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98–047 PDF 2004

ENSURING ACCURACY AND ACCOUNTABILITY IN

LABORATORY TESTING: DOES THE EXPERIENCE

OF MARYLAND GENERAL HOSPITAL EXPOSE

CRACKS IN THE SYSTEM? PART II

HEARING

BEFORE THE

SUBCOMMITTEE ON CRIMINAL JUSTICE,

DRUG POLICY AND HUMAN RESOURCES

OF THE

COMMITTEE ON

GOVERNMENT REFORM

HOUSE OF REPRESENTATIVES

ONE HUNDRED EIGHTH CONGRESS

SECOND SESSION

JULY 7, 2004

Serial No. 108–252

Printed for the use of the Committee on Government Reform

(

Available via the World Wide Web: http://www.gpo.gov/congress/house

http://www.house.gov/reform

(II)

COMMITTEE ON GOVERNMENT REFORM

TOM DAVIS, Virginia, Chairman

DAN BURTON, Indiana

CHRISTOPHER SHAYS, Connecticut

ILEANA ROS-LEHTINEN, Florida

JOHN M. MCHUGH, New York

JOHN L. MICA, Florida

MARK E. SOUDER, Indiana

STEVEN C. LATOURETTE, Ohio

DOUG OSE, California

RON LEWIS, Kentucky

JO ANN DAVIS, Virginia

TODD RUSSELL PLATTS, Pennsylvania

CHRIS CANNON, Utah

ADAM H. PUTNAM, Florida

EDWARD L. SCHROCK, Virginia

JOHN J. DUNCAN, JR., Tennessee

NATHAN DEAL, Georgia

CANDICE S. MILLER, Michigan

TIM MURPHY, Pennsylvania

MICHAEL R. TURNER, Ohio

JOHN R. CARTER, Texas

MARSHA BLACKBURN, Tennessee

PATRICK J. TIBERI, Ohio

KATHERINE HARRIS, Florida

HENRY A. WAXMAN, California

TOM LANTOS, California

MAJOR R. OWENS, New York

EDOLPHUS TOWNS, New York

PAUL E. KANJORSKI, Pennsylvania

CAROLYN B. MALONEY, New York

ELIJAH E. CUMMINGS, Maryland

DENNIS J. KUCINICH, Ohio

DANNY K. DAVIS, Illinois

JOHN F. TIERNEY, Massachusetts

WM. LACY CLAY, Missouri

DIANE E. WATSON, California

STEPHEN F. LYNCH, Massachusetts

CHRIS VAN HOLLEN, Maryland

LINDA T. SANCHEZ, California

C.A. ‘‘DUTCH’’ RUPPERSBERGER, Maryland

ELEANOR HOLMES NORTON, District of

Columbia

JIM COOPER, Tennessee

BETTY MCCOLLUM, Minnesota

———

BERNARD SANDERS, Vermont

(Independent)

MELISSA WOJCIAK, Staff Director

DAVID MARIN, Deputy Staff Director/Communications Director

ROB BORDEN, Parliamentarian

TERESA AUSTIN, Chief Clerk

PHIL BARNETT, Minority Chief of Staff/Chief Counsel

SUBCOMMITTEE ON CRIMINAL JUSTICE, DRUG POLICY AND HUMAN RESOURCES

MARK E. SOUDER, Indiana, Chairman

NATHAN DEAL, Georgia

JOHN M. MCHUGH, New York

JOHN L. MICA, Florida

DOUG OSE, California

JO ANN DAVIS, Virginia

JOHN R. CARTER, Texas

MARSHA BLACKBURN, Tennessee

PATRICK J. TIBERI, Ohio

ELIJAH E. CUMMINGS, Maryland

DANNY K. DAVIS, Illinois

WM. LACY CLAY, Missouri

LINDA T. SANCHEZ, California

C.A. ‘‘DUTCH’’ RUPPERSBERGER, Maryland

ELEANOR HOLMES NORTON, District of

Columbia

——— ———

EX OFFICIO

TOM DAVIS, Virginia HENRY A. WAXMAN, California

J. MARC WHEAT, Staff Director

ROLAND FOSTER, Professional Staff Member

MALIA HOLST, Clerk

TONY HAYWOOD, Minority Counsel

(III)

C O N T E N T S

Page

Hearing held on July 7, 2004 ................................................................................. 1

Statement of:

Notebaert, Edmond F., president and chief executive officer, University

of Maryland Medical System; Mary E. Kass, M.D., president, College

of American Pathologists; and Carol Benner, Director, Office of Health

Care Quality, Maryland Department of Health and Mental Hygiene ...... 40

Turner, Kristin S., former employee of Maryland General Hospital ........... 26

Letters, statements, etc., submitted for the record by:

Benner, Carol, Director, Office of Health Care Quality, Maryland Department of Health and Mental Hygiene, prepared statement of ................... 85

Cummings, Hon. Elijah E., a Representative in Congress from the State

of Maryland, prepared statement of ............................................................ 8

Kass, Mary E., M.D., president, College of American Pathologists, prepared statement of ........................................................................................ 55

Notebaert, Edmond F., president and chief executive officer, University

of Maryland Medical System, prepared statement of ................................ 42

Ruppersberger, Hon. C.A. Dutch, a Representative in Congress from the

State of Maryland, prepared statement of .................................................. 11

Souder, Hon. Mark E., a Representative in Congress from the State

of Indiana, prepared statement of ............................................................... 4

Turner, Kristin S., former employee of Maryland General Hospital, prepared statement of ........................................................................................ 27

(1)

ENSURING ACCURACY AND ACCOUNTABILITY

IN LABORATORY TESTING: DOES THE EXPERIENCE OF MARYLAND GENERAL HOSPITAL

EXPOSE CRACKS IN THE SYSTEM? PART II

WEDNESDAY, JULY 7, 2004

HOUSE OF REPRESENTATIVES,

SUBCOMMITTEE ON CRIMINAL JUSTICE, DRUG POLICY AND

HUMAN RESOURCES,

COMMITTEE ON GOVERNMENT REFORM,

Washington, DC.

The subcommittee met, pursuant to notice, at 3 p.m., in room

2203, Rayburn House Office Building, Hon. Mark Souder (chairman of the subcommittee) presiding.

Present: Representatives Souder, Cummings, Ruppersberger, and

Carter.

Staff present: J. Marc Wheat, staff director and chief counsel; Roland Foster, professional staff member; Malia Holst, clerk; Tony

Haywood, minority counsel; and Teresa Coufal, minority clerk.

Mr. SOUDER. The subcommittee will come to order.

