Report of the clinical donor case workshop of the European Association of Tissue Banks annual meeting 2012

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 approaches taken to challenging situations regarding donor selection, it promotes consensus development in deciding tissue donor acceptability when donor health issues are not addressed in standards and regulations, and 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 Vienna in 2012. The cases presented dealt with problems encountered by tissue bank facilities concerning idiopathic thrombocytopenia and auto-immune disorders, hemodilution and blood sample identification, premalignant and malignant lesions, and Huntington’s disease. The discussions during the workshop demonstrate that the implications on the safety of tissue transplantation of various tissue donor illnesses, physical findings and behaviours, and the preventive measures taken by tissue facilities, may not always be agreed by tissue facility medical directors and other professionals. Moreover, they reveal that operating procedures, regulations and standards cannot comprehensively cover all tissue donor findings, medical histories and circumstances surrounding the cause of death. For many of the issues raised, there is a need for scientific research to provide a better evidence base for future deliberations about the suitability and eligibility of tissue allograft donors.     

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.     

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.     

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.     

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.     

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.     

医疗损害鉴定制度的改革与发展

医疗损害指因医疗机构及其医务人员的故意或过失（即医疗过错）,造成就医患者身体上或精神上的损害结果。医疗损害鉴定是指医疗机构及其医务人员在日常医疗行为中存在法定过错并造成患者人身损害而导致的医疗损害民事诉讼,人民法院针对医疗技术的高风险、高技术等问题对外委托的鉴定。其内容主要针对医疗行为整个过程的审查和分析,对照卫生行政法规、部门规章诊疗护理规范及常规,判定医师有无过错,医疗过错行为与损害结果之间是否存在因果关系,医疗过错行为在损害结果中的责任程度以及人体损伤残疾程度等方面。     

Selection and procurement of hearts for transplantation.

The success of orthotopic heart transplantation depends wholly on satisfactory function of the new heart on completion of the operation. This in turn depends on the quality of the donor heart before its removal, the effectiveness of the methods used to preserve it during transport from the donor to the recipient hospital, and the accuracy of the operative procedure. From January 1979 to December 1983, 62 donor hearts were transplanted into 61 recipients at Papworth Hospital. These hearts were selected from 250 offered for consideration. The most common reasons for not proceeding with an initial inquiry were failure of the donor to meet the medical criteria for selection (77 cases) and lack of intensive care facilities or staff shortages such that a transplant could not be accommodated at the time of inquiry (80). Eight early deaths occurred, of which three were due to primary failure of the donor heart. Actual one and three year survivals for the whole programme were 58% and 50% respectively, the current actual one year survival being 70%. Forty per cent of patients selected for transplantation died while waiting for a heart to become available. Their average survival time was 46 days. The number of donor hearts referred for transplantation depends on public attitudes towards organ transplantation, the willingness of doctors looking after brain dead patients to seek permission from relatives for the heart to be donated, and the cooperation of local kidney transplant surgeons. A larger number of suitable donor hearts to choose from would enable more patients to be treated, as transplant operations could be arranged so that existing facilities were used to their maximum capacity.     

Proteomics Data Collection - 2nd ProDaC Workshop 5 October 2007, Seoul, Korea

Proteomics Data Collection (ProDaC) is an EU-funded "Coordination Action" within the 6th framework programme. It aims to simplify the publication, dissemination and utilization of proteomics data by establishing standards that will support broad data collection from the research community. As a part of ProDaC, regular workshops are organized on a half-yearly basis to enable communication and discussion of the involved partners and to report on project progress. After the kick-off meeting (October 2006) in Long Beach, CA, USA and the 1st workshop in Lyon, France (April 2007), the 2nd ProDaC workshop took place at the COEX InterContinental Hotel in Seoul, Korea, on 5th October 2007, shortly before the HUPO World Congress. The progress achieved within the first year was presented by the leaders of the work packages. Additionally, a Journal's representative talked about his experiences and future plans concerning Proteomics standards; and two further external speakers presented their research related to data handling and Proteomics repositories.     

Regulatory aspects of tissue donation,banking and transplantation in India

Amendments to India’s Transplantation of Human Organs Act, 1994, have established the legality of tissue donation and transplantation from deceased donors and the conditions under which they are permitted. The amended Act, now known as The Transplantation of Human Organs and Tissues Act, 1994, seeks to prevent the commercialization of tissue donation and to guarantee the safety of indigenous allografts. Registration of tissue banks, compliance with national standards and the appointment of transplant co-ordinators in hospitals registered under the Act are now mandatory. A national registry and Regional and State networks for donation and transplantation of tissues have been introduced. Despite the amendments a few anomalies of the principal Act persist as some of the differences between tissue and organ donation and transplantation have been overlooked. These include the possibility of skin donation in locations other than hospitals; the donation of medical and surgical tissue residues which does not pose any risk to the living donor; the non-requirement for compatibility between donor and recipient; the delayed time factor between tissue donation and transplantation which makes identification of a recipient at the time of donation impossible; and the easy availability of alternatives to tissues which make waiting lists redundant for many tissues. Rules for the implementation of the amended Act were framed in 2014 but like the Act must be adopted by the State health assemblies to become universally applicable in the country.     

