Elements of a Biosafety Program
Richard W Gilpin PhD RBP CBSP SM(NRCM) – Dr Richard W Gilpin LLC, Baltimore MD.
Biological Safety Principles and Practices Third Edition. Diane O Fleming and Debra L Hunt (eds.) ASM Press Washington DC 2000.
Elements of a Biosafety Program Chapter 29. Dr Richard W Gilpin RBP CBSP SM(NRCM). Author, Trainer, Former Medical School Faculty. Address when written and submitted to ASM: Director, Biosafety Division, Occupational Safety & Environmental Health. Assistant Professor of Medicine, Department of Medicine. Johns Hopkins Institutions (University and Hospital). Baltimore MD.
Address when Published: Assistant Director, Biosafety Officer, Environmental Health & Safety. Adjunct Professor of Microbiology. University of Maryland Baltimore School of Medicine. Baltimore MD. https://www.researchgate.net/profile/Richard-Gilpin. Nineteen Appendences containing all biosafety program templates are available at Dr. Gilpin’s Research Gate website. The ASM book only contains nine Appendences.
Introduction. Biosafety as a professional discipline has expanded dramatically during the 1990’s as a result of increased numbers of regulations and guidelines directed toward reducing the potential for occupational illness and adverse environmental impacts from microorganisms and biological materials from many sources.
Biosafety deals with safe methods for managing infectious materials in the laboratory. This is accomplished by protection of personnel and the immediate laboratory environment from exposure to infectious agents (primary containment) and protection of the environment external to the laboratory from exposure to infectious materials (secondary containment). Primary containment includes good microbiological practices and techniques as well as safety equipment such as biological safety cabinets. Secondary containment includes good operational practices and facility design practices. Biosafety to some individuals also deals with the preparation of safe, US Food and Drug Administration (FDA)-regulated biologicals that are free from microbial contamination (biological safety).
The tools of the microbiologist are now used by more researchers with diverse areas of expertise use the tools of the microbiologist to conduct research in molecular biology and genetics. Therefore, the need for microbiological procedure and containment practice training and education for a wide audience has increased at a time when fewer individuals specialize in microbiology.
Biosafety officers need a good foundation in microbiological practices in order to assist staff members who may be encountering microorganisms for the first time. This chapter describes the major elements of the biosafety program at Johns Hopkins University and Johns Hopkins Hospital with comparisons to programs in other settings. For information about chemical safety, life safety, occupational safety, and radiation safety programs, the reader should consult publications specifically directed to those disciplines. The information in this chapter is presented in a structured format to assist individuals who are organizing a biosafety program.
Institutional Responsibility. The employer is ultimately responsible for promulgating and enforcing safety policies and programs. Therefore, the senior administration must designate one or more persons who will carry out the institution’s safety programs. The individual who heads up the overall safety program should be at the director level of the organization and have a staff who will carry out the daily activities required by the safety program. The principal investigator, chief, laboratory supervisor, or section head has the day-to-day responsibility for ensuring that employees receive proper safety training and follow the institution’s safety policies.
Biosafety Administrative Reporting. The administrative reporting structure for biosafety programs varies with the size of an organization and the service or product it produces. Generally, a biosafety program is one of several employee safety and health programs, which may include chemical safety (industrial hygiene), radiation safety, life safety, and occupational safety (workers compensation). Depending on the size and diversity of an organization, there may be several other employee-related safety and health programs such as employee health, medical surveillance, and employee staff and family assistance programs.
The biosafety profession has recently become a prominent specialty because of the breadth and depth of biosafety-related guidelines and regulations that have been enacted by the government to protect the health and welfare of the public. Biosafety officers need to pass on this information to employees and students. There are now biosafety registration and certification programs for microbiologists who choose to make this field their profession. The American Biological Safety Association (ABSA) has two programs that recognize biosafety professionals. The ABSA Registered Biological Safety Professional (RBP) program recognizes individuals with appropriate microbiological training and biosafety experience. The ABSA Certified Biological Safety Professional (CBSP) program recognizes individuals with microbiological training and biosafety experience who have passed the American Academy of Microbiology Specialist Microbiologist examination in Biological Safety Microbiology.
Academia. Academia includes many types of organizations, from small colleges, undergraduate universities, large undergraduate and graduate universities, and universities that include a medical school and a teaching hospital. Small colleges and some undergraduate universities may have one individual who carries out the functions of a biosafety officer, industrial hygienist, radiation safety officer, and occupational safety officer. This individual may report to a department chair, director of human resources, director of security, director of risk management, administrative dean, or academic dean.
Universities often have a diversified safety program with at least one safety officer and a radiation safety officer. The biosafety program may be a component of the safety officer’s duties or biosafety responsibilities may be assigned to a faculty member with an appropriate background in microbiology. There may be a safety manager or safety director to whom the safety officers report. This individual often reports to a director of risk management, director of human resources, or an administrative or academic dean.
Universities with a medical school and a teaching hospital are structured in two ways. Often the medical school campus is physically separated from the rest of the university. When this occurs, there may be distinct biosafety programs with different reporting structures at the two campuses. The medical campus may have a safety program that reports to an executive medical director or an executive administrative or academic director. The other university campus may have a safety program that reports to a director of risk management, human resources, or an administrative or academic dean. These safety programs often employ individuals with expertise in each of the major safety areas, biosafety, chemical safety, radiation safety, occupational safety and life safety.
