METADATA
last updated: 2026-03-05 by BA
file_name: CMS - CLIA Surveillance Testing SARS-CoV-2 Frequently Asked Questions (2021-10-21).md
file_date: 2021-10-21
title: CMS CLIA - Surveillance Testing SARS-CoV-2 Frequently Asked Questions
category: regulatory
subcategory: surveillance
tags: 
source_file_type: pdf
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pdf_gdrive_url: https://drive.google.com/file/d/1FN0e5vbU3eJ2hMSewH9to42yvYhWisCn
pdf_github_url: https://github.com/FocusOnFoundationsNonprofit/floodlamp-archive/blob/main/regulatory/surveillance/CMS%20-%20CLIA%20Surveillance%20Testing%20SARS-CoV-2%20Frequently%20Asked%20Questions%20%282021-10-21%29.pdf
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notes: 
summary_short: The CMS CLIA “SARS-CoV-2 Surveillance Testing” FAQ (revised 10/21/21) explains when facilities using pooled surveillance testing with non-patient-specific cohort reporting do not need a CLIA certificate during the COVID-19 public health emergency. It highlights key risks of pooled surveillance testing (including dilution-related false negatives/positives) and states that any positive/inconclusive pool results must be confirmed via individual testing at a CLIA-certified facility. It also notes that because these facilities are not CLIA-certified, CMS does not have oversight authority over their quality and safety of result reporting.


CONTENT

***INTERNAL TITLE:*** Frequently Asked Questions: SARS-CoV-2 Surveillance Testing
*Revised 10/21/21*

1. **Does my facility need a CLIA certificate if we are performing SARS-CoV-2 surveillance testing using a pooled sampling procedure with non patient-specific reporting?**

   A. During this COVID-19 Public Health Emergency, 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. 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.

   If at any time a *patient specific result* is to be reported by your facility, you *must first obtain a CLIA certificate* and meet all requirements to perform testing.

2. **What are the potential risks of using a surveillance pooled sampling procedure?**

   A. There may be a risk of obtaining false negative or false positive results when utilizing a pooled sampling testing model. According to the FDA website, “Surveillance with pooled or batched testing should be validated on a test platform and test of high sensitivity and positive tests should have a confirmatory test. Because samples are diluted, which could result in less viral genetic material available to detect, there is a greater likelihood of false negative results, particularly if not properly validated.” 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.

3. **Will CMS have oversight of testing facilities that perform pooled surveillance SARS-CoV-2 testing?**

   A. As these facilities are not CLIA certified, CMS will have no oversight authority to ensure quality and safety of result reporting.