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The 90s paradox: QA efforts reduce total quality
Pergamon
PH: S0955-3886(97}00059-3
Trans[us. ScL Vol. 18, No. 4, pp. 597-602, 1997 © 1997 Elsevier Science Ltd. All fights reserved Printed in Great Britain 0955-3886/97 $17.00 + 0.(30
The 90s Paradox: QA Efforts Reduce Total Quality Michael I. Fuller*t Paul V. Holland, MD*
• The focus on "closing the window" of infectious risks in transfusion has concentrated limited health care resources on marginal increases in blood safety in the name of quality assurance (QA}. Significant investments in testing and medical history additions have been made to restrict further any release of unsuitable blood and apheresis donations. As funds are used in a disproportionate manner with regard to these quality benefits, the depletion of resources precludes investment in quality enhancements {e.g. potency} other than safety, and actually may reduce quality over all. Although safety is an important element of quality, it is not the only element. Increasingly, blood center customers expect, but are unwilling to pay for, limited increases in product safety, such as anti-HCV 3.0 and HIV p24 antigen testing; they should be encouraging improved potency and efficacy for QA. In the future, blood service providers must demonstrate the value of additional QA activities--~therwise, they will not receive reimbursement. Total quality remains the objective goal. However, the investment in QA efforts must yield a benefit equal to, or greater than, investment in the quality assurance process. © 1997 Elsevier Science Ltd •
quality assurance measures actually may be contributing to a decrease in the provision of quality health care and transfusion medicine services. The paradox works this way: as significant resources are expended to assure further increases in blood safety and quality, the marginal results are not reimbursed or cost-effective. Consuming limited resources for minimal improvements of quality assurance actually diverts economic resources from other beneficial quality programs like outcomes research, which ultimately may identify better medical practices. With limited health care dollars, any misdirected or marginal investment in quality assurance consumes these limited resources and precludes other, more cost-beneficial, programs. Under one military metaphor,1 any expenditure was justified that gave the slightest incremental increase in quality. However, the days of unlimited medical resources are gone. Limitations on resources began with implementation of Diagnosis Related Groups (DRGs) for prospective Medicare reimbursement but are driven today by health maintenance organizations (HMO} and insurance plans. Now, each dollar invested in health care m u s t yield a concomitant benefit. Further, no customer will pay for quality assurance, as quality is expected. In recent years, quality assurance efforts have been significantly increased with little, or no, increased value and only minimal contribution to total quality. A look at the recent evolution of quality assurance initiatives may give an indication of why we find such a significant invest-
Not only do quality assurance (QA) efforts not pay for themselves today,
*Sacramento Medical Foundation Blood Centers, 1625 Stockton Boulevard, Sacramento, CA 95816-7089, USA tAuthor for correspondence. 597
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ment being made in QA for an almost non-existent return on that investment. The rebirth of quality began, in part, as a backlash to the wastefil consumptive practices of the 1950s and 1960s. During the 1960s, many organizations seemed to embrace built-in obsolescence--a concept that flew in the face of increased quality. These decades saw, perhaps, the largest disregard of quality with resulting waste and outrage. Did it take the outcomes of built-in obsolescence to propel Demming to the quality forefront? After all, he had helped rebuild Japan after World War II by focusing on quality. The "wake-up" call sent by Japan to the United States demonstrated, first with cars and cameras, that "Quality Pays". As a result, the 1980s saw a rebirth and refocus on quality and quality assurance Ifor our industries to survive). Programs and processes, such as TQM, GMPs, CQI and Quality Circles, also appeared to cause health care organizations to focus on quality as a goal-but, did they really? These quality programs could have sent us on a tangent that only paralleled true quality. To address this issue, the obligatory definitions are provided. First, Webster's dictionary defines quality as la) "an inherent feature", or Ib) "degree of excellence". Quality assurance is defined as a program for the systematic monitoring and evaluation of the various aspects of a project, service or facility to ensure that standards of quality are being met. Quality control IQC} is defined as "an aggregate of activities designed to ensure adequate quality, especially in manufactured products". It is worth noting that quality assurance is not defined in the US Code of Federal Regulations. However, after documenting this omission in the Guideline for Quality Assurance in Blood Establishments, the US Food and Drug Administration's IFDA} Center for Biologics Evaluation and Research [CBER) atoned and published a 34-page guideline. In the Guideline, quality assurance was defined as "a system
designed and implemented to ensure that manufacturing is consistently performed in such a way as to yield a product of consistent quality. QA is the sum of activities planned and performed to provide confidence that all systems and their elements are functioning as expected and relied upon." Quality assurance is rooted in the regulations promulgated by the federal government, arguably one of a blood center's "customers". But what value is identified by this customer, other than the continued safety of the blood supply? Based on the Webster definition of "quality" I"a degree of excellence"), safety is only one element, albeit, an important one. In this context, quality appears synonymous with safety, which, although not bad, places us on a parallel to total quality. Ostensibly, the FDA is also concerned about the purity, potency and efficacy of the blood supply, but safety has become the overriding issue. If safety is the only aspect of quality on which we concentrate, the ability to achieve total quality or a degree of excellence is limited. Cost accounting for safety seems somewhat un-American. After all, we are the nation that should have zero risk in everything we do, as plaintiffs' attorneys constantly remind us. However, the cost/benefit analysis of safety is an important factor in the provision of blood service. Perhaps, the most offensive misuse of our limited health care resources was the implementation of the HIV p24 antigen test in the name of safety/quality. After a year of testing in the United States, only one donor was identified as truly antigen-positive but HIV antibodynegative. This begs the question-should upwards of $60 million have been spent to identify one such HIVinfected donor? Could this money have been better spent in preventive medicine, health education or in actual quality areas? An affirmative answer for HIV antigen testing would be laughable to answer the question, "Do Quality Assurance efforts pay for themselves?"
