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Should hospitals collect blood components? Yes: Hospitals put patients first
Pergamon
PH: S0955-3886(97)00053-2
Transfus~ Sci. Vol. 18, No. 4, pp. 553-558, 1997 © 1997 Elsevier Science Ltd. All rights rescued Printedin Great Britain 0955-3886/97 $17.00 + 0.00
Should Hospitals Collect Blood Components? Yes: Hospitals Put Patients First David Ciavarella, MD*
a maximum of common sense. Finally, when hospitals control their own donor programs, costs are more easily tracked and better controlled. © 1997 Elsevier Science Ltd •
• Stand-alone blood collection centers throughout the world have suffered in recent years from cost overruns, quality and regulatory problems of major proportion, and a subsequent deterioration of service levels to their communities. Their leaders have been probed by public interest groups, the media and governmental bodies, removed from positions of authority, and sadly, subpoenaed, vilified in public and even jailed. Patients, healthcare providers and hospitals have suffered through this period as well, and continue to search for alternatives to their largely monopoly suppliers. In most cases, the best alternative is the one they control themselves. Should hospitals collect blood components? Yes, since their mission--patient care--takes precedence over that of any non-provider healthcare organization. Patients and the public-at-large gain many things by the continued presence of hospitals in the provision of donor services: provider and patient needs are given first billing, and innovation in blood services is encouraged by the transfusion medicine physicians and allied health professionals who are closest to the patient. Service requirements are recognized and met faster and in simpler ways, and quality concerns are addressed with a minimum of bureaucracy and
INTRODUCTION AND BACKGROUND
The last 15-20 years have been exciting, but not exactly kind, to large blood centers. The scientific evolution of the field has been remarkable: glass bottles to leukocyte filters, whole blood to the dawn of an all-apheresis component blood supply, new and highly efficacious blood derivatives, the emergence of nucleated cell therapies and sophisticated cellular analysis, the discovery and rapid development of diagnostics for hepatitis C (HCV} and human immunodeficiency (HIV) viruses, the appearance of new publications and growth of educational programs and specialty societies suited to the rapidly changing science of the field. These accomplishments are by and large the legacy of the world's outstanding academic centers, scientists, physicians, technologists and nurses, and medical device, diagnostic and pharmaceutical companies. The field's transition from an isolated domain of immunohematology enthusiasts to a fully developed clinical specialty renamed Transfusion Medicine is
"Coral Therapeutics, Braintree, MA 02184, USA. 3"$ 18: 4-C
553
554 Transfus. Sci. Vol.18, No. 4 complete. The emergence of large blood centers is a very important part of this history, and most flourished while contributing significantly to the field. Under cover of federal and local mandates, blood service organizations that functioned as monopolies or oligopolies were created and protected. They succeeded in their most basic mission-consolidating the donor base and blood supply and setting up workable distribution systems throughout a region or country. Unfortunately, many of these dominant blood centers have left another legacy as well, one that has been documented in a different way. 1 Since the early- to mid-1980s, in journals, newspapers, magazines, books and films, the national and international press have published a steady stream of charges against blood centers and their senior management: arrogance and preoccupation with self-interest over mission; financial imprudence and often incompetence; lack of accountability to their constituencies; hostility to, and ignorance of, appropriate quality and regulatory controls; and appallingly bad judgment regarding evident epidemics of human immunodeficiency and hepatitis C viruses. Courtrooms throughout the world have witnessed many lawsuits related to the culpability, or lack thereof, of the blood collection establishment in the transmission of these viruses by blood products or derivatives. In a sad and surprising development, criminality has been rarely proved, resulting in jail sentences, public demonstrations of real anger and disappointment, and a world-wide re-examination of the structure, processes and functions of blood establishments. Given this picture, how should blood collection establishments evolve in the next century? For hospitals, it would appear that maintaining the skills and flexibility to manage this essential function are more important than ever, and unique means and resources are emerging to assist them in this regard.
