Clinical sample management poses unique compliance challenges for laboratories. Sample collection, tracking and consent all become more regulated (GLP, GCLP, HIPAA) when managing clinical samples, and require a greater depth of record-keeping and reporting. Although keeping up with these regulations can seem like a daunting task, you can simplify and get a good start on improving regulatory compliance by focusing on 4 basic sample tracking questions: What? When? How? and Who?.
Lab staff should be able to answer these questions for every clinical sample managed in the lab. In order to do this, your lab will need to capture all details around the collection, receipt, storage, processing and handling of samples. With each sample requiring the capture of so many data points, it is essential to have modern sample management software designed to support the management of clinical samples.
What? – Fully and accurately define your samples, sample types and sources.
Document the type(s) of samples you will receive/create including the descriptive metadata that you want to collect for each sample type. Make sure to consider the source of the sample (perhaps a clinical trial participant), derivatives, and any other related details you need to capture.
When? – Track dates for everything related to your samples.
Capture dates for all events in the lifecycle of a sample including when it was collected, received, processed, stored, and shipped. This data should be readily available and exportable for further analysis during an audit.
How? – Capture everything that has been done to your samples in detail.
Track step-by-step how tasks were performed in the lab in relation to a sample. This includes all of the steps taken during sample receipt, checking of tubes for breakages or possible contamination and documenting storage conditions. Utilize a sample management system to capture SOPs in lab workflows and audit trails.
Who? – Capture who has worked with your samples.
Capture who in the lab performed any work or handling of the samples. This is both valuable for accountability and troubleshooting in the lab as well as for supplying auditors with additional information that they may need.
Clinical Sample Management with LabKey Sample Manager
Efficient and compliant management of clinical samples requires sample management software that is both powerful and easy to use. Sample Manager is a cloud-based sample management system that helps:
- Track the full history and chain of custody for each sample.
- Register and define samples using all relevant metadata
- Manage task-based workflows that accurately reflect SOPs
- Support barcoding and unique, human-readable sample ID creation
- Easily manage freezers and sample storage
Click here to learn about Sample Manager and take a product tour!