Refusal for religious reasons of a blood transfusion for her husband by wife as legal proxy ignored by the doctors - can the wife claim damages?

A scenario is presented in which a wife's request for religious reasons, and in accordance with her husband's wishes, that her husband not be given a potentially life-saving blood transfusion was ignored by the doctors. Her husband subsequently died. The question then arose whether her husband's estate, or she as his legal proxy, could bring an action for pain and suffering and sentimental damages against the doctors on behalf of her husband. When a patient dies and medical malpractice is involved, the patient's legal rights are extinguished, and their estate cannot begin or continue with a legal action for pain and suffering or sentimental damages - unless the pleadings in the case have been closed (litis contestatio). The result is that the estate or the spouse of a deceased patient may not sue for pain and suffering or sentimental damages on behalf of such patient. The spouse may only claim damages for pain and suffering and sentimental damages if he or she can show that the defendants' conduct regarding the deceased directly affected the spouse concerned. Where emotional shock was caused negligently, a spouse may only recover patrimonial damages and damages for pain and suffering. Where such shock was caused by intentional conduct, additional sentimental damages may also be claimed.

Vida para Ruth (1962) de Basil Dearden y el veredicto (2017) de Richard Eyre. Los testigos de Jehová y las transfusiones de sangre: dos visiones cinematográficas del mismo dilema / Life for Ruth (1962) by Basil Dearden and The Children Act (2017) by Richard Eyre. Jehova’s Witnesses and blood transfusions: two cinematographic visions of the same dilemma

El rechazo de las transfusiones de sangre por parte de los Testigos de Jehová representa un ejemplo clásico en el ámbito de la Bioética y la relación médico-paciente, cuando entran en colisión las intenciones y actuaciones de los médicos y las instituciones sanitarias, que tratan de salvaguardar la salud del paciente, con el necesario respeto de las decisiones personales del mismo respecto a las medidas terapéuticas que pudiera necesitar. Conceptos como la debida información, la confidencialidad, la libertad y la ausencia de toda coacción cobran entonces una especial importancia. En este aspecto, presentamos dos visiones cinematográficas sobre el mismo dilema: qué hacer cuando un Testigo de Jehová rechaza una transfusión sanguínea, poniendo en serio peligro su propia vida. La primera de ellas es Vida para Ruth (1962) de Basil Dearden, una película realizada apenas un par de décadas después de que las máximas instituciones de los Testigos de Jehová adoptaran la firme decisión de rechazar este tratamiento. La segunda ella, tras el adecuado sosiego dogmático, nos la proporciona El veredicto (2017) de Richard Eyre, donde una juez especializada en asuntos familiares debe sentenciar respecto a unos padres, Testigos de Jehová, que deniegan una transfusión de sangre a su propio hijo, menor de edad y gravemente enfermo. (AU)

The rejection of blood transfusions by Jehova´s Withnesses represents a classic example in the field of Bioethics and doctor-patients relationship, where the intentions and actions of doctors and health institutions collide, trying to safeguard the healthy of the patient with the necessary respect for his personal decisions regarding the therapeutic measures he mat need. Concepts such as proper information, confidentiality, freedom and the absence of any coercion are especially important. In this regard, we present two cinematographic visions on the same dilemma: what to do when a Jehova´s Witness refuses a blood transfusion, putting his own life in serious danger. The first of them is Life for Ruth (1962) by Basil Dearden, a film made just a couple of decades after the highest institutions of Jehova´s Witnesess made the firm decision to reject these therapeutic measures. The second one, with the appropriate dogmatic calm, provided by The Children Act (2017) by Richard Eyre, in which a specialized judge in family matters must sentence with respect to some parents, Jehova´s Witnesses, who deny a blood transfusion to their own minor and seriously ill child. (AU)

Heart transplant in Jehovah's Witness patients: A case-control study.

