that it would be appropriate to take action. As we gather more information, that assessment may change.

Dr. TUNIS. And on the CLIA regulatory side, as well as the State side, you know, the November 2002 survey was triggered by a complaint and, in fact, that survey did identify some problems; a plan of correction was developed and proposed; it simply wasn't implemented. So there was, I think, a pathway by which the complaint could have been addressed and resolved at that point in time. Similarly, although much later, in December 2003, a complaint was filed with the State. The State actually undertook, in January 2004, a survey and identified additional problems. It is my understanding that the full extent of the problems, which gradually emerged, was somewhat difficult to determine based on the records that were available to review. So in terms of being able to identify the urgency of the situation, again, some of that goes back to the integrity of the information that is available on this.

Mr. SOUDER. So if you would have had the information you had toward the end at the beginning, you would have acted to discontinue their testing more rapidly? Or would you have had not to have that authority? In other words, looking at this just from a layman's standpoint, for people who are watching or just a Member of Congress who is looking at this, we are obviously going through a similar question like this in Iraq right now, that somebody does a complaint, people look at it, they try to decide how quick they are going to respond, they learn there is a picture, then they do a report. What about if the local guy doesn't do it?

At what point do you say this is grave enough that we are going to shut it down right now? And do you have the authority to override the State to do that? If you had known what you know now, would you have acted immediately or would you have waited from April to August, waited until the next year? I don't understand what the trigger is. Is this always going to be, even if it is a test that could put people's lives at risk, something that is going to take us a year to get to the shutdown of the testing?

Dr. TUNIS. This is Virginia Wanamaker.

Mr. SOUDER. I need to have you state your name and spell it for the record, and I need to swear you in.

Ms. WANAMAKER. Virginia Wanamaker, W-A-N-A-M-A-K-E-R. Mr. SOUDER. Would you raise your right hand? I need to give you the oath.

[Witness sworn.]

Mr. SOUDER. The record will show the witness responded in the affirmative.

Ms. WANAMAKER. I am going to speak to your question about when we would have reacted with the information. Back in 2002, the type of information that was available did not speak to the specific issue. In December 2003, when the information that spoke specifically to the issue of the type of testing, which pinpointed the area to look-had we or had the State or had the accrediting body or CMS had that information in 2002, yes, the answer is we would have acted immediately to cease that testing in that laboratory, had we known what was going on at that time.

Mr. SOUDER. And you could override the State and do that?

Ms. WANAMAKER. CMS has the ultimate authority for the CLIA survey.

Now, the State of Maryland has a separate State licensure law. They could do the same thing or different things under their State licensure law, but as far as the CLIA aspect and the State working for CMS under the CLIA survey, yes, the regional office has the authority to call what we phrase an immediate jeopardy, an immediate threat to public health and safety, and we can have a laboratory cease testing.

Mr. SOUDER. So as I understand it, and see if I have kind of the basic layout as we move into this hearing, the FDA clears the equipment that as you hear of complaints or things, you will check that, decide whether the equipment is being used properly and basically whether the equipment is safe. And in this case you decided, thus far, you are continuing to investigate it, but it was primarily a technician failure.

From Mr. Tunis' standpoint, that with the parameters of the equipment, it is possible that people can report false results and, basically, while you will followup on complaints and you will check the surveys, that basically phony data will lead to phony conclusions, and you are really dependent upon whistleblowers and complaints somewhere in the system, either to the hospital, to the State, or to the Federal Government to stop that. But if the complaints are serious enough, the Federal Government has the ability to step in and override the local.

Dr. TUNIS. That is correct. And I would also make the point that if there is that kind of activity going on in the laboratory, it may very well be detectable through the other aspects of the survey process, which look at the quality assurance activities of the laboratory, other aspects of laboratory process, interview with personnel. So even though you may not be able to identify a specific issue with a specific device, there usually would be other clues about overall laboratory management and processes that would also be triggers for action.

Mr. SOUDER. If people manipulate results, are there criminal sanctions?

Dr. TUNIS. I don't think we have the answer to that question.
Mr. SOUDER. Thank you.

