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The Clinical Laboratory Improvement Act of 1988 (CLIA 88) was passed in the USA subsequent to the publication of an article in November 1987 in The Wall Street Journal entitled "Lax Laboratories: The Pap Test Misses Much Cervical Cancer Through Labs Errors", which alerted the public to the fact that a pap smear may be falsely negative.
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. [1]
Part 2-012: Particular requirements for climatic and environmental testing and other temperature conditioning equipment Part 2-020 : Particular requirements for laboratory centrifuges Part 2-030 : Particular requirements for equipment having testing or measuring circuits
CLSI participates in the development of international standards as the Secretariat of ISO Technical Committee (TC) 212, clinical laboratory testing and in vitro diagnostic test systems. This responsibility was delegated to CLSI by the American National Standards Institute (ANSI), an ISO member body. CLSI also serves as the administrator for the ...
Every medical treatment facility should have policies and processes on equipment control and asset management. Equipment control and asset management involves the management of medical devices within a facility and may be supported by automated information systems (e.g., enterprise resource planning (ERP) systems are often found in U.S. hospitals, and the U.S. military health system uses an ...
To this end, much of the work done by medical laboratory scientists involves ensuring specimen quality, interpreting test results, data-logging, testing control products, performing calibration, maintenance, validation, and troubleshooting of instrumentation as well as performing statistical analyses to verify the accuracy and repeatability of ...
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Ortho Clinical Diagnostics (now QuidelOrtho) is an in vitro diagnostics company that made products and diagnostic equipment for blood testing.Ortho served two primary industries in the medical field: clinical laboratories, by producing platforms and assays that test for a variety of diseases, conditions, and substances; and immunohematology, by providing the means to ensure blood transfusion ...
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