In cooperation with The National Academies of Sciences, Engineering, and Medicine THE PAKISTAN ACADEMY OF SCIENCES This activity was supported by the Pakistan Academy of Sciences, the U.S. National Academies of Sciences, Engineering, and Medicine, and the U.S. State Department. The Pakistan Academy of Sciences is solely responsible for this publication and the contents are the responsibility of the individual chapter authors. International Standard Book Number-13: 978-0-578-46481-7 Additional copies of this report are available from the Pakistan Academy of Sciences. Copyright 2019 by the Pakistan Academy of Sciences. All rights reserved. Suggested Citation: Pakistan Academy of Sciences. 2019. Good Clinical Laboratory Practices in Pakistan. Islamabad, Pakistan. Printed by Shiuman Design & Print, Blue Area, Islamabad-Pakistan Price: $15; PKR 1500 Good Clinical Laboratory Practices in Pakistan Preface & Acknowledgements The Handbook for Good Clinical Laboratory Practices in Pakistan, created by the Pakistan Academy of Sciences (PAS) in cooperation with the U.S. National Academies of Sciences, Engineering, and Medicine (NASEM), is intended to serve as an informational guide for clinical laboratories in order to improve the health and wellbeing of people and animals in Pakistan. Promotion of laboratory best practices and communication between and among laboratories is the best way to enhance disease surveillance and to help establish the relationships that keep experts engaged with the international community of responsible practitioners working for the public good. Ultimately, the creation of this handbook is a starting point to continue the discussion and evolution of creating and implementing best practices within clinical laboratories. PAS and NASEM hope that the content will be useful to the thousands of dedicated men and women supporting the people, animals, plants, and environment of Pakistan in the spirit of “One Health” and in some way, lead to a strengthening of the population of talented humans responsible for the health and well- being of the citizens of Pakistan. Each of the 25 chapters in the handbook focuses on a common issue and/or process faced by those working in the wide range of clinical laboratories across the country. The information in the handbook was provided by a diverse and highly talented group of laboratory leaders, scientists, and experts, their names and affiliations are listed on the title page of each chapter. Without their wisdom, experience, and hard work the handbook would not have become a reality. The preparation of this handbook was a true collaboration between PAS and NASEM. The initial concept and vision for the project came from Dr. Anwar Nasim, President of PAS at the time of project initiation. Dr. Nasim suggested that PAS and NASEM work together to develop a document to strengthen Pakistani laboratories, human and veterinary, throughout the country. Professor (Dr.) Aamer Ikram, now the Executive Director of the National Institute of Health, Islamabad, took the lead in coordinating the effort in Pakistan from concept development to the final published product. In April of 2017, Dr. Ikram and then PAS Secretary General, Dr. Zabta Shinwari held a meeting in Islamabad with NASEM staff to discuss the handbook, meet with potential chapter authors, and plan the project. Under Dr. Ikram's leadership, a small team from PAS and NASEM developed the goals, proposed content for the handbook, and met with potential chapter authors. Pakistani scientists and clinicians, selected by the joint team, then developed initial drafts of all the chapters. A small group of U.S. scientists and clinicians served as co-authors, reviewing and contributing thoughts to the drafts. After the chapter authors completed their initial drafts, PAS and NASEM organized a workshop in January 2018 in Bangkok, Thailand designed to allow the chapter authors to present and discuss their draft chapters with the other chapter authors and assembled experts. Project leaders used the input from this workshop to construct the final version of the handbook. In producing the final draft, the project leaders and chapter authors drew on data gathered during a 2016 PAS and NASEM workshop on promoting best practices in and improving communications, cooperation, and coordination among public, private, and animal health clinical laboratories in Pakistan. Although the handbook is the result of a collaborative process between PAS appointed Pakistani chapter authors and NASEM Good Clinical Laboratory Practices in Pakistan i appointed experts in the United States, PAS is solely responsible for this publication and each chapter is the responsibility of the individual author or authors. As PAS and NASEM have worked together, communicating, writing and editing we have created a positive and productive community of understanding. PAS and NASEM thank Dr. Nasim and Dr. Shinwari for the PAS's broad support and encouragement. We thank Mr. Adnan Bashir, of the PAS and NIH staff for their administrative support. We are grateful to Dr. David Franz, Dr. Rita Guenther, and Mr. Benjamin Rusek for their contributions from the NASEM and to Dr. Krista Versteeg also from the NASEM for editorial support. Special thanks goes to Dr. Ikram for the many hours spent guiding the authors along the journey and for his absolutely critical substantive and editorial contribution to the final handbook. The diverse and highly talented group of authors and co-authors shared their wisdom, experience and hard work for making this manual a reality. We are thankful to Dr. Kahlid Naeem for covering veterinarian aspects of laboratories under 'one health' concept. Although the first edition of the written handbook is designed to help the Pakistani laboratory community strengthen their practices, PAS intends for the handbook to be a “living document” to allow for revisions as technology and best practices change. The handbook will be printed and widely distributed and is posted on the websites: PAS (www.paspk.org/); and NIH (www.nih.org.pk/). Future editions may be produced as a web application for easier viewing by smartphone users. Prof. Zabta Khan Shinwari Prof. Muhammad Qasim Jan Ex-Secretary General President Pakistan Academy of Sciences Pakistan Academy of Sciences ii Good Clinical Laboratory Practices in Pakistan Forward Clinical laboratories are considered an indispensable and fundamental component of the health system and contribute directly to the improvement of health services delivery. Accurate, reliable and timely results from laboratory investigations are critical elements in decision-making in clinical settings. From the public health perspective, critical decisions concerning health security, diseases surveillance, response, outbreak detection and meeting international obligations, such as the International Health Regulations (IHR) 2005, also depend upon reliable laboratory services. As part of a multi-year project to promote a cooperative relationship between Pakistani and American health and infectious disease experts, the Pakistan Academy of Sciences (PAS), together with the U.S. National Academies of Sciences, Engineering, and Medicine (NASEM) has produced this handbook for improving laboratory services in Pakistan with a special focus on raising the quality and capabilities of laboratories functional even in the remotest areas of the country. This laboratory manual has been developed covering all key aspects of laboratory operations and functions, under a 'One Health' concept. It has been written with developing countries context, providing simple and hands-on guidance on pre-analytical, analytical and post analytical components of the laboratory operations. The manual has been drafted through a consultative process involving various subject matter experts thereby consolidating a vast range of knowledge and experience. The first edition of this Handbook for Good Clinical Laboratory Practices in Pakistan will be a helpful guide and reference not only for the beginners but mid to higher tiers as well as specialists in various laboratory disciplines. The main concept was to cover up all those deficient areas not covered under different curricula. The content aims to address some of the laboratory associated challenges in developing countries along with their practical solutions. The manual provides guidelines for establishing laboratory management, laboratory operations, and quality management systems. The manual covers a broad range of topics including facility design, biorisk management, data management and networking, laboratory quality management system, contingency planning, surveillance & reporting and laboratory leadership. As such it will remain an asset for all the biomedical laboratories besides clinical side. This handbook will eventually be published in local languages and promoted and disseminated across Pakistan. Prof. Dr. Aamer Ikram, SI(M) Executive Director National Institute of Health Good Clinical Laboratory Practices in Pakistan iii Summary The Handbook for Good Clinical Laboratory Practices in Pakistan is divided into four sections based on overarching themes: laboratory management, laboratory safety, laboratory operations, and quality management systems. Each of the sections is divided into chapters that provide standard information on best practices and specific suggestions that will assist individuals in the clinical laboratory setting. Additionally, the handbook contains appendices that help to elucidate various aspects of laboratory duties and tasks