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, Volume 1
United States. Congress. House. Committee on Government Reform. Subcommittee on Criminal Justice, Drug Policy, and Human Resources
U.S. Government Printing Office, 2004 - Diagnostic errors
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accreditation accrediting organizations action actually Adaltis additional agencies American assurance aware Baltimore better Chairman changes Class CLIA Clinical College complaint concerns conducted continue correct Cummings deficiencies Department developing device director Drug effectiveness employees ensure entities equipment facility fact Federal findings follow forward going Gutman happened hearing identified important Improvement inspection involved issues Italy laboratory Labotech look machine manufacturers March Maryland General Hospital Maryland General Hospital's Maryland Medical System meet necessary Office operation opportunity oversight patients performed personnel prevent problems quality control question received record regulations regulatory requirements response safety serious situation Souder specific staff standards statement subcommittee sure survey taken test results testimony Thank thing Tunis understand University of Maryland
Page 32 - 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 3 - 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 5 - Thank you all for being here today. We look forward to your testimony and insights.
Page 20 - Director of the Center for Devices and Radiological Health (CDRH) at the Food and Drug Administration (FDA or the Agency). I am...
Page 21 - Act) to give FDA specific authority to regulate the safety and effectiveness of medical devices. The FD&C Act...
Page 22 - ... sufficient to provide reasonable assurance of the safety and effectiveness of the device...
Page 12 - Subcommittee on Criminal Justice, Drug Policy, and Human Resources Committee on Government Reform US House of Representatives 109th Congress Hearing on "The National Parks: Will They Survive for Future Generations?