The Best of AACC Middle East

PROGRAM BOOK

March 23-24, 2017 | Rosewood Hotel - Abu Dhabi

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TABLE OF CONTENTS

Welcome Letters .................................................................................... 2

Committees ............................................................................................ 4

Accreditation .......................................................................................... 5

Agenda .................................................................................................. 6

Faculty & Abstracts ................................................................................ 8

Notes .................................................................................................. 29

Sponsors .............................................................................................. 32

AACC Mobile App ..................................................................................33

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Dear Colleagues:

Best of AACC is a program aimed at providing highlights of AACC’s scientific and educational symposia around the world.

AACC is a global scientific and medical professional organization dedicated to clinical laboratory science and its application to healthcare. AACC provides essential content, conducts advocacy and outreach, and stimulates collaboration to help lab professionals adapt to change and provide vital clinical insight and guidance so patients get the care they need. Delivering high quality education and knowledge resources is integral to this mission. AACC offers more than 60 educational programs annually, including the AACC Annual Scientific Meeting & Clinical Lab Expo, which is attended by 20,000 laboratory medicine professionals and healthcare leaders, and features more than 730 exhibitors, 200 educational sessions, and nearly 800 scientific abstracts.

In 2016, Best of AACC held conferences in Rio de Janeiro, Brazil, and in Shanghai and Shenzhen, China, that explored topics ranging from cardiac markers to HIV testing. The upcoming conference in the UAE will feature a selection of AACC’s latest groundbreaking laboratory medicine content, presented by internationally recognized speakers. I am pleased to share that this will be the first time AACC has offered educational programing in the Middle East.

Sincerely,

Michael J. Bennett, PhD2017 AACC President

I welcome you to the Best of AACC Middle East in Abu Dhabi.

We at AACC hope you enjoy your stay in Abu Dhabi and look forward to continuing to expand our educational programs in laboratory medicine to benefit healthcare professionals throughout this region.

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On behalf of Al Borg Medical Laboratories, it is my pleasure to welcome you to “The Best of AACC 2017 Middle East” scheduled to be held on March 23-24, 2017 in Abu Dhabi United Arab of Emirates. This program has been designed to provide a comprehensive overview of selected relevant topics in the field of clinical laboratory medicine presented by renowned international and national speakers. This will be the first time for the American Association of Clinical Chemistry (AACC) to offer such an educational program in the region of the Middle East. This is considered a great chance for the attendees to update their knowledge, stimulate collaboration with each other and exchange experiences with a distinguished line-up of experts. The Best of AACC 2017 Abu Dhabi is expected to be an exciting venue to hear and discuss the latest scientific advances in all disciplines pertinent to the field of laboratory medicine including laboratory quality management and accreditation, clinical chemistry, newborn screening, genetics, oncology and many other interesting and emerging topics. Al Borg Medical Laboratories are committed to making a major contribution to excellence in patient care by using modern techniques inside the lab and modern concepts of management. The Best of AACC 2017 is considered a great chance for Al Borg labora--tories to advance and support the competency in medical knowledge, practice-based learning, communication skills, and safety to laboratory professionals throughout the Middle East.

We hope that this meeting will be of great benefit to all participants in the region, we also hope and trust that you will enjoy your visit to Abu Dhabi, the capital of the United Arab of Emirates, and a vibrant and fast-growing city that combines state of the art facilities and infrastructure, as well as a glimpse into an ancient and endlessly fascinating past.

We wish you all a great event.

Sincerely,

Hisham Elbanawy, MD,PhD Conference ChairmanAl Borg Medical Laboratories, Regional manager, Qatar

Dear Colleagues:

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• Sameh El Sheikh, CEO, Al Borg Medical Laboratories, Middle East• Hosam Fouad, Country Manager - Al Borg Medical Laboratories, UAE• Khaled Afify, General Manager, Mena Conference, UAE• Fran Grega, President, Encore Medical Education, USA• Rachel Smith, Operations Manager - Al Borg Medical Laboratories, UAE• Tarek Shaker, Development and Training Manager - Al Borg Medical Laboratories HQ, KSA• Basma Elsayed, MD, Laboratory Director - Al Borg Medical Laboratories, UAE• Elham Attieh, MD, Pathologist - Al Borg Medical Laboratories, UAE• Mohamed Ibrahim, Digital Marketing Manager, Al Borg Medical Laboratories, UAE

Organizing Committee

• Hisham Elbanawy, MD, PhD. Al Borg Medical Laboratories, Regional Manager, Qatar

Conference Chairman

Scienti�c Committee

• Lisa Dunay, Professional Education Manager, AACC, USA

• Hisham Shams Maher, MD, PhD. Group Medical Director, Al Borg Medical Laboratories, Middle East

• Rania Nabil Bedair, MD, PhD. Molecular Biology Unit Head, Al Borg Medical Laboratories, KSA

• Laila Abdelwareth, MBBCh, FCAP, FRCPC, EMHCA. Chief Clinical Pathology. Medical, Pathology & Laboratory Medicine Institute, Cleveland Clinic, Abu Dhabi, UAE

• Waleed Al-Tamimi, PhD. Sc (ASCP) NRCC, President of Saudi Society of Clinical Chemistry, KSA

• Rania Medhat Seliem, MD, Head of Pathology Laboratory, Rashid hospital, Dubai, UAE

• Nigel Clarke, PhD. Senior Science Director for Mass Spectrometry and Automation, Quest Diagnostics Nichols Institute, San Juan Capistrano, California, USA

• Andrea Ferreira-Gonzalez, PhD. Chair of the Division of Molecular Diagnostics, Department of Pathology, Virginia Common Wealth University, Richmond, VA,USA

• Jeanne Mumford, Pathology Manager over Point of Care Testing, Johns Hopkins Medicine, Baltimore, MD, USA

• Bradley Pine, Vice President, Education and Meetings, AACC, USA

• Rodney W. Forsman, Assistant Professor Emeritus, Laboratory Medicine and Pathology College of Medicine, Mayo Clinic, Rochester, MN, USA

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Target Audience

CME Accreditation Statement

Meeting Highlights

Learning Objectives

• Laboratory directors• Laboratory supervisors/managers• Laboratory administration• Quality managers• Pathologists• Clinical chemists• Immunologists• Molecular biologists• Technologists• IVD industry scientists• Research scientists• Health care professionals interested

• Medical Students in laboratory medicine

• Laboratory management essentials and leadership teams• Point-of-care testing in health care systems for patient

centered care• Accreditation of medical laboratories• Six sigma applications in clinical laboratories• Quality performance indicators• Clinical and laboratory updates on cancer biomarkers and

hematological malignancies• Applications of Next Generation Sequencing in clinical practice.• Newborn screening programs• Non-invasive prenatal testing• Cervical cancer screening• Updates on Diabetes mellitus and renal diseases• Clinical applications of Mass Spectrometry• Analytical challenges and controversies in Clinical Chemistry• Emerging topics in laboratory medicine

Health Authority – Abu Dhabi designates this educational activity “The Best of AACC Middle East Conference” for a total of 12.5 CME hours in the Category 1 credit of HAAD Designation. Each health professional must claim only those credits that he/she actually spent in the activity.

Certi�cate of Attendance

Delegates may collect their certificate of attendance from the registration desk at the end of the second day of the conference on Friday, 24th March, 2017 at 5:00 pm

• Identify key attributes of a successful leadership team, recognize perspectives of individual team members; and employ techniques to enhance their influence.• Describe the expanding role of POCT into diverse clinical settings for patient-centered care and

identify POCT clinical considerations, best quality practices, and regulatory compliances.• Discuss recognized criteria for effectiveness, limitations, and biases of cancer screening tests with

emphasis on clinical utility.• Describe the main applications of Six Sigma methodology in medical laboratory settings.• Identify errors in clinical laboratories, discuss the error disclosure process, and explain the different

views of errors handling by pathologists.• Explain the value of interim self-inspection and highlight the best practice in its application.• Explain advances in cutting-edge noninvasive applications for precision medicine.• Discuss current challenges and controversies in clinical chemistry and newborn screening programs.