Good afternoon. I thank you all for being here. Today’s hearing

will continue to examine the investigation of lab testing at Maryland General Hospital in Baltimore, MD.

At the request of the ranking democratic member of the subcommittee, Elijah Cummings, we held a hearing on this topic on

May 18th. 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 the 14 month period between June 2002 and August

2003, the hospital issued more than 450 questionable HIV and hepatitis test results. Despite the instrument readings showing that

the test results might be inaccurate, managers at the hospital

failed to act. Similarly, State insepctors did not respond to a 2002

letter from lab workers who warned of serious and longstanding

testing problems that put patients and problems 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 insepctors inVerDate 11-MAY-2000 12:49 Feb 11, 2005 Jkt 000000 PO 00000 Frm 00005 Fmt 6633 Sfmt 6633 D:\DOCS\98047.TXT HGOVREF1 PsN: HGOVREF1
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vestigated 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 discovery the serious problems until this year.

Subsequent inspections by State officials prompted by the whistle

blower 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 up pages and pages of violations of testing standards.

The College of American Pathologists has 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 process of the laboratory that were found to be deficient. Each oversight entity addressed these issues, but did not inform all the remaining involved

parties of their findings. Therefore, each oversight entity did not

have the benefit of the findings 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 workers 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 the

Maryland General Hospital. The second panel will include Mr. Edmond Notebaert, President and Chief Executive officer 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 College of American Pathologists.

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Thank you all for 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.

[The prepared statement of Hon. Mark E. Souder follows:]

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Mr. 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. 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 a 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 message from

testing instruments indicating that results might be incorrect. On

May 18th, we heard 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 and unfortunately to no avail.

On the last of the three panels, we heard statements from representatives of the parent institution of Maryland General Hospital, the private accrediting body responsible for federally certifying the Maryland General laboratory as them being in compliance

with Federal standards, Maryland’s 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 dialog we began in May with the

latter group. And I do appreciate your 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 Dr.

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 am 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, MD, 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

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faith that the laboratory tests that helped to determine the course

of their medical treatments 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 CLIA 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 risk 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, 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 No. 1, 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 Mr. Notebaert for your efforts.

So today, each of our witnesses is in a position to provide an informed perspective on 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.

[The prepared statement of Hon. Elijah E. Cummings follows:]

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Mr. SOUDER. Two brief things before I yield to Mr.

Ruppersberger. First, I want to commend Tony on the Democratic

staff for arranging the musical accompaniment to your opening

statement. Second, this hearing appears to forever trigger votes. So

you just heard the bell, so we’re going to have a vote to 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.

Mr. Ruppersberger.

Mr. 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. That’s what we’re really here about.

So, good job.

The followup 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 Maryland General Hospital has and is in the process of implementing

is accurate in design and scope. Both the employees and patients

of 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 and 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 test 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 the second question that promoted 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 questions Congress should be considering to assure quality

in clinical labs.

Mr. Chairman, I ask unanimous consent to have the CRS memo

inserted into the record as part of my opening statement.

Mr. SOUDER. Without objection, so ordered.

Mr. RUPPERSBERGER. Thank you. The questions raised by the

Congressional Research Service cover 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.

[The prepared statement of Hon. C.A. Dutch Ruppersberger follows:]

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Mr. SOUDER. I thank you. And the subcommittee stands in recess.

[Recess.]

Mr. SOUDER. The subcommittee will come to order.

It’s the custom of this committee that we swear in our witnesses,

as the oversight committee. So if you’ll raise your right hand.

[Witness sworn.]

Mr. SOUDER. Let the record show the witness responded in the

affirmative.

I’m glad you are able to join us today, and we look forward to

your testimony.

STATEMENT OF KRISTIN S. TURNER, FORMER EMPLOYEE OF

MARYLAND GENERAL HOSPITAL

Ms. 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.

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, if there’s any other 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.

But just initially, I think that it worries me that the lack of 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.

I realized, I noticed after reading the statement from them that

Adaltis didn’t, it was left up to the responsibility of Adaltis to report the incident 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 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.

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. It

seems like there needs to be something that says, 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’ll just answer anything you have to ask

me.

[The prepared statement of Ms. Turner follows:]

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Mr. SOUDER. Your full statement will be inserted into the record

again. As you probably know, we read your statement the last

time, so it was already read into the record.

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

Mr. CUMMINGS. Thank you very much. Ms. Turner, as I’ve said

to you before, when I first met you, and I say it to you again, I

do thank you for coming forward. I have seen with my own eyes,

and I’ve heard with my own ears vast improvements at Maryland

General Hospital. 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 to work in the lab.

Ms. TURNER. Good.

Mr. CUMMINGS. By the way, you may be getting some notes from

them, they got a pay raise.

Ms. TURNER. Great.

Mr. CUMMINGS. Because of you. And we heard some testimony—

so I thank you very much. Do you know Teresa Williams?

Ms. TURNER. I met her once.

Mr. CUMMINGS. 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 news shows. I guess one of the things 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 comes in, have an opportunity to express their concerns? What are your feelings on

that?

Ms. TURNER. I was at Maryland General for a couple of CAP inspections. 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.

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 the machine, for example, or problems with a section in general as far as like, we’re 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 person who said, this is really messed up, and all that,

so there could be an anonymous way for us to report to CAP. Face

to face would be great.

Mr. 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?

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

Mr. CUMMINGS. Say that again?

Ms. TURNER. I think it’s a great step. I’m not sure how well—

it depends, I guess, on what the response would be to complaints

that were made. Because complaints were made to the directors 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.

Mr. CUMMINGS. And if there were a system by which, when inspectors came in, they, say from CAP or from the State, that emVerDate 11-MAY-2000 12:49 Feb 11, 2005 Jkt 000000 PO 00000 Frm 00033 Fmt 6633 Sfmt 6633 D:\DOCS\98047.TXT HGOVREF1 PsN: HGOVREF1
30

ployees were, it was made known, say, for example, to the employees, that they were looking for any concerns that the employees

might have. Say for example, they gave them a little card and said,

you can send in an anonymous, typed-up bit of information. Do you

think that would be helpful.

Ms. TURNER. I think that would be great. I think it would be

very helpful. I was thinking also that it might be really good if

there were concerns made that maybe there were three copies, and

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 followup on that, so there’s accountability at every level. I

think that would be a very good thing to happen.

Mr. 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?

Ms. TURNER. I did, yes.

Mr. CUMMINGS. Tell us what you did.

