U.S. REPRESENTATIVE MARK SOUDER (R-IN) CHAIRMAN U.S. REPRESENTATIVE MARK SOUDER (R-IN) HOLDS HEARING ON ACCURACY IN LAB TESTING

Washington Transcript Service July 7, 2004

Washington Transcript Service 07-07-2004 HOUSE COMMITTEE ON GOVERNMENT REFORM: SUBCOMMITTEE ON CRIMINAL JUSTICE, DRUG POLICY AND HUMAN RESOURCES HOLDS A HEARING ON FAULTY MEDICAL LAB TESTS JULY 7, 2004 SPEAKERS:

U.S. REPRESENTATIVE MARK SOUDER (R-IN) CHAIRMAN U.S. REPRESENTATIVE NATHAN DEAL (R-GA) VICE CHAIRMAN U.S. REPRESENTATIVE JOHN M. MCHUGH (R-NY) U.S. REPRESENTATIVE JOHN MICA (R-FL) U.S. REPRESENTATIVE DOUG OSE (R-CA) U.S. REPRESENTATIVE JO ANN DAVIS (R-VA) U.S. REPRESENTATIVE EDWARD L. SCHROCK (R-VA) U.S. REPRESENTATIVE JOHN R. CARTER (R-TX) U.S. REPRESENTATIVE MARSHA BLACKBURN (R-TN) U.S. REPRESENTATIVE ELIJAH E. CUMMINGS (D-MD) RANKING MEMBER U.S. REPRESENTATIVE DANNY K. DAVIS (D-IL) U.S. REPRESENTATIVE WILLIAM LACY CLAY (D-MO) U.S. REPRESENTATIVE LINDA T. SANCHEZ (D-CA) U.S. REPRESENTATIVE C.A. “DUTCH” RUPPERSBERGER (D-MD) U.S. REPRESENTATIVE ELEANOR HOLMES NORTON (D-DC) U.S. REPRESENTATIVE CHRIS BELL (D-TX) WITNESSES:

PANEL I KRISTIN TURNER FORMER EMPLOYEE MARYLAND GENERAL HOSPITAL PANEL II EDMOND NOTEBAERT PRESIDENT UNIVERSITY OF MARYLAND MEDICAL SYSTEM CAROL BENNER DIRECTOR OFFICE OF HEALTH CARE QUALITY STATE OF MARYLAND DR. MARY KASS PRESIDENT AMERICAN COLLEGE OF PATHOLOGISTS [*] SOUDER: The subcommittee will come to order.

Good afternoon and I thank you all for being here today.

Today’s hearing will continue to examine the investigation of (inaudible) at the Maryland General Hospital in Baltimore, Maryland.

At the request of the ranking Democratic member of this subcommittee, Congressman Elijah Cummings, we held a hearing on this topic on May 18th but due to time constraints and a lot of votes, we were unable to complete the questioning of the final panel.

Today we will welcome back that panel of witnesses as well as Kristin Turner, a former lab worker at the Maryland General Hospital, who was unable to attend the May 18th hearing due to illness at that time.

During a 14-month period between June 2002 and August 2003, the hospital issued more than 450 questionable HIV and hepatitis test results.

Despite the instrument reading showing that the test results might be inaccurate, managers at the hospital failed to act. Similarly, state inspectors did not respond to a 2002 letter from lab workers who warned of serious and longstanding testing problems that put patients and employees at risk.

During this period in July 2003, the hospital lab was inspected and accredited by the College of American Pathologists. CAP officials have assured the subcommittee that their inspection standards were even more stringent than required by the federal government, yet the inspection did not identify the ongoing deficiencies in lab testing.

The problems at Maryland General Hospital weren’t taken seriously until this year when state inspectors investigated another warning letter sent in December from a former employee, Kristin Turner.

State officials have confirmed the existence of the 2002 letter.

They said they took the allegations seriously, but found them vague and did not discover the serious problems until this year.

Subsequent inspections by state officials prompted by the whistleblower showed that the laboratory was in the midst of serious problems at the very time the accreditation inspection was conducted. State inspectors concluded the lab was understaffed and rife with equipment malfunctions, and state and federal inspectors later turned out pages and pages of violations of testing standards. The College of American Pathologists has since — they’ve also since suspended its approval for two key laboratory divisions.

The complaint that led to these findings alleged that the machinery used in HIV and hepatitis testing was not adequately maintained and that possibly erroneous test results were provided as a result.

In all of these inspections, similar issues were identified concerning the management and quality assessment processes of the laboratory that were found to be deficient. Each oversight entity addressed these issues but did not inform all of the remaining involved parties of their findings. Therefore, each oversight entity did not have the benefit of the finding of the others.

Only after a December 2003 complaint to the state survey agency that pinpointed a specific problem area to investigate did the entities involved begin to communicate their findings to each other, yet the College of American Pathologists did not even receive the 2002 lab worker’s complaint until the day prior to this subcommittee’s first hearing on this matter in May.

Fortunately, the hospital has retested many patients and found the original results were mostly accurate, and steps have been taken to ensure patients are now receiving reliable test results.

State and federal regulators are now overseeing Maryland General’s efforts to improve its laboratory operations. A state Medicaid fraud investigation and a federal investigation by the Department of Health and Human Services’ Office of Inspector General are also ongoing.

The purpose of this hearing, therefore, is to gain a better understanding of all the issues that led to the deficiencies at Maryland General Hospital and how these problems went undetected and not addressed for such a long period of time despite inspections and warnings from lab personnel.

Our goal is to make sure that a similar situation never happens again at other hospitals and that patients can be assured that when they visit a hospital and have tests taken that the results they receive are accurate and reliable.

We also want to be sure that all those adversely impacted by the problems at Maryland General Hospital are identified and given proper test results.

Our first panel will be Kristin Turner, former employee at the Maryland General Hospital. The second panel will include Mr. Edmond Notebaert, president of the University of Maryland Medical System; Ms. Carol Benner, director of the Office of Health Care Quality for the state of Maryland;

and Dr. Mary Kass, president of the American College of Pathologists.

Thank you for all being here today and we look forward to your testimony and insights on this issue.

Now I’d like to yield to the ranking member, Mr. Elijah Cummings.

CUMMINGS: Thank you very much, Mr. Chairman, and I thank you for holding this second hearing to examine issues related to the release of invalid HIV and hepatitis tests to hundreds of patients at Maryland General Hospital in Baltimore City.

This subject is extremely important to my constituents, who like myself, receive health care from Maryland General Hospital. And I appreciate your taking an interest in this controversy and the broader oversight issues it raises for the Congress of the United States.

In May, we held our first hearing looking into allegations first reported by the Baltimore Sun in March that from June 2002 to August 2003 Maryland General Hospital released more than 450 invalid HIV and hepatitis test results despite error messages from testing instruments indicating that results might be incorrect.

On May 18th, we heard the testimony from FDA concerning the process for approving the Adaltis Labotech device that produced the invalid test results and from the Centers for Medicare and Medicaid Services concerning implementation of federal regulations to ensure accuracy and accountability in lab testing.

We also heard compelling testimony from Teresa Williams, a former laboratory technician and supervisor at Maryland General who made numerous attempts to call attention to deficiencies in laboratory operations ultimately, unfortunately, to no avail.

On the last of the three panels, we heard statements from representatives of the parent institution, the Maryland General Hospital;

the private and crediting body responsible for certifying the Maryland General laboratory as in being in compliance with federal standards, the Maryland Department of Health and Mental Hygiene; and the manufacturer of the Labotech testing instrument.

Because of time constraints we encountered during the final panel, our questioning was cut short, and today’s hearing provides a rare opportunity to continue the dialogue we began in May with the latter group.

And I do appreciate you holding this second hearing.

We are joined today by Edmond Notebaert, president of the University of Maryland Medical System; Carol Benner, director of the Office of Health Care Quality for the state of Maryland; and Ms. Mary Kass, president of the College of American Pathologists.

Today’s hearing also gives an opportunity to hear from former Maryland General employee, Kristin Turner, who was unable to attend the hearing in May due to poor health.

Ms. Turner is responsible for bringing the Maryland General lab testing problems to the light of day. I salute her for her courage in coming forward, and I’m happy that she is able to join us today to share her experiences and perspective.

Although the events that initially caught the subcommittee’s attention occurred at a single hospital in Baltimore, Maryland, they have implications for health care consumers all across this great nation.

My goal in requesting these hearings is to ensure that nothing like what occurred at Maryland General happens again anywhere in the United States. Fortunately, in the case of Maryland General, 99 percent of those who received invalid tests had their original test results confirmed, but we cannot rely on luck as a public health safety net when lives are in the balance.

The American people are entitled to have faith that the laboratory tests that help to determine the course of their medical treatment are as reliable and accurate as they can possibly be. That is a promise set forth in the Clinical Laboratory Improvement Amendments Act, and we must ensure that the regulatory system established to enforce CLIAA is adequate to fulfill that promise.

Sadly, the case of Maryland General appears to be one in which laboratory supervisors not only failed to ensure their proper quality controls were in place, but also deliberately altered or concealed information that would have led to the discovery of invalid test results being released to patients. Moreover, employees who expressed concerns about the inadequate quality controls and unreliable results were discouraged from expressing their concerns within the laboratory and outside of it.

It shocks the conscience that health professionals would deliberately engage in conduct that clearly places the lives of patients at unnecessary risks. But it is equally disturbing that the process for detecting deficiencies was so easily circumvented. One would hope that such abhorrent conduct by laboratory personnel is rare, but the system of enforcement should account for the fact that there may be bad actors in positions of authority who will seek to conceal evidence of serious lab deficiencies from inspectors. It is far from clear to me that the system in place does this adequately.

I must say, Mr. Chairman, I’ve had an opportunity just recently in the last week to visit Maryland General and I am very pleased with the progress that has been made by Mr. Notebaert.

I think there have been just tremendous efforts to, number one, find those patients that were tested and improve the lab.

As I said last week, I think now the lab and the hospital is probably one of the best run in the country because it has come under the eye of so many agencies, and I want to applaud you, Mr. Notebaert, for your efforts.

And so today, each of our witnesses is in a position to provide an informed perspective of what gaps in the system may exist and how they can and should be addressed.

I thank all of our witnesses for their appearance before the subcommittee today and I look forward to their candid testimony.

Thank you very much.

SOUDER: I have two brief things before I yield to Mr.

Ruppersberger.

First off, I want to commend Tony (ph) on the Democratic staff for arranging the musical accompaniment to your opening statement.

Secondly, this hearing appears to forever trigger votes. So you just heard the bell, so we’re going to have a vote start. Fortunately, it’s only one vote.

So we’ll have Mr. Ruppersberger’s opening statement, we’ll go over, vote, and then be back as quick as we can walk over and back.

RUPPERSBERGER: First, Mr. Chairman, thank you.

And Congressman Cummings, you’ve really done a great job in pulling this together, and I think that your efforts and working closely with Maryland General Hospital will improve hopefully our whole system throughout the country, and that’s what we’re really here about. So good job.

The follow-up hearing today is very important for two main reasons: First, it allows us to revisit this topic and discuss the steps Maryland General Hospital has taken in the interim to address the problems its lab experienced.

We need to make sure the plan that Maryland General Hospital has, is in the process of implementing, is accurate in design and scope. Both the employees and patients at Maryland General Hospital deserve the best lab environment to ensure the community is receiving the quality of care they deserve.

I look forward to today’s testimony and hearing an update on these critical concerns.

Second, returning to this topic allows us to look nationwide and consider what Congress can do to protect labs throughout the country.

In light of all that has happened, Maryland General Hospital is probably one of the best places to have your lab tests performed today, but I worry about labs elsewhere.