Qatar Council for Healthcare Practitioners- Accreditation Department (QCHP-AD) recognises Health Authority Abu Dhabi (HAAD)

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Best of AACC Middle East - Scientific Program

Day 1 : Thursday March 23, 2017

Time Topic Speaker

07:30 - 08:30 Registration

08:30 - 09:25 Opening Session (Welcome and Introduction) Moderator: Hisham Elbanawy, MD, PhD. Conference Chairman, Regional Manager, Al Borg Medical Laboratories, Qatar

08:30 - 08:35 Opening Speech – Official Inauguration

08:35 - 08:45 AACC Welcome and Overview Chief Executive Officer, American Association for Clinical Chemistry, Washington DC, USA

Janet Kreizman

08:45 - 09:00 Welcome Speech Chief Executive Officer, Al Borg Medical Laboratories, GCC

Sameh Al Sheikh, MD.

09:00 - 09:10 Learning Objectives of the Conference and CME Information Molecular Biology Unit Head, Al Borg Medical Laboratories, Jeddah, KSA

Rania Bedair, MD, PhD

09:10 - 09:25 Challenges in healthcare - The value of Integrated Diagnostic Information Services Executive Director, Advanced Diagnostic Solutions, Global Markets, Quest Diagnostics, USA

Stephen Becker

09:25 - 10:25 Morning short course: Laboratory Management Essentials.Moderator: Ola Elgaddar, MD, PhD

09:25 - 09:50 The Leadership Team: Contributing to Organizational Health Rodney Forsman, BS

09:50 - 10:10 Influencing Your Leadership Team Rodney Forsman, BS

10:10 - 10:25 Panel discussion

10:25 - 10:40 Break

10:40 - 12:55 Oncology and Hematology TrackModerator: Hisham Shams, MD, PhD

10:40 - 11:10 Screening for Cancer in the MENA region, Recommendations and Controversies

Shahinaz Bedri, MD, FCAP

11:10 - 11:40 Addressing Familial and Hereditary Breast Cancer in Different Cultural Environments - the Saudi Arabia Experience

Omalkhair Abulkhair MD, PhD

11:40 - 12:10 Myelodysplastic Syndromes Diagnostic Challenges and Helpful Hints Rania Medhat Seliem, MD

12:10 - 12:40 The WHO is New: Updates to the Diagnosis, Risk-Stratification, and Management of Polycythemia Vera

Amina Hassab, MD, PhD

12:40 - 13:10 Panel Discussion

13:10 - 14:10 Lunch

14:10 - 15:10 Afternoon short course: Expanding Point of Care Testing In Health Care Systems for Patient Centered Care Moderator: Hisham Elbanawy, MD, PhD

14:10 - 14:30 Expanding Point of Care Testing In Health Care Systems for Patient Centered Care: Getting Started

Jeanne Mumford, MT (ASCP)

14:30-14:55 Expanding Point of Care Testing In Health Care Systems for Patient Centered Care: Maintaining Standards

Jeanne Mumford, MT (ASCP)

14:55 - 15:10 Panel Discussion

15:10 - 17:40 Quality and Accreditation TrackModerator: Rania Mohamed El Sharkawy, MD, PhD

15:10 - 15:40 Improving the Quality and Value of the Laboratory Self-Inspection Ola Elgaddar, MD, PhD, MBA, CPHQ

15:40 - 16:10 KPIs-Integrating the Balanced Scorecard with Lean Six Sigma Metrics in Clinical Laboratory

Sahar El-Wakil. MD, PhD

16:10 - 16:40 Reducing Medical Errors - A Six Sigma Approach Ashish Bhatia, MBBS, DCP, DNB

16:40 - 17:10 Stepping Out from the Shadows; Disclosure of Errors in Pathology and Laboratory Medicine

Rania Medhat Seliem, MD

17:10 - 17:40 Panel Discussion

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Day 2 : Friday March 24, 2017

Time Topic Speaker

07:30 - 08:30 Registration

08:30 - 09:30 Morning Short Course: Clinical Applications of Next Generation SequencingModerator: Adel Abdelmagid, MD, PhD

08:30 - 08:50 Next Generation Sequencing (NGS) in Clinical Practice Andrea Ferreira-Gonzalez, PhD

08:50 - 09:15 Next Generation Sequencing (NGS) in Clinical Oncology Andrea Ferreira-Gonzalez, PhD

09:15 - 09:30 Panel Discussion

09:30 - 12:15 Emerging Topics in Laboratory Medicine TrackModerator: Laila Abdel Wareth, MD, FCAP, FRCPC, EMHCA

09:30 - 10:00 Current Status, Challenges and Future Perspective of Newborn Screening programs in the Kingdom of Saudi Arabia

Ali Al Othaim, MD, D.E.S, D.I.U.

10:00 - 10:30 The Increasing Role of Mass Spectrometry in the Clinical Diagnostic Laboratory

Nigel J. Clarke, Ph.D

10:30 - 10:45 Break

10:45 - 11:15 Advances in Pre-Natal Genetic Screen Felicitas L. Lacbawan, MD, FCAP, FACMGG

11:15 - 11:45 Cervical Cancer Screening, New Thinking, New Choices Hisham Shams, MD, PhD

11:45 - 12:15 Panel discussion

12:15 - 14:15 Prayers and Lunch

14:15 - 15:15 Industry Workshops (unaccredited)

14:15- 15:15 Clinical Excellence and Operational Efficiency in Times of Financial Pressures (Bailasan Meeting Room)

Abbott Diagnostics

14:15- 15:15 Responsible Genomic Approaches using Advanced Diagnostics for Personalized Medicine (Zambaq Meeting Room)

Quest Diagnostics

15:15-18:00 Clinical Chemistry TrackModerators: Samia Sobki, MD, PhD; Rodney Forsman, BS

15:15 - 15:45 Diagnosing Diabetes with HbA1c in Sickle Cell Trait Patients Laila Abdel Wareth, MBBCh, FCAP, FRCPC, EMHCA

15:45 - 16:15 How Should we Assess Renal Function in Diabetes? Eric Stephen Kilpatrick MBChB, MD, FRC Path FRCP Ed

16:15 - 16:45 Practical Approaches to validate and Interpret Body Fluids Testing in the Clinical Laboratory

Waleed Tamimi, PhD

16:45 - 17:15 Laboratory Investigations in Familial Hypercholesterolemia Khalid Al-Rasadi, BSc, MD, FRCPC, ABCL

17:15 - 18:00 Panel Discussion

18:00 Closing

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SPEAKERS

Sameh Al Sheikh, MDCEO & Co-Founder OF Al Borg medical laboratories Co - GCC

Dr. Sameh obtained his Bachelor degree of Medicine and Surgery from Kasr El-Aini school of medicine in Cairo University. He is currently the Chief Executive Officer of Al Borg Medical Laboratories.

Al Borg Medical Laboratories is the largest chain of private standalone medical laboratories in GCC region with 57+ laboratories and more than 17+ years of providing medical laboratory services in Saudi, UAE, Qatar, Kuwait, Oman, Bahrain, Sudan and Ethiopia.

Dr. Sameh is a highly accomplished and visionary healthcare executive offering over 23 years of proven success. His success is a result focused and effective leadership with proven ability to deliver and sustain revenue and profit. He possesses excellent, strong business acumen and comprehensive knowledge of the laboratory diagnostic marketplace. He succeeded to maintain an exemplary network of business associates through outstanding communications and interaction with senior leadership.

Dr. Sameh ensures the commitment of Al Borg Medical Laboratories to making a major contribution to excellence in patient care throughout the Middle East by using modern techniques inside the lab and modern concepts of management. Al Borg Medical Laboratories are committed to advance and support the competency in medical knowledge, practice-based learning, communication skills and safety to our staff as well as our clients.

