[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?

=======================================================================

                                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

                               __________

                              MAY 18, 2004

                               __________

                           Serial No. 108-248

                               __________

       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
97-962                      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          ------ ------
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 May 18, 2004.....................................     1
Statement of:
    Eckloff, Richard, Adaltis US Inc., Allentown, PA; Nelson J. 
      Sabatini, Secretary, Maryland Department of Health and 
      Mental Hygiene, Baltimore, MD; Ronald B. Lepoff, M.D., 
      F.C.A.P., Chair of the Commission on Laboratory 
      Accreditation, College of American Pathologists, 
      Northfield, IL; and Edmond Notebaert, president, University 
      of Maryland Medical System, Baltimore, MD..................    82
    Gutman, Steven I., M.D., Director, Office of In Vitro 
      Diagnostics Device Evaluation and Safety, Food and Drug 
      Administration, Department of Health and Human Services; 
      and Sean Tunis, M.D., chief clinical officer, Centers for 
      Medicare and Medicaid Services (CMS) and Deputy Director, 
      Office of Clinical Standards and Quality, CMS, Department 
      of Health and Human Services, accompanied by Virginia 
      Wanamaker..................................................    14
    Williams, Teresa, former employee of Maryland General 
      Hospital; and Kristin Turner, former employee, Maryland 
      General Hospital, as delivered by Malia Holst, subcommittee 
      clerk......................................................    50
Letters, statements, etc., submitted for the record by:
    Cummings, Hon. Elijah E., a Representative in Congress from 
      the State of Maryland, prepared statement of...............    10
    Eckloff, Richard, Adaltis US Inc., Allentown, PA, prepared 
      statement of...............................................    84
    Gutman, Steven I., M.D., Director, Office of In Vitro 
      Diagnostics Device Evaluation and Safety, Food and Drug 
      Administration, Department of Health and Human Services, 
      prepared statement of......................................    17
    Lepoff, Ronald B., M.D., F.C.A.P., Chair of the Commission on 
      Laboratory Accreditation, College of American Pathologists, 
      Northfield, IL, prepared statement of......................    95
    Notebaert, Edmond, president, University of Maryland Medical 
      System, Baltimore, MD, prepared statement of...............   103
    Ruppersberger, Hon. C.A., a Representative in Congress from 
      the State of Maryland, prepared statement of...............    71
    Souder, Hon. Mark E., a Representative in Congress from the 
      State of Indiana, prepared statement of....................     4
    Tunis, Sean, M.D., chief clinical officer, Centers for 
      Medicare and Medicaid Services (CMS) and Deputy Director, 
      Office of Clinical Standards and Quality, CMS, Department 
      of Health and Human Services, prepared statement of........    29
    Williams, Teresa, former employee of Maryland General 
      Hospital, prepared statement of............................    54

 
 ENSURING ACCURACY AND ACCOUNTABILITY IN LABORATORY TESTING: DOES THE 
  EXPERIENCE OF MARYLAND GENERAL HOSPITAL EXPOSE CRACKS IN THE SYSTEM?

                              ----------                              


                         TUESDAY, MAY 18, 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 10:36 a.m., in 
room 2154, Rayburn House Office Building, Hon. Mark E. Souder 
(chairman of the subcommittee) presiding.
    Present: Representatives Souder, Cummings, Ruppersberger, 
and Norton.
    Staff present: Marc Wheat, staff director and counsel; 
Roland Foster, professional staff member; Malia Holst, clerk; 
Tony Haywood, minority counsel; and Jean Gosa, minority clerk.
    Mr. Souder. Good morning, and thank you all for being here.
    Today's hearing will examine the investigation of lab 
deficiencies at the Maryland General Hospital in Baltimore, MD.
    Upon learning of these serious problems, Congressman Elijah 
Cummings, the ranking Democrat member of this subcommittee, 
immediately requested the subcommittee to hold a hearing on 
this troubling situation.
    During a 14-month period between June 2002 and August 2003, 
the hospital issued more than 450 questionable HIV and 
hepatitis test results.
    In July 2003, during this period, the hospital lab was 
inspected and accredited by the College of American 
Pathologists. CAP officials have ensured the subcommittee that 
their inspection standards were even more stringent than those 
required by the Federal Government. Yet, the inspection did not 
identify the ongoing deficiencies in lab testing.
    Despite instrument readings showing that the test results 
might be inaccurate managers at the hospital failed to act.
    Similarly, State inspectors did not respond to a 2002 
letter from lab workers who warned of serious and longstanding 
testing problems that put patients and employees at risk.
    These problems weren't taken seriously until this year, 
when State inspectors investigating a similar warning letter in 
December from a former employee, Kristin Turner.
    State officials have confirmed the existence of the 2002 
letter. They said they took the allegations seriously but found 
them vague and did not discover the serious problems until this 
year.
    Subsequent investigations by State officials, prompted by 
the whistleblower, show 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.
    CAP has also since suspended its approval for two key 
laboratory divisions.
    The complaint that led to these findings alleged that 
machinery used in HIV and hepatitis testing was not adequately 
maintained and that possibly erroneous test results were 
provided as a result. In all of these inspections, similar 
issues were identified concerning the management and quality 
assessment processes of the laboratory that were found to be 
deficient. Each oversight entity addressed these issues but did 
not inform all the remaining involved parties of their 
findings. Therefore, each oversight entity did not have the 
benefit of the findings of the others.
    Only after the 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.
    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.
    Yet many questions remain about the full scope of this 
particular situation, as well as the potential for similar 
problems to occur elsewhere.
    The purpose of this hearing, therefore, is to gain a better 
understanding of all of the issues that led to the deficiencies 
at MGH 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 MGH are identified and given proper test 
results.
    Our first panel will include Dr. Steven Gutman, the 
Director of the Office of In Vitro Diagnostics Device 
Evaluation and Safety of the Food and Drug Administration, and 
Dr. Sean Tunis, the chief clinical officer and director of the 
Office of Clinical Standards and Quality at the Centers for 
Medicare and Medicaid Services.
    Our second panel will be Ms. Teresa Williams, a former 
employee of the Maryland General Hospital. Ms. Kristin Turner, 
another former employee of Maryland General Hospital, was also 
invited to attend but is unable to attend today's hearing due 
to illness.
    And our final panel will feature Mr. Richard Eckloff of 
Adaltis US Inc.; Dr. Ronald Lepoff, Chair of the Commission on 
Laboratory Accreditation at the College of American 
Pathologists; Mr. Edmond Notebaert, president of the University 
of Maryland Medical Center; and the Honorable Nelson Sabatini, 
secretary of the Maryland Department of Health and Mental 
Hygiene.
    Thank you all for being here today. We look forward to your 
testimony and insights on this very important issue.
    [The prepared statement of Hon. Mark E. Souder follows:]

    [GRAPHIC] [TIFF OMITTED] T7962.001
    
    [GRAPHIC] [TIFF OMITTED] T7962.002
    
    [GRAPHIC] [TIFF OMITTED] T7962.003
    
    Mr. Souder. Now I yield to Mr. Cummings for his opening 
statement.
    Mr. Cummings. I want to thank you, Mr. Chairman, for your 
cooperation and assistance in holding this hearing today. I 
must say that when this hearing was requested, you immediately 
agreed that we should hold this hearing, and we were both of 
the agreement that this is neither a Republican nor a 
Democratic issue, but this is one that concerns the safety of 
Americans when they go to visit a hospital and, particularly in 
this case, receive laboratory testing.
    One of the things that I do want to mention, Mr. Chairman, 
before I get started here, is I want to recognize my colleague 
from the State of Maryland's Senate, Senator Verna Jones, who 
has been a strong advocate of health care in our State and one 
who lives in the district where Maryland General is located and 
certainly is my neighbor.
    So I want to thank you, Senator Jones, for being here.
    I requested this hearing in March so that the subcommittee 
could explore important issues raised by a deeply troubling set 
of revelations concerning health care delivery in my 
congressional district. On March 11th, the Baltimore Sun 
reported that, from June 2002 to August 2003, Maryland General 
Hospital in Baltimore City had released more than 450 invalid 
HIV and hepatitis test results, despite error messages from the 
testing instrument indicating that the test results might be 
incorrect.
    Today's hearing is an important opportunity to examine the 
factors that led to this unconscionable situation in which 
lives were endangered by the actions or inactions of persons 
charged with protecting the public health.
    It is critical that we understand what caused the testing 
problems to occur, whether the health of any patients has been 
adversely affected, and why testing and related problems were 
not uncovered and addresses sooner by the State. Whether there 
are basic problems with the equipment used to run the tests and 
whether the instruments should have been used for HIV and 
hepatitis C testing are also important questions, as the 
instruments may still be in use in other laboratory facilities 
throughout the United States. My hope is that by airing and 
understanding these issues from all sides, we can help to 
ensure that nothing like this ever happens again in my 
congressional district or anywhere in the United States.
    Although most of this hearing will be focused on what 
happened at one laboratory in Baltimore, this controversy has 
potential implications for laboratories everywhere. Clinical 
laboratory regulation is comprised of a multifaceted network of 
State and Federal governing entities. When Congress enacted the 
Clinical Laboratory Improvement Amendments [CLIA], Act in 1988, 
it did so with the goal of ensuring that all labs across this 
country would adhere to stringent quality standards. 
Additionally, Food and Drug Administration laws and regulations 
are designed in part to ensure the safety and effectiveness of 
medical devices marketed in the United States. The severity and 
duration of the problems at Maryland General call into question 
the adequacy of the regulatory regime established to ensure 
compliance with Federal standards. States and private 
accreditation organizations also play important roles in what 
is a rather complex network that relies upon communication in 
order to be effective. The system must be attentive and 
responsive to the concerns of laboratory employees. This 
controversy was an unnecessary one that could have been avoided 
entirely if the concerns of employees had been listened to and 
taken seriously at all levels.
    We will hear today from the major entities in this 
controversy. Hearing all of their perspectives in the context 
of this hearing will help us to understand the dimensions of 
the problem and what, if any, changes to the current regulatory 
regime may be necessary and appropriate to prevent such 
problems from occurring in the future.
    On the first of our three panels, representatives from the 
Food and Drug Administration and the Centers for Medicare and 
Medicaid Services will testify concerning their respective 
roles in the regulatory regime that governs device safety and 
effectiveness in laboratory testing. On the second panel we 
will hear testimony from two former employees of Maryland 
General Hospital whose complaints helped bring this unfortunate 
situation to light. On the last panel we will hear from the 
representatives of Adaltis US, Inc., the manufacturer of the 
laboratory equipment that generated the suspect tests; the 
College of American Pathologists, the accrediting body for the 
Maryland General Hospital laboratory; the Maryland Department 
of Health and Mental Hygiene, the State regulatory agency 
responsible for ensuring compliance with State laboratory 
licensure law; and the University of Maryland Medical System, 
the parent company of Maryland General Hospital. I want to 
thank all of our witnesses for appearing before the 
subcommittee today to discuss some very difficult issues.
    As you know, Mr. Chairman, this subject matter strikes a 
very deep chord because Maryland General is a very familiar 
place for me. I live only seven or eight blocks from the 
hospital, and I have received excellent health care from that 
facility. But the health care that I received must not be the 
basis of policy for this hospital or any other. With nearly 
1,800 employees, Maryland General is a significant source of 
employment for my constituents, and it serves as a safety net 
hospital to many patients in my community. The lives endangered 
in this episode belong to the people with whom I share that 
community. From the outset, I have been concerned primarily 
about the imminent life and death consequences of the testing 
problems, but also about the message this whole affair sends to 
people served by Maryland General, as well as communities like 
it around this country.
    All patients, all patients are entitled to full faith and 
confidence in the accuracy of medical test results they 
receive. This is the fundamental promise of CLIA. In this 
instance, it was not kept, and that broken promise has an 
impact beyond the individuals who received questionable test 
results.
    Maryland General Hospital's efforts to respond to all 
dimensions of the problem are an important part of this story. 
Fortunately, their retesting efforts have shown, thus far, that 
the vast majority of the initial 460 test results were correct. 
Preliminary fears that hundreds of thousands of people might 
have received incorrect test results have been largely 
alleviated. That number remains below 2,500, and I say that we 
are fortunate. But, Mr. Chairman, luck cannot be the foundation 
of our public health system. The need for answers and 
accountability from all parties is no less compelling today 
than it was 2 months ago.
    The issues we are discussing today have life and death 
implications. I look forward to getting to the heart of these 
matters during this proceeding, and again I thank you, Mr. 
Chairman, for your cooperation in calling this hearing so 
rapidly. I also thank staff of the Republican side and the 
Democratic side who worked so hard to interview so many 
witnesses so that we would be prepared for this hearing today.
    With that, I yield back.
    [The prepared statement of Hon. Elijah E. Cummings 
follows:]

[GRAPHIC] [TIFF OMITTED] T7962.004

[GRAPHIC] [TIFF OMITTED] T7962.005

[GRAPHIC] [TIFF OMITTED] T7962.006

[GRAPHIC] [TIFF OMITTED] T7962.007

    Mr. Souder. Thank you very much.
    I ask unanimous consent that all Members have 5 legislative 
days to submit written statements and questions for the hearing 
record, and that any answers to written questions provided by 
the witnesses also be included in the record. Without 
objection, it is so ordered.
    I also ask unanimous consent that all exhibits, documents, 
and other materials referred to by Members and the witnesses 
may be included in the hearing record, and that all Members be 
permitted to revise and extend their remarks. Without 
objection, it is so ordered.
    It is our standard practice to ask witnesses to testify 
under oath, so if the first panel would rise and raise your 
right hands.
    [Witnesses sworn.]
    Mr. Souder. Let the record show that each of the witnesses 
responded in the affirmative.
    We thank you both for coming, and I will now yield to Mr. 
Gutman.

