Lab Matters Fall 2025 | Page 23

FEATURE SPOTLIGHT: PUBLIC HEALTH PREPAREDNESS AND RESPONSE

By Michael Marsico, program manager, Public Health Preparedness and Response

The International Organization for Standardization( ISO) 35001 Standard: Biorisk management for laboratories and other related organisations defines a process to identify, assess, control and monitor risks associated with biological threats. ISO 35001 is built on the concept of continual improvement, following the Plan-Do-Check-Act Cycle( PDCA)( Figure 1). This approach provides a system to identify problems, implement solutions, evaluate results and make changes for ongoing improvement of the laboratory system specifically around the quality of laboratory operations and the safe handling of potential threats.

APHL and the US Centers for Disease Control and Prevention( CDC) are working to pilot the implementation of the ISO 35001 standard at multiple pilot public health laboratories.

Michael Stevenson, PhD Deputy Laboratory Director New Hampshire Public Health Laboratories

The ISO 35001 standard has helped the New Hampshire Public Health Laboratories to:

● Include a safety assessment component to the annual Clinical Laboratory Improvement Amendments( CLIA) competency assessment requirements.

● Consolidate documentation of all quality events, including nonconforming events and safety incidents, into a single electronic workflow process using Ideagen Quality Management( aka, Qualtrax).

● Implement an Excel safety risk assessment template for identifying biological, chemical and radiological hazard risks and mitigation steps, across all New Hampshire Public Health Laboratories testing units.

Figure 1. A visual representation of the Plan-Do-Check-Act Cycle.

● Mentor an APHL Fellow in Biosecurity and Biosafety— now in

his second year with us!

● Validate our autoclave biowaste sterilization cycles and have consistent quality controls in the cycle runs.

● Provide justification for and ultimately hire a dedicated laboratory safety officer.

Michael A. Pentella, PhD, director, and Andrea Morris, MPH, biological threat coordinator / biological safety officer State Hygienic Laboratory at the University of Iowa( SHL)

Participating in the ISO 35001 pilot program provided SHL with the opportunity to evaluate our current biosafety program, identifying both strengths and areas for improvement. In preparation for the audit, SHL conducted a review of the program and initiated some changes. The preparation for the audit and the review by the auditors supplied us a fresh perspective and helped us see improvements that could be made.

For example, post-audit we implemented comprehensive documentation of all biological safety cabinets and fume hoods within our Quality Management System( QMS), including task reminders for necessary maintenance. Additionally, we have begun recording safety findings and conducting drills within our QMS. We have also revised our onboarding process to ensure consistent provision of recommended vaccinations and are incorporating a dedicated safety section into our annual management review.

By promoting safety with a focus on quality improvement, SHL continues to strengthen our culture of safety, address areas needing improvement and ensure the sustainability of a robust biosafety program.

Having an international standard that blends both quality and safety is imperative to support all laboratory operations. APHL is eager to continue to collaborate with these pilots to implement this standard and promote the value of ISO 35001 with other public health laboratories in the future. g

and producing reliable results. Two of our initiatives— a lab-wide continuous temperature and humidity monitoring system and streamlining training processes— are rooted in process standardization, training / competency, risk management and process improvement; thereby demonstrating intersectionality. When QAS works together, these actions result in improved commitment, employee support, accountability and credibility with our customers. g