Statistical process control : the Deming paradigm and beyond

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Worldwide, people with haemophilia have been the primary users of plasma products, as they are often prescribed coagulation factors on a long-term basis. However, global demand for plasma is today driven by the expansion of immunoglobulin therapies for diverse indications Farrugia, Whereas traditionally blood was thought of in terms of its direct clinical applications, its value is also related to the information that can be derived from it. Once extracted from the body, blood can be used for the purpose of diagnostic tests and for research.

Discussion of these wider uses of blood goes beyond the scope of this study, but we want to highlight their close relationship.

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As we have seen with the use of other human tissues, the framing of human biological material as surplus or as waste can facilitate the procurement of blood for research uses within a wider blood economy Kent, ; Parry, ; Svendsen and Koch, Whether for research or therapeutic uses, the value of donated blood relates as much to the processes and standards of its procurement and storage as it does to its physical attributes.

Public policies on blood donation in many regions have been shaped by notions of altruism and common good — as well as by the need to provide resources for transfusion medicine Healy, ; Rabinow, ; Titmuss, ; WHO, In Britain, the ideals underlying the blood transfusion service chimed with the founding principles of the National Health Service NHS , launched in that it should meet the needs of everyone, be free at the point of delivery, and be based on clinical need, not the ability to pay. The importance attributed to voluntary unpaid blood donation was for many years bolstered by a widespread belief that unpaid donation was the primary factor in securing blood safety.

With the development of more sophisticated techniques for screening and viral inactivation of blood, safety in blood and plasma is now recognised to be a function of multiple factors, and consequently, the simple equating of safety with unpaid donation provides an inadequate account of contemporary realities. Even so, blood donation has diverse meanings and framings in different parts of the world Adams et al.

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Our discussion here will focus on the blood economy in Europe and particularly on recent challenges faced by policymakers and regulators of blood safety in the United Kingdom. We will also refer to policies in the European Union EU that impact on blood safety and supply in the United Kingdom, as these are salient in both political and practical terms. We argue that there is increased instability in this area as relations between different actors in this field have become more politicised in recent years. The association of blood banks in Europe with citizenship, solidarity and imagined national communities continued well beyond the post-war years when many such projects were first established Rabinow, Different interpretations of the moral and legal imperatives for VNRBD exist across the EU, as do the local practical arrangements of the various blood services: it is recognised that some organisations operating in the member states do provide some recompense for donors European Commission, ; WHO, Notwithstanding these diverse practices, the principle of altruism remains very influential in blood policy and law in the EU.

In practice, increasingly stringent practices of donor selection and exclusion cut across claims of universalism in this domain Valentine, In these and other respects, the ideological framing of blood policy is somewhat in tension with modern practices in this field. Once the contamination of the blood supply with HIV and Hepatitis C in the s and s was taken up as a matter of public concern, accusations of irresponsibility levelled at health authorities and blood service authorities led to a series of investigations and inquiries in the countries affected Feldman and Bayer, Although in the United Kingdom the government declined to take up the call made by patient groups for an official inquiry, an unofficial inquiry was eventually undertaken into these events in England and Wales Archer et al.

In addition, the Scottish government — having gained substantial devolved powers over health policy in recent years — set up an official inquiry in Following on from widespread recognition of the harm that occurred as a result of patients receiving infected blood in these years, policymakers and regulators have sought to take a precautionary stance to blood safety, seeking to anticipate and manage potential threats Watkins et al. Although the threat of transfusion-transmitted HIV or Hepatitis C has greatly receded in countries with well-resourced health systems, the risk of blood-borne infections has become a part of the way that publics and politicians perceive blood.

Public recognition of the capacity of blood to transmit feared infections does not replace but sits alongside an understanding of its capacity to sustain and even save lives. Accordingly, those who claim a stake in these decisions include diverse groups going beyond the boundaries of those conventionally involved in patient safety.

Blood safety has become a highly politicised issue characterised by litigation, tribunals and inquiries and institutional and regulatory reform Farrell, In recent years, a wider range of interests has mobilised in relation to blood donation as well as blood services. There has been renewed interest on the part of those with an interest in blood donation and supply, those of donors, and of would-be donors who have been excluded, for example, men who have sex with men Berner, ; Hurley, Suppliers of plasma products have sought to put forward their perspectives in the public domain, especially on the difficult balance that needs to be struck between safety and sufficiency of supply, and some have developed alliances with patients groups Plasma Protein Therapeutics Association, As well as being logistically complex, the supply of blood components and plasma products is politically sensitive in the EU.

