September 04, 2019
One of the key requirements of a laboratory is to ensure that the sample is properly received and tracked throughout its lifecycle. The outcome of the test results largely depends on the quality of the samples being tested. If the sample quality is compromised, it may alter the test results, thus leading to an erroneous judgment. The practice of tracking and documenting the sample’s journey completely is referred to as Laboratory Sample Management.
Some of the sample management activities carried out by labs include:
1. Precise recording of the sample information when it is received.
2. Appropriate labeling of samples.
3. Processing and making aliquots or derivatives from them
4. Storing the samples at an appropriate temperature for future use
5. Maintaining sample quantity for tests or experiments
Some of the challenges that can arise while managing samples include a compromise in the sample quality, sample loss due to mismanagement, inappropriate labeling, maintaining the relationship of aliquots and derivatives with their parent samples, etc. Managing the sample records using spreadsheets makes it a tedious task to locate the samples from their storage location within the lab. This may cause undue delay in processing customer’s requests that may, in turn, harm the market reputation of the laboratory. Therefore, it is highly essential to follow Standard Operating Protocols (SOPs) to avoid mismanagement of samples.
Sample management is essential for accurate laboratory results as it has a significant impact on the test and research results. Testing on deteriorated samples may lead to a loss of time, effort and money, and ultimately, affecting the market reputation of the laboratory.
Some best practices for sample management components provided by the World Health Organization (WHO) are as follows:
1. The appropriate recording of sample data should be done to keep track of data in all phases from recording to reporting.
2. Restricting user access rights to prevent data alteration.
3. Standard methods of record-keeping following regulatory compliances.
4. Good documentation practices to maintain data integrity.
5. Rejected sample data should also be recorded with appropriate justification.
An efficient method of managing samples based on the WHO guidelines is by using a laboratory sample management system. Some of the capabilities of sample management software include:
1. Accessioning the samples based on group-wise and role-based hierarchy available in the organization so that data is accessed by authorized personnel only.
2. Maintain a complete chain of custody of the samples throughout the sample lifecycle.
3. Recording sample storage location within the laboratory.
4. Maintain geneology to keep a record of the aliquots or derivatives derived from the parent sample.
5. Monitoring and alerts regarding the sample expiry, freeze/thaw cycle, temperature.
6. Maintaining the user information for activities such as sample collection, storage, shipping, relocating or disposal.
7. Tracking all user activities performed in your lab with a comprehensive audit trail and electronic signatures.
8. Tracking freeze-thaw cycles to maintain sample integrity.
Efficient sample management is the most crucial step for any laboratory or biobank. If the sample is misplaced or data is not recorded accurately, it may result in testing delays, testing the wrong sample or getting inaccurate test results leading to re-tests and hence increasing costs. A sample management software or Laboratory Information management System (LIMS) ensures the data security and accuracy of all the samples right from when they are received in the lab until they are processed, tested and shipped out. The sample management system allows laboratories to follow regulatory guidelines such as HIPAA and 21 CFR Part 11 to ensure best sample management practices which, in turn, assures the accuracy and reliability of testing, and increase confidence in results.