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 |
From inside the book
Results 1-5 of 18
Page 15
... machine . It is believed that ap- proximately 2500 of these devices have been placed in labs world- wide . FDA takes seriously and investigates MDRS reported to the agency . We are continuing to evaluate whether there are systemic ...
... machine . It is believed that ap- proximately 2500 of these devices have been placed in labs world- wide . FDA takes seriously and investigates MDRS reported to the agency . We are continuing to evaluate whether there are systemic ...
Page 22
... machine with specific test conditions and procedures . Development or modification of these assay procedures is performed subject to regulations developed under CLIA a program administered by CMS . The Labotech is considered a class I ...
... machine with specific test conditions and procedures . Development or modification of these assay procedures is performed subject to regulations developed under CLIA a program administered by CMS . The Labotech is considered a class I ...
Page 41
... machine that has been cleared by you for safety purposes , when they modify it , do they have to go through FDA ? Mr. GUTMAN . I am sorry , I didn't mean that they would modify the machine . They could modify the assay . The machine can ...
... machine that has been cleared by you for safety purposes , when they modify it , do they have to go through FDA ? Mr. GUTMAN . I am sorry , I didn't mean that they would modify the machine . They could modify the assay . The machine can ...
Page 42
... machine if there are flexibilities that can make the ma- chine's data inaccurate if you manipulate it . Dr. TUNIS ... machine and would use that machine , and it is largely regulated through the quality require- ments that would indicate ...
... machine if there are flexibilities that can make the ma- chine's data inaccurate if you manipulate it . Dr. TUNIS ... machine and would use that machine , and it is largely regulated through the quality require- ments that would indicate ...
Page 43
... machine ? Dr. GUTMAN . Anything is possible , but there have been very few signals that would suggest this is actually a systemic problem . So I don't want to speculate on how the outcome will be . Mr. CUMMINGS . And I don't want you to ...
... machine ? Dr. GUTMAN . Anything is possible , but there have been very few signals that would suggest this is actually a systemic problem . So I don't want to speculate on how the outcome will be . Mr. CUMMINGS . And I don't want you to ...
Other editions - View all
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.