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A certificate of analysis (COA) is a formal laboratory-prepared document that details the results of (and sometimes the specifications and analytical methods for) one or more laboratory analyses, signed—manually or electronically—by an authorized representative of the entity conducting the analyses. This document gives assurances to the ...
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 typical method of sample acceptance (in a clinical chemistry lab) is as follows: Sample is received. Sample is checked (to ensure that the sample is sent in the correct container for the specimen). Patient's details checked and matched on both form and sample (non-matching samples and/or forms rejected).
This is because relying solely on the lab-internal quality management can create a false sense of safety. Laboratories are instructed to treat proficiency testing samples in the same way as normal patient samples. [1] For a laboratory, gaining and keeping the ISO 17025 accreditation status is of high commercial importance.
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.
Custom in-house solutions were developed by a few individual laboratories, while some enterprising entities sought to develop commercial reporting solutions in the form of special instrument-based systems. [1] In 1982 the first generation of LIMS was introduced in the form of a centralized minicomputer, which offered automated reporting tools.
Clinical data management ensures collection, integration and availability of data at appropriate quality and cost. It also supports the conduct, management and analysis of studies across the spectrum of clinical research as defined by the National Institutes of Health (NIH). The ultimate goal of CDM is to ensure that conclusions drawn from ...
A laboratory specimen is sometimes a biological specimen of a medical patient's tissue, fluids, or other samples used for laboratory analysis to assist in differential diagnosis or staging of a disease process. These specimens are often the most reliable method of diagnosis, depending on the ailment.