Download - Cche clinical lab in five years 7 7-2012
CCHE Clinical Lab in Five Years
Khaled Shaaban
CCHE Lab Director
Flow Cytometry Specialist
Clinical Pathology Department
Children`s Cancer Hospital Egypt
57357
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.
2/9/2017 3
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.
2/9/2017 4
Values
The following values will
be the guide to achieve this
vision:
Teamwork
Integrity
Respect
Compassion
Excellence
Innovation
Accountability
Leadership
2/9/2017 5
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.
2/9/2017 6
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.
2/9/2017 7
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.
2/9/2017 8
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
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
2/9/2017 10
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
2/9/2017 11
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.
2/9/2017 12
Services provided by the CCH Lab
–Biochemistry
– Endocrinology
–Hematology
–Cytochemistry
–Cytogenetics
– Flow Cytometry
–Molecular Biology
–Bacteriology
–Mycology
–Virology
– Serology
– Immunology
2/9/2017 13
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.
2/9/2017 14
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
2/9/2017 15
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.
2/9/2017 16
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.2/9/2017 17
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 Tests2/9/2017 18
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.
2/9/2017 19
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.
2/9/2017 20
Services provided by the CCH Lab
Lab total tests performed since opening:
3,364,281 test
2/9/2017 21
1st year2nd year
3rd year4th 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%
Daily Work Load
27 404 6 3
486
323
392
237253
427
255
189
92 109
32 1759
16 33 31 100
100
200
300
400
500
600
-
00
:00
- 0
0:5
9
01
:00
- 0
1:5
9
02
:00
- 0
2:5
9
05
:00
- 0
5:5
9
06
:00
- 0
6:5
9
07
:00
- 0
7:5
9
08
:00
- 0
8:5
9
09
:00
- 0
9:5
9
10
:00
- 1
0:5
9
11
:00
- 1
1:5
9
12
:00
- 1
2:5
9
13
:00
- 1
3:5
9
14
:00
- 1
4:5
9
15
:00
- 1
5:5
9
16
:00
- 1
6:5
9
17
:00
- 1
7:5
9
18
:00
- 1
8:5
9
19
:00
- 1
9:5
9
21
:00
- 2
1:5
9
22
:00
- 2
2:5
9
23
:00
- 2
3:5
9
Tot Cnt
Tot Cnt
2/9/2017 22
Daily
Work
Load
Hour of Day - In Lab Tot CntAverage 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 00:502/9/2017 23
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)
2/9/2017 24
Follow up of ALL Cases
2/9/2017 25
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 indicatedAs 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 indicatedWith each intrathecal
treatment
Follow up of ANLL Cases
2/9/2017 26
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 indicatedAs 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
ExaminationAs indicated As indicated As indicated
Pattern of Paediatric haematological malignancies
In the last 5 years,
We diagnosed
1700 new Acute
Leukaemia case
0
200
400
600
800
1000
1200
14001297
403
ALL76%
ANLL24%
2/9/2017 27
Pattern of Paediatric Acute leukaemia cases
54%
5%
17%
22%
1% 1%
0%
0%
Sales Precursor B-cell lymphoblasticleukemia
Mature B phenotype
T-cell lymphoblastic leukemia
ANLL
2ry AML
Mixed phenotype leukemia
Natural Killer Cell Leukemia
Blastic plasmacytoid dendriticcell neoplasm
2/9/2017 28
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)
2/9/2017 29
0
10
20
30
40
50
60
70
80
90
PharmacyStudents
ScienceStudents
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
2/9/2017 30
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)
2/9/2017 31
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)
2/9/2017 32
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
2/9/2017 33
2/9/2017 34
2/9/2017 35