What we have learned in the first hearing and what still needs to be addressed is how we will ensure that this problem does not happen again in another lab. It is in the second question that prompted me to request an analysis from the Congressional Research Service in May 2004 outlining the questions raised in the first hearing, the background involved and the question Congress should be considering to assure quality in clinical labs.

Mr. Chairman, I ask unanimous consent to have the CRS memo inserted in the record as part of my opening statement.

SOUDER: Without objection, so ordered.

RUPPERSBERGER: Thank you.

The questions raised by the Congressional Research Service covers several categories. These include defining the scope of the problem, oversight and coordination, and compliance and enforcement.

I encourage my colleagues to consider this memo as we explore legislation options to address this important issue.

Thank you.

SOUDER: I thank you.

And the subcommittee stands in recess.

(RECESS) SOUDER: The subcommittee will come back to order.

It is customary in this subcommittee (inaudible) as the oversight committee, so if you’ll raise your right hand.

Do you swear the testimony you will give today is the truth, the whole truth and nothing but the truth, so help you God?

WITNESSES: We do.

SOUDER: Let the record show the witness responded in the affirmative.

I’m glad you’re able to join us today.

TURNER: Thank you.

SOUDER: We look forward to your testimony.

TURNER: Thank you for inviting me to testify, and thank you for making this issue important enough that you’re going to make sure that what happened at Maryland General happens nowhere else.

SOUDER: Would you pull the mike just a little closer so they can hear in the back?

TURNER: And I want to thank the University of Maryland Medical System for taking the steps that they took in making sure that the issues were taken care of in such a quick manner.

I don’t have an additional written statement from the statement of before. I’m here more for if there’s any information you would like to know from me in addition to my written statement.

I had a couple of concerns about some of the testimony that was given in May as far as — and just very minimal things. I have a lot I would like to say, but it would be more than we have time for.

Initially just — I think that it worries me the lack of — gosh — action that the FDA seems to be able to take as far as medical devices goes. I think that there needs to be more people in the loop as far as reporting of incidents with medical devices.

And I noticed after reading the statement from them that (inaudible) is left up to the responsibility of the doctors to report the incident from happening and that they didn’t report it initially because there was no infection that resulted. They didn’t even think that it was important enough to report until — unless something happened secondary to that exposure, and I think that the incident itself is what needs to be reported immediately to whoever is doing the oversight for medical devices.

And I think that is part of what worries me the most, is whose responsibility is it to report problems with medical equipment to the FDA?

If it’s left up to the manufacturers, that just scares me. It doesn’t seem like they would be real excited about reporting their failures and it seems like there needs to be something that says that when something happens no matter how minimal you might think it is, it needs to be reported as an incident and investigated.

That’s pretty much it. I will answer anything that you have.

SOUDER: Your full statement will be inserted in the record. And again, as you probably know, we read your statement at the last hearing, so it was already read into the record.

I’m going to yield to Mr. Cummings for the first questions.

CUMMINGS: Thank you very much.

And, Ms. Turner, as I have said to you before when I first met you and I’ll say it to you again, I do thank you for coming forward.

I have seen with my own eyes and I have heard with my own ears vast improvements…

TURNER: Right.

CUMMINGS: … at Maryland General Hospital. And I don’t know if you know this, but many employees that you may have worked with are so pleased with what has happened there that they have come back..

TURNER: Oh, good.

CUMMINGS: … to work in the lab.

By the way, you may be getting some notes from them. They got a pay raise…

TURNER: Oh, great. All right.

CUMMINGS: … because of you.

TURNER: OK.

CUMMINGS: And you know, we heard some testimony — and so, I thank you very much.

What’s Teresa’s last name?

SOUDER: Williams.

CUMMINGS: Teresa Williams. Do you know Teresa Williams?

TURNER: I met her once.

CUMMINGS: OK. Teresa Williams testified before us back in May and she talked about feeling intimidated. As a matter of fact, it was on a lot of the news shows.

And I guess one of the things that we’re trying to get to, and the committee is very concerned about, is how do we make sure that people like you, when the College of American Pathologists come in, for example, or the state come in, have an opportunity to express their concerns? And, you know, what are your feelings on that?

TURNER: Well, I was at Maryland General for a couple of CAP inspections and I know that we were aware that they were there, but they never actually communicated with the individuals who were actually doing the work. They were communicating with the supervisors and the lab directors and things like that. And I guess it would be very helpful if there was a way that we were able to talk to them, and if there was anything that needed to be done, it would be done in an anonymous manner.

So if there was a problem with a machine, for example, or if there were problems with infection in general, as far as like we were worried about results or worried about how something was being done, if we could report that to CAP and know that our name was not going to be brought up as being the people who said, “Well, this is really messed up,” and, you know, if there could be an anonymous way for us to report to CAP face to face that would be great.

CUMMINGS: One of the things that has happened as a result of your actions and people like Teresa is that Mr. Notebaert has established a system by which anonymous complaints can be made directly to him.

Is that good enough, do you think?

TURNER: I definitely think that’s a great step.

CUMMINGS: Say that again.

TURNER: I think it’s a great step, but I’m not sure how well — it depends, I guess, what the response would be to complaints that were made, because complaints were made to the director of the lab and that, obviously, wasn’t enough. So I guess to be able to go to the top would be a good thing.

CUMMINGS: And if there were a system by which — when inspectors came in they — say from CAPs or from the state — that employees were made — it was made known, say, for example, to the employees that they were looking for any concerns that the employees might have and that — say like, for example, they gave them a little card and said just that you could send in an anonymous, typed up bit of information; do you think that would be helpful?

TURNER: I think that would be great. I think that would be very helpful.

I was thinking also that it might be really good if there were concerns made that they were made to — that maybe there are three copies and that, you know, three different departments or three different people were notified of that so that if two people dropped the ball, then there’s one person to follow up on that. There would be accountability at every level.

I think that that would be a very good thing to happen.

CUMMINGS: Now, you went to great lengths within the system and outside the system to put the word out that you had concerns. Is that right?

TURNER: I did, yes.

CUMMINGS: Tell us what you did.

TURNER: Well, I — probably in my recollection, it seemed like I did this on a weekly basis where I told the administrative laboratory director, as well as my supervisor of the department, and I was told actually to keep it within the lab. I was told that — because I asked on a number of occasions about going to risk management, which is one thing that we’re told that you can do.

Like when you come in from your orientation, you know, you’re told that you can go to risk management if you have an issue. But I was told in the lab that the lab handles the lab’s business.

CUMMINGS: So basically what you had was although you were giving information, telling the people in charge of the lab what the problems might have been, there was no way for that information — the information to your knowledge wasn’t flowing past your supervisors or whoever was right there in the lab?

TURNER: And it took the lab to realize that, but that was what I came to understand what was happening — was that it was stopping there rather than being reported further on where something was actually going to be done. And in fact, it seemed to me that the problems regarding the particular issues that I knew about were almost being kind of kept away from the other people who should know about it even in the lab itself.

CUMMINGS: Now, when I had an opportunity to talk to you a few months ago you said something that was very interesting, and you said that a number of people at the hospital and particularly in the lab had left because they were so frustrated…

TURNER: Right.

CUMMINGS: … that they could not — that nothing was happening.

So I assume that you could see certain problems reoccurring and you didn’t see any results taking place. Did you ever try to go above the lab and the supervisors in the lab?

TURNER: I did not. The furthest that I went was to Dr. Stewart.

CUMMINGS: And Dr. Stewart was the head of the lab?

TURNER: He was the administrative lab director and so he was — there was a medical director above him, and my understanding was that they communicated about everything, so — but that didn’t turn out to be the case. So that is where I took it. That was the top of the lab for me and my position.

CUMMINGS: What was the thing that got all of this started?

I mean, what’s the first thing that you noticed that kind of got you upset?

TURNER: Well, I was concerned about the machine and the results that were coming from it, just because there were so many errors with the machine. And there were runs that were failing, but there were also things that were happening with the machine, like it was missing steps; we were missing re-agents. And every step is required to have a valid result, but the machine wouldn’t be aware that it had made this mistake.

So if I didn’t happen to be standing there watching it, then I would think that the results were OK at the end, which is not really such a good thing.

And so, I voiced both concerns lots of times. And the machines were always broken and nothing — they would never be fixed adequately.

They would be fixed and maybe they would work for a couple of days and then we would have to call service again. And it seemed like that wasn’t such a good deal. It seemed like something could be done better.

And then the incident that resulted in my exposure happened, and I went in the day after the accident to fill out some paperwork and things like that, and I went into the lab and the very next day they had people working on the same machines — well, the Labotechs.

I don’t know if it was the same machine in particular, but all of the machines where it showed the same problems, and that worried me because it seems that you would investigate to make sure that you weren’t putting your employees in harm’s way being that there had just been a serious accident that happened. I would think that they would, in the very least, look into that before just putting people back on the machines.

And most of the information that I have I received after my accident and it was as a result of other people, outside people looking into the accident and how it happened — other departments in the hospital.

And they uncovered all kinds of information that was kind of — it was in, I guess, little — not cubicles or something, but like it was like separated from everything else. So like somebody had knowledge of it, but it wasn’t being connected with what was happening now.

And so, like the seriousness of everything since the machine got to the lab didn’t become apparent until after my accident occurred.

And so, it was at that time that everybody now had all of the information from when Teresa Williams was there, all the way up to my accident.

And the realization came that somebody knew that there was something really wrong from a really long time ago. And so, I thought that maybe now that everybody had this information, surely the hospital would fix it. And so, I gave them quite a while to fix it.

And then, when I found out that I had been terminated — I found out by accident, they didn’t actually even tell me this — that was kind of my signal that they had decided not to deal with it, but they had decided more to push it under the rug, and I became very concerned at that point.

I had really given them every chance and every benefit of the doubt that they were going to fix it on their own.

CUMMINGS: Now, you said you knew about when CAPs came in. Is that right?

TURNER: Yes.

CUMMINGS: Did you know when the state came in?

TURNER: No.

And that’s a huge issue I think, because for CAPs, we knew weeks in advance that they were coming and the lab was always — everybody from the supervisors on down, everybody was saying, “CAP is coming, so do this, clean up this area, or do this, or do this, or get ready,” you know.

And everybody was getting ready at every level whether — for us, it didn’t really affect us so much as just making sure that where we were working was maybe cleaned up or was, you know — whatever — was organized better so that it didn’t give them anything to have to look at. But the supervisors and things like that, they were — it was almost chaos for them trying to get ready for CAPs coming.

But with the state you have no warning. So I think that that’s an amazing thing. I think that…

CUMMINGS: Is that a better system, you think, no warning?

TURNER: Absolutely. Absolutely. Because I think that — and when the state comes in it’s my understanding that they come in and they don’t say, “No, not in two hours. I don’t want this information. I want you to take me in now and I want the information and I want to see it for myself what’s happening now.” And I think that that is how inspections should be done of laboratories.

CUMMINGS: Let me just ask you this because I’ve run out of time, but let me ask you this. You just said that there was a lot of clean up and there was, I guess — I’m not trying to put words in your mouth, but it’s almost panic time when they came, the CAPs inspectors. Did the CAP inspectors get a true picture of what the lab was like on a day-to-day basis or did they get something else?

TURNER: I think they got a cleaned up Sunday church version of the lab.

CUMMINGS: A cleaned up Sunday church version.

TURNER: Yes.

CUMMINGS: OK.

TURNER: I mean, honestly, I think that…

CUMMINGS: No, I just want to make sure I heard what you said.

