Report of the clinical donor case workshop of the European Association of Tissue Banks annual meeting 2014

The European Association of Tissue Banks (EATB) donor case workshop is a forum held within the program of the EATB annual congress. The workshop offers an opportunity to discuss and evaluate possible approaches taken to challenging situations regarding donor selection. Donor case workshops actively engage participants with diverging background and experience in an informal, secure and enjoyable setting. The resulting discussion with peers promotes consensus development in deciding tissue donor acceptability, especially when donor health issues are not conclusively addressed in standards and regulations. Finally the workshop serves to strengthen the professional tissue banking networks across Europe and beyond. This report reflects some of the discussion at the workshop during the annual congress in Lund, Sweden, in 2014. The cases presented demonstrate that the implications of various donor illnesses, physical findings and behaviours on the safety of tissue transplantation, may be interpreted in a different way by medical directors and other professionals of different tissue facilities. This will also result in diverging preventive measures and decisions taken by the tissue facilities. Some of the donor cases illustrate varied responses from participants and demonstrate that operating procedures, regulations and standards cannot comprehensively cover all tissue donor illnesses, medical histories and circumstances surrounding the cause of death. For many of the issues raised, there is a lack of published scientific evidence. In those cases, tissue bank medical director judgement is critical to guarantee transplantation safety. This judgement should be based on a proper and documented risk assessment case by case. Conditions or parameters taken into account for risk assessment are amongst others, the type of tissue, the type of processing, the characteristics of the final product, and the availability of an adequate sterilisation methodology. By publishing these difficult donor suitability cases, and the resulting discussions, we provide information for future similar cases and we identify needs for future literature review and scientific research. In this way the donor case workshops play a role in optimizing the quality and security of tissue donation.     

Results of the clinical donor case and quality system case workshops of the European Association of Tissue Banks annual meeting 2009

The European Association of Tissue Banks (EATB) Donor Case Workshop and Quality System Case workshop are forums held within the program of the EATB Annual Congress. These workshops offer an opportunity to discuss and evaluate approaches taken to challenging situations, regarding donor selection and quality issues, and strengthen the professional tissue banking and regulatory networks across Europe. This report reflects some of the discussion at the congress workshops and also subsequent correspondence between the various individuals who submitted cases for discussion. The cases presented to the workshops demonstrate that the findings, their interpretation, deducted actions and preventive measures in tissue banks are not predictable. The varied responses and lack of consensus corroborate this and clearly indicate that operating procedures cannot comprehensively cover or prepare for all eventualities. For many of the issues raised there is a lack of information in the published literature. The workshops actively engage participants, representing a wide array of international expertise, in an informal, secure and enjoyable setting, which facilitates learning from peers and provides potential solutions to those submitting cases. By publishing a summary of the discussions, we hope to reach a wider audience and to stimulate individuals to undertake full literature reviews or research on some of the discussed subjects.     

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.     

Report of the 17th International Congress of the European Association of Tissue Banks (EATB) held jointly with the 17th Annual Congress of the British Association for Tissue Banking (BATB) including EATB/BATB/American Association of Tissue Banks (AATB) Cardiovascular Symposium

The 17th Annual Meeting of the European Association of Tissue Banks (EATB) was held in Edinburgh in November 2008 together with the British Association for Tissue Banking (BATB) and received excellent evaluation by its participants. The meeting included, for the first time, a cardiovascular symposium co-organised by EATB and BATB together with the American Association of Tissue Banks (AATB). This was a first in terms of collaboration for the three associations. The many professionals involved in organising the meeting created an excellent clinical and scientific programme including regulatory issues and featured, also for the first time three interactive workshops about clinical donor cases, quality management and cardiovascular allografts.     

