CCHE 57357 Hospital, Clinical Lab progress

1. CCHE Clinical Lab in Five Years
Khaled Shaaban
CCHE Lab Director
Flow Cytometry Specialist

2. Clinical Pathology Department
Children`s Cancer Hospital Egypt
57357

3. Vision
To be the region`s preferred source of
laboratory services and recognized
internationally as a laboratory providing
world-class scientific services, supporting
the Children Cancer Hospital Egypt
(CCHE) in fulfilling its vision.
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4. Our Mission
Provide High quality, integrated laboratory services through the
team efforts of our valued employees. Supporting CCHE in
the accomplishment of all identified missions, goals,
objectives and strategic planning's.
Ensure efficient means exist to produce timely, accurate service,
with maintaining excellence in performance while
continuously striving to improve the quality of patient care we
provide.
Our services will be provided within a professional environment
that is patient focused, caring toward employees, team-
oriented, and upholds the values of Children`s Cancer Hospital
Egypt.
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5. Values
The following values will
be the guide to achieve this
vision:
Teamwork
Integrity
Respect
Compassion
Excellence
Innovation
Accountability
Leadership
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6. GENERAL INFORMATION
• The CCH Clinical Lab Dep. located on the
ground floor includes different specialty
units as:
– Clinical Hematology,
– Clinical Chemistry,
– Microbiology (Virology, Bacteriology),
– Immunology,
– Cytology & Cell Culture,
– Flow Cytometry,
– Cytogenetics and
– Molecular Biology,
in addition to the Outpatient specimen
collection site.
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7. The Clinical Laboratory Core Sections
•The Clinical Laboratory Core Sections:
operate Sunday through Thursday, day
shift schedule from 7:00 AM to 5:00 PM,
providing laboratory testing essential to
patient care.
•Outpatient phlebotomy services: Main
service site open Sunday through
Thursday, 6:30:00am until 5:00pm.
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8. The Clinical Laboratory Core Sections
•STAT Lab: 24 hours per day, 365
days per year, providing laboratory
testing essential to ICU unit and
emergency cases at night shifts by
on call resident and technician.
•Lab Director, Consultants and
residents are available 24 hours a
day, seven days a week, to aid and
consult.
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9. 2/9/2017 9
Lab Organizational
Structure
The Lab is staffed with 6
full time (FT) consultants
and 4 part time (PT)
consultants,
1 (FT) resident and 15
(PT) registrars (on shift
base),
8 FT chemists,
10 FT technicians,
4 (FT) phlebotomists,
7 (FT) secretaries,
4 (FT) porters