Heart transplantation (HTx) improves quality of life and survival in patients with advanced heart failure. Jehovah's Witnesses (JW) patients decline blood transfusion (including red cells, plasma and platelets) and are prohibited from heart transplantation at many centers. We report our experience with 20 consecutive JW patients with advanced heart failure who declined blood products referred to our center for HTx consideration. Of these, 7 were declined for transplant due to prior sternotomy, need for multi-organ transplant, or being too well. Of 13 JW patients accepted for heart transplant listing, 8 underwent HTx at our center. Compared to non-JW controls without prior cardiac surgery matched for age and listing status, JW HTx recipients had comparable incidence of primary graft dysfunction, rejection, allograft vasculopathy, and survival and hemoglobin up to 1 year. With appropriate selection, patients who are JW and decline blood products may successfully undergo heart transplantation.

HIV transmission network analysis allows identifying unreported risk factors in HIV-positive blood donors in France.

OBJECTIVES: As sex between men is a major route of human immunodeficiency virus (HIV) infection in most western countries, restrictive deferral rules for blood donation have largely been implemented regarding men having sex with men (MSM). Here, we sought here to assign unreported HIV risk factors in blood donors (BDs) and reevaluated the MSM-associated fraction of HIV transfusion residual risk (%RRMSM ). METHODS: We applied a genetic distance-based approach to infer an HIV transmission network for 384 HIV sequences from French BDs and 1337 HIV sequences from individuals with known risk factors (ANRS PRIMO primary HIV infection cohort). We validated the possibility of assigning a risk factor according to clustering using assortative mixing. Finally, we recalculated the %RRMSM . RESULTS: A total of 81 of 284 (28.5%) male and 5 of 100 (5%) female BDs belonged to a cluster; 72 (88.9%) of the 81 male BDs belonged to MSM clusters. After cluster correction, 8 of 67 (11.9%), 4 of 21 (19.0%), and 19 of 88 (21.6%) HIV-positive (HIV+) male BDs with heterosexual, other, or unknown risk factors could be reclassified as MSM, accounting for 10.9% of the total HIV+ male BDs. Overall, 139 of 284 HIV+ male donors (48.9%) could be considered MSM between 2000 and 2016 in France. Between 2005 and 2016, the %RRMSM increase varied from 0 to 19%, without differing significantly from the %RRMSM before reclassification. CONCLUSION: Network inference can be used to complement declaration data on risk factors for HIV infection in BDs. This approach, complementary to behavioral studies, is a valuable tool to evaluate the effect of changes in deferral criteria on BD compliance.

In vitro diagnostics for screening the blood supply: the new European regulation for IVD and the WHO IVD prequalification programme.

Blood transfusion remains a routine life-saving medical procedure that helps replace blood lost due to surgery, injury or disease. The quality of transfused blood is crucial in this process as blood donors must be free of transfusion-transmissible infections and donated blood should be compatible to that of the recipient. The quality of donated blood could be affected by the quality of in vitro diagnostic medical devices (IVDs) used in the screening process. Consequently, the need for high-quality, safe and well-performing IVDs for use in transfusion medicine arises, accompanied by the need for tight regulations in this domain. In the European Union, the new IVD Regulation will replace the existing IVD Directive within a five-year transitional period. Manufacturers of IVDs are expected to fully comply with the new Regulation by 26 May 2022. In this review, we address the major differences relating to marketing authorization and testing between this new Regulation and its predecessor. We further present the main elements of the prequalification assessment introduced by the WHO for IVDs, including disease-specific IVDs for blood screening laboratories.

The development of a legal framework for blood donation and blood safety in China over 24 years.

BACKGROUND: This study analyzes the regulation of and developments in blood donation in China from 1996 to 2019, and demonstrates the government's efforts to improve blood safety. RESULTS: Since the implementation of the Blood Donation Law in 1998, the number of blood donors in China increased by 275% from 1998 to 2018 (from 4 million to 15 million). The principle of no-fault liability was proposed and has been applied since 2010 to the tort liability related to blood transfusion malpractice. In 2015, mutual blood donation accounted for 4.2% of the national collection. However, in some provinces of China, the percentage of mutual blood donation increased from 9.3 to 35.6% in 2016. The National Health Commission canceled mutual blood donation in March of 2018. Since 2015, nucleic acid amplification testing has become a routine test item for screening blood. CONCLUSIONS: The Chinese government institutionalized the voluntary non-remunerated donation principle, enacted regulations for the management of blood transfusion, and adopted advanced blood testing technology to sustain blood supply and ensure blood safety. Despite increased blood donation, blood shortages persist. The quality and safety of blood collection can be further improved through the cancellation of mutual blood donation and incentive measures for voluntary non-remunerated donation of blood, which needs facilitation by governmental legislation.

