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High Complexity Testing
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. CLIA Program In accord with the CLIA, the CLIA Program sets standards and issues certificates for clinical laboratory testing. CLIA defines a clinical laboratory as any facility which performs laboratory testing on specimens derived from humans for the purpose of providing information for: * diagnosis, prevention, or treatment of disease or impairment * health assessments An objective of the CLIA is to ensure the accuracy, reliability and timeliness of test results regardless of where the test was performed. Most Laboratory Developed Tests have been regulated under this program. In 2014 the FDA started a public discussion about regulating some LDTs. Test Complexity Per CLIA, each specific laboratory system, assay, examination is graded for leve ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Medical Laboratory
A medical laboratory or clinical laboratory is a laboratory where tests are conducted out on clinical specimens to obtain information about the health of a patient to aid in diagnosis, treatment, and prevention of disease. Clinical medical laboratories are an example of applied science, as opposed to research laboratory, research laboratories that focus on basic science, such as found in some academia, academic institutions. Medical laboratories vary in size and complexity and so offer a variety of testing services. More comprehensive services can be found in acute-care hospitals and medical centers, where 70% of clinical decisions are based on laboratory testing. Doctors offices and clinics, as well as skilled nursing and Nursing home, long-term care facilities, may have laboratories that provide more basic testing services. Commercial medical laboratories operate as independent businesses and provide testing that is otherwise not provided in other settings due to low test vol ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
