<DOC>
[108th Congress House Hearings]
[From the U.S. Government Printing Office via GPO Access]
[DOCID: f:97962.wais]
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
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[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
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[GRAPHIC] [TIFF OMITTED] T7962.006
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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:]
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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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