The 90s Paradox: QA Efforts Reduce Total Quality 599
Another example is the enhancement of the anti-HCV assay to the current 3.0 version. Again, the question is--"Did the increased expenditure concomitantly increase safety, and was the cost justified,v' It would be difficult to docum e n t the increase in safety, especially since not all blood centers use the "improved" test, and no quality problems have been identified with those centers that did not implement the antiHCV 3.0 enzyme-linked immunoassay. What is more disturbing is that the customers {hospitals, physicians, patients} do not even ask what test is being used, 2.0 or 3.0, and certainly are not willing to pay for the "better" anti-HCV test. Once again, we have millions of dollars spent with little or no documented increase in safety as this measure of quality. Broadening our outlook, total quality should include other factors that customers feel are important. If we return to the original definition of quality as "a degree of excellence", who determines the degree of excellence to be sought.~ Is it safe to say that the customer determines quality or excellence,z If the answer is "yes", then quality is essentially linked with the customer's perception of quality and their willingness to pay its costs, not merely the absence of defects. To illustrate this concept of quality, a production manager was overheard discussing the success of his company's TQM process, but lamenting the lack of sales. It seems that before TQM, the company made bad products that customers did not want. After implementation of TQM, the same company made high quality products that customers did not want. The conclusion was that absence of defects was not the definition of quality. Value in the customer's eye was a m u c h better gauge. Do our customers perceive a higher quality or increased value of blood transfusions since implementation of the tests for anti-HCV 3.0 and HIV p24 antigen.Z Are they willing to pay the high cost for the slightly higher level of safety? Have we asked.~
Let us broaden the discussion and change the focus from infectious disease testing. Perhaps one of the best examples of misguided, non-beneficial QA is in the area of labeling, or relabeling, as it were. The dairy {milk} industry was recently "asked" to change the labeling on cartons of milk to reflect the fat content more accurately. This did not change the contents of the carton in any way~ it merely changed the wording on the outside. This attempt at assuring consistency and quality in the dairy industry cost the consumer/customer an estimated $5 million {very conservative, especially when you consider all the scrap from unused cartons}. As a customer, do you feel the effort promulgated by the FDA had value and will pay for itself.~ Did you notice the change.~ Is the value or quality of milk enhanced, and will quality now be assured.~ A labeling example that parallels and more closely relates to transfusion medicine is the recent change in leukodepleted/reduced components. Again, the contents of the carton {bag) were not altered or improved. No significant change was made in production, and it is arguable that the consumer/customer was even aware of this one word change {from "depleted" to "reduced"}. This attempt at assuring quality cost blood banking organizations an estimated $450,000. IThis cost was calculated by documenting the per unit cost at the Sacramento Medical Foundation and multiplying by total blood center collections nationally.) Will it pay for itself.~ Will customers reimburse us for this.~ Has quality been enhanced.~ The answer to these questions is a resounding "no". For the most part, the ultimate customers {physicians and patients} are not even aware of the change~ and, again, there was no demonstrated increase in quality. Although the cost of the labeling changes for leukoreduced blood components does not compare in size to relabeling milk cartons, these are both examples of QA requirements imposed by the FDA that translate into very
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little, if any, value to the customer. Add this labeling change to the most recent tests, HIV p24 antigen and anti-HCV 3.0, additional medical history questions on HIV-type O, potential PCR testing of plasma for further manufacture of derivatives, Creutzfeldt-Jakob Disease risk questions on the medical history, and the potential transition to solvent/detergent plasma, and the price tag to the US consumer~customer is easily in excess of $100 million per year. What tangible benefit did, or will, the customers receive, and will the enhancement be worth the price.~ Better yet, were the customers even asked, or are they aware of the changes? Are the customers willing {and ablel to pay for these incremental, but costly, "improvements" in QA? The cost of compliance at our blood center has been calculated at $10.00 per unit collected. 