and IgA assays are used
490446 -                to confirm the true positive cardiolipin screen
490447 -                specimens, and to rule out those cardiolipin screen
490448 -                positive specimens that may be attributed to other
490449 -                undefined reactants.
490451 -             ..
490452 -            Cardiolipin Screen             Positive       Negative
490453 -
490454 -        -------------------------------------------------------------
490456 -         ..
490457 -        Performing Laboratory Information
490459 -         ..
490460 -        NI  Nichols Institute 33608 Ortega Hwy, San Juan Capistrano
490461 -            CA  92690  Laboratory Director:  RH Reitz, MD
490463 -         ..
490464 -        SJ  Quest Diagnostics 967 Mabury Road San Jose CA  95133
490465 -        Laboratory Directory:  James E Fitzwater, MD
490470 -         ..
490471 -        [Handwritten symbol, could be an initial, looks like an S or
490472 -        an ampersand character "&"....]
490474 -         ..
490475 -        Page 2 of 2  - End of Report
490476 -
490477 -
490478 -
490479 -
490480 -
490481 -
490482 -
490483 -
490484 -
4905 -