TURNER: Yes, it’s not the everyday runnings in any way;

everything is just cleaned up. Everything is shown in the very best light that it possibly can be and you kind of hope they don’t look in the shadows, I think, is kind of how the lab approached it.

CUMMINGS: So if you were trying to — looking backwards now and looking at the fact that CAPs came in and CAPs didn’t detect certain things, and maybe it’s just the way they do it and the kind of information that might be available to them, what would your recommendations be with regard to — I know one of them would be that CAPs not announce when it’s coming in.

TURNER: Right.

CUMMINGS: What other recommendations would you have? Because you’ve got to keep in mind that CAPs is doing these inspections all over the country.

TURNER: Right.

I think maybe there could be somehow more unbiased — I’m not saying that CAP is biased. I don’t mean — but they’re all members of the same organization. They’re all laboratory members who have — it’s to their advantage to have laboratories pass, I mean, because that’s what they do.

But — I don’t know. It’s kind of hard (inaudible) with that answer. I guess…

CUMMINGS: Well, let me try to help you. Let me just ask you this. You’ve watched CAPs do inspections, have you not?

TURNER: Yes.

CUMMINGS: And you talked about the clean up before CAPs came.

TURNER: Yes.

CUMMINGS: Let me just finish.

And it just seems to me that if we are operating a lab which is performing tests that could result in a person getting treatment for a life-threatening ailment or not…

TURNER: Right.

CUMMINGS: … it seems as if the standards would be constant.

It shouldn’t be a clean up.

TURNER: Right.

CUMMINGS: And so, I’m trying to figure out what it is you were cleaning up, and what it is — and I guess what we’re trying to come up with is trying to make sure that a hospital in rural Indiana where Mr. this web site maryland general hospital

Souder is from, if a CAPs inspection team comes in, that his constituents, just like my constituents in Baltimore, would feel comfortable that there is an agency like CAPs that is doing a good inspection, and when they put the good housekeeping seal of approval on it, it means something.

And all I’m asking you, and you may not be able to answer this, what would you like to see happen to make sure that that good housekeeping seal is valid?

TURNER: Well, I think the surprise inspections — the chance that any minute of any day somebody can come in and revoke your ability to operate based on what they see is an amazing motivator.

I think that just maybe having there be some way where CAPs used something other than what the lab shows them — like I know that for paperwork and things like that, they see whatever the supervisors get ready and present to them. So they don’t go looking on their own. They don’t — I mean, it’s my understanding that they don’t. I never saw them go looking through the file drawers on their own. They took it — they value what the lab said and what they told them or what they showed them as far as paperwork.

Other than that, maybe just making sure that there are other agencies that can maybe overlap that responsibility so that they’re not the final word, or there needs to be something other than passing CAP inspections for maintaining a lab and being able to operate a lab when people’s lives are at risk.

SOUDER: Thank you, Ms. Turner.

I have a couple of follow-up questions, because you’ve raised some really problematic questions regarding your particular laboratory that I’m not sure I’m comfortable with extrapolating beyond that.

If I understand, do you believe the person who ran your lab got a particular tip from the inspector, or what made you think that they knew about the inspection?

TURNER: Oh, no. CAP inspections are scheduled so they know when CAP — when CAP is coming, the laboratory is notified if not a month in advance, it’s earlier than that.

SOUDER: They testified under oath that that isn’t true nationally.

TURNER: Oh. Well, I’m not sure…

SOUDER: So we’ll hear that in the second panel. So if your place was…

TURNER: Well, that’s my — I mean, we were aware that CAP was coming.

SOUDER: Is that not what I understood them to say last time under oath, is that they were unscheduled?

(UNKNOWN): My recollection is that they are scheduled.

SOUDER: They are scheduled in advance.

(UNKNOWN): (Inaudible) SOUDER: Is the person who’s going to testify from the pathologists here? Can you nod your head? Are they scheduled or unscheduled?

They are scheduled. OK. I’m incorrect.

So if they’re scheduled in advance, that is problematic, because I needed to see whether — because I agree with Mr. Cummings that they should be unscheduled and I thought that we understood that they were not, and that that was a matter in debate.

Why do you believe that — well, let me ask you another question.

Were you terminated by the lab or by the hospital? I forget from the last time. Is the lab an independent entity that rents space from the hospital?

TURNER: No. It’s all part of Maryland General.

SOUDER: So your checks came from the hospital?

TURNER: Yes.

SOUDER: And do you have an appeal process if you get terminated?

TURNER: I was told no. I requested that it be looked at, because I was sent a letter that said that I would be left on medical leave, that I wouldn’t be terminated. And then I came to find out by accident that I had been terminated.

SOUDER: Did you appeal past the lab? I mean, did you write a letter to the hospital or anybody beyond the lab?

TURNER: I did, and I sent a copy of the letter that I had received and they never…

SOUDER: And the hospital didn’t respond to you?

TURNER: No.

SOUDER: Did you raise concerns that it might be because you raised concerns in the lab? In other words, did you tell them that you had…

TURNER: At that point I didn’t.

I thought that — but I also know that it’s much easier to — if somebody is making trouble or bringing up issues that then have to be dealt with, it’s easier to kind of push them under the rug or get them out of the circle so that they can’t make noise anymore within the organization.

SOUDER: But you don’t know whether the hospital knew you were, in fact…

(CROSSTALK) TURNER: Oh, well…

SOUDER: … because what I understood your — let me see if I understood this correctly — that you gave — you went to the lab director inside the lab, but they didn’t want you to go outside their unit.

Did you make anybody aware outside the unit that you had concerns?

TURNER: Not at that point.

SOUDER: At any point before you were terminated?

TURNER: I’m not sure. I don’t…

SOUDER: Because part of the question here is what did the hospital know? If they didn’t know you were complaining…

TURNER: Right.

SOUDER: … they can’t…

TURNER: Well, I know that my termination came from inside the lab, like the lab turned in the papers, because when I had talked to human resources, they were kind of in a shuffle trying to figure out how that actually happened because they weren’t aware on all of the levels that they needed to be aware that that had actually taken place.

SOUDER: And at the last hearing we had testimony that the Labotech equipment, other than two kind of minor concerns — one was more significant than the other — over many years, it had not had this problem at other locations. Is that what they told you? And what did they tell you on a regular basis when you filed your complaint?

TURNER: Adaltis? Are you asking about what Adaltis told me?

Their technical service did tell me that we seem to have more problems than anywhere else, and I guess I questioned that because there was a variety of people running the machine, from medical technologists with 20-plus years of experience to people with less than one. But there was not just one single person that was having problems with the machine, and both machines that we had there — we had a total of three — but the two machines that were in service at the time had significant problems constantly.

And so, every time that we called them, every time they sent service out, it was just — they acted like it was something that was different and yet service was constantly busy.

SOUDER: Did you hear any discussion inside the lab that was, if, in fact, there wasn’t problems at other labs, why your lab just didn’t get new machines then?

TURNER: Well, there was a lot of concern as to if our labs are having this many troubles, then how can this be OK, you know?

SOUDER: But let me give you an example.

We’ve had a common — we had a regular problem with one of our Xerox machines — presumably Xerox, whatever company it was — in our office breaking down. And at some point we said, “We’re sick of the service complaints.

Give us a new one.” TURNER: Right.

SOUDER: Did that happen, because that would force them to either say, “Look, it’s the machine or the operators”?

TURNER: That did happen actually with the very first machine that we had, and Adaltis’ response was to agree to provide Maryland General with another machine, exactly the same.

So now Maryland General had two machines. The problem was that the other machine that they provided had the same problems. So it should be maybe that if one machine was broken, you had another one to turn to.

But more often than not, you can’t rely on either one and they refused, the hospital — or the laboratory administration refused to replace the machines, even with all the problems that we had.

And, you know, every machine, there can be a lemon, no matter if it’s a Mercedes or whatever it is, you know, it doesn’t matter. They can make lemons, and Adaltis refused to even acknowledge that that was possible, you know.

But I think the chances of getting three lemons all at the same time are kind of strange. It’s a little bit low on the chance thing there.

I’m sorry.

SOUDER: No, no, that’s fine.

I understand that. You’d think that one of them would work.

TURNER: Right. It’s kind of a bad sign if you get three machines and they all have the same problems.

SOUDER: The normal thing is you look for a different machine.

TURNER: Right.

Which actually we provided information about other options and other companies that made machines that had been tested and that other laboratories loved and can rely upon, and they wouldn’t even hear of the option of replacing it. We brought it up and it was like, “Nope, we’re keeping the Labotech.” Why?

SOUDER: Mr. Ruppersberger?

RUPPERSBERGER: Yes.

First, I thank you for coming forward and your courage, and you will make a difference in this whole issue.

I want to save my questions for the second panel.

SOUDER: Thank you.

Do you have any more questions?

(UNKNOWN): (Inaudible).

SOUDER: OK.

Mr. Cummings?

CUMMINGS: I just want to go to the one thing that’s very, very important.

In a few minutes, Ms. Mary Kass of — Dr. Mary Kass, president of the College of American Pathologists, is going to testify, and part of her testimony is — I just want you to comment on because we won’t be calling you back except for some written questions.

She says here, as you may recall, and this is part of her testimony, “The CAP stated in its May 18 testimony that the quality control deficiencies for HIV and hepatitis C testing were not uncovered by CAP inspectors during a routine April 2003 inspection or by state inspectors in fall of 2002″ — now listen to this now — “because quality control data in this area were found to have been edited.” Who would have done that editing?

TURNER: That depends on…

CUMMINGS: Do you know what this means, first of all?

I mean, you’re familiar with these terms, I take it?

TURNER: Yes, I think that I do.

I think that that would be — she was probably referring to the internal quality controls which — and those are the values that — there was a big issue when the Labotech would fail a one and it would be because the positive control was out of range, or it were that the negative control was out of range. And at that point we were instructed to call Adaltis.

And when we would call Adaltis, they would say OK — actually, they would give us passwords and all this other stuff to go in — and they’d say, “OK, I’ve changed this number.” And it’s like, well, is that OK?

I mean, these are controls for the entire assay. You know, this should just be run again.

And at that point it was more of a money thing. It was a cost thing, because to rerun it, you know, regardless of what it means to the patients on the other end, you know, it would cost — you’d have to reuse every single — you’d have to use up almost a whole kit to rerun it.

So a whole kit for one run is ridiculous, you know. So it would just be — it was cost reasons I think was the thing that — when I asked Adaltis about that, they said that they have a formula or something that shows them that actually it is only this that maybe went wrong. And so, then they can just tell us to change the numbers to this.

And what happens though is that if you change the control value to where it works, it changes the other values. Obviously, it changed all of the patient values the same based on whatever formula they give you. So say the positive control is like 2.1 or something and it was low, so instead you’d take it up. You add something to the positive value so that it will be in the positive control range. Then it adds that same amount to the patients.

CUMMINGS: OK. Let me try to put it in lay language.

TURNER: Sorry.

CUMMINGS: No, that’s OK. Let me make sure I understand what you’re saying.

TURNER: OK.

CUMMINGS: You’re saying that when these tests were done and there was a question as to their accuracy, instead of them being rerun you all might call Adaltis, the manufacturer of the machine. Is that right?

TURNER: Right.

CUMMINGS: And you would say to Adaltis — what would you say to Adaltis?

TURNER: Well, usually it was that Dr. Stewart had asked us to call and…

CUMMINGS: I’m sorry, say that again.

TURNER: Dr. Stewart would instruct us to call them, first of all…

CUMMINGS: I see.

TURNER: … because we would go to him and say, “Look, we had this failed run.” And he’d say, “Well, what’s wrong?” Well, the controls are out of synch with each other or they just aren’t in the right range.