Report from the GHPP-BloodTrain inspection workshop in Harare the 20th to the 24th of May 2019.

During the training workshop on Inspection of Blood Establishments, which was hosted by the PEI GHPP BloodTrain in Harare from the 20th to the 24th of May 2019, participants from the National Regulatory Authorities from seven Sub-Sahara African countries presented their current experiences related to regulation and inspection of blood establishments in their respective countries. While in all seven countries regulation and inspection of conventional medicinal products manufacturer is performed, the regulatory situation of blood and blood components as well as inspection of blood establishments is still heterogeneous.

The rise and fall of heterologous transfusion.

Now a routine lifesaving treatment, blood transfusion between humans became a safe procedure only after many early therapeutic disasters. Performed between different species, heterologous transfusions actually succeeded homologous transfusions, those performed between members of the same species. In the early history of transfusion, both homologous and heterologous transfusions were performed in many clinical settings. Early clinicians were unable to distinguish between deaths caused by baseline illness and those resulting from transfusions. This report examines both early experiments with homologous transfusion between animals and later efforts investigating and finally abandoning heterologous transfusion. Topics explored include: 1) contributions and lessons learned from key individuals, 2) how these researchers suggested, performed, advocated, or challenged the practice of heterologous transfusion, and 3) why heterologous transfusions were even considered as a mode of therapy.

Parents refusing blood transfusions for their children solely on religious grounds: Who must apply for the court order?

The South African Constitution provides that children have the right to healthcare, as well as all other rights. Furthermore, in all matters affecting them, their best interests must be 'of paramount importance'. It seems common practice that, when parents refuse blood transfusions for their children solely on religious grounds, doctors and health authorities apply for a court order to overturn such refusals. However, since the implementation of the Children's Act of 2005, it may be that the onus is no longer on doctors and authorities to apply to court to reverse the decision of parents and guardians. It can be argued instead that the burden has shifted to the parents to apply to court for an order to overrule the decision of doctors, by proving to the court that alternative choices are available. Guidance is given for situations, particularly in the public sector, where alternative choices are not available.

Is the Italian consent to transfusion really informed? A medico-legal analysis between old ghosts and new evidence.

In healthcare systems of developed countries, obtaining informed consent is a necessary and fundamental requirement for the administration of any medical treatment. In Italy, for the administration of the recipient's informed consent for a blood transfusion, a pre-printed form is used in line with the Decree of the Ministry of Health dated 2 November 2015. This paper aims to analyse this form in light of the European legal provisions and following the enactment of Italian Law No. 219 of 2017 on informed consent and advance treatment directives. Our review shows that the structure of the form can be improved in light of the new direction provided by Italian law, the scientific advancement on transfusion risks, and the potential to reduce the use of blood components. Revising this form could be the opportune time to include written information on Patient Blood Management strategies. Though not exhaustive, this proposal may stimulate debate on the point and produce further contributions.

Emergency Supply Policy of Cryopreserved RBC and PLT: The Czech Republic Concept.