WHY SHOULD HOSPITALS COLLECT BLOOD COMPONENTS? Hospitals Must Meet Their Needs
First, hospitals have always collected blood, although the relative amount varies from region to region and country to country. Hospital collections continue to amount to 10-15% of blood collection in the US, 2 and a great deal more in other countries, such as Italy and Germany. It is self-evident that not all hospitals should collect blood, nor should any individual hospital feel compelled by any argument to attempt se]_f-su/ficiency when conditions are not appropriate to meet that goal. However, when resources permit and specific needs are identified, hospitals should strongly consider the provision of their own donor services. Historically, blood centers have been slow, unable and/or unwilling to meet compelling hospital requests, such as specialized pediatric products, limited donor exposure programs, apheresis platelets, autologous and directed donations, pre-storage leukocyte reduced components, and hematopoietic stem cell services. The mission and regional sweep of a blood center might favor its provision of critical, but infrequently used, services, such as the development and maintenance of HLA-typed or IgAdeficient donor pools and rare RBC units. In many communities, these services are un- or underdeveloped, due to apathy, lack of medical direction or expertise or the misperception that although these services are needed and the blood center's mission is to provide them, they are too difficult to maintain. Thus, hospitals should seek to provide these services for themselves, alone or with outsourcing companies or partner hospitals when feasible, and alternatives to the local blood center aggressively sought on a routine basis. Innovation
Many blood centers spend a significant portion of their product income on
Hospitals Put Patients First 555
"research". However, with few exceptions, national blood collection establishments and US blood centers and their staffs are not viewed as leaders by the research community. Their output cannot be compared to academic medical centers and medical schools, national research organizations such as the Centers for Disease Control and the National Institutes of Health, 1 and commercial research and development efforts. Concentration of all blood collection activities in the monopoly providers would seriously hinder the experimentation that occurs when multiple investigators approach a problem or issue from unique viewpoints. This is evident in virtually all sectors of the economy. Examples include the widespread improvements in telephone service offerings and quality after the break-up of AT&T, and the innovation in package delivery services wrought by Federal Express. Should AT&T and the US Postal Service have the power to prevent this sort of experimentation? It is in the nature of a monopoly to control all areas related to their products and services; hence the need for vigilant enforcement of longstanding antimonopoly laws. By their overt and covert actions and statements, many, if not all, blood centers seek to exert complete control over blood collection activities in their communities. Transfusion Medicine innovations have been largely driven by physicians at the hospital level3: development of algorithms and strategies to limit unnecessary use, limited donor exposure programs, production of leukocyte-reduced and apheresis components, the need for cytomegalovirus and human T-lymphotrophic virus seronegative components, advances in pediatric transfusion therapies, therapeutic apheresis services, surgical blood management procedures such as intraoperative autotransfusion, surrogate tests for infectious diseases, and hematopoietic stem cell processing. Ironically, it is now common to observe blood centers, which often refused to provide such services or products upon initial
request, attempting to use their considerable market leverage to coerce hospitals to relinquish their own programs and outsource them to the blood center. To continue the analogy used above, it is as if the US Postal Service, now aware of the profitability of specialized delivery services, threatened not to deliver the mail unless businesses used their newly created and inferior express delivery service to the exclusion of Federal Express.
