While facilities conducting a SARS-CoV-2 cohort test would not be required to have CLIA certification, CLIA certification would be required in certain circumstances.
The Centers for Medicare and Medicaid Services (CMS) provided answers to frequently asked questions that clinical laboratories could have regarding pooled surveillance SARS-CoV-2 testing.
The first question addressed if facilities need Clinical Laboratory Improvement Amendments (CLIA) certificates when performing SARS-CoV-2 surveillance testing using a pooled sampling procedure with non patient-specific reporting.
CMS answered: “Facilities performing SARS-CoV-2 surveillance testing using a pooled sampling procedure to report non patient-specific SARS-CoV-2 cohort results will not require CLIA certification.” CMS further explained, “This testing is not considered by CMS to be diagnostic of SARS-CoV-2 infection, and participants should not rely on information received from this type of testing for decision-making purposes.”
The second question asked about the potential risks of using a surveillance pooled sampling procedure. CMS responded that there are not any tests currently authorized by the FDA for use on pooled specimens. CMS also said in their answers, “There may be a risk of obtaining false negative or false positive results when utilizing a pooled sampling testing model.”
CMS also discussed the risk of dilution that could occur with pooled samples: “To possibly mitigate this risk, all positive and inconclusive SARS-CoV-2 results from pooled sampling must be confirmed by having each participant whose sample was contained within the cohort to be tested by a CLIA-certified facility.”
The final question addressed by CMS asked if CMS would have oversight of facilities performing pooled surveillance SARS-CoV-2 testing. CMS responded, “As these facilities are not CLIA certified, CMS will have no oversight authority to ensure quality and safety of result reporting.”
The CMS FAQ resource was published June 19, 2020. Preceding the June 19 CMS document, the federal Food and Drug Administration (FDA) issued a June 16 update: Facilitating Diagnostic Test Availability for Asymptomatic Testing and Sample Pooling.
There is interest in sample pooling, according to federal officials, in order to preserve testing resources.