 STATEMENTS OF STEVEN I. GUTMAN, M.D., DIRECTOR, OFFICE OF IN 
 VITRO DIAGNOSTICS DEVICE EVALUATION AND SAFETY, FOOD AND DRUG 
 ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES; AND 
SEAN TUNIS, M.D., CHIEF CLINICAL OFFICER, CENTERS FOR MEDICARE 
  AND MEDICAID SERVICES (CMS) AND DEPUTY DIRECTOR, OFFICE OF 
 CLINICAL STANDARDS AND QUALITY, CMS, DEPARTMENT OF HEALTH AND 
       HUMAN SERVICES, ACCOMPANIED BY VIRGINIA WANAMAKER

    Dr. Gutman. Good morning, Mr. Chairman, and members of the 
subcommittee. I am Dr. Steven Gutman, Director of the Office of 
In Vitro Diagnostic Device Evaluation and Safety in the Center 
for the Devices and Radiological Health at the FDA. I am 
pleased to speak about FDA's role in regulating medical devices 
and to provide information regarding the Adaltis Labotech 
device.
    FDA is responsible for protecting the public health by 
ensuring the safety and effectiveness of drugs, biologics, 
food, cosmetics, medical devices, and products that emit 
radiation.
    This hearing specifically touches on FDA's medical device 
regulatory authorities. Among the broad menu of device products 
that FDA regulates are commercialized analytical tests and 
laboratory equipment intended for use in clinical laboratories. 
FDA refers to these as in vitro diagnostic devices.
    The Medical Device Amendments of 1976 gave FDA specific 
authority to regulate medical devices. FDA places every medical 
device into one of three classes depending on the degree of 
control needed to provide reasonable assurance of safety and 
effectiveness. Devices posing the lowest risk are placed in 
Class I and are subject to general controls. These include 
company registration, quality system requirements for 
manufacturing, provisions regarding adulteration and 
misbranding, recordkeeping, and reporting of adverse events. 
FDA refers to these adverse event reports as medical device 
reports, or MDRs. Class II devices, such as instruments for 
measuring glucose or hemoglobin, generally pose higher risks 
than Class I devices. In addition to general controls, they are 
subject to one or more of a wide range of special controls that 
the agency may designate. Class III devices are subject to pre-
market approval. Examples of Class III devices include new 
tests for diagnosis of cancer or serious infectious diseases 
such as SARS. Pre-market approval requires manufacturers to 
submit an application which is subject to careful scientific 
review by FDA.
    A general control applicable to all classes of devices is 
adverse event reporting. Under FDA regulations, user facilities 
are required to report device-related deaths to FDA and device-
related serious injuries to manufacturers. Of course, FDA 
encourages anyone with knowledge of a device-related problem, 
even a less serious one, to report it to us through our 
MedWatch system.
    The agency uses MDRs to help provide signals of device 
problems so it can determine whether followup is necessary. If 
FDA does followup and discovers a problem with a device, there 
is a broad menu of actions that can be taken depending on the 
problem. FDA inspects device manufacturing facilities to ensure 
conformance with requirements. The responsibility for 
inspection and oversight of clinical labs that use those 
devices lies with CMS under the CLIA program.
    As the focus of this hearing is the erroneous test results 
at Maryland General, I would like to discuss the Labotech 
device used there. The Labotech device is an automated device 
intended for use in performing controlled chemical reactions 
that are the basis of a variety of lab tests. This device can 
be programmed by each individual lab to run up to 400 test 
assays. The lab development or modification of these assays is 
performed subject to regulations under CLIA.
    The Labotech is considered a Class I device and is subject 
to general controls. FDA first cleared the Labotech device for 
marketing in 1992 and has only received one MDR, the Maryland 
General report of injury to an operator of the machine. It is 
believed that approximately 2500 of these devices have been 
placed in labs worldwide. FDA takes seriously and investigates 
MDRs reported to the agency. We are continuing to evaluate 
whether there are systemic problems with the Labotech.
    FDA first became aware of the problem with test results 
generated at Maryland General when our press office received an 
inquiry on March 19, 2004. We contacted our colleagues at CMS, 
who indicated test results had been reported without following 
usual quality procedures. FDA has remained in contact with both 
CMS and the Maryland Department of Health to share information 
and see what we can do to assist in investigating this problem.
    As an independent measure, FDA conducted an inspection of 
the Allentown, PA facility of the US distributor of Labotech. 
No serious problems were identified. Since this US site is only 
a distribution center, FDA is also scheduling a full inspection 
of the manufacturing site in Italy this summer.
    Two adverse reports about Labotech have appeared in 
European data bases. FDA is still investigating whether these 
reports should have been submitted to our data base. There is 
no evidence of continued problems in the European Union, but 
FDA expects to followup on this issue during the inspection 
this summer.
    FDA has recently initiated mechanisms for working with 
Europe to monitor post-market device performance. Problems 
identified in European Union data bases are now being shared 
with FDA.
    Mr. Chairman, FDA will continue to advance our mission to 
protect the public health by staying abreast of this 
unfortunate situation through continued communication with both 
CMS and the Maryland Department of Health. We will be following 
up on device performance issues with a planned inspection in 
Italy this summer. After that inspection we will determine if 
further investigations or actions are needed.
    I am happy to answer any questions. Thank you.
    [The prepared statement of Dr. Gutman follows:]

    [GRAPHIC] [TIFF OMITTED] T7962.008
    
    [GRAPHIC] [TIFF OMITTED] T7962.009
    
    [GRAPHIC] [TIFF OMITTED] T7962.010
    
    [GRAPHIC] [TIFF OMITTED] T7962.011
    
    [GRAPHIC] [TIFF OMITTED] T7962.012
    
    [GRAPHIC] [TIFF OMITTED] T7962.013
    
    [GRAPHIC] [TIFF OMITTED] T7962.014
    
    [GRAPHIC] [TIFF OMITTED] T7962.015
    
    [GRAPHIC] [TIFF OMITTED] T7962.016
    
    Mr. Souder. Thank you.
    Dr. Tunis.
    Dr. Tunis. Chairman Souder and Representative Cummings, my 
name is Sean Tunis. I am the chief clinical officer for CMS, 
and I am accompanied today by several staff who have direct 
oversight of the CLIA program who may be able to answer 
additional technical questions that you have.
    I thank you for the invitation to appear here this morning 
to discuss the efforts to ensure quality lab services at 
Maryland General Hospital and to find ways to prevent similar 
problems in the future.
    CMS is responsible for ensuring that all laboratories in 
the United States meet quality standards established under 
CLIA. We understand that Maryland General Hospital's lab has 
not fully complied with these standards and is now under new 
management, and they are sending HIV and hepatitis lab services 
to an outside lab.
    This morning I would like to discuss CMS's general efforts 
at ensuring laboratory quality and then the specifics of this 
case in question.
    The 1988 CLIA legislation establishes standards for 
laboratories performing tests on human specimens. CLIA 
regulations are based on complexity of test methods; thus, the 
more complicated test, the more stringent the compliance and 
oversight requirements.
    Laboratories performing tests covered under CLIA must 
register, pay fees, and if they are performing moderate and 
high complexity tests, be surveyed by one of the State agencies 
working under contract with CMS or by one of the private 
accrediting bodies whose standards CMS has accepted as being 
equal to or more rigorous than those established under CLIA. 
These labs continue to be subject to a biennial CMS survey 
process and data show that since CLIA was implemented in 1992, 
quality deficiencies in clinical labs have decreased from 35 
percent of labs with quality problems to under 10 percent with 
quality problems in recent years. And just to give you an idea 
of the magnitude of the accrediting process, in 2003, 19,000 
labs in the United States were surveyed for compliance with 
CLIA.
    When CMS finds problems during the survey, the lab is 
generally provided an opportunity to correct those problems 
prior to enforcement actions. Over the past 5 years, CMS has 
proposed 6,084 actions and carried out 487 compliance and 
enforcement actions. Overall, CLIA oversight of labs works 
extremely well, but obviously the system can be improved.
    The State surveyor for CMS in Maryland is the Maryland 
Department of Health and Mental Hygiene. Labs may also choose 
to be approved by private accrediting organizations, as was the 
case with Maryland General Hospital, who chose the CAP 
accreditation. The surveyor determines, based on observation of 
the laboratory's practices, interviews with lab personnel, and 
review of the lab's relevant documents, whether the lab is 
meeting the requirements of CLIA. Emphasis is placed on overall 
lab performance and the structures and processes contributing 
to the reliability of testing.
    Since it would be impossible to review every test and every 
document in the lab, the surveyor reviews the selected cross-
section of information to see if the laboratory has established 
and implemented appropriate mechanisms for monitoring and 
evaluating its practices. If problems identified during the 
survey or as a result of a complainer are not remedied in a 
reasonable amount of time, CMS can impose various sanctions, 
which may range from onsite monitoring to fines to loss of 
Medicare reimbursement.
    Maryland General's lab is accredited by the College of 
American Pathologists and is located in a State with a 
laboratory licensure law. Labs must meet both CLIA and State 
requirements. The routine biennial inspection was performed by 
CAP in April 2003. The State of Maryland had also conducted a 
CLIA survey based on a compliant in November 2002. In both of 
these inspections, similar issues were identified concerning 
the management and quality assessment processes of the 
laboratory that were found to be deficient.
    Each oversight entity addressed these issues but did not 
inform all of the remaining involved parties of their findings 
and did not followup to ensure that these problems were 
resolved. In retrospect, this was clearly a serious problem. 
Only after the December 2003 complaint did the State survey 
agency that pinpointed a specific problem area to investigate, 
and CMS recognized the severity of the issue, did all of the 
entities involved communicate their findings to each other.
    It should be noted that Maryland General stopped HIV and 
hepatitis testing in August 2003, a few months after the CAP 
survey, having recognized problems with their tests. In March 
2004, the Maryland General Hospital lab was surveyed by CMS, 
the State of Maryland, the Joint Commission on Accreditation of 
Health Care Organizations, after CMS was notified of serious 
problems with the lab.
    Because of these problems with Maryland General's lab, CMS 
notified the hospital that the lab was no longer deemed to meet 
the CLIA conditions by virtue of its accreditation by CAP. CMS 
placed the lab under the jurisdiction of the Maryland State 
agency and the hospital was given 10 days to respond with a 
plan of correction. Maryland General has submitted a 400 page 
plan of correction that is currently under review by CMS.
    When viewed in the larger context of CLIA survey work and 
enforcement, the problems at Maryland General Hospital are 
fortunately atypical. Typically, the clarity of the hospital 
regulations, coupled with regular oversight, has resulted in 
high quality lab services in the United States. However, as a 
result of this experience at Maryland General, CMS is 
developing a plan for tighter communication protocols to 
coordinate activities among the State agencies surveying on 
behalf of CMS, the CMS regional offices, and the accrediting 
organizations. CMS is also specifically addressing the 
communications process for complaints and accreditation 
organization validation surveys through its State agency 
Performance Review Program.
    These strengthened processes will be communicated through 
training and the pre-approval process. This improved 
communication will ensure that entities performing reviews of 
lab services are aware of complaints and deficiencies that each 
has found so that a pattern of problems over time can be 
readily identified and a reoccurring of a situation like that 
occurring at Maryland General can hopefully be avoided.
    Thanks for the opportunity to appear before the committee, 
and I am available to answer any questions that you have.
    [The prepared statement of Dr. Tunis follows:]

