Biocontainment Reference eBook
This book is a collection of management experiences, insights, and lessons learned on building and operating high-containment facilities from facility planners, project directors, owners, end users, science program managers, and facility operators who have worked in the high-containment arena for the ten-year period 2002-2012.
The book is available online from Amazon and Google Books. All proceeds from the book are being donated to biocontainment facility operations training programs in Africa to help fund special courses in high-containment facilities management, maintenance, and operations. The following is the forward of the book.
High-containment facilities are defined here as research facilities that are operated at BSL-3 or BSL-4 (biological safety levels 3 or 4) as specified by the U.S. National Institutes of Health and the U.S. Centers for Disease Control and Prevention in their jointly published reference, Biosafety in Microbiological and Biomedical Laboratories, 5th Edition (BMBL). Parallel designations in Canada and the UK would be CL-3 or -4 and Level 3 or 4, respectively. The designation for BSL-3 involving small and medium-sized animals is ABSL-3, and for BSL-3 involving large (agricultural) animals the designation established by the U.S. Department of Agriculture is BSL-3Ag.
This is not a book about design details, specific floor plans, or detailed procedural protocols. Nor is it about science facilities in general. Rather, it is about the management of capital projects and operational programs that have specific high-containment program elements involving potentially dangerous biological agents or toxins. The high-containment factor injects special management challenges into facilities planning, construction, and operations for which there is now a significant body of experience to guide successful outcomes.
Our objective here is to produce a work that will be an authoritative planning and management reference for anyone involved with capital projects or facilities operations where high-containment is involved. This is directed especially to all people of all disciplines who are new to high-containment (the next-generation players), to administrators who need a clear picture of the level of institutional commitment that high-containment facilities entail, and to veterans in the field who have yet to codify their thinking on the elements of their success or possibly even failures.
Worldwide research activity involving a long list of pathogens connected with human, animal, and plant health continues to grow and modernize. Much facility development, expansion, and improvement work as well as major challenges in facility operations are still ahead of us. More institutions will become involved. Institutions already involved will expand capacities and upgrade existing facilities. Regulatory authorities will design new programs for oversight and compliance for safety. All of this will take place against a backdrop of many successes achieved to date, but also where too many project and program failures litter the landscape—failures that can be traced to the improper management of high-containment issues. Now is the time to start pulling together planning and management principles that have been learned over the past 10 years of high-containment experience in order to stack the odds in favor of future success for high-containment facility initiatives.
The ten-year period—2002 to 2012—represents the most active, aggressive, and well-funded decade of high-containment facility growth in history. In the U.S. alone, two major national biocontainment laboratory facilities were built, nine regional laboratories have been built or are in their final stages of completion, and hundreds of research universities and hospitals, government research agencies, private sector biopharmaceutical and diagnostic companies, and research institutes have completed or are putting in place new facility capacity for high-containment research programs. Many of these facilities have now accumulated significant start-up, commissioning, and operational experience.
This book distills critical management principles from an extensive body of experience in making high-containment facilities safer, more efficient in the use of capital funds, less costly to operate, and more useful for future science programs. The goal is to eliminate future outcomes in which facilities fail to operate or meet certification and safety requirements, capital budgets are overrun, operating costs are higher than planned, startups are delayed, or the future research needs of scientific users cannot be met.
Veteran project managers and program directors of research facility initiatives of all types testify that for highly technical facility projects the big challenge is the challenge of managing processes—the processes of capital project formation, team formation, budgeting, design, equipment selection, construction, commissioning, operational staffing and training, start up, and daily facility operations. How each of these program elements is managed will be the prime determiner of success, and failure in the management in any one of these elements will likely lead to costly errors.
Everyone who is involved with high-containment programs—from planning and design to operations—is a manager of some part, and there are five basic things managers do. They plan. They organize. They staff (recruit and train). They direct (or if you prefer, they lead). And lastly, they control, meaning that they monitor performance and take corrective action as needed. In the chapters that follow you will read about experiences, insights, and lessons learned in these five areas of management activity as they pertain to all aspects of high-containment facility initiatives and programs. From this body of information will come two sets of management principles for high-containment facilities: normative principles (general recommendations of what should be done) and descriptive principles (what happens when certain things are done or are not done). These are principles that the authors feel are fundamental to the success of future high-containment research programs.
Whereas management principles developed in this book can be applied to both levels of containment (3 and 4), the majority of references, experiences, and opinions contained herein relate primarily to BSL-3 facilities instead of the significantly more expensive, complex, and rare BSL-4 facilities. With respect to high containment with animals, the experience of the contributors is mainly (but not entirely) with small and medium-sized animals, but the generalized management principles stated in this work are felt to be applicable to all high-containment facilities including those involving large animals.
This work is a compilation of subject chapters written by 18 contributors. The editors and publisher have to some degree attempted to blend the chapters into a single body of content, but much of the individual writing styles of the contributors have been left intact in order to preserve the contributors’ full intent and emphasis. Where statements made by chapter authors are based on specific sources, footnote references are given. Otherwise, the statements made by chapter authors are based on their own personal experience, observation, or opinion.
By Steve Westfall, Ph.D.
Executive Editor
Tradeline, Inc.
