LIS feature

Thousands of hospital laboratories like this one benefit from the use of a laboratory information system.

An LIS feature is one or more pieces of functionality that appear within a laboratory information system (LIS).

The LIS has traditionally been utilized in clinical, pathology, and medical research laboratories as well as numerous public health institutions. Yet as laboratory demands have changed and technological progress has continued, the functions of an LIS have also changed, with the distinction between an LIS and a laboratory information management system (LIMS) fading as some LIMS vendors have adopted the case-centric information management normally reserved for an LIS..

Despite the blurring of distinction between an LIS and a LIMS, the LIS generally continues to feature the following:

• patient management, including admission date, admitting physician, ordering department, specimen type, etc.
• specimen management and tracking
• configurable decision support, including comparisons of lab orders with their respective ICD codes
• quality assurance of ordered tests
• workload and management reporting

Of course, there are LIS features that are difficult to categorize or simply contribute to the whole of the LIS rather than add a function. For example, multilingual support allows users to interact with the LIS in more than one language. Some functionality may also overlap several research phases, making it difficult to firmly classify.

The features described below come from an analysis of freely available LIS product information on vendor websites. An attempt was made to discover the features most utilized in vendors' LIS products and collect information on those features for each LIS. Not every possible feature is referenced here; some LIS products fill specific niches, utilizing unique functionality to solve a specific problem.

That said, keep in mind the categorization of features below is very loose. It may be viable to argue a feature belongs under a different section or multiple sections. For the purposes of organizing this information in an uncomplicated manner, however, some liberty has been taken in the categorizing of features.

Experiment, patient, and data management

To hide the contents of this section for easier reading of other sections, click the "Collapse" link to the right.

 

Sample login and management

Sample login and management—often referred to as accessioning or specimen management—is an important component of the clinical laboratory, whether it's a molecular pathology lab testing samples for disease indicators or a contract lab running pharmacokinetic and biomarker analysis on samples from a clinical trial. As such, researchers and technicians who work in these types of labs are unable to complete their tasks without an effective method of managing samples. The process of sample management and accessioning includes, but is not limited to:

• storing related sample information, including demographics, dates, and external links
• creating and documenting viewable sample container schemas with name and status
• assigning sample access rights
• assigning custom sample ID or accessioning numbers based on a specification
• applying additional processing to the sample before storage and/or analysis

Additional functionality that could potentially fall under this feature:

• barcoding or RFID tagging of samples
• defining sample points and series
• creating data associations for samples, such as pedigree for sample/aliquot relationships or relationships based on experiment, etc.
• issuing sample receipts

Sample tracking

Where's sample 20110512_122GJH? Sample tracking functionality will let you know which lab oven it's in.

For most laboratory personnel, knowing that a sample has arrived to the lab isn't good enough; they need to know where it's located and what actions are being performed on it. Enter the sample tracking feature. Without it, many problems arise. In the forensic world, for example, many samples are linked to a criminal investigation. In this case, misidentification, contamination, or duplication can become significant issues: a lost sample is essentially missing evidence, while a duplicated sample can render it useless as evidence.

After sample reception and its initial handling procedures, many LIMS can then track sample location as well as chain of custody. Location tracking usually involves assigning the sample to a particular freezer location, often down to the granular level of shelf, rack, box, row, and column. The process of tracking a sample has become more streamlined with increasing support of barcode and radio frequency ID (RFID) technology. While handwritten labels were the norm, barcode and RFID support in an LIS can "tie together a vast amount of information, clearly relating each sample to a specific case." Other event tracking such as freeze and thaw cycles that a sample undergoes in the laboratory may also be required. As each laboratory's needs for tracking additional data points can vary widely, many modern LIS have implemented extensive configurability to compensate for varying environments.

The functionality of sample tracking strongly ties into the audit trail and chain of custody features of an LIS.

Sample and result batching

What is batching? The United States Environmental Protection Agency (EPA) defines a batch as "a group of samples which behave similarly with respect to the sampling or testing procedures being employed and which are processed as a unit." This definition can be applied to many laboratories which handle large quantities of samples for some form of analysis or processing. A LIMS that has the ability to check in, link, and track groups of samples across one or multiple facilities is valuable to such laboratories. Additionally, batching the analysis results of multiple samples or groups of samples gives laboratories more flexibility with how they manage their data. Batching also offers the benefit of mimicking the production groups of samples while also capturing quality control data for the entire group.

