Biosafety Program Research Articles

New Strategy to Monitor and Assess Laboratory Biosafety Programs

Laboratory biosafety -- a component of biosecurity -- has elements that comprise a facility‰Uas capability to protect employees and the surrounding public and environment. Six logic models comprising a laboratory biosafety program (LPBs) were established: laboratory biosafety, biosurety, procedural, biocontainment, information security, and training. And 161 indicators were mapped to the logic model elements. These formed a toolset to monitor and evaluate LBPs. While evaluation of cost-impacts provides business intelligence for resource planning, this integrated approach also provides information about LBPs gaps.

A Practical Guide to Implementing a BSL-2+ Biosafety Program in a Research Laboratory

Biosafety Level Two Plus (BSL-2+) is a term frequently used to describe laboratories where work with microorganisms is conducted in a BSL-2 laboratory with biosafety practices and procedures typically found at BSL-3. The risk assessment process may determine that safety practices over and above those required at BSL-2 are needed for a research project, yet a more complex BSL-3 laboratory facility is not necessary. This hybrid approach has been used for many years; however, many research institutions still find it challenging to decide when to use this approach and which BSL-3 practices to use. This is due to the fact that it is not a recognized containment level in biosafety guidance documents such as the Centers for Disease Control and Prevention's (CDC) Biosafety in Microbiological and Biomedical Laboratories (BMBL) (U.S. Department of Health and Human Services, 2009) or the National Institutes of Health's (NIH) Guidelines for Recombinant DNA Research (the Guidelines) (NIH, 2011). This article aims to assist environmental health and safety and biosafety professionals by detailing a practical approach to implementing BSL-2+, including how to identify what projects may benefit from BSL-3 practices and how to modify BSL-3 practices and selected facility requirements for the BSL-2 environment based on institutional needs. In addition, strategies to ensure researchers are properly trained in the use of BSL-3 practices in a BSL-2 laboratory and for developing a project-specific Standard Operating Procedure (SOP) are detailed. Implementing BSL-2+ can be successful when there is a collaboration among the Principal Investigator, Biosafety Officer, Institutional Biosafety Committee, and laboratory personnel.

Establishing a National Biological Laboratory Safety and Security Monitoring Program

The growing concern over the potential use of biological agents as weapons and the continuing work of the Biological Weapons Convention has promoted an interest in establishing national biological laboratory biosafety and biosecurity monitoring programs. The challenges and issues that should be considered by governments, or organizations, embarking on the creation of a biological laboratory biosafety and biosecurity monitoring program are discussed in this article. The discussion focuses on the following questions: Is there critical infrastructure support available? What should be the program focus? Who should be monitored? Who should do the monitoring? How extensive should the monitoring be? What standards and requirements should be used? What are the consequences if a laboratory does not meet the requirements or is not willing to comply? Would the program achieve the results intended? What are the program costs? The success of a monitoring program can depend on how the government, or organization, responds to these questions.

A New Initiative: Organizing a Biosafety Officer Symposium in the Republic of Georgia

The Republic of Georgia is developing and implementing a biosafety program using international standards and best practices to tailor the program to Georgian laboratories and research facilities that are involved with Extremely Dangerous Pathogens (EDPs). Because the Georgian Biosafety Officer (BSO) plays a critical role in this effort, a Biosafety Officer Symposium was held for Georgian BSOs for the first time in October 2011 to provide a forum for learning, communicating, planning, mentoring, and networking. Participants included the Biosafety Officers, their alternates, and Lab Directors from laboratories working with EDPs. Many challenges were overcome to host this Symposium. First, approval was obtained from several different Georgian ministries. Interest and attendance at the Symposium were dependent upon the approval of these ministries to send BSOs to the 5-day Symposium. Further, human, veterinary, and research institutes had to work together to make this successful, and all had to be willing to participate and share experiences, issues, and problems with their colleagues. The Symposium was structured (lectures, refresher training sessions, BSO presentations, practical demonstrations, tabletop exercises and simulations, discussions) to help the BSOs identify issues and arrive at solutions relevant to their institutions. The BSO Symposium provided mentoring opportunities to the BSOs as they assume leadership responsibilities for biosafety in Georgia. The BSO Symposium also gave improved direction and focus to Battelle's Threat Agent Detection and Response (B-TADR) Biosafety & Biosecurity (BS&S) Team to improve relevant training and mentoring activities, especially in the form of field and laboratory practical exercises. The BSO Symposium will be an annual event.

Quantifying Competency in Biosafety: Adaption of the Instructional Systems Design Methodology (ISD) to Biosafety and Laboratory Biosecurity

A competency training program for international public health laboratories was designed by detailing all biosafety tasks in the context of working laboratory procedures. The list of biosafety tasks was used to develop practical, laboratory-based training checklists that can be used to demonstrate individual competencies across multiple trainers. Because of the intensive nature of the training, in this program, we employed two types of trainers: The Biosafety Instructor and the Laboratory Trainer and we expanded the number of trainers to include a Laboratory Trainer in each laboratory. This Train-the-Trainer course defines a step-bystep process to establish competency training programs in a facility. In the Biosafety Instructor training program, biosafety officers and laboratory managers are trained alongside each other as trainers. This type of program establishes facility-specific, quality-controlled training programs that promote the transfer of biosafety working procedures from the classroom to the laboratory. The program design gives the Laboratory Manager, Biosafety Officer, and biosafety committee ownership in the biosafety program, establishing a role for the laboratory manager as a Laboratory Trainer and encouraging a culture of biosafety within the facility.