European Association of Tissue Banks Standards for Cryopreserved Cardiovascular Tissue Banking

The Cardiovascular Tissue Banking Standards are designed as an addition to the General Standards of the European Association of Tissue Banks to provide a minimum acceptable level for the donation, processing, storage, testing, labelling and distribution of cardiac tissue throughout Europe. The aim is that all heart valve banks in Europe should work to these Standards so that heart valves can be exchanged between countries without having to check the individual protocols of the donor processing facility. The writing of the Standards has been performed by the Heart Valve Council of EATB with input from cardiac surgeons. It is proposed that once the Standards are accepted they will form the document on which EATB may accredit tissue banks in the future and may form the basis on which National Legislation for Tissue Banking is based.     

Report on the ILAR International Workshop on the Development of Science-based Guidelines for Laboratory Animal Care

The Institute for Laboratory Animal Research of the National Academies hosted a meeting in November 2003 in Washington, DC, titled "International Workshop on the Development of Science-based Guidelines for Laboratory Animal Care." The purpose of the workshop was to bring together experts from around the world to assess the available scientific knowledge that can have an impact on the current and pending guidelines for laboratory animal care. Platform presentations focused on a variety of issues, from information exchange on mechanisms for the development of regulations across different countries and cultures, to data-based scientific studies on the effects of environmental enrichment on research outcomes. In the discussion sessions, participants were tasked with addressing the current scientific literature on the specific session topics; identifying gaps in the current knowledge in order to encourage future research endeavors; and assessing the effects of current and proposed regulations on facilities, research, and animal welfare. Participants had ample opportunities to share research outcomes and viewpoints in the multiple breakout sessions. Summaries of all breakout sessions were presented in the general session. On the final day of the workshop during the point/counterpoint session, a diverse group of speakers presented their cases for and against harmonization of standards. Although some of the speakers had serious reservations about harmonization, most of the panel members supported some form of harmonization. A positive outcome of the workshop was the opportunity for scientists and veterinarians from many countries to begin a dialogue with a goal of understanding the basis for the differences in regulatory approaches in laboratory animal care and the hope of continuing discussions on ways to work together toward some type of harmonization.     

Exclusion of deceased donors post-procurement of tissues

The EU Tissues and Cells Directive (2004/23/EC, 2006/17/EC, 2006/86/EC) (EUTCD) provides standards for quality and safety for all aspects of banking of tissues and cells for clinical applications. Commission Directive 2006/17/EC stipulates that the complete donor record with all the medical information is assessed for suitability before releasing tissues for clinical use. The aim of this study was to investigate the medical reasons for post-procurement donor exclusion, to identify the various potential sources for gathering information about donors’ medical and behavioural history and to evaluate their contribution to maximising the safety of donations. Information was collected from the Tissue Services (TS) records of 1000 consecutive deceased donors submitted to National Health Service Blood and Transplant (NHSBT) medical officers for authorisation for release for subsequent tissue processing and then for transplantation. Of the 1000 donors 60 (6%) were excluded because they did not fulfil the donor selection requirements of the EUTCD and NHSBT donor selection guidelines. The main reasons for medical exclusion were the presence of significant local or systemic infection in 32 donors (53% of those excluded for medical reasons) and a history of past or occult malignancy in 9 donors (15% of those excluded for medical reasons) which was not identified prior to procurement. The information leading to post-procurement exclusion was obtained from autopsy reports in 35 of the 60 excluded donors for medical reasons (58%) and from the general practitioner for 10 donors (17% of those excluded for medical reasons). In summary, careful evaluation of complete donor records reduces the potential risk of disease transmission by tissue allografts and ensures compliance with regulations and guidelines. The findings may lead to changes in donor selection policies with the aim of improving efficiency without compromising safety.     

21世纪医患关系的伦理学评判

随着医疗技术的迅猛发展,医疗水平不断提高,为人们带来福音的同时,使得医患关系的矛盾尤为凸显。21世纪的医患矛盾已经不仅仅是医生和患者之间的矛盾与冲突,而是两大社会群体之间的问题。在法律还无法规范的前提下,医学伦理学的评判标准可以为新时期医患关系提出更根本的指引与解释。     

Report of the roundtable discussion organised by the Swiss Proteomics Society (SPS), Bern, 8th December 2004

How close are we to using proteomics tools in the every day practice of physicians? What are the socio-economical issues our health care system may face with the advent of biomarkers for early diagnosis? How to get the specialists from the various disciplines integrated in proteomics to establish a common understanding of the clinical issues and develop the necessary standards (methods, biochemicals and IT)? These were the kind of questions a panel of specialists tried to answer during the roundtable discussion that took place in Bern during the Swiss Proteomics Society 2004 congress.     

