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Project summary:

Accreditation Projects to obtain ISO15189:

HEI Labs Certification  Project, Program of Continuous Improvement and Qualification for Accreditation in HEI, Project Management Unit, Ministry of Higher  Education.

http://www.heep2.edu.eg/sc/index.php   

http://www.qaap.edu.eg/sc/forms.html

  • Title of the project: Preparation for accreditation of Bone Marrow Transplantation Laboratory Unit at National Cancer Institute
  • Project Code: LP3-027-CAI
  • Director: Dean of the NCI, Cairo University
  • Executive Director: Azza M Kamel, Prof. of Clinical Pathology, NCI, Cairo University
  • Project Team:

Category

Number of Staff involved in the project

Assistant  Staff

5

Teacher/lecturer/Assistant  Professor

4

Associate Professor

Not applicable

Professor

2

Nonacademic Staff

- Biomedical Engineers

- IT Engineers

- Accountant

- Technicians

 

2

2

1

7

Total number of academic and non-academic staff involved in the project

23

  •  Accreditation Scope of the project:

BMT Lab Unit sub specialization

Tests to be accredited

Flow Cytometry

IPT, DNA Ploidy, CD34 Counting

Molecular Genetics

Fusion gene transcripts in ALL and AML, FLT3 ITD, JACK2  mutations

Immunogenetics

Class I MHC Serological typing

Class II MHC Molecular Typing

Pharmacogenomics

Allele Detection

 

  • Project Summary:

The National Cancer Institute, Cairo University is a comprehensive cancer centre. The Bone Marrow Transplantation Laboratory Unit (BMT Lab Unit) is in charge of the advanced diagnostic techniques namely Flow Cytometry, Molecular Genetics, Immunogenetics and Pharmacogenomics. It is the national reference laboratory in Flow Cytometry and also in immunogenetics for choice of donors and follow up of recipients of allogeneic BMT. The unit is involved in several national and international research projects.

Immunogenetics includes tissue typing and chimerism studies. The BMT Lab Unit is the national referral centre and receives samples from the Ministry of health and University hospitals. Hence quality assurance is very important.

The Flow Cytometry Lab is the most active at the national level. It is involved in BMT services namely CD34 counting and evaluation of graft components. It is also involved in research projects meant to improve the service. Being at the NCI, our Flow Cytometry Lab is the centre of excellence for all studies relevant to haematopoietic malignancies including Immunophenotyping, DNA ploidy and cell cycle analysis, MDR expression and functional assay as well as minimal residual disease (MRD) detection.  MRD is extremely sensitive in detecting very low number of malignant cells. However this requires a high level of quality control both for the machine and the test itself.  Being a centre of excellence in the field of Flow Cytometry, a wide range of applications in other fields was developed including evaluation of lymphocyte subsets, PNH screening, detection of cytokines….etc.
We also aim to start researches on "Cancer Stem Cells" which is claimed to be the key cell in occurrence of cancer, resistance to therapy and cause of relapse. Molecular genetics of leukemia patients: Started since the establishment of the unit. Detection of chimeric genes is an integral part of the prognostic workup of patients. Its quantitative evaluation is important in the follow up to detect MRD which is also crucial in prognosis. The values detected are very small and it is an absolute must to have proper quality control to be able to apply these tests. The same applies to follow up of patients on Glivec therapy. Pharmacogenomics: includes study of risk susceptibility to various diseases as well as the individual response to drugs. Study of single nucleotide polymorphisms (SNPs) is used to test the sensitivity to chemotherapy at the individual case level. This is extremely important for patient safety to be able to predict and prevent toxicity of cancer chemotherapeutics. Also to adjust the dose according to the need of each patient (individualized medicine). Again it is crucial to have these tests under stringent quality control system as they directly influence both treatment efficiency and drug safety to the patients. The NCI has achieved the certificate of ISO 9001: 2000 in 2006 and ISO 9001: 2008 in August, 2009, from ASR American Systems Registrars. We were part of that but the BMT Lab Unit needs a more specialised type of ISO.