Physical Examination of Potential Deceased Organ and Tissue Donors: An Overview of the European Landscape.

Physical examination (PE) of donors is essential to identify potential risks to the safety and efficacy of donated organs and tissues and is mandatory in the EU. However, no detailed guidance is available as to how PE should be performed. Health authorities (HA) and health professionals (HP) in member states of the European Committee on Organ Transplantation of the Council of Europe (CD-P-TO) and observer countries completed surveys relating to the regulatory requirements for PE and the professional practice of PE in their countries for organ and tissue donors. The HA survey addressed regulatory aspects, and the HP survey addressed professional practices, training, and respondents' opinions on the value of PE. These surveys revealed significant inter-country variation in the regulatory approach to PE and the performance of PE by professionals. Most respondents opined that PE was important and yielded valuable information in identifying contraindications to donation. There is no consensus at a regulatory or professional level as to how PE should be performed on organ and tissue donors. There is a requirement for agreed best practice guidelines in this area.

An intervention study for the prevention of vasovagal reactions and evaluating donors' experience: Analysis of donors' return for subsequent donation.

BACKGROUND AND OBJECTIVES: The EPISoDe (Experience Success in Donation) study investigated the effect of interventions on self-reported vasovagal reactions (VVRs) in first-time and novice (second to fourth donation) whole blood donors aged ≤30 years, demonstrating a 23% reduction of VVR from water drinking shortly before donation in the novice donors. Because donation experience and complications affect donor retention, we analysed intervention group donors' return for subsequent donation, a predefined secondary outcome. MATERIALS AND METHODS: The interventions were as follows: 330 ml water, 500 ml water, ball squeezing before phlebotomy (placebo) and a control group. All donors received an online questionnaire about their experience within a week after donation. In the Netherlands, eligible donors are invited at least yearly depending on hospitals' needs. We analysed attendances within 421 days through return percentages and binomial logistic regression. RESULTS: Of the 8300 EPISoDe participants, 6538 (78.8%) returned within 421 days. Return did not differ between the two water groups, whereas odds for return were significantly higher in both water and placebo intervention donors compared to the control group (odds ratio [OR] 1.14, 95% confidence interval [CI] 1.00-1.29 and 1.22, 1.05-1.43, respectively) after adjustment for occurrence of VVR, unsuccessful collection, gender and donation history. Staff-recorded or self-reported VVR at index donation was associated with reduced odds for return (OR 0.47, 95% CI 0.37-0.60 and OR 0.53, 95% CI 0.46-0.61, respectively). CONCLUSION: In this cohort of younger inexperienced blood donors, 78.8% returned for subsequent donation. Donors who received an active study intervention, either water or placebo, were more likely to return than control group donors.

How donor selection criteria can be evaluated with limited scientific evidence: lessons learned from the TRANSPOSE project.

BACKGROUND AND OBJECTIVE: Donor selection criteria (DSC) are a vital link in the chain of supply of Substances of Human Origin (SoHO) but are also subject to controversy and differences of opinion. Traditionally, DSC have been based on application of the precautionary principle. MATERIALS AND METHODS: From 2017 to 2020, TRANSPOSE (TRANSfusion and transplantation PrOtection and SElection of donors), a European research project, aimed to identify discrepancies between current DSC by proposing a standardized risk assessment method for all SoHO (solid organs excluded) and all levels of evidence. RESULTS: The current DSC were assessed using a modified risk assessment method based on the Alliance of Blood Operators' Risk-based decision-making framework for blood safety. It was found that with limited or diverging scientific evidence, it was difficult to reach consensus and an international standardized method for decision-making was lacking. Furthermore, participants found it hard to disregard their local guidelines when providing expert opinion, which resulted in substantial influence on the consensus-based decision-making process. CONCLUSIONS: While the field of donation-safety research is expanding rapidly, there is an urgent need to formalize the decision-making process regarding DSC. This includes the need for standardized methods to increase transparency in the international decision-making process and to ensure that this is performed consistently. Our framework provides an easy-to-implement approach for standardizing risk assessments, especially in the context of limited scientific evidence.

Critical pathway for deceased tissue donation: a novel adaptative European systematic approach.

A 'Critical pathway for deceased tissue donation' was developed by the European Committee on Organ Transplantation of the Council of Europe (CD-P-TO) with the aim of providing a common systematic approach to the deceased tissue donation process. Definitions of tissue donors according to the donation stage have been developed so that they can be adapted to different local scenarios. This critical pathway can be used retrospectively to evaluate the potential of tissue donation, assess performance in the tissue donation process and identify areas for improvement. It sets the basis to build indicators to compare organizations, regions and countries. The critical pathway can also be used prospectively to promote good practices in tissue donation programmes aimed at covering the tissue transplantation needs of patients.

