Practical Considerations for Navigating Withdrawal from the Federal Select Agent Program.

Introduction: Clear guidance is provided by the Federal Select Agent Program (FSAP) to assist registered entities in nearly all facets of compliance with the Federal select agent regulations (7 CFR Part 331; 9 CFR Part 121; 42 CFR Part 73). If a registered entity chooses to discontinue its registration, detailed instructions for registration withdrawal are deeply embedded within a document entitled "eFSAP Form 1 Amendment Instructions," which is found on the FSAP website within the electronic Federal Select Agent Program (eFSAP) Resource Center. Methods: Using the information found within the eFSAP Form 1 Amendment Instructions, as well as extensive written and verbal guidance provided by the lead assigned entity point of contact at the FSAP, we completed the FSAP withdrawal process during a 12-month period between 2022 and 2023. Discussion: This commentary shares our recent professional experiences navigating the FSAP withdrawal process at the University of Texas Health Science Center at Houston (UTHealth Houston). Successes, challenges, and lessons learned are shared so that others planning or considering withdrawing may benefit from our experience. Conclusion: The resources provided for withdrawal within the eFSAP Form 1 Amendment Instructions are relatively basic, and additional details are not currently found in other FSAP guidance documents. Therefore, direct communication and support from the FSAP to the entity Responsible Officials are imperative to ensure a safe, secure, and compliant withdrawal.

A Means of Codifying Safety Cross-Training Knowledge Expectations for Biosafety Professionals.

Introduction: The health and safety issues encountered by biosafety professionals in the daily conduct of their work is rarely limited solely to potentially infectious pathogens. A basic understanding of the other types of hazards inherent to laboratories is necessary. As such, management of the health and safety program at an academic health institution sought to ensure crosscutting competency for its technical staff, including staff members within the biosafety program. Methods: Using a focus group approach, a team of safety professionals from a variety of specialties developed a list of 50 basic health and safety items that any safety specialist should know, inclusive of basic but important information about biosafety that was considered imperative for staff members to understand. This list was used as the basis for a formal cross-training effort. Results: Staff responded positively to the approach and the associated cross-training, and overall compliance with an array of health and safety expectations was experienced across the institution. Subsequently, the list of questions has been shared broadly with other organizations for their own consideration and use. Discussion/Conclusion: The codification of the basic knowledge expectations for technical staff within a health and safety program at an academic health institution, which includes the biosafety program technical staff, was warmly received and helped establish what information was expected to be known and what issues warranted input from other specialty areas. The cross-training expectations served to expand the health and safety services provided despite resource limitations and organizational growth.

Pivoting the Biosafety Program in Response to COVID-19: Recommendations of Key Services and Tasks to Consider for the Next Pandemic.

Introduction: With the onset of the COVID-19 pandemic, a rapid adjustment of work tasks was necessary for many biosafety programs (and other safety programs) to address drastic shifts in workload demands amid pandemic-related shutdowns and subsequent needs for supporting COVID-19-related safe work protocols, diagnostic testing, research, vaccine development, and so forth. From a program management standpoint, evaluating and understanding these tasks were critically important to ensure that appropriate support and resources were in place, especially during such unprecedented times of rapid change and significant impact to normal life and routine. Methods: Described here are examples of how the biosafety program at The University of Texas Health Science Center at Houston (UTHealth Houston) addressed these challenges. Results: As part of this required pivot, key services and tasks emerged into three distinct categories: (1) those that were temporarily diminished, (2) those that had to continue despite COVID-19 and the associated shutdowns for safety or compliance purposes, and (3) those that dramatically increased in volume, frequency, and novelty. Conclusion: Although the adjustments described were made in situ as the pandemic evolved, the cataloging of these tasks throughout the experience can serve as a template for biosafety programs to plan and prepare for the next pandemic, which will inevitably occur.

Assessing the Established Competency Categories of the Biosafety, Infection Prevention, and Public Health Professions: A Guide for Addressing Needed Professional Development Training for the Current and Next Pandemic.

A recent series of widespread infectious disease outbreaks has highlighted commonalities and differences between three key professions that operate on the front lines of response in support of research and/or direct healthcare providers: biosafety, infection prevention, and public health. This assessment, which builds upon previous study by the authors, examines the stated professional competency categories for these three areas, highlighting similarities and differences. This assessment is important as these professions are being drawn together in an operational environment driven by the current pandemic and inevitably future disease outbreaks. Cross-training opportunities for the various professions are proposed.

An assessment of outpatient clinic room ventilation systems and possible relationship to disease transmission.

BACKGROUND: With healthcare shifting to the outpatient setting, this study examined whether outpatient clinics operating in business occupancy settings were conducting procedures in rooms with ventilation rates above, at, or below thresholds defined in the American National Standards Institute/American Society of Heating, Refrigerating and Air-Conditioning Engineers/American Society for Health Care Engineering Standard 170 for Ventilation in Health Care Facilities and whether lower ventilation rates and building characteristics increase the risk of disease transmission. METHODS: Ventilation rates were measured in 105 outpatient clinic rooms categorized by services rendered. Building characteristics were evaluated as determinants of ventilation rates, and risk of disease transmission was estimated using the Gammaitoni-Nucci model. RESULTS: When compared to Standard 170, 10% of clinic rooms assessed did not meet the minimum requirement for general exam rooms, 39% did not meet the requirement for treatment rooms, 83% did not meet the requirement for aerosol-generating procedures, and 88% did not meet the requirement for procedure rooms or minor surgical procedures. CONCLUSIONS: Lower than standard air changes per hour were observed and could lead to an increased risk of spread of diseases when conducting advanced procedures and evaluating persons of interest for emerging infectious diseases. These findings are pertinent during the SARS-CoV-2 pandemic, as working guidelines are established for the healthcare community.