Task and event scheduling

Within the context of an LIS, the ability to schedule a task or event is a natural extension of how work was done in a laboratory before the advent of data management systems. Sample processing, data analysis, equipment maintenance, and case management follow-ups are assigned to technicians and other personnel. Outpatient scheduling is another aspect of some clinical atmospheres, better handled with computerized scheduling functionality. While these tasks have in the past been performed without the LIS, a modern data management system can now optimize those tasks and provide additional scheduling functionality to streamline the operation of a lab. Some LIS will include, for example, a scheduling calendar for recurring test orders, rules-based orders, and pre-defined selection lists. Additional functionality within this feature group includes the ability to configure automated assignments of experiment requests, establish recurring events, and in most cases, create printable reports.

Examples of tasks and events that can feasibly be scheduled in an LIS include:

• production of reports
• creation and sending of e-mails and alerts
• maintenance of equipment
• assignment of accessioning tasks to technicians
• scheduling outpatient visits

Option for manual result entry

While many LIS vendors tout the ability of their product to automate the entry of sample analysis results into an LIS or other database, the need for manual data entry of analysis results still exists. This feature is important to laboratories obtaining analysis results from multiple sources, including non-digital paper-based results and instruments that can't be connected to the LIS. Additional functionality associated with this feature includes a customizable spell-check dictionary and the ability to add comments, notes, and narratives to many of the data items in the LIS.

Multiple data viewing methods

Hospitals, physicians, and clinical research facilities produce reams of data, and the LIS exists to help organize and distribute that data to the necessary entities. Additionally, even before the existence of the LIS, scientists have had a corresponding need for visually representing that data for clearer analysis and hypothesis creation. Today an LIS can not only collect and analyze data, but it also can represent that data in reports, graphs, gradients, and spreadsheets. Depending on the LIS, more than one way to visually represent the data may exist.

This category ties in with the custom templates and forms functionality apparent in some LIS, providing both custom and standardized ways to present information across a healthcare or medical research enterprise.

Configurable templates and forms

Similar to an electronic laboratory notebook (ELN), a template in an LIS is a functionality item which allows users to increase the productivity and quality of their work by allowing for the creation of a standardized analysis page, patient page, or reporting process across a healthcare or medical research enterprise. These templates allow researchers to maintain more consistent data representation for similar tasks in the LIS and save time by not needing to manually input common data outputs or recreate experiments. Templates and forms typically utilize a wide field library, and the data that is posted to those template fields can also be normalized to a specific standard. Types of templates that may be created include those for renal and blood pressure analysis, patient demographics, test ordering, and department-level reports.

Data and trend analysis

Some LISs allow users to analyze patient test results or clinical research data with built-in software tools.

For public health centers and pharmaceutical research centers alike, data analysis plays an important role in their operations, helping clinicians and researchers make better sense of their collected data and reach valuable conclusions about them. While this important phase of laboratory work has often been done externally from the LIS, today's LIS commonly has basic data analysis tools included. Such tools allow raw data to be imported directly to the LIS, which then can store, process, and display it in a shareable form. Vendors may include data analysis functionality by simply including Microsoft Excel compatibility or providing advanced reporting tools, or they may take a more advanced approach by programming and including their own custom data and trend analysis tools in their informatics software. As data analysis has become increasingly vital, such functionality—which has often come in the form of a separate application or analysis device—continues to end up in software like LIS, LIMS, and other laboratory informatics solutions.

Data and equipment sharing

Aside from data storage and sample registration, a modern LIS's major contribution to the laboratory is aiding in the sharing of test results, reports, and patient data with other entities across the clinical and research enterprise. Rather than pieces of information becoming misplaced or locked away in a physician's office or pathology lab, the LIS makes it easier to test results and increase the efficiency of patient-doctor-lab collaboration in general. However, data is more than just test results; it also can come in the form of charts, reports, policy and procedure, and other documents. Additionally, the need for controlling who has access to those types of data is also an important consideration. As such, this feature is at least partially tied to other features like document management and configurable security.

Data mining

Data mining, in the field of computational science, involves "the process of discovering interesting and useful patterns and relationships in large volumes of data" and includes three computational steps: model-learning, model evaluation, and model usage. As informatics software allows both research and clinical laboratories to collect and manage increasing quantities of data, a corresponding demand for tools capable of modeling that data is appearing. For example, public health laboratories may wish to utilize data mining for statistical analysis and surveillance of populations for specific diseases. LIS like Livextens and Orchard Harvest are examples of laboratory informatics software which incorporate data mining and reporting tools.

Customizable fields and/or interface

As thorough as some user interface (UI) developers may be in adding relevant fields and interface options for end users, there are at times options that are either omitted or unanticipated. This has traditionally required the end user to contact the vendor and ask if the needed option(s) can be added in the next release. However, many modern LIS vendors have responded instead by adding functionality that gives end users and/or LIS administrators more control over the user interface.