Al Borg laboratories are accredited by the College of American Pathologists (CAP), ISO 15189 and the Joint Commission International (JCI). This is an international recognition of the laboratory commitment to quality, competency and reliable test results.

Janet KreizmanChief Executive Officer, American Association for Clinical Chemistry, Washington DC, USA

Janet Kreizman has served as AACC’s Chief Executive Officer since 2013. Janet brings 30 years of association management and public policy expertise to AACC. During Janet’s tenure, AACC has grown its Annual Scientific Meeting & Clinical Lab Expo, enhanced its advocacy and outreach efforts to raise awareness and visibility of the laboratory medicine field, added a new major laboratory medicine journal to its publishing enterprise, and has broadened its engagement with organizations outside of the U.S.

Prior to joining AACC, Janet served in senior leadership positions at the Endocrine Society and the American Medical Directors Association, and as public policy staff for three other associations in Washington, DC.

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Rania Bedair, MD, PhD Al Borg Medical Laboratories, Saudi Arabia

Dr. Rania Nabil Bedair is a lecturer of Chemical Pathology in Medical Research Institute, Alexandria University. She is currently the head of Molecular Diagnostics, Analytical Chemistry and Newborn screening units in Al Borg Medical Laboratories, HQ, KSA.

After graduating from Alexandria University School of Medicine in 2003, Dr. Rania had joined the Chemical Pathology department as a resident where she completed her clinical attachment and got her Masters and MD degrees in Chemical Pathology. She was appointed as an assistant lecturer, then a consultant and a lecturer of Chemical Pathology in Alexandria University. She joined Hassab Medical laboratories in 2006 where she was a member of the team responsible for achieving the ISO 15189 accreditation. In Hassab labs, Dr. Rania was appointed as Head of immunoassay unit, Head of Molecular Biology unit then Technical manager for all technical departments.

Dr. Rania has attended and participated in numerous scientific conferences and workshops in the field of laboratory medicine and Molecular Biology and has publications in reputable peer-reviewed journals.

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Stephen Becker Executive Director, Advanced Diagnostic Solutions, Global Markets Quest Diagnostics

Stephen Becker is currently the Executive Director, Advanced Diagnostics Solutions, Global Markets, for Quest Diagnostics, Inc. Prior to this role he was the Executive Director, Neurology Solutions, Quest Diagnostics. He came to Quest through the acquisition of Athena Diagnostics, a leader in rare disease and neurological molecular diagnostics where he was the Executive Director of Sales and Marketing. During his tenure with the neurology business of both Athena and Quest he oversaw the development and market release of over 100 molecular diagnostics assays for neurology and other rare genetic disorders. Prior to Athena, he was Executive Vice President of Commercial Operations at RainDance Technologies, Inc., Other past employers where he held leadership positions included Agilent Technologies, GE Healthcare, Amersham Pharmacia Biotech, Spectrum Chemicals, and Coulter Diagnostics.

From a technology perspective Mr. Becker has deep expertise in molecular diagnostics technologies such as Next Generation Sequencing, Chromosomal Microarray, Mass Spectrometry, Proteomics and Bioinformatics. He was directly involved with the human genome project. His passion lies with bringing technologies such as these to the bedside, providing personalized and precision medicine solutions delivering better outcomes for patients.

Challenges in healthcare - The value of integrated diagnostic information servicesThe new healthcare consumer is becoming more informed. Accessing and delivering healthcare at the right time, in the right place, and at the right cost provides efficiencies. Integrated diagnostic information services along the care continuum provides value for various stakeholders: consumers, employers/employees, providers health plans and government payers, and hospital systems.

The aim of this session is to review global healthcare trends facing laboratories, and the healthcare systems they support; to illuminate strategies that develop and deliver innovative solutions; that help physicians manage patients continuum of care with a disease; to highlight data integration: lab, clinical data, medical diagnostics, engagement, decision support, and medical services to uncover important insights to focus on implementation science as a path forward for the community.

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Rodney W. Forsman, BSAsst. Professor Emeritus, Laboratory Medicine and Pathology, College of Medicine, Mayo Clinic Secretary/Treasurer Clinical Laboratory Management Assn.

Spanning the past five decades, Rod Forsman was a member of the Department of Laboratory Medicine and Pathology at Mayo Clinic in Rochester, MN. He has participated in the expansion of that laboratory practice from a local outreach program to one serving thousands of hospitals worldwide. His roles have touched on nearly every aspect of laboratory service from technical operations to administration. Rod has met with laboratorians and C-level hospital administration in all 50 states and observed their unique challenges while communicating successful approaches to capitalizing upon outreach development opportunities for their own laboratories. He has directed a three day ACCME accredited workshop on the subject of “Community Laboratory Insourcing” which convened 25 times since 1996. These workshops have been attended by nearly 2,000 physicians, administrators and managers.

Rod has delivered more than 500 lectures to national professional meetings on various aspects of laboratory management. He is recognized as a tireless communicator of the value of the clinical laboratory in medicine and has lectured to audiences in Portugal, South Africa, Russia, Mexico, Germany, Canada and the U.S. on that subject. He has more than 50 publications on scientific and management topics.

He actively participates in laboratory advocacy efforts together with the Clinical Laboratory Coalition, the Clinical Laboratory Management Association and the American Association for Clinical Chemistry. He has been a member of the AMA Molecular Pathology CPT coding workgroup, the Mayo Public Affairs-Federal committee, The AACC Government Relations Committee, the CLMA Legislative Compliance and Regulatory committee and coordinated quality assurance, licensure, accreditation and legislative affairs for the department of laboratory medicine and pathology at Mayo Clinic.

Laboratory Management EssentialsThe Leadership Team: Contributing to Organizational HealthHealthy organizations create a culture of selling ideas rather than autocracy. Building a cohesive team requires discipline in modeling desired team behaviors. The successful team creates clarity around business objectives and communicates to employees the why, how, and what of achieving organizational goals.

Influencing Your Leadership TeamThe role of management is to optimize the return on resources entrusted to it. Your effectiveness as a laboratory manager is dependent on your ability to positively influence your leadership team. It is important for you to recognize your role and to understand each individual member’s perspectives. You can then tap into various approach styles to overcome barriers, build consensus, and influence decision making. The presentation will draw from over 30 years of experience working with C-level health care teams.

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Shahinaz Bedri, MD, FCAP Dr. Bedri is an Adjunct Assistant Professor of Pathology and Laboratory Medicine at Weill Cornell Medicine in Qatar. She received her MD from the University of Khartoum and completed her postgraduate training in Pathology at both Tufts University, and Harvard Medical School where she completed a three-year fellowship in cardiac pathology. She is a board certified anatomic pathologist with more than fifteen years experience in diagnostic surgical pathology with a focus on breast, reproductive oncologic pathology, and immunohistochemistry. Her clinical and research interests are in translational research in particular in both breast and cervical cancer and she has more than twelve years of experience running translational core facilities and studies.

Her current research focuses on the tumor microenvironment in breast cancer and the role of tumor infiltrating lymphocytes. Dr. Bedri also conducts research on the role of cytotoxic CD8 T:

- lymphocytes within the tumor environment and specifically their role as a prognostic marker of disease; and,

- free survival in breast cancer. She is also involved in the development of an Immunoscore for invasive breast cancer as a prognosticator.

She is a member of the Immunoscore Task Force, an international consortium of scientists and physicians. Her research in cervical cancer focuses on identifying surrogate biomarkers of cervical neoplasia in low-income settings and in cervical cancer screening. She is also currently focusing on TIL in patients with HPV related cervical cancer as a survival prognisticator.

Screening for Cancer in the MENA region, recommendations and controversiesThe presentation will initially focus on an update of the WHO guidelines for cancer screening within the MENA region as compared to other regions such as western countries and focusing on specific cancers such as: Breast, Cervix, Colorectal and Prostate cancers with other honorable mentions.

Following the introduction we will focus on the background of cancer in the region, facilities, and show examples of specific cancer such as breast and cervix as examples of how recommendations and

controversies differ regionally. The focus of the talk will be on the use of biomarkers for cancer screening and their availability, reliability, efficacy etc.

