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This guideline provides recommendations for designing autoverification algorithms for specific disciplines and types of testing in the medical laboratory (eg, chemistry, coagulation, hematology, immunochemistry, infectious diseases, toxicology, and urinalysis), as well as guidance for human...
This standard specifies requirements for the data exchange associated with the analytical workflow between medical laboratory in vitro diagnostic (IVD) instruments and the systems managing their work. This data exchange includes test orders and test results for both patients and QC specimens....
This standard specifies technical and operational requirements and technical implementation procedures related to information technology (IT) security of in vitro diagnostic (IVD) systems (devices, analytical instruments, data management systems, etc.) installed at a health care organization (HCO)....
Automation protects against both unsafe conditions and human errors. It is the key to safety in the nuclear power industry. This is the message of this book, written by Béla Lipták, a consultant with more than 50 years' experience in automation and industrial safety.After reviewing the Three Mile...
This document presents a standard for specimen label content, format, and placement. This document is intended for health care providers; laboratory information system (LIS) vendors, diagnostic vendors, and vendors that manufacture labels and/or label printers; and for all other entities that...
Preface You see it all the time: a new head of a department, or of a company for that matter, comes into a new position in the industrial automation environment from a different industry. The press release talks in glowing terms of the skills and capabilities the new office holder had in his or her...
This standard provides a protocol for communications between Laboratory Automation Systems (LASs), Laboratory Information Systems (LISs), automated instruments (analyzers), and pre-and postanalytical (pre-and postexamination) automated instruments (analyzers), and pre-and postanalystical (pre-and...
The laboratory industry is quickly moving into the era of electronic reports, transmission of information via the Internet, etc., and there is a need to develop guidelines that can provide consistency in the industry. The purpose of this guideline is to address the validation of LIS systems and any...
This guideline specifies recommendations for the design, building, implementation, validation, and compliance of the algorithms used for autoverification of laboratory results. The intended users of this guideline are information system vendors; hospital, reference, independent, and physician...
This standard ensures that identification of specimen container bar codes will be effective in automated laboratory systems and for sample handling in automated instrumentation. The standard uses Code 128, a bar-code symbology which accommodates many different languages and recommended phasing out...