Required transition from research to clinical application: Report on the 4D treatment planning workshops 2014 and 2015

Since 2009, a 4D treatment planning workshop has taken place annually, gathering researchers working on the treatment of moving targets, mainly with scanned ion beams. Topics discussed during the workshops range from problems of time resolved imaging, the challenges of motion modelling, the implementation of 4D capabilities for treatment planning, up to different aspects related to 4D dosimetry and treatment verification.This report gives an overview on topics discussed at the 4D workshops in 2014 and 2015. It summarizes recent findings, developments and challenges in the field and discusses the relevant literature of the recent years. The report is structured in three parts pointing out developments in the context of understanding moving geometries, of treating moving targets and of 4D quality assurance (QA) and 4D dosimetry.The community represented at the 4D workshops agrees that research in the context of treating moving targets with scanned ion beams faces a crucial phase of clinical translation. In the coming years it will be important to define standards for motion monitoring, to establish 4D treatment planning guidelines and to develop 4D QA tools. These basic requirements for the clinical application of scanned ion beams to moving targets could e.g. be determined by a dedicated ESTRO task group.Besides reviewing recent research results and pointing out urgent needs when treating moving targets with scanned ion beams, the report also gives an outlook on the upcoming 4D workshop organized at the University Medical Center Groningen (UMCG) in the Netherlands at the end of 2016.     

Applying instructional design theories to bioinformatics education in microarray analysis and primer design workshops

The need to support bioinformatics training has been widely recognized by scientists, industry, and government institutions. However, the discussion of instructional methods for teaching bioinformatics is only beginning. Here we report on a systematic attempt to design two bioinformatics workshops for graduate biology students on the basis of Gagne's Conditions of Learning instructional design theory. This theory, although first published in the early 1970s, is still fundamental in instructional design and instructional technology. First, top-level as well as prerequisite learning objectives for a microarray analysis workshop and a primer design workshop were defined. Then a hierarchy of objectives for each workshop was created. Hands-on tutorials were designed to meet these objectives. Finally, events of learning proposed by Gagne's theory were incorporated into the hands-on tutorials. The resultant manuals were tested on a small number of trainees, revised, and applied in 1-day bioinformatics workshops. Based on this experience and on observations made during the workshops, we conclude that Gagne's Conditions of Learning instructional design theory provides a useful framework for developing bioinformatics training, but may not be optimal as a method for teaching it.     

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.     

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.     

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.     

细胞药物的标准及质量控制——细胞药物连载之四

细胞药物最终用于人体,必须建立相应的质量标准,进行质量控制。系统地贯彻到供者筛查、组织采集、细胞分离、培养、冻存、复苏、放行、运输、使用等全过程,确保产品的安全性、有效性和稳定性。近年来,我国逐渐改变了把细胞治疗作为第三类医疗技术管理的思路。一方面,已有第三类医疗技术取消行政审批;另一方面,又把除自体外的干细胞移植纳入药物管理,并建立了相应的质量标准和质量管理办法。     

负压封闭引流技术在腹部带蒂皮瓣供瓣区的应用

目的:探讨负压封闭引流(vaccumsealingdrainage,VSD)技术在腹部带蒂皮瓣供瓣区中的治疗作用。方法:10例上肢深度创面大小为9×6 cm-14×9 cm,创面清创后行腹部带蒂皮瓣移植,皮瓣面积10×7 cm-20×15 cm,供瓣区应用VSD覆盖,医用半透性贴膜封闭整个术区,连接中心负压,持续低负压吸引,每日外用1000 mL生理盐水持续冲洗VSD。约3周后行皮瓣断蒂术,供瓣区植皮。结果:10例皮瓣全部存活,1例患者术后当天引流区域出现疼痛,经止痛治疗后未再出现。1例患者术后2周出现VSD堵塞,经处理后恢复正常引流。无VSD装置更换病例。供瓣区周边皮肤无浸渍及感染现象,VSD撤除后见基底肉芽组织生长新鲜,创面均无感染,移植皮片存活。结论:VSD技术可以有效保护供瓣区,刺激肉芽生长,为后期皮片移植闭合创面提供了良好条件。VSD技术可安全有效的应用于腹部带蒂皮瓣供瓣区。     

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.