CUMMINGS: So that’s like a red flag going up when you see what you…

TURNER: Yes. And that should be…

CUMMINGS: Whatever would have caused you to go to Dr. Stewart would be like, you know, lights going off, saying something is wrong.

TURNER: Right.

Only because when we would rerun them — if he would find out that we automatically reran them, then he would — that would not be OK with him.

CUMMINGS: So he would be upset based upon what you just said a moment ago because he was worried about the costs of rerunning tests that may have been inaccurate…

TURNER: Exactly.

CUMMINGS: … for the person who did or may not have had AIDS.

TURNER: Exactly. So he…

CUMMINGS: Hepatitis.

TURNER: Exactly.

CUMMINGS: Because of money?

TURNER: Yes.

And his instructions were to call Adaltis and see if they can get it to work. He then…

(CROSSTALK) CUMMINGS: And then when you would call Adaltis, they would give you a formula.

TURNER: They would give us new numbers to put in the control values so that the whole assay passed. And their explanation was that actually all of the values were valid — all of the results were valid, but just the controls — maybe it was contaminated or maybe the reader was just reading that particular well too high or something like that.

And it was really frightening. And so, that is just — gosh, I don’t know.

(CROSSTALK) TURNER: I mean, the positives were automatically repeated. I mean, I repeated them anyway. So those are the things.

But it’s like with the mistakes that the machine made, how many samples got missed and were really — the possibility was there, that there were positives that were missed because they weren’t even sampled.

CUMMINGS: This is the last question.

You just said it was frightening. Why did you say that? What was frightening?

TURNER: Just the fact that we’re being told to go in and change controls. I was — because controls are the only basis — like the controls have gone through the assay like all of the re-agents, all of the patients.

Every well represents a patient. So the controls are the only thing that has gone through that. That’s your indicator of whether everything was done correctly.

If your positive control works, your negative control works and they’re in duplicate, then you know that probably the — you can count on the results that are coming out at the end.

But that’s really the only kind of way that you know if every re- agent was dispensed or if everything went through the right time period of incubation or anything like that. That’s your indicator. So if that’s wrong, it should automatically be trashed and rerun. They should never be changed. And you should never have to — it should never be allowed that you’re told to change it as part of your job.

CUMMINGS: Did you ever say to Dr. Stewart, “Doc, there’s just something awfully wrong with this. I just think that there’s something that just doesn’t sit right”? I mean, did you ever say that to him when you were going through that process you just described?

TURNER: Absolutely.

CUMMINGS: And what did he say?

TURNER: I said how do we — well, my problem was that if we were — I said this on a number of occasions to him that if we were running these tests on the machine that fails a run, we don’t know why it fails.

I mean, maybe it is controls, maybe it is re-agents, maybe — who knows what’s wrong with it. And you’re telling me to go rerun it on the same machine and if the machine was broken, you can’t ever rely on those results that come out of there. And so, these are people.

I don’t think that he really made the association — at least it’s my opinion — he didn’t make the association that the numbers on the page represented people in the community, because to him it was just numbers and make it work.

And so, it’s scary just that somebody would ask you to change controls, because that is the only scientific way that you know that everything went correctly.

CUMMINGS: Well, let me say this, and this is my last comment, it is thoroughly frightening — you’re absolutely right — that when someone can look at numbers and forget that they’re people — they’re real live people, they’re somebody’s mother, father, brother, sister, neighbor — and deal with it from a statistical standpoint trying to get it right.

Thank you.

TURNER: Sure.

SOUDER: I’d like to make a couple comments and then see if you have any last — there are some things that I think become fairly clear from your testimony, and that is is that the people who were doing the auditing, the normal auditing, the preplanned auditing, it would be best if it’s done unannounced.

Almost every category of inspections we do, we do it unannounced.

That, however, doesn’t mean that even if it had been unannounced by anybody that they would have caught it if the information had been doctored. In other words, just because the place has been cleaned up and tidied up does not mean if — garbage in, garbage out.

If you have the wrong information there, it doesn’t mean that a surprise inspection would have caught it either. You’d have another substantive problem in the system.

It’s also not a given, and I think it’s important for the record to show, that a medical group monitoring a medical group is going to be any less effective than an outside group that doesn’t have a medical background.

I understand the risk of that, because a pathologist — and that’s why I asked you did the person seem to know the people, what made you make kind of the statement, was it an inside inspection that — while sometimes you wonder, particularly when you see bad results coming out in the sense that they didn’t catch the problem, it — generally speaking, if the pathologist in charge of the lab is deliberately one way or another because of either cost pressures from the hospital, which is in itself under tremendous cost pressures in a community — if anybody is under tremendous duress — many doctors, for example, aren’t very happy with the cost constraints a hospital will give them or medical plans give them or health insurance gives them or anybody else gives them. They’d just as soon do whatever.

But once then in violation of the Hippocratic Oath, which is to put the person first, your problem is far more than an inspection because, in fact, they’ve given up the number one goal of the medicine, which is to protect the individual.

And I think it’s — while I understand given the history of what’s happened there to make a leap and say that the bureaucratic staff are coming out of the state government or federal government is going to be any more reliable in figuring out what’s in a lab than a medical person — I do believe it’s good to have checks and balances, but here the fact is is that — why do you think your letters of concern weren’t given to the inspectors, because they didn’t hear about your letters until we had the hearing?

TURNER: Right.

SOUDER: You know, we can talk about whether it got caught, but they didn’t know about it until Elijah Cummings asked for a hearing. They didn’t even know — the inspectors didn’t know. That is another problem that’s deeper than who’s doing the inspection.

TURNER: Right.

And I think actually at Maryland General it’s important to kind of make a distinction between the medical director, the laboratory and the administrative laboratory director, The M.D., the pathologist of the laboratory.

And obviously it’s his job to know that there is something wrong there. But I think that the information about specifically the Labotech was kept from him by the administrative laboratory director, I think that’s part of the concealment.

SOUDER: Shouldn’t it be a mandatory policy of the hospital and the lab that any complaints are given to whoever is doing the inspections in any hospital? I mean, I would think that this would be a national standard that the…

TURNER: That’s kind of where I think that maybe there needs to be three or four copies of every single complaint or anything that’s made and have it go to four different people so that at least one person can follow up.

SOUDER: But like you say, if that stays even — the reason I wanted to elaborate on that is you said three copies — but if that stays within the hospital and not the inspection group — in other words, it should be…

TURNER: Right.

Well, maybe it needs to go to CAP and FDA and…

SOUDER: Any complaint ought to go to…

(CROSSTALK) TURNER: … risk management of the hospital, as well as the lab so that there is just somebody keeping an eye on everybody and making sure that that happens.

SOUDER: Well, thank you for your willingness to come forth and testify. I hope you continue to have good health.

TURNER: Thank you.

SOUDER: And with that, you’re dismissed.

And would the second panel come forth?

Ms. Carol Benner, director of the Office of Health Care Quality, Department of Health and Mental Hygiene; Dr. Mary Kass, president, the College of American Pathologists; and Mr. Edmund Notebaert, president, University of Maryland Medical System.

And as soon as you get comfortable, I’ll ask you to stand again.

(LAUGHTER) If you would raise your right hand? Do you swear the testimony you will give today is the truth, the whole truth and nothing but the truth, so help you God?

WITNESSES: Yes.

SOUDER: Let the record show that each of the witnesses responded in the affirmative.

I guess we’ll start with Dr. Notebaert since you’re getting round two. We appreciate your coming again today.

NOTEBAERT: Thank you very much, Mr. Chairman, Congressman Cummings, distinguished members of the committee, members of the staff.

My name is Edmond Notebaert.

I’m president and chief executive officer of the University of Maryland Medical System, which is the parent organization of the Maryland General Hospital, as well as a number of other hospitals in the Baltimore region.

I have provided testimony on previous occasions and I have provided written testimony before this committee began.

I would like to offer a few remarks, and I’m not going to be quite as wordy as I was in previous testimony to provide opportunity for questions and answers. see here maryland general hospital

But I would like to say simply that the University of Maryland Medical System’s response to the issues at Maryland General Hospital has been swift, it’s been decisive and it’s been comprehensive in its nature.

I would like to just briefly provide you with an overview of the matters that have occurred.

We have engaged in a full-blown laboratory improvement program.

We have engaged independent third parties to come in and assist us with this process. We have done so without regard to expense to make sure that this problem is fixed properly.

We have restructured the hospital from top to bottom, including a new administrative director in the laboratory, a new pathologist heading up the laboratory. We’re in the process of searching for a new chief executive officer. And there have been a number of other organizational changes inside the hospital.

We have conducted retesting of as many individuals as we can find, and I’m pleased to report to you that over 1,800 of the total of 2,700 individuals tested have been accounted for.

And in the retesting process, the accuracy — not the validity, but the accuracy of the original tests has been affirmed in 99.4 percent of the cases.

I acknowledge the issue related to the validity questions around the quality control, and those matters have been addressed and are in the process of being finalized in preparation for inspections by all of the various agencies that inspect the hospital.

On the issue of — well, why don’t I just simply stop there.

But I would like to maybe make one comment with respect to one of the matters that was raised by Ms. Williams in the previous testimony.

I was as shocked as the members of the committee were to hear her testimony regarding fear of reprisal, and we have put in comprehensive systems not only in the Maryland General Hospital, but systems to allow employees to go outside of the Maryland General Hospital designed to remove any hesitation that an employee might have regarding problems that he or she feels are not being properly addressed, including confidential hotlines

We have done our best to put in place many mechanisms that will allow employees to go out of channel and without fear of reprisal.

And I wish to say before this panel that as long as I have the privilege of serving in my position, that kind of attitude will not exist in any of our institutions.

So I think with that, Mr. Chairman, I would like to relinquish my time and be available to respond to any questions that the committee might have. I recognize that I didn’t cover all the testimony, but I know it takes more than my five minutes and I’m sure that the questions might be more insightful than my testimony.

Thank you, sir.

SOUDER: Plus everybody’s written testimony will be inserted, and if you have any additional things you want to insert after today’s hearing, you can do that too, that’ll supplement.

Dr. Kass?

KASS: Thank you.

Good afternoon, Mr. Chairman, Representative Cummings and other members of the subcommittee.

My name is Dr. Mary Kass and I’m president of the College of American Pathologists.

Since the May 18th hearing, the college has conducted an unannounced inspection of the MGH laboratory as a follow up to our April 2004 decision to suspend accreditation in two disciplines, chemistry and point-of-care testing. This inspection revealed few deficiencies and the hospital has responded to those that were cited. The college’s Commission on Laboratory Accreditation is scheduled next week to review those responses and the status of the MGH laboratory.

As you may recall, the CAP stated in its May 18th testimony that quality control deficiencies for HIV and hepatitis C testing were not uncovered by CAP inspectors during a routine April 2003 inspection or by state inspectors in the fall 2002 because quality control data in this area were found to have been edited.

Specifically, Maryland state inspectors allege in their 2003 inspection report that, and I quote, “Review of HIV records from June 2002 through August 2003 show that approximately 10 to 15 percent of patient runs were invalid because of unacceptable values of the negative controls used to determine cutoff values.

“On May 14th, 19th, 21st and 23rd, 2003, instrumentation printouts showed edited control values, but there were no printouts for the plates and no other records to show repeat testing for either the control materials or the entire plate of patient specimens. In a run for hepatitis C testing on July 18th, 2003, the instrumentation printout showed manually edited acceptable values for the negative control materials, but the plate printout showed unacceptable negative controls,” end quote.

Based upon these findings by the state, we have concluded that neither our inspection process nor any other would have detected these problems without the benefit of the whistleblower complaint information, which ultimately led to the state’s findings.

