Taylor Maldonado

TGen, an affiliate of the City of Hope, is a multidisciplinary medical research institution with laboratories located in Phoenix and Flagstaff. Both locations utilize a variety of biological materials including pathogenic microorganisms in the course of conducting research. TGen’s Environmental Health and Safety (EH&S) program, which includes biosafety, works to mitigate biorisk. TGen currently provides multiple resources for employees to work safely with biohazardous materials including policies, training, and personal protective equipment. However, some resources are not easily located, forcing laboratory staff to sift through multiple documents in search of pertinent safety information. This has led to an inefficient system that relies heavily on the Manager of EH&S, to relay information and promote biosafety.  In order to improve biosafety oversight at TGen, consideration should be given to the implementation of a systems approach to biosafety oversight. Accordingly, the goal of my project is to investigate the ISO Standard 35001:2019 Biorisk management for laboratories and contextualize how it can be applied to TGen. I began by conducting a document analysis of the standard by breaking it down to its main sections. Then, in order to gain an understanding of the foundation of biosafety, I conducted a literature review of key biosafety documents from the NIH, CDC and WHO as well as the TGen policies and procedures relevant to biosafety. Finally, I prepared a survey to understand what biohazards are currently handled in the labs. All of this information was used to create a roadmap and gap analysis matrix toward the implementation of a biorisk management system for TGen. Once the gap analysis was completed, a roadmap toward the implementation of the ISO 35001 standard was created. One gap of particular focus was the lack of a cohesive biosafety reference document; thus, I created a biosafety manual to serve as a one-stop resource for all things biosafety. Additionally, I evaluated the use of biosafety committees to help support the biorisk management system. Understanding where all the gaps are will help create a framework toward the implementation of a biorisk management system. Using a systems management approach, oversight becomes more efficient and streamlined and ultimately creates a safer work environment.