User:Shawndouglas/sandbox/sublevel12

Sandbox begins below

Title: What are the key elements of a LIMS or LIS for medical microbiology?

Author for citation: Shawn E. Douglas

License for content: Creative Commons Attribution-ShareAlike 4.0 International

Publication date: April 2024

Introduction

This brief topical article will examine the informatics needs of the medical microbiology lab, including a base set of laboratory information management system (LIMS) or laboratory information system (LIS) functionality (i.e., system requirements) that is critical to fulfilling the information management and workflow requirements of this type of lab. Additional unique requirements will also be briefly discussed.

Note: Any citation leading to a software vendor's site is not to be considered a recommendation for that vendor. The citation should however still stand as a representational example of what vendors are implementing in their systems.

Base LIMS or LIS requirements for medical microbiology labs

Like other labs, medical microbiology labs increasingly require an informatics solution that meets all or most of its workflow requirements. These requirements are often driven by standardized test methods, in turn driven by regulations and accreditation requirements. This requires a pre-configured and future-configurable solution that enables medical microbiology personnel to quickly select and use standardized test methods and forms, and make the changes they need to those methods and forms if those changes make sense within the overall data structure of the LIMS or LIS.

What follows is a list of fundamental LIMS or LIS functionality important to most any medical microbiology laboratory, with a majority of that functionality found in many vendor software solutions.

Test, sample, and result management

• Sample log-in and management, with support for unique IDs
• Sample batching
• Barcode and RFID support
• End-to-end sample and inventory tracking
• Pre-defined and configurable industry-specific test and method management for a variety of physical, mechanical, and chemical analyses
• Pre-defined and configurable industry-specific workflows
• Configurable screens and data fields
• Specification management
• Test, sampling, instrument, etc. scheduling and assignment
• Test requesting
• Data import, export, and archiving
• Robust query tools
• Analytical tools, including data visualization, statistical analysis, and data mining tools
• Document and image management
• Project management
• Facility and sampling site management
• Storage management and monitoring

Quality, security, and compliance

• Quality assurance / quality control mechanisms
• Mechanisms for compliance with ISO/IEC 17025, ISO 9000, ASTM, A2LA, ANAB, and other requirements
• Result, method, protocol, batch, and material validation, review, and release
• Data validation
• Trend and control charting for statistical analysis and measurement of uncertainty
• User qualification, performance, and training management
• Audit trails and chain of custody support
• Configurable and granular role-based security
• Configurable system access and use (i.e., authentication requirements, account usage rules, account locking, etc.)
• Electronic signature support
• Data encryption and secure communication protocols
• Archiving and retention of data and information
• Configurable data backups
• Status updates and alerts
• Incident and non-conformance notification, tracking, and management

Operations management and reporting

• Configurable dashboards for monitoring, by material, process, facility, etc.
• Customizable rich-text reporting, with multiple supported output formats
• Custom and industry-specific reporting, including certificates of analysis (CoAs)
• Email integration
• Bi-directional instrument interfacing and data management
• Third-party software interfacing (e.g., scientific data management system [SDMS], other databases)
• Data import, export, and archiving
• Instrument calibration and maintenance tracking
• Inventory and material management
• Supplier/vendor/customer management
• Customer portal

Specialty LIMS requirements

Some laboratory informatics software vendors are addressing medical microbiology laboratories' needs beyond the features of a basic all-purpose LIMS. A standard LIMS tailored for materials testing may already contribute to some of these wider organizational functions, as well as more advanced laboratory workflow requirements, but many may not, or may vary in what additional functionality they provide. In that regard, a materials testing LIMS vendor may also include specialized functionality that assists these labs. This includes the provision of:

• A pre-defined library of materials specifications: Given the wide variety of materials tested by these labs, a built-in materials library that can be referenced throughout the LIMS will have some utility. The reality may be that this feature is more useful for those labs conducting research and development (R&D) on new materials. However, some analytical and quality testing labs may also find access to such a library useful, particularly if any built-in or customizable test methods can also be linked to specific materials in the library.
• Integrative support for third-party materials databases: A variety of third-party materials databases—e.g., from SpringerMaterials—provide extra value to many materials testing labs. The ability of the LIMS to support connections to and importing of data from these databases extends the value of those databases. When tools like the OPTIMADE API are included, even further integrations and standardized querying becomes available.
• Tools for recipe, mix, and blend design and management: When it comes to R&D of materials, numerous iterations of a material may emerge, requiring multiple recipe, mix, or blend processes. Some LIMS vendors recognize this, adding tools that allow these materials to more readily be designed, optimized, and analyzed directly from the LIMS, across multiple iterations.
• Pre-built and configurable lab test forms (i.e., worksheets) and reporting templates: Conformance to regulations and accrediting bodies is a significant concern for materials testing laboratories. From ASTM and AASHTO to A2LA and ANAB, specific requirements for lab test methods and their associated reports are placed on such labs. A thorough LIMS vendor catering to materials testing labs will include pre-built, customizable templates for properly recording and reporting all analytical results for stakeholders.
• Robust document management: Appropriate documentation is vital to the workflow of the materials testing laboratory. The system should support the attachment of photos, calibration records of test equipment, analytical readings, diagrams, 3D models, and more to other documents in the system.
• Robust data normalization and aggregation: Materials testing data can at times be highly heterogeneous and hierarchical, bringing additional data management complexity beyond the typical lab. Materials data management requires robust data normalization rules and tools that can help make materials data more searchable and usable. Whether coming from instruments or third-party materials databases, standardizing nomenclature and other metadata fields in order for the lab to make the most out of its data is vital.
• Support for multiple industry-specific data formats: In some cases, industry-specific data formats arise within a given industry, and the materials testing world is no different. The LIMS should be able to support industry-specific data formats such MatML and ThermoML.