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, Part 1 |
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Page 7
... [ 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 Adminis- tration laws and regulations are designed in part to ensure ...
... [ 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 Adminis- tration laws and regulations are designed in part to ensure ...
Page 8
... CLIA . In this instance , it was not kept , and that broken promise has an impact beyond the individuals who re- ceived questionable test results . Maryland General Hospital's efforts to respond to all dimensions of the problem are an ...
... CLIA . In this instance , it was not kept , and that broken promise has an impact beyond the individuals who re- ceived questionable test results . Maryland General Hospital's efforts to respond to all dimensions of the problem are an ...
Page 11
... 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 ...
... 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 ...
Page 12
... 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 ...
... 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 ...
Page 15
... CLIA program . As the focus of this hearing is the erroneous test results at Mary- land General , I would like to discuss the Labotech device used there . The Labotech device is an automated device intended for use in performing ...
... CLIA program . As the focus of this hearing is the erroneous test results at Mary- land General , I would like to discuss the Labotech device used there . The Labotech device is an automated device intended for use in performing ...
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Common terms and phrases
Adaltis U.S. American Pathologists Associated Press Baltimore C.A. Dutch Ruppersberger Centers for Medicare Chairman CLIA survey College of American compliance Criminal Justice deficiencies Department of Health director Drug Policy Edmond F Elijah Cummings ELIJAH E ensure entities equipment Federal going GUTMAN healthcare hearing hepatitis test HIV and hepatitis identified instrument invalid test results investigation issues Jerry Lymas Kristin Turner laboratory personnel Labotech device Lepoff machine malfunctions manufacturers Maryland Department Maryland General Hospital Maryland General Hospital's Maryland Medical System MDRs Medicaid medical devices Medicare monitor Notebaert University oversight panel patients performed plan of correction private accrediting organizations problems at Maryland quality assurance quality control question regulations requirements response retesting RUPPERSBERGER Sabatini safety and effectiveness SOUDER specific staff standards SUBCOMMITTEE ON CRIMINAL surveyor Testimony of Edmond tion TUNIS University of Maryland whistleblower WILLIAMS
Popular passages
Page 30 - CLIA in 1988, establishing quality standards for all laboratory testing to ensure the accuracy, reliability, and timeliness of patient test results regardless of where the test was performed.
Page 103 - BEFORE THE HOUSE GOVERNMENT REFORM SUBCOMMITTEE ON CRIMINAL JUSTICE, DRUG POLICY, AND HUMAN RESOURCES, REGARDING THE IMPACT OF THE DRUG TRADE ON BORDER SECURITY AND NATIONAL PARKS March 10, 2003 Mr.
Page 9 - I yield back. [The prepared statement of Hon. Elijah E. Cummings follows:] Opening Statement of Representative Elijah E. Cummings, D-Maryland Ranking Minority Member Hearing on "Department of Defense and Counternarcotics: What Is Congress Getting for Its Money?
Page 1 - 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 2:10 pm, in room 2154, Rayburn House Office Building, Hon.
Page 3 - Thank you all for being here today. We look forward to your testimony and insights.
Page 18 - Director of the Center for Devices and Radiological Health (CDRH) at the Food and Drug Administration (FDA or the Agency). I am...
Page 19 - Act) to give FDA specific authority to regulate the safety and effectiveness of medical devices. The FD&C Act...
Page 20 - ... sufficient to provide reasonable assurance of the safety and effectiveness of the device...
Page 30 - CLIA is defined as any facility that performs laboratory testing on specimens derived from humans for the purpose of providing information for the diagnosis, prevention, or treatment of a disease or impairment, or to assess the patient's health.