Ms. TURNER. Probably, in my recollection, it seems like I did this

on a weekly basis, told the administrative laboratory director, as

well as my supervisor over the department. I was told, actually, to

keep it within the lab. Because I asked on a number of occasions

about going to risk management, which is something that we’re

told you can do.

When you come in for your employee orientation, you’re told 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.

Mr. 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.

Ms. TURNER. And it took a while to realize that. But that was

what I came to understand 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.

Mr. CUMMINGS. When I had an opportunity to talk to you a few

months ago, you said something that was very interesting. You

said a number of people at the hospital, particularly in the lab, had

left because they were so frustrated that they could not, that nothing was happening. So I assume that you could see certain problems recurring, and you didn’t see any results taking place. Did

you ever try to go above the lab and the supervisors in the lab?

Ms. TURNER. I did not. The farthest that I went was to Dr. Stewart.

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

Ms. TURNER. He was the administrative lab director. So he was,

there was a medical director above him. My understanding was

that they communicated about everything. 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 in my position.

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

What’s the first thing that you noticed that kind of got you upset?

Ms. 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. There were also things that were happening with the machine, like it was missing steps or missing reagents. 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

the results were OK at the end, which is not really such a good

thing.

So I voiced those 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. It seemed like

that wasn’t such a good deal. It seemed like something could be

done better.

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. I went into the lab and the very next day, they

had people working on the same machines. Well, then Labotech, I

don’t know if it was the same machine in particular, but all of the

machines there showed the same problems. 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 they

would at 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. They uncovered all kinds of information that was kind of,

it was in, I guess kind of little, not cubicles, but it was separated

from everything else. So somebody had knowledge of it, but it

wasn’t being connected with what was happening now. So the seriousness of everything, since the machine got to the lab, didn’t become apparent until after my accident occurred.

So it was at that time that everybody now had all of the information from when Teresa Williams was there all the way up through

my accident. And the realization came that somebody knew that

there was something really wrong from a really long time ago. So

I thought that maybe now that everybody had this information,

surely the hospital would fix it. So I gave them quite a while to

fix it.

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 had really given them

every chance and every benefit of the doubt that they were going

to fix it on their own.

Mr. CUMMINGS. You said you knew about when CAP came in, is

that right?

Ms. TURNER. Yes.

Mr. CUMMINGS. Did you know when the State came in?

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Ms. TURNER. No. And that’s a huge issue, I think. Because for

CAP, we knew weeks in advance they were coming and the labs

were always, everybody from the supervisors on down, it was like,

OK, CAP is coming so do this, clean up this area, or do this, do

this, get ready. Everybody was getting ready at every level. For us,

it didn’t really affect us so much as just making sure that where

we were working was maybe cleaned up or whatever, was organized better, so it didn’t give them anything to have to look at.

But the supervisors and things like that, it was almost chaos for

them trying to get ready for CAP coming. But the State, you have

no warning. So I think that’s an amazing thing.

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

Ms. TURNER. Absolutely. Because I think, when the State comes

in, it’s my understanding that they come in and they don’t say, no,

not in 2 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. I think that is how inspections should

be done of laboratories.

Mr. CUMMINGS. Let me just ask you this, and then I’ve run out

of time, but let me ask you this. You just said there was a lot of

cleanup, and I’m not trying to put words in your mouth, but it was

almost panicking, panic time when it came time for the CAP 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?

Ms. TURNER. I think they got the cleaned-up, Sunday church version of the lab.

Mr. CUMMINGS. The cleaned-up, Sunday church version.

Ms. TURNER. Yes.

Mr. CUMMINGS. OK.

Ms. TURNER. Honestly, I——

Mr. CUMMINGS. I just wanted to make sure I heard what you

said.

Ms. TURNER. Yes. It’s not the every day runnings in any way. Everything is just cleaned up, everything is shown in the very best

light that it possibly can be, and kind of, you hope they don’t look

in the shadows, I think, is kind of how the lab approached it.

Mr. CUMMINGS. So if you were trying to, looking backward now,

and looking at the fact that CAP came in and CAP 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 CAP not announce when it’s coming in.

Ms. TURNER. Right.

Mr. CUMMINGS. What other recommendations would you have?

You have to keep in mind that CAP is doing these inspections all

over the country.

Ms. TURNER. Right. I think maybe there could be somehow more

unbiased, I’m not saying that CAP is biased, but they are all members of the same organization, they are all laboratory members, it’s

to their advantage to have laboratories pass, because that’s what

they do. It’s kind of hard. I’m not very organized with that answer.

Mr. CUMMINGS. Let me try to help you. Let me just ask you this.

You’ve watched CAP do inspections, have you not?

Ms. TURNER. Yes.

33

Mr. CUMMINGS. And you talked about the cleanup before CAP

came. 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, it seems as if the standards

would be constant. It shouldn’t be a cleanup.

Ms. TURNER. Right.

Mr. CUMMINGS. So I’m trying to figure out what it is you were

cleaning up. What we’re trying to come up with is trying to make

sure that a hospital in rural Indiana, where Mr. Souder is from,

if a CAP inspection team comes in that his constituents, just like

my constituents in Baltimore, would feel comfortable that there is

an agency like CAP that is doing a good inspection. And when they

put the Good Housekeeping seal of approval on it, it means something.

What I’m asking you, and you may not be able to answer this,

what would you like to see happen to make sure that Good Housekeeping seal is valid?

Ms. 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 CAP sees

something other than what the lab shows them.

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. It’s my understanding that they don’t. I

never saw them go looking through the file drawers on their own.

They took at face 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.

Mr. CUMMINGS. Thank you, Mr. Chairman.

Mr. SOUDER. I have a couple of followup questions. 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?

Ms. TURNER. CAP inspections are scheduled. So they know when

CAP is coming. The laboratory is notified, if not a month in advance, it’s earlier than that.

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

Ms. TURNER. Oh. Well, I’m not sure about that.

Mr. SOUDER. We’ll hear that in the second panel. So if you place

was——

Ms. TURNER. We were aware that CAP was coming.

Mr. SOUDER. That’s what I understood them to say last time

under oath, is that they were unscheduled.

They are scheduled in advance or not scheduled? Is the person

who is going to testify from the Pathologists here? Can you nod

your head, are they scheduled or not scheduled? They are scheduled. OK. I’m incorrect.

34

So if they are scheduled in advance, that is problematic. I agree

with Mr. Cummings that they should be unscheduled, and I

thought that we understood they were not, and 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?

Ms. TURNER. No, it’s all part of Maryland General.

Mr. SOUDER. So your checks came from the hospital?

Ms. TURNER. Yes.

Mr. SOUDER. Do you have an appeal process if you get terminated?

