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.

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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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Values

The following values will

be the guide to achieve this

vision:

Teamwork

Integrity

Respect

Compassion

Excellence

Innovation

Accountability

Leadership

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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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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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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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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

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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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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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Services provided by the CCH Lab

–Biochemistry

– Endocrinology

–Hematology

–Cytochemistry

–Cytogenetics

– Flow Cytometry

–Molecular Biology

–Bacteriology

–Mycology

–Virology

– Serology

– Immunology

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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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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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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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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.

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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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Services provided by the CCH Lab

Lab total tests performed since opening:

3,364,281 test

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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

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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)

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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 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

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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 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%

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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

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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

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

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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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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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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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