[House Hearing, 108 Congress]
[From the U.S. Government Publishing Office]





 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


                                 ______

                    U.S. GOVERNMENT PRINTING OFFICE
98-047                      WASHINGTON : 2004
____________________________________________________________________________
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                     COMMITTEE ON GOVERNMENT REFORM

                     TOM DAVIS, Virginia, Chairman
DAN BURTON, Indiana                  HENRY A. WAXMAN, California
CHRISTOPHER SHAYS, Connecticut       TOM LANTOS, California
ILEANA ROS-LEHTINEN, Florida         MAJOR R. OWENS, New York
JOHN M. McHUGH, New York             EDOLPHUS TOWNS, New York
JOHN L. MICA, Florida                PAUL E. KANJORSKI, Pennsylvania
MARK E. SOUDER, Indiana              CAROLYN B. MALONEY, New York
STEVEN C. LaTOURETTE, Ohio           ELIJAH E. CUMMINGS, Maryland
DOUG OSE, California                 DENNIS J. KUCINICH, Ohio
RON LEWIS, Kentucky                  DANNY K. DAVIS, Illinois
JO ANN DAVIS, Virginia               JOHN F. TIERNEY, Massachusetts
TODD RUSSELL PLATTS, Pennsylvania    WM. LACY CLAY, Missouri
CHRIS CANNON, Utah                   DIANE E. WATSON, California
ADAM H. PUTNAM, Florida              STEPHEN F. LYNCH, Massachusetts
EDWARD L. SCHROCK, Virginia          CHRIS VAN HOLLEN, Maryland
JOHN J. DUNCAN, Jr., Tennessee       LINDA T. SANCHEZ, California
NATHAN DEAL, Georgia                 C.A. ``DUTCH'' RUPPERSBERGER, 
CANDICE S. MILLER, Michigan              Maryland
TIM MURPHY, Pennsylvania             ELEANOR HOLMES NORTON, District of 
MICHAEL R. TURNER, Ohio                  Columbia
JOHN R. CARTER, Texas                JIM COOPER, Tennessee
MARSHA BLACKBURN, Tennessee          BETTY McCOLLUM, Minnesota
PATRICK J. TIBERI, Ohio                          ------
KATHERINE HARRIS, Florida            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                 ELIJAH E. CUMMINGS, Maryland
JOHN M. McHUGH, New York             DANNY K. DAVIS, Illinois
JOHN L. MICA, Florida                WM. LACY CLAY, Missouri
DOUG OSE, California                 LINDA T. SANCHEZ, California
JO ANN DAVIS, Virginia               C.A. ``DUTCH'' RUPPERSBERGER, 
JOHN R. CARTER, Texas                    Maryland
MARSHA BLACKBURN, Tennessee          ELEANOR HOLMES NORTON, District of 
PATRICK J. TIBERI, Ohio                  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


                            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

 
 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 investigated another warning letter 
sent in December from a former employee, Kristin Turner.
    State officials have confirmed the existence of the 2002 
letter. They said they took the allegations seriously, but 
found them vague and did not 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.
    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:]

    [GRAPHIC] [TIFF OMITTED] T8047.001
    
    [GRAPHIC] [TIFF OMITTED] T8047.002
    
    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 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:]

[GRAPHIC] [TIFF OMITTED] T8047.003

[GRAPHIC] [TIFF OMITTED] T8047.004

    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:]

[GRAPHIC] [TIFF OMITTED] T8047.005

[GRAPHIC] [TIFF OMITTED] T8047.061

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[GRAPHIC] [TIFF OMITTED] T8047.011

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[GRAPHIC] [TIFF OMITTED] T8047.015

[GRAPHIC] [TIFF OMITTED] T8047.016

[GRAPHIC] [TIFF OMITTED] T8047.017

[GRAPHIC] [TIFF OMITTED] T8047.018

    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:]

    [GRAPHIC] [TIFF OMITTED] T8047.019
    
    [GRAPHIC] [TIFF OMITTED] T8047.020
    
    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 
employees 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.
    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?
    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.
    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.
    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 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?
    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 re-run 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, 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.
    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. 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.]
    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 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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    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.
    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 individuals who report the problems to 
Government or private oversight bodies and to the oversight 
bodies themselves.
    Patient safety legislation now before Congress would 
establish 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 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.
    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 industry 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.
    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 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.
    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 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 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.
    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 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, pathologists, 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 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 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 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 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.
    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?
    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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