Oliver Schacht

When an infectious disease outbreak emerges, healthcare administrators in long-term care facilities face the difficult task of monitoring the situation within their own facility, state and region while also following government and national health authority recommendations. When it comes to novel disease pandemics, such as the COVID-19 coronavirus, updates, regulations and best-practices can change on a daily or even hourly basis.

Pandemic response efforts in healthcare settings are evolving to provide more precise information, at a faster rate and in a more collaborative format thanks to new rapid diagnostic and surveillance technologies. These technologies enable healthcare workers and researchers to pinpoint affected patients and track the spread of infection from these individuals to others on a local, regional and even national scale.

This two-fold approach is scalable and should be applied to long-term care and nursing facilities, where many high-risk patients reside. However, there is still room for improvement and lessons to be learned from ongoing situations, such as the COVID-19 outbreak.

Guarding the front lines with diagnostics

At the outset of any outbreak event, facilities must identify who has been infected or exposed to a virus or bacteria. Tracking exposure, not just symptomatic patients, enables workers and administrators to predict where the outbreak may head next and take preventative action.

In nursing and long-term care facilities, paying close attention to transmission rates and test results is even more critical as the patient population is at greater risk for developing severe symptoms and complications. In these scenarios, whole genome sequencing (WGS) diagnostics and polymerase chain reaction (PCR) tests capable of identifying the underlying cause of common symptoms and indications are valuable tools.

By analyzing bacterial, fungal and viral pathogen genomes, these diagnostics identify disease-causing variants with speed and precision. Many tests can deliver results in a matter of hours, rather than days, positioning them to keep pace with rapid transmission rates. With this information at their fingertips, clinicians and caregivers can deliver faster treatment and improve outcomes for some of the most vulnerable patients. However, when it comes to getting rapid testing technology into the hands of healthcare workers at long-term care facilities and in other settings where they are needed most, challenges remain.

Breaking down testing barriers

Countless diagnostic testing technologies have been developed to identify pathogens that commonly cause outbreaks. This includes those targeting drug-resistant fungi and bacteria known to cause UTIs and respiratory infections. However, these technologies get held up by rigorous FDA approval processes, which can take months or even years.

The CDC was quick to issue testing guidelines for COVID-19, allowing certain technologies to be put in the “fast lane” to approval. This timely response, while necessary to address the pandemic, is unprecedented when considering other potentially useful technologies that have been left in regulatory limbo.

Widespread access to WGS diagnostics and PCR test kits is also vital. Long-term care facilities and at-risk patients should be prioritized immediately when an outbreak event begins — particularly when that outbreak is lethal to compromised communities, as is the case with COVID-19. Clinicians should not be forced to send out test samples to just a few approved locations and endure long wait times. Rather, on-site or even local testing and analysis should be the goal during fast-moving outbreaks like COVID-19, especially in long-term care facilities where at-risk patients and their caregivers cannot afford to wait for results.

Regulatory agencies must do their part to provide crucial facilities with an adequate number of tests and the necessary technology to analyze results locally. The CDC and FDA must exercise due diligence when ensuring hospitals, nursing homes and clinics are well-equipped and backed up by a framework that can replicate the development of test kits when necessary. Regulatory bodies are beginning to take cues from other players in the industry and, as rapid testing technologies evolve and informatics companies rally to create new solutions, we can expect FDA approval processes to accelerate in tandem.

Following an outbreak with surveillance

The second step of the two-fold outbreak response, both on a global scale and in individual facilities, is looking at confirmed cases through a wider lens. With cloud-based software platforms, the surveillance process has been simplified in recent years. Diagnostic test results and outcomes from a long-term care patient can be entered into a database and then compared to similar cases at that facility and others around the world. This is possible through the power of genotypic and phenotypic analysis, which creates a repository of thousands of clinical isolates gathered and updated in real-time.

Surveillance can provide the missing link to understanding how an individual infection becomes a transmission event. This capability is crucial during a pandemic where transmission is possible across vulnerable nursing facility patients. Further, surveillance enables administrators and clinicians to assess their infection control protocols and make changes to improve outcomes in the future.

Outbreak management techniques are improving as key players from government, regulatory agencies and the healthcare industry grapple with COVID-19. Everyone working in these areas has been forced to learn lessons on the fly and adjust protocols each day. At long-term care facilities, this is all done with the common goal of keeping high-risk patients safe.

In order to keep pace with outbreaks and set up a framework of best-practices that will hold up to future events, we need improved access to diagnostic tools and more widespread, collaborative use of surveillance platforms for big-picture analysis. With these goals achieved, hospitals, clinics and long-term care facilities will all be better-equipped to protect patients and empower staff to manage future outbreak threats.  

Oliver Schacht is the CEO of OpGen, Inc., a pioneering informatics and genomic analysis company providing complete solutions for patient, hospital, and network-wide infection prevention and treatment.