Starting a COVID-19 Testing Lab

Published in

LabLynx

6 min readNov 30, 2020

Is Now a Good Time to Get Started? And if So, What’s Involved?

The answer to that question is easy: YES! Never mind the ongoing daily battles to limit the initial outbreak since March, it is becoming clear, as we transition into Winter of 2020 and the prospect of year two of the pandemic, that what was once acute has now become chronic. And SARS-CoV-2 may be with us for quite some time, if not indefinitely, like the annual flu virus.

No matter how our understanding changes with each new piece of information from the various ongoing studies, testing is firmly at the center of any effort to diagnose, and thus manage, coronavirus cases. The demand for testing is greater now than it ever has been. Testing is perhaps even more pressing as businesses, schools and other organizations grow more concerned about their ability to remain locked down or continue doing a fraction of their pre-COVID activities. The reality is this virus could prove far more deadly to organizations and businesses than to people.

Screening Programs

Organizations are turning to internal screening programs that ensure employees, students, organization members, etc. minimize risk to themselves and others, enabling the resumption of normal, or close to normal, activities. The recent availability of rapid, lateral flow assay kits introduces a game-changing element to assist with this process. Organizations can partner with CLIA-certified entities and healthcare workers to implement onsite screening on a daily or weekly basis.

Additionally, there is still plenty of lab testing needed for those individuals that test positive using the POC (Point of Care), lateral flow assay kits. The simple CLIA-waived lateral flow tests can be useful for screening with the use of the PCR-based lab tests to confirm. Weekly screening programs can still be 100% PCR-based where labs are capable of swift, 1–3 day turnaround times (TAT). And as labs automate and streamline processes and PCRs are introduced that can bring results to multiple specimens in an hour or less, TAT is being reduced even further, making PCR-based testing viable even for screening programs. The general, ongoing demand for testing from physician offices, clinics, hospitals, nursing homes, etc. remains as well.

So — What’s Involved?

Regulatory Requirements, Safety

There is no getting around the fact that any human, health-related testing requires CLIA certification and HIPAA compliance. Either you must already meet those criteria or have a plan for getting there. Having state-level buy-in helps, as in the case of Innovative Genomics’ startup COVID-19 testing lab. According to Hope Henderson at IGI, “…under revised guidelines from the CDC, FDA, CDPH, and an emergency declaration from Governor Gavin Newsom, we can expedite the clinical testing approval process.”

Additionally, you need to meet the regulations for the safe handling of potentially biohazardous materials. This may require little more than an extension of your existing OSHA and GLP practices and procedures, modified to reflect the unique nature of COVID-19 screening, and clearly communicated to your staff. Guidance on these and many other areas concerning laboratory COVID-19 testing can be found in a free LIMSwiki.org e-book published this week.

Automation

In this pandemic, if you expect to provide services to a school, business, or organization with many individuals and/or frequent testing, you will need to be able to handle high throughput. This is the single biggest challenge in COVID testing, along with its related challenge: fast turnaround time.

There is no use pretending otherwise; your setup needs to be as automated as possible. That means you need a LIS/LIMS (Laboratory Information [Management] System). Manual test requests, accessioning, data entry and reporting are just not going to hack it. Moreover, you will need to interface with a physician web portal or EMR, and/or patient web portal for fast submission and reporting. Not just any LIMS/LIS will work. It must be able to roll out quickly, support PCR workflows and have interfaces able to readily use various formats — at a minimum. Consider a well-established company with a product that has been specifically aimed at the unique challenges of the COVID-19 pandemic, such as COVIDLiMS from LabLynx.

You Need a LIMS/LIS

An article published in the Journal of the American Medical Informatics Association in August sought to identify the unique needs of a COVID testing lab. They included LIS functionality related to managing increased test demand during the COVID-19 crisis:

Tools for test ordering
Standardized order sets integrated into a computerized provider order entry module
Notifications on shipping requirements
Automated triaging based on digital metadata forms
Establishment of databases with contact details of other laboratories and primary care physicians to enable automated reporting
Data mining and reporting of actionable daily summary statistics to governing bodies and other policymakers
Round-the-clock laboratory testing
Process large numbers of potentially biohazardous samples every day

They further noted:

“… leveraging the capabilities of electronic laboratory information systems (LIS) to streamline all phases of laboratory testing (preanalytical, analytical, and post-analytical) has proven essential.”
“COVID-19 is a laboratory diagnosis with immediate consequences in the health sector (hospitalization, patient isolation, postponing surgery, etc.). Therefore, clinical laboratories face specific challenges that require dedicated LIS functionality to ensure safe, reliable testing and acceptable turnaround times.”

There are a lot of more detailed requirements, advice, and templates for ramping up COVID testing, written and shared by some who have accomplished it.

As COVID-19 becomes a chronic part of the public health landscape, the demand for testing will continue expanding. You can help meet this unprecedented need by offering COVID-19 testing to your current healthcare clients as well as the many organizations desperately seeking screening options. Be sure to leverage a LIMS/LIS that can ensure reliable testing, timely reporting, and rapid turnaround times.

Guidance

Guidance in the areas of starting a COVID-testing lab or transitioning an existing lab into COVID-19 testing is, unfortunately, thin on the ground. However, the free e-book published this week by LIMSwiki.org, “COVID-19 Testing, Reporting, and Information Management in the Laboratory”, is an excellent and thorough resource.