Aspects of the LIS's user interface that are often customizable by the end user include:

• report interface and display
• patient profile display
• project and experiment display

Increasingly, today's vendors tend to refer to their systems as being "configurable" rather than "customizable." For example, vendors such as Autoscribe Informatics include screen editing and other tools that administrators can user to configure the various screens, data fields, nomenclature, etc. of the solution.

Note in many cases an interface may be customized through the use of templates and forms, and as such, this functionality may be closely tied to the configurable templates and forms functionality.

Query capability

As was the case before the advent of databases and electronic data management solutions, today researchers must search through test results, patient notes, and other types of data to better draw conclusions from experiments, diagnose patient illnesses, and plan pharmaceutical research activities. Whereas this used to mean browsing through laboratory notebooks, Excel spreadsheets, or Access databases, now powerful query tools exists within data management tools like the LIS and ELN. A flexible search algorithm can be implemented to allow users to search a dataset by patient name (full or partial) or by any accessioning number. Or more advanced query tools may be implemented to collate and search across multiple datasets.

Query functionality often includes the ability to:

• search both transactional data and archived data tables
• search multiple databases via an application programming interface (API) or open database connectivity (ODBC) connection
• filter and sort data
• collate queried data for further analysis and visualization
• create ad hoc queries

Import data

Data can originate from numerous places in the laboratory. The ability to import that data into an LIS can be beneficial, especially when an instrument can't be connected or external clients collaborating on a project need to submit relevant data. Of course instrument interfacing allows for even more importation options. Additional data validation procedures may be applied to the imported data to guarantee information homogeneity. For the LIS, one of the common sources of importing data is a separate electronic medical record (EMR) or electronic health record (EHR) system, for collecting patient data and test orders.

Internal file or data linking

Many informatics systems allow for internal linking of data; however, entities outside of the system often need to access the data housed within. An LIS is often capable of such external data linking.

This feature allows research collaborators using an LIS to link together sample batches, reports, protocols, results, and more, providing greater contextual clarity to projects and datasets. Examples include:

• linking a sample batch to a test or sample preparation methodology
• linking a test process to a particular experiment
• linking a report to a sample batch
• linking a group of experiment results to a raw data file
• linking multiple images to a patient record
• linking all experiment results with the correct reporting test methods

External file or data linking

This feature allows research collaborators using an LIS to link together data and files housed in the database with data, files, and customers outside the LIS's domain. Examples include:

• linking to an external practice management or electronic medical record (EMR) system using an an HL7-compliant interface
• linking one public health data source with others to pool demographic and medical information for better disease modeling
• linking to separate clinical trial laboratory data files within a report

ELN support or integration

The functionality of solutions such as an LIS and LIMS began to blur with that of an ELN in the 2000s, with both types of software incorporating features from the other. More than a decade later, the ELN has become more distinct in purpose and functionality and is typically sold as a stand-alone solution. However, some vendors such as Genohm have decided to integrate ELN functionality into their solution in order to provide greater flexibility to researchers. While it has been more common to see this sort of melding in a LIMS, it has been less common in the LIS. Yet some LIS may include some sort of integration or compatibility with an ELN, and thusly this functionality is at least mentioned.

Export to MS Excel

While Microsoft Excel had long been used within the laboratory setting, a slow shift towards relational databases and LIMS occurred in the late 1990s and early 2000s. Additional concerns with the difficulties of Excel's validation and compliance with FDA 21 CFR Part 11 and other regulations ultimately led many labs to turn to data management solutions that are easier to validate. Several decades later, some laboratories continue to use Excel in some fashion, and thus having an LIS capable of handling Excel data remains useful. In particular, selecting and exporting the LIS' data (from test results to quality control charts) into a format such as Excel may further data visualization, insights, and dissemination for some users.

Raw data management

While not described as a feature on most LIS vendor websites, a few indicate their product is capable of managing (import, export, editing, etc.) data in its raw format for future analysis. This raw data is typically implied to be originating from instruments that interface with the LIS, which in itself is not unusual. That raw data may remain housed in instruments, getting transformed into reportable data in the LIS, but presumably most LIS are also capable of housing the raw instrument data as well. Clinical research labs may also turn to scientific data management systems to better manage their raw data sources.

Data warehouse

an LIS' data warehouse serves the important function of storing, extracting, and managing the data that laboratories produce for the purposes or analysis, reporting, and process management, typically separate from the primary storage database. Data warehouses also offer the benefit of speeding up queries, making queries and data mining more user-friendly, and smoothing out data gaps.

