Category: About LabKey

Clinical sample management requires laboratories to put a significant amount of thought and effort into record-keeping and reporting in order to meet compliance requirements. Regardless of the type of compliance (HIPAA, Part 11, GLP, etc),  managing clinical samples requires a commitment to actively maintain an audit ready-state. For many labs that are getting started with clinical sample management, this can be a daunting task. Check out the 3 tips below to get started. 

Clinical Sample Management Compliance Tips

1. Traceability of Clinical Samples 

Your staff should be able to the “what, when, how, who” of every human-derived sample in the lab. Sample tracking should include the capture of all details around the collection, receipt, storage, processing and handling samples.

What? – Document the type(s) of samples you will receive/create including the descriptive metadata that you want to collect for each sample type.
When? – Capture dates for all events in the lifecycle of a sample including when it was collected, received, processed, stored, and shipped.
How? – Track step-by-step how tasks were performed in the lab in relation to a sample. Utilize sample management software to capture SOPs in workflows and audit trails.
Who? – Capture who in the lab performed any work or handling of the samples. This is both valuable for accountability and troubleshooting.

2. Sample Identification & Barcoding

Clinical samples should have clear and unique identifiers that are appropriate to the laboratory type. Among other considerations, do your samples need to be de-identified for a specific laboratory or can they have PHI in the identifier? Do your naming patterns easily provide information and context for a given sample? 

Sample Receipt – Consider how samples will be labeled from the collection site and received into the laboratory. Do they need to be de-identified before use in the lab?

Laboratory-Specific Identification – Define naming patterns that account for the uniqueness of your samples, aliquots, derivatives, and repeat samples. Although you may also use barcoding, consider having your identifier be “human-readable” so that lab staff can identify samples on-the-fly. 

3. Standard Operating Procedures

When managing clinical samples it is essential to have clear SOPs that document sample processing tasks and workflows.  SOPs should accurately document the work to be done in the lab as well as capture any results from sample processing tasks.

Document – With the help of your team, draft an example of the sample lifecycle in the lab. Be sure to capture areas of possible deviation, key variables and decision points.
Create/Update SOPs – Compare the sample lifecycle with your SOPs to ensure procedures are aligned with what is taking place in the lab.
Evaluate – Conduct a “trial run” of your clinical sample intake, processing and storage to ensure SOPs accurately reflect real-world procedures.
Maintain – Define a schedule to regularly review processes and track any changes to SOPs using documented change requests. Internal audits should also be scheduled at set intervals to keep your lab in an “audit-ready” state.

4. Record Keeping

All work performed on clinical samples should be documented and include the same  “what, when, how, who” details mentioned before. This should be a record of the actual work that was done, versus your SOPs, which layout a plan and methodology for the work. Keep regulatory requirements in mind when determining how this documentation will be captured, stored and shared.

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 definine samples using all relevant metadata 
• Manage task-based workflows that accurately reflect SOPs
• Support barcoding and unique, human-readable sample ID creation
• Retain records of the complete life-cycle of each sample.
• Easily manage freezers and sample storage 

Click here to learn about Sample Manager and take a product tour!

It’s no surprise that our users are overwhelmingly happy with the ease and efficiency that Sample Manager has brought to their labs. After all, Sample Manager was created in close consultation with labs of all shapes and sizes to ensure that we were creating the best sample management software on the market. We recently asked lab managers what they love most about Sample Manager and how it has impacted their labs. Their responses varied, but all shared a common theme- Sample Manager makes lab work easier and faster.   

“Sample Manager is so easy to use. It makes all of our days easier and more productive.”

With a beautifully simple user interface and intuitive features that are essential for modern laboratories, Sample Manager is designed to bring ease and efficiency to sample management tasks. From bulk importing and storing samples to tracking lab workflows and managing data, Sample Manager makes the management of lab samples faster and easier than ever before. 

“The Sample Timeline is amazing, I can finally see the complete history of a sample and who in the lab has touched it.”

Our Sample Timeline feature provides an audit-ready view of the complete history of each sample. By reviewing the chain-of-custody, you can easily see the “who, what, when and where” for each event in the timeline of a sample. Events may include sample registration, storage changes, sample check-in/check-out events, assay runs and more. The sample timeline can also be exported to Excel for further analysis and review.

“No more searching for lost samples! The freezer management features alone have saved us so much time.”

Helping our users efficiently search their sample inventory and manage their freezer storage is a core function of Sample Manager. Our flexible freezer management tool allows you to create an exact match of your physical freezer storage options within the application. You can also use our Sample Finder tool to build custom queries to search, group and take action on related samples.

“The lineage tracking capability has been a gamechanger. We can now easily tie samples back to their sources and aliquots that have been created.“

Tracking samples and their derivatives has been made as easy and intuitive as possible within Sample Manger. Using a visual lineage tree, users can easily see the context and details of samples including all sources and aliquots. We’ve also streamlined the creation of aliquots from samples to boost efficiency in the lab. 

Learn More About Sample Manager:

• Product Page & Tour
• Freezer Management
• Sample Tracking
• Lab Workflow Management
• Assay Data Management

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!

The Ohio State University is using Sample Manager to manage veterinary samples for its influenza monitoring program.

Presented at the LabKey User Conference, Andrew Bowman, Associate Professor at The Ohio State University shared how his lab is using Sample Manager for veterinary sample management to support a surveillance program monitoring influenza viruses circulating in swine and waterfowl. His presentation provided an overview of the work being done in the lab, their need for a sample management system, benefits they have seen since adopting Sample Manager, and future plans. 

The lab generates more than 10,000 veterinary samples per year and conducts approximately 15,000 tests on these samples annually. The samples being handled by the lab include swabs, environmental samples, serum and PBMC. Projects assigned to the lab have varying data reporting requirements and sample information being captured. As can be expected, one of the major challenges is managing the volume of data and samples.

Prior to Sample Manager, the lab was using an outdated veterinary sample management system based on Filmaker databases. The system was difficult to use and lacked the flexibility needed to adapt to new projects and sample processing requirements. Being an academic lab, there is a continuous turnover of students using the system, creating the need for an easy-to-use application that requires minimal training and IT support.

Sample Manager was chosen as the veterinary sample management system for the following reasons: 

• Sample Research-focused data management and the flexibility to meet data reporting requirements
  
• Sample-centered, alignment with workflow
  
• Easily customizable to meet the needs of new projects and assay
  
• Intuitive and user friendly- requiring minimal training and support

Some of the key features being used include:

• The ability to add multiple sources per sample and general flexibility of the system
  
• The ease by which new assays can be added and data can be managed/tracked
• Customer support- LabKey is incredibly responsive and solution-oriented in its approach!

Click Here to learn more and take a tour of Sample Manager!

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