As we have seen, the view that blood donation should be voluntary and unremunerated features widely in public policy in many national health systems, as well as in EU law and in international safety initiatives. The idea that nations should develop their own blood sourcing and supply arrangements is often traced to a wish to avoid the exploitation of blood donors in developing countries WHO, Among these were the advent of greatly increased demand for blood and plasma and limited investment in the infrastructure for the fractionating of plasma and making of products derived from it.

Fractionation and manufacturing techniques were developed that required specialised infrastructure, and new organisations took on this specialised form of production. This infrastructure includes sourcing plasma outside Europe for the manufacture of products distributed worldwide. Once these changes were introduced, plasma products became more stable and acquired a longer shelf life — in contrast to other blood products — and could be more easily shipped to wherever they were required Starr, In other words, these properties allowed for the production and the application of plasma products to be decoupled, and this has allowed for the development of specialised organisations and supplier networks for them.

As the supply of plasma products became internationalised, a number of specialist plasma producers were established, some of which were not-for-profit organisations and others for-profit companies. This situation contrasts with the supply of blood components, as national blood systems and not-for-profit agencies such as the Red Cross have controlled the supply to a greater extent.

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However, these not-for-profit blood suppliers fear that arrangements for supplying blood components are liable to change, as entry of for-profit companies into this market threatens the stability and safety of supply that existing providers currently offer European Blood Alliance, For-profit fractionators represent the great majority of fractionating capability worldwide, with not-for-profit agencies accounting for around one-fifth of this activity Australian Government, Worldwide, the United States accounts for approximately 70 per cent of plasma collected, and within the United States, the bulk of plasma collected comes from paid plasma donors Australian Government, : This reliance on US-sourced plasma extends to Europe, including countries that have made extensive efforts to boost their plasma collection capacities.

The political sensitivity of relying on paid plasma donors to supply health-care requirements in the EU is such that it is difficult to confirm up to date figures for the plasma economy. However, data from the s point to over 50 per cent of the EU market being sourced from plasma collected in the United States Farrell, It will be evident from this brief outline that the plasma economy does not conform to notions of national self-sufficiency of supply or of unpaid donation but rather it contradicts these.

These principles remain influential, however, and accordingly, some countries have sought to retain their own plasma collecting and fractionating capabilities. Nevertheless, the collection and fractionation of plasma and the production of plasma derivatives usually involve considerable interpenetration of private and public agencies and transactions. The links between public and private sectors intensified with the purchase by the Department of Health of a US plasma company in , with the aim of securing supply of plasma for the United Kingdom in the wake of alarm about the implications of variant Creutzfeldt—Jakob disease vCJD House of Lords, Other national plasma providers, such as Sanquin in the Netherlands, also offer contract fractionation services to countries that do not have their own suppliers.

In short, the plasma and blood economies are networked and interconnected, characterised by cross border flows of products that are essential to deliver modern health care. Arrangements for the production of plasma products contrast with the production of blood components — which can be stored for shorter periods of time — for which local or regional supply remains the norm.

Blood components are usually supplied from a point relatively close to hospitals where they will be used. In contrast, the production of plasma derivatives is a global business. Thus, there are complex and multiple chains for the supply of a range of products derived from human blood and used in medicine. The procurement and supply of these are shaped to some extent by national governments and regulatory bodies and by coordinating bodies internationally. However, they are also shaped by the global plasma industry. A third factor is that responses to blood safety threats, which are often unpredictable, affect market demand and supply for these products and their value.

As with other tissues and cells, the therapeutic use of blood is mediated through a range of technological interventions. Although blood transfusion originally involved the use of whole blood, as we have seen, it is now more usual for blood to be in the form of components or plasma products. In common with many other biological tissues, the raw material of donated blood requires an investment of effort and resources to be formulated in the ways that are required for its diverse applications Hoeyer, ; Waldby, : Given the moral sensitivities about discussing blood and its derivatives in the same terms that are used to discuss the prices paid for commodities such as oil, foods or metals, there are some difficulties associated with making an assessment of the monetary value of blood.

