​​​Fall 2025

​Gone are the days of mouth pipetting and eating lunch at the bench. But how can laboratories maintain quality assurance, quality control and general laboratory safety, as well as biosafety and biosecurity, in the era of machine diagnostics and artificial intelligence? Is it easier or harder to adhere to certifications and quality control as the human element is further eliminated from some testing procedures? And how are laboratorians protecting themselves from unintended exposures? 

This issue explores how public health laboratories use a variety of practices to ensure their readiness to respond to natural and manmade threats—and keep staff members safe.

​​​​More than 500,000 workers are employed in laboratories in the United States. These workers are regularly exposed to numerous potential hazards, including chemical, biological, physical and radioactive hazards, as well as musculoskeletal stresses from repetitive motions and actions. While laboratory safety itself is governed by numerous local, state and federal regulations, it has often been the responsibility of each individual laboratory to educate its staff on laboratory safety practices.

For public health laboratories, who perform testing on both human and environmental samples, keeping all staff members safe is critical. Development of a culture of safety—with accountability up and down the administrative and scientific fields—has resulted in facilities that are, in fact, safe and healthy environments in which to teach, learn and work. However, funding cuts and staffing shortages are a harsh reality on a regular basis requiring public health laboratories to use a variety of practices to ensure their readiness to respond to natural and manmade threats are available to keep staff members safe.

The Evolution of Biosafety

For much of the 20th century, there was little emphasis on laboratory safety or security. Historical accounts can produce hair-raising stories about past practices; from mouth pipetting to storing lunches in refrigerators where specimens were stored, and working on the open bench without personal protective equipment available. Biological safety cabinets were also not commonly available.  

“The formation of the American Biological Safety Association (ABSA) in 1984 to promote safety as a scientific discipline and the availability of OSHA’s bloodborne pathogen standards in 1992, were key events in the movement to promote biosafety practices in the laboratory,” said Peter Iwen, PhD, D(ABMM), F(AAM), director and senior biosafety officer of the Nebraska Public Health Laboratory.  “And then when [US Department of Health and Human Services] put out their rule on the storage and transfer of select agents, that was when the idea of biosafety and biosecurity for laboratories really started.”

Into this fledgling biosafety sphere came the anthrax events of 2001, reinforcing the fact that even though laboratories had started a move towards greater safety and protection for their staff, there was still much work to do. Add in the Ebola virus outbreak of 2014–2016, and then the COVID-19 pandemic in the 2020s, and biosafety has now become a top priority for public health laboratory operations.

“We now recognize biosafety and biosecurity as scientific disciplines, where previously they were an afterthought,” said Iwen. “We’ve learned more about the importance of risk assessments and the development of biosafety guidelines with every biological event.”

Tim Southern, PhD, D(ABMM), was a post-doctoral clinical microbiology fellow in Iwen’s laboratory during the Ebola virus outbreak.

“We weren’t just testing samples, we were supporting the care of individuals with an awful disease,” he said. “We were bagging samples, sanitizing the bags, putting them in coolers and walking those samples between laboratories through corridors with other people and patients.” Now as director of the Nevada State Public Health Laboratory, Southern knows that his experience was a career-thinking game changer.

“Pete and other team members instilled in me very quickly the importance  of laboratory biosafety including critical activities like performing risk assessments that ultimately keep staff and programs safe. Quality was also a daily focus for the Nebraska team; we focused on all aspects of quality as it related to diagnostic testing and patient care.”

Today’s 21st century public health laboratory not only incorporates biosafety and biosecurity awareness but also sees how risk assessments and continuous training ensure data quality and quality assurance for all laboratory activities. In 1995, the US Centers for Disease Control and Prevention​ (CDC) created the Epidemiology and Laboratory Capacity for Prevention and Control of Emerging Infectious Diseases (ELC) cooperative agreement.  This included funds that have been traditionally used to subsidize biosafety and biosecurity initiatives within public health laboratories. After the Ebola virus outbreak, CDC provided funds to state and local health departments via the Domestic Ebola Supplement to the ELC, which enabled 62 state, local and territorial public health laboratories to strengthen their biosafety and biosecurity activities. 

In early 2025, significant cuts were made to federal funding provided under the ELC cooperative agreement. This funding was a significant source of support for many of the nation’s public health laboratories and impacted everything from replacement or maintenance contracts for essential laboratory equipment to construction or renovation of laboratory facilities. Along with these impacts, 439 full-time employees within the public health laboratory system were lost, which caused the reduction of elimination of many important testing services, as well as a decrease in personnel trained in biosafety and biosecurity.

