Laboratories dealing with high volumes of samples will be all too familiar with the logistical and operational difficulties related to tracking sample inventories. Maintaining a clear audit trail across the lifespan of each sample is crucial in the case that analysts need to justify their findings. Following best practices in sample tracking is important for labs from a multitude of standpoints, namely in ensuring the integrity of data and analysis and following stringent regulatory requirements. Implementing these best practices into your inventory management processes will help loosen bottlenecks and streamline processing operations.
One first area of concern for labs in the handling of samples is compliance. Labs will need to be compliant with a host of regulations depending on the nature of samples being processed. Lab practices in the US are regulated by a number of governing bodies such as the Food and Drug Administration (FDA) – notably 21 CFR Part 11 – and Environmental Protection Agency (EPA), as well as federal laws such as the Health Insurance Portability and Accountability Act (HIPAA). The Good Laboratory Practice (GLP) guidelines were established to help regulated companies stay compliant in management of samples and maintain standards for handling and tracking.
The purpose of these regulations is clear when examining how things can go wrong. In 2013, a vial containing the Guanarito virus, a pathogen that causes hemorrhagic fever, went missing from a research facility in Texas, suspected to have been accidentally destroyed during cleaning processes. Similarly in health settings, as many as 160,000 adverse patient events occur in the US each year due to errors in identifying specimens. Additionally, proper identification and tracking of samples is crucial in ensuring an accurate determination of guilt or innocence in criminal proceedings. Beyond these administrative and health risks, there are considerable financial costs associated with inadequate sample tracking. The Patient Safety Network cites several studies estimating the average costs of lost and misplaced specimens. Irretrievably lost specimens tend to cost around $548 each, with cumulative costs over a 3-month period adding up to a speculated $20,430. Separately, mislabeling costs per specimen averaged out at $712. These costs can accumulate quickly and put pressure on lab revenue if the underlying causes persist.
Managing Storage Units
One of the principal logistical issues in tracking samples is retaining oversight of specimens in different types of storage units. For example, some types of specimens may need to be stored in freezers at -20 degrees Celsius, -80 degrees Celsius, and even in liquid nitrogen. Others may be stored in refrigerators at +4 degrees Celsius. It is likely that these storage facilities will not be co-located, requiring manual work to transport samples, as well as creating data sprawl in recording the status and movement of individual specimens. This difficulty is compounded when having to manage and track samples across their placement in shelves, racks, and boxes. Furthermore, samples may be spread over several distinct freezers, consuming space and using up valuable time in tracking, storing, and retrieving. It is crucial that sample movements be recorded, however, this process can be laborious and time-consuming.
Navigating Labeling Systems
Several complications can arise in sample management from illegible labels or inadequate labeling conventions. Many labs do not follow best practices for sample tracking, and it is common to see handwritten specimen labels – which introduces a costly human error component into the tracking process. Firstly, manually entering data onto labels presents an opportunity for transcription errors which can make it difficult to ensure that the correct sample has been retrieved. Labels may also be stuck poorly onto containers which often results in those labels falling off in freezers. Additionally, different individuals in the lab may have used different labeling conventions, or writing could be illegible or fade over time. As a result, samples may sit unused in storage due to uncertainty about their contents. These avoidable errors work to create “[bottlenecks] in your laboratory”.
On a similar note, unclear labeling systems can lead to miscommunications about samples or test results. In a story all too familiar in the COVID-19 landscape, The American Association for Clinical Chemistry reports on a mix-up resulting from the differences between two organizations in their labeling conventions, leading to a miscommunication of COVID test results. Four patients returning to the US from China were mistakenly assigned negative test results and were wrongly excused from quarantining. Subsequently, the report identifies a higher rate of incidence in mislabeling events during the pre-analytic phase.
