An iLAB, or integrated laboratory, is a new type of laboratory informatics system—a total laboratory automation system. The value of an iLAB can best be appreciated by exploring four key problems with today’s informatics systems:
- No real-time control of users—On a daily basis, analysts are required to follow standard operating procedures (SOPs), but there is no way to enforce them. For example, analysts are expected to confirm that a reagent is suitable for the test being conducted, but the system cannot ensure that the check was made. It is the responsibility of the analyst to adhere to SOP requirements and make decisions about each step in the process. Analysts are being asked to make far too many decisions about the procedures they are conducting.
- Limited management of work flow— How does an informatics system adjust itself when an instrument breaks down? The system should check if a different instrument can be used for the same tests. If this is not possible, then it needs to reassign samples so that the high-priority samples are analyzed first. The system may need to reschedule the work for another test so that repair of the instrument is a priority. The system may need to notify others outside of the laboratory that the test results will be delayed. All of these decisions should be automatic, and need to take into account all of the available information about the laboratory and its resources. Today’s informatics systems are not close to providing real management of work flow.
- Most processes are human driven or paper driven, not event driven—If a process is paper based, it is human driven, not event driven. Analysts are expected to make too many decisions— approving results, prioritizing work, and confirming that procedures are being followed. A totally automated system makes virtually all of the decisions. The system will ensure that the correct procedures are being followed the same way at all times. These decisions will be based on events that take place. An event can be something an analyst does, such as selecting an instrument from a list, or an action taken by the system, such as verifying training records.
- Limited integration of information— Anyone who works with more than one software system in the laboratory is familiar with the problem of lack of integration between software systems and between instruments and software systems. Proper integration provides two very valuable benefits: Information is only stored in one place, and it is instantly available when and where needed.
These four key issues add up to lack of automation of work flow control. If users are not removed from the decision-making process and systems are not integrated, automated work flow control is not possible.
Description of iLAB
An iLAB system is shown in Figure 1. Depicted are the main laboratory application systems, i.e., LIMS, electronic laboratory notebook (ELN), instrument software, etc. Each operates independently and carries out very specific functions for the laboratory.
Figure 1 - In the iLAB, applications are connected through the real-time integration layer. Work flow control automates work flow decisions by applying business rules to information from all applications.
Each application is connected to all of the other applications through the real-time integration layer, not directly to each other. This is critical in the design of the system. Any information in any of the applications is available to all of the other applications, when and where it is required. If the ELN needs information about the calibration of an instrument, it obtains it from the calibration application through the real-time integration layer.
Above the real-time integration layer is the work flow control layer, which takes information from all applications and applies business rules to maximize the correct work flows. If an instrument breaks down, it is this layer that reschedules the work, so that the entire laboratory is best able to meet its targets.
Because real-time integration and work flow control are vital in iLAB design, each is discussed in detail below.
Real-time integration means that data are available immediately, when and where required. The system can thus perform a multitude of automated checks and can prevent errors from occurring. It is also able to make decisions for users.
Data and events are validated immediately and automatically. Each new piece of data is evaluated, approved, and stored in its correct location. Events are reviewed and approved by the system before subsequent events can be initiated. Data are stored in a single correct location. Maintaining information in more than one location can be very problematic to an automated system.
Work flow control
Each event automatically initiates other events. Some of these events will require a human to complete and others will be done automatically. Since some will affect the current schedule, future events will have to be rescheduled and reprioritized. For example, in an iLAB, selecting a balance will automatically initiate the following series of events:
Figure 2 - Nexxis iLAB meets all of the requirements of an iLAB, but does not include applications for instrument software, LIMS, or enterprise resource planning (ERP).
- Check for calibration
- Check suitability of the balance
- Check training records
- Log use of the balance into an instrument log book
- Retrieve calibration information
- Retrieve an instructional SOP.
In this example, the single event of selecting a balance triggered an interaction with as many as five other applications.
Nexxis iLAB description
Nexxis iLAB (Labtronics Inc., Guelph, Ontario, Canada) provides additional functionality to the iLAB system (see Figure 2). These are described below.
Figure 3 - Using an API for communication, applications can be interchanged with a simple screen configuration.
The design of the connection between the application and the real-time integration layer is essential to the iLAB’s ability to support the selection of best-of-breed applications. Labtronics has designed a set of application programming interface (API) standards for communication between the applications and the integration layer. This means that the applications are interchangeable. For example, a Nexxis scientific data management system (SDMS) can be replaced with either a NuGenesis (Waters Corp., Milford, MA) or OpenLAB ECM (Agilent Technologies, Palo Alto, CA) application with no loss of functionality (Figure 3). Since the API design for the SDMS is the same for each of these applications, substituting one for another requires only a simple one-screen configuration. Once configured, the real-time integration layer is unaware of which SDMS is connected.
The Nexxis iLAB API is so generic that even widely used documentation systems can be utilized in place of the SDMS. This plug-and-play feature is very important when adding iLAB to a laboratory that already employs informatics systems. There is no need to replace existing systems.
Much of Nexxis iLAB has been designed to provide simple configuration instead of scripting and programming custom solutions. For example, the ReDI™ technology in Nexxis ELN allows users to create automated work sheets with simple click-and-drag functionality. Connecting an ELN work sheet to instrument calibration information, training records, and updating instrument log books is accomplished in a minute or two using a simple configuration. Connection to existing LIMS is through standardized LIMS modules, which require only simple, one-screen configurations.
An iLAB is a new type of laboratory informatics system that uses real-time integration and work flow control to solve the four key problems with today’s laboratory informatics systems: 1) No real-time control of users; 2) limited management of work flow; 3) most processes are human driven or paper driven, not event driven; and 4) limited integration of information. By solving these problems, an iLAB enhances the value of LIMS and other existing systems by integrating them into a total laboratory system in which:
- All data in the system are available immediately, when and where required
- Data and events are validated as soon as they occur
- Mistakes are prevented—For example, instead of simply tracking training records, an iLAB enforces training, preventing analysts from doing work if training has expired
- Procedures are highly controlled to ensure they are always followed correctly
- Resources are managed in real time—Expiration dates on chemicals are always current and the calibration of instruments is always enforced.
The iLAB environment facilitates simplified approval processes and faster product releases.
Mr. Pavlis is President, Labtronics Inc., 546 Governors Rd., Guelph, Ontario N1K 1E3, Canada; tel.: 519-767-1061; fax: 519-836-4431; e-mail: firstname.lastname@example.org.