Ms. TURNER. I was told no. I requested that it be looked at, because I was sent a letter that said 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.

Mr. SOUDER. Did you appeal past the lab? Did you write a letter

to the hospital or anybody beyond the lab?

Ms. TURNER. I did. And I sent a copy of the letter that I had received and they never——

Mr. SOUDER. The hospital didn’t respond to you?

Ms. TURNER. No.

Mr. SOUDER. Did you raise concerns that it might be because you

raised concerns in the lab? In other words, did you tell them?

Ms. TURNER. At that point, I didn’t. I thought, 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 push them

under the rug or get them out of the circle, so they can’t make

noise any more within the organization.

Mr. SOUDER. But you don’t know whether the hospital knew you

were in fact—because what I understood, 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?

Ms. TURNER. Not at that point, no.

Mr. SOUDER. At any point before you were terminated?

Ms. TURNER. I’m not sure.

Mr. SOUDER. Because part of the question here is what did the

hospital know. If they didn’t know you were complaining, they

can’t——

Ms. TURNER. Well, I know that my termination came from inside

the lab, 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

the levels that they needed to be aware that had actually taken

place.

Mr. 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 they 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 the complaints?

Ms. TURNER. Are you talking about what Adaltis told me? Their

technical service did tell me that we seemed to have more problems

35

than anywhere else. And I guess I questioned that, because there

was a variety of people running the machines, from medical technologists with 20 plus years of experience to people with less than

1. 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,

that the two machines that were in service at the time had significant problems constantly. So every time that we called and every

time they sent service out, they acted like it was something that

was different, and yet service was constantly busy.

Mr. SOUDER. Did you hear any discussion inside the lab if in fact

there wasn’t problems at other labs why your lab just didn’t get

new machines in?

Ms. TURNER. Well, there was a lot of concern as to if our labs

were having this many troubles, then how can this be OK.

Mr. SOUDER. But let me give you an example. We had a regular

problem with one of our Xerox machines, presumably Xerox, whatever it was, in our office, breaking down. At some point we said,

‘‘we’re sick of the service complaints, give us a new one.’’ Did that

happen, because that would force them to either say, look, it’s the

machine or the operators?

Ms. 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 couldn’t rely

on either one. And they refused, the hospital or the laboratory administration refused to replace the machines, even with all the

problems we had. And every machine, there can be a lemon, no

matter, if it’s a Mercedes or whatever it is, it doesn’t matter, they

can make lemons. Adaltis refused to even acknowledge that was

possible.

But I think that 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.

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

work.

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

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

Ms. 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 were relied

upon. They wouldn’t even hear of the option of replacing it. We

brought it up, and they said no, keeping the Labotechs.

Mr. SOUDER. Mr. Ruppersberger.

Mr. RUPPERSBERGER. First, I thank you for coming forward and

your courage, and you will make a difference in this whole issue.

I’m going to save my questions for the second panel.

Mr. SOUDER. Thank you. Judge Carter, do you have any questions?

36

Mr. CARTER. I think I’m going to wait, thank you, Mr. Chairman.

Mr. SOUDER. Mr. Cummings.

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

very important. In a few minutes, Dr. Mary Kass, president of the

College of American Pathologists, is going to testify. Part of her

testimony, I 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, 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 the fall of 2002. Now, listen to this. Because quality

control data in this area was found to have been edited.

Who would have done that editing?

Ms. TURNER. That depends on——

Mr. CUMMINGS. Do you know what this means, first of all? Are

you familiar with these terms?

Ms. TURNER. I think I do. I think that would be, she was probably referring to the internal quality controls. Those are the values

that there was a big issue when the Labotech would fail a run, and

it would be because the positive control was out of range, or the

negative control was out of range. At that point, we were instructed

to call Adaltis. And when we would call Adaltis, they would say,

OK, actually they’d give us passwords and all this other stuff to go

in, and they’d say, OK, change this number. And it was like, well,

is that OK? These are controls for the entire assay. 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, regardless of what it means to the patients on the other end, it would cost, you would have to re-use almost every single, you’d have to use up almost a whole kit to rerun it. A whole kit for one run is ridiculous. So it was cost reasons,

I think, was the thing.

But when I asked Adaltis about that, they said that they have

ways, they have a formula or something that shows them that actually it is only this that maybe went wrong, so then they can just

tell us to change the numbers to this. And what happens through

is if you change the control value to where it works, it changes the

other values, obviously it changes 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——

Mr. CUMMINGS. Let me try to put it in lay language. Let me

make sure I understand what you’re saying. You’re saying that

you, 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?

Ms. TURNER. Right.

Mr. CUMMINGS. And you would say to Adaltis, what would you

say to Adaltis?

Ms. TURNER. Well, usually it was that Dr. Stewart expected us

to call them, first of all, because we would go to him and say, look,

37

we had this failed run, well, the controls are out of synch with each

other, and they just aren’t in the right range.

Mr. CUMMINGS. So that’s like a red flag going up?

Ms. TURNER. Yes.

Mr. CUMMINGS. Whatever would have caused you to go to Dr.

Stewart would have been like lights going off saying something is

wrong.

Ms. TURNER. Right. Only because when we would rerun them, if

he would find out that we automatically reran them, then that

would not be OK with him.

Mr. CUMMINGS. So he would be upset, based on what you just

said a moment ago, because he was worried about the costs of rerunning tests that may have been inaccurate for the person who

did or may not have had AIDS or hepatitis?

Ms. TURNER. Exactly.

Mr. CUMMINGS. Because of money?

Ms. TURNER. Yes. And his instructions were to call Adaltis and

see if they could get it to work.

Mr. CUMMINGS. Then when you would call Adaltis, they would

give you a formula——

Ms. 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. It was really frightening.

Mr. CUMMINGS. Let me just ask you——

Ms. TURNER. The positives were automatically repeated. I repeated them, anyway. Those are the things. But it’s like, with the

mistakes that the machine made, how many samples got missed,

and the possibility was there that there were positives that were

missed, because they weren’t even sampled.

Mr. CUMMINGS. Last question. You just said it was frightening.

Why did you say that? What was frightening?

Ms. TURNER. Just the fact that we’re being told to go in and

change control values. Because controls are the only basis, like the

controls have gone through the assay, all of the reagents, 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 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 that if every

reagent 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 it should never be allowed that you’re told to change it as part of your job.

Mr. CUMMINGS. Did you ever say to Dr. Stewart, Doc, this is 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?

Ms. TURNER. Absolutely.

38

Mr. CUMMINGS. And what did he say?