10. Laboratory Information System (LIS)
• The lab is fully controlled by
Laboratory Information System
(LIS) which is part of the HIS
• Barcode sample label including
patient data and full patient
demographics
• Direct bidirectional interface with
all major automated analyzers
• This assures
– good lab quality,
– minimize human error,
– speed lab process
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11. Lab Setup
• The lab is equipped
with almost 194
different small and large
equipments coming
from at least 65
different manufacturers
represented by 25 local
supplier
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12. Scope of services
• We provide laboratory testing
dedicated to pediatric Oncology
service, for initial diagnosis and
follow up of the cases
• we also include all other
categories of our community.
• We aim to serve the medical
community by providing high
quality, integrated laboratory
services through the team efforts
of our valued employees.
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13. Services provided by the CCH Lab
–Biochemistry
–Endocrinology
–Hematology
–Cytochemistry
–Cytogenetics
–Flow Cytometry
–Molecular Biology
–Bacteriology
–Mycology
–Virology
–Serology
–Immunology
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14. Routine Activities (Clinical chemistry lab)
• All biochemical tests are performed on any
kind of body fluid, but mostly on serum or
plasma.
• This large array of tests can be further sub-
categorized into:
– General or routine (e.g., liver and kidney
function tests).
– Special chemistry - such
as electrophoresis
• Clinical endocrinology - study of hormones,
and diagnosis of endocrine disorders.
• Tumor markers.
• Blood gases and Electrolytes.
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15. Routine Activities (Hematology Lab)
• Different tests are done for initial
diagnosis as well as follow up of
the patients:
– Bone marrow examination for both
hematological cases as well as for
solid tumors.
– Cytochemical stains are done as
required for proper initial diagnosis.
– CSF and different body fluids cell
count as well as cytomorohologic
examination.
– CBC, ESR, reticulocytic count, and
different coagulation tests
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16. Routine Activities (Cytogenetic Lab)
• Conventional karyotyping for all
newly diagnosed cases with
different hematological
malignancies.
• FISH (Fluorescence in situ
hybridization) using a wide panel
of probes for hematological
malignancies for initial diagnosis
and follow up.
• DNA stress test for Fanconi
anemia.
• Conventional karyotyping and FISH
for congenital disorders, eg. DS,
hereditary retinoblastoma, etc.
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17. Routine Activities (Molecular Biology Lab)
• Molecular characterization of new Acute
Leukemia cases by detection of fusion
gene transcripts of chromosomal
translocations by RT-PCR.
• Follows-up of certain acute leukemia cases
for MRD detection by Real time-PCR.
• Tissue typing:
• Serological typing.
• Molecular typing: SSP, SSOP by Luminex
technology.
• Variable Number Tandem Repeat (VNTR).
• Flt3 ITD, TPMT genotyping, Factor V
leiden.
• LOH analysis for Wilm's tumor.
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18. Routine Activities (Flow Cytometry Lab.)
• Immunophenotypic classification of new
cases with full panel for B, T & Myeloid
markers Using multiparametric flow
cytometry (5 colours, BC FC500)
• Minimal Residual Disease (MRD) evaluation
and study, using multiparametric flow
cytometry (5 colours, BC FC500) which will
be upgraded to Navios FC 6 colours in the
next two weeks and up to 10 colours....
• DNA Index and Cell Cycle Study
• Stem Cell Counting
• Lymphocytes Subsets Study
• Multiple Drug Resistance Study
• PNH Tests
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19. Routine Activities (Virology lab.)
• It performs a wide panel of tests
through: Serological and
molecular techniques
• The lab provides a rapid
screening , diagnosis and follow
up of the patients with good
communication between the
physician and the lab, it plays an
important role in ID control at the
hospital.
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20. Routine Activities (Bacteriology Lab.)
• The lab Performs the Clinical
Microbiology Service:
– Bacteriology, Mycology, Mycobacteriology,
Parasitology and Serology.
– Routine culture identification, subcultures to
specific media for optimal recovery of
microbes and antibiotic susceptibility of
microbes isolated
– Antibody detection and other techniques.
• Plays an important role in infection
control at the hospital, reporting not
only routine data but also monthly and
yearly statistical data of hospital
infections and when required.
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21. Services provided by the CCH Lab
Lab total tests
performed since
opening:
3,364,281 test
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1st year
2nd year
3rd year
4th year
5th year
197,149
513,481
682,695
830,944
997,012
Tests/Year
Testst/Year
1st year
2nd year 160%
3rd year 33%
4th year 22%
5th year 20%

22. Daily Work Load
27 40
4 6 3
486
323
392
237253
427
255
189
92 109
32 17
59
16 33 31 10
0
100
200
300
400
500
600
-
00:00-00:59
01:00-01:59
02:00-02:59
05:00-05:59
06:00-06:59
07:00-07:59
08:00-08:59
09:00-09:59
10:00-10:59
11:00-11:59
12:00-12:59
13:00-13:59
14:00-14:59
15:00-15:59
16:00-16:59
17:00-17:59
18:00-18:59
19:00-19:59
21:00-21:59
22:00-22:59
23:00-23:59
Tot Cnt
Tot Cnt
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23. Daily
Work
Load
Hour of Day - In Lab Tot Cnt
Average Actual TAT In Lab
to Completed
00:00 - 00:59 40 0 00:39
01:00 - 01:59 4 0 00:11
02:00 - 02:59 6 0 00:03
05:00 - 05:59 3 0 00:07
06:00 - 06:59 486 0 02:05
07:00 - 07:59 322 0 01:08
08:00 - 08:59 389 0 01:31
09:00 - 09:59 235 0 00:41
10:00 - 10:59 253 0 00:41
11:00 - 11:59 425 0 01:03
12:00 - 12:59 254 0 01:01
13:00 - 13:59 186 0 00:49
14:00 - 14:59 90 0 00:45
15:00 - 15:59 106 0 01:35
16:00 - 16:59 27 0 04:09
17:00 - 17:59 15 0 04:22
18:00 - 18:59 59 0 01:03
19:00 - 19:59 16 0 00:19
21:00 - 21:59 33 0 00:49
22:00 - 22:59 31 0 00:45
23:00 - 23:59 10 0 00:50
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24. Diagnostic workup for New Cases
• BM and P.Blood examination including:
– CBC with Diff
– Coagulation screen
– Chemistry profile
– Bone marrow evaluation (Aspiration & Biopsy)
• Morphology
• Cytochemistry
• Immunohistochemistry
• Flow Cytometry in Haematological Malignancies
– Immunophenotypic Study with full panel for B, T & Myeloid markers
– DNA Index
– Flow Cytometry detection of leukaemia associated phenotype
• Cytogenetic Haematological Malignancies
– Conventional karyotyping
– FISH
• Molecular Biology Haematological Malignancies
– RT-PCR for detection of fusion transcripts (of chromosomal translocations)
– RQ-PCR for positive cases
– PCR fot detection of FLT3/ITD in AML cases
• CSF Microscopic Examination
• Other studies as clinically indicated
• HLA typing for high and slandered risk cases (Patients & Siblings)
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25. Follow up of ALL Cases
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Induction/Consolidation Continuation Reinduction I&II
CBC with Diff Daily or as indicated Every 4w or as indicated
3 – 7 days or as indicated
Coagulation screen As clinically indicated As clinically indicated As clinically indicated
Chemistry Profile As indicated
As indicated As indicated
Bone marrow
evaluation
Day 14
+ day 26
Day 42
W 48
W 120
W 146 (boys)
W 7
W 17
MRD study by
Flow Cytometry
Molecular
FISH
Day 14
+ day 26
Day 42
W 48
W 120
W 146 (boys)
W 7
W 17
CSF Microscopic
Examination
With each intrathecal
treatment
With each intrathecal
treatment & as indicated With each intrathecal
treatment

