As the number of COVID-19 vaccinations increases and total number of new cases decreases, clinical laboratories are now finally starting to experience a drop in the demand for diagnostic testing. This dynamic has enabled many labs to focus on helping local businesses and schools reopen safely. In fact, many organizations are now contracting clinical laboratories to test employees and visitors.
As the Chair of the AMP Infectious Diseases Subdivision and Member of the AMP COVID Response (ACR) Steering Committee, I can assure you that clinical laboratory professionals across the country are committed to accelerating a safe reopening. Accurate and timely screening testing remains the fundamental key to any successful reopening strategy.
Today, there are many different types of laboratories offering tests for SARS-CoV-2. These facilities can range from the large and small commercial referral labs to academic medical centers to community hospitals to mobile testing sites. The entire process of selecting a laboratory can be an overwhelming process for anyone not familiar with the nuances of molecular testing.
Below is a quick checklist for any organization looking to contract a clinical laboratory for COVID-19 screening testing as part of its reopening strategy.
1. Is the laboratory accredited and known for high-quality, accurate testing?
The ability to perform high-quality testing must be the most important factor in your decision.
You should ask about the qualifications of the professionals running the tests. These molecular diagnostic services should be provided by either a physician or qualified doctoral scientist with specialized training and experience as the Laboratory Director.
Be sure to ask for the laboratory’s accreditation information. Clinical laboratories are regulated by the Centers for Medicare & Medicaid Services (CMS) under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), in addition to state level requirements, and professional accreditation bodies. AMP recommends selecting an accredited, high-complexity, CLIA-certified laboratory.
I also encourage you to check with references to learn more about their customer experiences and ask for a copy of their verification reports for the tests they use.
2. What does the full test menu look like? How many different COVID-19 testing platforms do they have?
It’s important to consider the full test menu offered by each clinical laboratory. What types of tests does that laboratory offer and how do their performance characteristics vary? If the laboratory only offers COVID-19 testing, that should be a red flag.
You will also want to know about the number of COVID-19 testing platforms they have available. Using different platforms can guard against delays due to instrument malfunctions or supply shortages.
The laboratory’s sample volumes could give you a better sense of where your organization would fit in terms of the laboratory’s prioritization. Also, be sure to ask about turnaround times for results to make sure that they meet the needs of your organization.
3. How are the samples collected and delivered to the laboratory? How are the results reported? Which entity is responsible for tracking down individuals with positive results?
You will want to define a sample collection protocol that works for both the organization and the laboratory. How are the samples collected? Are the samples collected by a trained professional? What steps are taken to ensure the samples are not contaminated? Will the samples be couriered to the laboratory?
The reporting responsibilities can vary because each state has its own set of requirements. You’ll want to make sure you know which entity is responsible for reporting positive results and what the necessary protocols are.
There is widespread progress with laboratory testing capabilities over the past year and we are now ready to put that excess capacity to use. With the right precautions, a screening test contract can be a valuable strategy that enables local businesses and organizations to reopen safely and quickly.
Donna M. Wolk, PhD
Chair of the AMP Infectious Diseases Subdivision
Division Director of Molecular and Microbial Diagnostics and Development, Diagnostic Medicine Institute at Geisinger