 “There are going to be impacts to our work going forward, and we have to keep telling our policymakers and anyone who will listen about the criticality of the work we do,” said Southern. “But I think they are prepared to hear more from us, and I think we have to be more candid about why what we do is so important and should be funded.” 

Automating for the Future​

Even before the COVID-19 pandemic, public health laboratories embraced testing automation to respond to emergency testing requests as well as to relieve some of the work burden from laboratory staff. With the introduction of large machines to conduct diagnostic testing, however, there came another set of concerns.

“Automation is something that laboratory directors should  consider because of the current workforce constraints in public health laboratory science,” Southern said. “And when you talk about machines powering science, you have to consider the safety and security profiles of the instrument, as well as the safety and security practices of the individual running the instrument before you implement a new device or method in your laboratory.” With the advent of multi-use machines or testing platforms that can perform more than one type of test at a time, the procedures and processes used to stand up, perform, sterilize and then stand down the instrument take time, but is just one way that public health laboratories can ensure safety.

Laboratory automation is not a new concept. Clinical chemistry has used automation in their core laboratories for years. Because laboratories needed high throughput testing during the COVID-19 pandemic, transitioning to automated diagnostics was scrutinized in a way that incorporated the need for laboratory safety and security. Public health laboratory scientists invested in biosafety and biosecurity began to educate their communities not only about the need for automation, but about selection, use and personal protection while using this technology.
“Automation is designed to not only increase the throughput of testing, but also to enhance safety protocols and prevent human errors,” said Iwen. “But that doesn’t mean that automation is a panacea for laboratory personnel, especially when upfront and ongoing costs can be a burden to their laboratories.” 

“We are now engaging our industry partners in a meaningful way such that when they develop devices, they are thinking about the safety and security of the end user as much as they are thinking about an instrument that will bring in revenue,” said Southern.​

Educating the Workforce 

Gone are the days when a laboratory scientist is doing antibody serology by hand, streaking plates, picking pathogen colonies from an agar plate and ensuring chemical reactions on tubes remain controlled. Southern agrees that with that loss of knowledge, there is a tendency to place undue pressure on bench scientists and administrators to move faster between testing processes and procedures. 

“With the dependence on technology, we’re losing human skills, such as reading plates,” Southern said. “I think automation is setting up unrealistic expectations for laboratories, because there are still errors that occur and need human intervention.” But one advantage that new laboratorians have over previous scientists is the notion that biosafety and biosecurity are essential for laboratory practice, be it clinical, commercial or public health laboratory. And not only is it the training that is critical but staying informed of new practices and techniques.
“You need to track everything [related to a process],” said Marian Downing, RBP, CBSP, SM(NRCM), biological safety consultant and American Biological Safety Association (ABSA) representative to APHL’s Biosafety and Biosecurity Committee. “You need to track training and what processes people are trained to do, even including how to break down and sterilize a machine, because if you have cross-contamination in your piece of equipment the results are junk. Quality and safety should be hand in hand.”

It is important to note that these safety precepts not only apply to bench-level scientists but also to laboratory administrators and facilities personnel who are invested in quality assurance, safety and security for the laboratory. There also is a critical need to continue engagement with laboratory scientists to promote career development and to assure that cross-training and other practices are being utilized.

“As laboratory personnel, you need to have an understanding of not only how the equipment functions and what the features are, but also how waste will be removed by your custodians and where the venting from that biosafety cabinet hood goes,” said Downing. “A basic understanding of laboratory design goes a long way to ensuring fewer accidental exposures.” Southern agrees.

“I believe the most effective scientist-leader is someone who can do the job from beginning to end, regardless of automation,” he said. “I want my laboratory scientists to learn how to make media, perform testing with all the appropriate controls,  and thoughtfully evaluate all results. I even want my scientists to know how to take the trash out and run the autoclave. I believe by focusing on the end-to-end processes, including safety and security that accompanies those workflows, you are building a better foundation for your laboratory program.”

“We continue to be in the early stages of establishing professional biosafety and biosecurity training programs,” said Iwen. “Public health is somewhat behind the curve in the development of these training programs, as are clinical, commercial and manufacturing laboratories.  Although we are more attuned to biosafety practices in the laboratory, there are still opportunities available to improve the work environment.”​