Cancer screening biomarkers will be defined as those that can be objectively measured as reliable indicators of cancer. Examples of those maybe fluid as well as tissue biomarkers and those such as radiological parameters etc.

The presentation will depend on a peer review of medical publications and other sources.

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Omalkhair Abulkhair, MD, PhD Dr. Omalkhair Abulkhair is currently the Chairman of Hematology/Oncology Department in the Specialized Medical Center Hospital – Riyadh, Kingdom of Saudi Arabia and Assistant Professor in King Saud bin Abdulaziz University for Health Sciences. She is also currently appointed as Chairman for Breast Cancer Research at King Abdullah International Medical Research Center (KAIMRC), Riyadh.

Being one of the renowned oncologists in the Middle East, she was nominated to be part of the Women in High Places: Fight Against Cancer, an international organization of prominent women in their respective areas. She is the Course Director of major symposia which is the “Middle East Best of San Antonio Breast Cancer Symposium” and “Cancer Prevention and Early Detection Symposium.” She was also selected as the Chairman for MENA-NCCN Guidelines Committee for Breast Cancer. This committee aims to unify the guidelines for breast cancer management in the region. Furthermore, Dr. Abulkhair has written numerous publications and abstracts which leads to receiving three awards for best abstract. She has also contributed as speaker and chairperson to various conferences she has attended.

Addressing familial and hereditary breast cancer in different cultural environments - the Saudi Arabia experienceThe most common cancer among Saudi female is breast cancer which represents 27.4% of all newly diagnosed malignancies with regional variations. The highest rate in age group of 30-44 years and more than 40% at advanced stage. Moreover, it is considered the most important cause of death in Saudi age group and estimated that by year 2025, the incidence will reach 35% and mortality of 16% considering the natural growth and aging of country population. While majority of breast cancer are sporadic, familial susceptibility to breast cancer accounts for 25% of all cases BRCA 1 and BRCA 2 explains 20-25% of the hereditary breast cancer and 5-10% of all breast

cancer. The average cumulative risk of developing breast cancer in BRCA 1 and BRCA 2 mutation carrier by age 70 years estimated to be 65% and 45% respectively. The prevalence of BRCA 1 and BRCA 2 germ line mutations varies among ethnic group and among geographical area’s population, specific mutations have been described. Although Saudi Arabia population especially in the central, eastern and south regions are homogeneous and consanguinity are very common, prevalence of BRCA 1 and BRCA 2 as well as disease characteristics are not well studied. Available evidence is conflicting and not conclusive.

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Rania Medhat Seliem, MDDr. Seliem did her Anatomic and Clinical pathology Residency in Baystate Medical Center, Tufts University, USA after doing two years of research in Columbia University in St. Luke’s Roosevelt hospital in New York City. She then joined Massachusetts General Hospital, Harvard Medical School as a Senior/Chief resident in Anatomic and Clinical pathology then completed both Surgical Pathology and Hematopathology Fellowships in the same institution. She successfully obtained the American Board in Anatomic/Clinical Pathology and Hematology in 2005 and 2006.

She joined the Pathology and laboratory medicine department in Dubai Health Authority as a Hematopathology consultant and has been appointed as the chair of Rashid Hospital Pathology Department and hematology unit since December 2006.

Dr. Seliem has several publications in the field of hematology, especially neoplastic hematopathology. She is the chair of several scientific committees and the scientific chair of the Emirates Society of Hematology (ESH) since 2012. She also holds an academic position in Dubai Medical college as an associate professor. Her main areas of interest are Neoplastic Hematopathology and Flow Cytometry and she is especially interested in improving the health care practices and quality standards in the United Arab Emirates.

Stepping Out From The Shadows; Disclosure Of Errors In Pathology And Laboratory MedicinePatient safety emphasizes the reporting, analysis, and prevention of medical errors. Pathologists have been shifting the burden of disclosure to the treating clinicians. We need to seriously consider how, and by whom, our errors as pathologists are to be dis-closed. Efficient communication systems need to be developed on the organizational and national levels to help the pathologists and laboratory directors to

comply with the international guidelines of disclosure. In this presentation; evaluation of errors that arise in pathology and medical laboratories will be discussed with categorization of the errors and an overview of methods for their reduction. A literature review of the role of the pathologist in the error disclosure process will also be discussed with details.

Myelodysplastic Syndromes Diagnostic Challenges and Helpful HintsMDS diagnosis is complex, very challenging and requires a systemic approach to arrive to the best classification. The pathologist plays a central role in diagnosis MDS and must supplement the morphologic evaluation with ancillary studies to arrive at the correct diagnosis in addition to his/her knowledge of the clinical details and close communication with clinical colleagues. In this

presentation the use of a multidisciplinary approach to work up MDS cases is detailed with emphasis on a pragmatic approach for the diagnosis, diagnostic challenges, and pitfalls. MDS mimickers and unique types will also be highlighted with key clues for the diagnosis. In addition, an Overview of the 2016 WHO revision for MDS classification will be outlined along with this revision’s impact on the diagnosis.

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Amina Hassab, MD, PhD Professor of Clinical Pathology Alexandria University, Egypt

Dr. Amina Hassab obtained her bachelor degree of Medicine and Surgery from Alexandria School of medicine in Egypt. She then obtained her masters degree in Microbiology and Immunology from Oklahoma State University (OSU ) in USA where she was appointed as teaching assistant from 1976 up to 1979 teaching graduate students Immunology & Virology Courses. In 1988, she obtained her doctorate degree in Clinical and Chemical Pathology. From 1998 till 2005, Dr.  Hassab had contributed to the establishment and development of the immunology laboratory in the Clinical Pathology department. She was appointed as manager of all laboratories and Chairman of Clinical and Chemical Pathology department in Alexandria Faculty of Medicine. She managed to improve the methods used back then from manual to automation together with introduction of Lab Information System. She then focused on the improvement of the quality of performance. She directed a series of workshops from 2006 till 2017 aiming to spread the culture of quality performance among laboratory professionals in Egypt. This education led to the pursuit of accreditation by many labs in Egypt.

The WHO is New: Updates to the diagnosis, risk-stratification, and management of Polycythemia VeraPolycythemia Vera (PV) is a stem cell disorder cha-racterized as a panhyperplastic, malignant, and neo-plastic marrow disorder. Its most prominent feature is an elevated absolute red blood cell mass because of uncontrolled red blood cell production. Other disease features include leukocytosis, splenomegaly, throm-bosis, bleeding, microcirculatory symptoms, pruritus, and risk of leukemic or fibrotic transformation.

PV is defined by a JAK2 mutation, whose absence, combined with normal or increased serum erythro-poietin level, makes the diagnosis unlikely. Risk fac-tors for survival include advanced age, leukocytosis, and thrombosis. Leukemic transformation rates at 20 years are estimated at <10% fibrotic transformation rates are slightly higher.

Current risk stratification in PV is designed to es-timate the likelihood of recurrent thrombosis: high--risk is defined by the presence of age >60 years or presence of thrombosis history; low-risk is defined by the absence of both of these two risk factors. Recent data consider JAK2V617F and cardiovascular risk factors as additional risk factors.

The main goal of therapy in PV is to prevent throm-bohemorrhagic complications. In low risk patients, this is accomplished by the use of low-dose aspirin and phlebotomy (hematocrit target <45%) in PV. In high risk (for thrombosis) patients, treatment with hydroxyurea is additionally recommended. Treatment with busulfan or interferon-α is usually effective in hydroxyurea failures and the additional value of JAK inhibitor therapy in such cases is limited.

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Jeanne Mumford, MT (ASCP) Pathology Manager, Point of Care Testing, KEYPOCC President 2017, Johns Hopkins Medicine, Department of Pathology

Jeanne Mumford is currently the Pathology Manager over Point of Care Testing for Johns Hopkins Medicine, including two academic hospitals, three community hospitals and around 60+ ambulatory physician offices.  She obtained a Bachelor of Science in Medical Technology in 2000. She is the current President of KEYPOCC--Keystone Point of Care Coordinators.

