Recently Approved Documents
Remote Access to Clinical Laboratory Diagnostic Devices via the Internet (AUTO9-A); Laboratory Documents: Development and Control (GP2-A5); Quality Assurance of Laboratory Tests for Autoantibodies to Nuclear Antigens (I/LA2-A2)

 Second Notice

AUTO9-A—Remote Access to Clinical Laboratory Diagnostic Devices via the Internet;
Approved Standard
This document provides a standard communication protocol that will allow remote connections to laboratory devices, which can be used to monitor the instruments' subsystems to determine proper operation; collect diagnostic data for remote system troubleshooting; and collect data that would allow for electronic inventory management.
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GP2-A5—Laboratory Documents: Development and Control; Approved Guideline—Fifth Edition
This guideline presents the important components of writing and managing documents for the clinical laboratory. This guideline describes common and specific sections for inclusion in laboratory documents. Several examples of process and procedure documents for preexamination, examination, and postexamination laboratory activities are provided in the form of appendixes; such appendixes are simply illustrative, and not prescriptive.
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I/LA2-A2—Quality Assurance of Laboratory Tests for Autoantibodies to Nuclear Antigens: (1) Indirect Fluorescence Assay for Microscopy and (2) Microtiter Enzyme Immunoassay Methods: Approved Guideline—Second Edition
This document addresses the criteria for ANA testing by immunofluorescence and by enzyme immunoassay, including test components, quantification of results, and classification criteria.
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