Applied Biosafety

Public health logic models divide interventions into three categories: inputs, activities, and outcomes. Similarly, biosafety programs can be described using this same logic model by describing inputs in the form of program staffing and budget; program activities in the form of risk assessments, routine surveillance, training, incident response, and other services; and outcomes in the form of reported exposures, injuries, compliance, finances, and client satisfaction.

Described here is a systematic means of collecting and displaying biosafety program activity data monthly so that the organizational leadership and associated safety committees can readily grasp the scope of various activities undertaken by the biosafety program to support the broader organizational goals.

The simplified public health logic model affords guidance on inputs, activities, and outcomes that biosafety programs can use to their advantage. The importance of succinctly reporting the data describing activities can inform and educate upper management and other stakeholders regarding the resources needed to avoid injuries and illnesses and maintain compliance.

Within the biosafety profession, on a good day, “nothing bad happens,” so conveying the message of the value of prevention can be challenging. By capturing and readily presenting data that describes the efforts of a biosafety program, individual programs can articulate their needs for staffing and resources more successfully, and the profession stands a better chance of maintaining strong administrative and stakeholder support.

Infectious disease outbreaks present significant public health and economic challenges that continue to persist worldwide. Accidental laboratory release or criminal misuse of infectious agents adds to these challenges, underscoring the need for responsible research and adequate biological risk (biorisk) mitigation. Countries such as Armenia that lack comprehensive legal frameworks for biosafety and biosecurity are proactively adopting standards such as International Organization for Standardization (ISO) 35001:2019 to enhance their safety culture and build a strong foundation through a structured Biorisk Management System. This study aimed to evaluate the biorisk management gaps at the Reference Laboratory of Especially Dangerous Pathogens (RLEDP) and implement the necessary steps to achieve ISO 35001:2019 certification.

RLEDP worked with both the Management Systems and Business Consultants to perform a gap analysis of the current situation at RLEDP as it pertains to biorisk management, and with international subject matter experts through the Defense Threat Reduction Agency Biological Threat Reduction Program (BTRP) program to provide guidance and training to assist RLEDP.

The gap analysis highlighted areas that needed improvement, such as documentation, risk assessment methodologies, and staff training. The analyses and requirements led to the development and/or finalization of 11 facility-specific documents and the completion of 40 individual training courses for RLEDP staff. This work culminated in the development of a Biorisk Management Plan and ISO 35001:2019 certification.

In 2022, RLEDP achieved ISO 35001:2019 certification and passed its first annual audit in 2023, demonstrating its commitment to biosafety and biosecurity. Continuous updates, interdepartmental collaboration, and legislative improvements remain essential for maintaining high standards.

Biosafety and biosecurity principles and practices were introduced to Indonesia over the last two decades, with the Avian influenza outbreak serving as the main catalyst. Both have been implemented in parallel following the establishment of Biosafety Level 3 laboratories in Indonesia for handling highly pathogenic agents. A national standard for biorisk management was initiated by a group of expert panelists from the government and universities, who adopted the CEN Working Agreement 15793 standard. This standard was then endorsed by the Indonesian National Standardization Body as Indonesian National Standard (SNI) 8340 in 2016. The Laboratory Assessment Tool (LAT) for the Biorisk Management System was developed based on the SNI 8340 standard and is used to assess laboratory compliance and performance.

The LAT for the Biorisk Management System has been developed based on the SNI 8340 standard and used in assessing the laboratory current condition and compliance. This assessment tool consists of 16 elements and 54 questions.

The LAT has been used as a basis to assess different laboratories in broader fields where biological hazardous materials are present. The LAT assesses laboratories according to their degree of conformity with the established standard, and the level of compliance is reported as a percentage. Various charts are used to present detailed results, allowing for comparisons to monitor future progress.

This LAT outlines laboratory achievements in biorisk management. It has been proven to be an effective, easy-to-use, and practical tool that supports laboratories in meeting the Indonesian standards for laboratory biorisk management.

Laboratory staff working in animal facilities face occupational risks beyond biological and chemical hazards. Organizations working with hazardous agents and animals must protect staff by developing safety programs focusing on risk reduction and fostering a positive safety culture.