2 This is now being validated by other institutions. Although this does not equate to the cost of total QA, it gives us another data point to refer to when estimating the cost of quality assurance. We believe that the investment in compliance has been helpful in minimizing problems in inspections by regulatory agencies and accrediting organizations, but we do not believe that our quality has been equivalently improved. Further, many of the customers that we serve do not care; they want cheaper blood and readily compare us to other centers, or organizations, that advertise lower prices and, of course, do not mention their quality problems. The context in which we place this discussion is of paramount importance. With managed care infecting much of the nation, and Medicare reimbursement already inadequate and more cuts imminent, who is going to pay for these questionable or marginal increases in quality and the obligatory program of quality assurance.Z This is a question too long without an answer. During the 50s, 60s, and 70s prior to DRGs, another military metaphor was accurate. We waged war on disease, fought life and
death battles in operating rooms [OR}, and used new medical instruments as weapons of that war. Fee-for-service provided all the funds necessary to implement any campaign that simply hinted at safety or quality. As in war, nothing was too expensive if it meant victory. That military metaphor does not work today. Resources for medical care are limited, and better utilization of the health care dollar is crucial. Quality assurance must be implemented and measured with the ultimate goal in mind of creating value for the customer. With the above military metaphor in mind, any amount of resources was acceptable to check the spread of disease or illness, just as any expense was acceptable in the defense of our nation. A 100% safe blood supply may be ultimately achievable, but at what cost? The more appropriate question is--what is the customer willing to pay.~ As before, has the customer/consumer been asked, especially the customer expecting quality or taking QA for granted.~ Were choices delineated? Or, do we even know who the customer is, especially the customer expecting or taking for granted QA? Before customer choices are discussed, let us revisit the definitions of quality and quality assurance. Quality is a degree of excellence, and to paraphrase, QA is a program to assure that standards of quality are being met. With these definitions in mind, it is apparent that only a part of the quality that blood centers are charged to deliver is being addressed. With AIDS, safety [and possibly purity) superseded the other areas of total quality--potency and efficacy. It will take all these elements in concert to deliver a "degree of excellence", or total quality. Potency and efficacy were relegated to the "back burner" as the focus on safety intensified. It is interesting to note that blood component potency and the quality assurance programs to assure component efficacy are the QA efforts that have the best chance of paying for themselves. Certainly, in the initial
The 90s Paradox: QA Efforts Reduce Total Quality 601
stages of fighting the AIDS epidemic, safety and the QA efforts associated with safety [donor screening and HIV antibody testing) more than paid for themselves. The financial resources saved through the prevention of just a few cases of AIDS paid for virtually all testing and screening that blood centers did for blood and component collections. The fact is that safety QA efforts now cost many times more than the improved safety/quality that they deliver. Increased component potency, however, could impact health care costs in m u c h the same way as the original anti-HTLV-III test and AIDS screening did. Perhaps, the original question would be more accurately posed as, " A r e the marginal results from the additional safety and purity efforts blood centers currently employ paying for themselves?" The answer to this question is a profound " n o " . If, however, quality efforts to improve efficacy and potency are included in the total quality picture, the answer may be different. The issues of limited resources and customer input are as important today as the initial donor screening efforts and development of the first AIDS antibody tests were in assuring quality/safety during the 1980s. If educated, informed customers are given a voice, potency/ efficacy would now almost certainly rank first on their list of priorities. When included in the total mix, safetypurity-efficacy-potency, total quality is closer to being addressed. The customer should be the most important variable in the process of assuring total quality. As previously stated, the FDA may actually be filling the role of a customer, but not the ultimate, and certainly not the paying, customer. The real customer is the hospital, physician, and, most assuredly, the patient, supported by his/her HMO, health insurance company, or the Health Care Financing Administration {HCFA). To determine whether any QA program pays for itself, there are only three ways to evaluate this. First, and most
