The laboratory side of diagnostic blood testing has achieved extraordinary efficiency and precision through automation. I spent the majority of my career developing the analyzers, assays, and large-scale automation systems that run in clinical laboratories today and are used to perform the vast majority of diagnostic tests. The last few decades of technology have allowed labs to simplify and automate sample processing to streamline operations and remove opportunities for human error. Today’s clinical laboratory looks more and more like a manufacturing line and less and less like a scientist’s bench. However, the upstream processes of sample collection and preparation have remained largely unchanged over the same period, and in fact haven’t changed much for the past 70 years. Since founding Babson Diagnostics, I’ve had the opportunity to work on technologies that affect how samples are collected and prepared before they reach the laboratory. Current trends in health care are driving rapid innovation in these areas, which have seen little investment and automation until recently. New technologies are emerging to address the increasing need to expand access to care, increase staffing flexibility, and improve sample quality.
Expanding Access To Care
Economically speaking, diagnostic blood testing is exceptionally efficient; it is a low-cost medical procedure that, if consistently done when appropriately called for, can reduce high-cost medical treatments—such as medications, surgeries, and hospitalizations—by detecting diseases and guiding prompt interventions. Ensuring widespread access to testing services is therefore an efficient way to improve population health and reduce health care costs (so long as the testing is appropriate and necessary). Increasing access means offering testing in more places, which also addresses consumer demand; it's becoming less and less acceptable to people to wait in long lines, travel long distances to out-of-the-way places, and be treated in an unfriendly way to access care. The consumer increasingly has a powerful voice in health care, and that will push everybody to improve. The demand for accessibility and convenience will drive testing in nontraditional places such as retail stores and at the home.
Specifically, retail pharmacies have proven to be excellent for delivering transactional health care services. When a health care service is a fixed transaction, such as picking up a prescription or getting a vaccine, the path is straightforward and deterministic, so the consumer has an expectation that they can get in, get it done, and get out. This is quite different from more complex and nuanced health care services, such as a hospital stay or even a physical exam, which could lead to discussion about various health issues and decisions about treatment, requiring a more specialized setting.
Blood collection is a transactional health care service, better suited for places that are designed around modern consumer expectations. However, traditional blood collection and preparation technologies are not readily compatible with these venues, typically requiring a building-within-a-building that sacrifices the retailer’s sales-per-square-foot and must be run by separate, specialized staff. Therefore, expanding access to care will necessarily drive innovations for sample collection and preparation that work within existing retail facilities and operations.
Increasing Staffing Flexibility
Bringing blood testing services to more locations requires expanding the pool of professionals who can collect blood. The ongoing shortage of health care professionals, including those who collect blood, can be a barrier to making testing available in a broad and timely manner. A study by the College of American Pathologists regarding turnover among laboratory professionals noted that “phlebotomist staff had the highest median of the 3-year average turnover rates,” and the US Bureau of Labor Statistics predicts that the demand for phlebotomists will continue to increase “faster than the average for all occupations” over the next decade.
Given that staffing shortages already impact access to care, even when care is largely centralized, a move toward decentralization risks further exacerbating the shortage. To keep up with both increasing demand and widened distribution, new technologies are needed that facilitate blood collection and preparation by more people. In particular, technologies that allow the person collecting blood to not only be a non-phlebotomist, but also to easily intersperse blood collections with other tasks (such as administering vaccines and filling prescriptions) rather than being dedicated to one service, will be vital for decentralizing access while contending with labor shortages.
Improving Sample Quality
The sample preparation steps that occur between blood collection and arrival at the laboratory—labelling, mixing, centrifugation, storage at the correct temperature, and transportation to the laboratory—are often the source of sample quality issues. It has been documented that sample preparation (also referred to as the “pre-analytical” or “pre-pre-analytical” phase) is where the vast majority of diagnostic errors occur. This is an aspect of diagnostics that is rarely studied, and there has been very little focus on exploring opportunities for automation to address it. As these quality issues have persisted even in traditional health care settings staffed by skilled specialists, momentum toward utilizing nontraditional locations and less-skilled labor risks further worsening precision and accuracy.
It’s important to note that blood is a delicate human tissue that is easily damaged, and when damaged, will lead to inaccurate test results. When a sample is incorrectly mixed or centrifuged, improperly stored or transported, or mislabeled, the laboratory often has no way of detecting that an issue occurred, meaning that the laboratory is unaware they are reporting incorrect test results (or results for the wrong tests and/or patient). Therefore, sample preparation errors represent a higher risk than other quality issues that are more readily detectable. As these risks come to light, and especially as blood collection and preparation are handled by a wider range of locations and professionals, innovations focused on automation will become indispensable.
Steps that have traditionally been performed manually by skilled professionals will in the future need to be performed automatically by machines. Such automation would raise the standard of sample quality while also enabling an expanded labor pool to deliver care in an expanded range of settings. The future of diagnostic blood testing will close the current gaps in access, flexibility, and quality by bringing technologies for upstream diagnostic processes up to date with the downstream.
Eric Olson is the founder and chief operating officer of health technology company, Babson Diagnostics. He is a global healthcare leader and entrepreneur, with extensive experience in diagnostic testing and clinical laboratory technologies. Prior to starting Babson in 2017, Eric served in executive roles at Siemens Healthineers, one of the world’s largest MedTech companies. He can be reached at founder@babsondx.com.