How do I think about blood donor eligibility criteria for medical conditions?

Every blood center must determine blood donor eligibility criteria for donors with medical conditions, often based on very limited published data and variable practice. This manuscript briefly outlines possible impacts of donor medical conditions on donor and recipient safety and product quality, and describes the multidisciplinary approach used in Canada to think about donor criteria issues. Many years of experience are distilled into practical considerations in determining criteria, possible sources of information, and factors for successful change implementation, to hopefully assist medical and technical staff engaged in decision-making around donor eligibility.

Blood donation by men who have sex with men: using evidence to change policy.

BACKGROUND: In 2011 in the United Kingdom (UK), excluding Northern Ireland, the deferral of men who have sex with men (MSM) changed from lifetime to 12 months. We describe MSM who donated before and after this to inform further policy reviews. MATERIALS AND METHODS: Characteristics and sexual behaviours of donors identifying as male from routine surveillance are described. Rates of infections are compared pre- and post-implementation of a 12-month deferral. Donors are compared with screen negative male donors responding to a large-scale survey during 2013/2014. RESULTS: Comparing the five years pre- and post-change, the rate of confirmed positives for markers of HBV, HCV, HIV and syphilis decreased by 6·9% from 14·1 to 13·1/100 000 donations. The rate of recent infections was unchanged (1·72/100 000). Of 22 776 survey responses identifying as male, MSM disclosed sex between men over 12 months ago giving 99·35% compliance among male donors. Two-thirds of the 72 non-compliant MSM reported one to two partners and one-third had no new partners within 12 months. The most commonly reported reason for non-compliance from MSM both positive and negative for infection was 'not important to declare' (37·2% and 40·7%). Test seeking was rare (9·3% and 2·1%). CONCLUSION: Compliance with the 12-month MSM deferral policy was very high. The very low rates of infections post-change demonstrated the effectiveness of the policy. These data were an important part of the 2017 review of all sexual behaviour deferrals.

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.

Cancer Immunotherapy Using Chimeric Antigen Receptor Expressing T-Cells: Present and Future Needs of Clinical Cancer Centers.

Chimeric Antigen Receptor-T cells (CAR-T) are considered novel biological agents, designed to selectively attack cancer cells expressing specific antigens, with demonstrated clinical activity in patients affected with relapsed/refractory B-cell malignancies. In consideration of their complexity, the use of CAR-T requires dedicated clinical setting and health care practitioners with expertise in the selection, treatment, and management of toxicities and side effects. Such issue appears particularly important when contextualized in the rapid progress of CAR-T cell treatment, translating into a constant need of updating and evolution. Moreover, the clinical grade manufacturing of CAR-T cells is complex and implies articulated regulatory and organizational aspects. The main goal of this review is to summarize and provide an accurate analysis of the clinical, logistic, and regulatory requirements of CAR-T cell centers. Finally, we describe a new occupational figure called "CAR-T specialist" devoted to the establishment and coordination of the required facilities and regulatory landscape in the context of cancer centers.

[The limits of a principlist approach in the ethics of donation of elements and products of the human body. About some examples]. / Les limites d'une approche principiste dans l'éthique du don d'éléments et produits du corps humain. À propos d'exemples.

Voluntary, non-remunerated donations are fundamental principles with anonymity regarding donations of elements and products of the human body in France. Blood donation was a model to organize donation of organs, hematopoietic stem cell or gamete. These principles, which at first glance appear to be intangible, commonly accepted and transposable between the different types of donation, though reveal singularities regarding to a collective imagination, a biological reality, evolution of society, medicine and science. Through the study of these different principles applied to donated human body parts, this article aims to highlight the ethical limitations of a single principlist approach. The notions of anonymity, consent, voluntariness, non for profit, under their universal aknowledge, reveal variability of interpretation and scope due to the heterogeneous characteristics, implications and purposes between these donations of different elements and the uses made of them.

Position paper on the preparation of immune plasma to be used in the treatment of patients with COVID-19.

Passive immunotherapy with plasma derived from convalescent patients recovering from SARS-CoV-2 infection can be a promising approach in the treatment of COVID-19 patients. It is important that blood establishments are ready to satisfy requests for immune plasma by defining the requirements applicable to plasma donors and the standards for preparation, qualification, storage, distribution, and control of product use. This Position paper aims to give recommendations on the biological characteristics of a plasma preparation from convalescent donors and to support the evaluation of this therapeutic approach in more rigorous investigations.

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.

Blood donation history and eligibility assessment in a community-based sample of men who have sex with men.

BACKGROUND: In 2016, the US Food and Drug Administration changed the regulation from a permanent deferral from donation for men who have sex with men (MSM) to a 1-year deferral since last sexual contact. It is unknown what proportions of MSM try to donate and if they would be willing to answer individual risk-based questions to assess their current eligibility. STUDY DESIGN AND METHODS: The National HIV Behavioral Surveillance surveys periodically measure human immunodeficiency virus (HIV) prevalence and risk behaviors among MSM using a venue-based, time-location sampling method. In the 2014 cycle, that is, before the policy change, investigators in San Francisco and New Orleans added questions about blood donation. Questions inquired into three domains: donation history, policy awareness, and knowledge about HIV testing of donations. RESULTS: There were 404 and 557 respondents in San Francisco and New Orleans, respectively. Nearly one in three MSM in San Francisco (27.4%) and New Orleans (31.4%) tried to donate after their first MSM contact. A majority (63.1% in San Francisco, 58.8% in New Orleans) somewhat or strongly agreed that they would be willing to be asked detailed questions for donation eligibility assessment. CONCLUSIONS: The proportion of MSM who reported trying to donate was similar in the two cities. However, a substantial proportion did not agree to be asked more detailed risk behavior questions to assess eligibility. In these two geographic locations, prominent regional differences were not evident.