Recommendations for HLA Genotyping Data Standards and Clinical Laboratory Staffing Considerations

Abstract

The rapid advances in HLA genotyping technology and the massive amounts of associated data have created a demand for better and more efficient laboratory data management practices. However, while some standards have been developed, there is a need for comprehensive guidelines that include all laboratory data-related processes such as messaging, storage and retention, documentation, reporting, validation and quality control. An important consideration in developing these recommendations is the feasibility of application in a laboratory setting without posing a substantial staff and cost burden for implementation and long-term maintenance and the availability of publicly available tools. This article presents evidence-based recommendations for multiple laboratory general data practices, focusing on HLA genotyping data and associated meta-data. These recommendations are compiled by experts in the fields of histocompatibility and immunogenetics (H&I) and representation from multiple H&I worldwide professional society leadership with the long-term goal of adopting these recommendations in future laboratory accreditation requirements.