Project and/or task management

Project and task management within an LIS typically involves the scheduling of tasks to technicians and organizing associated tasks into a more cohesive unit for better tracking and management. While the functionality of task and event scheduling can also be found in project and task management, many LIS include functionality beyond scheduling that warrants the addition of the project and/or task management feature. This functionality includes:

• job allocation and rescheduling
• instrument workload tracking
• pending workload verification
• project- and experiment-based workflow management
• sample, batch, and document linking
• work template sharing
• recurring event management

See also: Patient and case management

Test, experiment, and/or trial management

Specimen or sample test management is a common component of an LIS, while experiment and research trial management functionality is a component of some LIS, often limited to those that are designed to help manage clinical trials. Test, experiment, and trial management can cover a wide variety of tasks, from setting up the design of a clinical trial to specimen task assignments, from ordering tests for patients to planning trial experiments. Note: this may also be referred to as "order management" with some vendors.

It's worth noting this functionality category may seem broad in scope and include other functionality listed on this page, including workflow management and project and task management. Its inclusion when reviewing software functionality is primarily to indicate when a vendor or project team indicates the existence of specific test, experiment, or trial management tools in their software.

Inventory management

Laboratories use a wide array of inventory and equipment, from reagents and radiopharmaceuticals to glassware and laboratory baths. With that comes the need to know how much/many and the frequency of use. For this, LIS solutions include some sort of inventory management functionality.

• register origin, demographics of incoming materials
• track used and in-use items via barcodes or RFID
• track inventory reduction based on usage and shipping out of the lab
• create alerts for when items reach a certain stock level
• calculate inventory cost and fluctuation
• manage transportation and routing
• manual incrementing/decrementing of item counts
• track location and usage of laboratory equipment
• assign storage locations
• track forensic evidence

Document and/or image management

Standard operating procedures, workflow diagrams, and business models can all be handled effectively with document management functionality.

Standard operating procedures (SOPs), specifications, safety manuals and protocols, regulatory files, certificates, reports, graphs, images, and receipts are all collected and used in the average laboratory. With an LIS already designed to manage and store sample and experiment data, it makes sense to include functionality to create, import, export, and manage other sorts of data files. As sample and experimental data can be indexed, queried, and linked, so too can documents. Functionality of a typical document management system includes the ability to:

• upload and index documents of most any file type and size
• enforce version control
• provide full text search
• convert and/or export to PDF or other relevant formats
• add documents as attachments to other analyses, files, projects, etc. in the system

Patient and case management

The LIS has played an important role in the case management tasks of patient-centric and clinical laboratories. LIS products have included patient or case management tools suitable for the clinical, public health, and veterinary industries, as well as the fields of law enforcement and forensic science. Functionality seen in the patient and case management feature includes:

• case accessioning and assignment
• disease tracking
• trend analysis
• clinical history follow-up
• out-of-range result alerts
• document and result association
• evidence control
• study management
• collating of patient data across multiple spectrum

Workflow management

Capturing workflow in the lab is becoming more commonplace for laboratory informatics products.

Workflow management is common in the laboratory, acting as a graphical representation of planned sequential steps to either fully or partially automate a process within the lab. Separate standards-based workflow management systems (in the form of a software component) have traditionally performed this task. However, in the late 2000s laboratory informatics vendors began incorporating workflow management functionality into their software, reducing the headaches that customization of a solution often brought.

Modern commercial and open-source LIS solutions recognize clinical laboratory workflow often has its own share of requirements, requiring specific workflow management functionality, including:

• managing the request cycle within a laboratory
• organizing and executing diagnostic testing
• managing specific chemistry- and biology-related procedures
• defining activity attributes
• managing automation tools to better workflows
• re-routing samples based on changes to a process
• dynamically modifying workflow in case of future changes
• receiving notification of changes to the workflow

Specification management

Specification (spec) management is vital to not only the manufacturing and research industries but also to a host of other laboratories requiring precise measurements and infallible test methods. Just as ASTM offers standards and specs for LIS, so too do LIS users have standards and specs for their laboratory.

Spec management has primarily been seen in a manufacturing execution system (MES) or a laboratory information management system (LIMS), but occasionally an LIS may appear which includes such functionality. With spec management in place, laboratories can then:

• enforce standard operating procedures and business rules
• create specs down to a project or sample level
• validate recipes and procedures
• accept or reject sample batches
• document internal and external spec history

Note some of the functionality of spec management may cross over into the realm of quality control and data validation.