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    Mr. Souder. Thank you very much.
    Maybe I could start with Dr. Gutman. As I heard both your 
testimonies, my understanding is that you don't believe it was 
predominantly caused by poor equipment, it was caused by poor 
management?
    Dr. Gutman. That is correct.
    Mr. Souder. Were the problems that you saw in the European 
examples similar?
    Dr. Gutman. No. I didn't see a similarity between the 
issues that were going on in this particular episode.
    Mr. Souder. Were you aware of any other circumstances where 
the lab equipment utilized at Maryland General Hospital had 
produced faulty results, or was it just limited to HIV and 
hepatitis?
    Dr. Gutman. I was aware only of those two.
    Mr. Souder. Has there since been any checking to see if 
there was anything else?
    Dr. Gutman. We have looked in our data bases and found no 
other reports.
    Mr. Souder. One suggestion was that the lab equipment used 
at the hospital may have been manipulated to disguise deficient 
test results. Is this possible? And, in general, are diagnostic 
tools vulnerable to manipulation?
    Dr. Gutman. It is possible, and, actually, it is acceptable 
practice to modify products. That is not unusual. It is 
unusual, however, to do it and not to be on top of it, not to 
do it well.
    Mr. Souder. So what are you saying?
    Dr. Gutman. Laboratories have a fair amount of freedom in 
modifying or in establishing variations to tests. There is 
nothing wrong with that, but it should be done in a high 
quality system.
    Mr. Souder. If they modify a machine that has been cleared 
by you for safety purposes, when they modify it, do they have 
to go through FDA?
    Mr. Gutman. I am sorry, I didn't mean that they would 
modify the machine. They could modify the assay. The machine 
can't be modified.
    Mr. Souder. So they can modify the results that come to 
you? I didn't understand the word.
    Mr. Gutman. They can set up the parameters. This machine is 
an open system that actually encourages you to set up 
parameters for a particular assay, so they can set the way in 
which the electric eye reads or they can set the incubation 
time for an assay, or they can set the amount of chemical 
delivered for an assay. This machine lends itself to those 
kinds of modifications.
    Mr. Souder. And can those kinds of modifications give 
substantially different results that can lead to people being--
in other words, if you are clearing--pardon me, because this is 
a new area for me.
    Dr. Gutman. Sure.
    Mr. Souder. I wouldn't say I am medically stupid, just 
medically ignorant, which amounts to about the same thing in 
asking the questions.
    But if you are clearing the machine to see that it gives 
accurate readings, and we have a problem that the readings are 
coming back and we have concluded that it is the lab making the 
mistakes, in effect, could these machines actually be not 
working around the country, but people modifying those 
parameters to give false readings that would make you think all 
the machines are working?
    Dr. Gutman. Well, that, I think, is what happened in this 
case, that is, a deviation from normal laboratory practice, 
which would preclude that from happening.
    Mr. Souder. And so when you audit--and maybe Mr. Tunis 
could respond to this. When you audit, are you looking to see 
whether they have altered parameters, when you are checking? 
Because you have confused me as to we have a Federal standard, 
but then we have to see how they are using that standard and 
what they are doing in the results. Otherwise, it wouldn't do 
any good to have a machine if there are flexibilities that can 
make the machine's data inaccurate if you manipulate it.
    Dr. Tunis. I think the survey process is generally reliant 
on, as I said, more of the integrity of the process in place in 
the lab to identify problems and correct them, and also reliant 
on the document that is provided. So if there are in fact 
alterations in the documentation to hide errors, there truly is 
no way for the survey process to detect those kinds of changes. 
So there is a presumption made that, in a well-managed 
laboratory, the information provided about the performance of 
the machinery accurately reflects the experience with those 
devices.
    Mr. Souder. In your testimony you said they have now 
contracted this out to a well-managed laboratory. Is that 
another independent hospital? Do you certify that? Have you 
worked with them before?
    Dr. Tunis. It is an independent laboratory that is 
accredited and approved and has had no history of problems, so 
there is no reason to believe that there are issues with that 
laboratory.
    Mr. Souder. Thank you.
    Mr. Cummings.
    Mr. Cummings. Thank you very much, Mr. Chairman.
    Mr. Gutman, tell me how this Labotech became classified as 
a level I, low level. And what does that mean?
    Dr. Gutman. This is a Class I because it is used as a 
general purpose instrument or tool. And what it means is that 
it is a general instrument that operates according to certain 
specifications; that it can pipet a certain amount of reagent, 
that it can incubate or heat the reaction for a certain amount 
of time, that it has an electronic eye that will read chemical 
reactions. So it is a general purpose instrument. But its 
specific use is determined by the lab that would put chemicals 
onto that machine and would use that machine, and it is largely 
regulated through the quality requirements that would indicate 
that if in fact it is pipetting, dispensing one milliliter of 
material, that it actually does dispense one milliliter of 
material within a reasonable specification. If it reads 
chemical reactions in a particular wavelength, that it actually 
reads them at that wavelength.
    So it is viewed sort of like a surgical scalpel. It is more 
complicated, but it is like a surgical scalpel; it can be used 
to remove a wart, it can be used for open heart surgery, but it 
has sort of a general purpose use. And the person who is 
manning the scalpel or who is using the instrument makes a lot 
of determination in how that is actually used.
    Mr. Cummings. Does FDA have a recall process? At some 
point, when you see certain problems that you can recall?
    Dr. Gutman. Absolutely. We have a recall process that 
allows us to work with companies to--we actually have a very 
broad menu of regulatory choices when problems occur. Sometimes 
you simply send out safety notices or labeling corrections; 
sometimes you would actually recall and have the product 
physically removed; sometimes you would have some kind of 
software or instrumentation fixed. If the company is 
cooperative, we like to try and work with the company to deal 
with the issue. If the company is non-cooperative, we have a 
wide variety of enforcement choices: seizures and injunctions 
and fines and criminal penalties. So there is a very broad menu 
of things we can put on the table hopefully to collaborate with 
companies to resolve problems, but, if necessary, to lean on 
them a little bit to solve problems.
    Mr. Cummings. I think that you said, with regard to 
Labotech, you had received a complaint in the United States, 
and that was from Maryland General, is that right?
    Dr. Gutman. That is correct.
    Mr. Cummings. What was the date of that?
    Dr. Gutman. I am sorry, I don't know the exact date.
    Mr. Cummings. Was it this year?
    Dr. Gutman. Yes.
    Mr. Cummings. And where is that; where does that stand 
right now? In other words, when you receive a complaint, what 
do you do?
    Dr. Gutman. We would evaluate the complaint and make a 
decision whether further action is necessary. We would look to 
see if it is the only complaint; we would look to see the 
severity of the complaint; we would look to see the 
circumstances of the complaint; and then we would determine 
appropriate followup based on that.
    Mr. Cummings. Can you tell us the status of that complaint?
    Dr. Gutman. That complaint has been reviewed and is being 
held while we continue to gather information. We are very 
interested in seeing, when we go to visit the Italian firm, if 
that is an isolated complaint or if there are other complaints 
like it.
    Mr. Cummings. You said when you visit the Italian. Tell me, 
where are you going to go in Italy?
    Dr. Gutman. I don't know the location of the company.
    Mr. Cummings. In other words, you are going to the company. 
OK.
    Dr. Gutman. We have plans to actually have an inspection of 
the quality system for this company. It is scheduled for either 
late June or early July.
    Mr. Cummings. So it is quite possible that you may recall 
this machine?
    Dr. Gutman. Anything is possible, but there have been very 
few signals that would suggest this is actually a systemic 
problem. So I don't want to speculate on how the outcome will 
be.
    Mr. Cummings. And I don't want you to. I just want to see 
exactly where you are. The thing that we are concerned about is 
trying to figure out whether or not our controls at FDA are 
sufficient and the regulations are sufficient to make sure that 
you can do the job that you need to do. And I am just curious 
as to how you feel about your tools for making sure that these 
kind of things don't happen.
    Dr. Gutman. I think we have good tools. They are not 
perfect tools and there are opportunities for people to under-
report or to misreport, but I think in general our tools are 
appropriate and, in general, effective.
    Mr. Cummings. Let me ask you, Mr. Tunis. You said something 
that I found on page 9 of your testimony, I think. You talked 
about changes that need to be made and what you all were 
looking at as far as changes, and I took it that it is as a 
result of this episode. Do you have your testimony there? On 
page 9 it says: ``However, as a result of this experience at 
Maryland General Hospital, CMS is developing a plan with 
tighter communication protocols to coordinate activities among 
the States with licensure programs, the State agencies 
surveying on behalf of CMS, the CMS regional offices, and the 
accrediting organizations.''
    I guess what I am trying to get to is does that--why don't 
you go ahead and explain why you are doing that and why does it 
come as a result of this episode. I assume that is what you 
were saying.
    Dr. Tunis. That is correct. And I think the explanation, in 
part, emerges from the timeline that you can see on the next 
page of the testimony, which sort of outlines surveys that have 
been done, back to November 2002, of the Maryland General 
Hospital lab. And in November 2002 there were some issues 
identified in terms of the lab director responsibilities and 
quality assurance. When the College of American Pathologists 
surveyed in April 2003, found similar deficiencies, and in the 
absence of having these entities able to communicate more 
freely about patterns of deficiencies over time, it is less 
easy to identify those laboratories that have a single 
deficiency that they correct versus ones that may have a 
pattern over time of having had deficiencies and not correcting 
those deficiencies. In fact, the plan of correction that was 
proposed by Maryland General in November 2002, my understanding 
is that the plan of correction was never implemented. The 
hospital did not ensure that the implementation occurred, and 
none of our organizations also took the step of ensuring that 
those changes had been made. It is possible that some time 
could have been saved by better communication about what was 
going on.
    Mr. Cummings. So you had a situation where the right hand 
didn't know what the left hand was doing and the head didn't 
know what either hand was doing. That is what it sounds like to 
me.
    Dr. Tunis. Well, again, there are an extraordinarily large 
number of these labs that are being surveyed. There are a fair 
number of quality problems that are of a minor nature that are 
identified, so there is potentially a lot of information that 
needs to flow. But you would certainly want to be able to 
extract out of all of that information the patterns of 
recurring problems that would separate out true potential for 
patient injury from minor deficiencies that can be corrected. 
And in this case one would hope that we could set up some form 
of communication such that if a problem is identified in 
November of a given year, 4 months later similar problems are 
identified by another organization that is trying to do the 
same thing of ensuring lab quality, that information comes to 
people's attention and the kinds of intensive survey that we 
actually did in March 2004 would have occurred much earlier and 
potentially have prevented some poor lab results.
    Mr. Cummings. Well, our job here is to try to come up with 
solutions to problems, and we want to make sure that if there 
is something that the Congress needs to be doing to help you 
accomplish what you just said, that we do it. Do you need any 
regulatory authority for you to be able to accomplish what you 
just talked about?
    Dr. Tunis. My understanding at this point is that we have 
existing regulatory authorities through which a significant 
amount of this can be accomplished, but we are fairly early in 
the problems-solving stage in terms of what we need here. And 
if there are in fact some barriers in terms of information 
sharing between the organizations that need to share 
information, I would suggest that would be a place where we 
would advise you that there are limitations on regulatory 
authority that need to be addressed. What those are right now, 
I can't identify for you, but our plan would be to do that.
    Mr. Cummings. Thank you.
    Mr. Souder. I'd like to ask a couple more questions on how 
whistleblowing works. In effect, is the only way you learned 
about this because of a type of whistleblowing complaint, in 
other words, an employee went outside the normal system to 
complain?
    Dr. Tunis. Well, there are existing mechanisms for 
employees to register complaints with the State agency as well 
as with CMS, including the opportunity when lab personnel are 
actually interviewed during surveys there is an opportunity to 
raise any issues that the lab personnel may have encountered. 
There is also lots of information on the Web site that provides 
contact information where problems can be reported. In fact, my 
understanding is that in this case problems were reported 
through existing channels and simply not acted on at the 
hospital level, at the laboratory level. So I am not sure that 
it is an absence of ability to report problems to places they 
can be acted on, but obviously failure to act will not lead to 
the correction of those problems.
    Mr. Souder. Well, Dr. Tunis and also Dr. Gutman, my 
question would be, I think it was in Dr. Gutman's testimony 
that the first complaint you didn't know the level of the 
complaint or how serious it was. What triggers a fast response 
from the FDA's side of this could be a device problem that 
could be in every lab in the United States, or it could be a 
Maryland lab problem where people are either being told they 
have HIV or told they don't have HIV, could be dying as a 
result of that decision? What gravity, what level triggers a 
response?
    Dr. Gutman. Certainly the information that we have based on 
that single event, which appears to have been difficult for the 
company to duplicate when they did their health hazard analysis 
or their design analysis, and which appears to have perhaps 
occurred under conditions of use that would not actually 
normally be expected. Based on the information we have now, we 
have not taken action. The fact that we have not taken action 
would suggest that at least, based on the information that we 
have now, we don't think that it would be appropriate to take 
action. As we gather more information, that assessment may 
change.
    Dr. Tunis. And on the CLIA regulatory side, as well as the 
State side, you know, the November 2002 survey was triggered by 
a complaint and, in fact, that survey did identify some 
problems; a plan of correction was developed and proposed; it 
simply wasn't implemented. So there was, I think, a pathway by 
which the complaint could have been addressed and resolved at 
that point in time. Similarly, although much later, in December 
2003, a complaint was filed with the State. The State actually 
undertook, in January 2004, a survey and identified additional 
problems. It is my understanding that the full extent of the 
problems, which gradually emerged, was somewhat difficult to 
determine based on the records that were available to review. 
So in terms of being able to identify the urgency of the 
situation, again, some of that goes back to the integrity of 
the information that is available on this.
    Mr. Souder. So if you would have had the information you 
had toward the end at the beginning, you would have acted to 
discontinue their testing more rapidly? Or would you have had 
not to have that authority? In other words, looking at this 
just from a layman's standpoint, for people who are watching or 
just a Member of Congress who is looking at this, we are 
obviously going through a similar question like this in Iraq 
right now, that somebody does a complaint, people look at it, 
they try to decide how quick they are going to respond, they 
learn there is a picture, then they do a report. What about if 
the local guy doesn't do it?
    At what point do you say this is grave enough that we are 
going to shut it down right now? And do you have the authority 
to override the State to do that? If you had known what you 
know now, would you have acted immediately or would you have 
waited from April to August, waited until the next year? I 
don't understand what the trigger is. Is this always going to 
be, even if it is a test that could put people's lives at risk, 
something that is going to take us a year to get to the 
shutdown of the testing?
    Dr. Tunis. This is Virginia Wanamaker.
    Mr. Souder. I need to have you state your name and spell it 
for the record, and I need to swear you in.
    Ms. Wanamaker. Virginia Wanamaker, W-A-N-A-M-A-K-E-R.
    Mr. Souder. Would you raise your right hand? I need to give 
you the oath.
    [Witness sworn.]
    Mr. Souder. The record will show the witness responded in 
the affirmative.
    Ms. Wanamaker. I am going to speak to your question about 
when we would have reacted with the information. Back in 2002, 
the type of information that was available did not speak to the 
specific issue. In December 2003, when the information that 
spoke specifically to the issue of the type of testing, which 
pinpointed the area to look--had we or had the State or had the 
accrediting body or CMS had that information in 2002, yes, the 
answer is we would have acted immediately to cease that testing 
in that laboratory, had we known what was going on at that 
time.
    Mr. Souder. And you could override the State and do that?
    Ms. Wanamaker. CMS has the ultimate authority for the CLIA 
survey.
    Now, the State of Maryland has a separate State licensure 
law. They could do the same thing or different things under 
their State licensure law, but as far as the CLIA aspect and 
the State working for CMS under the CLIA survey, yes, the 
regional office has the authority to call what we phrase an 
immediate jeopardy, an immediate threat to public health and 
safety, and we can have a laboratory cease testing.
    Mr. Souder. So as I understand it, and see if I have kind 
of the basic layout as we move into this hearing, the FDA 
clears the equipment that as you hear of complaints or things, 
you will check that, decide whether the equipment is being used 
properly and basically whether the equipment is safe. And in 
this case you decided, thus far, you are continuing to 
investigate it, but it was primarily a technician failure.
    From Mr. Tunis' standpoint, that with the parameters of the 
equipment, it is possible that people can report false results 
and, basically, while you will followup on complaints and you 
will check the surveys, that basically phony data will lead to 
phony conclusions, and you are really dependent upon 
whistleblowers and complaints somewhere in the system, either 
to the hospital, to the State, or to the Federal Government to 
stop that. But if the complaints are serious enough, the 
Federal Government has the ability to step in and override the 
local.
    Dr. Tunis. That is correct. And I would also make the point 
that if there is that kind of activity going on in the 
laboratory, it may very well be detectable through the other 
aspects of the survey process, which look at the quality 
assurance activities of the laboratory, other aspects of 
laboratory process, interview with personnel. So even though 
you may not be able to identify a specific issue with a 
specific device, there usually would be other clues about 
overall laboratory management and processes that would also be 
triggers for action.
    Mr. Souder. If people manipulate results, are there 
criminal sanctions?
    Dr. Tunis. I don't think we have the answer to that 
question.
    Mr. Souder. Thank you.
    Mr. Cummings. Would you recommend that there be criminal 
sanctions, particularly in an instance where people may be 
getting the wrong results and may be going out and spreading 
disease, thinking that they don't have the disease?
    Dr. Tunis. You know, I think I honestly can't make a 
judgment about the appropriateness of criminal sanctions.
    Mr. Cummings. Well, let me ask you this way. Do you 
consider such actions, that is, when people manipulate results, 
do you consider that to be a very serious situation?
    Dr. Tunis. You know, obviously from a clinical perspective, 
the reliability of laboratory test results in important 
clinical problems like HIV and hepatitis are of very high level 
of significance, so it is obviously a non-trivial problem.
    Mr. Cummings. That means it is a serious problem.
    Dr. Tunis. Yes, sir.
    Mr. Cummings. And so how soon can you all get us 
information with regard to that question of criminal penalties 
for this? I would think that you would know that, by the way.
    Dr. Tunis. For violation of the accreditation, we have the 
ability to impose civil money penalties. I have not head of any 
authority to impose criminal penalties under the CLIA 
regulations. But we can verify that for you probably very 
quickly, within a day or two.
    Mr. Cummings. Let me ask you this. Mr. Sabatini, the 
Secretary of Health, said in a Sun paper article in an 
interview, something to the effect--and he is here, so he will 
correct me if I am wrong--he said something to the effect that 
the Feds never close down anybody anyway, as if to say that the 
Federal Government just doesn't close down labs. And I am just 
wondering is that accurate? Have you ever done it?
    Ms. Wanamaker. Yes, we have closed labs. In fact, there 
have been sanctions against 45 labs in 2002. So there are, from 
time to time, labs that are closed, labs that cannot respond or 
do not respond, do not send an appropriate plan of correction, 
just can't seem to get beyond their problems. And, yes, we take 
sanctions or actions against those laboratories.
    Mr. Cummings. I am going to come back to you all. I want to 
go back to Mr. Gutman.
    Mr. Gutman, tell me something. Are you aware of any FDA 
problems experienced with Labotech in other countries?
    Dr. Gutman. I am, actually. I am aware that there were 
problems reported in the UK in 1996 and in 1999. I am not aware 
of any more recent reports.
    Mr. Cummings. And I take it the 1999 report, which I have a 
copy of, it says, in part, ``We have considered the risk 
assessment together with the possible implications of a false 
negative result for clinical management and have a number of 
recommendations on the need to repeat testing.'' And it goes on 
to talk about the problems with this machine.
    You are familiar with that?
    Dr. Gutman. I am familiar with that report.
    Mr. Cummings. As you go through and try to determine 
whether there was a major problem with this machine and whether 
it should continue to be used, do you take that into 
consideration when you are looking?
    Dr. Gutman. Absolutely. We would be very interested in 
understanding why that was not reported to FDA, it actually 
should have been, and what actions were taken to correct that 
problem.
    Mr. Cummings. I want to go back to something the chairman 
said to all of you. At what point does this matter become an 
urgent situation? In other words, if you have people walking 
out of a hospital who are told that they don't have HIV/AIDS 
and they do have it, and then you are getting information in, 
at what point? It sounds to me, Mr. Gutman, like this may be a 
decision that might be made next year.
    Dr. Gutman. Well----
    Mr. Cummings. No, let me finish. I am almost finished. And 
the thing I don't understand is do we need to put some urgency 
into your regulations so that you all can act much more 
quicker? Because that person who is suffering and that person 
who is told that they do have AIDS and they don't, or vice 
versa, that is a major problem, and it is an urgent situation. 
It seems like we are just kind of sitting around, watching 
things go by, and people could be possibly going out there 
spreading this disease and bringing harm to other people and 
not even know it, and it is not their fault.
    Dr. Gutman. Yes. I guess we do take this very seriously, 
and we have scheduled this foreign inspection as quickly as we 
can; it is the highest priority we were able to take. I must 
say that although we take it seriously, and I don't wish to 
prejudge, the fact that there have been no European reports 
since 1999, the fact that there have been no adverse reports to 
FDA, the fact that we have actually looked at the published 
literature and seen reports, but they seem to suggest the 
device works fine; we have monitored list service; this event 
was reported, there were no additional complaints. We actually 
don't have a signal to suggest that--and based on the 
information that this appears to be a quality lapse of the lab, 
not a problem of the machine, although we are taking this very 
seriously, we do not have actually the expectation that this is 
fundamentally an instrument failure. We would argue, actually, 
the fact that the instrument was providing information 
suggesting it was out of control, it was giving quality control 
error signals, that the instrument was doing what it was 
supposed to do, which is signal that something was wrong.
    Mr. Cummings. Same urgency question, Mr. Tunis.
    Dr. Tunis. Some perspective on that question, obviously, is 
the laboratory did, as I mentioned earlier, in August 2003, 
discontinue use of this machine. At that point in time there 
was no information that we had had from either the State survey 
in November 2002 or the CAP survey in April 2003 that problems 
of this seriousness and significance existed. And, again, I 
would go back to saying that you can only do as good a survey 
as the documentation allows you to do. So by the time the 
additional complaint was made in December 2003, and a great 
deal of attention was focused on that and a lot of things have 
rolled out since then, the immediate peril associated with the 
machine had been addressed by discontinuing the use of the 
machine.
    But I think you ask a very valid question, which is, is 
there something more we should have known in November 2002, 
April 2003 that would have given us a greater ability to look 
more closely and identify this problem at those points in time. 
And, again, I can say that is something we are looking at very 
closely and trying to answer exactly that question.
    Mr. Cummings. Just one real quick question, Mr. Chairman.
    Do you have faith in the College of American Pathologists 
to do this job? Mr. Sabatini had expressed to me in a 
conversation that he was concerned about whether we are getting 
valid results from the college. Do you have faith?
    Dr. Tunis. I do, and it is not just based on a general 
feeling, it is based on that every year we do a validation 
survey of our own, checking on 5 percent of the labs that are 
accredited by the private accrediting organizations and look 
for any systematic deviations in the results that they get and 
the results that we get independently. And we have not found 
reason to have any systematic problems with the College of 
American Pathology accreditation process.
    Mr. Souder. I want to thank our first panel.
    We have four votes going on, so we are going to take a 
recess. Hopefully it will be no longer than 20 minutes, but it 
could be as long as 30 minutes.
    With this, we stand in recess.
    [Recess.]
    Mr. Souder. The subcommittee will come to order.
    Ms. Williams, will you stand and raise your right hand?
    [Witness sworn.]
    Mr. Souder. Let the record show that she responded in the 
affirmative.
    Thank you for your patience, and we will now hear your 
testimony.