Some universities, such as Johns Hopkins University, have a medical school, a teaching hospital, a school of public health, and a school of nursing on one campus and traditional undergraduate and graduate schools of arts and sciences, continuing studies, and engineering at another campus. These universities may have a combined safety program that includes the university and the hospital. The combined safety program offers the advantage of a uniform application of safety policies and procedures at all schools and the hospital. Employees and students need to become familiar with only one set of safety policies and procedures, which makes it easier for them to move between schools and departments on the different campuses. Employee safety training and health records of a combined safety program can follow employees when they move between different administrative units of the university and hospital. The reporting structure for a combined university and hospital safety program consists of managers of each safety section; Biosafety, Chemical safety, Life safety, Occupational safety, and Radiation safety, reporting to an executive director of safety and health. This director may chair a joint committee on health, safety and environment composed of directors of major functional units at the hospital and university. This executive director may report to an academic executive of the university and an executive head of medical affairs at the hospital. The combined safety and health organization at Johns Hopkins has both hospital and university employees. The safety program includes; Biosafety, Chemical safety, Life safety, Occupational safety, and Radiation safety. The employee health program includes; Occupational health services (employee health clinic), Occupational injury (workers compensation clinic and office), Staff and family assistance programs, and a Center for Occupational and Environmental Health. The Center provides safety services and occupational medicine services to companies and organizations nationwide. This combined safety and health organization is named Johns Hopkins Institutions to reflect the fact that it combines both the for-profit hospital and the non-profit university safety and health programs.
Government. Government safety programs often resemble a university structure with a chief or director of safety and health with direct reports who manage biosafety, chemical safety, life safety, and radiation safety. A safety representative in charge of biosafety may report to a supervising division chief in charge of safety personnel who reports to a division chief responsible for the overall safety training and procedures of the facility.
Supervisors ensure that employees receive appropriate biosafety training. The safety office responds to emergencies and publishes biosafety regulations and procedures for personnel and facility operations. In military laboratories, a chief or director of safety and health may report to the chief of the medical division, who reports to the commander of the facility. The management structure of government safety and health programs has a more defined chain of command than is the case at most universities. The safety staff may report to a supervisor who passes the information up the chain of command to the individual who is authorized to make decisions.
Industry. Industry safety reporting structures depend on the size of the organization. Small companies may have a safety consultant that covers all aspects of safety programs and reports to the president of the company. Larger companies may have a safety officer on staff who covers all aspects of safety. This safety officer may report to the company president, operations director, risk management director, human resources director, or other director. Biosafety issues are incorporated into the duties of this position.
Large companies often have a larger safety staff with section managers of each safety discipline (biosafety, chemical safety, life safety, occupational safety, and radiation safety). The reporting structure varies depending on the company’s product or service. Most companies have a life safety and chemical safety officer who reports to a director of medical affairs, quality assurance, operations, human resources, risk management, or executive administration. Companies with several facilities worldwide may have a safety staff headquartered at the home office with general safety staff members located at strategic plants. These individuals often report to a safety director at the home office and to a director level executive at the local facility.
Pharmaceutical and biotechnology companies have, in addition, a biosafety officer to oversee recombinant DNA, bloodborne pathogens, select agents, and other biosafety-related programs. A general safety officer, an industrial hygienist, or a research scientist may take on the duties of a biosafety officer, although many companies now employ biosafety officers who have training and experience with microbiological practices and procedures.
Biosafety Line Management Functions. The biosafety program at Johns Hopkins Institutions has both line management and advisory functions. Line management operations include those for which the biosafety program has direct responsibility. Line management can be defined as vested with a certain amount of discretion and independent judgement, or that an employee so designated is invested with the general conduct and control of his employer’s business.
Advisory functions are of a consulting nature to various functional units of the hospital and university. Four biosafety staff members report to the biosafety officer who reports to an executive director of employee health and safety divisions described in the academia administrative reporting section above. Specific biosafety line management activities are described in this section.
Summary. This chapter is organized in a format that will hopefully make a biosafety manager’s organizational and regulatory functions easier. The elements of the Johns Hopkins Institutions biosafety program presented here is an example of a rather large program, although selected portions of the program may be useful to individuals who are beginning a biosafety program.
Biosafety management at large institutions has become a full time job – at Johns Hopkins Institutions it is a five-person full time job. Major increases in government regulation and adherence to biomedical/pharmaceutical industry consensus standards has required more documentation. Regulations promulgated by the Environmental Protection Agency, the Occupational Safety and Health Administration, the Joint Commission on Accreditation of Hospitals, and several state and local regulatory agencies (departments of health and environment) have produced an increase in the number of on-site inspections and fines.
Much of this regulatory activity represents an expansion from the traditional chemical and radiation safety issues to biological safety in industry, government, and university clinical and basic research laboratories. There is currently a deficit of microbiologically trained biosafety professionals to handle these new regulatory activities.
All of these appendix templates are available at Dr. Gilpin’s Research Gate website. The ASM book only contains nine of the nineteen appendices.
Appendix A – BSC & CAB Daily Field Service Printout. Appendix B – Safety Section of University Information Checklist. Appendix C – IBC Research Registration Form. Appendix D1 – Potential Pathogenic Material Research Update Letter. Appendix D2 – Recombinant DNA Research Update Letter. Appendix E1 – Potential Pathogenic Material Research Registration Letter. Appendix E2 – Recombinant DNA Research Registration Letter. Appendix F – Employee Training Database. Appendix G – BSC & CAB Certification and Service Database. Appendix H – BSC & CAB Certification Renewal Letter. Appendix I – Portable HEPA Unit Service Database. Appendix J – PAPR Service Database. Appendix K – Bag-In Bag-Out Service Database. Appendix L – IBC Research Registration Database. Appendix M – IBC Select Agent Registration Database. Appendix N – Shipping Certification Training Database. Appendix O – Johns Hopkins Institutions BSL-3 Specifications. Appendix P – BSL-3 Standard Operating Procedures Outline. Appendix Q – Laboratory Survey Checklist.