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
... continuing to evaluate whether there are systemic problems with the Labotech . FDA first became aware of the problem with test results gen- erated at Maryland General when our press office received an in- quiry on March 19 , 2004. We ...
... continuing to evaluate whether there are systemic problems with the Labotech . FDA first became aware of the problem with test results gen- erated at Maryland General when our press office received an in- quiry on March 19 , 2004. We ...
Page 16
... continue to advance our mission to pro- tect the public health by staying abreast of this unfortunate situa- tion through continued communication with both CMS and the Maryland Department of Health . We will be following up on device ...
... continue to advance our mission to pro- tect the public health by staying abreast of this unfortunate situa- tion through continued communication with both CMS and the Maryland Department of Health . We will be following up on device ...
Page 25
... continue to advance our mission to protect the public health by staying abreast of this unfortunate situation ... continue to be a safe and effective diagnostic device , we will continue to investigate this issue . I am happy to answer ...
... continue to advance our mission to protect the public health by staying abreast of this unfortunate situation ... continue to be a safe and effective diagnostic device , we will continue to investigate this issue . I am happy to answer ...
Page 26
... continue to be sub- ject to a biennial CMS survey process and data show that since CLIA was implemented in 1992 , quality deficiencies in clinical labs have decreased from 35 percent of labs with quality problems to under 10 percent ...
... continue to be sub- ject to a biennial CMS survey process and data show that since CLIA was implemented in 1992 , quality deficiencies in clinical labs have decreased from 35 percent of labs with quality problems to under 10 percent ...
Page 43
... continue to gather information . We are very inter- ested in seeing , when we go to visit 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 ...
... continue to gather information . We are very inter- ested in seeing , when we go to visit 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 ...
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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.