Ms. TURNER. He said, how do we—well, my problem was that, I

sent this on a number of occasions to him, I said we were running

this test on a machine that fails a run, we don’t know why it fails,

maybe it’s controls, maybe it’s reagents, maybe—who knows what’s

wrong with it. And you’re telling me to go rerun it on the machine,

on the same machine. And if the machine is broken, you can’t ever

rely on those results that come out of there.

So these are people, I don’t think that he really made the association, at least it’s my opinion that 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. 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.

Mr. CUMMINGS. Well, let me say this, and this is my last comment. It is thoroughly frightening, you’re absolutely right, when

someone can look at numbers and forget that there are people,

there are real live people, there’s somebody’s mother, father, brother, sister, neighbor, and deal with it from a statistical standpoint

trying to get it right.

Ms. TURNER. Right.

Mr. CUMMINGS. Thank you.

Mr. SOUDER. I’d like to make a couple of comments and see if you

have any last. There are some things that I think become fairly

clear from your testimony, and that is that the people who were

doing the auditing, the normal auditing, the pre-planned 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 if it had been unannounced by

anybody that they would have caught it if the information had

been doctored. In other words, just because a place has been

cleaned up and tidied up does not mean if the—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 had 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, and that’s why

I asked you, did the persons seem to know the people, what made

you make the statement? Was it an inside inspection that while

sometimes you wonder, particularly when you see bad results coming out, in the sense of they didn’t catch the problem, generally

speaking, if the pathologist in charge of the lab is deliberately, or

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 hospitals give

them or that medical plans give them or that health insurance

gives them or anybody else gives them? They would just as soon

do whatever.

But once they’re in violation of the Hippocratic oath, which is to

put the person first, your problem is far more than an inspection.

39

Because in fact they’ve given up the No. 1 goal of their medicine,

which is to protect the individual. And I think 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 a State government

or a 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, 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.

Ms. TURNER. Right.

Mr. SOUDER. 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.

Ms. TURNER. Right. And I think actually at Maryland General

it’s important to kind of make a distinction between the medical director of the laboratory and the administrative laboratory director.

The M.D., the pathologist of the laboratory, obviously it’s his job to

know, so there was 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.

Mr. SOUDER. Shouldn’t it be a mandatory policy of the hospital

and the lab that any complaints are given to whoever’s doing the

inspecting in any hospital?

Ms. TURNER. Absolutely.

Mr. SOUDER. I would think this would be a national standard

that we ought to——

Ms. TURNER. That’s kind of why 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 followup.

Mr. 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——

Ms. TURNER. Maybe it needs to go to CAP and FDA and the risk

management of the hospital as well as the lab, so that there’s just

somebody keeping an eye on everybody and making sure that happens.

Mr. SOUDER. Well, thank you for your willingness to come forth

and testify. I hope you continue to have good health.

Ms. TURNER. Thank you.

Mr. SOUDER. 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, College of American Pathologists; Mr. Edmond Notebaert,

president, University of Maryland Medical System. As soon as you

get comfortable, I’ll ask you to stand again. [Laughter.]

If you’ll raise your right hands, please.

[Witnesses sworn.]

40

Mr. SOUDER. Let the record show that each of the witnesses responded in the affirmative. We’ll start with Dr. Notebaert, since

you’re getting round two. We appreciate your coming again today.

STATEMENTS OF EDMOND F. NOTEBAERT, PRESIDENT AND

CHIEF EXECUTIVE OFFICER, UNIVERSITY OF MARYLAND

MEDICAL SYSTEM; MARY E. KASS, M.D., PRESIDENT, COLLEGE OF AMERICAN PATHOLOGISTS; AND CAROL BENNER,

DIRECTOR, OFFICE OF HEALTH CARE QUALITY, MARYLAND

DEPARTMENT OF HEALTH AND MENTAL HYGIENE

Mr. 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. But I would like to say simply that the Maryland,

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 review, 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 test 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 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. 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

41

properly addressed, including confidential hotlines and including a

restricted e-mail address that’s directed to me exclusively.

We have done our best to put in place many mechanisms that

will allow employees to go out of channel without fear of reprisal.

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 5 minutes. I’m sure that the

questions might be more insightful than my testimony.

Thank you, sir.

[The prepared statement of Mr. Notebaert follows:]

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46

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48

49

50

51

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Mr. SOUDER. 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 will supplement.

Dr. Kass.

Dr. 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 followup 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 of 2002, because quality

control in this area were found to have been edited.

Specifically, Maryland State inspectors allege in their 2003 inspection report that, ‘‘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, instrument 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 18, 2003, the instrumental printout showed manually

edited acceptable values for the negative control materials, but the

plate printout showed unacceptable negative controls.’’

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 whistle blower 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

12, 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 CLIA 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.

53

Most recently, at the May 18th hearing, CMS reaffirmed its support of CAP accreditation. The College welcome and has encouraged States 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 asked 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.

Protection for whistle blowers.

Mr. CUMMINGS. Mr. Chairman, could she read that for the

record, please?

Dr. 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. Then there’s a toll-free number at the

bottom.

Protection for whistle blowers. We commend the whistle blowers

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 whistle blowers, both for the individVerDate 11-MAY-2000 12:49 Feb 11, 2005 Jkt 000000 PO 00000 Frm 00057 Fmt 6633 Sfmt 6633 D:\DOCS\98047.TXT HGOVREF1 PsN: HGOVREF1
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uals who report the problems to Government or private oversight

bodies and to the oversight bodies themselves.

Patient safety legislation now before Congress would establish

whistle blower 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 responded to any questions.

Thank you.

[The prepared statement of Dr. Kass follows:]

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Mr. SOUDER. Thank you.

Ms. Benner.

Ms. 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 would 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. Kristin

Turner sent an e-mail to the Baltimore City Health Department,

who in turn sent that to our AIDS administration, who in turn sent

that to us. 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. 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 serving 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 an 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

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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 that 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.

[The prepared statement of Ms. Benner follows:]

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Mr. SOUDER. Thank you. Let me just make this clear for the

record. I have national interests at stake, I don’t have the similar

Baltimore issues at stake. This is the second time, and I want to

make it absolutely clear where I stand. That 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

get 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

this ought to be, 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.

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 when he

didn’t share, and telling us we need a 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

Mr. Notebaert. You say that it was 99.4 percent accurate when it

came back?

Mr. NOTEBAERT. That’s correct.

Mr. SOUDER. And 1,800 cases?

Mr. NOTEBAERT. Over 1,800 cases.