I have attached a copy of the state’s report for the record.

Any claim that CAP accreditation is not rigorous or objective is not supported by the facts.

Mr. Chairman, I have attached to my statement the September 12th, 2001, Federal Register notice extending to the college deemed status under the Clinical Laboratory Improvement Amendments of 1988. A review of this document will clearly show that the CAP inspection process exceeds CLIAA requirements in several areas.

Moreover, our program is subject to annual CMS validation surveys conducted by state inspectors. These surveys typically are unannounced to laboratories and never announced to the college.

CMS validation surveys always have shown results comparable to CAP findings and a discrepancy percentage well below the threshold that would trigger a federal review of our program.

CMS, in fact, has clear authority to revoke the college’s deemed status if it finds our program to be substandard. Most recently, at the May 18th hearing, CMS reaffirmed its support of CAP accreditation.

The college welcomes and has encouraged state authorities to review our program to determine whether CAP accreditation meets the requirements of their respective state laws.

For example, college representatives met with Maryland Health and Mental Hygiene Secretary Nelson Sabatini on June 17th as an initial step in efforts to improve communication and formalize our relationship with the state. As a result of that meeting, we have received a letter from department director Carol Benner requesting information from the college so that the state can formally evaluate the college’s program for equivalence to the state program.

We are encouraged by this development and look forward to continued discussions with the state.

We believe the MGH case is highly unusual and does not point to a pervasive problem in the accreditation or inspection process. But the case highlights important issues that can translate to improvements in the accreditation process.

First, better communication: The MGH case underscores the need for better communication and sharing of inspection information between accrediting organizations and governmental entities involved in the inspection process.

The CAP also asks CMS to schedule a meeting of stakeholders to discuss ways to improve communication among state and federal oversight agencies and private accrediting bodies, such as the CAP. We understand that CMS intends to convene such a meeting, but has not yet scheduled it.

CMS leadership in this effort is essential to developing a protocol with clear requirements for sharing of complaint information amongst accrediting bodies.

Enhanced complaint reporting: Laboratory employees must have easily accessible and effective ways to communicate complaints and other concerns to accrediting organizations, such as the CAP.

The college has moved forward with plans to enhance communication with clinical laboratory personnel to ensure their awareness of the college’s complaint reporting system. As initial steps in a comprehensive program, we have developed a special laboratory signage promoting a dedicated, toll-free number to allow ease of use in complaint reporting. This is the signage that we will be posting in our accredited laboratories.

CUMMINGS: Mr. Chairman?

Would you read that for the record, please?

KASS: I’d be happy to.

“This laboratory is accredited by the College of American Pathologists. Please alert us to any questions or concerns you may have about quality patient testing or laboratory employee safety. Your communication with the CAP will be kept strictly confidential.” And then there’s a toll-free number at the bottom.

Protection for whistleblowers: We commend the whistleblowers in the MGH case. Without their courageous actions, the state and hospital might never have learned about the testing problems and taken steps to identify recipients of potentially erroneous laboratory results.

We believe this case clearly illustrates the need for strong federal protections for whistleblowers, both for the individuals who report the problems to government or private oversight bodies and to the oversight bodies themselves. Patient safety legislation now before Congress would establish whistleblower protections, and we urge Congress to extend those protections to reports to private accrediting organizations.

The college thanks the subcommittee for its interest in ensuring the highest quality laboratory testing. The CAP is firmly committed to working with Congress and federal and state agencies to achieve that goal.

We would be happy to respond to any questions.

Thank you.

SOUDER: Thank you.

Ms. Benner?

BENNER: Good afternoon, Mr. Chairman and members of the committee.

My name is Carol Benner.

I am the director of the Office of Health Care Quality at the Maryland Department of Health and Mental Hygiene. I work for the secretary of health, Nelson Sabatini, who was here on May 18th.

Secretary Sabatini sends his regrets that he could not be here today. He has asked me to speak on his behalf and to carry his message to you.

I’d also like to thank Kristin Turner for coming today and also for coming forward with her complaint to us. I think it’s important.

Chairman Souder asked how we got the complaint.

Department who, in turn, sent that to our AIDS administration who, in turn, sent that to us, and that’s how we learned of the issues with the piece of equipment.

In his May 18th testimony, Secretary Sabatini was emphatic that the problem is not Maryland General Hospital. The issue that we need to focus on is the failure of the regulatory and oversight systems to identify the problems and to get those problems fixed.

Under federal and state laws we, both state and federal governments, have turned our regulatory responsibilities over to private accreditation organizations, and we have done so with little or no provision for communication, coordination or oversight.

Up until January 2004, in the Maryland General example there were four different organizations: the state, CMS, CAP and the Joint Commission on Accreditation of Health Care Organizations, who were all surveying the hospital and its laboratory.

Problems were identified and documented, but survey results were not shared. Consumers sent complaints, but these were not shared either.

What resulted was essentially in absence of regulation a situation that could have had serious consequences.

Secretary Sabatini believes, and I share his position, that we were fortunate this time. The outcome could have been much worse.

It is our responsibility to make sure that a Maryland General situation does not happen again.

Regarding Maryland General, I would like to briefly bring you up- to-date on our progress since the May 18th hearing.

We have visited the hospital on several occasions and we can say with certainty that the hospital laboratory has undertaken and continues to implement corrective action.

We will conduct a full survey of the hospital laboratory within the next 60 days to determine overall compliance with all state and federal regulations.

The secretary has met with representatives of the College of American Pathologists and we are working together to devise a joint program, one with integrity and reliability that will be effective and will guarantee proper oversight of laboratories in Maryland.

We intend to expand this effort to include all health care providers that are presently deemed to meet state licensure programs based on third-party accreditation decisions.

The secretary has also met with legislative leaders in Maryland who have expressed interest in changing our state law so that the state will not be required by law to accept accreditation reports as evidence of meeting state licensure standards.

Mr. Sabatini has also met with Congressman Stark, who shares his concerns. We are hopeful that there will be some movement in this direction on the federal level.

I understand the time is short so I will stop here. I assume that you all have a copy of Secretary Sabatini’s May 18th testimony, and I’ll be happy to answer any questions that you may have.

Thank you.

SOUDER: Thank you.

Let me just make this clear for the record.

I don’t have — I have national interest at stake. I don’t have similar Baltimore issues at stake.

This is the second time that I want to make it absolutely clear where I stand, and that is is that I find it a bit cute to have a witness say that they need federal legislation to share information when my staff shared the information when we got it with the accreditation lab and they didn’t get it from the state. There was no law required for you to share that when you got it into your system with the accreditation association.

It shouldn’t have been my staff sharing it. We didn’t need a federal law to share it with an accreditation lab.

And while I don’t necessarily disagree with the end point that there ought to be some kind of working with the state with this, I don’t appreciate twice now getting testimony telling me what we need to do at the federal level when the state failed.

The state could have shared that with the accreditation lab and didn’t, and they don’t need a federal law to share that.

Like you’re doing now, sitting down and working it out is commendable and that ought to be done in every state, and if it isn’t done in every state, maybe we need to look at federal legislation.

But I personally got my dander up now twice on this matter because of the tone of Mr. Sabatini telling us that when he didn’t share and telling us we need the law to share, because the state, in fact, did fail as part of this as did everybody down the line.

Now, a lot of that was structural and I don’t disagree with him that there are structural flaws in this.

I also have a question for Dr. Notebaert.

You say that it was 99.4 percent accurate when it came back?

NOTEBAERT: That’s correct.

SOUDER: In 1,800 cases.

NOTEBAERT: They’d gotten over 1,800 cases.

SOUDER: Does that mean there were 12 people who were either told they had AIDS or didn’t have AIDS who…

NOTEBAERT: No.

There are individuals who — being mindful of the patient confidentiality issue, whose testing was different on the retesting, and there are reasonable explanations for those changes in results between the first test and the second test that are related to the specific patients themselves.

Ninety nine point four percent is an extremely statistically significant number, and in the individual cases, we have looked at them and there are explanations beyond the mechanics of the testing process that explain that deviation.

SOUDER: And then the validity; is that what we were talking about earlier, about the controls? In other words…

NOTEBAERT: That’s correct. Yes, sir.

SOUDER: And that’s still being…

NOTEBAERT: That is substantially fixed and we believe when we’re inspected by the various agencies that inspect us, they will find that the efforts that we have put in to create all of the appropriate quality controls meet the highest standards.

SOUDER: So it’s still the hospital’s position that it’s not the Labotech machine?

NOTEBAERT: No, we have not taken that position.

We’re not commenting on the Labotech machine except to say that we do not use the Labotech machine in any of our organizations…

SOUDER: So you’ve switched…

NOTEBAERT: Immediately upon the discovery of this event, we discontinued the use of that equipment.

SOUDER: OK. Thank you. I had forgotten that. You probably said that last time and I forgot.

Dr. Kass, why would you do announced inspections?

KASS: First of all, let me state that the college does both announced and unannounced inspections.

SOUDER: No, let me clarify. We were just looking at the past testimony.

But your unannounced inspections were between certain dates where they had the range of the dates. Is that common?

KASS: Our unannounced inspections — not quite.

Our unannounced inspections are in response to either a complaint, allegation that we have to investigate. It may be in response to deficiencies that we found on a routine inspection that we’re not confident have been corrected — we can go in and do an unannounced inspection.

The college retains the right to do unannounced inspections at any time for any laboratory that it accredits.

We are required to do a routine inspection every two years. That is part of our deemed status from CLIAA. We have to do this every two years and we have to do it within a certain period of time so that the lab can get its accreditation redone.

We have always felt — and, in fact, CMS is the regulatory authority here. CMS, in the Federal Register in 1998, and I would like to quote, “We agree with commenters who recommended announced inspections for all laboratories. We have instituted a policy of announced inspections for all initial and recertification purposes, which allows a laboratory the latitude to include multiple members of the staff in the inspection process for the education value. Announced routine inspections are more efficient in that the laboratory can make previous testing records more accessible before the inspection and these inspections are also less intrusive.

“Furthermore, surveys must make every effort to minimize the impact of the survey on laboratory operations, patient care activities and to accommodate schedules and departmental workloads as much as possible.

In facilities providing direct patient care, surveyors must avoid interfering with patient care,” end quote.

SOUDER: That all presumes that somebody isn’t — I mean, it’s kind of the reverse of what I commented to Kristin Turner, and that is — is because you may have a deeper problem if somebody is manipulating.

But I’ve never heard of announced inspections not causing changes, like she said, getting ready for your Sunday best. I grew up in the retail business — if OSHA is going to come and give me an announced inspection, I don’t care whether I’m in major violation, minor violation, because you always assume something’s wrong and you’re going to start scurrying around if you have an announced inspection.

Certainly with nursing homes, this is a huge issue.

And yes, any unannounced inspection, for example, on a retailer with OSHA, on a polluter with EPA, an unannounced inspection means that, yes, you’re going to have a little more time there because they don’t have all the records ready, you’re going to have some disruption of service.

But if the goal here is ultimately patient protection, and I presume by commentators you mean the industry itself commenting on what disruption it would be — that’s usually the process — and needless to say, I’m very sympathetic to the problems facing all types of people in the medical profession and I believe you ought to take commentary in from those people.

But I’m not sure that I would necessarily take the people audited’s word that they — of course, they’re going to prefer — who wouldn’t prefer announced inspections?

What I asked was, a philosophical reason why you believe announced inspections would really wind up with better protection for the consumers, not why it would be easier for the lab.

This is a different question because you gave me reasons that are easier for the lab, because it’s less time intrusive, less intrusive for the people involved, all the people will be on duty that day; you know, all things which are beneficial to the lab, but aren’t necessarily beneficial to making sure that the information is.