Customer, supplier, and physician management

Unless a laboratory is conducting internalized independent research, in most cases it will do business with external entities such as contract labs, physician offices, equipment providers, and reagent suppliers. In some cases, even internal employees may be considered a customer, necessitating documentation of who is using the system and in what ways. For a veterinary lab, the customer may be the animal and handler. For a forensic lab the customer may be more complex: internal staff, university staff, police departments, and maintainers of nationwide crime databases may all at some point act as customers. In these cases, documenting these various points of contact and linking them to tests, equipment, and patients becomes vital. Managing demographics, complaints, correspondence, and history are all feasible with customer, supplier, and physician management functionality. This process is often made simpler through the use of a more context-neutral entity creation system, which allows for more flexible management of contacts.

This feature may also be referred to as contact management, an address book module, or a customer service module.

Billing and revenue management

While the finances of a laboratory are important, they've typically been handled separately as a business process. However, some LIS include additional functionality to make handling financial transactions and documentation of all sorts possible within the LIS. In theory, such functionality brings the possibility of keeping more of a laboratory's data centrally located and queryable. This feature may include:

• payment processing
• expense reporting
• price quotes
• revenue cycle management
• workload tracking of billable hours
• bill of materials
• sales team and client management
• profitability analysis
• medical necessity checks

 

Quality, security, and compliance

To hide the contents of this section for easier reading of other sections, click the "Collapse" link to the right.

 

Regulatory compliance

The topic of whether or not an LIS meets regulatory compliance is often a complex one. While Title 21 CFR Part 11 has arguably had the largest influence on an electronic data management system's compliance, other influential standards have shaped the way laboratory informatics systems handle and store data. Other compliance-based codes, standards, and regulations include:

• ASTM standards
• ASCLD/LAB crime lab accreditation
• Freedom of Information Act
• GALP and GAMP
• HIPAA
• Health Level 7
• ICD
• ISO/IEC 17025
• ISO 9000/9001
• ISO/TS 16949
• ODBC
• TNI and NELAP enviromnental lab accreditation
• Title 40 CFR Part 3

With so many codes, standards, and regulations, it can be challenging for potential LIS buyers to fully vet whether a vendor's solution meets regulatory requirements, let alone helps labs meet the regulations and standards that affect them. In truth, most reputable vendors today have regulatory compliance well considered for their LIS solutions, which are often purpose-built. However, it is ultimately up to the potential buyer to confirm that the vendor's solution complies to activities within their industry. Buyers are advised to contact vendors with their user requirements and ask how the vendor's software meets and/or exceeds those requirements.

QA/QC functions

The quality management functions of an LIS allow users to maintain a level of necessary quality across many of the functions in a laboratory. Some of the activities quality assurance / quality control functionality allows for includes:

• force random review of cases by second pathologist before case verification
• receive and process QC results from laboratory analyzers
• create user rules
• set up custom alerts and flags for out-of-range results
• observe standard deviations in outcome research
• review and sign off on data electronically
• delta checking

Performance evaluation

As prevalent as document management has become in clinical and research laboratories, it makes sense that the LIS should also provide functionality to collate and store all the documentation associated with employee training and certification. Changes to laboratory techniques, scientific understanding, and business practices force researchers to learn, reevaluate, and demonstrate competency in order to maintain quality levels in the laboratory. Evaluations can frequently extend beyond staff members, however. Clinics, visit types, vendors, or test species can also be tracked and evaluated based on custom criteria. The performance evaluation functionality of an LIS makes this possible.

That functionality typically includes the ability to maintain training records and history, and also to link that training to a technique or piece of equipment. Afterwards, the staff member, vendor, etc. can be marked as competent or certified in the equipment, knowledge, or process. Periodical assessment of the training and its practical effectiveness can later be performed. Productivity of an entity or process can also be gauged over a certain date range based on tracked time, pre-determined milestones, or some other criteria.

Audit trail

Whether validating an instrument's data or an entire LIS, maintaining an audit trail is an important part of 21 CFR Part 11 compliance.

As laws and regulations like Title 21 CFR Part 11 mandate "computer systems (including hardware and software), controls, and attendant documentation" utilize electronic signatures and audit trails, LIS developers must put serious thought into how their software handles audit trail functionality. The audit trail—documentation of the sequence of activities that have affected an action—must be thorough and seamlessly integrated into the software, and it has become a mandatory feature for labs operating in regulated environments.

Information recorded in the audit trail typically includes:

• operator code
• time stamp
• location
• case number
• accessioning number
• transaction type
• amount and quantity prior to change
• user notes (e.g., reason for change)
• in some cases, data in temporary memory

Chain of custody

The chain of custody (COC) of an item is of varying importance, depending on the type of laboratory. A highly regulated laboratory that works under Code of Federal Regulation or other guidelines makes tracking COC a vital part of its operations. This is especially true in forensic labs, which depend on continuous accountability of their evidence collection, retention, and disposal procedures. At its core, the COC strives to answer at least these five questions:

1. Where is my sample or specimen now?
2. Who possess my sample or specimen now?
3. When did that individual take possession of my sample or specimen?
4. Where has my sample or specimen been?
5. Who has been in possession of my sample or specimen?

