Thomas Frieden, CDC Director from 2009 to 2017: “The CDC got this right with H1N1 and Zika, and produced huge quantities of test kits that went around the country. I don’t know what went wrong this time.”

This is a very, very big question, one I suspect we’ll be discussing long after the crisis is passed. South Korea has tested roughly 140,000 people. The US has tested about 1500. South Korea is obviously physically closer to China and I would assume has denser transportation links. But it’s not necessarily clear that it got to South Korea earlier than it did to the US or as much earlier as many are thinking. It now seems clear that COVID-19 has been spreading in the United States for at least six weeks. What’s less clear is whether that spread first took hold in Washington state and more recently fanned out into the multiple states now reporting cases or whether it’s been spreading independently from multiple seeding points the whole time.

Not having adequate tests has made it very difficult to know the current spread of infection and thus know the proper level of mitigation actions to take. But again, why did this happen?

This is significantly an unknown. But one aspect of what happened seems broadly clear from public health experts and epidemiologists.

The test that had problems was under the authority of the CDC. This is a new disease and test development can have problems. It’s not really shocking or necessarily a sign of incompetence that one test and test-creation process had problems. The bigger issue was somewhere else. The United States has a great deal of test development and manufacturing capacity outside of the CDC. There are big state labs, academic research institutions and private sector capacity. But those organizations were barred from rolling out their own tests without approval from the FDA. And that wasn’t forthcoming until a few days ago. That is even though in recent weeks lots of labs and public health authorities were pressing the FDA to give the go-ahead.

The FDA and the CDC are both parts of the Department of Health and Human Services, with significantly overlapping mandates. This appears to have been the biggest issue and the biggest as yet unexplained problem. It appears to have been significantly a management and leadership issue.

We’ve known for two months and possibly longer that COVID-19 would likely appear in some form in the United States. As soon as it was clear that there were any problems with the CDC test, it made sense to bring online the other national test-creation capacities to fill any potential gap or shortfall. As an outsider to this subject, I would think that building in some redundancy would make sense even if there wasn’t a problem. But that’s my speculation. Regardless, that is where a key ball appears to have been dropped. And precisely why we don’t know, though lack of focus from the top seems likely to be at least a partial explanation.