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 18
... developing regulations that further protect the American people , and enforcing the regulations and the statutes that govern these products . This hearing specifically touches on FDA's medical device regulatory authorities . As defined ...
... developing regulations that further protect the American people , and enforcing the regulations and the statutes that govern these products . This hearing specifically touches on FDA's medical device regulatory authorities . As defined ...
Page 24
... developing mechanisms for working with Europe to monitor post - market device performance as part of initiatives in the area of global harmonization of device regulation . Problems with device performance that have been included in the ...
... developing mechanisms for working with Europe to monitor post - market device performance as part of initiatives in the area of global harmonization of device regulation . Problems with device performance that have been included in the ...
Page 27
... developing a plan for tighter communication protocols to coordinate activities among the State agencies surveying on behalf of CMS , the CMS regional offices , and the accrediting organizations . CMS is also specifically addressing the ...
... developing a plan for tighter communication protocols to coordinate activities among the State agencies surveying on behalf of CMS , the CMS regional offices , and the accrediting organizations . CMS is also specifically addressing the ...
Page 33
... develop a plan to monitor their entire operation to identify and resolve their quality- related problems . Because ... developing an outcome oriented survey process is to not only determine the laboratory's regulatory compliance , but ...
... develop a plan to monitor their entire operation to identify and resolve their quality- related problems . Because ... developing an outcome oriented survey process is to not only determine the laboratory's regulatory compliance , but ...
Page 37
... develop , implement , and maintain an effective , ongoing hospital - wide , data - driven QAPI program . The hospital's governing body must ensure that the program reflects the complexity of the hospital's organization and services ...
... develop , implement , and maintain an effective , ongoing hospital - wide , data - driven QAPI program . The hospital's governing body must ensure that the program reflects the complexity of the hospital's organization and services ...
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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.