laboratoryFrom a CDC press conference held on Friday, June 11:

CDC DIRECTOR DR. TOM FRIEDEN: First, we had the potential exposure to anthrax at CDC’s laboratory. Second, earlier this week, we learned about an incident in CDC’s influenza laboratory. And third, we had the discovery of vials labeled as smallpox in a storage room on the NIH campus and CDC’s work to secure and to characterize these materials. I’ll give you the facts about each of these three incidents and for the two that happened here at CDC, what we're going to do to address these incidents because fundamentally, what they reveal was totally unacceptable behavior. Before I discuss the details, I’ll give you my perspective which is plain and simple. These events should never have happened. Together, these events I’m sure have many people asking and questioning government labs. They may be wondering whether we're doing what we need to do to keep our workers and our communities safe. And I think it's fair to raise those questions. I’m disappointed by what happened, and frankly, I’m angry about it.

The American people depend on us 24/7 to protect them. Our scientists go anywhere in the world at a moment's notice to stop an outbreak. And just as the American people depend on CDC to protect their health, our workers should be able to depend on us to protect their health. And Americans should know that we're implementing the highest levels of safety and security in our laboratories and throughout our work. Our labs, our lab scientists are a national treasure. We are essentially the reference laboratory for the world. So when something like this happens here, I’m deeply concerned about it. These events should never happen. And if you remember nothing else from what I say this morning, I want you to remember three things.

First, I’ve issued a moratorium on CDC transferring any biological samples out of any BSL-3 or BSL-4 laboratory either within CDC or outside of CDC until we have given a lab-by-lab assessment and allow that process to resume. Second, I’m appointing a single point of accountability, Dr. Michael Bell, who's with us this morning, to be Director of Laboratory Safety for CDC and to oversee implementation of the recommendations that I’ll be talking to you about later and to report directly to me. And third, I’ve directed that appropriate disciplinary action be taken for any staff member at CDC who knowingly violated protocols or who failed to appropriately report a lab incident. Now I’d like to describe each of the three incidents in more detail, and we can provide additional detail in the question/answer if you'd like. Each of the incidents is complicated, so please bear with me because I want to be sure to give you all of the information that we're aware of up to this moment.

A laboratory scientist working with anthrax "made a mistake"

First is the potential exposure to anthrax. Today, we're releasing the results, in fact, our full internal investigation of that incident as well as the steps we're taking that will do everything humanly possible to make sure that nothing like that happens again. On June 5th of this year, a laboratory scientist working in one of our bioterrorism response laboratories made a mistake. They used a process that they thought would kill the anthrax bacteria, and it may not have. We've looked carefully at the factors that led to that mistake. But because of that, workers in other laboratories who received materials that that laboratory prepared may have been exposed to anthrax. While we've assessed the event, we've learned more about what happened. I can later go into some details about this, but as I think about it, what we learned made us more reassured about the likelihood that people were actually exposed, which now looks very, very unlikely. But more concerned about the policies and procedures that allowed this event to occur in the first place.

So just to give a little bit more details, what happened was that the process to inactivate the anthrax spores was not appropriate. And it was not done as it was supposed to have been done. So there is the possibility that some spores were transferred to other laboratories within CDC and potentially exposed other workers. We did additional experiments to replicate in a worst-case scenario what might have happened in that process. And those experiments which we did and a partner laboratory, the Michigan Department of Community Health did, suggested that for one form of anthrax, the form that grows, this procedure certainly killed all of the organisms. For another form of anthrax growing, what are called spores, which are quite resistant to being killed, there is the possibility, although unlikely, that some got out. The way that experiment was used was basically a worst-case scenario experiment. If you had a huge concentration of spores and you followed the procedure that was used, would any of them survive?  And out of a huge number put in, there was a tiny amount of growth found. What that tells us was that it was not impossible that some spores were transferred, but it was extremely unlikely. Now, that doesn't excuse in any way what happened or minimize it.

Scientists failed to follow protocol

We're very concerned about the health and well-being of our own staff. And the fact that they had to deal with uncertainty, stress, potential risk and to take preventive medicines that can have adverse events as a result of this incident is something that I feel terrible about, and I wish had not happened. The report we're releasing today, though, looks at the root cause of this incident. And the root cause fundamentally was that the scientists failed to follow a scientifically derived and reviewed protocol that would have assured that anthrax was inactivated and that the material was confirmed to be sterile before it ever left the lab. That should have happened, and it didn't.