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

    Ms. Williams. Good morning, Mr. Chairman and Mr. Cummings. 
My name is Teresa Williams, and I am a health care worker. I 
come here today to represent the voice of the countless victims 
of the atrocities that took place at Maryland General Hospital. 
I speak for the patients, the public, and the workers.
    I am here to put a face to one of the many who came forward 
then and now, who look beyond job security and stepped outside 
their comfort zone and was willing to fight for those who were 
unaware that their health was at stake, for those who deserved 
so much better.
    In light of all the information that has been uncovered by 
the State and other government investigators, does it frighten 
you that only Kristin and I have come forward publicly? If it 
doesn't, it should. The information that we were privy to pales 
in comparison to the information that others could and should 
have come forth with. I suppose that is a cross that they will 
have to bear.
    I don't have to argue as to whether there were problems 
with the quality of care at Maryland General Hospital; you know 
that. I don't have to argue as to whether the patients, public, 
and workers were put at work; you know that. I don't have to 
argue as to whether the instrumentation malfunctioned and had 
problems; you know that too.
    I am hoping that my experiences, Kristin's experiences, 
along with a few others who are now willing to come forward to 
speak of what they witnessed at Maryland General Hospital will 
once and for all bring closure to the Maryland General Hospital 
event and will help to prevent this from happening anywhere 
ever again.
    Hopefully, after this collective body has adjourned, there 
will be a clearer understanding of the culture and mind-set 
that existed 2 years at Maryland General Hospital when I worked 
there.
    There are certain assumptions that we all make on a daily 
basis. When we board a plane, we assume that the engine is 
working properly, or the airlines wouldn't let it off the 
ground. We assume that when we eat at a restaurant that the 
food is safe for human consumption.
    As a health care worker, when you work for an organization 
and you recognize, identify, and inform your superiors of 
impending danger, the assumption is that something will be done 
to correct the problem. As a patient, you assume and trust that 
your doctor, the hospital, and all those involved with your 
health care will do their best to make sure that you are 
provided the treatment necessary to enhance your lives. As a 
public, you assume that there are practices, policies and 
safeguards in place to prevent harm to you as an unsuspecting 
public.
    As a new lead tech at Maryland General Hospital, I listened 
to the voices of those who worked diligently alongside me. 
After working there and through my own observations, I found 
that their concerns and complaints were not without merit.
    As a new employee and someone who has worked in an 
environment that encouraged problems to be reported so that the 
necessary changes could be made to prevent further harm to 
those who we were being paid to serve, I found this very 
troubling. One of the documents that I submitted was my March 
2004 letter is one from an employee to the then-director, which 
speaks of her frustrations and despair. She and I, along with 
others, talked about the problems and ways to correct them, but 
felt as though no one cared or listened.
    My feeling was, and still is, if you have legitimate 
concerns and can prove them, and can assist in providing 
solutions, then there is someone out there who does care, who 
will listen, who has to act.
    We took our concerns to our superiors individually and 
collectively to make them aware of the conditions in the lab 
and to let them know that this was not fair to the patients. We 
let them know the problems with the controls. We complained of 
our fears about the questionable results, the dangers of the 
Labotech and other instruments, and how we were fearful of 
patient harm. This happened on m any occasions during my employ 
at Maryland General.
    As time went on, I realized that this disorder and 
resultant desperation was so entrenched and had become a 
culture, a mind-set that was resigned to the fact that nothing 
will change and this must be the norm.
    Many said, ``don't make a fuss, just do your job and leave 
at the end of the day.'' How could I do my job? How could any 
of us do our job? Our job was to serve our patients. Our job 
was to provide them the type of care that any one of us would 
have demanded.
    There were many who truly believed that things could be 
better, so we continued to voice our concerns and to fight.
    Kristin, who is not here, and I are just two faces, two 
lives, and two souls committed to quality health care at 
Maryland General Hospital.
    If some bushes have been shaken, then let the bad fruit 
fall where it may.
    I find solace in the fact that it is now in the hands of 
those who do care. The public's health is in the hands of those 
who are committed to fixing the problems. The public can now 
rest assured that their welfare and health is not being 
protected by those who are willing to take whatever steps are 
necessary to protect them.
    I applaud Maryland Secretary of Health Nelson Sabatini for 
his relentless efforts to uncover, investigate, and eradicate 
the ``broken systems,'' at Maryland General Hospital. If the 
State had been furnished all the necessary information and were 
informed of all the problems when they made their 2002 
inspection of Maryland General Hospital, there wouldn't be 
thousands of questionable results, retests, and loss of public 
confidence, and I feel that Kristin Turner would not be HIV-
positive today.
    My understanding of what takes place when the State comes 
in to inspect was that everyone had to provide everything and 
anything necessary to uncover problems; that workers were 
automatically protected from retaliation, therefore, they were 
free to speak about their concerns with immunity. If the 
hospital had taken the lead in being forthcoming when the State 
came to inspect in 2002, then that would have set the stage for 
the workers to follow suit. This awful cycle of improper health 
care would have halted 2 years ago, well before Kristin Turner 
was infected. The assistance and guidance that is now being 
provided by the State would have put in place the proper 
systems of checks and balances that were not in place then.
    But because Maryland General Hospital chose to tie the 
hands of the State and not ask for the much-needed help that 
was required to correct the problems, they have created a 
climate of public distrust and loss of confidence in the health 
care system as a whole. I would just ask everyone here today to 
take a moment and think of someone that you truly love, a 
parent, spouse, child, other family member or friend. Would you 
have allowed that loved one to be treated at Maryland General 
Hospital if you knew what was taking place?
    Isn't it a blessing that you have the luxury of being able 
to make that decision? Unfortunately, there are thousands that 
didn't have that option.
    I have to grapple with this every day. What more could I 
have done? Maybe if I had fought harder, fought longer, 
screamed louder, maybe it would have made a difference. But the 
ability to exact change was beyond my reach. When I left, I was 
discouraged, distraught, and broken.
    This is a golden opportunity for Maryland General to do the 
right thing now. If they are truly committed to correcting the 
problems, then provide a forum whereby no one is afraid to 
expose all their concerns; allow them to be questioned by State 
and government agencies without the presence of hospital 
administration or hospital lawyers. Take this opportunity to 
fix the problems that plague the hospital once and for all.
    The following is a list of some recommendations that I have 
made. Should I present those also?
    Mr. Souder. Why don't you go ahead and read them?
    Ms. Williams. OK.
    No. 1 is to make patient, public, and employee safety a No. 
1 priority; devise a system that demands and encourages the 
bottom line to be health care-driven as opposed to dollar-
driven; institute a system of checks and balances on all 
levels, where there is a direct accountability for problems and 
for their resolution; create a citizen review board that 
includes people from all sectors of the community that has some 
oversight over the hospital operations; employ a risk 
management representative in each department who is available 
to address any complaint or concern at the root level, and let 
this person be accountable and report directly to the risk 
management director; have focus groups where employees can 
discuss their concerns openly; develop a problem-tracking 
system that documents a problem and tracks it from the initial 
complaint to its resolution; use a SIX SIGMA program as a 
template for health care excellence. This program was started 
by General Electric in the 1990's and was designed to address 
and improve issues that are critical to quality. It has already 
been adopted in the health care industry. Include your ``ground 
troupes,'' the people who actually are responsible for carrying 
out the duties, in the decisions made regarding each 
department; ensure that continued monitoring and recordkeeping 
of OSHA reportables is present so that problem areas can be 
easily identified, addressed, and resolved in a timely manner.
    These recommendations are easily achieved and extremely 
cost-effective; they will save millions of dollars in 
litigation, retesting, and costs incurred to restore public 
confidence.
    [The prepared statement of Ms. Williams follows:]

