Customizing a commercial laboratory information management system for a forensic genetic laboratory

Article Outline

• Abstract
• 1. Introduction
• 2. Materials and methods
• 3. Results and discussion
  • 3.1. Process flow
  • 3.2. Data validity and traceability
  • 3.3. Sample flow and instrument integration
  • 3.4. Result evaluation
• 4. Conclusion
• Conflict of interest
• Role of funding
• Acknowledgements
• Copyright

Abstract 

The need for high-throughput laboratories to comply with regulatory requirements makes data management an important aspect of forensic genetics. A Laboratory Information Management System (LIMS) enables efficient workflows and ensures traceability if designed and implemented properly. We customized a commercial LIMS to support STR typing of reference samples according to in-house defined requirements. The customization focused on data validity, traceability and automated solutions.

Keywords: LIMS, Automation, Traceability, Forensic genetics

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1. Introduction 

A well-functioning Laboratory Information Management System (LIMS) is essential to forensic genetic laboratories that handle large volumes of data according to accreditation standards. We decided to implement a new LIMS for management of reference sample STR (short tandem repeat) typing in order to increase efficiency and to replace paper-based procedures with electronic traceability. To achieve a LIMS tailored to our needs within a reasonable time and budget, we chose to customize a commercial product, LabWare LIMS.

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2. Materials and methods 

A Microsoft SQL Server 2005 database was combined with the client/server application LabWare LIMS version 5.02m from the automation software vendor LabWare, Inc. (Wilmington, DE, USA). The system was extended with LabWare's Forensics module, which provides functionalities for management of cases and evidential materials. Customization of LabWare LIMS was achieved with the scripting language LIMS Basic. Data validation via double entry was enabled by a product from AnyDoc Software, Inc. (Tampa, FL, USA).

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3. Results and discussion 

3.1. Process flow 

The configurability of LabWare LIMS was used to create a system that supports the entire process of STR typing reference samples. The process flow includes the following steps:

3.2. Data validity and traceability 

Ensuring data validity and traceability was a focal point in the implementation of the new LIMS. LabWare LIMS includes an audit trail facility that provides traceability via audit logs, which we supplemented with tailor-made reports focusing on specific events.

A procedure for double data entry was created to enable accurate transfer of information from requisitions to the LIMS. The procedure, which involves OCR processing and manual data entry, was developed using AnyDoc software. Furthermore, LabWare's approval management system was configured to ensure that changes made to valid data by one individual must be approved by another individual before the new information is considered valid.

3.3. Sample flow and instrument integration 

Special emphasis was also put on developing automated solutions and advanced functions for batch handling of samples. The LIMS supports STR typing of all types of reference samples. FTA Cards account for the majority of samples. Sample fractions are collated in batches on each laboratory step. After a punch procedure, FTA Card fractions go through a wash step, PCR and electrophoresis. Fig. 1 illustrates the automatic generation of a wash step batch based on an output file from a BSD600 punch instrument (BSD Robotics, Australia). Other examples of instrument integration in the LIMS are creation of worklists for liquid handler robots and generation of plate records for ABI 3130 XL instruments.

The batch management customizations include a functionality for the creation of a batch from a batch at the preceding laboratory step. For example, a PCR batch can be created from a wash batch so that sample fractions that were successfully processed in the wash step are included in the PCR batch. If an entire laboratory procedure fails, the corresponding batch can be annulled, and the annulment feature automatically reassigns new laboratory tests to the affected samples according to type of batch and type of reference sample.

3.4. Result evaluation 

When the sample fractions have been processed in the laboratory, electrophoresis results are evaluated in a multistep process (Fig. 2):

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4. Conclusion 

We have successfully customized and implemented a commercial LIMS that fulfils the requirements of an ISO 17025 accredited forensic genetic laboratory in regard to traceability and data quality and provides automated solutions for laboratory procedures and result handling.

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Conflict of interest 

None.

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Role of funding 

None.

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Acknowledgements 

We thank Signe A. Hansen, Tanja Bonde, Lars Hesselberg, Gethyn Boustead and Michal Virag for technical assistance.