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 14
... QUALITY , CMS , DEPARTMENT OF HEALTH AND HUMAN SERVICES , ACCOMPANIED BY VIR- GINIA WANAMAKER Dr. GUTMAN . Good ... control needed to provide reasonable assurance of safety and effectiveness . Devices posing the lowest risk are placed in ...
... QUALITY , CMS , DEPARTMENT OF HEALTH AND HUMAN SERVICES , ACCOMPANIED BY VIR- GINIA WANAMAKER Dr. GUTMAN . Good ... control needed to provide reasonable assurance of safety and effectiveness . Devices posing the lowest risk are placed in ...
Page 15
... controls that the agency may designate . Class III devices are subject to pre - market ... control applicable to all classes of devices is adverse event reporting ... quality procedures . FDA has remained in contact with both CMS and the ...
... controls that the agency may designate . Class III devices are subject to pre - market ... control applicable to all classes of devices is adverse event reporting ... quality procedures . FDA has remained in contact with both CMS and the ...
Page 19
... control needed to provide reasonable assurance of safety and effectiveness of the device for its intended use ... Quality System Requirements for manufacturing , provisions regarding adulteration and misbranding , record keeping , and ...
... control needed to provide reasonable assurance of safety and effectiveness of the device for its intended use ... Quality System Requirements for manufacturing , provisions regarding adulteration and misbranding , record keeping , and ...
Page 31
... quality standards for the latter two categories . Waived laboratories must enroll in CLIA , pay the applicable fee ... Control and Prevention ( CDC ) is responsible for the CLIA studies , convening the Clinical Laboratory Improvement ...
... quality standards for the latter two categories . Waived laboratories must enroll in CLIA , pay the applicable fee ... Control and Prevention ( CDC ) is responsible for the CLIA studies , convening the Clinical Laboratory Improvement ...
Page 32
... quality assurance focus and an educational approach to assess compliance . Labs subject to routine biennial surveys ... control : Labs must have a process for monitoring personnel , testing equipment and the testing environment to ensure ...
... quality assurance focus and an educational approach to assess compliance . Labs subject to routine biennial surveys ... control : Labs must have a process for monitoring personnel , testing equipment and the testing environment to ensure ...
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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.