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    Mr. Souder. Thank you. Next we are going to do something a 
little unusual.
    If Malia Holst could come forward. She is the 
subcommittee's clerk. It is M-A-L-I-A H-O-L-S-T. She is going 
to read Kristin Turner's statement, who was referred to in the 
last testimony, and who is ill and could not come to read her 
statement.
    Ms. Holst [reading]. Thank you for inviting me to testify 
at this very important hearing. I am sorry that I cannot attend 
in person, but I have become ill and was unable to travel to 
Washington. I hope these comments are of some help to you as 
you consider these important matters.
    In March 2003 my life was forever changed because of the at 
best irresponsible conduct of a hospital and a biomedical 
equipment company. The focus of this hearing is not what 
happened to me, but rather why the hospital and company were 
allowed to engage in such dangerous practices.
    There are two immediate things I hope are achieved through 
this hearing. First, I am not sure how much emphasis is being 
placed on the issues surrounding the Labotech. This is the 
instrument that in my view was designed poorly and dangerously, 
resulting in unreliability, inaccuracy, and injury. I am now 
aware that there have been international warnings issued 
regarding the lack of reliability of the results because of 
both mechanical and programming errors. Maryland General 
utilized three different Labotechs during the time of my 
employment, and all three consistently malfunctioned and failed 
runs. Adaltis, the distributor of the machines in use at 
Maryland General Hospital, was responsible for repairing the 
machines and many times each month sent people in to ``fix'' 
the machines, yet they were never able to be used for more than 
2 to 3 days after each repair without having more problems.
    The most frightening and consistent malfunction to occur 
with the Labotech was missed samples. Missed samples means that 
a patient's sample was not dispensed onto the test plate, and 
therefore a negative result was obtained. In reality, the 
machine never performed the test. The negative result obtained 
could possibly have been a ``false negative.'' There is no way 
of knowing how many ``false negatives'' have been reported to 
patients. The thought of patients being delayed prompt 
treatment and unknowingly spreading a disease they were just 
tested for because of a false negative is frightening.
    The problems with the Labotech are not related to any 
individual instrument, the problem is in the design and the 
programming. Adaltis must be required, since they apparently 
haven't taken the proper steps on their own, to remove every 
Labotech from service and hire an outside company to inspect 
each instrument for safety and reliability before it is allowed 
to be put back into use. There are over 2,500 Labotechs 
currently in use in the United States. The number of 
potentially inaccurate results being reported out to patients 
each day because of instrument malfunctions is staggering. 
Please take some action to protect the public from this 
machine. There must be more stringent requirements enforced 
before allowing an instrument like the Labotech to be released 
and put into use.
    The second action I hope is taken is to make sure that 
better oversight is put in place for hospitals and hospital 
labs. The problems at Maryland General stemmed from a lack of 
accountability at every level in administration and a grave 
disregard for the health and safety of the people in the 
community. In the laboratory, one man was allowed to choose 
profit over patient safety, and his actions were never 
questioned by his superiors, making them just as responsible 
for the multitude of problems that resulted from his decision. 
Patients were provided less than optimal care, and were 
provided results from a machine that he knew was unreliable and 
unable to be validated. He demanded that the results be run in-
house instead of sent out, even with the equipment problems, 
because the Labotech was the ``money-maker'' for the 
laboratory, and to send out tests would have cost the hospital 
money. In my view, his conduct was a betray of the community's 
trust which the administration allowed to continue.
    He also refused to provide a safe environment for the 
employees in the lab. By refusing to replace a defective piece 
of equipment, the Labotech, and inform the employees of the 
seriousness and longstanding malfunctions, he knowingly placed 
employees in harm's way. On March 12, 2003, the instrument had 
a major malfunction, exposing me to blood. I did everything I 
was instructed to do, from the protective equipment I was 
wearing to how I handled the malfunction, and the treatment 
following the exposure. However, in June, while hospitalized 
for a severe flu-like illness, my blood tests came back 
positive for both HIV and hepatitis C. I tested negative on the 
day of the incident. My life has been irreversibly changed in 
every way imaginable. I only tell you this because this 
incident could have been completely prevented. I learned only 
after the accident that administrative director of the lab, 
James E. Stewart, was made aware of serious problems with the 
machine from the very first week it was brought into the lab. 
He also knew that the machine had never been safety tested or 
inspected by the hospital's own engineering staff. I later 
learned that on numerous occasions many of the laboratory staff 
requested that the machine be sent back and replaced by a 
different machine from a different company that was actually 
proven to be reliable and safe. Instead, another dysfunctional 
Labotech was brought in and put to use. If proper safety 
procedures were followed as set out by both the hospital and 
OSHA, after the extreme number of problems with Labotech, it 
should have been removed from service, long before I began my 
employment. Please don't let what happened to me happen to 
anybody else with this or any other dangerous and defective 
piece of equipment.
    What is particularly disappointing is Maryland General 
Hospital's response to this public health catastrophe. When its 
laboratory practices were first called into question, the 
hospital circled the wagons around Mr. Stewart and the other 
administrators who failed to do their jobs. They denied 
responsibility and awareness of the serious problems their lack 
of action caused. Also disappointing is the fact that following 
my complaint, the State found many more problems in the 
laboratory than those I cited, yet Maryland General's lab had 
passed all the accreditation and certification inspections that 
had recently been conducted. This flies in the face of all 
common sense and seriously calls into question the validity of 
the inspections and accreditation process established to ensure 
public safety. The agencies responsible to ensure the proper 
operation of hospital labs must also be held accountable and 
required to take responsibility for their failures and breach 
of the public trust. I fear the problem of lack of proper 
oversight is not a problem limited to Maryland General 
Hospital. New guidelines ought to be considered and/or the old 
ones enforced for the health and well being of every patient.
    Thank you again for the opportunity to share my information 
with this congressional subcommittee. I have all the confidence 
in the world that you will take whatever action is appropriate 
to help prevent these messes from occurring in the future in 
other hospitals and with other pieces of biomedical equipment. 
You have the power to prevent what happened in Baltimore and to 
me from happening anywhere else.
    Sincerely, Kristin Turner.
    Mr. Souder. Thank you.
    And to state again for the record, that was Kristin 
Turner's testimony. It was unsworn testimony, so we didn't have 
the witness here to do that. We normally don't do this in a 
committee, particularly when there are fairly serious charges 
made in the testimony, but I felt that given that it was a 
pivotal part of this case and given that the witness's excuse 
was very good, namely, that they had a health problem arising 
from the case, that we should break our precedent.
    Mr. Cummings. Mr. Chairman, just one point. I had an 
opportunity, Mr. Chairman, to interview Ms. Turner for 2 hours, 
and I found her to be a very credible person. I was extremely 
impressed with her concerns, and I just wanted to put that on 
the record, Mr. Chairman.
    Mr. Souder. Thank you.
    I yield to Mr. Ruppersberger for a statement.
    Mr. Ruppersberger. Mr. Chairman, thank you, and Elijah, 
Congressman Cummings, I want to thank you for your leadership 
in bringing this important issue. Congressman Cummings is 
always there in his community, and attempting to work as hard 
as he can. I also acknowledge that Senator Verna Jones is here, 
who also represents the district where Maryland General 
Hospital is located. And all of you for coming here to help us 
better understand the issues and responses related to the 
laboratory incidents at Maryland General Hospital.
    First, I would like to state for the record that I am no 
stranger to the University of Maryland Medical System. As many 
of you might know, I was in a very serious accident in 1975, 
and as a result of the shock trauma system, I am alive here 
today. I am also vice chair of the Board of Visitors, which is 
an advocacy group, non-statutory, that promotes for the whole 
Maryland emergency medical system. Beyond the realities of 
hospitals like Maryland General Hospital, what they give to 
communities every day and remain important employers, health 
care professionals go into this line of work because they 
ultimately care about people; and this I know and I think we 
know.
    I also know that Congressman Cummings is deeply engaged in 
this important matter, as it directly impacts so many of his 
7th District constituents, but constituents throughout the 
Baltimore region. The impact of these laboratory issues on 
patients is, first and foremost, what everybody involved in 
this matter should be focused on. I look forward to learning 
from the individuals who helped bring this issue to light, from 
Maryland General to better understand the response, and from 
the involved regulatory agencies and also you, Ms. Williams. 
Thank you for being here so that we can get the views on what 
actually happened. From what I know about the situation, it is 
clear that mistakes were made. It also seems clear that there 
has been aggressive and decisive action taken to address and 
remedy identified problems. We need to make sure that action is 
on target and that it continues.
    Now, of course it is easy to focus on fixing problems once 
they have been identified. I would expect nothing less than a 
tremendous response to an incident such as this, a situation 
that had the potential to affect so many patients. I am 
encouraged to hear that new tests largely confirm the results 
of the original tests. This is great news for patients and the 
community, and I hope that trend continues.
    But my main interest here today goes beyond simply looking 
at the response to this incident at Maryland General Hospital. 
We need to determine whether there is any way that the many 
working parts in the machinery that make up our health care 
oversight and accreditation system are working together the way 
they should.
    Obviously, an individual institution such as Maryland 
General, and in some cases a parent organization like the 
University of Maryland Medical System, has an obligation to 
make sure its laboratory is delivering test results in which 
patients can have confidence. But I am also concerned that, 
with all the other organizations involved here that were 
supposed to play a role in preventing situations from becoming 
so dire, this problem wasn't readily discovered until employees 
stepped forward with information.
    In Maryland we have the Department of Health and Mental 
Hygiene, and we need to know why their inspection process 
didn't turn up these problems. We have CMS, who also had a role 
here too. So did the independent accrediting bodies like the 
College of American Pathologists and the Joint Commission on 
Accreditation of Health Care Organizations. Why didn't all of 
these groups and organizations work together the way they 
should to prevent, not just fix, this problem at Maryland 
General Hospital?
    I am hopeful that what we hear today will help us determine 
whether changes need to be made at the State level or the 
Federal level that will prevent situations like this from 
arising in other communities in Maryland and around the 
country. With all the time, energy, and money the health care 
institutions and government have invested in oversight and 
inspection, we must find ways to prevent these kinds of 
problems in the future. Hopefully, we will take a few steps 
down that road through this process today.
    Thank you.
    [The prepared statement of Hon. C.A. Dutch Ruppersberger 
follows:]

