Given the dynamic nature of their operations, today’s clinical laboratories need to be nimble and agile. They need to cope with ever‐changing requirements brought about by changing technology, increased government regulation, growing competition, expanding public health reporting responsibilities, and greater expectations from both medical professionals and patients alike.
For the clinical laboratory manager, the days of simply producing and communicating high quality test results are long gone. The laboratory manager must ensure that the lab’s internal processes are up to the task of delivering increasing quality and efficiencies driven by LEAN or Six Sigma quality programs. Of course, labs must consistently produce and manage analytical and private patient data in a way that is defendable against increasing regulatory scrutiny. What is more, today’s lab is expected to continuously improve access to and control of clinical information to enable the Data → Information → Knowledge → Decisions cycle for better patient outcomes.
To make all this possible, laboratories need information systems that are more powerful and sophisticated than the previous generation of Laboratory Information Systems (LIS). They need informatics solutions that provide flexible management capability — Laboratory Information Management Systems (LIMS). An effective LIMS can and should serve as the central nervous system of the lab, responsible for:
Sample Identification—barcode labeling, specimen attribute validation
Work Scheduling—test initiation and assignment
Data Acquisition—automated or manual entry of results generated by analytical instruments
Data Analysis—calculations, reference ranges, statistical analysis, and quality control
Reporting—analytical test results, management summaries, ad hoc reporting, and data extracts
Lab Management—Sample /job tracking, invoicing, SOP’s, QA/QC, training, certification, and compliance
Automation Support—data and process integration, bidirectional interfacing, electronic transport
LIS and LIMS: What is the Difference?
Traditionally, laboratory management software has fallen into two distinct categories: Laboratory Information Systems (LIS), exclusively serving clinical laboratories, and Laboratory Information Management Systems (LIMS), serving analytical, manufacturing, and R&D laboratories across many industries. Due to the wide variety of business requirements managed by LIMS across diverse industries, LIMS software is required to be inherently more flexible. However, LIMS software traditionally lacked key clinical functionality such as reference ranges, patient management, delta checks, Westgard rules/Levey‐Jennings plots, configurable differential keypads, and special capabilities to manage the requirements of histology and microbiology testing. LIS software included the required clinical functionality but traditionally lacked flexibility with regard to accommodating new or modified workflows within a clinical laboratory.
The Need for Flexibility in Laboratory Information Systems
Looking toward the future, a number of factors are at play which should lead clinical laboratories to demand more capability and flexibility from their laboratory informatics system:
Led by the new paradigm emerging from post‐genomic biomedical science, molecular medicine is transforming health care on a fundamental level. Molecular methods are increasingly finding their way into all areas of the clinical laboratory, including immunology, microbiology, hematology, and histology. The implications for the clinical laboratory are significant. The laboratory must accommodate the increasing use of diagnostic tests involving biomarkers and must be equipped to make these tests cost‐effective and practical—while managing large volumes of data in a way that supports interoperability but still protects patient privacy.
Increasing awareness of public health issues such as bio/chemical terrorism, re‐emergence of ancient public health issues such as tuberculosis and diseases impacting the food chain (e.g. avian flu, mad cow disease) have resulted in increased government spending on public health reporting infrastructures. In turn, this has led to an increase in the public health reporting burden on many clinical laboratories. Requirements include the ability to accommodate standard code sets (SNOMED/LOINC) and interoperability for reporting data via a variety of public health reporting channels.
The explosion in health care costs is exerting growing pressure on all parts of the healthcare chain, including the clinical laboratory. Point‐of‐care tests, including home kits and instruments (e.g. glucose, pregnancy, drug, HIV, etc.), are compromising the test volumes at clinical laboratories. The emergence of regional health clusters and increasing specialization has increased outsourcing to reference labs in some areas. This requires that clinical labs be equipped to implement LEAN/Six Sigma improvement programs to drive increased efficiency and effectiveness.
Shortage of Skilled Clinical Laboratory Workers
Severe shortages of skilled laboratory workers are challenging clinical laboratories everywhere. This is forcing labs to cope with higher workloads with less staff.
