Picture this: you’re a study coordinator at a clinical research site, and your organization has recruited a sick patient to screen on a trial for an exciting new study drug. This patient has not responded to other treatments that are already widely available on the market, so this trial could be one of their few remaining options.
You schedule the patient’s Screening visit, and they drive two hours each way to your facility. Upon the patient’s arrival, you pull the lab kit and help the nurse scour through the lab manual to determine which samples need to be collected and processed per the provided instructions. You carefully package each specimen, attempting to maintain alignment with the prescribed shipping procedures.
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Four business days go by, and you get a notification that the first patient lab results are available. You log into the central lab’s online portal, open the lab report, and are hit with a devastating notice that some of the patient’s results have been canceled. The realization is painful. In a best case scenario, the patient graciously agrees to come back for a Rescreening visit that will demand more of their time and energy — and there is no guarantee that the patient will even be eligible for the study.
This frustrating scenario highlights the human impact of testing cancellations. Arguably one of the most consequential events that can happen during the life of a study, these gaps in patient results not only amplify the patient burden in the immediate term — they can also delay study milestones that allow an effective new drug to become more accessible to the general population.
In this blog we dive into the most common reasons for testing cancellations — from sample stability issues to administrative discrepancies — and how to prevent these events from happening in the first place.
Specimen Not Received
Although self-explanatory, “specimen not received” cancellations are all too common throughout the life of a study. In some cases, biospecimens simply aren’t collected due to an accidental oversight or a protocol deviation; in others, clinicians may collect the sample, but then forget about it in storage or ship it to the wrong location.
Unless a specimen cannot be collected due to extenuating circumstances, a non-received specimen is likely a direct result of human error. Instructions around sample collection, storage, and shipment are easy to overlook or misinterpret when sifting through a complex lab manual. Even when biospecimens are stored properly, they can be easily lost or forgotten about in freezers.
Recent innovations in technology can increase compliance with procedures for specimen collection, storage, and shipment. By turning their lab manuals into software-guided workflows, sites can ensure that samples are collected in alignment with the protocol visit schedule and shipped in accordance with the designated shipping procedures for their studies. Our Ultimate Guide on Managing Biological Samples delves into other best practices for specimen management.
Specimen Out of Stability for Testing
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Despite site staff’s best efforts to properly collect specimens, they sometimes may be unviable by the time they are ready to be tested. From the time of collection, many assays have a designated stability window during which testing must be performed; if a sample doesn’t arrive at the testing facility in time, then the lab may not be able to guarantee the accuracy of results, resulting in the testing being canceled altogether.
This scenario can play out for a number of reasons. If a specimen is to be stored in a freezer for a designated amount of time before shipment, clinicians may forget to ship the sample until it’s too late. Sites may also run into a situation where they ship a sample on the wrong day or too late in the day to guarantee that the receiving lab will be able to process the specimen in time. For example, some labs and couriers have limited operations on the weekends or during holidays, which can extend transit times and sample processing times. For biospecimens that have a short stability window and should be shipped on the day of collection, study coordinators may also miss the last window of opportunity to schedule a sample pickup with a courier if it is too late in the day. As a result, the specimen can’t be picked up until the following business day, and the sample doesn’t make it to the testing lab in time.
Fortunately, these cancellations are entirely preventable with the right tools for managing specimens in storage and sample shipments. Leveraging a clinical trial sample management platform can enable sites to take advantage of sample shipping alerts and keep clinicians apprised of shipping blackout days for various labs.
Specimen Received in the Incorrect Condition
In order for a biospecimen to be viable for testing, it usually needs to be received by the testing lab at a certain temperature — for instance, some samples should be received in ambient condition, while other samples may need to be received frozen in order to maintain the sample’s integrity in transit. Accidental misinterpretations of lab manual instructions, improper packaging, or delays in sample transit times can cause a specimen to arrive at the testing lab at the wrong temperature.
This is another cancellation that can be prevented with readily available technology. Software-guided workflows that are configured based on the lab manual can guide sites through the entire sample processing, storage, and shipment process to ensure that biospecimens are stored at the correct temperatures, placed in the proper shippers, and shipped on the right days.
Quantity Not Sufficient
Many assays require a certain amount of a patient sample in order to yield a result. The stakes can be especially high for biopsy samples, for which testing may not be possible if an insufficient amount of tissue is sent in for processing.
Lab manuals offer guidance on the amount of biospecimen that should be obtained from the patient during collection in order for the sample to be viable for analysis. Unfortunately, these instructions may be overlooked during the rush of specimen collection, resulting in cancellations at testing labs. These insufficient collections may be especially common for samples that require aliquoting or division into multiple return containers or slides, as site personnel may not initially realize that they do not have sufficient material for all of the required testing.
Configuring collection instructions in a digital workflow can ensure that these key collection instructions are not missed so that the right amount of sample is collected every single time.
Clotted or Hemolyzed Specimen
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Mishandling during specimen collection, processing, and shipment can also cause a sample to physically break down before it can be tested. In the case of sample hemolysis, red blood cells deteriorate as a result of sample mishandling during collection and transportation. Clotting, on the other hand, occurs when a specimen is not adequately mixed with the anticoagulant in an EDTA tube during the processing step. These scenarios unfortunately compromise a sample’s integrity and result in cancellations at the testing lab.
Preventing these data gaps requires meticulous attention to specimen collection, processing, and shipment procedures. This once again highlights the importance of leveraging digital technology to ensure that critical specimen management steps are never missed.
Administrative Discrepancies
Discrepancies on requisition forms and return containers can do more than cause lab queries — they can also cause lab results to be canceled altogether. In clinical trials it is not uncommon for study coordinators to have to pull a lab kit for one visit type — like a Cycle 2 Day 1 — in order to perform another visit — like a Cycle 1 Day 1. If the testing that is performed on these two visits differs from one another, then naturally the contents of each of these kits will also differ. Even if the site correctly updates the requisition to indicate that the lab kit is being used for a different visit, the lab may not have all of the return containers that it needs for the new visit assignment.
Leveraging a digital platform to manage inventory ensures that site staff always have the appropriate kits on hand. This reduces the need for clinicians to improvise workarounds for a stockout of lab kits, which can cause processing issues downstream.
Patient ID discrepancies on lab requisitions and return containers can also cause chaos at a testing lab. Many facilities have strict rules about processing biospecimens that are associated with the wrong patient ID — especially if the site that collected the samples has another patient with that identifier who was seen at the clinic on the same day. If site staff are managing specimens for multiple patients on the same study on the same day, it’s easy to see how these accidental mixups can occur.
By leveraging software-guided workflows during sample collection and processing, clinicians can eliminate the risk of getting their wires crossed when managing biospecimens for multiple patients simultaneously. Rather than having to contend with a disorganized paper trail, site staff can take advantage of a digital platform that automatically captures pertinent sample data during specimen collection and processing, thereby reducing the risk of a transcription error.
The Bottom Line: Digital Solutions Can Reduce the Risk of Testing Cancellations
There is no question that digitizing sample management processes at clinical research sites can have far-reaching benefits by significantly reducing the risk of various testing cancellations. Slope’’s Biospecimen360™ platform harnesses the power of technology by enabling guardrails that ensure that vital specimen management steps are never missed.
Click here to learn more about Biospecimen360™ and how it can maximize efficiency and compliance on your studies.
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