The necessity of strengthening the cooperation between tissue banks and organ transplant organizations at national, regional, and international levels

The donation of tissues and organs increases significantly when tissue banks and organ transplant organizations work together in the procurement of organs and tissues at donor sources (hospitals, coroners system, organ procurement agencies, and funeral homes, among others). To achieve this important goal, national competent health authorities should considered the establishment of a mechanism that promote the widest possible cooperation between tissue banks and organ transplant organizations with hospitals, research medical institutions, universities, and other medical institutions and facilities. One of the issues that can facilitate this cooperation is the establishment of a coding and traceability system that could identify all tissues and organs used in transplant activities carried out in any country. The promotion of national, regional, and international cooperation between tissue banks and organ transplant organizations would enable the sharing of relevant information that could be important for medical practice and scientific studies carried out by many countries, particularly for those countries with a weak health care system.     

The establishment of a network of European human research tissue banks

This is a report of a workshop held on the establishment of human research tissue banking which was held in Levi, Finland 21–24 March 2002.There were 21 participants from 7 European countries. This meeting was attended by representatives from academia, research tissue banks and from the Biotech and Pharmaceutical Industries. The principal aim of the workshop was to find a way to progress the recommendations from ECVAM workshop 44 (ATLA 29, 125–134,2001) and ECVAM workshop 32 (ATLA 26, 763–777, 1998). The workshop represented the first unofficial meeting of the European Network of Research Tissue Banks (ENRTB) steering group. It is expected that in the period preceding the next workshop the ENRTB steering group will co-ordinate the ethical,legislative and organisational aspects of research tissue banking. Key issues dealt with by the Levi workshop included the practical aspects of sharing expertise and experiences across the different European members. Such collaboration between research tissue banks and end users of such material seeks to ultimately enable shared access to human tissue for medical and pharmaco-toxicological research while maintaining strict adherence to differences in legal and ethical aspects related to the use of human tissue in individual countries. This revised version was published online in July 2006 with corrections to the Cover Date.     

Pan-African sanctuary alliance: status and range of activities for great ape conservation

While wild populations continue to decrease, the number of orphaned primates, sanctuaries, and attempts to reintroduce primates back to the natural environment are increasing. An umbrella organization called the Pan-African Sanctuary Alliance (PASA) was formed in 2000 and recently the IUCN Reintroduction Specialist Group developed a set of specific policy guidelines for primates (2002). Data presented in this report are based upon questionnaire responses by managers from 17 African facilities that have become members of PASA (membership in PASA is defined by attendance at an annual PASA workshop). These PASA facilities house over 500 great apes. (There may be other facilities not represented here simply because their managers did not attend a PASA workshop.) The majority of the apes arrived at the sanctuaries when they were less than 4 years old and half were confiscated. Over 40% were found awaiting sale, and 30% had been previously kept as pets. Common ailments upon arrival included internal parasites, behavioral abnormalities, and malnutrition; 20% of the total sanctuary population died prematurely. Most sanctuaries use a combination of enclosures surrounded by electric fencing and cages to accommodate the apes. Sanctuaries actively participate in conservation education, habitat protection, tourism, scientific data collection, local development, and reintroduction. The median total facility operating cost was 65,000 US dollars per annum. The median facility cost per ape was 2,222 US dollars per annum. Most funding comes from overseas nongovernmental agencies. Discussion focuses on evaluating the present status of sanctuaries, the problems facing them, and their potential role in African conservation issues.     