Supply of blood for urgent substitution is a strategic logistical problem for the military medical services across the world. The limited shelf life of blood- derived bioproductsin the liquid state and the need for special transport and use conditions, apart from donor and donations availability are among the causes for concern. To solve these problems many national health-care authorities implemented the national emergency blood crisis policy, to get a large amount of blood at any time at any place in the case of disaster, terrorist attack or war. The civil therapeutic problems in immunohematolgy cases can also be solved by stocks of fresh and cryopreserved homologous or autologous blood for patients with rare RBCs antigens or HLA / HPA platelet refractoriness with no chance to use common blood. The short shelf life of fresh platelets limits their efficient inventory management and availability during a massive transfusion protocol. Building an inventory of frozen blood components can mitigate the risk of insufficient availability. Since the beginning of the century in the Czech Republic, used, like other countries, the use of of cryopreserved blood-derived bioproducts has become the current method used to overcome the shortages of a timely supply. The Military University Hospital, Prague, and its bank of cryopreserved blood have been operating under this policy since 2006. There is currently a stock of frozen RBCs for military reserve, for a national blood crisis and, also, a stock of rare RBC units. For crisis management there are also stored, frozen PLTs, which are used in the treatment of heavily bleeding polytrauma patients. Both the containment and research development mitigation policy programs are in place for civil / military emergency situations. Even pathogen reduced frozen PLTs and frozen RBCs were successfully investigated for clinical use if demands arose. Currently, it is possible to meet operational demand while reducing the number of resupply transports and loss of products due to expiration. A lesson has been learned from the current containment, reseach and mitigation programs of efficient blood supply management with cryopreserved blood and blood derived bioproducts.

Residents' knowledge in transfusion medicine and educational programs: A pilot study.

BACKGROUND: Residents' knowledge in transfusion medicine significantly impacts the optimal use of blood and patient safety. Little is known regarding this topic in France in particular. The objectives were to evaluate their basic knowledge, to determine whether the objectives of the curricula were attained and subsequently to suggest ways for improvement. METHODS: A cross-sectional study was conducted on 50 first year medical and surgical specialty residents rotating in a French university hospital. RESULTS: Major gaps in the knowledge were noted among residents of various specialties, equally between those with low and sustained transfusion practice. The majority of these young doctors expressed difficulties in prescribing and handling transfusions, identifying and managing its complications and understanding their responsibilities. The roles of hemovigilance practitioners were further somehow unclear for participants. CONCLUSION: Given these results, action plans appear needed to limit consequences. A special transfusion medicine educational program should be added to the currently available medical education curriculum in order to ensure physicians have adequate knowledge of transfusion basics; at least a practical assisted situation during residency would be of valuable interest.

Malaria blood safety policy in five non-endemic countries: a retrospective comparison through the lens of the ABO risk-based decision-making framework.

BACKGROUND: In non-endemic countries, malaria risk is addressed by selectively testing or deferring at-risk donors. These policy decisions were made using a variety of decision-making frameworks prior to the development of the Alliance of Blood Operators Risk Based Decision-Making Framework. It is unclear whether the range of items assessed in the decision-making process would be increased if the Framework were used. We compared assessments considered in France, England and Australia for decisions to implement selective testing, plus donor selection criteria (Canada and the USA included) with those recommended by the Framework. MATERIALS AND METHODS: Elements of the Framework were identified: the intervention, safety threat, availability threat, donor impact, financial implications, risk communication, stakeholder and regulatory aspects. Decisions about selective testing and donor selection criteria were analysed separately. Assessments were compared against elements of the Framework and the level of concern for considerations rated. RESULTS: Sufficiency of the blood supply (plus safety in France) were the drivers for selective testing; main trade-offs were high operational impact and cost. In three donor criteria examples, transfusion-transmitted malaria cases prompted the change. Social concerns were high in France and Australia, political/regulatory concerns influenced decisions in France, Australia and Canada, while sufficiency was a consideration in Canada and the USA. Decision trade-offs involved moderate operational impact. DISCUSSION: The assessments considered in each country were generally consistent with the assessments recommended by the Framework. When data supported quantified risk assessment, safety and operational feasibility had the greatest weight. When risk was not well defined, contextual factors such as social and political concern had greater weight.

[Home blood transfusion in France: Benefits and development terms]. / Transfusion à domicile : intérêt et conditions de développement dans le contexte français.