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    Mr. Souder. Thank you.
    Mr. Cummings, do you want to start the questioning?
    Mr. Cummings. I just wondered if Ms. Norton had a 
statement.
    Mr. Souder. Do you have an opening statement?
    Ms. Norton. Thank you very much.
    I just want to thank Mr. Cummings for bringing this to the 
committee's attention, and you, Mr. Souder, for moving on it 
quickly. I don't know if I have ever heard of a more egregious 
situation. What particularly bothers me is the extent to which 
equipment, faulty equipment, was involved, given the--obviously 
also personnel, but particularly given how hard-pressed 
hospitals are these days and the financial pressures on them. I 
read Chairman Souder's statement, in which he says that so far 
as we have been able to tell, the situation at Maryland was 
unique. But he also says in his statement that we don't have 
any way of knowing whether that is the case. And, of course, 
this seems to have been discovered by accident, virtually.
    So I am led to believe that with hospitals under great 
duress, that a place to skimp may be on equipment that perhaps 
should have been replaced. I recognize that State regulatory 
oversight is the first line of defense here, but it only makes 
me wonder about the hospitals in my own city, when I hear of 
mistakes like this. They have excellent reputations. We have 
had to close down the general hospital. I won't be able to stay 
for the entire questioning, but I do want to note that in Ms. 
Williams' testimony she says ``the information that we were 
privy to pales in comparison to the information that others 
could and should have come forward with,'' which leads me to 
believe that what you have done here, Chairman Souder, calls 
for, at least at the State level, more investigation, perhaps 
using the subpoena power. And perhaps some of this will come 
out in Ms. Williams' testimony.
    Thank you again for calling this hearing.
    Mr. Souder. Thank you.
    Mr. Cummings.
    Mr. Cummings. Thank you very much, Mr. Chairman. I want to 
thank my colleagues for their opening statements.
    Ms. Williams, first of all, I want to thank you for what 
you said. But perhaps more importantly, I want to thank you for 
standing up for others, because you didn't have to do it, but 
then again I guess you did have to do it, because your 
conscience would not allow you to do otherwise. And I just want 
to thank you.
    Your position was what lead tech, is that what you said? 
What does that entail?
    Ms. Williams. What it is is working the bench every day, 
and you have supervisory responsibilities: the scheduling, the 
ordering, the checking out new equipment, talking with the 
reps, all the normal supervisory responsibilities.
    Mr. Cummings. And you came to Maryland General when?
    Ms. Williams. I came on full-time--I worked per diem prior 
to January 2001, but I came on full-time as the Infectious 
Disease Department Chemistry II Lead Tech January 2001.
    Mr. Cummings. Now, when did you leave?
    Ms. Williams. I left August 2002.
    Mr. Cummings. And why did you leave?
    Ms. Williams. Well, it is mainly because I had problems 
with my mother. You know, I was going back--I live in Jersey. 
She was sick. I had to travel back and forth. But the other 
issue was the fact that I couldn't fight this fight any longer 
by myself. There was a group of us who had rallied together and 
had gone to management, gone outside the laboratory and talked 
with the vice president of human resources and told him of the 
problems, and he took it to the president of the hospital.
    Mr. Cummings. You know for a fact that he took it to the 
president of the hospital?
    Ms. Williams. I can only say that is what he told us.
    Mr. Cummings. But you know what you did.
    Ms. Williams. Right.
    Mr. Cummings. OK, go ahead.
    Ms. Williams. And as the issue regarding the controls, 
regarding the instrumentation. You have to understand this 
meeting was prior to the validation studies that I was 
responsible for for the Labotech, so I was addressing the other 
issues, the other issues that were mentioned in the article 
regarding the clerk being made to verify patient results, along 
with other issues.
    We took it outside the laboratory because no one in the lab 
wanted to hear it. They wouldn't act upon it. When we came to 
them with the problems, we would look for changes, we would 
look for things that they had done to correct the problem. 
There were none. So we decided to take it outside the 
laboratory, and it fell on deaf ears also. We looked to see 
whether or not there were edited verify reports that we could 
check to see whether or not corrections were made to the 
patients that test results went out improperly on the edited 
verify reports. There was nothing, there were no corrections. 
So we knew that even though in the meeting they said we have 
taken care of that, don't worry about it, there was nothing 
that we could identify that proved that they did. So we decided 
that we were going to take it outside of the hospital totally 
and go to the State.
    You have to understand the environment there was such that 
there was intimidation. We were afraid. And I am afraid right 
now, because I know that this affects a lot of people's jobs. I 
know that there are still friends of mine that work there that 
want to come forward, who will come forward now, but someone 
had to step forward first. But it was intimidation. You know, 
we were told keep it up, we could lose our jobs.
    Mr. Cummings. You were told that you would lose your job if 
you came forward?
    Ms. Williams. Yes. To keep your mouth shut. I have one 
document that I submitted with my 2004 letter, which was an 
email that Jim Stewart sent to one of the group.
    Mr. Cummings. Jim Stewart was who?
    Ms. Williams. He was the lab director. That he told her 
that she was the focal point of constructive criticism of the 
laboratory and basically to stop spreading it, to keep your 
mouth shut. She was one of the initial six that left the 
laboratory and sought help outside. Because everyone was so 
afraid, they didn't want to sign their name to the letter. You 
know, we had started the letter together, we all had a draft of 
what we wanted to say and how we would do it, and then they 
became afraid.
    Mr. Cummings. Well, I am about to run out of time on my 
cycle here, but let me just ask you this. You said you are 
afraid right now, and that is always a major concern to Members 
of Congress. If we ask people to come or subpoena people to 
come in to testify, and they express fear about testifying, we 
want to make sure that we send a strong message out that we 
will do every single thing in our power and the authority of 
the Federal Government to make sure that you are protected. And 
I don't know whether that helps you or makes you feel better, 
but I am just saying that is a fact. We will not, under any 
circumstances, tolerate that kind of thing, and that is on both 
sides of the isle, Republicans and Democrats, because it goes 
against the very process that we are involved in here. Do you 
understand that?
    Ms. Williams. Thank you.
    Mr. Cummings. So what are you so fearful of? I am just 
curious.
    Ms. Williams. Well, by coming forward, I have ruffled the 
feathers of some very important people. Some very important 
people have lost their jobs. But I have to look beyond that. I 
have to think about there may have been four or five very 
important people who lost their jobs, but there were thousands 
of equally as important people whose lives are at stake. So, 
yes, I am fearful. There are others who want to come forward 
who have said that they will come forward if it is the proper 
forum, and that is why I put it in my testimony, allow them to 
be able to speak freely.
    When the State came in in 2002, I wasn't there, but I did 
get panic phone calls that the employees were told don't say 
anything that would jeopardize the hospital. When you tell your 
employees, who know what is going on is not right, don't say 
anything that is going to jeopardize the hospital, that means 
you can't say anything. So they didn't. Give them the 
opportunity now, with immunity, to come forward and tell of 
everything. I mean, if you are really serious, Maryland 
General, of really correcting this, let it all out right now. 
Clean it up; correct it.
    Mr. Cummings. I am just curious, just one question. The 
chairman asked a little earlier a question of an earlier 
witness. I guess you have been in the room the whole time?
    Ms. Williams. Yes.
    Mr. Cummings. About if there is a situation where people 
are altering tests and messing with results when these agencies 
come in who are supposed to address these tests, whether the 
folks at CLIA considered it a serious offense to have criminal 
penalties with regard to that. What is your view on that?
    Ms. Williams. It is very serious. No. 1, I read the 
article, and that is what got me really outraged, that they had 
accused the technologists of manipulating the Labotech results. 
We can't manipulate them. I mean, the instrument is set up and 
designed where the protocol is already preprogrammed, so we 
will put the specimen on the instrument, but it samples it, 
does its calculations, and prints out a hard copy of its 
results. So there is no manipulation as far as us going in and 
changing the results, because it flows form there and then it 
goes directly into the hospital computer system. So I am not 
sure of where that is coming from, as far as technologists 
manipulating results.
    Now, if you are talking about documentation not being 
present to verify those results, I understand that was a 
problem. There is a law, I think it is under CLIA, that says 
that the patient results and control results have to be kept 
for 7 years. When the State went in, they could not find all 
the patient results and control results. That is a 
responsibility of the director. The techs run it, we staple it, 
we set it out there, it is sent down to storage. That is the 
responsibility that the director and the operations manager 
have to follow through on after we have done our job. So as far 
as manipulating, no.
    Mr. Cummings. Thank you.
    Ms. Williams. That would have to be done--I am sorry, but 
if there were some manipulating, that would have to be done on 
a programming level or an engineering level, not on a tech 
level. We don't have that knowledge or capability.
    Mr. Cummings. Thank you.
    Mr. Souder. Did you operate the machine?
    Ms. Williams. I was part of the validation studies. As far 
as the testing that is in question right now, I wasn't there 
for the patient testing. I was there when the instrument came 
in and the validation studies were being done.
    Mr. Souder. You heard the earlier testimony from FDA that 
there aren't any other machines that are malfunctioning in the 
United States, to their knowledge, and that the two European 
examples that they had didn't have the same problems, and they 
haven't had a problem for 5 years, that is why they came to the 
conclusion that there was something that could be in the 
programming of the parameters or in the documentation. Ms. 
Turner's testimony referred to the machine repeatedly breaking 
down. Did you see that, too?
    Ms. Williams. Yes.
    Mr. Souder. Could you describe some of what that is and in 
what way?
    Ms. Williams. What happens, a lot of times it would fail 
calibrations; it would mis-step, where it goes to sample the 
patient specimen and it wouldn't put the specimen in the well, 
or else it would double another well, so there were two 
patients in the same well. The other thing that I have seen is 
that it wouldn't drop the tip. As it pipettes, it would carry 
over. So you would have cross-reactivity as far as the reagent 
boat and it going to the next patient.
    Mr. Souder. Were the machines serviced on a regular basis? 
Is that something that is required to do? Because you would 
think that would show up in other hospitals as well as a 
problem, unless there was some sort of internal maintenance or 
less training than necessary at the hospital, some programming 
error in the machine.
    Ms. Williams. All I can say is that this instrument--I 
understand that there were three ultimately, but I only worked 
on one--had problems from the day that it came into the lab. 
First of all, when it came in, it was contaminated. There was 
blood already in it, because it was refurbished. It wasn't a 
new instrument. So we had to call Adaltis to come in to 
decontaminate before they did their actual validation studies 
of the instrument itself. Once they are finished with their 
validation studies of the instrument, then that is when we 
perform our validation studies of the reagents.
    There were problems with parts malfunctioning, things that 
we could not troubleshoot, things that were beyond our scope in 
training. So we had to call them in regularly. As a matter of 
fact, we had to have two training sessions. The first training 
session we didn't get trained well enough, not all because of 
Adaltis, but because we were pulled away to preform other 
responsibilities, which interfered with us getting thoroughly 
trained on the instrument. So they did come in for a second 
session. But the instrument itself had inherent problems.
    Mr. Souder. You said there were three machines?
    Ms. Williams. That is what I have heard yesterday, that 
there were three, there was more than the one that I actually 
operated.
    Mr. Souder. Has anybody come forth on the other machines, 
do you know?
    Ms. Williams. I think Kristin.
    Mr. Souder. She was on a different machine than you were?
    Ms. Williams. Yes.
    Mr. Souder. OK.
    Ms. Williams. Now, I don't know if the machine that 
exploded on her is the same machine that I operated. I don't 
have any information regarding that.
    Mr. Souder. Is part of the reluctance of some people to 
come forth the fact that one of the troubling things here is it 
the machine or is it the people, and it makes it difficult for 
the people to come forth if they in fact then get blamed for 
the problem?
    Ms. Williams. No. I think that people are afraid--well, the 
finger has been pointed at people who did come forward, who 
tried to correct the problems. So, yes, of course you are going 
to be afraid that they are going to blame it on me when I tried 
to help. But I think they are afraid for their jobs. They are 
afraid of being blackballed. They are afraid of coming forth 
because they don't know--who goes to Capitol Hill? You know, we 
are just low-level workers here. This is a forum that we are 
not accustomed to, you know, so what do we say, how do we 
protect ourselves? You have University of Maryland and Maryland 
General Hospital, who have 10,000 attorneys that can come to 
their defense. I sit here alone today. So, yes, they are afraid 
for all of those reasons.
    Mr. Souder. Well, thank you for being willing to testify.
    We are going to run into a very tight time problem here, 
because we have to be out of the room in a little more than a 
half hour, and we have another panel.
    So, Mr. Ruppersberger, if you have some questions.
    Mr. Ruppersberger. Sure. Real quick.
    First thing, you are not alone. You have a lot of people 
here supporting what you are saying. We are trying to get to 
the facts so that we can fix the system that didn't work. One 
of the issues is macro and micro. The fact is this a systemic 
problem is affecting hospitals and testing places all over the 
country, really, if not the world, and we are trying to get to 
the facts.
    Now, you said you are a low-level worker. You are not a 
low-level worker, you are front line. And I think you get a lot 
of information from front line.
    Now, I am sorry I wasn't in the first panel; I had another 
function where I had to be. But one of my concerns is the 
actual testing itself. Are you familiar with CMS and what CMS 
does?
    Ms. Williams. No.
    Mr. Ruppersberger. CMS is really required--let me explain 
what CMS really is. CMS is the Centers for Medicare and 
Medicaid Services. There is a law called CLIA. It was passed in 
1998, Clinical Laboratory Improvements, and it really kind of 
controls what we do here as far as inspections. CMS is charged 
with implementation of the law, including laboratory 
registration, fee collection, surveys, surveyor guidelines, 
training enforcement, approving entities that test laboratory 
proficiency, selecting accrediting organizations, and 
identifying States that can be exempt from this law as a result 
of their own licensure requirements.
    From your perspective from being on the front line, I would 
like to know a little bit more about the testing issue. And let 
me give you some background on that. From what my research has 
shown, you have about 180,000 labs throughout the country, such 
as Maryland General Hospital and all over the country. Maryland 
General Hospital, I think just in a year, had over 554,000 lab 
tests that were conducted. Now, of those, 2,000 are in question 
here. And we really need to focus on why, I think, that the 
organization whose responsibility it is to conduct these 
surveys and inspections would not pick this up. And that is 
where I really want to focus because Maryland General Hospital, 
they have done a lot, they have reacted to this, they have 
tried to fix it and they are fixing it, and that is important. 
We have to move on, but we have to learn from those mistakes, 
and for people's lives. That is why Congressman Cummings has 
brought this to our attention, to make sure that we fix it.
    From your perspective, tell me about the survey, if you 
have any personal knowledge, and what you have seen. Were 
questions asked? Of the 2,000 test areas that we are looking 
at, there were subsystems that were there. Were these 
subsystems looked at? Because when you really look at the 
facts, Maryland General Hospital was accredited and considered 
to be one of the better labs. So there was a breakdown. Do you 
have any comments on that?
    Ms. Williams. I think----
    Mr. Ruppersberger. Long question, but it is important to 
get that out.
    Ms. Williams. I can speak to the CAP inspections. I wasn't 
there when the State came in. But the way it is set up is that 
you are given a booklet, prior to the inspection, of areas that 
you need to address and questions that will be asked. So I had 
been there 3 months, taking over the Chemistry I and II 
departments, to run those, 3 months before the inspection of 
2001 took place. So we were just given a pamphlet. We had to 
address it, we had to make new procedure manuals, clean the 
area, make sure all the reports were up to date. But we knew 
what we were going to be asked.
    I think what was a problem with the CAP inspection process 
is that the inspection team was from right there in Baltimore, 
from one of the hospitals that--I guess neighborhood hospitals, 
where people had worked there before, they knew each other. 
That could pose a problem. When I had talked to the screening 
team last week, I felt that maybe it would be better to have an 
inspection team that came from out of State, where no one 
worked for anyone, no one knew anyone. Also, to have inspectors 
that were familiar with the instrumentation that you were 
using, because if you are using a hospital that is using a 
manual method to perform the same test that you are doing 
automated, there could be an information flow problem, because 
if you are doing it manually, you know how it is supposed to go 
from beginning to end. If you are doing it by an automated 
method, there are certain assumptions that are already in place 
because the machine does that for you. So you would have to 
have someone who knows your instrument, even if it meant having 
a team that came from several different places to do the 
inspection. It doesn't have to come from just one hospital and 
everyone from each department represents someone that inspects 
the other person in your department. Have someone from out of 
State that has no ties, nothing associated with your hospital. 
And let them know ahead of time, if they are going to make them 
aware of questioning, let them be educated in the instrument 
that they are coming to test for.
    Mr. Ruppersberger. I think your comments are extremely 
valid. I know my red light is on and we have to move forward, 
but I think if we are going to resolve the issue and look at 
the whole systemic problem on a national basis and a local 
basis, we need to talk to people such as yourself so that we 
know what questions to ask and where there could be breakdowns.
    Thank you for coming here today.
    Ms. Williams. You are welcome.
    Mr. Souder. Thank you also for your willingness to speak 
out. Your recommendations are very interesting. I know 
sometimes whistleblowers feel like people say, oh, well, 
they're just a complainer. You know what? Complainers don't ask 
for SIX SIGMA audits. You are asking for very particular 
reasonable things to be done in this type of thing, and I 
commend you for your willingness to speak out, and the others 
who have also been willing to speak out.
    Thank you for coming.
    Mr. Cummings. Mr. Chairman, just one thing. Mr. Chairman, I 
just hope that--you know, this witness has provided some very 
valuable testimony. Unfortunately, I know we are running out of 
time. I just want to be able to perhaps followup with some 
written questions, things that we may not have been able to get 
to today.
    And I too really appreciate you doing what you are doing. 
You have probably affected a whole lot of people's lives that 
you will never hear from because they won't even know you did 
it. But on behalf of all of them, I just want to say thank you.
    Ms. Williams. Thank you.
    Mr. Souder. Thank you.
    If the third panel could come forward. Mr. Richard Eckloff, 
the Honorable Nelson Sabatini, Mr. Lepoff, and Mr. Notebaert. 
And if you could remain standing.
    Part of the problem is this is the main committee room, and 
they have another hearing at 2. We hadn't allowed for that many 
votes to intervene. So we will need to keep moving.
    If you could each stand and raise your right hand.
    [Witnesses sworn.]
    Mr. Souder. Let the record show that each of the witnesses 
responded in the affirmative.
    I appreciate your patience. We will start with Mr. Richard 
Eckloff, who is Adaltis US Inc., from Allentown, PA.

