Next-generation sequencing (NGS) has made genetic information part of mainstream medical practice. Labs that have delivered common clinical tests from routine blood draws to pathology work ups now also perform genetic testing. In addition, hospitals are building dedicated labs, like the Mount Sinai Genetic Testing Laboratory, to meet clinical and research sequencing needs.
Clinical Laboratory Improvement Amendments
Any lab handling any type of clinical sample from human patients must ensure that their processes comply with the Clinical Laboratory Improvement Amendments (CLIA) of 1988. CLIA is supported by three U.S. agencies: the Centers for Medicare and Medicaid Services, the FDA and the Centers for Disease Control and Prevention. Together these agencies specify and enforce the standards and practice guidelines to which labs handling clinical samples must adhere. The agencies also handle the inspections (also known as audits) that labs must undergo to achieve and maintain CLIA accreditation, often in conjunction with other accreditation groups, such as the College for American Pathologists (CAP), as well as state health agencies.
These regulations exist to ensure labs conduct high-quality operations that ensure patient safety and confidentiality. Under CLIA, labs must certify that all of their processes deliver the same results, each time they are performed. This means labs must know—and be able to provide information about—not just what they have done at any given time, but how they did it, including which tools or systems were used, by whom.
Laboratory Information Management Systems (LIMS) can help clinical labs by providing a way to track laboratory processes, especially the complicated, data-intensive workflows associated with NGS. The best LIMS help automate workflows by integrating directly with instrumentation to minimize manual data entry and reduce human error. Laboratory management systems should also track data at every “touch,” logging what was done, by whom, when, and ideally maintaining a record of both the original data and the changed state.
CLIA-Certified LIMS Misconception
While LIMS play a critical role in helping labs organize and validate their processes, ultimately laboratories, and not hardware or software vendors, are responsible for validating workflows and the technology they have deployed. A common misconception, which some vendors perpetuate, is that software can be CLIA-certified. Certainly a vendor that conducts its own sequencing with clinical samples can claim that its software has been used in a CLIA-compliant lab—but once that software is used outside of that lab, such claims are irrelevant. CLIA applies to lab processes and is a certification given to a lab and its workflows, not to the specific instruments, software, and other technology the lab uses.
Validation is the first step labs take in preparing for audits, and vendors can help their customers by making validation easier. Core has developed a validation package for Core LIMS that includes test scripts for installation qualification (IQ) and operation qualification (OQ) so that labs can validate the technical environment that supports their laboratory information management system. Core also provides scripts that validate the base functionality in Core LIMS needed for production qualification (PQ), and our dedicated customer support teams assist customers in developing custom scripts to validate use cases specific to their LIMS implementation.
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