ASTM International taps into the expertise of 30,000 of the world’s top technical and business minds, creating the test methods, specifications, and guides critical to a wide range of industries and governments around the world. Over 12,000 of its standards are used worldwide to improve quality, safety, and market access and trade.
One of their resources was created expressly to demystify the lab informatics life cycle from inception to retirement: the ASTM Standard Guide for Laboratory Informatics.
At just over 50 pages, the guide covers everything from standard industry terms and minimum requirements to high-level advice on integration and a timeline for developing software products. LabVantage’s Jeff Vannest is a task group leader working on the 2017 version of this guide. His group is writing the new guide sections on data integrity, cyber security and the protection of personal information.
In this post, we’d like to highlight a few of the most useful sections of the ASTM Standard Guide.
Creating a Detailed Lab Workflow and Data Model
The start of the guide describes the lab informatics system life cycle, breaking down the phases into initial implementation, followed by operations and then maintenance.
According to the guide, properly defining your lab’s unique needs and data model at the start is critical to successful implementation and deployment.
Defining the Lab Data Model
Many labs use procedure-centric data models, where test methods are defined by approved external procedures and SOPs. Relying on the user’s experience, this model offers the greatest flexibility for an R&D lab with diverse sample submissions. With other models, a group of “approved” tests are run together and always applied to one sample type. This type of model is useful for a QA lab handling product release.
Working With Your Resources and Timeline
After deciding what level of customization and configuration is needed, the project team should focus on:
- resource availability
- time remaining until the go-live date
- project scope
- budget
Keeping all these elements in mind is the best way to achieve maximum benefit, while working realistically within the constraints imposed.
When to Consult the Lab Informatics Experts
Talking to lab informatics solution experts is especially useful at the start of the project and during requirements analysis. Experts can clearly explain all the functions and tell you what is reasonable and feasible. Experts are key during the design and configuration, and help with testing and initial operation.
Potential Benefits of LIMS Implementation
When looking at potential benefits of installing a LIMS, most ultimately result in saving money. This savings can not only help justify the decision, but also underscore the need to prioritize rolling out certain features or installing certain models.
Installing a LIMS can help you:
- Increase number of samples processed
- Decrease sample processing time
- Cut number of analyst hours needed for processing
- Reduce error rates
- Reduce frequency of process inspection
- Speed release of manufactured products
- Reduce customer service needs by offering self-service, read-only access to sample status and test results
In addition, a few intangible benefits include:
- Achieving and demonstrating regulatory compliance more easily
- Detecting and correcting errors earlier
- Improving customer satisfaction
Common Errors in Cost-Benefit Analysis
To get the most benefits, preparation for the system should be as realistic and thorough as possible. Common errors to look out for in the cost-benefit equation include:
- Assuming your organization can go completely paperless in the initial phase
- Miscalculating the time needed for customization by expecting the systems will easily meet all the requirements
- Not allowing for repeated corrections needed for deliverables
- Making unreasonable forecasts of productivity gains
- Underestimating time required to train staff on new system and continue to use current system
- Failing to strategically plan for the funds, personnel and space to expand and eventually replace the system
- Failing to anticipate the time needed to revise business practices not automated by new system
- Not factoring in the intangible benefits like improved competitiveness, enhanced reputation, or protecting brand value
How to Choose a LIMS Vendor
When choosing a vendor, asking for a scripted vendor demonstration can be very worthwhile. Using a script lets you compare the systems more easily and see which one requires the least customization to meet your needs. Give the vendor at least two weeks to plan. Supply them with examples of sample types and test methods, with a set of scenarios and expected results critical to your system’s success. Typical elements you might want to see are:
- administrative tools and functions to configure and customize the system
- the sample receiving process
- complex traceability issues such as tracking of subsamples or aliquots
- test method calculations or limit checking
- automatic generation of samples and assigning tests for skip lot testing
- complex retest/rescheduling logic
Give the vendor enough time to explain how the functionality was configured or customized, to detail unusual features and alternative solutions, and to pinpoint what sets their technology apart.
Using Lab Informatics to Create a Lean Laboratory
Lab informatics can help implement lean concepts by effectively boosting productivity, quality and efficiency while cutting costs.
The lean concepts most likely to be fostered are:
- Workload leveling and flow, by ensuring consistent workflow each day
- Visual management, via color coding, easily recognizable symbols and icons, and dashboards with updates in real time
- Continuous process improvement, by displaying data on dashboards and charts concerning error rates, turnaround times, and inventory control
- Waste reduction, through review by exception, automation, and paperless processes
These are just a few of the tips packed into the ASTM guide—an invaluable resource for anyone working in lab informatics. To see more, or to learn more about the organization, visit ASTM International.
