CLN - Industry Insights
Sponsored by Sapio Sciences
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Prior to the emergence of Laboratory Information Management Systems (LIMS) in the late 1970s, clinical and diagnostic laboratories relied on manual systems such as record books and spreadsheets to manage their laboratory operations. As diagnostic testing evolved, more specialized solutions were developed and deployed to keep pace. As a result, laboratories adopted multiple disparate systems to meet the requirements of high throughput testing, new diagnostic capabilities, advanced instrumentation, ever-changing workflows, and copious amounts of data. Unfortunately, these solutions have left a trail of operational bottlenecks in their path, such as delays in turnaround time, poor visibility into sample tracking, fragmented data and compliance risks.
A configurable, open lab platform can fit your laboratory like a well-tailored suit – customized to your unique workflows, instruments, and existing IT systems. Today’s modular LIMS are designed to streamline multiple laboratory operations from sample tracking to processing and reporting while ensuring efficient data organization and compliance with industry standards.
An end-to-end LIMS platform can optimize laboratory operations in four key areas: turnaround time, sample traceability, data access and compliance. Addressing these issues can dramatically improve laboratory performance. Below is an overview of each challenge along with how a configurable LIMS platform can overcome them.
A majority of delays in turnaround time can be attributed to the pre-analytical phase. According to multiple studies, pre-analytical factors can account for between 66% and 76% of total turnaround time (TAT) delays in clinical laboratories.1,2 The pre-analytical phase includes test requests, patient and specimen identification, specimen collection, transport, accessioning, and processing. The use of manual processes or disparate software platforms can further complicate the process leading to slower accessioning, transcribing errors, lost or misidentified samples and delays in processing and results reporting.
A fully integrated LIMS platform can automate the ordering process, accessioning, processing, and reporting can solve for all of the problems related to TAT. Test orders can be submitted through a physician portal electronically, eliminating the need for paper requisitions that can get lost or misinterpreted. Upon receipt, samples can be accessioned through barcodes, QR codes, or RFID tags to ensure each sample is uniquely identified and linked to the correct patient and test order. It can also support the appropriate routing of the sample to the relevant departments within the lab for analysis.
The ability to track and trace samples throughout their journey outside of and within the lab is a significant concern for clinical laboratories. Effective sample tracking ensures that your business has full visibility of the sample’s status, location, history, and progress in real-time. Manual accessioning errors and siloed systems that don’t communicate well with each other are the major contributors to poor visibility and breakdowns in chain of custody.
With a holistic LIMS platform, labs can maintain sample lineage, including its source and any transformations or handling it has undergone during its lifecycle. This can include the documentation of where the sample came from, how it was processed, and where it has been within the lab's workflow. As a sample continues its journey and is sectioned and distributed, a LIMS maintains a detailed chain of custody to track the control, transfer, and analysis of a sample from collection to final disposition.
Fragmented test data and reporting is a significant challenge in clinical laboratories. Fragmentation can arise from legacy systems, poorly integrated data, inconsistent data standards, old manual entry techniques, and siloed information. And when different departments use various data management systems that do not integrate effectively, it makes it challenging to maintain a unified and accurate data repository. This makes it harder to compile test results from multiple departments and search for data.
A centralized LIMS integrates data from various sources into a unified platform, eliminating silos. Standardized data formats reduce inconsistencies, making analysis and reporting easier. The platform automates data consolidation, generating comprehensive patient reports. This approach to unifying lab data into a single system ensures that all relevant data is accessible from one location, reducing the risks of data fragmentation.
Today’s clinical must adhere to stringent regulatory requirements, such as Good Laboratory Practices (GLP) and Good Clinical Practices (GCP), ISO standards, and FDA regulations. Adhering to regulatory standards is a fundamental requirement for clinical labs. Non-compliance can result in penalties (including loss of regulatory certification), legal issues, and damage to the lab’s reputation. Continuous monitoring, accurate record-keeping, and integrated data systems are essential for ensuring comprehensive audit trails. Manual data entry, disconnected systems, and incompatible standards can undermine compliance, potentially leading to failed audits, legal liabilities, and compromised patient safety.
An end-to-end configurable LIMS platform supports compliance in multiple ways. It minimizes human errors in record-keeping by providing built-in validation rules and automated data entry processes. It can provide automated audit reporting, and automatically generate audit reports that comply with regulatory standards, reducing the burden on lab personnel. And with real-time compliance monitoring an integrated platform can continuously monitor data against compliance criteria, alerting users to any potential issues as they arise. This proactive approach allows for immediate corrective actions, helping to maintain compliance and prevent issues before they escalate.
Today’s clinical diagnostic laboratories face significant operational challenges, primarily due to high test volumes, coupled with stringent regulatory requirements and soaring expectations for faster turnaround times. Manual processes and siloed systems compound these issues by disrupting critical workflows and impeding visibility into laboratory operations. This results in slower turnaround times, misplaced samples, fragmented data, and compliance risks.
Implementing a configurable, no-code Laboratory Information Management System (LIMS) like Sapio LIMS can address these issues by automating workflows, ensuring real-time tracking, consolidating data, and supporting regulatory adherence with built-in compliance. Sapio LIMS is specifically designed to address the complex needs of clinical and molecular diagnostic laboratories and serves as the operational backbone for leading clinical diagnostic labs worldwide.
For more information visit https://www.sapiosciences.com/clinical-diagnostics/
Dara McCreary, PhD, is a scientific business analyst at Sapio Sciences.