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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.
Clinical laboratory in a hospital setting showing several automated analysers.. 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]
A blood test is a laboratory analysis performed on a blood sample that is usually extracted from a vein in the arm using a hypodermic needle, or via fingerprick. Multiple tests for specific blood components, such as a glucose test or a cholesterol test , are often grouped together into one test panel called a blood panel or blood work .
A medical test is a medical procedure performed to detect, diagnose, or monitor diseases, disease processes, susceptibility, or to determine a course of treatment. Medical tests such as, physical and visual exams, diagnostic imaging, genetic testing, chemical and cellular analysis, relating to clinical chemistry and molecular diagnostics, are typically performed in a medical setting.
The tests are classified by speciality field, conveying in which ward of a hospital or by which specialist doctor these tests are usually performed. The ICD-10-CM is generally the most widely used standard by insurance companies and hospitals who have to communicate with one another, for giving a overview of medical tests and procedures.
The application must show that the test meets the criteria in 42 U.S.C. § 263a(d)(3), that the test is simple and will not cause harm to the patient if performed incorrectly. [36] These test classifications determine the certifications needed for laboratories to perform said tests.
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