Senators Warner, Kaine Join Colleagues in Pushing for More Information, Transparency on Coronavirus Testing

From Sen. Mark Warner’s office:

WARNER, KAINE JOIN COLLEAGUES IN PUSHING FOR MORE INFORMATION, TRANSPARENCY ON CORONAVIRUS TESTING

~ Press Coronavirus Task Force for plan to address testing shortfalls ~

WASHINGTON – U.S. Sens. Mark R. Warner and Tim Kaine (both D-VA) joined Sen. Tina Smith (D-MN) and 43 other Senators in calling on the Coronavirus Task Force and the Federal Emergency Management Agency (FEMA) to conduct a national inventory of the coronavirus (COVID-19) diagnostic testing supply, publicly release data on testing results, and provide a detailed plan and timeline for addressing future shortages and gaps in the testing supply chain.

“Over three weeks after President Trump declared the COVID-19 outbreak a national emergency, we continue to hear from our states and Tribal Nations about the lack of supplies and testing kits to diagnose our constituents for the coronavirus,” wrote the Senators. “State departments of health, hospitals, health care providers, and first responders lack the tests and equipment—including personal protective equipment (PPE), testing swabs, and reagents—needed to conduct adequate public health surveillance to contain and stop the spread of coronavirus.

“Widespread diagnostic testing is crucial to controlling the COVID-19 outbreak. In the short term, quickly obtaining test results for hospitalized patients allows hospitals to preserve supplies of PPE and prevents unnecessary quarantines of front-line health care workers and first responders. In the long run, experts have argued that widespread testing will be needed to track and contain COVID-19 cases, allowing communities to slowly lift general social distancing restrictions without putting the public at risk.”

They continued, “We urge you to promptly develop a national, real-time, public-facing inventory of COVID-19 diagnostic tests and results. This resource will provide the transparency that our states and Tribal Nations need to anticipate the national testing supply chain and the information that the federal government needs to anticipate and proactively address any testing shortages.”

In their letter, the Senators also requested answers to the following series of questions:

1. How many COVID-19 diagnostic tests are available on a daily basis, and to which states and Tribes are manufacturers sending these tests? How many of these tests screen for coronavirus antibodies?
2. To which public health, academic, and commercial laboratories are COVID-19 diagnostic test manufacturers sending tests, and how many tests are being sent to these labs?
3. Which laboratories—public health, academic, and commercial—can run COVID-19 diagnostic tests, and what is their daily capacity to run these tests? Please provide a breakdown of this information by lab type, test type, and state if possible.
4. What is the wait time for laboratories to process and receive results for COVID-19 tests?  Do providers have to wait minutes, hours, or days to receive their patients’ results?
5. What supplies do America’s public health, academic, and commercial laboratories need on hand to run at full capacity to process COVID-19 tests? Which of these supplies are in shortage, and what steps is the Administration taking to expand the capacity of these supplies?
6. In a March 10 interview, Secretary Azar referenced an “IT reporting system… to keep track of how many we’re testing.” What is the status of this system? What information is tracked in this system?
7. Will the Task Force commit to making all collected information about testing capacity and volume publicly available with daily updates, and to release relevant information on testing results?
8. Which federal agency is managing the supply chain and distribution of tests and testing supplies to states, territories, and Indian Tribes?  Which official is leading the testing supply and distribution effort within that agency?

A copy of the letter is available here or below:

Vice President Michael Pence
The White House
1600 Pennsylvania Avenue N.W.
Washington, D.C. 20050               

Dear Vice President Pence: 

We write to urge the Coronavirus Task Force to direct the Department of Health and Human Services (HHS) and the Federal Emergency Management Agency (FEMA) to conduct a national inventory of the country’s COVID-19 diagnostic test supply, publicly release comprehensive data on testing results, and provide a detailed plan and timeline for addressing future shortages and gaps in the testing supply chain. Currently, the federal government is not meeting its responsibility to coordinate testing capacity among states and Indian Tribes and is failing to release crucial information to the public. We urge you to provide public transparency and leadership without delay.

Over three weeks after President Trump declared the COVID-19 outbreak a national emergency, we continue to hear from our states and Tribal Nations about the lack of supplies and testing kits to diagnose our constituents for the coronavirus. State departments of health, Indian Tribes, hospitals, health care providers, and first responders lack the tests and equipment—including personal protective equipment (PPE), testing swabs, and reagents—needed to conduct adequate public health surveillance to contain and stop the spread of coronavirus.