STATEMENTS OF RICHARD ECKLOFF, ADALTIS US INC., ALLENTOWN, PA; 
 NELSON J. SABATINI, SECRETARY, MARYLAND DEPARTMENT OF HEALTH 
  AND MENTAL HYGIENE, BALTIMORE, MD; RONALD B. LEPOFF, M.D., 
F.C.A.P., CHAIR OF THE COMMISSION ON LABORATORY ACCREDITATION, 
 COLLEGE OF AMERICAN PATHOLOGISTS, NORTHFIELD, IL; AND EDMOND 
 NOTEBAERT, PRESIDENT, UNIVERSITY OF MARYLAND MEDICAL SYSTEM, 
                         BALTIMORE, MD

    Mr. Eckloff. On behalf of Adaltis US Inc., thank you for 
your invitation to testify at this investigative hearing. As 
the company that sold and serviced the laboratory equipment on 
which the tests that are the subject of this hearing were 
performed, Adaltis US appreciates this opportunity to assist 
the subcommittee with its efforts to address the serious public 
health concerns raised by this matter.
    From late 1994 until April 8th of this year----
    Mr. Souder. Can you raise your voice, please?
    Mr. Eckloff. From late 1994 until April 8th of this year, I 
was the general manager of Adaltis US, the domestic distributor 
for Adaltis Italia S.p.A., which manufactures automated 
processors. Adaltis US also distributed diagnostic products 
manufactured by other companies. As general manager, I was 
responsible for sales, marketing, and product support for these 
products in the continental United States.
    The equipment on which the tests at issue were performed is 
called the Labotech Automated Microplate Analyzer. The Labotech 
was cleared by the Food and Drug Administration as a Class II 
medical device in 1992. The Labotech is designed to robotically 
perform the processing steps that a medical technologist would 
manually perform to complete tests that are known as enzymatic 
immunoassays, or EIAs.
    The Labotech is an ``open system.'' This means that it is 
programmable to perform tests utilizing test kits made by many 
different manufacturers. These test kits contain samples, 
called calibrators and controls, that are necessary to 
calibrate the analyzer to perform a particular manufacturer's 
test properly. Adaltis did not manufacture the HIV or hepatitis 
kits that were used by Maryland General Hospital to perform the 
tests that are at issue here.
    There are more than 2500 Labotechs currently in daily use 
at locations throughout the world. Of these, approximately 170 
are currently in use in the United States, including Labotechs 
installed at prestigious medical institutions such as the 
National Institutes of Health in Bethesda, MD, Walter Reed Army 
Medical Center in Washington, DC, and the Cleveland Clinic.
    To our knowledge, invalid test results have not been 
generated by a Labotech and then reported to a patient by any 
hospital or laboratory other than Maryland General Hospital.
    We understand that the test results at issue were generated 
at the Maryland General Hospital between June 2002 and August 
2003. We further understand that the test results were invalid 
because control readings were not within the ranges set by the 
test kid manufacturers. A review of our records indicates that, 
during this time period, there was a high number of service 
support requirements for this account. Nearly all of these 
support requirements, however, were responsive to maintenance, 
training, and operator issues unrelated to failed runs due to 
test kit control readings. Our records indicated that only four 
calls were received from the hospital due to such failed runs. 
Our records also indicate that all of these reported incidents 
were addressed by employing normal troubleshooting procedures 
and were satisfactorily resolved. Adaltis US was not aware that 
invalid test results were generated or that invalid test 
results were reported to patients. These facts came to our 
attention when they were reported by the press in or about 
March of this year.
    Adaltis US has also learned that the Maryland Department of 
Health has conducted an investigation of this matter and that a 
report has been prepared. We were not contacted by the 
Department in connection with its investigation. We have, 
however, followed the reports on the Department's investigation 
that have appeared in the press.
    For example, in an Associated Press article published in 
the Washington Times on March 20, 2004, it was reported that: 
``[A]ccording to the State inspection report, lab personnel 
manipulated and eliminated readings showing completed blood 
tests might be inaccurate. The report said workers at all 
levels allowed results to be reported even when instrumentation 
and quality control materials were used improperly.'' 
Similarly, on March 23, 2004, the Associated Press reported 
that: ``[A]ccording to a State inspection report, lab workers 
manipulated and eliminated machine readings showing that 
recently completed blood tests might be inaccurate and should 
be discarded.''
    We are also aware that the College of American 
Pathologists, which is represented on this panel, issued a 
press release on May 11th stating that: ``After thorough 
investigation, the College determined that what caused the 
errors appeared to have been deliberate data manipulation by 
laboratory employees. The employees edited the quality control 
reports of the testing instrument used.''
    Our own internal investigation, which is still underway, 
has uncovered no evidence that is inconsistent with the press 
reports.
    In summary, all the information available to Adaltis US at 
this time indicates that the circumstances that caused invalid 
test results to be generated and conveyed to patients of 
Maryland General Hospital were related to hospital personnel 
and procedures, not to any malfunction of the Labotech. And we 
are unaware of any instances, other than those reported by 
Maryland General Hospital, where invalid test results have been 
generated by a Labotech and conveyed to patients.
    Again, let me thank you for this opportunity to testify 
before you today. I would be happy to respond to questions you 
may have or to provide supplemental information you may 
request.
    [The prepared statement of Mr. Eckloff follows:]

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    Mr. Souder. Thank you very much.
    Next is Mr. Nelson Sabatini, Secretary of the Maryland 
Department of Health and Mental Hygiene, Baltimore, MD.
    Mr. Sabatini. Thank you, Mr. Chairman. I appreciate the 
invitation to testify today. I also want to thank you, 
Representative Cummings and Representative Ruppersberger, for 
holding this hearing. You are opening the public debate on what 
I believe is a critical health care issue that is facing this 
Nation.
    At this point we are all well aware of the problems that 
occurred at the Maryland General Hospital laboratory, and while 
we are here primarily to talk about Maryland General, I believe 
it would be a terrible mistake to characterize this as an 
isolated event. In 1999, the Institute of Medicine published a 
report estimating that as many as 100,000 patients a year die 
from medical errors in hospitals. Let me repeat that. 100,000 
patients die every year from errors in hospitals. And that is 
about 2,000 a week or 250 people a day across this country.
    As far as we know, none of the Maryland General patients 
has died, so the thousand or so medical errors that we are 
talking about today don't even show up on the radar screen. The 
Institute of Medicine study focused only on medical errors with 
fatal outcomes.
    The Institute's report should horrify all of us. The report 
said that these errors are caused by ``systems problems'' that 
go undetected and uncorrected by hospitals. This is certainly 
the case at Maryland General; the problems went undetected or 
ignored by the hospital for an extended period of time. But 
given the IOM report, I believe we can assume that Maryland 
General's problems are not unique in the industry.
    We have to ask ourselves how can this be happening in a 
country that I believe provides the best health care in the 
world? And I would submit that what we are seeing is the direct 
result of a 30-year experiment in self-regulation by the 
hospital industry.
    I believe the Maryland General experience is merely a 
symptom of a system failure, and I believe it calls into 
question the legitimacy and adequacy of the entire regulatory 
process. I have said publicly that the system is broken and it 
needs an overhaul, and I mean just that. In the case of 
Maryland General Hospital, the system was not equipped to 
address the problems at the hospital or its lab. The Federal 
and State regulatory agencies, which bear ultimate 
responsibility for ensuring quality health care, do not have 
the regulatory tools they need to provide any credibility of 
quality assurance. Let me explain why.
    Federal law, and a comparable State law in Maryland, grant 
what is known as ``deemed status'' to any laboratory accredited 
by the College of American Pathologists or the Joint Commission 
on Accreditation of Health Care Organizations. Accredited 
facilities are ``deemed'' to be in compliance with all 
applicable Federal and State regulations, and thus are exempt 
from routine Federal and State surveys. In Maryland this 
legislation was passed about 30 years ago and embodied the 
logical-sounding idea that no one is better equipped to 
regulate doctors and hospitals than doctors and hospitals 
themselves. So we, the government regulators, have passed the 
baton to private entities like the Joint Commission, which 
answers not to government, not to the public, but to the 
American Hospital Association and the American College of 
Surgeons.
    We depend on these accreditation organizations to conduct 
their own periodic surveys, provide us with assurance that they 
are high standards of quality are being met and that patients 
can feel safe in a ``deemed'' facility. Patient safety is 
ultimately a government regulatory responsibility, but we have 
subcontracted it out. The Federal Government and many State 
agencies have abdicated, have turned over their authority to 
private sector organizations, which in my view have 
uncomfortably close ties to the industry and the people that 
they survey.
    Accreditation surveys are generally announced in advance, 
and even if unannounced, they are fairly predictable. You heard 
that from the earlier witness. The surveys are collegial in 
nature and leisurely in execution, and they focus almost 
entirely on process instead of outcomes. This is like saying a 
business is doing fine as long as its books appear to be in 
order.
    By way of contrast in Maryland, we regulate nursing homes 
by looking first at outcomes, not at process, and it is our 
consistent experience that bad outcomes are a very good 
indicator of systemic problems in a facility. We do care about 
process, but we try to care more about people. And when it 
comes to regulating hospitals, the liability to care about 
either is less than ideal.
    Deeming limits the ability of government to exercise its 
inherent regulatory authority. Even though hospitals operate 
under licenses granted by the State, we have no authority to 
routinely inspect these facilities. We can only conduct surveys 
in response to specific complaints, and when those surveys do 
turn up problems, our ability to mandate corrective action is 
limited. The corrective process is slow, it is bureaucratic, 
and it is based on the assumption that once a hospital knows of 
a problem, it will fix that problem, even without the 
expectation of a followup survey.
    There is also the issue of disclosure, of transparency. 
Those 100,000 deaths a year are not spread evenly among all 
hospitals; there are good hospitals, there are not-so-good 
hospitals. But the public has very little chance to know which 
is which. Survey reports by the private sector accrediting 
organizations are not routinely disclosed to the general 
public. In theory, some of the reports are public, but actual 
disclosure requires the consent of the facility. The public has 
no consistent and reliable way to evaluate a hospital before 
choosing one.
    In contrast, surveys we conduct at nursing homes and other 
long-term care facilities are periodic, unannounced, 
comprehensive, and public. The results of our surveys are 
published on our Web site. As a regulatory agency, we can't 
guarantee that a good facility today won't have problems 
tomorrow, but at least we give the public a chance to look at 
the track record before they pick a facility. Equally 
important, the reports help the public, and the legislature, 
judge how well we are doing our job and to hold us accountable.
    When it comes to hospital laboratories, though, there are 
at least four different agencies or organizations involved in 
quality oversight, the State and Federal Government, and at 
least two accrediting organizations, which means, among other 
things, that when something does go wrong, you see what you 
have seen throughout this hearing today, a reaction of this, 
that is who is to blame and that is who accountable.
    You are going to hear a lot of people explain how someone 
else dropped the ball today. Let me say this as pointedly as I 
can: we all dropped the ball. I am not proud of the way the 
State acted in this situation. I am not proud of the way the 
State acts and reacts and fulfills its regulatory 
responsibility with regard to hospitals.
    At Maryland General, as early as 2002, the State and 
Federal agencies identified potentially serious problems. There 
was no followup to ensure corrective actions. The hospital was 
to notify the accrediting organization and alert it to the 
Federal investigation and deficiencies. This also did not 
happen. There was no direct or indirect sharing of information 
between the government and private survey agencies. In April 
2003, the College of American Pathologists conducted its 
routine inspection, and even though its surveys identified 
problems similar to those identified by us in 2002, it granted 
the laboratory accreditation ``with distinction,'' and the 
deficiencies went on and on and were not fixed. It was only in 
January of this year----
    Mr. Souder. Mr. Sabatini, are you about done? You are over 
time and we are going to run out of time here.
    Mr. Sabatini. I will be done within 30 seconds.
    Mr. Souder. OK.
    Mr. Sabatini. It was only in January of this year that a 
strongly worded complaint reached both us and the local 
newspaper that the hospital, and its gaggle of regulatory and 
accrediting agencies, began to address the problem.
    The current system is frightening, it is cumbersome, it is 
bureaucratic, and even if there were good communications among 
all the agencies, there are too many of them.
    I am going to stop there.
    Mr. Chairman, we need to and we owe it to the public who 
depend on us to make sure that when they enter a health care 
facility in this country, that they can be convinced of the 
safety of the care that they are getting. We are not doing that 
and we are not fulfilling our obligation in that regard. We 
need to work together and fix it.
    Mr. Souder. Thank you. And if you have additional materials 
or further statement you want to submit to the record, we will 
put it into the full record.
    Mr. Lepoff, who is the Chair of the Commission on 
Laboratory Accreditation at the College of American 
Pathologists from Northfield, IL.
    Mr. Lepoff. Good afternoon, Mr. Chairman, other members of 
the subcommittee, Mr. Cummings----
    Mr. Souder. If you can bring the mic up so the full room 
can hear.
    Mr. Lepoff. My name is Ron Lepoff, and I am the Chair of 
the College of American Pathologists Commission' on Laboratory 
Accreditation.
    In April 2003, a 13-member CAP inspection team conducted a 
required biennial inspection of the laboratory at Maryland 
General Hospital. This multi-disciplinary team used a 2100 item 
checklist to guide its evaluation. The inspection team cited 
the laboratory with nine deficiencies, including failing to 
carry out its own plan for quality assurance. The CAP gave the 
laboratory 30 days to remedy the deficiencies or face possible 
revocation of its accreditation. Subsequently, the laboratory 
attested and provided documentation to show that it had 
corrected the cited deficiencies. Only after evaluating this 
documentation did CAP re-accredit the Maryland General Hospital 
laboratory.
    In hindsight, however, it is clear that quality assurance 
issues and extensive employee complaints about Maryland General 
extend back to 2002, when Teresa Williams filed her formal 
complaint with the State of Maryland.
    The complaint alleges that the laboratory routinely failed 
to monitor quality control and instrumentation, falsified 
federally required proficiency testing results, failed to 
follow manufacturer instrumentation protocols, and reported 
patient results on testing runs for which quality control 
checks failed. The CAP only yesterday was provided with a copy 
of Ms. Williams' complaint. Had the College been given this 
complaint in 2002, it would have responded quickly with a 
focused complaint investigation. If the allegations had been 
substantiated, it almost certainly would have led to revocation 
of the laboratory's accreditation, and possibly additional 
penalties by CMS.
    The State subsequently received the December 2003 complaint 
from Kristin Turner that alleged multiple quality issues, 
including improper HIV and hepatitis testing. Again, the 
College was not provided a copy of this complaint until 
yesterday.
    In response to Ms. Turner's complaint, the State inspected 
the MGH laboratory in January 2004 and found that laboratory 
personnel improperly altered quality control values on reports 
produced by the instrument when initial reports indicated 
values outside an acceptable range. This improper practice 
would have concealed the quality control problems from CAP 
inspectors. No inspection team would have uncovered the quality 
control issues based on a standard review of quality control 
records because those records had been altered.
    The College commends the laboratory personnel who came 
forward in the MGH case. They did the right thing. This 
underscores the critical need for laboratory personnel to 
interact openly with and identify issues for inspectors without 
fear of retaliation from their employers.
    In this case, the laboratory personnel reported working 
``beneath a cloud of fear'' and, according to reports, remained 
silent during the 2002 State inspection. During the College's 
April 2003 inspection, no employee conveyed concerns to the CAP 
inspection team.
    Questions have been raised about why the College awarded 
the MGH laboratory ``accreditation with distinction.'' We 
believe this designation has been misinterpreted as being the 
highest rating on a multi-level graded scale from poor to 
excellent. The College recognizes only two accreditation 
levels: meeting basic CLIA standards or meeting the College's 
additional standards to merit accreditation with distinction. 
The ``accreditation with distinction'' designation recognizes 
that CPA accredited laboratories adhere to additional College 
standards that exceed those mandated by CLIA and are, 
therefore, ``distinct'' from Federal standards.
    In summary, the MGH case highlights the fact that no 
inspection can identify every possible deficiency and that 
Federal, State, and private accrediting bodies must promptly 
share complaint information. Multiple levels of oversight and 
review are necessary, including the laboratory inspection 
itself, proficiency testing, responsible laboratory quality 
assurance management, and self-reporting by laboratory 
personnel.
    The College is committed to preventing events like those at 
Maryland General Hospital by modifying its inspection and 
accreditation process to enhance self-reporting by laboratory 
staff of quality issues.
    Additionally, we recommend that Congress ensure that 
whistleblower protections and patient safety legislation now 
before Congress include worker reports to private accrediting 
organizations.
    Finally, we recommend that governmental agencies develop 
and utilize clear protocols for communicating with private 
accrediting bodies in a timely manner regarding complaints so 
that private accrediting organizations can meet their 
obligations.
    The College thanks the subcommittee for its interest in 
ensuring the highest quality laboratory testing. The CAP is 
firmly committed to working with stakeholders at all levels, 
public and private, to achieve that goal.
    I would be happy to answer any questions the subcommittee 
might have.
    [The prepared statement of Mr. Lepoff follows:]