Service
Service by its nature can be interpreted in many ways, and good service to one healthcare provider may be suboptimal or even inadequate to another. However, it is likely that most would define good service as the ability of the customer to obtain what is requested from the supplier, reliably and as promised, and to know one's concerns and issues are carefully listened to and addressed in an open, fair and respectful manner. The record of large blood suppliers is decidedly mixed in this area. 4~ Despite monopoly positions, serious blood shortages recur, occasionally due to acts of God and other reasons outside the ability of any organization to manage, z Unfortunately, though, critical shortages derive also from bad decision-making, lack of organizational focus and innovation and inattention to detail. 1,5,6,8 For example, group AB fresh frozen plasma is often unavailable when large volume requirements occur {such as a patient undergoing repeated plasma exchange}, although the means to prevent this using apheresis plasma collection has existed for decades, z In addition, large blood suppliers have always resisted providing specialized components or services, such as HLA matched or family member collections, apheresis granulocytes and autologous and directed donations, even when well compensated, because they are unwilling or unable to write appropriate procedures, train their staff, or be diverted in any fashion by goals or demands
556
Transfus. Sci. Vol. 18, No. 4
not originated intemally. Blood center physicians, who are often clinically inexperienced, are expected to triage and allocate resources to meet these requests for special products. This practice is doomed to failure, since a few physicians with laboratory or administrative strengths cannot practice medicine appropriately for an entire region. Conceptually, a single policy-making physician, such as the monopoly supplier's medical director, may be capable of preventing development or provision of needed products or services, bolstered by philosophical [e.g. directed donationsl or financial [e.g. rare red cell phenotypesl excuses or lack of updated medical information [e.g. hematopoietic stem cell services or apheresis granulocytes}. Blood centers and their physicians have practiced and promoted "managed blood care" for decades, deciding largely without competition or serious oversight what, when and how to produce and price blood components and how to make them available. These practices began in the chaos of the 1960s and 1970s, when legitimate needs existed to allocate these new community resources wisely. In recent years, however, as physician control has eroded and preoccupation with regulatory issues became synonymous with survival tactics, these practices have served to limit service and maintain pricing power and monopoly control, not to lower costs or distribute resources equitably. In the US, competitive forces have led to reductions in service levels and a restructuring of customer agreements and contracts. Charges and lawsuits over anti-trust behavior [including improper differential and predatory pricing and illegal bundling of services) have occurred with some frequency. 5 Larger hospitals are favored; smaller hospitals are bereft of good service, good pricing or good alternatives.
Quality If quality is defined as following good manufacturing practices or ISO 9000,
neither blood centers nor hospitals can claim excellence in this regard. In a practical sense, a hospital's smaller size, closer supervision and medical care focus continue to be advantages in assuring that important patient care issues are recognized and addressed. From a regulatory perspective, the knowledge base and time investment needed to ensure that good manufacturing practices or equivalent are adhered to might favor the larger organization. The facts reveal the opposite, however. ~,4,s,s A govemmental commission in Canada convened to study that nation's blood supply has recommended that the country reduce the influence and responsibility of their national blood supplier, the Canadian Red Cross Society. Three US blood centers accounting for some 60% of the US blood supply, the American National Red Cross, Blood Systems, Inc. and the New York Blood Center, Inc. are now operating under consent decrees from the US Food and Drug Administration. In each case, this step was deemed necessary to correct serious quality issues and to prevent revocation of their licenses to operate. Among the many reasons for this condition are those relating to poor crisis management, t Blood collection agencies world-wide missed the value of what, in retrospect, were clear safety and quality improvement opportunities: direct questioning of donors regarding risk factors for HIV; use of surrogate tests such as alanine aminotransferase and antibody to hepatitis B core antigen; prompt use of limited donor exposure programs, such as apheresis components and autologous programs; expedient implementation of lookback and donor notification programs; and an inability to recognize the value of and implement production of leukocyte-reduced cellular components. In many hospitals, these and other steps to safeguard the blood supply were created and implemented. It is likely that these errors in judgment were made not out of negligence or malfeasance, but from a misreading of the public's
Hospitals Put Patients First 557
fear about the blood supply, a misunderstanding of the economics of their industry, and an inward focus based on a belief that their judgment should not be questioned. Concerns about the adequacy of the blood supply and the costs of safety and quality were obviously appropriate, but the isolation and narrow focus that accompany the governmental or quasi-governmental agencies that blood centers had become led to an underestimation of the problem and, as shown in subsequent years, a clear inability to manage the complex business and medical issues created by the crisis. 1 An important failure of central blood suppliers was the lack of investment in information systems. Documentation requirements exploded, caused by institution of quality mandates and increasing test volumes, and this was perhaps the single most important reason for the multitude of problems facing blood suppliers. Vision and innovation were lacking, as was a focus on quality. Twenty years without competition withered the discipline and critical thinking abilities of the industry. Insufficient management expertise and depth, an inability to cooperate as an industry, and the inherent poor capitalization of non-profit and governmental establishments contributed as well. Blood centers may well be too big to be properly managed or efficient, 9 yet many are seeking to grow larger via mergers or acquisitions in an attempt to lower their cost structures.
