Balancing agendas in donor testing

Attend any transfusion medicine forum on the industry's annual calendar and inevitably there will be clear affirmations from presenters of just how high the bar has been raised with respect to the safety of the blood supply. To be sure, advances in blood safety are something for all of us to be proud of. The investments made within the transfusion medicine system—investments in good manufacturing practice, facilities, equipment, automation, information technology, employee training, and quality management systems oversight—are enormous. But any conversation about progress must also include the impact of testing and the part test manufacturers have had in improving blood safety. One might reasonably argue that testing for bloodborne pathogens, now in its eighth decade, can be broken down on a time line into three distinct segments. The first stretch of its history was a period when testing blood was simplicity itself and merely consisted of a syphilis assay. We can place another notch on the time line starting around 1970 and then check it off at 1990 which traverses the years of watershed screening improvements: two hepatitis B tests, two human immunodeficiency virus (HIV) assays, and a hepatic C test. After HIV and these middle decades, nothing would be the same again. The most recent stretch from the early 1990s through the millennium up until now has been a blur. Where did the time go and what was accomplished? Since 1990, the effect that test manufacturers have had upon blood safety has been transformative; in the succeeding years, test suppliers created—and the industry has implemented—the platform for nucleic acid testing, bacterial screening for platelet products, and new assays for West Nile virus and Trypanosoma cruzi (the Chagas' disease agent). Together with the numerous enhancements to hepatitis and HIV kit sensitivity and specificity, the momentum has been nothing short of incredible. Typically, in journals and publications, this chronicle of incremental safety is depicted as a stair-stepped graphic accompanied by a data table reflecting the associated cost increases of a unit of RBCs. And while cost of safety and the offset of threats to the blood supply must be tracked, in some respects, looking at both metrics at the same time strictly through an economic lens is to miss the magnitude of what has been accomplished in reducing both risk and human suffering. For some time now, industry conversations have affirmed that there are fundamental changes taking place in our understanding of what is important and sensible in transfusion medicine. Unequivocally, safety and adequacy of the blood supply remain at the top of every blood center's priority list, but declarations about zero risk and strict adherence to the precautionary principle have raised an essential question: “at what price?” Going forward, it is clear that safety and quality are to be measured and balanced with cost. It is also evident that the decision-making process for implementing new tests in the industry needs improvement. Many transfusion medicine executives and leaders now believe that infectious disease-testing policy making in the United States has become a fragmented process at best, and needs to be revamped. How exactly does any new threat to the safety of the blood supply, a new virus, a new pathogen, come to light in the first place? And how does that threat gain credence and traction; who articulates it and who calculates it? And how does this new risk get prioritized and fast-tracked? Do test manufacturers view this new development as an opportunity for marketplace growth or is it viewed as a responsibility because it is the business they are in—or both? And finally, whose responsibility is it to establish an industry standard on how a new assay is to be implemented? Interwoven with this overriding issue about blood safety and cost is some recognition that test manufacturers themselves are also concerned about the business environment and transfusion marketplace, specifically, how to compete, sustain, and grow their business without running contrary to the needs of customers. It is generally recognized that there is a paucity of suppliers in the industry and this viewpoint holds true with respect to testing manufacturers. Too few testing suppliers represent a future with limited innovation and increased test prices, putting blood centers on a collision course with a strategic horizon where increases cannot be passed along to hospitals. Annually, 27 million units of blood components are transfused by hospitals, a customer base that is dealing with a 15% uninsured patient populace, and a customer base well informed about the blood supply and unwilling to pay more for low-yield safety measures. Perception is important and there is a prevailing sentiment in many quarters that testing vendors have deep pockets and corporate agendas that are incongruent with nonprofit blood missions of blood providers, specifically in pursuing revenue or earnings growth and in maximizing shareholder profit. This issue surfaces again and again. Assemble a group of blood bankers and the discourse will include a growing concern about the misalignment between stakeholders, between the suppliers and the supplied, between blood center executives and test manufacturers. Both are appealing to each other for greater empathy and understanding about the business they are in. Central to the gap in understanding is the issue of money and profitability. More recently, the gap includes paradigm shifts in test implementation approaches coupled with the cost of low-yield safety measures. Blood bank CEOs are sending key messages to test manufacturers to communicate more openly and incorporate customer or operational feedback during test system development. They want the focus narrowed to major risks in transfusion medicine and they want assay manufacturers to tacitly recognize that the donor screening market is directly connected with a not-for-profit industry. Communication can always be improved and usually on both sides. Test manufacturers want the industry to accept high entry price points for newly developed assays. Their historical paradigm is industry acceptance of universal testing and long life span products. Going forward, they view it as reasonable that newly licensed tests should deliver sustainable earnings that recoup research and development dollars that were plowed into the test in the first place. Test suppliers are puzzled that transfusion medicine executives are not more comfortable with corporate strategies driving revenue and earnings growth to meet shareholder obligations. The disconnect is evident in how both factions—blood center operators and the publicly held companies that service this marketplace—view each other's business drivers. Accountable to shareholders and investors, all major test manufacturers embrace their business model: to find and meet new customer needs, and to win market share and deliver consistent growth. To varying degrees, they view blood centers as community institutions, quite similar to monopolistic public utilities. Not surprisingly, blood banks see themselves as collegiate institutions with emphasis on blood supply stewardship and working efficiently