Mr. SOUDER. Does that mean there were 12 people who were either told they had AIDS or didn’t have AIDS who——

Mr. NOTEBAERT. No, there are individuals who, being mindful of

the patient confidentiality issue, whose testing was different on the

retesting. There are reasonable explanations for changes in results

between the first test and the second test that are related to the

specific patients themselves; 99.4 percent is an extremely statistically significant number. In the individual cases, we have looked

at them and there are explanations beyond the mechanics of the

testing process that explain that deviation.

Mr. SOUDER. And in the validity, is that what we were talking

about earlier, about the controls?

Mr. NOTEBAERT. That’s correct, yes, sir.

Mr. SOUDER. And that’s still being——

Mr. 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.

Mr. SOUDER. So it’s still the hospital’s position that it’s not the

Labotech machine?

Mr. NOTEBAERT. 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.

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Mr. SOUDER. So you’ve switched?

Mr. NOTEBAERT. Immediately upon the discovery of this event,

we discontinued the use of that equipment.

Mr. SOUDER. Thank you. I forgot that. You probably said that

last time, and I forgot.

Dr. Kass, why would you do announced inspections?

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

Mr. SOUDER. 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.

Dr. 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 2 years. That is part of our deemed

status from CLIA. We have to do this every 2 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, ‘‘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, and 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.’’

Mr. SOUDER. That all presumes that somebody isn’t—it’s kind of

the reverse of what I commented to Kristin Turner. 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’s going to come in 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, 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 inVerDate 11-MAY-2000 12:49 Feb 11, 2005 Jkt 000000 PO 00000 Frm 00092 Fmt 6633 Sfmt 6633 D:\DOCS\98047.TXT HGOVREF1 PsN: HGOVREF1
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dustry itself commenting on what disruption it would be to the

process. Needless to say, I’m very sympathetic to the problems facing all types of people in the medical profession. I believe you ought

to take commentary in from those people.

But I’m not sure that I would necessarily take the people who

are audited word for what they prefer. Of course they 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, which 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, all things which are beneficial to the lab,

but aren’t necessarily beneficial to making sure that information

is——

Dr. KASS. There are two aspects to your question that I’d like to

respond to. First of all, the laboratory is extremely important in patient care; 70 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 shock trauma unit, you

don’t want your lab result 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 cytogenetics

or molecular pathology or cytology, 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.

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Mr. SOUDER. 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 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. We in fact have taken this position in

OSHA. And in fact, if you’re getting any whistle blower 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 people have this number where they could call, if they

provided something like that, there could be an insertion?

Mr. NOTEBAERT. No. We do payroll inserts regularly. Stuffing another one in is not really a problem.

Mr. SOUDER. We think that would be a great thing nationally, in

addition to a poster. Because sometimes, having been in a place

and seeing all those 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

to move it 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 whistle blower if it’s unannounced, if it’s not unannounced, you’ll never catch them. That’s

the dilemma.

Because the goal here isn’t to play gotcha. 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 happened 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. That is, 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 visits, you

can also have a scurrying around that isn’t just fixing at the edges

and moving the ball forward, but is in fact deceiving the investigators. And that’s a dilemma.

Dr. 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-pros, Q-trap, PIP and PAP programs

which are all programs that are voluntary, but they all measure

outcomes of laboratory practice and whether it’s good or not.

Whistle blowers, it is extremely important that we create, that

hospitals create, that indeed the entire health care industry creates

an atmosphere, an environment where employees feel comfortable

bringing forth problems that can be not only identified by can be

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addressed. This has to be done. This is why this legislation that we

are supporting is so important. If it had not been for the whistle

blowers in this case, we would not have known of these problems.

So it’s absolutely essential.

Mr. SOUDER. Thank you. Mr. Cummings.

Mr. CUMMINGS. Dr. Kass, do you think this is happening other

places? I mean, the fact that you’re getting inaccurate information,

it seems from your testimony, I’ve listened to you very carefully,

that if you get inaccurate information you cannot make an accurate

assessment.

Dr. 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 have 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.

Mr. CUMMINGS. So when Ms. Benner said a moment ago the very

chilling words that there is an absence of regulation, I guess you

disagree with that?

Dr. KASS. I disagree very much with that.

Mr. CUMMINGS. Why is that?

Dr. KASS. I have 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 followup. 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.

Mr. CUMMINGS. Obviously there is an issue, there’s a problem

based on what you just said and what you’ve been saying. Just a

moment ago you were kind enough to hold up that poster. I was

very pleased to see that. And you talk about communication and

you talk about, you and Ms. Benner talked about this effort to try

to communicate better between the State and your agency.

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

Maryland. If we are doing this here, in Maryland now, 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 whistle blowers, and by the way, since

these hearings have begun, we’ve gotten information from various

places, people all over the country on these kinds of issues.

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And I’m just wondering, Ms. Benner said she wanted the Federal

Government to, she 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. Let me just make sure you’re

clear where I’m going with this. You have voluntarily agreed to do

this in Maryland with Maryland General Hospital. I guess other institutions in Maryland, too? Just Maryland General or all the hospitals?

Dr. KASS. All the laboratories that are accredited by CAP.

Mr. CUMMINGS. So Maryland—after the hearing, right. So I’m

wondering two things. One, has this issue—you’re the president,

and congratulations, madam president.

Dr. KASS. I don’t think they’re in order right now. [Laughter.]

Mr. CUMMINGS. I know the feeling.

But I’m just wondering if, 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 have a feeling that by the time you all finish, it will be like

a wonderful, you will have 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?

I’m sure you’ve thought about these issues, and this is a big issue

for the College, I’m sure.

Dr. KASS. Only about 15 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 serves our patients’ needs very well, that

could certainly be used as examples. 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. Then if the complaints are substantiated,

we notify CMS about them.

Mr. CUMMINGS. So you don’t see any further role for Federal

Government in all this?

Dr. KASS. I wouldn’t know what to recommend to the Federal

Government, to be honest with you.

Mr. 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 that

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you may have that agreement in Maryland where, for example, information flows to CAP, CAP 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’m just trying to figure out, since you all deal nationally, how do

you guarantee, 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 another whole standard in the next

State?

Dr. KASS. It certainly would be helpful if complaints regarding

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.

Mr. CUMMINGS. Certainly.

Mr. SOUDER. Would you favor also sharing your complaints with

the other agencies?

Dr. KASS. Absolutely.

Mr. SOUDER. In other words, there could be, kind of a whistle

blower sharing?

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

Mr. CUMMINGS. Did the State fail here? Are you familiar with

this case? Have you read all the material?

Dr. KASS. 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 JCHO

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.