Small Program, Big Needs

Resources are typically scarce in any safety program, but they may be especially limited and difficult to access when the program is relatively small. California State University, Fullerton, has a broad-scope radioactive material license with around ten faculty-users, so while the amount of radioactive material used is not large, its obligation to provide support to those users is. Research is conducted primarily using undergraduate students, so emphasis on safety is paramount. Additionally, when one's duties also include oversight to the biosafety program and support of the hazardous waste program, the ability of a single person to provide what is needed becomes part art, part miracle. I have created a program that conforms to the license's regulatory requirements, while drawing on resources in a variety of places to produce a highly-visible, high-quality program from this one-person office (me). Using humor, respect, good science and good grammar, anyone can get a higher quality, and more compliant radiation safety program than he or she thought possible. This model could be expanded to fit larger programs as well.

Successfully Capturing and Displaying a Biosafety Program's “Goodwill Value”

Successfully Capturing and Displaying a Biosafety Program's “Goodwill Value”

Inactivation of Hantaan Virus-Containing Samples for Subsequent Investigations outside Biosafety Level 3 Facilities

Objectives: The potential risk of accidental infection by hantaviruses in a clinical or research laboratory necessitates special precautionary measures. A biosafety program must address handling and disposal of infectious materials as well as appropriate virus inactivation or depletion procedures to permit necessary further processing of specimens outside the biosafety level 3 laboratory. Methods: To study the elimination of hantavirus infectivity, the effects of different chemical and physical inactivation and depletion procedures were investigated on Hantaan virus-containing materials. An infectivity assay for hantaviruses was utilised to verify these procedures which are commonly preceding investigations such as ELISA, flow cytometry analysis, Western blot or immunofluorescence assay. Results: Chemical inactivation with methanol, paraformaldehyde, acetone/methanol and detergent-containing lysis buffer as well as physical forces such as UV irradiation and filtration efficiently reduced viral infectivity in infected cells and their supernatants below the detection limit. Conclusion: The virus inactivation and depletion methods described herein are suitable to prepare non-infectious samples for further use in immunological, virological and cell-biological assays.

Laboratorians at Risk: The Threat of Exposure to Infectious Agents and the Role of the Biosafety Program

Daily, laboratory workers are exposed to microorganisms that cause infections. Today, the primary risks are associated with exposure to viruses present in blood and body fluids (eg, hepatitis viruses, human immunodeficiency virus) and the handling of infectious agents amplified in culture (eg, Mycobacterium tuberculosis ). These risks to employees have prompted regulatory agencies to draft mandatory, comprehensive biosafety programs for laboratories. The strategies for the prevention and management of laboratory-associated infections include assessing each laboratory task, containing infectious agents by physically separating them from the laboratory worker, educating employees, and providing access to an employee health program. Adherence to these biosafety guidelines will reduce but not totally eliminate the risk of occupational exposure to infectious agents in the workplace. Employees must be aware of these risks and use appropriate methods to reduce exposure to themselves and their coworkers.

Laboratory-associated infections and biosafety.

An estimated 500,000 laboratory workers in the United States are at risk of exposure to infectious agents that cause disease ranging from inapparent to life-threatening infections, but the precise risk to a given worker unknown. The emergence of human immunodeficiency virus and hantavirus, the continuing problem of hepatitis B virus, and the reemergence of Mycobacterium tuberculosis have renewed interest in biosafety for the employees of laboratories and health care facilities. This review examines the history, the causes, and the methods for prevention of laboratory-associated infections. The initial step in a biosafety program is the assessment of risk to the employee. Risk assessment guidelines include the pathogenicity of the infectious agent, the method of transmission, worker-related risk factors, the source and route of infection, and the design of the laboratory facility. Strategies for the prevention and management of laboratory-associated infections are based on the containment of the infectious agent by physical separation from the laboratory worker and the environment, employee education about the occupational risks, and availability of an employee health program. Adherence to the biosafety guidelines mandated or proposed by various governmental and accrediting agencies reduces the risk of an occupational exposure to infectious agents handled in the workplace.

Laboratory-associated infections and biosafety.

An estimated 500,000 laboratory workers in the United States are at risk of exposure to infectious agents that cause disease ranging from inapparent to life-threatening infections, but the precise risk to a given worker unknown. The emergence of human immunodeficiency virus and hantavirus, the continuing problem of hepatitis B virus, and the reemergence of Mycobacterium tuberculosis have renewed interest in biosafety for the employees of laboratories and health care facilities. This review examines the history, the causes, and the methods for prevention of laboratory-associated infections. The initial step in a biosafety program is the assessment of risk to the employee. Risk assessment guidelines include the pathogenicity of the infectious agent, the method of transmission, worker-related risk factors, the source and route of infection, and the design of the laboratory facility. Strategies for the prevention and management of laboratory-associated infections are based on the containment of the infectious agent by physical separation from the laboratory worker and the environment, employee education about the occupational risks, and availability of an employee health program. Adherence to the biosafety guidelines mandated or proposed by various governmental and accrediting agencies reduces the risk of an occupational exposure to infectious agents handled in the workplace.