Stanford Law Library 3 6105 063 576 248 COMMITTEE ON GOVERNMENT REFORM DAN BURTON, Indiana TOM DAVIS, Virginia, Chairman CHRISTOPHER SHAYS, Connecticut RON LEWIS, Kentucky JO ANN DAVIS, Virginia TODD RUSSELL PLATTS, Pennsylvania CANDICE S. MILLER, Michigan MARSHA BLACKBURN, Tennessee HENRY A. WAXMAN, California JOHN F. TIERNEY, Massachusetts 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 PHIL BARNETT, Minority Chief of Staff/Chief Counsel SUBCOMMITTEE ON CRIMINAL JUSTICE, DRUG POLICY AND HUMAN RESOURCES CONTENTS Eckloff, Richard, Adaltis US Inc., Allentown, PA; Nelson J. Sabatini, Secretary, Maryland Department of Health and Mental Hygiene, Balti- more, 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 Mary- land Medical System, Baltimore, MD 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 Williams, Teresa, former employee of Maryland General Hospital; and Kristin Turner, former employee, Maryland General Hospital, as deliv- ered by Malia Holst, subcommittee clerk Letters, statements, etc., submitted for the record by: Cummings, Hon. Elijah E., a Representative in Congress from the State Eckloff, Richard, Adaltis US Inc., Allentown, PA, prepared statement Gutman, Steven I., M.D., Director, Office of In Vitro Diagnostics Device Page 10 17 Lepoff, Ronald B., M.D., F.C.A.P., Chair of the Commission on Laboratory Accreditation, College of American Pathologists, Northfield, IL, pre- Ruppersberger, Hon. C.A., a Representative in Congress from the State 71 Souder, Hon. Mark E., a Representative in Congress from the State 4 Tunis, Sean, M.D., chief clinical officer, Centers for Medicare and Medic- 29 Williams, Teresa, former employee of Maryland General Hospital, pre- 54 (III) |