KASS: There are two aspects to your question that I would like to respond to.

First of all, the laboratory is extremely important in patient care. Seventy percent of diagnoses now that are made on patients come from laboratory data. So it is extremely important that the laboratory is able to generate accurate results in a timely fashion.

When you come into an emergency room or a shock trauma unit, you don’t want your lab results to take an hour or two to get there. So sometimes speed is of the essence. And to disrupt that process would be extremely difficult, if not very adverse to patient care. That’s the patient care aspect.

As far as the inspection process, our inspection process is announced. The laboratories know exactly what we expect of them. We have set standards. We have thousands of standards that laboratories have to meet and they know what they are.

The college has always stood for quality in laboratory practice.

So we don’t feel that an inspection process should be a black box where people have to guess what they’re supposed to be doing. Our job is to show them the best laboratory practice, what the standards are for best laboratory practice and then to see whether or not they are complying with those standards.

So if they tidy up the lab and they clean up a few things, that’s fine, but that’s not what we’re looking at.

We’re looking at a sustained repetition of the process that’s been going on since the last inspection. We are focusing on those deficiencies that they had before to see whether they’ve really done on a sustained level over a period of time what they said they were going to do.

And we send in a team of individuals. These aren’t just pathologists going in and talking to pathologists. There are pathologists on our team, medical technologists, Ph.D.s, clinical laboratory scientists.

It is a whole team of individuals with expertise in the areas that they are inspecting, and they have to be in practice now. They cannot be retired. They have to be aware of all the current technologies and the current standard of laboratory practice.

If the laboratory does a specialized form of testing, like cybergenetics or molecular pathology or scatology, we send specialized inspectors with special expertise in those areas to inspect those areas of the laboratory. That’s how the process works.

I hope I answered your question.

SOUDER: Yes, you did.

I want to say for the record that I disagree with your first part. I understand nobody wants to be disrupted in the emergency room or a laboratory.

But given the choice of making sure that there is accuracy, I will wait a little longer in getting my lab test to know that, in fact, I didn’t get told wrong results for AIDS — that I don’t find a compelling argument.

Your second part is similar to what we’re working with and is part of the argument over whether we have private agencies or government agencies, and we, in fact, have taken this position at OSHA.

And, in fact, if you’re getting any whistleblower complaints — and by the way, I wanted to ask Dr. Notebaert, do you see a problem not only at your hospital, but this would be interesting nationally, with why that couldn’t be inserted with paychecks every so often so that people have this number where they could call whoever the — you know, if they provided something like that to be an insertion…

(CROSSTALK) NOTEBAERT: No. We do payroll inserts regularly and stuffing another one in is not really a problem.

SOUDER: And I would think that would be a great thing nationally in addition to a poster, because sometimes having been in a — you see all these posters around there and you also get things in your envelopes, but the reinforcing would be good.

But as we work through, we don’t want to play government gotcha with all these different regulations. The goal is long term, that we look forward.

I thought that was a very eloquent statement of how you do that.

But that is dependent also on occasionally having the uncertainty with it, because if you have somebody who’s altering results and you wouldn’t have a whistleblower, if it’s unannounced, if it’s not unannounced, you’ll never catch them, and that’s the dilemma.

Because the goal here isn’t to play gotcha, and that’s the danger of having people who don’t understand the laboratory, who aren’t trying to move the full health field forward. And that’s what’s happening in other agencies of the government where, in fact, the inspectors are so rare and when they come it’s almost like they have to justify their salary by going and picking at something on the side, and that’s I know what people in the labs are worried about if we change the control of this system.

On the other hand, this is a direct challenge that if you don’t have unannounced is that you can also have the scurrying around that isn’t just fixing at the edges and moving the ball forward, but it is, in fact, deceiving the investigators and that’s the dilemma.

KASS: I think to ensure good laboratory quality you need not only the inspection process — and I welcome multiple layers of inspection.

I think that’s fine to have state look at it, to have CMS look at it, to have CAP look at it. The more eyes you have looking at it, the less likely anything is to slip through.

We also have proficiency testing. Proficiency testing measures outcomes. We also have Q-probes (ph), Q-traps (ph), pip and pap programs, which are all programs that are voluntary, but they all measure outcomes of laboratory practice, of whether it’s good or not.

Whistleblowers — it is extremely important that we create — the hospitals create, that, indeed, the entire health care industry creates an atmosphere, an environment were employees feel comfortable bringing forth problems that can be not only identified, but can be addressed.

And this has to be done. This is why this legislation that we are supporting is so important. If it had not been for the whistleblowers in this case, we would not have known of these problems. So it’s absolutely essential.

SOUDER: Thank you.

Congressman Cummings?

CUMMINGS: Dr. Kass, do you think this is happening at other places?

I mean, the fact that you’re getting inaccurate information — it seems from your testimony, and I’ve listened to you very carefully, that if you get inaccurate information you cannot make an accurate assessment.

KASS: I do not think that this is a pervasive problem throughout the United States, and I say that for several reasons.

First of all, the college has been accrediting laboratories. We accredit over 3,000 laboratories a year. We’ve been doing that since 1961.

I think that if there were severe issues with our process that they would have become apparent somewhere along that time line before now.

I think MGH represents an unusual set of circumstances that occurred. Does that mean that our process cannot be improved? Absolutely not. It can be improved. We will learn from this. We will make our process better.

Can we improve communication with the state and with CMS?

Absolutely. And we intend to do that. So I do not think this is a pervasive problem, no.

CUMMINGS: So when Ms. Benner said a moment ago the very chilling words that there’s an absence of regulation, I guess you disagree with that.

KASS: I disagree very much with that.

CUMMINGS: And why is that?

KASS: I worked in laboratories for almost 40 years. I’ve been a laboratory director.

The laboratory is probably the most regulated area of medicine that exists. We have been regulated longer than anyone else. We constantly get more and more regulation to the point where it’s becoming difficult to comply with all the regulations because there are so many.

I don’t think it’s a lack of regulation. I think it’s a lack of communication, a lack of follow up. I don’t think we need more. If we don’t talk to each other, another layer isn’t going to help.

So I think that it’s extremely important for this communication aspect to be fixed.

CUMMINGS: Obviously there’s a problem based upon what you just said and what you’ve been saying. Just a moment ago you were kind enough to hold up that poster and I was very pleased to see that.

And you talk about communication and you talk about — you and Ms. Benner talk about this effort to try to communicate better between the state and your agency.

The problem is this: Obviously there is a communication problem, and I want to take it past Maryland because this is bigger than Maryland.

If we’re doing this here in Maryland though, that says to me that it is likely that this problem needs to be solved somewhere else in other places.

In other words, Maryland is not — you cannot convince me that Maryland is that unique that the failure to have cooperation between whistleblowers — and by the way, we’ve gotten — since these hearings have begun, we’ve gotten information from various places, from people all over the country on these kind of issues.

And I’m just wondering — Ms. Benner said she wanted the state — I mean, the federal government to — “wanted to see movement on the federal level,” and that’s a quote, but I’m just wondering what movement would you like to see on the federal level?

And let me just make sure you’re clear where I’m going with this.

You all have voluntarily agreed to do this in Maryland with Maryland General Hospital, and I guess other institutions in Maryland too — just at Maryland General or all the hospitals?

KASS: All of the laboratories there accredited by CAP.

CUMMINGS: OK. So Maryland…

(UNKNOWN): (Inaudible) CUMMINGS: Yes, after the hearing, right.

So I’m wondering two things: One, has this issue — you’re the president, and congratulations, Madam President, but…

KASS: I don’t think they’re in order right now.

(LAUGHTER) CUMMINGS: I know the feeling.

But I’m just wondering has this been an issue before with regard to the college?

And two, how do we take what has now become a voluntary situation coming out of these hearings and guaranteeing — I’ve got a feeling that by the time you all finish, you know, it’ll be like a wonderful — we’ll have us something good going on in Maryland, but that doesn’t do anything for Mr. Souder in Indiana.

So I’m just trying to figure out what do you see the college doing other than the poster and that kind of thing? Is there something that you would like to see happen? Suppose you don’t get the cooperation?

It’s not happening in Hawaii; what happens then?

And so, I’m sure you’ve thought about these issues, and this is a big issue for the college, I’m sure.

KASS: Only about 50 percent of our states have state lab licensure laws, and then only a certain percentage of those have the regulatory authority to deem private accrediting organizations. Maryland happens to be one of those.

We do have agreements, formal agreements with three states that are very well crafted and serve the states’ needs very well, but most importantly, I think serve our patients’ needs very well.

That could certainly be used as examples. And we do modify our accreditation standards, always raising them or addressing specific complaints or specific needs of certain states. We’ve done this in Florida. We’ve done this in Pennsylvania.

And we certainly — the college could certainly initiate relationships with all those states that have state lab licensure laws to do a reporting-type of communication with them.

I want to emphasize that the college already reports all substantiated complaint allegations to CMS. We report all of those to them.

And we get about 70 to 100 complaints a year. We investigate every one of those. We take them very seriously. Those are all handled anonymously, and then if the complaints are substantiated, we notify CMS about those.

CUMMINGS: So you don’t see any further role for the federal government in all of this?

KASS: I wouldn’t know what to recommend to the federal government, to be honest with you.

CUMMINGS: In other words, you know, you don’t want a situation where — let’s say, for example, you come up with this agreement that you’re trying to work out with the state of Maryland, and it’s the greatest thing that ever came about.

I guess my concern is is that you may have that agreement in Maryland where, for example, information flows to CAPs, CAPs doesn’t have to find out about it at a hearing and that kind of thing. But what about the other states? That’s where I’m trying to go with this.

This is not so much about Maryland, it’s beyond that.

I mean, what — I’m just trying to figure out, since you all deal nationally, how do you make sure you don’t have one standard in one state, talking about the cooperation and working together and information flowing so that you can get the best and most accurate results, and then have a whole another standard, you know, in the next state?

KASS: It certainly would be helpful if complaints regarding a laboratory from any state, whether or not they have licensure laws or not, could be somehow shared with the college, if that laboratory is CAP accredited.

That would be extremely helpful.

SOUDER: Would you favor you also sharing your complaints with the other agencies?

KASS: Absolutely.

SOUDER: In other words, there could be kind of a whistleblower sharing (inaudible).

KASS: Absolutely. We would have no problem with that whatsoever.

CUMMINGS: Did the state fail here? Are you familiar with this case? I mean, have you read all the material? I know it’s quite a bit.

KASS: Yes, I am. Yes, I am familiar with it.

I think that there were several failures here. I’ve learned in medicine that when bad things happen, it’s not that one bad thing happens;

it’s always multiple bad things. It’s always amazing to me.

I think that the state failed to notify the college when it got the complaints. I think that CMS failed to notify us. And I think (inaudible) failed to notify us.

They all knew. They all went in as a result of the complaint to re-inspect the lab, but nobody told us. Nobody told us until we read about it in the newspaper. That’s not the way to find out about it.

CUMMINGS: Let me ask you this.

You know, we had the testimony of Teresa Williams, and just listen to what she said. In her testimony she describes serious problems at Maryland General laboratory that she observed even prior to the arrival of the Labotech instrument in June 2002. For example, she states — now listen to this, this is incredible. For example, she states that “certain tests were delivered late to other departments of the hospital and that there was a concern among techs that certain test results, including hepatitis B, were unreliable.” It was also alleged that a refurbished Labotech was purchased for cash, arrived with dried blood on its interior, bypassed the biomedical engineering department, failed the initial validation test and had to be sent back to the manufacturer for repairs.