Mr. CUMMINGS. Would you recommend that there be criminal sanctions, particularly in an instance where people may be getting the wrong results and may be going out and spreading disease, thinking that they don't have the disease?

Dr. TUNIS. You know, I think I honestly can't make a judgment about the appropriateness of criminal sanctions.

Mr. CUMMINGS. Well, let me ask you this way. Do you consider such actions, that is, when people manipulate results, do you consider that to be a very serious situation?

Dr. TUNIS. You know, obviously from a clinical perspective, the reliability of laboratory test results in important clinical problems like HIV and hepatitis are of very high level of significance, so it is obviously a non-trivial problem.

Mr. CUMMINGS. That means it is a serious problem.
Dr. TUNIS. Yes, sir.

Mr. CUMMINGS. And so how soon can you all get us information with regard to that question of criminal penalties for this? I would think that you would know that, by the way.

Dr. TUNIS. For violation of the accreditation, we have the ability to impose civil money penalties. I have not head of any authority to impose criminal penalties under the CLIA regulations. But we can verify that for you probably very quickly, within a day or two. Mr. CUMMINGS. Let me ask you this. Mr. Sabatini, the Secretary of Health, said in a Sun paper article in an interview, something to the effect—and he is here, so he will correct me if I am wrong— he said something to the effect that the Feds never close down anybody anyway, as if to say that the Federal Government just doesn't close down labs. And I am just wondering is that accurate? Have you ever done it?

Ms. WANAMAKER. Yes, we have closed labs. In fact, there have been sanctions against 45 labs in 2002. So there are, from time to time, labs that are closed, labs that cannot respond or do not respond, do not send an appropriate plan of correction, just can't seem to get beyond their problems. And, yes, we take sanctions or actions against those laboratories.

Mr. CUMMINGS. I am going to come back to you all. I want to go back to Mr. Gutman.

Mr. Gutman, tell me something. Are you aware of any FDA problems experienced with Labotech in other countries?

Dr. GUTMAN. I am, actually. I am aware that there were problems reported in the UK in 1996 and in 1999. I am not aware of any more recent reports.

Mr. CUMMINGS. And I take it the 1999 report, which I have a copy of, it says, in part, "We have considered the risk assessment together with the possible implications of a false negative result for clinical management and have a number of recommendations on the need to repeat testing." And it goes on to talk about the problems with this machine.

You are familiar with that?

Dr. GUTMAN. I am familiar with that report.

Mr. CUMMINGS. As you go through and try to determine whether there was a major problem with this machine and whether it should continue to be used, do you take that into consideration when you are looking?

Dr. GUTMAN. Absolutely. We would be very interested in understanding why that was not reported to FDA, it actually should have been, and what actions were taken to correct that problem.

Mr. CUMMINGS. I want to go back to something the chairman said to all of you. At what point does this matter become an urgent situation? In other words, if you have people walking out of a hospital who are told that they don't have HIV/AIDS and they do have it, and then you are getting information in, at what point? It sounds to me, Mr. Gutman, like this may be a decision that might be made next year.

Dr. GUTMAN. Well

Mr. CUMMINGS. No, let me finish. I am almost finished. And the thing I don't understand is do we need to put some urgency into your regulations so that you all can act much more quicker? Because that person who is suffering and that person who is told that

they do have AIDS and they don't, or vice versa, that is a major problem, and it is an urgent situation. It seems like we are just kind of sitting around, watching things go by, and people could be possibly going out there spreading this disease and bringing harm to other people and not even know it, and it is not their fault.

Dr. GUTMAN. Yes. I guess we do take this very seriously, and we have scheduled this foreign inspection as quickly as we can; it is the highest priority we were able to take. I must say that although we take it seriously, and I don't wish to prejudge, the fact that there have been no European reports since 1999, the fact that there have been no adverse reports to FDA, the fact that we have actually looked at the published literature and seen reports, but they seem to suggest the device works fine; we have monitored list service; this event was reported, there were no additional complaints. We actually don't have a signal to suggest that—and based on the information that this appears to be a quality lapse of the lab, not a problem of the machine, although we are taking this very seriously, we do not have actually the expectation that this is fundamentally an instrument failure. We would argue, actually, the fact that the instrument was providing information suggesting it was out of control, it was giving quality control error signals, that the instrument was doing what it was supposed to do, which is signal that something was wrong.