Proteomics and Beyond: a report on the 3rd Annual Spring Workshop of the HUPO-PSI 21-23 April 2006, San Francisco, CA, USA

The theme of the third annual Spring workshop of the HUPO-PSI was "proteomics and beyond" and its underlying goal was to reach beyond the boundaries of the proteomics community to interact with groups working on the similar issues of developing interchange standards and minimal reporting requirements. Significant developments in many of the HUPO-PSI XML interchange formats, minimal reporting requirements and accompanying controlled vocabularies were reported, with many of these now feeding into the broader efforts of the Functional Genomics Experiment (FuGE) data model and Functional Genomics Ontology (FuGO) ontologies.     

The Generation of Six Clinical-Grade Human Embryonic Stem Cell Lines

The edict for producing clinically compliant human embryonic stem cells (hESCs) necessitates adherence to global ethical standards for egg procurement and embryo donation, conformity to regulations controlling clinical-grade cell and tissue product development, and compliance with current good tissue and manufacturing practices (cGTPs and cGMPs, respectively). For example, the U.S. FDA Center for Biologics Evaluation and Research recently promulgated regulations regarding human cells and cellular-based products (HCT/Ps) intended for tissue repair or replacement. Issued under Code of Federal Regulations parts 1270 and 1271 (Code of Federal Regulations, 2006a, 2006b), the rules are broadened by requirements for donor selection and cGMPs for HCT/Ps. By adhering to regulations and in anticipation of future standards, we have generated six clinical-grade hESC lines. Here we describe their manufacture, from embryo procurement to line characterization, including sterility and pathogen testing (Figure 1). To our knowledge, the lines represent the first to have been produced in compliance with international regulatory requirements, suitable for therapeutic use.     

Workshop summary. Biomedical and Space-Related Research with Heavy Ions at the BEVALAC

The authors provide an overview of papers presented at a workshop on Biomedical and Space-Related Research with Heavy Ions at the BEVALAC at Lawrence Berkeley Laboratory. Goals of the meeting were to determine the critical experiments using heavy ions as probes in radiation physics, radiation chemistry, macromolecular and cellular biology, evolution science, basic neurophysiology, and medical therapies; how beam lines and facilities at Lawrence Berkeley Laboratory can be improved for these experiments; and implications in priorities and funding for national policy. Workshop topics included physics and facilities, cellular and molecular biology, tissue radiobiology, and the future of heavy ion research.     

Proteomics for everyday use: activities of the HUPO Brain Proteome Project during the 5th HUPO World Congress

Long Beach hosted this year's annual congress of the Human Proteome Organisation (HUPO). In addition to the numerous sessions, talks and poster presentations organized by HUPO itself, several events were arranged by the HUPO initiatives. The Brain Proteome Project (HUPO BPP) was very active, initiating three pre-congress workshops: (i) the kick-off meeting of the EU-funded ProDaC consortium (Proteomics Data Collection) that is aiming at the bioinformatics Standardization in the proteomics field; (ii) the workshop "Standardization Issues in Proteomics: Perspectives from Vendors" giving an overview about the lessons learned by proteomics industrial partners; (iii) the 6th HUPO BPP Workshop "New Proteomics Approaches for further HUPO BPP Studies" offering new concepts for brain-related proteomics studies.     

Tissue allograft coding and traceability in USM Tissue Bank,Malaysia

In Malaysia, tissue banking activities began in Universiti Sains Malaysia (USM) Tissue Bank in early 1990s. Since then a few other bone banks have been set up in other government hospitals and institutions. However, these banks are not governed by the national authority. In addition there is no requirement set by the national regulatory authority on coding and traceability for donated human tissues for transplantation. Hence, USM Tissue Bank has taken the initiatives to adopt a system that enables the traceability of tissues between the donor, the processed tissue and the recipient based on other international standards for tissue banks. The traceability trail has been effective and the bank is certified compliance to the international standard ISO 9001:2008.     

