With the exciting advances in research and drug development, the importance of sample management has never been higher. After recent examples of near misses and sample management mishaps, we ask: Do you know where your samples are?
In this blog, let’s explore some of the common causes of inventory mis-management and best practices to guard against sample loss and near misses.
It all starts with a good Inventory Management System!
The first step in successful inventory management is developing or selecting a validated and compliant inventory management system (IMS). When doing so, it’s important to consider the longevity of the system. It’s easier to conduct more research upfront by identifying a system, training your staff, and installing system upgrades, rather than switching IMS brands and installing an entire new system every several years. There’s great value in tribal knowledge and that’s diluted if you change the system frequently. A sophisticated IMS should be electronic signature compliant, guard against data manipulation, and provide a full audit trail. Also, don't lose sight of the need for prompt technical support of your IMS system; resource location and availability is of utmost importance when a problem with the system arises.
Choose Your Storage Provider Wisely
Clients should partner with a storage provider that will store the sample for the full duration of its lifecycle. Oftentimes, clients move material frequently between different competitors which can expose the samples to various environmental elements. Each time the samples are re-inventoried there is potential for discrepancies to arise due to multiple movements without verifications. The less touches, the better it is for the sample and its data management.
The 3 P’s: Processes, Policies, Procedures
Any comprehensive IMS needs to be used in conjunction with the 3 P’s: processes, policies, and procedures. The 3P’s are guiding documents that staff can follow to ensure samples are inventoried accurately. By enforcing the 3 P’s it ensures staff follows the same protocol in how to receive and distribute samples, and record data in a timely and precise manner.
An electronic manifest is provided by the client and includes all information pertaining to the sample shipment so the receiving team is prepared for the inbound arrivals. When the e-manifest is uploaded by the storage provider, the receiving staff is able to scan and receive the samples against the e-manifest data to ensure double data entry and accuracy. By verifying several fields on the e-manifest with the sample, it also guarantees that staff isn’t solely relying on the barcode for information related to the sample.
Secure Quality Checks and Reports
In addition to knowing where samples are located many clients want to verify that their samples are being stored at the correct temperature. A comprehensive IMS often provides a quality reporting feature that supplies this information.
When samples are received and entered into the IMS, it’s important to conduct a statistical quality check. This is an industry accepted standard to randomly pull a representative population of samples and verify their location. For example, if 10,000 samples are entered into the IMS, the statistical quality check will randomly select 200 samples and verify their location. If the results show that the samples are in the correct location, then the quality check is passed.
Audits and Spot Checks
Most, if not all, storage providers are subject to frequent client-requested audits and spot checks. During an audit or spot check clients will often ask the storage provider to pull randomly selected samples from their inventory, as described above. These precautionary measures ensure the IMS is effective and accurate.
Three Person Touch Team
Multiple movements of samples create multiple opportunities for errors in inventory management. However, unavoidable situations, such as freezer failure, do occur and requires the samples to move from their initial location. When inventory errors arise they are typically due to transactional activity that occurs after the initial receipt of the sample.
Samples should be moved sequentially to their new location in the same fashion as they were pulled. By utilizing a three person touch team it instills a system of checks-and-balances when moving samples throughout the biorepository. One individual is responsible for moving the samples, the second individual verifies the movement, and third person does a quality check and final verification.
Gone are the days of maintaining inventory with pencil and paper, Lotus Notes, or Microsoft spreadsheets. In this day and age, a validated IMS is necessary to guarantee the proper management of your samples. By following these best practices and establishing good client-provider communication, inventory management accuracy can be greatly improved.
Receiving samples into inventory follows a specific process for establishing accuracy and maintaining temperature compliance. To learn more about the importance of these processes, download our eBook Protecting Your Protocol: Operating a Flawless Clinical Agent Repository.