basic, is there a customer that is willing to pay? As many blood centers found with the implementation of HIV p24 antigen, the answer was "no". Secondly, does the increase in quality create efficiencies in production to offset the cost of QA.~ Using the HIV p24 antigen test again as the example, the answer is " n o " . Finally, the last way to judge the cost/benefit would be to use the measure called a quality-adjusted life year IQALYI.3 Using this element on the previous example of HIV p24 antigen, the answer is still "no". AuBuchon et al. projected that the QALY for HIV p24 antigen testing, when compared to HIV antibody, would be $2,281,000 per QALY. Based on HIV p24 antigen testing to date, this may be a very conservative estimate. Since only one donor has been identified instead of the forecasted eight, the actual cost per QALY may be eight times the original calculation. Since this is essentially an accounting evaluation of QA, we must go to the proverbial "bottom line". The question remains--who is going to pay for increases in QA.~ One branch of the federal government requires compliance IFDAI, whereas another branch refuses to reimburse [HCFAJ or, at least, adequately reimburse le.g. autologous blood, especially if not transfused). The message may well be that the regulators cannot make up their collective minds; if FDA and HCFA [and our legislators who hold their purse strings) thought that HIV p24 antigen testing of the blood supply was worthwhile, should Medicare not increase reimbursement? If the FDA felt that HIV p24 antigen testing or leukoreduced unit labeling had a positive cost/benefit ratio, would not the FDA have worked with or alerted Congress and, thence, HCFA for adequate reimbursement so that these QA efforts would at least be paid for? The federal government is not the only customer who would not pay for increased QA. Many blood centers have found hospital administrators, HMOs, and health insurance carriers unable, or unwilling, to reimburse for increased
602 Transfus. Sci. Vol. 18, No. 4
QA, such as additional donor screening and testing activity. A significant number of blood centers had to find the money to implement such new QA measures in an already tight budget situation. Only the vendors of the infectious disease tests were reimbursed for their efforts. Hopefully, all affected customers will be included in the future, before investments are made in QA to determine whether the customer really wants the "improvements", and will demonstrate that fact by being willing to reimburse blood centers for them. Although the ability to demonstrate that current safety/purity QA programs pay for themselves is not possible, the inclusion of potency/efficacy QA programs in this equation may provide value to our customers. Ironically, increased focus on efficacy/potency may have a more positive effect on safety and cost, e.g., fewer donor exposures, more effective components, and the lower cost of using fewer, but better, components, than current QA initiatives. Additionally, the generation of revenue through better utilization processes or development of improved components m a y provide resources for stepped-up QA programs, which are being required but not funded. If we return to the opening paradox, that increased QA costs may actually be decreasing overall quality, the issue of limited funding impacts the focus on quality assurance. Revisiting the relabeling example in the dairy industry, it may be accurate to say that, if dairies were under some form of DRGs (Dairy Related Groups) that prevented direct cost recovery, more national discussion would have been heard regarding the cost benefit of such a request. Instead, the cost of relabeling was merely being passed on to the consumer. The example is analogous to all testing done in blood banking before prospective Medicare reimbursement based on the real DRGs (Diagnosis Related Groups). The difference today is that there are no funds available to reimburse for marginal increases in quality. The gov-
e m m e n t is not willing to pay even for a test that it mandates. This leads hospital customers, administrators, physicians, technologists and nurses to try to balance the provision of service with the limited funds available. Many hospital customers see no quality difference between paid and volunteer components, or the regulatory status of their primary blood supplier. If these customers of the blood center are unwilling to differentiate, or are unaware of basic quality differences, how can blood centers expect reimbursem e n t for marginal QA efforts? The sign in our office states "Quality Pays". There is no doubt that this axiom should relate to the provision of any product or service. In transfusion medicine, quality is an essential elem e n t and is related to patient health. Quality assurance efforts that contribute little or nothing to the overall provision of our services, however, can actually have an inverse relationship to the provision of quality service. Without a more definitive cost justification, some recent efforts at further improving blood safety provide, at best, marginal increases in quality. What is more important is that these marginal contributions divert attention from potentially larger improvements attainable elsewhere, deplete limited economic resources and thus actually have a negative overall impact on quality.
REFERENCES
1. Annas GJ: Beyond the military and market metaphors. Healthcare Forum Journal 1996; 39:30--34. 2. 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. 3. AuBuchon JP, Birkmeyer JD, Busch MP: Cost.effectiveness of expanded human immunodeflciency virus testing protocols for donated blood. Transfusion 1997; 37:45-51.
