Evolution of the nation's blood supply system

A fter the human immunodeficiency virus epidemic, changes began in the US blood supply system. Quality and regulatory activities became more stringent, blood supply organizations became more business-like, and operations and finances became more tightly managed. Longstanding unspoken understandings regarding donor groups and hospital service areas were no longer recognized and competition for hospital blood contracts and for donor groups emerged. At the same time, efforts to contain health care costs caused hospitals to press for lower costs for their blood supply. Recently new medical data regarding indications for transfusion, the management of anemic or bleeding patients, and the complications of transfusion have appeared. It is clear that patients can be maintained at lower hemoglobin levels than have been the longstanding custom. Robotic, minimally invasive, and other surgical techniques have led to decreases in surgically related blood transfusion. Pharmacologic agents such as erythropoietin or tranexamic acid have eliminated transfusion in some situations. Implementing these practice changes using blood management programs is a positive for patients, but has resulted in declining blood use, which has led to decreasing revenue for blood supply organizations. These organizations are now experiencing major financial pressure in attempts to reset production capacity while implementing technology, regulatory, and quality developments. While revenues decline, there have been increased costs. Screening tests such as West Nile virus and Trypanosoma cruzi and bacterial culture of platelets (PLTs) have been added. Some test methods involve DNA amplification and thus must be done in complex laboratories. These factors and changes have transformed the organizations that provide the nation’s blood supply into barebones operations, with little product development and tense competition for hospital contracts and blood donors. There has been wonderful innovation in transfusion medicine supported by blood centers, federal funding, industry, and universities. Federal funding continues at a substantially reduced level, but there is almost no support for innovation from the other three sources. Industry is no longer willing to develop new products as there is little likelihood that the innovations will be implemented. There has even been a call for federal mandate as a way to introduce innovation. As a result, blood supply organizations are exploring new organizational structures and strategic alliances including: 1) affiliations, 2) purchasing groups, 3) partnerships, and 4) networks. However, these strategies do not constitute sufficient integration and alignment to respond effectively to the turbulent market conditions. With a few exceptions, true integration is not yet occurring and the benefits of consolidation will not be achieved. For example, there is continuation of multiple Food and Drug Administration (FDA) licenses, overlapping sets of standard operating procedures, inconsistent policies regarding donor selection and deferral, quality systems, conflicting approaches to regulatory affairs, and multiple accounting and software systems are coexisting. Providing blood and blood products is costly. Some activities can be carried out more efficiently by larger organizations through economy of scale. However, while the United States has seen consolidation across many of its health care sectors, that impact on quality (i.e., patient outcomes) is less clear. “The harsh reality is that it is difficult to find well-documented examples of health care mergers that have generated measurably better outcomes or lower overall costs. ” As hospitals, health insurers, and physician groups have experienced, cost pressures usually lead to a smaller number of larger organizations thus altering the current structure; yet the same tools, tests, and workflow are still likely to be in place. There is very little evidence that mergers improve quality and costs will not necessarily decrease. Thus, policy makers should anticipate that a new blood supply system will develop.