issues from all sides, we can help to ensure that nothing like this ever happens again in my congressional district or anywhere else in our nation.

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 multi-faceted network of state and federal governing entities. When Congress enacted the Clinical Laboratory Improvement Amendments (or "CLIA") Act in 1988, it did so with the goal of ensuring that all labs across this country would adhere to stringent quality standards. Additionally, Food and Drug Administration laws and regulations are designed in part to ensure the safety and effectiveness of medical devices marketed in the United States. The severity and duration of the problems at Maryland General call into question the adequacy of the regulatory regime established to ensure compliance with federal standards. States and private accreditation organizations also play important roles in what is a rather complex network that relies upon communication in order to be effective. The system must be attentive and responsive to the concerns of laboratory employees. This controversy was an unnecessary one that could have been avoided entirely if the concerns of employees had been listened to and taken seriously at all levels.

We will hear today from the major entities in this controversy. Hearing all of their perspectives in the context of this hearing will help us to understand the dimensions of the problem and what, if any, changes to the current regulatory regime may be necessary and appropriate to prevent such problems from occurring in the future.

On the first of our three panels, representatives from the Food and Drug Administration and the Centers for Medicare and Medicaid Services will testify concerning their respective roles in the regulatory regime that governs device safety and effectiveness in laboratory testing. On the second panel, we will hear testimony from two former employees of Maryland General Hospital whose complaints helped bring this

unfortunate situation to light. On the last panel, we will hear from 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 the 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 Hospital is very familiar to me. I live near the hospital and I often receive my health care there. With nearly 1800 employees, Maryland General is a significant source of employment for my constituents and it serves as a s 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 the people served by MGH - as well as communities like it around the country.

All patients are entitled to full faith and confidence in the accuracy of the medical test results they receive. That 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 this 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 or thousands of people might have received incorrect test have been largely alleviated, s that number remains below 2,500. I say we are fortunate. But luck cannot bethe foundation of our public health system. The need for

answers and accountability from all parties is no less compelling today than it was two 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.

Again, I thank you Mr. Chairman for your cooperation in convening this critical hearing.

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Mr. SOUDER. Thank you very much.

I ask unanimous consent that all Members have 5 legislative days to submit written statements and questions for the hearing record, and that any answers to written questions provided by the witnesses also be included in the record. Without objection, it is so ordered.

I also ask unanimous consent that all exhibits, documents, and other materials referred to by Members and the witnesses may be included in the hearing record, and that all Members be permitted to revise and extend their remarks. Without objection, it is so ordered.

It is our standard practice to ask witnesses to testify under oath, so if the first panel would rise and raise your right hands.

[Witnesses sworn.]

Mr. SOUDER. Let the record show that each of the witnesses responded in the affirmative.

We thank you both for coming, and I will now yield to Mr. Gutman.

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

Dr. GUTMAN. Good morning, Mr. Chairman, and members of the subcommittee. I am Dr. Steven Gutman, Director of the Office of In Vitro Diagnostic Device Evaluation and Safety in the Center for the Devices and Radiological Health at the FDA. I am pleased to speak about FDA's role in regulating medical devices and to provide information regarding the Adaltis Labotech device.

FDA is responsible for protecting the public health by ensuring the safety and effectiveness of drugs, biologics, food, cosmetics, medical devices, and products that emit radiation.

This hearing specifically touches on FDA's medical device regulatory authorities. Among the broad menu of device products that FDA regulates are commercialized analytical tests and laboratory equipment intended for use in clinical laboratories. FDA refers to these as in vitro diagnostic devices.

The Medical Device Amendments of 1976 gave FDA specific authority to regulate medical devices. FDA places every medical device into one of three classes depending on the degree of control needed to provide reasonable assurance of safety and effectiveness. Devices posing the lowest risk are placed in Class I and are subject to general controls. These include company registration, quality system requirements for manufacturing, provisions regarding adulteration and misbranding, recordkeeping, and reporting of adverse events. FDA refers to these adverse event reports as medical device reports, or MDRs. Class II devices, such as instruments for measuring glucose or hemoglobin, generally pose higher risks than Class I devices. In addition to general controls, they are subject to one

or more of a wide range of special controls that the agency may designate. Class III devices are subject to pre-market approval. Examples of Class III devices include new tests for diagnosis of cancer or serious infectious diseases such as SARS. Pre-market approval requires manufacturers to submit an application which is subject to careful scientific review by FDA.

A general control applicable to all classes of devices is adverse event reporting. Under FDA regulations, user facilities are required to report device-related deaths to FDA and device-related serious injuries to manufacturers. Of course, FDA encourages anyone with knowledge of a device-related problem, even a less serious one, to report it to us through our MedWatch system.

The agency uses MDRs to help provide signals of device problems so it can determine whether followup is necessary. If FDA does followup and discovers a problem with a device, there is a broad menu of actions that can be taken depending on the problem. FDA inspects device manufacturing facilities to ensure conformance with requirements. The responsibility for inspection and oversight of clinical labs that use those devices lies with CMS under the CLIA program.

As the focus of this hearing is the erroneous test results at Maryland General, I would like to discuss the Labotech device used there. The Labotech device is an automated device intended for use in performing controlled chemical reactions that are the basis of a variety of lab tests. This device can be programmed by each individual lab to run up to 400 test assays. The lab development or modification of these assays is performed subject to regulations under CLIA.

The Labotech is considered a Class I device and is subject to general controls. FDA first cleared the Labotech device for marketing in 1992 and has only received one MDR, the Maryland General report of injury to an operator of the machine. It is believed that approximately 2500 of these devices have been placed in labs worldwide. FDA takes seriously and investigates MDRS reported to the agency. We are continuing to evaluate whether there are systemic problems with the Labotech.

FDA first became aware of the problem with test results generated at Maryland General when our press office received an inquiry on March 19, 2004. We contacted our colleagues at CMS, who indicated test results had been reported without following usual quality procedures. FDA has remained in contact with both CMS and the Maryland Department of Health to share information and see what we can do to assist in investigating this problem.

As an independent measure, FDA conducted an inspection of the Allentown, PA facility of the US distributor of Labotech. No serious problems were identified. Since this US site is only a distribution center, FDA is also scheduling a full inspection of the manufacturing site in Italy this summer.

Two adverse reports about Labotech have appeared in European data bases. FDA is still investigating whether these reports should have been submitted to our data base. There is no evidence of continued problems in the European Union, but FDA expects to followup on this issue during the inspection this summer.