New global reporting system for serious (product) events and adverse reactions in hematopoietic stem cell donation and transplantation.

Annually more than 21,000 volunteer unrelated hematopoietic stem cell donations are performed worldwide for patients with life-threatening diseases such as acute leukaemia. Donor safety issues and donor protection is one of the top priorities for the international cooperation of unrelated hematopoietic stem cell donor registries represented by the World Marrow Donor Association (WMDA). With this new global reporting system for serious events and adverse reactions (S(P)EARs), the WMDA aims to become the global leading online platform for hematopoietic stem cell donor organisations to report their S(P)EARs from both unrelated and family donors. Software developer Cogapp developed the platform using a Knack environment based on requirements of experienced reporters and reviewers. On July 1st WMDA launched a robust online reporting system for S(P)EARs in order to provide accurate information about potential risks to donors. The collected data about S(P)EARs occurring in donors will be analysed and used to provide statistics on the type of reports being submitted and to put in place best practices to mitigate such effects and occurrences. Via the annual S(P)EAR reports the results will be disseminated worldwide.

Can we prevent vasovagal reactions in young inexperienced whole blood donors? A placebo controlled study comparing effects of a 330 vs 500 mL water drink prior to donation.

BACKGROUND: Complications of donation reduce donor return. Younger and less experienced donors are more likely to experience vasovagal-type reactions (VVR). A water drink of approximately 500 mL shortly before donation may reduce VVR, but the effect of a smaller volume of water has not been investigated. STUDY DESIGN AND METHODS: A placebo-controlled comparative study was conducted among donors < 30 years who attended for a 1st-4th whole blood (WB) donation. Collection centers were assigned to offer one of three interventions: 500 mL water drink, 330 mL water drink, or a placebo intervention consisting of pre-donation arm exercise. Within 7 days after attending, participants received an electronic questionnaire about possible symptoms during and after donation. In additional centers, control donors were recruited, who only received standard care and were also sent the questionnaire. Self-reported VVR and other complications were evaluated in all groups. RESULTS: Out of 8,300 participating donors, 6,921 (83%) returned the questionnaire. Overall, 18.5% of responding donors reported moderate or worse VVR symptoms. In 2nd-4th time donors, both water volumes decreased the odds of a VVR compared to standard care controls (OR500ml 0.75, 95% CI 0.59-0.94; OR330ml 0.73, 0.58-0.91; adjusted combined OR 0.77, 0.64-0.94). There was no effect in new donors or the placebo group compared to controls. CONCLUSION: In young donors making their 2nd-4th WB donation, drinking water was associated with 23% fewer VVR with no difference between 330 and 500 mL. This decrease was not found in the placebo group. The findings support advocating drinking water for the prevention of VVR.

No increased risk of transfusion-transmissible infections after tattooing, body piercing, or acupuncture among blood donors in the Netherlands.

BACKGROUND: In the Netherlands, needle-related events (NREs) including tattoos, piercings, and acupuncture are a reason for temporary blood donor deferral. This study aims to evaluate whether donors with recent NREs had a higher risk of transfusion-transmissible infections (TTIs) compared to donors without recent NREs. STUDY DESIGN AND METHODS: Data from 2006 through 2015 on all blood donation attempts in the Netherlands were collected. Multivariate regression models (for repeated measurements) were used to assess the associations between recent NREs and the acquisition of TTIs. Posttest counseling data were used to determine the most likely risk factor in TTI-positive new and repeat donors. RESULTS: Recent NREs were documented in 97,518 out of 9,266,036 (1.1%) donation attempts; 14,097 (14.5%) NREs resulted in NRE-based donor deferral. Recent NREs reported pre-donation were not associated with an increased risk for TTIs. A total of 29 out of 287 TTI-positive donors (11 repeat donors, 18 new donors) reported a recent NRE pre- and/or post-donation. Recent NREs, all needle-stick injuries, were the likely route of transmission in 12 out of 287 (4.2%) of TTI-positive donors. The donor health questionnaire (DHQ) identified only 1 out of 12 TTI-linked NREs. Non-return after NRE deferral, any deferral, or no deferral was 24, 15, and 5%, respectively. DISCUSSION: Recent tattoos, body piercings, or acupuncture were not associated with an increased risk for TTIs in Dutch donors. Given the lower return rates of donors following a temporary NRE-based deferral, we advocate ending blood donor deferral policies for acupuncture, tattooing, and body piercings, but not needle-stick injuries, in countries where these practices can be considered safe.