Cost
For many years, and to a considerable extent today, blood centers have viewed themselves as unique and essential organizations i m m u n e from the intense cost pressures that the healthcare system now experiences. In their minds, they sat in the eye of the hurricane sweeping the industry, and they would emerge unchanged once the wind died down. It is clear that major investments,
either conceptually or operationally, were not made in understanding how efficiencies, cost savings and quality improvements could be realized. Instead, their traditional practice was simply to pass on the costs 1° of the essential quality mandates forced upon the industry. Big hospitals with large blood bills were especially vulnerable. In recent years, limited pricing discounts have been granted to politically savvy or influential customers, and small or politically weak hospitals are left to pay the highest prices. Diversification into what are perceived as new profit-generating ventures, such as patient services, has been emphasized, resulting in further distraction from their fundamental blood collection mission. The end result is that blood component prices have climbed steadily as hospital reimbursement has fallen. This has led to a greater search for alternatives to blood centers by hospitals. In some communities, platelet concentrates and especially apheresis platelets have been priced disproportionately high. Hospitals with proper expertise have lowered their costs significantly by managing or outsourcing their own donor services, while reaping the quality and service benefits of providing boutique blood products for their specific patient needs. This scenario will likely always be the case for some hospitals.
CONCLUSION The arguments in favor of blood collection by hospitals fall into two categories. Benefits accrue directly to hospitals, as they are better able to recognize and meet specific patient and physician needs, generate opportunities for innovation, research and career training and growth programs for professionals, deliver better service, improve quality, and finally, control their costs directly. In addition, maintaining alternatives to the monopoly supplier is a worthy goal, since shortages still occur, mistakes by
558 Transfias.Sci. Vol. 18, No. 4
blood centers are not infrequent, and professional oversight of c o m m u n i t y blood centers is best accomplished when finding another supplier is not an idle threat. A final question remains: do blood collection efforts by hospitals hurt blood centers, or stated in another fashion, are some of the financial and other problems of blood centers a result of competition from hospitals? An emphatic " N o " is the answer. Hospital donor recruitment efforts are frequently derided as confusing to donors, who (it is said) may be less likely to donate to anyone. There is no evidence for this except as regards blood center vs. blood center feuds. 4,s, 11 In many communities and cities throughout the world, collection efforts by hospitals and blood centers have co-existed for decades, and in practice, they appeal to different and complementary donor populations. 6A2 Hospital collection efforts undertaken to control costs are also derided by blood centers, which state that their financial and operational capablilities are being damaged by this "commoditization" of blood components. 4 This treatment of a local resource--the blood donor and his donations--as commodity items that are controlled by blood centers and bartered solely on price, however, is a result of blood center fighting blood center, not of hospital donor activities.4,s, ~1 Hospitals are under intense pressures to adapt quickly to changing environments, and they must continue to pursue their missions in the manner that best meets their patient needs. This includes the active provision of donor services where c o m m u n i t y support and medical and administrative expertise co-exist. Other, often smaller hospitals will continue to depend on the regional or national blood supplier, and their patients should expect that these centers will: accept and proactively implement regulatory and quality mandates; focus on improving the service and cost structure of their operations, especially on the development
and implementation of m o d e m information systems; and listen carefully and respond to customer needs without threat or undue exercise of monopoly power. Blood centers must be willing to c h a n g e ~ b u t in ways that their constituencies need. If they do not, they may discover that they no longer have a reason to exist.
