Laboratory Information Systems and Instrument Software Lack Basic Functionality for Molecular Laboratories.

Laboratory information systems (LISs) have some basic functionality necessary for molecular workflow that is glaringly absent. This study determined functionality gaps of LISs in molecular laboratories and the associated impact to workflow, efficiency, and security by collecting anonymous survey data from clinical laboratory professionals. A 34-question survey (30 required + 4 optional) was compiled using an online survey tool. Participants were recruited through several professional molecular society listservs and given 4 weeks to complete the survey. Data collected included participant demographics, scope of testing, software capabilities for the LIS and molecular instruments, and comments. Eighty respondents completed the entire survey. Many desired versus actual functionality gaps were identified. Prominent among these were bar coding, LIS interfacing, storage of preanalytical data, Health Insurance Portability and Accountability Act compliance/information security, and reporting. Much basic functionality is lacking in molecular LISs and molecular instrument software. Some of these results indicate that instruments and LISs are not compliant with the Health Insurance Portability and Accountability Act. Collaboration between molecular professionals and manufacturers of instruments and software is necessary to correct these deficits and is critically important to ensure the continued high quality and safety of molecular practice as the volume of testing skyrockets.