Mr. CUMMINGS. Let me ask you this. We had the testimony of Teresa Williams. Just listen to what she said. In her testimony, she

describes serious problems at Maryland General laboratory that

she arrived 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 tests results, including hepatitis B,

were unreliable.

It was also alleged that a refurbished Labotech was purchased

for cash, arrived with dry 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 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?

Dr. 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

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a 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, etc.

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. 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.

Mr. CUMMINGS. Ms. Turner, when she was testifying, talked

about that she kind of wished that the CAP inspectors could have

gone a little further. I take it that you all have certain parameters,

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 still, she talks about what a whistle blower

would have 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?

Dr. KASS. Right. First of all, when the College goes in to do an

inspection, it looks at thousands of things. The checklists are literally thousands of things that we look at. However, and I didn’t

go into a great deal on 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.

Mr. CUMMINGS. What you just said, what you just described, is

that something new?

Dr. 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.

Mr. CUMMINGS. Is that in part a result of what has happened in

this case?

Dr. KASS. Yes, it is.

Mr. CUMMINGS. So I’m just curious. How does the College work?

This is a group of people that get together and do what? How are

they assigned? How does that happen?

Dr. KASS. How are the inspectors assigned?

Mr. CUMMINGS. Yes.

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Dr. 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 monitor our inspection

and accreditation process.

All of the people in our inspected labs that are eligible to be inspectors are in a data base. These are assigned on a regional basis

by the regional and State inspectors, commissioners, to assign people to an inspection team. The inspection, 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 them. But we do have

certain rules about who can be inspectors. You can never inspect

the same laboratory two times in a row, VA people cannot inspect

VA 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

that come in and inspect our lab.

Mr. CUMMINGS. That was my next question. You go ahead.

Dr. KASS. We looked at our data and actually 57 percent of our

inspectors did not require hotel or air travel accommodations, 43

percent did, which means that they’re coming from significantly far

away. Now, just because they didn’t require hotel or 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.

And 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.

That’s not a hotel stay and it’s not an air travel. But it is certainly

not a local Baltimore hospital.

Mr. CUMMINGS. Maybe I missed this. Is this like a side job for

them or is this what they do all the time?

Dr. KASS. No. Anybody that is inspected by the College is required, if they are asked and 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 technology.

Now, for specific types of inspections, as I mentioned before, cytogenetics, molecular path, cytology, 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 to 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.

Mr. CUMMINGS. I’m 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

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happened at Maryland General. 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 it’s also, I ask you that question for one other reason,

too. That is for Kristin Turner, who I’m sure many times has wondered whether, was there a result of what she did.

Dr. KASS. There is absolutely a result of what she did. I can’t emphasize that enough. I think that more than doing new things,

we’re expanding activities to make them more comprehensive. 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.

Mr. CUMMINGS. Thank you.

Mr. 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 about from the subcommittee

staff.

Dr. KASS. That is correct.

Mr. SOUDER. There were multiple sources, none however were

done——

Dr. KASS. Not the usual means, yes.

Mr. SOUDER. Second, I want to reinforce the importance, because

I know that medical people aren’t necessarily, and this is very important to pick up, 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, as a Tom Peters concept, is at minimum 4 years old.

But in most retail businesses, like in my family, that was one of

the first things. You walk around the store, you don’t just sit in a

room and talk to 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 and figure out what’s going in first.

So I’m glad you’re doing it. It’s about time. Hopefully maybe the

Federal Government and Defense Department will learn the same

thing, maybe to check out a prison before we run into problems. It’s

not uniform just in private sector agencies. The Government itself

has this kind of principle to hole up and not do management by

walking around. That’s very important, and one of the great outgrowths of this is to listen to the people who are on the front lines,

as well as the management, who may have perspective. But then

that hopefully will come with whistle blower complaints and other

things as well.

Dr. KASS. Couldn’t agree with you more.

Mr. SOUDER. Mr. Ruppersberger.

Mr. RUPPERSBERGER. First, I think we’ve all learned from the

hearing, the two hearings we’ve had, of 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, patholoVerDate 11-MAY-2000 12:49 Feb 11, 2005 Jkt 000000 PO 00000 Frm 00100 Fmt 6633 Sfmt 6633 D:\DOCS\98047.TXT HGOVREF1 PsN: HGOVREF1
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gists, which is College pathologists, States, FDA is 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 a local

government, took. And I’m not sure that would solve the problem

here. What I’d like the panel to address is what they think, what

you think is the best mechanism to bring about a more efficient

process of checks and balances of where laboratory quality would

be. The mechanism, 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 the 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 accountability and transparency is very important as it relates to this issue. I think a lot of the issues here are about accountability and in bringing all the stakeholders together.

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

We’ll start with Mr. Notebaert.

Mr. NOTEBAERT. Well, there are five or six things that I would

comment on from the position of a hospital stakeholder. 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 and 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.

Mr. RUPPERSBERGER. By the way, I think a lot of focus has been

on the State of Maryland, thanks to Congressman Cummings. I

think that we have a wakeup 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.

I mentioned stakeholders. Is there a better way that all the

stakeholders can really come together to work on this issue without

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having a congressional hearing? 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.

Mr. NOTEBAERT. I certainly think that this hearing has been the

impetus for that in Maryland, and maybe Maryland can be the

model that can be used. I think that Dr. Kass and——

Mr. RUPPERSBERGER. I’ve been told that Maryland has two of the

best hospitals in the world, is that true?

Mr. NOTEBAERT. It has two of the finest medical centers, academic medical centers, probably in the whole——

Mr. RUPPERSBERGER. I shouldn’t have done that. [Laughter.]

Mr. NOTEBAERT. And certainly one that got the top ranking in

U.S. News and World Report, which is our neighboring hospital in

eastern Baltimore.

In any event, the comments that I was making really were comments from a global perspective. 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. I haven’t really figured out how to do that. I think

that there have been some references to that in the other testimony.

Those are the things that I would think as a general rule would

be very helpful from a hospital standpoint.

Mr. RUPPERSBERGER. I will point out, Maryland is rated, considered to have the best trauma system in the world, shock-trauma

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 accreditations that really don’t mean

anything, but look at really what we do and what the end result

is. That’s important also.

Dr. Kass.

Dr. KASS. I’ve been sitting here thinking about what you could

do on a Federal level to really enhance this process. Certainly if

you got together an advisory group of the stakeholders and they

could come up with a plan whereby reporting of complaints between accrediting bodies would be in some way mandated.

Mr. RUPPERSBERGER. On a regular basis.

Dr. KASS. Well, quickly, not 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 is some way 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.

Mr. RUPPERSBERGER. Ms. Benner.