REFERENCES
1. Committee to study HIV transmission through blood and blood products: HIV and the Blood Supply: an Analysis of Crisis Decisionmaking, Institute of Medicine, Leveton LB, Sox HC, Stoto MA (edsl: National Academy Press, Washington, DC, 1995. 2. Wallace EL, Churchill WH, Surgenor DM, et al.: Collection and transfusion of blood and blood components in the United States, 1992. Transfusion 1995; 35:802-812. 3. Popovsky MA, Triulzi D: The role of the Transfusion Medicine consultant. Am J Clin Pathol 1996; 105:798-801. 4. Westphal RG: Donors and the United States blood supply. Transfusion 1997; 37:237-241. 5. Finkelstein KE: Blood money. The New Republic, 12 August 1996, pp. 17-18. 6. Mayo DJ: Evaluating donor recruitment strategies (editorial). Transfusion 1992; 32:797-799. 7. Ciavarella D: Can (should) apheresis supplant whole blood collections?. Transfus Sci 1992; 13:201-205. 8. Gallery MF, Nevalainen DE, Kirst TM: Quality systems and total process control in blood banking. Transfusion 1994; 34:899-906. 9. Fuchs V: Managed care and merger mania. J Am Med Assoc 1997; 277:920921. 10. Smith EN, Holland PV, Holliman SM, Fuller MJ: Staff costs associated with the implementation of a comprehensive compliance program in a community blood center. Transfusion 1995; 35:679682. 11. Evans C: Blood feud lowers cost. The Daily Camera 31 December 1996; Boulder Colorado. 12. Royse D, Doochin KE: Multi-gallon blood donors: who are they? Transfusion 1995; 35:826-831.
PH: S0955-3886(97)00053-2
Transfus~ Sci. Vol. 18, No. 4, pp. 553-558, 1997 © 1997 Elsevier Science Ltd. All rights rescued Printedin Great Britain 0955-3886/97 $17.00 + 0.00
Should Hospitals Collect Blood Components? Yes: Hospitals Put Patients First David Ciavarella, MD*
a maximum of common sense. Finally, when hospitals control their own donor programs, costs are more easily tracked and better controlled. © 1997 Elsevier Science Ltd •
• Stand-alone blood collection centers throughout the world have suffered in recent years from cost overruns, quality and regulatory problems of major proportion, and a subsequent deterioration of service levels to their communities. Their leaders have been probed by public interest groups, the media and governmental bodies, removed from positions of authority, and sadly, subpoenaed, vilified in public and even jailed. Patients, healthcare providers and hospitals have suffered through this period as well, and continue to search for alternatives to their largely monopoly suppliers. In most cases, the best alternative is the one they control themselves. Should hospitals collect blood components? Yes, since their mission--patient care--takes precedence over that of any non-provider healthcare organization. Patients and the public-at-large gain many things by the continued presence of hospitals in the provision of donor services: provider and patient needs are given first billing, and innovation in blood services is encouraged by the transfusion medicine physicians and allied health professionals who are closest to the patient. Service requirements are recognized and met faster and in simpler ways, and quality concerns are addressed with a minimum of bureaucracy and
INTRODUCTION AND BACKGROUND
The last 15-20 years have been exciting, but not exactly kind, to large blood centers. The scientific evolution of the field has been remarkable: glass bottles to leukocyte filters, whole blood to the dawn of an all-apheresis component blood supply, new and highly efficacious blood derivatives, the emergence of nucleated cell therapies and sophisticated cellular analysis, the discovery and rapid development of diagnostics for hepatitis C (HCV} and human immunodeficiency (HIV) viruses, the appearance of new publications and growth of educational programs and specialty societies suited to the rapidly changing science of the field. These accomplishments are by and large the legacy of the world's outstanding academic centers, scientists, physicians, technologists and nurses, and medical device, diagnostic and pharmaceutical companies. The field's transition from an isolated domain of immunohematology enthusiasts to a fully developed clinical specialty renamed Transfusion Medicine is
"Coral Therapeutics, Braintree, MA 02184, USA. 3"$ 18: 4-C
553
554 Transfus. Sci. Vol.18, No. 4 complete. The emergence of large blood centers is a very important part of this history, and most flourished while contributing significantly to the field. Under cover of federal and local mandates, blood service organizations that functioned as monopolies or oligopolies were created and protected. They succeeded in their most basic mission-consolidating the donor base and blood supply and setting up workable distribution systems throughout a region or country. Unfortunately, many of these dominant blood centers have left another legacy as well, one that has been documented in a different way. 1 Since the early- to mid-1980s, in journals, newspapers, magazines, books and films, the national and international press have published a steady stream of charges against blood centers and their senior management: arrogance and preoccupation with self-interest over mission; financial imprudence and often incompetence; lack of accountability to their constituencies; hostility to, and ignorance of, appropriate quality and regulatory controls; and appallingly bad judgment regarding evident epidemics of human immunodeficiency and hepatitis C viruses. Courtrooms throughout the world have witnessed many lawsuits related to the culpability, or lack thereof, of the blood collection establishment in the transmission of these viruses by blood products or derivatives. In a sad and surprising development, criminality has been rarely proved, resulting in jail sentences, public demonstrations of real anger and disappointment, and a world-wide re-examination of the structure, processes and functions of blood establishments. Given this picture, how should blood collection establishments evolve in the next century? For hospitals, it would appear that maintaining the skills and flexibility to manage this essential function are more important than ever, and unique means and resources are emerging to assist them in this regard.