PH: S0955-3886(97}00059-3
Trans[us. ScL Vol. 18, No. 4, pp. 597-602, 1997 © 1997 Elsevier Science Ltd. All fights reserved Printed in Great Britain 0955-3886/97 $17.00 + 0.(30
The 90s Paradox: QA Efforts Reduce Total Quality Michael I. Fuller*t Paul V. Holland, MD*
• The focus on "closing the window" of infectious risks in transfusion has concentrated limited health care resources on marginal increases in blood safety in the name of quality assurance (QA}. Significant investments in testing and medical history additions have been made to restrict further any release of unsuitable blood and apheresis donations. As funds are used in a disproportionate manner with regard to these quality benefits, the depletion of resources precludes investment in quality enhancements {e.g. potency} other than safety, and actually may reduce quality over all. Although safety is an important element of quality, it is not the only element. Increasingly, blood center customers expect, but are unwilling to pay for, limited increases in product safety, such as anti-HCV 3.0 and HIV p24 antigen testing; they should be encouraging improved potency and efficacy for QA. In the future, blood service providers must demonstrate the value of additional QA activities--~therwise, they will not receive reimbursement. Total quality remains the objective goal. However, the investment in QA efforts must yield a benefit equal to, or greater than, investment in the quality assurance process. © 1997 Elsevier Science Ltd •
quality assurance measures actually may be contributing to a decrease in the provision of quality health care and transfusion medicine services. The paradox works this way: as significant resources are expended to assure further increases in blood safety and quality, the marginal results are not reimbursed or cost-effective. Consuming limited resources for minimal improvements of quality assurance actually diverts economic resources from other beneficial quality programs like outcomes research, which ultimately may identify better medical practices. With limited health care dollars, any misdirected or marginal investment in quality assurance consumes these limited resources and precludes other, more cost-beneficial, programs. Under one military metaphor,1 any expenditure was justified that gave the slightest incremental increase in quality. However, the days of unlimited medical resources are gone. Limitations on resources began with implementation of Diagnosis Related Groups (DRGs) for prospective Medicare reimbursement but are driven today by health maintenance organizations (HMO} and insurance plans. Now, each dollar invested in health care m u s t yield a concomitant benefit. Further, no customer will pay for quality assurance, as quality is expected. In recent years, quality assurance efforts have been significantly increased with little, or no, increased value and only minimal contribution to total quality. A look at the recent evolution of quality assurance initiatives may give an indication of why we find such a significant invest-
Not only do quality assurance (QA) efforts not pay for themselves today,
*Sacramento Medical Foundation Blood Centers, 1625 Stockton Boulevard, Sacramento, CA 95816-7089, USA tAuthor for correspondence. 597
598
Trans[us. Sci. Vol. 18, No. 4
ment being made in QA for an almost non-existent return on that investment. The rebirth of quality began, in part, as a backlash to the wastefil consumptive practices of the 1950s and 1960s. During the 1960s, many organizations seemed to embrace built-in obsolescence--a concept that flew in the face of increased quality. These decades saw, perhaps, the largest disregard of quality with resulting waste and outrage. Did it take the outcomes of built-in obsolescence to propel Demming to the quality forefront? After all, he had helped rebuild Japan after World War II by focusing on quality. The "wake-up" call sent by Japan to the United States demonstrated, first with cars and cameras, that "Quality Pays". As a result, the 1980s saw a rebirth and refocus on quality and quality assurance Ifor our industries to survive). Programs and processes, such as TQM, GMPs, CQI and Quality Circles, also appeared to cause health care organizations to focus on quality as a goal-but, did they really? These quality programs could have sent us on a tangent that only paralleled true quality. To address this issue, the obligatory definitions are provided. First, Webster's dictionary defines quality as la) "an inherent feature", or Ib) "degree of excellence". Quality assurance is defined as a program for the systematic monitoring and evaluation of the various aspects of a project, service or facility to ensure that standards of quality are being met. Quality control IQC} is defined as "an aggregate of activities designed to ensure adequate quality, especially in manufactured products". It is worth noting that quality assurance is not defined in the US Code of Federal Regulations. However, after documenting this omission in the Guideline for Quality Assurance in Blood Establishments, the US Food and Drug Administration's IFDA} Center for Biologics Evaluation and Research [CBER) atoned and published a 34-page guideline. In the Guideline, quality assurance was defined as "a system