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    Mr. Souder. Thank you.
    And our final witness is Mr. Edmond Notebaert, who is the 
President of the University of Maryland Medical System in 
Baltimore, MD.
    Mr. Notebaert. Thank you, Mr. Chairman, Congressman 
Cummings. It is a pleasure to appear before you this afternoon, 
giving me the opportunity to speak to you. My name is Edmond F. 
Notebaert. I am the President and Chief Executive Office of the 
University of Maryland Medical System, which is the parent 
organization of Maryland General Hospital. I have been the 
President and Chief Executive Officer of the University of 
Maryland Medical System since September 1, 2003.
    When the University of Maryland Medical System first became 
aware of the issues at Maryland General Hospital in early 
March, the response was immediate, decisive, and comprehensive. 
On March 8th, the very first day Maryland General Hospital 
executives revealed this problem, the University of Maryland 
Medical System dispatched its top senior vice president of 
strategy & corporate operations to the Maryland General 
Hospital. This individual was assigned the responsibility to 
lead the System's team in understanding and addressing all of 
the issues identified by the regulatory agencies at Maryland 
General Hospital. This individual met with Maryland General 
Hospital's management daily and remained on the site well into 
the evening for the first 6 weeks of the effort to identify and 
remedy problems in the laboratory operations and processes. He 
continues to be involved with that hospital on a daily basis.
    Within 5 days of learning about the situation at Maryland 
General Hospital, the University of Maryland Medical System 
elected to bring in a lab management company, and within 10 
days identified and hired Park City Solutions, the leading 
laboratory consulting and management services provider in the 
United States and Canada, to provide lab management services to 
Maryland General Hospital. Park City Systems [sic] took over 
the operation of the laboratory on March 19th, 16 days after 
the State issued its report citing deficiencies in the 
laboratory. As part of the System's comprehensive approach, we 
hired Park City Solutions not only to fix the identified 
deficiencies, but to conduct a top-to-bottom review of the 
laboratory and fast-track the implementation of any necessary 
changes. We rejected taking any sort of band-aid incremental 
approach.
    During their first week at Maryland General Hospital, Park 
City Solutions brought in the lab administrator and two 
technical experts. Shortly thereafter, they recommended 
additional people be brought in, and, in fact, we told them to 
bring in whomever they needed. We gave PCS broad authority to 
take all necessary actions to understand and address Maryland 
General Hospital's laboratory issues. In addition to providing 
an initial assessment of the situation and addressing problems 
as they were identified, PCS administers the laboratory's 
operations on a day-to-day, which includes placing specialists 
to oversee each and every section of the laboratory, 
implementing new procedures and policies, putting in place a 
system of quality, and providing training to laboratory 
personnel to ensure their competence. As issues are resolved 
and tasks completed, their presence will decrease. However, in 
the indefinite future, PCS will be retained as the laboratory 
administrator until all issues are resolved at Maryland General 
Hospital, and the lab staff and management has embodied the 
culture of quality that the University of Maryland Medical 
System stands for.
    Quality is the most important goal of the University of 
Maryland Medical System. Our own review shows that there were 
insufficient quality controls and quality improvement processes 
in the Maryland General Hospital laboratory. Retesting has 
confirmed that the original test results were overwhelmingly 
accurate. The quality processes that validated the test 
accuracies and provided integrity to the results were below the 
standards that we would expect.
    Over the last few weeks of the investigation, we have 
learned a great deal. First and foremost, we have learned that 
there was a breakdown in Maryland General Hospital's policies 
and procedures, adherence to those policies and procedures and 
management reporting systems. However, apparently, even when 
problems were brought to the attention of management, they were 
not sufficiently addressed. That response is unacceptable.
    The University of Maryland Medical System found that the 
supervisory structure was poorly defined in the hospital. 
Certain laboratory supervisors did not take responsibility, 
hospital management did not sufficiently involve itself, and 
salaries were not competitive. We also found that the staff was 
not well trained in quality assurance processes.
    Various steps are being taken, including working with PCS, 
to bring immediate and positive change to Maryland General 
Hospital. Sometimes bad things happen in good hospitals. 
Maryland General Hospital is, and will continue to be, a good 
hospital providing services to the citizens of the surrounding 
community who need and deserve quality health care. Indeed, our 
objective for Maryland General Hospital is to provide first-
class lab services.
    I can and want to assure you that the Maryland General 
Hospital lab is fully operational today, that its results are 
accurate, and that its personnel are competent. PCS is 
finalizing the documentation and quality improvement processes 
that will make this lab a model.
    Maryland General Hospital voluntarily implemented a patient 
notification and retesting process to locate, retest, and 
identify every patient and employee who had been tested on the 
Labotech machines at Maryland General Hospital. Maryland 
General Hospital, in an effort to be comprehensive, responded 
with a sensitive approach to the community and expanded its 
testing well beyond anything that was required by any 
regulatory agencies. The Maryland General Hospital continues to 
go to great lengths to locate and contact all patients who were 
identified as having been tested on the Labotech machine.
    The vast majority of these tests have been reconfirmed. In 
particular, 99.6 percent of the HIV test results have been 
reconfirmed to be consistent with the original tests. What this 
means is that while the quality control processes within 
Maryland General Hospital's laboratory were not up to our 
standards, this circumstance did not result in a significant 
set of mistakes in the actual testing or the test results thus 
far. In fact, we are fairly confident----
    Mr. Souder. Mr. Notebaert, we really need you to wrap up 
because we are running out of time. We will insert your full 
statement, as well as we are inserting the testimony of Mr. 
Lymas' full statement.
    Mr. Notebaert. Thank you, Mr. Chairman. I think in light of 
the time I will save my remarks for submission through the 
written testimony. Thank you for the opportunity to appear 
before the committee.
    [The prepared statement of Mr. Notebaert follows:]

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    Mr. Souder. Thank you. And I know you were making it clear 
that you have indeed followed up with each patient, which is 
important to have on the record, and I appreciate that you did 
that.
    I wanted to ask just a brief question of Mr. Lepoff. Do you 
do the certification on PCS as well, the firm that came in to 
replace the laboratory?
    Mr. Lepoff. We continue to accredit part of the Maryland 
General Hospital laboratory. We have reinspected the laboratory 
in April, on April 26th, and we will be conducting an 
unannounced reinspection of the laboratory at some time between 
now and May 26th, an another full inspection of the laboratory 
in August of this year.
    Mr. Souder. You said in your testimony that you hadn't 
heard the complaints until yesterday. Did the committee staff 
make you aware of those complaints or anybody else?
    Mr. Lepoff. Yes, sir, committee staff.
    Mr. Souder. So no one had contacted you before our 
committee staff the day before the hearing?
    Mr. Lepoff. We did not receive copies of the complaints 
until yesterday.
    Mr. Souder. Mr. Cummings.
    Mr. Cummings. I just want to say this is a mess. You know, 
the more I have listened to all of this, I can understand, Mr. 
Sabatini, why you said what you said and when you did this, 
saying that everybody is blaming everybody else. That is 
exactly what has happened, and, sadly, the people who suffer 
are the poor patients. In some kind of way we have to get this 
communication thing right. There is absolutely no reason why 
you should have the agency--and I am not just talking to you, I 
am talking to the whole panel--have the agency CAP, who is 
doing the accreditation, not find out about employee complaints 
that go to the very essence of what you are evaluating. The 
only way you found out was because of this hearing. That is 
ridiculous. That is crazy. In some kind of way in the United 
States, where we can send a man to the moon, we ought to be 
able to communicate amongst each other.
    Let me just ask you this, Mr. Lepoff. Is it normal that a 
local group of evaluators go into a laboratory and evaluate? 
You heard, I think, what Ms. Williams said. She was very 
skeptical about that procedure. Is that accurate? Is that the 
way it usually happens and is that what happened here?
    Mr. Lepoff. It is true that in 2001 and 2003 the groups 
that inspected Maryland General were from the general Baltimore 
area.
    Mr. Cummings. But can you understand her concern about 
credibility?
    Mr. Lepoff. Yes. First of all, many of our inspections 
occur with teams from out of State.
    Mr. Cummings. Well, right now I am talking about Maryland 
General and I am talking about trying to make sure this doesn't 
happen again anywhere in the country. But it happened here, is 
that correct? We had a local team going in.
    Mr. Lepoff. We had a local team, but our experience has 
been that laboratorians are perfectly capable of being 
objective about other people's laboratories.
    Mr. Cummings. Now, Mr. Sabatini, let me ask you this. I 
heard what you just said, and, to your credit, you said 
everybody has a stake in this, everybody had a problem, did 
something or failed to do something that caused this problem. 
What is it that you would suggest be done? I mean exactly. Mr. 
Lepoff talked about layers. You sound like basically what you 
are saying is the less the better.
    Mr. Sabatini. Well, I think that, one, there ought to be 
some way to identify a responsible editing for regulatory 
oversight, as opposed to three, four, or five.
    Mr. Cummings. That are not communicating.
    Mr. Sabatini. That are not communicating and have no reason 
to communicate. I mean, it works in the nursing home industry, 
and it should be able to work in hospitals. Hospitals, you 
assume that they meet standards when they are accredited by an 
organization that is basically dependent upon the industry for 
their support. Let me just very briefly read a quote from what 
I think is one of the better books that has been published on 
medical errors. It says: ``As we have described, the Joint 
Commission on Accreditation of Health Care Organizations has 
begun to call safety balls and strikes, but the Joint 
Commission is a voluntary organization. Hospitals aren't 
required to be accredited, and most of the Joint Commission's 
resources come from the hospitals themselves. This makes JCOA a 
key problem in the patient safety crusade, but one that may be 
inclined to back off when hospital administrators cry kill the 
ump.''
    We wouldn't allow Enron or anybody else to behave the way 
this industry is behaving in terms of regulatory oversight. The 
review process is done on a schedule. People prepare and 
rehearse in preparation for it, they are not unannounced 
surveys, and, again, there is no single accountable agency. So 
we can all sit here and say it wouldn't have happened if the 
other guy would have told me. That is not good enough.
    Mr. Cummings. Well, what is your relationship with the 
College of Pathologists?
    Mr. Sabatini. None.
    Mr. Cummings. You have no relationship?
    Mr. Sabatini. No. Other than the fact that if they accredit 
a laboratory, then I, by statute, have to assume that 
laboratory is in compliance with all of the standards and 
quality standards that have been set by both the Federal and 
State government.
    Mr. Cummings. Well, I see my time is up, but let me just 
say this. In some kind of way we have to--so many lives are at 
stake here. We have to find a way to communicate. I know there 
have been several recommendations that you all have made.
    The thing that I would recommend also, Mr. Chairman, it 
seems like there are some State issues. We will make sure that 
all of this testimony gets to our State agencies, too, our 
State legislature.
    But some kind of way we have to work through this because, 
as I listened to this, and if I were a patient, my confidence 
in getting accurate results from a laboratory in a hospital, if 
it is run the way this is, I would be afraid to even go in to 
try to get a test.
    And I am not blaming that just on Maryland General, I want 
you to understand that, Mr. Notebaert. I think you all have 
done a great job in trying to correct this and address the 
problems, but this is more of a bigger picture than that. The 
College is not just a local entity, they look at laboratories 
and hospitals all over the country. So it is just that Maryland 
General, I think what happened here may very well help us to 
bring some kind of revision that will benefit hospitals and 
laboratories all over the country.
    And I want to thank all of you, and you all will hear more 
from us, and we really appreciate you.
    Mr. Souder. Thank you. I am sorry, Mr. Ruppersberger, we 
have to leave, by agreement with the chairman. I appreciate 
both his leadership and Mr. Cummings' leadership in Baltimore. 
I know we are going to have some additional written questions. 
Two of you are on contradiction under oath about whether visits 
are unannounced or announced, and we are going to have to get 
that sorted out for the record that contradicted each other 
multiple times. I find it appalling that in the State of 
Maryland you do not have a procedure, when you have a 
certification organization, to notify. It sounds to me like the 
poor employees are very confused as to where they are supposed 
to go. Their immediate result is likely to go first to the 
hospital, then to the State, and somebody has to get 
interconnected. Maybe we can streamline the processes, maybe we 
won't streamline the processes, but bottom line is those 
individuals involved need to be sharing much better than they 
have been in the past.
    Thank you all for coming. And if you want to submit any 
additional things for the record, please do so.
    With that, the subcommittee stands adjourned.
    [Whereupon, at 1:55 p.m., the subcommittee was adjourned, 
to reconvene at the call of the Chair.]
    [Additional information submitted for the hearing record 
follows:]

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