November 21, 2023

Tired of Being Bogged Down by Lab Queries? Here’s What’s Causing Them, and What You Can Do to Reduce the Burden.

It’s no secret that lab queries present a major obstacle for research sites in their clinical trial operations. Study coordinators and dedicated site personnel often balance multiple trials simultaneously — managing patient care, clinical inventory, and patient samples through a disjointed web of manual, disconnected, and sometimes paper-based processes. In this complex web of responsibilities, mistakes are inevitable.

When these lapses occur, they can trigger downstream lab queries. The receiving labs must confirm missing data or discrepancies on requisition forms and sample return containers before they can register patient samples into their systems or report lab results. Repercussions extend beyond mere inconvenience; responding to lab queries — in the form of neverending emails, phone calls, and faxes — becomes a cumbersome, time-consuming ordeal for everyone involved. Many study coordinators understand the challenge of tracking down essential data across disjointed, paper-based resources.

Unfortunately, the stakes are higher than the administrative burden alone. Lab queries pose a direct threat to patient progression within a trial. Vital lab results, subsequent sample processing, and the shipment of samples from central labs to specialty labs are all susceptible to potential delays. For this reason, it’s important to not only reduce the occurrence of lab queries, but to also be able to quickly address them when they do arise. 

In this blog, we explore the most common root causes of lab queries — and what sites can do to not only reduce their frequency, but also streamline the process of addressing them.

Root Causes of Lab Queries

Research sites often find themselves buried under a mountain of lab queries that hinder efficiency and consume valuable time. Identifying the root causes of these queries is the first step in digging sites out of this dilemma.

Manual Site Processes in Managing Sample Data

It’s worth highlighting that at many research sites, it’s common for sample data to change hands. The person filling out a requisition form may not be the same person who collected the samples and recorded the source sample data. Anytime the person recording the data forgets to write down collection times and other administrative data, or anytime someone commits a transcription error, complications in the handoff of sample data can occur — and these complications can lead to errors that trigger lab queries. 

The manual nature of recording this data further amplifies the challenge. Site staff, often contending with multiple tasks at a time, may face interruptions or obstacles that heighten the likelihood of inadvertent oversights. 

Requisition Form Errors

Requisition-related queries may range from missing requisition forms to discrepancies in data; illegible handwriting; blank sections on the requisition; and even instances where the wrong lab kit is used and not relabeled. These errors are more likely due to the site processes mentioned above, but the management of lab kits can also play a role. Due to having insufficient inventory for an imminent patient visit, sites may find themselves scrambling to build a “frankenkit” — a makeshift lab kit using on-hand supplies — or pulling a lab kit that is intended for a different visit. If the requisition form is not properly relabeled to the correct visit, or otherwise not provided to the destination lab, this will inevitably trigger lab queries.

Discrepancies on Sample Return Containers

Misabeling return containers is another common pitfall that can provoke lab queries. Whether a site uses the wrong patient ID, study ID, lab accession number, or sample identifier on a biospecimen label, there are many possibilities for discrepancies on physical tube labels, tissue blocks, and other return containers. Sending samples in the wrong return tube can further complicate matters. These inconsistencies can compromise sample and data integrity, and ultimately prolong lab query resolution times. 

Lab Kits Received Out of Order per Schedule of Events

The sequence of lab kit receipt per the schedule of events is crucial for maintaining compliance with the protocol. Deviations from this schedule — whether due to an inadvertent oversight or the use of kits designated for a different visit that weren’t relabeled — can lead to downstream complications. Receiving labs may also not have visibility to the visit deviations that led to an expected patient visit being missed, which will inevitably generate a lab query.

3 Ways to Prevent Lab Queries  (and How Much Time You Are Spending on Them)

Preventing lab queries is as crucial as resolving them efficiently. Research site personnel can significantly enhance their operations and minimize the time they are spending on addressing lab queries by adopting the following proactive solutions.

Take Advantage of Centralized, Digital Inventory Tracking

Embracing a centralized and digitized platform for managing lab kits can work wonders for reducing downstream lab queries. This solution empowers study coordinators to standardize their processes for tracking lab kits and other kinds of clinical inventory in a single location. By maintaining real-time visibility of on-hand inventory quantities, expiration dates, and the status of incoming lab kit orders, research sites can ensure ample preparation for every patient visit. This not only reduces the likelihood of deviations, but also mitigates downstream processing issues at the lab, saving valuable site time that would otherwise be spent rectifying inventory-related discrepancies.

Improve Compliance Using a Software-Guided Workflow

Static lab manuals and site-made templates for sample collections often pose challenges in ensuring consistent and optimal compliance. Not only do these documents make it easy to overlook critical biospecimen management steps, but they also are not conducive to implementing study changes that stem from protocol amendments and lab manual modifications. By transforming these sources of information into digitized, user-friendly workflows, research sites can revolutionize their approach to sample collection, processing, storage, and shipping across their entire organization. This not only simplifies complex processes but also enforces guardrails that guarantee adherence to proper sample procedures. The digitized steps act as an interactive guide for site personnel, minimizing errors in recording sample data and ensuring that every sample follows the correct procedures. The result is a streamlined workflow that reduces the likelihood of lab queries arising from procedural errors, ultimately saving sites a significant amount of time that would otherwise be spent on query resolution.

Use Technology to Automatically Capture the Sample Audit Trail

When faced with lab queries, it’s important to respond swiftly. Utilizing technology to automatically capture and retrieve the sample audit trail can streamline the query resolution process for sites. With the ability to access any piece of sample data in mere seconds, research sites can respond promptly to lab queries, expediting the resolution process. This not only reduces the burden on site personnel, but also contributes to enhanced collaboration with labs, CROs, and sponsors.

Use Slope to Reduce Lab Queries and Improve Your Query Response Times

Using Slope’s clinical trial execution platform — which is free for sites — research staff can centralize and digitize their inventory management processes across all of their trials and sponsors; avoid deviating from the latest version of the protocol and lab manual thanks to software-guided workflows; and automatically capture sample chain-of-custody data and other critical sample data pieces. As a result, sites are not only able to reduce the volume of lab queries they are receiving in the first place, but they also have instant real-time access to sample data that may save the day when responding to lab queries.

Most sites today rely on static lab manuals, self-made templates that are based on the lab manual, and paper requisition forms in order to manage their sample collection, processing, storage, and shipment procedures, as well as their sample data. So how does Slope streamline that process?

To learn more, check out our white paper, which dives into the value of using the Slope platform to turn your lab manuals into software-guided workflows. And if you’re ready to take your site operations to the next level, click here to sign up for Slope — it’s free for sites!

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