designed and implemented to ensure that manufacturing is consistently performed in such a way as to yield a product of consistent quality. QA is the sum of activities planned and performed to provide confidence that all systems and their elements are functioning as expected and relied upon." Quality assurance is rooted in the regulations promulgated by the federal government, arguably one of a blood center's "customers". But what value is identified by this customer, other than the continued safety of the blood supply? Based on the Webster definition of "quality" I"a degree of excellence"), safety is only one element, albeit, an important one. In this context, quality appears synonymous with safety, which, although not bad, places us on a parallel to total quality. Ostensibly, the FDA is also concerned about the purity, potency and efficacy of the blood supply, but safety has become the overriding issue. If safety is the only aspect of quality on which we concentrate, the ability to achieve total quality or a degree of excellence is limited. Cost accounting for safety seems somewhat un-American. After all, we are the nation that should have zero risk in everything we do, as plaintiffs' attorneys constantly remind us. However, the cost/benefit analysis of safety is an important factor in the provision of blood service. Perhaps, the most offensive misuse of our limited health care resources was the implementation of the HIV p24 antigen test in the name of safety/quality. After a year of testing in the United States, only one donor was identified as truly antigen-positive but HIV antibodynegative. This begs the question-should upwards of $60 million have been spent to identify one such HIVinfected donor? Could this money have been better spent in preventive medicine, health education or in actual quality areas? An affirmative answer for HIV antigen testing would be laughable to answer the question, "Do Quality Assurance efforts pay for themselves?"
The 90s Paradox: QA Efforts Reduce Total Quality 599
Another example is the enhancement of the anti-HCV assay to the current 3.0 version. Again, the question is--"Did the increased expenditure concomitantly increase safety, and was the cost justified,v' It would be difficult to docum e n t the increase in safety, especially since not all blood centers use the "improved" test, and no quality problems have been identified with those centers that did not implement the antiHCV 3.0 enzyme-linked immunoassay. What is more disturbing is that the customers {hospitals, physicians, patients} do not even ask what test is being used, 2.0 or 3.0, and certainly are not willing to pay for the "better" anti-HCV test. Once again, we have millions of dollars spent with little or no documented increase in safety as this measure of quality. Broadening our outlook, total quality should include other factors that customers feel are important. If we return to the original definition of quality as "a degree of excellence", who determines the degree of excellence to be sought.~ Is it safe to say that the customer determines quality or excellence,z If the answer is "yes", then quality is essentially linked with the customer's perception of quality and their willingness to pay its costs, not merely the absence of defects. To illustrate this concept of quality, a production manager was overheard discussing the success of his company's TQM process, but lamenting the lack of sales. It seems that before TQM, the company made bad products that customers did not want. After implementation of TQM, the same company made high quality products that customers did not want. The conclusion was that absence of defects was not the definition of quality. Value in the customer's eye was a m u c h better gauge. Do our customers perceive a higher quality or increased value of blood transfusions since implementation of the tests for anti-HCV 3.0 and HIV p24 antigen.Z Are they willing to pay the high cost for the slightly higher level of safety? Have we asked.~
Let us broaden the discussion and change the focus from infectious disease testing. Perhaps one of the best examples of misguided, non-beneficial QA is in the area of labeling, or relabeling, as it were. The dairy {milk} industry was recently "asked" to change the labeling on cartons of milk to reflect the fat content more accurately. This did not change the contents of the carton in any way~ it merely changed the wording on the outside. This attempt at assuring consistency and quality in the dairy industry cost the consumer/customer an estimated $5 million {very conservative, especially when you consider all the scrap from unused cartons}. As a customer, do you feel the effort promulgated by the FDA had value and will pay for itself.~ Did you notice the change.~ Is the value or quality of milk enhanced, and will quality now be assured.~ A labeling example that parallels and more closely relates to transfusion medicine is the recent change in leukodepleted/reduced components. Again, the contents of the carton {bag) were not altered or improved. No significant change was made in production, and it is arguable that the consumer/customer was even aware of this one word change {from "depleted" to "reduced"}. This attempt at assuring quality cost blood banking organizations an estimated $450,000. IThis cost was calculated by documenting the per unit cost at the Sacramento Medical Foundation and multiplying by total blood center collections nationally.) Will it pay for itself.~ Will customers reimburse us for this.~ Has quality been enhanced.~ The answer to these questions is a resounding "no". For the most part, the ultimate customers {physicians and patients} are not even aware of the change~ and, again, there was no demonstrated increase in quality. Although the cost of the labeling changes for leukoreduced blood components does not compare in size to relabeling milk cartons, these are both examples of QA requirements imposed by the FDA that translate into very