In your — what you do when you all do your inspections, how would that information get to you? Would it only get to you perhaps through somebody whistle blowing?

KASS: No.

We require of all laboratories a complete listing of all the equipment they have and the testing that they’re using that for.

If we saw that a piece of equipment came in and went out of the laboratory, it would be our job to ask what happened to this piece of equipment.

Most likely, the documentation would show that there were problems with it.

I don’t know whether any patient results were generated on that piece of equipment or not.

It is not uncommon for a piece of equipment to come into a laboratory and for that piece of equipment to be tested by the techs using extra blood samples, but not reporting out the results, just to see how it works, to see if it’s reliable, et cetera.

But if that piece of equipment were used to generate patient results, then by reviewing the documentation — OK, that was in the laboratory — we would ask why was that piece of equipment pulled out of the laboratory?

And hopefully, we would be told that there were problems with it. We would ask then what did you do to validate that the tests that you generated on those patients were, indeed, valid, that they were accurate?

CUMMINGS: Ms. Turner, when she was testifying talked about that she kind of wished that the CAPs inspectors could have gone a little further.

I take it that you all have certain parameters that you — I mean, only a certain — you go but so far. You talked a little bit earlier about certain things that you do. You come in, you’re looking for certain things. But it seems like there was still — I mean, she talked about what a whistleblower had been able to reveal to you.

I’m just trying to figure out, are there other ways to find out that kind of information that goes perhaps beyond where you would normally go?

KASS: Right.

First of all, when the college goes in to do an inspection, it looks at thousands of things. The check lists are literally thousands of things that we look at.

However — and I didn’t go into a great deal in this — the college is setting up an entire program to enhance the communication between the laboratory staff and the inspection team when they’re there. Not only are we allowing them to communicate with us when we’re not there, but also when we are there.

Perhaps setting up small group meetings behind closed doors without any supervisors, any managers, where we can tell them and hopefully have them believe us that anything they say will be held strictly confidential, because if you know where to look — if someone specifically describes what is being done, it’s a lot easier to detect problems.

CUMMINGS: What you just said, what you just described, is that something new?

KASS: Yes.

This is a part of the program that the college wants to put in place to improve the environment, the atmosphere in laboratories so that people are not afraid to speak up, to enhance the ability of people to tell us if there are problems that we might not detect in an inspection.

CUMMINGS: Is that in part a result of what has happened in this case?

KASS: Yes, it is.

CUMMINGS: So I’m just curious, when — how does the college work? This is a group of people that get together and do what? I mean, do they see you? I mean, how are they assigned? How does that happen?

KASS: How are the inspectors assigned?

CUMMINGS: Yes.

KASS: The college has — it’s not a bunch of guys that get together. Well, it used to be a bunch of guys.

Now it is a group of individuals. We have a staff of approximately 450 people, full-time professional staff. We have an entire division of laboratory inspection and accreditation. These are all highly-trained professional individuals that really have implemented and monitored our inspection and accreditation process.

All of the people in our inspected labs that are eligible to be inspectors are in a database. These are assigned on a regional basis by the regional and the state inspectors — commissioners to assign people to an inspection team.

The size of the inspection team is determined by the team leader.

It usually varies anywhere from 10 to 25 people depending on the size of the laboratory. For the big system laboratories, we actually get other people from systems laboratories to go and inspect those. But we do have certain rules about who can be inspected.

You can never inspect the same laboratory two times in a row.

V.A. people cannot inspect V.A. labs. People from commercial labs cannot inspect another laboratory owned by that same entity.

And I think there was something said that this is just a bunch of guys from the neighborhood, you know, that come in and inspect our lab.

(CROSSTALK) CUMMINGS: That was my next question.

KASS: Oh, OK. I’m sorry.

CUMMINGS: You go ahead.

KASS: OK.

We looked at our data and actually 57 percent of our inspectors did not require hotel or air travel accommodations. Forty-three percent did, which means that they’re coming from significantly far away.

Now, just because they didn’t require hotel or, you know, air travel doesn’t mean that they’re from around the block. The people that inspected Maryland General were actually from Andrews Air Force Base.

That’s not a next-door hospital.

In this Maryland area, people from Silver Spring, people from D.C., people from Cockeysville, people from the Eastern Shore — they could all come in to inspect a Baltimore hospital lab. You know, that’s not a hotel stay and that’s not air travel, but it is certainly not a local Baltimore hospital.

CUMMINGS: Maybe I missed this.

Is this like a side job for them or is this what they do all the time?

KASS: No.

Anybody that is inspected by the college, OK, is required if they are asked and they are able to, to inspect another laboratory. We make all of our inspectees be inspectors.

This is the process the college uses because we want people that are actively engaged in the practice of laboratory medicine and understand the new technologies.

Now, for specific types of inspections, as I mentioned before — cybergenetics, molecular path, scatology — we have an entire list of people that have sub-specialty certification in those areas and we call on them.

They do have to fly almost all the time and go and inspect another laboratory, and these are all volunteers.

The college does have a cadre of paid inspectors who are all medical technologists. They frequently complement the team or they may go in to inspect a very small rural hospital that’s under 100 beds.

CUMMINGS: I’ve run out of time, but I just want to ask you this last question.

Can you tell me — you have now said at least two things, maybe even more, of things that you all, the College of Pathologists, have done or are doing as a result of the problems that happened at Maryland General.

And we, in the Congress, need to know in detail what those things are.

Are there other things that you are doing?

We just need to know because if we are going to look at legislative remedies, it would be good to know what’s already being done.

And I ask you that question for one other reason too and that is for Kristin Turner, who’s sitting here, who I’m sure at many times has wondered whether, you know — I mean, was there a result of what she did and I…

KASS: There is absolutely a result of what she did, and I can’t emphasize that enough.

And I think that more than doing new things, we’re expanding activities to make them more comprehensive. And I think that this case has pointed out to us ways that we can improve our program, and I would be happy to share with the members of this committee in explicit detail what those are going to be.

CUMMINGS: All right. Thank you.

SOUDER: I want to clarify for the record, Kristin Turner, as you stated, you learned about her through the newspaper. The 2002 lab workers letter you learned from the subcommittee staff…

KASS: That is correct.

SOUDER: … or multiple sources; none of, however, which were governmental…

KASS: Not the usual means, yes.

SOUDER: And secondly, I want to reinforce the importance, because I know that medical people aren’t necessarily — and this is very important to pick up because — aren’t necessarily trained in management techniques, they’re medical people.

But if you’re going to do management-type things, this is pretty basic stuff you’re talking about implementing — management by walking around. It’s a Tom Peters’ concept that’s at a minimum 40 years old, but in most retail businesses like in my family that was one of the first things, is you walk around the store. You don’t just sit in a room and talk to the management; you go talk to the people.

Sam Walton wrote a whole book about this, because when he goes and calls his associates, he goes in and talks to them; first locks the management out to try to figure out what’s going on in the lab first.

So I’m very pleased you’re doing it. It’s about time.

Hopefully, maybe the federal government and the Defense Department will learn the same thing, maybe to check out a prison before we run into problems?

So it’s not uniform just in private sector agencies. The government itself has this kind of principle to hold up and not do management by walking around.

But that’s very important, and one of the great outgrowths of this is to listen to the people who are in the front lines, as well as the management who may have perspective, but then that hopefully will come up with whistleblower complaints and other things as well.

KASS: Couldn’t agree with you more.

SOUDER: Mr. Ruppersberger?

RUPPERSBERGER: The first thing — I think what we’ve all learned from the two hearings that we’ve had is the importance of oversight, coordination and stockholder participation in the whole process of regulatory laboratory testing.

I think as far as the stakeholder issue — the stakeholders that I see involved, and I’d like your opinion if you think there are more or less, would be hospitals, pathologists, which is the College of Pathologists, states, FDAs in charge of the equipment, CDS in charge of testing and employee representation.

Now, I think the next logical question is how the oversight should occur. I do not believe — I think, Dr. Kass, as you said, we need more unfunded mandates, that’s because I come from local government too, and I’m not sure that, you know, that would solve the problem here.

What I would like the panel to address is what you think is the best mechanism to bring about a more efficient process of checks and balances on what laboratory quality would be. And the mechanisms, in my opinion, should be to identify whether changes are needed at the state or federal level and should be able to report these findings.

Should Congress — and this is a question — should Congress establish a federal task force or an advisory committee, perhaps reporting to the secretary of health and human services, made up of the stakeholders that I just mentioned in laboratory testing, and require that group to come back to Congress on a regular basis?

I believe, you know, accountability and transparency is very important as it relates to this issue. And I think a lot of the issues here are about accountability and then bringing all the stakeholders together.

So could you please comment on my long question, all three?

We’ll start with Mr. Notebaert and go down.

NOTEBAERT: Well, you know, there are five or six things that I would comment on from the position of a hospital stakeholder, and I think many of the things that I will speak to have become apparent in these rooms during these hearings and during the work that we’ve been doing at Maryland General.

First, I think we need better coordination between and among the various surveying entities in the hospitals.

I think we need better communication. It’s been apparent in the testimony to me that improved communication would go a long way toward helping the respective agencies do the work that’s so valuable.

I think uniform standards — I believe right now the standards are not entirely uniform from agency to agency.

But equally important, maybe more important, is a uniform interpretation of those standards, because a standard interpreted by one surveyor can be a different standard if it’s interpreted by another surveyor.

So I think that there needs to be probably an improved process of interpreting the standards, or let’s say an official interpretation that’s uniform among the various surveyors.

I think that it’s also become obvious that we can improve the work that’s done by removing some of the interagency issues, and that’s occurring in Maryland on a voluntary basis.

But I think the interagency issues have come out in these hearings and I don’t think there’s a place for those interagency issues and grandstanding and things of that nature.

RUPPERSBERGER: By the way, I think a lot of focus has been on the state of Maryland thanks to Congressman Cummings, and I think that we have a wake-up call and there’s a lot happening there.

But we’re doing this from a national perspective, and that’s really how I would like you to address the issue, from a national perspective, and I mentioned stakeholders.

I mean, is there a better way that all the stakeholders can really come together to work on this issue without having a congressional hearing? I mean, that’s kind of where I’m going, and then how do we implement it and what’s the accountability factor and let’s move forward.

NOTEBAERT: Well, I certainly think that this hearing has been the impetus for that, and maybe Maryland can be the model that can be used.

I think that Dr. Kass and…

RUPPERSBERGER: I recall that Maryland has two of the best hospitals in the world. Is that true? You don’t have to answer that question.

(CROSSTALK) NOTEBAERT: Two of the finest medical centers — academic medical centers probably in the whole…

(CROSSTALK) RUPPERSBERGER: I didn’t mean that. Let’s get back to the issue.

NOTEBAERT: … and certainly one that got the top ranking in U.S. News & World Report, which is our neighboring hospital in eastern Baltimore.

The comments that I was making really were comments from a global perspective.

And I think the final issue — and I’m not sure how to do this, but I believe that there ought to be — hospitals have accountabilities, very high levels of accountabilities, both through the legal systems, through the accrediting systems.

I think there needs to be a form of periodic accountability for the inspecting agencies, and I haven’t really figured out how to do that.

I think that there have been some references to that in the other testimonies.

So those are the things that I would think, as a general rule, would be very, very helpful from a hospital stakeholders’ point of view.

(CROSSTALK) RUPPERSBERGER: I will point out Maryland is rated, I think — considered to have the best trauma system in the world — the shock trauma Maryland emergency medical system.

I think it’s wise for everyone to look at systems in the medical field that are working and not just because we say they’re working, like the accreditations that really don’t mean anything, but look at really what we do, what the end result is, and that’s important also.

Dr. Kass?

