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Clinical Laboratories and Pathology Groups

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Agreement with Germany’s INSTAND will include developing clinical lab proficiency testing program in Egypt

DATELINE: CAIRO, EGYPT—Here in Egypt’s capital city, the Egyptian Society of Laboratory Medicine (ESLM) is conducting its 22nd Annual Conference. One of Wednesday’s main sessions during this gathering of pathologists and clinical laboratory scientists centered on the topic of ISO 15189, as well as Lean and Six Sigma methods.

Your Dark Daily Editor, Robert Michel, is here in Cairo and delivered two presentations during this session. One presentation addressed growing global acceptance of ISO 15189. The second presentation discussed the adoption and use of Lean and Six Sigma by medical laboratories throughout the world. There is keen interest in ISO 15189 among Egyptian pathologists because the nation is incorporating ISO 15189 into its national program for accreditation of clinical pathology laboratories.

How Accreditation Contributes to Higher Quality in Clinical Pathology Labs

Also speaking as part of Wednesday morning’s session about ISO 15189 was Dr. Gihan Kamal Aly. She is Professor of Clinical and Chemical Pathology at the Ain Shams University School of Medicine. She is also the Quality Manager at Al Borg Laboratories. This is one of Egypt’s largest independent clinical laboratory companies. (See Dark Daily, “Globalization of Laboratory Medicine Is Seen in Two Big Cairo Clinical Pathology Laboratories,” March 10, 2011.)

Egyptian Society of Laboratory Medicine

In Cairo this week at the Egyptian Society of Laboratory Medicine (ESLM) 22nd Annual Conference–from L: Dr. Klaus Janitsche, INSTAND German-Egyptian Program Coordinator; Dr. Hadya Hussein Bassim, Professor of Clinical Pathology at Ain Shams University (ASU); Dr. Gihan Kamal Aly, Professor of Clinical and Chemical Pathology at ASU; Robert Michel, Editor-Dark Daily; Dr. Sawsan Hosny Hamza, Professor of Clinical Pathology, and ESLM President and Conference Director; Dr. Laila Abou El-Magd, Director at Laila Abou El-Magd Laboratory; Dr. Soheir Helal, Professor of Clinical Pathology, Cairo University.

The title of Professor Gihan’s presentation was “Accreditation: Impact on Clinical Interpretation of Laboratory Tests.” She discussed how adoption of the quality management system (QMS) that is embedded in ISO 15189 can improve the analytical integrity of the test results produced by the clinical laboratory.

During the past 24 months, the Cairo laboratory facility of Al Borg Laboratories has earned its accreditation to ISO 15189 in the chemistry department. The lab company is actively working to have that laboratory location become fully accredited to the ISO 15189 standard. Active efforts are under way to similarly earn accreditation to ISO 15189 for Al Borg’s other 92 laboratory locations in Egypt.

Thus, Professor Gihan had fresh data to share about how her laboratory team was performing quality assurance (QA) and quality control (QC) functions, guided by the QMS of ISO 15189. In particular, she demonstrated how her laboratory was developing reference ranges for each assay and how those reference ranges—based on testing of Egyptian patients—correlated to the reference ranges provided by the in vitro diagnostics (IVD) manufacturers.

Egypt’s Medical Laboratory Accreditation Program

Egypt’s national ISO 15189 program is administered by the Egyptian Accreditation Council, known as EGAC. Egypt has entered into an agreement with INSTAND of Germany to help it develop all aspects of Egypt’s national accreditation, licensure, and proficiency program. INSTAND is the acronym for the Society for Promotion of Quality Assurance in Medical Laboratories, e.V.

This is an example of an international collaboration in laboratory medicine that will help standardize clinical practices and quality across national borders. INSTAND will help Egypt develop proficiency testing programs. This service is likely to be based on EQAS (External Quality Assessment Services), a program that INSTAND uses for similar purposes in Germany.

At the ESLM conference yesterday, Dr. Hans-Peter Grünert, Professor of Pathology at the CharitéCentrume in Berlin, Germany, gave a presentation about the EQAS program and how it supports virus safety of blood and blood products. According to Dr. Grünert, each year, EQAS handles approximately 120,000 samples, and more than 1,100 laboratories from 60 countries participate in this program.

All of these examples show how cross-border collaboration is the approach used by some nations, as a more rigorous scheme of national licensure and accreditation of clinical pathology laboratories is implemented. In the case of the agreement between Egypt’s EGAC and Germany’s INSTAND, Egypt benefits from its participation in the proficiency testing programs sponsored by INSTAND.

For its part, INSTAND will have access to specimens from Egypt, which may have different strains of bacteria or viruses that have yet to be seen in Europe, for example. This will help INSTAND in its work with laboratories and IVD manufacturers, to ensure that infectious disease test kits are capable of detecting these new strains.

The ESLM conference is typically a large event, attracting as many as 1,500 delegates in its busiest year. The conference concluded yesterday. On tap for your editor today is a visit to the pyramids and maybe a side trip to see King Tut at the Egyptian National Museum. Then it will be a full 24-hour journey this weekend to fly home to Austin, Texas!

From Cairo, Egypt,

Robert Michel


Related Information:

Globalization of Laboratory Medicine Is Seen in Two Big Cairo Clinical Pathology Laboratories

ISO 15189 Laboratory Accreditation