As with an audit trail, a laboratory depends on recorded information like user ID, time stamp, and location ID to maintain a robust and accurate COC. Barcodes, inventory management, and configurable security roles all play an important part in maintaining chain of custody.

Configurable roles and security

Many roles exist within the clinical and research setting, each with its own set of responsibilities. And just as the role an individual plays within the laboratory may change, so may the responsibilities associated with each role. This sort of change necessitates a flexible and configurable security system, one that allows for the placement of individual LIS users into standardized security roles which provide role-specific access to certain functionality. Additionally, as responsibilities change within roles, that same flexible configuration is necessary for assigning or restricting access to specific functionality for each existing or newly created role.

Of course, roles aren't always assigned on an individual level. Often large groups of individuals may need to be assigned to roles, necessitating group assignments for security purposes. For example, a group of hospital laboratory trainees may not be given access to the inventory management functionality of the system through a custom "Trainees" group role, while the head of the lab may be given the "Administrator" role, which allows that individual to access a much broader spectrum of the LIS's functionality.

Data normalization

For the purposes of describing LIS functionality, "data normalization" specifically refers to the process of ensuring data that moves into the LIS is formatted in a standardized way, matching the format of existing LIMS data.

Here's an example to better explain this issue. When an LIS is initially configured, in most if not all cases a clear standard can be set for how logged samples and their associated measurements pre- and post-analysis are recorded in the system. Perhaps all temperatures will be recorded in Celsius to two decimal places. If temperature data imported from a spreadsheet or a lab instrument is not in this format, the LIS can normalize the incoming data to match the standard already set for existing LIS temperature data. This ensures consistency within the LIS database and typically leads to better data validation efforts later on.

Note: Some LIS developers may include data normalization functionality within what they may refer to as "data validation" functionality. The line between these two may be blurred or not exist at all.

Data validation

In an LIS, data and data models can be forced through a validation process to remove errors and reconcile that those data and models.

For the purposes of describing LIMS functionality, "data validation" specifically refers to the process of ensuring existing data in the LIMS—either pre-analysis or post-analysis—sufficiently meets any number of standards or thresholds set for sample login, sample analysis, or any other data management process in the LIMS. This validation process may be completely automatic and system-based, or it may also include additional steps on the part of the user base utilizing additional LIMS functionality, including verification of standard operating procedures (SOPs), QC samples, and QA approval.

Note: This functionality shouldn't be confused with the process of validating the application itself, which is an entirely different process partially falling under regulatory compliance and involves the process of ensuring "the software is performing in a manner for which it was designed."

Data encryption

The existence of this functionality in LIS software generally indicates the LIS has the ability to protect the integrity and authenticity of its housed data through the use of a variety of technologies which makes data unreadable except to those users or systems possessing a key/right/etc. to unlock/read the data. This functionality has been important for the web-enabled LIMS, which transfers information over the internet in a client-server relationship, and it has become an increasingly vital part of cloud-based software offerings managing data in transit and at rest. As a wide variety of encryption technologies exist, it's generally a good idea to consult with the developers of an LIS to determine the strengths and weaknesses of their employed encryption methods.

Version control

Version control is a form of safeguard which helps preserve data integrity. This is typically done by creating a modifiable new version of a piece of information rather than allowing the original to be modified. Such versioning may be applied to a wide variety of digital information housed in the LIS, including test methods, training certifications, instrument logs, specifications, and process and procedure (P&P) documentation. Information tracked with such revisions includes attributes like user name, time the edit was made, and what exactly was edited. This also benefits those managing audit trails and chains of custody.

Some LIS vendors may choose to employ a different form of version control called file locking, which simply puts the affected information into a read-only mode for users while someone else is busy editing it. Another popular strategy is to, rather than locking the file, allow multiple people edit to a piece of information, later merging the various edits. Potential LIS buyers may need to inquire with developers to determine what type of versioning scheme is used in the vendor's software.

Automatic data backup

The functionality of automatic data backup in an LIS usually means information contained in one or more associated databases or data warehouses can be automatically preserved in an additional backup file. The save location for that file as well as the scheduled backup time is configurable, typically through the administrative module of the LIS. As cloud-based LIS have slowly increased in number, scheduled cloud-to-cloud data backups of software data are becoming more practical.