Ms. BENNER. Mr. Ruppersberger, thank you for your question. As

an aside, I might say that I was the director of the laboratory at

the shock-trauma center in the mid-1970’s.

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

Ms. 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. This

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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 nursing home, we are

working on behalf of the Federal Government.

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 there are some changes at the Federal level.

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

Ms. BENNER. I couldn’t agree more.

Mr. RUPPERSBERGER. And 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 know politics is

probably worse in medicine than it is in politics. But 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 you don’t have any

accountability and communication, and you’re saying, well, we’re

doing it pursuant to Federal rules. That still doesn’t solve the ultimate problem to get to the bottom line.

Ms. 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——

Mr. RUPPERSBERGER. I still haven’t heard any 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.

Ms. BENNER. Perhaps joint surveys, where the State goes on a

survey with the CAP inspection team.

Mr. RUPPERSBERGER. But you still need the standards and the

accountability. That’s something that has to be.

Ms. BENNER. 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 do the

survey together. We become far more powerful.

Mr. RUPPERSBERGER. That’s a result. Dr. Kass, you said that

each State has different accreditation issues, too, correct?

Dr. KASS. A lot of States have special requirements of us. And

a lot of States go in with us on inspections.

Mr. RUPPERSBERGER. So would you think there needs to be a

Federal standard? Sometimes the Feds get in and they muck it up.

We want to make sure——

Dr. KASS. I’ve heard that happens.

Mr. RUPPERSBERGER. It happens a lot. Unfunded mandates, too.

But let me get to the issue. 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?

Dr. KASS. I think to have a standard of reporting, of communication, of complaint investigation, would be helpful. In fact, CMS is

holding a meeting next week, and I think CMS, I may be speaking

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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. It would seem to me that CMS has the authority to demand

this.

If not, though, I’m certain you could give it.

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

Dr. KASS. Just do it.

Mr. RUPPERSBERGER. Let me ask you this. What are the implications of having four regulatory agencies simultaneously involved in

surveying labs, surveying a lab to discover potential deficiencies,

and monitor the implementation of solutions? Right there you have

four different agencies involved. What are the implications of that,

as it relates to what we know now?

Dr. 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 followup our inspections by their own inspections, unbeknownst to us,

and they find anything we’ve missed let us know. That works very

well.

For instance, in Pennsylvania, the State there does, we do an inspection every 2 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.

Sometimes what is good for one State isn’t necessarily good for another.

Mr. RUPPERSBERGER. My time is running out. I’m looking for solutions. I think we need to develop that. And we want to know,

from our perspective, and we’ll make an analysis through the

chairman or ranking member, where we go with this.

Dr. KASS. I think the solution to this——

Mr. RUPPERSBERGER. We want to make sure we don’t create another problem by a Federal program that’s not going to work.

Dr. KASS. A solution to this might come out of the stakeholders

meeting that CMS I’m sure will call very shortly.

Mr. RUPPERSBERGER. That’s very important and very relevant.

Dr. KASS. Right.

Mr. RUPPERSBERGER. Do you agree with the stakeholders that I

mentioned? Is there anybody that’s missing, hospitals, pathologists,

States, FDA, CDC, employee representatives?

Dr. KASS. CMS, obviously, and JCHO.

Mr. RUPPERSBERGER. Anybody else, any other stakeholders?

Ms. BENNER. There are other accreditation organizations that go

into laboratories. COLA is one.

Mr. RUPPERSBERGER. But they need to come under one. You have

too many in a room, you’re not going to get anything accomplished.

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

Mr. RUPPERSBERGER. Is there one stakeholder in that group that

I mentioned that really might have too much power or too much

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influence, that might affect the whole group as a whole coming together?

Ms. BENNER. I don’t think so, no.

Mr. RUPPERSBERGER. What do you think, Mr. Notebaert?

Mr. NOTEBAERT. Well, I think simplification and standardization

are the goals for any body that’s convened.

Mr. RUPPERSBERGER. I agree.

Mr. NOTEBAERT. 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 standardization.

Mr. RUPPERSBERGER. And also, I would think, oversight, coordination and accountability, those five.

Mr. NOTEBAERT. Absolutely.

Mr. SOUDER. Mr. Cummings.

Mr. CUMMINGS. Just one last statement. Whenever we sit in

these hearings, I’m often, I often think about what I say to my constituents. A hundred years ago, none of us were here, 100 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.

I just want to make sure, I can see where Mr. Ruppersberger

was going, trying to come to some kind of conclusion as to where

we go from here, so it is not something that just, we had a hearing,

and then 10 years from now, when another Maryland General

crops up, hopefully some place else, then we are saying the same

things, different set of people, people having suffered, people having gotten wrong results, whatever.

I guess what I’m saying to you, Dr. Kass, it sounds like CAP and

CMS seem to be going in the direction of doing some things about

it. The question that 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 to make things better? I think it would be

criminal if we did not take this moment to make things better.

So what do you suggest we do? Mr. Ruppersberger was very clear

that not everything, 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? Do we take a look at this,

say 6 months from now, and see where we are? 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.

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

102

Dr. 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. 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 in making this

happen, in getting the kind of oversight and accountability that I

think everybody here wants, I can assure you, I know who to call.

Mr. 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.

Dr. KASS. I would not hesitate one moment.

Mr. CUMMINGS. All right.

Mr. SOUDER. I was concerned you were enjoying this testimony

so much you would want to come up here multiple times over the

next few years. [Laughter.]

I want to tell Ms. Benner that while I don’t agree with Mr.

Sabatini’s proposal at this time, he’s one who can help it remain

accountable, if in fact CMS doesn’t move to continue to be vociferous in doing that.

I want to say to Mr. Notebaert that first off, it’s clear than 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. That’s a strong management praise for how you handled

that.

Mr. NOTEBAERT. Thank you.

Mr. 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 in nursing homes, all

divisions of hospitals, we try 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, that depending on what inspector you have no a housing site,

there’s so much variation, it is just very difficult. 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’ve 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. 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 of health. And that’s our

constant tradeoff.

So I wouldn’t hold your breath to have the clarity coming in from

each inspector in every agency, all 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.

Mr. RUPPERSBERGER. Mr. Chairman, may I make one comment?

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Mr. SOUDER. Yes.

Mr. RUPPERSBERGER. 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.

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 can 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.

Mr. SOUDER. And he doesn’t seem to have much reluctance so

far, so I’m sure he’ll continue to do so. [Laughter.]

With that, the subcommittee stands adjourned.

[Whereupon, at 5:38 p.m., the subcommittee was adjourned, to

reconvene at the call of the Chair.]

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