The Challenge

Q² Solutions is in the process of constructing a new BSL-3 laboratory and wants to evaluate and improve their current Biorisk Management System (BMS) to meet BSL-3 laboratory safety guidelines. The BMS integrates modern safety risk management and management decision making, increased confidence in risk controls, an effective interface for knowledge sharing, and a safety promotion framework to support a culture of safety and responsibility. A team of biosafety professionals was needed to provide comprehensive consulting services to aid in the completion of the BMS.

The Solution

Our team of professional engineers and biosafety subject matter experts needed to learn as much about Q² Solutions’ current BMS so that the team could prioritize action items and communicate to leadership a plan to implement corrective actions. We prepared an initial gap analysis to review existing documentation prepared for the BSL-3 laboratory located at RTP including the Biosafety Manual, biosafety SOPs, existing risk assessments, and laboratory design. Our approach was to review Q² Solutions’ program using biosafety guidance documents, regulations, and best practices as standards of care in accordance with the Centers for Disease Control and Prevention (CDC), the National Institutes of Health (NIH), and Occupational Safety and Health Administration (OSHA) requirements. A drawing of the laboratory was reviewed to ensure that the layout will meet the needs of the intended work.

For the biosafety SOPs and risk assessments to be effective, they must match the organization’s operations, new design, and remain plausible for the employees carrying out the processes. As part of the Gap Analysis, we provided a comprehensive review of the SOPs and offered solutions to gaps and unaddressed risks. Upon review of the SOPs, we provided comments and recommendations to improve existing BSL-3 biosafety SOPs so that the user’s perspective is properly captured, matches the new laboratory design, and Q² Solutions’ policies and procedures are documented appropriately.

World BioHazTec played a crucial role during the Construction Phase by ensuring that the design intent and operational parameters of the BSL-3 laboratory were fully realized. Our team conducted a site visit when the construction reached 75% completion to verify that the Biosafety Manual and biosafety SOPs drafted earlier aligned seamlessly with the actual laboratory setup. This hands-on approach allowed us to address any discrepancies or unforeseen challenges promptly, ensuring the smooth integration of biosafety protocols into the operational workflow of the facility.

The Result

Q² Solutions is committed to designing and implementing a BMS that will enhance their reputation, build trust among stakeholders, and improve collaborations with other Q² Solutions sites. The Gap Analysis Report of Findings provided leadership with a roadmap to enhance safety culture. Under our advice, Q² Solutions is designing and implementing a BMS that meets its organizational objectives and complies with applicable regulations and standards related to biorisk management including local and national guidelines and best practices in the field. Prior to occupancy of the BSL-3 laboratory, Q² Solutions will have a systematic assessment process that enables them to evaluate risks in terms of their likelihood and potential impact, thereby prioritizing mitigation efforts.

We are currently working with the IBC to formalize processes and registration reviews. World BioHazTec’s biosafety consultant is meeting with the IBC members in-person to collaborate on action items, provide IBC training, and launch the IBC.

World BioHazTec developed autoclave cycle validation protocols and will perform hands-on testing of autoclaves upon construction completion. The testing is based on “worst case scenario” use conditions, ensuring BSL-3 laboratory waste is treated in a way that will reduce the possibility of exposure to or the transmission of infectious materials to workers, the public, and the environment. We developed Thermal Effluent Decontamination System (EDS) cycle validation protocols and will perform hands-on testing of the EDS. The testing ensures adequate sterilization of waste prior to removal from the facility. The validation coincides with training Q² Solutions personnel on the use of the EDS.

Upon successful completion and acceptance of the Biosafety Manual and SOPs and validation testing, we will visit Q² Solutions for three days to provide hands-on BSL-3 safety training, and we will remain as a consultant for Q² Solutions to provide quarterly inspections of the occupied BSL-3 laboratory and train new biosafety staff so they can effectively monitor, maintain, and improve the BMS.