Over the last 17 years, she has worked in various roles in laboratory medicine, including transfusion medicine, immunology, special chemistry, and laboratory management.  Ms. Mumford offers years of experience in regulatory oversight, quality assurance projects, and laboratory inspection preparedness and planning. 

She was part of the team responsible for building the laboratory files and implementing a universal EMR for Johns Hopkins Medicine. 

Her team of point of care coordinators works closely with providers across the enterprise to support patients’ needs by engaging, educating, and evaluating clinical testing personnel.

Expanding Point of Care Testing In Health Care Systems for Patient Centered CarePart 1: Getting StartedPoint of Care (POC) testing is evolving and the ex-pansion of POC testing to support patient centered care within growing healthcare systems presents new challenges and opportunities for POC testing man-agement programs. Amid modern models for patient care practices there are new opportunities for poten-tial POC testing expansion in novel applications and clinical integration. This session will discuss those practices used to standardize diverse clinical settings and review some successes and failures of one such healthcare system.

Part 2: Maintaining StandardsMaintaining regulatory standards and harmonizing workflows in a growing health care enterprise pres-ents many challenges. One key to a smooth transi-tion in an expanding health care system  is recog-nizing strengths and working collaboratively with representatives from each facility. This session will teach key considerations for building multidisciplinary teams and approaches to meaningful communication amongst these teams.

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Ola Elgaddar, MD, PhD, MBA, CPHQDr. Ola Elgaddar is a lecturer of Chemical Pathology, and director of the quality assurance unit, Medical Research

Institute, Alexandria University, Egypt. After obtaining her bachelor of medicine and surgery from Alexandria University Faculty of Medicine, she started her fellowship in the Chemical Pathology department in the Medical Research institute teaching hospital. She obtained a master degree, then a PhD in Chemical Pathology and she was appointed a lecturer position in the same academic department.

Dr. Elgaddar started her career in management with a certified professional in healthcare quality from the National Association of Healthcare Quality (NAHQ), followed by a master in business administration and a green belt in lean six sigma methodology. She has a long experience in setting and monitoring quality systems in all healthcare settings with a special interest in medical laboratories. She is a quality consultant and trainer who integrates an academic background with a strong practical experience to deliver the required knowledge and skills to staff working in medical laboratories applying for accreditation, or to those labs that are accredited already and working on improving their quality systems.

Laboratory self-inspection is a check of one’s own physical space, processes, and practices to identify unsafe conditions. This presentation aims to explain the value and importance of the interim self-inspection, apply best practices to prepare for your interim self-inspection to describe how the interim self-inspection will improve lab quality, patient and employee safety, and prepare you for an unannounced on-site inspection.

What you may find during an interim self-inspection is that your in-house inspector tends to find more deficiencies than an outside inspector when a section of the laboratory is inspected. The inspector from your laboratory knows where to look for deficiencies! It is a best practice to look for new opportunities for improvement.

The purpose of the self-inspection is to comply with CAP standards and current checklist requirements, to prepare for the next on-site inspection, and to provide better patient care.

Improving the Quality and Value of the Laboratory Self-Inspection

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Sahar El-Wakil, MD, PhDDr. Sahar El-Wakil was born in Cairo, Egypt; she received her Bachelor’s degree in internal medicine & general surgery, her Master’s degree in clinical and chemical pathology and her Doctoral degree in hematopathology from Faculty of medicine, Cairo University.

She studied laboratory quality management and earned a Capstone certificate in laboratory Quality Management from Wisconsin University School of Medicine and Public Health, Madison, WI.

She interned and served her residency of clinical pathology in faculty of medicine, Cairo University and also served as registrar, researcher and consultant hematopathologist at Cairo university hospitals.

She moved to Saudi Arabia and joined Saudi German hospital where she worked for ten years as consultant hematopathologist, laboratory quality manager, and clinical laboratory director.

Currently she is working as consultant hematopathologist, clinical laboratory and blood bank Chairperson in Dr. Soliman Fakeeh hospital in Jeddah.

She has many nationally and internationally published scientific researches, her research interests focus on hematopathology, blood bank and laboratory quality management.

She has presented several workshops, lectures and seminars in laboratory quality assurance, quality control, method validation and quality planning.

KPIs-Integrating the balanced scorecard with lean six sigma metrics in clinical laboratoryQuality in laboratory has huge impact on diagnosis and patient management as about 80% of all diagnosis is made on the basis of laboratory tests. Improving how test results are managed and communicated to patients can help laboratories achieve savings in staff time and can improve the quality of care.

Key performance indicators (KPIs) have been developed to assist laboratories in demonstrating their contribution to patient management pathways. KPIs are a company’s measurable goals, typically tied to an organization’s strategy, as revealed through performance management tools such as the Balanced Scorecard.

The balanced scorecard approach includes lagging and leading indicators across the four perspectives: financial, customer, internal processes, and employee learning and growth.

Laboratory errors are classified as pre pre-analytical, pre-analytical, analytical, and post-analytical to measure errors objectively; six sigma adopts a scientific model for problem solving (DMAIC) which emphasizes the use of data to make an objective assessment of quality. Six sigma helps in discovering customer perceptible defects and works to quantify and eliminate them.

These two performance systems can be successfully implemented together into one organization. Using the BSC to focus on developing mission, strategic goals, key performance indicators, and to link them to specific operational initiatives while using Six Sigma to provide a solid performance improvement framework, by utilizing the DMAIC approach: define, measure, analyze, improve, and control.

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Ashish Kumar Bhatia, MDMasters in Science - Healthcare Management from Swansea University, Swansea, Wales 2015Post Graduate Diploma in Business Administration from Institute of Management Technology, Ghaziabad 2004Diplomate of National Board - DNB (Pathology) from National Board of Examinations, New Delhi 2000Diploma in Clinical Pathology – DCP from Department of Pathology, AFMC, Pune 1998Bachelor of Medicine & Surgery from MSR Medical College, Bangalore 1994

Dr. Bhatia has 17 years experience as a Pathologist (General) with having a profound experience in evaluating feasibility and suitability of various healthcare projects, leading to its timely completion including the establishment of processes for their successful operations. The wealth of expertise also includes New Business Development, New Lab Set-Ups, Sales & Marketing, Administration, Training & Development as well as Quality Control & Assurance.

Dr. Bhatia is a strong believer that the right mix of leadership style can lead the healthcare team towards establishment of an error free working environment along with deployment of effective and efficient human and work processes. In addition, Dr. Bathia is a Certified Internal Auditor for ISO 15189:2012, Dubai Accreditation Council, Dubai, UAE and Certified in Six Sigma Green Belt, BSI.

Reducing Medical Errors - A Six Sigma ApproachIntroduction

Six Sigma is a business management strategy com-monly used in production industries to improve pro-cess efficiency and quality. During the past decade, these process improvement techniques increasingly have been applied outside of the manufacturing sec-tor, for example, in health care.

This presentation concerns the potential use of Six Sigma to improve the processes involved in a clinical laboratory setting whereby its use in interpreting the key performance indicators is highlited and improv-ing the rate of errors to go down. Errors in healthcare result in part from poorly designed complex systems. Improving quality, reducing errors, and speeding up the turn around time for results are prime objectives of any clinical laboratory and at the same time of this presentation.

Methods

This presentation presents a description of the main principles, practices, and methodologies used in Six Sigma. Specific examples of laboratory key perfor-mance indicator(s) have been used and they have been presented in a manner that is concerning the use of these six sigma techniques to make interpreta-tion and decision making more useful.

Conclusions

Six Sigma process improvement methodologies are well suited to help achieve a goal of making clinical laboratory more efficient and cost-effective, enhanc-ing the quality of the services of the laboratory.

