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Stanford Law Library

3 6105 063 576 248

COMMITTEE ON GOVERNMENT REFORM

TOM DAVIS, Virginia, Chairman DAN BURTON, Indiana

HENRY A. WAXMAN, California CHRISTOPHER SHAYS, Connecticut

TOM LANTOS, California ILEANA ROS-LEHTINEN, Florida

MAJOR R. OWENS, New York JOHN M. MCHUGH, New York

EDOLPHUS TOWNS, New York JOHN L. MICA, Florida

PAUL E. KANJORSKI, Pennsylvania MARK E. SOUDER, Indiana

CAROLYN B. MALONEY, New York STEVEN C. LATOURETTE, Ohio

ELIJAH E. CUMMINGS, Maryland DOUG OSE, California

DENNIS J. KUCINICH, Ohio RON LEWIS, Kentucky

DANNY K. DAVIS, Illinois
JO ANN DAVIS, Virginia

JOHN F. TIERNEY, Massachusetts
TODD RUSSELL PLATTS, Pennsylvania WM. LACY CLAY, Missouri
CHRIS CANNON, Utah

DIANE E. WATSON, California
ADAM H. PUTNAM, Florida

STEPHEN F. LYNCH, Massachusetts EDWARD L. SCHROCK, Virginia

CHRIS VAN HOLLEN, Maryland JOHN J. DUNCAN, JR., Tennessee

LINDA T. SANCHEZ, California NATHAN DEAL, Georgia

C.A. “DUTCH” RUPPERSBERGER, Maryland CANDICE S. MILLER, Michigan

ELEANOR HOLMES NORTON, District of TIM MURPHY, Pennsylvania

Columbia
MICHAEL R. TURNER, Ohio

JIM COOPER, Tennessee
JOHN R. CARTER, Texas
MARSHA BLACKBURN, Tennessee
PATRICK J. TIBERI, Ohio

BERNARD SANDERS, Vermont
KATHERINE HARRIS, Florida

(Independent)

MELISSA WOJCIAK, Staff Director
DAVID MARIN, Deputy Staff Director/Communications Director

ROB BORDEN, Parliamentarian

TERESA AUSTIN, Chief Clerk
PHIL BARNETT, Minority Chief of Staff/ Chief Counsel

SUBCOMMITTEE ON CRIMINAL JUSTICE, DRUG POLICY AND HUMAN RESOURCES

MARK E. SOUDER, Indiana, Chairman NATHAN DEAL, Georgia

ELIJAH E. CUMMINGS, Maryland JOHN M. MCHUGH, New York

DANNY K. DAVIS, Illinois JOHN L. MICA, Florida

WM. LACY CLAY, Missouri DOUG OSE, California

LINDA T. SANCHEZ, California JO ANN DAVIS, Virginia

C.A. “DUTCH” RUPPERSBERGER, Maryland JOHN R. CARTER, Texas

ELEANOR HOLMES NORTON, District of MARSHA BLACKBURN, Tennessee

Columbia PATRICK J. TIBERI, Ohio

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

1

(II)

CONTENTS

Page

1

82

10

Hearing held on May 18, 2004

Statement of:

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

of Maryland, prepared statement of

Eckloff, Richard, Adaltis US Inc., Allentown, PA, prepared statement

of

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

Lepoff, Ronald B., M.D., F.C.A.P., Chair of the Commission on Laboratory

Accreditation, College of American Pathologists, Northfield, IL, pre-

pared statement of

Notebaert, Edmond, president, University of Maryland Medical System,

Baltimore, MD, prepared statement of

Ruppersberger, Hon. C.A., a Representative in Congress from the State

of Maryland, prepared statement of

Souder, Hon. Mark E., a Representative in Congress from the State

of Indiana, prepared statement of

Tunis, Sean, M.D., chief clinical officer, Centers for Medicare and Medic-

aid Services (CMS) and Deputy Director, Office of Clinical Standards

and Quality, CMS, Department of Health and Human Services, pre-

pared statement of

Williams, Teresa, former employee of Maryland General Hospital, pre-

pared statement of

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