week, I felt that maybe it would be better to have an inspection team that came from out of State, where no one worked for anyone, no one knew anyone. Also, to have inspectors that were familiar with the instrumentation that you were using, because if you are using a hospital that is using a manual method to perform the same test that you are doing automated, there could be an information flow problem, because if you are doing it manually, you know how it is supposed to go from beginning to end. If you are doing it by an automated method, there are certain assumptions that are already in place because the machine does that for you. So you would have to have someone who knows your instrument, even if it meant having a team that came from several different places to do the inspection. It doesn't have to come from just one hospital and everyone from each department represents someone that inspects the other person in your department. Have someone from out of State that has no ties, nothing associated with your hospital. And let them know ahead of time, if they are going to make them aware of questioning, let them be educated in the instrument that they are coming to test for. Mr. RUPPERSBERGER. I think your comments are extremely valid. I know my red light is on and we have to move forward, but I think if we are going to resolve the issue and look at the whole systemic problem on a national basis and a local basis, we need to talk to people such as yourself so that we know what questions to ask and where there could be breakdowns. Thank you for coming here today. Ms. WILLIAMS. You are welcome. Mr. SOUDER. Thank you also for your willingness to speak out. Your recommendations are very interesting. I know sometimes whistleblowers feel like people say, oh, well, they're just a complainer. You know what? Complainers don't ask for SIX SIGMA audits. You are asking for very particular reasonable things to be done in this type of thing, and I commend you for your willingness to speak out, and the others who have also been willing to speak out. Thank you for coming. Mr. CUMMINGS. Mr. Chairman, just one thing. Mr. Chairman, I just hope that-you know, this witness has provided some very valuable testimony. Unfortunately, I know we are running out of time. I just want to be able to perhaps followup with some written questions, things that we may not have been able to get to today. And I too really appreciate you doing what you are doing. You have probably affected a whole lot of people's lives that you will never hear from because they won't even know you did it. But on behalf of all of them, I just want to say thank you. Ms. WILLIAMS. Thank you. Mr. SOUDER. Thank you. If the third panel could come forward. Mr. Richard Eckloff, the Honorable Nelson Sabatini, Mr. Lepoff, and Mr. Notebaert. And if you could remain standing. Part of the problem is this is the main committee room, and they have another hearing at 2. We hadn't allowed for that many votes to intervene. So we will need to keep moving. If you could each stand and raise your right hand. [Witnesses sworn.] Mr. SOUDER. Let the record show that each of the witnesses responded in the affirmative. I appreciate your patience. We will start with Mr. Richard Eckloff, who is Adaltis US Inc., from Allentown, PA. STATEMENTS OF RICHARD ECKLOFF, ADALTIS US INC., ALLENTOWN, PA; NELSON J. SABATINI, SECRETARY, MARYLAND DEPARTMENT OF HEALTH AND MENTAL HYGIENE, BALTIMORE, MD; RONALD B. LEPOFF, M.D., F.C.A.P., CHAIR OF THE COMMISSION ON LABORATORY ACCREDITATION, COLLEGE OF AMERICAN PATHOLOGISTS, NORTHFIELD, IL; AND EDMOND NOTEBAERT, PRESIDENT, UNIVERSITY OF MARYLAND MEDICAL SYSTEM, BALTIMORE, MD Mr. ECKLOFF. On behalf of Adaltis US Inc., thank you for your invitation to testify at this investigative hearing. As the company that sold and serviced the laboratory equipment on which the tests that are the subject of this hearing were performed, Adaltis US appreciates this opportunity to assist the subcommittee with its efforts to address the serious public health concerns raised by this matter. From late 1994 until April 8th of this year Mr. SOUDER. Can you raise your voice, please? Mr. ECKLOFF. From late 1994 until April 8th of this year, I was the general manager of Adaltis US, the domestic distributor for Adaltis Italia S.p.A., which manufactures automated processors. Adaltis US also distributed diagnostic products manufactured by other companies. As general manager, I was responsible for sales, marketing, and product support for these products in the continental United States. The equipment on which the tests at issue were performed is called the Labotech Automated Microplate Analyzer. The Labotech was cleared by the Food and Drug Administration as a Class II medical device in 1992. The Labotech is designed to robotically perform the processing steps that a medical technologist would manually perform to complete tests that are known as enzymatic immunoassays, or EIAs. The Labotech is an "open system." This means that it is programmable to perform tests utilizing test kits made by many dif ferent manufacturers. These test kits contain samples, called calibrators and controls, that are necessary to calibrate the analyzer to perform a particular manufacturer's test properly. Adaltis