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Andrea Ferreira-Gonzalez, PhD Chair of the Division of Molecular Diagnostics, Department of Pathology, Virginia Commonwealth University Health System

Andrea Ferreira-Gonzalez, PhD, was appointed Chair of the Division of Molecular Diagnostics, in the Department of Pathology at the Virginia Commonwealth University Health System in July 2008. She has also been the director of the Molecular Diagnostics Laboratory at the VCU Health System since 1994.

Dr. Ferreira-Gonzalez has devoted over 25 years to the field of Molecular Diagnostics and has been recognized nationally and internationally for her work in this field. Dr. Ferreira-Gonzalez is an expert in molecular diagnostics in the area of genetics, oncology, personalized medicine, pharmacogenetics and infectious diseases.in transplantation. In addition, Dr. Ferreira-Gonzalez has played a major role in shaping national policy regarding the practice, reimbursement and guideline development for molecular diagnostics and molecular genetic testing.

At the national level, Dr. Ferreira-Gonzalez is a consultant for the US Health and Human (HHS) Secretary for the FDA’s Clinical Genetics Panel of the Medical Devices Advisory Committee, Center for Devices and Radiological Health. She served in the HHS Advisory Committee on Genetics, Health and Society (SACGHS) where she was the Chair of the SACGHS Task Force on Genetic Testing Oversight and on the Personalized Healthcare Workgroup. She also served as a member of HHS Clinical Laboratory Improvement Advisory Committee. She has been involved in the development of clinical guidelines with the Clinical Laboratory Standard Institute and Association for Molecular Pathology (AMP). Dr. Ferreira-Gonzalez also served as President of AMP and Chair of the Professional Relations Committee and currently the treasurer for the same organization. More recently, Dr. Ferreira-Gonzalez was approached by the White House Science and Technology Office to serve on the Department of Justice and National Institute of Standard and Technology National Commission on Forensic Sciences. Dr. Ferreira-Gonzalez serves as a member of the Molecular Biology Education Committee for IFCC.

Dr. Ferreira-Gonzalez has over 90 peer reviewed publications in journals of high impact such as New England Journal of Medicine, Clinical Chemistry, Journal of Molecular Diagnostics, Blood and Cancer Research. She also is the author of 11 chapters in books related to the practice of Molecular Genetics. Dr. Ferreira-Gonzalez received her PhD degree from the George Washington University in Washington DC in 1994 and previously a master degree in Clinical Biochemistry from the National University of Cordoba, Argentina and she is board certified by the American Board of Bioanalysis as High Complexity Laboratory Director and Clinical Consultant.

Clinical Applications of Next Generation SequencingNext Generation Sequencing (NGS) in Clinical Practice: Genomic sequencing technology is transforming diagnostics by enabling genetic based profiling for inherited disease and cancer patient management and therapy selection. Their complexity  and scope of Next Generation Sequencing technology (NGS) re-quires not only substantial knowledge and expertise but also an evolving framework for test design, valida-tion and implementation.  This presentation will review the current state of clinical NGS technology including aspects of assay validation, bioinformatics infrastruc-ture, interpretation, and reporting.

Next Generation Sequencing (NGS) in Clinical Oncology Next generation DNA sequencing technology is revo-lutionizing precision cancer medicine by improving di-agnosis, prognosis and directing molecularly targeted therapies. Adoption of NGS brings unprecedented challenges in incorporating this technology in clini-cal setting. This presentation will provide a compre-hensive overview on the key practice guidelines and challenges in the implementation of clinical NGS in oncology.

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Ali Alothaim, MB, BS, D.E.S., D.I.U.French board in Chemical Pathology – Biochemical Genetics

Currently Head Division Toxicology – Biochemical Metabolic lab at King Abdulaziz Medical City and Assistant Professor in King Saud Bin Abdulaziz University for Health Science. Dr. Alothaim graduated from Paris Descartes University in France with French Board in Specialized Clinical Chemistry and further sub specialized in Metabolic Biochemistry (Inborn Errors of Metabolism). Upon his return from Scholarship in 2011, he participated in implementation of Newborn Screening Program and testing at National Guard Hopsital in Riyadh.During his scholarship in France, he rotated in all the reference centers of metabolic disorders in Paris like Necker Hospital, Robert Debree Hospital and Saint Loius Hospital.

Current Status, challenges and future Perspective of Newborn Screening programs in the Kingdom of Saudi Arabia Newborn screening began in the early 1960s and during the four decades it has become a recognized vital public health prevention program. It has evolved conceptually from a laboratory test for a single disorder, phenylketonuria, to a comprehensive 6-part public health system of education, screening, follow-up, diagnosis, management, and evaluation.

The need for early detection and early start of management is of paramount importance, the time factor could not be ignored, for these reasons

neonatal screening programs are very important in identifying these infants, diagnose them and report them in a considerable time to prevent morbidity and mortality which will be the natural end point.

Newborn screening in different countries has been successful because of the efforts of a single individual or group of individuals interested in improving the health of children. This presentation aims at addressing the current and future status of Newborn screening programs in Saudi Arabia.

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Nigel J. Clarke, PhDVice President, Advanced Technology and Solution Development. Quest Diagnostics Nichols Institute

Dr. Clarke received his Ph.D. in Mass Spectrometry and Analytical Chemistry from the University of Kent at Canterbury in England, and completed postdoctoral fellowship training in Biomedical Mass Spectrometry at the Mayo Clinic in Rochester, MN. He was a Principle Investigator at the Schering-Plough Research Institute in Kenilworth, NJ where he ran the drug discovery metabolite identification group and worked at ActivX Biosciences (a biotechnology company) as Director of Mass Spectrometry before joining Quest Diagnostics Nichols Institute.

At Nichols Institute, Dr. Clarke is the Vice President for Advance Technology and Solultion Development overseeing R&D groups which develop the LC-MS/MS and Immunology assays utilized across Quest Diagnostics. His staff is involved in training visiting scientists from other Quest Diagnostics business units, adopting the new technology and assays developed in Dr. Clarke’s laboratory. He also oversees the running of LCMS assays across multiple operations laboratories within the Quest network.

Dr. Clarke is involved in several academic collaborations with groups at multiple sites including Cedars-Sinai, the CDC and Massachusetts General Hospital and UCSF, utilizing the LC-MS/MS assays he and his group have developed to create and refine standardized reference ranges for both clinical studies and diagnostic usage.

He has published widely on his use of mass spectrometry in a variety of biological arenas, is a reviewer for multiple journals and received multiple awards including the Michael Barber Award for Mass Spectrometry, The President’s Award for Discovery from the Schering-Plough Research Institute and the Medical Innovations Award from Quest Diagnostics.

The increasing role of Mass Spectrometry in the Clinical Diagnostic LaboratoryLiquid Chromatography Tandem Mass Spectrometry (LC-MS/MS) has become a major technique in the diagnostic field over the last 10 years. It has been ac-knowledged as superior to many existing automated platforms, direct RIAs and even some extraction RIAs by professional societies including the Endocrine So-ciety. The technique affords greatly increased speci-ficity and sensitivity compared with traditional meth-odologies but is poorly understood outside the world of the esoteric diagnostic testing labs at present. This is partly due to its very recent emergence on the di-agnostic landscape, but mainly to it being a physio-chemical measurement rather than a biologically based system. Most medical professionals are very familiar with antibodies and their mode of operation,

but not LC-MS/MS as it is currently rarely covered in medical or med tech courses.

With this in mind the presentation will address the concepts and technologies involved in obtaining the results; how does a mass spectrometer work, what are the advantages of the technique, what are the disadvantages and how are they avoided. To do this a series of LC-MS/MS assays will be discussed in-cluding those for testosterone, 25-OH Vitamin D and Plasma Renin Activity highlighting the differences in results gained between various common techniques and LC-MS/MS. Discussion as to how these results may impact patient care or diagnosis will be present-ed.