The approach taken here will be to look at some examples, rather than to endeavour to set out a complete picture of the payments associated with the supply of blood products. As we have seen, there are a range of suppliers for blood and plasma products, some of which are run by national or regional health services and others by separate commercial bodies, not-for-profit agencies or hybrid organisations.

As with the sourcing of blood, transactions relating to the use of blood have long been subject to social and ethical constraints. Nevertheless, the processing of blood is associated with significant costs and results in a product that is of value in a clinical context. Subject to logistical and regulatory constraints, these products may be exchanged for a price across different national and regional health systems. In cases where national health services operate an internal market, as is the case in England, the explicit charging of fees to hospitals for the supply of blood makes it easier to consider this issue.

As far as we have been able to ascertain, most national blood services do not publish financial statements. However, these services all require specialist infrastructures and staff, and most have systems in place to recoup at least some of the costs of these.

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In these ways, blood products can acquire exchange value within the systems that supply and use them, notwithstanding the rules prohibiting the buying and selling of blood. Thus, the ideals surrounding voluntary blood donation do not prevent the generation of exchange value from donated blood. Whereas it is difficult to obtain detailed information on the exchange value of blood products, when it comes to the suppliers of plasma products, more data are available. Healthy sales of plasma products have been reported by commercial plasma fractionators.

According to a recent review:. The market is dynamic, complex and highly competitive, and in respect of some products there is virtually unrestricted global trade.

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Australian Government, : Some of these products are highly valued for their clinical applications for patients with haemophilia and with rare or orphan diseases. Furthermore, as companies forge alliances with patient groups, they may secure the demand for their products and thereby enhance the monetary value of these goods CSL Limited, To sum up, the economic dimensions of the extensive trade in plasma are well documented; the availability of data is in part a consequence of the categorising of plasma products as pharmaceutical products and of their being supplied by commercial as well as not-for-profit agencies.

On the contrary, the monetary value associated with the supply of blood components is not well documented and is difficult to quantify. These activities generally take place within state or non-profit organisations; the language used about the supply of blood by these organisations reflects the prohibition on the buying and selling of blood, the ethics of blood services , rather than trade, and is as a result rather opaque. Nevertheless, the supply of blood components is an expensive, complex and resource-intensive activity, with diverse transactions taking place between donors and organisations involved in the procuring, processing and distribution of blood components.

While the initial exchange is usually based on voluntary giving of the blood, the component parts subsequently acquire a price or exchange value. The value of both plasma products and blood components is related to quality management. This in turn depends on demonstrable efforts being in place to screen the donor, donated blood and the inactivation of pathogens. Risks are frequently understood in epidemiological terms as related to donor population. Consequently, if the donor population is known, or assumed, to have a higher rate of any disease transmissible via blood, then the value of blood sourced from that population is likely to be greatly decreased.

We have a dedicated site for Germany. Organ transplantation is a much-discussed subject, and the importance of living organ donation is increasing significantly. Yet despite all efforts, too few donor organs are available to help all patients in need.

This book analyses whether the national legal regulations are also partly responsible for the organ shortage in the Member States of the European Union. In addition to a detailed analysis of the various national regulations, the main arguments in favour of and against legal restrictions on living organ donation are considered.

Based on the results of the analysis, the author establishes a Best Practice Proposal for living organ donation. JavaScript is currently disabled, this site works much better if you enable JavaScript in your browser. Law International, Foreign and Comparative Law. An ethical analysis of allowing families to overrule donation intentions.

Transplantation ; 3 : Psychosocial impact of pediatric living-donor kidney and liver transplantation on recipients, donors, and the family: a systematic review.

Transplant International ;28 3 Could minors be living kidney donors? A systematic review of guidelines, position papers and reports. Transplant International ; — Transplant International ; Nov until Oct ; see www. Ambagtsheer F.

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Organ Trade. PhD Thesis. Erasmus University Rotterdam Ambagtsheer F, Weimar W Eds. Results and Recommendations. Reply to comment on the article: On patients who purchase organ transplants abroad.

American Journal of Transplantation ;17 1 On patients who purchase organ transplants abroad. American Journal of Transplantation ;16 10 Ambagtsheer F, Weimar W. The Hague Recommendations: Improving the nonlegislative response to trafficking in human beings for the purpose of organ removal. Transplantation Direct ;2 2 :e Transplantation ; 1