At the Abigail Wexner Research Institute at Nationwide Children’s Hospital, we formed a department-specific employee safety team tasked with rolling out the Employee Safety Bundle (ESB). The ESB outlines practices and tools to prevent incidents and ensure a safe work environment. This program requires departments with frequent Occupational Safety and Health Administration recordable incidents to develop a Quantitative Risk Assessment framework. The ESB components assist with reducing the overall risks in each area by developing procedure-specific risk mitigations. Additionally, the department-specific employee safety team must develop initiatives to improve the overall safety culture within the department.

The quantitative risk assessment tool helped us identify the high-risk areas within our animal resources core (ARC) facility. We then utilized the hierarchy of controls to develop risk mitigation plans and decrease the overall risk score in each area within the ARC facility. Additionally, this program requires annual re-evaluation and a focus on continuous improvement that has helped the animal facility reduce injuries, increase near-miss reporting, and improve the safety culture.

This risk score-based framework has evolved into a more holistic risk mitigation system that involves department staff members, senior leadership, safety, and other subject matter experts working together to improve the operations within an animal facility.

The safe and compliant transportation of infectious substances and biological specimens is critically essential for public health, scientific research, and disease diagnostics. With its global implications, this study aims to evaluate the International Transportation Association (IATA) regulations for shipping infectious substances and biological specimens in Pakistan. It explores the current level of awareness of IATA regulations and identifies existing gaps and challenges.

Develop and implement training modules that comply with IATA regulations and the Global Biorisk Management Curriculum (GBRMC).

To promote the adoption of IATA regulations in Pakistan, the Association for Biorisk Management and Health Security Partners collaborated with experts, including certified IATA developed a project in partnership with experts and certified IATA professionals in Pakistan to start a series of workshops in Pakistan focused on IATA regulations. The project comprised two initial phases: a survey to assess the gaps in the existing regulations and their implementation for shipping infectious substances and a series of workshops based on the training of trainers concept. The project was spread over 2 years.

Only 1.29% of institutions surveyed offer training in this domain. There is a pressing need to enhance the IATA and local regulations governing the shipment of infectious substances from laboratories. Drawing on international regulations and experiences, we can bolster Pakistan’s capacity to manage the shipping of infectious agents based on national requirements and priorities.

Sharps injuries pose a significant occupational risk for healthcare and laboratory workers, with hundreds of thousands of incidents reported annually. While protocols for blood-borne pathogens like HIV and hepatitis viruses are well-established, the risk of traumatic inoculation with Mycobacterium tuberculosis (M. tuberculosis) is under-recognized.

This case series reviews six separate instances of healthcare and laboratory personnel across multiple academic health systems in a northeastern U.S. metropolitan region who developed cutaneous tuberculosis following sharps injuries in environments where M. tuberculosis was present. This series was used to identify gaps in current sharps safety guidelines and to propose improved and standardized safety protocols.

All patients were previously nonsensitized to M. tuberculosis and presented with tuberculous chancre at the inoculation site. Diagnosis was delayed in several cases, resulting in prolonged morbidity and unnecessary exposure to ineffective treatments. Treatment regimens varied considerably across the cases, reflecting a lack of standardized guidelines for managing this rare form of the disease. Furthermore, no established post-exposure prophylaxis (PEP) protocols for M. tuberculosis exist for direct inoculation, in stark contrast to guidelines for airborne TB exposure.

This review highlights critical gaps in occupational health and biosafety policy. We conclude that awareness of primary cutaneous tuberculosis as a potential sequela of sharps injuries is essential for early diagnosis and effective management. These findings support the development of standardized diagnostic algorithms and evidence-based PEP recommendations to better protect workers from this preventable hazard.

Building on risk communication scholarship, this study examines the effectiveness of communication efforts of the National Bio and Agro-Defense Facility through a survey of community residents living near the facility.

An online survey (n = 478) was conducted in summer of 2024 with residents living within 20 miles of the National Bio and Agro-Defense Facility.

Results indicate that sufficient and consistent communication efforts by the facility, though directly relating to knowledge levels and information seeking behaviors, were also directly associated with the community’s risk and preparedness perceptions, circumventing knowledge and information seeking behaviors. Misinformation frequency led to increased knowledge and information seeking behaviors. While knowledge was not associated with risk or preparedness perceptions, it increased information seeking behaviors, which in turn led to higher risk perceptions.

Findings imply the importance of leveraging local partners, like the local university, to increase knowledge about the science conducted at the National Bio and Agro-Defense Facility, while at the same time pointing to the fact that information consistency and sufficiency are more important in increasing community preparedness than knowledge itself.