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 15
... Italy this summer . Two adverse reports about Labotech have appeared in European data bases . FDA is still investigating whether these reports should have been submitted to our data base . There is no evidence of con- tinued problems in ...
... Italy this summer . Two adverse reports about Labotech have appeared in European data bases . FDA is still investigating whether these reports should have been submitted to our data base . There is no evidence of con- tinued problems in ...
Page 16
... Italy this summer . After that inspection we will determine if further investigations or actions are needed . I am happy to answer any questions . Thank you . [ The prepared statement of Dr. Gutman follows : ] STATEMENT BY STEVEN GUTMAN ...
... Italy this summer . After that inspection we will determine if further investigations or actions are needed . I am happy to answer any questions . Thank you . [ The prepared statement of Dr. Gutman follows : ] STATEMENT BY STEVEN GUTMAN ...
Page 23
... Italian firm . Our U.S. inspection , which was conducted from April 12 though 14 , 2004 , focused on whether Adaltis U.S. was aware of the problems and took corrective action . No serious problems were identified . Since this U.S. site ...
... Italian firm . Our U.S. inspection , which was conducted from April 12 though 14 , 2004 , focused on whether Adaltis U.S. was aware of the problems and took corrective action . No serious problems were identified . Since this U.S. site ...
Page 24
... Italy to include an evaluation of the quality systems in place and the complaint files . As a result of questions raised at a briefing with this Subcommittee's staff on April 29th , we became aware of two adverse reports about the ...
... Italy to include an evaluation of the quality systems in place and the complaint files . As a result of questions raised at a briefing with this Subcommittee's staff on April 29th , we became aware of two adverse reports about the ...
Page 43
... Italian firm , if that is an isolated complaint or if there are other complaints like it . Mr. CUMMINGS . You said when you visit the Italian . Tell me , where are you going to go in Italy ? Dr. GUTMAN . I don't know the location of the ...
... Italian firm , if that is an isolated complaint or if there are other complaints like it . Mr. CUMMINGS . You said when you visit the Italian . Tell me , where are you going to go in Italy ? Dr. GUTMAN . I don't know the location of the ...
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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.