WHY SHOULD HOSPITALS COLLECT BLOOD COMPONENTS? Hospitals Must Meet Their Needs
First, hospitals have always collected blood, although the relative amount varies from region to region and country to country. Hospital collections continue to amount to 10-15% of blood collection in the US, 2 and a great deal more in other countries, such as Italy and Germany. It is self-evident that not all hospitals should collect blood, nor should any individual hospital feel compelled by any argument to attempt se]_f-su/ficiency when conditions are not appropriate to meet that goal. However, when resources permit and specific needs are identified, hospitals should strongly consider the provision of their own donor services. Historically, blood centers have been slow, unable and/or unwilling to meet compelling hospital requests, such as specialized pediatric products, limited donor exposure programs, apheresis platelets, autologous and directed donations, pre-storage leukocyte reduced components, and hematopoietic stem cell services. The mission and regional sweep of a blood center might favor its provision of critical, but infrequently used, services, such as the development and maintenance of HLA-typed or IgAdeficient donor pools and rare RBC units. In many communities, these services are un- or underdeveloped, due to apathy, lack of medical direction or expertise or the misperception that although these services are needed and the blood center's mission is to provide them, they are too difficult to maintain. Thus, hospitals should seek to provide these services for themselves, alone or with outsourcing companies or partner hospitals when feasible, and alternatives to the local blood center aggressively sought on a routine basis. Innovation
Many blood centers spend a significant portion of their product income on
Hospitals Put Patients First 555
"research". However, with few exceptions, national blood collection establishments and US blood centers and their staffs are not viewed as leaders by the research community. Their output cannot be compared to academic medical centers and medical schools, national research organizations such as the Centers for Disease Control and the National Institutes of Health, 1 and commercial research and development efforts. Concentration of all blood collection activities in the monopoly providers would seriously hinder the experimentation that occurs when multiple investigators approach a problem or issue from unique viewpoints. This is evident in virtually all sectors of the economy. Examples include the widespread improvements in telephone service offerings and quality after the break-up of AT&T, and the innovation in package delivery services wrought by Federal Express. Should AT&T and the US Postal Service have the power to prevent this sort of experimentation? It is in the nature of a monopoly to control all areas related to their products and services; hence the need for vigilant enforcement of longstanding antimonopoly laws. By their overt and covert actions and statements, many, if not all, blood centers seek to exert complete control over blood collection activities in their communities. Transfusion Medicine innovations have been largely driven by physicians at the hospital level3: development of algorithms and strategies to limit unnecessary use, limited donor exposure programs, production of leukocyte-reduced and apheresis components, the need for cytomegalovirus and human T-lymphotrophic virus seronegative components, advances in pediatric transfusion therapies, therapeutic apheresis services, surgical blood management procedures such as intraoperative autotransfusion, surrogate tests for infectious diseases, and hematopoietic stem cell processing. Ironically, it is now common to observe blood centers, which often refused to provide such services or products upon initial
request, attempting to use their considerable market leverage to coerce hospitals to relinquish their own programs and outsource them to the blood center. To continue the analogy used above, it is as if the US Postal Service, now aware of the profitability of specialized delivery services, threatened not to deliver the mail unless businesses used their newly created and inferior express delivery service to the exclusion of Federal Express.
