By Jeffrey Lee Schantz and Michael Weiss / Special to Healthcare Facilities Today

After 9/11 and the subsequent Anthrax attacks, the nation responded to bioterrorist threats by building a network of national, regional, state, and municipal biological laboratories to respond to terror attacks, public health threats, and emerging infectious diseases. The network was designed to build capacity for monitoring, surveillance, response, and rapid diagnostics to pandemics like COVID-19.

The bolstered defenses included two national biocontainment laboratories, ten regional biocontainment laboratories, and investing in state level public health labs. How has this strategy worked for this pandemic and how should we adjust our thinking for this and future pandemics?

Capacity

The thinking after 9/11 was to build capacity by building biocontainment labs at Biological Safety Levels (BSL) 2/3/4. By building high containment labs, we would provide space to cope with the surge in diagnostic testing when the crisis came. While we built a lot of square footage, it turns out we did not build enough capacity for the following reasons:

• The technology of molecular detection and rapid reverse transcription polymerase chain reaction (RT/PCR) evolved into high throughput automated closed systems. This is a game changer because testing can now be done at BSL-2 for pathogens like COVID-19, meaning we need less high biocontainment space.

• This approach addressed building needs, it did not provide operating or program funding. As a result, much of the capacity was not maintained or was repurposed for other programs.

• The facilities approach was intended for research and confirmatory testing at national and regional labs, and CDC. Monitoring, surveillance, and diagnostics was intended to be done at the state and local level. By time COVID-19 arrived, the confirmatory technology was in place, but the high throughout was not at confirmatory labs. Many labs are underfunded, and have not acquired the proper equipment or maintained the staffing levels necessary in times of high demand. Those that have it are short of consumable supplies.

Biocontainment

The profession learned a lot about how to correctly build and operate high containment labs during this period. The technology of materials, controls, isolation, and protocol advanced quickly as lab designers and architects innovated to meet the demands of public health responders. Some of the lessons learned were difficult ones that influenced lab design of the era. Some key lessons include:

• The biocontainment labs built after 9/11 are generations behind current diagnostic automated technology. While flexibility was planned in at BSL-2, BSL-3/3E/4 labs simply do not offer enough adaptability to pivot quickly to changing missions. We need to develop technologies that create BSL-3 containment on demand utilizing modular and movable containment.

• Protocol drives design by integrating validation, repeatability, reliability, and safety into the work stream. The guidance on protocols from CDC, NIH, USDA, WHO, and others is critical. One point of confusion initially for COVID-19 was around which BSL to use. It was understood from the beginning of the outbreak that we were dealing with an emerging pathogen without a prophylactic, vaccine, or cure. By NIH/BMBL standards, that would be defined as BSL-4.

However, considering isolation and closed systems technology, along with personal protective equipment (PPE) and good protocols, it is safe to run diagnostics at BSL-2 with enhancements (per CDC guidance).

• Since the biggest threat in this pandemic is to our frontline health care workers, we need to invert our thinking on containment. We should not be building biocontainment labs or isolation wards, we should be designing better PPE that can be produced faster, on demand, and used safely in flexible program space that can be converted without intensive validation to use with patients or testing. We want our doctors, nurses, clinicians, first responders, and patients to be safe. Locking them in a room without protective gear is bringing a knife to a gunfight.

• Prioritize equipment, not buildings, for testing. Provide the closed system equipment and instruments, including isolators and biosafety cabinets, first. As the commercial diagnostics industry has proven, you can setup a lab in warehouse building far cheaper and faster than you can build a certified public health lab.

Preparedness

The US response to COVID-19 should heed key lessons from the post 9/11 response. The most important lesson to learn is to fight the current war and plan for the next, but don’t fight the last war. Much of the infrastructure we built post 9/11 was designed to deal with an entirely different threat, not a global pandemic.

• Supply chain is key. All the facilities we designed post 9/11 were required to remain operational during a disaster, meeting DOJ Level 4 requirements for survivability, and DOD UFC requirements for security. Most were also designed to operate without resupply for 7-30 days, so facility designs included warehouses to store critical supplies. Were they properly stocked and maintained?

• Just in Time manufacturing doesn’t work for global pandemics. When a pandemic occurs, you either have the supplies on hand or you don’t. What belongs in that critical supply chain is PPE, consumables for diagnostic equipment, decontamination agents, isolators, and equipment.

Relying on offshore manufacturing and on demand supply management is not a strategy. The US needs a domestic industry protected from competition to achieve this.

• All hands-on deck. Commercial Laboratories are having to step in to provide capacity because the public health labs are confirmatory, not high-throughput. They are built for accuracy, not speed. The high-throughput equipment is in commercial labs, so why not make them part of the preparedness plan?

• Push the response out of the Lab. The drive through testing clinics for gathering samples is very effective. The next step would be sample collections done at home and sent via courier using the point of contact model to reduce the burden on healthcare institutions. The materials handling protocols are in place, we should take advantage of it. This would make testing available to everyone quickly.

We learned a lot after 9/11, we going to learn even more after COVID-19 is history. We face many challenges ahead, not just the economic fallout, but also the fact that climate change will create even deadlier viruses as the planet warms. We should embrace the opportunity to constantly improve and be better prepared.

Jeffrey Lee Schantz, AIA, NCARB, E4H Environments for Health Architecture. Michael Weiss, PhD, is President and CEO Retired, The WorkingBuildings Group of Companies. For more information, visit www.e4harchitecture.com.