OBJECTIVES: Patients with cancers or malignant homeopathies can suffer from chronic anemia and be regularly transfused in hospitals. Most of the time, their performance status is low. Few local structures currently provide blood transfusion services and patients have to go under difficult and costing transportation to the hospital. The objective of this work is to evaluate benefits and development terms of home blood transfusion for patients with chronic anemia and having to get transfused regularly. METHODS: A field investigation-mixing observations and interviews and a literature review were conducted. RESULTS: Home blood transfusion represented a little part of home health care activity. When it was practiced, its organization was heterogeneous: it was sometimes performed by a doctor, sometimes by a nurse. Home blood transfusion was benefic for patients: it was more comfortable and it allowed them to avoid harmful transportation to the hospital. Few adverse events occurred during various experiments, all were mild. Before its revaluation in March 2018, home blood transfusion was not enough funded by National health insurance. Home blood transfusion also suffered from a lack of framework until the publication of recommendations in April 2018. CONCLUSIONS: Lack of a framework and sufficient funding prevented home blood transfusion development until changes that occurred in 2018. Therefore, this activity should develop in years to come. Allowing reducing unnecessary hospitalizations, home blood transfusion fit into French health national strategy.

[The jurisprudence about blood transfusion and informed consent of Jehovah witnesses]. / Jurisprudencia sobre transfusión de sangre y consentimiento informado de Testigos de Jehová.

The law N° 20.584 established the informed consent. This could suggest that patients have a right to refuse a blood transfusion. However, the dominant jurisprudence in protection claims filed against Jehovah Witnesses who rejected a blood transfusion, reveals that they do not have such a right. There were two exceptions in 2008, where courts acknowledged the patient's autonomy and denied the petition to authorize a blood transfusion. Most cases precede law N° 20.584. However, those cases which were upheld by the courts after the promulgation of the law, although few, follow exactly the same doctrine as before the appearance of this act.

Jurisprudencia sobre transfusión de sangre y consentimiento informado de Testigos de Jehová / The jurisprudence about blood transfusion and informed consent of Jehovah witnesses

The law N° 20.584 established the informed consent. This could suggest that patients have a right to refuse a blood transfusion. However, the dominant jurisprudence in protection claims filed against Jehovah Witnesses who rejected a blood transfusion, reveals that they do not have such a right. There were two exceptions in 2008, where courts acknowledged the patient's autonomy and denied the petition to authorize a blood transfusion. Most cases precede law N° 20.584. However, those cases which were upheld by the courts after the promulgation of the law, although few, follow exactly the same doctrine as before the appearance of this act.

[Is the research of posttransfusional alloantibodies still relevant?] / Est-ce que la réalisation de la recherche d'anticorps antiérythrocytaires post­transfusionnelle est toujours pertinente ?

The decision of November 6th, 2006 defining the principles of best practices recommends that posttransfusional red cell alloantibodies research is performed after one to three months after. In the University hospital of Brest, the haemovigilance unit takes charge of sending the medical prescription within the required time and centralizing the results. We wished to estimate if the realization of this research still remains relevant. METHODS: A prospective analysis was performed in 2015. We evaluated the realization rate, the red cell alloantibodies rate and the recipient adverse reactions with the diagnostic category: alloimmunization (delayed serological transfusion reaction, DSTR). RESULTS: In 2015, 2162 prescriptions were sent to the 3271 transfused patients. One thousand and eighteen red cell alloantibodies research were done, i.e. a return rate of 61%. Among them, 12 alloantibodies appeared (0.9%) within an average of 56 days. Thirty-three other alloantibodies appeared and were discovered most frequently before a new transfusion. In 10 cases, a posttransfusional research was done that was negative. A survey was conducted among GHCOH members to describe the practices in these health institutions. Twelve questionnaires were analysed. Ten institutions performed a posttransfusional alloantibodies research by issuing a prescription at the patient's exit with a return rate between 0.14 and 16%; 1 institution has a centralized organization with a return rate of 68.3%; 1566 red cell alloantibodies research were performed and among them, 24 alloantibodies appeared (1.53%). CONCLUSION: These results indicate that to be effective, the management of this biological test must be centralized. Despite this, the red cell alloantibodies rate remains very low (0.9 and 1.53%) and raises the question of the relevance of this systematic testing after transfusion, which is in any case mandatory before a new transfusion of red blood cells.