With the explosion in the use of smart phones and tablets that provide anytime, anywhere access to a broad variety of business and personal information, patients and clinicians alike have increasing expectations with regard to timely access to clinical laboratory data.
The Role of LIMS in Today’s Lab
Considering all the above‐mentioned challenges, it is evident that only the most flexible and full‐scale informatics solutions can meet the needs of clinical laboratories in the coming years. The Laboratory Information Systems that were sufficient in the past decades do not offer the level of managerial functionality and flexibility that the lab needs. Some commercial LIMS systems have evolved significantly in recent years and are well equipped to address the present and future challenges faced by clinical laboratories.
STARLIMS is one such LIMS system which provides the functionality of a classical LIS solution together with flexible laboratory management capabilities. STARLIMS includes the following features that distinguish it as a modern clinical LIMS system:
STARLIMS leverages XML, .NET, and other advanced Internet technologies to facilitate data management and decision‐ making throughout the lab and across the enterprise. STARLIMS is a pure web application that also provides outreach capabilities for specimen pre‐login and data entry for test ordering at the site where the specimen is collected. Its on‐ line reporting capabilities provide clinicians with convenient and timely access to specimen testing status and results.
A rich GUI
The system provides a highly intuitive user dashboard, which presents key performance indicators in a clear graphical format. The dashboard is automatically refreshed and issues alerts and reminders for outstanding tasks.
Powerful workflow management tools
STARLIMS includes full workflow support across a variety of clinical lab disciplines, enabling fully integrated reporting of laboratory results. Flexible wizard‐driven tools can accommodate new diagnostic techniques involving advanced technologies such as genetic sequencing and PCR. This makes it easy and convenient to change workflows within the clinical laboratory. A GUI‐based rules manager simplifies the task of creating a new reflex, retest, or automated comment rule for a laboratory supervisor.
STARLIMS enables effective information flow to all stakeholders of the laboratory with powerful interoperability capabilities including XML, web services, HL7, TCP/IP, file transfer, and database communication tools. STARLIMS supports unidirectional and bidirectional interfaces with clinical instruments, robots, and sample handlers viaHL7, ASTM, proprietary protocols and a variety of file based formats. In addition, STARLIMS supports integration with standard nomenclature such as LOINC, SNOMED‐CT, and ICD‐9/10.
SDMS (Scientific Data Management System)
This integrated STARLIMS module provides centralized management of documents, automatic document routing and indexing , and unique parsing and recognition technology that transforms any document (instrument file, report from outside reference lab, legacy report, etc.) into structured information that can be conveniently queried.
STARLIMS provides the ability to manage bio specimen inventory–including specimen annotation from multiple sources, powerful query capability to identify specimens of interest, chain‐of‐custody functionality, management of pull‐lists, specimen preparation, transfer, shipping and disposition, and aliquot/derivative & pooled sample tracking. STARLIMS also provides dashboard alerts to help lab staff manage incoming and outgoing sample shipments from partner/reference labs.
Looking to the Future
As clinical laboratories look to modernize their informatics systems, they must look to protect their long‐term investment to the greatest extent possible. In many legacy clinical laboratory information systems (both LIS and LIMS), the technology and the business rules components are compiled together and cannot be separated. Often, custom code is developed to meet dynamically changing lab and business needs. In parallel, vendors make modifications to their product code to incorporate new IT technology. Consequently, these parallel developments are normally incompatible, so users must forgo their customized applications if they wish to upgrade to newer versions.
A modern LIMS system such as STARLIMS avoids this issue by using a multi‐tier approach that partitions technology related development and application maintenance tasks. Therefore, new and advanced features that are developed can be rapidly integrated, validated, and distributed enterprise‐wide, without compromising the configured application business rules or the adoption of the latest technology components. Consequently, users can modify business rules to meet evolving requirements, without departing from STARLIMS's overall development path. This approach increases adoption of ongoing upgrades, while bringing annual ownership costs down to the level of ongoing maintenance costs.