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
... actions or inactions of persons charged with pro- tecting the public health . It is critical that we understand what caused the testing prob- lems to occur , whether the health of any patients has been ad- versely affected , and why ...
... actions or inactions of persons charged with pro- tecting the public health . It is critical that we understand what caused the testing prob- lems to occur , whether the health of any patients has been ad- versely affected , and why ...
Page 10
... actions or inaction of persons charged with protecting the public health . It is critical that we understand what caused the testing problems to occur , whether the health of any patients has been adversely affected , and why testing ...
... actions or inaction of persons charged with protecting the public health . It is critical that we understand what caused the testing problems to occur , whether the health of any patients has been adversely affected , and why testing ...
Page 15
... actions that can be taken depending on the problem . FDA inspects device manufacturing facilities to ensure conformance with requirements . The responsibility for inspection and oversight of clinical labs that use those devices lies ...
... actions that can be taken depending on the problem . FDA inspects device manufacturing facilities to ensure conformance with requirements . The responsibility for inspection and oversight of clinical labs that use those devices lies ...
Page 16
... 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 , M.D. DIRECTOR OFFICE OF IN 16.
... 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 , M.D. DIRECTOR OFFICE OF IN 16.
Page 21
... actions that can be taken depending on the nature and severity of that problem . These include issuing public health information to alert users on how to avoid the problem ; requiring corrective actions such as recalls , repairs and ...
... actions that can be taken depending on the nature and severity of that problem . These include issuing public health information to alert users on how to avoid the problem ; requiring corrective actions such as recalls , repairs and ...
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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.