Widespread diagnostic testing is crucial to controlling the COVID-19 outbreak. In the short term, quickly obtaining test results for hospitalized patients allows hospitals to preserve supplies of PPE and prevents unnecessary quarantines of front-line health care workers and first responders. In the long run, experts have argued that widespread testing will be needed to track and contain COVID-19 cases, allowing communities to slowly lift general social distancing restrictions without putting the public at risk. 

The lack of tests is reportedly forcing the administration, in concert with private actors, to funnel available supplies to certain areas.  For example, Abbott Labs, which recently developed a rapid 5-minute COVID-19 diagnostic test, said it is, “working with the administration to deploy the tests to areas where they can have the greatest impact,” like COVID-19 hot spots. This may explain why, even though the Food and Drug Administration (FDA) has now issued emergency use authorizations (EUAs) for 32 COVID-19 diagnostic tests, many of our states and Tribal Nations have not seen the benefit of this rapid private-sector innovation. While it is important to provide tests for COVID-19 hot spots, tests cannot be limited to those areas. Without prompt and sufficient access to coronavirus tests, we risk exacerbating outbreaks and becoming a nation of hot spots. 

Furthermore, the decentralized system of tracking tests and the corresponding lack of transparency into when and where these tests are being sent makes it challenging for our nation as a whole to systemically plan its public health response to the COVID-19 outbreak. Currently, hospitals are finding that some labs are working through significant backlogs, leaving samples untested for days or weeks, while others are able to turn results around quickly, within 24 to 48 hours. Without detailed information about the capacity and turnaround time for each lab, it is impossible to efficiently distribute testing capacity on the nationwide scale that is required by this crisis. Given the Administration’s track record of over-promising and under-delivering on testing for COVID-19, the public deserves full transparency about our national capacity for COVID-19 testing, including where tests are available, how many have been conducted, which patients have access to testing, and what the results of these tests revealed.

These persistent gaps in the availability of COVID-19 diagnostic tests and the lack of public transparency about where tests are available raise the need for a national inventory of COVID-19 diagnostic tests. The recently passed Coronavirus Aid, Relief, and Economic Security (CARES) Act granted HHS the authority to collect test results from any laboratory. Additionally, you recently wrote to hospitals asking them to report their internal test results to the Federal Emergency Management Agency (FEMA) on a daily basis, although this requirement does not apply to tests conducted by commercial and academic labs. We urge you to extend data collection efforts to commercial and academic labs, coordinate data collection between each agency, the Indian Tribes, and the states, and make the resulting information available to the public as rapidly as possible. 

Specifically, this public-facing inventory should provide real-time data that answer the following questions: 

1. How many COVID-19 diagnostic tests are available on a daily basis, and to which states and Tribes are manufacturers sending these tests? How many of these tests screen for coronavirus antibodies?
2. To which public health, academic, and commercial laboratories are COVID-19 diagnostic test manufacturers sending tests, and how many tests are being sent to these labs?
3. Which laboratories—public health, academic, and commercial—can run COVID-19 diagnostic tests, and what is their daily capacity to run these tests? Please provide a breakdown of this information by lab type, test type, and state if possible.
4. What is the wait time for laboratories to process and receive results for COVID-19 tests?  Do providers have to wait minutes, hours, or days to receive their patients’ results?
5. What supplies do America’s public health, academic, and commercial laboratories need on hand to run at full capacity to process COVID-19 tests? Which of these supplies are in shortage, and what steps is the Administration taking to expand the capacity of these supplies?

Additionally, we request answers to the following questions:

6. In a March 10 interview, Secretary Azar referenced an “IT reporting system… to keep track of how many we’re testing.” What is the status of this system? What information is tracked in this system?
7. Will the Task Force commit to making all collected information about testing capacity and volume publicly available with daily updates, and to release relevant information on testing results?
8. Which federal agency is managing the supply chain and distribution of tests and testing supplies to states, territories, and Indian Tribes?  Which official is leading the testing supply and distribution effort within that agency? 

We urge you to promptly develop a national, real-time, public-facing inventory of COVID-19 diagnostic tests and results.  This resource will provide the transparency that our states and Tribal Nations need to anticipate the national testing supply chain and the information that the federal government needs to anticipate and proactively address any testing shortages.

Sincerely,