KASS: Well, I have been sitting here thinking about what you could do on a federal level to really enhance this process and if there is a — certainly if you got together an advisory group of the stakeholders and they could come up with a plan whereby reporting of complaints between crediting bodies would be in some way mandatory.

RUPPERSBERGER: On a regular basis, that sort of thing.

KASS: Well, quickly. Not, you know, next year, but as soon as they are investigated and they are substantiated.

You could even have two categories of reporting — those that were investigated that weren’t substantiated and those that were.

But if there’s some way that that could be mandated and people could comply with that, I would see no problem with that at all. I would think that might be helpful.

RUPPERSBERGER: Ms. Benner?

BENNER: Mr. Ruppersberger, thank you for your question.

And as an aside, I might say that I was the director of the laboratory — the shock trauma center in the mid-’70s.

RUPPERSBERGER: That’s when I was a patient there.

BENNER: I probably did your lab work while you were there.

I’d like to clarify one thing.

And I’m not certain that everyone here fully understands the relationship of CMS to the states, and this is why in Secretary Sabatini’s testimony and in my statement today that we said that we hope the federal government will follow our lead.

Each state has a contract with CMS, and when we go into a hospital laboratory or a hospital or a nursing home, we are working on behalf of the federal government. And so, when we go into one of these regulated entities, we are bound by the federal rules and regulations.

So that is why I said that we hope that there are some changes at the federal level.

RUPPERSBERGER: But I don’t see the groups really communicating as they should.

BENNER: I couldn’t agree more.

RUPPERSBERGER: And you know, you might have federal regulations — again, I meant it when I said, why do we have to have a congressional hearing to bring the parties to the table?

I mean, I know politics is probably worse than medicine than it is in politics. But you know, notwithstanding that, people’s lives are involved here and thank goodness Congressman Cummings made it an issue, because it’s going to hopefully set standards throughout the country.

But if you don’t have the accountability and the communication, and you’re saying, “Well, we’re doing it pursuant to federal rules,” that still doesn’t solve the ultimate problem when you get to the bottom line.

BENNER: I agree with that, and I think if you go back to Secretary Sabatini’s testimony, he says — and Congressman Cummings asked the question, did the state fail?

We all failed. We all failed. And what…

RUPPERSBERGER: We still haven’t heard any really strong resolution. That’s why I asked that question on what we’re going to do or what we should do as members of Congress.

BENNER: I think we need perhaps joint surveys where the state goes on a survey with the CAP inspection team so that the state…

RUPPERSBERGER: As you told me, the standards and the accountability, that’s something that has to be. If you don’t have accountability, then it’s going to fling off to…

(CROSSTALK) BENNER: Well, that would automatically bring together the communication.

If CAP, before it went in to do its inspection talked with the state who knows the hospital laboratory or knows the laboratory and says, “Are there complaints? What do you know? What do you hear,” and we’re working together and we go in and we do the survey together, we become far more powerful.

RUPPERSBERGER: Dr. Kass, you said that each state has different accreditation issues too, correct?

KASS: A lot of states have special requirements of us and a lot of states go in with us on inspections.

RUPPERSBERGER: So would you think there needs to be a federal standard as far as — you know, sometimes the feds get in and they muck it up, so you know, we want to make sure that that’s…

KASS: I’ve heard that that happens.

RUPPERSBERGER: It happens a lot — unfunded mandates too.

But let me get to the issue that, do you feel, based on what you know about what’s happened here, that we need a national standard to hold people accountable, to have the transparency that is needed to resolve the issue?

KASS: I think to have a standard, OK, of reporting, of communication, of complaint investigation would be helpful.

And in fact, CMS is holding a meeting next week, and I think CMS — I may be speaking totally out of turn here because I’m not an expert on this — but I think CMS probably has the authority to do this.

We are asking them to call a meeting of all the stakeholders to discuss these issues, and it would seem to me that CMS has the authority to demand this. If not though, I’m certain you could give it…

RUPPERSBERGER: What’s the Nike phrase? Just do it.

KASS: Just do it.

RUPPERSBERGER: Let me ask you this.

What are the implications of having four regulatory agencies simultaneously involved in surveying a lab to discover potential deficiencies and monitoring the implementation of solutions?

I mean, right there you have four different agencies involved.

What are the implications of that as it relates to what we know now?

KASS: Scheduling is difficult, getting everybody together is difficult, but those are just difficulties that can be overcome.

I think the more people you have looking at something, the better it is. And whether or not state inspectors go with us or don’t go with us — CMS frequently can go with us. They frequently follow up our inspections by their own inspections unbeknownst to us, and then they find anything we missed and let us know. That works very well.

For instance, in Pennsylvania, the state there does — we do an inspection every two years. They do an inspection in the intervening year, their own inspection. That’s another way to go about it.

There are many ways to address this issue which can be worked out, and sometimes what is good for one state isn’t necessarily good for another.

RUPPERSBERGER: My time is running out too.

I mean, I’m looking for solutions and, you know, I think we need to develop that. And we want to know from our perspective, and we’ll make announcements through the chairman or ranking member, you know, where we go with this…

KASS: I think that the solution…

(CROSSTALK) RUPPERSBERGER: … make sure we don’t create another problem.

Again, a federal program is not going to work.

KASS: A solution to this might come out of the stakeholders’ meeting that CMS, I’m sure, will call very shortly.

RUPPERSBERGER: It’s very important and very relevant.

Do you agree with the stakeholders that I mentioned, is there anybody that’s missing — hospitals, pathologists, states, FDA, CDC and employee representatives?

KASS: CMS, obviously, and JCHL (ph).

RUPPERSBERGER: (Inaudible).

KASS: Right.

RUPPERSBERGER: Anybody else? Any other stakeholders that you think…

BENNER: There are other accreditation organizations that go into laboratories — COLA is one.

RUPPERSBERGER: They need to come under one. If you have too many in a room, you’re not going to get anything accomplished.

BENNER: The same problems that exist with the CAP accreditation could easily exist with the other laboratory accrediting organizations.

RUPPERSBERGER: Is there one stakeholder in that group that I mentioned that really might have too much power or too much influence that might affect the other — the whole group as a whole coming together?

BENNER: I don’t think so.

RUPPERSBERGER: What do you think, Dr. Notebaert?

NOTEBAERT: Well, I think simplification and standardization are the goals for any body that’s convened.

From the hospital stakeholder point of view, having multiple agencies inspecting, using different standards and different interpretations is burdensome, it’s not cost efficient and it really wastes talented resources of the various agencies.

So I’m in favor of them getting together, creating simplification and standardizations.

RUPPERSBERGER: And also I would think oversight, coordination and accountability. Those five…

NOTEBAERT: Absolutely.

RUPPERSBERGER: OK. Thank you.

CUMMINGS: Just one last statement.

Whenever we sit in these hearings I often think about what I say to my constituents. A hundred years ago none of us were here. A hundred years from now none of us will be here.

The question is, what do we do while we are here for each other?

And I really don’t want this issue at this critical moment — this is a critical moment thanks to Ms. Turner and Ms. Williams and other people at Maryland General — a critical moment to do something.

If we don’t do it now, it may not be done, not during our tenure here anyway.

And I just want to make sure we just don’t — I could see where Mr. Ruppersberger was going, trying to come to some kind of conclusion as to where we go from here so that it is not something that is just — we had a hearing and then 10 years from now when another Maryland General crops up — hopefully someplace else — then we are saying the same things;

a different set of people, people having suffered, people having gotten the wrong results or whatever.

And I guess what I’m saying to you, Dr. Kass, it sounds like CAPs and CMS seem to be going in the direction of doing some things about it.

The question still remains is how do we — going back to Mr.

Ruppersberger’s inquiry, how do we make sure that we take advantage of this moment and make things better?

I think it would be criminal if we did not take this moment to make things better.

And so, I mean, what do you suggest that we do?

Mr. Ruppersberger was very clear and the chairman was even clear that everything does not require a federal solution. But where all else fails and we’re dealing with life-threatening circumstances, then sometimes I think the federal government or government has to step in.

So how do we do that balancing thing?

I mean, do we take a look at this, say, six months from now and see where we are? I mean, what do you suggest?

And I direct it toward you because it seems like you’ve been moving — your organization has been moving in the direction of trying to address it. It doesn’t sound like you just stuck your head in the sand and just said, “Look, this is not a problem.” You understand our concerns, and we all have a responsibility to make a difference.

And so, I just don’t want to leave here feeling like we had motion, commotion, emotion and no results.

KASS: Mr. Cummings, I agree absolutely with you.

And I know that you’ve never met me before, however, I can assure you I will be president of the college for another year and a half, OK.

This is my top priority. I will assure you that the college will implement all of the things that I’ve alluded to today.

We will provide you with a detailed description of what those changes are in our process.

I will also promise you that I am absolutely confident that CMS is going to move in the right direction with the stakeholders conference.

However, if I run up against a brick wall, OK, in making this happen and getting the kind of oversight and accountability that I think everybody here wants, I can assure you I know who to call.

CUMMINGS: Well, since you’re into promises and stuff, let me promise you that you can call on us and we will back you up.

KASS: I would not hesitate one moment.

CUMMINGS: All right.

SOUDER: Personally, I was concerned you were enjoying this testimony so much you’d want to come up here multiple times over the next few years.

KASS: No, thank you, sir, for the invitation.

(LAUGHTER) SOUDER: And I want to tell Ms. Benner that while I don’t agree with Mr. Sabatini’s proposal at this time, he’s one that can help it remain accountable if, in fact, CMS doesn’t move to continue to be vociferous in doing that.

I also want to say to Mr. Notebaert that first off it’s clear that when confronted with a problem that was clearly at serious proportions in Baltimore in consumer confidence, you acted decisively, aggressively across the board, which was to be commended, because no matter what question it’s been, you were dealing with it and realized it was going to be a general threat if you didn’t deal with it decisively, and that’s a strong management praise for how you handled that.

NOTEBAERT: Thank you.

SOUDER: The other thing I wanted to say is your pipe dream that we’re going to be clear by surveyor in anything we do in health care is never going to happen.

This is the nursing homes, all divisions of hospitals — we tried to do this. It’s the biggest complaint we get in any related medical field.

But we get it in the business area, we get it in the environmental area, depending on what inspector you have on a housing site.

There is so much variation. It is just very difficult and even when we apparently write it in clear English, often we’re so busy compromising the fudge words in the debate that by the time it gets through, even if they tried to implement it, it would be confusing.

Nevertheless, it’s a goal we ought to have in government to make it as clear as possible, because when we talk about the cost of health care in the United States, we add to that. And the less clear we are, the more inspectors you have, even though we’re trying to protect the health, that’s part of the cost to health and that’s our constant trade off.

So I wouldn’t hold your breath to have the clarity coming in from each inspector in every agency all being suddenly seeing the light saying, “Oh, this is what this particular word means.” Nevertheless, it’s an admirable goal that we ought to strive for.

RUPPERSBURGER (?): Mr. Chairman, may I make one comment?

SOUDER: Sure.

RUPPERSBURGER (?): Mr. Sabatini’s name has been mentioned here.

I, too, have not agreed with him on every issue, but I have a lot of respect for him. Unfortunately, he’s retiring I understand, and he is one of those individuals that does get to the bottom line when it deals with health issues.

So maybe Dr. Kass or someone else should consult him now that he’s going to be gone, and he could really tell it like it is to help us with this issue, because I think he is a true professional and he does usually want to get to the bottom line. I’m sorry he’s leaving, but maybe we can use his expertise.

SOUDER: And he doesn’t seem to have much reluctance so far, so I’m sure he’ll continue to do so.

With that, the subcommittee stands adjourned.

END

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