The Challenge

The addition of World BioHazTec to the team came at a critical juncture marked by significant environmental and safety lapses at Dugway Proving Ground. The 2015 report from the Pentagon revealed a decade-long issue of live anthrax being mistakenly sent from its West Desert Test Center. Recognizing the gravity of the situation and the need for expertise in risk management, World BioHazTec were brought in to ensure the success of the Laboratory Science and Technology Facility (LSTF) through rigorous inspections and certifications mandated by the Centers for Disease Control and Prevention and the U.S. Army.

The engagement aimed to navigate the aftermath of environmental and occupational safety breaches, ensuring adherence to guidelines, standards, and regulations. The facility, under scrutiny from regulators and enforcers, required the expertise of a Subject Matter Expert (SME) to establish conformity.

A significant challenge in this project was testing engineering controls for directional airflow, given the interconnected nature of new and existing buildings through a common containment corridor. With independent ventilation systems and HVAC systems surrounding containment zones, potential failures could result in airflow reversals, posing a serious risk to containment. World BioHazTec stepped in to address these challenges, contributing expertise to “stand-up” the United States Army’s biocontainment laboratory and ensure the facility’s compliance and safety.

The Solution

Our team of containment professionals and engineers prepared a laboratory certification plan to build a complete Biorisk Management System that addressed:

• Documentation approval steps
• Policy statement
• Regulatory requirements and guidelines
• Roles and responsibilities
• Authorities and organizational charts
• Biological safety manual
• Biosecurity program
• Medical surveillance program
• Emergency response program
• Maintenance and operations program
• Precertification plan
• Laboratory certification plan
• Test scripts
• Ventilation risk assessments

In preparation for upcoming inspections, World BioHazTec’s biosafety professionals conducted a thorough review of current Standard Operating Procedures (SOPs) and the Biosafety Manual. Their expertise led to the preparation of comprehensive recommendations aimed at strengthening documentation to ensure compliance with regulatory requirements. Additionally, our team scrutinized the Operations and Maintenance Plan, providing valuable guidance on preventive maintenance issues to enhance the overall safety and functionality of the facility.

Taking a proactive approach, we developed acceptance criteria for the facility in alignment with ANSI Z9.14-2014, focusing on testing and performance-verification methodologies for ventilation systems in Biosafety Level 3 (BSL-3) and Animal Biosafety Level 3 (ABSL-3) Facilities. This effort was backed by the firsthand knowledge of our principal, Mr. Traum, who participated in the ANSI Z9.14-2014 committee and drafted the section on “Guidelines for Implementing Testing and Performance Verification.”

As leaders in the field, World BioHazTec took charge of the commissioning and certification of the BSL-3 laboratory. Our professionals developed testing scripts for nine laboratory configurations of BSL-2/BSL-3 convertible labs. Over a three-week period, we supervised and conducted over three thousand integrated system tests, assessing failure scenarios of mechanical and electrical systems while maintaining facility containment. The collected data were analyzed and presented in a concise format to demonstrate compliance with directional airflow acceptance criteria, reinforcing the facility’s readiness for inspections.

The Result

The successful passage of required inspections, approval to resume laboratory operations, and the continued operation of the laboratory stand as a testament to the efforts and expertise contributed by World BioHazTec. Our commitment to ensuring compliance with regulatory standards, coupled with thorough reviews, recommendations, and rigorous testing processes, has resulted in a facility that not only meets but exceeds the necessary criteria for biosafety and containment.