Environmental monitoring

While not common, a few LIS may allow users to monitor the environmental conditions of not only sample storage containers but also the entire laboratory itself. Attributes like humidity, air quality, and temperature may be monitored to ensure sample storage units and experiments maintain desired conditions. This monitoring may be done by treating the storage container as a device, which must be interfaced with the LIS. Alarms may be able to be configured to notify staff if a storage container's environmental attributes go beyond a certain threshold.

 

Reporting, barcoding, and printing

To hide the contents of this section for easier reading of other sections, click the "Collapse" link to the right.

 

Custom reporting

Reporting is a vital part of an LIS, as it allows users to gain a clearer picture of collected data and potential trends. At a minimum, a number of pre-configured report styles come standard with a LIS. However, some LIS are more flexible than others, offering the ability to customize reports in numerous ways. The most popular attributes of custom reporting include custom headers, custom information placement (such as branding), charts, pivot tables, and multiple output formats.

Note: Some LIS vendors will offer custom reporting as an option as an added cost, depending on both the base reporting functionality of the LIS and the level of customization required.

Synoptic reporting

Synoptic reporting is a specific type of reporting applicable to pathology and other associated laboratories. Synoptic reporting essentially involves a structured, pre-formatted "checklist" of clinically and morphologically relevant data elements (ideally passed to a relational database where they are efficiently organized, searched, and retrieved), with the intent of making reporting more efficient, uniform, and relevant to internal and external researchers. This style of reporting has the advantage of obviating the need for transcription services, reducing specimen turnaround time, and prioritizing the presentation of large amounts of diagnostic information. Some LIS, especially those oriented towards pathology, may include this specialized functionality. In some cases, a configurable templates or form may be utilized to structure a report in a synoptic format, providing similar functionality to a separate synoptic reporting module.

Report printing

Today's LIS software almost universally offers the ability to print reports and other materials, so this feature may seem a bit redundant to list. Nonetheless, printer support is a feature worth confirming when considering a piece of LIMS software.

Label support

The label—typically affixed to a sample or evidence container—is a vital part of the sample tracking process. Identifying information such as sample number, batch number, and barcodes are printed on such labels to ensure optimized sample management and more precise sample data. As such, some LIS allow users to design and print labels directly from the software.

The word "Wikipedia" encoded in Code 128 and Code 39

Barcode and/or RFID support

Barcodes offer many advantages to laboratory techs handling samples, including more accurate data input, tighter sample/instrument associations, tighter sample/study associations, and more room for human-readable information on a label. As such, LIS developers have integrated barcode support into their laboratory information systems, including support for symbologies like Code 128, Code 39, and Interleaved 2 of 5. Aside from printing options, a LIS may also offer support for a variety of barcode readers.

Radio-frequency identification (RFID) technology has also made inroads into the laboratory. Like barcode labels, RFID tags can be placed on samples and get read when exposed to active RFID scanning devices. This technology has some advantages over barcodes in that direct line of sight isn't required, the scanning and tracking process is more automated, and more data can be encoded. With these apparent advantages, some LIMS vendors have also added support for RFID-fed sample information.

Barcode/RFID support and label support are typically found together in LIS software, but not always, thus their separation into two features of a LIS.

Export to PDF

An LIS with this feature is able to collect and save information into a Portable Document Format (PDF).

Export to MS Word

An LIS with this feature is able to collect and save information into a Microsoft Office Word format.

Export to HTML or XML

An LIS with this feature is able to collect and save information into a HyperText Markup Language (HTML) and/or Extensible Markup Language (XML) format.

Fax integration

An LIS with this feature is able to connect with a fax machine and send information to it via manual input, automatically, and/or at scheduled intervals. However, with the declining popularity of the fax machine, this feature is starting to disappear from modern LIS.

Email integration

An LIS with this feature is able to integrate with and use the electronic mail information exchange method to send reports, alerts, and more manually, automatically, and/or at scheduled intervals.

 

Base functionality

To hide the contents of this section for easier reading of other sections, click the "Collapse" link to the right.

 

Administrator management

The administrator management tools of a LIMS allow lab technicians and researchers to set up the LIS most optimally for the laboratory. Through the administrator management interface of a LIS, other features may be accessed like setting up user roles and scheduling automatic data backups.

Like report printing, administrator management is nearly ubiquitous in LIS software, generally considered a mandatory feature. However, for the purposes of being thorough, it's important to point out its existence.

Modular

This feature indicates that an LIS has an intentional modular design, which separates some functionality into manageable components of the overall system. Generally speaking, a modular design allows for 1. the structured addition of new functionality to an LIS and 2. the limiting of overall effects on the system design as new functionality is added.

