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The Clinical Laboratory Improvement Amendments (CLIA) of 1988 are United States federal regulatory standards that apply to all clinical laboratory testing performed on humans in the United States, except clinical trials and basic research.
This file is a work of the Centers for Disease Control and Prevention, part of the United States Department of Health and Human Services, taken or made as part of an employee's official duties. As a work of the U.S. federal government , the file is in the public domain .
Stark II" extended the "Stark I" provisions to Medicaid patients and to DHS other than clinical laboratory services. [3] The Centers for Medicare and Medicaid Services has issued rules in the Federal Register to implement Stark Law, including a 2001 "Phase I" final rule, a 2004 "Phase II" interim final rule, and a 2007 "Phase III" final rule. [4]
Laboratories first began receiving CAP accreditation in 1964, [8] and the organization was later given authority to accredit medical laboratories as a result of the Clinical Laboratory Improvement Amendments of 1988. [9] The CAP publishes checklists containing requirements pertaining to the performance of laboratory tests.
Virginia Health Quality Center (VHQC) was an independent, not-for-profit corporation that primarily focused on health care quality assessment services. Their role was to assess the needs, implement improvements, and evaluate results as it related to how medical care is delivered by health care providers within a targeted geographic area.
The Clinical and Laboratory Standards Institute (CLSI) is a volunteer-driven, membership-supported, not-for-profit, standards development organization. CLSI promotes the development and use of voluntary laboratory consensus standards and guidelines within the health care community.
The laboratory industry is a part of the broader healthcare and health technology industry. Companies exist at various levels, including clinical laboratory services , suppliers of instrumentation equipment and consumable materials, and suppliers and developers of diagnostic tests themselves (often by biotechnology companies).
Regarding health care access and economics, the Board sets the income limitations on medically indigent patients and sets the charges to be paid for the medical care services of the Department. [6] It works with the Virginia Health Planning Board to consider issues of health care policy and financing and issues formal studies on these subject. [7]