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Felicitas L. Lacbawan, MD, FCAP, FACMGG Felicitas L. Lacbawan, MD, FCAP, FACMGG is the Medical Director of Genetics and Advance Diagnostics, VarIQTM (Variant Annotation), and Oncology (Germline) at Quest Diagnostics, Nichols Institute. Dr. Lacbawan is board certified in four medical specialties, ABMG-ABP Molecular Genetic Pathology (MGP), ABMG Clinical Genetics, ABP Anatomic Pathology, and ABP Clinical Pathology. The combination of her academic, clinical and research experiences is uncommon and she has been in the genetics and genomics field for 20 years. She served as a faculty member in various medical institutions with highest rank of Clinical Professor. Prior to joining Quest in 2015, she was the Section Head of Molecular Pathology at the Robert J Tomsich Pathology and Laboratory Medicine Institute, Cleveland Clinic with responsibilities of Chair of the Department of Molecular Pathology after its reorganization. She led the reorganization and launched an unprecedented number of in-house developed molecular tests as well as process improvements in genetics and genomics, hematopathology, oncology, and cytogenomics. She initiated the genetics/genomics test review (GGTR) utilization management (UM) and led the accreditation of the MGP Fellowship program of the Clinic. She established and directed two other accredited molecular genetics and molecular pathology laboratories. She held various clinical and academic leadership positions at the National Human Genome Research Institutes (NHGRI)-National Institutes of Health (NIH), Children’s National Medical Center (CNMC), George Washington University School of Medicine and Health Sciences, SUNY-Downstate College of Medicine and Lombardi Cancer Center, Georgetown University Medical Center. She practiced clinical genetics for more than 10 years in hospitals within the metropolitan Washington, DC area and conducted clinical genetics research and bench work at NHGRI-NIH and CNMC under an NIH interagency agreement. She remains a special volunteer with the Undiagnosed Disease Program of the NIH to this day. Her research and scholarly work are on clinical molecular genetics and molecular pathology, including neurologic, developmental, connective tissue and vascular disorders, chromosomal anomalies, pharmacogenomics, cancer, laboratory proficiency, test verification, and GGTR and UM. She served on expert panels in the various national and international meetings, committees and working groups of professional societies, regulatory and prominent government organizations and the healthcare industry including the CAP, ACMGG, CDC, Roche Molecular Center of Excellence, CLSI, and NCI-NIH Think Tank.

Advances in Pre-Natal Genetic ScreenThe performance of cell-free DNA (cfDNA) testing for fetal aneuploidies is now widely used for core trisomies. Understanding the principle of the test and its limitations will explain the breadth of clinical applications of non-invasive prenatal screen (NIPS). This session will review the technologies utilized in NIPS and the factors that may influence assay

accuracy. Various efforts to improve NIPS accuracy and expand its utility will be highlighted.

This aim of this presentation is to review the principle of cfDNA testing, enumerate the clinical applications of non-invasive prenatal screen, and discuss the advances and expanded utility of cfDNA testing.

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Hisham Shams Maher, MD, PhD Group Medical Director of Al Borg medical laboratories in the GCC

Dr. Hisham obtained his Bachelor degree of medicine and surgery from Kasr El-Aini School of Medicine in Cairo University, followed by a residency of Clinical Pathology, and subsequently a Clinical Master’s degree and Clinical PhD in Clinical Chemistry. He worked as a fellow in the National Cancer Institute, Cairo University, and as a Medical Director of laboratory medicine department in Saudi German Hospital-Jeddah.

He is currently the Group Medical Director of Al Borg Medical Laboratories in the GCC. He is also the Head of the accreditation compliance department in the same organization.

Dr. Hisham has publications the field of hematology and was a speaker in many events. Of the topics he likes to talk about is the laboratory preventive role in healthcare.

Cervical cancer screening, new thinking, new choicesAround the world, each year, more than half a million women suffer from cervical cancer, and almost half of them will die. This was proved preventable with regular screening and early treatment.

The vast majority of women who develop cervical cancer are either under screened, or never screened at all.

A first look at the prevalence of cervical cancer in the Middle East, as being very low, in most of the Middle East Countries, can be misleading. However, knowing that there is not a national screening program, and that a few number of women have regular screening, highlights the fact that more structured data is need in order to conclude an accurate prevalence.

For several years, pap remained the only tool that was used to screen for cervical cancer.

As tools used to communicate with each other change with time, it is time for doctors and their patients to think about the HPV test as a diagnostic toll that can be used as: a first line of defense alternative to pap; or, as a reflex test; or, as a co-test.

There are different strategies that exist and it is really a hot spot that is seeing many changes. However, the bottom line is that a pap alone should not remain a choice.

This presentation will shed light on the changing technologies in the field of cervical cancer screening, the studies that compare their sensitivities and specificities, and the new studies that suggest different screening strategies. Self testing as a way to increase screening take up will also be discussed in brief.

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Laila O. Abdel-Wareth, MBBCh, FRCPC, FCAP, EMHCADr. Laila Abdel-Wareth is currently the Chief of Clinical Pathology at the Pathology & Laboratory Medicine Institute at Cleveland Clinic Abu Dhabi. Graduated as a medical doctor from Faculty of Medicine, Ain Shams University Cairo, Egypt she then went ahead and did her post graduate training at the University of British Columbia, Canada and obtained the Canadian and American boards in Medical Biochemistry and Clinical Pathology respectively. She also obtained a Masters Degree in Health Care Administration (EMHCA) from Zayed University, UAE.

Dr. Abdel Wareth’s previous employment was at British Columbia Children’s & Women’s Hospital in Vancouver, Canada, followed by Mafraq & SKMC hospitals in Abu-Dhabi. Her last appointment prior to joining CCAD was as a Chief Medical Officer of Pathology & Laboratory Medicine Services at SEHA and the Chair of Pathology & Laboratory Medicine Department at Sheikh Khalifa Medical City. Abu Dhabi, UAE.

She is an active member in various scientific societies and has several publications to her credit in the field of laboratory medicine. Dr. Abdel-Wareth is a recipient of Dr. Arthur Bloomfield Award for Excellence in Medical Education as well as Sheikh Rashid Award for Scientific Outstanding.

Diagnosing Diabetes with HbA1c in Sickle Cell Trait PatientsDiabetes mellitus (DM) is a common chronic disorder. Glycated hemoglobin has a key role in the assess-ment of glycemic control. A1C is the non-enzymatic gycated product of the Hb beta-chain at the valine terminal residue. The A1C accounts for about 60 – 80% of the total glycated hemoglobin. Hemoglobin A1c (HbA1c) concentration is widely used for routine monitoring of patients with DM. It reflects glycemic control over the past 120 days which is the normal life span of red blood cells. The recent American Dia-betes Association (ADA)) guidelines recommend the use of HbA1c as a diagnostic test for DM. Studies showed that patients with sickle cell trait (SCT) have

lower HbA1c concentrations at any given fasting glu-cose level or 2 – hour postprandial glucose compared with HbA1c concentration among individuals without SCT. This presentation will address the challenges of using HbA1c in patients with sickle cell trait and how it can be addressed in the laboratory in light of the recent ADA guidelines reflecting the potential effect of race and other variables on HbA1c levels. The 2017 guidelines address the effect of those factors on di-agnosis and treatment of diabetes. Clinicians should be made aware of the many factors affecting HbA1c levels, and those should be considered when diag-nosing and treating patients with hyperglycemia.

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Eric Kilpatrick, MB, ChB, MD Professor Eric Kilpatrick is the Division Chief in Clinical Chemistry at Sidra Medical and Research Center and

is honorary full Professor of Clinical Biochemistry at Hull York Medical School in the UK. He is also the former President of the Association for Clinical Biochemistry and Laboratory Medicine in the UK and currently Chairs the Scientific Committee of the European Federation of Clinical Chemistry and Laboratory Medicine.

After graduating in medicine from the University of Glasgow in 1988, Prof. Kilpatrick trained in Clinical Biochemistry in Glasgow and then Manchester before being appointed as the consultant Head of Department of Clinical Biochemistry at Hull Royal Infirmary in 1998. He subsequently led the 250 staff there from all laboratory disciplines as Clinical Director for Pathology.