Prioritizing of bacterial infections transmitted through substances of human origin in Europe.

BACKGROUND: Bacteria are the pathogens most frequently transmitted through substances of human origin (SoHO). The European Centre for Disease Prevention and Control (ECDC) organized an expert consultation, with the objective of developing a priority list of bacterial pathogens transmissible via SoHO. The list will be used to further assess risks and determine appropriate preventive measures. STUDY DESIGN AND METHODS: The 14 most frequently SoHO-transmitted bacteria identified through a scoping literature review were then prioritized during an expert workshop through a methodology based on multicriteria decision analysis. The selection of the prioritization method was based upon an ECDC framework for best practices in conducting risk-ranking exercises. Three transmission pathways, blood and blood components, tissues and cells, and organs, were considered in the ranking exercise. RESULTS: According to the ranking score (RS), bacteria were organized within each SoHO pathway into one of four risk tiers: Tier 1 (RS ≥ 0.70), Tier 2 (RS = 0.60-0.69), Tier 3 (RS = 0.40-0.59), or Tier 4 (RS < 0.40). The most consistently identified pathogens in the highest risk Tiers 1 and 2 of all three pathways were: Staphylococcus aureus, Klebsiella spp., Escherichia coli, ß-hemolytic streptococci, Pseudomonas spp., and Acinetobacter spp. CONCLUSION: Six bacteria were defined as being of the highest priority in respect of the threat to the safety of SoHO and will be the subject of subsequent in-depth risk assessments to be conducted by ECDC to identify measures to mitigate the risk posed by these bacteria.

Risk factors for rejection for morphological reasons of heart valves for transplantation.

The study aim was to identify risk factors for morphological rejection of aortic and pulmonary valves for transplantation that could be used to optimize donor selection. The files of all Dutch heart valve donors, donating in a 2.5 years period, whose hearts were processed at Heart Valve Bank Rotterdam, were reviewed for all factors that could be relevant for valve rejection and related to outcome of morphological assessment of the valves. Valves were retrieved from 813 deceased Dutch donors, 24.1% also donating organs. For 797 aortic and 767 pulmonary valves, who met retrieval criteria, morphological assessment was done. 69.5% of aortic and 37.5% of pulmonary valves were considered unsuitable for transplantation at morphological assessment. Backward stepwise multivariate logistic regression analysis, showed age, cardiac cause of death, cerebrovascular accident as cause of death or in medical history, and number of cardiovascular risk factors in a donor to be independent risk factors for morphological rejection of aortic valves. Age, sex, weight >100 kg and ruptured aortic aneurysm as cause of death were independent risk factors for morphological rejection of pulmonary valves. Being an organ donor was an independent predictor of morphological approval of aortic and pulmonary valves, while hypertension was an independent predictor for morphological approval of aortic valves. Thus, independent factors were identified that are associated with morphological rejection of aortic and pulmonary valves for transplantation, and that could be used to optimize donor selection by preventing unnecessary retrievals, limiting costs, while improving yield per donor with minimal compromise for availability.

Protection of haematopoietic progenitor cell donors: an updated overview of the European landscape.

Haematopoietic progenitor cell donation from bone marrow and mobilised peripheral blood obtained from related and unrelated donors is an established procedure. The donation process in general has proven to be safe, but in rare cases severe and even fatal events have been reported. The present study aimed at providing a description of the current situation of donor protection measures in Council of Europe member States. A specific questionnaire was developed to compile information on donation activities, graft sources, legal frameworks, donor protection measures, collection of donor outcome data, and long-term follow-up of paediatric and adult related and unrelated donors. The outcome of this survey served as a basis for elaborating the Recommendation CM/Rec(2020)6 of the Committee of Ministers to member States on establishing harmonised measures for the protection of haematopoietic progenitor cell donors.

The value of autopsy and other histological examinations for the safety of tissue transplantation.