Mr. CUMMINGS. Same urgency question, Mr. Tunis.

Dr. TUNIS. Some perspective on that question, obviously, is the laboratory did, as I mentioned earlier, in August 2003, discontinue use of this machine. At that point in time there was no information that we had had from either the State survey in November 2002 or the CAP survey in April 2003 that problems of this seriousness and significance existed. And, again, I would go back to saying that you can only do as good a survey as the documentation allows you to do. So by the time the additional complaint was made in December 2003, and a great deal of attention was focused on that and a lot of things have rolled out since then, the immediate peril associated with the machine had been addressed by discontinuing the use of the machine.

But I think you ask a very valid question, which is, is there something more we should have known in November 2002, April 2003 that would have given us a greater ability to look more closely and identify this problem at those points in time. And, again, I can say that is something we are looking at very closely and trying to answer exactly that question.

Mr. CUMMINGS. Just one real quick question, Mr. Chairman.

Do you have faith in the College of American Pathologists to do this job? Mr. Sabatini had expressed to me in a conversation that he was concerned about whether we are getting valid results from the college. Do you have faith?

Dr. TUNIS. I do, and it is not just based on a general feeling, it is based on that every year we do a validation survey of our own, checking on 5 percent of the labs that are accredited by the private accrediting organizations and look for any systematic deviations in the results that they get and the results that we get independently. And we have not found reason to have any systematic problems with the College of American Pathology accreditation process.

Mr. SOUDER. I want to thank our first panel.

We have four votes going on, so we are going to take a recess. Hopefully it will be no longer than 20 minutes, but it could be as long as 30 minutes.

With this, we stand in recess.

[Recess.]

Mr. SOUDER. The subcommittee will come to order.

Ms. Williams, will you stand and raise your right hand?

[Witness sworn.]

Mr. SOUDER. Let the record show that she responded in the affirmative.

Thank you for your patience, and we will now hear your testimony.

STATEMENTS OF TERESA WILLIAMS, FORMER EMPLOYEE OF MARYLAND GENERAL HOSPITAL; AND KRISTIN TURNER, FORMER EMPLOYEE, MARYLAND GENERAL HOSPITAL, AS DELIVERED BY MALIA HOLST, SUBCOMMITTEE CLERK

Ms. WILLIAMS. Good morning, Mr. Chairman and Mr. Cummings. My name is Teresa Williams, and I am a health care worker. I come here today to represent the voice of the countless victims of the atrocities that took place at Maryland General Hospital. I speak for the patients, the public, and the workers.

I am here to put a face to one of the many who came forward then and now, who look beyond job security and stepped outside their comfort zone and was willing to fight for those who were unaware that their health was at stake, for those who deserved so much better.

In light of all the information that has been uncovered by the State and other government investigators, does it frighten you that only Kristin and I have come forward publicly? If it doesn't, it should. The information that we were privy to pales in comparison to the information that others could and should have come forth with. I suppose that is a cross that they will have to bear.

I don't have to argue as to whether there were problems with the quality of care at Maryland General Hospital; you know that. I don't have to argue as to whether the patients, public, and workers were put at work; you know that. I don't have to argue as to whether the instrumentation malfunctioned and had problems; you know that too.

I am hoping that my experiences, Kristin's experiences, along with a few others who are now willing to come forward to speak of what they witnessed at Maryland General Hospital will once and for all bring closure to the Maryland General Hospital event and will help to prevent this from happening anywhere ever again.

Hopefully, after this collective body has adjourned, there will be a clearer understanding of the culture and mind-set that existed 2 years at Maryland General Hospital when I worked there.

There are certain assumptions that we all make on a daily basis. When we board a plane, we assume that the engine is working properly, or the airlines wouldn't let it off the ground. We assume that when we eat at a restaurant that the food is safe for human consumption.