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 2
... specific problem area to investigate did the entities involved begin to communicate their findings to each other . Fortunately , the hospital has retested many patients and found the original results were mostly accurate , and steps ...
... specific problem area to investigate did the entities involved begin to communicate their findings to each other . Fortunately , the hospital has retested many patients and found the original results were mostly accurate , and steps ...
Page 5
... specific problem area to investigate did the entities involved begin to communicate their findings to each other . Fortunately , the hospital has retested many patients and found the original results were mostly accurate and steps have ...
... specific problem area to investigate did the entities involved begin to communicate their findings to each other . Fortunately , the hospital has retested many patients and found the original results were mostly accurate and steps have ...
Page 14
... specific au- thority to regulate medical devices . FDA places every medical de- vice into one of three classes depending on the degree of control needed to provide reasonable assurance of safety and effectiveness . Devices posing the ...
... specific au- thority to regulate medical devices . FDA places every medical de- vice into one of three classes depending on the degree of control needed to provide reasonable assurance of safety and effectiveness . Devices posing the ...
Page 19
... specific authority to regulate the safety and effectiveness of medical devices . Using a risk - based classification framework , FDA places every medical device into one of three " classes " depending on the degree of regulatory control ...
... specific authority to regulate the safety and effectiveness of medical devices . Using a risk - based classification framework , FDA places every medical device into one of three " classes " depending on the degree of regulatory control ...
Page 20
... events to the Agency and currently has regulatory staff with specific expertise in IVDs monitoring reports for these products . The Agency uses MDRs to help provide signals of device problems so it can determine whether follow - up 3 20.
... events to the Agency and currently has regulatory staff with specific expertise in IVDs monitoring reports for these products . The Agency uses MDRs to help provide signals of device problems so it can determine whether follow - up 3 20.
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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.