Dedicated laboratory automation for hemostasis testing

Aug. 26, 2024

Now more than ever, laboratories are tasked with the combined aim of maximizing test volume and reliability, while minimizing turnaround time (TAT) and cost. Automation is an essential tool to meet the challenges of rising labor costs and a shrinking laboratory professional work force. Table 1 provides examples of the potential benefits of laboratory automation. Laboratories can use a variety of key performance indicators (KPIs) to monitor the effects of automation, such as those shown in Table 2.

Although hemostasis testing accounts for approximately 20% of the total test volume in many laboratories, it represents a significant opportunity for improved efficiency due to variables such as the relatively poor stability of coagulation factors, the high potential for assay interferences, and the time-sensitive role hemostasis testing plays in the management of critically ill patients.

Automation for hemostasis testing may be implemented as part of a total laboratory automation (TLA) system, which is typically designed to support multiple areas of the laboratory (e.g., chemistry, hematology).

Benefits of a dedicated, specialized hemostasis automation system

Alternatively, hemostasis-dedicated automation solutions are available, which may provide increased connectivity with hemostasis instruments, allowing for a higher degree of customization and potential optimization. These dedicated hemostasis automation systems are physically smaller and less complex than TLAs and therefore can be delivered and installed faster and more easily than a full TLA system. Furthermore, the cost of a dedicated, specialized hemostasis automation system is relatively low, typically in the range of 10–20% of the cost of automating an entire laboratory. Finally, hemostasis automation systems also may benefit from specialized service and support staff who are trained to address the challenges unique to hemostasis instruments and assays.

Centrifugation

Most hemostasis testing is performed using platelet-poor plasma (PPP). Producing PPP requires more intense centrifugation (higher force and/or longer time) than standard centrifugation protocols used to separate plasma or serum for typical clinical chemistry tests. Some dedicated, specialized hemostasis automation systems have been specifically designed to address this issue, with hemostasis-specific centrifugation protocols to achieve PPP in less than five minutes of spin time.1  For TLA systems to incorporate hemostasis testing, labs often employ one of three strategies: 1) centrifuge all samples at high enough intensity to achieve PPP; 2) spin hemostasis samples twice, typically with a manual centrifuge for STAT testing; or 3) provide a dedicated centrifuge for hemostasis testing.

Sample transport

After centrifugation and prior to separation of the PPP supernatant, PPP must not be agitated, or platelets will become resuspended, potentially impacting hemostasis test performance.1 Dedicated, specialized hemostasis automation systems achieve this using short, smooth, stable, and carefully leveled tracks. In contrast, more effort may be required to ensure that TLA systems do not result in significant sample agitation (See Figure 1).

System integration

For a laboratory to take full advantage of hemostasis automation, hemostasis analyzers must be closely integrated with the automation system, allowing bidirectional communication relative to test priority, system status, resource availability, and process details.

A dedicated, specialized automation system that incorporates a deep understanding of hemostasis testing and automation needs provides these connections, allowing data exchange that delivers intelligent routing and efficient workflow while providing laboratory personnel with the in-depth operational information essential for process improvement. Based on these capabilities, state-of-the-art, dedicated hemostasis automation systems provide dynamically updated sample routing with customizable rerun/reflex testing and sample sorting/banking.

As of 2024, few TLA providers manufacture both hemostasis analyzers and assays. Furthermore, most current on-market TLA solutions do not offer the same degree of data connectivity with analyzers as a dedicated hemostasis automation workcell. Table 3 compares the level of connectivity and data exchange for dedicated hemostasis automation versus typical TLA systems.

Conclusion

Laboratories wishing to automate their hemostasis testing should carefully consider use of a dedicated, specialized hemostasis automation workcell. A dedicated system can provide capabilities not currently available from non-specialized TLA systems, which may allow laboratories to more fully realize the potential benefits of automation.

References

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  2. Armbruster DA, Overcash DR, Reyes J. Clinical Chemistry Laboratory Automation in the 21st Century - Amat Victoria curam (Victory loves careful preparation). Clin Biochem Rev. 2014;35(3):143-153.
  3. Yu HE, Lanzoni H, Steffen T, et al. Improving Laboratory Processes with Total Laboratory Automation. Lab Med. 2019;50(1):96-102. doi:10.1093/labmed/lmy031.
  4. Da Rin G, Lippi G. Total Laboratory Automation of Routine Hemostasis Testing. J Lab Autom. 2014;19(4):419-422. doi:10.1177/2211068213511246.
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