Are Clinical Sites Really The Source of Sample Tracking Problems?
Sample handling challenges are often understood to originate with the clinical site.
As we were deploying our sample tracking platform for one of our sponsors, we discovered another root issue, and it came as quite a surprise to us.
It’s an issue that occurs far before a site collects a sample. It occurs before the sites enroll their first subject. It occurs even before the SIV.
Background
When TruLab conducted our market research before building the TruLab sample tracking platform, we determined that the root of 95% of sample logistics challenges occur at the clinical site.
As we toured various sites, we quickly understood why. To no one’s surprise, sites were simply busy – often understaffed and overworked.
The staff’s first responsibility is taking care of sick patients. They’re managing multiple studies, many of which are increasingly complex. Each study has its own unique design, which adds the taxing burden of context switching from study to study. This leads us to the first layer of the onion we uncovered.
Are Lab Manuals and Protocols Used as Intended?
As we began talking to site staff, and they became comfortable with us, they began to disclose the little secrets that everyone knows, but are reluctant to admit. They said the quiet part out loud.
Although they’re given protocol and lab manual documents that are meticulously assembled, validated, and signed off on, many rarely reference it as intended when an actual patient visit occurs.
Again, the site staff are busy, multitasking and performing their primary responsibility, which is taking care of patients.
Invariably, we found that each site came up with their own homegrown way to accomplish their main responsibilities, while doing their best to comply with each protocol.
Many used cheat sheets that were prepared in advance based on the protocol and lab manual prior to the visit. These cheat sheets may have the schedule of assessments, special sample handing instructions, and even storage and shipment information.
Paper Requisition Forms
Also, we noticed that the paper requisition forms packed with the sample kits were often used as reference and instructional guides for the patient visit.
This makes complete sense. The requisition forms are readily available. It doesn’t require flipping through pages upon pages. And it’s designed to match the day’s visit and sample collection requirements.
But therein lies the problem, and where things can easily go off the rails…by design (or misdesign). And probably one of the most common sources of queries that consume an inordinate amount of time, may delay a study, or may even go completely unresolved.
Recent Kit QC
The TruLab platform was intentionally designed to be protocol agnostic. And as a part of TruLab’s quality control process for each study, we request kits from the vendor providing them for the study.
These kits aren’t just demo kits. We validate our platform on the real kits that will be used for that particular study.
In one of our recent studies, we received a kit, per our normal QC process, from one of the large central labs. As our team was performing our QC, we found several discrepancies in the kits themselves…and it became crystal clear one of the issues that may be leading to sample problems at the site.
Mismatched Requisition Forms to Sample Containers – In one kit, there were 5 aliquot tubes, but the requisition form incorrectly referenced 6 tubes. To add to the confusion, the lab manual (also created by the same central lab) referenced 4 aliquots. The correct number was 5 aliquots.
Confusing Data Fields – Sample requisition form design was not instinctive and the instructions were confusing. For example, there were 3 spaces for the month field. The site had to read the fine print to discover the form required the first 3 letters of the month and not a number.
Confusing Shipping Instructions – The testing lab for some of the biomarker samples were listed by name on the requisition form. The testing lab for the PBMC sample was not. This inconsistency could lead to confusion as both samples had to be shipped directly to the respective testing lab the same day.
Inaccurate Barcodes – Human readable accession number on the kit was different from what was encoded in the barcode.
TruLab Clears Up Kit Confusion
It’s nearly impossible for the sponsor to control the quality of sample kits or the design of the paper requisition forms. The sponsor is physically removed from the actual kits and requisition form designs are rigidly mandated by the central labs.
And other than discovering discrepancies, such as the case here when doing our kit validation, TruLab has little control over the kit quality either and no input on requisition form design. But here is one substantial way TruLab can mitigate sample issues.
TruLab Ensures Protocol Compliance
A Head of Clinical Operations for one of our sponsor clients recently gave us an unsolicited observation…that the TruLab mobile app ensures protocol compliance.
We asked him what he meant by that.
He explained the Schedule of Assessments in our mobile app clearly and easily guides a clinician step by step through the sample collections of a day’s visit. And our anomaly detection alerts the sites, sponsors and monitors when a deviation has taken place…in real-time.
Conclusion
It turns out, our mobile app helps sites stay on track without the site staff having to create their own cheat sheets, and without having to reference a requisition form or kit that may or may not be correct. In essence, the TruLab app is a digital lab manual…a digital ‘cheat sheet’, but one that is validated by a rigorous QC process, not one hastily created right before a patient visit.