Directive 2006/17/EC requires that all available medical information, including autopsy reports, is evaluated before releasing tissues for transplantation. The aim of this study was to investigate whether evaluation of results of autopsy and other histological examinations contributes to the safety of tissue transplantation. From the files of all deceased Dutch donors, from whom tissues were retrieved in a 6-month period, results of autopsy and other histological examinations (remnant heart after valve donation and biopsies obtained during retrieval) were evaluated for contraindications for transplantation. Of 758 donors at least one tissue was considered suitable for transplantation at initial assessment. 637 Donors donated corneas, 256 skin, 177 heart valves and 61 musculoskeletal tissues. On 220 donors (29.0%) autopsy was done. Of seven donors no autopsy results were requested, since a contraindication was detected earlier in the medical screening. In 19 donors with autopsy (8.9%) general or tissue-specific contraindications were detected. There were no differences in distribution of detected contraindications among donors who donated different tissues. For 136 donors (17.9%) results of histological examinations other than autopsy were available; results of examination of remnant hearts for all, brain autopsy for two (0.3%) and retrieval biopsy for four donors (0.5%). Contraindications were detected in nine of these donors with histology results other than autopsy (6.6%). For 402 donors (53%) no histological examinations were done. Evaluation of results of autopsy and other histological examinations improves the safety of tissue transplantation for all types of tissues. In donors without autopsy alternative histological examinations can contribute to enhance the safety of tissue transplantation.

Physical examination of potential tissue donors: results of a risk management procedure to identify the critical elements of the physical examination.

To identify critical elements of physical examination (PE) of potential tissue donors that could help to improve the safety of tissue transplantation. Physical signs were identified that can indicate the presence of a contraindication mentioned in EU Directive 2006/17/EC and that can theoretically be detected at PE. A risk assessment was designed, according to the Failure Mode and Effects Analysis model. Signs were scored on several aspects, taking into account various control measures, either required in the EU Directive or additional non-required measures. 106 signs associated with general and tissue-specific contraindications were identified. Signs of advanced infection with HIV, hepatitis B/C and syphilis (n = 13, 12.3%) can be omitted, since these contraindications will be detected by the required serological testing. With the required control measures, risk priorities are unacceptably "high" for 17.3% of the signs. For 64.5% of the signs, additional control measures are possible, which result in acceptable risk priorities for all signs. This risk management procedure identified the minimal necessary content of PE in potential tissue donors. Furthermore, risks associated with tissue donation were elucidated and possible risk control measures were identified as well as their impact on the safety of tissue transplantation.

A Q Fever Outbreak in the Netherlands: Consequences for Tissue Banking.

BACKGROUND: Emerging infectious diseases can compromise the safety of tissues for transplantations. A recent outbreak of Q fever, a zoonosis caused by the bacterium Coxiella burnetii, in the Netherlands compelled the Dutch tissue banks to assess the risk of Q fever transmission through tissue transplantation in order to maintain optimal safety. MATHODS: This article describes the systematic approach that was followed in the Netherlands. This approach included a review of the literature, a qualitative risk assessment, expert opinion gathering and investigations for specific strategies that can help to maintain the balance between tissue safety and availability. RESULTS: This resulted in a specific donor selection policy and in development of further research to fill in gaps in knowledge about Q fever in tissue transplantation. CONCLUSION: The strategy described in this article may be useful for tissue bankers facing similar outbreaks of emerging infections or may be useful for development of future guidelines or assessment strategies for tissue banking.

Physical examination of the potential tissue donor, what do European tissue banks do?

According to the EU Directive 2006/17/EC, European tissue banks are required to perform a physical examination on every potential tissue donor. The directive itself, however, does not specify the content of this examination. The aim of this study was to investigate the current practice of physical examination in European tissue banks. A questionnaire was drawn up and sent to the members of the European Association of Tissue Banks and the European Eye Bank Association. Information was gathered on the type of procurement; the personnel involved (number, educational background and training); the content of physical examination; the problems encountered; and the outcome of the performed physical examinations. Completed questionnaires were received from 32 European tissue banks (response rate of 35%). Of these tissue banks, 73% perform a physical examination. The most frequently encountered problems are the inability to open the mouth due to rigor mortis, the inability to examine the total body surface and the incapacity to palpate the lymph nodes. Tissue banks reject potential donors, based on the results of the physical examination in 5% of cases (median rejection rate). Twenty-seven percent of the responding tissue banks do not perform a physical examination. This was most often due to a lack of adequate educational background and/or a lack of appropriate training.

Allocation of corneas in europe.

