1 FOREWORD Disease diagnosis, human or animal sample analysis, epidemiological studies, scientific research, and pharmaceutical developments: all of these activities are carried out in biomedical laboratories in the private or public sectors. Biosafety and biosecurity in biomedical laboratories is the cornerstone of an effective biorisk management system and practices. The information contained in this guideline is in accordance with the World Health Organization (WHO) guidelines on Biosafety, Occupational Safety and Health Act (OSHA) 2007 regulation, Environmental Management and Coordination Act (EMCA) 1999 and National Infection Prevention and Control Guidelines for Health Care Services in Kenya. Biological materials are handled worldwide in laboratories for numerous genuine, justifiable and legitimate purposes, where small and large volumes of live microorganisms are replicated, where cellular components are extracted and many other manipulations undertaken for purposes ranging from educational, scientific research, medicinal and health-related to mass commercial and industrial production. Among them, an unknown number of the facilities, large and small, work with dangerous pathogens or their products every day. The public expects laboratory personnel to act responsibly and not to expose the community to biorisks, to follow safe working guidelines (biosafety) associated with practices that will help keep their work and materials safe and secure (biosecurity), and to follow an ethical code of conduct (bioethics). Laboratory-acquired infections should no longer be considered acceptable, no infection or disease should be as a result of a breach in biosafety or biosecurity resulting from unsafe or insecure laboratory work practices. This guideline is intended to be used as a template by individual laboratories at all levels in the country to develop their own biosafety and biosecurity manuals. Dr S K Sharif Dr Francis Kimani Director Public Health and Sanitation Director of Medical Services Ministry Of Public Health and Sanitation Ministry of Medical Servic 2 ACKNOWLEDGEMENTS This document is a result of efforts from many individuals and institutions. Specific acknowledgements go to Ministry of Public Health and Sanitation (MOPHS) and Ministry of Medical Services (MOMS), National Public Health Laboratory Services (NPHLS) National Biosafety and Biosecurity Office, President's Emergency Plan for AIDS Relief (PEPFAR), Center for Disease Control (CDC) Atlanta, Center for Disease Control (CDC) Kenya, and Kenya Medical Research Institute (KEMRI) for technical and financial support. The following are acknowledged for tirelessly contributing towards the development of this Biosafety and Biosecurity guideline. Dr. Jane Wasike National Public Health Laboratory Services Dr. Margaret Oduor National Blood Transfusion Centre-NBI Dr. Jane Mwangi Center for Disease Control/Kenya Dr. Thomas Stephens Center for Disease Control/Atlanta Dr. Shanna Nesby Center for Disease Control/Atlanta Mr. Albert Bunyasi National Public Health Laboratory Services Prof. Eucharia Kenya Kenyatta University Dr. Angela Amayo Management Science for Health Ms. Doris Bota Management Science for Health Dr. Caryl Griffins Griffins Foundation U.S.A Dr. Daniel Kimani Center for Disease Control Dr. Willis Akhwale Department of Disease Prevention and Control MOPHS Ms. Mercy Njeru Center for Disease Control Ms. Margaret Mburu Center for Disease Control Mr. Linus Odawo Center for Disease Control Mr. David Muteti Center for Disease Control Ms. Josephine Kaburi Kenya Medical Research Institute Dr. Bonventure Juma Walter Reed Project Ms. Ephy Khaemba International Livestock Research Institute Mr. Kevin Omondi Risk Accredit Management Systems –Africa Ms. Rukia Kibaya Kenya Medical Research Institute /CCR 1 Mr. Joseph Karinga National Public Health Laboratory Services Mr. John Matoke National Public Health Laboratory Services Mr. James Mwalloh National Public Health Laboratory Services Ms. Nancy Wangari National Public Health Laboratory Services Mr. Japheth Otieno National Public Health Laboratory Services Mr. Ali Gakweli Government Chemist-Kenya Mr. Patrick Olero Homabay District Hospital Ms. Gladys Gathoni Trans Nzoia West District Hospital Mr. Habakuk Okutoi Kitale District Hospital Ms. Pamela Juma National Public Health Laboratory Services Ms. Risper Sewe National Public Health Laboratory Services Ms. Nancy Njiine National Public Health Laboratory Services Ms. George Ogana National Public Health Laboratory Services Mr. Jared Okelloh Siaya District Hospital Mr. Stanley Otara Kisii District Hospital Mr. Francis Gitonga Nyeri Provincial General Hospital Mr. Douglas Denje Coast Provincial General Hospital Mr. Moses Machimbo Kwale District Hospital Mr. Bernard Sande National Public Health Laboratory Services Ms. Alice Salamba Kisumu District Hospital Mr. Raphael Kalama Kilifi District Hospital Mr. Charles Macharia Karatina District Hospital Mr. Joel Rotino Ortum Missionary Hospital Mr. Charles Wakhungu Kakamega Provincial General Hospital Ms. Victoria Nabwire National Public Health Laboratory Services Ms. Jane Mwakuwanda Msambweni District Hospital Ms. Charity Kiarie Muranga District Hospital Ms. Ruth Michuki Mariakani District Hospital Mr. Fred Okuku Program for Appropriate Technology in Health Ms. Beth Njaramba National Public Health Laboratory Services 2 TABLE OF CONTENTS ACKNOWLEDGEMENTS .......................................................................................................................... 1 FOREWORD ................................................................................................................................................ 2 ACRONYMS AND ABBREVIATIONS ..................................................................................................... 9 OVERVIEW OF BIOSAFETY AND BIOSECURITY ............................................................................. 11 General introduction ............................................................................................................................... 11 Rationale ................................................................................................................................................. 12 General objectives ................................................................................................................................... 12 The biorisk management approach ......................................................................................................... 12 The biorisk management culture ............................................................................................................. 13 Biorisk management ............................................................................................................................... 13 i. Securing valuable biological materials (VBM) ................................................................... 13 ii. Distinctions within VBM .................................................................................................... 14 CHAPTER ONE ......................................................................................................................................... 15 1.0 INTRODUCTION ............................................................................................................................ 15 1.1 MANAGEMENT AND RESPONSIBILITY ................................................................................... 16 1.1.2 National Level ............................................................................................................................ 16 1.1.3 National Laboratory Biosafety and Biosecurity Office ............................................................. 17 1.1.4 National Biosafety and Biosecurity Committee ......................................................................... 17 1.1.5 County Level .............................................................................................................................. 18 1.1.6 District Level ............................................................................................................................. 18 1.1.7 Health Care Facility (Dispensaries) ........................................................................................... 19 1.1.8 Responsibilities of the Employer ............................................................................................... 20 1.1.9 Biosafety and Biosecurity Officer .............................................................................................. 21 1.1.10 The Laboratory Personnel ........................................................................................................ 22 CHAPTER TWO ........................................................................................................................................ 24 2.0 GOOD LABORATORY WORK PRACTICE AND TECHNIQUES .............................................. 24 2.1 Introduction ....................................................................................................................................... 24 3 2.2 Preparing for Laboratory Work ......................................................................................................... 24 2.3 Standard Laboratory Work Practices ................................................................................................ 25 2.4 Hand Washing ..................................................................................................................................