Applying Best Practice to Converting Blood Collection Tube Suppliers: Overcoming Laboratory Supply Shortages

Abstract

Abstract Introduction/Objective Changing blood tube suppliers is a complex process that requires systematic validation. It can serve to expand a laboratory’s options during a supply shortage, and can lead to cost savings. Just prior to the pandemic, our laboratory underwent a large-scale conversion of blood tube suppliers after successful validation of serum, plasma, and whole blood tubes for blood bank, chemistry, immunology, hematology, coagulation, molecular diagnostics, and flow cytometry. Methods/Case Report First, we designed a patient consent form for collecting extra blood samples. Per CLSI standards, validation of blood tubes is needed for each testing methodology but not for each analyte. Hence, we selected high-impact assays to represent each testing methodology used by our instrument platforms. We designed comparison studies to test the new blood tubes for result accuracy, precision and specimen stability that covered an assay’s reportable range. Allowable error limits were set based on Westgard and CAP guidelines. Spiked specimens were used when positive patient samples were not feasible. We also took the opportunity to optimize the blood tube sizes, e.g., converting the lavender-top tubes from 2 ml (vendor A) to 3 ml (vendor B). We then confirmed with our reference labs the acceptability of the new vendor’s products, and administered an electronic survey to solicit staff feedback. Finally, we coordinated supply chain, formulary changes and test catalog updates. Results (if a Case Study enter NA) Data analyses showed 100% acceptable performance of the new supplier’s blood tubes. The survey showed that our phlebotomists supported the new products, citing their ease of use and good vacuum. Our hematology technologists provided favorable feedback on the larger lavender-top tubes that reduced the number of insufficient samples. On the economic front, this supplier conversion has yielded a 26% cost savings. Conclusion To our knowledge, our study is the most comprehensive of all blood collection device comparison analyses published. Our validation strategies that were designed to comply with best practice standards have led to our confidence in the interchangeability of the new and old blood tube products. This initiative serves to elucidate a protocol to add vendor options that can be replicated by other laboratories to mitigate blood tube supply shortages and backorders. It has helped us control supply costs without compromising quality.