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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).
In a hospital setting, sample processing will usually start with a set of samples arriving with a test request, either on a form or electronically via the laboratory information system . Inpatient specimens will already be labeled with patient and testing information provided by the LIS.
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.
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 ...
The LIMS then tracks chain of custody as well as sample location. Location tracking usually involves assigning the sample to a particular freezer location, often down to the granular level of shelf, rack, box, row, and column. Other event tracking such as freeze and thaw cycles that a sample undergoes in the laboratory may be required.
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The header identifies the FDA district office that performed the inspection, the date(s) of inspection, name and address of the facility that was inspected, the name and title of the individual to whom the 483 is issued to (usually the most responsible individual physically present in the facility), a brief description of the type of facility, and the facility's FEI (FDA Establishment ...
ssued to a laboratory to allow the laboratory to conduct nonwaived (moderate and/or high complexity) testing until the laboratory is surveyed (inspected) to determine its compliance with the CLIA regulations. Only laboratories applying for a certificate of compliance or a certificate of accreditation will receive a certificate of registration. CoC