Instrument interfacing and management

Laboratories depend on instruments, and with those instruments comes scientific measurements which produce data. It's therefor natural a lab technician would want to connect those instruments to a laboratory information management system, which is already organizing and storing laboratory data for hospitals and medical research facilities. This sort of interfacing is typically handled with instrument-to-LIS interfaces, which started out as merely a data-transfer mechanism. By the 2000s, that interface mechanism became much more robust as a data management tool, though often at great expense with heavy involvement from third parties. This eventually meant that "vendors [could] act as single source providers of the entire instrument interfacing solution,", providing a cheaper and smoother solution to LIS customers. Today, instrument interfacing is integral to an LIS and is considerably easier to do than prior decades. In the clinical laboratory setting, an LIS vendor may also have additional considerations to make, such as Health Level 7 (HL7) triggers, messages, and segments transported across communication interfaces.

The ability to calibrate and schedule maintenance for interfaced instruments may also be included in this category.

In some cases mobile devices like these may access and utilize an LIS, typically through a Web portal or special mobile version of the software.

Mobile device integration

Some LIS vendors tout support for mobile devices using their laboratory information system. This feature has become increasingly common with the advent of first the web-based LIMS, followed by the cloud-based LIMS. This has given clinicians the ability to collect data in the field, approve results remotely, and manage clinical trial and experiement workflow on the fly.

Third-party software integration

A few LIS vendors either incorporate third-party software into their product or they provide the means to integrate the LIS with other applications. The most typical integration involves simply communicating with common authoring tools like Microsoft Word, allowing users to work directly from the third-party application and then transferring the information to the LIS. More recently, integrations with other software systems such as an EHR system have become more common, typically using some sort of application programming interface (API).

Alarms and/or alerts

Alarms and alerts in an LIS can be automatic or scheduled, and they can come in the form of an e-mail, a pop-up message, or a mobile text message. For example, when a test result goes out-of-range, an automatic warning message can appear on the screen of the lab analyst responsible for the test. Another example: a scheduled alert can be e-mailed to a lab technician every month indicating a piece of laboratory equipment needs routine maintenance. Both scenarios represent a tiny fraction of the possible implementation of alarms and alerts in an LIS, highlighting how powerful (yet easy to take for granted) this feature is.

Work-related time tracking

This feature specifically refers to an LIS' ability to track the amount of time an employee spends at work in general (for payroll purposes) or on more specific projects and tasks (as part of an employee work evaluation program). May also be referred to as "workload tracking" or "workload tracking."

Voice recognition system

An LIS with this feature allows some functions of the software (for example, accessing test results) to be accessed via voice commands.

External monitoring

This feature allows clients and/or collaborators outside the laboratory to monitor the status of experiments, test results, and more via an online web portal or, less commonly, as activity alerts sent via e-mail or SMS.

An instant messaging client built into an LIS often makes it easier to collaborate.

Messaging

The messaging feature of an LIS may refer to one of two (or both) things:

• a built-in instant messaging system that allows users to converse with each other through text messages real-time, or
• SMS text messaging integration that allows users or the LIMS itself to send messages or alerts to a user's mobile or smart phone.

Commenting

Clinical data collection and research collaboration require data sharing and communication tools to be most effective. One of the collaborative communication features of some LIS is commenting on test results, patient records, or study protocols.

Multilingual

If an LIS is listed as multilingual, its an indication the software interface can be configured to display more than one language depending on the preference a user or administrator chooses. Some LIS interfaces can only be displayed in one of two languages (English or German, for example), while others come configured with support for dozens of languages.

Network-capable

This feature is perhaps archaic and/or obvious, but it is mentioned nonetheless. It's generally applied to a non-web-based (on-premises) LIS installed over a local or wide-area computer network, essentially indicating the LIS is not an isolated application, but rather one that can interface with other instances or other networked instruments.

Web client or portal

A LIS with a web client or portal is either a web-based LIMS (one that is not installed on every computer, but rather is hosted on a server and accessed via a web browser) or a non-web-based LIS with an included portal to access it via the internet.

Online or integrated help

This indicates an LIS has help infrastructure integrated into the software, support documentation via the vendor's website, or both.

Software as a service delivery model

This indicates the software can be licensed and utilized via the software as a service (SaaS) delivery model. This typically constitutes a LIS vendor having a "cloud-based" offering.

Usage-based cost

While rare, some LIMS vendors allow potential clients to license and utilize the vendor's software under a usage-based cost model. An example of this model in use is Bytewize AB's O3 LimsXpress, which has a cost directly related to the amount of samples processed each month. You may also see this sort of usage-based cost on some cloud-based LIMS.