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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.
WHO Good Clinical Laboratory Practice (GCLP) ISBN 978-92-4-159785-2; Stevens W. (2003) Good Clinical Laboratory Practice (GCLP): The need for a hybrid of Good Laboratory Practice and Good Clinical Practice guidelines/standards for medical testing laboratories conducting clinical trials in developing countries. Quality Assurance, 10: 83–89.
All analytical procedures should be validated. Identification tests are conducted to ensure the identity of an analyte in a sample through comparison of the sample to a reference standard through methods such as spectrum, chromatographic behavior, and chemical reactivity. [5] Impurity testing can either be a quantitative test or a limit test.
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 distance from the mean is measured in standard deviations. It is named after Stanley Levey and E. R. Jennings, pathologists who suggested in 1950 that Shewhart's individuals control chart could be used in the clinical laboratory. [5] The date and time, or more often the number of the control run, is plotted on the x-axis.
The current journal, The International Journal of Laboratory Hematology, is the official journal of the ISLH. [2] It provides an international forum for new developments in the research and practice of laboratory hematology and includes invited reviews , original articles, research results, [ 3 ] and correspondence.
The FDA requires nonclinical laboratory studies on new drugs, food additives, and chemicals to assess their safety and potential effectiveness in humans in compliance with 21 CFR Part 58, Good Laboratory Practice for Nonclinical Studies under the Federal Food Drug and Cosmetic Act and Public Health Service Act. [16]
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]