Ready or not: Operational readiness for HCID patients

Operational readiness for high-consequence infectious diseases (HCIDs) remains one of the most critical challenges in modern healthcare. While much attention is often directed toward frontline clinical teams, the clinical laboratory plays an equally pivotal—yet sometimes underrecognized—role in protecting patients, clinicians, and the broader community. Successful patient outcomes depend on timely and accurate diagnostics, and laboratories must be prepared to safely process specimens from potentially infected individuals at any moment, regardless of their facility’s size, resources, or geographic location.

Patients with suspected HCIDs may present to any healthcare setting, from a 10-bed rural critical access hospital to a 1,000-bed tertiary care center. Illness does not respect institutional readiness. When people are unwell, they seek care wherever it is immediately accessible—ideally in their own communities. Therefore, every hospital laboratory must maintain a foundational level of competency, safety readiness, and operational fluency to manage specimens from patients under investigation for HCIDs. The literature consistently emphasizes that timely diagnostic testing is critical not only for patient stabilization but also for ensuring diagnostic accuracy and survival.¹ During an HCID assessment, it is neither ethically nor clinically acceptable to withhold standard of care interventions while awaiting confirmatory testing. Even as advanced molecular diagnostics are pending, routine laboratory studies often guide early interventions that prevent deterioration.

To support national readiness, the National Emerging Special Pathogens Training and Education Center (NETEC) has established itself as the premier resource for HCID preparedness across the United States. NETEC provides comprehensive training, technical assistance, and evidence-based guidance to hospitals and laboratories. In addition, NETEC operationalizes and is the coordinating body for the National Special Pathogens System (NSPS)—a tiered network of healthcare facilities designed to address gaps in national healthcare readiness and support scalable, standardized responses during outbreaks.² The NSPS Level 2 Resource Guide³ serves as a practical and operational framework that helps laboratories strengthen their preparedness across multiple domains, including communication systems, safety protocols, risk assessments, and testing workflows. This is in the context of organizing readiness into 11 key capability domains — spanning from physical infrastructure and PPE supply through laboratory operations, training and exercises, personnel management, infection prevention and control, waste management, decedent care, research, emergency management, treatment and care delivery, and communication/coordination. These domains reflect the breadth of systems and operational elements a facility must address to safely receive, treat, and discharge patients with HCIDs.

High-quality care for HCID patients requires early identification and containment. NETEC’s guiding mantra—Identify, Isolate, Inform—remains foundational to safe and effective response efforts.^4,5 Clinicians must first identify patients who present with epidemiologic risk factors or symptoms consistent with an HCID. Next, patients must be isolated promptly to prevent transmission. The final step—inform—is often the most crucial for laboratory safety. This notification must extend beyond infection prevention and clinical leaders to explicitly include the laboratory. When laboratory personnel are informed early that a specimen may contain a high-consequence pathogen, they can implement targeted biosafety measures, modify workflows, and reduce unnecessary exposure risks. Numerous studies highlight that laboratories are safer and operationally more effective when communication occurs before specimen arrival.⁶

Mitigating risk to clinical laboratorians

Safe laboratory operations form the backbone of effective HCID management. Protecting laboratorians is not optional—it is essential to maintaining uninterrupted diagnostic capacity. Both historical evidence and contemporary HCID events demonstrate that laboratory workers face measurable risk when biosafety practices are incomplete or inconsistent.⁷ Even in high-volume laboratories that routinely process thousands of specimens daily, each sample carries potential risk.⁸ The key to risk mitigation lies in recognizing that HCID-associated hazards are not unique; rather, they often mirror risks inherent in routine laboratory tasks. What differs is the potential severity of consequences following an exposure.

Procedures that generate aerosols—centrifugation, vortexing, pipetting, opening blood tubes, or mixing specimens—are among the most common sources of exposure. These routine steps can result in aerosolization or surface contamination, especially when performed quickly or under pressure. Understanding these workflow vulnerabilities is essential when handling specimens that may contain high-consequence pathogens.⁹  

While research laboratories working with Biosafety Level-4 (BSL-4) pathogens have established extensive biosafety protocols, they represent a specialized subset of facilities, and accidental laboratory infections have been exceedingly rare in the United States, with no recorded deaths.^10,11 Importantly, advancements in therapeutics during recent Ebola, Lassa, and Marburg outbreaks have introduced viable post-exposure prophylaxis options, further enhancing safety for laboratorians when exposures occur.¹²

Risk assessments provide laboratories with a systematic method for evaluating their workflows, identifying potential hazards, and determining appropriate mitigation strategies.¹³ A robust risk assessment considers physical layout, specimen transport pathways, equipment safety, staff experience, and the complexity of laboratory procedures. When used effectively, risk assessments drive the development of targeted training, engineering controls, and evidence-based policies that safeguard employees and ensure testing continuity.

To further enhance national laboratory readiness, the NETEC Laboratory Working Group is developing a comprehensive risk assessment tool tailored specifically to special pathogen preparedness. Scheduled for release in mid-2026, this resource will provide laboratories with a structured, standardized approach to evaluating and strengthening their biosafety practices. The tool is expected to support institutions of all sizes—from small community hospitals to large academic centers—allowing them to identify gaps and systematically improve safety infrastructure.

Lessons learned: The Iowa Lassa fever case

The Iowa Lassa fever case in 2024 serves as a compelling reminder of the importance of effective communication and preparedness.¹⁴ In this event, delays in recognizing and notifying the laboratory led to unintended exposures among laboratory staff across several facilities.¹⁵ This case illustrates how routine workflows can be impacted when information is incomplete. There are instances when laboratories do not receive advance notice that a specimen may contain an HCID, which can increase the risk to staff. This incident also underscores how quickly routine laboratory processes can be disrupted when key clinical information is missing. As reported in the BMJ, the 2024 U.S. Lassa fever case involved a traveler who likely contracted the infection in West Africa and whose illness was not initially recognized as a high-consequence pathogen.¹⁴ Situations like this demonstrate how easily an HCID can enter the healthcare system without early suspicion, leaving laboratories unaware that a specimen may require enhanced biosafety measures. For readers less familiar with these workflows, laboratories rely heavily on clinical clues—such as travel history, symptom patterns, or known exposure risks—to decide when to implement specialized procedures, personal protective equipment, or containment devices. When that information is delayed or incomplete, staff may handle samples using standard methods that offer insufficient protection. Clear communication at the time of specimen submission is therefore essential to safeguarding both laboratory personnel and the diagnostic process.

This incident reinforces the fundamental message: laboratorians must remain vigilant. It’s crucial to avoid complacency, especially in high-throughput environments where speed and volume can overshadow caution. Effective communication, robust risk assessments, and sustained preparedness efforts are essential to protecting both patients and staff.

REFERENCES

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2. National Special Pathogens System (NSPS) Fact Sheet. US Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response. Published April 2021. Accessed December 1, 2025. https://aspr.hhs.gov/HealthCareReadiness/HPP/Documents/NSPS%20Fact%20Sheet%20April%202021.pdf.
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