CRC highlights this project to demonstrate our experience working for the Department of Defense at a highly secure military installation. This project required CRC to provide Subject Matter Expertise to design, construct, commission and certify a complex BSL-3 facility that meets rigorous containment requirements. Big-D Construction was the prime contractor for the design, construction, commissioning and certification for a BSL-2/BSL-3 convertible laboratory called the Life Science Test Facility (LSTF) designed with moving containment boundaries. At 65% construction completion, the United States Army Corps of Engineers (USACE) determined that a biocontainment expert was needed to determine if the facility would meet the certification standards, regulations and guidelines put forth in “Biosafety in Microbiological and Biomedical Laboratories, 5th Edition,” National Institutes of Health Biosafety Level 3 Laboratory Certification Requirements and Checklist, U.S. Army Commissioning Checklist/Inspection Checklist, Army Pamphlet 385-69 and Select Agent Inspection Checklist for BSL-3 Laboratories.
To ensure that the Life Science Test Facility would pass the rigorous inspections and certifications required by the Centers for Disease Control and Prevention and the United States Army, a risk management expert was needed. It was understood that following the severity of such environmental, occupational safety and health infractions that a Subject Matter Expert was needed to ensure conformity to guidelines, standards and regulations as the facility was expected to be scrutinized by regulators and enforcers.
CRC served as the driving proponent of risk reduction. Using the aforementioned standards, guidelines and regulations, we applied the recently published ANSI Z9.14: Testing and performance verification methodologies for ventilation systems for Biological Safety Level 3 (BSL-3) and Animal Biological Safety Level 3 (ABSL-3) facilities which is a risk assessment for evaluating the acceptance of laboratory operational ventilation systems as containment is based upon directional airflow. This risk assessment was a primary driver for the reopening of the laboratories within Dugway Proving Ground after the reported anthrax incident.
CRC was the appointed containment expert to ensure the proper certification of the Life Science Testing Facility, Dugway Proving Ground, which was designated by the Department of Defense to conduct testing for chemical and biological defense. We provided a Laboratory Certification Plan that provided in-depth procedures to meet the aforementioned standards, guidelines and regulations. The plan detailed all of the documentation (Biosafety Plan, policies and procedures) and tests that must be completed prior to the Life Sciences Division’s (LSD) request for a preoperational survey/inspection from the Office of the Director of Army Safety (ODSAF) and the Centers for Disease Control and Prevention (CDC), Division of Select Agents and Toxins (DSAT).
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, and ventilation risk assessments. Our biosafety professionals reviewed current Standard Operating Procedures and the Biosafety Manual and prepared recommendations to strengthen documentation to make them compliant with regulatory requirements in preparation for upcoming inspections. We also reviewed the Operations and Maintenance Plan and provided guidance on preventive maintenance issues.
CRC led 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. During the next three weeks, CRC supervised and conducted over three thousand integrated system tests of failure scenarios of mechanical and electrical systems while maintaining facility containment. The data collected were analyzed and presented in a concise format to show compliance with the directional airflow acceptance criteria.
Another project hurdle were testing the engineering controls for appropriate directional airflow. Stakeholders involved were the local United States Army Corp of Engineers, contractors (prime and subcontractors), base facilities personnel, site facility personnel and the laboratory’s risk management group. At the time of CRC’s engagement, the new building and the existing building connected through a common containment corridor and the buildings were independently balanced. The buildings had independent ventilation systems with independent HVAC systems surrounding the containment zones. Failure of a single HVAC system affected directional airflow with airflow reversals causing breeches in containment. CRC developed an acceptance criterion for the facility in accordance with ANSI Z9.14-2014 Testing and performance-verification methodologies for ventilation systems for Biosafety Level 3 (BSL-3) and Animal Biosafety Level 3 (ABSL-3) Facilities. As CRC’s principal, Mr. Traum was an ANSI Z9.14-2014 committee participant and drafted the section on “Guidelines for Implementing Testing and Performance Verification”, he provided first-hand knowledge of the standard’s intent.
For this engagement, CRC was to “stand-up” the United States Army’s biocontainment laboratory (obtain approval to receive select bioterrorism agents). The laboratory passed the required inspections and was approved to resume laboratory operations.