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97–962 PDF 2004

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
(II)

COMMITTEE ON GOVERNMENT REFORM

TOM DAVIS, Virginia, Chairman

DAN BURTON, Indiana

CHRISTOPHER SHAYS, Connecticut

ILEANA ROS-LEHTINEN, Florida

JOHN M. MCHUGH, New York

JOHN L. MICA, Florida

MARK E. SOUDER, Indiana

STEVEN C. LATOURETTE, Ohio

DOUG OSE, California

RON LEWIS, Kentucky

JO ANN DAVIS, Virginia

TODD RUSSELL PLATTS, Pennsylvania

CHRIS CANNON, Utah

ADAM H. PUTNAM, Florida

EDWARD L. SCHROCK, Virginia

JOHN J. DUNCAN, JR., Tennessee

NATHAN DEAL, Georgia

CANDICE S. MILLER, Michigan

TIM MURPHY, Pennsylvania

MICHAEL R. TURNER, Ohio

JOHN R. CARTER, Texas

MARSHA BLACKBURN, Tennessee

PATRICK J. TIBERI, Ohio

KATHERINE HARRIS, Florida

HENRY A. WAXMAN, California

TOM LANTOS, California

MAJOR R. OWENS, New York

EDOLPHUS TOWNS, New York

PAUL E. KANJORSKI, Pennsylvania

CAROLYN B. MALONEY, New York

ELIJAH E. CUMMINGS, Maryland

DENNIS J. KUCINICH, Ohio

DANNY K. DAVIS, Illinois

JOHN F. TIERNEY, Massachusetts

WM. LACY CLAY, Missouri

DIANE E. WATSON, California

STEPHEN F. LYNCH, Massachusetts

CHRIS VAN HOLLEN, Maryland

LINDA T. SANCHEZ, California

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

ELEANOR HOLMES NORTON, District of

Columbia

JIM COOPER, Tennessee

——— ———

———

BERNARD SANDERS, Vermont

(Independent)

MELISSA WOJCIAK, Staff Director

DAVID MARIN, Deputy Staff Director/Communications Director

ROB BORDEN, Parliamentarian

TERESA AUSTIN, Chief Clerk

PHIL BARNETT, Minority Chief of Staff/Chief Counsel

SUBCOMMITTEE ON CRIMINAL JUSTICE, DRUG POLICY AND HUMAN RESOURCES

MARK E. SOUDER, Indiana, Chairman

NATHAN DEAL, Georgia

JOHN M. MCHUGH, New York

JOHN L. MICA, Florida

DOUG OSE, California

JO ANN DAVIS, Virginia

JOHN R. CARTER, Texas

MARSHA BLACKBURN, Tennessee

PATRICK J. TIBERI, Ohio

ELIJAH E. CUMMINGS, Maryland

DANNY K. DAVIS, Illinois

WM. LACY CLAY, Missouri

LINDA T. SANCHEZ, California

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

ELEANOR HOLMES NORTON, District of

Columbia

——— ———

EX OFFICIO

TOM DAVIS, Virginia HENRY A. WAXMAN, California

J. MARC WHEAT, Staff Director

ROLAND FOSTER, Professional Staff Member

MALIA HOLST, Clerk

TONY HAYWOOD, Minority Counsel
(III)

C O N T E N T S

Page

Hearing held on 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

(1)

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.
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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
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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:]
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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
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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
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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:]
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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
15

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.
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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
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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 re-
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occurring 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,
42

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
43

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 noncooperative, 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
44

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
45

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 problemssolving 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
46

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?
47

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.
48

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
49

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.
50

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.
51

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.
52

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
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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 costeffective; 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.
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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
69

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.
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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?
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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,
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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 sys-
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tem. 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
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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.
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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
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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.
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[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.
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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,
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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 longterm 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
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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
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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
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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 com-
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pleted, 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——
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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.
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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
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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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