Service
Service by its nature can be interpreted in many ways, and good service to one healthcare provider may be suboptimal or even inadequate to another. However, it is likely that most would define good service as the ability of the customer to obtain what is requested from the supplier, reliably and as promised, and to know one's concerns and issues are carefully listened to and addressed in an open, fair and respectful manner. The record of large blood suppliers is decidedly mixed in this area. 4~ Despite monopoly positions, serious blood shortages recur, occasionally due to acts of God and other reasons outside the ability of any organization to manage, z Unfortunately, though, critical shortages derive also from bad decision-making, lack of organizational focus and innovation and inattention to detail. 1,5,6,8 For example, group AB fresh frozen plasma is often unavailable when large volume requirements occur {such as a patient undergoing repeated plasma exchange}, although the means to prevent this using apheresis plasma collection has existed for decades, z In addition, large blood suppliers have always resisted providing specialized components or services, such as HLA matched or family member collections, apheresis granulocytes and autologous and directed donations, even when well compensated, because they are unwilling or unable to write appropriate procedures, train their staff, or be diverted in any fashion by goals or demands
556
Transfus. Sci. Vol. 18, No. 4
not originated intemally. Blood center physicians, who are often clinically inexperienced, are expected to triage and allocate resources to meet these requests for special products. This practice is doomed to failure, since a few physicians with laboratory or administrative strengths cannot practice medicine appropriately for an entire region. Conceptually, a single policy-making physician, such as the monopoly supplier's medical director, may be capable of preventing development or provision of needed products or services, bolstered by philosophical [e.g. directed donationsl or financial [e.g. rare red cell phenotypesl excuses or lack of updated medical information [e.g. hematopoietic stem cell services or apheresis granulocytes}. Blood centers and their physicians have practiced and promoted "managed blood care" for decades, deciding largely without competition or serious oversight what, when and how to produce and price blood components and how to make them available. These practices began in the chaos of the 1960s and 1970s, when legitimate needs existed to allocate these new community resources wisely. In recent years, however, as physician control has eroded and preoccupation with regulatory issues became synonymous with survival tactics, these practices have served to limit service and maintain pricing power and monopoly control, not to lower costs or distribute resources equitably. In the US, competitive forces have led to reductions in service levels and a restructuring of customer agreements and contracts. Charges and lawsuits over anti-trust behavior [including improper differential and predatory pricing and illegal bundling of services) have occurred with some frequency. 5 Larger hospitals are favored; smaller hospitals are bereft of good service, good pricing or good alternatives.
Quality If quality is defined as following good manufacturing practices or ISO 9000,
neither blood centers nor hospitals can claim excellence in this regard. In a practical sense, a hospital's smaller size, closer supervision and medical care focus continue to be advantages in assuring that important patient care issues are recognized and addressed. From a regulatory perspective, the knowledge base and time investment needed to ensure that good manufacturing practices or equivalent are adhered to might favor the larger organization. The facts reveal the opposite, however. ~,4,s,s A govemmental commission in Canada convened to study that nation's blood supply has recommended that the country reduce the influence and responsibility of their national blood supplier, the Canadian Red Cross Society. Three US blood centers accounting for some 60% of the US blood supply, the American National Red Cross, Blood Systems, Inc. and the New York Blood Center, Inc. are now operating under consent decrees from the US Food and Drug Administration. In each case, this step was deemed necessary to correct serious quality issues and to prevent revocation of their licenses to operate. Among the many reasons for this condition are those relating to poor crisis management, t Blood collection agencies world-wide missed the value of what, in retrospect, were clear safety and quality improvement opportunities: direct questioning of donors regarding risk factors for HIV; use of surrogate tests such as alanine aminotransferase and antibody to hepatitis B core antigen; prompt use of limited donor exposure programs, such as apheresis components and autologous programs; expedient implementation of lookback and donor notification programs; and an inability to recognize the value of and implement production of leukocyte-reduced cellular components. In many hospitals, these and other steps to safeguard the blood supply were created and implemented. It is likely that these errors in judgment were made not out of negligence or malfeasance, but from a misreading of the public's
Hospitals Put Patients First 557
fear about the blood supply, a misunderstanding of the economics of their industry, and an inward focus based on a belief that their judgment should not be questioned. Concerns about the adequacy of the blood supply and the costs of safety and quality were obviously appropriate, but the isolation and narrow focus that accompany the governmental or quasi-governmental agencies that blood centers had become led to an underestimation of the problem and, as shown in subsequent years, a clear inability to manage the complex business and medical issues created by the crisis. 1 An important failure of central blood suppliers was the lack of investment in information systems. Documentation requirements exploded, caused by institution of quality mandates and increasing test volumes, and this was perhaps the single most important reason for the multitude of problems facing blood suppliers. Vision and innovation were lacking, as was a focus on quality. Twenty years without competition withered the discipline and critical thinking abilities of the industry. Insufficient management expertise and depth, an inability to cooperate as an industry, and the inherent poor capitalization of non-profit and governmental establishments contributed as well. Blood centers may well be too big to be properly managed or efficient, 9 yet many are seeking to grow larger via mergers or acquisitions in an attempt to lower their cost structures.
