scope:

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 intervention, whether results are generated from an automated system or manual result entry. Additionally, it provides recommendations for the creation of scalable algorithms that provide levels of adaptation from simple to more complex criteria and the actionable implementation of autoverification in the medical laboratory.

The intended users of this guideline are clinical pathologists, medical directors, and medical technology staff responsible for the timely delivery of actionable health care information provided by medical laboratories. Additionally, laboratory personnel responsible for the information systems, medical informatics vendors, and in vitro diagnostics vendors should ensure their products and services comply with the recommendations provided in this guideline.

This guideline is not intended to provide a specific programming language, vendor-specific implementations for autoverification for a discipline, or analyte-specific autoverification algorithms. This guideline is not applicable to all possible medical permutations that are present in the medical laboratory respective to a specific discipline. These recommendations are not applicable to transfusion medicine, microbiology, molecular medicine, anatomic pathology, or point-of-care testing.