What role can labs play in helping to meet the suddenly very relevant federal law recently re-authorized as the Pandemic and All-Hazards Preparedness and Advancing Innovation Act (PAHPAIA), Public Law №116–22?
As we all continue to navigate through the unfamiliar waters of global lockdown, wearing of masks, gloves and other PPE, authorities are recognizing three main keys to successful pandemic prevention and management:
- Social Behavior (Social distancing, etc.)
- Contact Tracing
The third imperative, tracing contacts of patients who test positive for COVID-19 so as to warn, treat and contain, is an area White House senior adviser Jared Kushner’s task force is reportedly investigating, within the authorizations conferred by the Pandemic and All-Hazards Preparedness and Advancing Innovation Act (PAHPAIA), Public Law №116–22. What a national network would look like in terms of technology, what entities are involved and how, and reporting and privacy issues are all aspects of pandemic prevention and management that factor into a potential national policy.
In a free society, social behaviors can be advised and, to some extent mandated, but ultimately they are up to individuals to exercise. Technology has little or nothing to add in this area. However, in the areas of both testing and tracing, technology can prove a source of significant benefit.
In the area of testing, the focus is mainly about the ability to provide appropriate, accurate testing capabilities quickly and to all areas in need. This means not only in public health and national reference labs like Quest and LabCorps, but at point of care (POC) like physician offices, urgent cares and even local authorities and communities in the form of simple, quick assays (lateral flow assays) that don’t require expensive equipment and long turnaround times. It took a while, but we are now starting to see the availability of these kinds of tests begin to meet the demand.
But in addition to the assays themselves, data management systems need to be in place that are flexible enough to rapidly support new tests, data analysis and reporting.
For labs, that means an LIS (Laboratory Information System), or LIMS (Laboratory Information Management System). The two are essentially the same thing, but systems set up for medical use tend to be referred to as the former and those set up for any other kinds of labs as the latter.
Some systems are built to be flexible enough to span both medical and other laboratory feature sets. One such system, by LabLynx, Inc., has been configured and prepackaged specifically to help labs cope with COVID-19 testing. Called COVIDLiMS, it comes with qPCR and ICP based workflows as well as processing paths for confirmation testing where simple initial screening tests have been performed. It also handles inventory, QC and reporting tasks (as well as a full range of typical lab data management functions) — all in full compliance with state and federal regulations and standards and reporting requirements.
Contact tracing has been around far longer than the current pandemic. It is used by hospitals and health departments in cases of sexually transmitted diseases and other contagious diseases like measles and tuberculosis. The standard practice involves well-trained, skilled interviewers, called “disease intervention specialists”. It is labor and time-intensive, and imperfect because it is dependent on memory, interviews and detective work. Dealing with a global pandemic like COVID-19 is also much more problematic than tracking something like HIV. Instead of intimate encounters, we’re trying to track merely being within 6 feet of someone, or perhaps touching something that someone with the virus also touched. Faster, more accurate and thorough methods are needed. And existing numbers of tracers are far short of those needed to cope with the much greater case load. Tom Frieden, a former director of the Centers for Disease Control and Prevention, estimates around 300,000 trained staff are needed to handle contact tracing effectively. Rapidly hiring and training disease intervention specialists — not to mention the cost — is problematic, especially if it is to happen quickly enough to be relevant. Clearly, technology needs to step in.
While labs aren’t directly involved with the process, they can help if they can interface with the tracing systems in place so that data are transferred quickly and accurately in both directions. And labs that are able to work with the technology will also tend to be the go-to facilities for all related testing generated by identifying at-risk contacts. So that means more business for commercial labs. Laboratory technology companies like the aforementioned LabLynx understood the need early on, and their COVIDLiMS also includes the ability to work directly with any of the contact tracing apps and central databases in use or being considered, while maintaining required privacy.
The protection of personal health information (PHI) is mandated in the US by HIPAA and elsewhere by similar legislation. So disease intervention specialists already must proceed accordingly while still working to identify, warn, treat and if necessary quarantine those spreading or exposed to contagious diseases. Any technological systems need to do the same. Whenever contact tracing is mentioned, protecting privacy is almost always mentioned as well. The public are wary of any intrusive measures, especially in the US where individual liberties are at the very foundation of the nation’s conception.
Privacy is as much the focus of any technological answers to the contact tracing challenge as effectiveness. Most technologies developed to support contact tracing have been designed to alert individuals when they have been in the vicinity of a known COVID-19 case. They can then take the decision whether to act on the information.
A discussion of the various technologies and apps is available from the Johns Hopkins Bloomberg School of Public Health Center for Health Security in an article entitled “Review of Mobile Application Technology to Enhance Contact Tracing Capacity for COVID-19”.
LabLynx’s CovidLIMS is designed to be used by labs regardless of whether they already have a LIMS/LIS or not. “LabLynx existing clients can have the CovidLIMS installed as a module to augment their existing LabLynx LIMS and other labs can add this LIMS to manage their COVID-19 or other infectious/pandemic disease data alongside their current system and go live in a matter of a few days and with low cost,” said Jones.