within low cost recovery nonprofit business models. At this point in time, within the context of economic crisis and a busted healthcare system, blood bank leaders are strongly challenging the assumptions and business agendas of major test vendors. Sitting across from each other at the contract negotiation table, blood banks and test vendors are perhaps more at odds now than at any time in the industry's history. In his book, Get There Early, Bob Johansen1 envisions a future where there is increased volatility, uncertainty, complexity, and ambiguity. He labels this world with the acronym VUCA. To many of the leaders who have shaped the transfusion medicine industry, there is a growing sense that blood centers and suppliers to the industry, including test manufacturers, are indeed headed for more volatile and complex times. To some, it may appear that one era in blood banking has ended and another is about to begin. The acquired immunodeficiency syndrome crisis of the 1980s reshaped blood industry thinking about new threats to safety; after HIV, no one was going to get caught flat-footed with risk. One by one, major threats to the blood supply were addressed with new tests being rolled out and licensed with universal testing being the norm. Fast-forward to the present where new pathogens are assessed to see if testing measures on a continuum ranging from universal to seasonal to selective to regional testing should be applied. The industry mood about the future, particularly with regard to donor testing operations, is mixed. There is by and large consensus that there will be fewer and larger testing laboratories as a result of further consolidation. This amalgamation will be driven by an operating environment where there is intense focus on cost control and where there is continued scarcity of laboratory professionals. Remaining labs will manage the pressures of providing excellent turnaround time cost effectively and with full regulatory compliance by seeking process and systems improvement. To accomplish this, labs will look to test manufacturers to improve upon existing automated platforms and sample handling equipment. It is also likely that the surviving laboratories will utilize more than one testing manufacturer to ensure the continuity of testing services. In short, blood centers want all of the major testing suppliers in the game. It is foreseeable that with a backdrop of healthcare reform, there will be a reckoning about passing along price increases. Accordingly, blood centers and blood center testing laboratories are signaling that brakes need to be applied and soon. With respect to the science behind testing in the industry, we might reasonably expect some old or legacy tests—syphilis and human T-lymphotropic virus I-II for example—to go by the wayside. A good precedent for this would be p24 antigen testing, an important but brief life spanned assay that was subsequently replaced by a better test. By many accounts, tests for new infectious agents associated with low-yield safety will draw controversy and undergo very close scrutiny for cost–risk benefit. In the presence of any industry equivocation about the merit of a new test, manufacturers will be doubly sure to add detailed contractual language specifying the rollout and adoption of a new assay by customers. Anyone suggesting that all major stakeholders in transfusion medicine need to work more collaboratively and effectively runs a risk of being accused of gross oversimplification. But this is precisely what it is going to take. The framework for more collaborative industry conversations is shaping up and earlier this year, the Department of Health and Human Services via its Advisory Committee on Blood Safety and Availability is on record to address these issues. The American Association of Blood Banks (AABB), in its 2009 government affairs agenda, will also be tackling the issue of industry infrastructure with an eye to facilitate discussions with the Food and Drug Administration (FDA) about smoothing the barriers to bring new tests and innovation into the marketplace. Nonetheless, the array of issues connected with donor testing—new pathogens, zero-risk doctrine and precautionary principle, cost recovery, and regulation via mandate versus guidance—remains complicated and snarled with politics of medicine, scientific research, regulation, and business. It will take nothing less than movement of partisans on all sides toward the center if anything of substance is to be delivered or a new way forward is to be mapped. Industry associations and CEOs of blood centers have already begun to vocalize what the process of working together might look like. Ambitiously, it has been suggested that industry researchers and physicians, regulators and standards setters, executives from transfusion medicine, and test manufacturing should assemble and develop an industry strategic plan specifically for blood safety. The charter of this ensemble would be to outline and prioritize a list of the next major threats, in other words, to preplan what work remains and what needs to be done. Long-term strategic planning to address remaining threats to the blood supply might involve assessing and sequencing risks such as malaria, dengue, Babesia, chikungunya, and Lyme disease, for example. AABB's Transfusion Transmitted Diseases Committee is taking promising steps in identifying, prioritizing, and categorizing emerging infectious disease agents. A second component of working together more effectively might include reconciling differing business philosophies between for-profit test manufacturers and nonprofit blood providers. Rebuilding trust and understanding about respective business missions is going to take some doing and could be accomplished with a meeting of minds via a series of supplier–customer forums. At the top of the agenda would be sharing economic risk and rewards (as opposed to winner take all), wherein the middle ground consists of acceptance of some cost increases (blood centers) and living with lower margins (test manufacturers). By any stretch of the imagination, this has a large measure of built-in idealism and pulling it off would be a tall order indeed. Finally, working together more effectively could entail addressing the list of unmet needs in the donor testing arena which includes but is not limited to: Licensed confirmatory tests; Full viral testing panels: all suppliers; Improving mechanisms for selective testing; Improving automated sampling, laboratory management system interfaces, and software for high-volume testing; Effective bacterial detection; Improving equipment or device reliability; and Eliminating unnecessary tests. Making headway on the issues outlined here is severely restricted by strict regulation, limited capital access, inability to pass along price increases to embattled hospitals, and a blood usage demand curve that seems to be arcing south. The tenacity of leaders on both sides, those who have shaped and reshaped the industry thus far, will again be called upon to create a new approach for the next decade on the transfusion medicine time line. The history of our industry is encouraging in this regard. The author declares no conflict of interest.

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