26. Follow up of ANLL Cases
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Induction I Induction II Consolidation I, II, III
CBC with Diff Daily or as indicated As indicated As indicated
Coagulation screen As clinically indicated As clinically indicated As clinically indicated
Chemistry Profile As indicated
As indicated As indicated
Bone marrow evaluation
MRD by:
Flow Cytometry
Molecular
FISH
Day 22
+At Start of induction II
(does not apply to patients who
begin induction II immediately
following the day 22 evaluation)
End of Induction II
Pre next phase
At the time of count recovery
and every 4 months for 1 year
CSF Microscopic
Examination
As indicated As indicated As indicated

27. Pattern of Paediatric haematological
malignancies
In the last 5 years,
We diagnosed
1700
new Acute
Leukaemia case
0
200
400
600
800
1000
1200
1400
1297
403
ALL
76%
ANLL
24%
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28. Pattern of Paediatric Acute leukaemia cases
54%
5%
17%
22%
1% 1%
0%
0%
Sales Precursor B-cell lymphoblastic
leukemia
Mature B phenotype
T-cell lymphoblastic leukemia
ANLL
2ry AML
Mixed phenotype leukemia
Natural Killer Cell Leukemia
Blastic plasmacytoid dendritic
cell neoplasm
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29. Scientific Activity
• We do scientific meetings
with all the department`s
staff
• The department is
participating in many of
the committees and
combined clinics weekly
in the hospital
• Training for a science &
pharmacy students from
governmental and private
universities
(30hours/student)
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0
10
20
30
40
50
60
70
80
90
Pharmacy
Students
Science
Students

30. Scientific Activity
• Papers and Posters:
– Clinical Significance of Immunophenotypic Markers in
Pediatric T-cell Acute lymphoblastic leukemia. Journal of
The Egyptian National Cancer Institute, Vol.20(2) June,
2008.
– Prognostic Significance of Absolute Lymphocyte Count in
Pediatric Acute Lymphoblastic Leukemia. (Accepted as a
poster presentation at SIOP,2012).
– Prevalence of FLT3 Internal Tandem Duplication in
Pediatric Patients with Acute Myeloid Leukemia at
Children Cancer Hospital EGYPT (CCHE), poster in the
ASPHO, 23rd annual meeting
– Frequencies of ETV6-RUNX1 gene fusion and secondary
chromosomal abnormalities in pediatric lymphoblastic
leukemia. Poster accepted at SIOP 2012
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31. Scientific Activity
• Supervision of:
– Tyrosine hydroxylase expression as a marker of
minimal residual disease and its impact on outcome
of high risk neuroblastoma pediatric patients
following autologous bone marrow transplantation.
(MD Thesis)
– MTHFR C677T, FV leiden, Prothrombin G20210A and
risk of thrombosis in pediatric ALL patients. ( Msc.
Thesis)
– The impact of ABCG2 polymorphism 421 C>Aon the
dose of methtrexate in childhood ALL. ( Msc. Thesis)
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32. Scientific Activity
– The effect of genetic variation of vitamin D receptor
on bone mineral density and fracture risk in
pediatric acute lymphoblastic leukemia. ( Msc.
Thesis)
– Disease outcome of newly diagnosed pediatric acute
myeloid leukemia patients treated at Children
Cancer Hospital, Egypt (CCHE) ( Msc. Thesis)
– The effect of Cyclophosphamide-metabolizing
enzyme Cyp2B6 polymorphism on the
pharmacokinetics of Cyclophosphamide. (PhD.
Thesis)
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33. Scientific Activity
• Research Project :
–TEL/AML1 gene fusion in Pediatric acute
lymphoblastic leukemia.
–A study for patients with low/special risk
ALL as defined by no evidence of minimal
residual disease early in induction therapy
Based on the RE-ALL-05 protocol study
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