A laboratory information management system (LIMS) is a computer program or information management system designed to handle the workflow and data tracking of laboratory information. Although there are subtle differences within the industry, the term LIMS is often used interchangeably with laboratory information system (LIS). For many years the clinical diagnostic lab—and healthcare in general— depended upon paper orders and requisitions and results reporting.
In February 2014 the Department of Health and Human Services (HHS) issued an amendment to the Clinical Laboratory Improvement Amendments of 1988 (CLIA) known as the “Final Rule” that significantly increases patient access and empowerment. The Final Rule gives patients (or their authorized representative) the right to access test reports directly from a laboratory without first receiving authorization from a healthcare provider. It does not require laboratories to interpret test results, just to provide them.
Moreover, the Final Rule eliminates an exception under HIPAA that exempted CLIA-certified or CLIA-exempt laboratories from providing individuals access to their own health information.
Under the Final Rule, patients can still receive test reports from their doctors if they choose, but now they have the option to obtain results from the laboratory. Surveys indicate that the vast majority of patients want that access. The burden of providing it and providing it in a way that is meaningful and reliable, is on the shoulders of the healthcare industry and the clinical laboratories.
A modern LIMS has numerous components, including computerized provider order entry (CPOE), rules-making ability, barcoding, direct interfaces with laboratory instrumentation and the LIMS, EMR, EHRs, patient portals, and potential for adding rich content and patient-oriented data interpretation.
With over a quarter-million different laboratories, numerous different lab types, and the multiple complicated connections a LIMS needs to make between physicians, hospitals, clinics, insurers, and patients, connectivity and standardization is not a simple matter.
The federal government in general, and specifically through legislation such as the Patient Protection and Affordable Care Act (ACA) and the Health Information Technology for Economic and Clinical Health (HITECH) Act of 2009, have provided incentives and penalties for all healthcare providers, including laboratories, to adopt electronic health information technology (HIT) that is interoperable and accessible.
Last Friday, Roche announced an agreement to acquire Viewics, Inc., of Sunnyvale, Calif., in a transaction that, subject to regulatory clearance, is expected to close on Nov. 21. Viewics sells a middleware analytics solution to clinical labs. Terms of the sale were not announced. Viewics was founded in 2010.
CEO SUMMARY: One by one, new business models for clinical laboratory testing are popping up. Each is a response to healthcare’s rapid evolution, the ongoing decline in lab test reimbursement, and the growing role for molecular diagnostics and genetic testing. In Cambridge, Massachusetts, Claritas Genomics, formerly the molecular lab at Boston Children’s Hospital, is one