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little, if any, value to the customer. Add this labeling change to the most recent tests, HIV p24 antigen and anti-HCV 3.0, additional medical history questions on HIV-type O, potential PCR testing of plasma for further manufacture of derivatives, Creutzfeldt-Jakob Disease risk questions on the medical history, and the potential transition to solvent/detergent plasma, and the price tag to the US consumer~customer is easily in excess of $100 million per year. What tangible benefit did, or will, the customers receive, and will the enhancement be worth the price.~ Better yet, were the customers even asked, or are they aware of the changes? Are the customers willing {and ablel to pay for these incremental, but costly, "improvements" in QA? The cost of compliance at our blood center has been calculated at $10.00 per unit collected. 2 This is now being validated by other institutions. Although this does not equate to the cost of total QA, it gives us another data point to refer to when estimating the cost of quality assurance. We believe that the investment in compliance has been helpful in minimizing problems in inspections by regulatory agencies and accrediting organizations, but we do not believe that our quality has been equivalently improved. Further, many of the customers that we serve do not care; they want cheaper blood and readily compare us to other centers, or organizations, that advertise lower prices and, of course, do not mention their quality problems. The context in which we place this discussion is of paramount importance. With managed care infecting much of the nation, and Medicare reimbursement already inadequate and more cuts imminent, who is going to pay for these questionable or marginal increases in quality and the obligatory program of quality assurance.Z This is a question too long without an answer. During the 50s, 60s, and 70s prior to DRGs, another military metaphor was accurate. We waged war on disease, fought life and
death battles in operating rooms [OR}, and used new medical instruments as weapons of that war. Fee-for-service provided all the funds necessary to implement any campaign that simply hinted at safety or quality. As in war, nothing was too expensive if it meant victory. That military metaphor does not work today. Resources for medical care are limited, and better utilization of the health care dollar is crucial. Quality assurance must be implemented and measured with the ultimate goal in mind of creating value for the customer. With the above military metaphor in mind, any amount of resources was acceptable to check the spread of disease or illness, just as any expense was acceptable in the defense of our nation. A 100% safe blood supply may be ultimately achievable, but at what cost? The more appropriate question is--what is the customer willing to pay.~ As before, has the customer/consumer been asked, especially the customer expecting quality or taking QA for granted.~ Were choices delineated? Or, do we even know who the customer is, especially the customer expecting or taking for granted QA? Before customer choices are discussed, let us revisit the definitions of quality and quality assurance. Quality is a degree of excellence, and to paraphrase, QA is a program to assure that standards of quality are being met. With these definitions in mind, it is apparent that only a part of the quality that blood centers are charged to deliver is being addressed. With AIDS, safety [and possibly purity) superseded the other areas of total quality--potency and efficacy. It will take all these elements in concert to deliver a "degree of excellence", or total quality. Potency and efficacy were relegated to the "back burner" as the focus on safety intensified. It is interesting to note that blood component potency and the quality assurance programs to assure component efficacy are the QA efforts that have the best chance of paying for themselves. Certainly, in the initial
The 90s Paradox: QA Efforts Reduce Total Quality 601
stages of fighting the AIDS epidemic, safety and the QA efforts associated with safety [donor screening and HIV antibody testing) more than paid for themselves. The financial resources saved through the prevention of just a few cases of AIDS paid for virtually all testing and screening that blood centers did for blood and component collections. The fact is that safety QA efforts now cost many times more than the improved safety/quality that they deliver. Increased component potency, however, could impact health care costs in m u c h the same way as the original anti-HTLV-III test and AIDS screening did. Perhaps, the original question would be more accurately posed as, " A r e the marginal results from the additional safety and purity efforts blood centers currently employ paying for themselves?" The answer to this question is a profound " n o " . If, however, quality efforts to improve efficacy and potency are included in the total quality picture, the answer may be different. The issues of limited resources and customer input are as important today as the initial donor screening efforts and development of the first AIDS antibody tests were in assuring quality/safety during the 1980s. If educated, informed customers are given a voice, potency/ efficacy would now almost certainly rank first on their list of priorities. When included in the total mix, safetypurity-efficacy-potency, total quality is closer to being addressed. The customer should be the most important variable in the process of assuring total quality. As previously stated, the FDA may actually be filling the role of a customer, but not the ultimate, and certainly not the paying, customer. The real customer is the hospital, physician, and, most assuredly, the patient, supported by his/her HMO, health insurance company, or the Health Care Financing Administration {HCFA). To determine whether any QA program pays for itself, there are only three ways to evaluate this. First, and most