There were multiple other problems found, a lack of standard operating procedures, a lack of lab - adequate laboratory oversight, a lack of an approved study plan, use of unapproved sterilization techniques for anthrax, the transfer of material that wasn't confirmed to be inactive. In fact, the use of anthrax at all for this experiment should not have been done. It was not appropriate. And there was a lack of scientific knowledge in this laboratory about inactivation because there were articles in the published literature that indicated that this was not a perfect method to inactivate anthrax. This laboratory is closed, and it will remain closed with respect to what we call select agents which are the most dangerous microbes until it is completely reviewed and until Dr. Mike Bell and his group recommends to me and I approve its reopening under different conditions that we'll do everything humanly possible to assure that nothing like this happens again.

A dangerous cross-contamination

That brings me to the second incident relating to influenza. And for me personally, this is the most distressing of the three incidents for two reasons. First, because it happened in our influenza laboratory. And second, because it happened six weeks ago, and I learned about it less than 48 hours ago. On Wednesday of this week, we learned of another event at CDC. Our influenza laboratory was preparing a less harmful strain of animal influenza for shipment to a partner laboratory. In the process, unknowingly, they cross-contaminated that strain with highly pathogenic H5N1 influenza. As a result when they sent it to the U.S. Department of Agriculture laboratory to see for the research that they were doing on the low pathogenic, the relatively safe influenza strain, that laboratory saw that it was not behaving as a low pathogenic strain would behave. And they therefore did tests and identified on May 23rd or thereabouts that it was contaminated with H5N1. They informed the CDC laboratory staff, the CDC laboratory staff did testing to confirm that, in fact, it was the specimen we sent there that was contaminated and that when we got the strain into our laboratory, it wasn't contaminated, so it happened here.

We're still just beginning the investigation to determine how this happened. The work was done in one room. So that leads to some early hypotheses of what might have happened. But it's going to take a detailed investigation. And we may not know for certain exactly what happened, but we'll do everything we can to find out. Now, on July 7th, that's when -- earlier this week -- six weeks after it should have been reported, the incident was reported to senior leadership. I want to make clear in this incident, all of the materials were handled in what's called enhanced biosafety level 3 facilities. That means people shower out. That means they wear highly protective form of personal respiration, and we have a high degree of confidence that no one at CDC was exposed and that there was no release of these samples. So they're really events that serve as a warning that the protocols are not what they need to be to ensure that our laboratories operate safely.

So as I’ve said, I’ve taken a series of steps in response to these incidents. The first is the moratorium on biological material leaving BSL-3 and BSL-4 laboratories, and we will assess laboratory by laboratory before reopening. The second is that we will -- I’ve appointed Dr. Michael Bell to be Director of Laboratory Safety and serve as the single point of accountability to improve all laboratory safety protocols and practices and procedures. And I’ve established a high-level working group chaired by Dr. Bell that will report to me to accelerate improvements in laboratory safety and serve as the transition group for permanent single point of accountability on laboratory safety which is something called for in the review of the potential exposure to anthrax incident. The culture of laboratory safety needs to improve at some CDC laboratories.

Third, the general issue of inactivation, how do you kill bacteria or viruses before you transfer them out, that procedure will be looked at every laboratory that works on not just select agents but any dangerous pathogen at CDC, and if needed, we will improve it. Fourth, I’ve begun the process of establishing an external advisory group that will be part of the advisory committee to the director, and I will issue invitations to the leading scientists of that group by the end of next week. Fifth, I’ve ordered an investigation to determine the root causes that led to contamination of H5N1 in the influenza laboratory. Sixth, I’ve reported the incident through the proper channels -- or CDC has reported the incident through the proper channels to the select agent oversight body, the agriculture department's inspection service which is known as APHIS. We've established a review group under the direction of the Associate Director for Science to look at procedures leading to these events and ways to prevent them in the future. This review will be done in conjunction with the internal investigation and in coordination with the external working group.

Eighth, our response to future incidents will be improved by rapidly using incident management systems such as the one that we use for external events. We'll use that for certainly events when we need to. Ninth, as I mentioned, I’m requiring that disciplinary action be taken as appropriate for any staff member who knowingly departed from lab safety protocols or who knew about lab safety incidents and didn't report them promptly. And tenth, we're looking at the implications for select agents and virulent pathogens more broadly, not just within CDC but throughout the scientific community including in our regulatory function at CDC where we have a unit called the Division of Select Agents and Toxins. Given the critical nature of our investigations, the work that we do here to protect Americans, it's crucial that we do this safely and that we protect our staff while we do it. I will personally track the implementation of these plans.