Managing Audit Trails
Maintaining a thorough audit trail across the entire sample lifespan is important for protecting the validity of data, and in staying compliant. Many labs, however, continue to use legacy systems to track the movements of samples – commonly, these are paper-based systems or spreadsheets. The first issue with legacy systems concerns ensuring that all information is entered into records in the same format and using the same terminology. Having to consult a key or index to this end and manually transcribe or input data increases the incidence of recording errors. Additionally, capturing the level of information needed on spreadsheets or paper records is difficult when considering the need to record sample contents, type of container, storage location, expiry or retention dates, sample movements between stores, etc. This leads to a need to continually take notes when moving around the lab, which is not only laborious but again increases the frequency of recording errors – information also then becomes outdated quickly, and spotting anomalies can be difficult.
Maintaining oversight of samples across their entire lifespan can be laborious – but you can look to implement systems that streamline the maintenance of audit trails and make the best use of your storage facilities. Firstly, it is important to monitor and track free storage space. In labs with high throughput, storage space will be held at a premium. 2D barcoded tubes such as those produced by Matrix, Azenta, and Micronic, can save substantial amounts of space. One downside of 2D barcoded tubes is the lack of human readable information that may be important in sample processing in the case that a scanner is unavailable.
Clearly mapping out available space simplifies the storage of new inventory and helps planning efforts. When auditing your space tracking, it may be worthwhile to consider whether sample management software could create some efficiencies and reduce time-consuming tracking tasks. Freezerworks and Titian are a couple of leaders in this space. This software provides an easy-to-update alternative to manually drawn diagrams of storage space and can be used to audit store use and identify redundant items. The maintenance of freezers and refrigerators is costly, so storing samples represents a possible opportunity cost – keeping unused or redundant samples stored due to poor space management, for example, can be expensive. On a similar note, keeping back-up freezers and storage facilities in the case of a store breakdown is prudent to minimize any disruption during a technical fault.
Additionally, it can be helpful to map out labware usage and take stock of how many of each type of container are in use. This process can present opportunities for standardizing equipment, which in turn brings bulk purchase savings. As well as saving on equipment costs, standardization simplifies the movement of consumables between labs and aids the consistent use of protocols, as well as integrating with racks, storage compartments, and automation.
A report issued in the Journal of Applied Laboratory Medicine listed improved collaboration and communication between labs as the top recommendation to reduce the frequency of specimen identification errors. Human error is a persistent issue in specimen labeling and tracking, which can be combated by streamlining cooperation in hand-offs. Other best practices to reduce the impact of human error in sample tracking include the use of labeling automation, the implementation of bar-coding, and the use of tracking software. To this effect, the creation of consistent naming conventions and vocabulary is crucial in minimizing specimen mix-ups. Bar-coding is an increasingly popular solution to ambiguously or inconsistently labeled specimens. In a similar way to how hospital staff scan both the barcode on the patient wristband and medication being administered, implementing barcode identification and applying the same principles in the lab can prevent costly mistakes. Finally, labs may want to consider providing staff with incentives to find and report on labeling discrepancies.
Thorough tracking through the entire lifespan of each sample is crucial – records need to be kept not only of sample locations, but also of storage conditions at all times in each facility. Time spent in and out of storage units, time spent in analysis, and how many times a sample has been thawed, all needs to be recorded. Many labs could improve the accuracy of their audit trails through the use of LIMS, or lab information management systems. These systems boast many advantages and efficiencies over the manual recording of data in spreadsheets or paper documents, housing all relevant data centrally in an easy-to-update interface. Furthermore, labs may wish to consider the consolidation of standard operating procedures in a central document library or interface that can be updated when changes occur – this ensures continued compliance with regulations as well as efficiency.
As lab throughput continues to rise, opportunities to save time and effort where possible are more valuable than ever. Here at TubeWriter, we believe in freeing up your staff to focus on quality science. TubeWriter has the unique ability to label most labware and provide not only human readable label information, but also 1D or 2D bar codes. Get in touch today to find out how TubeWriter labware printing systems can modernize your sample tracking and empower your lab.
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