Cost
For many years, and to a considerable extent today, blood centers have viewed themselves as unique and essential organizations i m m u n e from the intense cost pressures that the healthcare system now experiences. In their minds, they sat in the eye of the hurricane sweeping the industry, and they would emerge unchanged once the wind died down. It is clear that major investments,
either conceptually or operationally, were not made in understanding how efficiencies, cost savings and quality improvements could be realized. Instead, their traditional practice was simply to pass on the costs 1° of the essential quality mandates forced upon the industry. Big hospitals with large blood bills were especially vulnerable. In recent years, limited pricing discounts have been granted to politically savvy or influential customers, and small or politically weak hospitals are left to pay the highest prices. Diversification into what are perceived as new profit-generating ventures, such as patient services, has been emphasized, resulting in further distraction from their fundamental blood collection mission. The end result is that blood component prices have climbed steadily as hospital reimbursement has fallen. This has led to a greater search for alternatives to blood centers by hospitals. In some communities, platelet concentrates and especially apheresis platelets have been priced disproportionately high. Hospitals with proper expertise have lowered their costs significantly by managing or outsourcing their own donor services, while reaping the quality and service benefits of providing boutique blood products for their specific patient needs. This scenario will likely always be the case for some hospitals.
CONCLUSION The arguments in favor of blood collection by hospitals fall into two categories. Benefits accrue directly to hospitals, as they are better able to recognize and meet specific patient and physician needs, generate opportunities for innovation, research and career training and growth programs for professionals, deliver better service, improve quality, and finally, control their costs directly. In addition, maintaining alternatives to the monopoly supplier is a worthy goal, since shortages still occur, mistakes by
558 Transfias.Sci. Vol. 18, No. 4
blood centers are not infrequent, and professional oversight of c o m m u n i t y blood centers is best accomplished when finding another supplier is not an idle threat. A final question remains: do blood collection efforts by hospitals hurt blood centers, or stated in another fashion, are some of the financial and other problems of blood centers a result of competition from hospitals? An emphatic " N o " is the answer. Hospital donor recruitment efforts are frequently derided as confusing to donors, who (it is said) may be less likely to donate to anyone. There is no evidence for this except as regards blood center vs. blood center feuds. 4,s, 11 In many communities and cities throughout the world, collection efforts by hospitals and blood centers have co-existed for decades, and in practice, they appeal to different and complementary donor populations. 6A2 Hospital collection efforts undertaken to control costs are also derided by blood centers, which state that their financial and operational capablilities are being damaged by this "commoditization" of blood components. 4 This treatment of a local resource--the blood donor and his donations--as commodity items that are controlled by blood centers and bartered solely on price, however, is a result of blood center fighting blood center, not of hospital donor activities.4,s, ~1 Hospitals are under intense pressures to adapt quickly to changing environments, and they must continue to pursue their missions in the manner that best meets their patient needs. This includes the active provision of donor services where c o m m u n i t y support and medical and administrative expertise co-exist. Other, often smaller hospitals will continue to depend on the regional or national blood supplier, and their patients should expect that these centers will: accept and proactively implement regulatory and quality mandates; focus on improving the service and cost structure of their operations, especially on the development
and implementation of m o d e m information systems; and listen carefully and respond to customer needs without threat or undue exercise of monopoly power. Blood centers must be willing to c h a n g e ~ b u t in ways that their constituencies need. If they do not, they may discover that they no longer have a reason to exist.
REFERENCES
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