Using a LIMS to improve laboratory management

Laboratory information management systems (LIMS) are well known for their ability to manage sample data and their associated test results. However, many lab managers may be surprised at how LIMS can also help with many other laboratory management functions to improve efficiency and help support the needs of industry standards and regulation such as ISO/IEC 17025 and GxP.

Expanding the basic testing functionality

Commercially available LIMS can improve basic operational laboratory efficiency through:

• automatic allocation of tests and workflow tasks to samples at registration;
• elimination of time-consuming paperwork and other cumulative process-related time savings;
• elimination of transcription errors through automatic data capture;
• automated checking of results against defined specifications or limits;
• enforcement of workflow steps such as double-blind data entry and independent verification of results;
• streamlining of final report production and delivery based on the needs of the laboratory and the customer.
   

Many other benefits are available from a fully functioning LIMS. For example, laboratory workload can be managed through calendar scheduling of testing, based on resource availability. In support of this, a LIMS can be used to record the operational status of each piece of equipment to prevent work being allocated to an instrument that is out of calibration or maintenance. Such a system will also keep a history of all maintenance and calibration events for audit purposes and provide reminders of pending calibration and maintenance tasks.

Having this data available also allows the laboratory to evaluate maintenance costs and instrument reliability. Not only must instruments be available in an operational state, the staff allocated to use them must also be appropriately trained. Indeed, ISO/IEC 17025 requires documentation that all staff are suitably qualified for the tasks that they undertake in terms of appropriate education, training, experience and/or demonstrated skills.

A LIMS should include functionality to record and manage personnel skills and training records. Attendance at training courses can be recorded for lab personnel and certificates of competency issued and stored to provide a historical record of skills acquired. Automatic renewal reminders can be issued for time-dependent qualifications. Unqualified personnel, or personnel whose qualifications have lapsed, can be prevented from carrying out specific tasks. A LIMS can also be configured to include the costs associated with running different tests to allow the automatic generation of quotations and invoices. While there are clear benefits here for contract testing laboratories, this capability can also help internal labs keep track of their operating costs.

Supporting the full testing process

Any sophisticated LIMS should support all aspects of the sample and test life cycle to drive efficiency and best practice; for example, full support for analytical worksheets including the automatic inclusion of the required blanks, controls, standards and spikes as well as the unknown samples. These worksheets can also be used to generate instrument runsheets that can be automatically uploaded to the required instruments with the completed results sent back to and automatically entered into the LIMS. This both increases the efficiency of the laboratory and eliminates human-based transcription errors.

Work allocation — defining which laboratory technician will work on which samples and what equipment they will use to perform the work — can also be managed by a LIMS. This ensures that the most appropriate equipment and staff are used for each task to maximise overall efficiency of the laboratory. Once allocated, work lists or work instructions can be created to ensure everyone knows their allocated tasks.

Reagents and other consumables in a laboratory may be managed by an inventory manager within the LIMS. This helps ensure laboratory staff only use items that are within their shelf life. Stock levels can also be monitored and reordering triggered when levels drop to a predefined level. Managing inventory in this way ensures the laboratory always has appropriate levels of valid stock for its normal operation.

Sample storage is yet another area where a LIMS can improve efficiency dramatically. The LIMS can note exactly where a sample is stored, whether that be in long-term storage in a freezer or in a reception fridge awaiting accession. Using the storage management feature built into a LIMS, users will always be able to locate and retrieve samples quickly, wherever they are. This storage location functionality can also form the basis of a biobank management system designed to manage specimen storage and usage.

This review illustrates that, beyond the basic functionality that many people associate with a LIMS, there is much functionality that helps drive good laboratory management and daily working practices. There are few, if any, laboratories that cannot benefit from the implementation of a LIMS.

Wider-ranging management capabilities

A LIMS can also be used to address or support wider lab management functions, many of which are requirements for accreditation to ISO/IEC 17025:2017(E)¹. These include:

• control of management system documents;
• control and management of other records;
• actions to address risks and opportunities;
• quality and management improvement;
• corrective actions (CAPA);
• internal audits;
• management reviews.
   

All laboratory processes and procedures should be documented and provision made for access for everyone who needs them. It is possible for a LIMS to track, store and distribute all documents from a central location. Document versioning provides a full audit trail, allowing the history of revised documents to be traced for internal and external auditing and reporting.

Laboratories also need to be accountable for the analytical results that they produce. ISO/IEC 17025 requires policies to be in place to deal with customer complaints, with records of any complaints and subsequent investigations undertaken and corrective actions implemented being maintained. A LIMS can also be used to document and monitor any preventive action plans that laboratories have in place to identify improvement opportunities and potential sources of nonconformities.

Utilising the data

By providing access from a single integrated source to the type of operational and management data described above, very many of the requirements of ISO/IEC 17025 can be addressed. In addition, historical data that can be of huge value to an organisation is available in the LIMS. Using statistical process control methods, it is possible to monitor the laboratory processes to reveal trends, identify areas for potential improvement and detect serious problems. The LIMS can be used to model the effect of potential business changes. For example, by using historical information on turnaround times and the number of trained analysts available, it is possible to assess the impact on the laboratory that an increased sample throughput could have.

Choosing a suitable LIMS

Given the diversity of data that can be managed using a LIMS, the software must be flexible enough to support the different needs and working practices of any laboratory. Most commercial LIMS can be adapted to meet the requirements of the individual laboratory, but the ability to configure the LIMS at the user level without writing any new code streamlines the process. In this way, the system can be readily adapted to the needs of the laboratory and the inevitable future changes can be simply incorporated.

A well-configured LIMS offers much more than just a repository of information regarding sampling, testing and results. It becomes a business-critical system that enables informed decisions to be made regarding a multitude of laboratory processes, as well as providing the foundation for ISO/IEC 17025 accreditation and other regulatory or standardisation requirements.

_{1. http://www.iso.org/standard/66912}

*Tim Daniels has 30+ years of experience working in national and international markets across a range of software/high-technology products. He has been Marketing Manager at Autoscribe Informatics for eight years. Autoscribe Informatics provides database management solutions such as laboratory information management systems (LIMS) that are graphically configurable, requiring no scripting or custom coding to configure solutions. Tim’s broad background provides a unique blend of practical knowledge and insight to drive all aspects of product and corporate marketing within Autoscribe Informatics.