BACKGROUND: To safeguard a fair distribution of available corneas, (inter)national and regional allocation principles have to be developed and implemented. METHODS: To obtain information about allocation principles over the world, a literature search was done. Allocation in Europe was investigated by international data of Bio Implant Services Foundation (BIS) over the period 2002-2007. RESULTS: For 4 different types of corneal grafts, e.g. random, HLA-typed, lamellar and emergency corneas, different allocation principles are described. Applying allocation criteria leads to dynamics in the donor and patient pool, which could be monitored by establishing the mean waiting time for each kind of corneal graft. Specific attention should be given to the division of corneas over the pools of different graft types, to ensure equal access to a transplant for all cornea patients. CONCLUSIONS: Due to new surgical techniques and seasonal changes in the supply of corneal grafts, allocation is a dynamic process, which has to be closely monitored.

Physical examination of the potential tissue donor, what does literature tell us?

European Tissue Banks should carry out a physical examination as a part of the donor selection procedure. This is one of the obligations concerning donation and procurement mentioned in the European Commission directives on tissue banking. As the directives do not give any further specification on the content or on the procedure of the physical examination, a search of literature was done in order to find more information. Although data in literature generally remain quite vague, it was possible to set up a list of items which should be looked at during physical examination. This list can be used temporarily until further information is gathered from an international survey and from a risk assessment analysis.

EATB Donor Case Workshop 2007.

The European Association of Tissue Banks (EATB) Donor Case Workshop is a forum held within the programme of the EATB annual Congress since 2003. This workshop has been used to discuss clinical donor cases with peer review of practice. It was agreed in advance that the experience of the 2007 workshop should be shared by publication as an example of participative learning which can be extended to other fields within tissue banking and which may be applicable in other disciplines. The EATB Congress in 2008 will extend the idea of participative open workshops with two additional workshops, one on Quality System cases and another on heart valve cases.

Evaluation of the autopsy report before releasing musculoskeletal tissue donors; what is the benefit? EATB International Conference, October 17-20, Budapest, Hungary.

EU directive 2006/17/EC requires that all available medical information, including the autopsy report, is evaluated before releasing tissues for transplantation. The study objective was to investigate whether evaluation of autopsy results of musculoskeletal tissue donors contributes to safety and availability of transplantable tissues. The files of all donors of whom musculoskeletal tissues were retrieved by BIS in 2006 were reviewed for death cause and autopsy results. Of 84 donors musculoskeletal tissues were retrieved. In 47 donors autopsy was performed (56.0%). The groups with and without autopsy were similar in sex, age, length, and weight. In one donor no autopsy results were evaluated, since the donor was already rejected because of positive blood tests. In 13 donors (28.1%) death causes before autopsy were unknown. In 12 of these donors a death cause could be established after autopsy. In nine of the donors with a clear suspected death cause (27.3%), the death cause after autopsy differed from the suspected death cause. Four donors with autopsy (8.7%) had a general contraindication for donation, a (possible) sepsis in three and a persisting unknown death cause in one. Eight donors (17.4%) had musculoskeletal-specific contraindications, i.e. local infections. In conclusion, in 26.1% of the donors with autopsy, general or musculoskeletal-specific contraindications for donation were found. Furthermore, performance of autopsies enlarges the potential donor pool, since death causes can be established in almost all autopsies done in case of an unknown death cause. Therefore, evaluation of autopsy results improves the safety and quantity of tissues for transplantation.

Whole Blood Donation Affects the Interpretation of Hemoglobin A1c.

INTRODUCTION: Several factors, including changed dynamics of erythrocyte formation and degradation, can influence the degree of hemoglobin A1c (HbA1c) formation thereby affecting its use in monitoring diabetes. This study determines the influence of whole blood donation on HbA1c in both non-diabetic blood donors and blood donors with type 2 diabetes. METHODS: In this observational study, 23 non-diabetic blood donors and 21 blood donors with type 2 diabetes donated 475 mL whole blood and were followed prospectively for nine weeks. Each week blood samples were collected and analyzed for changes in HbA1c using three secondary reference measurement procedures. RESULTS: Twelve non-diabetic blood donors (52.2%) and 10 (58.8%) blood donors with type 2 diabetes had a significant reduction in HbA1c following blood donation (reduction >-4.28%, P < 0.05). All non-diabetic blood donors with a normal ferritin concentration predonation had a significant reduction in HbA1c. In the non-diabetic group the maximum reduction was -11.9%, in the type 2 diabetes group -12.0%. When eligible to donate again, 52.2% of the non-diabetic blood donors and 41.2% of the blood donors with type 2 diabetes had HbA1c concentrations significantly lower compared to their predonation concentration (reduction >-4.28%, P < 0.05). CONCLUSION: Patients with type 2 diabetes contributing to whole blood donation programs can be at risk of falsely lowered HbA1c. This could lead to a wrong interpretation of their glycemic control by their general practitioner or internist.