Trends and weekly and seasonal cycles in the rate of errors in the clinical management of hospitalized patients

Studies on the rate of adverse events in hospitalized patients seldom examine temporal patterns. This study presents evidence of both weekly and annual cycles. The study is based on a large and diverse data set, with nearly 5 yrs of data from a voluntary staff-incident reporting system of a large public health care provider in rural southeastern Australia. The data of 63 health care facilities were included, ranging from large non-metropolitan hospitals to small community and aged health care facilities. Poisson regression incorporating an observation-driven autoregressive effect using the GLARMA framework was used to explain daily error counts with respect to long-term trend and weekly and annual effects, with procedural volume as an offset. The annual pattern was modeled using a first-order sinusoidal effect. The rate of errors reported demonstrated an increasing annual trend of 13.4% (95% confidence interval [CI] 10.6% to 16.3%); however, this trend was only significant for errors of minor or no harm to the patient. A strong "weekend effect" was observed. The incident rate ratio for the weekend versus weekdays was 2.74 (95% CI 2.55 to 2.93). The weekly pattern was consistent for incidents of all levels of severity, but it was more pronounced for less severe incidents. There was an annual cycle in the rate of incidents, the number of incidents peaking in October, on the 282 nd day of the year (spring in Australia), with an incident rate ratio 1.09 (95% CI 1.05 to 1.14) compared to the annual mean. There was no so-called "killing season" or "July effect," as the peak in incident rate was not related to the commencement of work by new medical school graduates. The major finding of this study is the rate of adverse events is greater on weekends and during spring. The annual pattern appears to be unrelated to the commencement of new graduates and potentially results from seasonal variation in the case mix of patients or the health of the medical workforce that alters health care performance. These mechanisms will need to be elucidated with further research.     

West Nile Virus workshop: scientific considerations for tissue donors

This report contains selected excerpts, presented as a summary, from a public workshop sponsored by the American Association of Tissue Banks (AATB) held to discuss West Nile Virus (WNV) and scientific considerations for tissue donors. The daylong workshop was held 9 July 2010 at the Ritz-Carlton Hotel at Tyson's Corner in McLean, Virginia, United States (U.S.). The workshop was designed to determine and discuss scientific information that is known, and what is not known, regarding WNV infection and transmission. The goal is to determine how to fill gaps in knowledge of WNV and tissue donation and transplantation by pursuing relevant scientific studies. This information should ultimately support decisions leading to appropriate tissue donor screening and testing considerations. Discussion topics were related to identifying these gaps and determining possible solutions. Workshop participants included subject-matter experts from the U.S. Food and Drug Administration, the Centers for Disease Control and Prevention, U.S. Department of Health and Human Services, Health Canada, the Public Health Agency of Canada, AATB-accredited tissue banks including reproductive tissue banks, accredited eye banks of the Eye Bank Association of America, testing laboratories, and infectious disease and organ transplantation professionals. After all presentations concluded, a panel addressed this question: "What are the scientific considerations for tissue donors and what research could be performed to address those considerations?" The slide presentations from the workshop are available at: http://www.aatb.org/2010-West-Nile-Virus-Workshop-Presentations.     

The challenge of including social and ethical aspects in the development of nanobiotechnology

Nanotechnology as an enabling technology for many future medical applications touches on issues such as sensitivity of genetic information, the gap between diagnosis and therapy, health care resources and tensions between holistic and functional medicine. On the other hand nanotechnology will add a new dimension to the bio (human) and non-bio (machine) interface such as brain chips or implants, which eventually might raise new ethical issues specific to NanoMedicine. This requires careful analysis of ethical aspect in view of existing standards and regulations by ethics committees at the European scale. At the same time new nanomedical inventions have to be evaluated for new ethical aspects by Ethical, Legal and Social Aspects — specialists. The most crucial point in this regard is an early proactive analysis of new technological developments to identify and discuss possible issues as soon as possible. This requires a close collaboration and co-learning of technology developers and ethics specialists assisted by communication experts to ensure open and efficient information of the public about ethical aspects (old or new) related to nanomedicine. This co-evolution will ensure a socially and ethically accepted development of innovative diagnostic and therapeutic tools in NanoMedicine.