basic, is there a customer that is willing to pay? As many blood centers found with the implementation of HIV p24 antigen, the answer was "no". Secondly, does the increase in quality create efficiencies in production to offset the cost of QA.~ Using the HIV p24 antigen test again as the example, the answer is " n o " . Finally, the last way to judge the cost/benefit would be to use the measure called a quality-adjusted life year IQALYI.3 Using this element on the previous example of HIV p24 antigen, the answer is still "no". AuBuchon et al. projected that the QALY for HIV p24 antigen testing, when compared to HIV antibody, would be $2,281,000 per QALY. Based on HIV p24 antigen testing to date, this may be a very conservative estimate. Since only one donor has been identified instead of the forecasted eight, the actual cost per QALY may be eight times the original calculation. Since this is essentially an accounting evaluation of QA, we must go to the proverbial "bottom line". The question remains--who is going to pay for increases in QA.~ One branch of the federal government requires compliance IFDAI, whereas another branch refuses to reimburse [HCFAJ or, at least, adequately reimburse le.g. autologous blood, especially if not transfused). The message may well be that the regulators cannot make up their collective minds; if FDA and HCFA [and our legislators who hold their purse strings) thought that HIV p24 antigen testing of the blood supply was worthwhile, should Medicare not increase reimbursement? If the FDA felt that HIV p24 antigen testing or leukoreduced unit labeling had a positive cost/benefit ratio, would not the FDA have worked with or alerted Congress and, thence, HCFA for adequate reimbursement so that these QA efforts would at least be paid for? The federal government is not the only customer who would not pay for increased QA. Many blood centers have found hospital administrators, HMOs, and health insurance carriers unable, or unwilling, to reimburse for increased
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QA, such as additional donor screening and testing activity. A significant number of blood centers had to find the money to implement such new QA measures in an already tight budget situation. Only the vendors of the infectious disease tests were reimbursed for their efforts. Hopefully, all affected customers will be included in the future, before investments are made in QA to determine whether the customer really wants the "improvements", and will demonstrate that fact by being willing to reimburse blood centers for them. Although the ability to demonstrate that current safety/purity QA programs pay for themselves is not possible, the inclusion of potency/efficacy QA programs in this equation may provide value to our customers. Ironically, increased focus on efficacy/potency may have a more positive effect on safety and cost, e.g., fewer donor exposures, more effective components, and the lower cost of using fewer, but better, components, than current QA initiatives. Additionally, the generation of revenue through better utilization processes or development of improved components m a y provide resources for stepped-up QA programs, which are being required but not funded. If we return to the opening paradox, that increased QA costs may actually be decreasing overall quality, the issue of limited funding impacts the focus on quality assurance. Revisiting the relabeling example in the dairy industry, it may be accurate to say that, if dairies were under some form of DRGs (Dairy Related Groups) that prevented direct cost recovery, more national discussion would have been heard regarding the cost benefit of such a request. Instead, the cost of relabeling was merely being passed on to the consumer. The example is analogous to all testing done in blood banking before prospective Medicare reimbursement based on the real DRGs (Diagnosis Related Groups). The difference today is that there are no funds available to reimburse for marginal increases in quality. The gov-
e m m e n t is not willing to pay even for a test that it mandates. This leads hospital customers, administrators, physicians, technologists and nurses to try to balance the provision of service with the limited funds available. Many hospital customers see no quality difference between paid and volunteer components, or the regulatory status of their primary blood supplier. If these customers of the blood center are unwilling to differentiate, or are unaware of basic quality differences, how can blood centers expect reimbursem e n t for marginal QA efforts? The sign in our office states "Quality Pays". There is no doubt that this axiom should relate to the provision of any product or service. In transfusion medicine, quality is an essential elem e n t and is related to patient health. Quality assurance efforts that contribute little or nothing to the overall provision of our services, however, can actually have an inverse relationship to the provision of quality service. Without a more definitive cost justification, some recent efforts at further improving blood safety provide, at best, marginal increases in quality. What is more important is that these marginal contributions divert attention from potentially larger improvements attainable elsewhere, deplete limited economic resources and thus actually have a negative overall impact on quality.
REFERENCES
1. Annas GJ: Beyond the military and market metaphors. Healthcare Forum Journal 1996; 39:30--34. 2. 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. 3. AuBuchon JP, Birkmeyer JD, Busch MP: Cost.effectiveness of expanded human immunodeflciency virus testing protocols for donated blood. Transfusion 1997; 37:45-51.