did not manufacture the HIV or hepatitis kits that were used by Maryland General Hospital to perform the tests that are at issue here. There are more than 2500 Labotechs currently in daily use at locations throughout the world. Of these, approximately 170 are currently in use in the United States, including Labotechs installed at prestigious medical institutions such as the National Institutes of Health in Bethesda, MD, Walter Reed Army Medical Center in Washington, DC, and the Cleveland Clinic. To our knowledge, invalid test results have not been generated by a Labotech and then reported to a patient by any hospital or laboratory other than Maryland General Hospital. We understand that the test results at issue were generated at the Maryland General Hospital between June 2002 and August 2003. We further understand that the test results were invalid because control readings were not within the ranges set by the test kid manufacturers. A review of our records indicates that, during this time period, there was a high number of service support requirements for this account. Nearly all of these support requirements, however, were responsive to maintenance, training, and operator issues unrelated to failed runs due to test kit control readings. Our records indicated that only four calls were received from the hospital due to such failed runs. Our records also indicate that all of these reported incidents were addressed by employing normal troubleshooting procedures and were satisfactorily resolved. Adaltis US was not aware that invalid test results were generated or that invalid test results were reported to patients. These facts came to our attention when they were reported by the press in or about March of this year. Adaltis US has also learned that the Maryland Department of Health has conducted an investigation of this matter and that a report has been prepared. We were not contacted by the Department in connection with its investigation. We have, however, followed the reports on the Department's investigation that have appeared in the press. For example, in an Associated Press article published in the Washington Times on March 20, 2004, it was reported that: "[A]ccording to the State inspection report, lab personnel manipulated and eliminated readings showing completed blood tests might be inaccurate. The report said workers at all levels allowed results to be reported even when instrumentation and quality control materials were used improperly." Similarly, on March 23, 2004, the Associated Press reported that: "[A]ccording to a State inspection report, lab workers manipulated and eliminated machine readings showing that recently completed blood tests might be inaccurate and should be discarded." We are also aware that the College of American Pathologists, which is represented on this panel, issued a press release on May 11th stating that: "After thorough investigation, the College determined that what caused the errors appeared to have been deliberate data manipulation by laboratory employees. The employees edited the quality control reports of the testing instrument used." Our own internal investigation, which is still underway, has uncovered no evidence that is inconsistent with the press reports. In summary, all the information available to Adaltis US at this time indicates that the circumstances that caused invalid test results to be generated and conveyed to patients of Maryland General Hospital were related to hospital personnel and procedures, not to any malfunction of the Labotech. And we are unaware of any instances, other than those reported by Maryland General Hospital, where invalid test results have been generated by a Labotech and conveyed to patients. Again, let me thank you for this opportunity to testify before you today. I would be happy to respond to questions you may have or to provide supplemental information you may request. [The prepared statement of Mr. Eckloff follows:] TESTIMONY ON BEHALF OF ADALTIS U.S. INC. BY RICHARD ECKLOFF FORMER GENERAL MANAGER ADALTIS U.S. INC. Before The Committee on Government Reform Subcommittee on Criminal Justice, Drug Policy and Human Resources United States House of Representatives Investigative Hearing: The Conditions and Circumstances That May 18, 2004 Chairman Souder, Congressman Cummings, and Members of the Criminal Justice, Drug Policy and Human Resources Subcommittee, my name is Richard Eckloff. On behalf of Adaltis U.S. 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 U.S. 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, I was the General Manager of Adaltis U.S. Until late 1999, when its name was changed, the company was called Biochem Immunosystems U.S., Inc. On April 8th of this year, Adaltis U.S. sold all of its assets to Trinity Biotech. Adaltis U.S. was, at all times relevant to your investigation, the domestic distributor for Adaltis Italia S.p.A., which manufactures automated processors. Adaltis U.S. 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 a LABOTECH Automated Microplate Analyzer. The LABOTECH was cleared by the Food and Drug Administration (“FDA”) 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 test kits that were used by Maryland General Hospital to perform the tests that are at issue here. |