Academically, he gained his higher MD degree from Glasgow in 1996, with his thesis combining his interest in the laboratory medicine and clinical diabetes. Since then, he has become an international authority on assessing glucose control in diabetes and has published over 150 peer-reviewed articles contributing, in 2006, to him becoming the first honorary full Professor at Hull York Medical School.

Prof Kilpatrick’s other leadership roles include being Chair of national audit in his field of medicine between 2004 and 2010 as well as providing expert advice to the UK Government and the National Institute for Health and Care Excellence (NICE) on aspects of diabetes care.

Prof. Kilpatrick’s work has also led to him to become a seasoned presenter at diabetes and clinical biochemistry conferences, including over 25 international meetings in the last decade. He has additionally gained recognition by receiving international lectures and awards from countries such as the UK, Canada and Australia.

How should we assess renal function in diabetes?Diabetic nephropathy is still the leading cause of renal failure. Accurately predicting and assessing any decline in renal function can lead to early identification of the disease while it is still amenable to intervention aimed at slowing its progression.

Serum creatinine remains the bedrock of renal assessment for most patients either with or without diabetes. In the last decade the test has been refined in its usefulness by standardisation of the measurement. This was followed by its use in formulae to estimate glomerular filtration rate (GFR) more accurately, based at least on the age and gender of the patient.

Even with these developments, there are still inherent limitations to serum creatinine measurement as a marker of GFR. Many of these limitations are not present with another maker called cystatin C. This test can be especially useful in patients where creatinine

is not able to unequivocally determine if a patient has normal or impaired renal function. However, a lack of widespread adoption of standardisation and the cost of the test has hampered widespread adoption so far.

The early stages of diabetic nephropathy are most sensitively detected by the presence of an increased urinary albumin excretion. Spot measurements of the urinary albumin:creatinine ratio have thankfully been shown to be as good a predictor of nephropathy progression as a timed collection. It also adds to eGFR such that a raised urine albumin and reduced eGFR compound the risk of end stage renal disease developing.

Together, these tests have improved how diabetic kidney disease is identified and monitored thereby allowing a more personalised approach to management.

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Waleed Tamimi, PhDKing Fahad National Guard Hospital, Saudi ArabiaPhD in Biochemistry from University of Essex (UK)Fellowship in Clinical Chemistry at Barns Hospital, Washington University, St. Louis, USABoard Certified as consultant from National Registry for Clinical Chemistry (NRCC) (USA)Head of Clinical Chemistry Lab, King Fahad National Guard, Riyadh, Saudi ArabiaAssociate Professor, College of Medicine, King Saud University for Health Sciences, RiyadhPresident of Saudi Society for Clinical Chemistry65+ publications in peer reviewed journals, 45+ poster abstracts

Practical Approaches to validate and Interpret Body Fluids Testing in the Clinical LaboratoryThe body fluids are derived from different organs in the human body and include fluids such as cerebrospinal fluid (CSF), drain fluid, wound fluids, and essentially any other body fluid other than blood or urine. Most body fluids (pleural, peritoneal, pericardial) are collected by physicians and transported to the hospital’s laboratory. Formation of excessive fluid occurs pathologically for a variety of reasons. Pathologic increases in extravascular fluid volume occur due to amplification in either production of the fluid or reduction in the rate of fluid absorption.

It is the responsibility of the clinical laboratory to ensure accurate test results from all body fluids specimens. Therefore, proper analysis of these fluid types is integral to the diagnosis and management

of many pathological conditions. One of the major benefit of body fluid analysis is the differentiation of transudates from exudates for fluids originating from pleural effusions which may aid in the diagnosis and treatment.

The College of American Pathologists (CAP) has added clear requirements to the inspection checklists, which instruct laboratories to validate their assays in order to measure these body fluids samples. However, many questions and issues remain unanswered and unclear. In these presentations, authors tried to address these questions and issues and suggest a practical approach to resolve and find solutions to many of them.

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Khalid Al Rasadi, BSc, MD, FRCPC, ABCL Senior Consultant Biochemist/Lipidologist Head of Biochemistry Department at Sultan Qaboos University Head of Lpid and LDL-Apheresis Unit at Sultan Qaboos University Hospital President of Oman Society of Lipid & Atherosclerosis (OSLA), Muscat, Oman

Dr. Khalid Al Rasadi was born in Oman where he studied medicine and obtained his Medical Degree in 1998. Dr. Al Rasadi obtained his postgraduate training in Medical Biochemistry at McGill University in Canada during 2002-2006. He spent another two years in Canada, working as scientist at the Royal Victoria Hospital, McGill University, under the supervision of Prof. Jacques Genest. There he performed a number of studies on the molecular genetics of familial hypercholesterolemia and hypoalphalipoproteinemia. In that period Dr. Al Rasadi also received training at the lipid clinic of the Royal Victoria Hospital, McGill University. He was also awarded a certificate in Clinical Lipidology by the National Lipid Association in the United State in 2008.

Dr. Al Rasadi is the Head of Department of Biochemistry at the Sultan Qaboos University in Oman and head of lipid and LDL-Apheresis unit at Sultan Qaboos University Hospital. He is one of the founding members of the Oman Society of Lipid and Atherosclerosis (OSLA) and its current President. He is also the founder of the Arab States of the Gulf (GCC) Familial Hypercholesterolemia Foundation and its current President. He contributed significantly to the recognition of OSLA as an active society nationally and internationally by promoting meetings aimed at education and general awareness relating to lipid disorders and atherosclerosis. He organized conferences involving experts in the field of lipid research. His activities include public outreach meetings in Oman. International collaboration has also been initiated via OSLA. OSLA has received the IAS-Pfizer educational grant for the management of dyslipidemia in the Gulf region.

Dr. Al Rasadi is a member of national and international medical associations and a member of Oman Medical Journal and BBA-Clinical Journal editorial board. Dr. Al-Rasadi is an Editor in-Chief, OSLA section in the Open Cardiovascular Medicine Journal. He is an International Atherosclerosis Society (IAS) executive board member and assessor for Fellowships. He has around 68 publications and one chapter book (total Citations 949, H-Index: 12).

Laboratory investigations in Familial HypercholesterolemiaFamilial hypercholesterolemia (FH) is a common ge-netic cause of premature coronary heart disease (CHD), due to lifelong elevated plasma low-density lipoprotein (LDL) cholesterol levels.

The prevalence of heterozygous FH (HeFH) is esti-mated between 1 in 200-500 and the homozygotes FH (HoFH) between 1 in 160,000-300,000. The prev-alence of FH in Gulf and Arab countries is not known.

Diagnosis of FH relies on five criteria: very high to-tal cholesterol or LDL cholesterol on repeated mea-surements, family history, clinical history of prema-ture CHD, physical examination for xanthomas and corneal arcus, and/ or a causative mutation detected by molecular genetics. Secondary causes of hyper-lipidaemia must be excluded by determining that liver

enzymes, renal function, and thyroid hormones are normal and that there is no hyperglycaemia or albu-minuria.

Molecular genetic testing is done to screen for the most common genes known to cause FH like muta-tions in low density lipoprotein receptor (LDLR), apo-lipoprotein B (APOB), proprotein convertase subtilisin/kexin type 9 (PCSK9) and LDLR adapted protein (LD-LRP1). Conventional DNA testing of FH disease–caus-ing genes is mostly based on direct capillary sequenc-ing, with multiplex ligation-dependent probe amplifica-tion (MLPA) used for the detection of large insertions or deletions. During the past few years, high-throughput next-generation sequencing (NGS)–based methods have become available for DNA analysis in FH.

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About AACC:

AACC is dedicated to achieving better health through laboratory medicine and brings together more than 50,000 clinical laboratory professionals, physicians, research scientists, and business leaders from around the world focused on clinical chemistry, molecular diagnostics, mass spectrometry, translational medicine, lab management, and other areas of progressing laboratory science. Since 1948, AACC has worked to advance the common interests of the �eld, providing programs that advance scienti�c collaboration, knowledge, expertise, and innovation.

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